Section8 - European Commissionec.europa.eu/environment/archives/enlarg/handbook/gmo.pdf · Chemicals and Genetically Modified Organisms - Overview 917 The Asbestos Directive 941 Decision

Section 8CHEMICALS AND GMO LEGISLATION

SECTION 8 – CHEMICALS AND GMO LEGISLATION

Handbook on the Implementation of EC Environmental Legislation 915

List of Contents

Chemicals and Genetically Modified Organisms - Overview 917

The Asbestos Directive 941

Decision on the Montreal Protocol (Depletion of the Ozone Layer) 947

The Regulations on Ozone Depleting Substances 953

The Biocides Directive 961

The Regulation on the Export and Import of Dangerous Chemicals 969

Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 979

The Directive on Contained Use of Genetically Modified Organisms 987

The Genetically Modified Organisms Deliberate Release Directive 995

The Directive on the Protection of Animals Used for Experimental and Other Scientific Purposes 1009

The Directive on the Inspection and Verification of Good Laboratory Practice 1015

The Directive on the Application of the Principles of Good Laboratory Practice 1021

SECTION 8 – CHEMICALS AND GMO LEGISLATION

916 Handbook on the Implementation of EC Environmental Legislation

SECTION 8 – CHEMICALS AND GMO LEGISLATION CHEMICALS AND GENETICALLY MODIFIED ORGANISMS - OVERVIEW


Chemicals and Genetically Modified Organisms -

Overview

1. Introduction and Overview

This section of the Handbook deals with EC legislation related to chemicals and genetically modified organisms. It contains an introductory overview of the sector followed by individual fiches for selected pieces of legislation.

1.1 EU Policy

The adoption of the directive on the classification, packaging and labelling of dangerous substances (67/548/EEC) provided the first controls over the use of hazardous chemicals. It established a common system for the classification and labelling of such substances before they are marketed, and laid down procedures to be used to establish the physico-chemical properties and hazards to human health and the environment of substances that might present a risk under conditions of normal usage. The directive has undergone a number of amendments reflecting changes to its scope and purpose. It has also undergone numerous “adaptations to technical progress” (ATPs) by means of Commission directives that implement and change items of a more technical nature from within the directive and its major amendments. The broad thrust of this legislation is to establish a common system across EU Member States and so prevent barriers to trade by the introduction of different national standards.

As first conceived, the directive on the classification, packaging and labelling of dangerous substances was concerned with specifying and providing a warning system for certain classes of intrinsic hazard, pertaining to chemical substances. These hazards were, in the first instance, related either directly to human health (toxicological properties) and later on also to the environment, or indirectly to the risk to humans from so-called physico-chemical properties such as flammability or explosivity. In this context, the directive (that is, all the various amendments and ATPs) lays down specific classes of hazardous property and also specific criteria and specific test methodology by which it may be ascertained whether the substance in question should be classified. Once a hazard is identified, the directive lays down how the substance shall be labelled to warn the user of the hazard and in some cases how the substance shall be packaged to reduce the hazard to specific parts of the population (for example, to children or the blind).

Annex I is the sole basis on which hazard labelling is applied to a listed substance within the EU. For substances not listed in Annex I, there is a requirement that the manufacturer determines



what is known about the substance and then applies the classification, packaging and labelling rules within the directive before continuing to market the substance.

Under Directive 67/548/EEC (as amended) there are currently 15 classes of danger examples, among them “explosive”, “very toxic”, “carcinogenic” or “dangerous for the environment”. Annex I includes the list of substances classified as dangerous. Danger symbols (such as a skull and crossbones) are applied to substances in Annex II. Standard phrases on the nature of special hazards from substances (R-phrases, “risk phrases”) appear in Annex III. The wording of safety phrases (S-phrases) relating to the handling and use of dangerous substances is found in Annex IV. Annex V contains testing methods to determine the dangerous properties of substances. Annex VI provides detailed criteria on the proper choice of the class of danger and on how to assign the danger symbols and R- and S-phrases to a tested substance. Annexes VII and VIII do not relate to the classification or labelling of substances, but to the notification of “new” substances. Annex IX includes provisions on childproof fastenings and tactile warning devices including special packaging and labelling elements.

The sixth amendment of the directive (79/831/EEC) introduced for the first time requirements for the notification of new substances. The purpose of this is to gather information on each substance placed on the market in the EU including its identity and its (eco)toxicological and physico-chemical characteristics. The European Commission has developed two lists for the purposes of the directive: the European Inventory of Existing Chemical Substances (EINECS) and the European List of New Chemical Substances (ELINCS). EINECS was published in 1990 and lists all substances placed on the market in the EU before 1981. ELINCS is also published regularly in the Official Journal of the European Communities and contains substances placed on the market for the first time since 1981.

The sixth amendment also introduced for the first time the classification “dangerous for the environment”, which was brought into effect with the publication of the criteria for this classification in the 18th ATP (93/21/EEC). As part of the notification procedure, substances are considered for classification (including the classification “dangerous for the environment”). If classified, the classification decision becomes included in Annex I of the directive.

The seventh amendment of the directive (92/32/EEC), besides harmonising the requirements for the notification of small quantities of new substances, also introduced the requirement that the data obtained in the notification process should be used to assess the risk of the substance to humans and the environment. This requirement was implemented by Directive 93/67/EEC on the principles of risk assessment of new chemicals.

The term “European Economic Community” was replaced by “European Community” in the eighth amendment of the directive (96/56/EC), to take account of the due modification of the treaty.

Finally, the ninth amendment accorded derogations as regards the labelling of certain dangerous substances in Austria and Sweden until 31 December 2000.

The directive is continually updated to take account of scientific and technical progress in the field of dangerous substances. To date (2008) it has been amended nine times and adapted to technical progress 29 times.

As indicated above, Directive 67/548/EEC, through its subsequent amendments, has requirements to develop data and perform risk assessments for new substances. The Existing Substances Regulation (ESR, EEC/793/93) brought into effect a system whereby all existing substances, manufactured or imported above certain tonnage thresholds, had to be reported to the Commission. Among other requirements, this report must include the amount manufactured/imported, all available data on physico-chemical, toxicological and ecological studies and the manufacturer’s classification and labelling proposals (if the substance is not listed in Annex I of Directive 67/548/EEC). Based on this information, together with the views expressed by Member States, the EU required the producing of formal lists of “priority” chemicals. Four such priority lists (around 140 substances in total) have been decided during the time the ESR has been in force.



A Member State rapporteur is allocated to each priority chemical and this rapporteur has the task to evaluate the risks to humans and the environment. Following the discussion and finalisation of the rapporteur’s risk assessment report by the Member States, a decision is taken as to which measures should be taken in order to minimise the risks of the substance (this means also possible restrictions on the marketing and use of the substance).

The Directive on Dangerous Preparations (1999/45/EC) specifies the hazard classification, packaging and labelling requirements for chemical preparations (mixtures or solutions composed of two or more substances). When a dangerous substance is used as part of a preparation, the producer is required to determine or calculate the content and apply the correct classification and labelling. The directive does not apply to articles in finished states, intended for the final user, or to the carriage of dangerous preparations or those in transit under customs supervision.

The directive identifies the methods for determining the dangerous properties of preparations and lists general principles of classification and labelling depending on the degree and specific nature of the hazards involved. It also sets out procedures for evaluating health and environmental hazards. Member States must take measures to ensure proper packaging and labelling, and ensure that the persons responsible for placing the preparation on the market provide the requisite data sheet. Member States must also appoint a body responsible for receiving information relating to preparations. They may also provisionally prohibit the placing on the market of a preparation or subject it to special conditions in their territory. If this is done, the Member State must immediately inform the Commission and other Member States of such action and provide reasons for the same.

As the existing substances programme under the ESR did not fulfil expectations, and since progress was very slow for several reasons, critics from all involved parties initiated a discussion about a comprehensive revision of the complete chemicals policy in the EU. After a study of the main legal instruments for chemicals management in the EU (Directives 67/548/EEC, 1999/45/EC and 76/769/EEC, Regulation (EC) 793/93) and the white paper on the new chemicals policy, both provided by the European Commission, in 1993 the Commission adopted a legislative proposal for a new regulation on the registration, evaluation, authorisation and restriction of chemicals (REACH).

This regulation introduces a unique system for new and existing substances, strengthens innovation, puts in practice the precautionary principle and the “no data no market” rule, shifts responsibility from authorities to industry and puts more emphasis on risk management than scientific accuracy. The last point regarding risk management has the following implications:

• effective measures for “substances of very high concern”;

• joint use of data;

• high degree of flexibility using available information should reduce animal testing;

• new instruments to enhance workplace safety;

• intensive communication within the supply chain in both directions;

• involvement of the downstream users should improve the safety in handling and use of chemicals in particular at the workplace.

After the legal process between 2004 and 2006, the REACH Regulation ((EC) 1907/2006) entered into force on 1 June 2007. Most of the provisions will be applied at a later stage, mainly from 1 June 2008. As of this date, Regulation (EC) 793/93 (ESR) will be repealed as well as the provisions of Directive 67/548/EEC relating to the notification of new substances. One year later, the Limitations Directive (Directive 76/769/EEC) will be replaced by the restriction part of the REACH Regulation.

The provisions concerning classification and labelling in Directive 67/548/EEC and Directive 1999/45/EC will remain until they are replaced by a new regulation that is currently being negotiatied in the first reading of the co-decision procedure (the CLP Regulation).



There are several other regulations related to the REACH Regulation (No. 1907/2006), listed further in this section of the Handbook covering the risk assessment and control of existing substances. However, it should be noted that there are additional legal instruments not included in earlier versions of this Handbook. Commission Regulation (EC) 2592/2001 imposes further information and testing requirements on the manufacturers or importers of certain priority substances in accordance with the REACH Regulation (No. 1907/2006). Commission Regulation (EC) No. 1217/2002 requires importers or manufacturers of certain EINECS substances to supply certain information and perform certain tests pursuant to the REACH Regulation (No. 1907/2006).

Although the sale to developing countries of chemicals, particularly pesticides that were banned in developed countries, became an issue in the 1970s with a call for “prior informed consent” (PIC) before export, the European Community did not place controls on exports until 1988. The first regulation ((EC) 1734/88) was replaced in 1992 by Regulation (EC) 2455/92 (since amended), which requires importing countries to be informed before exports are made of a number of substances banned or severely restricted in the EU. In addition, exports may not be made to countries participating in the “prior informed consent procedure” established by UNEP and FAO without the countries’ specific consent.

Commission Regulation (EC) 300/2002 amends Annex II of Council Regulation (EEC) 2455/92 (further to Art. 5(3)) and replaces the previous Annex II list of chemicals in accordance with the international PIC procedure and the PIC decisions of participating importing countries in Annex II. The amendments reflect the opinion of the committee established by Article 29 of Council Directive 67/548/EEC and is based on PIC Circular XIII (June 2001).

The introduction of restrictions on the marketing and use of substances is an example of the “substance-orientated approach” to chemicals control. This approach was put forward in the Fourth Environmental Action Programme, and early examples of such an approach were the directives on the prevention and reduction of environmental pollution by detergents (73/405/EEC, 82/242/EEC and 82/243/EEC) and by asbestos (87/217/EEC), which were aimed at controlling pollution of air, water and land by detergents and asbestos. (Although the detergent directives are still in force, they are largely historical.) Similarly, Regulation (EC) 2037/2000, amending (EC) 3093/94, aimed to combat ozone depletion by placing restrictions on the production, sale and use of ozone-depleting substances.

This latter regulation ((EC) 3093/94) has since been replaced by Regulation (EC) 2037/2000, which is the European Union's current legislative instrument to phase out ozone-depleting substances (ODSs). This regulation introduces measures which are stricter than those provided for in Council Regulation (EC) 3093/94 and stricter than those of the Montreal Protocol.

ODSs covered by the regulation are identified as controlled substances in line with the definitions of the Montreal Protocol. The regulation includes controls on production, importation, exportation, supply, use leakage and recovery of controlled substances. It also establishes a licensing procedure for all imports of ODSs.

Amendments to Regulation (EC) 2037/2000 comprise Regulation (EC) 2038/2000 of the European Parliament and of the Council of 28 September 2000 as regards metered dose inhalers and medical drug pumps; and Regulation (EC) 2039/2000 as regards the base year for the allocation of quotas of hydrochlorofluorocarbons.

Four Decisions further elaborate upon Regulation (EC) 2037/2000. Commission Decision 2002/612/EC lists the quantity of controlled substances in groups I-V and VII that may be used for essential medical and laboratory uses (although this has been changed in every previous year and can be expected to change for every following year). Commission Decision 2002/654/EC specifies the methodology for determining the consumption quantity of hydrochlorofluorocarbons by use of individual production and importation quotas and Decision 2003/256/EC also allocates yearly import quotas for controlled substances under Regulation (EC) 2037/2000. Commission Decision 2003/160/EC regulates the use of halon 1301 and 1211.



Given the potential hazards of chemicals, a central requirement of the European Community chemicals legislation is the obligation to conduct thorough high-quality safety tests before a new chemical product may be placed on the market. Whilst this legislation lists the methods that should be used to conduct these tests it does not make any general provisions relating to laboratory practices. Therefore, the need arose to introduce a system providing for mutual recognition of safety data in order to avoid the duplication of safety tests on chemical products due to differences in laboratory practices from one Member State to another.

Such a system of mutual recognition must be based on a scheme guaranteeing the reliability and high quality of safety data. Under the auspices of the OECD, good laboratory practice (GLP) principles have been developed to promote the quality and validity of test data used for determining the safety of chemicals and chemical products. Through Council Directive 87/18/EEC and Council Directive 88/320/EEC, the GLP principles were integrated into European Community legislation. Moreover, it was considered necessary to monitor the activities of laboratories conducting safety tests for regulatory purposes. Therefore, Council Directive 88/320/EEC requires Member States to set up a monitoring authority to inspect all laboratories claiming to apply GLP principles and to verify whether the tests are actually conducted in compliance with GLP principles. The purpose of this system of mutual recognition is twofold: first, the abolition of non-tariff barriers impeding trade between Member States; and secondly, the guarantee of a high degree of protection of human health and the environment.

Although Council Directive 86/609/EEC (as amended by Directive 2003/65/EC) also deals with certain aspects of safety tests required under European Community chemicals legislation, it is mainly concerned with the harmonisation of the protection of animals used for certain experimental purposes. The significant differences between the legal systems of Member States with respect to the protection of animals used for experimental purposes presented a risk of distorting the functioning of the internal market. Another major aim of the directive is the reduction of the number of animal experiments. This should be achieved by the mutual recognition of test results.

Compared to the legislation on chemical control, concern about the environmental hazards of genetically modified organisms (GMOs) is more recent. Initial concerns in the early 1970s, when the potential of genetic engineering became apparent, were directed at potential risks to people, specifically laboratory staff dealing with GMOs in research and development. Such concerns led to an initial scientific and public discussion on the potential risks of GM technology (e.g. at the Asilomar conference in 1975). However, these concerns subsided when measures to control GMO hazards by containment were introduced, for example with safety guidelines for work with GMOs (first developed by the US National Institutes of Health). In recent years, concerns about the potential risks of releasing GMOs, especially GM plants, into the environment have been expressed by environmental non-governmental organisations (NGOs). These concerns are shared by a substantial part of the general public and taken into account by governments.

As a result of the public interest in GMOs, the area is highly politicised. This is specifically true for the deliberate release of GMOs into the environment and GM food and feed applications (so-called green biotech applications), as well as for the genetic modification of animals. Medical applications of biotechnology (so-called red biotechnology) are less contentious in terms of the public and politics.

Legal control of GMOs by European legislation, however, is based on whether the GMO is intended for contained use or for deliberate release into the environment and, if intended for deliberate release, whether it is for the purposes of research and development or the placing on the market of products containing GMOs.

The Contained Use Directive (Directive 98/81/EC, amending Directive 90/219/EEC) covers the human health and environmental risks associated with applications of GMOs and specifically genetically modified micro-organisms (GMMs) in contained facilities. GMMs are defined as being any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. The directive covers only applications of GMMs that do not



comprise any intentional release into the environment. Thus it is concerned mainly with the classification of GMMs into several risk classes and containment measures for GMMs according to their risk classification.

Commission Decision 2000/608/EC concerning guidance notes for risk assessment under the Contained Use Directive has been created for the purpose of codifying a risk assessment process which requires the application of two procedures.

Procedure 1 requires the initial assessment of the potential harmful properties of the GMM and the allocation to an initial risk class (classes 1-4) based on the severity of the potential harmful effects. This is to be followed by an assessment of the risk of harmful effects, as a prerequisite to the appropriate allocation of containment measures.

Under Procedure 2, the final classification of specific GMMs is determined, along with the actual containment measures required for their use.

The Deliberate Release Directive (Directive 2001/18/EC amending Directive 90/220/EEC) covers the human health and environmental risks associated with the deliberate release into the environment of genetically modified organisms, defined as being any biological entity capable of replication or of transferring genetic material in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. The directive lists techniques that lead to genetic modification as well as techniques that do not lead to genetic modification in the sense of the directive.

The Deliberate Release Directive is based on the application of the precautionary principle concerning risk assessment and possible authorisation for use of GMOs. It imposes different requirements for deliberate releases of GMOs for research and development purposes (releases according to Part B of the directive) and releases for the placing on the market of products containing GMOs (releases according to Part C of the directive). The provisions relating to the placing on the market of products containing GMOs do not apply to products covered by other pieces of Community legislation, for example GM food and feed products (which are regulated by Regulation (EC) 1829/2003) and medical products containing GMOs. However, these specific regulations need to be based on the same principles as, and stipulate similar requirements to, Directive 2001/18/EC. Specifically, they need to provide for a risk assessment similar to the assessment as outlined by the Deliberate Release Directive.

Both Directive 98/81/EC and Directive 2001/18/EC use terms such as “harm” and “environment”, which are not very well defined and thus need to be interpreted by individual Member States in a way compatible with the spirit and wording of the directives. Both directives include procedures for adapting the technical annexes in the light of the development of the scientific state of the art.

Harm to the environment is meant to be interpreted widely and thus covers also indirect and cumulative long-term effects of releases of GMOs, and the consequences to wildlife of growing herbicide-tolerant GMO crops upon treatment with the respective herbicides. Harm to people refers to direct and indirect risks for human health. Some Member States furthermore wish to include ethical, social and economic considerations in their assessments of specific GMOs, while others do not.

As a result, the assessment of specific GMOs may differ between different Member States. This can create specific problems with respect to EU-wide approval concerning the placing on the market of GMOs. Therefore the introduction of adequate guidance — for example for the risk assessment process — is crucial for the implementation of the regulation. Accordingly, Directive 90/220/EEC was repealed by Directive 2001/18/EC and further clarifications were introduced with subsequent amendments and decisions (see chapter on Directive 2001/18/EC).

While the primary aims of Directive 2001/18/EC remain much the same as those of Directive 90/220/EEC, it improves and strengthens certain deliberate release requirements, including, in particular, those related to risk assessment, monitoring, public information and consultation, labelling and the traceability of GM products. The directive also clarifies the scope and definitions of the regulation, introduces a timeframe for authorisations to expire and phases out the release



of GMOs containing certain antibiotic resistance marker (ARM) genes, which may have adverse effects on human health and the environment.

This directive also implements a harmonised step-by-step approval process on a case-by-case basis for GMO releases (as did Directive 90/220/EEC). Such an assessment of risks to human health and the environment has to be undertaken before consent for release into the environment can be obtained.

The directive comprises four parts. Part A covers general provisions such as objectives and definitions; Part B covers the deliberate release of GMOs into the environment for purposes other than marketing; and Part C covers the placing on the market of GMOs as or in products. Part D contains final provisions regarding confidentiality, labelling, the consultation of committees at the EU level, and obligations of the Member States. The text of the directive is accompanied by several annexes outlining definitions as well as principles and guidance for specific procedures, such as environmental risk assessment.

1.2 EC Legal Instruments

The chemical and GMO sector considered in this Handbook, as individual fiches, covers 13 pieces of legislation, comprising nine directives, one decision and three regulations. This legislation can be subdivided into three categories — chemicals, GMOs, and good laboratory practice and animal experiments.

Legislation Covered in Separate Fiches in this Section on Chemicals and GMOs

Chemicals

• Council Directive 87/217/EEC on the prevention and reduction of environmental pollution by asbestos, as amended by Regulation (EC) 87/2003

• Council Decision 88/540/EEC concerning the conclusion of the Vienna Convention for the protection of the ozone layer and the Montreal Protocol on substances that deplete the ozone layer

• Regulation (EC) No. 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer, as amended by Regulation (EC) No. 2039/2000

• Commission Decision 2002/612/EC under Regulation (EC) No. 2037/2000 on the allocation of quantities of controlled substances allowed for essential uses in the Community

• Commission Decision 2002/654/EC under Regulation (EC) No. 2037/2000 determining a mechanism for the allocation of quotas to producers and importers for hydrochlorofluorocarbons for the years 2003 to 2009

• Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market, as amended by Regulation (EC) 1882/2003 and Directives 2006/50/EC and 2006/140/EC, Commission Directives 2007/20/EC, 2007/47/EC, 2007/69/EC and 2007/70/EC

• Regulation (EC) No. 304/2003 of the European Parliament and of the Council of 28 January 2003 concerning the export and import of dangerous chemicals, as amended by Commission Regulation (EC) No. 1213/2003 and Commission Regulation (EC) No 775/2004

• Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency

GMOs:

• Council Directive 90/219/EEC on the contained use of genetically modified



microorganisms as amended by Directive 98/81/EC, 2001/204/EC and Decision 2005/174/EC

• Commission Decision 2000/608/EC concerning guidance notes for risk assessment

• Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms, repealing Council Directive 90/220/EEC, as amended by Decision 2002/623/EC, Decision 2002/811/EC, and Regulation (EC) No. 1830/2003

Animal Experiments and Good Laboratory Practice

• Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (OJ L 358, 18.12.1986), as amended by Directive 2003/65/EC

• 1999/575/EC: Council Decision of 23 March 1998 concerning the conclusion by the Community of the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes

• Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (codified version)

• Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version)

Other legislation referred to but not separately covered:

Chemicals

• Directive on the classification, packaging and labelling of dangerous substances (Commission Directive 67/548/EEC)178

• Decision 1999/314/EC of 9 April 1999 concerning the questionnaire relating to Council Directive 96/82/EC on the control of major-accident hazards involving dangerous substances

• Decision 2002/654/EC specifying the methodology for determining the consumption quantity of hydrochlorofluorocarbons

• Regulation (EC) No 2039/2000 as regards the base year for the allocation of quotas of hydrochlorofluorocarbons

• Commission Regulation (EC) No 2364/2000 of 25 October 2000 concerning the fourth list of priority substances as foreseen under Council Regulation (EEC) No 793/93

• Commission Regulation (EC) No 2161/1999 of 12 October 1999 imposing further testing requirements on the importers or manufacturers of a certain priority substance as foreseen under Council Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substances

GMOs

• Council Decision 2002/812/EC on the summary information format relating to the marketing of genetically modified organisms as or in products

• Council Decision 2002/813/EC dstablishing a summary notification information format relating to the release of genetically modified organisms for purposes other than marketing

178 Note that this Directive will be replaced by a proposed regulation.



• Commission Decision 2003/701/EC establishing, pursuant to Directive 2001/18/EC, a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market

• Commission Decision 2004/204/EC laying down detailed arrangements for the operation of registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC

• Regulation (EC) No. 1830/2003 concerning the traceability and labelling of GMOs and the traceability of food and feed products produced from GMOs

• Regulation (EC) 65/2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms

• Commission Decision of 27 September 2000 concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified micro-organisms.

• Commission Decision 2002/623/EC establishing guidance notes supplementing Annex II to Directive 2001/18/EC.

• Council Decision 2002/811/EC establishing guidance notes supplementing Annex VII to Directive 2001/18/EC

The overall objective of all the legislation on chemicals and GMOs is to minimise risk to health and/or the environment. The GLP directives have the principle aim of ensuring that specified health, environmental and safety tests carried out in different laboratories in different countries are all performed to acceptable and audited standards. Through the OECD implementation of the mutual acceptance of data (MAD) agreement, this should ensure the worldwide acceptance of GLP-derived data, avoid the duplication of safety tests and within the EU achieve the abolition of non-tariff barriers. The mutual recognition of safety test data avoids the duplication of safety tests and, therefore, facilitates the trade in chemicals and chemical products. In contrast, one of the main objectives of Council Directive 86/609/EEC (as amended by Directive 2003/65/EC) is to minimise the suffering of animals used for experimental purposes.

1.2.1 Legislation on Chemicals

As indicated under Section 1.1, Directive 67/548/EEC has a very wide ranging scope and inter alia regulates the classification, packaging and labelling of dangerous substances for direct and indirect danger to people and danger to the environment. Regulation (EC) 300/2002 amending (EEC) 2455/92 standardises notification and information procedures for importing and exporting dangerous chemicals; and a number of regulations, primarily the REACH Regulation (No. 1907/2006), are concerned with the assessment of risks from chemicals. Directive 87/217/EEC (asbestos) and Regulation (EC) 2037/2000 (ozone-depleting substances) are primarily concerned with the environment. However, each of these measures is concerned with wider impacts than are indicated above, with environmental measures affecting public health and vice versa.

The legislation documented in this section is related to other legislation included in the environmental acquis as indicated in Table 1. Moreover, the legislation on environmental hazards of chemicals is also a subset of other legislation on chemicals. For example, the control of asbestos is the subject of several other directives aimed at protecting the health and safety of people, and their adoption has indirectly assisted environmental protection.

1.2.2 Legislation on GMOs

The principal directives within the environmental acquis at the EU level on the application of GMOs are Directive 90/219/EEC, as amended by Directive 98/81/EC on the contained use of GMOs; and Directive 2001/18/EC on the deliberate release and placing on the market of GMOs.



These two directives are closely linked with other EC legislation not covered by the environmental acquis, such as Regulation (EC) 1829/2003 on genetically modified food and feed and Council Directive 90/679/EEC on the protection of workers from risks relating to exposure to biological agents at work. Although this directive does not specifically deal with GMOs, it contains provisions on the classification of micro-organisms according to the hazards they present.

The regulations concerning GM food and feed relate to the protection of human health and to consumer information. They introduce mandatory labelling and traceability of GM products in similar ways to the provisions of Directive 2001/18/EC (amended by Regulation (EC) 1830/2003).

It is therefore important to implement the legislation discussed in the GMO section discussed in this Handbook in parallel with the above-mentioned regulations and directives (further specified in the section on Directive 2001/18/EC).

Implementation guidance notes for the risk assessment of notifications under Directive 98/81/EC and Directive 2001/18/EC are outlined in Decision 2000/608/EC and Commission Decision 2002/623/EC respectively. With Council Decision 2002/811/EC, guidance notes were established for monitoring supplementing Annex VII of Directive 2001/18/EC.

Under Part B of Directive 2001/18/EC (as amended by Decision 2002/623/EC), prior notification must be provided to the Member State’s competent authorities of applications to release genetically modified organisms into the environment for purposes other than marketing. Equally, under Part C of Directive 2001/18/EC (as amended by Decision 2002/623/EC), prior notification must be provided to the competent authority of applications to place on the market any genetically modified organisms or products containing genetically modified organisms.

