COUNCIL DIRECTIVE of 23 April 1990 on the contained use of genetically modified micro-organisms (90/219/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 130s thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas, under the Treaty, action by the Community relating to the environment shall be based on the principle that preventive action shall be taken and shall have as its objective to preserve, protect and improve the environment and to protect human health;
Whereas the Council Resolution of 19 October 1987 (4) concerning the Fourth Environmental Action Programme of the European Communities declares that measures concerning the evaluation and best use of biotechnology with regard to the environment are a priority area on which Community action should concentrate;
Whereas the development of biotechnology is such as to contribute to the economic expansion of the Member States; whereas this implies that genetically modified micro-organisms will be used in operations of various types and scale;
OJ No C 246, 27. 9. 1989, p. 6.
OJ No C 96, 17. 4. 1990.
Whereas the contained use of genetically modified micro-organisms should be carried out in such way as to limit their possible negative consequences for human health and the environment, due attention being given to the prevention of accidents and the control of wastes;
Whereas micro-organisms, if released in the environment in one Member State in the course of their contained use, may reproduce and spread, crossing national frontiers and thereby affecting other Member States;
Whereas, in order to bring about the safe development of biotechnology throughout the Community, it is necessary to establish common measures for the evaluation and reduction of the potential risks arising in the course of all operations involving the contained use of genetically modified micro-organisms and to set appropriate conditions of use;
Whereas the precise nature and scale of risks associated with genetically modified micro-organisms are not yet fully known and the risk involved must be assessed case by case; whereas, to evaluate risk for human health and the environment, it is necessary to lay down requirements for risk assessment;
Whereas genetically modified micro-organisms should be classified in relation to the risks they present; whereas criteria should be provided for this purpose; whereas particular attention should be given to operations using the more hazardous genetically modified micro-organisms;
Whereas appropriate containment measures should be applied at the various stages of an operation to control emissions and to prevent accidents;
Whereas any person, before undertaking for the first time the contained use of a genetically modified micro-organism in a particular installation, should forward to the competent authority a notification so that the authority may satisfy itself that the proposed installation is appropriate to carry out the activity in a manner that does not present a hazard to human health and the environment;
Whereas it is also necessary to establish appropriate procedures for the case-by-case notification of specific operations involving the contained use of genetically modified micro-organisms, taking account of the degree of risk involved;
Whereas, in the case of operations involving high risk, the consent of the competent authority should be given;
Whereas it may be considered appropriate to consult the public on the contained use of genetically modified micro-organisms;
Whereas appropriate measures should be taken to inform any person liable to be affected by an accident on all matters relating to safety;
Whereas emergency plans should be established to deal effectively with accidents;
Whereas, if an accident occurs, the user should immediately inform the competent authority and communicate the information necessary for assessing the impact of that accident and for taking the appropriate action;
Whereas it is appropriate for the Commission, in consultation with the Member States, to establish a procedure for the exchange of information on accidents and for the Commission to set up a register of such accidents;
Whereas the contained use of genetically modified micro-organisms throughout the Community should be monitored and to this end Member States should supply certain information to the Commission;
Whereas a committee should be set up to assist the Commission on matters relating to the implementation of this Directive and to its adaptation to technical progress,
HAS ADOPTED THIS DIRECTIVE:
Article 1
This Directive lays down common measures for the contained use of genetically modified micro-organisms with a view to protecting human health and the environment.
