EUROPEAN COMMISSION - AgroParisTech

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EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

Directorate D – Food Safety: production and distribution chain D3 – Chemicals, contaminants and pesticides

SANCO D3/AS D(2005) File:SYNOPTIC DOCUMENT(2005.07.25)

“SYNOPTIC DOCUMENT”

PROVISIONAL LIST OF MONOMERS AND ADDITIVES NOTIFIED TO EUROPEAN COMMISSION AS SUBSTANCES WHICH MAY BE USED IN THE MANUFACTURE OF PLASTICS OR COATINGS INTENDED

TO COME INTO CONTACT WITH FOODSTUFFS (updated to June 2005)

- Please read carefully the Explanatory Note to avoid any misunderstanding. - This document may also be found at the following internet address:

http://europa.eu.int/comm/food/food/chemicalsafety/foodcontact/synoptic_doc_en.pdf

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NOTE FOR READER

1. Documents that explain the Community legislation on food contact materials and thus may help the reader with interpretation of the “Synoptic Document” can be found at http://europa.eu.int/comm/food/food/chemicalsafety/foodcontact/documents_en.htm.

2. The meaning of some abbreviations and words is explained in the document “List of the

abbreviations and explanations”. 3. If you notice mistakes, or you have suggestions, to improve this or the other documents

appearing on the website, e.g. addition of new sections and/or texts please send your suggestions to European Commission (for the attention of Ms. Annette Schaefer) (for address see document “EU and National Authorities”). The Commission may insert these proposals in an updated version of this document or in the “Practical Guide”.

http://europa.eu.int/comm/food/food/chemicalsafety/foodcontact/documents_en.htm

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TABLE OF CONTENTS

CONTENT PAGE

Note for reader 2

Table of contents 3

Warning 4

Explanatory Note 5

Appendix 1: General information or abbreviations of the main terms 7

Appendix 2: Definition of SCF lists 14

Appendix 3: Notes related to the column “Restrictions and/or Specifications 16

Table: Status of the substances 19

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WARNING

If you notice a mistake in the document, please inform as soon as possible Ms A. Schaefer by e-mail: [email protected] or by fax: +32.2.299.18.56. 1. Any information concerning the evaluation by the European Food Safety Authority (EFSA) and

the SCF should be addressed to EFSA/AFC Panel to Mr D. Spyropoulos (E-mail: [email protected]) (see “EU and National Authorities” document).

2. It is recommended to consult the website of EFSA in order to know the results of the last meetings,

held after the date of the update of the Synoptic document: http://www.efsa.eu.int/science/afc/afc_opinions/catindex_en.html.

3. An explanation of the columns is given in Appendix 1. The meaning of some numbers or asterisks,

which appear in the field “Restrictions and Specifications”, is explained in Appendix 3.

4. This document should be considered as a working document and not as a legal or binding document and therefore it may be subject to relevant updates, changes or modifications.

mailto:[email protected]

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EXPLANATORY NOTE

1. This document contains all the monomers and additives (see an explanation of the terms in the appendix 1 and 2) notified to the European Commission in view of their use in plastic materials intended to come into contact with foodstuffs. It summarises the Community situation and the evaluations of the listed substances carried out by a) the Scientific Committee on Food (SCF) until May 2003 and b) the AFC Panel on food additives, flavourings, processing aids and materials in contact with food of the European Food Safety Authority (EFSA), which replaced the SCF, until 27 April 2005. This document should not be considered the appropriate document to examine the legal situation of surface coatings even if a certain number of substances that are used only in surface coatings appear in this document. The document contains the monomers and additives listed in the inventory list of the Council of Europe Resolution AP (2004) on coatings intended to come into food contact. However, not all substances listed have been evaluated by the SCF or by EFSA.

2. In principle, this document does not contain aids to polymerisation, colorants, inks, adhesives

and solvents, although some may be listed. Moreover, it must be stressed that the substances appearing in this document shall not be considered, at this stage, as the only monomers and additives legally used at Community level because the process of harmonisation of the national lists is ongoing. To know whether or not a substance, which does not appear in the Community directives, is authorised in the Member States, it is necessary to examine national laws or to consult the national authorities, whose address can be found in the document “EU and National Authorities”.

In conclusion this document should be considered as a working document and not as a legal or binding document, and, therefore, it may be subject to relevant modifications (integration, deletion and changes).

3. The Commission services intend to include definitively in the future Community lists, if any, only the substances classified into lists 0-4 by SCF or EFSA. The date when the list of additives (see definition later) becomes a positive list will be fixed before 31 December 2007. The persons interested in a substance classified into SCF lists 6-9, are invited to submit as soon as possible and not later than 31 December 2006 the data requested by EFSA following the recommendations of “Note for Guidance”, included in the website. The authorisation procedure is described in the Framework Regulation (EC) No 1935/2004. For further information on the list of additives see "Practical Guide", Chapter I, Section 3 Paragraph 3.2.

4. At this stage, the Commission services are unable to specify whether the list will be extended

to aids to polymerisation ("substances which directly influence the formation of polymers"), colorants, solvents, inks and adhesives. Therefore any extrapolation of the list to these substances is premature. Moreover, the Commission services can only add a) that the discussion on the type of rules to be applied to these substances will start after the Community lists for monomers and additives for plastics and coatings are adopted and b) that they are unable to specify any date on this matter.

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5. In principle the Commission services intend to update this document when the relevant number of changes justifies an update (e.g. adoption of a Directive or EFSA opinion). In order to know the last evaluations of the substances, see also the website of EFSA: http://www.efsa.eu.int/science/afc/afc_opinions/catindex_en.html Any information concerning the EFSA evaluation should be addressed to EFSA AFC Panel, to Mr D. Spyropoulos (E-mail: [email protected]) (see “EU and National Authorities” document).

http://www.efsa.eu.int/science/afc/afc_opinions/catindex_en.html

mailto:[email protected]

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APPENDIX 1

GENERAL INFORMATIONS OR ABBREVIATIONS OF THE MAIN TERMS USED IN THIS DOCUMENT

Monomers and other starting substances “Monomer and other starting substance", means any substance used in the manufacture of a macromolecule, which constitutes the repeating unit of a polymer chain or polymer network of any substance used in the manufacture of a plastic for food contact application. It also includes substances used to modify existing natural or synthetic macromolecular substances. According to Directive 2002/72/EC, Annex 2, paragraph 1, the following substances are included in this definition:

"- substances undergoing polymerisation, which include polycondensation, polyaddition or any other similar process, to manufacture macromolecules;

- natural or synthetic macromolecular substances used in the manufacture of modified macromolecules, if the monomers or the other starting substances required to synthesise them are not included in the list;

- substances used to modify existing natural or synthetic macromolecular substances."

Although the definition and the examples seem very precise, some difficulties arise in the identification of "monomers and other starting substances" in practice. Therefore, it is recommended to read carefully the explanation given in Practical Guide, Chapter I, Section 3, paragraph 2.

Additives See also paragraph 3 of the explanatory note of this document.

The list set out in the Table shall contain all the other substances not included in the definition of monomers and other starting substances and not included in the definition of aids to polymerisation (see below).

Therefore this list shall include:

a) substances which are incorporated into plastics to achieve a technical effect in the finished product; they are intended to be present in the finished articles ("additive");

b) substances used to provide a suitable medium in which polymerisation occurs or substances which directly influence the formation of polymers (conventionally these substances will called "polymer production aids")

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Therefore this list will include for example the following categories of substances:

"Category I"

- antifoaming agents

- antiskinning agents

- antioxidants

- antistatic agents

- driers

- emulsifiers

- fillers

- flame retardants

- foaming agents

- hardening agents

- impact modifiers

- lubricants

- miscellaneous additives

- optical brighteners

- plasticizers

- preservatives

- protective colloids

- reinforcements

- release agents

- solvents (see paragraph 2 of the Explanatory Note)

- stabilizers

- thickeners

- UV absorbers

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"Category II"

Polymer production aids - anti-foam reagents/de-gassing agents

- blowing agents

- buffering agents

- build-up suppressants

- dispersing aids

- emulsifiers

- flow control agents

- nucleating agents

- pH regulators

- solvents (see paragraph 2 of the Explanatory Note)

- surfactants

- suspension agents

- stabilisers

- thickening agents

- water treatment reagents

"Category III"

Aids to polymerisation They are "Substances which directly influence the formation of polymers" - accelerators

- catalysts

- catalyst de-activators

- catalyst supports

- catalyst modifiers

- chain scission reagents

- chain transfer or extending agents

- chain stop reagents

- cross-linking agents

- initiators and promoters

- molecular weight regulators

- polymerization inhibitors

- redox agents

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EXPLANATION OF THE COLUMNS

A short explanation of the fields and of some abbreviations is given below. Column 1 ("REF_N") This contains the substance reference numbers. Conventionally the following numbers have been assigned:

Monomers: 10000-29999

Additives: >30000

A substance listed as a monomer as well as an additive will be assigned two different REF.N. In some cases, a cross-reference of the REF.N. is inserted in order to find a substance having a synonym, commonly used. Column 2 ("CAS_N") This contains the CAS (Chemical Abstracts Service) registry number, if any. If the substance is a mixture of substances, the CAS number refers to the mixture. Where an indent has been placed in the column, it means that a research for CAS N. has been made, but that the result was negative. If the result of the search was found to be doubtful or that the research has not yet been made, a question mark appears in the column. Where there is inconsistency between the CAS number and the chemical name, the chemical name shall take precedence over the CAS number. If there is inconsistency between the CAS number reported in EINECS and the one in the CAS-Register, the CAS-number in the CAS-Register shall apply. Column 3 ("NAME") This contains the chemical name attributed by the Commission services. In some cases, a cross-reference of the REF.N. is inserted in order to find a substance having a synonym, commonly used (see Column 4) Column 4 ("SYNONIM") This contains the REF.N. of a substance being a synonym, commonly used. Column 5 ("DIR") This indicates that a) the substance is included in the Commission Directive 2002/72/EC, relating to plastic materials and articles intended to come into contact with foodstuffs (as amended by Directive 2004/1/EC and Directive 2004/19/EC); b) the substance is proposed to be inserted in the next amendment to Directive 2002/72/EC (usually referred as 3rd amendment) or c) the substance was mentioned in previous directives but it was later deleted for a particular reason. There are several reasons why a substance is deleted. For example:

� The substance appears under another more appropriate name � The substance is no longer requested by the petitioner � The individual substance can be covered under a generic name � The generic name has been deleted because the substances have been introduced individually � Deleted because considered as “basic polymer”. Basic polymers mean any polymeric substance, such as

plastic or polymer, which is capable of functioning as the main structural component of finished materials and articles. They are not listed if their monomers are listed and they comply with Article 2 of Framework Directive.

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The following abbreviations appear in this column: DIR = a) Substance included in the Directive 2002/72/EC of 6 of August 2002 (as last amended) 3AM = b) Substance proposed to be inserted in the 3rd amendment of the Directive 2002/72/EC D = c) Substance previously mentioned in former directives but later deleted for a particular reason Only the monomers and additives which are mentioned in the other document "EU SUBSTANCES" (document available on the website) are considered substances approved at EU level. The other appearing in the table below are substances which likely have been approved at national level but which will not be included in the EU lists if the data requested by EFSA is not supplied on time (see also paragraph 3 of the explanatory note of this document) Column 6 ("RESTRICTIONS AND SPECIFICATIONS") This column contains the restrictions and/or specifications for the use of the substance as they appear in the Directive 2002/72/EC and amendments. See also Appendix 2 (definition of the SCF lists) and Appendix 3 (notes related to the column “restrictions and/or specifications”). It may include:

� specific migration limit (SML), � maximum permitted quantity of the substance in the finished material or article (QM), � maximum permitted quantity of the substance in the finished material or article expressed as

mg per 6 dm2 of the surface in contact with foodstuffs (QMA), � other restriction specifically mentioned, � specifications related to the substance or to the polymer.

For some of the substances the Specific migration limits (SML) are specified. SML are obtained by the Commission Services using the following conversions: 1) For substances with an ADI/TDI established - by multiplying the ADI/TDI values by a factor of 60. This factor is derived from the convention that a person of 60 kg daily could ingest up to 1 kg of foodstuffs in contact with a plastic article always containing the considered substance at a concentration corresponding to the SML; 2) For substances where an ADI/TDI is not established – For these cases, restrictions can be mentioned, frequently derived from reduced toxicity dossiers, leading directly to fixed migration limits e.g. R=0.05 or R=5mg/kg food or food simulant. For these substances the SML generally corresponds to the restriction (=R) which appears in the toxicological SCF/EFSA assessment. Sometimes the QMA is mentioned. The relationship between the two restrictions SML and QMA is QMA = SML*kg/6dm2. The value is derived from the SML by assuming a) that the substance migrates completely (% of migration) and b) S/V report equal 6 dm²/1 liter. For substances where the specific migration limits or other restrictions, are not indicated, the overall migration limit of 60 mg/kg or 10 mg/dm2, according to the case, is applied. For other abbreviations see explanation for column 8

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Table: Relation between the SCF List, restriction and SML SCF List RESTRICTION

L0 In principle, no restriction L1 SML = ADI x 60 L2 SML = TDI x 60 L3 SML = Restriction (=R) proposed by SCF/EFSA L4 SML = not detectable, detection limit: 10 ppb or 20 ppb (when

analytical tolerance is included) L5 Not authorised

L6A Not authorised L6B Not authorised

Restriction (=R) proposed by SCF/EFSA may be indicated L7 Not established – data needed L8 Not established – data needed L9 Not established – data needed

Note: Only substances classified in L0-L4 appear in the Directives. Column 7 ("SCF_List") This contains the number of the list in which the substance is classified by the EFSA, SCF or by SCF-WG “FCM”. The meanings of the number or other abbreviations, which appear in this column, are described in Appendix 2. When letter “P” appears, this means “Postponed”. If a substance was already evaluated in the past, P clarifies that the previous classification is not longer valable pending the examination of the new data submitted to the SCF/EFSA and a re-evaluation of the substance. Column 8 ("EFSA/SCF OP") This contains the opinion of the SCF or EFSA updated to 27 April 2005. As from September 2002, the SCF changed the format of the opinions. A more extensive and detailed text summarises the historical background of the substances as well as the assessment given by the SCF. Therefore, it has been decided to link the substance directly with the SCF opinion published on Internet and no longer to repeat all the content of the SCF evaluation. For EFSA opinions the proposed restrictions and the remarks for the Commission are indicated and the link for the opinion published on the Internet is also provided. When the substance was re-evaluated by EFSA, only the EFSA opinion is indicated. The link for the previous SCF opinion is in some cases mentioned in the background of the opinion for information. Other abbreviations which may appear in this Column: Ac Substances which is requested to be used only in coatings ADI Acceptable Daily Intake DET Detectable DL Limit of detection FS Food simulants NCO Isocyanate moiety NS Not specified QM Maximum permitted quantity of the "residual" substance in the material or article.

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QMA maximum permitted quantity of the substance in the finished material or article expressed as mg per 6 dm² of the surface in contact with foodstuffs (QMA). The value is derived from the SML by assuming a) that the substance migrates completely (100 % of migration) and b) S/V report equal 6 dm²/1 liter.

QM (T) Maximum permitted quantity of the "residual" substance in the material or article expressed as total of moiety/ substance(s) indicated.

SML Specific migration limit in foods or in food stimulant. SML (T) Specific migration limit in foods or in food simulant expressed as total of

moiety/substance(s) indicated. The number between brackets which appears after the restriction refers to the Notes appearing in Annex VI of Directive 2002/72/EC.

TDI Tolerable Daily Intake (this is a concept equivalent to the ADI, but applicable only to the packaging sector and not to food additives).

Column 9 ("PL") The sign + means that the substance was requested for plastics. Column 10 ("CT") The sign + means that the substance is listed in the inventory list of the Council of Europe Resolution AP (2004) on coatings intended to come into food contact. Other abbreviations which may appear in the Document: W when it appears in column "SCF_L", it refers to a "new substance". If it is alone, it means

that the substance is not yet evaluated. If it is followed by a number, this number indicates the SCF-L."

? Means that there is a doubt on the information given. FP Finished product (= material or article in finished state)

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APPENDIX 2

DEFINITION OF THE SCF LISTS

Substances for which the Committee was able to express an opinion

List 0 Substances, e.g. foods, which may be used in the production of plastic materials and articles, e.g. food ingredients and certain substances known from the intermediate metabolism in man and for which an ADI need not be established for this purpose.

List 1 Substances, e.g. food additives, for which an ADI (=Acceptable Daily Intake), a t-ADI (=temporary ADI), a MTDI (=Maximum Tolerable Daily Intake), a PMTDI (=Provisional Maximum Tolerable Daily Intake), a PTWI (=Provisional Tolerable Weekly Intake) or the classification "acceptable" has been established by this Committee or by JECFA.

List 2 Substances for which a TDI or a t-TDI has been established by this Committee.

List 3 Substances for which an ADI or a TDI could not be established, but where the present use could be accepted.

Some of these substances are self-limiting because of their organoleptic properties or are volatile and therefore unlikely to be present in the finished product. For other substances with very low migration, a TDI has not been set, but the maximum level to be used in any packaging material or a specific limit of migration is stated. This is because the available toxicological data would give a TDI which allows that a specific limit of migration or a composition limit could be fixed at levels very much higher than the maximum likely intakes arising from present uses of the additive.

LIST 4 (for monomers)

Section 4A Substances for which an ADI or TDI could not be established, but which could be used if the substance migrating into foods or in food simulants is not detectable by an agreed sensitive method.

Section 4B Substances for which an ADI or TDI could not be established, but which could be used if the levels of monomer residues in materials and articles intended to come into contact with foodstuffs are reduced as much as possible.

LIST 4 (for additives)

Substances for which an ADI or TDI could not be established, but which could be used if the substance migrating into foods or in food simulants is not detectable by an agreed sensitive method.

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List 5 Substances which should not be used.

List 6 Substances for which there exist suspicions about their toxicity and for which data is lacking or is insufficient.

The allocation of substances to this list is mainly based upon similarity of structure with that of chemical substances already evaluated or known to have functional groups that indicate carcinogenic or other severe toxic properties.

Section 6A: Substances suspected to have carcinogenic properties. These substances should not be detectable in foods or in food simulants by an appropriate sensitive method for each substance.

Section 6B: Substances suspected to have toxic properties (other than carcinogenic). Restrictions may be indicated.

List 7 Substances for which some toxicological data exist, but for which an ADI or a TDI could not be established. The required additional information should be furnished.

List 8 Substances for which no or only scanty and inadequate data was available.

List 9 Substances and groups of substances which could not be evaluated due to lack of specifications (substances) or to lack of adequate description (groups of substances).

Groups of substances should be replaced, where possible, by individual substances actually in use. Polymers for which the data on identity specified in "SCF Guidelines" are not available.

List W "Waiting list". Substances not yet included in the Community lists, as they should be considered "new" substances, i.e. substances never approved at national level. These substances cannot be included in the Community lists, lacking the data requested by the Committee.

In the substances used only for coatings this letter means that the substance is listed in the inventory list of the Council of Europe Resolution AP (2004) on coatings intended to come into food contact and are not evaluated by the SCF or EFSA.

List W7 Substances for which some toxicological data exists, but for which an ADI or a TDI could not be established. The required additional information should be furnished.

List W8 Substances for which no or only scanty and inadequate data was available.

List W9 Substances and groups of substances which could not be evaluated due to lack of specifications (substances) or to lack of an adequate description (groups of substances).

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APPENDIX 3

NOTES RELATED TO THE COLUMN “RESTRICTIONS AND/OR SPECIFICATIONS

(1) Warning: there is a risk that the SML could be exceeded in fatty food simulants.

(2) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as reference Nos: 10060 and 23920.

(3) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as reference Nos: 15760, 16990, 47680, 53650 and 89440.

(4) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as reference Nos: 19540, 19960 and 64800.

(5) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as reference Nos: 14200, 14230 and 41840.

(6) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as reference Nos: 66560 and 66580.

(7) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as reference Nos: 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030.

(8) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as reference Nos: 38000, 42400, 64320, 67896, 73040, 85760, 85840, 85920 and 95725.

(9) Warning: there is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the finished product does not comply with the second indent of Article 2 of Directive 89/109/EEC.

(10) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as reference Nos: 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120.

(11) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels (expressed as Iodine) of the following substances mentioned as reference Nos: 45200, 64320, 81680 and 86800.

(12) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as reference Nos: 36720, 36800, 36840 and 92000.

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(13) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as reference Nos: 39090 and 39120.


(15) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as reference Nos: 15970, 48640, 48720, 48880, 61280, 61360 and 61600.

(16) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as reference Nos: 49600, 67520 and 83599.

(17) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as reference Nos: 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120.









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(26) QM(T) in this specific case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances mentioned as reference Nos: 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332, 22420, 22570, 25210, 25240 and 25270.

(27) QMA(T) in this specific case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances mentioned as reference Nos: 10599/90A, 10599/91, 10599/92A and 10599/93.



(30) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as reference Nos: 86480, 86960 and 87120

(31) Compliance testing when there is a fat contact should be performed using saturated fatty food simulants as simulant D.

(32) Compliance testing when there is a fat contact should be performed using isoctane as substitute of simulant D (unstable).

(33) QMA(T) in this specific case means that the restriction shall not be exceeded by the sum of the residual quantities of the following substances mentioned as reference Nos: 14800 and 45600.

(34) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as reference Nos: 55200, 55280 and 55360.’

REF_N CAS_N NAME SYNONIM DIR RESTRICTIONS

AND SPECIFICATIONS

SCF List EFSA/SCF_OP PL CT

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10030 000514-10-3 Abietic acid DIR 2 Group TDI: 1 mg/kg b.w. 90-day and 2-year oral rat studies. (Ind Bio Test, 1962). (SCF, 17th Report, 1986).

+ +

10060 000075-07-0 Acetaldehyde DIR SML(T) = 6 mg/kg (2) 2 Group TDI = 0.1 mg/kg b.w. (calculated as acetaldehyde (including 10060 and 23920) Toxicity profiles similar to methaldehyde. A 2-year oral rat study and a 3-generation oral rat study including teratogenicity with methamethaldehide. The reports on nasal carcinogenicity after inhalation were considered without relevance for effects from oral intake of smaller doses. (adopted at 113rd SCF meeting)(17-18 September 1998) http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html

+ +

10090 000064-19-7 Acetic acid Same 30000 DIR 1 Group ADI: not specified. (SCF, 25th Series, 1990).

+ +

10120 000108-05-4 Acetic acid, vinyl ester DIR SML = 12 mg/kg 2 TDI: 0.2 mg/kg b.w. 90-day oral studies and metabolism studies in mice and rats, teratogenicity studies in rats and several mutagenicity studies negative. (Hazleton: 2146-51/4 January 1980; 2511-51/11-14 and 2195-51/6 & 7).

+ +

10150 000108-24-7 Acetic anhydride Same 30280 DIR 2 Group TDI: included in the ADI not specified for acetic acid. (SCF, 25th Series, 1990).

+

10155 000542-02-9 Acetoguanamine Same 15280 D 8 +

10160 002206-94-2 alpha-Acetoxystyrene D 6A +

10162 010521-96-7 beta-Acetoxystyrene D 6A +

10180 000556-08-1 p-(Acetylamino)benzoic acid

D 8 SCF_List 8 Needed data or information: Data according to the new SCF-Guidelines. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out

+

http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html


http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf


AND SPECIFICATIONS


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181_en.pdf

10210 000074-86-2 Acetylene DIR 3 Residues of this gas in plastics are very small. The gas has low toxic potential. Migration into food will be toxicologically negligible. (NIOSH, Criteria for a recommended standard, HEW Publ. n. 76-195).

+

10240 - Acids, aliphatic, dicarboxylic, esters with alcohols, aliphatic, monohydric

D 9 +

10270 - Acids, aliphatic, dicarboxylic (C3-C12), esters with alcohols, unsaturated (C3-C18)

D 9 +

10300 - Acids, aliphatic, dicarboxylic, saturated (C4-C18)

D 9 +

10330 - Acids, aliphatic, dicarboxylic, unsaturated (C4-C12)

D 9 +

10360 - Acids, aliphatic, dicarboxylic, unsaturated, esters with polyethyleneglycol

D 9 +

10390 - Acids, aliphatic, dicarboxylic, unsaturated, esters with polypropyleneglycol

D 9 +

10420 - Acids, aliphatic, mono- and dicarboxylic (C2-C20), vinyl esters

D 9 +

10450 - Acids, aliphatic, monocarboxylic (C3-C12), esters with alcohols, unsaturated (C3-C18)

D 9 +

10480 - Acids, aliphatic, monocarboxylic,

D 9 +



AND SPECIFICATIONS


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saturated (C2-C24)

10510 - Acids, aliphatic, monocarboxylic, unsaturated (C3-C24)

D 9 +

10540 - Acids, aliphatic, monocarboxylic, unsaturated (C3-C8), esters with alcohols, aliphatic, monohydric, saturated (C2-C12)

D 9 +

10570 - Acids, aliphatic, monocarboxylic, unsaturated, esters with polypropyleneglycol

D 9 +

10599/65 068955-98-6 Acids, fatty, saturated (C16-C18) and unsaturated (C18)

W +

10599/70 ? Acids, fatty, unsaturated(C18)

D 9 +

10599/90 061788-89-4 Acids, fatty, unsaturated(C18), dimers

Same 10599/90A

and 10599/91

D D +

10599/90A 061788-89-4 Acids, fatty, unsaturated (C18), dimers, distilled

Same 10599/90

and 10599/91

DIR QMA(T) = 0.05 mg/6 dm² (27)

3 L3. http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf Group restriction: 0.05 mg/kg of food (for 10599/90A-10599/91-10599/92A and 10599/93). Remark for Commission: only a method for residual content is available. A QMA-limit is applicable. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/outcome_en.html opinions(SCF/CS/PM/GEN/M89)

+ +

10599/91 061788-89-4 Acids, fatty, unsaturated (C18), dimers, non

Same 10599/90

DIR QMA(T) = 0.05 mg/6 dm² (27)

3 Same references as 10599/90A. http://europa.eu.int/comm/food/fs/sc/scf/out

+ +



http://europa.eu.int/comm/food/fs/sc/scf/outcome_en.html

http://europa.eu.int/comm/food/fs/sc/scf/outcome_en.html



AND SPECIFICATIONS


22

distilled and 10599/90A

140_en.pdf

10599/92 068783-41-5 Acids, fatty, unsaturated(C18), dimers, hydrogenated

Same 10599/92A, 10599/93 and 17190

D D +

10599/92A 068783-41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, distilled

Same 10599/92, 10599/93 and 17190

DIR QMA(T) = 0.05 mg/6 dm² (27)

3 Same references as 10599/90A. http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf

+ +

10599/93 068783-41-5 Acids, fatty, unsaturated (C18), dimers, hydrogenated, non distilled

Same 10599/92,10599/92A,171

90

DIR QMA(T) = 0.05 mg/6 dm² (27)

3 Same references as 10599/90A. http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf

+ +

10600 - Acids, linear, with an even number of carbon atoms (C8-C22), and the dimers and trimers of the unsaturated acids

D D +

10630 000079-06-1 Acrylamide DIR SML = ND (DL = 0.01 mg/kg)

4A Neurotoxic for all 6 animal species tested. Teratogenic in rats. Genotoxic in several short term tests and carcinogenic in rats. (RIVM doc. March 1991).

+ +

10660 015214-89-8 2-Acrylamido-2-methylpropanesulphonic acid

DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Available: Migration data and mutagenicity tests. Considered non-genotoxic based on the available studies (CS/PM/2083).

+ +

10690 000079-10-7 Acrylic acid DIR 2 Group t-TDI: 0.1 mg/kg b.w. pending results of ongoing teratogenicity studies on acrylic acid. Available: a 90-day oral rat study, an oral reproduction study, 2- year oral rat and dog studies with acrylic acid and an oral teratogenicity study in rats with ethyl acrylate, 3-year oral rat and dog studies with acrylic acid, ethylene glycol monoester. (NTP; Union Carbide report N. 43-529 (26 August 1980) and N. 43-528 (22 August 1980); RIVM report 65116008 (June 1984); report Dow, 1967 and 1967; RIVM report

+ +









AND SPECIFICATIONS


23

06-02-1990). http://europa.eu.int/comm/food/fs/sc/scf/reports/scf_reports_30.pdf

10720 000999-55-3 Acrylic acid, allyl ester D 6A + +

10750 002495-35-4 Acrylic acid, benzyl ester DIR 2 Group TDI: 0.1 mg/kg bw (as acrylic acid). Hydrolysis (complete) data allow to allocate the same TDI as acrylic acid.

+ +

10775 084100-23-2 Acrylic acid, 4-tert-butylcyclohexyl ester

D 8 +

10780 000141-32-2 Acrylic acid, n-butyl ester

DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylic acid). See references for acrylic acid.

+ +

10810 002998-08-5 Acrylic acid, sec-butyl ester


+ +

10840 001663-39-4 Acrylic acid, tert-butyl ester


+ +

10870 002206-89-5 Acrylic acid, 2-chloroethyl ester

D 8 +

10900 - Acrylic acid, cyclohexylaminoethyl ester

D 8 +

10930 003066-71-5 Acrylic acid, cyclohexyl ester

D 8 Available: hydrolysis data, but hydrolysis is not complete.

+ +

10960 016868-13-6 Acrylic acid, cyclopentyl ester

D 8 +

10990 002156-96-9 Acrylic acid, decyl ester D 7 Needed: hydrolysis data. + +

11000 050976-02-8 Acrylic acid, dicyclopentadienyl ester

DIR QMA = 0.05 mg/6 dm² 3 R = 0.05 mg/kg of food. Available: Migration by worst case calculation < 50 ppb, 3 mutagenicity tests negative. (RIVM/TNO/ISS SDS CS/PM/2743, January 1996).

+

11005 012542-30-2 Acrylic acid, dicyclopentenyl ester

D 3AM

3 R = 0.05 mg/kg of food. +

11010 024447-78-7 Acrylic acid, diester with 2,2-bis(4-hydroxy phenyl)propane bis(2-

D 8 +

http://europa.eu.int/comm/food/fs/sc/scf/reports/scf_reports_30.pdf



AND SPECIFICATIONS


24

hydroxyethyl) ether

11020 019485-03-1 Acrylic acid, diester with 1,3-butanediol

D 8 +

11050 001070-70-8 Acrylic acid, diester with 1,4-butanediol

D 8 + +

11080 004074-88-8 Acrylic acid, diester with diethyleneglycol

D 8 + +

11090 002223-82-7 Acrylic acid, diester with 2,2-dimethyl-1,3-propanediol

8 +

11110 002274-11-5 Acrylic acid, diester with ethyleneglycol

D 8 + +

11140 013048-33-4 Acrylic acid, diester with 1,6-hexanediol

D 8 + +

11170 026570-48-9 Acrylic acid, diester with polyethyleneglycol

D 8 + +

11180 017831-71-9 Acrylic acid, diester with tetraethyleneglycol

D 8 + +

11190 001680-21-3 Acrylic acid, diester with triethyleneglycol

8 +

11195 068901-05-3 and 042978-66-5

Acrylic acid, diester with tripropyleneglycol

D 8 +

11200 002426-54-2 Acrylic acid, 2-(diethylamino)ethyl ester

D 8 +

11230 002439-35-2 Acrylic acid, 2-(dimethylamino)ethyl ester

D 7 Needed: hydrolysis data. + +

11245 002156-97-0 Acrylic acid, dodecyl ester

DIR SML = 0.05 mg/kg (1) 3 R = 0.05 mg/kg of food. Available: Migration data, 3 (negative) mutagenicity studies. (ISS/TNO SDS, March 1997 = CS/PM/2996/11245). Remark: Since high migration into fat has been demonstrated the WG recommends that the Commission take the necessary measures so that the restriction proposed is not exceeded.

+ +


AND SPECIFICATIONS


25

11260 000106-90-1 Acrylic acid, 2,3-epoxypropyl ester

Same 16116 D 6A + +

11290 - Acrylic acid, esters with alcohols, aliphatic,monohydric, saturated (C1-C21)

D 9 +

11320 - Acrylic acid, esters with alcohols, aliphatic, monohydric, unsaturated (C4-C18)

D 9 +

11350 - Acrylic acid, esters with alcohols, aliphatic, polyhydric (C2-C21)

D 9 +

11380 - Acrylic acid, esters with etheralcohols

D 9 +

11390 - Acrylic acid, esters with etheralcohols, aliphatic, monohydric, saturated (C1-C21)

D +

11410 - Acrylic acid, esters with glycolethers obtained from mono- and/or diglycols with alcohols, aliphatic, monohydric (C1-C18)

D 9 +

11425 ? Acrylic acid, ester with methoxydiethylene- glycol

8 +

11440 044992-01-0 Acrylic acid, ester with trimethylethanolammonium chloride

D 8 + +

11470 000140-88-5 Acrylic acid, ethyl ester DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylic acid). See references for acrylic acid.

+ +

11500 000103-11-7 Acrylic acid, 2-ethylhexyl ester

DIR 3 Restriction: 0.05 mg/kg of food http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdf

+ +

http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf





AND SPECIFICATIONS


26

11505 013402-02-3 Acrylic acid, hexadecyl ester

W +

11510 000818-61-1 Acrylic acid, hydroxyethyl ester

Same 11830 DIR See "Acrylic acid, monoester with ethyleneglycol"

+ +

11520 002918-23-2 Acrylic acid, 2-hydroxyisopropyl ester (= acrylic acid, 2-hydroxy-1-methylethyl ester)

D 7 Needed: hydrolysis data. +

11530 000999-61-1 Acrylic acid, 2-hydroxypropyl ester

DIR QMA = 0.05 mg/6 dm² for the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisoprpyl ester and in compliance with the specifications laid down in Annex V.

3 R = 0.05 mg/kg of food (for the mixture). Based on the reduced core set of toxicological data according to the migration level, see Appendix 2 Available: calculation of worst case migration is < 0.05 mg/kg of food; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (positive); gene mutation assay in cultured mammalian cells (negative); micronucleus assay (negative). RIVM/ISS/TNO SDS, July 2000 = CS/PM/3117 REV. I/11530. Remark for Commission: - Only a residual Q method is available. A QMA of 50 ug/6 dm2 is proposed. (Adopted at the 126th SCF meeting, 28 February 2001) http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdf

+ +

11532 002761-08-2 Acrylic acid, 3-hydroxypropyl ester

D 8 +

11560 005888-33-5 Acrylic acid, isobornyl ester

D 8 +

11590 000106-63-8 Acrylic acid, isobutyl ester


+ +




AND SPECIFICATIONS


27

11620 001330-61-6 Acrylic acid, isodecyl ester

D 8 + +

11650 029590-42-9 Acrylic acid, isooctyl ester

D 8 + +

11680 000689-12-3 Acrylic acid, isopropyl ester


+ +

11695 003121-61-7 Acrylic acid, 2-methoxyethyl ester

D 6B + +

11710 000096-33-3 Acrylic acid, methyl ester


+ +

11740 010095-13-3 Acrylic acid, monoester with 1,3-butanediol


11770 002478-10-6 Acrylic acid, monoester with 1,4-butanediol

D 8 + +

11800 013533-05-6 Acrylic acid, monoester with diethyleneglycol


11830 000818-61-1 Acrylic acid, monoester with ethyleneglycol

Same 11510 DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylic acid). See references for acrylic acid.

+ +

11860 - Acrylic acid, monoester with propyleneglycol

D 9 +

11875 004813-57-4 Acrylic acid, octadecyl ester


11890 002499-59-4 Acrylic acid, n-octyl ester

DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylic acid). Hydrolysis (complete) data allow to allocate the same TDI as acrylic acid.

+ +

11920 005048-82-8 Acrylic acid, phenylaminoethyl ester

D 8 +

11950 000937-41-7 Acrylic acid, phenyl ester


11980 000925-60-0 Acrylic acid, propyl ester DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as acrylic acid). See references for acrylic acid.

+ +

12010 040074-09-7 Acrylic acid, 2-sulphoethyl ester

D 8 +

12040 039121-78-3 Acrylic acid, D 8 +


AND SPECIFICATIONS


28

sulphopropyl ester

12055 094160-26-6 Acrylic acid, triester with glycerol tris(2-hydroxypropyl) ether

D 8 +

12062 075577-70-7 Acrylic acid, triester with 1,1,1- trimethylolpropane tris(2-hydroxyethyl) ether

D 8 + +

12070 002177-18-6 Acrylic acid, vinyl ester D 7 Needed: hydrolysis data. + +

12100 000107-13-1 Acrylonitrile DIR SML = ND (DL =0.020 mg/kg, analytical tolerance included)

4A (SCF, 13th Series, 1982). + +

12130 000124-04-9 Adipic acid Same 31730 DIR 1 ADI: 5 mg/kg b.w. (SCF, 25th Series, 1990).

+ +

12160 002998-04-1 Adipic acid, diallyl ester Same 32200 D 6A +

12190 000105-97-5 Adipic acid, di-n-decyl ester

Same 32320 D 8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.050 mg/kg, peroxisome proliferation study, too.

+

12220 027178-16-1 Adipic acid, diisodecyl ester

Same 32560 D 9 Group R: 0.05 mg/kg b.w. Needed: in first instance specifications and then on the specified substances toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.050 mg/kg, peroxisome proliferation studies too.

+

12250 000123-79-5 Adipic acid, di-n-octyl ester

Same 32880 D 8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCFguidelines) and, if migration exceeds 0.050 mg/kg, peroxisome proliferation study too.

+ +

12265 004074-90-2 Adipic acid, divinyl ester DIR QM = 5 mg/kg in FP. For use only as co-monomer.

3 R = 0.5% (w/w) as co-monomer. Hydrolysis data, inadequate. However residue level very low. (TNO SDS 1995-01-06).

+

12280 002035-75-8 Adipic anhydride DIR 2 Group TDI: 5 mg/kg b.w. + +


AND SPECIFICATIONS


29

Included in group ADI for adipic acid.

12310 - Albumin DIR 0 +

12340 - Albumin, coagulated by formaldehyde

DIR 3 Though albumin is a food component, it has been modified by formaldehyde which is classified in list 3 in 17th Series, SCF, 1986.

+

12370 - Alcohols, aliphatic, monohydric, saturated, primary, secondary or tertiary (C4-C22)

D 7 Needed: actual use, 28-day oral study of one lower and one higher alcohol.

+

12375 - Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)

DIR 3 90-day oral studies, metabolic and/or mutagenicity studies with some substances out of the group.

+ +

12400 - Alcohols, aliphatic, monohydric, unsaturated (up to C18)

D 9 +

12430 - Alcohols, aliphatic, polyhydric (up to C18)

D 9 +

12460 - Alcohols, cycloaliphatic, mono- and/or polyhydric, substituted (up to C18)

D 9 +

12490 - Aldehydes (C4) D 9 +

12520 - Alkadienes D 9 +

12550 - n-Alkenes (up to C16) D 9 + +

12573 068609-97-2 Alkyl(C12-C14)-2,3-epoxypropyl ethers

D +

12576 - Alkylphenols See also 12578

9 +

12578 - Alkyl(C1-C4)phenols (consisting of a mixture of mono, di, tri and tetra alkyl substituted phenols and up to 2% phenol)

5 Substance which should not be used. Available: inadequate migration data, acute toxicity data on several components of mixture. Evaluation is not possible from the data provided. Sources for the mixture mentioned do not exclude presence of toxic components. Quantitative ranges are lacking for many substances. (RIVM/TNO SDS, February 1997 =

+


AND SPECIFICATIONS


30

CS/PM/2993/12578).

12580 - p-Alkyl(C4-C9)phenols D 9 +

12610 000107-18-6 Allyl alcohol D 6A +

12640 000106-92-3 Allyl 2,3-epoxypropyl ether

D 6A +

12650 - Allyl ethers of mono-, di-, or trimethylolphenol

9 +

12670 002855-13-2 1-Amino-3-aminomethyl-3,5,5-trimethylcyclohexane

Same 19145 DIR SML = 6 mg/kg 2 t-TDI: 0.1 mg/kg b.w. Available: 13-week oral rat study, 2 negative mutagenicity studies. (RIVM summary data, April 1991)(CS/PM/921). Needed: in-vitro chromosome aberration and gene mutation in mammalian cells.

+ +

12700 000150-13-0 4-Aminobenzoic acid D 8 SCF_List 8 Needed data or information: Data according to the new SCF-Guidelines. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf

+

12730 000060-32-2 6-Aminocaproic acid D 8 +

12760 - omega-Aminocarboxylic acids, aliphatic, linear (C6-C12)

D 9 +

12761 000693-57-2 12-Aminododecanoic acid

DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Mutagenicity tests are negative and migration is low (less than 50 ppb). (RIVM/TNO doc. CS/PM/2162).

+

12763 000141-43-5 2-Aminoethanol Same 22337 and 67420

DIR SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC and for indirect food contact only, behind the PET layer

3 R = 0.05 mg/kg of food. Available: migration data from multilayer bottle and residual content in polymer; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); in vitro cell transformation assay (negative); toxicology summary on reproductive toxicity; general toxicological overview on MEA (made by the applicant). RIVM/TNO SDS, August 1999 =

+ +




AND SPECIFICATIONS


31

CS/PM/3337/22337. Remark: substance evaluated only for the requested use of indirect contact with non-fatty food. (Adopted at the 121 SCF meeting (20 June 2000)) http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdf

12765 084434-12-8 N-(2-Aminoethyl)-beta-alanine, sodium salt

Same 35180 DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food http://europa.eu.int/comm/food/fs/sc/scf/out61_en.pdf Available: specific migration in 3% acetic acid, 15% ethanol and 95% ethanol < 0.03 mg/kg food; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative) RIVM/ISS/TNO SDS, November 1999 = CS/PM/3352 REV. I/35180. Remark for Commission: * Send a letter to the applicant, concerning the "preparation" of the petition (poor quality of the dossier) * The commercial product (as 40% aqueous solution) is tested in the mutagenicity assays (Adopted at the 121 SCF meeting (20 June 2000))

+

12771 000111-41-1 N-(2-Aminoethyl)ethanolamine

Same 35284 W7 Available: Mutagenicity tests, migration data inadequate. Needed: Validation of analytical methods, in vitro chromosomal aberration study in mammalian cells. (RIVM Doc. CS/PM/2164).

+

12772 000140-31-8 N-Aminoethylpiperazine 8 +

12775 000124-68-5 2-Amino-2-methyl-1- 8 +






AND SPECIFICATIONS


32

propanol

12786 000919-30-2 3-Aminopropyltriethoxysilane

3AM 3 Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler. Remark for the Commission: Used only for the reactive surface treatment of inorganic fillers. http://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf

+

12788 002432-99-7 11-Aminoundecanoic acid

DIR SML = 5 mg/kg 3 R: 5 mg/kg of foods. Available: 3-month oral mouse and rat study, 2-year oral mouse and rat studies, several in vitro and in vivo mutagenicity tests negative.

+

12789 007664-41-7 Ammonia Same 35320 DIR 1 ADI: not specified. (SCF, 25th Series, 1991).

+ +

12789/5 009037-22-3 Amylopectin W +

12790 000080-46-6 p-tert-Amylphenol D 8 +

12795 - Anhydrides of acids, aliphatic, monocarboxylic (C2-C24)

D +

12820 000123-99-9 Azelaic acid DIR 2 Group TDI: 3 mg/kg b.w. A subacute oral rat study and absence of mutagenicity in bacterial systems with azelaic acid and a subacute oral rat study with sebacic acid. (Arch. f. Exp. Path. u. Pharmak., 197, 1941, 587-610).

+ +

12850 029602-44-6 Azelaic acid, bis(2-hydroxyethyl) ester

D 8 +

12880 000123-98-8 Azelaic acid dichloride D 7 Needed: hydrolysis and migration data. Pending these results necessity for further studies to be considered. http://europa.eu.int/comm/food/fs/sc/scf/out161_en.pdf

+

12910 001732-10-1 Azelaic acid, dimethyl ester

D 8 Group R : 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and, if

+

http://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf





AND SPECIFICATIONS


33

migration exceeds 0.050 mg/kg, peroxisome proliferation studies too.

12940 004080-88-0 Azelaic acid, diphenyl ester

D 8 +

12970 004196-95-6 Azelaic anhydride DIR 2 Group TDI: 3 mg/kg b.w. Included in the group TDI for azelaic acid.

+ +

12974 BADGE Same 13510; 13610; 39700

According to Commission Directive 2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs

2-3 On the basis of the available experimental data, a TDI can be established for BADGE and its hydrolysis products. Considering the NOAEL of 15 mg/kg b.w./day observed in the oral chronic toxicity/carcinogenicity study in the rat with BADGE, and applying an uncertainty factor of 100, a TDI of 0.15 mg/kg b.w. can be established for BADGE. As BADGE is rapidly and extensively metabolised in vivo into the corresponding mono- and bis-diol derivatives, the Panel includes these in the TDI. For the other regulated BADGE reaction products, i.e. the BADGE chlorohydrins BADGE.2HCl, BADGE.HCl, BADGE.HCl.H2O, in view of the lack of genotoxicity, the Panel considers that the current restriction of 1 mg/kg of food remains appropriate. The Panel is aware that other BADGE reaction products, with undefined toxicological properties and chemical identity, may be found at low levels in the migrate from epoxy coatings. For the assessment of these, and in general of minute amounts of unknown migrants from food contact materials, a general approach is currently under consideration by the Panel. EFSA opinion from 13 July 2004 http://www.efsa.eu.int/science/afc/afc_opinions/508/opinion_afc13_ej86_badge_v2_en1.pdf See the individual opinion on the substance

+ +

http://www.efsa.eu.int/science/afc/afc_opinions/508/opinion_afc13_ej86_badge_v2_en1.pdf




AND SPECIFICATIONS


34

(CS/PM/2812 Rev.1) which is reported in the Internet website: http://europa.eu.int/comm/food/fs/sc/scf/out28_en.pdf

12976 054208-63-8 BFDGE Same 13460; 39665

D According to Commission Directive 2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs Can still be used in heavy duty coatings

7 http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf

+ +

12980 008015-74-5 Beechnut oil 3 Food fat. +

12983/1 - Beechnut oil fatty acids 3/D Constituents of food fats. +

13000 001477-55-0 1,3-Benzenedimethanamine

DIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg of food. Mutagenicity tests are negative and migration is very low (less than 5 ppb).

+ +

13030 000539-48-0 1,4-Benzenedimethanamine

Same 37400 D 8 +

13050 000528-44-9 1,2,4-Benzenetricarboxylic acid

Same 25540 DIR See "Trimellitic acid" + +

13060 004422-95-1 1,3,5-Benzenetricarboxylic acid trichloride

DIR QMA = 0.05 mg/6 dm² measured as 1,3,5-benzenetricarboxylic acid.

3 R = 0.05 mg/6 dm² measured as 1,3,5-benzenetricarboxylic acid. Available: Calculation of worst case migration assuming 100% migration of residual monomer, three (negative) in vitro mutagenicity studies. Remark for Commission: no method of analysis is available for the enforcement of an SML. (RIVM/ISS/TNO SDS, October 1997 = CS/PM/3075/13060) (Adopted at 111th SCF meeting (18-19 March 1998)). http://europa.eu.int/comm/food/fs/sc/scf/out

+







AND SPECIFICATIONS


35

10_en.pdf

13075 000091-76-9 Benzoguanamine Same 15310 DIR See "2,4-Diamino-6-phenyl-1,3,5-triazine"

+ +

13090 000065-85-0 Benzoic acid Same 37600 DIR 1 Group ADI: 5 mg/kg b.w. (JECFA 27 M., 1983).

+ +

13120 000769-78-8 Benzoic acid, vinyl ester D 7 Needed: hydrolysis data. +

13150 000100-51-6 Benzyl alcohol Same 38400 DIR 1 Group ADI: 5 mg/kg b.w. in the ADI for benzoic acid. (SCF, 11th Series, 1981).

+ +

13160 039817-09-9 BFDGE and NOGE (inserted for memo)

See: 12976; 13460; 39665; 22552; 68200

D According to Commission Directive 2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs. Can still be used in heavy duty coatings.


+ +

13180 000498-66-8 Bicyclo[2.2.1]hept-2-ene Same 22550 DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html Available: Adequate migration data; adequate Ames test (negative); adequate gene mutation assay in cultured mammalian cells (negative); inadequate chromosomal aberration assay in cultured mammalian cells; adequate chromosomal aberration assay in cultured mammalian cells (negative). (RIVM/ISS/TNO SDS, January 1998 = CS/PM/2851 REV. I/13180). (adopted at 113rd SCF meeting)(17-18 September 1998)

+

13210 001761-71-3 Bis(4-Aminocyclohexyl)metha

DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Available: Adequate migration data and

+ +







AND SPECIFICATIONS


36

ne analytical report, showing specific migration of bis(4-aminocyclohexyl)methane is < 0.05 mg/kg food; inadequate report of gene mutation test in bacteria; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative). (RIVM/ISS/TNO SDS, April 1998 = CS/PM/ 2852 REV. I /13210). (Adopted at 114th SCF meeting) (10 December 1998) http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

13240 003377-24-0 2,2-Bis(4-aminocyclohexyl)propane

D 8 +

13250 000101-77-9 Bis(4-aminophenyl)methane

4A Considered as genotoxic carcinogen. Available: 2 oral carcinogenicity studies in rats and mice, positive Ames test (CS/PM/2009).

+

13270 022287-56-5 4,4'-Bis(4-chlorophenylsulphonyl)biphenyl

D W8 +

13300 038050-97-4 1,4-Bis(4',4''-dihydroxytriphenylmethyl)benzene

D 8 +

13317 132459-54-2 N,N'-Bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8-naphthalenetetracarboxydiimide

3AM 3 Restriction: 0.05 mg/kg food Remark for Commission: FRF is applicable N,N'-Bis[4-(ethoxycarbonyl)phenyl]-1,4,5,8- naphthalenetetracarboxydiimide (> 98.1 %) is requested as a co-monomer (max. 4 %) for polyesters (like PET, PBT). http://www.efsa.eu.int/science/afc/afc_opinions/468/opinion11_afc_ej65_list4_en1.pdf

+

13323 000102-40-9 1,3-Bis(2-hydroxyethoxy)benzene

DIR SML = 0.05 mg/kg 3 Restriction: 0.05 mg/kg of food. http://europa.eu.int/comm/food/fs/sc/scf/out

+



http://www.efsa.eu.int/science/afc/afc_opinions/468/opinion11_afc_ej65_list4_en1.pdf




AND SPECIFICATIONS


37

140_en.pdf

13326 000111-46-6 Bis(2-hydroxyethyl) ether

Same 15760,39160

and 47680

DIR See "Diethyleneglycol" + +

13328 000104-38-1 Bis(2-hydroxyethyl) ether of hydroquinone

D 8 +

13330 - Bis(2-hydroxyethyl)ether of hydroquinone and its condensation products with propylene oxide

D 9 +

13360 001620-68-4 2,6-Bis(2-hydroxy-5-methylbenzyl)-4-methylphenol

D 7 Needed: 90-day oral study, migration data. +

13380 000077-99-6 2,2-Bis(hydroxymethyl)-1-butanol

Same 25600, 39560 and

94960

DIR See "1,1,1-Trimethylol propane"

+

13390 000105-08-8 1,4-Bis(hydroxymethyl)cyclohexane

Same 14880 DIR 3 A limited 36-day oral rat study showed no adverse effects at 50 mg/kg b.w./day. (Eastman Kodak report, April 1966).

+ +

13395 004767-03-7 2,2-Bis(hydroxymethyl)propionic acid

DIR QMA = 0.05 mg/6 dm²

3 R: 0.05 mg/kg of food. http://europa.eu.int/comm/food/fs/sc/scf/out61_en.pdf Available: calculation of worst case migration based on extraction values; analytical method for quantification in aqueous simulants and in 95% ethanol is properly described; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative). RIVM/FR SDS, November 1999 = CS/PM/3358 REV. I/13395. Remark for Commission: No method of analysis in olive oil is available. A QMA would be indicated. (Adopted at the 121)

+ +

13420 000843-55-0 1,1-Bis(4-hydroxyphenyl)cyclohexane

D 8 +





AND SPECIFICATIONS


38

13450 000125-13-3 3,3-Bis(4-hydroxyphenyl)-2-indolinone

D 8 +

13453 001333-16-0;087139-40-0;002467-02-9;000620-92-8;002467-03-0

Bis(hydroxyphenyl)methane, mixture of Bis(2- and 4- and 2,4 hydroxyphenyl)methane

7 SCF_list: 7. Needed: -A properly validated method including data for the determination of Bisphenol F in a typical final product Or A properly validated method including data concerning the specific migration into food simulants of Bisphenol F from a typical final product. http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdf

+

13455 002467-02-9 Bis(2-hydroxyphenyl)methane

Same 13615 7 SCF_list: 7. See 13453. http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdf

+

13457 000620-92-8 Bis(4-hydroxyphenyl)methane

Same 39650 7 SCF_list: 7. See 13453. http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdf

+ +

13460 054208-63-8 Bis(2-hydroxyphenyl)methane bis(2,3-epoxypropyl) ether (=BFDGE)

Same 39665; 12976

D According to Commission Directive 2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs. Can still be used in heavy duty coatings.


+ +

13465 000126-00-1 4,4-Bis(hydroxyphenyl)pentanoic acid

Same 16525 8 +

13480 000080-05-7 2,2-Bis(4-hydroxyphenyl)propane

Same 13607/39680/62540/400

DIR SML(T) = 0.6 mg/kg (28)

2 See the specific opinion on this substances adopted on 17, April 2002. http://europa.eu.int/comm/food/fs/sc/scf/out

+ +











AND SPECIFICATIONS


39

60/19255 128_en.pdf

13510 001675-54-3 2,2-Bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (=BADGE)

Same 12974; 13610; 39700

DIR According to Commission Directive 2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs

2-3 On the basis of the available experimental data, a TDI can be established for BADGE and its hydrolysis products. Considering the NOAEL of 15 mg/kg b.w./day observed in the oral chronic toxicity/carcinogenicity study in the rat with BADGE, and applying an uncertainty factor of 100, a TDI of 0.15 mg/kg b.w. can be established for BADGE. As BADGE is rapidly and extensively metabolised in vivo into the corresponding mono- and bis-diol derivatives, the Panel includes these in the TDI. For the other regulated BADGE reaction products, i.e. the BADGE chlorohydrins BADGE.2HCl, BADGE.HCl, BADGE.HCl.H2O, in view of the lack of genotoxicity, the Panel considers that the current restriction of 1 mg/kg of food remains appropriate. The Panel is aware that other BADGE reaction products, with undefined toxicological properties and chemical identity, may be found at low levels in the migrate from epoxy coatings. For the assessment of these, and in general of minute amounts of unknown migrants from food contact materials, a general approach is currently under consideration by the Panel. EFSA opinion from 13 July 2004 http://www.efsa.eu.int/science/afc/afc_opinions/508/opinion_afc13_ej86_badge_v2_en1.pdf See the individual opinion on the substance (CS/PM/2812 Rev.1) which is reported in the Internet website: http://europa.eu.int/comm/food/fs/sc/scf/out28_en.pdf

+ +

13518 025036-25-3 2,2-bis(4- W +











AND SPECIFICATIONS


40

hydroxyphenyl)propane - 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether, copolymer

13520 000116-37-0 2,2-Bis(4-hydroxyphenyl)propane bis(2-hydroxypropyl)ether

3 R: 0.05 mg/kg of food (only to be used in the manufacture of adhesives). Available: 3 mutagenicity studies, negative. The worst case calculation as component of an adhesive gives a maximum migration value less than 50 ppb. (RIVM doc. 1994-11-08 = CS/PM/2460).

+

13530 038103-06-9 2,2-Bis(4-hydroxyphenyl)propane, bis(phthalic anhydride)

Same 13614 DIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg of food. 1 month oral rat study, 3 mutagenicity tests and migration data. (Rivm doc. 90/678908/010).

+

13540 002444-90-8 2,2-Bis(4-hydroxyphenyl)propane, disodium salt

D +

13545 129188-99-4 1,1-Bis(4-hydroxyphenyl)-3,3,5-trimethylcyclohexane

W7 Available: specific migration data < 0.05 mg/kg food; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); micronucleus assay (negative); acute toxicity data; 90-day oral rat study; reproduction study; teratogenicity study; scientific statement provided by the applicant. Needed: test for endocrine activity in accordance with US-EPA tiered approach. RIVM/TNO SDS, February 2000 = CS/PM/2644 REV.III/13545. (Adopted at the 123rd SCF meeting, 19 October 2000) http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf

+

13550 000110-98-5 Bis(hydroxypropyl) ether DIR See "Dipropyleneglycol"

+ +

13560 005124-30-1 Bis(4- Same 15700 DIR See + +




AND SPECIFICATIONS


41

isocyanatocyclohexyl)methane

"Dicyclohexylmethane-4,4'-diisocyanate"

13565 002778-42-9 1,3 - bis(alpha-isocyanatoisopropyl)benzene

W +

13570 000141-07-1 1,3-Bis(methoxymethyl)urea

D 8 +

13600 047465-97-4 3,3-Bis(3-methyl-4-hydroxyphenyl)-2-indolinone

DIR SML = 1.8 mg/kg 2 TDI: 0.03 mg/kg b.w. A 90-day oral rat study. (Bayer Bericht Nr. 8086, January 3, 1979).

+

13607 000080-05-7 Bisphenol A Same 13480/62540/40060/192

55/39680

DIR See "2,2-Bis(4-hydroxyphenyl)propane"

Under re-evaluation http://europa.eu.int/comm/food/fs/sc/scf/out128_en.pdf

+ +

13610 001675-54-3 Bisphenol A bis(2,3-epoxypropyl)ether

Same 13510; 39700; 12974

DIR See "2,2-Bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl)ether"

2-3 On the basis of the available experimental data, a TDI can be established for BADGE and its hydrolysis products. Considering the NOAEL of 15 mg/kg b.w./day observed in the oral chronic toxicity/carcinogenicity study in the rat with BADGE, and applying an uncertainty factor of 100, a TDI of 0.15 mg/kg b.w. can be established for BADGE. As BADGE is rapidly and extensively metabolised in vivo into the corresponding mono- and bis-diol derivatives, the Panel includes these in the TDI. For the other regulated BADGE reaction products, i.e. the BADGE chlorohydrins BADGE.2HCl, BADGE.HCl, BADGE.HCl.H2O, in view of the lack of genotoxicity, the Panel considers that the current restriction of 1 mg/kg of food remains appropriate. The Panel is aware that other BADGE reaction products, with undefined toxicological properties and chemical identity, may be found at low levels in the migrate from epoxy coatings. For the assessment of these, and in general of minute amounts of unknown migrants

+ +




AND SPECIFICATIONS


42

from food contact materials, a general approach is currently under consideration by the Panel. EFSA opinion from 13 July 2004 http://www.efsa.eu.int/science/afc/afc_opinions/508/opinion_afc13_ej86_badge_v2_en1.pdf See the individual opinion on the substance (CS/PM/2812 Rev.1) which is reported in the Internet website: http://europa.eu.int/comm/food/fs/sc/scf/out28_en.pdf

13614 038103-06-9 Bisphenol A bis(phthalic anhydride)

Same 13530 DIR See "2,2-Bis(4-hydroxyphenyl)propane, bis(phthalic anhydride)"

+

13615 002467-02-9 Bisphenol F Same 13455 7 SCF_list: 7. See 13453. http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdf

+

13617 000080-09-1 Bisphenol S Same 16090 DIR See "4,4'-Dihydroxydiphenyl sulphone"

+ +

13618 16068-37-4 1,2-Bis(triethoxysilyl)ethane

W +

13620 010043-35-3 Boric acid Same 40320 DIR SML(T) = 6 mg/kg (23) (expressed as Boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption (*).

2 Re-evaluation on the basis of an opinion of the SCF in another context. Group-TDI = 0.1 mg/kg b.w. (as B) (with REF_n. 36840, 40320 and 87040). The TDI is based on the No Adverse Effect Level (NOAEL) of 9.6 mg/kg b.w./day for effects on fetal body weight and skeletal anomalies in the rat developmental study. A Safety Factor (SF) of 100 is used. “Opinion of the Scientific Committee on Food on Arsenic, Barium, Fluoride, Boron and Manganese in Natural Mineral Waters (expressed on 13 December 1996, 105th plenary meeting of the SCF, completed on 13 June 1997 at the 107th plenary meeting

+ +









AND SPECIFICATIONS


43

of the SCF; 43rd Series of Reports of the SCF, 2000”. This opinion is also available on Internet. (Adopted by the SCF at the 127th meeting, 30 May 2001) http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

13630 000106-99-0 Butadiene DIR QM = 1 mg/kg in FP or SML =ND (DL =0.020 mg/kg, analytical tolerance included)

4A Suspected of having carcinogenic potential (NTP report 83-071, NIH publ. n. 84-2544, 1983).