The two decisions thus regulate the notification procedure for the deliberate release of GMOs into the environment for Part B and Part C releases. Notifications for marketing purposes are regulated by Council Decision 2002/812/EC and non-marketing purposes are regulated by Council Decision 2002/813/EC. These decisions specify the format (summary notification information format, SNIF) for prior notification of information to harmonise information exchange between Member States.

The results of deliberate releases of genetically modified higher plants into the environment for purposes other than placing on the market need to be notified according to Commission Decision 2003/701/EC.

Commission Decision 2004/204/EC lays down detailed arrangements for the operation of registers for recording information on GMOs, provided for in Directive 2001/18/EC. For unanimous identification of GMOs a system for the development and assignment of unique identifiers for genetically modified organisms was established by Regulation (EC) 65/2004/EC.

A crucial issue for the application of GM crops in agriculture is establishing conditions for the coexistence of GM crops with cultures of non-modified crops. Coexistence is not regulated specifically at the Community level but is under the responsibility of Member States. To provide consumers with a choice between organic, conventional and genetically modified products the Commission recommended in the Commission Recommendations of 23 July 2003 (on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming) that Member States should introduce specific measures at the national or regional level to address the issue. Several Member States subsequently introduced legislation to implement such measures. In order to provide a specific example of implementation, information is contained in the section on Directive 2001/18/EC describing how the issue is regulated in Austria.

1.2.3 Legislation on Good Laboratory Practice (GLP) and Animal Experiments

There are only two directives dealing with good laboratory practice: Council Directive 87/18/EEC and Council Directive 88/320/EEC. The former requires Member States to ensure that laboratories carrying out tests on chemicals or chemical products for regulatory purposes apply



GLP principles. The latter adds various requirements with respect to the monitoring and inspection of laboratories applying GLP principles to ensure compliance with the principles.

Both directives must be read in conjunction with various directives regulating chemicals and chemical products. The following directives and regulations are of particular importance: Council Directive 67/548/EEC (classification, packaging and labelling of dangerous substances), the REACH Regulation (No. 1907/2006), Council Directive 88/379/EEC (dangerous preparations), Council Directive 75/318/EEC (medicinal products), Council Directive 87/20/EEC (veterinary medicinal products), Council Directive 76/768/EEC (cosmetics), Council Directive 83/228/EEC (animal feed), Council Directive 89/397/EEC (food) and Council Directive 91/414/EEC (pesticides).

All these directives and regulations require the performance of comprehensive safety tests before the respective product or chemical may be placed on the market. Council Directive 87/18/EEC provides (for each of these directives and regulations) that the required safety tests must be carried out in compliance with GLP principles. This interrelationship between the GLP directives and legislation concerning specific chemicals must be carefully considered when drafting national implementing legislation.

Council Directive 86/609/EEC, as amended, is concerned with the protection of animals used for experimental purposes. This directive sets up the horizontal legal framework to carry out testing on animals in the EU, be it testing required for areas such as chemicals, medicines, biocides or cosmetics. In addition, some directives and regulations in the area of chemicals legislation specifically mention the reduction of animal experiments as one of their objectives. Council Directive 76/768/EEC (as last amended by Commission Directive 2008/14/EC) on the approximation of the laws of the Member States relating to cosmetic products, relates closely to Council Directive 86/609/EEC. It contains several provisions beneficial to animal protection, including a prohibition on the marketing of cosmetics containing ingredients or combinations of ingredients tested on animals.

Table - Summary of Key Relationships between the Chemical and GMO Sector and EC Legislation in the Environmental Acquis

Related Sector Legislation Relevance to Chemical and GMO Sector Horizontal Reporting Directive (91/692/EEC) This directive standardises reporting

requirements for certain other directives Air Quality Montreal Protocol (Depletion of the Ozone Layer), Council Decision 88/540/EEC and amending instruments

The EU has ratified the Vienna Convention and Montreal Protocol to limit and phase out production and use of compounds which destroy the ozone layer. The regulation on ozone depleting substances ((EC) 2037/2000 amending (EEC) 3093/94) implements the Montreal Protocol.

Waste Management Waste Framework Directive (2006/12/EC), Council Directive 91/692/EEC of 23 December 1991 and Commission Decision 96/350/EC of 24 May 1996)

This directive sets out a framework for handling and disposing of waste. This will affect installations handling dangerous chemicals.

Hazardous Waste Directive (91/689/EEC, as amended 94/31/EC)

This directive sets out a framework for handling and disposing of hazardous waste.

Water Sector The Dangerous Substances Directive (2006/11/EC, to be integrated into the Water Quality Framework Directive, 2000/60/EC)

This directive controls emissions of dangerous substances to waters.

IPPC and Risk Management



IPPC Directive (2008/1/EC)

The IPPC Directive introduces an integrated system of pollution prevention and control for a range of specified industrial activities. It established an integrated system of permits, which contain specific conditions including emission limit values and the application of best available techniques (BAT).

Seveso II Directive (96/82/EC) This directive aims to prevent major accidents involving dangerous substances and to limit their impacts on people and the environment.

Directive 2003/4/EC on the Freedom of Access to Information on the Environment

2. Development of a Sectoral Strategy and Implementation Plan

2.1 Key Factors Influencing Strategy Development

In Section 2.4 of the introductory chapters of this Handbook, the key activities to be undertaken in preparing a plan to implement environmental legislation are summarised in the implementation planning framework checklist.

The chemicals and the GMO sector are regulated through a wide range of measures. These include requirements for prior notification to and authorisation from the competent authority; risk assessment procedures; the classification, packaging and labelling of regulated substances (or organisms); and restrictions on control and supply. The following text outlines key considerations to be taken into account when planning the implementation strategy for the chemical and GMO sector:

• Identify stakeholders and arrange discussions between them, especially on the choice of a competent authority or (authorities).

• Following consultation, appoint a competent authority to implement the requirements of each directive and/or regulation.

• Specific provision has to be made for dealing with potentially hazardous chemicals or GMOs at the planning stage. Issues to be resolved will include how and where a substance (or GMO) is to be kept or used, the times when the substance (or GMO) may be present and the permanent removal of the substance (whenever possible).

• Provision must be made for controlling potentially dangerous activities before they commence, with competent authorities having appropriate powers to impose safety requirements. Substances (or organisms) falling within the scope of the controls are usually defined by reference to their hazardous qualities as well as threshold quantities.

• Provide financial resources for undertaking monitoring and other forms of assessment, for enforcement activities, and for collating and disseminating the results.

• Appoint an appropriate institution (or institutions) to undertake inspections and monitoring.

• Where relevant, once emission limits and/or product specifications have been established, introduce regulations and/or other legislative measures to implement and enforce them.

• Set up suitable quality assurance and technical advice and guidance for the assessment/inspection/monitoring programme, to include third-party accreditation for the analytical services.

• Prepare and implement action programmes to reduce adverse human and environmental health effects in the short term, when emission or critical limit values are in danger of



being exceeded, as well as programmes aimed at identifying and mitigating long-term effects on health, biodiversity and other environmental parameters.

• Prepare and implement integrated plans covering all the hazards concerned.

• Prepare a report at specific time intervals informing the Commission (and sometimes also other Member States, national authorities or the public) about implementation of the legislation throughout the national territory.

2.2 Potential Difficulties in the Implementation Process

The main problems likely to be faced in the implementation of these directives are likely to be related to the administrative arrangements required, which are extensive, and the trained staff required in both for the administration of the directives and in the industrial sectors to which they apply.

In addition, the costs incurred by industry, both as regards additional staff and testing, in achieving full compliance with these regulations will be very significant. Thus, consideration must be given to the speed with which they may be implemented.

2.3 Key Stages in Strategy Development

The development of an effective strategy for the implementation of the legislation relating to the control of chemicals and GMOs involves the following key stages:

1) Establishment of a strategy development project team.

2) Review and analysis of the existing situation.

3) Development and evaluation of options.

4) Preparation of a draft strategy and options paper for consultation with stakeholders.

5) Review of strategy and options following the consultation process.

6) Preparation of strategy and implementation plan.

The main considerations for each of these stages are outlined below.

2.3.1 Strategy Development Project Team

The project team should be drawn mainly from existing senior staff within the main pollution control organisation(s) and from governmental departments related to health and safety and trade and industry. However, it would also be useful to bring in, or at least consult with, senior technical and managerial staff from industry.

Essentially the team needs to have in-depth knowledge of the following:

• the current framework for the control and assessment of chemicals and GMOs and its development;

• the current activities regarding risk assessment of chemicals and GMOs as conducted by industry;

• the capacity of industry to absorb costs relating to the testing of chemical substances and GMOs;

• national and international legislation in the field of chemicals and GMOs; and

• the functioning and relationships of national, regional and local governmental organisations.

It is likely that the team will need to work together for a number of years with at least a core staff dedicated to the project on a full-time basis.



2.3.2 Review and Analysis of the Existing Situation

This stage involves compiling information relating to the control and assessment of chemicals and GMOs. This should include:

• a review of current legislation and its implementation;

• a review of permitting and notification procedures with particular reference to application procedures and documentation requirements. The review should also include an assessment of who is responsible for issuing permits and licences and handling notifications and at which level it is most appropriate for these tasks to be carried out (national, regional or local);

• an examination of current guidance made available to industry in these areas; and

• an examination of control procedures and enforcement practices.

2.3.3 Development and Evaluation of Options

Once the review and analysis is complete, sufficient information should be available to allow options for implementation to be put forward. The options put forward will include suggestions as to:

• how the requirements of the legislation may be met by the relevant institutions;

• how the existing permitting, licensing, notification, monitoring and control procedures could be improved;

• how the existing institutions may be strengthened, and whether interdisciplinary approaches would improve compliance;

• how to ensure effective co-ordination between the controlling authorities and the designation of responsibilities;

• how to manage relationships with industry during their applications for permits and licences and submission of notification, and what those permits, licences and notifications should cover;

• what guidance should be made available to industry on how to comply with this legislation;

• how to monitor and control permitted or licensed processes, and ensure that they remain within the limits imposed by the permits; and

• how to manage the repository of notifications and similar material and ensure proper dissemination.

The initial options put forward should vary from doing the minimum relative to the existing situation (whilst still complying with the requirements of the relevant directives and regulations) to introducing more extensive reforms.

For each of the options put forward there will need to be an assessment of the resource implications of implementation, which will include itemisation of the training, staffing and fixed resources required to complete the implementation. In addition, the time-scales associated with the options will need to be established.

2.3.4 Preparation of a Draft Strategy and Options Paper for Consultation with Stakeholders

As part of the initial stages of implementation it is advisable to undertake a series of consultation exercises in order to canvass the opinions of the various stakeholders. This would include the regulatory bodies; central, regional and local government; industry and industrial organizations; environmental organisations; and NGOs. It would initially involve the preparation of a consultation document to be circulated to the various interested parties. The document would



discuss the key issues associated with the implementation of the legislation relating to chemicals and GMOs, potential difficulties and possible options. Experience has shown this type of exercise to be very beneficial in smoothing the way forward for implementation, and in helping the preparation of all those likely to be involved.

2.3.5 Review of Strategy and Options Following the Consultation Process

Following the consultation process and feedback from the stakeholders, the strategy can be refined and the preferred options developed so that a detailed implementation plan can be drawn up.

2.3.6 Preparation of Strategy and Implementation Plan

At this stage, the main tasks, roles and responsibilities of the key bodies to be involved in the implementation process and the operation of the systems need to be defined. Possible bodies that could be involved are as follows:

• the government;

• the competent authority (CA);

• the permitting authority (PA) if required; and

• the regulatory body (RB) (in some cases this may be the same body as the PA).

A technical committee could be set up to co-ordinate the development of guidance notes and to act as an advisory body for policy issues.

3. Institutions and Relevant Parties

3.1 Stakeholders

A large number of stakeholders have an interest in, or may be affected by, the legislation covered in the chemicals and GMOs sector. The principal stakeholders and their role in the implementation of the legislation in this sector are summarised in the Box below. The following subsections focus on particular issues relating to key groups of stakeholders.

3.2 Central Government

Several ministries will be directly involved in the implementation of the legislation on chemicals, GMOs and GLP, while others will need to be informed and consulted. The principal ministries involved directly in implementation will be those responsible for the environment, health and welfare, labour, agriculture and industry. Implementation of the GLP legislation will also involve the ministry with responsibility for veterinary affairs.

There will also be a need to liase with other ministries on the implementation of the legislation. Ministries responsible for industry need to be consulted. given the economic importance of the chemicals sector, the significance of GMO legislation to the emerging biotechnology industry, and the desire to avoid the prohibition of certain chemicals in Member States due to concerns over testing procedures. The ministry with responsibility for foreign affairs will have an interest because of the interactions of EC legislation with international organisations and treaties, such as the World Trade Organisation, the Montreal Protocol, and the Cartagena Protocol on Biosafety in the framework of the Biodiversity Convention, as well as the implications for exporting and importing dangerous chemicals. The ministry with responsibility for agriculture would be concerned with legislation on GMOs and animal welfare, and the ministry responsible for labour protection would have interests in all three legislative fields: chemicals, GMOs and GLP.



A well-structured mechanism to provide governments with external advice is essential to meet the need for specialist inputs. Many matters arising in implementation in this sector require expertise which is not routinely present in government departments or being spread over many departments. In areas like chemicals and GMOs, it could be beneficial to create formal advisory committees to ensure the participation of the affected departments.

Principal Stakeholders and Their Roles in the Sector on Chemicals and Genetically Modified Organisms

Stakeholders Roles

Central government (e.g. a ministry or

department)

Implementation and maintenance of compliance with EU policies and legislation on chemicals, GMOs, GLP and animal experiments. Providing a general legislative framework for implementation of the REACH Regulation.

Environmental agencies working on

behalf of central government (e.g. regulatory authority, national standards laboratory, veterinary service)

Provision of planning, regulation and technical assistance. Assistence in risk assessment. Maintaining databases and inventories of manufactured, traded and used chemicals. Enforcement of legislation.

Regional and local government,

municipalities Planning consent and agreement of

localised activities (including enforcement of coexistence measures for GM crops). Air emission control and waste disposal. Notification to higher bodies with respect to water supply. Trade descriptions. Forum for public concerns

Chemical industry (dangerous

substances, manufacture of products including asbestos

Import, export, transportation and manufacture of dangerous substances. Play a larger role in ensuring the risk evaluation of existing and new chemicals covered by the REACH framework. Communicate to the competent authorities new information about the properties and risks associated with chemicals. Restrict and control the use of animals in experiments.

Construction industry Demolish buildings and develop

brownfield sites that may be contaminated with asbestos.



Private laboratories Chemical waste use and discharge. Experiments on animals and with GMOs. Carry out GMO analyses. Test the properties of chemicals.

Public

Health and safety concerns for workers handling dangerous substances and residents living near chemical installations. Lobby government on issues such as the release of GMOs to the environment and animal welfare.

NGOs Represent specific interest groups

such as GMOs and animal welfare. Lobby government about the siting and activities at chemical plants and experimental activities.

Research institutions

(e.g. universities) Technical research, inter alia, into

GMOs and GMO development.

3.3 Competent Authorities

The choice of competent authority will depend on the existing structure of government and the remit of the different ministries within the candidate countries.

In the chemicals area it could be useful to establish a chemicals supervisory service as competent authority responsible for risk assessments, notification, prior informed consent procedures etc. Such service could rationalise the administration. Also responsibilities under Council Directive 87/18/EEC on the application of GLP could be covered by the competent authority responsible for chemicals.

Where two or more competent authorities are appointed, there must be clear agreement about spheres of responsibility.

Competent authorities will be required to undertake a variety of activities as illustrated in the Box below. Many of these tasks require specialist technical knowledge.

3.4 Regional and Local Government

In general, regional and local governments are playing a minor role in relation to the implementation of legislation related to chemicals, GMOs and GLP. However, where the implementation will affect issues related to air quality, waste disposal, water management and integrated pollution prevention control, the regional and local governments will be involved. Also, activities that involve the handling of hazardous substances are often regulated at the stage of planning and development control at the regional and local levels.

Coexistence of GM crops and non-modified crops is commonly regulated at the level of the regional or local governments.

3.5 Private Sector Involvement

Industrial companies working in chemicals, pharmaceuticals, biotechnology, laboratory research, and their significant sub-sectors, will have legitimate interests in legislation covering chemicals



and GMOs. Major industries will often make individual representations to government, but a principal contact should be made with the relevant trade and branch organisations.

The interests of workers should be considered through consultation with trade unions and with relevant professional bodies.

3.6 Communication and Consultation

There is a requirement to inform and consult with the public in much of the EC legislation in this sector. In addition to providing information directly to the public by radio, TV and press, some legislation requires data to be made available in public registers.

Consultation with NGOs is also important. Although NGOs may present a wide range of views consultation with them is invaluable in demonstrating the transparency of legislation and its implementation.

Examples of Activities Undertaken by Competent Authorities

Planning:

• design procedures for e.g. licensing, compliance programmes, notification, inspection and verification, and safety requirements (87/18/EEC, 88/322/EEC, 98/81/EEC, 2037/2000, 2001/18/EC);

• establish a list of safe genetically modified micro-organisms, a classification system, containment conditions and waste disposal methods for GMMs (98/81/EC);

• establish a legislative and administrative framework and procedures for dealing with the risk assessments, and notification of the production and use of chemicals covered by the REACH Regulation (No 1907/2006).

Regulation:

• set limits for discharges from installations processing asbestos (87/217/EEC);

• monitor emissions and ensure controls are in place (87/217/EEC);

• ensure that manufacturers of controlled substances reduce and cease production (2037/2000);

• ensure that installations keep the required records, issue test certificates etc. (86/609/EEC, 87/18/EEC);

• inspect laboratories to verify compliance with procedures (86/609/EEC, 87/18/EEC, 88/320/EEC, 98/81/EC);

• arrange inspections at GMO sites (2001/18/EC);

• set up a data collection system and publish statistical information (86/609/EEC);

• evaluate data supplied by manufacturers and importers of chemical substances (67/548/EEC);

• evaluate risks to human health and the environment (REACH Regulation (No. 1907/2006), 98/81/EC, 2001/18/EC, 67/548/EEC);

• develop a strategy to limit risks (REACH Regulation (No. 1907/2006)) and ensure emergency plans are in place (98/81/EC);

• control the placing of dangerous substances on the market and the import and export of certain chemicals (67/548/EEC, 2037/2000, 2455/92).

Reporting:

• ensure compliance with rules on confidentiality of information (86/609/EEC, 87/18/EEC,



1907/2006, 2001/18/EC);

• ensure that third parties comply with notification requirements (2455/92, 98/81/EC, 2001/18/EC);

• publicise requirements to relevant manufacturers, importers, exporters, etc. (67/548/EEC, 87/217/EEC, 1907/2006, 2001/18/EC);

• ensure health and safety information is available to workers (98/81/EC);

• ensure the public is informed (98/81/EEC);

• report to the Commission (all legislation).

4. Technical Issues

Technical standards and guidelines are important in providing maximum compatibility across and between industries. They provide detailed technological information on, for example, methodologies for testing, construction, or use of materials. This type of information is not normally incorporated into primary legislation, often being very detailed and complex, and requiring periodic updates as technology advances.

Relevant standards may be prepared at different levels. The international level includes those produced by worldwide organisations such as the International Standards Organisation (ISO) or WHO, and European standards such as the European Standards Organisation (CEN). European standards must be applied in Member States and national standardisation bodies commonly adopt them as national standards. Standards do not have legal force in many European countries; in spite of this they are widely regarded by regulatory bodies as indicating best practice and their use often becomes obligatory for this reason.

A list of bodies producing standards which are significant in the chemical and GMO sector in Europe include:

• international e.g. World Health Organisation (WHO) guidelines and standards and ISO standards (e.g. ISO 14001);

• OECD guidelines for testing methodologies;

• European e.g. EU guidelines and standards;

• national e.g. technical instructions/regulations developed and introduced by government; formal standards issued by national standards bodies; and

• sectoral e.g. technical guidelines or specifications developed by industrial or professional associations applicable to a particular sector or type of activity.

In the chemicals and GMOs sector, competent authorities are required to set standards and prepare procedures on a variety of issues. As an example, Commission Decision 92/146/EEC sets out the format for the notification to the competent authority by manufacturers or importers who intend to place a product containing a GMO on the market.

Technical standards prepared for other environmental sectors are also relevant here. For example, some Member States have prepared technical guidance on integration pollution control, which may be relevant to the implementation of legislation in this sector, such as the Asbestos Directive.

The adoption of standards and guidelines to meet performance requirements will inevitably create the need to train staff and this must be recognised by regulatory authorities. In some cases, it might be difficult to implement legislation fully until training needs are met.



5. Regulation and Enforcement

5.1 Licensing, Inspection and Monitoring

The regulatory requirements in this sector relate mainly to notification of substances and authorisation of certain activities involving substances. In either case, monitoring and enforcement are key components of implementation of the legislation.

The main aspects of regulation are the same for most environmental legislation in this sector. Specific issues include:

• authorisation of establishments such as laboratories;

• the collection and evaluation of written or computerised information such as notifications from manufacturers, and exporter/importers;

• inspection and monitoring of activities to check that the correct procedures are being carried out; and

• enforcement action.

5.2 Data Collection and Reporting

Several pieces of legislation require Member States to gather and analyse data, for example to collect statistical information on laboratory experiments on animals or to assess the risk of certain substances.

The legislation requires Member States to inform the Commission about the text of legislation to transpose directives and actions taken to implement the legislation. There are also requirements to report other types of information to the Commission, for example:

• lists of licensed laboratories;

• instances of non-compliance;

• summaries of statistical data;

• sampling and analytical methods;

• alternative action taken;

• derogations; and

• notifications.

The frequency of reporting varies: sometimes reporting is required once, in other cases reports must be submitted annually, or three-yearly to the Commission. A number of directives, including Council Directive 87/217/EEC on asbestos, require that reporting be carried out in accordance with the Reporting Directive (Council Directive 91/692/EEC).

Other Member States must also be informed of certain actions taken by an individual Member State, for example, when environmental or single market issues are involved. In some cases, a Member State has the power to object to a decision taken by another, for example granting permission to market a GMO throughout the EU.

Member States also have to provide information to various third parties, particularly manufacturers, exporters, importers, trade unions, workers and the public. The main reasons for publication of such information are to ensure that the relevant bodies are aware of their duties under the legislation, to advise people of health and safety issues and to promote public participation as outlined by the legislation.

Further information on reporting requirements is provided in the relevant fiches following this sector overview.



6. Priorities and Timing

6.1 Prioritising the Implementation Tasks

In the chemical sector, the prioritisation of implementation tasks may be influenced by the economic importance or size of the industry, in particular asbestos and ozone-depleting substances; the potential health risks from that industry; and the existing degree of concordance between EC and national legislation. Major risks to the population and the environment may arise from chemical use, and the harm they cause is probably easier to define and identify as compared with the GMO sector.

In many Member States there is great public concern about GMOs and especially about the release of transgenic plants to the environment. Public pressure encourages placing a high priority on implementing GMO legislation. The absence of regulatory control may encourage experimentation with these organisms and create a substantial hostility towards governments.

It is very important to ensure that the GLP directives are implemented in conjunction with other chemicals legislation. All of the directives dealing with chemicals and chemical products are closely related with the GLP directives. Safety tests on all these chemicals and chemical products regulated by EC directives must be carried out in compliance with GLP principles.

The implementation of Council Directive 86/609/EEC can be a highly sensitive issue, since animal testing is a subject that is likely to cause strong public concerns. However, this can vary significantly from one Member State to the other. Governments should be prepared that animal rights groups may push for the quick adoption of legislation implementing this directive.

6.2 Time-scales

Considerable time is required to implement legislation fully, even for countries that aim to implement it as soon as possible. New directives must usually be implemented within two years from the date of their publication in the Official Journal, whereas regulations come into effect immediately on the date of their publication in the Official Journal. In principle, the candidate countries will need to ensure that the requirements of all the existing directives and regulations are in place by the date of accession. However, there may be instances where implementation of a specific requirement cannot be achieved by the desired date of accession, and in these cases candidate countries will have to negotiate appropriate transitional arrangements with the Commission.

The programme for implementing the legislation in this sector would be influenced considerably by the extent to which candidate countries have already adopted the measures and procedures required. For example, countries which have already ratified international conventions and protocols, such as the Montreal Protocol on substances that deplete the ozone layer, or which already have an established, regulated chemical industry, may be well placed to implement some of the legislation in this sector.

Implementation tasks that will tend to be especially time-consuming in the chemical and GMO sector are:

• procedures for implementation and enforcement of licences/permits;

• inventory of all affected industry and their individual functions or requirements; and

• data collation and statistical interpretation.

7. Economic and Financial issues

7.1 Principal Cost Areas



The principal cost areas associated with the implementation of legislation in the chemical and GMO sector consists of costs of establishing the implementation systems, the day-to-day costs of maintaining them and ongoing costs for tasks such as the classification of new chemical substances, dealing with notifications of GMOs, and employing specialist advisors/consultants. Costs will also be incurred by the competent authority to manage notifications and reporting obligations.

In general, costs to industry will be greater than those borne by the regulatory authority. In the chemical sector, manufacturers of new substances will bear the major part of the ongoing costs of implementation. The costs to the biotechnology industry of implementing the GMO regulations, including for instance the costs of providing the information required by the notification procedures, are also substantial.

It is critical in assessing the costs of the regulatory authority to consider the expected development in the sector in the future. For example, in the GMO sector, a relatively large implementation organisation will be necessary if the government, as a matter of policy, wishes to encourage research and development in biotechnology and the introduction of transgenic plants into agriculture. If it does not, a much smaller body will be appropriate.

Few studies have been undertaken on the cost of implementing legislation in the chemical sector. A DISAE project in Lithuania179 estimated that the implementation of the chemicals legislation would require an investment of EUR 476,000 (for institutions, laboratories etc.) in the public sector and EUR 12.1 million in the private sector (hazard communication unit, safety data sheets, modification of equipment for transport of dangerous goods etc.). A report published by the Danish Environmental Protection Agency 180 estimated that implementation of ozone-related legislation in the ten CEECs would cost just under DKK 1 billion (EUR 133 million) and were considered to be insignificant.

In a separate study181, the implementation cost of the chemicals legislation sector in Bulgaria alone was estimated at EUR 63 million.

A study by EDC182 failed to find reliable information on the use of asbestos in the construction industry in CEECs. However, they point out that asbestos was used in construction in the CEECs, and that it is extremely expensive to control asbestos emissions during demolition and land clearance operations.

7.2 Cost Recovery and the Application of Economic Tools

Candidate countries need to decide whether charges will be introduced for GMO notifications. For high levels of activity, charging may be adopted sufficient to meet the costs for operation of the notification procedure. If little activity is expected, the costs of setting up and operating a charge scheme may be much larger than the income from the scheme. In part, such considerations explain the wide range (from zero to about EUR 10,000 per notification) for notification work about releases of GMOs for marketing. Similar considerations as those above apply to costs in the chemicals sector.

The expenditures caused by the implementation of the GLP directives can at least partly be recovered by charging a fee for the inspection of the laboratories. There are different schemes possible. The Member State might charge a fee for every single inspection performed in a specific laboratory. The other alternative is the creation of a so-called monitoring programme with obligatory membership of all laboratories applying GLP. Then an annual membership fee might cover part of the costs for the monitoring programme.

