Section 8 CHEMICALS AND GMO LEGISLATION

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1 Section 8 CHEMICALS AND GMO LEGISLATION

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3 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 Handbook on the Implementation of EC Environmental Legislation 915

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5 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 Handbook on the Implementation of EC Environmental Legislation 917

6 CHEMICALS AND GENETICALLY MODIFIED ORGANISMS - OVERVIEW 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 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 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 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. 918 Handbook on the Implementation of EC Environmental Legislation

7 CHEMICALS AND GENETICALLY MODIFIED ORGANISMS - OVERVIEW 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 Most of the provisions will be applied at a later stage, mainly from 1 June 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). Handbook on the Implementation of EC Environmental Legislation 919

8 CHEMICALS AND GENETICALLY MODIFIED ORGANISMS - OVERVIEW 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 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 Handbook on the Implementation of EC Environmental Legislation

9 CHEMICALS AND GENETICALLY MODIFIED ORGANISMS - OVERVIEW 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 (socalled 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 Handbook on the Implementation of EC Environmental Legislation 921

10 CHEMICALS AND GENETICALLY MODIFIED ORGANISMS - OVERVIEW 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 922 Handbook on the Implementation of EC Environmental Legislation

11 CHEMICALS AND GENETICALLY MODIFIED ORGANISMS - OVERVIEW 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 Handbook on the Implementation of EC Environmental Legislation 923

12 CHEMICALS AND GENETICALLY MODIFIED ORGANISMS - OVERVIEW 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, ), 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. 924 Handbook on the Implementation of EC Environmental Legislation

13 CHEMICALS AND GENETICALLY MODIFIED ORGANISMS - OVERVIEW 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 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 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. Handbook on the Implementation of EC Environmental Legislation 925

14 CHEMICALS AND GENETICALLY MODIFIED ORGANISMS - OVERVIEW 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 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 926 Handbook on the Implementation of EC Environmental Legislation

15 CHEMICALS AND GENETICALLY MODIFIED ORGANISMS - OVERVIEW 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 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) Hazardous Waste Directive (91/689/EEC, as amended 94/31/EC) Water Sector The Dangerous Substances Directive (2006/11/EC, to be integrated into the Water Quality Framework Directive, 2000/60/EC) IPPC and Risk Management 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. This directive sets out a framework for handling and disposing of waste. This will affect installations handling dangerous chemicals. This directive sets out a framework for handling and disposing of hazardous waste. This directive controls emissions of dangerous substances to waters. Handbook on the Implementation of EC Environmental Legislation 927

16 CHEMICALS AND GENETICALLY MODIFIED ORGANISMS - OVERVIEW IPPC Directive (2008/1/EC) Seveso II Directive (96/82/EC) Directive 2003/4/EC on the Freedom of Access to Information on the Environment 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). This directive aims to prevent major accidents involving dangerous substances and to limit their impacts on people and 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 928 Handbook on the Implementation of EC Environmental Legislation

17 CHEMICALS AND GENETICALLY MODIFIED ORGANISMS - OVERVIEW 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 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. Handbook on the Implementation of EC Environmental Legislation 929