+ +

13660 000584-03-2 1,2-Butanediol D 8 +

13690 000107-88-0 1,3-Butanediol DIR 1 ADI: 4 mg/kg b.w. (JECFA 23 M., 1979).

+ +

13720 000110-63-4 1,4-Butanediol Same 40580 DIR SML(T) = 0.05 mg/kg (24)

3 5 mg/kg food http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

+ +

13750 000513-85-9 2,3-Butanediol D 8 +

13780 002425-79-8 1,4-Butanediol bis(2,3-epoxypropyl) ether

DIR QM = 1 mg/kg in FP (expressed as Epoxy group, Mw=43)

4A Genotoxic similar to glycidylethers. (CS/PM/2958).

+ +

13810 000505-65-7 1,4-Butanediol formal Same 21821 DIR QMA = 0.05 mg/6 dm² 3 R = 0.05 mg/kg of food. http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf Available: calculated (worst case) migration is < 0.05 mg/kg of food; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (positive); gene mutation assay in cultured mammalian cells (negative); micronucleus assay (negative); in vivo UDS assay (negative) RIVM/ISS/TNO SDS, January 2000 = CS/PM/2853 REV.I/13810. Remark for Commission: only a method for

+ +










AND SPECIFICATIONS


44

the residual quantity in the finished product (FP) is available. A QMA is proposed. (Adopted at the 123rd SCF meeting, 19 October 2000)

13840 000071-36-3 1-Butanol Same 40590 DIR 3 See references for "Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N. 12375) in SCF list 3.

+ +

13845 000075-65-0 tert-Butanol Same 40594 3 Residue in food less than 10 mg/kg. (EHC,65).

+

13870 000106-98-9 1-Butene DIR 3 Residues of this gas in plastics are very small. The gas has low toxic potential. Migration into food will be toxicologically negligible. (Patty's Industrial Hygiene and Toxicology, 3rd ed. 1981).

+ +

13900 000107-01-7 2-Butene DIR 3 Residues of this gas in plastics are very small. The gas has low toxic potential. Migration into food will be toxicologically negligible. (Patty's Industrial Hygiene and Toxicology, 3rd ed. 1981).

+ +

13930 006117-91-5 2-Buten-1-ol D 8 +

13932 000598-32-3 3-Buten-2-ol Same 40610 DIR QMA = ND (DL = 0.02 mg/6 dm²). To be used only as a co-monomer for the preparation of polymeric additive

4A n.d. (DL = 0.01 mg/kg) Available: worst case migration of <= 0.008 mg/kg in the case of use as co-monomer of a polymeric additive, made from less then 10% 1-buten-3-ol and used at less then 2.5% in PVC; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (positive); gene mutation assay in cultured mammalian cells (weakly positive). RIVM/FR SDS, January 2000 = CS/PM/3151 REV. III/13932. Remark for Commission: only a method for the determination of the residual content is available. (Adopted at the 121 SCF meeting (20 June 2000)) http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdf

+




AND SPECIFICATIONS


45

13960 001852-16-0 N-(Butoxymethyl)acrylamide

D 6A + +

13990 005153-77-5 N-(Butoxymethyl)methacrylamide

D 6A + +

14001 001320-16-7 tert-Butylbenzoic acid 8 +

14002 000098-73-7 p-tert-Butylbenzoic acid 7 Available: some data at RIVM. Needed: migration and mutagenicity studies.

+

14005 000098-29-3 4-tert-Butylcatechol Same 40640 8 +

14008 000098-52-2 4-tert-Butylcyclohexanol D 8 +

14020 000098-54-4 4-tert-Butylphenol Same 40850 DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Available: Adequate migration data for polycarbonate; calculation of worst-case migration for epoxy systems and butylated alkylphenolic resins; three (negative) mutagenicity studies. (RIVM/TNO SDS, March 1997 = CS/PM/2991 /14020). (Adopted at 111th SCF meeting (18-19 March 1998)) http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

+ +

14035 001746-23-2 4-tert-Butylstyrene D 6A +

14050 000111-34-2 Butyl vinyl ether D 7 Needed: hydrolysis data. +

14080 000926-02-3 tert-Butyl vinyl ether D 7 Needed: provided hydrolysis can be demonstrated, data on tert-butanol are requested.

+

14095 000503-17-3 2-Butyne 8 +

14110 000123-72-8 Butyraldehyde DIR 3 Occurs naturally in food. Used as flavour in food at 0.1-10 mg/kg. Migration into food would be self-limiting because of its taste.

+ +

14140 000107-92-6 Butyric acid DIR 0 +

14170 000106-31-0 Butyric anhydride DIR 3 Hydrolyses to corresponding acid. +

14185 008015-80-3 Candlenut oil 8 +

14188/1 - Candlenut oil fatty acids 8/D +

14200 000105-60-2 Caprolactam Same 41840 DIR SML(T) = 15 mg/kg 2 Group TDI = 0.25 mg/kg b.w. + +




AND SPECIFICATIONS


46

(5) Two 90-day oral rat studies and 90-day oral studies in mice and dogs. (CIVO report 3489 June 1971 and NTP Tech. Rep. Ser. 214, NTP 80-26).

14230 002123-24-2 Caprolactam, sodium salt DIR SML(T) = 15 mg/kg (5) (expressed as Caprolactam)

2 Group TDI = 0.25 mg/kg b.w. See references for caprolactam.

+

14260 000502-44-3 Caprolactone Same 41880 DIR 3 0.05 mg/kg food expressed as the sum of caprolactone and 6-hydroxyhexanoic acid http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf

+ +

14290 - Caprolactone, substituted D 9 +

14320 000124-07-2 Caprylic acid Same 41960 and 68560

DIR 0 + +

14350 000630-08-0 Carbon monoxide DIR 3 Low migration. +

14380 000075-44-5 Carbonyl chloride Same 23155 DIR QM = 1 mg/kg in FP 4A Residues of this gas in plastics will be very small. It is readily hydrolysed to CO2 and HCl. Has a strong odour. Migration into food would therefore be self-limiting.

+ +

14390 - Cardura +

14411 008001-79-4 Castor oil Same 42880 DIR 3 SCF_List: 3 Restriction: none. In small doses metabolised similarly to food fats See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf

+ +

14440 064147-40-6 Castor oil, dehydrated Same 42960 D 3 Similar to food fats. + +

14445 - Castor oil fatty acids 3/D Constituents of food fats. +

14450/1 - Castor oil fatty acids, dehydrated

3 Identical with or similar to constituents of food fats.

+

14453 061790-39-4 Castor oil fatty acids, hydrogenated

3 Identical with or similar to constituents of food fats.

+

14470 008001-78-3 Castor oil, hydrogenated Same 43120 D 3 Similar to food fats. + +

14500 009004-34-6 Cellulose Same 43280 DIR 0 + +








AND SPECIFICATIONS


47

14505 009004-35-7 Cellulose acetate 3 Inert material, modified natural cellulose. +

14508 009004-36-8 Cellulose acetate butyrate

Same 43300 3 Inert material, modified natural cellulose. +

14512 009004-39-1 Cellulose acetate propionate

3 Inert material, modified natural cellulose. +

14520 008001-20-5 Chinawood oil 8 +

14523/1 - Chinawood oil fatty acids

8/D +

14527 000115-28-6 Chlorendic acid Same 18250 +

14530 007782-50-5 Chlorine DIR 3 Residues of this gas in plastics will be very small. Migration into food would be self-limiting because of odour.

+

14560 000126-99-8 2-Chloro-1,3-butadiene D 6A All data considered show that chloroprene is hepatotoxic, teratogenic, mutagenic and causes chromosomal abnormalities in exposed workers. It affects testicular function in man and animals.

+

14570 000106-89-8 1-Chloro-2,3-epoxypropane

Same 16750 DIR See "Epichlorohydrin" + +

14587 001204-28-0 4-(Chloroformyl)phthalic anhydride

Same 13140 and 25552

3 QM = 0.05 mg/6 dm² for the chloride to be measured as trimellitic acid. Available: Hydrolysis data; calculation of worst case migration assuming 100% migration of residual trimellitic acid; two Ames assays (negative); two in vitro cytogenetic assays in Chinese hamster cells (negative); two HPRT assys (negative); acute oral toxicity data; subacute oral toxicity in the rat (trimellitic acid); inadequate subchronic oral toxicity in rat and guinea pig; teratogenicity study in the rat and guinea pig by inhalation; dermal effects in rabbit (trimellitic acid); effect on immune system by inhalation; eye irritation study in rabbit (trimellitic acid); sensitisation study in guinea pigs. (RIVM/ISS/TNO SDS, October 1997 = CS/PM3080/14587). (Adopted at 111th SCF meeting (18-19

+


AND SPECIFICATIONS


48

March 1998)) http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

14590 000615-67-8 Chlorohydroquinone D 8 +

14620 057981-99-4 Chlorohydroquinone diacetate

D 8 +

14650 000079-38-9 Chlorotrifluoroethylene DIR QMA = 0.5 mg/6 dm² 3 R = 0.5 mg/6 dm². Based on the reduced core set of toxicological data according to the migration level. The substance is extremely volatile and the toxicity data support an R = 0.05 mg/kg food. However this is analytically not enforceable due to the lack of a method for an SML. The residual content QM = 0.05 mg/6dm2, assuming 100% migration, is raised 10-fold as it has been demonstrated that more than 95% of migrants appear in the headspace because of the extreme volatility of the additive. Available: data on residual content of chlorotrifluoroethylene (CTFE); poor recovery of CTFE from food simulants; liquid/vapour partitioning data of CTFE in food simulants; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); limited in vivo SCE assay (negative). RIVM/IT/TNO SDS, March 2001 = CS/PM/2795 REV. II/14650. (Adopted at the 128th SCF meeting, 12 July 2001) http://europa.eu.int/comm/food/fs/sc/scf/out97_en.pdf

+

14680 000077-92-9 Citric acid Same 44160 DIR 1 Group ADI: not specified for citric acid and its salts. (SCF, 25th Series, 1990).

+ +

14685 008001-31-8 Coconut oil 3 Food fat. +






AND SPECIFICATIONS


49

14687 008050-09-7 Colophony Same 24100,24130,45055 and

83840

+ +

14693 008001-30-7 Corn oil 3 Food fat. +

14695/1 - Corn oil fatty acids 3/D Constituents of food fats. +

14698 008001-29-4 Cottonseed oil 3 Food fat. +

14700/1 - Cottonseed oil fatty acids 3/D Constituents of food fats. +

14710 000108-39-4 m-Cresol DIR 3 28-day oral rat study showed no adverse effects at 25 mg/kg b.w./day. (Shell Report, April 1978).

+ +

14740 000095-48-7 o-Cresol DIR 3 28-day oral rat study showed no adverse effects at 12 mg/kg b.w./day. (Shell Report, April 1978).

+ +

14770 000106-44-5 p-Cresol DIR 3 28-day oral rat study showed no adverse effect at 25 mg/kg b.w./day. (Shell Report, April 1978).

+ +

14800 003724-65-0 Crotonic acid Same 45600 DIR QMA(T) = 0.05 mg/6dm² (33)

3 SCF_list: 3 Restriction: 0.05 mg/kg of food. Remark for Commission: A QMA is proposed (QMA = 0.05 mg/6 dm2), because only a method for the residual content is available, however an SML is set for REF_n. 18888. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out141_en.pdf

+ +

14830 - Crotonic acid, esters with alcohols, mono- and polyhydric

D 9 +

14833 000623-43-8 Crotonic acid, methyl ester

D 8 +

14836 014861-06-4 Crotonic acid, vinyl ester 7? Needed: provided hydrolysis can be demonstrated, data on crotonic acid are requested. http://europa.eu.int/comm/food/fs/sc/scf/out161_en.pdf

+

14839 000623-68-7 Crotonic anhydride 6A Needed: information on crotonic acid. +






AND SPECIFICATIONS


50

14841 000599-64-4 4-Cumylphenol DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Available: migration data, 3 mutagenicity tests, negative. (TNO SDS 1995-01-16, RIVM SDS 1994-05-31).

+ +

14860 - Cycloalkenes D 9 +

14862 010016-20-3 alpha-Cyclodextrin same 46070 7 Under evaluation +

14863 007585-39-9 beta-Cyclodextrin 7 Under evaluation +

14864 017465-86-0 gamma-Cyclodextrin 7 Under evaluation +

14875 001687-30-5 1,2-Cyclohexanedicarboxylic acid

Same 18436 +

14880 000105-08-8 1,4-Cyclohexanedimethanol

Same 13390 DIR See "1,4-Bis(hydroxymethyl)cyclohexane"

Deleted because same as 13390. + +

14910 000108-94-1 Cyclohexanone Same 45720 6A Needed: adequate test for gene mutation and chromosomal aberration. (IARC (1989), 47, 151-169).

+

14920 002842-38-8 2-(Cyclohexylamino)ethanol

D 8 +

14950 003173-53-3 Cyclohexyl isocyanate DIR QM(T) = 1 mg/kg (expressed as NCO) (26).

4A See references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl.

+

14980 001631-25-0 N-Cyclohexylmaleimide D 6A +

15010 001131-60-8 p-Cyclohexylphenol D 8 +

15020 002182-55-0 Cyclohexyl vinyl ether D 7 Needed: provided hydrolysis can be demonstrated, data on cyclohexanol are requested.

+

15030 000931-88-4 Cyclooctene DIR SML = 0.05 mg/kg. For use only in polymers contacting foods for which simulant A is laid down in Directive 85/572/EEC.

3 R: 0.05 mg/kg of food; only for aqueous foodstuffs. Available: migration data from polyoctenamer and from blends with polypropylene in aqueous food simulants; migration data from polyoctenamer in HB307; three negative mutagenicity studies performed with cyclooctene; acute toxicity data.

+


AND SPECIFICATIONS


51

(RIVM/TNO SDS, October 1998 = CS/PM/2529 REV. III/15030). (Adopted at 117th SCF meeting) (17 June 1999) http://europa.eu.int/comm/food/fs/sc/scf/out37_en.pdf

15040 000542-92-7 1,3-Cyclopentadiene D 8 +

15060 000142-29-0 Cyclopentene D 8 +

15070 001647-16-1 1,9-Decadiene DIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg of food. 5 negative mutagenicity tests, 28-day oral study, bioaccumulation. (CS/PM/2221).

+

15095 000334-48-5 Decanoic acid Same 45940 DIR 0 Food constituent. + +

15100 000112-30-1 1-Decanol Same 46050 DIR 3 See references for "Alcohols aliphatic,monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N 12375) in SCF list 3.

+ +

15130 000872-05-9 1-Decene DIR SML = 0.05 mg/kg 3 R = 0,05 mg/kg of food. Available: Migration data and 3 mutagenicity tests negative. (RIVM/TNO/ISS SDS CS/PM/2744, January 1996).

+ +

15160 000765-05-9 Decyl vinyl ether D 7 Needed: hydrolysis data. +

15190 - Diamines, aliphatic, linear (C2-C12)

D 9 +

15220 000088-63-1 2,4-Diaminobenzenesulphonic acid

D +

15250 000110-60-1 1,4-Diaminobutane DIR 2 TDI: 0.6 mg/kg b.w. 28- and 90-day oral rat studies, mutagenicity tests. (RIVM report 88/6788097003, 03-05-1988).

+

15260 000646-25-3 1,10-Diaminodecane D 8 +

15267 000080-08-0 4,4'-Diaminodiphenyl sulphone

4,4-sulfonyldian

iline, Benzeneami

ne, 4,4

7 Under evaluation +




AND SPECIFICATIONS


52

15270 002783-17-7 1,12-Diaminododecane D 8 +

15272 000107-15-3 1,2-Diaminoethane Same 16960 and 53540

DIR See "Ethylenediamine" + +

15274 000124-09-4 1,6-Diaminohexane Same 18460 and 59240

DIR See "Hexamethylenediamine"

+ +

15280 000542-02-9 2,4-Diamino-6-methyl-1,3,5-triazine

Same 10155 D 8 Data inadequate. +

15295 000373-44-4 1,8-Diaminooctane D 8 +

15310 000091-76-9 2,4-Diamino-6-phenyl-1,3,5-triazine

Same 13075 DIR QMA = 5 mg/6 dm² 3 Restriction : 5 mg/kg of food. Based on the reduced core set of toxicological data according to the migration level. Available : migration data on aqueous food simulants and 50% ethanol ; log Po/w ; gene mutation assay in bacteria (negative) ; gene mutation assay in cultured mammalian cells (slightly positive at only toxic doses) ; chromosomal aberration assay in cultured mammalian cells (positive) ; micronucleus assay (equivocal) ; micronucleus assay with extended sampling time (72h) and scoring of at least 2000 PCE’s per animal (negative) ; 90-day oral rat study and 18 months oral carcinogenicity studies in mice and rats (limited studies due to too few animals and the use of only 2 dose levels). RIVM/ISS/FR/TNO SDS, October 2001 = CS/PM/3469 REV. IV/15310. Remark for Commission: primary amines can react with oil constituents and therefore a QMA seems an appropriate type of limit. (Adopted at the 130th SCF meeting, 13 December 2001) http://europa.eu.int/comm/food/fs/sc/scf/out115_en.pdf

+ +

15340 000109-76-2 1,3-Diaminopropane D 8 +

15355 025513-64-8 Mixture of (40% w/w) 1,6-diamino-2,2,4-trimethylhexane and

Same 22331 3 Re-evaluation to align this evaluation with other evaluations done by the SCF. R = 5 mg/6 dm2.

+




AND SPECIFICATIONS


53

(60% w/w)1,6-diamino-2,4,4-trimethylhexane

Remark for Commission: A QM would be indicated. The choice of a QM instead of SML is due to the reactivity of the substance with fat simulant. Available: migration data; three negative mutagenicity studies; 90-day oral rat study; 2-generation reproduction study (rat); two teratogenicity studies (rat and rabbit). RIVM/TNO SDS, November 2000 = CS/PM/2914/15355. (Adopted by the SCF at the 127th meeting, 30 May 2001) http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

15370 003236-53-1 1,6-Diamino-2,2,4-trimethylhexane

D QMA = 5 mg/6 dm². 3 R = 5 mg/6 dm2. Remark for Commission: A QM would be indicated. The choice of a QM instead of SML is due to the reactivity of the substance with fat simulant. Available: migration data; three negative mutagenicity studies; 90-day oral rat study; 2-generation reproduction study (rat); two teratogenicity studies (rat and rabbit). RIVM/TNO SDS, November 2000 = CS/PM/2914/15355. (Adopted by the SCF at the 127th meeting, 30 May 2001) http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

+

15400 003236-54-2 1,6-Diamino-2,4,4-trimethylhexane

D QMA = 5 mg/6 dm² 3 R = 5 mg/6dm2. Same references as for REF_N. 15370 (Adopted by the SCF at the 127th meeting, 30 May 2001) http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

+

15430 003749-77-7 4,4'-Dicarboxydiphenoxybutane

D 8 +

15460 003753-05-7 4,4'- D 8 +








AND SPECIFICATIONS


54

Dicarboxydiphenoxyethane

15490 002215-89-6 4,4'-Dicarboxydiphenyl ether

D 8 +

15520 004919-48-6 4,4'-Dicarboxydiphenyl sulphide

D 8 +

15550 002449-35-6 4,4'-Dicarboxydiphenyl sulphone

D 8 +

15565 000106-46-7 1,4-Dichlorobenzene DIR SML = 12 mg/kg 2 TDI : 0.2 mg/kg bw. A 4-week oral rat study, 3 and 6 month oral rat and mouse studies, teratogenicity study, mutagenicity studies not showing genotoxicity. Oral carcinogenicity studies in mice and rats indicate that there is limited evidence of carcinogenic potential in experimental animals. (NTP report n. 319, NIH publ, 87-2575, RIVM report 710401005 April 1991).

+ +

15580 001653-19-6 2,3-Dichloro-1,3-butadiene

D 6A +

15610 000080-07-9 4,4'-Dichlorodiphenyl sulphone

DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Based on the reduced core set of toxicological data according to the migration level, see Appendix 2 Available: migration data (< 0.05 mg/kg of food); gene mutation assay in bacteria (negative); two gene mutation assays in cultured mammalian cells (one negative and one positive); micronucleus assay (negative, however substance did not reach the bone marrow); in vitro/in vivo UDS assay (negative). RIVM/ISS SDS, May 2000 = CS/PM/3062 REV.I/15610. (Adopted at the 126th SCF meeting, 28 February 2001) http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdf

+ +

15640 000156-59-2 cis-1,2-Dichloroethylene D 8 +




AND SPECIFICATIONS


55

15670 000156-60-5 trans-1,2-Dichloroethylene

D 8 +

15695 000461-58-5 Dicyanodiamide Same 45670 and 47440

2 TDI : 1 mg/kg b.w. 2 year oral rat and dog studies and Ames tests. (American Cyanamide report 1969).

+

15700 005124-30-1 Dicyclohexylmethane-4,4'-diisocyanate

Same 13560 DIR QM(T) = 1 mg/kg (expressed as NCO) (26).


+ +

15730 000077-73-6 Dicyclopentadiene DIR/D 7 Under re-evaluation +

15735 000111-42-2 Diethanolamine Same 47620 8 Data inadequate. R: contact with food containing nitrite should be avoided.

+

15760 000111-46-6 Diethyleneglycol Same 13326, 39160 and

47680

DIR SML(T) = 30 mg/kg (3)

2 Group TDI: 0.5 mg/kg b.w. (SCF, 17th Series, 1986).

+ +

15790 000111-40-0 Diethylenetriamine DIR SML = 5 mg/kg 3 R: 5 mg/kg of food. Available: 3-month oral rat study, several mutagenicity studies negative. (RIVM 90/678608/009).

+ +

15820 000345-92-6 4,4'-Difluorobenzophenone

DIR SML = 0.05 mg/kg 3 R : 0.05 mg/kg in food. Available: three mutagenicity tests negative, very low migration.(Rivm report, April 1992).

+

15850 000383-29-9 4,4'-Difluorodiphenyl sulphone

+

15880 000120-80-9 1,2-Dihydroxybenzene Same 24051 DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w. A 90-day oral rat study, negative in vitro and in vivo mutagenicity tests, promoting effect in mouse skin painting assay. (SCC, 1983).

+ +

15910 000108-46-3 1,3-Dihydroxybenzene Same 24072 DIR SML = 2.4 mg/kg 2 TDI: 0.04 mg/kg b.w. A 90-day oral rat study 5 days a week, metabolism in rabbit and man, several negative in vitro mutagenicity tests and no immunosuppressive action. (Henkel report 29-01-1980).

+ +

15940 000123-31-9 1,4-Dihydroxybenzene Same 18867, 48620 and

DIR SML = 0.6 mg/kg 2 TDI: 0.01 mg/kg b.w. (SCF, 17th Series, 1986).

+ +


AND SPECIFICATIONS


56

60060

15970 000611-99-4 4,4'-Dihydroxybenzophenone

Same 48720 DIR SML(T) = 6 mg/kg (15)

2 Group TDI: 0.1 mg/kg b.w. (for 4,4'-dihydroxybenzophenone; 2,2'-dihydroxy-4-methoxybenzophenone;2-hydroxy-4-hexoxybenzophenone;2-hydroxy-4-n-octoxybenzophenone). 90-day oral rat studies (2,2'-dihydroxy-4-methoxybenzophenone, 2-hydroxy-4-methoxybenzophenone, 2-hydroxy-4-n-octyloxybenzophenone) a 18-week oral dog study (2-hydroxy-4-n-octyloxybenzophenone) and 2-year rat and dog studies (2-hydroxy-4-n-octyloxybenzophenone), a reproduction study (2-hydroxy-4-n-octyloxybenzophenone) plus metabolism. (J.Occup.Med. 1969, 11, 703, Food Cosm.Tox. 1972, 10, 41-50, RIVM report October 1972).

+

16000 000092-88-6 4,4'-Dihydroxybiphenyl Same 48760 DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w. 90-day oral rat study and limited mutagenicity studies. (RIVM Doc/Tox 300/495 June 1984).

+

16030 001965-09-9 4,4'-Dihydroxydiphenyl ether

D 8 +

16060 002664-63-3 4,4'-Dihydroxydiphenyl sulphide

D 8 +

16090 000080-09-1 4,4'-Dihydroxydiphenyl sulphone

Same 13617 DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Available: the substance is used as a comonomer for kitchen utensils, mainly intended for repeated use, and for oven cooking; migration has been tested upto 218 °C and is always below 0.05 mg/kg food (aqueous simulants, HB307); gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (positive); gene mutation assay in cultured mammalian cells (negative); micronucleus assay (negative). RIVM/FR/ISS/TNO SDS, February 2000 =

+ +


AND SPECIFICATIONS


57

CS/PM/2854 REV. II/16090. (Adopted at the 121 SCF meeting (20 June 2000)) http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdf

16100 060793-35-3 1,4-Dihydroxy-2-methylcyclohexane

8 +

16115 025167-70-8 Diisobutene 8 +

16116 000106-90-1 Glycidyl acrylate Same 11260 D +

16118 - Glycidyl ester of trialkyl(C5-C15) acetic acid

D + +

16119 000106-91-2 Glycidyl methacrylate Same 20590 D +

16120 000110-97-4 Diisopropanolamine Same 49065 D 8 R: contact with food containing nitrite should be avoided.

+

16150 000108-01-0 Dimethylaminoethanol Same 49235 DIR SML = 18 mg/kg 2 TDI: 0.3 mg/kg b.w. A 90-day oral rat study, studies in other species and observations in man. (Arch. Ind. Hyg. Occup. Med., 4, 1951, 119-122).

+ +

16180 005205-93-6 N-(Dimethylaminopropyl)methacrylamide

D 6A +

16190 000121-69-7 N,N-Dimethylaniline Same 49280 8 +

16200 000616-38-6 Dimethyl carbonate W8 Data inadequate. +

16210 006864-37-5 3,3'-Dimethyl-4,4'-diaminodicyclohexylmethane

DIR SML = 0.05 mg/kg (32). To be used only in polyamides.

3 SCF_list:3 Restriction: 0.05 mg/kg of food. Remark for Commission: substance is not stable in fat simulant. Only to be used in polyamides See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out142_en.pdf

+

16240 000091-97-4 3,3'-Dimethyl-4,4'-diisocyanatobiphenyl

DIR QM(T) = 1 mg/kg (expressed as NCO) (26).

4A (SCF, 17th Series, 1986). +






AND SPECIFICATIONS


58

16252 000110-03-2 2,5-Dimethyl-2,5-hexanediol

D 8 +

16265 156065-00-8 alpha-Dimethyl-3-(4'-hydroxy-3'-methoxyphenyl)propylsilyloxy, omega-3-dimethyl-3-(4'-hydroxy-3'-methoxyphenyl)propylsilyl polydimethylsiloxane

W7 Under evaluation +

16270 000526-75-0 2,3-Dimethylphenol Same 26377 D 8 + +



16360 000576-26-1 2,6-Dimethylphenol DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Available: Migration data showing not detectable at <0.012 mg/kg (3% acetic acid, 15% ethanol) or <0.020 mg/kg (olive oil) under test conditions of 30 min. at 100°C followed by 10 days at 40°C; Ames assy (negative); in vitro chromosomal aberration assay (positive); HPRT assay (negative) and in vivo bone marrow cytogenetic assay (negative) (RIVM/DK/UK SDS, October 1997 = CS/PM/3076/16360) (Adopted at 111th SCF meeting (18-19 March 1998)). http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

+ +

16363 000095-65-8 3,4-Dimethylphenol 8 +

16364 000108-68-9 3,5-Dimethylphenol 8 +

16390 000126-30-7 2,2-Dimethyl-1,3-propanediol

Same 22437 DIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg of food. Available: information on identity; migration data with a coating made with 17% of the substance used as comonomer; analytical method; data on residual content (with 17% of the substance used as comonomer), and corresponding analytical method; 3 negative mutagenicity studies.

+ +




AND SPECIFICATIONS


59

(RIVM/FR SDS, December 1998 = CS/PM/3251/16390). Remark: petitioner has to clarify the 40% (weight) in the formulation. (Adopted at 117th SCF meeting) (17 June 1999) http://europa.eu.int/comm/food/fs/sc/scf/out37_en.pdf

16420 000123-91-1 Dioxane Same 51160 D 6A +

16450 000646-06-0 1,3-Dioxolane DIR SML = 0.05 mg/kg 3 Under re-evaluation ----------------------------------------------------- R = 0.05 mg/kg of food. Available: migration and usage data showing exposure will be below 50 ppb, adequate 14-day, inadequate 28-day and 7-month oral toxicity studies, 3 inadequate reproduction studies, adequate teratogenicity study, several in vitro and in vivo mutagenicity studies. (CS/PM/2325, 1993-12-21).

+

16480 000126-58-9 Dipentaerythritol Same 51200 DIR 2 Group TDI: 1 mg/kg b.w. (with pentaerythritol). (SCF, 17th Series, 1986).

+ +

16510 000138-86-3 Dipentene Same 51300 D 8 Data made available for assessment of chewing gum not available for this group.

+ +

16540 000102-09-0 Diphenyl carbonate Same 51420 DIR SML = 0.05 mg/kg 3 SCF_List: 3 Restriction: 0.05 mg/kg of food Based on the reduced core set of toxicological data according to the migration level. Remark for Commission: In the absence of relevant information, the Fat (Consumption) Reduction Factor should not be applied to this substance See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf

+

16570 004128-73-8 Diphenylether-4,4'-diisocyanate

DIR QM(T) = 1 mg/kg (expressed as NCO)


+






AND SPECIFICATIONS


60

(26).

16600 005873-54-1 Diphenylmethane-2,4'-diisocyanate



+ +

16630 000101-68-8 Diphenylmethane-4,4'-diisocyanate



+ +

16650 000127-63-9 Diphenyl sulphone Same 51570 DIR SML(T) = 3 mg/kg (25)

3 R = 3 mg/kg food (same reference as REF_N. 51570). Remark : the same substance was previously evaluated as an additive (see Opinion on an additional list of monomers and additives for food contact materias expressed on 23 September 1999, at the 118th meeting of the SCF) and the same evaluation is extended now to its requested use as monomer. (Adopted at the 128th SCF meeting, 12 July 2001) http://europa.eu.int/comm/food/fs/sc/scf/out97_en.pdf

+

16660 000110-98-5 Dipropyleneglycol DIR 2 t-TDI: 1.5 mg/kg b.w. (SCF, 6th Series, 1978).

+ +

16670 034590-94-8 Dipropyleneglycol monomethyl ether

Same 51870 8 Data inadequate. +

16690 001321-74-0 Divinylbenzene DIR QMA = 0.01 mg/6 dm² or SML = ND (DL = 0.02 mg/kg, analytical tolerance included) for the sum of Divinylbenzene and Ethylvinylbenzene and in compliance with the specifications laid down in Annex V

4A R = Not detectable. Sum of divinylbenzene and ethylvinylbenzene (DL = 0.01 mg/kg). Available: calculated worst case migration < 1.3 ug/kg food, based on the determination of the residual content; two gene mutation assays in bacteria (negative); mouse inhalation study (shows weak clastogenic activity); acute toxicity data; skin/eye irritation study. RIVM/ISS/TNO SDS, February 2001 = CS/PM/2959 REV. III/16690. Remark for Commission: - Only a method for the determination of the residual content is available - Petition covers a mixture of substances of divinylbenzene and ethylvinylbenzene

+ +




AND SPECIFICATIONS


61

(Adopted at the 128th SCF meeting, 12 July 2001) http://europa.eu.int/comm/food/fs/sc/scf/out97_en.pdf

16697 000693-23-2 n-Dodecanedioic acid DIR 3 Toxicologically acceptable. Available: migration data in food simulants; gene mutation assay in bacteria (negative); gene mutation assay in cultured mammalian cells (negative); micronucleus assay (negative); 90-day oral rat study. RIVM/DK/TNO SDS, November 2000 = CS/PM/3793/16697. Remark: A high log Po/w of 3.17 can indicate the potential for accumulation but as the substance is readily metabolised by the normal fat metabolising route this is not the case for DDDA. For this reason there is also no reason for specifying a migration limit. (Adopted by the SCF at the 127th meeting, 30 May 2001) http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

+ +

16701 000112-53-8 1-Dodecanol Same 51975 3 See references for "Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N. 12375) in SCF list 3.

+

16704 000112-41-4 1-Dodecene DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Available: Adequate migration data, showing specific migration of 1-dodecene is <0.05 mg/kg food; three (negative) mutagenicity studies. (RIVM/ISS/TNO SDS, August 1997 = CS/PM/3063/16704). (Adopted at 111th SCF meeting (18-19 March 1998)). http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

+

16719 003813-52-3 Endomethylenetetrahydrophthalic acid

D 8 +








AND SPECIFICATIONS


62

16720 000826-62-0 Endomethylenetetrahydrophthalic anhydride

D 8 +

16750 000106-89-8 Epichlorohydrin Same 14570 DIR QM = 1 mg/kg in FP 4A Highly toxic. Induces forestomach tumours in rats after oral administration. (Report from Nat. Inst. of Publ. Health, Bilthoven 1982; International Program on Chemical Safety, Series Environmental Health Criteria, WHO, 33, 1984).

+ +

16778 000107-21-1 1,2-Ethanediol Same 16990 and 53650

D 2 + +

16780 000064-17-5 Ethanol Same 52800 DIR 1 Acceptable. (SCF, 11th Series, 1981).

+ +

16810 - Ether alcohols D 9 +

16840 - Ethers of N-methylolacrylamide

D 9 +

16870 - Ethers of N-methylolmethacrylamide

D 9 +

16900 013036-41-4 N-(Ethoxymethyl)acrylamide

D 6A +

16910 000111-35-3 3-Ethoxy-1-propanol 8 +

16925 009004-57-3 Ethylcellulose Same 53280 2 Group TDI : not specified based on Group ADI (=not specified) for certain modified cellulose. (JECFA 35 M., 1989).

+

16930 000075-00-3 Ethyl chloride D 8 +

16950 000074-85-1 Ethylene DIR 3 Residues of this gas in plastics are very small. The gas has low toxic potential. Migration into food will be toxicologically negligible. (Patty's Industrial Hygiene and Toxicology, 3rd ed. 1981).

+ +

16955 000096-49-1 Ethylene carbonate 3AM 3 Restriction: Residual content of ethylene carbonate: 5 mg/kg hydrogel at a maximum ratio of 10 g hydrogel/kg food. Ethylene glycol: SML= 30 mg/kg food Remark for Commission: No method available for specific migration; only a QM method for the monomer and ethylene

+


AND SPECIFICATIONS


63

glycol (hydrolysis product) http://www.efsa.eu.int/science/afc/afc_opinions/190/opinion_afc_06_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out141_en.pdf

16960 000107-15-3 Ethylenediamine Same 15272 and 53540

DIR SML = 12 mg/kg 2 TDI: 0.2 mg/kg b.w. Two 90-day oral rat studies. (ICI report, April 1975).

+ +

16990 000107-21-1 Ethyleneglycol Same 16778 and 53650


2 Group TDI = 0.5 mg/kg b.w. (with diethyleneglycol). See references for diethyleneglycol.

+ +

16993 000111-76-2 Ethyleneglycol monobutyl ether

Same 53765 2 Group t-TDI : 0.05 mg/kg b.w. (with 15780=48050, 16993=53765, 16996=53820, 16999, 17002=53860, 30015, 30120, 30200, 48030). See references for 16996.

+

16996 000110-80-5 Ethyleneglycol monoethyl ether

Same 53820 2 Group t-TDI : 0.05 mg/kg b.w. (with 15780=48050, 16993=53765, 16996=53820, 16999, 17002=53860, 30015, 30120, 30200, 48030, 48050) pending evaluation of NTP rat and mouse studies. Several short term oral rat and dog studies, reproduction and teratogenicity studies. Carcinogenicity studies in mice and rats not reported. Mutagenicity studies inadequate. (RIVM summary, March 1991 (=CS/PM/922) and RIVM SDS, July 1996 (= CS/PM/2916).

+

17005 000151-56-4 Ethyleneimine Same 53950 DIR SML = ND (DL = 0.01 mg/kg).

4A Highly toxic by all exposure routes. Carcinogenic for mice orally. (IARC Monographs Vol 9, p. 37, Lyon 1975).

+ +

17020 000075-21-8 Ethylene oxide DIR QM = 1 mg/kg in FP 4A Strongly mutagenic in several studies. Induces forestomach tumours in rats after oral administration. (Brit. J. Cancer, 1982, 46, 924; IARC Monographs Vol. 11 and Suppl. 4, Lyon 1976 and 1982; Toxicity of ethylene oxide and its relevance to man. ECETOC,

+ +

http://www.efsa.eu.int/science/afc/afc_opinions/190/opinion_afc_06_en1.pdf





AND SPECIFICATIONS


64

Technical Report n. 5, 1982).

17040 000149-57-5 2-Ethylhexanoic acid Same 54120 D 6B Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg of food, peroxisome proliferation studies too.

+ +

17050 000104-76-7 2-Ethyl-1-hexanol DIR SML = 30 mg/kg 1 ADI: 0.5 mg/kg b.w. (JECFA 41 M., 1993)

+ +

17080 000103-44-6 2-Ethylhexyl vinyl ether D 7 Needed: provided hydrolysis can be demonstrated, data on 2-ethylhexanol are requested.

+

17110 016219-75-3 5-Ethylidenebicyclo[2.2.1]hept-2-ene

DIR QMA = 0.05 mg/6dm². The ratio surface/quantity of food shall be lower than 2 dm²/kg

3 SCF_L: 3 Restriction: 0.05 mg/kg of food. Based on the reduced core set of toxicological data according to the migration level. Remark for Commission: Only a QM method is available, therefore a QMA limit is applicable. (Adopted at the 136th SCF meeting, 5 March 2003) http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdf

+ +

17111 038233-76-0 2-Ethylidene-1,4:5,8-dimethano-1,2,3,4,4a,5,8,8a-octahydronaphthalene

+

17116 005877-42-9 4-Ethyl-1-octyn-3-ol D 8 +

17118 025429-37-2 Ethylphenol 8 +

17120 000090-00-6 2-Ethylphenol 8 +

17121 000620-17-7 3-Ethylphenol 8 +

17122 000123-07-9 4-Ethylphenol 8 +

17140 000109-92-2 Ethyl vinyl ether D 7 Needed: hydrolysis data. +

17150 000078-27-3 1-Ethynylcyclohexanol D 8 +

17160 000097-53-0 Eugenol DIR SML = ND (DL = 0.02 mg/kg, analytical tolerance included)

4A Metabolize into epoxyeugenol having initiating activity. (RIVM summary data, 12.05.1992 (cs/pm/1586)).

+

17170 061788-47-4 Fatty acids, coco DIR 3 Equal to or similar to food fats. + +




AND SPECIFICATIONS


65

17175 068938-15-8 Fatty acids, coco, hydrogenated

3 Toxicologically acceptable. +

17195 091051-35-3 Fatty acids, peanut oil W +

17200 068308-53-2 Fatty acids, soya Same 88650 DIR 3 Equal to or similar to food fats. + +

17215 - Fatty acids, sunflower oil 3/D Equal to or similar to food fats. +

17230 061790-12-3 Fatty acids, tall oil Same 54710/0 and

54710/1

DIR 3 + +

17233 073138-53-1 Fatty acids, tall oil, dimers

8 +

17245 008016-13-5 Fish oil 3 Food fat. +

17247/1 - Fish oil fatty acids 3 Constituents of food fats. +

17260 000050-00-0 Formaldehyde Same 54880 DIR SML(T) = 15 mg/kg (22)

3 Residues of this gas in plastics will be very small. Formaldehyde is a normal intermediate in human metabolism. Carcinogenic for rats by inhalation at concentrations irritant to the respiratory tract. (Final report on a chronic inhalation study in rats and mice exposed to formaldehyde). (Battelle Columbus Labs. Columbus, Ohio, 1981).

+ +

17275 000064-18-6 Formic acid Same 55040 1 Group ADI : 3 mg/kg b.w. for formic acid and ethyl formate. (JECFA 17 M., 1973).

+

17290 000110-17-8 Fumaric acid Same 55120 DIR 1 ADI: 6 mg/kg b.w. (SCF, 25th Series, 1990).

+ +

17305 000141-02-6 Fumaric acid, bis(2-ethylhexyl) ester

D 8 +

17320 002807-54-7 Fumaric acid, diallyl ester

D 6A +

17350 000105-75-9 Fumaric acid, dibutyl ester


17365 002402-58-6 Fumaric acid, didodecyl ester

7 Needed: hydrolysis data. +

17380 000623-91-6 Fumaric acid, diethyl ester


17392 007283-70-7 Fumaric acid, 7 Available: 100% hydrolysis in intestinal +


AND SPECIFICATIONS


66

diisopropyl ester fluid within 30-40 minutes to mono-isopropylester of fumaric acid and isopropanol. Needed: migration and toxicological data of fumaric acid, diisopropyl ester according to the guidelines. (RIVM/TNO SDS, January 1999 = CS/PM/3252/17392). (Adopted at 117th SCF meeting) (17 June 1999) http://europa.eu.int/comm/food/fs/sc/scf/out37_en.pdf

17398 007283-68-3 Fumaric acid, dioctadecyl ester


17410 - Fumaric acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C18)

D 9 +

17440 - Fumaric acid, esters with alcohols, aliphatic, monohydric, unsaturated (C3-C18)

D 9 +

17470 - Fumaric acid, esters with alcohols, polyhydric

D 9 +

17500 000098-01-1 Furfural D 7 Needed: 90-day oral study and mutagenicity studies.

+ +

17505 000098-00-0 Furfurol Same 55160 8 +

17530 000050-99-7 Glucose DIR 0 +

17560 - Glucosides obtained from glucose and 1,3-butanediol


17590 - Glucosides obtained from glucose and 1,4-butanediol


17620 - Glucosides obtained from glucose and diethyleneglycol

D 7 Needed: hydrolysys data. +

17650 - Glucosides obtained D 7 Needed: hydrolysis data. +




AND SPECIFICATIONS


67

from glucose and 2,2-dimethyl-1,3-propanediol

17680 - Glucosides obtained from glucose and ethyleneglycol


17710 - Glucosides obtained from glucose and glycerol


17740 - Glucosides obtained from glucose and 1,6-hexanediol


17770 - Glucosides obtained from glucose and 1,2,6-hexanetriol


17800 - Glucosides obtained from glucose and pentaerythritol


17830 - Glucosides obtained from glucose and polyethyleneglycol (Mw > 200)


17860 - Glucosides obtained from glucose and polypropyleneglycol (Mw > 400)


17890 - Glucosides obtained from glucose and propanediol


17920 - Glucosides obtained from glucose and sorbitol


17950 - Glucosides obtained from glucose and sucrose


17980 - Glucosides obtained from glucose and 1,1,1-trimethylolpropane


18010 000110-94-1 Glutaric acid Same 55680 DIR 0 +

18040 029733-18-4 Glutaric acid, diisodecyl Same 55760 D 8 +


AND SPECIFICATIONS


68

ester

18070 000108-55-4 Glutaric anhydride DIR 3 Hydrolises to corresponding acid. +

18100 000056-81-5 Glycerol Same 55920 DIR 1 Group ADI: not specified for glycerol, glycerol diacetate, glycerol triacetate and glycerol monoacetate. (SCF, 11th Series, 1981).

+ +

18115 031566-31-1 Glycerol monostearate Same 57520 1 ADI : not specified. (JECFA 17 M., 1973).

+

18120 000107-22-2 Glyoxal Same 58310 6A +

18124 008016-24-8 Hempseed oil 3 Food fat. +

18126/1 - Hempseed oil fatty acids 3/D Constituents of food fats. +

18130 004371-64-6 1,1-Heptadecanedicarboxylic acid

D 8 +

18150 000111-70-6 1-Heptanol 3 See references for "Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)" (PM/REF_N. 12375) in SCF list 3.

+

18160 025339-56-4 Heptene D 8 +

18190 000592-76-7 1-Heptene D 8 +

18220 068564-88-5 N-Heptylaminoundecanoic acid

DIR SML = 0.05 mg/kg (1) 3 R:= 0.05 mg/kg of food. Available: migration into non-fat simulants, 5 negative mutagenicity studies, 90-day oral rat study (CS/PM/2376). Remark: since high migration into fat has been demonstrated, the WG recommends that the Commission take the necessary measures so that the restriction proposed is not exceeded.

+

18250 000115-28-6 Hexachloroendomethylenetetrahydrophthalic acid

Same 14527 DIR SML = ND (DL = 0.01 mg/kg)

4A Cancer in lung and liver of rats and mice, positive in mutagenicity study in mouse lymphoma cells. (NTP techn. Rep. 304, NIH publ. 87-2560 April 1987).

+

18280 000115-27-5 Hexachloroendomethylenetetrahydrophthalic anhydride

DIR SML = ND (DL = 0.01 mg/kg)

4A Hydrolyses easily to acid known for induction of lung cancer.

+

18310 036653-82-4 1-Hexadecanol Same 58790 DIR 3 See references for "Alcohols, aliphatic, + +


AND SPECIFICATIONS


69

monohydric, saturated,linear, primary (C4-C22)" (PM/REF.N. 12375) in SCF list 3.

18340 000822-28-6 Hexadecyl vinyl ether D 7 Needed: hydrolysis data. +

18370 000592-45-0 1,4-Hexadiene DIR 7 Available: calculated worst case migration < 0.012 mg/kg food; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (positive); gene mutation assay in cultured mammalian cells (positive); in vivo micronucleus assay in rats by inhalation (negative); acute toxicity data; two 4-hour inhalation rat studies; 28-day inhalation rat study; metabolism study. Needed: in first instance an in vivo micronucleus assay with an appropriate route (other than inhalation) and if negative an in vivo UDS assay should be performed. RIVM/FR/TNO SDS, February 2000 = CS/'PM/2421 REV. II/18370. (Adopted at the 121 SCF meeting (20 June 2000)) http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdf

+

18400 000592-42-7 1,5-Hexadiene D 7 Available: 4-week rat study by inhalation and mutagenicity tests. Needed: migration data and gene mutation in mammalian cells in vitro. If migration exceeds 0.05 mg/kg of food, additional study according to SCF guidelines should be supplied.

+

18430 000116-15-4 Hexafluoropropylene DIR SML = ND (DL = 0.01 mg/kg)

4A Not detectable. Available: gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (positive); gene mutation assay in cultured mammalian cells (negative); micronucleus assay (positive); UDS assay (negative). RIVM SDS, October 2000 = CS/PM/923 REV. I/18430.

+ +




AND SPECIFICATIONS


70

(Adopted by the SCF at the 127th meeting, 30 May 2001) http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

18436 001687-30-5 Hexahydrophthalic acid Same 14875 D 8 +

18441 000085-42-7 Hexahydrophthalic anhydride

D 8 +

18444 001076-97-7 Hexahydroterephthalic acid

7 (Adopted at 114th SCF meeting) (10 December 1998) http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

+

18449 003089-11-0 N,N,N',N',N'',N''-Hexakis(methoxymethyl)-2,4,6-triamino-1,3,5-triazine

8 +

18460 000124-09-4 Hexamethylenediamine Same 15274 and 59240

DIR SML = 2.4 mg/kg 2 TDI: 0.04 mg/kg b.w. A 28-day oral rat study. (RIV report n. 48/80 March 1981).

+ +

18490 015511-81-6 Hexamethylenediamine adipate

D 8 +

18520 038775-37-0 Hexamethylenediamine azelate


18550 - Hexamethylenediamine dodecanedicarboxylate

D 8 +

18580 - Hexamethylenediamine heptadecanedicarboxylate

D 8 +

18610 006422-99-7 Hexamethylenediamine sebacate

D 8 +

18640 000822-06-0 Hexamethylene diisocyanate


4A See references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl (PM/REF.N. 16240).

+ +

18670 000100-97-0 Hexamethylenetetramine Same 59280 DIR SML(T) = 15 mg/kg (22) (expressed as Formaldehyde)

3 Formaldehyde liberator. Evaluated by JECFA as a preservative for food. Amounts of formaldehyde likely to migrate into food are of no toxicological significance. (JECFA 17 M., 1993)

+ +

18700 000629-11-8 1,6-Hexanediol DIR SML = 0.05 mg/kg 3 SCF_list: 3 Restriction: 0.05 mg/kg of food.

+ +






AND SPECIFICATIONS


71

See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf

18730 002935-44-6 2,5-Hexanediol D 7 +

18760 000106-69-4 1,2,6-Hexanetriol D 8 +

18780 000111-27-3 1-Hexanol 3 See references for "Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N.12375) in SCF list 3.

+ +

18790 025264-93-1 Hexene D 8 +

18820 000592-41-6 1-Hexene DIR SML = 3 mg/kg 3 R = 3 mg/kg of food. Available: Migration data, 5 mutagenicity studies negative, 28-day and inadequate 90-day oral rat studies, 90-day inhalation rat study, combined reproduction/development toxicity screening study in rats, bioaccumulation. (TNO (Nov. 95) and Elias (Feb. 96) SDS CS/PM/2742, and RIVM summary data, 14-02-1991).

+ +

18850 000107-41-5 Hexyleneglycol Same 22072 and 59600

D 7 Needed: purity, physicochemical state, migration data.

+

18865 003031-66-1 3-Hexyn-2,5-diol D 8 +

18867 000123-31-9 Hydroquinone Same 15940, 48620 and

60060

DIR See "1,4-Dihydroxybenzene"

+ +

18875 151841-65-5 Hydroxy aluminium bis[2,4,8,10-tetra-tert.butyl-6-hydroxy-12h-dibenzo[d,g][1.3.2]-dioxaphosphocin-6-oxide

34650 3 +

18880 000099-96-7 p-Hydroxybenzoic acid DIR 2 TDI: 10 mg/kg b.w. The value of the TDI is based upon the evaluation of the esters. (JECFA 17 M., 1993)

+

18888 080181-31-3 3-Hydroxybutanoic acid-3-hydroxyopentanoic acid, copolymer

DIR In compliance with specifications included in Annex V

3 SML = 0.05 mg/kg of food (for crotonic acid). Available: Extensive data on production process and impurities; on copolymer, 28-day and 90-day oral rat studies, and two

+




AND SPECIFICATIONS


72

mutagenicity studies, negative; on the impurity crotonic acid, two mutagenicity tests, negative. (CS/PM/1510 of 25.03.92; CS/PM/2317 and 2538 of 10.02.95). Toxicologically acceptable provided the following specifications are met: STRUCTURAL FORMULA CH3 CH3 O CH2 O [-0-CH-CH2-C-]m-[O-CH-CH2-C-]n n/(m + n) greater than 0 and less or equal to 0.25 DESCRIPTION These copolymers are produced by the controlled fermentation of Alcaligenes eutrophus using mixtures of glucose and propanoic acid as carbon sources. The organism used has not been genetically engineered and has been derived from a single wild-type organism Alcaligenes eutrophus strain H16 NCIMB 10442. Master stocks of the organism are stored as freeze-dried ampoules. A submaster/working stock is prepared from the master stock and stored in liquid nitrogen and used to prepare inocula for the fermenter. Fermenter samples will be examined daily both microscopically and for any changes in colonial morphology on a variety of agars at different temperatures. The copolymers are isolated from heat treated bacteria by controlled digestion of the other cellular components, washing and


AND SPECIFICATIONS


73

drying. After isolation these copolymers are in the form of a white to off-white powder. These copolymers are normally offered as formulated, melt formed granules containing additives such as nucleating agents, plasticisers, fillers, stabilisers and pigments which all conform to the general and individual specifications. These copolymers are soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically insoluble in ethanol, aliphatic alkanes and water. MOLECULAR WEIGHT This copolymer must have a weight average molecular weight which is not less than 150,000 Daltons as measured by gel permeation chromatography. PURITY The migration of crotonic acid should not exceed 0.05 mg/kg food. Prior to granulation the raw material copolymer powder must contain: - not less than 98% poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate) analysed after hydrolysis as a mixture of 3-D-hydroxy butanoic and 3-D-hydroxypentanoic acids; - nitrogen content must be less than or equal to 2500 micrograms per gram; - zinc content must be less than or equal to 100 mg/Kg of plastic - copper content must be less than or equal to 5 mg/kg of plastic - lead content must be less than or equal to 2 mg/kg of plastic - arsenic content must be less than or equal to 1 mg/kg of plastic - chromium content must be less than or equal to 1 mg/kg of


AND SPECIFICATIONS


74

plastic.

18896 001679-51-2 4-(Hydroxymethyl)-1-cyclohexene

DIR SML = 0.05 mg/kg 3 SCF_List: 3 Restriction: 0.05 mg/kg of food. Based on the reduced core set of toxicological data according to the migration level. Remark for Commission: used in oxygen scavenging polymer; no direct food contact (except for dry foods). See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf

+

18897 016712-64-4 6-Hydroxy-2-naphthalenecarboxylic acid

DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg food Available: migration data from monolayer in direct contact with food simulants (SM < 0.046 mg/kg food); gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (positive); gene mutation assay in cultured mammalian cells (negative); in vivo micronucleus assay (negative). RIVM/TNO SDS, December 2000 = CS/PM/3812/18897. (Adopted at the 128th SCF meeting, 12 July 2001) http://europa.eu.int/comm/food/fs/sc/scf/out97_en.pdf

+

18898 000103-90-2 N-(4-Hydroxyphenyl) acetamide

DIR SML = 0.05 mg/kg 3 SCF_List: 3 Restriction: 0.05 mg/kg of food. Based on the reduced core set of toxicological data according to the migration level. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf

+

18900 000106-14-9 12-Hydroxystearic acid Same 61840 3/0 SCF_List: 3 Restriction: none. In small doses metabolised similarly to food fats See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf

+










AND SPECIFICATIONS


75

18905 002628-17-3 4-Hydroxystyrene D 6A +

18910 000288-32-4 Imidazole D 8 +

18940 000095-13-6 Indene D 8 +

18960 000089-65-6 Isoascorbic acid W +

18970 000078-83-1 Isobutanol Same 62270 D 8 Residue less than 1 mg/kg in food. No mutagenicity and oral data. (Directive 88/344/EEC).

+ +

19000 000115-11-7 Isobutene DIR 3 Residues of this gas in plastics are very small. The gas has low toxic potential. Migration into food will be toxicologically negligible. (Patty's Industrial Hygiene and Toxicology, 3rd ed, 1981).

+ +

19030 016669-59-3 N-(Isobutoxymethyl)acrylamide

D 6A +

19045 004548-27-0 N-(Isobutoxymethyl)methacrylamide

6A +

19060 000109-53-5 Isobutyl vinyl ether DIR QM = 5 mg/kg in FP 3 R = 0.05 mg/kg of food. Available: Hydrolysis data for iso-butylvinylether, showing rapid total (100%) hydrolysis of the monomer in simulated gastric fluid into isobutanol and acetaldehyde; calculated (worst case) migration is <0.05 mg/kg food, assuming 100% migration of residual isobutyl-vinylether from a typical dispersion film; three (negative) mutagenicity studies. (RIVM/ISS/TNO SDS, October 1996 = CS/PM/2907/19060). (Adopted at 111th SCF meeting (18-19 March 1998)). http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

+ +

19090 000078-84-2 Isobutyraldehyde D 8 +

19110 004098-71-9 1-Isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane

Same 19147 DIR QM(T) = 1 mg/kg (expressed as NCO) (26).

4A + +




AND SPECIFICATIONS


76

19120 025339-17-7 Isodecanol D 8 +

19130 026896-18-4 Isononanoic acid D 8 +

19140 026952-21-6 Isooctanol D 8 +

19145 002855-13-2 Isophorone diamine Same 12670 D + +

19147 004098-71-9 Isophorone diisocyanate Same 19110 D + +

19150 000121-91-5 Isophthalic acid DIR SML = 5 mg/kg 3 R = 5 mg/kg of food. Available: Migration data, 7 mutagenicity studies regarded as non-genotoxic, 28-day inhalation and 90-day oral rat studies, inhalation rat teratology study limited absorption and excretion data (RIVM/TNO SDS CS/PM/2757, January 96).

+ +

19180 000099-63-8 Isophthalic acid dichloride

D 7 Needed: original data on migration and genotoxicity.

+ +

19210 001459-93-4 Isophthalic acid, dimethyl ester

DIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg in food. Available: 3 mutagenicity tests, negative. Migration data less than 0.050 mg/kg. (Rivm summary data, May 1991, CS/PM/969).

+ +

19240 000744-45-6 Isophthalic acid, diphenyl ester

D 8 + +

19243 000078-79-5 Isoprene Same 21640 DIR See "2-Methyl-1,3-butadiene"

+ +

19255 000080-05-7 4,4'-Isopropylidenediphenol

Same 13480/13607/62540/400

60/39680


+ +

19270 000097-65-4 Itaconic acid DIR 0 Normal human metabolite. + +

19300 002155-60-4 Itaconic acid, dibutyl ester


19315 000617-52-7 Itaconic acid, dimethyl ester

8 +

19330 007748-43-8 Itaconic acid, 2,3-epoxypropyl diester

D 6A +

19360 - Itaconic acid, 2,3-epoxypropyl monoester

D 6A +

19390 - Itaconic acid, esters with alcohols, aliphatic,

D 9 +




AND SPECIFICATIONS


77

monohydric, saturated(C1-C18)

19420 - Itaconic acid, esters with alcohols, polyhydric

D 9 +

19435 - Itaconic acid, methyl esters

9 +

19450 - Lactams of omega-aminocarboxylic acids, aliphatic, linear (C7-C12)

D 9 +

19460 000050-21-5 Lactic acid Same 62960 DIR 1 ADI : not specified. (SCF, 25th Series, 1990).

+ +

19470 000143-07-7 Lauric acid Same 63280 DIR 0 + +

19480 002146-71-6 Lauric acid, vinyl ester DIR 3 Complete hydrolysis in simulated intestinal fluid to lauric acid and acetaldehyde (CS/PM/2334). Positive in gene mutation and chromosome aberration studies in vitro, most likely due to formation of acetaldehyde (CS/PM/2385).

+ +

19490 000947-04-6 Laurolactam DIR SML = 5 mg/kg 3 R = 5 mg/kg of food. Available: specific migration data; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); 90-day oral rat study. (RIVM/TNO SDS, July 1999 = CS/PM/2574 REV. II/19490). (Adopted at the 119th SCF meeting) (2 December 1999) http://europa.eu.int/comm/food/fs/sc/scf/out50_en.pdf

+ +

19510 011132-73-3 Lignocellulose DIR 3 Natural, non digestible fibre. +

19518 000060-33-3 Linoleic acid Same 64015 0 +

19526 028290-79-1 Linolenic acid Same 64150 0 +

19532 008001-26-1 Linseed oil Same 64160 3 Food fat. +

19534/1 - Linseed oil fatty acids 3/D Constituents of food fats. +

19540 000110-16-7 Maleic acid Same 64800 DIR SML(T) = 30 mg/kg 2 Group TDI = 0.5 mg/kg b.w. as maleic acid. + +




AND SPECIFICATIONS


78

(4) (SCF, 17th Series, 1986).

19570 000999-21-3 Maleic acid, diallyl ester D 6A + +

19600 000105-76-0 Maleic acid, dibutyl ester D 7 Under evaluation + +

19630 071550-61-3 Maleic acid, diester with 1,2-propanediol


19660 000141-05-9 Maleic acid, diethyl ester D 7 Needed: hydrolysis data. +

19690 014234-82-3 Maleic acid, diisobutyl ester


19720 001330-76-3 Maleic acid, diisooctyl ester


19750 000624-48-6 Maleic acid, dimethyl ester


19780 002915-53-9 Maleic acid, dioctyl ester D 7 Needed: hydrolysis data. + +

19810 - Maleic acid, esters with alcohols, aliphatic, saturated (C1-C18)

D 9 +

19840 - Maleic acid, esters with alcohols, polyhydric

D 9 +

19870 - Maleic acid, ester with 1,3-butanediol


19900 002424-58-0 Maleic acid, monoallyl ester

D 6A + +

19915 000925-21-3 Maleic acid, monobutyl ester


19930 - Maleic acid, monoesters with alcohols, aliphatic, monohydric, unsaturated(C3-C18)

D 9 +

19936 007423-42-9 Maleic acid, mono(2-ethylhexyl) ester

D 8 + +

19945 003052-50-4 Maleic acid, monomethyl ester

7 Needed : hydrolysis data. +

19960 000108-31-6 Maleic anhydride Same 64900 DIR SML(T) = 30 mg/kg (4) (expressed as Maleic acid).