179) DISAE Project LIT-109. Development of Action Programme for Implementation of EU Legislation on Chemicals in Lithuania. Soil & Water Ltd. November 1999. 180) DEPA, 1997. EU’s udvidelse mod øst - miljømaessige perspektiver. Miljøstyrelsen. 181) DISAE, 1998. Review of the Assessment of Accession Costs. Seminar Paper, June 1998. 182) EDC, 1997. Compliance costing for approximation of EU environmental legislation in the CEEC.



8. Summary of Key Issues

Implementation of EC legislation in this sector requires a large number of activities as described in more detail in the fiches.

A checklist of key questions to be considered in preparing and implementing EC legislation for chemicals and GMOs is presented below.

Checklist of Key Questions to be Considered in Preparing and Implementing EC Legislation for Chemicals and GMOs

Has a national strategy for implementation in the sector been developed?

Has framework and secondary legislation to allow implementation been produced?

Has a competent authority or authorities been designated?

Is the competent authority adequately staffed and equipped?

Has the competent authority taken steps to consult stakeholders and has it prepared and published guidance notes for stakeholders?

Has the competent authority demonstrated that it can manage notification and permitting procedures?

Is the competent authority able to monitor compliance with the regulations and carry out enforcement measures?

Has the competent authority established adequate data collection and data handling procedures to allow it to meet the reporting requirements of the directives and regulations?

Has the competent authority created formal reporting procedures?

Has the competent authority taken measures to provide a summary of the collected statistical information?

Can the competent authority ensure that commercially sensitive information is not published?



SECTION 8 – CHEMICALS AND GMO LEGISLATION THE ASBESTOS DIRECTIVE


The Asbestos Directive

Official Title: Council Directive 87/217/EEC on the prevention and reduction of environmental pollution by asbestos (OJ L 85, 28.3.87), as amended by Regulation (EC) 87/2003 (OJ L 122, 16.5.2003)

1. Summary of Main Aims and Objectives

The aim of the directive is to prevent and reduce pollution by asbestos, in order to protect human health and the environment. It requires Member States to restrict emissions of asbestos into the air and discharges of asbestos into water, and to take precautions when carrying out certain activities involving asbestos, such as the demolition of buildings and the transport and disposal of waste. It also lays down monitoring requirements.

Directive 87/217/EEC was amended by Regulation No. 87/2003. The regulation amends Articles 11 and 12 regarding the adaptation of the annexes to scientific and technical progress by fine-tuning the requirements regarding the procedure adhered to.

2. Principal Obligations of Member States

2.1 Regulation

• Take measures to prevent and reduce emissions of asbestos into the air, discharges of asbestos into water, and the production of solid asbestos waste (Art. 3).

• Ensure that asbestos is used in accordance with best available techniques not entailing excessive cost (BATNEEC), and that emissions of asbestos into the air comply with specified limit values (Arts. 3 and 4).

• Where asbestos cement or asbestos paper or board is manufactured, ensure that the effluent is recycled or, in the case of asbestos cement, that it is disposed of in accordance with specified conditions (Art. 5).

• Ensure that activities involving asbestos, including the demolition of buildings, the removal of asbestos, and the transport and disposal of waste containing asbestos, are carried out in accordance with the requirements of the directive to ensure that they do not cause pollution (Arts. 7 and 8).

2.2 Monitoring

• Monitor emissions of asbestos into the air and discharges of asbestos into water, in accordance with specified methods of sampling and analysis (Art. 6).



2.3 Reporting

Report to the Commission on:

• methods of sampling and analysis (Art. 6);

• implementation of the directive (Art. 13 and Council Directive 91/692/EEC);

• measures taken to comply with the directive (Art.14); and

• transposition, with texts of the main provisions of national law adopted in the field covered by the directive (Art. 14).

2.4 Additional Legal Instruments

A number of other legislative instruments are relevant to the implementation of this directive.

• Council Directives 76/769/EEC, as amended, and 83/478/EEC contain provisions to restrict the marketing of crocidolite (blue asbestos) and products containing crocidolite fibres, as well as provisions concerning the labelling of products containing asbestos.

• Council Directive 83/477/EEC lays down provisions to protect workers from the risks of exposure to asbestos at work.

• Several directives are concerned with the disposal of waste, and controlling pollution to air, e.g. the Waste Framework Directive (2006/12/EC, see Section 4 of the Handbook); the Hazardous Waste Directive (91/689/EEC, as amended, see Section 4 of the Handbook), the Waste Incineration Directive (2000/76/EC (see section 4 of the Handbook)); and the IPPC Directive, 2008/1/EC (see Section 7 of the Handbook).

• Reporting requirements have to be in accordance with the Reporting Directive (91/692/EEC, see Section 2 of the Handbook) and the Pollution Release and Transfer Regulation (166/2006).

• Methods of sampling and analysis in the annex refer to Council Directives 82/883/EEC and 2000/60/EC.

3. Implementation

3.1 Key Tasks

The key tasks involved in implementing this directive are summarised in the following checklist. The key tasks are arranged under subheadings and organised in chronological order of implementation wherever possible.

THE ASBESTOS DIRECTIVE – KEY IMPLEMENTATION TASKS

1 Planning

1.1

1.2

Designate the competent authority to be responsible for implementation.

Ensure that the competent authority is adequately staffed with trained personnel.

2 Regulation

2.1 Publicise the requirements of the directive to those affected by it (e.g. relevant manufacturers and others working with asbestos).

2.2 Enforce the requirements of the directive re discharge, recycling, handling, disposal, etc. of asbestos.

3 Monitoring



3.1

In consultation with manufacturers and other relevant parties, set limits for total discharges and the solid content of liquid wastes, ensure that liquid wastes containing asbestos are recycled and that the sampling and analytical methods set out in the annex to the directive — or equivalent measures — are used.

4 Reporting

4.1 Supply the Commission with information about the implementation of the directive.

4.2 Report to the Commission on:

• methods of sampling and analysis and related information; and

• transposition and implementation.

3.2 Phasing Considerations

It is important to control the hazards of inhalation of asbestos by implementing the appropriate directives. The relative urgency of implementing this directive, together with those relating to worker protection and marketing, will depend on the current situation for controlling asbestos in the country. Where production, use and marketing are relatively well controlled, attention should be focused on the removal of asbestos from buildings and other sources of contamination. This will point to the implementation of this directive as of the greater urgency. However, in certain Member States, the implementation of the various directives lead to interlocking regulations and, recently, the regulations have been extended to deal with all types of work which may lead to exposure. It may be beneficial to implement all the asbestos-related directives at the same time, rather than to deal with them separately.

Issues which may affect or retard the implementation programme would be related to a) the lack of necessary technical skills to measure dispersal of asbestos in the atmosphere and water, which may not be widely available; and b) the fact that asbestos is an essential commercial material for some purposes and that alternatives are less effective or much more expensive. This latter point indicated the need for substantial and possible lengthy consultation as a preliminary to implementation.

4. Implementation Guidance

Health problems caused by asbestos are primarily associated with the lungs, where inhalation of asbestos fibres can cause cancer. In the UK, the number of deaths attributable to asbestos is expected to rise from the existing level of ca. 3,000 at present to 10,000 per annum in the next millennium. This rise will primarily reflect past exposures rather then increased exposure. Nevertheless, there are still substantial risks and UK research has shown that workers in building-related trades are most at risk from asbestos.

This directive is one of a group of measures to control hazards which asbestos presents to people and the environment. This directive supplements the provisions of Council Directive 76/769/EEC to prevent, as far as possible, emissions of asbestos to the environment by reduction at source.

Member States are allowed to introduce more stringent measures than those laid down in the directive in order to protect health and the environment. In this connection, the Council of Ministers (Employment and Social Affairs) has asked the Commission to bring forward its proposals for amending current asbestos directives so as to tighten restrictions and set higher standards. Future developments should be monitored.

A number of general observations and good practice suggestions for implementing this directive are presented below based upon the collective experience of Member States.



4.1 Regulation

• The implementation of this directive has had relatively few implications for current Member States, due to the existing system of controls in those countries. For some of the candidate countries it seems that current controls are less satisfactory and that implementation of this and related legislation is urgent.

• It is important that the directive requires the use of BATNEEC to reduce or eliminate asbestos emissions. This allows the possibility of discussion with the competent authority about the use of one or other technology when the costs of these differ significantly.

• In enforcing the requirements of this directive, competence in the technical skills of analysis and sampling is required. Training will be needed in many cases for technicians and technical managers to ensure that sensitivity and precision targets are achieved. Staff carrying out this work will possess technical qualifications and their laboratories must be operating good laboratory practices (GLPs).

• Current Member States encourage public awareness of the directive by use of the media. As a result, the public is very well aware of the possibility of harm arising from contact with asbestos and that much of the impetus for remedial action in buildings has arisen from public pressure. The use of asbestos has decreased considerably in recent decades as the effects of asbestos on health have become more widely understood. Nevertheless, the consequences of past uses of asbestos are that many houses and commercial buildings contain substantial quantities of dangerous asbestos and that remedial work is still underway. Asbestos remains relevant within certain types of industries, in the demolition of buildings containing asbestos, and in the clean-up of sites contaminated with asbestos, e.g. old landfill sites.

• A complication of media exposure is that the public has come to believe that all uses of asbestos are harmful. Thus, there is unjustifiable concern that asbestos water pipes are unsafe, though there is no evidence that this is true. The World Health Organisation’s guidelines for drinking water quality supports this view of their safety.

Example of Practice in a Member State

In one Member State (SE), asbestos was extensively used for many years, particularly in the 1940s and 1950s. Imports peaked in the 1950s at 20,000 tonnes per year. In the mid 1970s a ban on asbestos use was introduced, due to suspicions concerning its effect on human health, based on research on worker exposure and disease. The National Board of Occupational Health and Safety (NBOHS) was created in 1949 and in 1963 the ordinance was extended to include protection against asbestosis. The NBOHS has since been responsible for regulating, monitoring and permitting the handling and usage of asbestos in the workplace. It monitors the health of workers and produces statistics on behalf of the government.

4.2 Monitoring

The directive lays down emission limit values for emissions to air and water, and requires that measures be taken to ensure that asbestos is not released in the course of work such as demolishing buildings or transporting waste containing asbestos. Other limits (e.g. volume of discharges of suspended matter) must be set by the competent authority. The competent authority will also need to carry out monitoring to ensure that the emission and discharge limits are complied with.

5. Costs



The main regulatory costs consist of establishing and implementing the legal framework. The ongoing costs for monitoring and enforcement can be substantial. In addition to these, there are high compliance costs, which will be borne by the asbestos-using industry and equally by the owners of buildings that require remedial treatment.



SECTION 8 – CHEMICALS AND GMO LEGISLATION DECISION ON THE MONTREAL PROTOCOL (DEPLETION OF THE OZONE LAYER)


Decision on the Montreal Protocol (Depletion of the

Ozone Layer)

Official Title: Council Decision 88/540/EEC concerning the conclusion of the Vienna Convention for the protection of the ozone layer and the Montreal Protocol on substances that deplete the ozone layer (OJ L 297, 31.10.88)

1. Summary of Main Aims and Provisions

The decision approves the Vienna Convention and the Montreal Protocol on behalf of the Community. It requires Member States to conclude their procedures for accession to and ratification of the convention and the protocol as soon as possible, in order to enable the whole Community to also become a contracting party to both the convention and the protocol.


2.1 General

Member States are required to ratify the Montreal Protocol and to notify the European Commission that they have done so.


A number of other legal instruments are relevant to this decision. They include:

• Commission Recommendation of 27 June 1990 on the reduction of chlorofluorocarbons used by the Community's refrigeration industry (90/438/EEC);

• Council Regulation (EC) No. 2037/2000 (as amended) on substances that deplete the ozone layer, as amended.

3. Implementation

3.1 Key Tasks



The key tasks involved in implementing this decision are summarised in the checklist below. They are organised in chronological order of implementation wherever possible. Note that most of these tasks are required by signature of the Montreal Protocol. States that ratified the protocol prior to accession will therefore already be carrying them out.

DECISION ON THE MONTREAL PROTOCOL (DEPLETION OF THE OZONE LAYER) –KEY IMPLEMENTATION TASKS

1 Planning the Implementation

1.1 Ratify the Vienna Convention and Montreal Protocol (as amended) if not already done.

1.2 Appoint a competent authority to implement the other requirements of the decision. In general, these requirements are:

• to set penalties for non-compliance (required in any case by the convention and the protocol);

• to specify the level of qualifications needed by those disposing of the substances (required in any case by the convention and protocol);

• to carry out investigations required by the Commission into the activities of single individuals or companies; and

• to carry out investigations required by the Commission into compliance with overall quotas.

1.3 Provide financial resources for undertaking the investigations.

1.4 Appoint an appropriate institution (or institutions) to control the substances.

1.5 Appoint a representative to the committee of representatives of the Member States which reviews proposals by the Commission for new or revised measures to be taken to reduce ozone depletion.

(Tasks 1.1 to 1.4 inclusive will already have been carried out if the protocol has been ratified and implemented).

2 Control

2.1 Maintain the capability to carry out investigations on behalf of the Commission when required.

3 Reporting and Review

3.1 Notify the Commission that the Vienna Convention and Montreal Protocol have been ratified.

3.2 Inform the Commission of the results of:

• investigations required by the Commission into the activities of single individuals or companies; and

• investigations required by the Commission into compliance with overall quotas.

3.3 Send a representative to attend meetings of the committee of representatives of the Member States.


Before any other activities can start, the required financial resources need to be estimated and allocated. A competent authority must be appointed at an early stage.




Implementation of the specific requirements of this decision will be influenced by, and must be tailored to, the present status, needs and conditions concerning the management of ozone-depleting substances in each candidate country. It has been reported that smuggling of ozone-depleting substances is an international crime second in scale only to the smuggling of drugs.

The Vienna Convention and the associated Montreal Protocol are international agreements to limit and phase out production and use of various compounds that destroy stratospheric ozone. The parties to these agreements hold regular meetings to review the list of substances that are banned or restricted. Four meetings have so far taken place, in London (1990), Copenhagen (1992), Montreal (1997) and Beijing (1999), and have resulted in amendments to the Montreal Protocol. It is the fourth amendment to the protocol that is currently in force.

The convention and protocol impose many requirements on their signatories. This Council decision does not directly add to these; it requires Member States to ratify the convention and protocol, and also ratifies it on behalf of the European Community. Since both the EU and the Member States have ratified together, it is practical for commitments regarding the production, import and trade of ozone-depleting substances to be enforced at a Community level. The Council has issued Regulation EC/2037/2000 requiring the regulation of classes of substances including chlorofluorocarbons (CFCs); other fully halogenated chlorofluorocarbons; halons; carbon tetrachloride CCl4; 1,1,1-trichloroethane; methyl bromide CH3Br (sometimes abbreviated to MeBr); hydrobromofluorocarbons (HBFCs); and hydrochlorofluorocarbons (HCFCs). Detailed definitions of the substances referred to are contained in Annex I.

This Council decision provides for joint implementation of the protocol, with many of the tasks that would otherwise fall on the competent authority of the Member State falling instead on the Commission.

The Council Decision does not forbid Member States from withdrawing from the Montreal Protocol, or the Vienna Convention as a whole, but the regulations would remain in force, so withdrawal would be ineffective. In practice, therefore, Member States are committed to the protocol indefinitely.

4.1 Planning Implementation

• The competent authority must ensure that the requirements of the Montreal Protocol are met and, in particular, that ozone-depleting substances are properly controlled, with penalties for non-compliance. It may be necessary to provide additional powers for the competent authority or others to bring about compliance with the protocol, where these do not already exist under other legislation.

• The competent authority must also specify the level of qualifications needed by those disposing of the substances.

• The appropriate institution (or institutions) to control ozone-depleting substances may be the police, customs authorities and/or national, regional or local authorities (including trading standards offices).

Examples of Practice from a Member State

In one Member State (UK), the secretary of state for the environment, food and rural affairs (Defra) is the competent authority for the purposes of the Council regulation. The requirement to set penalties for non-compliance is addressed through regulations imposed by government, which reflect the prohibitions imposed by the Council regulations. Defra therefore takes on most responsibilities for assisting the Commission and enforcing the national regulations. Matters relating to the import and export of controlled substances are left with the HM Revenue and Customs, which can seize controlled substances independently of Defra or the Commission.

4.2 Controlling Ozone-Depleting Substances



• For the most part, Regulation 2037/2000 imposes duties directly on the producers, importers, users and other handlers of the controlled ozone-depleting substances.

• The competent authority will need to ensure that there is appropriate control of ozone-depleting substances. To support this, it may be necessary to prepare and issue detailed technical advice and guidance to ensure a full understanding of the methods of detection, identification and control.

• The competent authority must carry out investigations required by the Commission, whether into the activities of single individuals or companies, or into compliance with overall quotas.

4.3 Reporting and Review

• When the Commission proposes new or revised measures to be taken to reduce ozone depletion, these proposals are reviewed by a committee of representatives of the Member States. This is the forum through which Member States influence the implementation of the protocol.

5. Costs

The following checklist describes the types of cost which are likely to be incurred to implement the decision. None of these are additional to the costs resulting from ratifying the Montreal Protocol. Further explanation is given below the checklist.

Checklist of the Types of Cost Incurred to Implement the Montreal Protocol

Initial set-up costs:

• establishment of the competent authority (CA) (cost incurred by the national government);

• provision of any necessary training (cost incurred by the CA);

• preparing any necessary technical guidance documents (cost incurred by the CA).

Capital expenditure:

• strengthening enforcement authorities (e.g. customs) with equipment (cost incurred by the CA and possibly by others);

• implementation of changes to air-conditioning and refrigerator equipment (cost incurred by the owners of equipment);

• purchase of alternative substances (cost incurred by owners of equipment).

Ongoing running costs:

• activities of enforcement authorities (e.g. customs): salaries, transport, offices, equipment (cost incurred by the CA and possibly by others);

• analysis of samples (cost incurred by the CA and/or possibly by others);

• carrying out of investigations (cost incurred by the CA and/or possibly by others);

• preparation of companies’ reports for the Commission (cost incurred by the CA and companies);

• support of the representative to the committee of representatives of the Member States (cost incurred by the CA and possibly by others).



Ratification of the Montreal Protocol may entail substantial costs, both to government for investigation and enforcement and to industry in finding alternative substances to use in various processes.

In practice, for states that would have ratified the protocol with or without this Council decision, costs may well be reduced, due to many of the tasks being taken on by the European Commission.

Industry may face additional costs if Council regulations impose more demanding measures than those set out in the protocol. However, there may also be some compensatory economic benefits, if European industries develop alternatives to ozone-depleting substances that can be marketed elsewhere in the world.



SECTION 8 – CHEMICALS AND GMO LEGISLATION THE REGULATIONS ON OZONE DEPLETING SUBSTANCES


The Regulations on Ozone Depleting Substances

Official Title: Regulation (EC) No. 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer (OJ L 244, 29.09.00), as amended by:

- Regulation (EC) No. 2038/2000 of the European Parliament and of the Council of 28 September 2000 (OJ L 244 25 29.9.2000)


- Commission Decision 2003/160/EC of 7 March 2003 (OJ L 65 29 8.3.2003)


- Commission Decision 2004/232/EC of 3 March 2004 (OJ L 71 28 10.3.2004)

- Commission Regulation (EC) No. 2077/2004 of 3 December 2004 (OJ L 359 28 4.12.2004)

- Commission Regulation (EC) No. 29/2006 of 10 January 2006 (OJ L 6 27 11.1.2006)


- Commission Regulation (EC) No. 1784/2006 of 4 December 2006 (OJ L 337 3 5.12.2006)

- Council Regulation (EC) No. 1791/2006 of 20 November 2006 (OJ L 363 1 20.12.2006)

- Commission Regulation (EC) No. 899/2007 of 27 July 2007 (OJ L 196 24 28.7.2007)

- Commission Decision 2007/540/EC of 30 July 2007

2002/612/EC: Commission Decision under Regulation (EC) No. 2037/2000 on the allocation of quantities of controlled substances allowed for essential uses in the Community (OJ L 196, 25.07.02)

2002/654/EC: Commission Decision under Regulation (EC) No. 2037/2000 determining a mechanism for the allocation of quotas to producers and importers for hydrochlorofluorocarbons for the years 2003 to 2009.




Regulation (EC) No. 2037/2000 replaced Council Regulation (EC) No. 3093/94 on substances that deplete the ozone layer, in such a way as to adapt the Community rules to the technical developments that had occurred since that regulation was adopted.

The aim of the regulation is to establish rules on the production, import, export, supply, placing on the market, use, recovery, recycling and reclamation and destruction of substances that deplete the ozone layer. It implements the Montreal Protocol to the Vienna Convention for the Protection of the Ozone Layer, but lays down more stringent requirements and prohibitions than the protocol for phasing out CFCs (chlorinated fluorocarbons), HCFCs (halogenated fluorocarbons) and methyl bromide. The regulation also introduces an import licence system that is administered by the Commission, and repeals Regulation (EC) No. 3093/94 (Art. 23).

Regulation (EC) No. 2038/2000 amended the main regulation, allowing temporary export authorisation to be granted for metered dose inhalers and medical drug pumps.

Regulation 2039/2000 merely changes the reference year for the percentage market share for producers and importers from 1996 to the percentage share assigned in 1999. Commission Decision 2002/612/EC lists the quantity of controlled substances in groups I-V and VII that may be used for essential medical and laboratory uses. Commission Decision 2002/654/EC has specified the methodology for determining the consumption quantity of hydrochlorofluorocarbons by use of individual production and importation quotas.

As this instrument is a regulation, see the introduction and the comments specifically about the legal requirements for candidate countries on accession as regards Community regulations.


2.1 Planning

• Appoint a competent authority (or authorities) to implement the requirements of the regulation, particularly on the control of imports and exports of controlled substances to and from Member States, third countries, states not party to the protocol and the candidate countries (Arts. 4, 6, 7, 8, 12).

• Establish penalties for non-compliance with the requirements of the regulation (Art. 21).

• Provide guidance to exporters on export authorisation and licensing requirements (Arts. 6, 12)

• Introduce systems for recovering, for the purposes of recycling, reclamation or ecologically acceptable destruction, CFCs, other fully halogenated CFCs, halons, carbon tetrachloride, 1,1,1-trichloroethane, hydrobromofluorocarbons, HCFCs and bromochloromethane contained in:

− refrigeration and air-conditioning equipment and heat pumps (except for household freezers and refrigerators up until 31 December 2001);

− equipment containing solvents;

− fire protection equipment and fire extinguishers.

• Lay down the minimum training requirements for personnel responsible for maintaining equipment containing those substances in order to prevent leakage of regulated substances.

2.2 Regulation



• Prohibit the use of some controlled substances as phased out in Regulation (EC) No. 2037/2000 and ensure that producers of controlled substances reduce, and eventually cease, production and supply of controlled substances in accordance with specified targets and time limits; and allow producers to exceed the prescribed levels only in accordance with specified conditions. (Arts. 3 and 4, Regulation (EC) No. 1804/2003 as regards the control of halon).

• Ensure that used controlled substances are recovered and are dealt with in accordance with specified conditions (Art. 16, Regulation (EC) No. 1804/2003 as regards the control of halon).

• Ensure that the production, use, import and supply of HCFCs are controlled, in accordance with specified targets and time limits (Arts. 4 and 5, Regulation (EC) No. 1804/2003).

• Ensure that the import and export of controlled substances, and of products containing these substances, from and to states that are not parties to the Montreal Protocol or territories not covered by the protocol, are regulated in accordance with specified conditions (Arts. 8, 9, 11, 13 and 14, Regulation (EC) No. 1804/2003).

• All exports of controlled substances must be authorised by the Commission. Such authorisations shall be issued to undertakings for 12-month periods beginning with a 2001 authorisation. Each exporter must notify the Commission of any changes in data and information that may occur during the validity of the authorised period. This could be facilitated by the relevant competent authority by having it act as an intermediary (Art. 12, Regulation (EC) No. 1804/2003).

• Ensure that the import of controlled substances from third countries is subject to the production of an import licence, and monitor compliance with quotas (Arts. 6 and 7, Regulation (EC) No. 1804/2003)).

• Take precautionary measures to prevent the escape of controlled substances. (Art. 17, Regulation (EC) No. 1804/2003).

• Prohibit the production, release for free circulation in the Community and inward processing, placing on the market and use of new substances listed in the regulation. Thus far, the only listed new substance is bromochloromethane.

• Provide for the application to the Commission for licences to produce and import controlled substances for certain “essential” uses (Art. 3, Regulation (EC) No. 1804/2003).

• Provide for the obligation to comply with decisions of the Commission which change the quantity of controlled substances for essential uses. The Commission has done so with respect to particular uses of group I-V and VIII substances the fixed [quality] of which must be set through appropriate national legislation (2002/612/EC: Commission Decision).

• Provide for the obligation to comply with Commission decisions that change the basis and mechanisms for the calculation of individual quotas. This power has been executed by specifying the methodology for determining consumption levels for hydrochlorofluorocarbons for refrigeration, foam production and solvents for the years 2003 to 2007(inclusive) (Arts. 2 & 3). These quantities must therefore be given effect in national law (2002/654/EC: Commission Decision).

• Introduce systems for recovering, for the purposes of recycling, reclamation or ecologically acceptable destruction, CFCs, other fully halogenated CFCs, halons, carbon tetrachloride, 1,1,1-trichloroethane, hydrobromofluorocarbons, HCFCs and bromochloromethane contained in:

− refrigeration and air-conditioning equipment and heat pumps (except for household freezers and refrigerators up until 31 December 2001);



− equipment containing solvents;

− fire protection equipment and fire extinguishers.

• Lay down the minimum training requirements for personnel responsible for maintaining equipment containing these substances in order to prevent leakage of regulated substances.

2.3 Reporting

• Report to the Commission on:

− proposals to authorise the production of controlled substances (Art. 3);

− the acquisition of rights to supply controlled substances (Art. 4);

− the licences used;

− the results of investigations carried out at the request of the Commission (Art. 20); and

− information on activities involving controlled substances, including their production, import, export, placing on the market, free circulation, supply and use (Art. 19).

3. Implementation

3.1 Key Tasks

The key tasks involved in implementing this regulation are summarised in the following checklist.

REGULATION ON OZONE DEPLETING SUBSTANCES – KEY IMPLEMENTATION TASKS

1 Administrative Arrangements and Planning

1.1 Appoint a competent authority with responsibility for implementing the regulation and communicating with the Commission.

1.2 Evaluate the need for institutional strengthening, in particular training, determining qualifications for personnel involved.

1.3 Design an authorisation system for the production and importation of controlled substances for essential uses as licensed by the Commission.

1.4 Consider the scope for introducing voluntary schemes — as in the Netherlands and the UK — to meet the reduction targets.

1.5 Monitor leakage of controlled substances.

1.6 Prepare guidelines for industry and the public.

2 Regulation

2.1 Identify (via consultation) and nominate, annually, essential uses/users of controlled substances and apply to the Commission for licences.

2.2 Design and implement a system of random inspection of imports to ensure compliance with the regulation.

2.3 Establish and impose penalties for non-compliance with the requirements of the regulation.

2.4 Establish procedures to ensure that the producers of controlled substances meet the requirements to reduce their production of controlled substances.



