COUNCIL DIRECTIVE 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 103s(1) thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social Committee (2),
Acting in accordance with the procedure laid down in Article 189c of the Treaty (3),
(1) Whereas, within the meaning of the Treaty, action by the Community relating to the environment should be based on the principle that preventive action is to be taken and shall have as its objective to preserve, protect and improve the environment and to protect human health;
(2) Whereas contained uses of genetically modified micro-organisms (GMMs) should be classified in relation to the risks they present for human health and the environment; whereas such classification should be in line with international practice and based on an assessment of the risk;
(3) Whereas in order to ensure a high level of protection the containment and other protective measures applied to a contained use must correspond to the classification of the contained use; whereas in case of uncertainty the appropriate containment and other protective measures for the higher classification should be applied until less stringent measures are justified by appropriate data;
(4) Whereas appropriate measures should be adopted and used for the control of the disposal of material from contained uses of GMMs;
(5) Whereas GMMs which are disposed of without appropriate provisions for specific containment measures to limit their contact with the general population and the environment do not fall within the scope of the present Directive; other Community legislation such as Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (4) may apply;
(6) Whereas exemptions pursuant to this Directive do not entail exemptions pursuant to any other Community legislation that may apply, such as Directive 90/220/EEC;
(7) Whereas for all activities involving GMMs the principles of good microbiological practice and good occupational safety and hygiene should apply in accordance with relevant Community legislation;
(8) Whereas the containment and other protective measures applied to contained uses should be reviewed periodically;
(9) Whereas people employed in contained uses should be consulted in accordance with the requirements of relevant Community legislation, in particular Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (5);
(10) Whereas weaknesses have been identified in Directive 90/219/EEC (6); whereas the administrative procedures and notification requirements should be linked to the risk of the contained uses;
(11) Whereas Directive 90/219/EEC did not permit sufficient adaptation to technical progress; whereas the technical parts of that Directive need to be adapted to technical progress;
(12) Whereas the implementation of Directive 90/219/EEC could benefit from the addition of a list of GMMs that are safe for human health and the environment; whereas these GMMs should meet certain criteria in order to establish their safety;
(13) Whereas, to take account of the pace at which biotechnology is advancing, the nature of the criteria to be developed and the limited scope of this list, it is appropriate for the Council to define and revise these criteria;
(14) Whereas there is now considerable experience and knowledge of the risks associated with the contained use of GMMs;
(15) Whereas Directive 90/219/EEC should therefore be amended accordingly,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Directive 90/219/EEC is hereby amended as follows:
1. Articles 2 to 16 shall be replaced by the following:
'Article 2
For the purposes of this Directive:
(a) "micro-organism" shall mean any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, animal and plant cells in culture;
(b) "genetically modified micro-organism" (GMM) shall mean a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.
Within the terms of this definition:
(i) genetic modification occurs at least through the use of the techniques listed in Annex I, Part A;
(ii) the techniques listed in Annex I, Part B, are not considered to result in genetic modification;
(c) "contained use" shall mean any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with the general population and the environment;
(d) "accident" shall mean any incident involving a significant and unintended release of GMMs in the course of their contained use which could present an immediate or delayed hazard to human health or the environment;
(e) "user" shall mean any natural or legal person responsible for the contained use of GMMs;
(f) "notification" shall mean the presentation of the requisite information to the competent authorities of a Member State.
Article 3
Without prejudice to Article 5(1) this Directive shall not apply:
- where genetic modification is obtained through the use of the techniques/methods listed in Annex II, Part A, or
- for contained uses involving only types of GMMs meeting the criteria listed in Annex II, Part B which establish their safety to human health and the environment. These types of GMMs shall be listed in Annex II, Part C.
Article 4
Article 5(3) and 5(6) and Articles 6 to 12 shall not apply to the transport of GMMs by road, rail, inland waterway, sea or air.
This Directive shall not apply to the storage, culture, transport, destruction, disposal or use of GMMs which have been placed on the market in accordance with Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (*) or pursuant to other Community legislation, which provides for a specific environmental risk assessment similar to that laid down in the said Directive, provided that the contained use is in accordance with the conditions, if any, of the consent for placing on the market.
(*) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Commission Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).
Article 5
1. Member States shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the contained use of GMMs.
2. To this end the user shall carry out an assessment of the contained uses as regards the risks to human health and the environment that these contained uses may incur, using as a minimum the elements of assessment and the procedure set out in Annex III, sections A and B.