2 Group TDI = 0.5 mg/kg b.w. as maleic acid. (SCF, 6th Series, 1978).

+ +

19972 000087-78-5 Mannitol Same 65520 1 ADI : acceptable. (SCF, 16th Series, 1985).

+

19975 000108-78-1 Melamine Same 25420, DIR See "2,4,6-Triamino- 2 See references for the same substance in + +


AND SPECIFICATIONS


79

65360 and 93720

1,3,5-Triazine" additive list.

19977 000060-24-2 2-Mercaptoethanol 8 +

19990 000079-39-0 Methacrylamide DIR SML = ND (DL =0.02 mg/kg, analytical tolerance included)

4A The classification is based on the decision made on the structurally related compound acrylamide classified in L4A and because it is not detected in food/food simulants. Available: migration data; Ames test; dominant lethal assay; 2 generation reproduction study; teratogenicity study in mice and three neurotoxicity studies. (RIVM/TNO SDS, November 1996 = CS/PM/2961).

+ +

20005 051410-72-1 Methacrylamidopropyltrimethylammonium chloride

6A +

20020 000079-41-4 Methacrylic acid DIR 2 Group t-TDI: 0.1 mg/kg b.w. pending the results of an adequate oral study. Available: a 2-year oral rat study and several other studies in several animal species with methyl methacrylate. (Tox. Appl. Pharmacol., 6, 1984, 29-36; RIV doc. Tox. 300730, February 1983).

+ +

20040 090551-76-1 Methacrylic acid, alkyl(C12-C16) esters

W +

20045 090551-83-0 Methacrylic acid, alkyl(C16-C18) esters

W +

20050 000096-05-9 Methacrylic acid, allyl ester

DIR SML = 0.05 mg/kg 3 R : 0.05 mg/kg of food. Available: Adequate migration data and analytical method and stability data in food simulants; three negative mutagenicity studies. (RIVM/DK/TNO SDS, June 1998= CS/PM/3077/Rev.1/20050). (Adopted at 114th SCF meeting) (10 December 1998) http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

+ +




AND SPECIFICATIONS


80

20080 002495-37-6 Methacrylic acid, benzyl ester

DIR 2 Group t-TDI: 0.1 mg/kg bw (as methacrylic acid). Hydrolysis (complete) data allow the allocation of the same TDI as methacrylic acid.

+ +

20090 003775-90-4 Methacrylic acid, 2-(tert-butylamino)ethyl ester

W +

20095 046729-07-1 Methacrylic acid, 4-tert-butylcyclohexyl ester

D 8 +

20110 000097-88-1 Methacrylic acid, butyl ester

DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as methacrylic acid). See references for methacrylic acid.

+ +

20140 002998-18-7 Methacrylic acid, sec-butyl ester


+ +

20170 000585-07-9 Methacrylic acid, tert-butyl ester


+ +

20200 001888-94-4 Methacrylic acid, 2-chloroethyl ester

D 8 +

20230 - Methacrylic acid, cyclohexylaminoethyl ester

D 8 +

20260 000101-43-9 Methacrylic acid, cyclohexyl ester

DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Remark for Commission: Method available for the determination of specific migration in aqueous and substitute food simulants (iso-octane). (Adopted at the 126th SCF meeting, 28 February 2001) http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdf

+ +

20290 016868-14-7 Methacrylic acid, cyclopentyl ester

D 8 +

20320 003179-47-3 Methacrylic acid, decyl ester


20350 - Methacrylic acid, (di-tert-butylamino)ethyl

D 8 +




AND SPECIFICATIONS


81

ester

20380 001189-08-8 Methacrylic acid, diester with 1,3-butanediol

D 8 Available: hydrolysis study shows incomplete hydrolysis.

+ +

20410 002082-81-7 Methacrylic acid, diester with 1,4-butanediol

DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Available: specific migration data in aqueous simulants and in iso-octane; two gene mutation assays in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (positive); gene mutation assay in cultured mammalian cells (negative); in vivo micronucleus assay (negative). acute toxicity test (LD50); three sensitisation tests (two positive and one negative); RIVM/UK/TNO SDS, December 1998 = CS/PM/3219 REV. I/20410. (Adopted at the 121 SCF meeting (20 June 2000)) http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdf

+ +

20425 002358-84-1 Methacrylic acid, diester with diethyleneglycol

8 +

20430 001985-51-9 Methacrylic acid, diester with 2,2-dimethyl-1,3-propanediol

8 +

20440 000097-90-5 Methacrylic acid, diester with ethyleneglycol

DIR SML = 0.05 mg/kg 3 SCF_List: 3 Restriction: 0.05 mg/kg of food. Based on the reduced core set of toxicological data according to the migration level. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf

+ +

20455 006606-59-3 Methacrylic acid, diester with 1,6-hexanediol

D 8 + +

20470 025852-47-5 Methacrylic acid, diester with polyethyleneglycol

D 8 +

20490 000109-17-1 Methacrylic acid, diester with tetraethyleneglycol

8 +






AND SPECIFICATIONS


82

20495 000109-16-0 Methacrylic acid, diester with triethyleneglycol

W +

20500 000105-16-8 Methacrylic acid, 2-(diethylamino)ethyl ester

D 8 +

20530 002867-47-2 Methacrylic acid, 2-(dimethylamino)ethyl ester

DIR SML = ND (DL = 0.02 mg/kg, analytical tolerance included)

4A R = not detectable (detection limit = 10 ppb). Remark for Commission: * No method of analysis is available for the enforcement of an SML. * The substance hydrolyses readily at neutral pH and above and so it will be unstable in many foods. The substance is stable in simulant B and will not hydrolyse in simulant D. (Adopted at 114th SCF meeting) (10 December 1998) http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

+ +

20560 000142-90-5 Methacrylic acid, dodecyl ester


20590 000106-91-2 Methacrylic acid, 2,3-epoxypropyl ester

Same 16119 DIR QMA = 0.02 mg/6 dm² 4B QMA: 20 ug/6 dm². Remark for Commission: - Including the epoxide hydrolysis products is not needed if the restriction is on a QM basis. - If a future application is made for a higher restriction level, which could then permit use as an additive in PVC organosols, then chlorohydrin formation would need to be considered. (Adopted at 117th SCF meeting) (17 June 1999) http://europa.eu.int/comm/food/fs/sc/scf/out37_en.pdf

+ +

20620 - Methacrylic acid, esters with alcohols, aliphatic, monohydric, saturated(C1-C21)

D 9 +






AND SPECIFICATIONS


83

20650 - Methacrylic acid, esters with alcohols, aliphatic, monohydric, unsaturated(C4-C18)

D 9 +

20680 - Methacrylic acid, esters with alcohols, polyhydric (C2-C21)

D 9 +

20710 - Methacrylic acid, esters with etheralcohols

D 9 +

20740 039670-09-2 Methacrylic acid, ester with ethoxytriethyleneglycol

D 8 Available: hydrolysis (incomplete) data. + +

20770 - Methacrylic acid, esters with glycolethers obtained from mono and/or diglycols with alcohols, aliphatic, monohydric (C1-C18)

D 9 +

20800 024493-59-2 Methacrylic acid, ester with methoxytriethyleneglycol

D 8 +

20830 - Methacrylic acid, esters with 1,2-propanediol

D 8 + +

20860 005039-78-1 Methacrylic acid, ester with trimethylethanolammonium chloride

D 8 + +

20875 002370-63-0 Methacrylic acid, 2-ethoxyethyl ester

8 +

20890 000097-63-2 Methacrylic acid, ethyl ester


+ +

20920 000688-84-6 Methacrylic acid, 2-ethylhexyl ester

D 8 + +

20935 002495-27-4 Methacrylic acid, hexadecyl ester


20940 000142-09-6 Methacrylic acid, hexyl ester



AND SPECIFICATIONS


84

20945 004664-49-7 Methacrylic acid, 2-hydroxyisopropyl ester (=methacrylic acid, 2-hydroxy-1-methylethyl ester)


20950 000923-26-2 Methacrylic acid, 2-hydroxypropyl ester

D 8 Available: hydrolysis data. However no significant hydrolysis has been measured.

+ +

20965 002761-09-3 Methacrylic acid, 3-hydroxypropyl ester

D 8 +

20980 007534-94-3 Methacrylic acid, isobornyl ester

D 8 + +

21010 000097-86-9 Methacrylic acid, isobutyl ester


+ +

21040 029964-84-9 Methacrylic acid, isodecyl ester

D 8 + +

21070 028675-80-1 Methacrylic acid, isooctyl ester

D 8 +

21100 004655-34-9 Methacrylic acid, isopropyl ester


+ +

21115 000816-74-0 Methacrylic acid, methallyl ester

D 6A +

21130 000080-62-6 Methacrylic acid, methyl ester


+ +

21160 - Methacrylic acid, monoester with 1,3-butanediol

D 8 +

21170 000997-46-6 Methacrylic acid, monoester with 1,4-butanediol

D 8 +

21190 000868-77-9 Methacrylic acid, monoester with ethyleneglycol


+ +

21220 032360-05-7 Methacrylic acid, octadecyl ester

D 8 Hydrolysis negligible (CS/PM/1689). + +

21250 002157-01-9 Methacrylic acid, n-octyl ester



AND SPECIFICATIONS


85

21280 002177-70-0 Methacrylic acid, phenyl ester

DIR 2 Group t-TDI: 0.1 mg/kg bw. (as methacrylic acid). Hydrolysis (complete) data allow the allocation of the same TDI as methacrylic acid.

+ +

21310 003683-12-3 Methacrylic acid, phenylethyl ester

D 8 +

21340 002210-28-8 Methacrylic acid, propyl ester


+ +

21370 010595-80-9 Methacrylic acid, 2-sulphoethyl ester

DIR 4A Restriction: Not detectable Remark for Commission: Monomer is used in coatings and a specific migration (SM) method is not available. QMA restriction is applicable in this case. http://www.efsa.eu.int/science/afc/afc_opinions/190/opinion_afc_06_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf

+ +

21400 054276-35-6 Methacrylic acid, sulphopropyl ester, potassium salt

DIR QMA = 0.05 mg/6dm² 3 SCF_List: 3 Restriction: R = 0.05 mg/kg food. Based on the reduced core set of toxicological data and on the very low migration. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf

+ +

21415 002549-53-3 Methacrylic acid, tetradecyl ester


21420 007779-31-9 Methacrylic acid, 3,3,5-trimethylcyclohexyl ester

W +

21430 004245-37-8 Methacrylic acid, vinyl ester


21460 000760-93-0 Methacrylic anhydride DIR 2 Group t-TDI: 0.1 mg/kg b.w. (as methacrylic acid). See references for methacrylic acid.

+ +

21490 000126-98-7 Methacrylonitrile DIR SML = ND (DL = 0.020 mg/kg, analytical tolerance included)

4A The chemical structure is similar to acrylonitrile. Methacrylonitrile should be treated in the same way as acrylonitrile.

+ +

21495 004203-89-8 3-[2-(Methacryloxy)ethyl]-

W +








AND SPECIFICATIONS


86

2,2-spirocyclohexyloxazolidine

21520 001561-92-8 Methallylsulphonic acid, sodium salt

DIR SML = 5 mg/kg 3 R = 5 mg/kg of food. Remark: since the substance is very soluble in water and has no lipophilic structural elements, the absence of accumulation can be expected. No additional data concerning the absence of accumulation are requested. (Adopted at the 123rd SCF meeting, 19 October 2000) http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf

+ +

21540 006143-33-5 1,4-Methano-1,4,4a,9a-tetrahydro-9H-fluorene


21550 000067-56-1 Methanol Same 65960 DIR 3 The toxicity profile well known also from intoxication of man. The potential migration into food will not be of toxicological significance. (SCF, 6th Series, 1978).

+ +

21580 003644-11-9 N-(Methoxymethyl)acrylamide

D 6A + +

21610 003644-12-0 N-(Methoxymethyl)methacrylamide

D 6A + +

21615 000150-76-5 4-Methoxyphenol Same 66030 8 +

21620 000107-98-2 1-Methoxy-2-propanol Same 66050 8 +

21630 001187-59-3 N-Methylacrylamide 6A +

21640 000078-79-5 2-Methyl-1,3-butadiene Same 19243 DIR QM = 1 mg/kg in FP or SML = ND (DL = 0.02 mg/kg, analytical tolerance included)

4A N.D. Remark for Commission: no method of analysis is available. However, the CEN-method for butadiene can be adapted. (Adopted at the 123rd SCF meeting, 19 October 2000) http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf

+ +

21670 000563-46-2 2-Methyl-1-butene D 8 +






AND SPECIFICATIONS


87

21700 000513-35-9 2-Methyl-2-butene D 8 +

21730 000563-45-1 3-Methyl-1-butene DIR QMA = 0.006 mg/6 dm². For use only in Polypropylene.

4B R = Only to be used in polypropylene at maximum residue level 0.001 mg/dm² of material. Available: Analytical data and migration by worst case calculation, 3 mutagenicity tests of which gene mutation in bacterial cells and in mammalian cells in vitro negative, chromosome aberration test in mammalian cells in vitro positive. (RIVM/TNO/ISS CS/PM/2745, January 1996).

+

21733 000115-19-5 2-Methyl-3-butyn-2-ol D 8 4-week oral rat study. Data inadequate. (Bayer Rep. 12557, 1984-03-22).

+

21736 002549-61-3 alpha-Methyl-epsilon-caprolactone

D 8 +

21739 002549-60-2 beta-Methyl-epsilon-caprolactone

D 8 +

21742 002549-58-8 delta-Methyl-epsilon-caprolactone

D 8 +

21745 002549-59-9 epsilon-Methyl-epsilon-caprolactone

D 8 +

21748 002549-42-0 gamma-Methyl-epsilon-caprolactone

D 8 +

21760 000694-91-7 5-Methylenebicyclo(2,2,1)hept-2-ene

D 8 +

21765 106246-33-7 4,4'-Methylenebis(3-chloro-2,6-diethylaniline)

DIR QMA = 0.05 mg/6 dm² 3 R = 0.05 mg/kg of food. http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf Available: residual content; calculation of worst case migration < 0.05 mg/kg food; log Po/w; two gene mutation assays in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); micronucleus assay (negative); in vivo UDS assay (negative). RIVM/IT/UK SDS, April 2000 = CS/PM/3413/21765.

+




AND SPECIFICATIONS


88

Remark for Commission: only a method for the residual quantity in the finished product (FP) is available. A QMA is proposed. (Adopted at the 123rd SCF meeting, 19 October 2000)

21790 000110-26-9 Methylenebisacrylamide D 6A + +

21820 013093-19-1 Methylenebiscaprolactam

D 8 +

21821 000505-65-7 1,4-(Methylenedioxy)butane

Same 13810 DIR See "1,4-Butanediol formal"

+ +

21827 000078-93-3 Methyl ethyl ketone Same 66655 3 R: 5 mg/kg of food. Same references as 66655.

+

21837 001116-90-1 4-Methyl-1,4-hexadiene D 6A +

21850 000095-71-6 Methylhydroquinone Same 66680 D 8 +

21880 000717-27-1 Methylhydroquinone diacetate

D 8 +

21910 000814-78-8 Methyl isopropenyl ketone

Same 66740 D 8 +

21940 000924-42-5 N-Methylolacrylamide DIR SML = ND (DL = 0.01 mg/kg)

4A Genotoxic carcinogen. (RIVM report 04-03-1991).

+ +

21970 000923-02-4 N-Methylolmethacrylamide

Same 66820 DIR 7 SCF_list: 7 Needed data or information: Analytical proof of the residual content. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf

+ +

22000 001118-58-7 2-Methyl-1,3-pentadiene D 8 +



22090 000763-29-1 2-Methyl-1-pentene D 8 +

22120 000760-20-3 3-Methyl-1-pentene D 8 +

22150 000691-37-2 4-Methyl-1-pentene DIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg in food. 28- and 90-day oral rat studies. Ames test negative, cytogenicity study doubtful. (RIVM summary 1990-02-22).

+

22180 004461-48-7 4-Methyl-2-pentene D 8 +




AND SPECIFICATIONS


89

22190 002163-42-0 2-Methyl-1,3-propanediol

3 R = 5 mg/kg of food. Available: Worst case migration < 0.6 mg/kg food; log Po/w; three (negative) mutagenicity studies; 14-day oral rat study; 90-day oral rat study. (RIVM/ISS/TNO SDS, April 1997 = CS/PM/2998/22190). (Adopted at 111th SCF meeting (18-19 March 1998)). http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

+

22210 000098-83-9 alpha-Methylstyrene DIR 3 0.05 mg/kg food http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

+ +

22240 000622-97-9 p-Methylstyrene Same 26292 D 6A + +

22242 006144-04-3 alpha-Methylstyrene dimer

D +

22270 000107-25-5 Methyl vinyl ether D 7 Needed: hydrolysis data. +

22300 000078-94-4 Methyl vinyl ketone D 6A +

22330 001822-74-8 Methyl vinyl thioether D 6A +

22330/50 - Mixture of (80%) 2,4-diamino-3,5-diethyltoluene and (20%) 2,6-diamino-3,5-diethyltoluene

7 SCF_list: 7 Needed data or information: - an in vivo/in vitro rat liver UDS on a representative batch - an explanation for the contradictory results observed in the Ames test. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf

+

22331 025513-64-8 Mixture of (35-45% w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65% w/w)1,6-diamino-2,4,4-trimethylhexane

Same 15355 DIR QMA = 5 mg/6 dm² 3 Re-evaluation to align this evaluation with other evaluations done by the SCF. R = 5 mg/6 dm2. Remark for Commission: A QM would be indicated. The choice of a QM instead of SML is due to the reactivity of the substance

+ +










AND SPECIFICATIONS


90

with fat simulant. Available: migration data; three negative mutagenicity studies; 90-day oral rat study; 2-generation reproduction study (rat); two teratogenicity studies (rat and rabbit). RIVM/TNO SDS, November 2000 = CS/PM/2914/15355. (Adopted by the SCF at the 127th meeting, 30 May 2001) http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

22332 - Mixture of (40% w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60% w/w) 2,4,4-trimethylhexane-1,6-diisocyanate


4A Not detectable +

22333 000079-11-8 Monochloroacetic acid 3 R = 0.05 mg/kg of food. Available: migration data in water; two gene mutation assays in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (equivocal); in vitro SCE assay (positive); sex-linked recessive lethal assay in Drosophila melanogaster (negative); 16-day oral mouse and rat studies; 90-day oral mouse and rat studies; 2-year oral mouse and rat studies. (RIVM/DE/TNO SDS, October 1998 = CS/PM/3065 REV. II/22333). (Adopted at 117th SCF meeting) (17 June 1999) http://europa.eu.int/comm/food/fs/sc/scf/out37_en.pdf

+

22337 000141-43-5 2-Aminoethanol Same 35170, 67420

3 R = 0.05 mg/kg of food. Available: migration data from multilayer bottle and residual content in polymer; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured

+ +






AND SPECIFICATIONS


91

mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); in vitro cell transformation assay (negative); toxicology summary on reproductive toxicity; general toxicological overview on MEA (made by the applicant). RIVM/TNO SDS, August 1999 = CS/PM/3337/22337. Remark: substance evaluated only for the requested use of indirect contact with non-fatty food. (Adopted at the 121 SCF meeting (20 June 2000)) http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdf

22340 000074-89-5 Monomethylamine W8 Data inadequate. +

22350 000544-63-8 Myristic acid Same 67891 DIR 1 ADI: Not specified. (SCF, 25th Series, 1989).

+ +

22360 001141-38-4 2,6-Naphthalenedicarboxylic acid

DIR SML = 5 mg/kg 3 R: 5 mg/kg of food Available: migration tests according to EU directives; extraction tests according to FDA; log Po/w; acute toxicity data; skin and eye irritation studies; gene mutation assay in bacteria (negative); two chromosomal aberration assays in cultured mammalian cells (one positive and one inadequate); gene mutation assay in cultured mammalian cells (negative); micronucleus assay (negative); 90-day oral rat study. (RIVM/ISS/TNO SDS, April 1999 = CS/PM/2220 REV. II/22360). (Adopted at the 118th SCF meeting) (23 September 1999) http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf

+

22390 000840-65-3 2,6-Naphthalenedicarboxylic acid, dimethyl ester

DIR SML = 0.05 mg/kg 7 Available: specific migration < 0.024 mg/kg food in water and 15% ethanol and <0.24 mg/kg food in 3% acetic acid and olive oil;

+






AND SPECIFICATIONS


92

hydrolysis data; acute toxicity data; 90-day oral rat study; gene mutation assay in bacteria (negative); chromsomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); micronucleus assay (negative). Needed: information on the absence of accumulation of the compound. RIVM/TNO SDS, September 1999 = CS/PM/3085 REV. I/22390. (Adopted at the 121 SCF meeting (20 June 2000) http://europa.eu.int/comm/food/fs/sc/scf/out61_en.pdf

22420 003173-72-6 1,5-Naphthalene diisocyanate



+ +

22424 026761-45-5 Neodecanoic acid, 2,3-epoxypropyl ester

6A Covered by 25360. +

22428 051000-52-3 Neodecanoic acid, vinyl ester

D 7/D Deleted because covered by 25380. +

22437 000126-30-7 Neopentylglycol Same 16390 DIR See "2,2-Dimethyl-1,3- Propanediol"

+ +

22450 009004-70-0 Nitrocellulose Same 43330 DIR 3 (SCF, 6th Series, 1978). + +

22465 000112-05-0 Nonanoic acid Same 68150 D 8 +

22480 000143-08-8 1-Nonanol DIR 3 See references for "Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N. 12375) in SCF list 3.

+ +

22510 027215-95-8 Nonene D 8 + +

22535 025154-52-3 Nonylphenol Same 68175 9 +

22540 000104-40-5 4-Nonylphenol Same 68185 D 8 + +

22550 000498-66-8 Norbornene Same 13180 DIR See "Bicyclo[2.2.1]hept-2-ene"

D +

22552 - Novolac glycidyl ethers (=NOGE)

Same 68200 See 13160

D According to Commission Directive


+ +






AND SPECIFICATIONS


93

2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs. Can still be used in heavy coatings.

22555 000112-92-5 1-Octadecanol Same 68225 3 See references for "Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N.12375) in SCF list 3.

+

22570 000112-96-9 Octadecyl isocyanate DIR QM(T) = 1 mg/kg (expressed as NCO) (26).


+

22580 000930-02-9 Octadecyl vinyl ether D 7 Needed: hydrolysis data. +

22585 003710-30-3 1,7-Octadiene D 8 +

22600 000111-87-5 1-Octanol Same 68750 DIR 3 See references for "Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N. 12375) in SCF list 3.

+ +

22630 025377-83-7 Octene (except 1-octene) D 8 +

22660 000111-66-0 1-Octene DIR SML = 15 mg/kg 2 t-TDI: 0.25 mg/kg b.w. pending results of fertility and teratogenicity studies. Available: a 90-day oral rat study and mutagenicity studies. (CIVO rep. V86.408/251091, 26 September 1986).

+ +

22690 001806-26-4 4-Octylphenol D 8 + +

22720 000140-66-9 4-tert-Octylphenol Same 25185 DIR/D See "4-(1,1,3,3-Tetramethylbutyl)phenol"

D See REF.N°. 25185. + +

22750 000929-62-4 Octyl vinyl ether D 7 Needed: hydrolysis data. +

22755 008016-35-1 Oiticica oil 8 Not food fat. +

22757/1 - Oiticica oil fatty acids 8/D It is not an oil from food sources. +

22763 000112-80-1 Oleic acid Same 69040 DIR 1 ADI : not specified. (SCF, 25th Series, 1990).

+ +

22766 000143-28-2 Oleyl alcohol Same 69760 3 Precursor of oleic acid. +

22775 000144-62-7 Oxalic acid Same 69920 DIR SML(T) = 6 mg/kg 2 TDI : 0.1 mg/kg b.w. + +


AND SPECIFICATIONS


94

(29) 2-year oral rat study, observations in man. (J. Am. Pharm. Ass. 1947, 36, 217-219, Patty).

22778 007456-68-0 4,4'-Oxybis(benzenesulphonyl azide)

DIR QMA = 0.05 mg/6 dm² 3 R = 0.05 mg/kg of food. Remark for Commission: only a method for the residual quantity in the finished product (FP) is available. A QMA is proposed. (Adopted at the 123rd SCF meeting, 19 October 2000) http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf

+

22780 000057-10-3 Palmitic acid Same 70400 DIR 1 ADI: not specified. (SCF, 25th Series, 1990).

+ +

22810 000504-60-9 1,3-Pentadiene D 8 +

22811 000591-93-5 1,4-Pentadiene D 8 +

22840 000115-77-5 Pentaerythritol Same 71600 DIR 2 Group TDI: 1 mg/kg b.w. (with dipentaerythritol). See references for dipentaerythritol.

+ +

22842 002590-16-1 Pentaerythritol diallyl ether

D 6A +

22858 005343-92-0 1,2-Pentanediol D 8 +

22861 000111-29-5 1,5-Pentanediol D 8 +

22870 000071-41-0 1-Pentanol DIR 3 See references for "Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C22)" (PM/REF.N. 12375) in SCF list 3.

+ +

22900 000109-67-1 1-Pentene DIR SML = 5 mg/kg 3 R: 5 mg/kg of food. Available: migration data showing specific migration < 0.05 mg/kg in food; log Po/w; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); two gene mutation assays in cultured mammalian cells (one inadequate and one negative); 90-day oral rat study. RIVM/TNO/ISS SDS, October 1999 = CS/PM/2855 REV. IV/22900. (Adopted at the 121 SCF meeting (20 June

+




AND SPECIFICATIONS


95

2000)) http://europa.eu.int/comm/food/fs/sc/scf/out61_en.pdf

22901 000109-68-2 2-Pentene D 8 +

22912 000627-19-0 1-Pentyne 8 +

22930 - Perfluoroalkyl (C1-C3) perfuorovinyl ethers

D 9 +

22932 001187-93-5 Perfluoromethyl perfluorovinyl ether

D 3AM

3 Restriction: 0.05 mg/kg food Remark for Commission: QMA restriction of 0.05 mg/6dm2 could be more appropriate for enforcement purposes. Only to be used for anti-stick coatings. http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdf

+

22935 003823-94-7 Perfluoromethyl vinyl ether

D 7 Needed: provided hydrolysis can be demonstrated, data on perfluoromethanol are requested.

+

22937 001623-05-8 Perfluoropropyl perfluorovinyl ether

DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Migration data and three mutagenicity studies negative. (RIVM SDS, May 1996 = CS/PM/2799).

+ +

22940 006996-01-6 Perfluoropropyl vinyl ether

D 7 Needed: provided hydrolysis can be demonstrated, data on perfluoropropanol are requested.

+

22960 000108-95-2 Phenol DIR 2 TDI: 1.5 mg/kg b.w. 90-day oral studies in mice and rats, multigeneration studies oral in rats and 2-year studies oral in mice and rats. (NTP 80-15, NIH Tech. report 203, J. Pharm. Exp. Ther. 184, 1973, 695).

+ +

22990 - Phenols, mono- and dihydric, alkoxylated or hydrogenated

D 9 +

23020 028994-41-4 alpha-Phenyl-o-cresol D 8 +

23050 000108-45-2 1,3-Phenylenediamine DIR SML = ND (DL = 0.02 4A Since the data on carcinogenicity by the oral + +








AND SPECIFICATIONS


96

mg/kg , analytical tolerance included)

route were inadequate and the substance demonstrated some genotoxic potential, it is only acceptable for use provided there is no detectable migration into food by an agreed sensitive method.

23070 000102-39-6 (1,3-Phenylenedioxy)diacetic acid

DIR QMA = 0.05 mg/6dm² 3 SCF_list:3 Restriction: 0.05 mg/kg of food. . Remark for Commission: No method of analysis for specific migration available. QMA= 0.05mg/6dm² See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out142_en.pdf

+

23080 001079-21-6 Phenylhydroquinone D 8 +

23110 058244-28-3 Phenylhydroquinone diacetate

D 8 +

23125 000103-71-9 Phenyl isocyanate 4A Isocyanates can hydrolyse to corresponding amines. Some aromatic amines are carcinogenic.

+

23140 000092-69-3 4-Phenylphenol Same 72320 D 8 + +

23155 000075-44-5 Phosgene Same 14380 DIR See "Carbonyl chloride"

+ +

23170 007664-38-2 Phosphoric acid Same 72640 DIR 1 MTDI: 70 mg/kg b.w. (as P). (SCF, 25th Series, 1990).

+ +

23173 001314-56-3 Phosphoric anhydride 1 MTDI : 70 mg/kg b.w. (as P). (SCF, 25th Series, 1990).

+

23175 000122-52-1 Phosphorous acid, triethyl ester

Same 25525 DIR QM = ND (DL = 1 mg/kg in FP)

3 QM = n.d. in the polymer (limit of detection = 1 ppm). Available: Adequate analytical method for determination of the residual content; calculation worst case migration; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (positive); in vivo UDS assay in rat liver (negative). (RIVM/ISS/UK SDS, July 1998 =

+




AND SPECIFICATIONS


97

CS/PM/3195/25525). (Adopted at 114th SCF meeting) (10 December 1998) http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

23185 - Phthalic acids D D +

23187 - Phthalic acid DIR See "Terephtahalic acid"

+

23200 000088-99-3 o-Phthalic acid Same 74480 DIR 2 Group TDI: 1 mg/kg b.w. Included in the group TDI for phthalic anhydride.

+ +

23230 000131-17-9 Phthalic acid, diallyl ester

DIR SML = ND (DL = 0.01 mg/kg)

4A Genotoxic carcinogen (mouse and rat). (RIVM doc. 91/679112/001).

+ +

23260 000088-95-9 o-Phthalic acid dichloride


23290 - Phthalic acid, halogenated derivatives

D 9 +

23320 - Phthalic acids, hydrogenated

D 9 +

23350 - Phthalic acids, hydrogenated, substituted, endosubstituted, and their halogenated derivatives

D 9 +

23380 000085-44-9 Phthalic anhydride Same 76320 DIR 2 Group TDI: 1 mg/kg b.w. (SCF, 17th Series, 1986).

+ +

23410 - Phthalic anhydride, hydrogenated

D 9 +

23440 000111-16-0 Pimelic acid D 8 +

23470 000080-56-8 alpha-Pinene DIR 3 Occurs naturally in food. Used as a flavour. Migration into food would be self-limiting, because of its taste. (Fd Cosmetic Tox. 16, 1978 suppl. 1, 853).

+ +

23500 000127-91-3 beta-Pinene DIR 3 Occurs naturally in food. Used as a flavour up to 600 mg/kg of food. Migration into food would be self-limiting because of its taste.

+ +




AND SPECIFICATIONS


98

(Food Cosmet. Toxicol. 16 (suppl.1) 1978, 859-861).

23530 025190-06-1 Poly(1,4-butyleneglycol)(Mw>1000)

Same 76570 D 7 Needed: molecular weight distribution curve.

+

23547 009016-00-6 and 063148-62-9

Polydimethylsiloxane (Mw> 6800)

Same 76721 DIR In compliance with the specifications laid down in Annex V

2 See the SCF opinion for the substance PM/REF.N. 76721. (Adopted at 111th SCF meeting (18-19 March 1998)

+ +

23560 - Polyethers based on ethylene oxide, propylene oxide and/or tetrahydrofuran, containing free hydroxyl groups

D 9 +

23590 025322-68-3 Polyethyleneglycol Same 76960 DIR 2 Group TDI: 5 mg/kg b.w. (with triethyleneglycol). See references for triethyleneglycol. (SCF, 6th Series, 1978).

+ +

23592 157567-90-3 Polyethyleneglycol isotridecyl ether methacrylate

W +

23615 029435-48-1 Polyhydroxybutyrate.to be deleted here and introduced in a special annex if authorized.

D +

23620 - Polyols derived from phenols and bisphenols, hydrogenated and/or condensed with epoxyalkanes and/or arylepoxyalkanes possibly halogenated, alkoxylated, aryloxylated

D 9 +

23650 025322-69-4 Polypropyleneglycol (Mw>400)

Same 23651 and 80800

D 3 Toxicologically acceptable. +

23651 025322-69-4 Polypropyleneglycol Same 23650 and 80800

DIR 3 Toxicologically acceptable. + +

23680 009002-89-5 Polyvinylalcohols Same 81280 D D + +


AND SPECIFICATIONS


99

23710 063148-65-2 Polyvinylbutyrals D 9 + +

23730 008002-11-7 Poppyseed oil 3 Food fat. +

23740 000057-55-6 1,2-Propanediol Same 81840 and 82065

DIR 1 ADI: 25 mg/kg b.w. (JECFA 17 M., 1973).

+ +

23770 000504-63-2 1,3-Propanediol DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Available: Adequate migration data; Ames tests (negative); in vitro cytogenetic assay in Chinese hamster cells (positive); HPRT forward mutation assay in Chinese hamster cells (negative); mouse bone marrow micronucleus assay (negative); teratogenicity study (segment II). (RIVM/ISS/TNO SDS, August 1997 = CS/PM/3066/23770). (Adopted at 111th SCF meeting (18-19 March 1998)). http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

+ +

23800 000071-23-8 1-Propanol Same 81880 DIR 3 (SCF, 11th Series, 1981; JECFA 25 M., 1981).

+ +

23830 000067-63-0 2-Propanol Same 62480 and 81882

DIR 1 t-ADI: 1.5 mg/kg b.w. (SCF, 11th Series, 1981)

+ +

23860 000123-38-6 Propionaldehyde DIR 3 Occurs naturally in food. Used as a flavour up to 13 mg/kg of food. Migration into food will be self-limiting because of its taste.

+

23890 000079-09-4 Propionic acid Same 82000 DIR 1 Group ADI: not specified. (SCF, 1st Series, 1974).

+

23920 000105-38-4 Propionic acid, vinyl ester

DIR SML(T) = 6 mg/kg (2) (expressed as Acetaldehyde)

2 Group-TDI = 0.1 mg/kg b.w. (included in the group-TDI of acetaldehyde). Available: Hydrolysis data for propionic acid vinylester, showing total (100% hydrolysis of the monomer in intestinal fluid, after 1hr at 37 °C, into propionic acid and acetaldehyde); calculation of (worst case) migration is <0.5 mg/kg food, assuming 100% migration of residual propionic acid vinylester from a typical dispersion film; a bacterial reversion assay (negative); a test for chromosomal

+ +




AND SPECIFICATIONS


100

aberrations in vitro (positive). Remark for the Commission: no method of analysis is available for the enforcement of an SML. (RIVM/ISS/TNO SDS, January 1997 = CS/PM/2909/23920). (Adopted at 111th SCF meeting (18-19 March 1998)). http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

23950 000123-62-6 Propionic anhydride DIR 1 Group ADI: included in the ADI not specified for propionic acid.(SCF, 1st Report, 1974).

+

23980 000115-07-1 Propylene DIR 3 Residues of this gas in plastics are very small. The gas has a low toxic potential. Migration into food will be toxicologically negligible.(Patty's Industrial Hygiene and Toxicology, 3rd ed., 1981).

+ +

24010 000075-56-9 Propylene oxide DIR QM = 1 mg/kg in FP 4A Mutagenic in several studies. Induces forestomach tumours in rats after oral administration. (Brit. J. Cancer 1982, 46, 924).

+ +

24040 000764-47-6 Propyl vinyl ether D 7 Needed: hydrolysis data. +

24045 008016-49-7 Pumpkinseed oil 3 Food fat. +

24051 000120-80-9 Pyrocatechol Same 15880 DIR See "1,2-Dihydroxybenzene"

+ +

24055 000089-05-4 Pyromellitic acid Same 13040 3 R: 0.05 mg/kg in food. Same references as pyromellyitic anhydride.

+

24057 000089-32-7 Pyromellitic anhydride DIR SML = 0.05 mg/kg (expressed as Pyromellitic acid)

3 R: 0.050 mg/kg in food. Available data: 3 requested mutagenicity, studies negative, no bioaccumulation, migration less than 0.05 mg/kg in all food simulants.

+ +

24070 073138-82-6 Resin acids and rosin acids

Same 83610 DIR 2 Group TDI: 1 mg/kg b.w. (SCF, 17th Series, 1986).

+ +

24072 000108-46-3 Resorcinol Same 15910 DIR See "1,3-Dihydroxybenzene"

+ +

24073 000101-90-6 Resorcinol diglycidyl ether

DIR QMA = 0.005 mg/6 dm² - Not for use in

3 R= 0.005 mg/kg of food; only to be used behind the PET barrier.

+




AND SPECIFICATIONS


101

polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC and for indirect food contact only, behind the PET layer.

Available: data on residual content in PHAE polymer, resulting in a worst case migration of 0.001 mg/kg food; gene mutation assay in bacteria (positive); chromosomal aberration assay in cultured mammalian cells (positive); micronucleus assay (negative) (the target organ was not reached); 2-week oral mouse and rat studies; 13-week oral mouse and rat studies; mouse and rat carcinogenicity studies; conclusions made in other scopes. RIVM/TNO SDS, August 1999 = CS/PM/3338/24073. Remark: Substance evaluated for the requested use of indirect contact with non fatty food. (Adopted at the 121 SCF meeting (20 June 2000)) http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdf

24100 008050-09-7 Rosin Same 14687,24130,45055 and

83840

DIR 2 Group TDI: 1 mg/kg b.w. (SCF, 17h Series, 1986).

+ +

24115 008050-31-5 Rosin, ester with glycerol

Same 84000 1 ADI= 12.5 mg/kg b.w. (SCF, 32nd Series, 1994).

+

24130 008050-09-7 Rosin gum Same 14687,24100,45055 and

83840

DIR See "Rosin" 2-D Group TDI: 1 mg/kg b.w. (SCF, 6th Series, 1978).

+

24150 Rosin, polymerized 9 +

24160 008052-10-6 Rosin tall oil DIR 3 + +

24190 008050-09-7 Rosin wood DIR 2 Group TDI: 1 mg/kg b.w. (SCF, 6th Series, 1978).

+

24220 009006-03-5 Rubber, chlorinated Same 84480 D 9 +

24250 009006-04-6 Rubber, natural Same 84560 DIR 3 Migration unlikely. + +

24260 008001-23-8 Safflower oil 3 Food fat. +

24270 000069-72-7 Salicylic acid Same 84640 DIR 3 Naturally occurring in food in low concentration.

+ +




AND SPECIFICATIONS


102

24280 000111-20-6 Sebacic acid Same 85030 DIR 2 Group TDI: 3 mg/kg b.w. (SCF, 17th Series 1986).

+ +

24310 000111-19-3 Sebacic acid dichloride D 7? Needed: migration and hydrolysis data. Pending these results necessity for a 28-day oral study and further studies to be considered. http://europa.eu.int/comm/food/fs/sc/scf/out161_en.pdf

+

24340 002432-89-5 Sebacic acid, di-n-decyl ester

D 8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.050 mg/kg, peroxisome proliferation studies too.

+

24370 000106-79-6 Sebacic acid, dimethyl ester

Same 85540 D 8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.050 mg/kg, peroxisome proliferation studies too.

+

24400 002918-18-5 Sebacic acid, diphenyl ester

D 8 +

24430 002561-88-8 Sebacic anhydride DIR 2 Group TDI : 3 mg/kg b.w. Included in the group TDI for sebacic acid.

+ +

24435 008008-74-0 Sesame oil 3 Food fat. +

24440 009000-59-3 Shellac Same 85550 1 ADI: Acceptable. (SCF, 26th Series, 1992).

+

24460 000124-41-4 Sodium methanolate D +

24475 001313-82-2 Sodium sulphide DIR 3 Organoleptically self limiting. + +

24490 000050-70-4 Sorbitol Same 88320 DIR 1 Acceptable. (SCF, 16th Series, 1985).

+ +

24520 008001-22-7 Soybean oil Same 88630/0 and

86630/1

DIR 3 Food fat. + +

24525 - Soybean oil fatty acids, dimers

8/D +

24540 009005-25-8 Starch, edible Same 88800 DIR 0 +

24545 068412-29-3 Starch, hydrolysed Same 88880 DIR 0 + +

24550 000057-11-4 Stearic acid Same 89040 DIR 1 ADI: not specified. (SCF, 25th Series, 1990).

+ +




AND SPECIFICATIONS


103

24560 000111-63-7 Stearic acid, vinyl ester D 8 Hydrolysis negligible (CS/PM/1895). + +

24610 000100-42-5 Styrene DIR 4B Several oral studies performed: 6-month rat, 19-month dog, carcinogenicity in mice (3) and in rats (4), 3-generation reproduction and teratogenicity in rats. Mutagenicity studies positive only with activation. (RIVM doc. 1990-05-03 (CS/PM/428), BGA doc. 1990-07-17 (CS/PM/475), CS/PM/915). NOTA BENE: the wg wishes to establish a limit for styrene in food and asked the Commission to provide migration data. The wg of the SCF has the intention to recommend to the Commission a ban for styrene in oven ware due to unacceptably high migration.

+ +

24640 - Styrene substituted by alkyl groups (alpha)

D 9 +

24670 - Styrene substituted in the benzene ring

D 9 +

24700 - Styrene substituted by halogens (alpha or beta)

D 9 +

24730 - Styrene substituted in the vinyl group

D 9 +

24760 026914-43-2 Styrenesulphonic acid DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Available: Adequate migration data in food simulants up to and including 175 °C; analytical method; four (negative) in vitro mutagenicity studies; acute toxicity; sensitisation study; eye irritation study. (RIVM/TNO SDS, August 1997 = CS/PM/2087 Rev I/24760). (Adopted at 111th SCF meeting (18-19 March 1998)). http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

+ +

24790 000505-48-6 Suberic acid D 8 +

24820 000110-15-6 Succinic acid Same 90960 DIR 1 ADI: not specified. (SCF, 25th Series, 1990).

+ +




AND SPECIFICATIONS


104

24835 000106-65-0 Succinic acid, dimethyl ester

Same 91135 7 Needed : hydrolysys data. +

24850 000108-30-5 Succinic anhydride Same 91170 DIR 2 TDI : not specified based on ADI (=not specified) for succinic acid.

+ +

24880 000057-50-1 Sucrose Same 91185 DIR 0 +

24887 006362-79-4 5-Sulphoisophthalic acid, monosodium salt

DIR SML = 5 mg/kg 3 R: 5 mg/kg in food. 90-day oral rat study, 3 mutagenicity studies negative, bioaccumulation and migration data. (Rivm summary data, May 1992 (CS/PM/1590)).

+ +

24888 003965-55-7 5-Sulphoisophthalic acid, monosodium salt, dimethyl ester

DIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg in food. Available: 3 mutagenicity tests, negative. Migration data less than 0.05 mg/kg. (Rivm summary data, August 1992 (cs/pm/1638)).

+

24895 008001-21-6 Sunflower oil 3 Food fat. +

24900 - Sunflower oil fatty acids, dimers

D +

24903 068425-17-2 Syrups, hydrolysed starch, hydrogenated

Polyglycitol syrup

3AM 3 In compliance with the purity criteria for maltitol syrup, E 965 (ii) http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf

+

24905 008002-26-4 Tall oil 3 Not a food oil but toxicologically acceptable. (SCF, 17th Series, 1986).

+

24910 000100-21-0 Terephthalic acid DIR SML = 7.5 mg/kg 2 t-TDI: 0.125 mg/kg b.w. Available: 3-month and 2-year oral rat studies, mutagenicity test negative. Needed: full reports from CIIT and ICI. (CIIT, 1982)(UK document "Terephthalic acid: proposed use in animal foodstuffs", 1984).

+ +

24940 000100-20-9 Terephthalic acid dichloride

DIR SML(T) = 7.5 mg/kg (as Terephthalic acid)

2 Group TDI: 0.175 mg/Kg b.w.(as terephthalic acid) Hydrolysis (complete) data allow the allocation of the same TDI of terephthalic acid.

+ +

24970 000120-61-6 Terephthalic acid, DIR 2 TDI: 1 mg/kg b.w. + +




AND SPECIFICATIONS


105

dimethyl ester 90-day oral mouse and rat studies and long-term studies in mice and rats not indicating tumour induction. (NCI Tech.report Series N. 121, 1979).

25000 001539-04-4 Terephthalic acid, diphenyl ester

D 8 +

25030 016646-44-9 Tetra(allyloxy)ethane D 6A +

25035 013810-83-8 Tetrabromophthalic acid 5 [Some organobromo compounds have a bioaccumulation potential and 1,2-dibromoethane is a category 2 carcinogen (EC classification).]

+

25050 005593-70-4 Tetrabutyl titanate W +

25060 000632-58-6 Tetrachlorophthalic acid D 8 +

25063 021635-90-5 Tetracyclo[4.4.0.12,5.1.7,10]dodeca-3-ene


25070 000112-72-1 1-Tetradecanol Same 92300 3 See references for "Alcohols, aliphatic, monohydric, saturated, linear, primary (C24-C22)" (PM/REF.N. 12375) in SCF list 3.

+ +

25080 001120-36-1 1-Tetradecene DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Available: Adequate migration data, showing specific migration of 1-tetradecene is < 0.05 mg/kg food; three (negative) mutagenicity studies. (RIVM/ISS/TNO SDS, January 1997 = CS/PM/2910/25080). (Adopted at 111th SCF meeting (18-19 March 1998)). http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

+ +

25090 000112-60-7 Tetraethyleneglycol Same 92350 DIR 1 ADI: 10 mg/kg b.w. (JECFA 23 M., 1979).

+ +

25105 000112-57-2 Tetraethylenepentamine 8 +

25120 000116-14-3 Tetrafluoroethylene DIR SML = 0.05 mg/kg 3 R: 0.050 mg/kg in food. Available 3 mutagenicity studies negative. No migration data available. (Summary data from RIVM, CS/PM/925).

+ +

25150 000109-99-9 Tetrahydrofuran Same 92430 DIR SML = 0.6 mg/kg 2 TDI: 0.01 mg/kg b.w. 6-month oral studies in mice, rats and

+ +




AND SPECIFICATIONS


106

rabbits. (Gig. Sanit. 34, 1969, 114, EPA 560/11-80-011, April 1980).

25158 000088-98-2 1,2,3,6-Tetrahydrophthalic acid

D 8 +

25161 000085-43-8 1,2,3,6-Tetrahydrophthalic anhydride

D 8 1-year oral rat study inadequate. (Allied Chem. Corp. 1958).

+ +

25163 002426-02-0 3,4,5,6-Tetrahydrophthalic anhydride

8 +

25180 000102-60-3 N,N,N,'N'-Tetrakis(2-hydroxypropyl)ethylenediamine

Same 92640 DIR 2 TDI: 1 mg/kg b.w. A 90-day oral rat study. (Hilltop Research Inst. Inc. January 3, 1956).

+

25185 000140-66-9 4-(1,1,3,3-Tetramethylbutyl)phenol

Same 22720 DIR/D 6B R= not detectable. Available: Inadequate migration data, inadequate mutagenicity studies, acute tox.data, 28-day oral rat study, two 90-day oral rat studies, reproduction study (special design), excretion study, skin and eye irritation studies, two oestrogenic studies. Needed: Confirmation of the claim of non-detectability at 5 ppb level; information on the composition of the test samples (particularly the amount of 4-(1,1,3,3-tetramethylbutyl)phenol used in the polycondensation process should be indicated); reasons for deviation from standard test conditions in migration experiments; a more extensive description of the method of determination (preferably according to the standard format) and sufficient information to allow evaluation of the data provided; detailed data on the level of 4-tert.octylphenol in the recovery experiments. In vitro chromosomal aberration assay in cultured mammalian cells; dependent of the outcome of the

+ +


AND SPECIFICATIONS


107

migration studies a one-generation reproduction study (special attention to be given to effects on male reproductive organs) may be needed. (RIVM/LST/TNO SDS, November 1996 = CS/PM/2793).

25208 026471-62-5 Toluene diisocyanate 4A See references for 3,3'-dimethyl-4,4'-diisocyanatobiphenyl.

+

25210 000584-84-9 2,4-Toluene diisocyanate DIR QM(T) = 1 mg/kg (expressed as NCO) (26).


+ +

25240 000091-08-7 2,6-Toluene diisocyanate DIR QM(T) = 1 mg/kg (expressed as NCO) (26).


+ +

25270 026747-90-0 2,4-Toluene diisocyanate dimer



+

25300 000088-19-7 o-Toluenesulphonamide D 8 + +

25330 000070-55-3 p-Toluenesulphonamide D 7 Needed: mutagenicity and reproduction studies on the commercial mixture to be specified.

+

25360 - Trialkyl(C5-C15)acetic acid, 2,3-epoxypropyl ester

DIR QM = 1 mg/kg in FP (expressed as Epoxy group, Mw=43)

4A Available: a 5-week oral rat study and mutagenicity tests. (Summary data only (CS/PM/932)). Structural similarity taken into account.

+ +

25380 - Trialkyl acetic acid (C7-C17), vinyl esters (=vinyl versatate)

DIR QMA = 0.05 mg/6 dm² 3 R = 0.05 mg/kg of food. Remark for Commission: only a method for the residual quantity in thin films is available. A QMA is proposed. (Adopted at the 123rd SCF meeting, 19 October 2000) http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf

+ +

25385 000102-70-5 Triallylamine DIR In compliance with the specifications laid down in Annex V

3 R = 40 mg/kg hydrogel at a ratio of 1 kg food to a max of 1.5 g hydrogel. Only to be used in hydrogels intended for non-direct food contact use. Available: adequate data on residual content

+




AND SPECIFICATIONS


108

of triallylamine in hydrogel; calculated migration; five in vitro (one positive) and in vivo mutagenicity tests. Although the one negative in vivo mutagenicity study is not enough to rule out the genotoxic potential completely, the risk is thought to be very low, if at all, based on the technical information (i.e. no migration) and the restriction for use. The WG therefore does not require a further in vivo mutagenicity study. (RIVM/TNO/ISS SDS CS/PM/2856, June 1996).

25390 000101-37-1 Triallyl cyanurate D 6A + +

25405 001025-15-6 Triallyl isocyanurate 6A +

25420 000108-78-1 2,4,6-Triamino-1,3,5-triazine

Same 19975, 65360 and

93720

DIR SML = 30 mg/kg 2 TDI: 0.5 mg/kg b.w. (SCF, 17th Series, 1986).

+ +

25450 026896-48-0 Tricyclodecanedimethanol

DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Based on the reduced core set of toxicological data according to the migration level, see Appendix 2 Available: adequate information on the identity of the substance; incomplete specific migration data in ethanol instead of olive oil; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative). RIVM/FR SDS, July 2000 = CS/PM/3253 REV. II/25450 http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdf

+ +

25480 000102-71-6 Triethanolamine Same 25922 and 94000

D 8 + +

25510 000112-27-6 Triethyleneglycol Same 94320 DIR 2 Group TDI: 5 mg/kg b.w. (with polyethyleneglycol).

+ +




AND SPECIFICATIONS


109

(SCF, 17th Series, 1986).

25520 000112-24-3 Triethylenetetramine 8 +

25525 000122-52-1 Triethylphosphite Same 23175 D +

25540 000528-44-9 Trimellitic acid Same 13050 DIR QM(T) = 5 mg/kg in FP.

3 Restriction: 5 mg/kg of food Remark for Commission: Group restriction together with the trimellitic anhydride REF No 25550 http://www.efsa.eu.int/science/afc/afc_opinions/468/opinion11_afc_ej65_list4_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

+ +

25550 000552-30-7 Trimellitic anhydride DIR QM(T) = 5 mg/kg in FP (expressed as Trimellitic acid).

3 Restriction: 5 mg/kg of food, expressed as trimellitic acid Remark for Commission: Group restriction together with the trimellitic acid REF No 25540 http://www.efsa.eu.int/science/afc/afc_opinions/468/opinion11_afc_ej65_list4_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

+ +

25561 002768-02-7 (Trimethoxy)vinylsilane Same 26320 D +

25570 000067-48-1 Trimethylethanolammonium chloride

Same 94880 D 8 +

25573 016938-22-0 2,2,4-Trimethylhexane-1,6-diisocyanate

4A +

25574 015646-96-5 2,4,4-Trimethylhexane-1,6-diisocyanate

4A +

25595 000077-85-0 Trimethylolethane 9 +

25600 000077-99-6 1,1,1-Trimethylolpropane

Same 13380, 39560 and

94960

DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w. A 90-day oral rat study. (Report Perstorp, Sweden).

+ +

25630 037275-47-1 1,1,1-Trimethylolpropane diacrylate











AND SPECIFICATIONS


110

25645 000682-09-7 1,1,1-Trimethylolpropane diallyl ether

D 6A +

25660 019727-16-3 1,1,1-Trimethylolpropane dimethacrylate


25690 - 1,1,1-Trimethylolpropane maleates

D 8 +

25720 007024-08-0 1,1,1-Trimethylolpropane monoacrylate


25750 007024-09-1 1,1,1-Trimethylolpropane monomethacrylate


25780 025723-16-4 1,1,1-Trimethylolpropane, propoxylated

D 8 +

25810 015625-89-5 1,1,1-Trimethylolpropane triacrylate

D 8 Available: hydrolysis only to the diacrylate and acrylic acid (CS/PM/2156). Known sensitiser. (Food Chem. Tox. 23, 124, 1985). Needed: in addition to data according to SCF guidelines, information on potential for sensitisation to plastics made from this monomer.

+ +

25840 003290-92-4 1,1,1-Trimethylolpropane trimethacrylate

DIR SML = 0.05 mg/kg 3 Restriction : 0.05 mg/kg of food. Based on the reduced core set of toxicological data according to the migration level. Available : migration data ; 2 gene mutation assays in bacteria (one negative, however no experimental details given (publication), one weak positive) ; chromosomal aberration assay in cultured mammalian cells (positive) ; 2 gene mutation assays in cultured mammalian cells (one positive, however no experimental details given (publication), one negative) ; in vivo micronucleus assay

+ +


AND SPECIFICATIONS


111

(negative) ; in vivo/in vitro UDS assay in rat liver (negative). RIVM/FR/DE SDS, October 2001 = CS/PM/3440 REV. III/25840. (Adopted at the 130th SCF meeting, 13 December 2001) http://europa.eu.int/comm/food/fs/sc/scf/out115_en.pdf

25870 000107-39-1 2,4,4-Trimethyl-1-pentene

D 8 +

25900 000110-88-3 Trioxane DIR SML = 0.05 mg/kg 3 Under re-evaluation. R = 0.05 mg/kg of food. (Adopted at 117th SCF meeting) (17 June 1999) http://europa.eu.int/comm/food/fs/sc/scf/out37_en.pdf

+ +

25910 024800-44-0 Tripropyleneglycol DIR 2 Group TDI: 1.5 mg/kg b.w. (with polypropyleneglycol and dipropyleneglycol). See references for dipropylenglycol.

+ +

25915 000090-72-2 2,4,6-Tris((Dimethylamino)methyl)phenol

Same 95400 8 +

25922 000102-71-6 Tris(2-hydroxyethyl)amine

Same 25480 and 94000

D D +

25927 027955-94-8 1,1,1-Tris(4-hydroxyphenyl)ethane

DIR QM = 0.5 mg/kg in FP. For use only in polycarbonates.

3 R = 0.5 mg/kg in finished product (polycarbonate). Available: calculated worst case migration; Ames /E. Coli assay; in vitro chromosomal aberration assay; two in vivo micronucleus assays; in vivo UDS assay; acute toxicity assay. (RIVM/TNO SDS, December 1996 = CS/PM/2911).

+

25930 001067-53-4 Tris(2-methoxyethoxy)vinylsilane

D 6A +






AND SPECIFICATIONS


112

25960 000057-13-6 Urea Same 95630 DIR 0 + +

25980 - Versatic acid (=acids, aliphatic, monocarboxylic, saturated, branched(C5-C15)

D +

25990 000689-97-4 Vinylacetylene D 6A +

25995 - Vinyl alcohol See 10120 D +

26020 001484-13-5 N-Vinylcarbazole D 6A +

26050 000075-01-4 Vinyl chloride DIR See Council Directive 78/142/EEC

4A (SCF, 1st Series, 1975). + +

26080 - Vinyl ethers of alcohols, aliphatic, monohydric, saturated (C2-C18)

D 9 +

26110 000075-35-4 Vinylidene chloride DIR QM = 5 mg/kg in FP or SML = ND (DL = 0.05 mg/kg)

4B (SCF 13th Series, 1982). + +

26140 000075-38-7 Vinylidene fluoride DIR SML = 5 mg/kg 3 R: 5 mg/kg of food. Many inhalation studies, 1-year oral rat study, carcinogenicity studies by inhalation in mice and rats negative, mutagenicity studies negative, reproduction study negative. (RIVM report 1992-10-29).

+ +

26155 001072-63-5 1-Vinylimidazole DIR QM = 5 mg/kg in FP 3 R = 0.05 mg/kg of food. Available: Adequate analytical method for determination of residual 1-vinylimidazole in terpolymer; calculated worst case migration is < 0.17 ppb into food; three negative mutagenicity studies. (RIVM/TNO SDS, April 1998 = CS/PM/3158 /95805). REMARK for Commission: Only a method for the determination for the residual content is available. (Adopted at 114th SCF meeting) (10

+ +


AND SPECIFICATIONS


113

December 1998). http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

26170 003195-78-6 N-Vinyl-N-methylacetamide

DIR QM = 2 mg/kg in FP 3 R = 2 mg/kg in finished product. Available: 5 mutagenicity studies considered to be non-genotoxic, physical-chemical data on VIMA; adequate analytical data and method for the residual content of VIMA in final product; calculation of worst case migration assuming 100% migration of residual monomer. (RIVM SDS, May 1994 = CS/PM/2371 and TNO SDS, August 1996 = CS/PM/2857).

+

26200 002867-48-3 N-Vinyl-N-methylformamide

D 6A +

26215 000100-69-6 2-Vinylpyridine 6A +

26217 000100-43-6 4-Vinylpyridine 6A +

26230 000088-12-0 Vinylpyrrolidone Same 95810 DIR 4A SCF_list: 4A Restriction: n.d. by an agreed sensitive method. Remark for Commission: only to be used in adhesives for paper and board and QMA < 10 µg/6dm². See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf

+ +

26260 001184-84-5 Vinylsulphonic acid D 6A + +

26290 025013-15-4 Vinyltoluene D 7 Needed: migration data and on that basis decide on indication for a 28/90 day oral study.

+ +

26292 000622-97-9 p-Vinyltoluene Same 22240 D D +

26320 002768-02-7 Vinyltrimethoxysilane Same 25561 DIR QM = 5 mg/kg in FP 3 R = 0.05 mg/kg of food. Remark: Given the data on rapid and complete hydrolysis no further questions concerning genotoxicity are raised. Remark for Commission: Complete and rapid hydrolysis in aqueous foodstuff and

+ +






AND SPECIFICATIONS


114

food simulants. (Adopted at 116th SCF meeting) (24 March 1999) http://europa.eu.int/comm/food/fs/sc/scf/out27_en.pdf

26340 008024-09-7 Walnut oil 3 Food fat. +

26345/1 - Walnut oil fatty acids 3/D Constituents of food fats. +

26360 007732-18-5 Water Same 95855 DIR In compliance with the Directive 98/83/EC.

0 Specification: Impurity levels not to exceed those set in the Drinking water Directive.

+ +

26370 001330-20-7 Xylene Same 95945 3 R: 0.02 mg/kg bw (with 95945,95947,95949,95951) based on allowing 1/10 of TDI for food contact materials. 2-year oral rat study, mutagenicity test negative. (WHO draft, Geneva, September 1992)(CS/PM/1712).

+

26375 000105-67-9 m-Xylenol Same 16300 D D +

26377 000526-75-0 o-Xylenol Same 16270 D D +

26379 000095-87-4 p-Xylenol Same 16330 D D +

30000 000064-19-7 Acetic acid Same 10090 DIR 1 Group ADI: not specified. (SCF, 25th Series, 1991).

+ +

30045 000123-86-4 Acetic acid, butyl ester DIR 1 t-ADI: 6 mg/kg bw. (SCF, 25th Series, 1991).