2.5 Establish control mechanisms to ensure that the production, placing on the market, use, import, export, recycling and reclamation and destruction of controlled substances conform to the rules laid down in the regulation.

2.6 Prohibit the use of controlled substances that are designed to be phased out.

2.7 Create a mechanism for Commission authorisation of controlled substances exports.

2.8 Ensure that controlled substances no longer in use are recovered.

2.9 Design and implement a system of monitoring and inspection for leakages and recovery operations to ensure compliance with the regulation.

3 Data Collection and Reporting

3.1 Establish reporting systems to ensure that the data required (see below) are collected.


• proposals to authorise the production of controlled substances for essential uses prior to authorisation;

• the acquisition of rights to supply controlled substances;

• the results of investigations carried out at the request of the Commission; and

• information on activities involving controlled substances, including their production, import, export, supply, use, storage, recycling and destruction.


In the European Union, bans on the production and use of most ozone-depleting substances are already implemented, except where they are licensed by the Commission for essential use. Since many of the requirements are also covered by the Montreal Protocol to the Vienna Convention, candidate countries that have already implemented this protocol are likely to be at least partly compliant with the regulation. However, the regulation contains different or stricter obligations than the Montreal Protocol and will impose new obligations, such as stricter standards and controls, different timescales for phasing out use, different information requirements and complete prohibitions.


Depletion of ozone in the upper atmosphere increases the irradiation of the earth’s surface by ultraviolet light and this will have harmful effects on people. The depletion of ozone results from the liberation of substances into the atmosphere that react with and destroy ozone. These substances are listed in the annex to the regulation and are referred to as “controlled substances”.

The need to protect and restore the ozone layer led to two international agreements — the Vienna Convention for the Protection of the Ozone Layer and the Montreal Protocol to this convention — which aim to limit and reduce the levels of consumption and production of certain controlled ozone-depleting substances.

Drawing upon the collective experience of Member States, a number of general observations and good practice suggestions for implementing this regulation are presented below.

4.1 Administrative Arrangements and Planning

• Regulations are directly applicable in all Member States, and do not therefore need to be transposed into national legislation (see further under the introduction section). However,



some new legislation may be required, for example to designate competent authorities, assign enforcement powers, and establish penalties for non-compliance with the requirements of the regulation.

• This regulation falls between environmental and health and safety fields. In other Member States, organisations from both fields have been nominated as competent authorities.

Examples of Practice in Member States

In one Member State (UK), the Department of the Environment, Food and Rural Affairs (Defra) acts as the competent authority for the control of ozone-depleting substances. Under the COSHH regulations (Control of Substances Hazardous to Health), the Health and Safety Executive plays a role in enforcement. Banks for halons and CFCs have been set up to serve as stores for recycled material required for essential purposes — such as halons for fire extinguishers, to reduce the need for their manufacture or import. Industry consortia are active in the management of the banks. Research has been undertaken by the government to develop non-ozone-depleting substances under contract from Defra.

In another Member State (SE), the competent authority is the national Environmental Protection Agency, which reports to the Ministry of Environment. Other responsible bodies include the county administration boards (CABs) and the municipalities, who are involved in day-to-day implementation, supervision of industry and all aspects of recovery of ozone-depleting substances (ODS) and refrigerants.

• The regulation sets out the prohibitions and reductions in the production, supply, use etc.

of controlled substances, subject to exceptions for certain licensed essential uses. A control mechanism should be introduced to ensure that these targets are met.

• Member States have introduced various mechanisms to achieve the targets, for example regulations and the use of voluntary agreements. Both types of scheme have been successful in achieving phase-out targets ahead of schedule.

• The United Nations has produced a wide range of information to help countries implement the technical and policy requirements to reduce the use of ozone-depleting substances.

• Member States have also produced extensive guidance for industry on alternatives for ozone-depleting substances, recovery procedures, and undertaking research to support the identification of non-ozone-depleting alternatives.

• Member States should provide a mechanism for exporters to understand the Commission export authorisation obligations.

4.2 Regulation

• The approach taken in this regulation is to phase out the use of controlled substances wherever possible. Therefore the licensing for essential uses is likely to become increasingly rare as alternatives become available.

• The information requirements of the regulation are extensive. Information is required on activities involving controlled substances, including their production, import, export, supply, use, recovery, storage, recycling and reclamation and destruction. The accuracy of the information provided should be monitored by undertaking random spot checks to audit data.

• Leakages of controlled substances must be controlled, and this includes the escape of substances from household equipment, factories, and installations which recover ozone-depleting substances. Leakages must be minimised by adopting precautionary measures. Operators should be monitored to ensure that the necessary measures are being taken.




The 1986 Montreal Protocol established an agreement to phase out ozone-depleting substances (ODS). This case study describes the route taken by one Member State (SE), which became a signatory to the protocol on 29 June 1988.

In 1986, this country’s CFC consumption was about 5,300 tonnes per annum, of which around 1,500 tonnes were for the production of refrigerants. Annual emissions due to leakage from domestic and industrial equipment which used CFCs and other ODS were considered to be high, but no particular attention was focused on this area. In the early 1980s, there was a significant increase in the development of heat pumps to provide heating for district and individual residences, most of which used CFCs.

Some time prior to EU membership, Sweden introduced comprehensive national legislation on the handling, usage and phasing out of ODS, which was seen to be more stringent than the requirements of the EC legislation. The national legislation included the main national ordinance of 1995 (95/636) as amended, which was based on earlier ordinances. In accordance with EC policy, there is no national ban on the import of CFCs and HCFCs. EC regulations have prevented the production of and imports into the EU of virgin CFCs from 1 January 1995. Production and imports of HCFCs from non-EU countries are gradually being reduced and will finally be banned by 1 January 2015.

Sweden banned the use of CFC and HCFC refrigerants in new equipment from 1 January 1995 and restrictions were introduced for CFCs for recharging existing equipment from 1 January 1998. Furthermore, the use of all equipment with CFC refrigerants, except for private use, was prohibited on 1 January 2000. This ban also applies to recovered CFCs and HCFCs, with the intention of compelling the use of non-ODS refrigerants.

The authorities worked extensively with industry to implement the ODS initiatives and suppliers are obliged to take back recovered refrigerants free of charge. Since 1997, permits have been required from the Environmental Protection Agency to export refrigerants and are only issued for destruction purposes. In 1988, the government took a policy decision to reduce the use and emissions of CFCs by 25% by 1 January 1991 and by 50% by 1 January 1993. Achievement of these targets required close co-operation with industry. The three largest trade associations formed the National Refrigeration Foundation (KYS) to promote higher standards in refrigeration, including those amongst the installation workers. Based on these discussions, the EPA issued a Refrigerants Order which accredited installation workers; promoted high production standards; promoted reuse of refrigerants; and promoted equipment maintenance. The accreditation system is regulated by SWEDAC, the national accreditation body.

Bulgaria introduced the national legislation already in 2000, which was finally amended in 2007 to cover all the requirements of the regulation. It follows the regulation almost exactly, although one of the last changes in 2007 was the introduction of the minimum requirements for the qualifications of the personnel dealing in any way with equipment containing the above substances. Imports and exports are licensed. Specific customs points are established for the import and export of these substances, equipped with the necessary facilities and units for testing. The competent authority is the Ministry of Environment and Water. Reporting to the Commission is done by MoEW, to which all bodies must report in due time.

4.3 Reporting

• Mechanisms will need to be established for reporting to the Commission on measures to implement the regulation, including, for example, data on production, import and export of controlled substances.

5. Costs The costs to Member States to implement this regulation are associated with:



• establishing and running the regulatory system; and

• costs to industry and the public related to the replacement of existing substances by non-ozone-depleting substances in products.

The costs of regulation are likely to be incurred mainly in monitoring and enforcing compliance with the timetables for phasing out production and use of controlled substances and controlling imports and exports.

As alternatives to ODS are becoming less costly, the compliance costs to industry and to purchasers of domestic refrigerating units are unlikely to be high..

SECTION 8 – CHEMICALS AND GMO LEGISLATION THE BIOCIDES DIRECTIVE


The Biocides Directive

Official Title: Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.04.98) as amended by Regulation (EC) 1882/2003 and Directives 2006/50/EC and 2006/140/EC, Commission Directives 2007/20/EC, 2007/47/EC183, 2007/69/EC and 2007/70/EC.

1. Summary of the Main Aims and Provisions.

The directive serves to harmonise the European market for biocidal products and their active substances by removing trade barriers whilst providing for a high level of protection for human and animal health and the environment. It does so by regulating the authorisation and the placing on the market for use of biocidal products within the Member States; providing for the mutual recognition of authorisations within the Community; as well as the establishment at Community level of a positive list of active substances that may be used in biocidal products. Annex I provides a list of these active substances. Directive 98/8/EC has been amended to include additional active substances in Annex I, as follows:

• Commission Directive 2006/140/EC of 20 December 2006 included sulfuryl fluoride as an active substance in Annex I.

• Commission Directive 2007/20/EC of 3 April 2007 included dichlofluanid as an active substance in Annex I thereto.

• Commission Directive 2007/69/EC of 29 November 2007 included diethialone as an active substance in Annex I

• Commission Directive 2007/70/EC of 29 November 2007 included carbon dioxide as an active substance in Annex IA

The directive has a very wide scope, with Annex V providing an exhaustive list of the biocidal products that fall within the scope of the directive and defined as “active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means." The directive excludes from its scope the list of products included in Article 1 (2).

183 Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market.




2.1 Planning

• Identify the needs for capacity building, particularly within the designated competent authority, with respect to carrying out co-ordination duties, monitoring, inspection and reporting to the Commission.

• Identify who the stakeholders are and what are their needs in complying with the directive.

• Prepare, possibly in consultation with the stakeholders, the groundwork for procedures relating to the authorisation, classification and the placing on the market of biocidal products in accordance with the requirements of the directive.

• Evaluate existing and new active substances to ascertain whether or not they will be included in Annex I

2.2 Regulation

National legal instruments to set up a competent authority responsible for establishing and maintaining:

• An authorisation procedure for the:

− placing on the market and the use of biocidal products that contain active substances that are listed in Annex I;

− inclusion of existing and new active substances in Annex I;

− use of unauthorised products (i.e. products not included in Annex I) in accordance with the directive.

• Procedures for the issuing of authorisations specifying:

− conditions of use specifying which procedures apply for the products listed in Annex V;

− the applicable timeframes for the authorizations.

• A system to process applications for the granting of authorisations requiring applicants to provide:

− the data to be included in the dossiers in accordance with Article 8 and the data as required in Annexes II, III and IV and V of the directive;

− any further information, where deemed necessary by the competent authority.

• The evaluation of data provided by applicants in accordance with the common principles (Annex VI).

• Conditions for the use of information in subsequent applications according to the requirements of Article 13.

• Procedures to authorise the use of unauthorised, biocidal products under the following circumstances:

− in an emergency as specified in Article 15(1);

− for use as specified in Article 15(2);

− for use in research and development as specified in Article 17(1).

• A system for the classification, packaging and labelling of biocides that provides for the formulation of safety data sheets to cover:



− biocidal products classified as dangerous according to the requirements of Article 10 of Directive 88/379/EEC;

− active substances used exclusively in biocidal products and how this compares to the requirements of Article 27 of Directive 67/548/EEC.

• A database, to be updated at regular intervals, on the status of authorised biocides providing:

− details of authorisations;

− details of applications refused, modified, renewed or cancelled;

− a list of authorised biocidal products;

− information on action to be taken in cases of suspected poisoning by authorised biocides.

• A system to prepare a positive list of active substances that may be included in Annexes I, IA or IB providing:

− the criteria and procedures for the listing of such active substances accordingly;

− a mechanism to (re)evaluate the risks associated with these active substances;

− the priorities according to which active substances should be included in the list.

2.3 Monitoring

The competent authority should have the following obligations under national legislation:

• implementing an effective inspection and enforcement system to secure compliance;

• monitoring biocidal products that have been placed on the market to ensure that this is carried out in accordance with the directive;

• monitoring the system established for the authorisation of biocidal products to ensure compliance with conditions of use when the authorisation was granted;

• reviewing modifications and cancellations of authorisations;

• ensuring commercial confidentiality and data protection;

• administering the system by the levying of appropriate fees, etc.;

• monitoring applications for authorisation conditions and enabling dossiers to be evaluated within 12 months;

• reviewing the information in the database on the status of the authorisation of biocidal products, assessing details of applications that are refused, modified, renewed or cancelled.

2.4 Reporting

• The competent authority must establish a system to carry out within the appropriate time-frames and on a permanent basis reporting requirements to the Commission, although this obligation may not be included in national legislation.

• The competent authority must establish a mechanism regarding the database on authorised biocides to exchange information with other Member States and the Commission.

• Legal instruments making it obligatory to report/provide information to the public both upon request and also at regular intervals such as, for example, in state of the



environment reports. Information must be made available to the public in cases of suspected poisoning.

3. Implementation

3.1 Key Tasks

The key tasks involved in implementing this directive are summarised in the checklist below. The tasks are arranged under subheadings and organised in chronological order of implementation wherever possible.

DIRECTIVE ON BIOCIDES – KEY IMPLEMENTATION TASKS

1 Planning

1.1 Assigning duties to competent authority/ies which would carry out regulatory, co-ordination and co-operation measures.

1.2 Devise memoranda of understanding for various competent authorities that will work together to implement the directive.

1.3 Organise stakeholder meetings to facilitate exchange of information, to ensure their participation in preparatory work and to identify user needs.

1.4 Assess capacity building needs to implement the directive.

2 Regulation

2.1 The competent authority shall establish a procedure for applying, issuing and authorising the placing on the market and use of biocidal products and the active substances from which they are composed.

2.2 Establish a procedure providing for the exceptional use of unauthorised products in accordance with the directive.

2.3 Establish a system for the classification, labelling and packaging of biocides including the requirements to provide safety data sheets when required by the directive.

2.4 Maintain a database to be updated at regular intervals, on the status of authorised biocides.

2.5 Establish a system to prepare a positive list of active substances that may be included in Annexes I, IA or IB.

2.6 Carry out the necessary monitoring to ensure compliance and to enforce operators to comply with conditions imposed by these systems and procedures.

3 Training and Capacity Building

3.1 Prepare and publish guidance on the duties and the role of the different stakeholders.

3.2 Provide safety guides for the use of biocides and active substances.

4 Reporting

4.1 Provide information at regular intervals on a national level and set up an infrastructure to handle demands upon request by the public or public authorities, whether national or from other Member States.


• the experience gained in implementing the directive;

• measures taken to comply with the directive;



• transposition; and

• obstacles met with in implementing the directive.

4.3 Given the importance of good co-ordination amongst public authorities to implement this directive, consider the appointment of one contact point responsible for co-ordination supported by a co-ordination structure.

4.4 Provide information to the public particularly regarding cases of poisoning but also information of a general nature.

4.5 Exchange information with the Commission and other Member States regarding the implementation of the directive.


Candidate countries are likely to already possess a system for the placing on the market and use of biocides and active substances. However, the designated competent authority and the users may need a substantial amount of time not only to transpose the directive but also to ensure the necessary capacity building both logistically and in terms of human resources. The major tasks involved that are likely to be time-consuming are: to set up the necessary administrative system to process applications for authorisations and to ensure better co-ordination at the national and EU level. Whilst the nature of the directive itself involves many stakeholders even amongst public authorities, consideration should be given to having one authority to regulate and monitor compliance and to be responsible for co-ordination and reporting to the Commission. All competent authorities must train their personnel with respect to procedures and best practices for interfacing with stakeholders as regards the provision of “sometimes sensitive” information.

4. Implementation Guide

4.1 General

During the transposition phase, careful consideration must be given to a number of legal and organisational issues to ensure compliance and better co-ordination. Legal issues that need to be addressed, given the nature of the obligations of the directive, include: principles of confidentiality, the mutual recognition of biocides approved in other Member States, conditions under which to allow the refusal of an application for the placing on the market of biocides and co-ordination between the public authorities involved. The training of officers in compliance is essential both for compliance purposes and good governance. It may be also valuable to publish legislation in order to avoid the stockpiling of biocides before the transposition of the directive.

4.2 Regulation

The definitions of the directive must be carefully transposed and abided by, in order to secure compliance. The exemptions should also be faithfully transposed so as not give rise to possible barriers to trade. The regulation of biocidal products and their placing on the market, in accordance with the directive, is based on three major criteria that are identified in the very first article of the directive:

• the authorisation and placing on the market for biocidal products within Member States

• mutual recognition of authorisation within the EU

• establish at the EU level a positive list of active substances which may be used in biocidal products



Application for authorisation shall be made by, or on behalf, of the person who will be responsible for the first placing on the market of a biocidal product in a particular Member State and the application shall be made to the competent authority of that Member State. Every applicant is required to have a permanent office within the Community.

Special attention must be given to determine the circumstances under which unauthorised substances shall be allowed as these may not go beyond the circumstances prescribed by the directive. The introduction into national legislation of more stringent measures than those in the directive may also lead to trade barriers. National legislation should leave as little discretion as possible to the public authorities when assessing applications and issuing authorisations, in order to ensure smooth implementation and uniform application across all Member States. Provision should also be made in legal instruments to establish when requests for applications may be refused such as when they are manifestly unreasonable or likely to be used and availed of for commercial purposes.

In case it is considered inappropriate to include certain measures in a legal instrument because of their predominantly administrative nature, it is recommended that memoranda of understanding be drawn up to ensure smooth and uniform implementation given the large number of public authorities that may be involved. Transparency is of vital importance. With respect to charges, Article 25 of the directive provides that Member States shall establish systems obliging those having placed or seeking to place biocidal products on the market and those supporting entries for active substances in Annexes I, IA or IB are to pay charges, corresponding as far as possible to their costs they incur in carrying out the various procedures associated with the provisions of this directive.

Example of competent authority in a Member State (IE)

The competent authority for the implementation of biocides legislation is the Pesticides Control Service (PCS) under the Statutory Instrument No. 625 of 2001, which transposes Directive 98/8/EC. Irish legislation defines biocides in an identical manner to the directive and requires all biocides on the market to be notified to the PCS using a standard notification form that provides basic information on the nature, composition and intended uses of a biocide. It is the responsibility of the company placing the biocide on the market in Ireland to ensure that the product is notified according to Statutory Instrument No. 625 of 2001. A company may act on behalf of another to apply for authorisation. The confidentiality of the data submitted is at the request of the applicant. The Irish legislation provides for transitional measures by distinguishing between existing biocides defined as those on the market in Ireland prior to 1 February 2002 and new biocides that have been placed on the market since that date.

4.3 Monitoring

The primary competent authority for implementing this directive may be the ministry for the environment or an agency for environment protection, which shall be the regulator responsible for monitoring compliance and enforcement. However, some Member States have established a health and safety authority (UK) or a standardisation authority (MT) as competent authority. The Biocides Consultative Committee advises the competent authority in the UK when the latter addresses the assessment of active substances and the approval of biocidal products. This is an independent committee made up of scientific experts and lay members who will represent the interests of consumers, workers and the environment. In Malta, a similar advisory body also represents other stakeholders in the public sector from the ministries of trade, agriculture, spatial planning, transportation, statistics and resources. Ultimately, only one competent authority should be responsible for co-ordination at the national and EU level. Since the directive provides for mutual recognition of authorised products, an applicant from one Member State, upon submitting an application and paying the necessary fees to the competent authority of another Member State, should also obtain an authorisation provided that any necessary data has been supplied and any conditions on inclusion in Annex I are met and are in accordance with the directive.



Example of monitoring in Member States (MT)

The Biocides Directive was transposed by the Regulations on Biocides, through subsidiary legislation under the Plant Health Act, although the implementation of and responsibility for the directive were later assumed by the market surveillance section of the Malta Standards Authority, which is currently overhauling the legislative process. The Regulatory Affairs Directorate is responsible for granting authorisations for the placing of biocidal products on the Maltese market. It is also responsible for the registration of biocides. Registration is a recently launched exercise to obtain information on the biocidal products that are currently on the market. It provided evidence that although Malta is not a place where biocides are manufactured, it is a hub for import and export of such products. As a result, the port, postal and airport authorities play an important role in enforcement; amendments to the current legislation are envisaged in order to give customs officers at these points of entry a market surveillance role.

4.4 Enforcement

The directive does not provide for penalties, although Article 31 establishes that the granting of authorisation and all other measures in conformity with this directive shall be without prejudice to general civil and criminal liability in the Member States of the manufacturer and, where applicable, of the person responsible for placing the biocidal product on the market or using it.

Example of enforcement in a Member State (UK)

In the UK, non-agricultural pesticides are regulated under the Control of Pesticides Regulations 1986 (COPR), as subsequently amended. Others are regulated by the Biocidal Products Regulations (BPR). The COPR provides a list of these types of pesticides. These products require approval before they can be advertised, sold, supplied, stored or used. The data that is required for the authorisation depends on the regulatory status of the active ingredients. The requirements are to provide a core set of data and additional data depending on the type of products and their use category. Data requirements can be fulfilled by the provision of a study report or else by a letter of access.

Enforcement is the responsibility of the Health and Safety Executive (HSE), local authorities and several other bodies. All these entities have a role in investigating incidents and ensuring enforcement for the control of the COPR and BPR. In general, local authorities control the advertisement and sale of pesticides and biocides, while the use of products is either enforced by HSE or local authority environmental health officers, depending on the context in which the product has been used. The Chemical Assessment Unit of the HSE provides assistance to enforcement bodies in general. The BPR allocate control responsibilities to local authorities for advertisement and sale, including their labelling and packaging. Control over the use of biocidal products under the BPR is divided between the HSE and local authorities.

5. Costs

Costs vary from state to state and depend on the authorities, which, in the majority of cases, charge only for administrative costs. In Ireland, all costs associated with the implementation are borne by the biocides industry although no blanket charges were levied for the notification of existing biocides (that is, those already on the market by 1 February 2002). Applications for the notification of a new biocide on the other hand were subject to a fee of EUR 254. Costs include charges to operators/users to cover the administrative costs of granting approvals, charges to others for the conducting of studies for approval, charges for requesting dossiers from manufacturers, or charges for the provision of chemical tests, which may be significantly higher.



SECTION 8 – CHEMICALS AND GMO LEGISLATION THE REGULATION ON THE EXPORT AND IMPORT OF DANGEROUS CHEMICALS


The Regulation on the Export and Import of Dangerous

Chemicals

Official Title: Regulation (EC) No. 304/2003 of the European Parliament and of the Council of 28 January 2003 concerning the export and import of dangerous chemicals (OJ L 63, 6.3.2003) (repealed Council Regulation EEC/2455/92 concerning the export and import of certain dangerous chemicals), as amended by Commission Regulation (EC) No. 1213/2003 of 7 July 2003 amending Annex I to Regulation (EC) No. 304/2003 of the European Parliament and of the Council concerning the export and import of dangerous substances (OJ L169, 08.07.2003) and Commission Regulation (EC) No 775/2004 of 26 April 2004 amending Annex I to Regulation (EC) No. 304/2003 of the European Parliament and of the Council concerning the export and import of dangerous chemicals (OJ L123/27, 27.4.2004).


The three main aims of Regulation No. 304/2003 are:

• to implement the Rotterdam Convention on the handling of prior approval of international transport of certain dangerous chemicals and pesticides;

• to promote shared responsibility and co-operation on controlling and monitoring the international transport of dangerous chemicals; and

• to contribute to a more environmentally friendly use of such chemicals.

Regulation (EC) No. 304/2003 substantially modifies and replaces Regulation (EEC) No. 2455/92, which established a common system of notification and information for imports and exports of certain dangerous chemicals into and out of the European Union. Regulation No. 2455/92 made the prior informed consent (PIC) procedure (established by the United Nations Environment Programme and the Food and Agriculture Organisation) mandatory within the EU. Under the PIC procedure, chemicals that are banned or severely restricted, in order to protect human health or the environment, should not be shipped internationally unless the importing country consents to the shipment. The regulation sought to ensure that the rules on classification, packaging and labelling of dangerous substances, laid down in other directives, also apply to exports of dangerous chemicals from the EU to third countries.

Regulation No. 304/2003 was adopted to reflect a series of changes at the EU and international level. Firstly, the Rotterdam Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade (the PIC Convention) was signed by



the European Community on 11 September 1998. The EU adopted Decision 2003/106/EC, now replaced by Decision 2006/730/EC, adopting the Rotterdam Convention on behalf of the European Community. Regulation No. 304/2003 sets out the implementation of the convention’s provisions within the European Union.

Regulation No. 304/2003 establishes the deadlines and obligations that will apply with respect to the notification procedure. The system requires that each exporter submit one export notification each year before the first export of a chemical. The notifications are recorded in a centralised register.

The regulation contains certain measures that are more stringent than those of the convention. Under the regulation, any chemical or pesticide that is banned or severely restricted within the Community, and any products containing these chemicals, must be accompanied by a notification. In addition, explicit consent for export is required for any dangerous chemical or pesticide that is banned or severely restricted within the Community, where it qualifies for PIC notification, even if that chemical or pesticide is not subject to the provisions of the convention and is not included in the list of products already subject to the PIC procedure. The regulation also imposes minimum standards concerning, for instance, the useful life of exported chemicals or pesticides, and storage conditions. The measures on labelling and packaging are also more stringent.

The export measures apply to exports to all countries and not just to those that are parties to the Rotterdam Convention. The regulation provides for the possibility of a complete ban on the export of certain specific chemicals or pesticides. The regulation contains a number of information and reporting requirements, for instance regular reports must be submitted on the quantities of exported chemicals and pesticides concerned. As regards the monitoring and evaluation of the functioning of the regulation, Member States must regularly submit information to the Commission, which in turn will draw up regular reports.

Each Member States must designate one or several national authorities to ensure that the regulation is properly implemented at national level.

Although Member States must designate national authorities responsible for the PIC procedures, the Commission acts as the single contact point regarding the EU’s interaction with the PIC Secretariat and other third parties of the convention as well as with other countries. Hence, the Commission plays a co-ordinating role between the Member States and between the EC and the institutions of the convention. The annexes to the regulation are amended by the Commission, assisted by a committee, according to a fast track procedure,.

Regulation No. 304/2003 has five annexes:

1) Annex I comprises three parts (Part 1 listing chemicals subject to export notification procedure; Part 2 listing chemicals qualifying the for PIC notification; and Part 3 listing chemicals subject to the PIC procedure under the Rotterdam Convention) (relevant to Art. 7).

2) Annex II concerns the content and specifics of notification of a banned or severely restricted chemical to the PIC Secretariat (relevant to Art. 10 of the regulation).

3) Annex III concerns export notification and required information therein (relevant to Art. 7 of the regulation).

4) Annex IV concerns information to be provided by the designated national authorities of the Member States to the Commission (relevant to Art. 9 of the regulation).

5) Annex V lists chemicals and products subject to an export ban (relevant to Art. 14 of the regulation).

Regulation No. 304/2003 has been amended twice: first by Regulation (EC) No. 1213/2003 amending Annex I; and later by Commission Regulation (EC) No. 775/2004.



• Regulation No. 1213/2003 modifies Parts 1 and 2 of Annex I, notably by moving chemical moncrotophos previously listed in Part 1 to Part 3 — that is, subject to the more stringent PIC procedure. The changes to Parts 1 to 3 concerned methyl parathion, monocrotophs, parathion, and tecnazene.

