1 EU food legislation affecting polyols EPA Technical Meeting – 9 March 2010 - Brussels.

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EU food legislation affecting polyols

EPA Technical Meeting – 9 March 2010 - Brussels

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New Regulation on food additives – implementing measuresAnnex II - Food Categorisation System & transfer of polyolsAnnex III - Additives in polyolsRevision of purity criteria for polyolsReview of EFSA guidelines for R.A. of additives

EFSA re-evaluation of polyols

Claims related to polyolsArticle 13.1 claimsNutrition claims

Review of labelling legislation – definition of polyols

Falsified medicines & pharmaceutical excipients

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New Regulation on food additivesImplementing measures

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Regulation Food Additives – implementation Annex II - Food Categorisation System

Timeframe

October & November 09: EPA comments on draft populations sent to Sanco End March 2010: first consolidated draft – for informal consultation until end April June 2010: presentation to Advisory Group – Formal public consultation September 2010: finalisation Community List October 2010: final consultation with MS in WP November 2010: EC Interservice consultation January 2011: presentation & possible vote at SCFCAH EP scrutiny (2 months) May 2011: adoption by Commission June 2011: publication in OJEU of a Regulation amending Regulation (EC) 1333/2008

Consideration of polyols Sanco is affirmative that polyols used for their non-sweetening properties are included in

Group I additives (i.e. QS additives)

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Regulation Food Additives – implementationAnnex III - Additives in polyols

PRO MEMORIA

Aim: population of Annex III – Part 2 “additives in additives”

Additives in polyols – request for “extension” of use sent to DG Sanco on 6 November 2008

Additives other than carriers in the following polyols:E 420 (i) sorbitol E 421 mannitolE 965 (i) maltitolE 967 xylitolE 968 erythritol

E N° Name Use as Maximum level of use (g/kg)

E 341 (iii) Tricalcium phosphate Anti-caking agent

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E 551 Silicon dioxide Anticaking agent

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E 552 Calcium silicate Anticaking agent

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E 553a (i) Magnesium silicate Anticaking agent

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E 553 a (ii) Magnesium trisilicate Anticaking agent

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E 553 b Talc Anticaking agent

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PRO MEMORIA

First feedback from Sanco in November 2008: EPA submission receivable Generalisation of the approach to all polyols possible:

to be in line with the “polyols” group of Annex II to future proof the entry, should a brand new polyol (powder) be authorised:

Polyols E341 iii, E551, E552, E553a, E553b @ 10 g/kg (as anticaking agents)

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1 December 09: first Sanco Ad hoc WG meeting Additives in Annex I of Dir 95/2/EC are authorised in additives and in enzymes List of questions on the use of certain conditionally permitted additives EPA submission (with indication maximum levels) slipped out of the review

further to Sanco turnover – Re-sending in December 2009 – seems now to be OK, except maybe for E 341 because estimated high intake. Potential contribution to the total dietary intake of E 341 through polyols may be expected.

Silicates (E 552-553): The WG agreed to maintain silicates as carriers and to introduce them as well in the list of additives in additives

28 Jan 10: 2nd Sanco Ad hoc WG meetingNo specific question related to polyols

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PRO MEMORIA

Next steps: Adoption by SCFCAH EP scrutiny (2 months) Adoption by Commission Regulation amending Regulation (EC) 1333/2008 - Date of application: 1 January

2011

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Regulation Food Additives – implementationRevised purity criteriaPRO MEMORIA

Mid-December 08: EPA required changes were included in the ELC consolidation document sent to Sanco

June 09: EPA conf call with Sanco to explain the rationale behind the required changes, which are found “reasonable” by Sanco

WG Sanco/MS Impact of Nanotechs discussion wrt size? ELC paper to oppose inclusion of

size in specs of non-nano additives

Adoption of Regulation by June 2011 (along with Annex II)

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Regulation Food Additives – implementationReview of EFSA guidelines for R.A. of additives

As all food additives, polyols developed in future may have to comply with safety criteria different from the safety criteria in place today (assessment according to 2001 SCF guidelines)

July 2009: publication of EFSA general data requirements for risk assessment of food additives (consultation of ELC in March 09)