+ +

30060 000071-48-7 Acetic acid, cobalt II salt W +

30080 004180-12-5 Acetic acid, copper salt DIR SML(T) = 30 mg/kg (7) (expressed as Copper)

2 For Copper, R = 5 mg/person based on http://europa.eu.int/comm/food/fs/sc/ scf/out176_en.pdf.

+

30100 000111-55-7 Acetic acid, diester with ethyleneglycol


30120 000111-15-9 Acetic acid, 2-ethoxyethyl ester

2 Group t-TDI : 0.05 mg/kg b.w. (with 15780=48050, 16993=53765, 16996=53820, 16999, 17002=53860, 30015, 30120, 30200, 48030)

+

30130 ? Acetic acid, ethoxypropyl ester

9 R : 0.05 mg/kg of food. +

30140 000141-78-6 Acetic acid, ethyl ester DIR 1 ADI: not specified. + +




AND SPECIFICATIONS


115


30160 see 30180 D +

30165 000108-21-4 Acetic acid, isopropyl ester


30180 002180-18-9 Acetic acid, manganese salt

DIR SML(T) = 0.6 mg/kg (10) (expressed as Manganese)

1-2 L2 for Manganese. Group TDI: 0.01 mg/kg b.w. (as Mn). Recommended daily allowance 2-3 mg/day. Average daily intake 10 mg. (Manganese. Environmental Health Criteria 17, WHO, Geneva 1981). L1 for acetic acid. Group ADI: Not specified. (SCF, 25th Series, 1991).

+

30190 see 30280 D +

30225 000628-63-7 Acetic acid, pentyl ester 7 Needed: hydrolysis data. +

30240 see 30330 D +

30245 000109-60-4 Acetic acid, propyl ester 7 Needed: hydrolysis data. +

30280 000108-24-7 Acetic anhydride Same 10150 DIR 2 Group TDI: included in the ADI not specified for acetic acid. (SCF, 25th Series, 1991).

+

30295 000067-64-1 Acetone DIR 3 Residue in food less than 5 mg/kg. (SCF, 11th Series, 1981).

+ +

30320 see 30370 D +

30330 - Acetone-nonylphenol-thiodipropionic acid didodecyl ester, copolymer

9 +

30340 330198-91-9 12-(Acetoxy)stearic acid, 2,3-bis(acetoxy)propyl ester

3AM 3 Restriction: None Remark for Commission: FRF is applicable http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdf

+

30345 001118-84-9 Acetylacetic acid, allyl ester

W +






AND SPECIFICATIONS


116

30350 000141-97-9 Acetylacetic acid, ethyl ester


30370 - Acetylacetic acid, salts DIR 0 +

30385 000123-54-6 Acetylacetone 8 +

30400 - Acetylated diglycerides DIR 1 ADI: not specified. (SCF, 7th report, 1978).

+

30401 - Acetylated mono- and diglycerides of fatty acids

3AM 1 ADI: not specified. +

30480 000140-04-5 Acetylricinoleic acid, butyl ester


30560 see 30620 D +

30610 - Acids C2-C24 aliphatic, linear, monocarboxylic from natural oils and fats and their mono-, di- and triglycerol esters (branched fatty acids at naturally occurring levels are included).


30612 - Acids C2-C24 aliphatic, linear, monocarboxylic, synthetic and their mono-, di- and triglycerol esters


30620 - Acids, aliph. monocarb. (C6-C24)

9 +

30640 - Acids, aliph., monocarb. (C8-C22), sec-butyl and oleyl esters

9 +

30720 - Acids, aliph., monocarb. (C8-C22), compounds with diethanolamine

9 +

30725 068603-38-3 Acids, aliph., monocarb. (C16-C18), compounds with diethanolamine

7 Same references as 39280. +

30800 - Acids, aliph., monocarb. (more than C5), esters with mannitol

9 +


AND SPECIFICATIONS


117

30880 - Acids, aliph., monocarb. (more than C5), esters with pentaerythritol

9 +

30960 - Acids, aliph., monocarb. (C6-C22) esters with polyglycerol

DIR 1 Group ADI: 25 mg/kg b.w. (SCF, 7th Series, 1978).

+ +

31040 - Acids, aliph., monocarb., hydroxylated (C12-C20) and their sulphonated and acetylated derivatives

9 +

31120 - Acids, aliph., monocarb. (C6-C24), Li, Mn and Sn salts

9 +

31200 - Acids, aliph., monocarb., sat.(more than C7), esters with alcohols, aliph. monoh.

9 +

31280 - Acids, aliph., monocarb. (C8-C22), compounds with triethanolamine

9 +

31302 - Acids carboxylic, esters with alcohols (for memo-to be del.later)

D +

31304 085566-24-1 Acids, fatty (C14-C18), alkyl (C14-C18) esters

Same 30490 8 +


9 +


9 +

31328 - Acids, fatty from animal or vegetable food fats and oils

DIR 3/D Constituent of food fats. +

31330 - Acids, fatty from animal or vegetable fats and oils, methyl esters

9 +

31350 125109-79-7 Acids, fatty (C14-C22), esters with pentaerythritol

9 +


AND SPECIFICATIONS


118

31352 085116-93-4 Acids, fatty (C16-C18), esters with pentaerythritol

9 +

31360 see 31470 D +

31382 - Acids, fatty, unsaturated(C18), dimers, hydrogenated -adipic acid-2ethylhexanol-1,2-propanediol, copolymer

7 Available: Molecular mass distribution and hydrolysis in simulated gastric juice (no hydrolysis). 3 mutagenicity tests with the dimeric acids were negative. Needed: Information on items 2 and 3 in the SCF guidelines in first instance (see page 50-51 of the "Practical Guide N.1"). (RIVM/TNO SDS, CS/PM/2648).

+

31384 - Acids, fatty, unsaturated(C18), dimers, hydrogenated-adipic acid-1,2-propanediol, copolymer

7? Available: Same text as 31382. Needed: Same text as 31382.

+

31440 - see 31490 D +

31455 - Acids, fatty, dimerized 9 +

31470 - Acids, sat., linear (C5-C10), esters with dipentaerythritol

9 +

31490 - Acids, substituted (C9-C20), and their trietha Nolamine salts

9 +

31492 - Acrylamide-acrylic acid-ethyl acrylate-ethyleneglycol methacrylate-polyethyleneglycol (EO=5) dodecylamine-toluene diisocyanate, copolymer (Mw= 5000-15000)

7? Available: molecular weight distribution curve. Needed: chemical structure, migration and toxicity data for the polymer according to SCF guidelines. Chemical structure of and and 3 mutagenicity tests for polyethyleneglycol (EO=5) dodecylamine.

+

31495 - Acrylamide-acrylic acid-methacrylic acid-polyethyleneglycol(EO=5 and 15)dodecylamine,

7 Needed: molecular weight distribution curve. Chemical structure of the polymer. Chemical structure of and 3 mutagenicity tests for methacrylic acid ester

+


AND SPECIFICATIONS


119

copolymer (Mw=10000-20000)

with polyethylenglycol (EO=15) dodecylamine and with methacrylic acid polyethyleneglycol (EO=5) dodecylamine.

31497 - Acrylamide-acrylic acid-methacrylic acid-polyethyleneglycol (EO=50)nonylphenyl ether, copolymer (Mw= 10000-20000)

7 Available: Use and average molecular mass. Needed: Structure of the polymer and molecular mass distribution in first instance. (CS/PM/2632).

+

31500 025134-51-4 Acrylic acid, acrylic acid, 2-ethylhexyl ester, copolymer

3AM 3 Group restriction 6mg/kg food for acrylic acid and 0.05 mg/kg food for acrylic acid, 2-ethylhexyl ester. http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out142_en.pdf

+

31505 - Acrylic acid, acrylic esters of alcohols, monohydric, primary, linear (C1-C18), copolymers

D +

31520 061167-58-6 Acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-methylphenyl ester

DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w. 3-month oral rat study. Mutagenicity studies. Migration data. No bioaccumulation in fish. (RIVM 90/678608/007; CS/PM/926).

+ +

31530 123968-25-2 Acrylic acid, 2,4-di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2-hydroxyphenyl)ethyl]phenyl ester

DIR SML = 5 mg/kg 3 R = 5 mg/kg food. 3-month oral rat study, 3 mutagenicity tests, negative, migration data. (TNO 1994-08-08).

+

31532 048076-38-6 Acrylic acid, eicosyl ester

W +

31534 025135-39-1 Acrylic acid-ethyl acrylate-methyl methacrylate, copolymer

W +

31536 009010-77-9 Acrylic acid-ethylene, copolymer

W +






AND SPECIFICATIONS


120

31540 - Acrylic acid-maleic anhydride, copolymer (Mw= 5000-20000)

7? Needed: migration and toxicity data for the polymer according to SCF guidelines.

+

31542 174254-23-0 Acrylic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters

Same 81960 3AM QM=0.5% w/w in final article

3 Restriction: Maximum quantity 0.5% w/w in the final article Remark for Commission: Restriction on maximum quantity (QM) is proposed to control migration of dodecylmercaptane if any. http://www.efsa.eu.int/science/afc/afc_opinions/768/afc_fcm_op_list6_2004.12.171.pdf http://www.efsa.eu.int/science/afc/afc_opinions/195/opinion_afc_01_en1.pdf

+

31545 025322-25-2 Acrylic acid-methyl methacrylate, copolymer (average Mw=1000-2000 dalton)

7? Needed: migration and toxicity data according to SCF guidelines on the polymeric additive itself.

+

31550 - Acrylic acid-methyl methacrylate-ethyleneglycol monomethacrylate phosphate, copolymer (Mw= 5000-20000)

7? Available: Use. Needed: Mw distribution curve, 3 mutagenicity tests for ethylenglycol monomethacrylate phosphate monomer. The need for further mutagenicity tests is under discussion. (CS/PM/2632).

+

31560 025085-34-1 Acrylic acid-styrene, copolymer

D + +

31580 - Acrylic acid-vinylpyrrolidone, copolymer

9 +

31595 - Acrylic polymers 9 +

31600 see 31700 D +

31605 009003-18-3 Acrylonitrile-butadiene, copolymer

D +

31610 009010-81-5 Acrylonitrile-butadiene-methacrylic acid, copolymer

W +

http://www.efsa.eu.int/science/afc/afc_opinions/768/afc_fcm_op_list6_2004.12.171.pdf





AND SPECIFICATIONS


121

31620 009010-94-0 Acrylonitrile-butadiene-methyl methacrylate- styrene, copolymer

D +

31640 009003-56-9 Acrylonitrile-butadiene-styrene, copolymer

D +

31660 009003-54-7 Acrylonitrile-styrene, copolymer

D +

31680 see 31730 D + +

31700 068411-97-2 N-Acylsarcosines where the acyl group is derived from the fatty acids of coconut oil

8 +

31730 000124-04-9 Adipic acid Same 12130 DIR 1 ADI: 5 mg/kg b.w. (SCF, 25th Series, 1991).

+ +

31760 - Adipic acid, alkyl, primary (C4-C13) esters

9 Group R= 0.05 mg/kg b.w. +

31840 025805-74-7 and 025718-70-1

Adipic acid-1,3-benzenedimethanamine, copolymer (=adipic acid, m-xylylenediamine, copolymers)

7? Available: Range of numerical molecular mass (Mn): 14.000 - 21300 D. Needed: Mw distribution curve. (CS/PM/2632).

+

31920 000103-23-1 Adipic acid, bis(2-ethylhexyl) ester

DIR SML = 18 mg/kg (1) 2 Statement on a new intake study. CS/PM/3276 REV.I/31920. http://europa.eu.int/comm/food/fs/sc/scf/reports/scf_reports_36.pdf

+ +

32000 000105-96-4 Adipic acid, bis(6-methylheptyl) ester

8 Group R: 0.05 mg/kg b.w. Needed : toxicological data depending on migration level (see SCF guidelines) and if migration exceeds 0.05 mg/kg peroxisome proliferation studies too.

+

32080 000110-29-2 Adipic acid, n-decyl n-octyl ester

8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies too.

+

32160 068515-75-3 Adipic acid, dialkyl esters (C7-C9)

9 Group R: 0.05 mg/kg b.w. Available: 90-day oral rat study. Needed: in first instance specifications.

+




AND SPECIFICATIONS


122

Toxicological data depending on migration level (see SCF guidelines) and, if migration data exceeds 0.05 mg/kg, peroxisome proliferation study of the specified substances.

32200 002998-04-1 Adipic acid, diallyl ester Same 12160 6A +

32240 000105-99-7 Adipic acid, dibutyl ester 8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation study too.

+

32320 000105-97-5 Adipic acid, di-n-decyl ester

Same 12190 8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation study too.

+

32395 025212-19-5 Adipic acid-diethylenetriamine-epichlorohydrin, copolymer

7 Available: Molecular mass distribution curve, data on use, impurities, residual amounts of starting substances. Needed: In first instance, information on identity of the fraction below 1000 D. DE/TNO SDS, June 1998 = CS/PM/3163 REV.1/32395). (Adopted at 114th SCF meeting) (10 December 1998) http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

+

32400 072088-98-3 Adipic acid-diethylenetriamine-epichlorohydrin- ethyleneimine, copolymer

D +

32480 000141-04-8 Adipic acid, diisobutyl ester

7 Group R: 0.05 mg/kg b.w. Available: inadequate 2-year oral rat study. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation study too.

+

32560 027178-16-1 Adipic acid, diisodecyl ester

Same 12220 9 Group R: 0.05 mg/kg b.w. Needed: in first instance specifications and

+




AND SPECIFICATIONS


123

then on the specified substances toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies too.

32640 033703-08-1 Adipic acid, diisononyl ester

9 Group R: 0.05 mg/kg b.w. Available: 90-day oral rat and dog studies and two mutagenicity studies. Needed: in first instance specifications, test for chromosome aberrations in mammalian cells in vitro and then the remaining toxicological tests depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies too.

+

32720 001330-86-5 Adipic acid, diisooctyl ester

9 Group R: 0.05 mg/kg b.w. Needed: in first instance specifications and then on the specified substances provide toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation study too.

+

32760 000627-93-0 Adipic acid, dimethyl ester

8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation study too.

+

32800 000151-32-6 Adipic acid, di-n-nonyl ester


+

32840 001119-74-0 Adipic acid, di-n-octadecyl ester


+

32880 000123-79-5 Adipic acid, di-n-octyl ester

Same 12250 8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and, if

+


AND SPECIFICATIONS


124

migration exceeds 0.05 mg/kg, peroxisome proliferation study too.

32920 - Adipic acid, esters with diols from C2-C6

9 Group R: 0.05 mg/kg b.w. +

32960 - Adipic acid, mixed esters with 1,2-propyleneglycol and alcohols, monoh.,sat., linear (C8-C10)

W9 Group R: 0.05 mg/kg bw. Provide informations on identity.

+

33040 094109-12-3 Adipic acid, mono-n-octadecyl ester, calcium salt


33105 146340-15-0 Alcohols C12-C14 secondary.beta.-(2-hydroxyethoxy)-ethoxylated

W7 Evaluated in EFSA-AFC and classified in List7. http://www.efsa.eu.int/science/afc/afc_opinions/195/opinion_afc_01_en1.pdf

+

33120 - Alcohols, aliph, monoh., sat., linear, primary (C4-C24)

DIR 3 90-day oral studies, metabolic and/or mutagenicity studies with some substances out of the group. (SCF, 17th Series, 1986).

+ +

33200 - Alcohols, aliph, monoh., sat., linear or secondary(C4-C22)

9 +

33280 - Alcohols, aliph., monoh., unsat., linear, (C16-C22) (except oleyl alcohol)

8 Needed: toxicological data on two representatives of the group according SCF guidelines. N.B. The evaluation is not applicable to oleyl alcohol.

+

33320 - Alcohols, cycloaliph., monoh.(up to C18), and substituted

9 +

33350 009005-32-7 Alginic acid DIR 1 ADI: not specified. (JECFA, 39M., 1992).

+

33360 - Alginic acid, salts D ADI: 50 mg/kg b.w. (JECFA 17 M., 1973).

+

33440 - Alkanes (b.p.up to 100 degrees celsius)

9 +

33460 - Alkanes, n, and iso,(C4-C14)

9 +




AND SPECIFICATIONS


125

33520 - n-Alkenes (C2-C14) 9 +

33535 152261-33-1 alpha-Alkenes(C20-C24)maleic anhydride-4-amino-2,2,6,6-tetramethylpiperidine, polymer

W +

33540 068439-57-6 alpha-Alkene(C14-C16)sulphonic acid, sodium salt

W +

33550 - Alkenylnorbornene-ethylene, copolymer

D +

33565 - Alkenylnorbornene-ethylene-propylene, copolymer

9 +

33600 - C-alkenyl(C12-C18) succinalkyl(C12-C18) imide

9 +

33680 - Alkyl(C8-C20)arylsulphonic acid

9 + +

33760 - Alkyl(C8-C18)arylsulphuric acid

9 +

33800 - Alkyl(C10-C13)benzenesulphonic acid

9 +

33801 - n-Alkyl(C10-C13)benzenesulphonic acid

DIR SML = 30 mg/kg 2 TDI = 0.5 mg/kg b.w. based on TDI for 52000.

+

33820 093062-35-2 Alkyl(C8-C14)benzene-sulphonic acid, sodium salt

D +

33840 - Alkyl(C11-C14)bis(hydroxyethyl)sulphonium bisulphate

9 +

33920 - Alkyl(C11-C14)bis(hydroxyethyl)sulphonium glycolsulphate

9 +

34000 - n-Alkyl(C11-C15)bis(hydroxyethyl)sulphonium sulphate

9 +


AND SPECIFICATIONS


126

34015 - Alkyl caprolactone phosphate

9 +

34080 - n-Alkyl(C11-C14)hydroxyethyl sulphide

9 +

34160 see 34230 D + +

34165 - Alkyl(C8-C18)phenoxybenezenedisulphonic acid, salts

9 +

34180 - Alkyl(C14-C29)poly(ethyleneglycol)glycolic acid

9 +

34195 - Alkyl(C8-C18)poly(ethylene-and/or propylene-and/or butyleneglycol)glycolic acid

9 +

34225 068037-49-0 Alkyl(C10-C18)sulphonic acids

W9 +

34230 - Alkyl(C8-C22)sulphonic acids

DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w. 1- and 2-year oral rat studies (Bayer report 1960).

+ +

34231 - n-Alkyl(C8-C22)sulphonic acids

2 TDI: 0.1 mg/kg bw based on TDI for 34230. +

34240 - Alkyl(C10-C20)sulphonic acid, esters with phenols

D 7 SCF_List: 7 Needed data or information: Chromosomal aberration assay in vitro according to prevailing guidelines, controlling the effects of test article on pH and osmolality of the medium, and providing historical data on spontaneous aberration frequencies in the test system. Data to demonstrate the absence of potential for accumulation in man. (Adopted at the 136th SCF meeting, 5 March 2003) http://europa.eu.int/comm/food/fs/sc/scf/out

+



AND SPECIFICATIONS


127

172_en.pdf

34241 - Alkyl(C10-C20)sulphonic acid esters with cresols or cresols and phenols

9 +

34245 085711-69-9 Alkyl(C13-C17-sec)sulphonic acid, sodium salts

W +

34250 085711-70-2 Alkyl(C14-C18-sec)sulphonic acid, sodium salts

W +

34275 085586-07-8 Alkyl(C12-C14)sulphuric acid, salts

Same 34295 9 Look at 34281. + +

34280 - Alkyl(C8-C22)sulphuric acids

9 Look at 34281. +

34281 - Alkyl(C8-C22)sulphuric acids, linear, primary, with an even number of carbon atoms

DIR 3 Toxicologically acceptable. (CS/PM/2472 = Elias SDS 1994-11-24).

+ +

34290 - Alkyl(C16-C18)sulphuric acid, salts

9 Look at 34281. +

34292 068585-47-7 Alkyl(C10-C16)sulphuric acid, sodium salt

D Covered by 34280. +


Same 34275 D Covered by 34275. +

34297 073296-89-6 Alkyl(C12-C16)sulphuric acid, sodium salts

W +


D Covered by 34290. +

34400 - Alkyl(C12-C16)trimethylammonium bromide

8 +

34415 - Alkyl(C1-C12) vinyl ethers-allyl alcohol, copolymers

9 +



AND SPECIFICATIONS


128

34430 - Alkyl(C1-C12) vinyl ethers - maleic acid or allyl alcohol, copolymer

9 +

34445 - Alkyl(C1-C12) vinyl ethers-maleic acid, copolymers

9 +

34452 - Allyl alcohol-vinyl acetate, copolymer

9 +

34470 - Aluminium calcium hydrophosphite

D +

34475 - Aluminium calcium hydroxide phosphite, hydrate

DIR 2-3 For Aluminium L2. Group TDI= 1mg/kg b.w. based on PTWI for Al of 7 mg/kg b.w. (SCF, 25th Series, 1991). For phosphite. L3. Phosphite easily oxidised to phosphate. Available: migration data, 28-day oral rat study, 4 mutagenicity studies. (RIVM SDS, August 1994).

+

34480 - Aluminium fibers, flakes and powders

DIR 2 TDI : 1 mg/kg b.w. (as Al) based on PTWI= 7 mg/kg (as Al) (SCF, 25th Series, 1991).

+ +

34560 021645-51-2 Aluminium hydroxide DIR 2 TDI: 1 mg/kg bw (as Al) based on PTWI: 7 mg/kg b.w. (as Al). (SCF, 25th Series, 1991).

+ +

34640 013170-05-3 Aluminium hydroxide bis(4-tert-butylbenzoate)

W8 L2 for Al. TDI: 1 mg/kg bw (as Al) based on PTWI: 7 mg/kg bw (as Al). (SCF, 25th Series, 1991). W8 for bis(4-tert.butylbenzoate).

+

34650 151841-65-5 Aluminium hydroxybis [2,2’-methylenebis (4,6-di-tert.butylphenyl) phosphate

18875 DIR SML = 5 mg/kg 3 SCF_List: 3 Restriction: 5 mg/kg of food. Based on the reduced core set of toxicological data according to the migration level. (Opinion adopted by the SCF at the 136th meeting, 5 march 2003) http://europa.eu.int/comm/food/fs/sc/scf/out

+



AND SPECIFICATIONS


129

172_en.pdf

34690 011097-59-9 Aluminium magnesium carbonate hydroxide

Same 64480 DIR 3 Inert material. +

34720 001344-28-1 Aluminium oxide DIR 2 TDI: 1 mg/kg bw (as (Al) based on PTWI: 7 mg/kg b.w. (as Al). (SCF, 25th Series, 1991).

+ +

34750 - Aluminium silicate, silanated

9 L2 for Al. TDI: 1 mg/kg bw based on PTWI: 7 mg/kg bw (as Al). (SCF, 25th Series 1991). L9 for "silanated".

+

34790 015306-17-9 Aluminium tris(ethyl acetylacetate)

W +

34800 - Amides of acids, aliph., monocarb. (C6-C22)

9 +

34850 143925-92-2 Amines, bis(hydrogenated tallow alkyl) oxidised

DIR QM = For use only : (a) in PO at 0.1% (w/w) but not in LDPE when it is in contact with foods for which the Dir. 85/572 establishes a RF< 3; (b) in PETat 0.25 % (w/w) in contact with foods other of those for which simulant D is laid down in Dir.85/572

3 SCF_List: 3 Restriction: Only to be used: ·in polyolefins at 0.1 % (w/w) and not for fatty food with a simulant D Reduction Factor less than 3 ·in PET at 0.25% (w/w) and only for food for which simulant D is not required. Remark for Commission: To make sure that also for the migration of Bis(hydrogenated tallow, C16-C18, alkyl) nitrones and (Hydrogenated tallow, C16-C18, alkyl) oximes into fatty foods a sufficient safety margin to the NOEL in the subchronic oral rat study exists the following restriction is proposed: Qm 0,1 % in polyolefins, not for fatty foods with a Reduction Factor < 3. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf

+

34875 - omega-Aminoacids (C6-C12)

9 +

34880 - Aminoacids, salts 9 +

34895 000088-68-6 2-Aminobenzamide DIR SML = 0.05 mg/kg. To 3 SCF_List: 3 +





AND SPECIFICATIONS


130

be used only for PET for water and beverages.

Restriction: 0.05 mg/kg of food. Based on the reduced core set of toxicological data according to the migration level. Remark for Commission: only requested in contact with water and beverages. Substance may be reactive with fat components, therefore authorisation should be restricted to requested application (PET for water and beverages). (Opinion adopted by the SCF at the 136th meeting, 5 March 2003) http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdf

34925 061789-40-0 3-Amino-N-(carboxymethyl)-N,N,-dimethyl-1-propanaminium, N-coco acyl derivatives hydroxides, inNer salt

W8 +

34940 014205-40-4 3-Aminocrotonic acid, diester with ethyleneglycol

8 Available: summary on 90-day study, migration into oil (< 0.25 ppm).

+

34960 - 3-Aminocrotonic acid, esters with butyleneglycol

7 Available: 90-day oral rat study, inadequate migration data (CS/PM/ 2034). Needed: 3 mutagenicity studies, physico-chemical and migration data, analytical method.

+

35040 - 3-Aminocrotonic acid, esters with mono- or dihydric alcohols

9 +

35120 013560-49-1 3-Aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether

Same 92820 DIR 2 t-TDI: 5 mg/kg b.w. pending results of mutagenicity studies. Available: 28-day and 90-day oral rat studies, metabolism, very low migration.

+

35160 006642-31-5 6-Amino-1,3-dimethyluracil

DIR SML = 5 mg/kg 3 R = 5 mg/kg of food. Remark for Commission: 6-amino-1,3-dimethyl-uracil hydrolyses in acetic acid.

+




AND SPECIFICATIONS


131

(Adopted at the 119th SCF meeting) (2 December 1999) http://europa.eu.int/comm/food/fs/sc/scf/out50_en.pdf

35170 000141-43-5 2-Aminoethanol Same 67420-12763-22337

DIR SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC and for indirect food contact only, behind the PET layer

3 + +

35180 084434-12-8 N-(2-Aminoethyl)-beta-alanine, sodium salt

Same 12765 D Available: specific migration in 3% acetic acid, 15% ethanol and 95% ethanol < 0.03 mg/kg food; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative) RIVM/ISS/TNO SDS, November 1999 = CS/PM/3352 REV. I/35180. Remark for Commission: * PM/REF No. should be changed * Send a letter to the applicant, concerning the "preparation" of the petition (poor quality of the dossier) * The commercial product (as 40% aqueous solution) is tested in the mutagenicity assays http://europa.eu.int/comm/food/fs/sc/scf/out61_en.pdf

+

35200 034730-59-1 N-(2-Aminoethyl)-2-aminoethanesulphonic acid, sodium salt

8 +

35280 - N-(2-Aminoethyl)-3-aminopropanesulphonic acid, salts

8 +

35284 000111-41-1 N-(2- Same 12771 DIR SML = 0.05 mg/kg. 3 R = 0.05 mg/kg of food. + +






AND SPECIFICATIONS


132

Aminoethyl)ethanolamine

Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC and for indirect food contact only, behind the PET layer.

Remark: substance evaluated only for the requested use for indirect contact with non-fatty food. (Adopted at the 121 SCF meeting (20 June 2000)) http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdf

35288 093820-52-1 N-(2-Aminoethyl)-N-(2-hydroxyethyl)-beta-alanine,N-coco acylderivatives, monosodium salts(+)

W8 +

35294 090268-48-7 4-Amino-4-oxo-2-sulfobutyric acid, N-tallow alkyl derivatives, disodium salts

W8 +

35320 007664-41-7 Ammonia Same12789 DIR 1 ADI: not specified. (SCF, 25th series, 1991).

+ +

35340 001066-33-7 Ammonium bicarbonate D +

35440 012124-97-9 Ammonium bromide DIR 1 Group ADI: 1 mg/kg b.w. (as Br) as pesticide residue. (JMPR "Pesticide residues in food", 1988, paper 93/2).

+

35520 012125-02-9 Ammonium chloride 1/D ADI: not specified. (SCF, 25th Series, 1991).

+ +

35600 001336-21-6 Ammonium hydroxide DIR 1 ADI: not specified. (SCF, 25th Series, 1991)

+ +

35680 001314-60-9 Antimony pentoxide 6B R : 0.01 mg/kg (as Sb) in food. Very low EEC limit for drinking water: 0.01 mg/1. Needed: actual use.

+

35760 001309-64-4 Antimony trioxide DIR SML = 0.02 mg/kg (expressed as Antimony and analytical tolerance included)

3 Restriction 0.04 mg/kg of food (as Sb) Remark for Commission: Migration limit might be exceeded at very high temperature. http://www.efsa.eu.int/science/afc/afc_opinions/190/opinion_afc_06_en1.pdf

+ +






AND SPECIFICATIONS


133


35840 000506-30-9 Arachidic acid Same 12810 DIR 0 + +

35845 007771-44-0 Arachidonic acid Same 12813 DIR 0 + +

35880 - Aromatic sulphonic acids-formaldehyde, copolymer

9 +

35920 - Arylsulphonic acid 9 +

35960 001332-21-4 Asbestos 5 [There is well-known occupational hazard and the disposal of materials containing asbestos may constitute an environmental hazard.]

+

36000 000050-81-7 Ascorbic acid DIR 1 Acceptable. (SCF, 22th Series, 1989).

+ +

36080 000137-66-6 Ascorbyl palmitate DIR 1 Acceptable. (SCF, 22th Series, 1989).

+

36160 010605-09-1 Ascorbyl stearate DIR 1 Acceptable. Covered by the assessment for ascorbyl palmitate.

+

36240 - Azelaic acid, alkyl, primary(C1-C12) esters


36320 000103-24-2 Azelaic acid, bis(2-ethylhexyl) ester

7 Group R: 0.05 mg/kg b.w. Available: inadequate 90-day study. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome prn_

+

36400 000106-03-6 Azelaic acid, bis(6-methylheptyl) ester


+

36480 000109-31-9 Azelaic acid, di-n-hexyl ester

7 Group R: 0.05 mg/kg b.w. Available: 90-day and 2-year oral rat, 1-year oral dog studies. Needed: toxicological data depending on migration level (see SCF guidelines) and if migration exceeds 0.05 mg/kg peroxisome

+




AND SPECIFICATIONS


134

proliferation studies too.

36560 002064-80-4 Azelaic acid, di-n-octyl ester

8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF g uidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation study too.

+

36640 000123-77-3 Azodicarbonamide DIR See Commission Directive 2004/1/EC ‘For use only as blowing agent. Use prohibited as from 2 August 2005.’

3 SCF_List: 3 Restriction: Only as a blowing agent and not for materials intended for contact with alcoholic beverages. http://www.efsa.eu.int/science/afc/afc_opinions/1005/afc_op_ej219_semicarbazide_en1.pdf. http://www.efsa.eu.int/science/afc/afc_documents/364/p_afc_doc_03_en11.pdf http://www.efsa.eu.int/science/afc/afc_documents/525/semicarbazide_afc_state02_1oct_en1.pdf http://www.efsa.eu.int/science/afc/afc_documents/365/p_afc_doc_0111.pdf See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf

+

36720 017194-00-2 Barium hydroxide DIR SML(T) = 1 mg/kg (12) (expressed as Barium)

3 R: 1 mg/kg (as Ba) in food (Rivm doc. May 1992 (CS/PM/1584)).

+ +

36800 010022-31-8 Barium nitrate DIR SML(T) = 1 mg/kg (12) (expressed as Barium)

2-3 List 2 for nitrate TDI: 3 mg/kg bw (for nitrate) based on ADI = 5 mg/kg bw on sodiumnitrate. (SCF, 26 Series, 1992). List 3 for Barium R: 1 mg/kg (as Ba) in food. (Rivm doc., May 1992 (CS/PM/1584)).

+

36840 012007-55-5 Barium tetraborate DIR SML(T) = 1 mg/kg 2-3 Re-evaluation on the basis of an opinion of +

http://www.efsa.eu.int/science/afc/afc_opinions/1005/afc_op_ej219_semicarbazide_en1.pdf



http://www.efsa.eu.int/science/afc/afc_documents/364/p_afc_doc_03_en11.pdf

http://www.efsa.eu.int/science/afc/afc_documents/364/p_afc_doc_03_en11.pdf

http://www.efsa.eu.int/science/afc/afc_documents/525/semicarbazide_afc_state02_1oct_en1.pdf



http://www.efsa.eu.int/science/afc/afc_documents/365/p_afc_doc_0111.pdf

http://www.efsa.eu.int/science/afc/afc_documents/365/p_afc_doc_0111.pdf




AND SPECIFICATIONS


135

expressed as Barium (12) and SML(T) = 6 mg/kg (23) (expressed as Boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption (OJ L 330, 5.12.1998, p.32).

the SCF in another context. List 3 for Barium. R = 1 mg/kg (as Ba in food). RIVM SDS, May 1992 = CS/PM/1584. List 2 for Borate. Group-TDI = 0.1 mg/kg b.w. (as B) (with REF_n. 36840, 40320 and 87040). The TDI is based on the No Adverse Effect Level (NOAEL) of 9.6 mg/kg b.w./day for effects on fetal body weight and skeletal anomalies in the rat developmental study. A Safety Factor (SF) of 100 is used. “Opinion of the Scientific Committee on Food on Arsenic, Barium, Fluoride, Boron and Manganese in Natural Mineral Waters (expressed on 13 December 1996, 105th plenary meeting of the SCF, completed on 13 June 1997 at the 107th plenary meeting of the SCF; 43rd Series of Reports of the SCF, 2000”. This opinion is also available on Internet. (Adopted by the SCF at the 127th meeting, 30 May 2001) http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

36880 008012-89-3 Beeswax DIR 0 + +

36960 003061-75-4 Behenamide DIR 3 Metabolized to ammonia and behenic acid +

37040 000112-85-6 Behenic acid Same 12990 DIR 0 + +

37120 - Behenic acid, esters with pentaerythritol


37200 053161-46-9 Behenic acid, monoesters with pentaerythritol


37240 - Behenic acid, salts D +

37280 001302-78-9 Bentonite DIR 3 Inert material. + +

37360 000100-52-7 Benzaldehyde DIR In compliance with note 9 in Annex VI

1 Group ADI = 5 mg/kg b.w. as benzoic acid. (JECFA 11 M., 1967)

+

37440 000080-17-1 Benzenesulphonic acid hydrazide

6A +




AND SPECIFICATIONS


136

37520 002634-33-5 1,2-Benzisothiazolin-3-one

7 Under re-evaluation Microbiological data missing. t-TDI: 0.02 mg/kg bw.

+ +

37530 111337-53-2 1,2-Benzisothiazolin-3-one, lithium salt

? Under re-evaluation +

37600 000065-85-0 Benzoic acid Same 13090 DIR 1 Group ADI: 5 mg/kg b.w. (JECFA 27 M., 1983).

+

37680 000136-60-7 Benzoic acid, butyl ester DIR 2 Group TDI: 5 mg/kg b.w. as benzoic acid for butyl-, ethyl-, methyl-, propylbenzoate on the basis of the Group ADI for benzoic acid. (JECFA 27 M., 1983)

+

37760 - Benzoic acid, esters with 1,2-propanediol

D +

37840 000093-89-0 Benzoic acid, ethyl ester DIR 2 Group TDI: 5 mg/kg b.w. as benzoic acid for butyl-, ethyl-, methyl-, propylbenzoate on the basis of the Group ADI for benzoic acid. (JECFA 27 M., 1983).

+

37920 000136-36-7 Benzoic acid, 3-hydroxyphenyl ester


38000 000553-54-8 Benzoic acid, lithium salt DIR SML(T) = 0.6 mg/kg (8) (expressed as Lithium)

1-2 L1 for benzoic acid. Group ADI: 5 mg/kg b.w.. (JECFA 27M., 1983). L2 for Lithium. Group TDI: 0.01 mg/kg b.w. (as Li). Available: 90-day oral rat studies, mutagenicity data, therapeutic use of Li salts. (Rivm summary, Sept. 1991).

+

38080 000093-58-3 Benzoic acid, methyl ester

DIR 2 Group TDI: 5 mg/kg b.w. as benzoic acid for butyl-, ethyl-, methyl-, propylbenzoate on the basis of the Group ADI for benzoic acid. (JECFA 27 M., 1983).

+

38160 002315-68-6 Benzoic acid, propyl ester

DIR 2 Group TDI: 5 mg/kg b.w. as benzoic acid for butyl-, ethyl-, methyl-, propylbenzoate on the basis of the Group ADI for benzoic acid.

+


AND SPECIFICATIONS


137

(JECFA 27 M., 1983).

38240 000119-61-9 Benzophenone DIR SML = 0.6 mg/kg 2 Group TDI: 0.01 mg/kg b.w. 90-day oral rat study and metabolism study (CIVO report R 3301, 1970).

+

38320 005242-49-9 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene

DIR In compliance with the specifications laid down in Annex V

3 R = Maximum amount to be used 0.05% (w/w).

+

38480 000056-93-9 Benzyltrimethylammonium chloride

8 +

38500 066822-60-4 Betaine type methacrylic polymer (N-methacrylolylethyl-N,N-dimethylammonium -alpha-N-methylcarboxylate,octadecyl methacrylate,ethyl methacrylate,cyclohexyl methacrylate,n-vinyl-2-pyrrolidone,copolymers

Same 65920 D +

38505 351870-33-2 cis-endo-Bicyclo[2.2.1]heptane-2,3-dicarboxylic acid, disodium salt

3AM 3 Restriction: 5 mg/kg of food (based on a daily consumption of 1 kg of packaged food per person. This restriction would correspond to a maximum intake of 0.1 mg cis-endo-bicyclo[2.2.1]heptane-2,3- dicarboxylic acid, disodium salt /kg b.w./day Such figure is at least two orders of magnitude lower than the NOAEL which can be extrapolated from the results on the most sensitive species.) Remark for Commission: Not to be used with polyethylene in contact with acidic foods Hydrophilic substance (based on logPo/w, and on highest migration into acidic foods) The purity of the substance tested was >= 98.8% The petitioner applies only for polypropylene (all food types) and polyethylene (non acidic foods) http://www.efsa.eu.int/science/afc/afc_opini

+



AND SPECIFICATIONS


138

ons/190/opinion_afc_06_en1.pdf

38510 136504-96-6 1,2-Bis(3-aminopropyl)ethylenediamine, polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine

DIR SML = 5 mg/kg 3 R: 5 mg/kg of food. +

38515 001533-45-5 4,4'-Bis(2-benzoxazolyl)stilbene

DIR SML = 0.05 mg/kg (1) 3 R: 0.05 mg/kg food. Available: 3 mutagenicity tests, negative and migration data. (RIVM SDS of 1994-10-25 and 1996-05-03 = CS/PM/2463 and CS/PM/2791). Remark: since high migration into fat has been demonstrated with the exception of PET, the WG recommends that the Commission take the necessary measures so that the restriction proposed is not exceeded.

+ +

38530 032509-66-3 Bis(3,3-bis(4-hydroxy-3-tert-butylphenyl)butanoic acid), ester with ethyleneglycol

Same 53670 D + +

38560 007128-64-5 2,5-Bis(5-tert-butyl-2-benzoxazolyl)thiophene

DIR SML = 0.6 mg/kg 2 TDI: 0.01 mg/kg b.w. 90-day oral dog and rat studies, 1-year (+ 0.5-year recovery) study in mice showed accumulation in tissues by fluorescence. (RIVM, doc. tox. 300/277, June 1981).

+ +

38565 090498-90-1 3,9-Bis[2-(3-(tert.butyl-4-hydroxy-5-methylphenyl)propionyloxy)-tert.butyl]-2,4,8,10-tetraoxaspiro[5.5]undecane

W7 Available: Migration data, 3-month oral rat study; 3 (negative) in vitro mutagenicity studies, high bioaccumulation potential. Needed: data demonstrating absence of bioaccumulation in vivo, especially in liver and fat. (RIVM SDS, = CS/PM/2994/38565).

+

38580 057569-40-1 Bis(2-tert-butyl-4-methyl-6-(3-tert-butyl-5-methyl-2-

Same 92205 D +



AND SPECIFICATIONS


139

hydroxybenzyl) phenyl)terephthalate

38600 000078-63-7 2,5-Bis(tert-butylperoxy)-2,5-dimethylhexane

9 Specification for use. +

38615 002212-81-9 1,3-Bis(tert-butylperoxyisopropyl)benzene


38625 002781-00-2 1,4-Bis(tert-butylperoxyisopropyl)benzene


38640 see 38700 D +

38700 063397-60-4 Bis(2-carbobutoxyethyl)tin-bis(isooctyl mercaptoacetate)

DIR SML = 18 mg/kg 2 t-TDI: 0.3 mg/kg b.w. pending additional mutagenicity studies. Available: 28-day in young rats and 90-day oral rat studies and Ames test. (RIVM report 89/678608/003, 1989-04-04).

+

38720 105350-68-3 2,2-Bis[4-(2-(3,5-di-tert-butyl-4-hydroxyhydro cinnamoyloxy))ethoxyphenyl]-propane

W +

38750 000118-82-1 Bis(3,5-di-tert-butyl-4-hydroxyphenyl)methane

Same 66320 D +

38780 023128-74-7 N,N'-Bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hexamethylenediamine

Same 59120 D + +

38800 032687-78-8 N,N'-Bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide

DIR SML = 15 mg/kg 2 TDI: 0.25 mg/kg b.w. 3 month oral rat study, mutagenicity studies. Migration data. (RIVM, September 1990).

+ +

38810 080693-00-1 Bis(2,6-di-tert-butyl-4-methylphenyl)pentaerythritol diphosphite

DIR SML = 5 mg/kg (sum of phosphite and phosphate)

3 R = 5 mg/kg of food (sum of phosphite and phosphate). Remark for Commission: only migration data of the additive from polypropylene into food simulants are available. (Adopted at 111th SCF meeting (18-19 March 1998)).

+


AND SPECIFICATIONS


140


38820 026741-53-7 Bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite

DIR SML = 0.6 mg/kg 2 TDI: 0.01 mg/kg b.w. 90-day oral rat and 4-month oral dog studies and Ames test. (RIVM, Doc. Tox. 300/335, June 1982).

+

38840 154862-43-8 Bis(2,4-dicumylphenyl)pentaerythritol-diphosphite

DIR SML = 5 mg/kg (as sum of the substance itself, its oxidised form bis(2,4-dicumylphenyl)pentaerythritol-phosphate and its hydrolysis product (2,4-dicumylphenol)).

3 R =5 mg/kg of food (assigned to Doverphos S-9228 including the stabiliser itself, its oxidised form bis (2,4-dicumylphenol) pentaerythritol-phosphate and its hydrolysed product (2,4-dicumylphenol). (Adopted at the 126th SCF meeting, 28 February 2001) http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdf

+

38879 135861-56-2 Bis(3,4-dimethylbenzylidene)sorbitol

DIR 2 Group TDI = 1 mg/kg bw (with 39760 and 38920). Available: 3 mutagenicity studies negative, 3 months oral rat study, bioaccumulation and migration data. (RIVM report 1995-08-22, CS/PM/2650).

+

38880 see 38820 D +

38885 002725-22-6 2,4-Bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-octyloxyphenyl)-1,3,5-triazine

W7 +

38920 see 38950 D +

38940 110675-26-8 2,4-Bis(dodecylthiomethyl)-6-methylphenol

3AM 3 Restriction: Group restriction of 5 mg/kg food as sum of 2,4- bis(dodecylthiomethyl)-6-methylphenol and 2,4-bis(octylthiomethyl)-6-methylphenol Remark for Commission: FRF is applicable http://www.efsa.eu.int/science/afc/afc_opinions/768/afc_fcm_op_list6_2004.12.171.pdf

+

38950 079072-96-1 Bis(4-ethylbenzylidene)sorbitol

DIR 2 Group TDI: 1 mg/kg b,w. (with bis(4-ethylbenzylidene) sorbitol, bis(methylbenzylidene) sorbitol and

+








AND SPECIFICATIONS


141

dibenzylidene sorbitol). Several 90-day mouse and rat studies, several mutagenicity tests negative. (RIVM Doc. 88/678608/008, 1 Nov. 1988; RIVM Doc. Tox 300/425, May 1983, RIVM 15 Nov. 1989).

38960 035958-30-6 2,2-Ethylidene-bis-(4,6-di-t-butylphenol)

Same 39060 D +

38970 - N,N-Bis-(2-ethylhexyl)glycine, sodium salt

8 +

39010 000088-24-4 Bis(2-hydroxy-3-tert-butyl-5-ethylphenyl)methane

Same 66400 D +

39025 000119-47-1 Bis(2-hydroxy-3-tert-butyl-5-methylphenyl)methane

Same 66480 D +

39040 see 39090 D + +

39045 004066-02-8 Bis(2-hydroxy-3-cyclohexyl-5-methylphenyl)methane

Same 66560 D +

39060 035958-30-6 1,1-Bis(2-hydroxy-3,5-di-tert-butylphenyl)ethane

Same 38960 DIR SML = 5 mg/kg 3 R: 5 mg/kg in food. Available: 3-month oral rat and dog studies, reproduction study and tests for mutagenicity negative. (RIVM doc. February 1992).

+

39090 - N,N-Bis(2-hydroxyethyl)alkyl(C8-C18)amine

DIR SML(T) = 1.2 mg/kg (13)

2 Nota bene Substance evaluated in the past (Additional List of Monomers and Additives Evaluated by the WG "Food Contact Materials" of the SCF During the 69th-70th Meetings (adopted during the 107th SCF meeting of 12 and 13 June 1997 see http://europa.eu.int/comm/food/fs/sc/oldcomm7/out12_en.html ) Only a clarification of the expression "free amine" appearing in the SCF restrictions of the substance 39120 (see below) was requested to the SCF. Therefore, this is not a re-evaluation of the substance

+ +

http://europa.eu.int/comm/food/fs/sc/oldcomm7/out12_en.html

http://europa.eu.int/comm/food/fs/sc/oldcomm7/out12_en.html


AND SPECIFICATIONS


142

because of new data. Group t-TDI = 0.02 mg/kg b.w. (with REF-n. 39120). Needed: three in vitro mutagenicity studies according to guidelines on either REF_N. 39090 or 39120. Remark: on the basis of the available studies it remains included in the group t-TDI pending the results of the required mutagenicity studies. If negative it will be classified in L3 with a restriction of 5 mg/kg of food. NOTE: both substances are covered when the mutagenicity studies are submitted. (Adopted by the SCF at the 127th meeting, 30 May 2001) http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

39120 - N,N-Bis(2-hydroxyethyl)alkyl(C8-C18)amine hydrochlorides

DIR SML(T) = 1.2 mg/kg (13) expressed as tertiary amine (expressed excluding HCl)

2 Group t-TDI = 0.02 mg/kg b.w. expressed as tertiary amine (expressed excluding HCl) (with REF_n. 39090). (Adopted by the SCF at the 127th meeting, 30 May 2001) http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

+

39140 000136-26-5 N,N-Bis(2-hydroxyethyl)decanamide

7? Same references as 39280. +

39160 000111-46-6 Bis(2-hydroxyethyl) ether

Same 15760,13326

and 47680

D +

39200 006200-40-4 Bis(2-hydroxyethyl)-2-hydroxypropyl-3-(dodecyloxy)methylammonium chloride

DIR SML = 1.8 mg/kg 2 TDI: 0.03 mg/kg b.w. 90-day oral rat study. (CIVO report R2491 September. 1967 and 2628 February 1968).

+

39280 000120-40-1 N,N-Bis(2-hydroxyethyl)lauramide

Same 63560 7? Available: 3-month oral rat and dog studies with different diethanolamides of fatty acids. Three mutagenicity studies, negative. Migration data.

+






AND SPECIFICATIONS


143

Needed: Reason for the choice of test sample (polymer and concentration of additive) for migration test, stability of additive in food simulants under the test conditions applied, physical-chemical data including Po/w and data on use. (RIVM SDS May 1996 = CS/PM/2801).

39360 - N,N-Bis(2-hydroxyethyl)octadecylamine, N(2-hydroxyethyl-N-octadecylglycine(monosodium salt/and N,N'- bis(hydroxyethyl)-N-(carboxymethyl) octadecanaminium hydroxide (inNer salt) compon. mixt. of reaction as maJor components of mixture prepared by reac

9 +

39440 058767-50-3 N,N-Bis(2-hydroxyethyl)-N-(n-octyl)-N-methylammonium 4-toluenesulphonate

8 +

39480 000093-83-4 N,N-Bis(2-hydroxyethyl)oleamide


39520 000093-82-3 N,N-Bis(2-hydroxyethyl)stearamide


39560 000077-99-6 2,2-Bis(hydroxymethyl)-1-butanol

Same 13380, 25600 and

94960

D + +

39600 000077-62-3 Bis(2-hydroxy-3-(1-methylcyclohexyl)-5-methylphenyl)methane

Same 66580 D +

39665 054208-63-8 Bis(2-hydroxyphenyl)methane bis(2,3-epoxypropyl) ether (=BFDGE)

Same 13460; 12976

D According to Commission Directive 2002/16/EC of 20 February 2002 on the


+




AND SPECIFICATIONS


144

use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs. Can still be used in heavy duty coatings.

39680 000080-05-7 2,2-Bis(4-hydroxyphenyl)propane

Same 13480/13607/62540/400

60/19255

DIR SML= 0.6 mg/kg (28) 2 http://europa.eu.int/comm/food/fs/sc/scf/out128_en.pdf

+

39700 001675-54-3 2,2-Bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (=BADGE)

Same 12974

13510; 13610;

DIR According to Commission Directive 2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs

2-3 On the basis of the available experimental data, a TDI can be established for BADGE and its hydrolysis products. Considering the NOAEL of 15 mg/kg b.w./day observed in the oral chronic toxicity/carcinogenicity study in the rat with BADGE, and applying an uncertainty factor of 100, a TDI of 0.15 mg/kg b.w. can be established for BADGE. As BADGE is rapidly and extensively metabolised in vivo into the corresponding mono- and bis-diol derivatives, the Panel includes these in the TDI. For the other regulated BADGE reaction products, i.e. the BADGE chlorohydrins BADGE.2HCl, BADGE.HCl, BADGE.HCl.H2O, in view of the lack of genotoxicity, the Panel considers that the current restriction of 1 mg/kg of food remains appropriate. The Panel is aware that other BADGE reaction products, with undefined toxicological properties and chemical identity, may be found at low levels in the migrate from epoxy coatings. For the assessment of these, and in general of minute amounts of unknown migrants from food contact materials, a general approach is currently under consideration by the Panel.

+ +




AND SPECIFICATIONS


145

EFSA opinion from 13 July 2004 http://www.efsa.eu.int/science/afc/afc_opinions/508/opinion_afc13_ej86_badge_v2_en1.pdf See the individual opinion on the substance (CS/PM/2812 Rev.1) which is reported in the Internet website: http://europa.eu.int/comm/food/fs/sc/scf/out28_en.pdf

39715 025036-25-3 2,2-Bis(4-hydroxyphenyl)propane - 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxy-propyl) ether, copolymer

W +

39730 025068-38-6 2,2-Bis(4-hydroxyphenyl)propane-epichlorohydrin copolymer

9 +

39750 025265-71-8 and 000110-98-5

Bis(hydroxypropyl) ether Same 51760 D + +

39760 see 39890 D + +

39815 182121-12-6 9,9-Bis(methoxymethyl)fluorene

DIR QMA = 0.05 mg/6 dm² 3 R: 0.05 mg/kg of food. Available: Maximum worst case migration is calculated to be 0.034 mg/kg; Ames assay (negative); in vitro chromosomal aberration assay (positive); in vitro mammalian cell gene mutation assay (negative); mouse bone marrow micronucleus assay (negative); rat bone marrow chromosome analysis (negative); in vivo UDS in rat liver (negative). (RIVM/ISS/UK SDS, October 1997 = CS/PM/ 3081/39815). (adopted at 113rd SCF meeting)(17-18 September 1998) http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html

+









AND SPECIFICATIONS


146

39890 087826-41-3 and 069158-41-4 and 054686-97-4/081541-12-0

Bis(methylbenzylidene) sorbitol

DIR 2 Group TDI: 1 mg/kg b.w. (with bis(4-ethylbenzylidene)sorbitol and bis(methylbenzylidene) sorbitol). 28- and 90-day oral rat studies, one in-vitro mutagenicity study. See references for bis(4-ethylbenzylidene)sorbitol.

+ +

39920 000085-60-9 1,1-Bis(2-methyl-4-hydroxy-5-tert-butylphenyl)butane

Same 40770 7? Available: data from 30- and 90-day oral rat studies inadequate. Needed: in first instance migration and mutagenicity data.

+

39925 129228-21-3 3,3-Bis(methoxymethyl)-2,5-dimethylhexane

DIR SML = 0.05 mg/kg 3 R: 0.05 mg/kg of food. Available: worst case migration levels based on compositional analysis and assumption of 1000% migration from 250 um layer thickness; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); two gene mutation assays in cultured mammalian cells (positive); in vivo UDS assay in rat liver (negative); in vivo micronucleus assay (negative). (RIVM/ISS/UK SDS, November 1998 = CS/PM/3223 REV. I/39925). Remark for Commission: No method of analysis for the determination of an SML is available. (Adopted at 116th SCF meeting) (24 March 1999) http://europa.eu.int/comm/food/fs/sc/scf/out27_en.pdf

+

39980 - Bis(N,N'-methyl-beta-hydroxyethyl)-hexamethylenebisurea

8 +

40000 000991-84-4 2,4-Bis(octylmercapto)-6-(4-hydroxy-3,5-di-tert-butylanilino)-1,3,5-

DIR SML = 30 mg/kg 2 TDI: 0.5 mg/kg b.w. 90-day oral rat and dog studies. (RIVM monograph 300/211, December

+ +




AND SPECIFICATIONS


147

triazine 1980).

40020 110553-27-0 2,4-Bis(octylthiomethyl)-6-methylphenol

DIR SML(T) = 5 mg/kg (41) with 38940

2 TDI: 0.1 mg/kg b.w. Available: 1- and 3-month oral rat studies and teratogenicity studies in rats. Bioaccumulation and mutagenicity studies and migration data. (RIVM 90/6786008/008).

+ +

40040 013259-35-3 Bis(pentaerythritol) adipate

9 +

40060 000080-05-7 Bisphenol A Same 13480/13607/19255//39680/62540

D http://europa.eu.int/comm/food/fs/sc/scf/out128_en.pdf

+

40080 013879-32-8 Bis(phenoxyethyl)formal 8 +

40120 - Bis(polyethyleneglycol)hydroxymethylphosphonate

DIR SML = 0.6 mg/kg 3 R = 0.6 mg/kg food Available: migration data (< 0.1 mg/kg); gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); 90-day oral rat study. Remark: no accumulation is expected. RIVM SDS, November 2000 = CS/PM/3813/40120. Remark (reasoning for calculating the restriction): Current approach is not setting a TDI based on abovementioned data-package. The restriction is calculated based on the “LOAEL” of 5 mg/kg b.w. (90-day study; change in thymus weight and liver changes) and making use of a safety factor of 500 (10 for intraspecies; 10 for interspecies and 5 for LOAEL to NOAEL). Body weight of 60 kg is used in the calculation. (Adopted at the 128th SCF meeting, 12 July 2001)

+




AND SPECIFICATIONS


148


40160 061269-61-2 N,N'-Bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-dibromoethane, copolymer

DIR SML = 2.4 mg/kg 2 t-TDI: 0.04 mg/kg b.w. Available: 90-day oral rat study, rat teratogenicity study and mutagenicity study. (HRC reports MTI 135/85733/ST, 24 Sept.1985 and MTI 133/85540, 14 August 1985 plus Farmitalia report 6 March 1985). Needed: Usage data, results of mutagenicity study in eukaryotic cells. (CS/PM/2632).

+

40240 - Bis(triethyleneglycol) hydroxymethylphosphonate

D t-TDI: 0.01 mg/kg b.w. Available: 90-day oral rat study and migration < 0.1 ppm. (RIVM doc. Oct. 1970). Needed: mutagenicity studies.

+

40320 010043-35-3 Boric acid Same 13620 DIR SML(T) = 6 mg/kg (23) (expressed as Boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption*.

2 Re-evaluation on the basis of an opinion of the SCF in another context. Group-TDI = 0.1 mg/kg b.w. (as B) (with REF_n. 36840, 40320 and 87040). The TDI is based on the No Adverse Effect Level (NOAEL) of 9.6 mg/kg b.w./day for effects on fetal body weight and skeletal anomalies in the rat developmental study. A Safety Factor (SF) of 100 is used. “Opinion of the Scientific Committee on Food on Arsenic, Barium, Fluoride, Boron and Manganese in Natural Mineral Waters (expressed on 13 December 1996, 105th plenary meeting of the SCF, completed on 13 June 1997 at the 107th plenary meeting of the SCF; 43rd Series of Reports of the SCF, 2000”. This opinion is also available on Internet. (Adopted by the SCF at the 127th meeting, 30 May 2001) http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

+ +






AND SPECIFICATIONS


149

40400 010043-11-5 Boron nitride DIR 3 Inert, insoluble material. +

40460 000052-51-7 2-Bromo-2-nitro-1,3-propanediol

8 +

40480 007166-19-0 2-Bromo-2-nitrostyrene 8 +

40490 009041-40-1 Butadiene-divinylbenzene, copolymer

9 +

40500 - Butadiene-divinylbenzene-methyl methacrylate-styrene, copolymer

9 +

40510 009052-84-0 Butadiene-divinylbenzene-styrene, copolymer

9 +

40520 - Butadiene-methacrylic esters of alcohols, aliphatic, monohydric, saturated (C1-C18)-styrene, copolymers

9 +

40530 - Butadiene-2-methyl-1,3-butadiene, copolymer

9 +

40535 - Butadiene-2-methyl-1,3-butadiene-styrene, copolymer

9 +

40545 025053-09-2 Butadiene-methyl methacrylate-styrene, copolymer

D +

40555 009003-55-8 Butadiene-styrene, copolymer

D +

40560 see 40630 D +

40570 000106-97-8 Butane DIR 3 Volatile compound. +

40580 000110-63-4 1,4-Butanediol Same 13720 DIR SML(T) = 0.05 mg/kg (24)

3 Same reference as 13720. (Adopted by the SCF at the 127th meeting, 30 May 2001) http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

+ +

40590 000071-36-3 1-Butanol Same 13840 3 See references for "Alcohols, aliphatic, monohydric, saturated, linear, primary (C4-C24)" (PM/REF.N. 33120) in SCF list 3.

+ +




AND SPECIFICATIONS


150

40592 000078-92-2 2-Butanol Same 13842 8 + +

40594 000075-65-0 tert-Butanol Same 13845 3 Residue in food less than 10 mg/kg. (SCF, 11th Series, 1981; EHC 65).

+

40597 025895-47-0 1-Butene-ethylene-propylene, copolymer

3 Specifications: copolymer with average molecular weight about 58000 Daltons, max. % of use = 2% in finished product. Toxicologically acceptable. (RIVM SDS 1995-01-24).

+

40600 - Butene-ethylene-propylene-vinyl esters-unsaturated aliphatic acids (inCluding their salts and esters), copolymers

D +

40618 005131-66-8 1-Butoxy-2-propanol 8 +

40621 025767-47-9 Butyl acrylate-styrene, copolymer

W +

40624 028185-36-6 Butyl acrylate-vinylpyrrolidone, copolymer

9 +

40630 002782-40-3 N-Butylbenzamide 8 +

40632 004299-07-4 2-Butyl-benzo[d]isothiazolin-3-one

7 Available: calculation of maximum migration assuming 100% migration of the additive over lifetime of the FCM; analytical method for the determination of 2-butyl-benzo[d]isothiazolin-3-one in PVC; log Po/w; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (positive); gene mutation assay in cultured mammalian cells (negative); in vivo micronucleus assay (negative; however no indication that the substance reached the bone marrow); in vivo UDS assay (negative); 90-day oral rat study. Needed: . "Evidence of absence of any preservative effect with the food" . Migration data and a well-described

+


AND SPECIFICATIONS


151

method. RIVM/TNO SDS, August 2000 = CS/PM/3132 REV. I/40632. Remark: discussion with WG-FMH on the method/details (will be determined later on). (Adopted by the SCF : http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html )

40640 000098-29-3 4-tert-butylcatechol Same 14005 8 +

40700 000075-91-2 tert-Butyl hydroperoxide W +

40720 025013-16-5 tert-Butyl-4-hydroxyanisole (=BHA)

DIR SML = 30 mg/kg 1 t-ADI: 0.5 mg/kg b.w. (SCF, 22th Series, 1989).

+

40770 000085-60-9 4,4'-Butylidenebis(6-tert-butyl-m-cresol)

Same 39920 D +

40800 013003-12-8 4,4'-Butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phosphite)

DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w. 90-day oral rat study. (CIVO report 5254, February 1977).