3. The assessment referred to in paragraph 2 shall result in the final classification of the contained uses in four classes applying the procedure set out in Annex III, which will result in the assignment of containment levels in accordance with Article 6:
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4. Where there is doubt as to which class is appropriate for the proposed contained use, the more stringent protective measures shall be applied unless sufficient evidence, in agreement with the competent authority, justifies the application of less stringent measures.
5. The assessment referred to in paragraph (2) shall especially take into account the question of disposal of waste and effluents. Where appropriate, the necessary safety measures shall be implemented in order to protect human health and the environment.
6. A record of the assessment referred to in paragraph (2) shall be kept by the user and made available in an appropriate form to the competent authority as part of the notification pursuant to Articles 7, 9 and 10 or on request.
Article 6
1. The user shall apply, except to the extent that paragraph 2 of Annex IV allows other measures to be applied, the general principles and the appropriate containment and other protective measures set out in Annex IV corresponding to the class of the contained use, so as to keep workplace and environmental exposure to any GMMs to the lowest reasonably practicable level, and so that a high level of safety is ensured.
2. The assessment referred to in Article 5(2) and the containment and other protective measures applied shall be reviewed periodically, and forthwith if:
(a) the containment measures applied are no longer adequate or the class assigned to the contained uses is no longer correct, or
(b) there is reason to suspect that the assessment is no longer appropriate judged in the light of new scientific or technical knowledge.
Article 7
When premises are to be used for the first time for contained uses, the user shall be required to submit to the competent authorities, before commencing such use, a notification containing at least the information listed in Annex V, Part A.
Article 8
Following the notification referred to in Article 7, subsequent class 1 contained use may proceed without further notification. Users of GMMs in class 1 contained uses shall be required to keep the record of each assessment referred to in Article 5(6), which shall be made available to the competent authority on request.
Article 9
1. For first and subsequent class 2 contained uses to be carried out in premises notified in accordance with Article 7, a notification containing the information listed in Annex V, Part B shall be submitted.
2. If the premises have been the subject of a previous notification to carry out class 2 or a higher class of contained uses and any associated consent requirements have been satisfied, the class 2 contained use may proceed immediately following the new notification.
The applicant can, however, himself request a decision on a formal authorisation from the competent authority. The decision must be made within a maximum of 45 days from the notification.
3. If the premises have not been the subject of a previous notification to carry out class 2 or a higher class of contained uses, the class 2 contained use may, in the absence of any indication to the contrary from the competent authority, proceed 45 days after submission of the notification referred to in paragraph 1, or earlier with the agreement of the competent authority.
Article 10
1. For first and subsequent class 3 or class 4 contained uses to be carried out in premises notified in accordance with Article 7, a notification containing the information listed in Annex V, Part C shall be submitted.
2. A class 3 or higher class of contained use may not proceed without the prior consent of the competent authority which shall communicate its decision in writing:
(a) at the latest 45 days after submission of the new notification, in the case of premises which have been the subject of a previous notification to carry out class 3 or a higher class of contained uses and where any associated consent requirements have been satisfied for the same or a higher class than the contained use with which it is intended to proceed;
(b) at the latest 90 days after submission of the notification, in other cases.
Article 11
1. Member States shall designate the authority or authorities competent to implement the measures which they adopt in application of this Directive and to receive and acknowledge the notifications referred to in Articles 7, 9 and 10.
2. The competent authorities shall examine the conformity of the notifications with the requirements of this Directive, the accuracy and completeness of the information given, the correctness of the assessment referred to in Article 5(2) and the class of contained uses and, where appropriate, the suitability of the containment and other protective measures, the waste management, and emergency response measures.
3. If necessary, the competent authority may:
(a) ask the user to provide further information or to modify the conditions of the proposed contained use or to amend the class assigned to the contained use(s). In this case the competent authority may require that the contained use, if proposed, does not begin, or, if in progress, is suspended or terminated, until the competent authority has given its approval on the basis of the further information obtained or of the modified conditions of the contained use;
(b) limit the time for which the contained use should be permitted or subject it to certain specific conditions.
4. For the purpose of calculating the periods referred to in Articles 9 and 10, any period of time during which the competent authority:
- is awaiting any further information which it may have requested from the notifier in accordance with paragraph 3(a), or
- is carrying out a public inquiry or consultation in accordance with Article 13
shall not be taken into account.
Article 12
If the user becomes aware of relevant new information or modifies the contained use in a way which could have significant consequences for the risks posed by it, the competent authority shall be informed as soon as possible and the notification pursuant to Articles 7, 9 and 10 shall be modified.