• Regulation No. 775/2004 amends Annex I to Regulation No. 304/2003 by adding chemicals to the list of chemicals set out in Parts 1 to 3 of Annex, I to reflect changes to EC chemicals legislation:

− adding to Parts 1 and 2 of Annex I amitraz, atrazine, fenthion and simazine, which are restricted in several decisions adopted in the framework of Directive 91/414/EEC concerning the placing of plant protection products on the market, banning or severely restricting chemicals;

− adding to Parts I and 2 of Annex I nonylphenol and nonylphenol ethoxylate, which are restricted for industrial use by Directive 2003/53/EC relating to restrictions on the marketing and use of certain dangerous substances and preparations;

− adding to Part 3 (interim PIC procedure) the asbestos fibres amosite, antyophyllite, actinolite and tremolite;

− adding to Parts 1 and 3 (interim PIC procedure) certain dustable powder formulations containing benomyl, carbofuran and thiram.


2.1 Planning

• Designate an authority (or authorities) to be responsible for implementing the notification and information procedures laid down in the regulation and inform the Commission about this designation (Art. 4).

• Designate authorities, especially customs authorities, responsible for controlling the import and export of chemicals listed in Annex I (Art. 17).

• Ensure that all chemicals listed in Annex I are handled and traded according to the provisions of the regulation.

• Ensure that the lists of chemicals listed in Part 1 (subject to export notification), Part 2 (subject to export notification and qualifying for the PIC notification procedure) and Part 3 (chemicals subject to the PIC procedure) are made available to the public in electronic format (Art. 6).

2.2 Regulation

• Ensure that exporters of chemicals comply with their obligations under the regulation, including:

− ensuring that chemicals and products listed in Annex V, which are prohibited in the EU, are not being exported (Art. 14(2));

− duly notifying exports to parties or other countries of chemicals listed in Parts 1 to 3 of Annex I to the competent authority, including:

• Part 1 chemicals have to be notified to the designated national authority of the Member State in which the exporter is established at least 30 days prior to the export, for first time exports, and for subsequent exports at least 15 days before the export. A new export notification has to be given in case of changes to EC legislation affecting requirements concerning the



marketing, use or labelling of substances or when the composition of a preparation has been altered (Art. 7(1), (3)). The export notification is not needed if the importing party has made an official consent or non-consent to the secretariat or made a waiver to the notification requirement (Art. 7);

• Parts 2 and 3 chemicals can only be exported if the exporter has obtained an explicit consent to the import through the designated national authorities of the country where the exporter is established and in the country of import. Part 3 chemicals cannot be exported unless the latest circular issued by the secretariat indicates such a consent (Art. 13(6));

• not exporting any chemical later than six months before the expiry date (Art. 13);

− annually submitting to the designated national authority of its Member State information on the quantity of the chemical shipped to each convention party or other country during the preceding year, along with a list of the names and addresses of each importer. This information must reach the authority during the first quarter of each year (Art. 9(1));

− notifying importing parties about chemicals listed in Annex I, including articles containing chemicals listed in Parts 2 and 3 of Annex I;

− to package and label chemicals in accordance with Community legislation, especially Directive 67/548/EEC, Directive 1999/45/EC, Directive 91/414/EEC and Directive 98/8/EC and Regulation 1907/2006. The label must be given in the official language of the country of destination (Art. 16);

− to label chemicals with the production date and the expiry date and, for pesticides, include specific information about storage conditions and stability suitable for the climatic conditions of the importing country (Art. 16(2) and Art. 13);

− ensure that chemicals are exported with accompanying safety data sheets and that such sheets are sent to each importer. This information must be in a language understood in the importing country (Art. 16(3));

− to comply with the decisions of the importing country (e.g. if the importing country requires continued export notifications by exporting parties) as well as to comply with decisions in each import response within six months of the secretariat first informing the Commission of such response (Art.7).

• Each importer is mainly obliged to:

− submit the information about the quantities imported into the EU;

− provide any additional information as requested by the Commission (Art. 9(1), (2)).

• The designated authority must comply with its obligations under the regulation, including:

− checking the notifications and their compliance with Annex III and forwarding the notification to the Commission (Art. 7(1));

− deciding on possible waivers to the export notification requirement and to allow immediate exports of chemicals in cases where a delay in transportation could endanger public health or the environment in the importing or other country (Art. 7(4));

− immediately forwarding notifications to the Commission and any ancillary information received where the designated authority receives any export notification directly or indirectly from relevant authorities from parties or other countries (Art. 8(2)).



• Ensure that those parties listed in Annex VI that require information on transit movements of chemicals falling under the PIC procedure receive the requested information. In such case, the Member States must ensure that, firstly, the exporter provides this information to the designated authority of the Member State in which the exporter is established no later than 30 days prior to the first transit, and at least 8 days before each further transit. Secondly, the designated authority must forward this information to the Commission (Art. 15(2)).

• Establish effective, proportionate and dissuasive penalties applicable in the event of infringements of the provisions of the regulation and take all necessary steps to ensure correct implementation. The Commission must be notified about these penalties and also in case of modifications to these sanctions (Art. 18).

• Ensure that the export of chemicals, the use of which is prohibited within the Community for the protection of human health or the environment, listed in Annex V, is prohibited.

• Ensure that amendments to Annex II of the regulation are reflected in national law on a timely basis.

2.3 Information and Reporting

• Facilitate the exchange of scientific, technical, economic and legal information (including toxicological and safety information) regarding chemicals under the regulation (Art. 19).

• Deal with confidential information as requested and in accordance with Article 19, especially regarding which information is to be regarded as confidential.

• Regularly send information to the Commission on the procedural operations, including functioning of customs controls, occurrences of infringements, penalties and remedial action, and provide details of the activities of customs authorities (Arts. 17 and 21).

• Provide the Commission with a yearly report with aggregated information in accordance with Annex IV (Art. 9(3)).

• Designated national authorities within the EU must make the import decisions available to affected parties (Art. 12(5)).


− the designation of competent authorities (Art. 4);

− national legislation restricting or banning a chemical (Art. 10(7)); and

− notifications regarding the export of chemicals subject to notification.


EC legislation that should be taken into consideration in the implementation of this regulation includes:

• Regulation (EC) No. 1907/2006 and Directive 79/117/EEC, which restrict the marketing and use of certain chemical substances and preparations within the EU. These do not apply to products exported to third countries.

• Council Directive 67/548/EEC (as amended by Directive 2001/59/EC) on the classification, packaging and labelling of dangerous substances. This is applicable to substances placed on the market in the Community.

3. Implementation



3.1 Key tasks

The key tasks involved in implementing this regulation are summarised in the checklist below. The key tasks are arranged under subheadings and organised in chronological order of implementation wherever possible.


This regulation cannot be fully implemented until appropriate systems for classifying chemicals and managing their marketing within the EU are in place. Its implementation should therefore be carried out in parallel with Council Directive 67/548/EEC and the REACH Regulation (No 1907/2006).

Some regulatory control of chemical import and export will already be in existence in candidate countries, especially those that are already participating in the international PIC procedure.

REGULATION ON THE EXPORT AND IMPORT OF DANGEROUS CHEMICALS – KEY IMPLEMENTATION TASKS

1 Planning

1.1

1.2

Designate a competent authority to take responsibility for the notification and information measures required for the import and export of chemicals requiring prior informed consent.

Designate authorities, especially customs authorities, responsible for controlling the import and export of chemicals listed in Annex I

2 Regulation

2.1 Do not export chemicals and products listed in Annex V, which are prohibited in the EU (Art. 14(2)).

Establish procedures and protocols to ensure that the competent authority complies with its obligations under the regulation, including:

• receiving notification of a proposed first export of a substance subject to notification at least 30 days before the intended export;

• informing the appropriate authorities in the country of destination of the intended export at least 15 days before the intended export;

• providing the necessary information to the Commission on transit movements to parties of the convention that require information on transit movements of chemicals subject to the PIC procedure;

• reporting to the Commission;

• taking appropriate actions in response to reactions from the country of destination;

• amending and implementing the revised Annex II on a timely basis;

• ensuring that dangerous substances for export to third countries comply with EC labelling and packaging requirements; and

• monitoring compliance with the provisions of the regulation.

Ensure that the export of chemicals whose use is prohibited within the Community for the protection of human health or the environment, listed in Annex V, is prohibited.

3 Obligations of the exporter



3.1 Develop and provide guidance to exporters on their obligations under the regulation, including:

• the packaging and labelling of chemicals in accordance with EC requirements;

• complying with the import decisions of countries of destination; and

• notifying competent authorities of the proposed first export of chemicals subject to notification to third countries.

4 Information and Reporting

4.1 Co-operate with the Commission in evaluating the risks posed by certain chemicals.

4.2 Provide the Commission with a yearly report with aggregated information in accordance with Annex IV.


• designation of competent authorities;

• notifications received relating to exports of chemicals;

• information on the operation of the notification system;

• national legislation to ban or severely restrict a chemical;

• penalties applicable in the event of infringements of the provisions of the regulation;

• the procedural operations, including the functioning of customs controls, occurrences of infringements, penalties and remedial action.


A number of general observations and good practice suggestions for applying the regulation are presented below based upon the collective experience of Member States.

4.1 Planning

• The competent authority/ies will vary depending on the administrative structure within the country concerned, but may include government departments or agencies with responsibility for the chemical industry, trade and customs control. If more than one competent authority is established, it must be made clear who is responsible for which tasks.


In one Member State (UK), the Health and Safety Executive (HSE) administers the regulation under the Export and Import of Dangerous Chemicals Regulations 2005. The Health and Safety Commission is the designated national authority to perform the administrative functions required by the regulation and to be the designated national authority that shall have the responsibility for controlling the import and export of chemicals listed in Annex I to the regulation. The Health and Safety Executive is the enforcing authority and penalties can be levied under the Health and Safety at Work Act of 1974.

In another Member State (SE), this regulation is primarily dealt with by the National Chemicals Inspectorate (KEMI) and the Customs Department. KEMI inspects permits and provides advice to the Ministry of Environment. KEMI is the competent authority according to the Rotterdam



Convention and participates in various Commission meetings. Sweden had a small chemical manufacturing industry and was reliant on the imports of chemicals for some years prior to accession to the EU. The country had developed a rigorous regulatory system early on and subscribed to the voluntary UNEP scheme in 1992, which included prior informed consent. Consequently, the implementation of this regulation had few implications for this Member State.

4.2 Regulation

• Once the competent authority has been designated, a procedure must be established for the notification of the export and import of dangerous chemicals. An exporter must notify the competent authority (in its own country) of its intention to export certain dangerous chemicals to a third country for the first time. This notification must be done at least 30 days before the export is to take place. Certain information must be included in the notification and this is laid down in Annex III of the regulation, together with a standard form that should be used. On receipt of the notification, the competent authority must notify the appropriate authorities in the country of destination at least 15 days before the export is to take place and inform the Commission. Exceptions from these notification requirements may be allowed in emergency situations.

• The Commission acts as the central authority for the PIC procedure. It notifies the competent bodies outside the EU of chemicals that are banned or severely restricted within the EU. On receipt of information about the export from the EU of a dangerous chemical, it assigns a reference number to the export, which is used also for each subsequent export of the same chemical from the Community to that third country. Member States are informed of this number and it is published in the Official Journal.

• The European Chemicals Bureau (ECB) in Ispra, Italy, is now responsible, on behalf of the Commission, for the exchange of information between the Member States, third countries and United Nations organisations (FAO and UNEP). It has created a useful database, EDEXIM, distributed to Member States in 1996, providing classification and labelling information about substances covered by the regulation. EDEXIM is available in confidential form to Member States and a publicly accessible form is also available from the ECB website.

• Once the Commission has issued the reference number to the Member State’s competent authority, and the third country has indicated that it will accept the substance, the export may take place. The reference number issued by the Commission must be used for all subsequent exports of the substance to that country.

• Dangerous chemicals that are exported from the EU must be packaged and labelled in accordance with Council Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances.

• A monitoring system should be established to ensure that the provisions of the regulation are complied with. This may involve inspection of exports as they leave the country concerned as well as inspection of the records of known exporters of chemicals.

• In accordance with the decisions on the international PIC procedure, Annex II will be amended from time to time. These amendments will need to be implemented in national law and practice. They require minute attention to detail, given the number of substances, participating countries and their respective decisions related to consent status. These changes will also have to be notified to relevant firms and competent/customs authorities in advance of their entry into force so as to provide sufficient time for dealing with the revised lists.

• In general, the Commission will act as the central authority in respect of imports of substances to the EU. However, where a Member State receives a notification of an import it is required to forward the notification to the Commission together with any



additional information provided, and to prohibit or restrict the import in accordance with the decision of the Commission.

4.3 Obligations of the Exporter

As the regulation is directly applicable for Member States (and candidate countries from day one of membership), guidance should be provided to exporters informing them of their obligations under the regulation to ensure successful implementation. This should specify:

• the information that must be included with a notification (as specified in Annex III of the regulation);

• to whom the notification must be sent;

• guidance on what information is required to be included with the export;

• information on the packaging and labelling required by the national legislation implementing Council Directive 67/548/EEC;

• the content of the Annex II list;

• details of how to make subsequent exports; and

• information on the circumstances under which a new notification must be made.

It may be appropriate for a competent authority to operate a helpline to assist exporters in the completion of notifications. In addition, information could be provided to exporters on which substances destination countries will and will not accept. Guidance is available from FAO/UNEP guidance documents.

4.4 Information and Reporting

• The European Commission acts as the central authority for the import of chemicals into the Community under the PIC procedure. As such, when a notification for import is received, the Commission must decide whether the import should be accepted, prohibited or restricted. In order to do this, the Commission forwards such notifications and any additional information to the Member States. This is done through co-operation and information sharing with the Member States.

• A Member State must report to the Commission when a third country has responded substantially to a notification for the export of a dangerous chemical. The Commission will then notify other Member States.

• Member States are required to report regularly to the Commission on the implementation of the regulation. To date, the Commission has published three reports on the implementation of the regulation (in 1993, 1998 and 2006). The last report, in 2006, found that between 2003 and 2005 the Member States dealt with a total of more than 2,200 export notifications, meaning a progressive increase in the annual number of notifications. Over 80% of notifications came from five Member States (France, Germany, the Netherlands, Spain and the United Kingdom). It was noted that the notification procedures function well and are effective. The main problem encountered were the delays in obtaining responses to requests for explicit consent, which resulted in increased administrative burden on exporters, the national authorities involved and the Commission. An "enterprise" version of the database on imports and exports (EDEXIM) is one proposal to simplify and speed up notification procedures. Several Member States emphasise the need to collaborate more closely as regards customs controls and the transmission of information to the customs authorities. However, the Commission noted that no major problems of non-compliance with the rules had been reported by the Member States.



5. Costs

The costs of implementing this regulation are concerned with establishing and running a notification and information system to support the import and export of dangerous chemicals.

A statutory import/export control system already exists in some countries. The additional costs to the regulatory authority to collect the information required by this regulation and to control the movement of chemicals is unlikely to be very large, particularly if the country already subscribes to similar schemes such as the UNEP or OECD schemes.

The costs to industry will be limited to additional administrative costs.

SECTION 8 – CHEMICALS AND GMO LEGISLATION REGULATION ON REGISTRATION, EVALUATION, AUTHORISATION AND RESTRICTION OF CHEMICALS (REACH)


Regulation on Registration, Evaluation, Authorisation and

Restriction of Chemicals (REACH)

Official Title: Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC


REACH is the new regulation on the registration, evaluation, authorisation and restriction of chemicals. It entered into force on 1 June 2007. It streamlines and improves the former legislative framework on chemicals of the European Union (EU).

The former legislative framework distinguished between existing substances and new substances. New substances had to be notified by industry according to the provisions of Directive 67/548/EEC and the national authority had to perform a risk assessment for these few substances. In contrast to this complex and expensive procedure for new substances, only a small number (141) of existing substances listed in one of the four priority lists (Commission Regulations (EC) No 1179/94, 2268/95, 143/97 and 143/97) had to be evaluated according to Regulation (EC) No. 793/93 and Regulation (EC) No 1488/94. The registration of substances under REACH basically does not distinguish between new and existing substances. Manufacturers and importers of substances have to register each substance, unless they are covered by an exemption, including a risk assessment and risk reduction measures if needed. Thus, the assessment of existing substances will be accelerated and information for limiting possible risks occurring when these substances are manufactured and used will be available for concerned actors.

The main aims of REACH are to improve the protection of human health and of the environment from the risks that can be posed by chemicals, to promote alternative test methods and the free circulation of substances on the internal market and to enhance competitiveness and innovation.



REACH makes industry responsible for assessing and managing the risks posed by chemicals and for providing appropriate safety information to their users. In parallel, the European Union can take additional measures on highly dangerous substances, where there is a need for complementary action at EU level.

All manufacturers and importers of chemicals must identify and manage the risks linked to the substances they manufacture and market. For substances produced or imported in quantities of 1 tonne or more per year per company, manufacturers and importers need to demonstrate that appropriate measures have been taken by means of a registration dossier, which must be submitted electronically to the European Chemicals Agency (ECHA) located in Helsinki.

In principle, REACH applies to all substances: not only substances used in industrial processes but also in our day-to-day life, for example in cleaning products and paints as well as in articles such as clothes, furniture and electrical appliances.

The ECHA may then check that the registration dossier complies with the regulation and shall examine all testing proposals to ensure that the assessment of the chemical substances will not result in unnecessary testing, especially on animals.

Where appropriate, authorities may also select substances for a broader risk-based substance evaluation to further investigate substances of concern.

REACH also foresees an authorisation system aiming to ensure that substances of very high concern are properly controlled, and progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. Where this is not possible, the use of substances may only be authorised where their use is of overall benefit to society.

In addition, EU authorities may impose restrictions on the manufacture, use or placing on the market of substances causing an unacceptable risk to human health or the environment.

The authorities of Member States are responsible for enforcing REACH through inspections as well as penalties in case of non-compliance.

One directive supplementing the REACH Regulation is Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. However, it is important to note that this directive will shortly be completely replaced by a new CLP Regulation.


2.1 Planning

Appoint a competent authority (authorities) responsible for performing the tasks allotted to it (them) under this regulation, such as performing substance evaluation of registered substances, installing a system for inspection and for controlling compliance with the regulation; establishing a system of applicable penalties for infringements of the provisions of the regulation; establishing a national helpdesk to provide advice to SMEs or other interested parties; and co-operating with the European Commission (EC), the European Chemicals Agency (ECHA) and competent authorities of other Member States in the implementation of the regulation.

2.2 Legislation

• Ensure that manufactures and importers do not manufacture, import or place on the market substances individually, in preparations or in products, unless:

− they have been registered in accordance with the specified criteria and procedures (Title II: Arts. 5–24).



− if additionally required, they have been granted an authorisation (Title VII: Arts. 56–66).

• Ensure that a substance on its own, in preparations or in articles, for which Annex XVII contains a restriction, is not manufactured, placed on the market or used unless it complies with the conditions of that restriction (Title VIII: Art. 67).

• Ensure that manufactures, importers, downstream users and distributors comply with their obligations to communicate relevant information up and down the supply chain (Title IV: Arts. 31–36).

2.3 Reporting

• Report to the Commission on the operation of this regulation in their respective territories, including sections on evaluation and enforcement (results of the official inspections, monitoring carried out, the penalties provided) (Arts. 117 and 127).

• Report to the ECHA on conclusions as to whether or how information obtained by substance evaluation should be used (Art. 48).

• Report to the general public on risks deriving from substances in order to protect human health and the environment (Art. 123).

Besides the ongoing reports, Member States must notify the Commission of provisions on applicable penalties for the infringement of the provisions of the regulation. The Commission must also be notified without dealy of any subsequent amendments affecting these provisions (Art. 126).


The following legislation should be taken into consideration when implementing and applying this regulation:

• As this regulation changes and improves the former legislative framework on chemicals it repeals parts of Council Directive 67/548/EEC. The parts of Council Directive 67/548/EEC dealing with the classification, labelling and packaging of substances are still in force until the new regulation implementing the globally harmonised system (GHS) enters into force. Directive 67/548/EEC and Directive 1999/45/EC (for the classification, packaging and labelling of dangerous preparations) still have a central role in the control of chemicals in addition to this regulation.

Furthermore, this regulation and Directive 67/548/EEC play an important integrating role related to chemicals legislation for the protection of workers and the Seveso II Directive.

Other legal instruments that should be taken into account when implementing this regulation:

• Council Directive 67/548/EEC last amended by Directive 2006/121/EC of the European Parliament and of the Council.

• Directive 1999/45/EC of the European Parliament and of the Council on the classification, packaging and labelling of dangerous preparations.

• Council Directive 76/769/EEC concerning restrictions on the marketing and use of certain dangerous substances and preparations (until 1 June 2009).

3. Implementation

3.1 Key Tasks



The key tasks involved in implementing this regulation are summarised in the checklist below. They are arranged under subheadings and organised according to their priority in chronological order of implementation whenever possible.

DIRECTIVE ON THE CLASSIFICATION, PACKAGING, AND LABELLING OF DANGEROUS PREPARATIONS – KEY IMPLEMENTATION TASKS

1. Planning

1.1 Designate a competent authority (Art. 121).

1.2 Establish an infrastructure to ensure access by the competent authority or authorities to the tools and databases of the ECHA.

1.3 Build up capacity for participating in the different committees (Art. 85), management board (Art. 79) and forum (Art. 86).

2. Legislation

2.1 Establish a national helpdesk providing information to manufacturers, importers and distributors to ensure that they understand the requirements of the regulation (Art. 124).

2.2 Establish a mechanism to ensure that all substances manufactured or imported from outside the EU are registered (Art. 125).

2.3 Establish a system of applicable penalties applicable for infringement of the provisions of this regulation (Art. 126).

2.4 Establish an effective system for the inspection and enforcement of the implementation of this regulation (Art. 125)

2.5 Establish a procedure for carrying out substance evaluation (Title VI: Arts. 44–49).

2.6 Establish procedures and criteria for maintaining industrial and commercial secrecy.

3. Reporting


• the operation of this regulation in their respective territories, including sections on evaluation and enforcement (Arts. 117 and 127).

3.2 Phasing Consideration

The REACH Regulation is a key regulation in the control of chemical hazards. It is likely to take a substantial amount of time to implement the regulation because of its potential effect on a range of stakeholders. The main aims of this regulation are to improve the protection of human health and the environment from the risks that can be posed by chemicals. This regulation places greater responsibility on industry to manage the risks that chemicals may pose to human health and the environment. There will be a need to co-ordinate this legislation between the relevant ministry departments.


This regulation plays a vital role in the protection of human health and the environment from chemical hazards. It should also enhance the competitiveness of the EU chemicals industry, a key sector in the economy of the EU, and should ensure the free circulation of substances on the EU internal market. It was adopted under Article 95 of the treaty establishing the European Union.

Some industrial sectors are partly exempted from the provisions of the regulation because they are covered by provisions in other Community legislation, for example sectors manufacturing medicinal products or food.



Implementation of the regulation requires a system that:

• ensures that all substances manufactured, imported and used are registered;

• establishes safety procedures to minimise the likelihood of a hazard becoming a risk; and

• ensures the communication of information regarding the safe handling of chemicals up and down the supply chain.

The regulation is very complex and has potential effects on many different industrial branches. As soon as a competent authority has been designated it is important for all involved staff (committee members, designated inspectors, helpdesk staff etc.) to acquire a good knowledge and understanding of the provisions of this regulation. In order to establish a national helpdesk for industry and to ensure co-operation with other Member States and the ECHA there will be a high demand for experts on this regulation and in related fields (e.g. toxicology, chemistry/substance identification).

4.1 Planning

• This regulation changes and improves the former legislative framework on chemicals of the European Union. It substitutes substantial parts of Directive 67/548/EEC (e.g. provisions on the notification of new substances) and implies all the provisions of Directive 76/769/EEC concerning restrictions on the manufacturing, placing on the market and use of certain dangerous substances, preparations and articles (Art. 139).

• The choice of a competent authority will require care, since the many government bodies will have a legitimate interest in the regulation. For example, a body concerned with worker safety may be considered to be the most appropriate, but it is essential that mechanisms for involving other departments and receiving input from them, particularly those with a remit for environmental protection, are established. Where more than one competent authority is appointed tasks must be clearly allocated — for example, carrying out substance evaluation, maintaining the national helpdesk and communicating with the Commission and the ECHA. Training or recruitment may be required to ensure that the competent authority/ies is adequately equipped to complete the substance evaluation required or to provide support for SMEs.

Examples of Competent Authorities in Member States

In one Member State (DE), the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety has the legal competence for this regulation. The Federal Institute for Occupational Safety and Health (BAUA) has been appointed as the competent authority responsible for implementation and enforcement of the regulation. Subsequent examination/evaluation of data is performed jointly with the Federal Environmental Agency (UBA), the Federal Institute for Risk Assessment (BfR), the Federal Institute for Materials Research and Testing (BAM) and the Safety and Health of Chemical and Biological Working Substances Department of the Federal Institute for Occupational Safety and Health. The authorties of the federal states are responsible for inspections.

In another Member State (PL), the Ministry of Health has the legal competence in relation to this regulation. The Bureau for Chemical Substances and Preparations (affiliated to the Ministry of Health) has been appointed as competent authority. This is an institution of Polish governmental administration, founded in the first half of 2001. The bureau was established after the adaption of Polish legislation on chemicals control to the relevant Community regulations. The bureau is also responsible for the organisation of a system for inspections. Inspections are performed by different regional inspectorates (mainly sanitary inspectorates).

In one Member State (AT), the competent authority responsible for the implementation and enforcement of the regulation is the Ministry for Agriculture, Forestry, Environment and Water Management. The ministry is responsible for establishing the legal basis for the enforcement and control of the implementation of this regulation and lays down the provisions on penalties



applicable for infringements of the provisions of the regulation in co-ordination with other ministries and involved stakeholders. For special tasks, such as substance evaluation, running the national helpdesk or sending experts to meetings, the compentent authority mandates the Umweltbundesamt (Environmental Agency), which acts in some fields of chemical legislation on behalf of the competent authority. The authorities of the nine Austrian federal states are responsible for inspections.

In another Member State (SL), the National Chemicals Bureau under the Ministry of Health has been appointed as the competent authority. The National Chemicals Bureau is competent for the preparation, implementation and supervision of implementation of legislation relating to chemicals. The Chemicals Bureau also co-ordinates the monitoring of the sale and use of chemicals and performs inspections.

• The regulation has a potential impact on many stakeholders, and, as a result, great care

must be taken to consult widely. For example, the stakeholders involved include not only companies and their workers and their representatives, but also environmental bodies, accident control authorities, emergency services, and a wide range of NGOs and government departments. This large number of interested parties reflects the importance of chemical substances in everyday life.

• Governments may benefit from consultation with the Commission, the ECHA, international organisations concerned with chemicals such as the OECD, and other national governments through, for example, the exchange of information, the discussion of best practices, or the pooling of common resources.