+

40820 009011-53-4 Butyl methacrylate-isobutyl methacrylate, copolymer

W +

40830 025608-33-7 Butyl methacrylate-methyl methacrylate, copolymer

W +

40840 001638-22-8 4-Butylphenol 8 +

40865 050696-71-4 tert-Butylphenol disulphide

Same 47120 D +

40880 015666-29-2 Butylthiostannoic acid D See '47210'. +

40960 026935-10-4 Butylurethane-formaldehyde, copolymer

Same 40635 D +

40980 019664-95-0 Butyric acid, manganese salt


2 L0 for butyric acid. L2= 0.01 mg/kg b.w. (as Mn). TDI: 0.01 mg/kg (as Mn). See references for 30180 in L2 in this report.

+

41000 000096-48-0 gamma-Butyrolactone 8 +

41010 ? Calcium aluminium D +




AND SPECIFICATIONS


152

hydroxyphosphite, basic

41020 065140-91-2 Calcium bis(3,5-di-tert-butyl-4-hydroxybenzyl- monoethyl)phosphonate

Same 46880 D + +

41040 005743-36-2 Calcium butyrate DIR 0 + +

41120 010043-52-4 Calcium chloride DIR 1 ADI: not specified. (SCF, 25th Series, 1991)

+ +

41200 007789-75-5 Calcium fluoride 7? Needed: migration data. +

41280 001305-62-0 Calcium hydroxide DIR 1 ADI: not specified. (SCF, 25th Series, 1991)

+ +

41360 010101-39-0 Calcium metasilicate 7? Needed: migration data. +

41440 - Calcium 2-methoxybenzoate

8 +

41520 001305-78-8 Calcium oxide DIR 1 ADI: not specified. (SCF, 25th Series, 1991)

+ +

41600 012004-14-7 and 037293-22-4

Calcium sulphoaluminate

DIR 2 TDI: 1 mg/kg bw (as Al) based on PTWI= 7 mg/kg bw (as Al). (SCF, 25th Series, 1991).

+

41680 000076-22-2 Camphor DIR In compliance with note 9 in Annex VI

3 Natural compound with strong flavour. +

41760 008006-44-8 Candelilla wax DIR 3 Natural wax. Purity to be specified. + +

41800 000142-62-1 Caproic acid Same 18770 and 59360

D + +

41840 000105-60-2 Caprolactam Same 14200. DIR SML(T) = 15 mg/kg (5)

2 Group TDI: 0.25 mg/kg b.w. Two 90-day oral rat studies and 90-day oral studies in mice and dogs. (CIVO report 3489 June 1971 and NTP tech. Rep. Ser. 214, NTP 80-26).

+

41920 - epsilon-Caprolactone-ethyleneimine-lauric acid, copolymer

W9 In first instance provide information on identity.

+

41960 000124-07-2 Caprylic acid Same 14320 and 68560

DIR 0 + +

42000 063438-80-2 (2-Carbobutoxyethyl)tin-tris(isooctyl mercaptoacetate)

DIR SML = 30 mg/kg 2 t-TDI: 0.5 mg/kg b.w. pending additional mutagenicity studies Available: 35-day in young and 90-day oral rat studies and Ames test. (RIVM report 89/678608/002, 1989-04-04).

+


AND SPECIFICATIONS


153

42080 001333-86-4 Carbon black 3 Under re-evaluation. ---------------------------------------------------- Criteria purity shall be established. Carbon black should be free from aromatic hydrocarbons (CS/PM/2041).

+ +

42160 000124-38-9 Carbon dioxide DIR 1 ADI: not specified. (JECFA 23rd M., 1980).

+

42240 - Carbon fibers 9 +

42320 007492-68-4 Carbonic acid, copper salt

DIR SML(T) = 30 mg/kg (7) (expressed as Copper)

2 For Copper. Same as Ref.No 30080. +

42360 010290-71-8 Carbonic acid, iron salt D + +

42400 010377-37-4 Carbonic acid, lithium salt

DIR SML(T) = 0.6 mg/kg (8) (expressed as Lithium)

2 Group TDI: 0.01 mg/kg b.w. (as Li). See references for benzoic acid, lithium salt.

+

42480 000584-09-8 Carbonic acid, rubidium salt

DIR SML = 12 mg/kg 2 TDI: 0.2 mg/kg b.w. 90-day oral rat study on diet low in K+. Normal food may contain up to 140 mg/kg, average daily intake for man 1-4 mg. (RIVM 617601002, 1981).

+

42500 - Carbonic acid, salts DIR 1 ADI: not specified for carbonate. (SCF, 25th Series, 1991)

+ +

42560 - Carbon vegetable 1/D Food grade acceptable. (SCF, 4th Series, 1977).

+

42640 009000-11-7 Carboxymethylcellulose DIR 2 Group TDI: not specified based on Group ADI (=not specified) for certain modified celluloses. (JECFA 35 M, 1989).

+ +

42680 003401-73-8 N-(3-Carboxy-2-sulphopropionyl)-N-octadecyl-l-aspartic acid, tetrasodium salt

W8 +

42720 008015-86-9 Carnauba wax DIR 3 Natural wax. Purity to be specified. + +

42800 009000-71-9 Casein DIR 0 + +

42880 008001-79-4 Castor oil Same 14411 DIR 3 Same as 14411 http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf

+ +

42960 064147-40-6 Castor oil, dehydrated Same 14440 DIR 3 Similar to fats food. +




AND SPECIFICATIONS


154

43040 - Castor oil, epoxidized (oxirane less than 5%, iodine Number less than 6)

8 +

43120 008001-78-3 Castor oil, hydrogenated Same 14470 3 Identical with or similar to food fat. + +

43200 - Castor oil, mono- and diglycerides

DIR 3 Toxicologically acceptable. +

43201 - Castor oil fatty acids mono- and diglycerides

3 SCF_List: 3 Restriction: none. In small doses metabolised similarly to food fats See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf

+ +

43230 008002-33-3 Castor oil, sulphated 9 +

43232 068187-76-8 Castor oil, sulphated, sodium salt

W +

43265 - Castor oil, sulphonated, sodium salt

8 +

43280 009004-34-6 Cellulose Same 14500 DIR 0 + +

43300 009004-36-8 Cellulose acetate butyrate

Same 14508 DIR 3 Inert material, modified natural cellulose. + +

43330 009004-70-0 Cellulose nitrate Same 22450 D +

43360 068442-85-3 Cellulose, regenerated DIR 2 Group TDI: not specified based on Group ADI (=not specified) for certain modified cellulose. (JECFA 35 M., 1989).

+

43390 009012-09-3 Cellulose triacetate 9 +

43410 008001-75-0 Ceresin Same 43440 D +

43440 008001-75-0 Ceresin Same 43410 DIR 3 Refined, natural, crystalline wax. Purity to be specified.

+

43480 064365-11-3 Charcoal, activated 3AM 3 Restriction: Only to be used in polyethylene terephthalate (PET) at a maximum amount of 10 mg/kg polymer. Purity criteria: in compliance with vegetable carbon (E 153), except for the ash content which can be up to 10%. http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf

+






AND SPECIFICATIONS


155

43490 001332-58-7 China clay (=natural aluminium silicate)

Same 62720 D +

43495 066402-68-4 China clay, calcined D +

43515 - Chlorides of choline esters of coconut oil fatty acids

Same 54660 and 63400

DIR QMA = 0.9 mg/6 dm² 3 R : to be used at a maximum amount of 0.015 g/m² (150 ug/dm²). Available: Method for determination of residual content; three (negative) mutagenicity studies (performed with lauroyl choline chloride); 28-day and 90-day oral rat studies (on coconut fatty acid esters of choline chloride, the largest component of which is lauric acid ester of choline chloride); bioaccumulation study (in Zebra fish). Remark: change name into 'Fatty acids of coconut oil, esters with choline chloride'. Remark: Given the physical/chemical data, there is no need for asking further data on possible accumulation. Remark: If hydrolysis data are provided (showing complete hydrolysis), then the restriction may be deleted. (RIVM/ISS/TNO SDS, April 1997 = CS/PM/2999/63400). REMARK for Commission: No method of analysis is available for the enforcement of an SML. (Adopted at 113th SCF meeting)(17-18 September 1998) http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html

+ +

43520 - Chlorides of choline esters of linear natural monocarb.acids

9 +

43590 000079-07-2 Chloroacetamide W +

43600 004080-31-3 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride

DIR SML = 0.3 mg/kg 2 TDI: 0.005 mg/kg b.w. Two 90-day oral rat and a dog studies and teratogenicity studies in rats and rabbits and negative mutagenicity studies.

+




AND SPECIFICATIONS


156

(RIVM doc. December 1983).

43650 000075-68-3 1-Chloro-1,1-difluoroethane

W7? Available: semichronic and chronic inhalation studies in rats, 2 inhalation teratogenicity studies in rats, several Ames tests and two in vivo mutagenicity studies, migration data. Needed: reproduction study.

+

43680 000075-45-6 Chlorodifluoromethane DIR SML = 6 mg/kg and in compliance with the specifications laid down in Annex V.

2 TDI: 0.1 mg/kg b.w. (based on teratogenicity study). Specification: content of chlorofluoromethane less than 1 ppm.One year oral rat study. Several inhalation studies in several animal species, including teratogenicity in rabbits. Mutagenicity tests in-vitro and in-vivo. N.B. The Committee has not considered the environmental implications of the use of the solvent in food technology, but recognises that environmental considerations may take precedence over its own evaluations on this occasion.

+

43760 026172-55-4 5-Chloro-2-methyl-4-isothiazolin-3-one

7 90-day oral rat and dog studies. Reproduction and teratogenicity studies in rabbits, 3 mutagenicity studies. (RIVM Doc.Tox.300/430 May 1979, September 1983, June 1984). Very potent sensitizer.

+ +

43820 - Chromic chloride complex with linear sat.monocarb.acids (C16 and above)

D +

43840 015659-56-0 Chromic chloride myristate

8 +

43920 015242-96-3 Chromic chloride stearate

9 +

43980 001308-38-9 Chromium (III) oxide 9 +

44000 001333-82-0 Chromium trioxide 5 Cr(VI) is a genotoxic carcinogen (IARC monograph 1980, vol. 23).

+


AND SPECIFICATIONS


157

44080 000104-55-2 Cinnamaldehyde 8 (Adopted at 111th SCF meeting (18-19 March 1998)). http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

+

44160 000077-92-9 Citric acid Same 14680 DIR 1 Group ADI: not specified for citric acid and its salts. (SCF, 25th Series, 1990).

+ +

44240 - Citric acid, alkyl, primary (C2-C12), esters


44300 110638-71-6*

Citric acid, lithium salt, reaction product with vermiculite

Same 95725 D See PM/REF.N. 95725. +

44320 001321-57-9 Citric acid, monoisopropyl ester

7 Needed: hydrolysis data and reports from Duel et al., (1951).

+

44400 001323-66-6 Citric acid, mono-n-octadecyl ester

7 Needed: hydrolysis data and reports from Duel et al., (1951).

+

44560 000077-94-1 Citric acid, tributyl ester 8 Group R: 0.05 mg/kg b.w. Needed: toxµ$icological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation study too.

+ +

44640 000077-93-0 Citric acid, triethyl ester DIR 1 ADI: 20 mg/kg b.w. (JECFA 28 M., 1984).

+ +

44720 007775-50-0 Citric acid, tri-n-octadecyl ester

8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and if migration exceeds 0.05 mg/kg peroxisome proliferation study too.

+

44800 007147-34-4 Citric acid, tris(2-ethylhexyl) ester


+

44880 001333-88-6 Cobalt aluminate 2-3 L2 for Al. TDI: 1 mg/kg bw (as Al) based on PTWI: 7 mg/kg bw (as Al). (SCF, 25th Series, 1991). L3 fo Co. R: 0.05 mg/kg of food (as Co).

+




AND SPECIFICATIONS


158

(Rivm, summary data, October 1992)(CS/PM/1707).

44960 011104-61-3 Cobalt oxide DIR SML(T) = 0.05 mg/kg (14) (expressed as Cobalt)

3 L3 for Cobalt. R: 0.05 mg/kg of food (as Co). (RIVM, summary data, October 1992=CS/PM/1707).

+

44980 061788-46-3 Cocoalkylamines W +

44985 061791-14-8 Cocoalkylamines, ethoxylated

W +

44995 061791-63-7 N-Cocoalkyltrimethylenediamines

W +

45040 061790-63-4 68603-42-9 and

Coconut oil fatty acids diethanolamide (add cas_N = 68440-04-0)

7? Same references as 39280. + +

45055 008050-09-7 Colophony Same 14687,24100,24130 and

83840

D +

45060/0 008002-13-9 Colza oil Same 45060/1,835

80/0 and 83580/1

D + +

45075 - Condensation products of ethylene oxide with alkyl- and dialkylamines (C1-C20)

9 +

45105 - Copolymers of acrylic or methacrylic esters with vinylpyrrolidone

9 +

45120 - Copolymers of acrylic,fumaric,itaconic,maleic and methacrylic acids with butadiene, butene, divinylbenzene, esters of these acids with sat. monoh. aliph. alcohols(C1-C18), ethylene, ethylene oxide,

9 +


AND SPECIFICATIONS


159

etC..

45130 - Copolymer of 1-alkenes (C20-C24) and diesters of maleic acid and tallow alcohol (C16-C18) containing max 13% tallow alcohol and max 5% 1-alkenes (C20-C24)

7? Needed: Migration data and also 3 mutagenicity tests on 1-alkenes, unless the industry confirms that they have straight chain.

+

45165 - Copolymers of linear or branched 1-alkenes(C3-C38) and mono- or diesters of maleic acid with linear or branched alcohols (C2-C36), ethoxylated alcohols (C1-C36) with ethoxylation degree between 2-36

9 Look at 45130. +

45195 007787-70-4 Copper bromide DIR SML(T) = 30 mg/kg (7) (expressed as Copper)


45200 001335-23-5 Copper iodide DIR SML(T) = 30 mg/kg (7) (expressed as Copper) and SML = 1 mg/kg (11) (expressed as Iodine)


45280 - Cotton fibers DIR 3 Inert, insoluble material. +

45360 008001-29-4 Cottonseed oil 3/D Equal to or similar to food fats. +

45440 - Cresols, butylated, styrenated

DIR SML = 12 mg/kg 2 t-TDI: 0.2 mg/kg b.w. Available: 3-month oral rat and 2-year oral rat and dog studies, rat reproduction study. (Food Drug Research Lab. 1964). Needed: specification and Mw distribution curve, in first instance. (to be confirmed by SCF)

+

45450 068610-51-5 p-Cresol- DIR SML = 5 mg/kg 3 SCF_list: 3 + +


AND SPECIFICATIONS


160

dicyclopentadiene-isobutylene, copolymer

Restriction: 5 mg/kg of food. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf

45520 - p-Cresol, styrenated 9 +

45560 014464-46-1 Cristobalite DIR 3 Inert material. + +

45600 003724-65-0 Crotonic acid Same 14800 DIR QMA(T) = 0.05 mg/6dm² (33)

3 Same references as 14800 http://europa.eu.int/comm/food/fs/sc/scf/out141_en.pdf

+

45610 025609-89-6 Crotonic acid-vinyl acetate, copolymer

9 +

45640 005232-99-5 2-Cyano-3,3-diphenylacrylic acid, ethyl ester

DIR SML = 0.05 mg/kg 3 SCF_list:3 Restriction: 0.05 mg/kg of food. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out142_en.pdf

+

45650 006197-30-4 2-Cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester

DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg food. Available: migration data (< 0.05 mg/kg food); gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); micronucleus assay (negative); acute toxicity data; 90-day oral rat study; teratogenicity study with rats. RIVM/TNO SDS, January 2001 = CS/PM/3818/45650. Remark: If data on the absence of potential for accumulation were available then a restriction of 5 mg/kg food could be assigned to this substance. (Adopted at the 128th SCF meeting, 12 July 2001) http://europa.eu.int/comm/food/fs/sc/scf/out97_en.pdf

+

45670 000461-58-5 Cyanoguanidine Same 15695 and 47440

D + +










AND SPECIFICATIONS


161

45680 - Cycloalkanes (0-100 degrees celsius)

9 +

45690 000291-64-5 Cycloheptane 8 +

45700 000110-82-7 Cyclohexane 8 +

45705 166412-78-8 1,2-Cyclohexanedicarboxylic acid, diisononyl ester

Hexahydrophthalic acid, diisononyl

ester

7 Under re-evaluation +

45710 000108-93-0 Cyclohexanol Same 14905 8 +

45720 000108-94-1 Cyclohexanone Same 14910 6A Needed: adequate test for gene mutation and chromosomal aberration. (IARC (1989), 47, 151-169).

+

45760 000108-91-8 Cyclohexylamine DIR 2 TDI: 1 mg/kg b.w. calculated with reference to the ADI for cyclamic acid of 11 mg/kg b.w. (JECFA 26 M., 1982).

+

45840 - Cyclopentadiene-cyclopentene-dicyclopentadiene-2-pentene-2-methyl-2-butene-1,3-pentadiene, copolymers, hydrogenated or Not

9 +

45841 - Cyclopentadiene-cyclopentene-dicyclopenbtadiene-2-pentene-2-methyl-2-butene-1,3-pentadiene, copolymers

7? Needed: Mw distribution curve, 3 mutagenicity tests on monomers not in L 0-4, in first instance.

+

45842 - Cyclopentadiene-cyclopentene-dicyclopentadiene-2-pentene-2-methyl-2-butene-1,3-pentadiene, copolymers, hydrogenated

8 Needed: data according to SCF guidelines on polymeric additives.

+

45880 000287-92-3 Cyclopentane 8 +

45920 009000-16-2 Dammar Same 15065,45925

DIR 3 Natural wax. Purity to be specified. +


AND SPECIFICATIONS


162

and 45930

45925 009000-16-2 Damar resin Same 15065, 45920 and

45930

D +

45930 009000-16-2 Damar wax Same 15065, 45920 and

45925

D +

45940 000334-48-5 n-Decanoic acid Same 15095 DIR 0 Food constituent. + +

46000 see 46070 D + +

46070 010016-20-3 alpha-Dextrin DIR 0 + +

46080 007585-39-9 beta-Dextrin DIR 0 + +

46160 - Dialkyl or alkyl (more than C8) phosphate

9 +

46240 - Dialkyldithiocarbamic acid, salts

9 +

46320 - Dialkyl(C8-C20)ketones 9 +

46375 061790-53-2 Diatomaceous earth Same 62880 DIR 3 Inert material. +

46380 068855-54-9 Diatomaceous earth, soda ash flux-calcined

Same 62885 DIR 3 Inert material. + +

46400 000120-78-5 Dibenzothiazyl disulphide

8 +

46440 000094-36-0 Dibenzoyl peroxide 8 + +

46480 032647-67-9 Dibenzylidene sorbitol DIR 2 Group TDI: 1 mg/kg b.w. (with bis(4-ethylbenzylidene)sorbitol and bis(methylbenzylidene) sorbitol). Several 90-day oral mouse and rat studies, several mutagenicity studies negative. See references for bis(4-ethylbenzylidene) sorbitol.

+ +

46560 000106-93-4 1,2-Dibromoethane 5 [Some organobromo compounds have a bioaccumulation potential and 1,2-dibromoethane is a category 2 carcinogen (EC classification).]

+

46640 000128-37-0 2,6-Di-tert-butyl-p-cresol (=BHT)

DIR SML = 3.0 mg/kg 1 ADI: 0.05 mg/kg b.w. (SCF, 22th Series, 1989).

+ +

46700 - 5,7-di-tert-Butyl-3-(3,4- and 2,3-dimethylphenyl)-3H-benzofuran-2-one

Same 67170 DIR SML = 5 mg/kg 3 R = 5 mg/kg of food. http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

+




AND SPECIFICATIONS


163

containing: a) 5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-3H-benzofuran-2-one (80 to 100% w/w) and b) 5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-3H-benzofuran-2-one (0 to 20% w/w)

46720 004130-42-1 2,6-Di-tert-butyl-4-ethylphenol

DIR QMA = 4.8 mg/6 dm² 3 R: 0.8 mg/dm². Available: 3 negative mutagenicity studies, 90-day oral rat and dog studies, bioaccumulation, calculation of the worst case as well as analytical method. (RIVM 93/6/3330/001, 1993-01-26=CS/PM/2011, TNO 1995-04-03=CS/PM/2580).

+

46750 000088-58-4 2,5-Di-tert-butylhydroquinone

W +

46790 004221-80-1 3,5-Di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester

Same 47200 DIR 2 TDI: 2 mg/kg bw. 90-day oral rat study. (RIVM report May 1973).

+ +

46800 067845-93-6 3,5-Di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester

Same 58800 DIR 2 TDI: 2.5 mg/kg b.w. 90-day oral rat and dog studies, reproduction study in rats, mutagenicity studies. (RIVM doc. 88/678608/001, 1 November 1988).

+

46870 003135-18-0 3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester

Same 49760 DIR 2 TDI: 1 mg/kg bw. A 90-day oral rat study. (CIBA-GEIGY report, 14 February 1970).

+

46880 065140-91-2 3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester, calcium salt

Same 41020 DIR SML = 6 mg/kg 2 TDI = 0.1 mg/kg b.w. A 4+4 week, a 13+4 week and a two year oral rat studies. (Ciba-Geigy reports CBG 174/78110, 10-07-1978 and CBG 192/781233, 22-03-1979, CBG 261/821163, 4 April 1984).

+ +

46960 030947-30-9 3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, monoethyl ester,

8 +


AND SPECIFICATIONS


164

nickel salt

47040 034137-09-2 3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid, triester with 1,3,5-tris(2-hydroxyethyl)-1,3,5- triazine-2,4,6-(1h,3h,5h)trione

8 Available: 90-day oral rat and dog studies and a reproduction study were inadequate.

+

47080 000110-05-4 Di-tert-butyl peroxide 8 +

47120 050696-71-4 Di(tert-butylphenol) disulphide

Same 40865 8 +

47200 004221-80-1 2,4-Di-tert-butylphenyl 3,5-di-tert-butyl-4- hydroxybenzoate

Same 46790 D TDI: 2 mg/kg b.w. 90-day oral rat study. (RIVM report May 1973).

+ +

47210 026427-07-6 Dibutylthiostannoic acid polymer [= thiobis(butyl-tin sulphide), polymer]

Same as 40880

DIR in compliance with the specifications laid down in Annex V.

2 t-TDI: 25 mg/kg b.w. Available: 70- and 90-day and 2-year oral rat studies, observations in man and migration data. Needed: mutagenicity studies.

+

47215 000683-18-1 Dibutyltin dichloride W +

47220 000077-58-7 Dibutyltindilaurate 8 +

47280 002782-57-2 Dichlorocyanuric acid D +

47360 000075-71-8 Dichlorodifluoromethane 7 Needed: migration data and specifications. +

47380 068611-44-9 Dichlorodimethylsilane, reaction products with silica

W +

47440 000461-58-5 Dicyanodiamide Same 15695 and 45670

DIR 2 TDI: 1 mg/kg b.w. 2-year oral rat and dog studies and Ames tests. (American Cyanamid report 1969).

+ +

47500 153250-52-3 N,N'-Dicyclohexyl-2,6-naphthalene dicarboxamide

3 Restriction: 5 mg/kg food http://www.efsa.eu.int/science/afc/afc_opinions/960/afc_op_ej218_8thlist_en1.pdf

+

47520 - Dicyclopentadiene-indene-styrene-alpha.methylstyrene-vinyltoluene-isobutylene, copolymer, hydrogenated

3 R: 5 mg/kg of food. Specifications to be added (range of percentage of comonomers, percentage with Mw < 1000 Daltons)? Toxicologically acceptable. Available: migration data, 5 Ames tests and an in vivo mutagenicit y study (negative)

+ +

http://www.efsa.eu.int/science/afc/afc_opinions/960/afc_op_ej218_8thlist_en1.pdf



AND SPECIFICATIONS


165

and a 3-month oral rat study. (RIVM February 1993, CS/PM/855). Remark: since high migration into fat has been demonstrated, the WG recommends that the Commission take the necessary measures so that the restriction proposed is not exceeded.

47535 007173-51-5 Didecyldimethylammonium chloride

W8 +

47540 027458-90-8 Di-tert-dodecyl disulphide

DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Available: migration data; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); acute toxicity studies with di-tert-dodecyl trisulfide (TPS20) and di-tert-dodecyl pentasulfide (TPS32); 4-week oral rat study with di-tert-dodecyl pentasulfide (TPS32); skin and eye irritation studies performed with TPS20 and TPS32; sensitisation studies performed with TPS20 and TPS32. (RIVM/TNO SDS, September 1999 = CS/PM/2964 REV. II/47540). (Adopted at the 119th SCF meeting) (2 December 1999) http://europa.eu.int/comm/food/fs/sc/scf/out50_en.pdf

+

47550 002123-19-5 Didodecyl ketone 8 +

47600 084030-61-5 Di-n-dodecyltin bis(isooctyl mercaptoacetate)

DIR SML = 12 mg/kg 3 Restriction: 0.05 mg/kg food (as sum of mono-n-dodecyltin tris(isooctyl mercaptoacetate), di-n- dodecyltin bis(isooctyl mercaptoacetate), monododecyltin trichloride and di-dodecyltin dichloride) expressed as the sum of mono- and di-dodecyltin chloride. http://www.efsa.eu.int/science/afc/afc_opinions/960/afc_op_ej218_8thlist_en1.pdf

+

47620 000111-42-2 Diethanolamine Same 15735 W8 Data inadequate. + +






AND SPECIFICATIONS


166

Restriction: contact with nitrite containing food should be avoided.

47630 000143-00-0 Diethanolamine dodecyl sulphate

Same 52400 D Same as 52400. +

47660 027027-16-3 3-Diethylaminoethyl methacrylate-methyl methacrylate, copolymer

D +

47680 000111-46-6 Diethyleneglycol Same 13326,15760

and 39160


2 Group TDI = 0.5 mg/kg b.w. (SCF, 17th Series, 1986).

+

47720 000120-55-8 Diethyleneglycol dibenzoate

W + +

47760 021209-30-3 Diethyleneglycol dioleate


47840 068818-39-3 Diethyleneglycol dipalmitate


47920 074356-18-6 Diethyleneglycol diricinoleate


48000 000109-30-8 Diethyleneglycol distearate


48080 000106-12-7 Diethyleneglycol monooleate


48160 036381-62-1 Diethyleneglycol monopalmitate


48240 005401-17-2 Diethyleneglycol monoricinoleate


48320 000106-11-6 Diethyleneglycol monostearate


48370 000100-37-8 Diethylethanolamine Same 48400 8 +

48400 000100-37-8 Diethylhydroxyethylamine

Same 48370 D + +

48460 000075-37-6 1,1-Difluoroethane DIR 3 Toxicologically acceptable. Available: Migration data, 2 gene mutation tests in bacteria and 1 in Drosophila, chronic toxicity/carcinogenicity rat inhalation study, rat inhalation teratology study. (RIVM/TNO SDS CS/PM/2747, November 95).

+

48470 029658-26-2 4,4'- 9 +


AND SPECIFICATIONS


167

Difluorobenzophenone-hydroquinone, copolymer

48480 059113-36-9 Diglycerol Same 15855 8 +

48500 000504-53-0 Di-n-heptadecyl ketone 8 +

48520 022986-69-2 Di-n-hexadecyl ketone 8 +

48560 036265-41-5 1,4-Dihydro-2,6-dimethyl-3,5-dicarbododecyloxypyridine

8 Available: oral studies in rats and dogs were inappropriate.

+

48590 086088-85-9 4,5-Dihydro-1-methyl-2-Nortallow alkyl-3-(2-tallow amidoethyl)-imidazolium, methyl sulphate

W8 +

48620 000123-31-9 1,4-Dihydroxybenzene Same 15940, 18867 and

60060

DIR SML = 0.6 mg/kg 2 TDI: 0.01 mg/kg b.w. (SCF, 17th Series, 1986).

+

48640 000131-56-6 2,4-Dihydroxybenzophenone


2 Group TDI: 0.1 mg/kg b.w. See references for 4,4'-dihydroxybenzophenone in list 2.

+

48720 000611-99-4 4,4'-Dihydroxybenzophenone

Same 15970. DIR SML(T) = 6 mg/kg (15)


+

48800 000097-23-4 2,2'-Dihydroxy-5,5'-dichlorodiphenylmethane

DIR SML = 12 mg/kg 2 TDI: 0.2 mg/kg b.w. 2-week and 13-week oral rat studies and observations in man from its therapeutic use. (J. Am. Leather. Chemists Assoc. 1944, 39, 203-209; J. Pharmacol. Exper. Therap. 1949, 96, 238-249).

+

48880 000131-53-3 2,2'-Dihydroxy-4-methoxybenzophenone



+

48960 000120-87-6 9,10-Dihydroxystearic acid

7 Evaluated in EFSA-AFC and classified in list7. http://www.efsa.eu.int/science/afc/afc_opinions/195/opinion_afc_01_en1.pdf

+

49040 001115-01-1 9,10-Dihydroxystearic acid, methyl ester

8 +




AND SPECIFICATIONS


168

49050 000108-83-8 Diisobutyl ketone 8 Available: no adequate oral data, Ames test. +

49055 027213-90-7 Diisobutylnaphthalenesulphonic acid, sodium salt

9 No data are available. +

49065 000110-97-4 Diisopropanolamine Same 16120 8 R: contact with food containing nitrite should be avoided.

+

49120 003271-22-5 2,4-Dimethoxy-6-(1-pyrenyl)-1,3,5-triazine

7 Needed: information on tissue accumulation. +

49160 000127-19-5 Dimethylacetamide 6B Suspected embryotoxicity/teratogenicity. +

49200 - Dimethylalkyl(C8-C18)benzylammonium chloride

9 Existing data are not available to the SCF. Provide them.

+

49202 068391-01-5 Dimethylalkyl(C12-C18)benzylammonium chloride

9 +

49235 000108-01-0 Dimethylaminoethanol Same 16150 2 TDI: 0.3 mg/kg b.w. See references for same substance (PM/REF. 16150) in monomer report.

+

49280 000121-69-7 N,N-Dimethylaniline Same 16190 8 +

49330 001879-09-0 2,4-Dimethyl-6-tert.-butylphenol

8 +

49340 061789-71-7 Dimethyl(cocoalkyl)benzylammonium chloride

9 Existing data are not available to the SCF. Provide them.

+ +

49360 - Dimethyldialkyl(C8-C18)ammonium chloride

9 +

49465 000068-12-2 Dimethylformamide 6B Suspected of embryotoxicity/teratogenicity. (EHC 114).

+

49472 095009-13-5 N,N-Dimethyl-2-hydroxy-N-(2-hydroxypropyl)-1-propanaminium, diester with vegetable oil fatty acids methyl sulphate

W8 +

49485 134701-20-5 2,4-Dimethyl-6-(1-methylpentadecyl)-phenol

DIR SML = 1 mg/kg 3 R = 1 mg/kg of food. Available: Adequate migration data showing specific migration into aqueous food simulants is < 0.05 mg/kg food and into olive oil < 0.12-0.48 mg/kg food; three (negative) mutagenicity studies; 28-day oral rat study; 90-day oral rat study (relatively

+ +


AND SPECIFICATIONS


169

low NOAEL + effects still observed after the recovery period); log Po/w; ADME study. Remark: Based on the hepatotoxic effects observed in both the 28-day and 90-day oral rat studies which resulted in the same low NOAEL of 10 mg/kg b.w., the SCF used a safety factor of 500 and a 60 kg person to establish a restriction of 1 mg/kg of food. (RIVM SDS, February 1998 = CS/PM/2917 REV. I/49485). (adopted at 113rd SCF meeting)(17-18 September 1998) http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html

49510 - alpha,omega-Dimethylpoly(o-butyl(polypropyleneglycol)(polyethyleneglycol)(polydimethylsiloxane)

9 +

49520 see 49580 D +

49540 000067-68-5 Dimethyl sulphoxide Same 16410 DIR 3 DMSO is used as carrier of drugs to facilitate skin penetration.

+

49580 029351-51-7 Dimethylthianthrene 8 +

49595 057583-35-4 Dimethyltin bis(ethylhexyl mercaptoacetate)

see 49600 3AM 2 L2 for tin Isooctyl refers to industrial mixture including substances with a branched chain of 8 atoms of carbon. Usually, x-methyl-C7, x,y-dimethyl-C6 are the major components of an isooctyl “mixture” (more than 90%). x-ethyl-C6 are present but not in a large quantities (less than 10%). The composition of this mixture could be slightly different according the oil feedstock used for the synthesis of it and of the process used for the “oxo” reaction.. In contrast, ethylhexyl (ethyl-C6) refers usually to 2-ethylhexyl structure which is perfectly defined chemically.

+




AND SPECIFICATIONS


170

In the scope of organotin compounds for which the toxicity is related to organic tin, studies done either with the “isooctyl” or the “ethylhexyl” could be used for evaluation of branched C8 organotin compounds.

49600 026636-01-1 Dimethyltin bis(isooctyl mercaptoacetate)

DIR SML(T) = 0.18 mg/kg (16) (expressed as Tin)

2 Group TDI: 0.003 mg/kg b.w. (as Sn) (with 67520 and 83599). See references for 83599 in list 2.

+

49680 000093-46-9 N,N'-Di-(2-naphthyl)-p-phenylenediamine

7 Needed: purity specification especially on presence of beta-naphthylamine

+

49720 - 2,4-Dinonylphenyl bis-(4-monononylphenyl) phosphite

D +

49760 003135-18-0 Di-n-octadecyl 3,5-di-tert-butyl-4-hydroxybenzyl phosphonate

Same 46870 2/D TDI: 1 mg/kg b.w. A 90-day oral rat study. (Ciba-Geigy report 14 February 1970).

+

49840 002500-88-1 Dioctadecyl disulphide DIR SML = 3 mg/kg 2 TDI: 0.05 mg/kg b.w. A 90-day oral rat study. (Hoechst report 1967).

+ +

49920 020297-71-6 Dioctadecyl 3-methyl-4-hydroxy-5-tert-butyl benzylmalonate

8 +

50000 001844-09-3 Dioctadecyl monosulphide

8 +

50080 003806-34-6 Dioctadecyl pentaerythritol diphosphite

W7 Available: Acute toxicity data; 90-day oral rat study (IBT study); 90-day oral dog study (IBT study); review of the IBT rat and dog studies; neurotoxicity study in the hen. Needed: Migration data (on the phosphite and phosphate); three in vitro mutagenicity studies and data to demonstrate the absence of potential for accumulation. (RIVM SDS, August 1996 = CS/PM/2903/ 50080). (Adopted at 111th SCF meeting (18-19 March 1998)). http://europa.eu.int/comm/food/fs/sc/scf/out

+



AND SPECIFICATIONS


171

10_en.pdf

50160 - Di-n-octyltin bis(n-alkyl(C10-C16) mercaptoacetate)


2 Group-TDI: 0.0006 mg/kg bw (as Sn) for all di-n-octyltin derivatives. See references for 50480. http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf

+

50240 010039-33-5 Di-n-octyltin bis(2-ethylhexyl maleate)

Same 64840 DIR SML(T) = 0.04 mg/kg (17) (expressed as Tin)


+

50320 015571-58-1 Di-n-octyltin bis(2-ethylhexyl mercaptoacetate)



+

50360 - Di-n-octyltin bis(ethyl maleate)



+

50400 033568-99-9 Di-n-octyltin bis(isooctyl maleate)



+

50480 026401-97-8 Di-n-octyltin bis(isooctyl mercaptoacetate)


2 Group-TDI: 0.0006 mg/kg bw (as Sn) for dioctyltin stabilisers (REF_N 50480) Group-TDI = 0.02 mg/kg b.w. (as Sn) for monooctyltin stabilisers (REF_N 67760) Available: migration data; several subacute studies in rats and dogs (performed with MOTTG, DOTTG, MOTC, DOTC and formulation of MOTC and DOTC); several semichronic studies in rats and dogs (performed with MOTTG, DOTTG and formulation of MOTTG and DOTTG); 2-year rat and dog studies (performed with DOTTG and formulation of MOTC and

+













AND SPECIFICATIONS


172

DOTC); gene mutation assays in bacteria (negative) (performed with MOTC, DOTC and formulation of MOTTG and DOTTG); gene mutation assays in cultured mammalian cells (negative) (performed with MOTC and DOTC); in vitro UDS assay (negative) (performed with DOTC); in vitro covalent DNA binding assay (negative) (performed with DOTC); micronucleus assays (negative; however, it was noted that no cytotoxicity was observed when performed with MOTC) (negative with formulation with MOTTG and DOTTG); in vivo SCE assay (negative) (performed with DOTC); 2-generation reproduction study in rats (performed with formulation of MOTTG and DOTTG); teratogenicity study in rats (performed with formulation of MOTTG and DOTTG); teratogenicity study in rabbits (performed with formulation of MOTTG and DOTTG). (RIVM SDS, October 1998 = CS/PM/3255/50480/67760). Remark for Commission: no analytical method is available. (Adopted at the 118th SCF meeting) (23 September 1999) http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf

50560 - Di-n-octyltin 1,4-butanediol bis(mercaptoacetate)



+

50640 003648-18-8 Di-n-octyltin dilaurate DIR SML(T) = 0.04 mg/kg (17) (expressed as Tin)


+

50720 015571-60-5 Di-n-octyltin dimaleate DIR SML(T) = 0.04 mg/kg 2 Group-TDI: 0.0006 mg/kg bw (as Sn) for all +








AND SPECIFICATIONS


173

(17) (expressed as Tin) di-n-octyltin derivatives. See references for 50480. http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf

50800 - Di-n-octyltin dimaleate, esterified



+

50880 - Di-n-octyltin dimaleate, polymers (n=2-4)


2 Group-TDI: 0.0006 mg/kg bw (as Sn) for all di-n-octyltin derivatives. See references for 50480. Evaluated in accordance with the previous guidelines. Decision endorsed despite lack of compliance with recent guidelines, in the light of the very low group t-TDI. (CS/PM/2632). http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf

+

50960 069226-44-4 Di-n-octyltin ethyleneglycol bis(mercaptoacetate)



+

51040 015535-79-2 Di-n-octyltin mercaptoacetate



+

51120 - Di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetate



+

51160 000123-91-1 Dioxane Same 16420 6A IARC evaluation: group IIb carcinogen. EU classification: Category 3 carcinogen. Primarily to be evaluated as monomer, also used as additive, hence cross reference. As contaminant (e.g. 46720) in finished products, dioxane should not be detectable

+














AND SPECIFICATIONS


174

in food or food simulants by an appropriate sensitive method.

51200 000126-58-9 Dipentaerythritol Same 16480 DIR 2 Group TDI: 1 mg/kg b.w. (with pentaerythritol). (SCF, 17th Series, 1986).

+

51300 000138-86-3 Dipentene Same 16510 8 Data made available for assessment of chewing gum not available for this group.

+

51440 015647-08-2 Diphenyl 2-ethylhexyl phosphite

8 +

51470 007144-65-2 o-Diphenyl glycidyl ether

Same 72560 D +

51500 000102-06-7 Diphenylguanidine D +

51520 026401-27-4 Diphenyl isooctyl phosphite

8 +

51570 000127-63-9 Diphenyl sulphone Same 16650 DIR SML(T) = 3 mg/kg (25)

3 R: 3 mg/kg of food Available: migration data; log Po/w; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); 4-week oral rat study; 3-months oral rat study. (RIVM/TNO SDS, April 1999 = CS/PM/2651 REV. II/51570). (Adopted at the 118th SCF meeting) (23 September 1999) http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf

+

51600 003375-11-9 Diphenylsulphone-3,3'-disulphonylhydrazide

Same 91400 6A +

51680 000102-08-9 N,N'-Diphenylthiourea DIR SML = 3 mg/kg 2 TDI: 0.05 mg/kg b.w. 28-day, 1-year and 2-year oral rat studies. (RIVM January 1967 and May 1973).

+

51700 147315-50-2 2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5-(hexyloxy)phenol

DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Available: Adequate migration data, three in vitro mutagenicity assays. (RIVM/ISS/TNO SDS, November 1996 = CS/PM/2748).

+




AND SPECIFICATIONS


175

51760 025265-71-8 and 000110-98-5

Dipropyleneglycol Same 39750 DIR 2 t-TDI: 1,5 mg/kg b.w. (SCF, 6th Series, 1978).

+ +

51840 027138-31-4 Dipropyleneglycol dibenzoate

7? Available: 3 month oral rat and dog studies (inadequate), metabolism, Ames test and migration data. (RIVM 06-09-88; Velsicol 14-09-1988). Needed: 3 month oral rat study chromosome aberration in vitro, gene mutation in mammalian cells.

+

51870 034590-94-8 Dipropyleneglycol monomethyl ether

Same 16670 8 Data inadequate. +

51900 028519-02-0 Disodium dodecyl diphenylether disulphonate

Same 52240 8/D +

51920 007558-79-4 Disodium hydrogen phosphate

D +

51930 055963-33-2 Distarch phosphate (=E1412)

W +

51932 068130-14-3 Distarch phosphate (= E1414)

W +

51933 064741-88-4 Distillates (petroleum), solvent-refined heavy paraffinic

W +

51935 064741-89-5 Distillates (petroleum), solvent-refined light paraffinic

W +

51938 068131-89-5 Distillates (petroleum), steam cracked, polymers with ethylene-manuf,-by-product piperylene-cut alkenes

W +

51940 000540-09-0 Diundecyl ketone 8 +

51950 - Diurethans arising from hexamethylene diisocyanate and alcohols aliph., monoh., sat. (C2-C20)

9 +

51975 000112-53-8 1-Dodecanol Same 16701 3 See references for the same substance in + +


AND SPECIFICATIONS


176

monomer list.

51985 009002-92-0 alpha-n-Dodecanol-omega-hydroxypoly(oxyethylene)

Same 77737 and 77920

9/D +

52000 027176-87-0 Dodecylbenzenesulphonic acid

DIR SML = 30 mg/kg 2 TDI: 0.5 mg/kg b.w. Two 2-year oral rat studies, mutagenicity studies. (RIVM Summary report March 1965).

+ +

52080 026264-05-1 Dodecylbenzenesulphonic acid, isopropylamine salt

8 +

52160 025155-30-0 Dodecylbenzenesulphonic acid, sodium salt

D +

52210 000112-55-0 n-Dodecylmercaptan W +

52240 028519-02-0 Dodecylphenoxybenzenedisulphonic acid, disodium salt

Same 51900 and 86880

+ +

52320 052047-59-3 2-(4-Dodecylphenyl)indole

DIR SML = 0.06 mg/kg 2 TDI: 0.001 mg/kg b.w. A 90-day oral rat study. (Inst. f. Biol. Forsch. Koln, report 1976).

+

52400 000143-00-0 Dodecylsulphuric acid, diethanolamine salt

Same 47630 8 For dodecylsulphuric acid L3. Toxicologically acceptable. Same references as for 34281. For diethanolamine L8. Not in contact with food containing nitrite.

+

52480 004722-98-9 Dodecylsulphuric acid, monoethanolamine salt

Same 67460 D Covered by 67441. +

52560 - Dodecylsulphuric acid, salts

D Covered by 34295. + +

52565 000151-21-3 Dodecylsulphuric acid, sodium salt

D Covered by 34281. + +

52640 016389-88-1 Dolomite DIR 3 Inert material. Purity to be specified. + +

52645 010436-08-5 cis-11-Eicosenamide DIR 3 Hydrolyses to innocuous substances. Available: specific migration in 3% acetic acid and 15% ethanol < 0.04 mg/kg, in olive oil maximum 2.8 mg/kg into food;

+


AND SPECIFICATIONS


177

comparable with oleamide and erucamide and thus complete hydrolysis to be expected in intestinal fluid in fatty acid and ammonia; gene mutation assay in bacteria (negative). (RIVM/TNO SDS, March 1999 = CS/PM/3269/52645). (Adopted at the 118th SCF meeting) (23 September 1999) http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf

52650 000112-79-8 Elaidic acid 8 +

52660 - Epichlorohydrin-polyamide, copolymer

9 (Adopted at 111th SCF meeting (18-19 March 1998)

+

52700 029564-58-7 2,3-Epoxypropyl methacrylate-methyl methacrylate- styrene, copolymers

9 +

52720 000112-84-5 Erucamide DIR 3 See the references for 68960. + +

52730 000112-86-7 Erucic acid Same 16775 DIR 3 Occurs in small amounts in some vegetable oils.

+ +

52780 - Esters of 12-hydroxystearic and stearic acid with C20-guerbet alcohols

7? Available: 2 mutagenicity studies (negative) and 4-week oral rat study (insufficient for the substances to be used for food contact materials). Needed: detailed information on the method of analysis and on decomposition products, gene mutation in mammalian cells, 3-month oral rat study, bioaccumulation, information on decomposition products from high temperature usage. (RIVM 1994-10-25 = CS/PM/2581).

+

52800 000064-17-5 Ethanol Same 16780 DIR 1 Acceptable. (SCF, 11th Series, 1981).

+ +

52880 023676-09-7 4-Ethoxybenzoic acid, ethyl ester

DIR SML = 3.6 mg/kg 2 t-TDI: 0.06 mg/kg b.w. Available: 28-days oral rat study and 3 mutagenicity tests. (RIVM, 17th March 1987). Needed: 90-day oral study.

+

52960 035001-51-5 2-Ethoxy-5-tert-butyl-2'- 8 +




AND SPECIFICATIONS


178

ethyl-4'-tert-butyloxalic acid bisanilide

53040 035001-52-6 2-Ethoxy-5-tert-butyl-2'-ethyloxalic acid bisanilide (=2-ethoxy-5-tert-butyl-2'-ethyloxanilide)

8 +

53080 - Ethoxycarbonylmethyl diethylphosphonate

7 Available: migration data, 4-week oral rat study, 2 mutagenicity studies negative. Needed: 90-day oral study, gene mutation in mammalian cells. (CS/PM/1709)

+

53120 065816-20-8 N-(4-Ethoxycarbonylphenyl)-N'ethyl-N'-phenylformamidine

W8 +

53200 023949-66-8 2-Ethoxy-2'-ethyloxanilide

DIR SML = 30 mg/kg 2 TDI: 0.5 mg/kg b.w. 90-day and 2-year oral rat studies. (Sandoz reports 1973 and 1975).

+ +

53230 - Ethyl acrylate-ethylene-methyl acrylate-methyl methacrylate-vinyl acetate and/or vinyl benzoate, copolymers

9 +

53232 026376-86-3 Ethyl acrylate-2-ethylhexyl acrylate, copolymer

W +

53235 - Ethyl acrylate-methacrylic acid-ethyleneglycol monomethacrylate-polyethyleneglycol (EO=50) nonyl phenyl ether-toluene diisocyanate, copolymer (Mw=50000-500000)

7? Available: Uses (as coating additive). Needed: Structure of the polymer, Mw distribution curve, toxicity testing in accordance with the guidelines on polymeric additives (version updated to 15 December 1995, CS/PM/2632). (Adopted at 111th SCF meeting (18-19 March 1998)

+

53238 - Ethyl acrylate-methacrylic acid-polyethyleneglycol (EO=25) alkyl(C32) ether, copolymer (Mw=

D +


AND SPECIFICATIONS


179

100000-500000)

53240 072275-83-3 Ethyl acrylate-methacrylic acid-poly(ethyleneglycol)-lauryl methacrylate ether, terpolymer

7? Needed: In first instance, information on the nature of the residue. (TNO, SDS, 1992 = CS/PM/2582 /53240. (Adopted at 111th SCF meeting (18-19 March 1998)

+

53255 000100-41-4 Ethylbenzene 3 R: 0.01 mg/kg b.w. based on allowing 1/10 of TDI (= 1 mg/kg.b.w.) for food packaging uses. Available: 6-month rat inhalation study, mutagenicity studies.

+ +

53270 037205-99-5 Ethylcarboxymethylcellulose

DIR 2 Group TDI: not specified based on group ADI (=not specified) for certain modified celluloses. (JECFA 35 M., 1989).

+

53280 009004-57-3 Ethylcellulose Same 16925 DIR 2 Group TDI: not specified based on Group ADI (=not specified) for certain modified celluloses. (JECFA 35M., 1989).

+ +

53310 - Ethylene-acrylic acid and/or maleic anhydride and/or vinyl acetate, copolymers

D +

53360 000110-31-6 N,N'-Ethylenebisoleamide

DIR 3 Chemically similar to 53520 in list 3. + +

53440 005518-18-3 N,N'-Ethylenebispalmitamide

DIR 3 90-day oral monkey study. Chemically similar to N'N-ethylene bisstearammide.

+

53520 000110-30-5 N,N'-Ethylenebisstearamide

DIR 3 Two inadequate 2-year oral rat studies and low migration (Hoechst report 13/05, 1963).

+ +

53540 000107-15-3 Ethylenediamine Same 15272 and 16960

2 TDI: 0.2 mg/kg b.w. Two 90-day oral rat studies. (ICI report, April 1975).

+

53570 027014-42-2 and 025214-63-5

Ethylenediamine-ethylene oxide and/or propylene oxide, copolymer

9 +

53600 000060-00-4 Ethylenediaminetetraacetic acid

DIR 2 TDI: 2.5 mg/kg b.w. as calcium disodium salt on the basis of JECFA ADI for calcium disodium EDTA.

+ +


AND SPECIFICATIONS


180

(JECFA 17 M., 1973; SCF 4th Series, 1977)

53610 054453-03-1 Ethylenediaminetetraacetic acid, copper salt


2 R= 5 mg/person (as Copper). based on (a) for copper same references as 30080 and (b) for calcium disodium EDTA (=2.5 mg/kg.bw, SCF, 4th Series, 1977).

+

53650 000107-21-1 Ethyleneglycol Same 16990 and 16778


2 Group TDI = 0.5 mg/kg b.w. (with diethyleneglycol). (SCF, 17th Series, 1986).

+ +

53670 032509-66-3 Ethyleneglycol bis [3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]

Same 38530 2 TDI = 0.1 mg/kg b.w. Available: acute oral toxicity data; 90-day oral rat study; 16-week oral rat study (after in utero exposure); 90-day oral dog study; 2-year oral dog study; 2.5 year oral rat study (combined chronic/ carcinogenicity study); one-generation reproduction study with rats; three negative mutagenicity studies. (RIVM SDS, January 1998 = CS/PM/3157/ 53670). REMARK for Commission: No method of analysis is available for the enforcement of an SML. (Adopted at 114th SCF meeting) (10 December 1998) http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

+ +

53680 see 53610 D +

53685 000624-04-4 Ethyleneglycol dilaurate Same 63360 D +

53760 see 53670 D + +

53820 000110-80-5 Ethyleneglycol monoethyl ether

Same 16996 2 Group t-TDI : 0.05 mg/kg b.w. (with 15780=48050, 16993=53765, 16996=53820, 16999, 17002=53860, 30015, 30120, 30200, 48030). See references for 16996.

+ +

53840 see 54005 D +

53845 004219-48-1 Ethyleneglycol monolaurate

Same 63440 D +

53860 000109-86-4 Ethyleneglycol monomethyl ether

Same 17002 2 Group t-TDI : 0.05 mg/kg b.w. (with 15780=48050, 16993=53765, 16996=53820, 16999, 17002=53860, 30015, 30120, 30200,

+




AND SPECIFICATIONS


181

48030). (See references for 16996)

53900 050586-59-9 Ethyleneglycol-trimethylolpropane, copolymer

9 +

53920 see 54120 D +

53930 025038-37-3 Ethylene-1,4-hexadiene-propylene, copolymer

D +

53950 000151-56-4 Ethyleneimine Same 17005 4 See references for same substance in monomer report.

+

53970 009006-26-2 Ethylene-maleic anhydride, copolymer

D +

53985 009010-79-1 Ethylene oxide-vinylpyrrolidone, copolymer

9 +

54000 see 54170 D +

54005 005136-44-7 Ethylene-N-palmitamide-N'-stearamide

DIR 3 Chemically similar to 53520 in list 3. +

54020 - Ethylene-propylene, copolymer

D +

54040 - Ethyleneurea-formaldehyde-isophthalic acid diamide, copolymer

9 +

54060 024937-78-8 Ethylene-vinyl acetate, copolymer

D +

54080 see 54260 D +

54085 - Ethylene-vinyl benzoate, copolymer

9 +

54100 - Ethylene-vinyl esters of sat., aliph., monocarb., acids (C2-C18), copolymer

9 +

54120 000149-57-5 2-Ethylhexanoic acid Same 17040 6B Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg of food, peroxisome proliferation study too.

+ +


AND SPECIFICATIONS


182

54130 024593-34-8 2-Ethylhexanoic acid, cerium salt

6B L6B for 2-ethylhexanoic acid Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg of food, peroxisome proliferation study too. L8 for cerium.

+

54140 000136-52-7 2-Ethylhexanoic acid, cobalt(II) salt

6B L3 for Cobalt. R: 0.05 mg/kg of food (as Co). (RIVM, summary data, 0ctober 1992=CS/PM/1707). L6B for 2-ethylhexanoic acid. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg of food, peroxisome proliferation study too.

+ +

54160 see 54300 D +

54170 093777-46-9 2-Ethylhexanoic acid, decyl ester

6B L0 for n-decanoic acid. L6B for 2-ethylhexanoic acid. Needed: toxicological data depending on migration level (SCF guidelines) and, if migration exceeds 0.05 mg/kg of food, peroxisome proliferation study too.

+

54190 015956-58-8 2-Ethylhexanoic acid, manganese salt

6B L2 for the Mn. Group TDI: 0.01 mg/kg b.w. (as Mn). See references for 30180 in L2 in this report. L6B for 2-ethylhexanoic acid. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg of food, peroxisome proliferation study too.

+

54220 022464-99-9 2-Ethylhexanoic acid, zirconium salt

6B L6B for 2-ethylhexanoic. Needed: same as 17040. L7 for zirconium. Available: Oral life span study in mice and rats and oral studies in rabbits and dogs

+


AND SPECIFICATIONS


183

(reports not seen). Needed: migration data and toxicity data according to SCF guidelines. (RIVM doc; (CS/PM/2091)).

54240 see 54380 D +

54245 - 2-Ethylhexyl maleate-vinyl acetate copolymer

9 +

54260 009004-58-4 Ethylhydroxyethylcellulose

DIR 2 Group TDI: not specified based on Group ADI (=not specified) for certain modified celluloses. (JECFA 35 M., 1989).

+

54270 - Ethylhydroxymethylcellulose

DIR 2 Group TDI : not specified based on Group ADI (=not specified) for certain modified celluloses. (JECFA, 35 M., 1989).

+

54280 - Ethylhydroxypropylcellulose

DIR 2 Group TDI : not specified based on group ADI (=not specified) for certain modified celluloses. (JECFA, 35 M., 1989).

+

54300 118337-09-0 2,2'-Ethylidenebis(4,6-di-tert-butyl phenyl) fluorophosphonite

DIR SML = 6 mg/kg 2 TDI = 0.1 mg/kg b.w. 3 month oral dog and 3 month combined oral fertility study in rats. Mutagenicity tests negative. (doc. CS/PM/841)

+

54320 see 54420 D +

54380 008047-99-2 N-Ethyltoluenesulphonamide

8 +

54395 035835-94-0 Ethyltriphenylphosphonium acetate

8 +

54400 see 54450 D + +

54420 000121-32-4 Ethylvanillin 1 ADI : 5 mg/kg b.w. (JECFA 35 M., 1990).

+

54450 - Fats and oils, from animal or vegetable food sources

DIR 3 Food fat. + +

54480 - Fats and oils, hydrogenated, from animal or vegetable food

DIR 3 Similar to food fats. + +


AND SPECIFICATIONS


184

sources

54560 - Fats and oils, refined, arising from bones, with unsaponifiable matter up to 1%

9 +

54640 - Fats and oils, sulphated, derived from animal or vegetable sources

9 +

54650 - Fats and oils, sulphonated, derived from animal or vegetable sources

9 +

54660 - Fatty acids of coconout oil, esters with choline chloride

Same 43515 and 63400

D http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html

+ +

54710/1 061790-12-3 Fatty acids, tall oil Same 17230 and 54710/0

3 +

54720 see 54650 D +

54730/1 - Fatty acids, tall oil, cobalt salts

3 L3 for fatty acids tall oil. L3 for Cobalt. R: 0.05 mg/kg of food (as Co). (RIVM, summary data, October 1992=CS/PM/1707).

+

54766 115438-43-2 Fatty acids, tallow, hydrogenated, 2-ethylhexylester

9 +

54768 064755-02-8 Fatty acids, tallow, lithium salts

+

54800 see 54860 D +

54820 - Fibers, natural, synthetic or metallic

D +

54840 007782-41-4 Fluorine W +

54860 016961-83-4 Fluorosilicic acid 7 Needed: use levels, migration data. +

54880 000050-00-0 Formaldehyde Same 17260. DIR SML(T) = 15 mg/kg (22)

3 See references for the same substance in monomer list. (SCF, 17th Series, 1986).

+ +

54900 009017-33-8 Formaldehyde- 9 + +




AND SPECIFICATIONS


185

naphthalenesulphonic acid, copolymer

54930 025359-91-5 Formaldehyde-1-naphthol copolymer [=poly(1-hydroxynaphthylmethane)]

Same 80330 DIR SML = 0.05 mg/kg 3 Available: Adequate migration data; mutagenicity studies on the polymeric additive itself (negative); mutagenicity data on the monomer 1-naphthol (negative). (RIVM/TNO SDS, October 1997 = CS/PM/ 3086/54930).+

+

54960 001338-51-8 and 025035-71-6

Formaldehyde-toluenesulphonamide, copolymer

9 +

54970 009003-08-1 Formaldehyde-2,4,6-triamino-1,3,5-triazine, copolymer

D +

55030 009011-05-6 Formaldehyde-urea, copolymer

D +

55040 000064-18-6 Formic acid Same 17275 DIR 1 Group ADI: 3 mg/kg b.w. for formic acid and ethyl formate. (JECFA 17 M., 1973).

+ +

55120 000110-17-8 Fumaric acid Same 17290 DIR 1 ADI: 6 mg/kg b.w. (SCF, 25th Series, 1990).

+

55160 000098-00-0 Furfurol Same 17505 8 +

55190 029204-02-2 Gadoleic acid Same 17510 DIR 0 +

55200 001166-52-5 Gallic acid, dodecyl ester DIR SML(T) = 30 mg/kg (34)

1 Group ADI: 0.5 mg/kg b.w. for gallic acid, octyl ester and gallic acid, propyl ester. (SCF, 22th Series, 1989).

+

55280 001034-01-1 Gallic acid, octyl ester DIR SML(T) = 30 mg/kg (34)

1 Group ADI: 0.5 mg/kg b.w. for gallic acid, dodecyl ester and gallic acid, propyl ester. (SCF, 22th Series, 1989).

+

55360 000121-79-9 Gallic acid, propyl ester DIR SML(T) = 30 mg/kg (34)

1 Group ADI: 0.5 mg/kg b.w. for gallic acid, dodecyl ester and gallic acid, octyl ester. (SCF, 22th Series, 1989).

+

55440 009000-70-8 Gelatin DIR 0 +

55520 - Glass fibers DIR 3 Inert material. +

55600 - Glass microballs DIR 3 Inert material. +

55630 000526-95-4 Gluconic acid (= E574) W +

55680 000110-94-1 Glutaric acid Same 18010 DIR 0 +


AND SPECIFICATIONS


186

55760 029733-18-4 Glutaric acid, diisodecyl ester

Same 18040 8 +

55840 028880-25-3 Glutaric acid, diisooctyl ester

8 +

55920 000056-81-5 Glycerol Same 18100 DIR 1 Group ADI: not specified for glycerol, glycerol diacetate, glycerol triacetate and glycerol monoacetate. (SCF, 11th Series, 1981).

+

56000 025395-31-7 Glycerol diacetate 1 Group ADI: not specified for glycerol, glycerol diacetate, glycerol triacetate and glycerol monoacetate. (SCF, 11th Series, 1981).

+ +

56020 099880-64-5 Glycerol dibehenate DIR 3 Toxicologically acceptable. + +

56040 - Glycerol dibutyrate 3 Toxicologically acceptable. + +

56055 027638-00-2 Glycerol dilaurate 3 Toxicologically acceptable. + +

56070 053563-63-6 Glycerol dimyristate 3 Toxicologically acceptable. + +

56080 025637-84-7 Glycerol dioleate 1 ADI: not specified. (JECFA 17 M., 1973).