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;
(b) 'genetically modified micro-organism' 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(i) genetic modification occurs at least through the use of the techniques listed in Annex I A, Part 1;
(ii) the techniques listed in Annex I A, Part 2, are not considered to result in genetic modification;
(c)
'contained use' shall mean any operation in which micro-organisms are genetically modified or in which such genetically modified micro-organisms are cultured, stored, used, transported, destroyed or disposed of and for which physical barriers, or a combination of physical barriers together with chemical and/or biological barriers, are used to limit their contact with the general population and the environment;
(d)
Type A operation shall mean any operation used for teaching, research, development, or non-industrial or non-commercial purposes and which is of a small scale (e.g. 10 litres culture volume or less);
(e)
Type B operation shall mean any operation other than a Type A operation;
(f)
'accident' shall mean any incident involving a significant and unintended release of genetically modified micro-organisms in the course of their contained use which could present an immediate or delayed hazard to human health or the environment;
(g)
'user' shall mean any natural or legal person responsible for the contained use of genetically modified micro-organisms;
(h)
'notification' shall mean the presentation of documents containing the requisite information to the competent authorities of a Member State.
Article 3
This Directive shall not apply where genetic modification
is obtained through the use of the techniques listed in
Annex I B.
Article 4
1. For the purposes of this Directive, genetically modified micro-organisms shall be classified as follows:
Group II: those satisfying the criteria of Annex II;
Group II:
those other than in Group I.
2. For Type A operations, some of the criteria in Annex II may not be applicable in determining the classification of a particular genetically modified micro-organism. In such a case, the classification shall be provisional and the competent authority shall ensure that relevant criteria are used with the aim of obtaining equivalence as far as possible.
3. Before this Directive is implemented, the Commission shall draw up guidelines for classification under the procedures of Article 21.
Article 5
Articles 7 to 12 shall not apply to the transport of genetically modified micro-organisms by road, rail, inland waterway, sea or air. This Directive shall not apply to the storage, transport, destruction or disposal of genetically modified micro-organisms which have been placed on the market under Community legislation, which includes a specific risk assessment similar to that provided in this Directive.
Article 6
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 genetically modified micro-organisms.
2. To this end, the user shall carry out a prior assessment of the contained uses as regards the risks to human health and the environment that they may incur.
3. In making such an assessment the user shall, in particular, take due account of the parameters set out in Annex III, as far as they are relevant, for any genetically modified micro-organisms he is proposing to use.
4. A record of this assessment shall be kept by the user and made available in summary form to the competent authority as part of the notification under Articles 8, 9 and 10 or upon request.
Article 7
1. For genetically modified micro-organisms in Group I, principles of good microbiological practice, and the following principles of good occupational safety and hygiene, shall apply:
iii(i) to keep workplace and environmental exposure to any physical, chemical or biological agent to the lowest practicable level;
ii(ii) to exercise engineering control measures at source and to supplement these with appropriate personal protective clothing and equipment when necessary;
i(iii) to test adequately and maintain control measures and equipment;
i(iv) to test, when necessary, for the presence of viable process organisms outside the primary physical containment;
ii(v) to provide training of personnel;
i(vi) to establish biological safety committees or subcommittees as required;
(vii) to formulate and implement local codes of practice for the safety of personnel.
2. In addition to these principles, the containment measures set out in Annex IV shall be applied, as appropriate, to contained uses of genetically modified micro-organisms in Group II so as to ensure a high level of safety.
3. The containment measures applied shall be periodically reviewed by the user to take into account new scientific or technical knowledge relative to risk management and treatment and disposal of wastes.
Article 8
When a particular installation is to be used for the first time for operations involving the contained use of genetically modified micro-organisms, 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 A.
A separate notification shall be made for first use of genetically modified micro-organisms in Group I and Group II respectively.
Article 9
1. Users of genetically modified micro-organisms classified in Group I in Type A operations shall be required to keep records of the work carried out which shall be made available to the competent authority on request.
2. Users of genetically modified micro-organisms classified in Group I in Type B operations shall, before commencing the contained use, be required to submit to the competent authorities a notification containing the information listed in Annex V B.
Article 10
1. Users of genetically modified micro-organisms classified in Group II in Type A operations shall, before commencing the contained use, be required to submit to the competent authorities a notification containing the information listed in Annex V C.
