Important legal notices
 
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Guide to the Approximation of European Union Environmental Legislation



Part 2

Overview of EU environmental legislation

G. Chemicals and Genetically Modified Organisms


The most important area of EU chemicals control legislation is that concerning the testing and notification of chemicals and preparations. The others are those concerning genetically modified organisms (GMOs), animal experimentation, good laboratory practices, and directives or regulations controlling products.

The directives on the Contained Use of Genetically Modified Organisms and on Deliberate Release establish a system controlling the use of genetically modified organisms. They were modelled on the chemicals notification directives.

The Animal Experiments Directive 86/609/EEC establishes minimum humane treatment standards for animals which are used for mandatory testing under the EU chemicals and preparations directives.

The Directive on Harmonisation of Good Laboratory Practice 87/18/EEC and its related Directive on Inspection and Verification of Good Laboratory Practice 88/320/EEC implement the relevant OECD Council acts aimed at ensuring that the OECD member countries recognise the validity of the data produced through the testing of chemicals according to these harmonised standards for good laboratory practice.

Finally, the Asbestos Directive 87/217/EEC provides an integrated set of controls on the release of asbestos into air water and land.


Table


G.1 Chemical Testing and Notification

Classification, packaging and labelling of dangerous substances

Council Directive 67/548/EEC on the testing, classification, packaging and labelling of chemicals which are dangerous to man and the environment. A pre-market testing and notification system for new chemicals placed on the Community market was introduced in 1979.

The directive distinguishes between 'new' and 'existing' chemicals. Existing chemicals are those which were placed on the Community market before 18 September 1981 and are listed in the European Inventory of Existing Commercial Chemical Substances (EINECS). 'New' chemical substances are those which are not in EINECS.

A producer or importer who places a new chemical substance on the market for the first time in the European Community must submit a notification dossier about the chemical to a national competent authority at least 45 days in advance.. This 'base set' of information is intended to be a screen for health and environmental hazards. Existing chemicals are exempt from notification. They have to be classified on the basis of their intrinsic properties by the competent authorities and provisionally by the manufacturers, distributors and importers.

There is also a reduced notification procedure for substances placed on the market in quantities of less than one tonne per annum per manufacturer.

The directive lists 14 categories for the classification of dangerous substances according to their physico-chemical or toxicological properties. It also specifies symbols and indications of danger for labelling as well as standard risk phrases and safety phrases. The directive also contains basic requirements for the packaging of dangerous substances.

All of the chemicals which the Community has classified as hazardous under the Directive are listed in Annex I, which is updated regularly. This annex defines the hazard symbol, risk and safety phrases to be put on the label.

Implementation considerations
  1. Implementation requires the development of efficient administrative and technical structures capable of managing and assessing the flow of information linked to the placing on the market of a new chemical substances. Strong international co-operation is also necessary to ensure that all the elements for the evaluation of such substances within the short time frame allowed are collected and available in order to fulfil the control role national authorities are charged with.
  2. The competent authorities should develop the necessary data bases to be consulted by manufacturers and importers to avoid unnecessary duplication of testing especially for what involves animal testing.
  3. Effective custom and internal controls together with penalties will be needed to avoid illegal import and marketing of non-notified chemicals from third countries. For the same reason, information campaigns focused to importers and manufacturers would be useful to rise the level of compliance with the detailed technical requirements linked to chemical notification.
  4. Permanent fora with the chemical industry sector would have to be created to allow effective exchange of information to take place and for the preparation of proposals for classification of existing substances.
  5. For new substances: Comparable lists to ELINCS and the list on NLP(no-longer polymer) have to be established.
  6. For existing substances: A list comparable to the EINEC-list has to be established. Data on existing substances should be compared with the EINEC-list and the Annex I of the Directive 67/548/EEC.
Classification, labelling and packaging of dangerous preparations

Council Directive 88/379/EEC adapts and extends the procedures and standards for the classification and labelling of dangerous chemicals under Directive 67/548/EEC to dangerous preparations. A preparation is a mixture of two or more chemical substances.

It applies to preparations which are placed on the market in the EU and which contain at least one substance classified as dangerous or which are regarded as dangerous. Preparations must be classified according to the greatest degree of hazard identified.

It does not apply to medicinal or veterinary products, cosmetic products, mixtures of substances in the form of wastes, and pesticides, which are covered by other Community legislation.