+ +

56120 026657-95-4 Glycerol dipalmitate 3 Toxicologically acceptable. + +

56160 026402-29-9 Glycerol dipropionate 3 Toxicologically acceptable. + +

56240 027902-24-5 Glycerol diricinoleate 3 Toxicologically acceptable. + +

56320 001323-83-7 Glycerol distearate Same 89240 1 ADI: not specified. (JECFA 17 M., 1973).

+ +

56360 - Glycerol esters with acetic acid

DIR + +

56400 - Glycerol, esters with acids, aliph., monocarb. (more than C6)

9 +

56480 - Glycerol, esters with acids, aliph., monocarb., hydroxylated (C12-C20)

9 +

56485 091052-28-7 Glycerol, esters with acids, aliph.,sat.(C14-C18) and acids, aliph. unsat (C16-C18)

9 +

56486 - Glycerol, esters with acids, aliph.,sat., linear with an even number of



AND SPECIFICATIONS


187

carbon atoms (C14-C18) and with acids aliph., unsat., linear, with an even number of carbon atoms (C16-C18)

56487 - Glycerol esters with butyric acid

DIR + +

56490 - Glycerol, esters with erucic acid


56495 - Glycerol esters with 12-hydroxystearic acid


56500 - Glycerol, esters with lauric acid


56510 - Glycerol, esters with linoleic acid


56520 - Glycerol, esters with myristic acid


56535 - Glycerol, esters with nonanoic acid


56540 - Glycerol, esters with oleic acid


56550 - Glycerol, esters with palmitic acid


56560 see 56600 D + +

56565 - Glycerol, esters with pelargonic acid

Same 56535 D D + +

56570 - Glycerol, esters with propionic acid

DIR + +

56580 - Glycerol, esters with ricinoleic acid

DIR 3 SCF_List: 3 Restriction: none. In small doses metabolised similarly to food fats. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf

+ +

56585 - Glycerol, esters with stearic acid

DIR + +

56600 026446-35-5 Glycerol monoacetate 1 Group ADI: not specified for glycerol, glycerol diacetate, glycerol triacetate and glycerol monoacetate.

+ +




AND SPECIFICATIONS


188


56610 030233-64-8 Glycerol monobehenate DIR 3 Toxicologically acceptable. + +

56640 026999-06-4 Glycerol monobutyrate 3 Toxicologically acceptable. + +

56720 026402-23-3 Glycerol monohexanoate DIR 3 Toxicologically acceptable. + +

56760 001323-43-9 Glycerol mono(12-hydroxystearate)


56780 027215-38-9 Glycerol monolaurate 3 Toxicologically acceptable. + +

56800 030899-62-8 Glycerol monolaurate diacetate

DIR 3 Chemically similar to natural fats. +

56840 027214-38-6 Glycerol monomyristate 3 Toxicologically acceptable. + +

56880 026402-26-6 Glycerol monooctanoate DIR 3 Toxicologically acceptable. + +

56960 025496-72-4 Glycerol monooleate 1 ADI: not specified. (JECFA 17 M., 1973).

+ +

57040 - Glycerol monooleate, ester with ascorbic acid

DIR 2 Group TDI: not specified. Similarity with the citric acid esters. (JECFA 17 M., 1973).

+

57120 - Glycerol monooleate, ester with citric acid

DIR 1 ADI: not specified for citric and fatty acid esters of glycerol. (SCF, 7th Series, 1978).

+

57150 026657-96-5 Glycerol monopalmitate 3 Toxicologically acceptable. + +

57200 - Glycerol monopalmitate, ester with ascorbic acid

DIR 2 Group TDI= not specified. Similarity with the citric acid esters. (JECFA 17 M., 1973)

+

57280 - Glycerol monopalmitate, ester with citric acid


+

57360 026894-50-8 Glycerol monopropionate

3 Toxicologically acceptable. + +

57440 001323-38-2 Glycerol monoricinoleate

3 Toxicologically acceptable. + +

57520 031566-31-1 Glycerol monostearate Same 18115 1 ADI: not specified. (JECFA 17 M., 1973).

+ +

57600 - Glycerol monostearate, ester with ascorbic acid

DIR 2 Group TDI= not specified. Similarity with the citric acid esters. (JECFA 17 M., 1973).

+

57680 - Glycerol monostearate, ester with citric acid


+


AND SPECIFICATIONS


189

57760 000102-76-1 Glycerol triacetate Same 93695 1 Group ADI: not specified for glycerol, glycerol diacetate, glycerol triacetate and glycerol monoacetate. (SCF, 11th Series, 1981).

+ +

57800 018641-57-1 Glycerol tribehenate DIR 3 Toxicologically acceptable. + +

57840 000060-01-5 Glycerol tributyrate Same 93810 3 Toxicologically acceptable. + +

57880 - Glycerol, triesters with acids, aliph., monocarb. (more than C6)

9 +

57920 000620-67-7 Glycerol triheptanoate DIR 3 Toxicologically acceptable. + +

57960 000538-24-9 Glycerol trilaurate 3 Toxicologically acceptable. + +

58000 068476-38-0 Glycerol trimontanate 7 Needed: hydrolysis data. +

58040 000555-45-3 Glycerol trimyristate 3 Toxicologically acceptable. + +

58060 000555-44-2 Glycerol tripalmitate 3 Toxicologically acceptable. + +

58080 000139-45-7 Glycerol tripropionate Same 95260 3 Toxicologically acceptable. + +

58160 000139-44-6 Glycerol tris(12-hydroxystearate)

Same 62040 3 Toxicologically acceptable. +

58240 000555-43-1 Glycerol tristearate 3 Toxicologically acceptable. + +

58300 - Glycine, salts DIR 1 ADI: acceptable. (SCF, 25th Series, 1991).

+

58310 000107-22-2 Glyoxal Same 18120 D + +

58320 007782-42-5 Graphite DIR 3 Inert material. +

58400 009000-30-0 Guar gum DIR 1 ADI: not specified. (SCF, 7th Series, 1978).

+

58480 009000-01-5 Gum arabic DIR 1 ADI: not specified. (JECFA, 35 M., 1989).

+ +

58560 - Gums, natural 9 +

58600 012173-47-6 Hectorite W +

58640 015655-33-1 2-Heptadecyl-4,4'-bis(methylene stearate)-1,3- oxazoline

7 Needed: report of 90-day oral study (BIBRA).

+

58680 000142-82-5 n-Heptane 8 +

58720 000111-14-8 Heptanoic acid DIR 3 Fatty acid from food. + +

58770 025637-99-4 Hexabromocyclododecane

5 [Some organobromo compounds have a bioaccumulation potential and 1,2-dibromoethane is a category 2 carcinogen

+


AND SPECIFICATIONS


190

(EC classification).]

58800 067845-93-6 Hexadecyl 3,5-di-tert-butyl-4-hydroxybenzoate

Same 46800 D +

58840 029316-77-6 Hexadecyl methacrylate-octadecyl methacrylate, copolymer

W +

58880 000123-03-5 Hexadecylpyridinium chloride

8 +

58960 000057-09-0 Hexadecyltrimethylammonium bromide

Same 18330 DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w. 400-day oral rat study. (RIVM report, September 1978).

+

59040 009011-17-0 Hexafluoropropylene-vinylidene fluoride, copolymer (Mw>70.000)

3 Average Mw above 70000. +

59080 166412-78-8 Hexahydrophthalatic acid, diisononyl ester

1,2-cyclohexanedicarboxylic acid, diison

7 +

59120 023128-74-7 1,6-Hexamethylene-bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide)

Same 38780 DIR SML = 45 mg/kg 2 TDI: 0.75 mg/kg b.w. 2-year and 90-day oral rat studies, teratogenicity studies in mice, rats, rabbits. (RIVM report 88/678608/010, 1989-01-24).

+ +

59200 035074-77-2 1,6-Hexamethylene-bis(3-(3,5-di-tert-butyl--4-hydroxyphenyl)propionate)

DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w. 90-day oral rat and dog (plus 4-week recovery period) studies and a 2-year oral study. (RIVM July 1975, report CBG 182/80928, 5 april 1982).

+ +

59240 000124-09-4 Hexamethylenediamine Same 15274 and 18460

2 TDI: 0.04 mg/kg b.w. See references for the same substance in monomer report.

+

59280 000100-97-0 Hexamethylenetetramine Same 18670. DIR SML(T) = 15 mg/kg (22) (35)(expressed as Formaldehyde)

3 See references for the same substance in monomer list.

+ +

59330 000110-54-3 n-Hexane 8 +

59332 - Hexane (isomers) 9 +

59360 000142-62-1 Hexanoic acid Same 18770 and 41800

DIR 0 + +


AND SPECIFICATIONS


191

59440 - 2,8,14,18,24,30-Hexaoxa-6,10,22,26-tetrathio-7,9,23,25-tetrastanna-7,7,9,9,23,23,25,25-octa-(n-dodecyl)-spiro(15,15)hentriacontane-3,13,19,29-tetraoxide

8 +

59520 002425-77-6 2-Hexyldecanol 8 +

59600 000107-41-5 Hexyleneglycol Same 18850 and 22072

7 Needed: purity, physicochemical state, migration data.

+

59760 019569-21-2 Huntite DIR 3 Inert, insoluble material. +

59815 - Hydrocarbon resins (for memo.to be deleted later)

D +

59816 267233-58-9 Hydrocarbon resins, aliphatic

W +

59817 267233-95-4 Hydrocarbon resins, aromatic

W +

59818 267233-62-5 Hydrocarbon resins, cyclodiene

W +

59819 267233-74-9 Hydrocarbon resins, hydrogenated

W +

59825 - Hydrocarbons, aliphatic up to C8

9 +

59840 - Hydrocarbons, aliphatic, (C10-C14) (b.p. 180-260 °C)

9 +

59841 see 59935 D +

59842 see 59950 D +

59920 see 59980 D +

59935 - Hydrocarbons (b.p. 180-260 °C, hydrogenated)

9 +

59950 - Hydrocarbons (b.p. 180-260 °C, conventional)

D +

59980 - Hydrocarbon wax, oxidized

9 +

59990 007647-01-0 Hydrochloric acid DIR 1 ADI: not specified. (SCF, 25th Series, 1991)

+ +


AND SPECIFICATIONS


192

60005 - Hydrochloric acid, salts D Deleted because the acid appears in the list. +

60020 010026-04-7 Hydrochloric acid, tetrasilicon salt

D +

60030 012072-90-1 Hydromagnesite DIR 3 Inert material. Purity to be specified. +

60060 000123-31-9 Hydroquinone Same 15940, 18867 and

48620

D +

60080 012304-65-3 Hydrotalcite DIR 3 Inert, insoluble material. +

60160 000120-47-8 4-Hydroxybenzoic acid, ethyl ester

DIR 1 Group ADI: 10 mg/kg b.w. for ethyl, methyl and propyl esters. (SCF, 1st Series, 1975).

+

60180 004191-73-5 4-Hydroxybenzoic acid, isopropyl ester

DIR 2 Group-TDI: 10 mg/kg bw based on group ADI = 10 mg/kg bw for ethyl, methyl and propyl esters.

+

60200 000099-76-3 4-Hydroxybenzoic acid, methyl ester


+ +

60240 000094-13-3 4-Hydroxybenzoic acid, propyl ester


+

60320 070321-86-7 2-[2-Hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl]benzotriazole

DIR SML = 1.5 mg/kg 2 TDI: 0.025 mg/kg b.w. 90-day oral rat study, 3 mutagenicity studies. (RIVM doc. 27 October 1987).

+ +

60400 003896-11-5 2-(2'-Hydroxy-3'-tert-butyl-5'-methylphenyl)-5-chlorobenzotriazole


2 Group TDI: 0.5 mg/kg b.w. for 2-(2'-hydroxy-3,5'-di-tert.butylphenyl)-5-chloro-benzotriazole and 2-(2'-hydroxy-5'methylphenyl)benzotriazole.

+ +

60480 003864-99-1 2-(2'-Hydroxy-3,5'-di-tert-butylphenyl)-5-chlorobenzotriazole


2 Group TDI: 0.5 mg/kg b.w. for 2-(2'-hydroxy-3'-tert.butyl-5'-methylphenyl)-5-chlorobenzotriazole and 2-(2'-hydroxy-5'-methyl phenyl)benzotriazole.

+ +

60560 009004-62-0 Hydroxyethylcellulose DIR 2 Group TDI: not specified based on Group ADI (=not specified) for certain modified celluloses. (JECFA 35 M., 1989).

+ +

60640 000150-39-0 N-(2-Hydroxyethyl)ethylenediaminetriacetic acid

8 +


AND SPECIFICATIONS


193

60800 065447-77-0 1-(2-Hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl piperidine-succinic acid, dimethyl ester, copolymer

DIR SML = 30 mg/kg 2 TDI : 0.5 mg/kg b.w. 90-Day oral rat and dog studies, 2-year oral rat study. (HRC report CBG 237/92271, 10 May 1983)

+ +

60880 009032-42-2 Hydroxyethylmethylcellulose

DIR 2 Group TDI: not specified based on Group ADI (=not specified) for certain modified celluloses. (JECFA 35 M., 1989).

+ +

60960 - Hydroxyethyloctadecylamine

8 +

61040 000111-58-0 N-(2-Hydroxyethyl)oleamide

Same 69500 8 +

61055 000122-99-6 2-Hydroxyethyl phenyl ether

8 +

61120 009005-27-0 Hydroxyethyl starch DIR 2 Group TDI: not specified. (JECFA 26 M., 1982).

+

61200 070198-29-7 1-(2-Hydroxyethyl)-2,2,6,6-tetramethyl-4-hydroxypiperidine/succinic acid,copolymer

9 +

61280 003293-97-8 2-Hydroxy-4-n-hexyloxybenzophenone



+

61340 000149-44-0 Hydroxymethanesulphinic acid, sodium salt

Same 70160 8 + +

61360 000131-57-7 2-Hydroxy-4-methoxybenzophenone



+ +

61390 037353-59-6 Hydroxymethylcellulose DIR 2 Group TDI: not specified based on Group ADI (=not specified) for certain modified celluloses. (JECFA 35 M., 1989).

+

61440 002440-22-4 2-(2'-Hydroxy-5'-methylphenyl)benzotriazole


2 Group TDI: 0.5 mg/kg b.w. for 2-(2'-hydroxy-3'-tert.butyl-5'-methylphenyl)-5-chlorobenzotriazole, 2-(2'-hydroxy-3,5'-di- tert.butylphenyl)-5-chloro-benzotriazole and 2-(2'-hydroxy-5'-methylphenyl)benzotriazole.

+ +


AND SPECIFICATIONS


194

Several 90-day oral rat and dog studies and a 2-year oral rat study and 3-4 month oral dosing of man. (HRC report CBG 161/78164).

61480 - Hydroxymethyl-1-phospha-2,6,7-trioxybicyclo(2.2.2)octane-3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate

D +

61520 004710-34-3 2-Hydroxyoctadecanesulphonic acid, sodium salt

8 +

61600 001843-05-6 2-Hydroxy-4-n-octyloxybenzophenone



+ +

61680 009004-64-2 Hydroxypropylcellulose DIR 2 Group TDI: not specified based on Group ADI (=not specified) for certain modified celluloses. (JECFA 35 M., 1989).

+ +

61760 009004-65-3 Hydroxypropylmethylcellulose

Same 66700 D Group TDI: not specified based on Group ADI (=not specified) for certain modified celluloses. (JECFA 35 M., 1989).

+ +

61800 009049-76-7 Hydroxypropyl starch DIR 1 ADI: not specified. (SCF, 13th Series 1982).

+ +

61840 000106-14-9 12-Hydroxystearic acid Same 18900 DIR 3 SCF_List: 3 Restriction: none. In small doses metabolised similarly to food fats. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf

+ +

61880 078616-19-0 12-Hydroxystearic acid, diester with glycerol


61920 - 12-Hydroxystearic acid-3-dimethylaminopropyl amine, copolymer

W9 +

62000 - 12-Hydroxystearic acid, esters with glycerol

D Toxicologically acceptable. +




AND SPECIFICATIONS


195

62080 - 12-Hydroxystearic acid-3-dimethylaminopropyl amine- dimethyl sulphate, copolymer

W9 In first instance provide information on identity.

+

62095 056780-58-6 2-Hydroxy-3-(trimethylammonio)propyl starch chloride

W +

62110 007681-52-9 Hypochlorous acid, sodium salt

6A Positive in several mutagenicity studies. (RIVM doc. CS/PM/2093).

+ +

62140 006303-21-5 Hypophosphorous acid DIR 3 Easily oxidized to phosphoric acid. + +

62160 007681-53-0 Hypophosphorous acid, sodium salt

3 Easily oxidized to phosphorous acid. +

62175 010025-82-8 Indium trichloride 8 +

62220 010045-89-3 Iron(ii) diammonium bisulphate

3 Iron maximum provisional tolerable daily intake 0.8 mg/kg bw. (27th M, JECFA, 1983).

+

62230 020344-49-4 Iron hydroxide oxide W +

62240 001332-37-2 Iron oxide DIR 2 ADI: not specified. (SCF, 1st Series 1975).

+ +

62245 012751-22-3 Iron phosphide 3AM 3 Restriction: None (Inert, insoluble material) Remark for Commission: It is requested only for use in PET polymers and co-polymers. http://www.efsa.eu.int/science/afc/afc_opinions/768/afc_fcm_op_list6_2004.12.171.pdf

+

62250 000089-65-6 Isoascorbic acid W +

62270 000078-83-1 Isobutanol Same 18970 8 Residue less than 1 mg/kg in food. No mutagenicity or oral data. (Directive 88/344/EEC)

+

62280 09003-29-6 Isobutylene-butene copolymers

Similar to 76520


62295 - Isobutene-2-methyl-1,3-butadiene, copolymer

D +

62320 see 62435 D +

62400 see 62450 D +

62405 031807-55-3 Isododecane 9 +

62415 097259-92-2 Isononanoic acid, butyl ester

W +




AND SPECIFICATIONS


196

62420 025103-52-0 isooctanoic acid Same 19135 8 +

62435 011087-88-0 Isooctyl epoxystearate 6A +

62450 000078-78-4 Isopentane DIR 3 Volatile. +

62480 000067-63-0 Isopropanol Same 23830 and 81882

D +

62500 - 1,1(Isopropylidenebis(p-phenyleneoxy))-bis(3-(p-(2,3-epoxypropoxy)-alpha,alpha-dimethylbenzyl)phenoxy))2-propanol

6A +

62540 000080-05-7 4,4'-Isopropylidenediphenol

Same 13480/13607/40060/192

55/39680

D http://europa.eu.int/comm/food/fs/sc/scf/out128_en.pdf

+

62560 092908-32-2 4,4'-Isopropylidenediphenylalkyl(C12-C15)phosphites

9 +

62640 008001-39-6 Japan wax DIR 3 Refined, natural wax. Purity to be specified. + +

62720 001332-58-7 Kaolin Same 43490 DIR 1 ADI: not specified. (SCF, 25th Series, 1990).

+ +

62800 - Kaolin, calcined DIR 3 Inert material. + +

62880 061790-53-2 Kieselguhr Same 46375 D +

62885 068855-54-9 Kieselguhr, soda ash flux calcined

Same 46380 D + +

62960 000050-21-5 Lactic acid Same 19460 DIR 1 ADI: not specified. (SCF, 25th Series, 1990).

+ +

63040 000138-22-7 Lactic acid, butyl ester DIR 2 Group TDI= not specified. Similarity with lactic acid, ethyl ester for which an ADI not specified was established by JECFA 26 M., 1982.

+ +

63120 007100-07-4 Lactic acid, iron salt D +

63200 051877-53-3 Lactic acid, manganese salt


1-2 L1 for lactic acid. ADI: not specified. (SCF, 25th Series, 1991). L2 for Manganese. Group TDI: 0.01 mg/kg bw (as Mn)

+




AND SPECIFICATIONS


197

See references for acetic acid, manganese(II) salt (PM/REF.N. 30180) in list 2.

63240 008006-54-0 Lanolin (pharmacopeia grade)

0 +

63260 091079-06-0 Lard oil, sulphated, ammonium salt

9 +

63280 000143-07-7 Lauric acid Same 19470 DIR 0 + +

63360 000624-04-4 Lauric acid, diester with ethyleneglycol

Same 53685 7 Needed: hydrolysis data. +

63400 025234-60-0 Lauric acid, ester with choline chloride

Same as 43515 and

54660

D http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html

+ +

63440 004219-48-1 Lauric acid, monoester with ethyleneglycol


63480 001338-39-2 Lauric acid, monoester with sorbitan

Same 87600 D +

63520 001793-68-6 Lauric acid, monoester with triethanolamine


63560 000120-40-1 Lauric diethanolamide Same 39280 D Same references as 39280. +

63600 000097-78-9 N-Lauroylsarcosine 8 +

63680 001344-40-7 Lead phosphite, dibasic D +

63760 008002-43-5 Lecithin DIR 1 ADI: not specified. (JECFA 17 M., 1973).

+ +

63840 000123-76-2 Levulinic acid DIR 0 +

63880 - Light petroleum hydrocarbons, odorless

9 Specifications on identity. +

63920 000557-59-5 Lignoceric acid DIR 0 +

63940 008062-15-5 Lignosulphonic acid 3AM 3 R = 0.04 mg/dm² = 0.24 mg/kg of food for the requested use, i.e. as dispersant for plastics dispersions. Available: molecular mass distribution curve; calculation of worst case migration assuming 100% transfer into food; gene mutation assay in bacteria (negative) and 16-week oral rat study. (RIVM/DE SDS, May 1999 = CS/PM/3284 REV. I/63940). Remark for Commission: No analytical

+ +




AND SPECIFICATIONS


198

method is available. (Adopted at the 118th SCF meeting) (23 September 1999) http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf

64000 003999-01-7 Linoleamide 8 +

64015 000060-33-3 Linoleic acid Same 19518 DIR 0 + +

64080 - Linoleic acid, esters with alcohols, aliph., monoh.

9 +

64150 028290-79-1 Linolenic acid Same 19526 DIR 0 + +

64160 008001-26-1 Linseed oil Same 19532 3 Food fat. + +

64240 008016-11-3 Linseed oil, epoxidized (oxirane less than 10%,iodine Number less than 6)

7 Available: inadequate 20 week oral rat study, Ames test said to be negative (no report supplied)(CS/PM/1517). Needed: data according to SCF guidelines. (N.B. Epoxidised linseed oil cannot be covered by data on epoxidised soya bean oil).

+ +

64300 001310-65-2 Lithium hydroxide 2 Group TDI: 0.01 mg/kg b.w. (as Li). See references for 38000 in list 2.

+

64320 010377-51-2 Lithium iodide DIR SML(T) = 1 mg/kg (11) (expressed as Iodine) and SML(T) = 0.6 mg/kg (8) (expressed as Lithium)

2 L2 for I. Group-TDI based on PMTDI: 0.017 mg/kg b.w. (as I). (JECFA 33 M., 1988). L2 for Li. Group TDI: 0.01 mg/kg bw (as Li). 90-day oral rat studies and metabolism and human use of lithium salts in therapy. (RIVM tox 105/76 July 1976, tox 204/78, November 1978, tox 126/79 October 1979). For Li see references for benzoic acid, lithium salt in list 2.

+

64400 001345-05-7 Lithopone 3 Free from water soluble barium. Insoluble, inert material.

+ +

64480 011097-59-9 Magnesium aluminium hydroxide carbonate

Same 34690 D Inert, insoluble material. +

64500 - Lysine, salts DIR 0 +




AND SPECIFICATIONS


199

64560 007786-30-3 Magnesium chloride 1/D ADI: not specified. (SCF, 25th Series, 1991)

+ +

64640 001309-42-8 Magnesium hydroxide DIR 1 ADI: not specified. (SCF, 25th Series, 1991)

+

64720 001309-48-4 Magnesium oxide DIR 1 ADI: not specified. (SCF, 25th Series, 1991)

+

64800 000110-16-7 Maleic acid Same 19540. DIR SML(T) = 30 mg/kg (4)

2 Group TDI: 0.5 mg/kg b.w. as maleic acid. (SCF, 17th Series, 1986).

+

64820 000142-16-5 Maleic acid, bis(2-ethylhexyl) ester

W +

64840 010039-33-5 Maleic acid, di-n-octyltin bis (2-ethylhexyl) ester

Same 50240 D Same references as 50240. +

64860 - Maleic acid, esters with pentaerythritol

9 +

64880 - Maleic acid, monohexadecyl ester, potassium salt


64900 000108-31-6 Maleic anhydride Same 19960 D +

64920 - Maleic anhydride-butene and/or ethylene and/or propylene, copolymers

D +

64940 - Maleic anhydride-ethylene or styrene or methyl vinyl ether, copolymer

9 +

64955 025119-65-7 Maleic anhydride-methyl methacrylate, copolymer

D +

64960 see 65020 D +

64970 - Maleic anhydride-methyl vinyl ether, copolymer

9 +

64972 028133-65-5 Maleic anhydride methyl vinyl ether, copolymer, sodium salt (Mw>70000)

7 Needed: In first instance, Mw distribution curve of the polymer (maleic anhydride methyl vinyl ether, copolymer, sodium salt). Remark: Monomer, i.e. methyl vinyl ether (PM/REF No. 22270) not yet evaluated (provide hydrolysis data). (Adopted at 111th SCF meeting (18-19 March 1998)

+

64985 025722-45-6 Maleic anhydride- 9 +


AND SPECIFICATIONS


200

propylene, copolymer

64990 025736-61-2 Maleic anhydride-styrene, copolymer, sodium salt

3AM 3 Restriction: None http://www.efsa.eu.int/science/afc/afc_opinions/768/afc_fcm_op_list6_2004.12.171.pdf

+

65000 - Maleic anhydride-vinyl esters, copolymers

D +

65020 006915-15-7 Malic acid Same 19965 DIR 1 ADI: not specified. (SCF, 25th Series, 1990).

+ +

65040 000141-82-2 Malonic acid Same 19968 DIR 3 Occurs in plants. +

65120 007773-01-5 Manganese chloride DIR SML(T) = 0.6 mg/kg (10) (expressed as Manganese)

2 Group TDI: 0.01 mg/kg b.w. (as Mn). (Environmental Health Criteria 17, WHO 1981).

+

65200 012626-88-9 Manganese hydroxide DIR SML(T) = 0.6 mg/kg (10) (expressed as Manganese)

2 Group TDI: 0.01 mg/kg b.w. (as Mn). See references for acetic acid, manganese(II) salt in list 2.

+

65280 010043-84-2 Manganese hypophosphite


2-3 L2 for manganese Group TDI: 0.01 mg/kg b.w. (as Mn). See references for acetic acid, manganese(II) salt in list 2. L3 for hypophosphite. Hypophosphite easily oxidised tp phosphoric acid.

+

65360 011129-60-5 Manganese oxide DIR SML(T) = 0.6 mg/kg (10) (expressed as Manganese)

2 Group TDI: 0.01 mg/kg b.w. (as Mn). See references for acetic acid, manganese(II) salt.

+

65440 - Manganese pyrophosphite


2-3 L2 for manganese. Group TDI: 0.01 mg/kg b.w. (as Mn). See references for acetic acid, manganese(II) salt in list 2. L3 for pyrophosphite. Easily oxidized to pyrophosphoric acid.

+

65520 000087-78-5 Mannitol Same 19972 DIR 1 ADI: acceptable. (SCF, 16th Series, 1985).

+

65630 000108-78-1 Melamine Same 19975,25420

and 93720

D See "2,4,6-triamino-1,3,5-triazine". + +

65768 000149-30-4 2-Mercaptobenzothiazole 6A Statement on 2-Mercaptobenzothiazole +




AND SPECIFICATIONS


201

(MBT) The Committee has received a request to comment on the safety of the proposed CEN extraction limit for MBT from rubber materials used for soothers and teats. - Considering that on the basis of well-conducted genotoxicity studies the previously expressed concern of possible carcinogenic effects related to the migration of low amounts of MBT from finished products can now be discounted. - Considering that based on the limit of 8 mg MBT/kg rubber extracted over 24 hours as proposed by CEN, a worst case exposure to MBT was calculated not to exceed 22 ug/kg b.w. for a baby weighing 2 kg, fed 8 times a day using a new teat of 5 g at each occasion and - In view of the existing toxicological studies, albeit insufficient for establishing a TDI, which show a NOAEL of 94 mg/kg b.w. from a 90-day oral mouse study leading to a margin of safety of around 4200, The Committee concludes that the potential oral exposure to MBT resulting from materials in compliance with the proposed CEN limit of 8 mg/kg rubber extracted over a 24 hour period does not constitute a health hazard. However, the Committee is aware that MBT has been reported, primarily in occupational settings, to induce sensitisation after dermal contact. As this issue is not related to food safety it is considered to be outside the remit of the Committee. Therefore the SCF recommends that the Commission seeks appropriate advice to consider whether direct contact exposure to MBT, through teats and soothers, constitutes a sensitisation hazard.


AND SPECIFICATIONS


202

Available: inadequate migration data and worst case calculations; gene mutation assays in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (positive); gene mutation assays in cultured mammalian cells (one assay negative and one assay weakly positive); SCE assay in vitro (positive); mouse bone marrow micronucleus assay (negative); in vivo rat liver UDS assay (negative); limited in vivo DNA binding assay (negative); three 16-day oral mouse and rat studies (one inadequate); two 90-day oral mouse and rat studies; 2 carcinogenicity studies (mouse and rat); two teratogenicity studies (rat); metabolism study; skin and eye irritation studies; sensitisation study; human data concerning sensitisation. RIVM/DK/ISS/TNO SDS, March 2000 = CS/PM/3224 A+B REV.IV/65768/65770. (Adopted at the 123rd SCF meeting, 19 October 2000 http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf

65770 002492-26-4 2-Mercaptobenzothiazole, sodium salt

6A Statement on 2-Mercaptobenzothiazole (MBT) The Committee has received a request to comment on the safety of the proposed CEN extraction limit for MBT from rubber materials used for soothers and teats. - Considering that on the basis of well-conducted genotoxicity studies the previously expressed concern of possible carcinogenic effects related to the migration of low amounts of MBT from finished products can now be discounted. - Considering that based on the limit of 8 mg MBT/kg rubber extracted over 24 hours as proposed by CEN, a worst case exposure to

+




AND SPECIFICATIONS


203

MBT was calculated not to exceed 22 ug/kg b.w. for a baby weighing 2 kg, fed 8 times a day using a new teat of 5 g at each occasion and - In view of the existing toxicological studies, albeit insufficient for establishing a TDI, which show a NOAEL of 94 mg/kg b.w. from a 90-day oral mouse study leading to a margin of safety of around 4200, The Committee concludes that the potential oral exposure to MBT resulting from materials in compliance with the proposed CEN limit of 8 mg/kg rubber extracted over a 24 hour period does not constitute a health hazard. However, the Committee is aware that MBT has been reported, primarily in occupational settings, to induce sensitisation after dermal contact. As this issue is not related to food safety it is considered to be outside the remit of the Committee. Therefore the SCF recommends that the Commission seeks appropriate advice to consider whether direct contact exposure to MBT, through teats and soothers, constitutes a sensitisation hazard. Available: inadequate migration data and worst case calculations; gene mutation assays in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (positive); gene mutation assays in cultured mammalian cells (one assay negative and one assay weakly positive); SCE assay in vitro (positive); mouse bone marrow micronucleus assay (negative); in vivo rat liver UDS assay (negative); limited in vivo DNA binding assay (negative); three 16-day oral mouse and rat studies (one inadequate); two 90-day oral mouse and rat


AND SPECIFICATIONS


204

studies; 2 carcinogenicity studies (mouse and rat); two teratogenicity studies (rat); metabolism study; skin and eye irritation studies; sensitisation study; human data concerning sensitisation. RIVM/DK/ISS/TNO SDS, March 2000 = CS/PM/3224 A+B REV.IV/65768/65770. (Adopted at the 123rd SCF meeting, 19 October 2000 http://europa.eu.int/comm/food/fs/sc/scf/out76_en.pdf

65800 068039-13-4 Methacrylamidopropyltrimethylammonium chloride, polymer (Mw= 10000-100000)

W7 Needed: Mw distribution curve; three mutagenicity studies with the monomer (which is now listed in L6A). (Adopted at 111th SCF meeting (18-19 March 1998)

+

65805 - Methacrylamidopropyltrimethylammonium chloride-trimethylethanolammonium chloride methacrylate, copolymer (Mw=10000-100000)

W7 Needed: Mw distribution curve; three mutagenicity tests with the monomers (which are listed in L6A or in L8). (Adopted at 111th SCF meeting (18-19 March 1998)

+

65830 000109-16-0 Methacrylic acid, diester with triethyleneglycol

W +

65905 007779-31-9 Methacrylic acid, 3,3,5-trimethylcyclohexyl ester

W +

65910 002530-85-0 [3-(Methacryloxy)propyl] trimethoxysilane

8 +

65920 066822-60-4 [N-Methacryloyloxyethyl-N,N-dimethyl-N-carboxymethylammonium chloride, sodium salt -octadecyl methacrylate-ethyl methacrylate-cyclohexyl methacrylate-N-vinyl-2-pyrrolidone, copolymers

Same 38500 DIR 2 TDI: 1 mg/kg b.w. 90-day oral rat study. Mutagenicity data not needed for this polymer. (RIVM doc. Tox 300/482 March 1984).

+




AND SPECIFICATIONS


205

66000 - 3'-Methoxy-4'-hydroxyphenyl-2-indole

8 +

66030 000150-76-5 4-Methoxyphenol Same 21615 8 +

66080 000613-93-4 N-Methylbenzamide 8 +

66160 016515-58-5 7-(5'-Methyl-6'-n-butoxy-benzotriazole(2))-3-phenylcoumarin

8 +

66200 037206-01-2 Methylcarboxymethylcellulose

DIR 2 Group TDI: not specified based on Group ADI (= not specified) for certain modified celluloses. (JECFA 35 M., 1989).

+

66240 009004-67-5 Methylcellulose DIR 2 Group TDI: not specified based on Group ADI (=not specified) for certain modified celluloses. (JECFA 35 M., 1989).

+ +

66270 000096-37-7 Methylcyclopentane 8 +

66320 000118-82-1 4,4'-Methylenebis(2,6-di-tert-butylphenol)

Same 38750 8 +

66350 085209-93-4 2,2'-Methylenebis(4,6-di-tert-butylphenyl) lithium phosphate

3AM 3 Restriction: 5 mg/kg food. Remark for the Commission: Lithium: Group restriction of 0.6 mg/kg food. http://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf

+

66360 085209-91-2 2,2'-Methylene bis(4,6-di-tert-butylphenyl) sodium phosphate

DIR SML = 5 mg/kg 3 R: 5 mg/kg in food. Available: 3-month oral rat study, mutagenicity tests negative, migration data. (RIVM doc. 15 Oct. 1991).

+

66400 000088-24-4 2,2'-Methylene bis(4-ethyl-6-tert-butylphenol)

Same 39010 DIR SML(T) = 1.5 mg/kg (20)

2 Group TDI: 0.025 mg/kg b.w.(with 66480). Available for 66480: two 90-day oral rat studies, 4-month oral dog study and mutagenicity studies. (RIVM Doc/Tox 300/418 April 1983 and CS/PM/171).

+

66480 000119-47-1 2,2'-Methylene bis(4-methyl-6-tert-butylphenol)

Same 39025 DIR SML(T) = 1.5 mg/kg (20)

2 Group TDI: 0,025 mg/kg b.w.(with 66400). Available: two 90-day oral rat studies, 4-month oral dog study, mutagenicity studies. (RIVM doc./Tox 300/418 April 1983 and CS/PM/171).

+




AND SPECIFICATIONS


206

66560 004066-02-8 2,2'-Methylenebis(4-methyl-6-cyclohexylphenol)

Same 39045 DIR SML(T) = 3 mg/kg (6) 2 TDI = 0.05 mg/kg b.w. (with 66580). Available for 66580 short-term oral rat and dog study, 90-day oral dog study and 2-year oral rat and dog study. (RIVM doc. CS/PM/2205).

+

66580 000077-62-3 2,2'-Methylenebis(4-methyl-6-(1-methyl-cyclohexyl) phenol)

Same 39600 DIR SML(T) = 3 mg/kg (6) 2 Group TDI = 0.05 mg/kg b.w. (with 66560). Available: short-term oral rat and dog study, 90-day oral dog study and 2-year oral rat and dog study (RIVM doc. CS/PM/2205).

+

66600 026545-58-4 Methylenebis(naphthalenesulphonic acid), disodium salt

8 +

66620 000075-09-2 Methylene chloride 3 R: 0.05 mg/kg of foods. (SCF, 29th Series, 1992).

+

66640 009004-59-5 Methylethylcellulose DIR 2 Group TDI: not specified based on Group ADI (=not specified) for certain modified celluloses. (JECFA, 35 M., 1989).

+

66655 000078-93-3 Methyl ethyl ketone Same 21827 3 R: 5 mg/kg of food. Available: 3 and 6 month inhalation studies in rats, teratogenicity studies by inhalation in mice and rats, mutagenicity tests. (RIVM doc. CS/PM/2098),(SCF, 29th Series, 1992).

+

66675 ? Methylheptadecanoic acid

D +

66680 000095-71-6 Methylhydroquinone Same 21850 8 +

66695 - Methylhydroxymethylcellulose

DIR 2 Group TDI: not specified based on group ADI (= not specified) for certain modified celluloses. (JECFA 35 M., 1989).

+

66700 009004-65-3 Methylhydroxypropylcellulose

Same 61760 DIR 2 Group TDI: not specified based on group ADI (= not specified) for certain modified celluloses. (JECFA 35M., 1989).

+ +

66715 000693-98-1 2-Methylimidazole 8 +

66720 see 66755 D + +

66725 000108-10-1 Methyl isobutyl ketone 3 R: 5 mg/kg of food. Available: 3 month oral rat study and 3

+


AND SPECIFICATIONS


207

month inhalation studies mice, rats, dogs and monkeys, teratogenicity studies by inhalation in mice and rats , mutagenicity tests. (WHO Env. Health Crit. n. 117 (1990) Geneva).

66740 000814-78-8 Methyl isopropenyl ketone (=2-methyl-2-penten-4-one)

Same 21910 8 +

66745 - Methyl isopropenyl ketone-styrene, copolymer

9 +

66755 002682-20-4 2-Methyl-4-isothiazolin-3-one


4A See references for 43760 in list 4. + +

66800 000139-99-1 Methyl oleate, sulphated D L8 +

66820 000923-02-4 N-Methylolmethacrylamide

Same 21970 7 +

66840 000107-83-5 2-Methylpentane 8 +

66860 000108-11-2 4-Methyl-2-pentanol Same 22080 8 +

66880 see 66950 D + +

66905 000872-50-4 N-Methylpyrrolidone 3AM 2 Restriction: None. Used as solvent. http://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf

+

66930 068554-70-1 Methylsilsesquioxane Same 86426 3AM 3 Residual monomer in methylsilsesquioxane: < 1 mg methyltrimethoxysilane /kg of methylsilsesquioxane http://www.efsa.eu.int/science/afc/afc_opinions/468/opinion11_afc_ej65_list4_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out114_en.pdf

+

66940 - alpha-Methylstyrene-N-octadecylmaleimide-N-(2,2,6,6-tetramethyl-4-piperidyl)maleimide, copolymer

W7 Available: Inadequate migration data, Mw, Mn, mutagenicity studies on the polymeric additive itself. Needed: Mw distribution,additional information on overall migration in olive oil

+








AND SPECIFICATIONS


208

and on specific migration, 3 mutagenicity tests on each of the starting substances not on List 0-4 (RIVM 1994-09-06).

66950 - alpha-Methylstyrene-styrene, copolymer, hydrogenated

3 R: 5 mg/kg of food. See the opinion for PM/REF.N. 66960.

+ +

66960 068441-38-3 alpha-Methylstyrene-vinyltoluene, copolymer, hydrogenated

3 R: 5 mg/kg of food. Available: molecular weight distribution curve and migration data showing high migration in fat simulants. Mutagenicity data (from 47520), 3-month oral rat and dog studies. (TNO 1995-05-22 = CS/PM/2594)(Elias CS/PM/838). Remark: since high migration into fat has been demonstrated the WG recommends that the Commission take the necessary measures so that the restriction proposed is not exceeded.

+ +

67040 014295-72-8 1(4-Methylsulphonylphenyl)-3-(4-chlorophenyl)-delta-2-pyrazoline

8 +

67120 012001-26-2 Mica DIR 3 Inert silicate. + +

67155 - Mixture of 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene, 4,4'-bis(2-benzoxazolyl) stilbene and 4,4'-bis(5-methyl-2-benzoxazolyl)stilbene)

3AM 3 R = Maximum amount to be used 0.05% (w/w).

+

67160 - Mixt.of:60% alkyl(C11-C14)-bis(hydroxyethyl)sulphonium glycolsulphate;17.9% alkyl(C11-C14)-

D +


AND SPECIFICATIONS


209

bis(hydroxyethyl)sulphonium sulphate;2,6% alkyl (C11-C14)bis(hydroxyethyl)sulphonium bisulphate;19.5 % alkyl etC.

67161 068439-49-6 Mixture of a)fatty alcohols(C16-C18)(approx. 48%); b)ethyleneglycol monoalkyl(C16-C18)ether(approx.24%); c)polyethyleneglycol(e0=2-6)monoalkyl(C16-C18)ether(approx. 28%)

Same 77895 D +

67162 - Mixture of lauric and myristic alcohol with their polyethyleneglycol ethers (1-10EO)

7 Needed: Migration and toxicity data on polyethyleneglycol ethers.

+

67165 - Mixture of:a)40-100% react.product of 2-mercaptoethyl oleate with dimethyltin dichloride,methyltin trichloride and sodium sulphide;b)0-40% 2-mercaptoethyl oleate;c)0-5% 2-mercaptoethanol;d)0-40% paraffin etC.

D +

67170 - Mixture of (80 to 100% w/w) 5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-2(3H)-benzofuranone and (0 to 20% w/w)5,7-di-tert-butyl-3-(2,3-dimethylphenyl)-2(3H)-benzofuranone

Same 83598 D SML = 5 mg/kg 3 R = 5 mg/kg of food. Available: Adequate migration data; log Po/w; three negative mutagenicity studies; 90-day oral rat study (including examination of the activity of the peroxisome associated enzymes); metabolism study (in vitro and in vivo) in rats; in vitro gene mutation assay in bacteria with the dimer (CG33-0941); ADE study. (RIVM/TNO SDS, March 1998 =

+


AND SPECIFICATIONS


210

CS/PM/2965 REV. I/67170). (Adopted at 114th SCF meeting) (10 December 1998) http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

67180 - Mixture of (50% w/w) phthalic acid n-decyl n-octyl ester, (25% w/w) phthalic acid di-n-decyl ester, (25% w/w) phthalic acid di-n- octyl ester.

Same 75850 DIR SML = 5 mg/kg (1) 3 R = 5 mg/kg of food or food simulant. Available: 3 mutagenicity studies negative, 3 months oral rat study, test on liver peroxisome proliferation, migration in aqueous food simulants only. Remark: high migration into fatty food is likely. (RIVM report 1995-09-04 (=CS/PM/2655)).

+

67185 028679-16-5 Mixture of (40% w/w) 2,2,4-trimethylhexane-1,6-diisocyanate and (60% w/w) 2,4,4-trimethylhexane-1,6-diisocyanate

Same 22332 D Not detectable +

67200 001317-33-5 Molybdenum disulphide DIR 3 Inert, insoluble material. +

67240 023850-94-4 Monobutyltin tris(2-ethylhexanoate)

W +

67280 000108-90-7 Monochlorobenzene 2 TDI: 0.6 mg/kg b.w. 90-day oral rat study, 2 year oral mouse and rat studies, Ames list negative, in vitro mutagenicity test positive. (Appendix to RIVM report 758701004 March 1990).

+

67355 - Mono-, di- and trialkyl(C4-C18)phenyl ethers of poly(ethylene-and/or propylene- and/or butyleneglycol)acetic acid

9 +

67360 067649-65-4 Mono-n-dodecyltin tris(isooctyl mercaptoacetate)

DIR SML = 24 mg/kg 3 Restriction: 0.05 mg/kg food (as sum of mono-n-dodecyltin tris(isooctyl mercaptoacetate), di-n- dodecyltin bis(isooctyl mercaptoacetate), monododecyltin trichloride and di-dodecyltin dichloride) expressed as the sum

+




AND SPECIFICATIONS


211

of mono- and di-dodecyltin chloride. http://www.efsa.eu.int/science/afc/afc_opinions/960/afc_op_ej218_8thlist_en1.pdf

67420 000141-43-5 Monoethanolamine Same 12763 and 35170

3 R = 0.05 mg/kg of food. Available: migration data from multilayer bottle and residual content in polymer; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); in vitro cell transformation assay (negative); toxicology summary on reproductive toxicity; general toxicological overview on MEA (made by the applicant). RIVM/TNO SDS, August 1999 = CS/PM/3337/22337. Remark: substance evaluated only for the requested use of indirect contact with non-fatty food. (Adopted at the 121 SCF meeting (20 June 2000))

+

67440 - Monoethanolamine alkyl sulphate

D Partially covered by 67441. +

67441 - Monoethanolamine alkyl(C8-C22)sulphate, linear, primary, even numbered

8 L3 and L8. For alkyl(C8-C22)sulphuric acids, linear, primary, even numbered. L3. Toxicologically acceptable. Same references as for 34281. For monoethanolamine. L8.

+

67442 090583-16-7 Monoethanolamine alkyl(C12-C14)sulphate

D Partially covered by 67441. +

67515 057583-34-3 Monomethyltin tris(ethylhexyl

see 67520 3AM 2 L2 for tin Isooctyl refers to industrial mixture

+




AND SPECIFICATIONS


212

mercaptoacetate) including substances with a branched chain of 8 atoms of carbon. Usually, x-methyl-C7, x,y-dimethyl-C6 are the major components of an isooctyl “mixture” (more than 90%). x-ethyl-C6 are present but not in a large quantities (less than 10%). The composition of this mixture could be slightly different according the oil feedstock used for the synthesis of it and of the process used for the “oxo” reaction.. In contrast, ethylhexyl (ethyl-C6) refers usually to 2-ethylhexyl structure which is perfectly defined chemically. In the scope of organotin compounds for which the toxicity is related to organic tin, studies done either with the “isooctyl” or the “ethylhexyl” could be used for evaluation of branched C8 organotin compounds.

67520 054849-38-6 Monomethyltin tris(isooctyl mercaptoacetate)


2 Group TDI: 0.003 mg/kg bw (as Sn) (with 49600 and 83599). See references for 83599 in list 2. .

+

67600 - Mono-n-octyltin tris(alkyl(C10-C16) mercaptoacetate)


2 Group-TDI: 0.02 mg/kg bw (as Sn) with 67680 and 67760. See references for 67760

+

67680 027107-89-7 Mono-n-octyltin tris(2-ethylhexyl mercaptoacetate)


2 Group-TDI: 0.02 mg/kg bw (as Sn)(with 67760 and 67600). See references for 67760 in list 2.

+

67760 026401-86-5 Mono-n-octyltin tris(isooctyl mercaptoacetate)


2 Group-TDI: 0.02 mg/kg bw (as Sn) for monooctyltin stabilisers (REF_N 67760) Group-TDI: 0.0006 mg/kg bw (as Sn) for dioctyltin stabilisers (REF_N 50480) Available: migration data; several subacute studies in rats and dogs (performed with MOTTG, DOTTG, MOTC, DOTC and formulation of MOTC and DOTC); several semichronic studies in rats and dogs

+


AND SPECIFICATIONS


213

(performed with MOTTG, DOTTG and formulation of MOTTG and DOTTG); 2-year rat and dog studies (performed with DOTTG and formulation of MOTC and DOTC); gene mutation assays in bacteria (negative) (performed with MOTC, DOTC and formulation of MOTTG and DOTTG); gene mutation assays in cultured mammalian cells (negative) (performed with MOTC and DOTC); in vitro UDS assay (negative) (performed with DOTC); in vitro covalent DNA binding assay (negative) (performed with DOTC); micronucleus assays (negative; however, it was noted that no cytotoxicity was observed when performed with MOTC) (negative with formulation with MOTTG and DOTTG); in vivo SCE assay (negative) (performed with DOTC); 2-generation reproduction study in rats (performed with formulation of MOTTG and DOTTG); teratogenicity study in rats (performed with formulation of MOTTG and DOTTG); teratogenicity study in rabbits (performed with formulation of MOTTG and DOTTG). (RIVM SDS, October 1998 = CS/PM/3255/50480/67760). Remark for Commission: no analytical method is available. (Adopted at the 118th SCF meeting) (23 September 1999) http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf

67840 - Montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol

DIR 3 3-4 month oral dog, 3 month rat and 2-year rat studies plus negative Ames tests. (RIVM report 05-03-1990).

+ +

67850 008002-53-7 Montan wax DIR 3 Inert compound, specifications needed. + +

67870 000110-91-8 Morpholine 5 [Possibility of the formation of carcinogenic +




AND SPECIFICATIONS


214

N-nitrosomorpholine in nitrite-containing foodstuffs, as well as from nitrite in saliva. To a minor extent this nitrosamine can also be formed from N-substituted morpholines.]

67878 - Morpholine, its salts of acids, aliph., monocarb., sat., more than C7

5 [Possibility of the formation of carcinogenic N-nitrosomorpholine in nitrite-containing foodstuffs, as well as from nitrite in saliva. To a minor extent this nitrosamine can also be formed from N-substituted morpholines.]

+

67882 - Morpholine, its salts of acids, aliph., monocarb., unsat., more than C7

5 [Possibility of the formation of carcinogenic N-nitrosomorpholine in nitrite-containing foodstuffs, as well as from nitrite in saliva. To a minor extent this nitrosamine can also be formed from N-substituted morpholines.]

+

67891 000544-63-8 Myristic acid Same 22350 DIR 1 ADI: NS (SCF, 25th Series, 1989).

+ +

67895 025263-97-2 Myristic acid, isobutyl ester


67896 020336-96-3 Myristic acid, lithium salt


1-2 Based on the above-mentioned data the substance is classified: SCF_List: L1 for myristic acid (ADI: Not specified). SCF_List: L2 for lithium (Group-TDI = 0.01 mg/kg bw. (as Li)) http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdf

+

67898 000544-64-9 Myristoleic acid Same 67898 8 +

67910 000085-47-2 1-Naphthalenesulphonic acid

8 +

67912 000120-18-3 2-Naphthalenesulphonic acid

8 +

67918 001338-24-5 Naphthenic acids W +

67921 061789-36-4 Naphthenic acids, calcium salts

W +

67930 061789-51-3 Naphthenic acids, cobalt salts

9 L3 for Cobalt. R: 0.05 mg/kg of food (as Co). (RIVM, summary data, October 1992=CS/PM/1707).

+




AND SPECIFICATIONS


215

L9 for napthenic acids.

67936 001338-02-9 Naphthenic acids, copper salts

W +

67946 001336-93-2 Naphthenic acids, manganese salt

9 L9 for naphthenic acids. L2 for the Mn. Group TDI: 0.01 mg/kg b.w. See references for 30180 in L2 in this report.

+

68000 - Naphthenic mineral oil 9 +

68001 - Naphthenic mineral oil (hydrogenated)

D +

68002 - Naphthenic mineral oil (conventional)

D +

68040 003333-62-8 7-(2H-Naphtho-(1,2-D)triazol-2-yl)-3-phenylcoumarin

DIR 2 TDI: 1 mg/kg b.w. 90-day oral rat and dog studies, two mutagenicity tests. (RIVM 300/234 Tox/75, July 1981).

+

68050 026896-20-8 Neodecanoic acid W +

68070 052270-44-7 Neodecanoic acid, cobalt (ii) salt

Similar to 68078

3/D L3 for neodecanoic acid. R: 0.05 mg/kg of food for neodecanoic acid. Not for fatty foods. Available: 3 negative mutagenicity tests and migration data for non-fatty foods for neodecanoic acid. L3 for Cobalt. R: 0.05 mg/kg of food (as Co). (RIVM, summary data, October 1992=CS/PM/1707).

+

68078 027253-31-2 Neodecanoic acid, cobalt salt

Similar to 68070

DIR SML(T) = 0.05 mg/kg (expressed as Neodecanoic acid) and SML(T) = 0.05 mg/kg (14) (expressed as Cobalt). Not for use in polymers contacting foods for which simulant D is laid down in Directive

3 List 3 for neodecanoic acid. R: 0.05 mg/kg of food for neodecanoic acid. Not for fatty foods. Available: 3 negative mutagenicity tests and migration data for non-fatty foods for neodecanoic acid. List 3 for Cobalt. R: 0.05 mg/kg of food (as Co). (RIVM, summary data, October 1992=CS/PM/1707)."

+


AND SPECIFICATIONS


216

85/572/EEC. (Adopted at the 126th SCF meeting, 28 February 2001) http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdf

68080 see 68040 D +

68112 027253-29-8 Neodecanoic acid, zinc salt

W +

68125 037244-96-5 Nepheline syenite DIR 3 Inert material. +

68140 007697-37-2 Nitric acid 2 TDI: 3 mg/kg bw based on ADI= 5 mg/kg bw on sodium nitrate. (SCF, 38th Series, 1997)

+

68145 080410-33-9 2,2',2"-Nitrilo[triethyl tris(3,3',5,5'-tetra-tert-butyl-1,1'-bi-phenyl-2,2'-diyl)phosphite]


3 R = 5 mg/kg of food (covering the sum of phosphite and phosphate). Available: adequate migration data, three in vitro mutagenicity studies; 90-day oral rat study, acute delayed neurotoxicity study; log Po/w. (RIVM/TNO SDS, November 1996 = CS/PM/2749).

+ +

68150 000112-05-0 Nonanoic acid Same 22465 8 +

68180 see 68125 D +

68185 000104-40-5 4-Nonylphenol Same 22540 8 +

68200 - Novolac glycidyl ethers (=NOGE)

same 22552 See 13160

D According to Commission Directive 2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs. Can still be used in heavy coatings.


+

68210 032536-52-0 Octabromodiphenyl ether

5 [Some organobromo compounds have a bioaccumulation potential and 1,2-dibromoethane is a category 2 carcinogen (EC classification).]

+

68225 000112-92-5 1-Octadecanol Same 22555 3 See references for same substance in monomer report.

+ +






AND SPECIFICATIONS


217

68240 000124-30-1 Octadecylamine 8 +

68320 002082-79-3 Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w. Several oral rat studies (3-weeks to 3-months), 2-year oral studies in mice and rats, two-generation and teratogenicity studies, mutagenicity tests. (RIVM doc. 31-03-92).

+ +

68400 010094-45-8 Octadecylerucamide DIR SML = 5 mg/kg 3 R: 5 mg/kg of food Available: specific migration in aqueous food simulants <0.4 mg/kg, in HB307 1.8 mg/kg; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); 90-day oral rat study (no NOAEL established). (RIVM/UK/TNO SDS, May 1999 = CS/PM/3273 REV. I/68400). (Adopted at the 118th SCF meeting) (23 September 1999) http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf

+

68480 016545-53-2 Octadecyl (4-hydroxy-3,5-dimethylbenzyl)merca ptoacetate

8 +

68560 000124-07-2 n-Octanoic acid Same 14320 and 41960

D + +

68640 007435-02-1 n-Octanoic acid, cerium salt

8 LO for n-octanoic acid. L8 for cerium.

+ +

68650 006700-85-2 n-Octanoic acid, cobalt salt

3 L3 for Cobalt. R = 0.05 mg/kg of food (as Co) (RIVM, summary data, October 1992=CS/PM/1707). L0 for n-octanoic acid.

+

68680 016577-52-9 n-Octanoic acid, lithium salt

0-2 L2 for the Lithium. Group TDI : 0.01 mg/kg b.w. (as Li). See references for 38000 in L2 in this report.

+




AND SPECIFICATIONS


218

L0 for n-octanoic acid.

68690 006535-19-9 n-Octanoic acid, manganese salt

2 L2 for the Mn. Group TDI: 0.01 mg/kg b.w. (as Mn). See references for 30180 in L2 in this report. L0 for n-octanoic acid.

+

68720 see 68775 D +

68730 018312-04-4 Octanoic acid, zirconium salt

9 L9 for octanoic acid. L7 for zirconium. See references for 54220.

+

68775 005333-42-6 2-Octyldodecanol 8 +

68800 000106-84-3 Octyl epoxystearate Same 70040 6A +

68840 000111-88-6 n-Octylmercaptan 8 +

68860 004724-48-5 n-Octylphosphonic acid DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg of food. Based on the reduced core set of toxicological data according to the migration level. Available : migration data (SM < 15 ppb) ; gene mutation assay in bacteria (negative) ; chromosomal aberration assay in cultured mammalian cells (negative) ; gene mutation assay in cultured mammalian cells (negative). RIVM/TNO SDS, June 2001 = CS/PM/3847 REV. I/68860. (Adopted at the 130th SCF meeting, 13 December 2001) http://europa.eu.int/comm/food/fs/sc/scf/out114_en.pdf

+

68880 000992-55-2 2-n-Octylthio-4,6-bis(4-hydroxy-3,5-di-tert-butylphenoxy)-1,3,5-triazine

8 +

68960 000301-02-0 Oleamide DIR 3 Hydrolyses to innocuous substances. Available: Migration data, Ames test, hydrolysis tests. (RIVM doc. 1990-09-12, CS/PM/2434).

+ +

69040 000112-80-1 Oleic acid Same 22763 DIR 1 ADI: not specified. + +




AND SPECIFICATIONS


219


69120 000142-77-8 Oleic acid, butyl ester 7 Needed: hydrolysis data. + +

69160 014666-94-5 Oleic acid, cobalt salt 3AM 3 SCF_List: 3 -Restriction : 0.05 mg/kg for cobalt SCF_List: 1 for oleic acid ; food additive "ADI not specified" Remark for Commission: Intended to be used in active packaging. http://www.efsa.eu.int/science/afc/afc_opinions/195/opinion_afc_01_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf

+

69200 - Oleic acid, esters with alcohols aliph., monoh.


69280 000111-62-6 Oleic acid, ethyl ester 7 Needed: hydrolysis data. +

69360 042254-63-7 Oleic acid, heptyl ester 7 Needed: hydrolysis data. +

69440 022393-86-8 Oleic acid, hexadecyl ester


69500 000111-58-0 Oleic acid, monoethanolamide

Same 61040 D +

69520 032953-65-4 Oleic acid, octyl ester 7 Needed: hydrolysis data. +

69560 003687-45-4 Oleic acid, oleyl ester 7 Needed: hydrolysis data. +

69600 000142-57-4 Oleic acid, pentyl ester 7 Needed: hydrolysis data. +

69680 000110-25-8 N-Oleoylsarcosine 8 +

69760 000143-28-2 Oleyl alcohol Same 22766 DIR 3 Precursor of oleic acid. + +

69840 016260-09-6 Oleylpalmitamide DIR SML = 5 mg/kg 3 R: 5 mg/kg of food. Available: 3-month oral rat study, mutagenicity studies negative, migration data. (RIVM doc. 17.03.92).

+

69848 - Organopolysiloxanes 9 +

69900 000122-51-0 Orthoformic acid, triethyl ester

Same 94160 D +

69920 000144-62-7 Oxalic acid Same 22775 DIR SML(T) = 6 mg/kg (29)

2 TDI: 0.1 mg/kg b.w. 2-year oral rat study, observations in man.

+ +






AND SPECIFICATIONS


220

(J. Am. Pharm. Ass. 1947, 36, 217-219, Patty).

70000 070331-94-1 2,2'-Oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

DIR 2 TDI: 10 mg/kg b.w. 90-day oral rat and dog studies, 2-generation rat study, 2 mutagenicity tests. (RIVM 85/627915/128 November, 1985).

+

70040 000106-84-3 Oxiraneoctanoic acid, 3-octyl, octyl ester

Same 68800 D +

70080 000080-51-3 4,4'-Oxybis(benzene sulphonyl hydrazide)

6A Waiting for an answer to the letter from EEC (CS/PM/374) to the interested industry using RIVM conclusions in CS/PM/366.

+

70160 000149-44-0 Oxymethanesulphinic acid, sodium salt

Same 61340 D +

70240 012198-93-5 Ozokerite DIR 3 Mineral wax. Purity to be specified. + +

70320 000629-54-9 Palmitamide 8 +

70400 000057-10-3 Palmitic acid Same 22780 DIR 1 ADI: not specified. (SCF, 25th Series, 1990).