4.2 Legislation

• The regulation requires the registration of each substance manufactured or imported in the EU. In order to register a substance, the manufacturer or importer sends a dossier electronically to the ECHA, which carries out a dossier evaluation including a compliance check of all submitted dossiers. A considerable number of the submitted dossiers have to be evaluated with respect to possible dangerous properties of high concern of substances. The so-called substance evaluation has to be done by the Member States. Information obtained from this evaluation process should be considered for identifying substances of very high concern, restriction and harmonised classification and labelling procedures and other similar procedures. A mechanism for carrying out this evaluation process and the possible following processes including co-operation with the ECHA must be established. Trained and experienced staff will be needed to handle these tasks.

• Guidance has been developed over the past few years for industry and for the authorities in order to ensure the smooth implementation of this regulation. A number of guidance documents were drafted and discussed within projects led by the European Commission services, involving stakeholders from industry, Member States and non-governmental organisations. A national helpdesk must be established in each Member State to provide further practical advice to industry (especially for SMEs) on how to fulfil their obligations under this regulation.

• An effective system for inspection and for the enforcement of the implementation of this regulation has to be established. It has to be ensured that all substances manufactured, imported and used within the EU are registered and have an authorisation if required and that there is no infringement of the provisions on restrictions on the marketing and use of certain dangerous substances.

• There are also requirements relating to the provision of safety data sheets. These contain information for the user on the safe handling of the substance during storage, transport and disposal, as well as information on hazards, fire-fighting, first aid, accidental release measures and toxicological and eco-toxicological properties. Once again, a system of



compliance monitoring will be required in order to ensure that data sheets are both provided and accurate.

• In addition, an adequate system of penalties for non-compliance will be required to provide an incentive for manufacturers and importers to meet the requirements of the regulation.

4.3 Reporting

The regulation requires Member States to report to the Commission and the ECHA on aspects of implementation.

Member States shall submit to the Commission a report on the operation of this regulation in their respective territories. This report shall include, in relation to enforcement, the results of official inspections, and information concerning the monitoring carried out, the penalties provided, and other measures taken concerning the control of compliance (Arts. 117 and 127).

Competent authorities must inform the general public about the risks arising from substances where this is considered necessary for the protection of human health or the environment. This activity has to be carried out in co-ordination with other Member States and the ECHA according to a guidance provided by the ECHA.

5. Costs

The main costs to governments of implementing this regulation comprise costs of establishing the implementation systems, the day-to-day costs of maintaining them, the employment of trained staff, and the payments to specialist advisors/consultants for carrying out substance evaluation, for running the national helpdesk and attending committee meetings and for special events.

Minor costs should also be taken into account for establishing and maintaining the IT infrastructure in order to have a secure connection to the ECHA IT system, which is necessary for the exchange of data between Member States and the ECHA, and for establishing measures to ensure the confidentiality of this data.

The implementation costs to be borne by industry are very much higher than those borne by governments. As this regulation shifts the responsibility for risk assessment for manufactured, imported and used substances to industry, the workload for companies required to register substances will be very high. Besides the costs of the staff involved, companies will need to pay for studies and tests as well as the registration fee(s). Depending on the manufactured or imported amount, and on the number of companies that have to register the same substance, the costs will differ considerably for different substances. The regulation foresees the establishment of so-called substance information exchange forums (SIEFs) in order to share information on existing data, to avoid additional testing on animals, and to save costs. It is possible for companies registering the same substance to make a joint submission (Art. 11). Registrants using this possibility can also benefit from a reduced registration fee.

For other actors in the supply chain of substances there will be a greater need for handling information on the substances, which will result in some additional costs for companies not involved in the registration procedure.

Checklist of the Types of Cost Incurred to Implement the Regulation


• establishment of competent authority(ies);

• building capacity for national helpdesks and substance evaluation (including further



actions);

• building capacity and expertise for co-operation with the ECHA and other Member States (participation at meetings, etc.);

• establishment of a system of penalties;

• training of staff and inspectors.

Ongoing costs:

• attendance at meetings ;

• carrying out substance evaluations and further actions.

SECTION 8 – CHEMICALS AND GMO LEGISLATION THE DIRECTIVE ON CONTAINED USE OF GENETICALLY MODIFIED ORGANISMS


The Directive on Contained Use of Genetically Modified

Organisms

Official Title: Council Directive 90/219/EEC on the contained use of genetically modified microorganisms (OJ L 117, 8.5.90) as amended by Directive 98/81/EC (OJ L 330 5.12.98), 2001/204/EC (OJ L 73, 15.3.2001)184 and Decision 2005/174/EC (OJ L 59, 5.3.2005)185

Related Commission Decision 2000/608/EC concerning guidance notes for risk assessment (OJ L 258/43 12.10.00)


The directive aims to protect human health and the environment from any adverse effects arising from using genetically modified micro-organisms (GMMs) in containment. It lays down common definitions and rules for use of GMMs in research laboratories and industrial facilities, and for systems of risk assessment and notification.

Commission Decision 2000/608/EC concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified micro-organisms (as amended) has been created for the purpose of codifying an opinion of the committee established under Article 21 of the directive on contained use of GMMs (90/219/EEC). The opinion is reflected in annexed guidance notes for risk assessment outlined in Annex III of Council Directive 90/219/EEC on the contained use of GMMs. These annexed notes are to be implemented by all Member States when an assessment of the contained use of GMMs is made pursuant to Article 5 of the directive on the contained use of GMMs.

The full risk assessment process established by the decision requires the application of two procedures. Procedure 1 requires the identification of potential harmful properties of the GMM and allocation to an initial class (classes 1 to 4) based on the severity of the potential harmful effects. Thereafter, there is an assessment of the possibility of harmful effects with containment

184 2001/204/EC: Council Decision of 8 March 2001 supplementing Directive 90/219/EEC as regards the criteria for establishing the safety, for human health and the environment, of types of genetically modified micro-organisms (Text with EEA relevance) 185 Commission Decision of 28 February 2005 establishing guidance notes supplementing part B of Annex II to Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms (notified under document number C(2005) 413) (Text with EEA relevance).



measures to be appropriately allocated. In procedure 2, the final classification is determined as are the actual containment measures.

Decision 2005/174/EC sets out guidance notes (in Annex 1) supplementing Part B of Annex II to Directive 90/219/EEC (in terms of the criteria for classifying genetically modified micro-organisms in group I (vector/insert)). The criteria listed in Part B of Annex II to Directive 90/219/EEC must be met in order to establish the safety of a genetically modified micro-organism (GMM) for human health and the environment and its suitability for inclusion in Part C of Annex II to that directive. These guidance notes are designed as an aid to ensuring that the national competent authorities carry out their preliminary assessment in an appropriate manner and provide appropriate information to users as to the content of dossiers to be submitted.


2.1 Planning

• Designate an authority or authorities to implement the requirements of the directive and to receive and assess notifications (Art. 11).

• Ensure that a system is put in place to facilitate the activation of administrative requirements in connection with the classification of contained use activities.

• Designate technical staff with the capability to advise third parties on the application of guidance notes for risk assessment procedures applied to the contained use of GMMs.

2.2 Regulation

• Ensure that users apply the general principles and protective measures laid down in the directive to ensure a high level of safety, and that they review the risk assessment and protective measures as required (Art. 6 and Annex IV).

• Ensure measures are taken to avoid adverse effects on human health and the environment that might arise from contained use of GMMs (Art. 5).

• Ensure that “users” (persons responsible for the contained used of GMMs) carry out risk assessments of the contained use and classify the contained use in accordance with the procedure laid down in the directive (Art. 5 and Annex III, also note the new guidance note set out in Annex 1 to Decision 2005/174/EC).

• Further to procedure 1 of Decision 2000/608/EC, in identifying the potential harmful properties of the GMM the following aspects should be addressed through regulations:

− the nature of the recipient organism;

− the nature of the donor organism;

− the features of the insert (identity, expression, source, history and location); and,

− the vector (nature, source, structure, amount, transfer capability).

Human health and environmental considerations must both be applied in determining levels and types of potential harmful properties of the organism (Art 5, Annex III and Decision 2000/608/EC).

• Further to the initial classification of procedure 1, compliance should be required with the measures specified in Annex IV of the directive for containment and other protection measures (Annex IV of the directive and Decision 2000/68/EC).

• In determining the level and nature of exposure to humans and the environment reference should be made to the:



− nature of activities to be undertaken;

− concentrations of the GMM and the scale; and

− culture conditions including the environment likely to be exposed, presence of susceptible species, survival potential of the GMM and effects on the physical environment (Decision 2000/68/EC).

• In implementing procedure 2 by regulatory and procedural mechanisms, the classification and containment measures required for the activity should be confirmed by re-visiting procedure 1 and comparison with the final class and containment requirements. Then the adequacy of final containment measures and the risk assessment should be confirmed as complete (Decision 2000/68/EC).

• Ensure measures are taken to protect human health and the environment from the disposal of waste and effluents (Art. 5).

• Ensure that users comply with the requirements relating to notification to the competent authorities of a proposed contained use, prior to proceeding with the use, in accordance with the notification requirements of the directive (which vary according to the class of contained use) (Arts. 7, 8, 9, 10 and 12).

• Ensure that users keep, and make available to the competent authority on request, a record of assessments carried out in respect of the use (Art. 8).

• Ensure that competent authorities receive and assess notifications of contained use and authorise contained use in accordance with the criteria and deadlines laid down in the directive (Arts. 11 and 12).

• Ensure that certain measures are taken in the event of an accident (an incident involving a significant and unintended release of GMMs in the course of their contained use which could present a hazard to human health or the environment) including the provision of information to the competent authority (Art.15).

• Ensure that competent authorities receive and assess requests from notifiers to keep information confidential, in accordance with the conditions laid down in the directive and in Council Directive 90/31/EEC (Art. 19).

• Ensure that inspection and other control measures are established to ensure compliance with the directive (Art. 17).

• Ensure that emergency plans are drawn up and the plans and information relating to them are made available to relevant national authorities and the public (Arts. 14 and 16).

2.3 Consultation and Reporting

• Provide for public consultation on contained use, where considered appropriate (Art. 13).


− class 3 and class 4 contained uses (annually) (Art. 18);

− experience in implementing the directive (every three years) (Art. 18);

− accidents (Art. 16);

− implementation of the directive (Art. 2 of Council Directive 98/81/EC); and

− transposition with text (Art. 2 of Council Directive 98/81/EC).

• Conduct training seminars for civil servants and third parties on the implementation of risk assessment procedures related to the contained use of GMMs (Decision 2000/608/EC).




The following legislation should be taken into consideration when implementing this directive:

• Council Directive 2001/18/EC on the deliberate release of genetically modified organisms, as amended by Decision 2002/623/EC186.

• Council Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work.

• Council Directive 90/313/EEC on access to environmental information (to be replaced by 2003/4/EC) (see Section 2 of the Handbook).

• Commission Directive 94/51/EC adapting to technical progress Council Directive 90/219/EEC.

• Commission Decision 91/448/EEC concerning the guidelines for classification referred to in Article 4 of Directive 90/219/EEC, as amended by Commission Decision 96/134/EC.

3. Implementation

3.1 Key Tasks

The key tasks required to implement this directive are summarised in the checklist below. The key tasks are arranged under subheadings in chronological order whenever possible.

DIRECTIVE ON CONTAINED USE OF GENETICALLY MODIFIED ORGANISMS – KEY IMPLEMENTATION TASKS

1 Planning

1.1 Establish a fully functional competent authority to oversee the implementation of the directive, and to receive and assess notifications.

1.2 Publicise the requirements of the directive and the national implementation measures to the community of GMM users, the public and other stakeholders.

1.3 Develop a system for linking administrative procedures to classification decisions.

1.4 Create staff capacity to advise on third-party risk assessment implementation procedures.

2 Regulation

2.1 Ensure that GMMs are classified in accordance with Commission Directive 91/448/EEC and the directive.

2.2 Establish containment conditions for each class of GMMs.

2.3 Establish waste disposal methods for class 2, 3 and 4 GMMs and, if desired, class 1 GMMs.

2.4 Inform the public about containment work being carried out under the directive.

186 2002/623/EC: Commission Decision of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. This decision sets out guidance notes supplementing the requirements laid down in Annex II to Directive 2001/18/EC. The guidance notes mainly concern the objective, elements, general principles and methodology of the environmental risk assessment referred to in Annex II.



2.5 Establish inspection and control measures, including conducting inspections, and ensure that containment measures, good laboratory practice and good occupational safety and hygiene are observed.

2.6 Examine the conformity of the notifications received with the requirements of the directive with regard to:

• accuracy and completeness;

• correctness of risk assessment;

• proposed containment; and

• waste management and emergency measures.

2.7 Interact with the applicant regarding any modifications required and inform them about approval or rejection of the application, within the time-scales set out in the directive.

2.8 Ensure that GMM users comply with the following obligations with regard to their activities:

• conduct a risk assessment, taking into account risk to human health and the environment according to Annex III, Sections A and B;

• apply Decision 2000/608/EC, procedure I and 2 methodologies in conducting the risk assessment;

• keep records of activities;

• ensure that control over the level of containment is exercised and reviewed;

• apply the general principles and protective measures set out in Annex IV to ensure a high level of safety;

• notify the competent authority of the first use of premises for the contained use of GMMs;

• notify the competent authority of the first and subsequent class 2, 3, and 4 contained uses in accordance with Article 7, with the information listed in Annex V, Part B;

• notify the competent authority/authorities where new information regarding the contained use and risk becomes available;

• take measures in the event of an accident; and

• provide full details of accidents to the competent authority.

2.9 Establish criteria for emergency plans to be adopted by users in the event of an accident and develop procedures to advise other Member States affected.

2.10 Through discussions with the notifier, define which items in a notification (which, under Directive 90/313/EE, are normally required to be made available to the public) may be deemed confidential and are not to be released to the public.

3 Reporting

3.1 Set up a document management system and a related database to hold information relating to implementation of the directive.

3.2 Meet reporting obligations to provide information to the Commission and the other Member States on the implementation of the directive.

3.2 Phasing



It is important to implement this directive as soon as possible, for two reasons:

1) there is growing public concern about genetically modified organisms, and governments will be expected to have introduced regulations to control them; and

2) in many candidate countries there are large numbers of GMMs in use in universities and other academic institutions, without any regulatory control. Such control needs to be introduced rapidly. The technical expertise necessary to implement the directive is likely to be present in these academic organisations.


4.1 Planning

• The details of implementation vary from one country to another as a consequence of national administrative structures. Sometimes the legislation used to implement both this directive and Directive 90/220/EEC on the deliberate release of GMOs has been based on one primary legal act. However, usually separate legislation is used for each directive.


In one Member State (SE), the two principal directives in the GMO sector, Directive 90/220/EEC and Directive 90/219/EEC, are implemented by the Genetically Modified Organisms Act and the Genetically Modified Organisms Ordinance, both from 1994. The implementation of the directives involves participation of seven national authorities, i.e. the National Board of Occupational Safety and Health, the Chemicals Inspectorate (KEMI), the National Board of Agriculture, the National Food Administration, the National Board of Fisheries, the National Board of Forestry, and the Medical Products Agency. Within their respective area, the authorities are responsible for, inter alia, issuing permits and receiving notifications, issuing regulations on precautionary measures and investigations, and conducting supervision of compliance with the legislation. EU membership gave rise to the creation of a new authority, the Gene Technology Advisory Board, which is functioning as an advisory body on ethical questions connected with the introduction of genetically modified organisms on the market. Although there is satisfactory co-operation between the involved authorities, the involvement of so many bodies is seen as cumbersome due to the time-consuming consultation procedure.

• The role of the competent authority is to implement the directive via notification,

monitoring and enforcement measures. One organisation is selected to become the competent authority in some countries; in others two are involved.

• A facility for third-party advice in connection with risk assessment procedure implementation and potential hazard identification and containment measures would greatly enhance regulatory compliance while permitting transparent information sharing on potential human health and environmental threats.


In one Member State (UK), the competent authorities are the Health and Safety Executive (HSE) and the Department for the Environment, Food and Rural Affairs (Defra).

In another Member State (DK), the Ministry of the Environment and the Ministry of Labour share the responsibility.

In a third Member State (NL), the Ministry of Housing, Spatial Planning and the Environment is the sole competent authority.

In the first two mentioned Member States, two competent authorities were named because the directive covers both the risk to human safety, especially in the workplace, and the risk to the



environment. In the third mentioned Member State it was decided that one organisation could meet the needs.

4.2 Regulation

• The implementation of the notification and risk assessment procedures in this directive is straightforward, with few options for national variation. Procedures for classification of GMMs into four classes, risk assessment and notification are set out in the articles and the annexes. Candidate countries should use forms to facilitate notification and copies are readily available from the competent authorities in Member States.

• The competent authority has many tasks to perform and to carry them out successfully requires specialists in many disciplines. For inspection and monitoring, the expertise must reside within a government body with legal powers and the best solution is to add the expertise to the staff of this body. Inspectorates are vitally important and high-quality staff are required with authority and technical competence which allows them to negotiate with those wishing to carry out trials and market products.


In one Member State (UK), the inspectorate is the Health and Safety Executive. In a second Member State (DK), the Environmental Protection Agency fills the role; and in a third (NL), the Department for the Enforcement of Environmental Legislation is responsible.

• For activities not involving inspection and monitoring, a specialist advisory committee

with members who cover the range of expertise required has been found to be a useful approach. This committee may include ex officio government officials. The use of an advisory committee ensures that the widest range of expertise can be obtained while retaining the ultimate decision within the competent authority itself. It is also a measure that contributes to transparency.


In one Member State (UK), the advisory body is the Advisory Committee on Genetic Manipulation (ACGM); and in another Member State (NL) it is COGEM. In a third Member State (DK), by contrast, there is no specialist advisory committee — individual ministries and specialists are consulted as necessary.

4.3 Reporting

• To meet the obligations on reporting to the Commission and other Member States, it is necessary to establish a high-quality information system to collect data, to incorporate it into a database and to distribute it as required. This is an office and document management issue.

• In addition to the well-defined reporting obligations set out above, experience shows that it is advisable to provide information to the users of GMOs and to the public about the national implementation of the directives, so as to ensure transparency. A multifaceted approach, using press releases, information leaflets, public meetings, private meetings with representative bodies, radio and television programmes, and publicity via the Internet is recommended. Information is more easily distributed to the users of GMMs, who acknowledge the obligation to conform to regulations, than to the general public, who welcome transparency but may not understand the terminology used. The public may need much reassurance that great care is being taken, though concern is much less



than was the case with the deliberate release of GMOs under Directive 90/220/EEC (now repealed and replaced by Directive 2001/18/EC).

5. Costs

The main costs to government of implementing this directive consist of indirect/overhead costs of establishing the implementation systems, the day-to-day costs of maintaining it and the payments to specialist advisors/consultants for attendance at committee meetings and for special events. As well, to the extent that expertise is lacking on the implementation aspects of the directive and decisions, salaries for competent authority specialised expert scientific staff may have to be added. The monetary value of these will vary greatly from country to country. Once the system is established, the total costs must depend on the number of cases needing consideration. The best guide to the cost is the charges made to applicants for dealing with notifications, for these are commonly designed to cover the costs of notifications. However, this approach is only practicable when a considerable number of notifications are received — otherwise the cost per application is prohibitive.

The costs of implementation to industry and academia are substantial but will be likely to be absorbed by firms or other economic interests that benefit from research and related activities in this field. The majority of the costs would be incurred even if notification were not required, since stringent precautions are required under other safety legislation for any work involving potentially or actually harmful GMMs.

SECTION 8 – CHEMICALS AND GMO LEGISLATION THE GENETICALLY MODIFIED ORGANISMS DELIBERATE RELEASE DIRECTIVE


The Genetically Modified Organisms Deliberate Release

Directive

Official Title: Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms, repealing Council Directive 90/220/EEC (OJL 106, 17.4.2001), as amended by Decision 2002/623/EC, Decision 2002/811/EC, and Regulation (EC) No. 1830/2003187.


Directive 2001/18/EC is part of the biosafety framework of the EU for the development and use of genetically modified organisms (GMOs). It regulates the deliberate release of GMOs into the environment, which is a crucial issue concerning the application of GMOs for the production of GM food and feed, environmental applications of GMOs and the use of GMOs as sources of feedstock for industrial production processes. While Directive 2001/18/EC is part of the environmental acquis, other important elements of the Community biosafety framework — for example Regulation (EC) 1829/2003 on genetically modified food and feed — are not.

Community legislation on the deliberate release of GMOs into the environment has existed since the early 1990s. Directive 2001/18/EC of 17 April 2001 was introduced to repeal previous legislation (Directive 90/220/EC).

The directive aims to protect human health and the environment, in accordance with the precautionary principle, from the risks arising from the deliberate release into the environment of genetically modified organisms (GMOs). Covered by the directive are research and development activities connected with the deliberate release of GMOs as well as the placing on the market (including importing) of products which contain or consist of GMOs (Art.1). With regard to the deliberate release of GMOs into the environment, Directive 2001/18/EC acts as a point of reference for the provisions on environmental risk assessment in other pieces of Community legislation and calls for the introduction of equivalent rules in these regulations.

While the primary aims remained the same:

187 Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC.



• Directive 2001/18/EC improves and strengthens the requirements regarding the deliberate release of GMOs, including, in particular, those related to risk assessment, monitoring, public information/consultation, the labelling of GMO products and traceability. It makes mandatory the assessment of indirect and cumulative long-term effects of GMOs on health and the environment.

• The directive also clarifies the scope and definitions of the earlier legislation and phases out the release of GMOs containing antibiotic resistance marker (ARM) genes, which confer resistance to antibiotics used in medical or veterinary treatment (since 31 December 2004 for GMOs, which are to be placed on the market; and by 31 December 2008 for deliberate releases of GMOs for research purposes).

• Directive 2001/18/EC also takes into consideration the precautionary principle and respects ethical principles recognised by Member States.

• The implementation of the directive shall ensure that the public is consulted during the preparation of measures and informed of the decisions taken.

• The directive also takes into account the requirements of international agreements, such as the Cartagena Protocol on Biosafety.

• Authorisations according to the directive expire after 10 years and need to be renewed based on a mandatory reassessment of GMO products.

Directive 2001/18/EC is structured into four parts and contains two annexes:

• Part A covers general provisions, including objectives and definitions according to the directive.

• Part B covers the deliberate release of GMOs for purposes other than marketing (e.g. deliberate release for research purposes) and describes the standard and differentiated authorisation procedures for these types of notifications.

• Part C covers the marketing of GMOs as or in products, including provisions on the Community procedures for authorisations involving the other Member States and the European Commission.

• Part D contains the final provisions on issues such as confidentiality, labelling, the consultation of scientific and ethics committees at the EU level (e.g. the European Food Safety Authority (EFSA) GMO Panel), and obligations on the Member States (e.g. for the exchange of information and reporting procedures).

• The annexes contain further information on definitions, principles for environmental risk assessment (ERA), guidelines for assessment reports, information requirements of applicants for notifications and guidelines for drafting monitoring plans and requirements for applications for the differentiated procedure according to Part B.

Directive 2001/18/EC puts in place a harmonised approval process on a case-by-case basis for GMO releases. Assessments of risks to human health and the environment have to be undertaken before approvals for release into the environment can be obtained (following guidelines according to the directive). Releases into the environment shall be carried out according to the step-by-step principle, with the deliberate release of GMOs for research purposes (according to Part B of the directive) as a necessary step in the development of most GMO products destined to be placed on the market.

The provisions adopt a precautious approach requiring a system of prior risk assessment, notification and consent from the competent authority of the Member State in which the release of GMOs is proposed. The directive does not apply to organisms obtained through certain techniques according to Annex 1 to the directive, which do not involve the use of recombinant nucleic acid molecules and other techniques listed in the annex.



No GMO releases can take place without the written consent of the competent authority, in line with this and other GMO release-related legislation. The consent will likely stipulate conditions that are to be met. Existing consents granted under Directive 90/220/EC have to be renewed, although there is a transition period.

The directive sets forth that, once the placing on the market of a GMO product has been authorised by one Member State, the other Member States may not restrict its marketing on their territory, unless there are justifiable reasons relating to the protection of the environment and human health that trigger the implementation of safeguard measures by a Member State.

It should be noted that certain products derived from GMOs, for example medical products as well as GM food and feed products, are not covered by Directive 2001/18/EC but by other specific EC legislation that shall stipulate similar basic requirements (concerning authorisation, ERA, and the treatment of new information) as Directive 2001/18/EC.

The issue of the coexistence of GM crops with conventional crops is implicit in the authorisation of GM crops according to Part C of Directive 2001/18/EC. However, it is not currently regulated by the directive itself or by other legally binding EC regulations. According to the guidelines of the Commission, the issue must be dealt with by Member States themselves at the national or regional level. National regulation on coexistence needs to be notified to the Commission before entry into force and may not duplicate assessment steps outlined by Directive 2001/18/EC.

Complementary regulations within the environmental acquis:

• Regulation (EC) 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (4) The regulation ensures that relevant information concerning any genetic modification is available at each stage of the placing on the market of GMOs and GM food and feed products in order to facilitate accurate labelling of GMOs and GM food and feed. In addition to rules on traceability and labeling, Regulation (EC) 1830/2003 sets a threshold for labelling at a proportion no higher than 0.9 % GM content, provided that these traces are adventitious or technically unavoidable. However any accidental presence of genetically modified material not authorised under Community legislation shall be avoided in food or feed products.

• Council Directive 90/219/EEC as amended by Directive 98/81/EC on the contained use of GMOs. This directive regulates applications of GMOs (specifically of genetically modified micro-organisms (GMMs)) in contained facilities, which are not intended to be released into the environment. The directive thus covers industrial applications of GMMs as well as research and development activities with GMOs in laboratory and glasshouse facilities.

• Regulation (EC) No. 1946/2003 of 15 July 2003 of the European Parliament and of the Council on the transboundary movement of genetically modified organisms. The regulation aims to set up a common system for notifying and exchanging information on transboundary movements to third countries of GMOs that may have adverse effects on the sustainable use of biological diversity and on human health.

Corresponding regulations in other regulatory fields (not covered by the environmental acquis):

• Since most GM crops that are released into the environment are developed for food and feed applications, the legislation framework according to Directive 2001/18/EC is closely linked to the EC regulations covering the authorisation and use of GM food and feed products: Regulation (EC) 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. The placing on the market of GMOs intended for food or feed and of food or feed products containing, consisting of or produced from GMOs is governed by this regulation. For food and feed products that contain or consist of GMOs or that are produced by the cultivation of the respective GM crops in the EU, the applicant shall submit the notification as a whole subject to



Regulation (EC) 1829/2003. For such notifications, the authorisation for the deliberate release of a GMO into the environment is considered during the application process according to Regulation (EC) 1829/2003 (for the use of this GMO in food and feed products). The respective assessment is based on the criteria laid down by Directive 2001/18/EC and with the involvement of the competent authorities according to Directive 2001/18/EC.


2.1 Planning

• Designate a competent authority (or authorities) to implement and enforce the requirements of the directive (Art. 4).

• Set up a national biosafety framework to ensure information exchange between national competent authorities as appropriate and to ensure that the tasks of the national competent authority (authorities) according to Directive 2001/18/EC within other regulatory procedures (e.g. relevant notifications for GM food and feed products according to Regulation (EC) 1829/2003) can be fulfilled.

2.2 Regulation

• Ensure that GMOs may only be deliberately released or placed on the market in conformity with the directive and that appropriate measures are taken to avoid adverse effects on human health and the environment that might arise from the deliberate release of GMOs (Art. 4).