Packaging of dangerous preparations must meet the same criteria as chemicals with respect to labels, strength, leak-tightness and fastening systems.

The Member States may on the basis of detailed information provisionally prohibit or limit the sale of a preparation which, although satisfying the directive, constitutes a hazard by reason of its classification, packaging or labelling.

Implementation considerations

1. The same remarks made for dangerous substances apply to dangerous preparations.

Existing Substances

Regulation 793/93 on the evaluation and control of existing substances establishes the obligation for manufacturers and importers to deliver data on substances produced or imported above certain quantities. On the basis of the information submitted and on the basis on the national lists of priority substances, the Commission draws up list of priority substances for which risk assessment will be carried out. The principles for risk assessment are defined by Regulation EEC 1488/94 supported by a detailed Technical Guidance Document. The Commission may propose risk reduction measures.

Implementation considerations
  1. Member States must evaluate the risk of dangerous substances based on the information provided by manufacturers and importers.
  2. They must introduce appropriate legal and administrative sanctions to deal with non-compliance by industries and importers
Animal Experiments

Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes aims to establish minimum standards for the use of animals for experimental or scientific purposes relating to fundamental and applied research, drugs, foodstuffs and other substances or products, and to the protection of the environment. Endangered species may only be used for research aimed at the preservation of the species or essential biomedical purposes where the species is the only one suitable.

It lays down general and specific requirements for housing, monitoring, avoidance of pain or stress, the elimination of discovered defects or suffering, and the humane killing of animals at the end of the experiment.

An experiment can only be performed if no other scientifically satisfactory method of obtaining the result sought, not entailing the use of animal, is available.

Breeding and user establishments must be approved, registered and maintain detailed records. Certain animals, including mice, rats, dogs, cats and non-human primates, must be bred animals unless prior exemption is obtained to use wild animals. In order to avoid duplication of testing, the Member States are encouraged to recognise the validity of data generated by experiments carried out in other Member States.

All experiments have to be notified in advance to the national authority. Where animal will, or may, be subject to severe and prolonged pain, the experiment has to be specifically authorised. On the basis of requests for authorisation and notifications the Member States are required to collect statistical information on the use of animals in experiments.

The research into the development and validation of alternative techniques involving fewer animals or which entail less painful procedures should be encouraged.

Implementation considerations
  1. The national competent authority must establish the requirements for providing authorisation to the institutes/companies and persons carrying out experiments on animals and on breeding companies.
  2. Specific bodies will have to be given responsibility for issuing authorisations and carrying out periodic controls both on the experiments themselves and on the establishments.
  3. The national competent authority should establish a network of information with authorities in other countries in order to avoid duplication of the experiments.
  4. The national competent authority must establish a data collection system to meet the requirements for statistical reporting. A summary of the information collected will need to be provided to the European Commission periodically.
Good Laboratory Practice and Inspection and Verification of Good Laboratory Practice

The purpose of these two directives is to avoid the duplication of mandatory chemicals testing in the OECD countries by providing harmonised test methodologies which will support the mutual acceptance of test data by the OECD member countries.

Directive 87/18/EC 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 requires that laboratories carrying out tests on chemical products under Directive 67/548/EEC comply with the principles of good laboratory practice (GLP) specified in Annex 2 to the Decision of 12 May 1981 of the Council of the OECD on the mutual acceptance of data for the evaluation of chemical products.

Directive 88/320/EEC on the inspection and verification of Good Laboratory Practice (GLP) establishes standards and procedures for the inspection and verification of Good Laboratory Practice (GLP)

Laboratories must certify that the tests have been carried out in compliance when submitting the results. The Member States must verify compliance with these principles, in particular by carrying out inspections and study audits in accordance with OECD recommendations.

The Member States must appoint authorities responsible for the inspection of laboratories and the auditing of studies to assess their compliance with GLP.

Implementation considerations
  1. The countries have to ensure that laboratories carrying out tests in accordance with Directive 67/548/EEC on the classification, packaging and labelling of chemical substances comply with the principles of good laboratory practice.
  2. A system of verification of compliance with the principles has to be set up. This system of inspections should include in particular inspections and study audits in accordance with OECD recommendations.


G.2 Genetically Modified Organisms

Contained Use

The purpose of Directive 90/219/EEC on the contained use of genetically modified micro-organisms (GMMs) is to provide common rules throughout the EU for the use of GMMs both in research laboratories and industrial facilities and to provide appropriate measures to protect human health and the environment from any risks arising from activities using GMMs.