+ +

70480 000111-06-8 Palmitic acid, butyl ester 7 Needed: hydrolysis data. +

70560 000628-97-7 Palmitic acid, ethyl ester 7 Needed: hydrolysis data. +

70640 026718-83-2 Palmitic acid, heptyl ester


70720 000540-10-3 Palmitic acid, hexadecyl ester


70760 020259-32-9 Palmitic acid, iron (III) salt

D +

70780 000110-34-9 Palmitic acid, isobutyl ester


70800 059231-33-3 Palmitic acid, isodecyl ester

W8 +

70870 002598-99-4 Palmitic acid, octadecyl ester


70880 016958-85-3 Palmitic acid, octyl ester 7 Needed: hydrolysis data. +

70960 031148-31-9 Palmitic acid, pentyl ester


71020 000373-49-9 Palmitoleic acid Same 22785 DIR 0 + +

71040 017281-74-2 Palmitoylbenzoylmethane

8 +

71100 063449-39-8 Paraffins, chlorinated 5 [IARC (1989; volume 48) has classified +


AND SPECIFICATIONS


221

chlorinated paraffins of average carbon-chain length C12 and average degree of chlorination approximately 60% as possibly carcinogenic to humans (group 2B).]

71120 008012-95-1 Paraffin oil 9 + +

71121 - Paraffin oil (hydrogenated)

D + +

71122 - Paraffin oil (conventional)

D + +

71150 068188-18-1 Paraffin oils, chlorosulphonated, saponified

W +

71200 - Paraffin, synthetic 9 + +

71201 - Paraffin, synthetic (hydrogenated)

D + +

71202 - Paraffin, synthetic (conventional)

D + +

71280 008002-74-2 and 063231-60-7

Hydrocarbon waxes, paraffin and microcrystalline

9 + +

71281 008002-74-2 and 063231-60-7

Hydrocarbon waxes, paraffin and microcrystalline (hydrogenated)

D + +

71282 - Hydrocarbon waxes, paraffin and microcrystalline (conventional)

D + +

71283 063231-60-7 Paraffin wax and hydrocarbon waxes, microcrystalline

D + +

71300 064742-51-4 Paraffin waxes (petroleum), hydrotreated

W +

71360 008002-03-7 Peanut oil 3 Food fat. +

71440 009000-69-5 Pectin DIR 1 ADI: not specified. (SCF, 7th Series, 1978).

+

71470 032534-81-9 Pentabromodiphenyl ether

5 [Some organobromo compounds have a bioaccumulation potential and 1,2-

+


AND SPECIFICATIONS


222

dibromoethane is a category 2 carcinogen (EC classification).]

71520 000117-97-5 Pentachlorothiophenol, zinc salt

8 +

71600 000115-77-5 Pentaerythritol Same 22840 DIR 2 Group TDI: 1 mg/kg b.w. (with dipentaerythritol). (SCF, 17th Series, 1986).

+ +

71625 054381-53-2 Pentaerythritol dimyristate


71635 025151-96-6 Pentaerythritol dioleate DIR SML = 0.05 mg/kg. Not for use in polymers contacting foods for which simulant D is laid down in Directive 85/572/EEC.

3 R = 0.05 mg/kg food. Available: migration data, 3 mutagenicity tests, not regarded as genotoxic. Remark: Since high migration into fat has been demonstrated, the SCF recommends that the Commission take the necessary measures, so that the restriction proposed is not exceeded. (RIVM SDS, October 1994= CS/PM/2465). (adopted at 113rd SCF meeting)(17-18 September 1998) http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html

+

71645 068818-38-2 Pentaerythritol monomyristate


71660 010332-32-8 Pentaerythritol monooleate


71670 178671-58-4 Pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)

DIR SML = 0.05 mg/kg 3 R = 0.05 mg/kg food. Available: migration data (< 0.05 mg/kg food); gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); acute toxicity data; 4-week oral rat study. RIVM/TNO SDS, January 2001 = CS/PM/3819/71670. (Adopted at the 128th SCF meeting, 12 July 2001) http://europa.eu.int/comm/food/fs/sc/scf/out97_en.pdf

+






AND SPECIFICATIONS


223

71680 006683-19-8 Pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4- hydroxyphenyl)-propionate]

Same 92655 DIR 2 TDI: 3 mg/kg b.w. Oral studies for 3 months and 2 years in rats, 3 and 4 months in dogs, lifetime in mice, reproduction and teratogenicity in mice and rats and mutagenicity studies. (RIVM report 89/678608/013, 1989-06-13).

+ +

71686 007575-23-7 Pentaerythritol tetrakis(3-mercaptopropionate)

8 +

71695 000115-83-3 Pentaerythritol tetrastearate

D +

71710 000098-77-1 Pentamethyleneammonium-pentamethylenedithiocarbamate

8 +

71720 000109-66-0 Pentane DIR 3 Volatile. +

71760 see 71686 D +

71840 see 71710 D +

71920 see 71720 D +

71935 007601-89-0 Perchloric acid, sodium salt monohydrate

DIR SML = 0.05 mg/kg (31)

3 SCF_list:3 Restriction: 0.05 mg/kg of food. Remark for Commission: for fatty food method only applicable with saturated fatty food simulant (e.g. HB307, Mygliol). See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out142_en.pdf

+

71960 003825-26-1 perfluorooctanoic acid, ammonium salt

8 + +

72000 see 72060 D + +

72001 see 72061 D + +

72002 see 72062 D +

72046 007727-54-0 Persulphuric acid, ammonium salt

8 +

72048 007727-21-1 Persulphuric acid, potassium salt

8 +

72060 008009-03-8 Petrolatum Same 72062 and 95695

D + +




AND SPECIFICATIONS


224

72061 - Petrolatum (hydrogenated)

D + +

72062 008009-03-8 Petrolatum (conventional)

Same 72060 and 95695

D +

72080 - Petroleum hydrocarbon resins

9 +

72081 - Petroleum hydrocarbon resins (hydrogenated)

7 Available: molecular weight and molecular weight distribution curve; residual amounts of monomers, hydrogenated monomers and catalysts; three (negative) mutagenicity studies (performed with the hydrogenated hydrocarbon resin). Needed: In first instance, migration data on the polymeric additive; explanation why the residual amount of the hydrogenated monomers and unpolymerizable components are rather high (in the product), because the WG expressed its concern for the lack of toxicity data; more information on specification, i.e. information on hydrogenation, purification and viscosity of final product. (RIVM/DE SDS, October 1997 = CS/PM/3082/72081).

+

72081/10 088526-47-0 Petroleum hydrocarbon resins (hydrogenated)

7 Under re-evaluation http://europa.eu.int/comm/food/fs/sc/scf/out172_en.pdf

+

72082 - Petroleum hydrocarbon resins (conventional)

9 +

72105 - Phenols and/or cresols-styrene and/or alpha- methylstyrene and/or (C3-C12) olefins, copolymers

9 +

72135 000092-84-2 Phenothiazine 8 +

72160 000948-65-2 2-Phenylindole DIR SML = 15 mg/kg 2 TDI: 0.25 mg/kg b.w. 1 and 2-year oral rat studies, migration data. (Arch. Toxicol. 1964, 20, 220-225).

+

72240 000090-43-7 2-Phenylphenol D +




AND SPECIFICATIONS


225

72320 000092-69-3 4-Phenylphenol Same 23140 8 +

72400 000132-27-4 2-Phenylphenol, sodium salt

D Deleted. Covered by 72240. +

72480 003645-61-2 4-Phenylphenol, sodium salt

D Deleted. Covered by 72320. +

72560 007144-65-2 3-(2-Phenyl)phenoxy-1,2-epoxypropane

Same 51470 6A +

72620 - Phosphonic acid, esters 9 +

72640 007664-38-2 Phosphoric acid Same 23170 DIR 1 MTDI: 70 mg/kg b.w. (as P). (SCF, 25th Series, 1990).

+ +

72650 068515-98-0 Phosphoric acid, alkyl(C3-C9) esters

W +

72710 000107-66-4 Phosphoric acid, dibutyl ester

W +

72720 002197-63-9 Phosphoric acid, di-n-hexadecyl esters

6B Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies and neurotoxicity studies too.

+

72760 003138-43-0 Phosphoric acid, di-n-nonyl ester

6B Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferations studies and neurotoxicity studies too.

+

72800 001241-94-7 Phosphoric acid, diphenyl 2-ethylhexyl ester

Same 72910 DIR SML = 2.4 mg/kg 2 TDI: 0.04 mg/kg b.w. (based on a 90-day study). The entire profile of this substance allows to allocate a TDI. Available: Acute toxicity data; two 90-day oral rat studies; inadequate 2-year oral rat and dog studies; one-generation reproduction study using rats; teratogenicity study; Ames assay (negative); gene mutation assay in mouse lymphoma cells (negative); in vivo bone marrow cytogenetic assay (negative); neurotoxicity study; peroxisome proliferation study.

+ +


AND SPECIFICATIONS


226

(RIVM SDS, June 1996 = CS/PM/2858/72800). Remark for Commission: no method of analysis is available for the enforcement of an SML. (Adopted at 111th SCF meeting (18-19 March 1998)). http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

72880 097489-40-2 Phosphoric acid, ethanolamine hexyl branched and linear ester


72910 001241-94-7 Phosphoric acid, 2-ethylhexyl diphenyl ester

Same 72800 D +

72915 012645-31-7 Phosphoric acid, 2-ethylhexyl ester

W +

72940 010402-24-1 Phosphoric acid, iron salt D +

72960 007446-27-7 Phosphoric acid, lead (II) salt

D +

73040 013763-32-1 Phosphoric acid, lithium salts


1-2 L2 for lithium. Group TDI: 0.01 mg/kg b.w. (as Li). See references for benzoic acid, lithium salt. L1 for phosphoric acid. MTDI: 70 mg/kg bw (as P). (SCF, 25th Series, 1991).

+

73120 010124-54-6 Phosphoric acid, manganese salt


1-2 L2 for Manganese. Group TDI: 0.01 mg/kg b.w. (as Mn). See references for acetic acid, manganese(II) salt. L1 for Phosphoric acid. MTDI: 70 mg/kg bw. (as P) (SCF, 25th Series, 1991)

+

73160 - Phosphoric acid, mono- and di-n-alkyl (C16 and C18) esters

DIR SML = 0.05 mg/kg 3 All 4 constituents of the mixture are allocated in List 3 with R = 0.05 mg/kg of food. The four constituents of the mixture are: - Phosphoric acid, mono-octadecyl ester

+ +




AND SPECIFICATIONS


227

(CAS no. 2958-09-9) - Phosphoric acid, di-octadecyl ester (CAS no. 3037-89-6) - Phosphoric acid, mono-hexadecyl ester (CAS no. 3539-43-3) - Phosphoric acid, di-hexadecyl ester (CAS no. 2197-63-9) (Adopted at the 126th SCF meeting, 28 February 2001) http://europa.eu.int/comm/food/fs/sc/scf/out84_en.pdf

73200 - Phosphoric acid, mono- and diesters with alcohols, aliph. (C9-C18), diethanolamine salt

9 Group R : 0.05 mg/kg b.w. +

73280 - Phosphoric acid, mono and diesters with alcohols, aliph. (C9-C18), salts

9 Group R: 0.05 mg/kg bw. +

73360 003539-43-3 Phosphoric acid, mono-n-hexadecyl ester

3 R: 0.05 mg/kg of food. Based on data for 73160.

+

73440 003900-04-7 Phosphoric acid, mono-n-hexyl ester


73480 - Phosphoric acid, nonyl ester, sodium salt


73520 039471-52-8 Phosphoric acid, octadecyl esters

D Group R: 0.05 mg/kg bw. +

73600 000078-51-3 Phosphoric acid, tributoxyethyl ester

6B Group R: 0.05 mg/kg b.w. Available: Ames test, 14-day and 18-week oral rat studies. Needed: Full report of 18 week oral rat study by Monsanto (1987) and tests for gene mutation and chromosome aberration in mammalian cells in vitro in the first instance.

+

73680 000126-73-8 Phosphoric acid, tributyl ester

6B Group R: 0.05 mg/kg b.w. Available: Ames test and several subchronic

+




AND SPECIFICATIONS


228

oral rat studies. Needed: remaining toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies and neurotoxicity studies too.

73720 000115-96-8 Phosphoric acid, trichloroethyl ester


4A Carcinogenic to rats. (NTP Tech. Rep. Ser. N. 391, May 1991).

+

73760 - Phosphoric acid, triethanol ester


73840 000126-71-6 Phosphoric acid, triisobutyl ester

6B Group R: 0.05 mg/kg bw. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg peroxisome proliferation studies and neurotoxicity studies too.

+ +

73920 000115-86-6 Phosphoric acid, triphenyl ester

6B Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, neurotoxicity studies too.

+

74000 000078-42-2 Phosphoric acid, tris(2-ethylhexyl) ester

6B Group R: 0.05 mg/kg b.w. Available: Ames test, 90-day and 2-year oral mouse and rat studies. Needed: remaining toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies and neurotoxicity studies too.

+

74010 145650-60-8 Phosphorous acid, bis(2,4-di-tert.-butyl-6-methylphenyl) ethyl ester


3 R = 5 mg/kg of food (covering the sum of phosphite and phosphate). Available: migration data, three in vitro mutagenicity tests, Ames/E. coli test with the oxidation product, 28-day oral rat study, 90-day oral rat study, "limited" delayed neurotoxicity study in hens. (RIVM/TNO SDS, October 1996 = CS/PM/2916).

+ +

74080 025448-25-3 Phosphorous acid, 6B Group R: 0.05 mg/kg b.w. +


AND SPECIFICATIONS


229

triisodecyl ester Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies and neurotoxicity studies too.

74160 013423-78-4 Phosphorous acid, tris-2-(cyclohexylphenyl) ester


+

74240 031570-04-4 Phosphorous acid, tris(2,4-di-tert-butylphenyl) ester

DIR 2 TDI: 1 mg/kg b.w. 90-day and 2-year oral rat studies, 2-generation study in rats and mutagenicity studies. (HRC report CBG 167/76339, 18 Aug.1976, LSR 80/CIA 015/111, 21 Oct. 1980, Ciba-Geigy 82 0873 Feb. 1985).

+ +

74320 039865-35-5 Phosphorous acid, tris((3-ethyl-3-oxetanyl)- methyl) ester


+

74400 - Phosphorous acid, tris(nonyl-and/or dinonylphenyl) ester

DIR SML = 30 mg/kg 2 TDI: 0.5 mg/kg b.w. 90-day oral rat and 2-year oral rat and dog studies, 3 generation oral rat reproduction study, 3 negative mutagenicity studies. (RIVM 08-1-1990).

+ +

74455 - Phthalate mixture of the ethyl- or butylester of glycolic acid with aliph, monoh, alcohols (C1-C4)

D +

74480 000088-99-3 o-Phthalic acid Same 23200 DIR 2 Group TDI: 1 mg/kg b.w. Included in the group TDI for phthalic anhydride.

+

74560 000085-68-7 Phthalic acid, benzyl butyl ester

2 Under re-evaluation + +

74640 000117-81-7 Phthalic acid, bis(2-ethylhexyl) ester

2 Under re-evaluation ------------------------------------------------- TDI: 0.05 mg/kg b.w. (see the individual report, CS/PM/2161 FINAL).

+ +


AND SPECIFICATIONS


230

74720 000117-82-8 Phthalic acid, bis(2-methoxyethyl) ester

8 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 6B to List 8. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. R: 0.05 mg/kg of food (by analogy with 53860). Suspected of embriotoxicity/teratogenicity. Available: some studies, but inadequate. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

+

74800 068515-42-4 Phthalic acid, dialkyl (C7-C11) esters

7 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 6B to List 7. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. Group R: 0.05 mg/kg b.w. Needed: in first instance specifications on identity. Toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies on specified substances. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

+

74880 000084-74-2 Phthalic acid, dibutyl ester

2 Under re-evaluation. ------------------------------------ TDI = 0.1 mg/kg b.w. Available: acute oral toxicity data; skin- and eye irritation data; ADME data; 3-week oral rat study; 4-week oral rat study; 13-week oral rat studies; peroxisome proliferation

+ +

http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf







AND SPECIFICATIONS


231

studies; metabolism study; two-generation reproduction study in rats; two teratogenicity studies in rats (one is limited); mutagenicity data; human data; 90-day mouse and rat studies; 2-generation reproduction study; 5 teratogenicity studies with rats; placental transfer study; androgen-regulated developmental study; peroxisome proliferation study; estrogenicity studies; conclusion of other scopes (a.o. CSTEE opinion). RIVM SDS, July 2000 = CS/PM/853 REV. I/74880. NOTE: The TDI is based on the LOAEL of 52 mg/kg b.w. from the 2-generation rat study with a continuous breeding protocol. Making use of an uncertainty factor of 500 (10 for interspecies; 10 for intraspecies and 5 for extrapolating from a LOAEL to a NOAEL), a TDI of 0.1 mg/kg b.w. is derived. Remark: no long-term/carcinogenicity study is available: not considered necessary. (To be adopted by the SCF)

74960 000084-61-7 Phthalic acid, dicyclohexyl ester

7 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 2 to List 7. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. t-TDI: 0.1 mg/kg b.w. Available: three 90-day oral rat studies, limited in vitro mutagenicity studies (RIVM 1988). Needed: reproduction and teratogenicity studies, tests for gene mutation and chromosome aberrations in mammalian cells in vitro. http://www.efsa.eu.int/science/afc/afc_docu

+




AND SPECIFICATIONS


232

ments/469/statement01_afc_phthalates_en1.pdf

75040 - Phthalic acid, diesters with hexadecanol and/or octadecanol

7 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 2 to List 7. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. Group t-TDI : 0.15 mg/kg bw (with 76120). Available: 3 months oral rat study, teratogenicity study and Ames test negative. (RIVM doc. 1990-09-11, CS/PM/529). Needed: reproduction study, peroxisome proliferation, gene mutation and chromosome aberration in mammalian cells in vitro. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

+

75100 - Phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60% C9.

2 Under re-evaluation. http://europa.eu.int/comm/food/fs/sc/scf/out50_en.pdf

+ +

75105 - Phthalic acid, diesters with primary, saturated C9-C11 branched alcohols more than 90% C10


+ +

75120 000084-66-2 Phthalic acid, diethyl ester

7 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 2 to List 7. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. t-TDI: 0.2 mg/kg b.w. Available: a 3-month oral rat study, in vitro mutagenicity studies, i.p. teratogenicity

+ +










AND SPECIFICATIONS


233

studies and peroxisome proliferation studies. (Fd. Cosm. Toxicol. 1978, 16, 415-422, RIVM 1986, June). Needed: reproduction and teratogenicity study. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

75200 003648-21-3 Phthalic acid, di-n-heptyl ester

7 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 6B to List 7. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. Group R: 0.05 mg/kg b.w. Available: Ames test. Needed: remaining toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies too. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

+

75280 000084-69-5 Phthalic acid, diisobutyl ester

8 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 6B to List 8. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies too. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

+ +

75360 026761-40-0 Phthalic acid, diisodecyl D This item is changed into a new item (see +











AND SPECIFICATIONS


234

ester 75105).

75440 028553-12-0 Phthalic acid, diisononyl ester

D This item is changed into a new item (see 75100).

+

75520 027554-26-3 Phthalic acid, diisooctyl ester

8 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 9 to List 8. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. Group R: 0.05 mg/kg b.w. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

+

75600 000131-11-3 Phthalic acid, dimethyl ester

7 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 6B to List 7. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. Group R: 0.05 mg/kg b.w. Available: limited oral rat chronic toxicity/carcinogenicity study, oral teratogenicity studies in rats and mice, Ames test. Needed: gene mutation and chromosome aberration in mammalian cells in vitro and migration data in the first instance. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

+ +

75680 000084-76-4 Phthalic acid, di-n-nonyl ester

8 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 6B to List 8. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. Group R: 0.05 mg/kg b.w.

+








AND SPECIFICATIONS


235

Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies too. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

75760 014117-96-5 Phthalic acid, di-n-octadecyl ester


+

75840 000117-84-0 Phthalic acid, di-n-octyl ester

7 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 6B to List 7. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. Group R: 0.05 mg/kg b.w. Available: Ames test, peroxisome proliferation study, oral mouse reproduction study, inadequate oral rat 90-day study, inadequate oral rat chronic toxicity/carcinogenicity study. Needed: gene mutation and chromosome aberration study in mammalian cells in vitro and migration data in the first instance. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.

+ +










AND SPECIFICATIONS


236

pdf

75850 - Phthalic acid, di-n-octyl and/or di-n-decyl and/or n-decyl n-octyl esters

Same 67180 7 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 3 to List 7. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. R: 5 mg/kg of food or food simulant. Available: 3 mutagenicity studies negative, 3 months oral rat study, test on liver peroxisome proliferation, migration in aqueous food simulants only. Remark: high migration into fatty food is likely. (RIVM report 1995-09-04 (=CS/PM/2655)). http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

+

75920 000119-06-2 Phthalic acid, di-n-tridecyl ester

7 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 6B to List 7. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. Group R: 0.05 mg/kg b.w. Available: Ames test. Needed: remaining toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies too. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

+

76000 - Phthalic acid, mixed esters with butyl glycolate and alcohols, aliph.,monoh., (C1-C4)

8 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 9 to List 8. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also

+









AND SPECIFICATIONS


237

needed. Group R: 0.05 mg/kg b.w. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

76005 000085-70-1 Phthalic acid, mixed esters with butyl glycolate and butanol

7 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 6B to List 7. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. Group R: 0.05 mg/kg b.w. Available: 30-day and 1-year oral rat studies and mutagenicity studies all inadequate. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg peroxisome proliferation studies too. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

+

76080 - Phthalic acid, mixed esters with ethyl glycolate and alcohols, aliph.,monoh., (C1-C4)

8 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 9 to List 8. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed. Group R: 0.05 mg/kg b.w. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

+

76085 000084-72-0 Phthalic acid, mixed esters with ethyl glycolate and ethanol

7 Due to the lack of data according to new SCF guidelines, the substance is transferred from List 6B to List 7. In first instance more data on the migration and use are needed in order to judge if further toxicity data are also needed.

+











AND SPECIFICATIONS


238

Group R: 0.05 mg/kg b.w. Available: 4-month and 2-year rat and 1-year dog studies all inadequate. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies too. http://www.efsa.eu.int/science/afc/afc_documents/469/statement01_afc_phthalates_en1.pdf

76160 001240-18-2 o-Phthalic acid, n-pentyl benzyl ester


+

76240 068389-55-9 o-Phthalic acid-2,2-triethyleneglycol benzoate, copolymer

9 +

76320 000085-44-9 Phthalic anhydride Same 23380 DIR 2 Group TDI: 1 mg/kg b.w. (SCF, 17th Series, 1986).

+ +

76400 007681-93-8 Pimaricin D Postponed. Waiting for an answer to the circular letter from EEC (CS/PM/324) asking informations on technological function of the substance. Date limit: 30.6.90.

+

76415 019455-79-9 Pimelic acid, calcium salt

Same as 23440

3AM 3 Restriction: None (the substance is a metabolite of a non toxic fatty acid) http://www.efsa.eu.int/science/afc/afc_opinions/190/opinion_afc_06_en1.pdf

+










AND SPECIFICATIONS


239

76455 - Polyacrylates and/or polymethacrylates, salts

D +

76460 009003-01-4 Polyacrylic acid 9 Look at 76461. +

76461 009003-01-4 Polyacrylic acid 7 Under re-evaluation ------------------------------------------------ (Restriction 5mg/kg)

+ +

76480 - Polyamides (Mw>6000) D In first instance, specify the nature of starting substances and provide the MW distribution curve.

+

76500 - Polyamides made by reacting acids, dicarboxylic, linear (C2-C4) with diamines (C2-C4)

D +

76510 009003-17-2 Polybutadiene D +

76513 - Polybutadiene, maleimidised

9 +

76516 - Polybutadiene, silylated 9 +

76520 009003-29-6 Polybutene Same 62280 D + +

76540 009003-49-0 Polybutyl acrylate 9 +

76560 see 76670 D +

76640 see 76690 D +

76660 - Polycarbonates D +

76665 025267-51-0 Poly(cyclooctene) 7 Awaiting data on the monomer with PM/REF.No 15030. Needed: Migration of monomer from relevant plastic materials. (RIVM/TNO SDS, February 1997 = CS/PM/2995/76665). Remark: Migration of this polymeric additive is covered by the limit for global migration. No need for bioaccumulation data, since no effects were seen in the lymphonodes and Kupfer cells in the 90-day study.

+

76670 - Polycyclopentadiene, D (Adopted at 111th SCF meeting (18-19 +


AND SPECIFICATIONS


240

hydrated March 1998)

76680 068132-00-3 Polycyclopentadiene, hydrogenated

DIR SML = 5 mg/kg (1) 3 R: 5 mg/kg of food. Toxicologically acceptable. Available: migration data, mutagenicity studies in vitro and in vivo negative, 3-month oral rat and dog studies, 2 generation and teratogenicity oral rat studies and bioaccumulation. (RIVM, March 1995 = CS/PM/2585). Remark: since high migration into fat has been demonstrated, the WG recommends that the Commission take the necessary measures so that the restriction proposed is not exceeded.

+ +

76681 - Polycyclopentadiene, hydrogenated

3AM Old 76680 3 R: 5 mg/kg of food Toxicologically acceptable. Available: migration data, mutagenicity studies in vitro and in vivo negative, 3-month oral rat and dog studies, 2 generation and teratogenicity oral rat studies and bioaccumulation. (RIVM, March 1995 = CS/PM/2585). Remark: since high migration into fat has been demonstrated, the WG recommends that the Commission take the necessary measures so that the restriction proposed is not exceeded.

+

76685 - Poly 1-decene, homopolymer, hydrogenated

7 Specifications: Average ponderal Mw < 10000 Daltons. Available: 3-month oral rat study and mutagenicity data on 1-decene, negative. Needed: migration data in first instance.

+

76690 - Polydienic resin synthetic, (m.w. about 1000)

9 +

76720 009016-00-6 and 063148-62-9

Polydimethylsiloxane Same 49525 and 23547.

D 2 TDI = 1.5 mg/kg b.w. based on ADI of 1.5 mg/kg bw. Specification of Mw > 6800. (JECFA 37 M).

+ +


AND SPECIFICATIONS


241

(Adopted at 111th SCF meeting (18-19 March 1998)

76721 009016-00-6 and 063148-62-9

Polydimethylsiloxane (Mw> 6800)

Same 49525 and 23547

DIR In compliance with the specifications laid down in Annex V.

2 TDI = 1.5 mg/kg b.w. based on ADI of 1.5 mg/kg bw. Specification of Mw > 6800. (JECFA 37 M).

+

76730 - Polydimethylsiloxane, gamma-hydroxypropylated

DIR SML = 6 mg/kg 2 TDI: 0.1 mg/kg b.w. 90-day oral rat study, in-vitro and in-vivo mutagenicity tests. (RIVM report, 1990-04-26).

+ +

76750 - Polyesters of acrylic and methacrylic acids with alcohols, aliphatic, monohydric, saturated (C1-C18)

9 +

76760 - Polyesters of adipic acid and/or azelaic acid with 1,2-propanediol, 1,3- and 1,4-butanediol or 1,6-hexanediol

9 +

76780 024937-93-7 Polyester of adipic acid with 1,3-butanediol

2 Group-TDI: 0.5 mg/kg .b.w. (with PM/REF Nos. 76790, 76865 and 80820). Same references as 76865. (Adopted at 114th SCF meeting) (10 December 1998) http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

+

76790 - Polyester of adipic acid with 1,3- and/or 1,4-butanediol and/or 1,2-propanediol, with free hydroxyl groups acetylated

2 Group-TDI: 0.5 mg/kg .b.w. (with PM/REF Nos. 76780, 76865 and 80820). Same references as 76865. (Adopted at 114th SCF meeting) (10 December 1998) http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

+

76800 see 76940 D +

76805 - Polyester of adipic acid with 1,3-butanediol and 1,6-hexanediol

9 +

76810 - Polyesters produced by reacting adipic acid,

9 +






AND SPECIFICATIONS


242

glycerol, and acids, aliphatic, monocarboxylic, saturated, linear (C6-C22)

76815 - Polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids

3AM 3 Restriction: Specifications: Fraction with Mw <1000D less than 5%. http://www.efsa.eu.int/science/afc/afc_opinions/768/afc_fcm_op_list6_2004.12.171.pdf

+

76820 - Polyester of adipic acid with propanediol

8 +

76824 - Polyester of adipic acid with 1,2-propanediol, n-octanol, n-decanol

7 Specifications : Average ponderal Mw<1000 Daltons. Available: 3-months oral rat study and mutagenicity data on 1-decene, negative. Needed: migration data, in first instance. Same as 76790; 76790 is covered by 76865.

+

76830 - Polyester formed from adipic,azelaic,decanedi-carboxylic,glutaric,maleic,phthalic,sebacic,succinic acids with one or more diols (C2-C6),glycerol,mannitol,2,2-bis(4-hydroxyphenyl)propane,pentaerythritol sorbitol, the terminal group may be ester.…

7 Needed: Specification of the polyesters in actual use, migration and toxicity data on representative esters based on other acids than adipic acid. (Adopted at 114th SCF meeting) (10 December 1998) http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

+

76840 - Polyesters of azelaic acid with n-hexanol and 2-ethylhexanol

9 +

76845 031831-53-5 Polyester of 1,4-butanediol with caprolactone

Polycaprolactone diol

3AM 3 Restriction: none. Remark for the Commission: The restriction for caprolactone (REF No 14260) and 1,4- butanediol (REF No 13720) shall be

+






AND SPECIFICATIONS


243

respected. http://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf

76850 - Polyester of pentaerythritol with adipic acid and oleic acid

9 +

76860 - Polyester of pentaerythritol with adipic acid and unsubstituted aliph., monocarb. acids (C16-C22)

9 +

76865 - Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C10-C18 or n-octanol and/or n-decanol

D SML = 30 mg/kg 2 http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

+ +

76866 - Polyesters of 1,2-propanediol and/or 1,3- and/or 1,4-butanediol and/or polypropyleneglycol with adipic acid, also end-capped with acetic acid or fatty acids C12-C18 or n-octanol and/or n-decanol

Same 76865 DIR SML = 30 mg/kg 2 Group-TDI = 0.5 mg/kg .b.w. (with PM/REF Nos. 76780, 76790 and 80820). Remark: The group TDI is based on analytical and toxicological studies carried out with different polyesters covered by the general description of PM Ref. N. 76865. http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

+

76868 026222-20-8 Polyester of 1,2-propanediol with sebacic acid

W +

76870 - Polyesters prod.by reacting 5 moles of pentaerythritol with 4 m.of adipic acid and 12 m.of oleic acid and/or

9 +








AND SPECIFICATIONS


244

polyester prod.by reacting 7 m.of pentaerythritol with 6 m.of adipic acid and 16 m.of sat. etC.

76880 see 76950 D +

76920 - Polyesters of terephthalic acid

D +

76930 - Polyesters, unsaturated D +

76940 - Polyether ether ketone 9 +

76945 - Polyetherpolyols W +

76950 009002-88-4 Polyethylene Similar to 80000

D Deleted because covered by 76951. +

76951 - Polyethylene and polyethylene wax

Same 76950/8000

0

D Available: migration data from PE, PS and PVC (samples do not contain the maximum indicated concentration of the additive). Needed: - characterisation of the type of PE material used in the migration test; - migration data into olive oil or a suitable alternative fatty food simulant. RIVM/DE SDS, June 2000 = CS/PM/3787/76951.

+ +

76954 064754-90-1 Polyethylene, chlorinated with a chlorine content up to 56%

7 Needed: Mw distribution curve; migration of the low molecular weight range; identity of the migrants, if not possible then information on the carbon chain length and the degree of chlorination. (TNO SDS, September 1995 = CS/PM/2662) (Adopted at 111th SCF meeting (18-19 March 1998)

+

76960 025322-68-3 Polyethyleneglycol Same 23590 DIR 2 Group TDI: 5 mg/kg b.w. (with triethyleneglycol). See references for triethyleneglycol. (SCF, 6th Series, 1978).

+ +

76980 024938-37-2 Poly(ethyleneglycoladipate)

7 Needed: hydrolysis data. + +


AND SPECIFICATIONS


245

77020 - Polyethyleneglycol alkyl(C3-C18) ether

9 +

77022 - Polyethyleneglycol (EO=25) alkyl(C32) ether (Mw=1500-3000)

W7 Needed: In first instance, Mw distribution curve and structure of the C32 alcohol. (Adopted at 111th SCF meeting (18-19 March 1998)

+

77025 - Polyethyleneglycol (EO=25) alkyl(C32) ether monomethacrylate (Mw=1500-3000)

W7 Needed: In first instance, Mw distribution curve and structure of the C32 alcohol. (Adopted at 111th SCF meeting (18-19 March 1998)

+

77030 068891-38-3 Polyethyleneglycol alkyl(C12-C14) ether sodium sulphate

Same 77035 9 + +

77035 068891-38-3 Polyethyleneglycol (EO=2-3) alkyl(C12-C14)ether sodium sulphate

Same 77030 8 + +

77040 see 76980 D + +

77070 068954-91-6 Polyethyleneglycol alkyl(C10-C12) ether sulphosuccinate, disodium salt

9 +

77072 068815-56-5 Polyethyleneglycol alkyl(C10-C16) ether sulphosuccinate, disodium salt

D + +

77105 068410-69-5 Polyethyleneglycol bis(tallow acyl amido ethyl)methyl ammonium methosulphate

W8 +

77120 - Polyethyleneglycol tert-butyl ether

9 +

77200 061791-14-8 Polyethyleneglycol cocoamine

9 +

77280 009005-02-1 Polyethyleneglycol dilaurate

2 Group TDI: 10 mg/kg bw for all PEG esters of food fatty acids. (CS/PM/1656).

+

77320 - Polyethyleneglycol dimyristate

2 Group TDI: 10 mg/kg bw for all PEG esters of food fatty acids.

+


AND SPECIFICATIONS


246

(CS/PM/1656).

77360 009005-07-6 Polyethyleneglycol dioleate


+

77370 070142-34-6 Polyethyleneglycol-30 dipolyhdroxystearate

Same 77850 3AM 3 Restriction: none http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out142_en.pdf

+

77440 - Polyethyleneglycol diricinoleate

DIR SML = 42 mg/kg 2 TDI: 0.7 mg/kg bw based on TDI for castor oil. (SCF, 7th Series, 1978)(CS/PM/1656).

+

77480 - Polyethyleneglycol dodecyl ether

9 +

77500 009014-92-0 Polyethyleneglycol dodecylphenyl ether

W +

77520 061791-12-6 Polyethyleneglycol ester of castor oil

Same 77522 and 77521


+ +

77521 - Polyethyleneglycol ester of castor oil fatty acids

Same 77520 2 TDI: 0.7 mg/kg bw based on TDI for castor oil. (SCF, 7th Series, 1978)(CS/PM/1656).

+

77522 061791-12-6 Polyethyleneglycol (EO = 20-40) ester of castor oil

Same 77520 9 +

77570 - Polyethyleneglycol esters of (C6-C22) fatty acids

D +

77600 061788-85-0 Polyethyleneglycol ester of hydrogenated castor oil

Same 77602 and 77601

DIR 3 L3. Based on TDI for 77520 and L3 for 14470.

+ +

77601 - Polyethyleneglycol ester of hydrogenated castor oil fatty acids

Same 77600 3 L3. Based on TDI for 77520 and L3 for 14470.

+

77602 061788-85-0 Polyethyleneglycol (EO = 40) ester of hydrogenated castor oil

Same 77600 D +






AND SPECIFICATIONS


247

77660 - Polyethyleneglycol esters of natural fatty acids


+

77680 see 77710 D + +

77702 - Polyethyleneglycol esters of aliph. monocarb. acids (C6-C22) and their ammonium and sodium sulphates

DIR 2 Group TDI: 10 mg/kg bw for all PEG esters of food fatty acids. (CS/PM/1656).

+ +

77705 - Polyethyleneglycol(>2O EO)ethers of alkyl phenols, sodium sulphates

9 + +

77708 09002-92-0;09004-95-9;09043-30-5;09002-92-0;68439-49-6;etc

Polyethyleneglycol (EO= 1-50) ethers of primary linear and branched C8-C22 alcohols


77708/10 069013-19-0 Polyethyleneglycol ethers of C8-C22 alcohols

D +

77710 - Polyethyleneglycol ethers of C10-C20 alcohols

9 Look also at 67162. + +

77710/5 068439-54-3 Polyethyleneglycol ethers of C11-C13-branched alcohols

W +

77711 068439-50-9 Polyethyleneglycol ethers of C12-C14 alcohols

D + +

77712 068213-23-0 Polyethyleneglycol ethers of C12-C18 alcohols

D + +

77713 009005-00-9 Polyethyleneglycol(EO=2) ethers of C18 alcohols

Same 78140 and 78550

9 +

77720 - Polyethyleneglycol ether of benzylphenol, and

9 +


AND SPECIFICATIONS


248

their sulphates and/or their sodium and ammonium sulphonates

77732 - Polyethyleneglycol (EO=1-30, typically 6) ether of butyl 2-cyano-3-(4-hydroxy-3-methoxyphenyl)acrylate

7 Under re-evaluation.

+

77733 - Polyethyleneglycol (EO=1-30, typically 5) ether of butyl 2-cyano-3-(4-hydroxyphenyl)acrylate


+

77735 059269-54-4 Polyethyleneglycol ether of dodecylphenol, sodium sulphate

9 + +

77737 009002-92-0 Polyethyleneglycol ether of dodecylalcohol

Same 51985 and 77920

9 +

77740 009014-90-8 Polyethyleneglycol ether of nonylphenol, sodium sulphate

Same 78460 D +

77747 058853-83-1 Polyethyleneglycol ether of octylphenol, sodium sulphate

9 + +

77750 053694-15-8 Polyethyleneglycol ether of sorbitol

9 +

77760 061791-28-4 Polyethyleneglycol ether of tallow fatty alcohol

D + +

77775 - Polyethyleneglycol ether of trimethylolpropane

9 +

77790 009004-95-9 Polyethyleneglycol hexadecyl ether

9 +

77800 068071-98-7 Polyethyleneglycol hydrogenated tallow amine ethylsulphate

9 +

77840 068951-50-8 Polyethyleneglycol hydroxymethylphosphonate

D +

77850 070142-34-6 Polyethyleneglycol 12- W7-D SCF_list: 7 +


AND SPECIFICATIONS


249

hydroxystearate Needed data or information: - Molecular weight distribution curve (differential and cumulative) - Details on MS spectra - Clarification of the inconsistency in the data from the petitioner in respect to the solubility of the test compound in various solvents. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out142_en.pdf

77880 009043-30-5 Polyethyleneglycol isotridecyl ether

8 +

77890 - Polyethyleneglycol isotridecyl ether sulphate, salts

8 +

77895 068439-49-6 Polyethyleneglycol (EO=2-6)monoalkyl(C16-C18) ether

Same 67161 DIR SML = 0.05 mg/kg and in compliance with the specifications laid down in Annex V

3 R = 0.05 mg/kg of food. Available: Adequate migration data; inadequate gene mutation assay in bacteria; incomplete chromosomal aberration assay in cultured mammalian cells (missing odd pages of the report); gene mutation assay in bacteria (negative); gene mutation assay in cultured mammalian cells (negative); chromosomal aberration assay in mammalian cells (negative). (RIVM/ISS/TNO SDS, April 1998 = CS/PM/2859 REV.II/77895). (Adopted at 114th SCF meeting) (9-10 December 1998) REMARK: The sum of all components present in Marlipal 1618/1 was determined in the migration experiments. A shift of the quantitative composition of the components migrated into the food simulants related to the initial composition of Marlipal 1618/1 was observed. The method is suitable to determine the sum of free fatty alcohol and the homologues of ethylene glycol ethers. REMARK :The toxicity studies were

+ +




AND SPECIFICATIONS


250

performed with Marlipal 1618/1 (commercial product with the specifications as given in the dossier). Adopted at 114th SCF meeting)(10 December 1998) http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

77920 009002-92-0 Polyethyleneglycol monododecyl ether

Same 51985 and 77737

9 +

78000 052019-36-0 Polyethyleneglycol monodecyl phosphate

9 +

78080 009004-81-3 Polyethyleneglycol monolaurate

2 Group TDI : 10 mg/kg bw for all PEG esters of food fatty acids. (CS/PM/1656).

+

78120 - Polyethyleneglycol monomyristate


+

78140 009005-00-9 Polyethyleneglycol monooctadecyl ether

Same 77713 and 78550

8 +

78160 009004-96-0 Polyethyleneglycol monooleate


+

78190 009004-98-2 Polyethyleneglycol monooleyl ether

9 +

78240 009004-94-8 Polyethyleneglycol monopalmitate

2 Group TDI: 10 mg/kg b.w. for all PEG esters of food fatty acids.(CS/PM/1656).

+

78320 009004-97-1 Polyethyleneglycol monoricinoleate


+

78360 009004-99-3 Polyethyleneglycol monostearate

D +

78400 009016-45-9 Polyethyleneglycol nonylphenyl ether

P + +

78440 026027-38-3 Polyethyleneglycol,4-nonylphenyl ether

W7 Needed: in the first instance, information on the composition of the substances used. RIVM doc. CS/PM/2223 (in CS/PM/2223 change title to "4-nonylphenyl-polyethyleneglycol ethers (PM/REF.N.78440)").

+ +




AND SPECIFICATIONS


251

78460 009014-90-8 Polyethyleneglycol nonylphenyl ether, sodium sulphate

Same 77740 P + +

78480 051811-79-1 Polyethyleneglycol nonylphenyl phosphate

9 + +

78520 009040-38-4 and 067999-57-9

Polyethyleneglycol nonylphenyl sulphosuccinate, disodium salt

9 + +

78550 009005-00-9 Polyethyleneglycol (EO=2) octadecylether

Same 77713 and 78140

7 Available: Toxicological review. Needed : migration data in first instance.

+

78555 062362-49-6 Polyethyleneglycol (EO=2) octadecyl ether phosphate

W +

78560 009002-93-1 and 009036-19-5

Polyethyleneglycol octylphenyl ether

9 + +

78640 - Polyethyleneglycol and/or polypropyleneglycol esters of aliph., monocarb.,acids (C6-C22) and their ammonium and sodium sulphates

D +

78720 - Polyethyleneglycol and/or polypropyleneglycol ethers of aliph., monoh.,alcohols (C8-C20) and their ammonium and sodium sulphates

9 Confirmed. Remark: some individual compounds are listed. (Adopted at 111th SCF meeting (18-19 March 1998)

+ +

78800 - Polyethyleneglycol and/or polypropyleneglycol ethers of alkylphenols and their ammonium and sodium sulphates

9 + +


AND SPECIFICATIONS


252

78880 - Polyethyleneglycol and/or polypropyleneglycol ethers of trimethylolpropane and/or sorbitol

9 +

78960 - Polyethyleneglycol sorbitan

9 +

79040 009005-64-5 Polyethyleneglycol sorbitan monolaurate

DIR 1 Group ADI: 10 mg/kg b.w. for polyethyleneglycol sorbitan monooleate, polyethyleneglycol sorbitan monopalmitate, polyethyleneglycol sorbitan monostearate, polyethyleneglycol sorbitan tristearate. (SCF, 15th Series, 1985).

+ +

79120 009005-65-6 Polyethyleneglycol sorbitan monooleate

DIR 2 Group TDI: 10 mg/kg b.w. for polyethylenglycol sorbitan monolaurate, polyethyleneglycol sorbitan monooleate, polyethyleneglycol sorbitan monostearate, polyethyleneglycol sorbitan tristearate. (SCF, 15th Series 1985).

+

79200 009005-66-7 Polyethyleneglycol sorbitan monopalmitate

DIR 1 Group ADI: 10 mg/kg b.w. for polyethyleneglycol sorbitan monooleate, polyethyleneglycol sorbitan monolaurate, polyethyleneglycol sorbitan monostearate, polyethyleneglycol sorbitan tristearate. (SCF, 15th Series, 1985).

+ +

79280 009005-67-8 Polyethyleneglycol sorbitan monostearate

DIR 1 Group ADI: 10 mg/kg b.w. for polyethyle~eglycol sorbitan monooleate, polyethyleneglycol sorbitan monopalmitate, polyethyleneglycol sorbitan monolaurate, polyethyleneglycol sorbitan tristearate. (SCF, 15th Series, 1985).

+ +

79360 009005-70-3 Polyethyleneglycol sorbitan trioleate

DIR 2 Group TDI: 10 mg/kg b.w. based on the group ADI 10 mg/kg b.w. for polyethyleneglycol sorbitan monolaurate and other polyethyleneglycol sorbitan esters. (SCF, 15th Series, 1985).

+

79440 009005-71-4 Polyethyleneglycol sorbitan tristearate

DIR 1 Group ADI: 10 mg/kg b.w. for polyethyleneglycol sorbitan monooleate, polyethyleneglycol sorbitan monopalmitate,

+


AND SPECIFICATIONS


253

polyethyleneglycol sorbitan monostearate, polyethyleneglycol sorbitan monolaurate. (SCF, 15th Series, 1985).

79520 - Polyethyleneglycol stearate


+

79550 009014-85-1 Polyethyleneglycol 2,4,7,9-tetramethyl-5-decyN-4,7-diol ether

3 Only to be used for no-stick polytetrafluoroethane (PTFE) coatings manufactured by sintering. Available: information on the nature of the decomposition residue of the substance (S-440); calculated worst case migration is 0.002 mg residue/dm2 from the final PTFE coating, assuming 100% migration of the solid residue; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); acute toxicity data; limited 28-day range-finding study; inadequate 90-day oral rat study; inadequate one-generation reproduction study. RIVM/TNO SDS, January 2001 = CS/PM/2906 REV. I/79550. (Adopted at the 128th SCF meeting, 12 July 2001) http://europa.eu.int/comm/food/fs/sc/scf/out97_en.pdf

+

79600 009046-01-9 Polyethyleneglycol tridecyl ether phosphate

3AM 3 Restriction: 5 mg/kg Remark for Commission: Specifications: Polyethyleneglycol (EO <=11) tridecyl ether phosphate (mono- and dialkyl ester) with a maximum 10% content of polyethyleneglycol (EO<=11) tridecyl ether http://www.efsa.eu.int/science/afc/afc_opinions/768/afc_fcm_op_list6_2004.12.171.pdf

+

79680 026913-06-4 and 009002-98-6

Polyethyleneimine W9-D +

79720 - Polyethyleneimine, D +






AND SPECIFICATIONS


254

modified with adipic acid, diethylenetriamine, and epichlorohydrin

79760 - Polyethyleneimine, butylated

2 TDI: 0.1 mg/kg b.w. Specification for ethyleneimine (R= 0.010 mg/kg). 90-day oral rat study, mutagenicity studies negative. (RIVM report 90/678608/002 February 1990).

+

79840 - Polyethyleneimine, modified

9 In principle List 9. Some substances covered by 79840 have been identified: (polymin (R) SN (CAS N. 103479-08-9)(see CS/PM 330) but documentation is inadequate. The substances must be listed individually and assessed accordingly. L8.

+

79841 103479-08-9 Polyethyleneimine, modified

D +

79842 114133-44-7 Polyethyleneimine, modified

D +

79920 009003-11-6 and 106392-12-5

Poly(ethylene propylene) glycol


79930 - Poly(ethylene propyleneglycol)(>20 EO and >20 P0)

9 + +

79950 - Poly(ethylene and/or propyleneglycol)- aliph., monoh., alcohols (C8-C20),copolymers and their ammonium and sodium sulphates

D +

79960 111905-54-5 Poly(ethylene propylene)glycol alkyl (C13-C15)ethers

D Same as 79968. +

79965 067167-17-3 Poly(ethylene propylene)glycol dioleate

9 +


AND SPECIFICATIONS


255

79967 055126-40-4 Poly(ethylene propylene)glycol distearate

9 +

79968 069227-21-0 and 111905-54-5

Poly(ethylene propylene) glycol ethers of C13-C15 alcohols

8 +

79969 037251-69-7 Poly(ethylene propylene)glycol nonylphenyl ether

P +

80000 009002-88-4 Polyethylene wax Similar to 76950

3AM 3 Restriction: None http://www.efsa.eu.int/science/afc/afc_opinions/11/opinion_afc_07_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

+

80077 068441-17-8 Polyethylene, oxidized 7 Needed data or information: -In first instance, mutagenicity tests on a well characterised (GPC profile, content of epoxy groups, content of peroxide groups and oxygen) low molecular weight fraction. -If the migration data stand, then the full core set of the toxicity data will be needed. -If a SML has to be allocated there will also be a need for an in house validated method for the determination in food simulants. http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

+ +

80080 068441-17-8 Polyethylene waxes, oxidized

Similar to 80077

D + +

80160 037349-34-1 Polyglycerol monostearate

1 ADI: 25 mg/kg b.w. (SCF, 7th Series, 1978).

+

80240 029894-35-7 Polyglycerol ricinoleate DIR 1 ADI: 7.5 mg/kg b.w. (SCF, 7th Series, 1978).

+

80320 009009-32-9 Polyglycerol stearate 1 ADI: 25 mg/kg b.w. (JECFA 26 M., 1982).

+

80330 025359-91-5 Poly(1-hydroxynaphthylmethane)(=formaldehyde-1-naphtalenol copolymer)

Same 54930 D See 54930. +








AND SPECIFICATIONS


256

80340 027924-99-8 Poly(12-hydroxystearic acid)

7 Available: Ames test + micronucleus test with 2 commercial product s; inadequate migration data. Needed: Mw distribution curve and adequate migration data.

+

80345 058128-22-6 Poly(12-hydroxystearic acid) stearate

octadecanoic acid, 12-hydroxy-, homopoly

W7 Under re-evaluation +

80360 009003-27-4 Polyisobutene 7 Available: contradictory information on Mw distribution. Needed: migration of products on the market with low average Mw.

+ +

80365 026335-74-0 Poly(isobutyl acrylate) 9 +

80380 009003-04-7 Polymer of acrylic acid, sodium salt

D +

80400 see 80340 D +

80410 - Polymers of dioctyltin bis(2-ethylhexyl maleate)

9 +

80425 - Polymers of dioctyltin bis(2-ethylhexyl mercaptoacetate)

9 +

80440 - Polymers of di-n-octyltin dimaleate

9 +

80460 025087-26-7 Polymethacrylic acid D +

80470 - Polymethacrylic acids, salts

D +

80480 082451-48-7 Poly(6-morpholino-1,3,5,-triazine-2,4,-diyl)-[(2,2,6,6,-tetramethyl-4-piperidyl)imino]-hexamethylene-[(2,2,6,6-tetramethyl-4-piperidyl)-imino]


+

80550 - Polyolefins (low molecular weight)

9 Look also at 76685. +

80560 068410-99-1 Polyolefins, chlorinated 9 +


AND SPECIFICATIONS


257

with a chlorine content of up to 56%

80640 - Polyoxyalkyl(C2-C4)dimethylpolysiloxane

DIR 3 Available: average MW ~7600, 2 negative mutagenicity tests, 90-day oral rat study (RIVM doc. CS/PM/91, 1987).

+ +

80670 - Polyphenylene oxide D +

80720 008017-16-1 Polyphosphoric acids DIR 1 MTDI: 70 mg/kg b.w. (as P). (JECFA 26 M., 1982).

+ +

80760 009003-07-0 Polypropylene D Look at 80765. +

80765 - Polypropylene and polypropylene wax

D +

80800 025322-69-4 Polypropyleneglycol Same 23650 and 23651


80820 025101-03-5 Polypropyleneglycol adipate

D Deleted. Covered by 76865. http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

+

80845 029408-67-1 Polypropyleneglycol azelate (end-capped with stearic acid)

W8 Needed: data according to SCF guidelines on polymeric additives. Remark: name need eventually be modified, add: end-capped with stearic acid.

+

80850 - Polypropyleneglycol butyl ether

9 +

80880 see 80820 D +

80890 - Polypropyleneglycol esters with acids, aliph., monocarb., sat. (C12-C20)

D +

80895 - Polypropyleneglycol esters of aliph.,monocarb.,acids(C6-C22) and their ammonium and sodium sulphates

9 +

80930 - Polypropyleneglycol ether of trimethylolpropane

9 +

80940 - Polypropyleneglycol laurate

9 +




AND SPECIFICATIONS


258

80950 - Polypropyleneglycol octadecyl phosphate

W9 +

80960 see 80950 D +

80970 - Polypropyleneglycol oleate

9 +

80985 - Polypropyleneglycol oleate butyl ether

9 +

81000 009003-11-6 Polypropyleneglycol polyoxyethylated

D +

81015 - Polypropyleneglycol ricinoleate

9 +

81030 - Polypropyleneglycol stearate

9 +

81040 see 81100 D +

81060 009003-07-0 Polypropylene wax Same 80765 3AM 3 Restriction: None http://www.efsa.eu.int/science/afc/afc_opinions/11/opinion_afc_07_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

+ +

81080 009003-53-6 Polystyrene D +

81100 068441-35-0 Polystyrene, hydrogenated

D +

81120 - Polyterpenes 9 Confirmed. + +

81122 - Polyterpenes, hydrogenated

9 +

81123 - Polyterpenes, hydrogenated

7 Available: Migration data, 3 mutagenicity studies on the polymeric additive itself negative, unacceptable 90-day oral rat study (unvalidated IBT study). Needed: Information on whether the substance tested is representative of other brands of polyterpene, hydrogenated resins. In first instance , explanation of presence of unhydrogenated monomer (100 ppm) in the polymeric additive (if presence is confirmed, 3 mutagenicity tests on unhydrogenated monomer will be required) as well a 90-day oral rat study on the polymeric additive itself.

+






AND SPECIFICATIONS


259

(RIVM/TNO SDS CS/PM/2750, January 96).

81160 009002-84-0 Polytetrafluoroethylene D + +

81200 071878-19-8 Poly[6-[(1,1,3,3-tetramethylbutyl)amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl-4-piperidyl)-imino]hexamethylene[(2,2,6,6-tetramethyl-4-piperidyl)imino]

DIR SML = 3 mg/kg 2 TDI: 0.05 mg/kg b.w. 3-month oral dog and 3- and 6-month oral rat studies, mutagenicity studies. (RIVM rep.89/678608/006 1989-04-11).

+ +

81215 065447-77-0 Poly/(2,2,6,6-tetramethylpiperidine-1,4-diyl)ethyleneoxysuccinyloxyl

Same 91150 D Same as 60800. +

81220 192268-64-7 Poly-[[6-[N-(2,2,6,6-tetramethyl-4-piperidinyl)-n-butylamino]-1,3,5-triazine-2,4-diyl][(2,2,6,6-tetramethyl-4-piperidinyl)imino]-1,6-hexanediyl[(2,2,6,6-tetramethyl-4-piperidinyl)imino]]-alpha-[N,N,N',N'-tetrabutyl-N"-(2,2,6,6-tetramethyl-4-piperidinyl)-N

DIR SML = 5 mg/kg 3 R = 5 mg/kg of food Available: molecular mass distribution curve, specifications; specific migration; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); 28-day oral rat study; gene mutation assay with two migrating by-products (negative). (RIVM/DE SDS, September 1999 = CS/PM/3272 REV. I/81220). (Adopted at the 119th SCF meeting) (2 December 1999) http://europa.eu.int/comm/food/fs/sc/scf/out50_en.pdf

+ +

81230 - Polyurethanes 9 +

81245 009003-20-7 Polyvinyl acetate D +

81260 - Polyvinyl acetate, partially hydrolyzed

7 Available: molecular weight distribution curve. Needed: migration data and toxicity data according to SCF guidelines on the compound with the highest concentration of

+ +




AND SPECIFICATIONS


260

the low molecular weight fraction.

81280 009002-89-5 Polyvinyl alcohols Same 23680 7 Needed: migration data on the compound with the highest concentration of the low molecular weight fraction.

+ +

81310 009002-86-2 Polyvinyl chloride D +

81325 025498-06-0 Polyvinylcyclohexane W7 Available: 3-mutagenicity tests on the polymer, negative and migration data, Ames test on the monomer. Molecular weight distribution curve. Needed: remaining mutagenicity studies according to the SCF guidelines on the monomer. (RIVM-TNO 1995-04-10 = CS/PM/2587)

+

81360 - Polyvinylethers 9 +

81390 025104-37-4 Poly(vinyl ethyl ether) 9 +

81440 024937-79-9 Polyvinylidene fluoride D +

81460 - Poly-N-vinyl-N-methylacetamide

9 +

81475 - Poly-N-vinyl-N-methylformamide (m.w.>40.000)

9 +

81485 025035-84-1 Polyvinyl propionate 9 +

81500 009003-39-8 Polyvinylpyrrolidone 9 +

81515 087189-25-1 Poly(zinc glycerolate) DIR 2-3 L3. Toxicologically acceptable. (TNO, 1995-04-11 = CS/PM/2588) L2 for Zinc Same as for 96180

+ +

81520 007758-02-3 Potassium bromide DIR 1 Group ADI: 1 mg/kg b.w. (as Br) as pesticide residue. See references for ammonium bromide in list 2.

+

81600 001310-58-3 Potassium hydroxide DIR 1 ADI: not specified. (SCF, 25th Series, 1991)

+ +

81680 007681-11-0 Potassium iodide DIR SML(T) = 1 mg/kg (11) (expressed as Iodium)

1 PMTDI: 0.017 mg/kg b.w. (as I). (JECFA 33 M., 1988).

+ +


AND SPECIFICATIONS


261

81760 - Powders, flakes and fibers of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron

DIR SML(T) = 30 mg/kg (7) (expressed as Copper); SML = 48 mg/kg (expressed as Iron)


81761 - Powders, flakes and fibres of chromium, molybdenum, nickel and their alloys

7 Needed: Migration data and justification of use.

+

81820 120498-03-5 1,3-Propanediamine,N,N"1,2-ethanediylbis-,polymer with N-butyl-2,2,6,6-tetramethyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine

Same 38510 3 R: 5 mg/kg of food. Available: Specific migration is 0.1-0.6 mg/kg food; three negative mutagenicity studies; acute toxicity data; 90-day rat gavage study (no NOAEL); skin/eye irritation studies; 90-day oral rat study. (RIVM/TNO SDS, March 1998 = CS/PM/2805 REV. I/81820). (Adopted at 114th SCF meeting) (10 December 1998) http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf

+

81840 000057-55-6 1,2-Propanediol Same 23740 and 82065

DIR 1 ADI: 25 mg/kg b.w. (JECFA 17 M., 1973).

+ +

81880 000071-23-8 1-Propanol Same 23800 3 See references for same substance in monomer report.

+

81882 000067-63-0 2-Propanol Same 23830 and 62480

DIR 1 t-ADI : 1.5 mg/kg b.w. (SCF, 11th Series, 1981).

+ +

81920 005520-20-7 1-Propanol,3-[1,3,3,3-tetramethyl-1-[(trimethyl silyl) oxy] disiloxanyl]-,hydrogen sulphate, compound with 2-propanamine(1:1)

W +

81960 174254-23-0 2-Propenoic acid, methyl ester, telomer with 1-dodecanethiol, C16-18 alkylesters (name to be checked)

Same 31542 D +

82000 000079-09-4 Propionic acid Same 23890 DIR 1 Group ADI: not specified. (SCF, 1st Series, 1974).

+ +




AND SPECIFICATIONS


262

82020 019019-51-3 Propionic acid, cobalt salt

DIR SML(T) = 0.05 mg/kg (14) (expressed as Cobalt)

1-3 L3 for Cobalt. R: 0.05 mg/kg of food (as Cobalt). (RIVM, summary data, October 1992= CS/PM/1707). L1 for propionic acid. See references for propionic acid.

+

82065 000057-55-6 1,2-Propyleneglycol Same 23740 and 81840

D +

82080 009005-37-2 1.2-Propyleneglycol alginate

DIR 1 Group ADI: 25 mg/kg b.w. (JECFA 17 M., 1973).

+

82160 - 1,3-Propyleneglycol alginate

8 +

82240 022788-19-8 1,2-Propyleneglycol dilaurate

DIR 1 Group ADI: 25 mg/kg b.w. (as propyleneglycol) for 1,2-propyleneglycol esters of fatty acids. (JECFA 17 M., 1973).