If information subsequently becomes available to the competent authority which could have significant consequences for the risks posed by the contained use, the competent authority may require the user to modify the conditions of, or suspend or terminate, the contained use.
Article 13
Where a Member State considers it appropriate, it may provide that the public shall be consulted on aspects of the proposed contained use, without prejudice to Article 19.
Article 14
The competent authorities shall ensure that before a contained use commences:
(a) an emergency plan is drawn up for contained uses where failure of the containment measures could lead to serious danger, whether immediate or delayed, to humans outside the premises and/or to the environment, except where such an emergency plan has been drawn up under other Community legislation;
(b) information on such emergency plans, including the relevant safety measures to be applied, is supplied in an appropriate manner, and without their having to request it, to bodies and authorities liable to be affected by the accident. The information shall be updated at appropriate intervals. It shall also be made publicly available.
The Member States concerned shall at the same time make available to other Member States concerned, as a basis for all necessary consultation within the framework of their bilateral relations, the same information as that which is disseminated to their nationals.
Article 15
1. Member States shall take the necessary measures to ensure that, in the event of an accident, the user shall be required to inform immediately the competent authority specified in Article 11 and provide the following information:
- the circumstances of the accident,
- the identity and quantities of the GMMs concerned,
- any information necessary to assess the effects of the accident on the health of the general population and the environment,
- the measures taken.
2. Where information is given pursuant to paragraph 1, the Member States shall be required to:
- ensure that any measures necessary are taken, and immediately alert any Member States which could be affected by the accident,
- collect, where possible, the information necessary for a full analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit the effects thereof.
Article 16
1. Member States shall be required to:
(a) consult with other Member States, likely to be affected in the event of an accident, on the proposed implementation of emergency plans;
(b) inform the Commission as soon as possible of any accident within the scope of this Directive, giving details of the circumstances of the accident, the identity and quantities of the GMMs concerned, the response measures taken and their effectiveness and an analysis of the accident, including recommendations to limit its effects and avoid similar accidents in the future.
2. The Commission, in consultation with the Member States, shall establish a procedure for the exchange of information pursuant to paragraph 1. It shall also set up and keep at the disposal of the Member States a register of accidents within the scope of this Directive, including an analysis of the causes of the accidents, experience gained and measures taken to avoid similar accidents in the future.`
2. Articles 18, 19 and 20 shall be replaced by the following:
'Article 18
1. Member States shall send to the Commission, at the end of each year, a summary report on class 3 and class 4 contained uses notified during that year pursuant to Article 10 including the description, purpose and risks of the contained use(s).
2. Every three years, Member States shall send the Commission a summary report on their experience with this Directive, the first time being on 5 June 2003.
3. Every three years, the Commission shall publish a summary based on the reports referred to in paragraph 2, the first time being on 5 June 2004.
4. The Commission may publish general statistical information on the implementation of this Directive and related matters, as long as it contains no information likely to cause harm to the competitive position of a user.
Article 19
1. Where its disclosure affects one or more of the items mentioned in Article 3(2) of Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment (*), the notifier may indicate the information in the notifications submitted pursuant to this Directive that should be treated as confidential. Verifiable justification must be given in such cases.
2. The competent authority shall decide, after consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decision.
3. In no case may the following information, when submitted according to Articles 7, 9 or 10, be kept confidential:
- the general characteristics of the GMMs, name and address of the notifier, and location of use,
- class of contained use and measures of containment,
- the evaluation of foreseeable effects, in particular any harmful effects on human health and the environment.
4. The Commission and the competent authorities shall not divulge to third parties any information decided to be confidential according to paragraph 2 and notified or otherwise provided pursuant to this Directive, and shall protect intellectual property rights relating to the data received.
5. If, for whatever reasons, the notifier withdraws the notification, the competent authority must respect the confidentiality of the information supplied.
(*) OJ L 158, 23.6.1990, p. 56.
Article 20
Amendments necessary to adapt Annex II, Part A, and Annexes III to V to technical progress and to adapt Annex II, Part C, shall be decided in accordance with the procedure laid down in Article 21.`
3. The following Article shall be inserted:
'Article 20a
Before 5 December 2000 Annex II, Part B, listing the criteria for inclusion of types of GMMs into Annex II, Part C, shall be adopted by the Council acting by qualified majority on a proposal from the Commission. Amendments to Annex II, Part B, shall be adopted by the Council acting by qualified majority on a proposal from the Commission.`
4. The Annexes are replaced by the Annexes shown in the Annex hereto.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 18 months after the date of its entry into force. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive enters into force on the day of its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
Done at Luxembourg, 26 October 1998.