Inclusion of these data requirements in the Commission guidelines for authorisations of additives, to be available by 16 Dec.2010 at the latest

EFSA in depth review of the guidelines for R.A. of additives (genotoxicity, toxicokinetics, nanotechs…): by July 2011 - public consultation organised in 2010

PRO MEMORIA

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SCFCAH 8 Feb 2010: adoption of Regulation on re-evaluation programme of food additives

All sweeteners (polyols & IS) re-evaluated by 31 December 2020

BUT…

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EFSA re-evaluation of polyols23 Nov. 2009: EFSA calls for information data on:

Preservatives & anti-oxidantsRe-evaluation programme: shall be evaluated by 31.12.2013Deadline for preliminary information to EFSA: 23 Feb 10, + 2 months (exceptionally) Deadline for EFSA to receive additional info: Dec. 2011

Emulsifiers, stabilisers and gelling agentsRe-evaluation programme: shall be evaluated by 31.12.2016Deadline for preliminary information to EFSA: 23 Feb 10, + 3 months (exceptionally)Deadline for EFSA to receive additional info: Dec. 2012

Waxes (re-evaluation programme: shall be evaluated by 31.12.2018)

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EFSA re-evaluation of polyols Format of the EFSA calls for information - Two-step approach:

First step

3 months to register the contact details of the interested party and to provide a description of the information available (using a pre-defined template)

Second step

20 working days to provide hard and/or electronic copies of the data selected by EFSA

+ additional EFSA/applicant exchanges on the information provided.

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EFSA re-evaluation of polyolsArea of Information (as far as possible the areas of information covered should be defined with reference to the applicable guidance document on food additives: SCF 2001 guidance document)

Type of information please choose from drop down menu in

each cell (Published or

unpublished data - previously evaluated

or not)

Confidential information

please choose from drop down

menu in each cell

(Yes or No)

Description of information Comments

Chemistry & Specifications (e.g. JECFA specifications, analytical results, etc)

at least a summarised description of the studies/reports/data and, if possible, also

the corresponding references

Published data/Previously evaluated

NO


NO

Manufacturing process (e.g. description of manufacturing process, raw materials etc)

at least a summarised description of the studies/reports/data and, if possible, also the corresponding references


No


No

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or not)



menu in each cell

(Yes or No)


Determination in food (e.g. analytical method etc)



NO


NO

Reaction and fate in food (e.g. stability studies etc)



No


No

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or not)



menu in each cell

(Yes or No)


Present Usage (e.g. typical use levels per food category, maximum use levels etc)

at least a summarised description of the studies/reports/data and, if possible, also the

corresponding references


NO


NO

Exposure (e.g. exposure assessment report, scientific publications, etc)



No


No

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unpublished data - previously

evaluated or not)



menu in each cell

(Yes or No)


ADME (Metabolism – Toxicokinetics)



NO


NO

Subchronic toxicity at least a summarised description of the studies/reports/data and, if possible, also the corresponding references


No


No

Genotoxicity (e.g. chromosomal aberrations etc)



No

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unpublished data - previously

evaluated or not)



menu in each cell

(Yes or No)


Chronic toxicity & carcinogenicity (e.g. long-term toxicity, carcinogenicity etc)



NO


NO

Reproduction & Developmental toxicity



No


No

Other studies (e.g. immunotoxicity, allergenicity etc)



No

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EFSA re-evaluation of polyolsArticle 6 - Regulation on re-evaluation programme:

“In the framework of the re-evaluation of a food additive, the interested business operator(s) or any other interested party shall inform EFSA and the Commission of any information relevant to any environment risks from the production, use or waste of that food additive”.

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EFSA re-evaluation of polyolsThe most difficult info for EFSA to retrieve is the original study reports:

• SCF archives not available anymore

• JECFA archives: 5 years back max

• WHO: some original dossiers may be available but not easy to obtain

• MS?

• FDA?

• Lot of BIBRA information lost during the transfer to TNO

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EFSA re-evaluation of polyols Time to start at EPA?

Collect information - review of existing studies, use REACH data EPA 31/09

Undertake gap analysis Continue intake assessment study

Shall we set up a WG to start working on it?