• Ensure that those proposing to release GMOs carry out a risk assessment before submitting a respective notification (Arts. 4, 13, Annex II).

• Ensure that those proposing to release GMOs first submit a notification to obtain consent for the release (Arts. 6, 13, Annex III).

• Ensure that competent authorities receive and evaluate notifications in accordance with the directive’s requirements, and only allow a release to proceed if satisfied that the notification complies with the directive (Arts. 6, 13, 14).

• Ensure that potential adverse effects of GMOs on human health and the environment are assessed on a case-by-case basis (Art. 4, Annex II).

• Ensure that inspections and other control measures are organised to ensure compliance with the directive (Art. 4).

• Ensure that measures are taken to terminate unauthorised releases (Art. 4).

• Ensure that mechanisms are in place to ensure traceability of all GMOs placed on the market (Art. 4, Annex IV; Regulation (EC) 1830/2003).

• Ensure that, in cases where written consent has already been given for the release of GMOs, in the event of any modification, unintended change or new information on risks, the competent authority evaluates such information, makes it available to the public, and requires, where appropriate, that the conditions of the release are modified and that the release be suspended or terminated (Arts. 8, 20).

• Ensure that the public are consulted and information is provided to them on the proposed deliberate release (Arts. 9, 24).

• Ensure that the notifier reports to the competent authority on the release undertaken (Art. 10).



• Ensure that notification information is exchanged between competent authorities and the Commission (Art. 11).

• Ensure that prior notification is submitted to the competent authority before the deliberate release/ placing on the market of GMOs is undertaken, in accordance with the notification and risk assessment requirements set out in the directive, and that notifiers proceed with the release only with the consent of the competent authority and in accordance with any conditions attached to the consent (Arts. 6, 10, 11, 13, 14, 15).

• Ensure that notifiers provide certain information to the competent authorities with regard to the risks to human health or the environment of releasing GMOs into the environment (Arts. 6, 8, 10, 13).

• Ensure that in cases before written consent is granted, the notifier alerts the competent authority of any new information regarding risks to health and the environment and amends the notification accordingly (Art. 13).

• Ensure that mechanisms are in place to assist with the requirements of post-release monitoring (Arts. 13, 19, 20, Annex VII).

• Ensure that an assessment report is prepared to guarantee compliance of the notification with the directive (Art. 14).

• Ensure that users of products consisting of or containing GMOs that are placed on the market comply with conditions attached to consents regarding their deliberate release, including conditions relating to packaging and labelling (Arts. 13, 19, 21, 26, Annex IV).

• Ensure that confidentiality of information and intellectual property rights are protected in accordance with the directive’s requirements (Art. 25).

• Do not prohibit, restrict or impede the placing on the market of products containing or consisting of GMOs which comply with the requirements of the directive, on grounds relating to notification and written consent (Art. 22). Provisional restrictions for the use and/or sale of GMO products (or usage bans in the context of a safeguard measure) may only be adopted according to the requirements of the directive on the grounds of risk to human health or the environment (Art. 23).

• Ensure that information on marketing consents is made available to the public (Art. 35(2)).

• Ensure that, in the event of severe risk, emergency measures such as suspension or termination of marketing consent shall be applied and the public so informed (Art. 23).

• Ensure that public registers are created which record releases (Art. 31).

• Ensure that penalties are in place for breaches of the directive (Art. 33).

• Ensure that exporters of GMOs observe the relevant requirements of the Cartagena Protocol on Biosafety, for example requirements of advanced informed agreement (AIA) (Art. 32, Regulation (EC) 1946/2003).

• Introduce national coexistence measures according to the framework outlined by the Commission recommendations188.

2.3 Reporting


188 Commission Recommendation 2003/556/EC on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming



• proposals for differentiated procedures for deliberate releases of GMOs according to Part B (Art. 7);

• notifications received by the competent authority (Arts. 11, 13, 14);

• final decisions of the competent authority regarding notifications (Arts. 11, 14, 15);

• additional information received by the competent authority regarding the risks of a product (Art. 20);

• a list of notifications rejected (Art. 11);

• a list of GMOs released on their territory (Art. 11);

• assessment report of the notification received (Art. 14);

• consents given for marketing releases (Arts. 15, 18);

• amendment of consents (Art. 20);

• monitoring of marketing releases (Art.20);

• provisional restrictions/prohibitions on the use and/or sale of a product on grounds of harm to human health or the environment (Art. 23);

• measures taken to implement the directive (Art. 31);

• transposition, with the texts of the main provisions of national law adopted in the field covered by the directive (Art. 34); and

• experiences gained with regard to risk prevention, assessment, monitoring and public information/consultation (Art. 31).

Report to other Member States on:

• notifications received for the placing on the market of GMOs (summary of notification) (Art. 13);

• final decisions of the competent authority regarding notifications (Arts. 9, 13,11, 18);

• additional information received by the competent authority regarding the risks of a product (Art. 20);

• consents given for marketing releases (Arts. 15, 18);

• amendments of consents and monitoring plans (Art. 20);

• monitoring of marketing releases (Art. 20);

• provisional restrictions/prohibitions on the use and/or sale of a product on grounds of harm to human health or the environment (Art. 23); and

• experiences gained with regard to risk prevention, assessment, monitoring and public information/consultation (Art. 31).


The following legislation should be taken into consideration when implementing this directive:

2.4.1 Concerning the implementation of Directive 2001/18/EC:

• Regulation (EC) No. 1830/2003 concerning the traceability and labelling of GMOs and the traceability of food and feed products produced from GMOs.

• Commission Decision 2002/623/EC establishing guidance notes supplementing Annex II to Directive 2001/18/EC.



• Council Decision 2002/811/EC establishing guidance notes supplementing Annex VII to Directive 2001/18/EC.

• Council Decision 2002/812/EC establishing, pursuant to Directive 2001/18/EC, the summary information format relating to the placing on the market of genetically modified organisms as or in products.

• Council Decision 2002/813/EC establishing, pursuant to Directive 2001/18/EC, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market.

• Commission Decision 2003/701/EC establishing, pursuant to Directive 2001/18/EC, a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market.

• Commission Decision 2004/204/EC laying down detailed arrangements for the operation of registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC.

• Regulation (EC) 65/2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms.

• Commission Recommendation 2004/787/EC on technical guidance for the sampling and detection of genetically modified organisms and material produced from genetically modified organisms as or in products in the context of Regulation (EC) 1830/2003.

• Commission Decision 2005/463/EC establishing a network group for the exchange and coordination of information concerning the coexistence of genetically modified, conventional and organic crops.

2.4.2 Coexistence guidelines:

• Commission Recommendation 2003/556/EC on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming

2.4.3 GM food and feed regulation:

• Regulation (EC) 1829/2003 on genetically modified food and feed.

2.4.4 Other corresponding regulations:

• Council Directive 98/95/EEC on genetically modified plant varieties and plant genetic resources.

• Council Directive 90/219/EEC (as amended by Council Directive 98/81/EC) on the contained use of GMOs.

• Council Directive on the protection of workers from risks related to exposure to biological agents at work

• Regulation (EC) 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority (EFSA) and laying down procedures in matters of food safety.

• Council Directive 91/414/EEC on the placing of plant protection products on the market.

2.4.5 Legislation concerning the protection of habitats and species:

• The Wild Birds Directive (79/409/EEC) (see Section 6 of the Handbook);



• The Habitats Directive (92/43/EEC) (see Section 6 of the Handbook).

2.4.6 Legislation concerning access to information:

• Council Directive 90/313/EEC on freedom of access to information on the environment (to be replaced by 2003/4/EC) (see Section 2 of the Handbook).

2.4.7 International agreements:

• Cartagena Protocol on Biosafety to the Convention on Biological Diversity (2000, in force since November 2003).

• Convention on Access to Environmental Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (the Aarhus Convention), 1998.

• Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) in the framework of the World Trade Organization (in force since January 1995).

3. Implementation

3.1 Key Tasks

The key tasks required to implement this directive are summarised in the following checklist. Tasks are arranged under subheadings.

GENETICALLY MODIFIED ORGANISMS DELIBERATE RELEASE DIRECTIVE – KEY IMPLEMENTATION TASKS

1 Planning

1.1 Designate a competent authority to implement and enforce the requirements of the directive.

1.2 Establish a mechanism for receiving and evaluating notifications and ensuring that they comply with the requirements of the directive.

1.3 Establish a mechanism for organising inspections and other control measures to ensure compliance with the directive.

1.4 Select appropriate mechanisms for public consultation and participation.

1.5 Ensure that mechanisms are in place for dealing with unauthorised releases, including mechanisms to undertake remedial action where necessary and to inform the public, Commission and other Member States of such releases, and, for issuing penalties.

1.6 Ensure that mechanisms are in place to ensure traceability.

2 Regulation

2.1

Inform potential applicants for deliberate release GMOs of the procedures established under this directive.

2.2 Interact with the notifiers with regard to notifications and inform them about risk assessments and approval or rejection of applications within the time scales set out in the directive.

2.3 Through discussions with the notifier, determine which aspects of a notification may be deemed commercially sensitive and are to be classified as confidential business information.

2.4 Establish mechanisms for informing/consulting the public about deliberate releases to



be carried out under the directive.

2.5 Circulate information to ensure that persons wishing to release a GMO:

• submit a notification to the competent authority prior to release of GMOs;

• notify the competent authority of any new information with regard to the risks of a product;

• do not proceed without the necessary written consent of the competent authority, and implement the deliberate release in conformity with any conditions in the consent; and

• notify the competent authority about the results of the release.

2.6 Create formats to be completed by notifiers.

2.7 Examine the notifications to ensure conformity with the requirements of the directive (“completeness check”).

2.8 Evaluate the risks from the proposed release.

2.9 Establish an inspection and monitoring mechanism to ensure the conditions of the directive are fulfilled.

2.10 Inform exporters of living GMOs that are intended for release into the environment that they need to observe the AIA requirements (as further specified by Regulation (EC) 1946/2003).

2.11 Establish procedures for liaising with the Commission and Member States as required by the directive.

2.12 In accordance with the directive, establish procedures to implement, or object to, marketing permissions granted by other Member States.

2.13 Request from the Commission, when appropriate, the application of simplified procedures for the release of certain types of GMOs.

2.14 Establish mechanisms to participate as competent authorities according to Directive 2001/18/EC under GM food and feed regulation:

Comment to the EFSA on ERA for notifications according to Regulation (EC) 1829/2003.

Submit proposals to take responsibility for ERA for GM food and feed cultivation notifications.

3 Reporting

3.1 Set up a document management system and a related database to record relevant information relating to the implementation of Directive 2001/18/EC.

Establish and maintain public registers to record:

• the locations of deliberate releases according to Part B of the directive; and

• the locations of GMOs grown under Part C authorisation (in order to facilitate monitoring).




• proposals for differentiated procedures;

• notifications received by the competent authority;

• assessment reports by the competent authority of notifications for placing on the market

• final decisions taken by the competent authority;

• new information received regarding the risks of products;

• assessment report of the notification received;

• a list of notifications rejected;

• a list of GMOs released;

• consents given for marketing releases;

• amended consents and monitoring plans;

• monitoring of marketing releases;

• provisional restrictions/prohibitions on the use or sale of a product;

• transposition and implementation;

• experience gained in implementing the directive.

3.3 Report to other Member States on:

• assessment reports by the competent authority of notifications for placing on the market;

• final decisions taken by the competent authority;

• additional information regarding the risks of a product;

• consents given for marketing releases;

• amended consents;

• monitoring of marketing releases;

• provisional restrictions/prohibitions on the use or sale of a product;

• experience gained under the directive.

3.2 Phasing

The public concern about risks to the environment and to human health of released GMOs and about the safety of food ingredients derived from GMOs, makes it essential that regulatory controls according to the directive are introduced as rapidly as possible or updated as appropriate.

In addition to the adoption of a national legal framework, the necessary steps to implement the regulatory framework in practice should be taken in a timely manner in order to establish the appropriate (information) mechanisms, select authorities, establish the appropriate advisory bodies and set up facilities and training programmes that are a prerequisite for the full implementation of the obligations of the directive. This may involve drafting national secondary legislation and making available the necessary funding and staff. Furthermore, all national stakeholders should be involved in the implementation process in an adequate manner.




The aim of Directive 2001/18/EC is to implement effective mechanisms to protect human health and the environment from risks arising from the release of GMOs. The key actors are government ministries with responsibilities for the environment, health and safety, and agriculture. They will establish a competent authority with responsibility for implementing and enforcing the directive’s requirements. It is recommended that they should establish a specialist committee to ensure that a wide range of specialised scientific knowledge is available to the competent authority.

The directive defines a GMO as “an organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination” (Art. 2). It also lists techniques which are, and are not, considered to result in genetic modification (Annex IA, Parts 1 and 2 respectively). The directive does not apply to organisms obtained through the techniques of genetic modification listed in Annex IB.

4.1 Planning

When planning the implementation of the directive, it should be noted that there is no definition in the directive of the term “adverse effects on human health and the environment” and that the interpretation of this term is therefore dependent on national attitudes: in this sense, national variations in approach are inevitable. The same is true for determining the appropriate level of protection for the application of the precautionary principle.

• Many countries already have existing environmental protection legislation that includes a reference to genetic engineering, and it may be possible to incorporate the requirements of the directive into existing legislation rather than to enact separate legislation. Directive 2001/18/EC and Directive 98/81/EC should be implemented in parallel.

• Member States can seek implementation guidance in the form of best practice from the European Commission or other Member States, particularly those that have produced guidance, for example, the UK189. In early 2007, the Commission published its second report on the experience of Member States regarding the implemention of the directive190.

• Member States may wish to provide guidance as to the obligations of key stakeholders under the directive and consider setting up a helpline or guidance-related website, particularly for advice on post-release monitoring (Directive 2001/18/EC Annex VII).

• Member States should consider carrying out research on GMO releases and sharing the results with other Member States, as advocated in Recital 21 of Directive 2001/18/EC, to support risk assessments tasks and implementation of the directive.

• Member States might consider contracting out post-release monitoring and tracing responsibilities to expert consultants, including work on the identification of unauthorised releases.

Examples of Legal Systems in Member States

In one Member State (UK), the Environmental Protection Act 1990 was used as the basis for new regulations on GMOs. The 2001 directive is implemented in the UK by new regulations introduced in 2002 and Part VI of the Environmental Protection Act 1990. The competent authority is the Department for the Environment, Food and Rural Affairs (Defra). Ministers are advised on risks posed by GMOs by the Advisory Committee on Releases to the Environment (ACRE). To enable the competent authority to perform effectively it believes that it must have access to a range of specialist scientific information and to advice from scientists, industry and

189 http://www.defra.gov.uk/environment/gm/regulation/pdf/gm-guide_draft.pdf 190 http://ec.europa.eu/environment/biotechnology/pdf/com_2007_81.pdf



other sectors of the community. The establishment of the Advisory Committee on Releases to the Environment should also support transparency. ACRE examines the environmental risk assessment that is submitted with each notification and, where required, demands more information from the notifier. Once it is agreed that it has all the necessary information, ACRE then offers advice to Defra ministers. In the case of proposed GMO research trials, the ministers then decide whether to grant or refuse consent. In the case of proposed marketing releases, the advice of ACRE informs the UK's position with respect to Community decision making at the EU level. References are made throughout the regulations requiring the secretary of state to have the agreement of the Health and Safety Executive (HSE) and/or the Food Standards Agency (FSA) before making certain decisions on applications. The other important organisation for the competent authority to establish is the inspectorate, for inspecting and monitoring to ensure regulations relating to GMOs are followed.

In another Member State (DK), the Act on Environment and Genetic Engineering (EGE) of 1986 (Act No. 356, sec. 27 6/6/1991) authorises the Ministry of Environment to legislate by statutory order, thereby transferring powers relating to GMOs to the Environmental Protection Agency. The competent authorities are the Ministry of Environment and the Ministry of Labour. They have not created a specialist advisory committee, but when specialist scientific knowledge is required, individual specialists and ministries are consulted on an ad hoc basis. The inspectorate for monitoring and enforcement is the Environmental Protection Agency.

In a third Member State (NL), the directive was implemented by extending the Chemical Waste Act. The relevant act is the Environmental Protection Act and implementing regulations include the Genetically Modified Organisms Decree pursuant to the Chemical Substances Act and the Ministerial Order on the Contained Use of Genetically Modified Organisms. The sole competent authority is the Ministry of Housing, Spatial Planning and the Environment. This has established a deliberations-based approach involving relevant constituencies through individual membership of an advisory committee, the COGEM. The Department for the Enforcement of Environmental Legislation is responsible for inspection and monitoring.

In another Member State (AT), Directive 2001/18/EC was transposed in 2004 by the amendment of the National Gene Technology Act (1994). This act also transposes Directive 90/219/EEC and thus regulates at the federal level the contained use of GMOs, the deliberate release of GMOs into the environment, the placing on the market of products that contain GMOs, and the application of biotechnology in human medicine, such as gene analysis and gene therapy. Furthermore, the act establishes an advisory board on gene technology (Gentechnikkommission) and its three scientific committees that support the three competent authorities (the Federal Ministry for Science and Research (BMWF) for GM applications at scientific institutions; the Federal Ministry for Health, Family and Youth (BMGFJ) for commercial applications; and the Federal Ministry for Agriculture, Forestry, the Environment and Water Management (BMLFUW) as competent authority for releases into the environment) in assessing notifications for deliberate release in Austria. For assessing Community notifications for the placing on the market of GMOs and GM food and feed applications the BMGFJ is supported by the Umweltbundesamt (Federal Environment Agency of Austria) and the Austrian Agency for Health and Food Safety (AGES), as well as individual scientific experts. The Umweltbundesamt is responsible for the environmental monitoring of GMOs. Procedural aspects of the Gene Technology Act are regulated by several ordinances as well as safeguard measures for four GM crops. To implement the recommendations of the Commission on coexistence measures, eight of the nine federal länder of Austria enacted special laws (so-called Gentechnik-Vorsorgegesetze or Genetic Engineering Precautionary Measures Acts). The Land Vorarlberg introduced similar provisions in its law on nature protection. The regulations on coexistence measures were notified to and approved by the Commission. They are ready to be enforced by the Austrian federal länder to guarantee coexistence within their territory and ensure the safety of fauna and flora. The provisions contained in the regulations outline an advanced regional notification procedure for any cultivation of GM crops. Crop-specific technical standards are being developed by a commission comprising representatives of the federal states and technical experts. These technical standards will offer guidance for decisions on individual notifications.



4.2 Regulation

• The competent authority has many tasks to perform and to carry them out successfully requires specialists in many disciplines. Access to a wide range of expert advice is required during implementation of the directive and it is usually impracticable to provide the whole of this from within government. The establishment of a specialist advisory body with members who cover the range of expertise required may be an appropriate approach. Government officials may be ex officio members of such a committee. The use of an advisory committee can ensure that a wide range of expertise can be obtained while retaining the ultimate decision within the competent authority itself. It is also a measure that contributes to transparency.

• Authorities may already exist in the candidate countries, for example in the ministry of environment, the ministry of labour, the ministry of health care or the ministry of social welfare, which have experience of the sector and which could act as competent authorities with the assistance of an advisory committee or supported by specialist advice.

• If the competent authority has obtained sufficient experience of the release of certain GMOs in certain ecosystems, they can apply to the Commission under Article 7 for a differentiated procedure for such releases.

Examples of Risk Assessment Practices in Member States

In one Member State (UK), the competent authority defines the acceptability of the risk of GMOs in the context of conventional agricultural practice and assesses how far GMOs pose an additional risk by comparison with conventional agricultural practice. When considering its first proposal to release herbicide-tolerant sugar beet the competent authority in another Member State defined its approach to assessment by using the criteria of "sustainable social development". While this was essential to enable them to achieve consensus within the country on GMO legislation, it caused problems with the other Member States. Furthermore, in assessing the agronomic effect of this directive it evaluates the acceptability of products in view of sustainable development. Two other Member States (SE and FR) operate using very similar assessment criteria.

The approach to assessment in another Member State (NL) is to seek to establish, through trial releases, that plausible effects are manageable. When negative environmental effects cannot be demonstrated in the field for a particular plant-gene combination it becomes a candidate for exemption from further risk assessment reviews by the advisory committee for a similar release. Inspection and monitoring institutions are vitally important and high-quality staff are required with authority and technical competence which allows them to negotiate with those wishing to carry out trials and market products.

Another Member State (AT) complements its involvement in the Community risk assessment exercise by actively pursuing biosafety research in areas of identified scientific uncertainty that are relevant to the assessment of risks to the environment and human health. Results and opinions are discussed in the relevant policy forum and with the scientific community. Additionally, specific baseline data relevant for possible further GMO monitoring are established, and regional coexistence conditions are investigated. National regulation concerning the adventitious presence of GMO in seeds and GMO labelling is actively enforced and the presence of GMO products on the market is monitored.

4.3 Reporting

• The obligations for reporting to the Commission and Member States are set out in the obligations and key tasks, above. To meet the obligations, it is necessary to establish a high-quality information system to collect data, to incorporate it into a database and to distribute it as required. This is an office and document management issue.



• In addition to the well-defined reporting obligations set out above, experience shows that it is advisable to provide information to the users of GMOs and to the public about the national implementation of the directives so as to ensure transparency. A multifaceted approach, using press releases, information leaflets, public meetings, private meetings with representative bodies, radio and television programmes, and publicity via the Internet is recommended.

5. Costs

The main costs to government of implementing this directive consist of indirect/overhead costs of establishing the implementation systems, the day-to-day costs of maintaining it and employment of trained staff and the payments to specialist advisors/consultants for attendance at committee meetings and for special events. The monetary value of these efforts will vary greatly from country to country. Once the system is established, the total costs will furthermore depend on the number of cases that have to be considered.

The costs of implementation borne by industry are different from those borne by the government. Notifiers have to cover the costs of research to satisfy regulatory requirements and the costs of the application for Europe-wide permission for releases.

SECTION 8 – CHEMICALS AND GMO LEGISLATION THE DIRECTIVE ON THE PROTECTION OF ANIMALS USED FOR EXPERIMENTAL AND OTHER SCIENTIFIC

PURPOSES


The Directive on the Protection of Animals Used for Experimental and Other

Scientific Purposes

Official Title: Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (OJ L 358, 18.12.1986), as amended by Directive 2003/65/EC (OJ L 230, 16.9.2003)191

1999/575/EC: Council Decision of 23 March 1998 concerning the conclusion by the Community of the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes


The directive establishes minimum standards for the use of animals for experimental or other scientific purposes. It applies to animal experiments that are conducted for one of a number of specified purposes, including the safety testing of drugs, foodstuffs and other substances or products. An experiment must not be performed if the aim can also be achieved by an alternative method which does not entail the use of an animal. The directive specifies detailed guidance for accommodation and care of animals, welfare requirements for the avoidance of pain or stress, and the humane treatment of animals at the end of an experiment. Establishments using animals for experiments, as well as breeding and supplying establishments, must be registered with, or approved by, the competent authority. The Member States must ensure that these establishments are run in compliance with the terms of the directive.

The directive is implementing the commitments under the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes, to which EU is a party.

191 Directive 2003/65/EC of the European Parliament and of the Council of 22 July 2003 amending Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes.

SECTION 8 – CHEMICALS AND GMO LEGISLATION THE DIRECTIVE ON THE PROTECTION OF ANIMALS USED FOR EXPERIMENTAL AND OTHER SCIENTIFIC PURPOSES



2.1 Planning

• Designate the competent authority responsible for verification purposes (Art. 6).

• Set up an authorisation or registration system for establishments conducting animal experiments and breeding and supplying establishments. Ensure that establishments keep detailed records regarding the animals sold, supplied, and used in experiments, to be kept for a minimum of three years and subject to inspections by the authority (Arts. 15, 17, 19).

• Set up a control system guaranteeing the inspection of the records kept by user, breeding, and supplying establishments on a regular basis and publish the collected statistical information; ensure that the confidentiality of commercially sensitive information is protected (Arts. 13, 17, 19).

2.2 Regulation

• Ensure that animal experiments are performed only by competent, authorised persons, and only if another suitable method is not available. Experiments must be carried out in a way that avoids distress and unnecessary pain and suffering; general and local anaesthesia are required, subject to certain exceptions set out in the directive (Art. 7).

• Ensure that persons carrying out or taking part in animal experiments, or the care of experimental animals, are suitably educated and trained (Art. 14).

• Prohibit experiments using endangered species listed in Appendix 1 of the Convention on International Trade in Endangered Species of Fauna and Flora (CITES) unless they comply with Regulation (EC) No. 3626/82 and the animals are used for research aimed at the preservation of the species in question or for essential biomedical purposes, where this species is the only suitable one for those purposes (Art. 4).

• Ensure that the choice of species is carefully considered; methods using the minimum number of animals, with the lowest degree of neurophysiological sensitivity and which are most likely to provide satisfactory results must be chosen (Art. 7).

• Ensure that wild animals are used for experiments only if other animals would not suffice for the aims of the experiment (Art. 7).

• Ensure that stray animals of domestic species are not used in experiments (Art. 19).

• Ensure that dogs, cats and non-human primates are provided with a unique identification mark before they are weaned or as soon as they are taken into an establishment (Art. 18).

• Ensure that experimental animals are provided with appropriate housing, freedom of movement, food, water and care, and that their environmental conditions are checked daily (Art. 5).

• Ensure that animals can satisfy their physiological and ethological needs to a maximum (Art. 5).

• Ensure that the state of health of experimental animals is observed by a competent person to prevent pain or avoidable suffering, distress or lasting harm; any defect or suffering must be eliminated immediately (Art. 5).

• Ensure that animals are treated humanely at the end of the experiment. A decision must be made by a competent person as to whether the animal will be kept alive or killed by a humane method. Animals may not be kept alive if they are likely to remain in lasting pain or distress or if they cannot be kept under the appropriate conditions in Article 5 (Art. 9).


PURPOSES


• Ensure that experimental animals are only set free subject to conditions relating to the animal’s well-being and where there is no danger to public health and the environment (Art. 11).

• Ensure that re-use of animals is only permitted in accordance with the directive and that animals are not used more than once in experiments entailing severe pain, distress or equivalent suffering (Art. 10).

• Establish procedures whereby experiments themselves or the details of persons conducting such experiments are notified in advance and ensure that experiments exposing animals to severe and prolonged pain may be conducted only after they are justified to, or specifically authorised by, the authority (Art. 12).

• Encourage research into the development and validation of alternatives for animal experiments and monitor trends in experimental methods (Art. 23).

• Recognise the validity of data generated by experiments carried out in other Member States, unless further testing is necessary to protect public health and safety (Art. 22).

2.3 Reporting


− legislation and administrative practice and factual information relating to animal experiments (Art. 22);

− transposition, with texts of the main provisions of national law adopted in the field covered by the directive (Art. 25); and

− measures taken in the field covered by the directive and statistical data on the use of animals in experiments (Arts. 13 and 26).


This directive is the first legislative measure the Community adopted in order to harmonise legislation regarding the conduct of laboratory tests on animals. It was followed by Directive 2004/10/EC and Directive 2004/9/EC, both on good laboratory practice (GLP). The three directives establish a system of harmonised test methodologies and quality standards that allow the mutual recognition of test results.