The Directive provides for an appropriate system of risk management. The use of GMMs must be notified to the competent authorities. The micro-organisms and the activities in which they are used are each classified in two categories, according to their potential risk, and containment and control measures, including the procedures for record keeping and notification of the competent authorities, are laid down and must be applied accordingly.

Effective risk management means that a careful risk assessment of contained uses must be made, the appropriate level of containment must be exercised and suitable preventive measures must be taken.

The Directive also lays down requirements, where necessary, for emergency planning and response in the event of an accident. Information on safety measures in the case of an accident must be supplied to persons liable to be affected. If an accident occurs, the user must give the information to the national competent authority. Each Member State where an accident happens must ensure that the necessary emergency measures are taken; immediately alert other Member States which might be affected; inform the European Commission; and analyse the accident and recommend actions to avoid similar accidents in the future.

Implementation considerations
  1. Countries must designate competent authorities to receive the notifications.
  2. These competent authorities have to organise inspections and other control measures.
  3. They must examine the conformity of the notifications received with the requirements of the directive.
  4. As this is a rapidly developing field, considerable attention should be given to training and to maintaining the scientific quality of the competent authorities.
Deliberate Release of GMOs

Council Directive 90/220/EEC covers the deliberate release of genetically modified organisms (GMOs) into the environment for research and development purposes (Part B releases) and the placing on the market of products (Part C releases) which contain or consist of GMOs, with some exceptions defined in Annex I B.

The Directive follows a preventive approach of prior assessment and approval. Its main elements can be summarised as follows :

The Directive has clear provisions on the protection of confidential information. However, some information may not be kept confidential and is therefore the minimum information which must be accessible to the public. This includes :

Implementation considerations
  1. Countries have to designate competent authorities to receive notifications and organise inspections and other control measures. Close collaboration with industry is necessary to ensure the availability of information. Scientific and technical expertise must be available to the CA.
  2. Effective penalties, such as extensive product liability would be advisable to minimise risk of insufficient testing and safety measures for the release of GMOs.
  3. Specific strategies for the immediate withdrawal from the market of potentially dangerous GMOs and the control of their release should be foreseen.
  4. International collaboration would be useful in order to exchange data and experience.


G.3 Product Controls

Asbestos

Directive 87/2I7/EEC on the prevention and reduction of environmental pollution by asbestos is the first 'substance oriented' directive which integrates controls on emissions to air, water and land. It is intended to supplement restrictions on asbestos laid down by Directive 76/769/EEC on marketing and use, and by other directives dealing with worker protection, discharges to air, and waste.

A general duty is placed on the Member States to ensure that asbestos emissions into the air, into water, and solid asbestos wastes are, as far as reasonably practicable, prevented by means of reductions at the source. A limit value for air emissions is set.

Liquid effluents from asbestos cement and paper and board manufacture must be recycled. If recycling from the manufacture of asbestos cement is not 'economically feasible', the asbestos content of the wastes must not exceed 30 g/m3.

Work with asbestos products and the demolition of buildings may not cause significant environmental pollution by asbestos fibres or dust. In the course of transport and landfill, no asbestos fibres or dust are to be released and no liquids containing asbestos fibres are to be spilled. Waste is to be treated, packaged or covered so that no release from landfill will occur.

Monitoring methods for discharges to air and water are laid down.

Implementation considerations
  1. Since the adoption of this directive most Member States have forbidden the abstraction and use of asbestos. Many of the requirements are now outdated and far less restrictive than existing national measures. As the directive imposes minimum requirements, stricter measures might be considered on the basis of accepted scientific evidence, when implementing this Directive.
  2. The issue of demolition or removal of asbestos containing structures will require major capital investment. A strategy for the assessment of the more urgent intervention must be developed. Risk assessment procedures specific to this issue will have to be developed together with safe remediation procedure.
  3. The waste management plans must consider also the need for the creation of safe disposal sites for asbestos containing waste.
Detergents

Council Directive 73/404/EEC prohibits the placing on the market and use of detergents where the average level of biodegradability of the surfactants contained therein is less than 90 percent for four categories: anionic, cationic, non-ionic and ampholytic. These surfactants must not be harmful to human or animal health under normal conditions of use.

The test methods for determining compliance with the directive are provided in Council Directive 73/405/EEC on the testing the biodegradability of non-ionic surfactants, which lays down three methods of testing the biodegradability of these surfactants. The Member States must notify each other and the Commission of the laboratories authorised to carry out these tests.