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Claims related to polyols- Article 13.1 claims

- Nutrition claims

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Article 13.1 claims related to polyolsSubstance Health relationship Compliance

with EFSA pre- screening (19 Jan. 09)

EFSA opinion

ID 618/2907 - Polyols Remineralisation of teeth OK In progress

ID 619 - Polyols Low glycemic properties OK In progress

ID 463 - Carbohydrates – non cariogenic e.g. isomaltulose, tagatatose, polyols, polydextrose. Absence of, or low fermentable carbohydrates

Dental health OK In progress

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Article 13.1 claims related to polyolsPRO MEMORIA

June 2009: Sanco ad hoc WG on Art. 13 claimsNon cariogenic claims generally not sufficiently characterised to allow an assessment of

the claimed effectLow GI carbohydrate claims: lack of internationally recognised methods for

characterising GI indexDental health/non cariogenic claims are comparative claims

Eligibility to EFSA evaluation was questioned

Withdrawal of these claims from the list of claims to be evaluated by EFSA was considered

Request to MS to confirm eligibility of these claims

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Article 13.1 claims related to polyols August – Oct 2009: EPA position papers & lobby

10 Nov. 09: EC confirmed eligibility of comparative claims to EFSA assessment

FSA report Feb.10: « MS have been unable to submit further clarification in support of the comparative claims so the additional information submitters sent to the Agency (i.e. FSA) to define the comparator for these claims has not been passed to EFSA. EFSA will assess these claims based on the information of the original application. »

Subsequent EPA’s request to MS and Sanco to send to EFSA the additional information provided by EPA on 1 Sept & 2 Oct 09

1 March 10: Sanco refuses to forward EPA clarification responsibility of MS

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Article 13.1 claims related to polyolsGeneral overview of the process

1 October 2009: publication first batch: 94 opinions covering 523 claims adopted on 2 July January 2010: publication by EFSA of list of 621 claims for which MS have not provided by June

2009 the clarification required by EFSA (EPA entries not in because eligibility of assessment was still questioned at that time) + 123 entries withdrawn upon MS request

25 February 2010: publication 2nd batch July 2010: publication 3rd batch? 2011: completion of work? (additional claims expected from MS) Community Register of (rejected/permitted) health & nutrition claims up and running on Sanco’s

website but does NOT include Article 13.1 claims (Sanco is working on Regulation for permitted claims as a priority for the new Commissioner: first draft in April/May?)

In the meantime, claims may be made under the responsibility of the business operator provided that they comply with Regulation (EC)1924/2006 – non misleading

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Article 13.1 claims related to polyolsTowards some opening of the process?

EC proposed that applicants may have the possibility in certain cases (e.g. emerging evidence/conflicting evidence/insufficient characterisation of microorganisms…) to present additional data via the EC.

Such option was presented to MS on 22 Feb and most of them were in principle in agreement on the possibility to allow for missing evidence or data to be provided by the operators

Still under discussion.

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Article 13.1 claims related to polyolsPRO MEMORIA

2010: if my polyol-related claim is accepted, what are the products that are allowed to bear it?

Nutrients profile (for nutrition (?) and health claims)Draft proposal Feb 2009: end IS consultation 2 March 3 negative opinions: SG, DG

Agri, DG EntAutumn 09: still under IS consultation – highly political – when (if) will it be

published?Application to nutrition claims: subject to legal interpretation (industry/EC). Not

submitted for decision by SCFCAHDiscussion due to resume now that the new Commission is up and running

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Article 13.1 claims related to polyols

Possible impact of nutrients profile on the use of polyols In latest drafts (Feb & 17 March 09), confectionery falls under “other foods”:

10 g/100 g sugars2g /100 g saturated fatty acids300 mg/100 g sodium

Polyol-related health claims & chocolate re. SFAs Double labelling: “Protect teeth” & “High SFAs content”Interest for chocolate manufacturers???

Polyol-related nutrition claims (Annex I)“With no added sugars” “Sugars-free”OK interpretation that no need to mention SFAs content in this case. This is industry’s

interpretation, not necessarily all MS interpretation.