Following Council Decision 1999/575/EC of 23 March 1998 concerning the conclusion by the Community of the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes, the Community has become party to the Council of Europe Convention ETS 123.

3. Implementation

3.1 Key Tasks

The key tasks involved in implementing this directive are summarised in the checklist below. The key tasks are arranged under subheadings and organised in chronological order of implementation wherever possible.

DIRECTIVE ON ANIMAL EXPERIMENTS – KEY IMPLEMENTATION TASKS

1 Planning

1.1 Appoint a competent authority.



1.2 Set up an authorisation or registration system for establishments using, breeding or supplying animals for experimental purposes.

1.3 Establish a data collection system regarding the use of animals in experiments and publish the statistical information periodically.

1.4 Set up procedures to ensure that laboratory staff are adequately trained to perform experiments on animals or to care for animals used for experimental purposes.

2 Regulation

2.1 Set up a control system to verify that establishments are run in compliance with the terms of the directive.

2.2 Set up a notification procedure for animal experiments or persons conducting them. Member States can also choose to introduce an authorisation system for approval of experiments or persons conducting them.

2.3 Ensure that commercially sensitive information is not published.

3 Reporting

3.1 Communicate to the Commission regarding:

• legislation and administrative practice relating to animal experiments; and

• the measures taken in this area and statistical information collected in accordance with the harmonised set of statistical tables agreed between Member States and the Commission in 1997.


Experience within Member States suggests that the most demanding and time-consuming tasks associated with implementing this directive are:

• transposing the requirements of the directive into national legislation and policy due to possible extensive discussions among the public;

• the preparation of a registration, notification or authorisation system for animal experiments (it should be noted that the current directive does not require authorisation of experiments or persons conducting experiments per se unless it is stipulated in national provisions) in user, breeding and supplying establishments;

• instituting an authority responsible for monitoring user, breeding and supplying establishments; and

• the collection of statistical data according to the harmonised format including assurance of data quality and timeliness.

These tasks should, therefore, be planned to commence during the initial phase of implementation.

During the whole transposition process, it should be borne in mind that legislation on animal experiments is a very controversial and politically sensitive issue. The government should be prepared for strong intervention by animal rights groups. Moreover, the public is likely to follow the legislation process very closely. Therefore, a well-reflected communications and public participation policy should be developed during the legislative process.


The directive aims to abolish trade barriers between EU Member States arising from the different legal requirements for the treatment of animals used for experimental purposes. Furthermore,


PURPOSES


the directive is designed to limit the use of animals in scientific experiments to a minimum. In cases where there are no suitable alternatives, animal experiments must be conducted so that the animal’s pain, suffering and distress during the experiment is minimised as much as possible.

Member States must introduce an authorisation or registration system for all establishments using, breeding or supplying animals for experimental purposes. As pointed out above, the directive, per se, does not require systematic authorisation or notification of experiments. The notification of the persons conducting experiments is sufficient. These establishments must be subject to inspections to ensure compliance with the requirements of the directive. Member States and the Commission should encourage research on the development and validation of alternative techniques that involve fewer animals or entail less painful procedures.

Implementation of the specific requirements of this directive will be influenced by the present status, needs and conditions concerning animal experiments in each candidate country. However, drawing upon the collective experience of the Member States, a number of general observations and good practice suggestions for implementing this directive are presented below.

4.1 Regulation

• In relation to notification/authorisation of experiments, most laboratories in the Member States have internal ethics committees that review, provide opinions on or sanction proposed work.

Example of Practice in Member States

In most Member States the ethics committees have only advisory tasks. At least two Member States (NL and SE) have given the ethics committees more power. In both of these countries, an animal experiment may be conducted only after an ethics committee has recommended the experiment. In one of these countries (NL), the ethics committees are not part of the public administration. They are private institutions admitted by the state to assess applications for animal experiments licences. In most other Member States, the ethics committees are integrated into the public administration, sometimes at a regional and sometimes at a local level.

• Member States have the option either to introduce an authorisation or a registration

system. Whereas the former requires a formal permit prior to the operation of an establishment, the latter requires only the entry of details of the establishment into a register.


One Member State (UK) has introduced a specific three-tiered authorisation system. According to this system, an animal experiment must be part of a programme of work authorised by a project licence. The person applying the regulated procedures must hold a personal licence and the establishment at which the experiment will take place must have a certificate of designation. Such a certificate of designation is issued to a senior representative of an establishment after the place has been assessed as meeting the requirements of the directive. A project licence is granted to an individual for a period of up to five years, if the project is in compliance with the requirements of the directive. The authorities issue a personal licence (valid for life but subject to five year review) if the individual is a suitable and competent person to carry out specified procedures on specified animals.

4.2 Reporting

• Member States must provide the Commission regularly with statistical information collected on the use of animals for experimental purposes. Due to the differences in



compilation of the statistical material in Member States, they agreed in 1997 to a set of eight harmonised tables on how the information should be presented to the Commission.

5. Costs

The implementation of this directive will entail costs for the European Commission, the Member States, science/academia, industry and private testing laboratories.

The creation of an authorisation and control system for all establishments related to animal experiments can generate high costs for the Member States, in particular if they have not had any, or only a less developed, control system regarding the treatment and use of animals in experiments. The main expenditures are expected to emerge from the permitting, monitoring, and investigative work required under the directive. The employment of additional staff, in particular of specialists qualified in the area of veterinary medicine, is probably the most important cost driver for the Member States. Part of the costs might be recovered from businesses through fees for permits, investigations and inspections.

The establishments covered by this directive are forced to make investments in order to meet the directive’s requirements for the accommodation and care of animals. The costs for a modernisation programme can vary enormously, depending on the current condition of the animal facilities. It is anticipated that industry, together with academic and scientific institutions, will have to bear some (or all) of the additional costs for experiments involving animals under this directive.

Checklist of the Types of Cost Incurred to Implement the Directive


• designate a competent authority;

• establish a data collection system;

• set up an authorisation system and licensing procedures;

• set up a control system;

• training and recruitment of inspectors and veterinary staff.

Ongoing costs:

• collecting data for reporting to the Commission;

• monitoring compliance with standards;

• issuing of permits and registration of establishments;

• compilation of statistical information.

SECTION 8 – CHEMICALS AND GMO LEGISLATION THE DIRECTIVE ON THE INSPECTION AND VERIFICATION OF GOOD LABORATORY PRACTICE


The Directive on the Inspection and Verification of

Good Laboratory Practice

Official Title: Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (codified version) (OJ L 50, 20.2.2004) (repealing and replacing Council Directive 88/320/EEC on the inspection and verification of good laboratory practice).


Directive 2004/9/EC (replacing former Directive 88/320) establishes standards and procedures for the inspection and verification of good laboratory practice (GLP), the principles of which are defined in Council Directive 2004/10/EEC. It concerns the inspection and verification of the organisational processes and the conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing of all chemicals (including cosmetics, industrial chemicals, medicinal products, food additives, animal feed additives and pesticides) for the purpose of assessing the effect of such products on humans, animals and the environment.

Member States must control all laboratories within their territory which carry out tests required under Community chemicals control legislation to assess their effects on humans, animals and the environment. (However, the directive is not concerned with the interpretation and evaluation of test results.) The control measures are to include the inspection of the laboratory and the auditing of tests carried out by the laboratory.

The annex to the directive lays down detailed guidelines for the inspection and verification of good laboratory practice, extracted from the relevant parts of the revised decision on compliance with principles of good laboratory practice of the Council of the Organisation for Economic Co-operation and Development (OECD). Member States must apply rules on the protection of commercially sensitive and other confidential information to which inspectors have access during inspections. Inspections and audits carried out in other Member States must be recognised.

The Member States must designate the authorities responsible for the inspection of laboratories within their territory. Member States must annually submit information to the Commission in a report listing the laboratories inspected, the date of the inspection and the conclusions of the inspection. Where the outcome of the inspection is positive, it is considered GLP-compliant and this decision is binding in the other Member States as well. However, in the event that a



laboratory claiming GLP compliance does not comply, the Member State must inform the Commission, which shall inform the other Member States.

Directive 2004/9/EC amends and repeals Directive 88/320/EEC on the inspection and verification of good laboratory practice. The purpose of this codified version is to take over all the provisions of the existing directives in this field and to thus make the legislation clearer to the Member States.


2.1 Planning

• Designate competent authorities for inspection and verification (Art. 3).

• Ensure that the competent authorities inspect laboratories and audit studies in accordance with the provisions laid down in the annex (Art. 3).

2.2 Regulation

• Grant laboratories the right to use a specified formula confirming compliance with the directive’s requirements, if the results of an inspection and verification are satisfactory (Art. 2).

• Ensure that commercially sensitive and other confidential information to which inspectors have access as a result of the inspection is protected in accordance with the rules laid down in the directive (Art. 4).

• Ensure that results of laboratory inspections and study audits on GLP compliance carried out by another Member State are recognised (Art. 5).

• Ensure that laboratories claiming to use GLP are inspected and that their compliance with GLP is verified in accordance with the provisions laid down in the annex to the directive (Art. 2).

2.3 Reporting


• the implementation of GLP, including a list of inspected laboratories, annually (Art. 4);

• any laboratory that claims to, but does not, comply with GLP (Art. 5);

• the results of consultations with another Member State over claims that a laboratory in the other Member State has not carried out a test in accordance with GLP (Art. 6);

• transposition, with texts of the main provisions of national law adopted in the field covered by the directive (Art. 9).


• Council Directive 87/18/EEC on the application of the principles of good laboratory practice.

• Commission Directive 99/12/EC adapting to technical progress for the second time the annex to Council Directive 2004/10/EC on the inspection and verification of good laboratory practice. This attaches the relevant extracts of the revised OECD decision/recommendation on compliance with principles of good laboratory practice.



3. Implementation

3.1 Key Tasks


DIRECTIVE ON THE INSPECTION AND VERIFICATION OF GOOD LABORATORY PRACTICE – KEY IMPLEMENTATION TASKS

1 Planning

1.1 Designate a competent authority to carry out inspections and verify compliance with GLP.

2 Regulation

2.1 Identify laboratories claiming compliance with GLP and ensure that their compliance is verified..

2.2 Design and implement a procedure for inspecting laboratories.

2.3 Establish procedures for enabling laboratories to formally claim compliance with GLP and for allowing appeals against decisions resulting from an inspection.

Develop procedures for the protection of confidential information

3 Reporting



• implementation of GLP, attaching a list of laboratories inspected;

• instances where a laboratory claiming GLP compliance does not in fact comply;

• instances where a laboratory in another Member State claiming GLP compliance has not carried out a test according to GLP.


Experience within Member States suggests that the most demanding and time-consuming tasks associated with implementing this directive are:

• transposing the requirements of the directive into national legislation and policy; and

• designating a monitoring authority and developing a monitoring programme.

These tasks should, therefore, be planned to commence during the initial phase of implementation.

GLP legislation should be developed and drafted in conjunction with other chemicals and product-specific legislation (e.g. industrial chemicals, biocides, plant protection products, food additives, drugs, explosives, and cosmetics).


Following Council Directive 2004/10 (former 87/18/EEC), which lays down a general obligation to set up a control system for laboratories applying GLP, this directive lays down specific



requirements for such a control system. The relevant parts of the OECD guidelines on compliance with principles of GLP are incorporated into the annex to the directive. The directive creates a legal framework to ensure that chemicals tests that are carried out in different Member States to the same standards of GLP are recognised on a mutual basis by other Member States. By incorporating the OECD guidelines into Community law, the directive guarantees that tests carried out in the Community in accordance with GLP principles are also recognised in other OECD member countries.

The present status, needs and conditions concerning GLP in candidate countries will influence implementation of the specific requirements of this directive. However, drawing upon the collective experience of the Member States, a number of general observations and good practice suggestions for implementing this directive are presented below.

4.1 Planning

• Those problems that occurred in implementing this directive have tended to involve distrust by the EU Member States of each other’s regulatory authorities. This problem of distrust has been largely assuaged by the Mutual Joint Visit Programme of GLP review set up under the auspices of the OECD chemicals programme. Here, regulatory authorities from two to three countries visit their counterpart in another OECD member state to review the GLP programme there.

• In addition, the OECD conducted a comprehensive survey of implementation of the OECD requirements and guidelines on GLP principles and mutual acceptance of data (MAD). This included a comprehensive questionnaire which was sent to all OECD member states for completion and which addressed the implementation by these member states (which include all EU Member States) of GLP and MAD requirements.

• Laboratories applying GLP must be identified and a programme for inspecting them and verifying their compliance with GLP principles (including carrying out study audits) must be developed and implemented. The number of inspectors required will depend upon the number of laboratories involved and the frequency of inspections.

Example of Monitoring Authorities in a Member State

One Member State (DE) has, due to its federal system, established 16 different monitoring authorities each responsible for one of the federal states (Bundesländer). In addition to these 16 monitoring authorities, a federal GLP bureau was created, which is responsible for international contacts and the co-ordination between the 16 monitoring authorities.

4.2 Regulation

• Setting up a laboratory monitoring system is a key task for ensuring GLP compliance. Inspectors must be trained to carry out inspections in accordance with the guidelines set out in the annex. For example, inspectors should establish contact with the laboratory’s internal quality assurance unit and should follow set procedures in carrying out inspections.


In one Member State (SE), GLP principles were introduced in 1979 (even before the OECD decision on GLP was issued), as a tool for evaluating the integrity of non-clinical safety data. Two monitoring authorities operate in the Member State. The Medicinal Products Agency (MPA) has the exclusive responsibility for the control and monitoring of medicines, veterinary medicines, cosmetic and hygienic products. Responsibility for all other chemicals for which GLP is required (industrial chemicals, pesticides) lies with the National Board of Accreditation and Conformity (SWEDAC). The main disadvantage of having two monitoring authorities, SWEDAC and MPA, is



the cost factor. The operation of two different monitoring authorities is likely to be more expensive and less efficient than having only one body responsible for all laboratories applying GLP for all products tested.

The power to issue implementing regulations regarding the requirements for safety data submitted to the authorities is also allocated between SWEDAC and MPA. MPA has been delegated the competence to adopt regulations with respect to testing of pharmaceuticals, and cosmetic/hygienic products, whereas the National Chemicals Inspectorate is responsible for regulations on testing requirements for industrial chemicals and pesticides. As a result of this division of competence, a large number of regulations, each applicable for specific products, deal with GLP.

Although both authorities run their own GLP compliance programme, the organisation of the programmes and the procedures are identical. A test facility enters the monitoring programme automatically when safety data generated by it have been submitted to the authorities as part of a registration or licensing procedure for a product for which testing in compliance with GLP is required. Then, the monitoring authority (MPA or SWEDAC) includes the laboratory in the programme and prepares an initial inspection of the facilities. Two weeks before the actual site visit, the monitoring authority informs the laboratory about its intention and requests general information on the facilities. After the initial inspection, the laboratory will be inspected approximately every two years.

• Member States must determine under which conditions a laboratory enters the national

monitoring programme and how often inspections will take place. Laboratory inspections will generally include study audits, which review ongoing or completed studies, but specific study audits are also likely to be requested by regulatory authorities and can be conducted independently of laboratory inspections.


In one Member State (NL), a laboratory that is not a member of the monitoring programme can also submit safety tests for regulatory purposes. These tests are not immediately refused, even though the receiving authority does not have any guarantee that the laboratory is actually operated in compliance with GLP principles. The receiving authority then directly asks the monitoring authority to inspect the laboratory. If the inspections prove that the laboratory is operated in compliance with GLP principles, it will be included in the monitoring programme.

4.3 Reporting

• Various documents will need to be published relating to the adoption of GLP principles but also providing details of the national GLP compliance programme, including information on the legal and administrative framework within which the programme operates and references to published acts, normative documents (e.g. regulations, codes of practice).

• It would be advisable to designate a person or a department, most likely within the monitoring authority, which is responsible for maintaining contacts with the Commission, other Member States and the OECD, compiling data, and submitting reports as required (e.g. reports to the Commission on implementation).

5. Costs

The implementation of Directive 2004/10/EC mainly generates costs for the competent authorities of the EU Member States. They are obliged to set up a team of inspectors having the necessary technical/scientific expertise and experience. Further administrative costs are caused by the obligation to publish documents informing industry and interested third parties on the



national GLP compliance programme and to maintain detailed records of the laboratories inspected. Part of the costs would normally be borne by the industry and the laboratories licensed to carry out tests in compliance with GLP. A fee for the right to use the compliance formula could also be levied to help to meet the costs to the authorities of carrying out inspections.

The expenditure of industry for product testing will substantially increase, especially as a result of the need to introduce a transparent internal audit system and a raw data archive such that an external audit may be performed at a later date. However, the mutual recognition of these tests leads to a reduction in the number of required tests and, therefore, to a reduction of costs, if a tested product is marketed in more than one country.



• establishment of competent authority(ies);

• development of compliance programmes;

• provision of training to inspectors;

• design of laboratory monitoring procedures;

• preparation of associated literature for technical and non-technical audiences.

Ongoing costs:

• periodic inspections of laboratories;

• collection and reporting of data;

• assessment of conformity with GLP.

SECTION 8 – CHEMICALS AND GMO LEGISLATION THE DIRECTIVE ON THE APPLICATION OF THE PRINCIPLES OF GOOD LABORATORY PRACTICE


The Directive on the Application of the Principles of Good Laboratory Practice

Official Title: Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) (repealing and replacing Directive 87/18/EEC, as amended by Commission Directive 1999/11/EC (OJ L 77, 23.3.1999)192


Directive 87/18/EEC introduced provisions (now replaced by Directive 2004/10/EC) harmonising the procedures under which specified tests are performed. All laboratory that are required under Community chemicals control legislation to determine whether a chemical product presents a danger to human beings or to the environment must be carried out in compliance with the principles of good laboratory practice (GLP). (Tests must be carried out under Council Directive 67/548/EEC but also under other Community legislation.) These principles are specified in the annex to the directive, which sets out the revised and updated Principles of Good Laboratory Practice of the Council of the Organisation for Economic Co-operation and Development (OECD) (which cancel and replace the original OECD principles adopted in 1981). The directive also applies where other Community provisions provide for the application of the principles of GLP to tests on chemical products to evaluate their safety for human beings and/or the environment.

The tests conducted on these different elements seek to obtain data on their properties and their safety with regard to human health and the environment.

Member States must set up a control system to verify that laboratories performing safety tests for the above-mentioned regulatory purposes actually carry out their tests in compliance with the principles of GLP as set out in the annex to the directive. Council Directive 88/320/EEC specifies the detailed standards and procedures for the inspection of laboratories and the auditing of studies. Placing on the market of chemical products tested in conformity with the principles of

192 Commission Directive 1999/11/EC of 8 March 1999 adapting to technical progress the principles of good laboratory practice as specified in Council Directive 87/18/EEC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances.



good laboratory practice may not be prohibited, restricted or impeded on grounds of test methodology.

Directive 87/18/EEC and its amending directive were replaced by Directive 2004/10/EC providing a codification clarifying the text for Member States. The purpose of the directive is to take over all the provisions from the existing directives in this field.


2.1 Planning

• Appoint a competent authority for verifying compliance with the principles of good laboratory practice and notify the European Commission (Art. 3).

2.2 Regulation

• Ensure that laboratories carrying out tests on chemical products comply with the principles of good laboratory practice as specified in the annex to the directive (Art. 1).

• Ensure that laboratories carrying out tests on chemical products certify that the tests have been carried out in conformity with the principles of good laboratory practice (Art. 2).

• Adopt control measures (including inspections and study audits) in accordance with the recommendations of the OECD to verify that the laboratories are operating in compliance with the principles of good laboratory practice (Art. 3).

• Ensure that the placing on the market of chemical products tested in accordance with the principles of good laboratory practice is not prohibited, restricted or impeded on grounds relating to the principles of good laboratory practice (subject to an exception for the provisional prohibition or restriction of substances that present a danger to man and the environment) (Art. 5).

• Ensure that the Commission and other Member States are informed if the marketing of a chemical product is provisionally prohibited or restricted under the Article 5 exception (Art. 5).

2.3 Reporting

• Report to the European Commission on:

− transposition, with texts of the main provisions of national law adopted in the field covered by the directive (Art. 6);

− the authority responsible for verifying compliance with the principles of good laboratory practice (Art. 3); and

− Member State decisions to provisionally prohibit or restrict the marketing of dangerous substances (Art. 5).


• Council Directive 2004/9/EC on the inspection and verification of good laboratory practice.

• Council Directive 67/548/EEC on classification, packaging and labelling of dangerous substances, which requires tests to be carried out on chemical substances in order to enable their potential risk to humans and the environment to be determined. In carrying out these tests it is necessary to comply with the principles of good laboratory practice.



• Other EC legislation that provides for the application of the principles of good laboratory practice in respect of tests on chemical products to evaluate their safety for humans and the environment.

• Commission Directive 99/11/EC adapting to technical progress the principles of good laboratory practice as specified in Council Directive 2004/10/EC. This publishes the full text of the OECD’s revised principles of GLP.

• Council Decision 89/569/EEC on the acceptance by the EEC of an OECD decision/recommendation on compliance with the principles of good laboratory practice. This approves the OECD decision/recommendation and attaches the text of it.

• Commission Directive 99/12/EC adapting to technical progress for the second time the annex to Council Directive 2004/9/EC on the inspection and verification of good laboratory practice. This attaches the full text of the revised annexes on the inspection and verification of good laboratory practice (which form part of the OECD Council decision/recommendation on compliance with principles of good laboratory practice).

• Council Directive 86/609/EEC regarding the protection of animals used for experimental and other scientific purposes, as amended.

• Directive 2004/10/EC should also be read in conjunction with Council Directive 2004/09/EC, which establishes standards and procedures for the inspection and verification of GLP principles.

3. Implementation

3.1 Key Tasks


PRINCIPLES OF GOOD LABORATORY PRACTICE – KEY IMPLEMENTATION TASKS

1 Planning

1.1 Appoint a competent authority for verifying compliance with the principles of GLP.

1.2 Ensure that tests carried out by foreign laboratories in accordance with the principles of good laboratory practice are fully recognised (“national treatment”).

1.3 Establish a certification system for laboratories that comply with the principles of good laboratory practice.

2 Regulation

2.1 Develop a system for the inspection and control of laboratories (in accordance with the requirements of Directive 2004/9/EC).

3 Reporting



• the authority responsible for verifying compliance with the principles of good laboratory practice; and

• decisions to provisionally prohibit or restrict the marketing of dangerous substances.



3.2 Phasing Considerations Experience within Member States suggests that the most demanding and time-consuming tasks associated with implementing this directive are:

• transposing the requirements of the directive into national legislation and policy; and

• designating a monitoring authority and developing a monitoring programme.

These tasks should, therefore, be planned to commence during the initial phase of implementation. GLP legislation should be developed and drafted in conjunction with other chemicals legislation.


The directive recognises the necessity to support the mutual acceptance of test results, to avoid further testing on chemical products that have already been tested in accordance with the principles of good laboratory practice. The mutual recognition of test results is an essential condition both for the reduction of costs caused by the marketing of chemical products and for the reduction of animal experiments. The directive supplements the Community legislation regarding chemicals and chemical products. Under several directives, laboratory tests of chemicals or chemical-related products are required (e.g. industrial chemicals, biocides, plant protection products, food additives, drugs, explosives). These tests must be carried out in accordance with the principles of good laboratory practice. Moreover, the directive contains the general requirement to adopt measures necessary for the verification of compliance with the principles of good laboratory practice. Council Directive 88/320/EEC specifies this general obligation and lays down standards and procedures for the inspection and verification of the principles of good laboratory practice.

Implementation of the specific requirements of this directive will be influenced by the present status, needs and conditions in each candidate country. However, drawing upon the collective experience of the Member States, a number of general observations and good practice suggestions for implementing this directive are presented below.

4.1 Planning

Examples of Practice in a Member States

In most Member States, the requirement to test chemical substances and products in compliance with GLP principles is spread over various laws. Most Member States have decided to incorporate this requirement into each product-specific law rather than adopting general GLP legislation that applies to all chemicals and chemical products.

One Member State (SE) has adopted the following general provision on which such regulations can be based: "The Government, or such authority as the Government may designate, may issue such prescriptions on the handling, importation and export of chemical products as are needed in consequence of (the country's) membership of the EU." Such a general authority is an appropriate tool to facilitate the implementation of EC directives.

• Those problems that have occurred have tended to involve distrust on the part of EU

Member States of one another’s regulatory authorities. The problem of distrust has been largely assuaged by the Mutual Joint Visit Programme of GLP review, set up under the auspices of the OECD chemicals programme. Here, regulatory authorities of two to three countries visit their counterpart in another OECD Member State to review the GLP programme there.



Examples of Practice in a Member State

In at least one Member State (DE), the party who notifies a chemical or chemical product is obliged to submit a certificate of compliance issued by the competent monitoring authority. Such a certificate proves that the laboratory that has carried out the safety tests is operated in compliance with GLP principles.

• In addition, the OECD conducted a comprehensive survey of implementation of the

OECD requirements and guidelines on GLP principles and mutual acceptance of data (MAD). This included a comprehensive questionnaire that was sent to all OECD member states for completion and which addressed the implementation by these states (which include all EU Member States) of GLP and MAD requirements.

• It may be appropriate to entrust the competent authority that is responsible for the enforcement of chemicals control legislation with the duties required under this directive.

• Training of laboratory staff and inspectors is an important part of implementation of the directive, which competent authorities should arrange.

Examples of Monitoring Practice in Member States

The monitoring authority of at least one Member State (AT) co-operates closely with the monitoring authority in another Member State (DE). Since there are only a few laboratories applying GLP principles in the former, there was the need for inspectors to gain experience abroad.

4.2 Regulation

• The requirement to recognise tests conducted by laboratories based in other Member States in accordance with the GLP principles has not always been implemented into national law. Although the administrative practice in Member States is mostly in compliance with the recognition requirements of the directive, these requirements must be incorporated into binding legislation.

4.3 Reporting

• The Member States should designate a person or a department, most likely within the monitoring authority, to be responsible for the contacts with the Commission, other Member States and the OECD.

5. Costs

The main expenditures caused by the implementation of Council Directive 87/18/EEC are the costs of the inspection and control system. Member States have to employ a sufficient number of inspectors to guarantee an efficient control of laboratories and test results. These inspectors must have qualifications and practical experience in the field of chemicals testing, together with a thorough understanding of both manual and electronic systems for raw data collection and storage. Regular training is necessary to ensure that the inspectors are familiar with state-of-the-art procedures and techniques. In addition, the Member State must employ staff for the administrative tasks related to the control system (e.g. certification). Part of the costs would normally be borne by industry and the laboratories licensed to carry out tests in compliance with the principles of good laboratory practice, and part of the costs recovered through a fee for certification and for inspections.



The expenditure of industry for product testing will substantially increase, especially as a result of the need to introduce a transparent internal audit system and a raw data archive such that an external audit may be performed at a later date. However, the mutual recognition of test results will lead to a reduction of tests and, therefore, to a reduction of test costs, if a product is marketed in more than one country.



• establishment of competent authority/ies;

• development of compliance programmes;

• provision of training;

• design of laboratory monitoring procedures;

• preparation of guidance.

Ongoing costs:

• periodic inspections of laboratories;

• certification and inspection fees;

• assessment of conformity with GLP.

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