Implementation considerations
  1. The countries would have to establish a system for assessing the toxicity and biodegradability of the detergents placed on the national market.
  2. A network of authorised testing laboratory must be created and their activity controlled to ensure reliability of data. The authorities have to keep a registry of these laboratories and notify the European Commission their authorisation.
  3. The competent authority must notify to the other competent authorities and the European Commission on all restrictions on national marketing of detergents not in compliance with the directive.
Restrictions on the marketing and use of certain dangerous substances and preparations

Council Directive 76/769/EEC created a framework and a simplified legislative procedure through which the EU may ban or restrict dangerous chemicals or preparations by adding the substances and controls to an annex to the directive.

Member States must take all necessary measures to ensure that these dangerous substances and preparations are only placed on the market or used subject to the conditions specified. These restrictions do not apply to marketing or use for the purposes of research and development.

The directive does not apply to transport, exports to non-EC member countries or substances in transit and subject to customs inspection.

Implementation considerations
  1. The controls on substances and products under the directive must be transposed into national law.
  2. A timetable would have to be established for the withdrawal from the market of the restricted products.
Export and Import of Dangerous Chemicals

Council Regulation (EEC) No 2455/92 concerning the export and import of certain dangerous chemicals establishes a common system of notification and information for exports to third countries of chemicals which are banned or severely restricted in the Community on account of their effects on human health and the environment. The Regulation also implements the UNEP/FAO Prior Informed Consent (PIC) procedure and makes it mandatory for EU Member States.

Implementation considerations
  1. Countries shall designate one or more authorities responsible for the operation of the Regulation and contact with exporters
  2. The designated authority(ies) shall ensure that exporters comply with the export notification and PIC procedures
  3. Countries shall take appropriate legal or administrative action to enforce the Regulation.
  4. Exporters of dangerous chemicals shall package and label their products in the same way as if they were to be marked in the EU
  5. Countries shall co-operate closely with the Commission in evaluating the risks posed by the chemicals included in the PIC procedure, in order to define EU decisions regarding the import of those chemicals into the EU
  6. Countries shall inform the Commission of notifications received regarding imports into the EU of chemicals for which the manufacture, use, handling, consumption, transport and/or sale are prohibited or restricted in the exporting country.
Ozone Depleting Substances

Regulation EC/3093/94 on substances that deplete the ozone layer implements the Montreal Protocol to the Vienna Convention for the protection of the ozone layer. It sets strict standards for CFCs, HCFCs, and methyl bromide and lays down rules for the importation from third countries of the controlled substances, and for the recovery, destruction and recycling. It accelerates the phasing out of use of ozone-depleting substances beyond what had been originally agreed at international level. Standards, stricter than those set in the Montreal Protocol are set for CFCs, HCFCs, and methyl bromide. Controls are placed on production, imports, exports, supply, use and recovery of controlled substances listed in Annex I. The use of HCFCs is prohibited except for certain named uses. The regulation also introduces an import license system delivered by the Commission.

Implementation considerations
  1. Countries shall design the competent authority responsible for the implementation of the regulation.
  2. Each producer, importer or exporter is to report information on produced, imported and exported quantities annually to the Commission and to the competent authority the country.
  3. A programme could be drawn up by the competent authority for the information of the parties concerned by the regulation
  4. As the regulation contains different or stricter obligations than the Montreal Protocol, the implementation of the regulation will impose new obligations to new accessing countries, such as stricter standards and controls, different phasing out and information reports to send to the Commission.


G.4 Transport of Dangerous Goods by Road

Transport of dangerous goods by road is governed by the European Agreement concerning the international carriage of dangerous goods by road (ADR). Part II of the Agreement distinguishes nine classes of substances and the special provisions for the various classes.

Council Directive 94/55/ECon the transport of dangerous goods by road, made the requirements of the Convention applicable not only to international transports within the EU, but to any transport of dangerous goods by road within the EU. Member States had to transpose the requirements of this Directive into national law by 1 January 1997.

Implementation considerations
  1. Countries which have already ratified ADR convention and implemented its requirements the transposition of the EU directive may need to make adjustments in the administrative and control structure already in place.
  2. Additional controls would have to be put in place to cover transport of dangerous goods within the national territory.
  3. National authorities would have to decide if pre-existing national safety rules may be accepted in the framework of the directive.