PRO MEMORIA

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Nutrition claims related to polyolsProposed amendments to Annex on nutrition claims of Regulation (EC)

1924/2006:With no added sugars: « A claim stating that sugars have not been added to a food,

and any claim likely to have the same meaning for the consumer , may only be made where the product does not contain any added mono- or disaccharides or any other food used for its sweetening properties except sweeteners as defined by Directive 94/35/EC. If sugars are naturally present in the food at a concentration higher than 0.5/100g or 100 ml, the following indication (should) shall also appear on the label: « contains naturally occuring sugars »

Reduced [name of the nutrient] & energy-reduced claims: 25 instead of 30 %

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Nutrition claims related to polyols

Adoption procedure: comitology with scrutiny (3 months)Discussion started in autumn 20091st amendment wrt omega 3 and unsaturated fats claims published in Feb

2010

Regulation updating the Annex : SCFCAH in March 2010 or later (pbs in IS consultation wrt legal aspects of « comparative claims » e.g. « now 10 % sugars less » in framework of Regulation (EC) 1924/2006.)

Both nutrition & health claims shall enter the Community Register:http://ec.europa.eu/food/food/labellingnutrition/claims/community_register/index_en.htm

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Review of labelling legislation

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Review of labelling legislationFirst reading (co-decision procedure)

EC « Poyols means alcohols containing more than two hydroxyl groups »

EP ENVI Committee Amdt 533 in draft report (H. Schnellhardt): definition of polyols « Polyols are defined as carbohydrates which are reduced mono-, di-, oligosaccharides or

polysaccharides and which are listed as permitted sweeteners » EP AGRI Committee (adopted opinion)

Amdt 94: « natural sugars » means monosaccharides and disaccharides naturally present in the food

Amdt 95: « added sugars » mans monosaccharides and disaccharides used as sweeteners Council (on-going discussion)

Polyols « covered by legislation » means alcohols containing more than two hydroxyl groups (footnote - stbc)

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Review of labelling legislationLobby:

EPA voting recommendations sent via e-mail + post mail (with brochure on polyols) to 38 MEPs of ENVI Cttee in February, including to:

Rapporteur (R. Sommer) Shadowrapporteurs

Gerben-Jan Gerbrandy (ALDE, NL) Glenis Willmott (S&D, UK) Stuan Stevenson (ECR, UK)

Inclusion in ELC voting recommendation to ENVI MEPsAddressed by ELC in meetings with MEPs: Sommer, Gerbrandy, SchnellhardtELC voting recommendation sent to CIAA for information Support to revision of definition included in ELC (final) letter to Spanish Presidency

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Review of labelling legislation Timetable – 1st reading

16 March 2010: ENVI vote

14 June 2010: Plenary vote

First reading agreement with Council is unlikely 2nd reading

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Falsified medicine & excipients

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Falsified medicines & excipientsProposed Directive amending Directive 2001/83/EC as regards the prevention of the entry

into the legal supply chain of falsified medicinal productsDraft Report ENVI (Matias amendt Jan 09)

Pharma excipients shall be subject to the same conditions of GMP and GDP than APIs /medicinal products

IPEC Europe GMP and GDP requirements for excipients should not be more demanding on the industry

than the current widely-accepted IPEC-PQG GMP and IPEC GDP guidelines

ELCGMP and GDP shall not be required for food grade excipients because their safety is already

guaranteed by EU legislation and food certification systems

CEFICGMP and GDP shall not be required:

for food grade excipients (food safety system already in place) for cosmetic ingredients (GMP guidelines already in place) for any other excipient that comply with IPEC- PQG GMP and IPEC GDP guidelines

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Falsified medicines & excipientsAdditional amendments to Draft Report ENVI – 3 March:

????? Not yet available

Timetable EP:6 April: adoption of ENVI report June: adoption in EP Plenary (indicative)

Council: proposed a definition for excipients (Sp. Pdcy) – not opposed to extension of the scope to excipients

1 EU food legislation affecting polyols EPA Technical Meeting – 9 March 2010 - Brussels.

Documents

additives additives

list of additives

authorisations of additives

qs additives

additives genotoxicity

wg meeting additives

polyols possible

polyols group of annex