+

82320 - 1,3-Propyleneglycol dilaurate

8 +

82400 000105-62-4 1,2-Propyleneglycol dioleate


+

82480 000821-69-2 1,3-Propyleneglycol dioleate

8 +

82560 033587-20-1 1,2-Propyleneglycol dipalmitate


+

82640 056414-56-3 1,2-Propyleneglycol diricinoleate

7? Needed: hydrolysis and migration data. http://europa.eu.int/comm/food/fs/sc/scf/out161_en.pdf

+

82720 006182-11-2 1,2-Propyleneglycol distearate


+

82800 027194-74-7 1,2-Propyleneglycol monolaurate

DIR 1 Group ADI: 25 mg/kg b.w. (as propyleneglycol) for 1,2-propyleneglycol esters of fatty acids.

+




AND SPECIFICATIONS


263

(JECFA 17M., 1973).

82880 - 1,3-Propyleneglycol monolaurate

8 +

82960 001330-80-9 1,2-Propyleneglycol monooleate

DIR 1 Group ADI: 25 mg/kg b.w. (as propyleneglycol) for 1,2-propyleneglycol esters of fatty acids. (JECFA 17 M., 1973)

+

83040 - 1,3-Propyleneglycol monooleate

8 +

83120 029013-28-3 1,2-Propyleneglycol monopalmitate


+

83200 - 1,3-Propyleneglycol monopalmitate

8 +

83280 026402-31-3 1,2-Propyleneglycol monoricinoleate

Same 83775 7? Needed: hydrolysis and migration data. http://europa.eu.int/comm/food/fs/sc/scf/out161_en.pdf

+

83300 001323-39-3 1,2-Propyleneglycol monostearate


+

83320 - Propylhydroxyethylcellulose

DIR 2 TDI: not specified based on group ADI (=not specified) for certain modified celluloses. (JECFA 35M., 1989).

+

83325 - Propylhydroxymethylcellulose

DIR 2 Group TDI: not specified based on group ADI (=not specified) for certain modified celluloses. (JECFA 35M., 1989).

+

83330 - Propylhydroxypropylcellulose

DIR 2 Group TDI: not specified based on group ADI (=not specified) for certain modified celluloses. (JECFA 35M., 1989).

+

83360 see 83300 D +

83440 002466-09-3 Pyrophosphoric acid DIR 1 MTDI: 70 mg/kg b.w. (as P). (JECFA 26 M., 1982).

+ +

83455 013445-56-2 Pyrophosphorous acid DIR 3 Easily oxidized to phosphoric acid. +

83460 012269-78-2 Pyrophyllite DIR 3 Inert material. +




AND SPECIFICATIONS


264

83470 014808-60-7 Quartz DIR 3 Inert material. + +

83475 121888-66-2 Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, benzoate lauryl sulphate, salts with bentonite

W +

83480 121888-67-3 Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, bis(hydrogenated tallow alkyl)dimethylammonium salt with hectorite

9 +

83510 121888-68-4 Quaternary ammonium compounds, benzyl(hydrogenated tallow alkyl)dimethyl, chlorides, compounds with bentonite and sodium stearate

9 +

83520 see 83610 D +

83530 071011-24-0 Quaternary ammonium compounds, benzyl(hydrogenated tallow alkyl)dimethyl, chlorides, compounds with bentonite

9 +

83535 068989-03-7 Quaternary ammonium compounds, coco alkyl bis(hydroxyethyl)-methyl, ethoxylated methyl sulphate

9 +

83555 071011-27-3 Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides, compounds with hectorite

W +


AND SPECIFICATIONS


265

83560 068953-58-2 Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, salts with bentonite

9 +

83565 093572-63-5 Quaternary ammonium compounds N,N,N'-tris(hydroxyethyl)-N,N'-dimethyl-N'-tallow alkyltrimethylene di-,bis(methyl sulphates), salts

W9 +

83580/0 008002-13-9 Rapeseed oil (food grade quality)

Same 45060/0,450

60/1,and 83580/1

D + +

83580/1 008002-13-9 Rapeseed oil Same 45060/0,450

60/1 and 83580/0

3 Food fat. + +

83595 119345-01-6 Reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with Friedel Craft reaction product of phosphorus trichloride and biphenyl

DIR SML = 18 mg/kg and in compliance with the specifications mentioned in Annex V.

2 TDI: 0.3 mg/kg b.w. 90-day oral rat study and mutagenicity studies. (Sandoz report 1979).

+ +

83598 181314-48-7 Reaction prod.of 3-hydroxy-5,7-di-tert.butylbenzofuran-2-one with o-xylene consisting of 5,7-di-tert.butyl-3-(2,3-dimethylphenyl)-(3h)-benzofuran-2-one and 5-7-di-tert.butyl-3-(3,4-dimethylphenyl)-(3h)-benzof.

Same 67170 D +

83599 068442-12-6 Reaction products of DIR SML(T) = 0.18 mg/kg 2 Group-TDI: 0.003 mg/kg b.w. (as Sn) (with +


AND SPECIFICATIONS


266

oleic acid, 2-mercaptoethyl ester, with dichlorodimethyltin, sodium sulphide and trichloromethyltin

(16) (expressed as Tin) 49600 and 67520). Available: migration data from PVC; hydrolysis in gastric fluid; two bacterial reversion assays; a mouse bone marrow micronucleus assay; with methyltin compounds two bacterial reversion assays; a mammalian cell gene mutation assay; an in vitro chromosomal aberration assay; a mouse bone marrow micronucleus test; an in vivo/in vitro UDS in rat liver; acute toxicity data; a subacute oral rat study; 90-days oral rat studies on 3 representative mixtures of methyltin stabilisers, on methyltin chlorides and on mercaptoethyloctadecenoic. (RIVM/ISS/TNO October 1996,=CS/PM/2908) (Adopted at 111th SCF meeting (18-19 March 1998)). http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

83600 see 83690 D +

83610 073138-82-6 Resin acids and rosin acids

Same 24070 DIR 2 Group TDI: 1 mg/kg b.w. (SCF, 17th Series, 1986)

+

83650 009008-34-8 Resin acids and rosin acids, manganese salts

2 L2 (= 1 mg/kg b.w.) for resin acids. L2 for the Mn. Group TDI: 0.01 mg/kg b.w. (as Mn). See references for 30180 in L2 in this report.

+

83680 see 83700 D +

83690 035732-94-6 Ricinoleamide 8 +

83700 000141-22-0 Ricinoleic acid Same 24075 DIR SML = 42 mg/kg 3 SCF_List: 3 Restriction: none. In small doses metabolised similarly to food fats. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out181_en.pdf

+

83760 - Ricinoleic acid, esters with alcohols, aliph., monoh.

9 +






AND SPECIFICATIONS


267

83775 026402-31-3 Ricinoleic acid, esters with 1,2-propanediol

Same 83280 D +

83840 008050-09-7 Rosin Same 14687,24100,24130 and

45055

DIR 2 Group TDI: 1 mg/kg b.w. (SCF, 17th Series, 1986).

+

83880 009010-69-9 Rosin acids, zinc salt Same 96280 D +

83920 - Rosin derivatives 9 +

84000 008050-31-5 Rosin, ester with glycerol

Same 24115 DIR 1 ADI= 12.5 mg/kg b.w. (SCF, 32th Series, 1992).

+ +

84080 008050-26-8 Rosin, ester with pentaerythritol

DIR 2 Group TDI= 1 mg/kg b.w. Included in the group TDI for colophony of 1 mg/kg b.w. (SCF, 6th Series, 1978) also including rosins (SCF, 17th Series, 1986).

+ +

84090 065997-04-8 Rosin, fumarated W +

84095 068201-58-1 Rosin, fumarated, polymer with formaldehyde

W +

84100 065997-11-7 Rosin, fumarated, polymer with pentaerythritol

W +

84210 065997-06-0 Rosin, hydrogenated Same 84420 DIR 2 Group TDI: 1 mg/kg bw. Included in the TDI for 24070/24130/24190/83610/83840/84080/ 84320/84400/84420. (SCF, 17th Series, 1986).

+ +

84240 065997-13-9 Rosin, hydrogenated, ester with glycerol


84320 008050-15-5 Rosin, hydrogenated, ester with methanol

DIR 2 Group TDI= 1 mg/kg b.w. Included in the group TDI for colophony of 1 mg/kg b.w. (SCF 6th, Series 1978) also including rosins (SCF, 17th Series, 1986).

+

84400 064365-17-9 Rosin, hydrogenated, ester with pentaerythritol

DIR 2 Group TDI= 1 mg/kg b.w. Included in the group TDI for colophony of 1 mg/kg b.w. (SCF, 6th Series 1978) also including rosins (SCF, 17th Series, 1986).

+ +


AND SPECIFICATIONS


268

84410 008050-28-0 Rosin, maleated W +

84420 065997-06-0 Rosin, partially hydrogenated

Same 84210 2 Group TDI: 1 mg/kg bw. Included in the TDI for 24070/24130/24190/83610/83840/84080/84210 84320/84400. (SCF, 17th series, 1986).

+

84425 065997-07-1 Rosin, polymer with formaldehyde

W +

84430 068475-37-6 Rosin, polymerised, ester with glycerol

W +

84435 083137-13-7 Rosin, reaction products with acrylic acid

W +

84480 009006-03-5 Rubber, chlorinated Same 24220 9 +

84560 009006-04-6 Rubber, natural Same 24250 DIR 3 Migration unlikely. +

84570 - Rubber, synthetic 9 +

84640 000069-72-7 Salicylic acid Same 24270 DIR 3 Naturally occurring in food in low concentration.

+

84720 000118-58-1 Salicylic acid, benzyl ester


84800 000087-18-3 Salicylic acid, 4-tert-butylphenyl ester

DIR SML = 12 mg/kg 2 TDI: 0.2 mg/kg b.w. 2-year oral rat study. (RIVM March 1972).

+ +

84880 000119-36-8 Salicylic acid, methyl ester

DIR SML = 30 mg/kg 1 ADI: 0.5 mg/kg b.w. (JECFA 11 M., 1967).

+ +

84960 000118-55-8 Salicylic acid, phenyl ester


85030 000111-20-6 Sebacic acid Same 24280 D + +

85040 - Sebacic acid, alkyl (C6-C12) esters


85120 000122-62-3 Sebacic acid, bis(2-ethylhexyl) ester

7 Group R: 0.05 mg/kg b.w. Available: Ames test and 3-week oral rat study. Needed: remaining toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies too.

+

85200 027214-90-0 Sebacic acid, bis(6-methylheptyl) ester

8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on

+


AND SPECIFICATIONS


269

migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg peroxisome proliferation studies too.

85280 052829-07-9 Sebacic acid, bis(2,2,6,6-tetramethyl-4-piperidyl) ester

7 Available: 4 mutagenicity studies. Needed: migration data, use, stability during production and use.

+

85360 000109-43-3 Sebacic acid, dibutyl ester

DIR 3 Toxicologically acceptable (hydrolyses in intestinal fluid to sebacic acid and butanol). Available: migration data in olive oil; hydrolysis data; inadequate semichronic oral rat and chronic oral rat and reproduction study; inadequate Ames test; inadequate Drosophila study; inadequate micronucleus assay; three adequate in vitro mutagenicity studies; peroxisome proliferations study. (RIVM/TNO July 1996,=CS/PM/2860)

+ +

85440 000106-79-6 Sebacic acid, dimethyl ester

Same 24370 8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg peroxisome proliferation studies too.

+

85520 002432-87-3 Sebacic acid, di-n-octyl ester

8 Group R: 0.05 mg/kg b.w. Available: "data inadequate"(extract from Lefaux book". Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies too.

+

85550 009000-59-3 Shellac Same 24440 1 ADI: acceptable. (SCF, 26th Series, 1992).

+

85580 007631-86-9 Silica Same 86240 D +

85600 - Silicates, natural D 3 Inert material. Some specific silicates have been allocated an ADI, not specified. (SCF, 25th Series, 1991)

+ +

85601 - Silicates, natural (with the exception of asbestos)

Same 85600 DIR 3 +

85610 - Silicates, natural, DIR 3 Inert material. + +


AND SPECIFICATIONS


270

silanated (with the exception of asbestos)

85680 001343-98-2 Silicic acid See also 85980/8642

7

DIR 2 TDI: not specified based on ADI: not specified for silicon dioxide. (SCF, 25th Series, 1991)

+ +

85760 012068-40-5 Silicic acid, lithium aluminium salt(2:1:1)


2-3 L2 for Li Group TDI: 0.01 mg/kg b.w. (as Li). See references for 38000 in L2 in this report. L2 for Al TDI: 1 mg/kg bw (as Al) based on PTWI: 7 mg/kg bw (as Al). (SCF, 25th Series, 1991). L2 for silicic acid. TDI: not specified, based on ADI: not specified for silicon dioxide and several silicates. (SCF, 25th Series, 1990)

+

85840 053320-86-8 Silicic acid, lithium magnesium sodium salt


2-3 Group TDI = 0.01 mg/kg b.w. (as Li). See references for benzoic acid, lithium salt. L2 for silicic acid. TDI: not specified, based on ADI: not specified for silicon dioxide and several silicates. (SCF, 25th Series, 1990)

+

85920 012627-14-4 Silicic acid, lithium salt DIR SML(T) = 0.6 mg/kg (8) (expressed as Lithium)

2-3 Group TDI: 0.01 mg/kg b.w. (as Li). See references for benzoic acid, lithium salt. L2 for silicic acid. TDI: not specified, based on ADI: not specified for silicon dioxide and several silicates. (SCF, 25th Series, 1990)

+

85950 037296-97-2 Silicic acid, magnesium-sodium-fluoride salt

3AM 3 Restriction: 0.15 mg fluoride/kg food Remark for Commission: This is a Group Restriction. No direct contact intended. Restriction may include this condition of use if necessary.

+


AND SPECIFICATIONS


271


85980 - Silicic acid, salts 85680/86427

D 2 TDI: not specified, based on ADI: not specified for silicon dioxide. (SCF, 25th Series, 1991)

+ +

86000 - Silicic acid, silylated DIR 3 Inert material. + +

86030 004766-57-8 Silicic acid, tetrabutyl ester

8 +

86050 000078-10-4 Silicic acid, tetraethyl ester

8 +

86052 068412-37-3 Silicic acid (H4SiO4), tetraethyl ester, hydrolysed

W +

86080 010101-52-7 Silicic acid, zirconium salt

7 L3 for silicic acid. L7 for zirconium. See references for 54220.

+

86160 000409-21-2 Silicon carbide DIR 3 Inert material. + +

86240 007631-86-9 Silicon dioxide Same 85580 DIR 1 ADI: not specified. (SCF, 25th Series, 1991)

+ +

86260 - Silicon dioxide amorphous, fluorinated

8 +

86280 - Silicon dioxide amorphous, silanated

3-D Inert material. +

86285 - Silicon dioxide, silanated DIR 3 Inert material. + +

86300 063148-62-9 Silicone oils 9 +

86320 - Silicones 9 +

86360 158061-44-0 Siloxanes and silicones, alkyl(C24-C28) methyl

W +

86380 133101-81-2 Siloxanes and silicones, dimethyl, ethoxy methyl, ethoxy phenyl, polymers with methyl silsesquioxanes and phenyl silsesquioxanes, ethoxy-terminated

W +

86400 - Siloxanes and silicones, dimethyl, ethyl

9 + +




AND SPECIFICATIONS


272

hydrogen, reaction products with polyethyleneglycol monoallyl ether

86401 189354-75-4 Siloxanes and silicones, dimethyl, hexadecyl methyl, 3-hydroxypropyl methyl, ethoxylated propoxylated

W +

86402 068037-78-5 Siloxanes and silicones, dimethyl, hexadecylmethyl, methyl octadecyl

9 + +

86404 - Siloxanes and silicones, dimethyl, hexadecylmethyl, octadecyl methyl, 11-methoxy-11-oxoundecylmethyl

9 +

86405 151662-01-0 Siloxanes and silicones, dimethyl, 3-hydroxypropyl group-terminated, ethoxylated propoxylated

W +

86405/5 068938-54-5 Siloxanes and silicones, dimethyl, 3-hydroxypropyl methyl, ethers with polyethyleneglycol monomethyl ether

W +

86406 068937-54-2 Siloxanes and silicones, dimethyl, 3-hydroxypropyl methyl, ethoxylated

9 + +

86408 068937-55-3 Siloxanes and silicones, dimethyl, 3-hydroxypropyl methyl, ethoxylated propoxylated

9 + +

86408/5 128192-17-6 Siloxanes and silicones, dimethyl, 3-

W +


AND SPECIFICATIONS


273

hydroxypropyl methyl, 3-hydroxypropyl group-terminated, ethoxylated propoxylated

86409 070131-67-8 Siloxanes and silicones, dimethyl, hydroxy-terminated

W +

86410 129893-29-4 Siloxanes and silicones, dimethyl, hydroxy-terminated, ethers with polyethylene-polypropyleneglycol monobutyl ether

9 + +

86411 155490-71-4 Siloxanes and silicones, dimethyl, hydroxy-terminated, ethers with polyethylene-polypropyleneglycol monomethyl ether

W +

86412 067762-96-3 Siloxanes and silicones, dimethyl, hydroxy-terminated, ethers with polypropyleneglycol monobutyl ether

9 + +

86414 064365-23-7 Siloxanes and silicones, dimethyl, hydroxy-terminated, ethoxylated propoxylated

9 + +

86416 067762-83-8 Siloxanes and silicones, dimethyl, methyloctadecyl

9 + +

86418 068554-66-5 Siloxanes and silicones, dimethyl, polymers with methylsilsesquioxanes, ethoxy-terminated

9 + +

86420 068554-67-6 Siloxanes and silicones, dimethyl, polymers with methylsilsesquioxanes, hydroxy-terminated

9 + +


AND SPECIFICATIONS


274

86422 068554-65-4 Siloxanes and silicones, dimethyl, polymers with methylsilsesquioxanes and polyethylene-polypropyleneglycol monobutyl ether

9 + +

86424 068554-64-3 Siloxanes and silicones, dimethyl, polymers with methylsilsesquioxanes and polypropyleneglycol monobutyl ether

9 + +

86424/5 155419-55-9 Siloxanes and silicones, dimethyl, polymers with phenylsilsesquioxanes, ethoxy-terminated

W +

86425 067762-90-7 Siloxanes and silicones, dimethyl, reaction products with silica

W +

86426 068554-70-1 Silsesquioxanes, methyl Same as 66930

D +

86426/5 133101-85-6 Silsesquioxanes, phenyl, ethoxy-terminated

W +

86427 001318-02-1 Silver alumino silicate replaced by 95995

D +

86432 - Silver-containing glass (Silver-magnesium-calcium-phosphate-borate)

3 Restriction: Group restriction of 0.05 mg Ag/kg of food. Remark for Commission: It is a surface biocide http://www.efsa.eu.int/science/afc/afc_opinions/468/opinion11_afc_ej65_list4_en1.pdf

+

86432/10 - Silver in glass +

86434 - Silver sodium hydrogen zirconium phosphate

3 Restriction: Group restriction of 0.05 mg Ag/kg of food. Remark for Commission: It is a surface biocide http://www.efsa.eu.int/science/afc/afc_opinions/468/opinion11_afc_ej65_list4_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out

+







AND SPECIFICATIONS


275

62_en.pdf

86437 - Silver zeolite A (silver zinc sodium ammonium alumino silicate), silver content 2- 5 %

Same 95995/1

3 Group restriction: 0.05 mg Ag/kg food, based on the human NOEL of about 10 g of silver for a total lifetime oral intake allocated by WHO (WHO, 2004) for drinking water. Maximum content in polymer: 10% (w/w) of silver zeolite A containing ≤ 5% silver. Only for repeated use articles made from polyolefins (up to 40°C for contact times below 1 day) and for poly(alkylene terephthalate) based polymers (up to 99°C for contact times below 2 hours) Remark for the Commission: It is a biocide http://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf

+

86437/50 - Silver-zinc- aluminium - boron - phosphate glass, mixed with 5-20% barium sulphate, silver content 0.35-0.6%

3 Group restriction: 0.05 mg Ag/kg food, based on the human NOAEL of about 10 g of silver for a total lifetime oral intake allocated by WHO (WHO, 2004) for drinking water. Group restriction: 1 mg Ba/kg food Group restriction: 6 mg B/kg food Maximum content in plastic: 1% (w/w) Remark for Commission: It is a biocide http://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf

+

86438 - Silver zinc zeolite A ( silver-zinc sodium alumino silicate calcium metaphosphate), silver content 1-1.6%

Similar to 86437 and 86438/50

3 Group restriction: 0.05 mg Ag/kg of food, based on the human NOAEL of about 10 g of silver for a total lifetime oral intake allocated by WHO (WHO, 2004) for drinking water. Remark for Commission: It is a biocide The Commission is advised to specify: - the maximum amount of additive (1%) and - the max. amount of silver in the additive (1.6%) or in the final food contact material http://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf

+









AND SPECIFICATIONS


276

86438/50 - Silver zinc zeolite A ( silver-zinc sodium magnesium alumino silicate calcium phosphate), silver content 0.34-0.54%

Similar to 86437 and

86438

3 Group restriction: 0.05 mg Ag/kg of food, based on the human NOAEL of about 10 g of silver for a total lifetime oral intake allocated by WHO (WHO, 2004) for drinking water. Remark: It is a biocide The Commission is advised to specify: - the maximum amount of additive (1%) and - the max. amount of silver in the additive (1.6%) or in the final food contact material http://www.efsa.eu.int/science/afc/afc_opinions/890/afc_op_ej201_fcm1.pdf

+

86440 ? Sodium aluminate 2 TDI: 1 mg/kg bw (as Al) based on PTWI : 7 mg/kg b.w. (as Al). (SCF, 25th Report, 1991).

+

86480 007631-90-5 Sodium bisulphite DIR SML(T) = 10 mg/kg (30) (expressed as SO2)

1 Group ADI: 0.7 mg/kg b.w. as SO2 (JECFA 27 M., 1983).

+ +

86560 007647-15-6 Sodium bromide DIR 1 Group ADI: 1 mg/kg b.w. (as Br) as pesticide residue. See references for ammonium bromide in list 2.

+

86640 009004-32-4 Sodium carboxymethylcellulose

D Group TDI not specified for natural, regenerated and modified cellulose (SCF 7th Report, 1978 and JECFA 17 M., 1973 and followin g).

+

86655 - Sodium dialkylsulphonimides

9 +

86670 007775-14-6 Sodium dithionite 8 +

86720 001310-73-2 Sodium hydroxide DIR 1 ADI: not specified. (SCF, 25th Series, 1991)

+ +

86800 007681-82-5 Sodium iodide DIR SML(T) = 1 mg/kg (11) (expressed as Iodine)

1 PMTDI: 0.017 mg/kg b.w. (as I) (JECFA 33 M., 1988).

+

86840 007681-57-4 Sodium metabisulphite W +

86880 - Sodium monoalkyl dialkylphenoxybenzenedisulphonate

DIR SML = 9 mg/kg 2 t-TDI: 0.15 mg/kg b.w. pending reproduction and teratogenicity studies. Available: 2-year oral rat and dog studies.

+ +




AND SPECIFICATIONS


277

86920 007632-00-0 Sodium nitrite DIR SML = 0.6 mg/kg 3 R: 0.01 mg/kg bw based on allowing 1/10 of t-TDI for food packaging uses. (SCF, 26th Series, 1992).

+ +

86960 007757-83-7 Sodium sulphite DIR SML(T) = 10 mg/kg (30) (expressed as SO2)

1 Group ADI: 0.7 mg/kg b.w. as SO2 (JECFA 27 M., 1983).

+ +

87040 001330-43-4 Sodium tetraborate DIR SML(T) = 6 mg/kg (23) (expressed as Boron) without prejudice to the provisions of Directive 98/83/EC on water for human consumption (OJ L 330, 5.12.1998,p.32)

2 Re-evaluation on the basis of an opinion of the SCF in another context. Group-TDI = 0.1 mg/kg b.w. (as B) (with REF_n. 36840, 40320 and 87040). The TDI is based on the No Adverse Effect Level (NOAEL) of 9.6 mg/kg b.w./day for effects on fetal body weight and skeletal anomalies in the rat developmental study. A Safety Factor (SF) of 100 is used. “Opinion of the Scientific Committee on Food on Arsenic, Barium, Fluoride, Boron and Manganese in Natural Mineral Waters (expressed on 13 December 1996, 105th plenary meeting of the SCF, completed on 13 June 1997 at the 107th plenary meeting of the SCF; 43rd Series of Reports of the SCF, 2000”. (Adopted by the SCF at the 127th meeting, 30 May 2001) http://europa.eu.int/comm/food/fs/sc/scf/out86_en.pdf

+ +

87120 007772-98-7 Sodium thiosulphate DIR SML(T) = 10 mg/kg (30) (expressed as SO2)

1 Group ADI: 0.7 mg/kg b.w. as SO2. Included in the group ADI for sulphites. (JECFA 27 M., 1983).

+

87200 000110-44-1 sorbic acid DIR 1 ADI: 25 mg/kg b.w. (SCF, 6th Series, 1978).

+ +

87280 029116-98-1 Sorbitan dioleate DIR 2 Group TDI: 5 mg/kg b.w. based on the group ADI 5 mg/kg b.w. for sorbitan esters of lauric and oleic acids. (SCF, 7th Series, 1978).

+ +

87360 - Sorbitan, esters with acids, aliph., monocarb. (more than C5)

9 +

87440 071902-01-7 Sorbitan isostearate 9 +




AND SPECIFICATIONS


278

87520 062568-11-0 Sorbitan monobehenate DIR 2 Group TDI= 5 mg/kg b.w. based on the group ADI 5 mg/kg b.w., for sorbitan esters of lauric and oleic acids. (SCF, 7th Series, 1978).

+ +

87560 054392-26-6 Sorbitan monoisostearate 8 +

87600 001338-39-2 Sorbitan monolaurate Same 63480 DIR 1 Group ADI: 5 mg/kg b.w. for sorbitan monolaurate and sorbitan monooleate. (SCF, 7th Series, 1978).

+ +

87680 001338-43-8 Sorbitan monooleate DIR 1 Group ADI: 5 mg/kg b.w. for sorbitan monolaurate and sorbitan monooleate. (SCF, 7th Series, 1978).

+ +

87760 026266-57-9 Sorbitan monopalmitate DIR 1 Group ADI: 25 mg/kg b.w. for sorbitan monostearate, sorbitan monopalmitate and sorbitan tristearate. (SCF, 7th Series, 1978).

+ +

87840 001338-41-6 Sorbitan monostearate DIR 1 Group ADI: 25 mg/kg b.w. for sorbitan monostearate, sorbitan monopalmitate and sorbitan tristearate. (SCF, 7th Series, 1978).

+ +

87920 061752-68-9 Sorbitan tetrastearate DIR 2 Group TDI: 5 mg/kg b.w. based on the group ADI 5 mg/kg b.w. for sorbitan esters of lauric and oleic acids. (SCF, 7th Series, 1978).

+ +

88000 054392-27-7 Sorbitan triisostearate 9 +

88080 026266-58-0 Sorbitan trioleate DIR 2 Group TDI: 5 mg/kg b.w. based on the group ADI 5 mg/kg b.w. for sorbitan esters of lauric and oleic acids. (SCF, 7th Series, 1978).

+ +

88160 054140-20-4 Sorbitan tripalmitate DIR 2 Group TDI: 5 mg/kg b.w. based on the group ADI 5 mg/kg b.w. for sorbitan esters of lauric and oleic acids. (SCF, 7th Series, 1978).

+ +

88240 026658-19-5 Sorbitan tristearate DIR 1 Group ADI: 25 mg/kg b.w. for sorbitan monostearate, sorbitan monopalmitate and sorbitan tristearate. (SCF, 7th Series, 1978).

+ +

88320 000050-70-4 Sorbitol Same 24490 DIR 1 Acceptable. (SCF, 16th Series, 1985).

+ +

88400 - Sorbitol, esters with 9 +


AND SPECIFICATIONS


279

acids, aliph., monocarb. (more than C5)

88480 - Sorbitol, esters with acids, hydroxylated, monocarb. (C12-C20)

9 +

88560 see 88600 D +

88600 026836-47-5 Sorbitol monostearate DIR 2 TDI= not specified based on the ADI for sorbitol. (SCF, 17th Series, 1986).

+ +

88630/1 008001-22-7 Soybean oil Same 24520 and 88630/0

3 Food fat. +

88640 008013-07-8 Soybean oil, epoxidized DIR In compliance with the specifications laid down in Annex V.

2 Restriction for baby food: http://www.efsa.eu.int/science/afc/afc_opinions/467/opinion_afc10_ej64_epox_soyoil_en1.pdf --------------------------------------- TDI: 1 mg/kg b.w. Available: 15-week and 2-year oral rat studies and 1-year oral dog study, reproduction and teratogenicity studies. ADI's and TDI's are allocated in the light of life long average exposure and allowing for sporadic intakes above the set limits. For the infants, however, the actual consumption pattern surveys have revealed intakes for prolonged periods of time which may exceed the TDI. (Bibra report n. 515/86; summary report prepared by UK January 1988).

+ +

88650 068308-53-2 Soybean oil fatty acids, polymerized

Same 17200 D +

88680 008002-23-1 Spermaceti wax 8 +

88720 - Sperm oil, hydrogenated 8 +

88770 009045-28-7 Starch acetate (= E1420) W +

88780 009057-06-1 Starch carboxymethyl ether

W +

88800 009005-25-8 Starch, edible Same 24540 DIR 0 + +

http://www.efsa.eu.int/science/afc/afc_opinions/467/opinion_afc10_ej64_epox_soyoil_en1.pdf




AND SPECIFICATIONS


280

88880 068412-29-3 Starch, hydrolysed Same 24545 DIR 0 + +

88920 066829-29-6 Starch octenylsuccinate, sodium salt (= E1450)

W +

88930 065996-62-5 Starch, oxidised (= E1404)

W +

88940 011120-02-8 Starch phosphate (= E1410)

W +

88950 039316-70-6 Starch succinate W +

88960 000124-26-5 Stearamide DIR 3 Same references as 68960. + +

89040 000057-11-4 Stearic acid Same 24550 DIR 1 ADI: not specified. (SCF, 25th Series, 1990).

+ +

89120 000123-95-5 Stearic acid, butyl ester 7 Needed: hydrolysis data. + +

89170 013586-84-0 Stearic acid, cobalt salt Same 89165 DIR SML(T) = 0.05 mg/kg (14) (expressed as Cobalt)

1-3 L3 for Cobalt. R: 0.05 mg/kg of food (as Co). (RIVM, summary data, October 1992=CS/PM/1707). L1 for stearic acid. See references for stearic acid.

+

89200 007617-31-4 Stearic acid, copper salt DIR SML(T) = 30 mg/kg (7) (expressed as Copper)


89240 001323-83-7 Stearic acid, diglyceride Same 56320 D +

89280 005303-25-3 Stearic acid, dodecyl ester

D Needed: hydrolysis data. +

89360 - Stearic acid, esters with alcohols, aliph.(C4-C22)


89440 - Stearic acid, esters with ethyleneglycol


2 TDI = 0.5 mg/kg b.w. (SCF, 6th Series, 1978).

+

89520 008045-34-9 Stearic acid, esters with pentaerythritol


89600 000111-61-5 Stearic acid, ethyl ester 7 Needed: hydrolysis data. +

89680 022047-49-0 Stearic acid, 2-ethylhexyl ester


89760 026739-53-7 Stearic acid, guanidine salt

D +

89840 024466-84-0 Stearic acid, heptyl ester 7 Needed: hydrolysis data. +

89920 001190-63-2 Stearic acid, hexadecyl 7 Needed: hydrolysis data. +


AND SPECIFICATIONS


281

ester

89950 003460-37-5 Stearic acid, hexyl ester 7 Needed: hydrolysis data. +

89970 005136-76-5 Stearic acid, iron salt D +

90000 000646-13-9 Stearic acid, isobutyl ester

7 Needed: hydrolysis data. + +

90080 031565-38-5 Stearic acid, isodecyl ester

8 +

90120 031565-37-4 Stearic acid, isotridecyl ester

W +

90160 052652-59-2 Stearic acid, lead (dibasic) salt

D +

90240 007428-48-0 Stearic acid, lead salt D +

90305 028084-19-7 Stearic acid, nonyl ester 9 +

90320 002778-96-3 Stearic acid, octadecyl ester


90400 000109-36-4 Stearic acid, octyl ester 7 Needed: hydrolysis data. +

90480 006382-13-4 Stearic acid, pentyl ester 7 Needed: hydrolysis data +

90560 014351-40-7 Stearic acid, 2-stearamidoethyl ester


90640 031556-45-3 Stearic acid, tridecyl ester


90720 058446-52-9 Stearoylbenzoylmethane DIR 2 TDI: 1.5 mg/kg b.w. 30-day oral rat, 90-day oral dog, 2-generation oral rat studies, mutagenicity and migration data. (RIVM report June 1979).

+ +

90800 005793-94-2 Stearoyl-2-lactylic acid, calcium salt

Same 90840 DIR 1 ADI: 20 mg/kg b.w. (SCF, 7th Series, 1978).

+

90840 005793-94-2 2-(2-Stearoyloxypropionyl)oxy)propionic acid, calcium salt

Same 90800 D +

90880 000142-48-3 N-Otearoylsarcosine 8 +

90930 - Styrene copolymers 9 +

90960 000110-15-6 Succinic acid Same 24820 DIR 1 ADI: not specified. (SCF, 25th Series, 1990).

+

91040 028801-70-9 Succinic acid, diisodecyl 8 +


AND SPECIFICATIONS


282

ester

91120 028880-24-2 Succinic acid, diisooctyl ester

8 +

91135 000106-65-0 Succinic acid, dimethyl ester


91150 065447-77-0 Succinic acid, dimethyl ester-(4-hydroxy-2,2,6,6- tetramethyl piperidyl)ethanol, copolymer

Same 81215 D +

91200 000126-13-6 Sucrose acetate isobutyrate

DIR 1 ADI: 10 mg/kg bw. (SCF, 25th Series, 1991)

+ +

91280 - Sucrose esters of monocarb. Acids

9 +

91360 000126-14-7 Sucrose octaacetate DIR 3 Bitter taste. +

91400 003375-11-9 3,3'-Sulphonyl-bis(benzenesulphonic acid)dihydrazide

Same 51600 D +

91440 - Sulphoricinic acid, salts 9 +

91520 005138-18-1 Sulphosuccinic acid 8 +

91540 - Sulphosuccinic acid, alkyl(C4-C20) esters, salts

9 Group R: 0.05 mg/kg bw. +

91545 090268-36-3 Sulphosuccinic acid, alkyl(C12-C18) esters, disodium salt

D +

91560 002373-38-8 Sulphosuccinic acid, bis(1,3-dimethylbutyl) ester, sodium salt

8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies.

+

91570 010041-19-7 Sulphosuccinic acid, bis(2-ethylhexyl)ester

8 Group R: 0.05 mg/kg b.w. Needed: toxicological data depending on migration level (see SCF guidelines) and if migration exceeds 0.05 mg/kg peroxisome proliferation studies too.

+ +

91572 000577-11-7 Sulphosuccinic acid, bis(2-ethylhexyl)ester, sodium salt

D + +


AND SPECIFICATIONS


283

91580 023386-52-9 Sulphosuccinic acid, dicyclohexyl ester, sodium salt

8 +

91600 see 91540 D +

91630 003006-15-3 Sulphosuccinic acid, dihexyl ester, sodium salt


+ +

91650 000127-39-9 Sulphosuccinic acid, diisobutyl ester, sodium salt

8 Group R: 0.05 mg/kg bw. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg bw, peroxisome proliferation studies too.

+

91665 029857-13-4 Sulphosuccinic acid, diisodecyl ester, sodium salt

8 Group R: 0.05 mg/kg bw. Needed: toxicological data depending on migration level(see SCF guidelines) and, if migration exceeds 0.05 mg/kg peroxisome proliferation studies too.

+

91672 055184-72-0 Sulphosuccinic acid, diisotridecyl ester, sodiium salt

8 Group R: 0.05 mg/kg bw. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg peroxisome proliferation studies too.

+

91680 001639-66-3 Sulphosuccinic acid, dioctyl ester, sodium salt

8 Group R: 0.05 mg/kg bw. Needed: toxicological data depending on migration level (see SCF guidelines) and, if migration exceeds 0.05 mg/kg, peroxisome proliferation studies too.

+ +

91720 000922-80-5 Sulphosuccinic acid, dipentyl ester, sodium salt


+ +

91760 002673-22-5 Sulphosuccinic acid, ditridecyl ester, sodium salt


+ +


AND SPECIFICATIONS


284

91780 067893-42-9 Sulphosuccinic acid, 4-[2-[(12-hydroxy-1-oxooleyl)-amino]ethyl]ester, disodium salt

W8 +

91800 037294-49-8 Sulphosuccinic acid, isodecyl ester, disodium salt


+

91840 007704-34-9 Sulphur DIR 3 Inert material. +

91920 007664-93-9 Sulphuric acid DIR 1 ADI: not specified. (SCF, 25th Series, 1991)

+ +

92000 007727-43-7 Sulphuric acid, barium salt

DIR SML(T) = 1 mg/kg (12) (expressed as Barium)

3 L3 for Barium. R: 1 mg/kg (as Ba) in food or in food simulant. (Rivm doc., May 1992 (CS/PM/1584)). L3 for the compound. Insoluble material.

+ +

92030 010124-44-4 Sulphuric acid, copper salt


2 L1 for sulphuric acid. ADI = not specified. See references for sulphuric acid in list 1. For copper(II). Same as Ref.No 30080.

+ +

92040 012202-17-4 and 052732-72-6

Sulphuric acid, lead (tri- and tetrabasic) salt

D +

92080 014807-96-6 Talc DIR 1 ADI: not specified. (SCF, 25th Series, 1991)

+ +

92100 061789-97-7 Tallow 3 Toxicologically acceptable. +

92120 - Tallow, sulphated, ammonium, potassium, or sodium salt

9 +

92150 001401-55-4 Tannic acids DIR According to the JECFA specifications

3 Toxicologically acceptable with JECFA specifications. (Doc. 1995-02-01 = CS/PM/2536)

+

92160 000087-69-4 Tartaric acid DIR 1 ADI: 30 mg/kg b.w. + +


AND SPECIFICATIONS


285

(SCF, 25th Series, 1991)

92180 000087-92-3 Tartaric acid, dibutyl ester


92195 - Taurine, salts DIR 0 +

92205 057569-40-1 Terephthalic acid, diester with 2,2'-methylenebis(4-methyl-6-tert-butylphenol)

Same 38580 DIR 2 TDI: 1 mg/kg b.w. A 90-day oral rat study. (CIVO report 5569, December 1977).

+

92240 see 92180 D +

92280 see 92205 D +

92320 - Tetradecyl-polyethyleneglycol(EO=3-8) ether of glycolic acid

DIR SML = 15 mg/kg 2 t-TDI: 0.25 mg/kg b.w. Available: 28- and 90-day oral rat studies. (CIVO/TNO 3108 October 1970, 3287 October 1970). Needed: mutagenicity data on polymeric additive itself and specify monomer content. Remark: after verification, name to be changed into "tetradecyl- polyethyleneglycol [E0= 3-8] ether of glycolic acid"

+

92350 000112-60-7 Tetraethyleneglycol Same 25090 DIR 1 ADI : 10 mg/kg b.w. (SCF, 17th Series, 1986).

+

92400 000097-77-8 N.N'-Tetraethylthiuram disulphide

8 +

92430 000109-99-9 Tetrahydrofuran Same 25150. 2 TDI: 0.01 mg/kg b.w. See references for same substance in monomer report.

+

92450 000097-99-4 Tetrahydrofurfurol 8 +

92480 - Tetrakis(2,4-di-tert-butylphenyl)-2,4'-biphenylylene diphosphonite

7 Needed: neurotoxicity study in hens. +

92560 038613-77-3 Tetrakis(2,4-di-tert-butyl-phenyl)-4,4'-biphenylylene diphosphonite

DIR SML = 18 mg/kg 2 TDI: 0.3 mg/kg b.w. 90-day oral rat study and mutagenicity studies. (Sandoz report 1979).

+


AND SPECIFICATIONS


286

92640 000102-60-3 N.N.N.'N'-Tetrakis(2-hydroxypropyl)ethylenediamine

Same 25180 DIR 2 TDI: 1 mg/kg b.w. (SCF, 17th Series, 1986).

+

92655 006683-19-8 Tetrakis[methylene(3,5-di-tert-butyl-4-hydroxy)hydrocinnamate]methane

Same 71680 D +

92700 078301-43-6 2,2,4,4-Tetramethyl-20-(2,3-epoxypropyl)-7-oxa-3,20-diazadispiro[5.1.11.2]-heneicosan-21-one, polymer

DIR SML = 5 mg/kg 3 R = 5 mg/kg of food. Available: adequate migration data; acute toxicity data; 90-day oral study (Hostavin N30); three in vitro mutagenicity studies (Hostavin N30) and three in vitro mutagenicity studies (Hostavin N20). (RIVM/TNO SDS, July 1996 = CS/PM/2861).

+ +

92720 000137-26-8 N.N'-Tetramethylthiuram disulphide

8 +

92740 011067-82-6 Tetrapropylene benzene sulphonic acid, sodium salt

8 +

92760 000096-69-5 Thiobis(6-tert-butyl-m-cresol)

Same 92800 and 92840

D +

92800 000096-69-5 4,4'-Thiobis(6-tert-butyl-3-methylphenol)

Same 92760 and 92840

DIR SML = 0.48 mg/kg 2 t-TDI: 0.008 mg/kg b.w. pending results of ongoing 2-year and reproduction studies. Available: 28- and 90-day oral rat studies, one in-vitro mutagenic test. (RIVM doc. 88/678608/007, 1 November 1988).

+

92820 013560-49-1 Thiobis(ethyleneglycol 3-aminoCrotonate)

Same 35120 D +

92840 000096-69-5 Thiobis(2-methyl-4-hydroxy-5-tert-butyl)benzene

Same 92760 and 92800

D +

92880 041484-35-9 Thiodiethanol bis(3-(3,5-di-tert-butyl-4-hydroxy phenyl) propionate)

Same 92900 DIR SML = 2.4 mg/kg 2 TDI: 0.04 mg/kg b.w. 90-day oral rat study, mutagenicity studies. Desirable: migration data. (RIVM report 88/678608/009, 1989-01-24).

+ +

92900 041484-35-9 Thiodiethylenebis(3,5-di-tert-butyl-4-

Same 92880 D +


AND SPECIFICATIONS


287

hydroxyhydrocinnamate)

92930 120218-34-0 Thiodiethanolbis(5-methoxycarbonyl-2-6-dimethyl-1,4-dihydropyridine-3-carboxylate)

DIR SML = 6 mg/kg 2 TDI = 0.1 mg/kg b.w. 90-day oral rat study, mutagenicity tests negative, absence of bioaccumulation. (CS/PM/305,336,358,460).

+

92960 000111-17-1 Thiodipropionic acid 8 +

93040 - Thiodipropionic acid, dibehenyl ester


+

93120 000123-28-4 Thiodipropionic acid, didodecyl ester


3 Group R: 5 mg/kg of food (with thiodipropionic acid, dioctadecyl ester=93280) Available: Adequate migration data from PVC and ABS; acute toxicity data; 28-day oral rat study; 90-day oral rat study; inadequate data on long-term toxicity; three oral teratogenicity studies using mice, hamsters and rabbits; studies on absorption, distribution, metabolism and excretion; peroxisome proliferation study (this study deviated from the SCF guidelines on peroxisomal proliferation); two Ames assays (negative); in vitro chromosomal aberration assay (negative); gene mutation assay in mouse limphoma cells (negative). Remark: Data insufficient for allocating a TDI (no reproduction study and no long-term study). The WG decided not to ask for a new peroxisome proliferation study, since the 90-day study showed only increased liver weights (no morphological changes) at very high doses (1000 mg/kg b.w.). In view of the structure of the compound and the metabolism data provided there is no need for demonstration of the absence of potential for accumulation.

+ +


AND SPECIFICATIONS


288

No need for a long-term toxicity study, since myocarditis was not seen after the recovery period of the 90-day study. (RIVM/TNO SDS, May 1996 = CS/PM/2862/93120). (adopted at 113rd SCF meeting)(17-18 September 1998) http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html

93200 003287-12-5 Thiodipropionic acid, dihexadecyl ester


+

93280 000693-36-7 Thiodipropionic acid, dioctadecyl ester


3 Group R: 5 mg/kg of food (with 93120= dilauryl thiodipropionate) based on data available for 93120. (adopted at 113rd SCF meeting)(17-18 September 1998) http://europa.eu.int/comm/food/fs/sc/scf/out16_en.html

+ +

93360 016545-54-3 Thiodipropionic acid, ditetradecyl ester


+

93420 007646-78-8 Tin(iv) chloride 1 PTWI: 14 mg/kg b.w. (JECFA, 33M., 1989).

+

93440 013463-67-7 Titanium dioxide DIR 1 Acceptable. (SCF, 1st Series, 1975).

+ +

93520 000059-02-9 and 010191-41-0

alpha-Tocopherol DIR 1 Acceptable. (SCF, 22th Series, 1989).

+

93540 000108-88-3 Toluene Same 25205 3 R: 1.2 mg/kg of food. See references for the same substance (PM REF. 25205) in monomer report.

+ +

93585 000104-15-4 p-Toluenesulphonic acid 8 +

93680 009000-65-1 Tragacanth gum DIR 1 ADI: not specified. (SCF, 21th Series, 1989).

+






AND SPECIFICATIONS


289

93695 000102-76-1 Triacetin Same 57760 D +

93720 000108-78-1 2,4,6-Triamino-1,3,5-triazine

Same 19975, 25420 and

65360

DIR SML = 30 mg/kg 2 TDI: 0.5 mg/kg b.w. (SCF, 17th Series, 1986).

+ +

93730 2,4,6-Triamino-1,3,5-triazine resins

9 +

93760 000077-90-7 Tri-n-butyl acetyl citrate New studies on-going. ------------------------------------------------------ R = 5 mg/kg of food. Available: specific migration values in 3% acetic acid and olive oil ranging from 9.0-28.2 mg/6 dm2; 14-day range-finding rat study; 90-day rat study; 2-generation reproduction study using rats; gene mutation assay in bacteria (negative); two chromosomal aberration assays in cultured mammalian cells (both negative); two gene mutation assays in cultured mammalian cells (one negative and one positive); in vivo UDS assay (negative); metabolism study (rat); skin and eye irritation studies (only summaries available); sensitisation study. RIVM/ISS/TNO SDS, January 2000 = CS/PM/2966 REV.II/93760. Remark for Commission: since high migration into fat has been demonstrated with the exception of PET, it was recommended that the Commission take the necessary measures so that the restriction proposed is not exceeded. http://europa.eu.int/comm/food/fs/sc/scf/out10_en.pdf

+ +

93810 000060-01-5 Tributyrin Same 57840 D +

93840 000087-90-1 Trichlorocyanuric acid D +

93870 000071-55-6 1,1,1-Trichloroethane D +

93872 000079-00-5 1,1,2-Trichloroethane D +

93900 000079-01-6 Trichloroethylene D +




AND SPECIFICATIONS


290

93920 000075-69-4 Trichlorofluoromethane 7 Needed: migration data and specifications. +

93930 003380-34-5 2,4,4'-Trichloro-2'-hydroxydiphenyl ether

3 Restriction: 5 mg/kg of food Remark for Commission: - Migration could exceed 5 mg/kg of food - The use of this substance should not lead to a lowering of hygienic standards in food handling - The Fat (consumption) Reduction Factor is not applicable despite log Po/w = 4.8, because migration in aqueous simulants maybe higher than 10 % of the SML allocated to this substance,i.e. 5 ppm. - Concerning efficacy, none of the data submitted demonstrated whether there is a significant effect on microbial numbers under in-use conditions of triclosan and to what extent the substance might contribute to reduce cross contamination. - The Panel noted that no data were submitted to demonstrate activity against common food pathogens such as Campylobacter spp. http://www.efsa.eu.int/science/afc/afc_opinions/11/opinion_afc_07_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out62_en.pdf

+

93970 - Tricyclodecanedimethanol bis(hexahydrophthalate)


+

94000 000102-71-6 Triethanolamine Same 25480 and 25922

8 + +

94040 085665-45-8 Triethanolamine alkyl(C8-C14)sulphate

D +

94060 090583-18-9 Triethanolamine alkyl(C12-C14)sulphate

D +

94080 - Triethanolamine alkylsulphuric acids, salts

D +

94081 - Triethanolamine alkyl(C8-C22)sulphuric

8 For alkyl(C8-C22)sulphuric acids, linear, primary, even numbered.

+








AND SPECIFICATIONS


291

acids, linear, primary, even numbered and its salts

L3. Toxicologically acceptable. Same references as for 34281. For triethanolamine. L8.

94100 002717-15-9 Triethanolamine oleate 8 L8 for triethanolamine. L1 for oleic acid. ADI : not specified. (SCF, 25th Series, 1990).

+

94160 000122-51-0 Triethoxymethane Same 69900 8 +

94240 000077-89-4 Triethyl acetylcitrate 8 + +

94320 000112-27-6 Triethyleneglycol Same 25510 DIR 2 Group TDI: 5 mg/kg b.w. (with polyethyleneglycol). (SCF 17th Series, 1986).

+ +

94400 036443-68-2 Triethyleneglycol bis[3-(3-tert-butyl-4-hydroxy -5-methylphenyl) propionate]

DIR SML = 9 mg/kg 2 SCF_list: 2 TDI = 0.15 mg/kg b.w. See SCF evaluation in the website: http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf

+ +

94480 026523-64-8 Trifluorotrichloroethane 7 Needed: migration data and specification. +

94560 000122-20-3 Triisopropanolamine DIR SML = 5 mg/kg 3 R: 5 mg/kg of food. Available: migration, 3 negative mutagenicity tests, 90-day oral rat and dog studies. (CS/PM/2324). Hydrophilic so no data on bioaccumulation required.

+

94640 - 1,3,5-Triisopropylbenzene-2,4-polycarbodiimide

8 +

94720 068515-60-6 Trimellitic acid, trialkyl(C7-C9) ester

W9 Group R: 0.05 mg/kg bw. +

94800 003319-31-1 Trimellitic acid, tris(2-ethylhexyl) ester

W6B Group R: 0.05 mg/kg b.w. Available: Ames test and indication of peroxisome proliferation. Needed: peroxisome proliferation study and tests for gene mutation and chromosome

+




AND SPECIFICATIONS


292

aberrations in mammalian cells in vitro.

94880 000067-48-1 Trimethylethanolammonium chloride

Same 25570 8 +

94960 000077-99-6 1,1,1-Trimethylolpropane

Same 13380, 25600 and

39560

DIR SML = 6 mg/kg 2 TDI = 0.1 mg/kg b.w. (SCF, 17th Series, 1986).

+ +

95000 028931-67-1 Trimethylolpropane trimethacrylate-methyl methacrylate copolymer

DIR 3 Toxicologically acceptable. Available : data on use; data on residual monomers and the fraction with molecular mass < 1000 D. Remark: the two monomers (starting substances) have been evaluated by the SCF in the past and classified in list 2 and list 3, respectively. The two monomers are: ? Methyl methacrylate (REF_N. 21130); list 2 with a group t-TDI = 0.1 mg/kg b.w. (as methacrylic acid) (Reference: Scientific Committee for Food 42nd series of reports of the SCF, 2000) ? Trimethylolpropane trimethacrylate (REF_N. 25840); list 3 with a restriction of 0.05 mg/kg of food. (Reference: Opinion of the Scientific Committee on Food on the 16th additional list of monomers and additives for food contact materials, adopted by the SCF on 13/12/2001) RIVM/DE SDS, April 2001 = CS/PM/3324 REV. I/95000. (Adopted at the 131st SCF meeting, 27 February 2002) http://europa.eu.int/comm/food/fs/sc/scf/out124_en.pdf

+

95040 001462-84-6 2,3,6-Trimethylpyridine 8 +

95120 000108-75-8 2,4,6-Trimethylpyridine 8 +

95200 001709-70-2 1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene

DIR 2 t-TDI: 1 mg/kg b.w. pending check of the reports. 2-year oral studies in rats and dogs and oral carcinogenicity studies in mice and rats. (Shell reports n. TLGR 0023.68. March

+ +




AND SPECIFICATIONS


293

1969, TLGR. 0024.68, Sept. 1968, TLGR. 0019.69, March 1969).

95260 000139-45-7 Tripropionin Same 58080 D +

95265 227099-60-7 1,3,5-Tris(4-benzoylphenyl) benzene

3AM 3 Restriction: 0.05 mg/kg food http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf http://europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf

+

95270 161717-32-4 2,4,6-Tris(tert-butyl)phenyl-2-butyl-2-ethyl-1,3-propanediol phosphite

DIR SML = 2 mg/kg (as sum of phosphite, phosphate and the hydrolysis product = TTBP)

3 R = 2 mg/kg food (sum of phosphite, phosphate and the hydrolysis product (TTBP)) Remark for Commission: in aqueous food simulants to be measured as 2,4,6-tri-tert-butylphenol. (Adopted at the 119th SCF meeting) (2 December 1999) http://europa.eu.int/comm/food/fs/sc/scf/out50_en.pdf

+

95280 040601-76-1 1,3,5-Tris(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

DIR SML = 6 mg/kg 2 t-TDI: 0.1 mg/kg b.w. Available: 90-day oral rat and dog studies. (RIVM document, June 1989). Needed: mutagenicity and migration data, impurities to be specified.

+

95360 027676-62-6 1,3,5-Tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

DIR SML = 5 mg/kg 3 R: 5 mg/kg of food Available: 3-month oral rat study, mutagenicity studies negative, migration data. (RIVM doc. February 1992).

+ +

95400 000090-72-2 2,4,6-Tris[(dimethylamino)methyl]phenol

Same 25915 8 +

95440 000144-15-0 Tris(2-ethylhexyl) acetylcitrate


+

95520 068958-97-4 1,1,3-Tris(2-methyl-4-ditridecyl phosphite-5-

8 +

http://www.efsa.eu.int/science/afc/afc_opinions/675/afc_opinion20_ej109_list5_en1.pdf%0d%0ahttp:/europa.eu.int/comm/food/fs/sc/scf/out180_en.pdf







AND SPECIFICATIONS


294

tert-butylphenyl) butane

95600 001843-03-4 1,1,3-Tris(2-methyl-4-hydroxy-5-tert-butylphenyl) butane

DIR SML = 5 mg/kg 3 R: 5 mg/kg of food Available: adequate migration data (SM 0.003-1.8 mg/dm2); log Po/w; acute toxicity data; inadequate 90-day oral dog study; inadequate 12-week oral rat study; 13-week oral rat study; gene mutation assay in bacteria (negative); chromosomal aberration assay in cultured mammalian cells (negative); gene mutation assay in cultured mammalian cells (negative); excretion studies. (RIVM/TNO SDS, April 1999 = CS/PM/2905 REV. I/95600). (Adopted at the 118th SCF meeting) (23 September 1999) http://europa.eu.int/comm/food/fs/sc/scf/out41_en.pdf

+

95630 000057-13-6 Urea Same 25960 D + +

95645 - Urea resins D +

95680 000121-33-5 Vanillin 1 ADI: 10 mg/kg b.w. (JECFA 11 M., 1967).

+

95695 008009-03-8 Vaseline Same 72060 and 72062

D +

95710 - Vegetable oils, from food sources, hydrogenated or not

3 Food fats or similar to food fats. +

95720 - Vegetable oils, inedible D +

95725 110638-71-6 Vermiculite, reaction product with citric acid, lithium salt

Same 44300 DIR SML(T) = 0.6 mg/kg (8) (expressed as Lithium)

2 Group TDI = 0.01 mg/kg b.w. as Li (see references for 38000). Available: Migration data, 28-day oral rat study, Ames test, in vivo micronucleus test. No further data needed in view of its mineral nature. (RIVM SDS CS/PM/2423).

+

95726 025213-24-5 Vinyl acetate-vinyl alcohol, copolymer

W +

95728 025086-48-0 Vinyl acetate-vinyl alcohol, vinyl chloride,

W +




AND SPECIFICATIONS


295

copolymer

95730 009003-22-9 Vinyl acetate-vinyl chloride, copolymer

D + +

95735 009005-09-8 Vinyl acetate-vinyl chloride-maleic acid, copolymer

W +

95740 - Vinyl acetate-vinyl chloride-vinyl propionate, copolymer

9 +

95755 025086-89-9 Vinyl acetate-vinylpyrrolidone, copolymers

9 +

95760 see 95880 D + +

95761 see 95881 D + +

95762 see 95882 D +

95770 - Vinyl chloride-vinyl esters of sat., aliph., monocarb., acids (C2-C18),copolymers

9 +

95780 025853-89-8 Vinyl chloride-vinyl propionate, copolymer

9 +

95800 - Vinylidene chloride copolymers

9 +

95810 000088-12-0 Vinylpyrrolidone Same 26230 4A Same references as 26230 http://europa.eu.int/comm/food/fs/sc/scf/out140_en.pdf

+

95820 - Vinylpyrrolidone-methacrylic acid, esters with alcohols aliph.,monoh.,sat.(C1-C18), copolymers

9 +

95830 - Vinylpyrrolidone-vinyl acetate and/or vinyl propionate, copolymers

9 +

95835 003039-83-6 Vinylsulphonic acid, sodium salt

W +

95840 see 95905 D +

95855 007732-18-5 Water Same 26360 DIR In compliance with the 0 Specification: Impurity levels not to exceed + +




AND SPECIFICATIONS


296

Directive 98/83/EC. those set in the Drinking Water Directive.

95857 - Waxes=mineral hydrocarbons (only for documents allocation)

D +

95859 - Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks


2 Group ADI = 20 mg/kg bw for waxes conforming to the following specification: Viscosity not less than 11 centiStokes at 100°C; Carbon number not less than 25 at the 5% boiling point. Average molecular weight not less than 500. (SCF, 37th Series, 1997)

+ +

95860 - Waxes, natural D + +

95870 - Wheat protein 0 +

95880 008042-47-5 White mineral oil Same 95882 9 + +

95881 - White mineral oil (hydrogenated)

D + +

95882 008042-47-5 White mineral oil (conventional)

Same 95880 D +

95883 - White mineral oils, paraffinic, derived from petroleum based hydrocarbon feedstocks


2 Group ADI = 4 mg/kg bw for oils conforming to the following specifications: Viscosity: not less than 8.5 centiStokes at 100xC; Carbon number: not less than 25 at the 5% boiling point; Average molecular weight: not less than 480. (SCF, 37th Series, 1997)

+ +

95890 008002-74-2 White soft paraffin D +

95905 013983-17-0 Wollastonite DIR 3 Inert material. + +

95920 - Wood flour and fibers, untreated

DIR 3 Inert material. +

95921 - Wood flour and fibers 9 Confirmed. +

95935 011138-66-2 Xanthan gum DIR 1 ADI : not specified. (JECFA, 30M., 1986).

+ +

95945 001330-20-7 Xylene Same 26370 3 Group R: 0.02 mg/kg bw (with 95947,95949,95951) based on allowing 1/10 of TDI for food contact

+ +


AND SPECIFICATIONS


297

materials. 2-year oral rat study, mutagenicity test negative. (WHO draft, Geneva, September 1952)(CS/PM/1712).

95995 001318-02-1 Zeolites Ex 86427 W +

95995/1 - Zeolite A, silver Same as 86437

+

96000 - Zinc alkylaryldithiocarbamate

9 +

96080 - Zinc dialkyldithiocarbamate

9 +

96160 000136-23-2 Zinc dibutyldithiocarbamate

8 +

96180 - Zinc dust 2 Group TDI= 1 mg/kg b.w.(as Zn) based on JECFA PMTDI= 1 mg/kg b.w. (as Zn)(JECFA, 26M, 1982).

+

96190 020427-58-1 Zinc hydroxide DIR 2 Same as for 96180. + +

96200 055799-16-1 Zinc hydroxyphosphite 2-3 L2 for Zn For Zinc the same reference as for 96180. L3 for phosphite. Phosphite easily oxidised to phosphate.

+

96220 000557-09-5 Zinc octanoate D + +

96240 001314-13-2 Zinc oxide DIR 2 Same as for 96180. + +

96280 009010-69-9 Zinc salt of resinic acids Same 83880 D +

96320 001314-98-3 Zinc sulphide DIR 2 Same as for 96180. + +

96400 053801-45-9 Zirconium oxide 7 L7 for zirconium. See references for 54220.

+

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