2. Users of genetically modified micro-organisms classified in Group II in Type B operations shall, before commencing the contained use, be required to submit to the competent authorities a notification containing:
- information on the genetically modified micro-organism(s),
- information on personnel and training;
- information on the installation,
- information on waste management,
- information on accident prevention and emergency response plans,
- the assessment of the risks to human health and the environment referred to in Article 6,
the details of which are listed in Annex V D.
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 Article 8, Article 9 (2) and
Article 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 classification and, where appropriate, the adequacy of the waste management, safety, 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. In this case the proposed contained use cannot proceed 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. In the case of first-time use in an installation as referred to in Article 8:
- where such use involves genetically modified micro-organisms in Group I, the contained use may, in the absence of any indication to the contrary from the competent authority, proceed 90 days after submission of the notification, or earlier with the agreement of the competent authority;
- where such use involves genetically modified micro-organisms in Group II, the contained use may not proceed without the consent of the competent authority. The competent authority shall communicate its decision in writing at the latest 90 days after submission of the notification.
5. (a) Operations notified under Article 9 (2) and Article 10 (1), may, in the absence of any indication to the contrary from the competent authority, proceed 60 days after submission of the notification, or earlier with the agreement of the competent authority.
(b) Operations notified under Article 10 (2) may not proceed without the consent of the competent authority. The competent authority shall communicate its decision in writing at the latest 90 days after submission of the notification.
6. For the purpose of calculating the periods referred to in paragraphs 4 and 5, any periods 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
1. 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 the contained use, or if the category of genetically modified micro-organisms used is changed, the competent authority shall be informed as soon as possible and the notification under Articles 8, 9 and 10 modified.
2. If information becomes available subsequently 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, suspend or terminate the contained use.
Article 13
Where a Member State considers it appropriate, it may provide that groups or the public shall be consulted on any aspect of the proposed contained use.
Article 14
The competent authorities shall ensure that, where necessary, before an operation commences:
(a) an emergency plan is drawn up for the protection of human health and the environment outside the installation in the event of an accident and the emergency services are aware of the hazards and informed thereof in writing;
(b) information on safety measures and on the correct behaviour to adopt in the case of an accident is supplied in an appropriate manner, and without their having to request it, to persons liable to be affected by the accident. The information shall be repeated and 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 immediately to inform the competent authority specified in Article 11 and provide the following information:
- the circumstances of the accident,
- the identity and quantities of the genetically modified micro-organisms released,
- any information necessary to assess the effects of the accident on the health of the general population and the environment,
- the emergency measures taken.
2. Where information is given under paragraph 1, the Member States shall be required to:
- ensure that any emergency, medium and long-term measures necessary are taken, and immediately alert any Member State 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 liable to be affected in the event of an accident in the drawing up and 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 genetically modified micro-organisms released, the emergency response measures employed 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 under 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 which have occurred, including an analysis of the causes of the accidents, experience gained and measures taken to avoid similar accidents in the future.
Article 17
Member States shall ensure that the competent authority organizes inspections and other control measures to ensure user compliance with this Directive.
Article 18
1. Member States shall send to the Commission, at the end of each year, a summary report on the contained uses notified under Article 10 (2) including the description, proposed uses and risks of the genetically modified micro-organisms.
2. Every three years, Member States shall send the Commission a summary report on their experience with this Directive, the first time being on 1 September 1992.
3. Every three years, the Commission shall publish a summary based on the reports referred to in paragraph 2, the first time being in 1993.
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. The Commission and the competent authorities shall not divulge to third parties any confidential information notified or otherwise provided under this Directive and shall protect intellectual property rights relating to the data received.
2. The notifier may indicate the information in the notifications submitted under this Directive, the disclosure of which might harm his competitive position, that should be treated as confidential. Verifiable justification must be given in such cases.
3. The competent authority shall decide, after consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decision.
4. In no case may the following information, when submitted according to Articles 8, 9 or 10, be kept confidential:
- description of the genetically modified micro-organisms, name and address of the notifier, purpose of the contained use, and location of use;
- methods and plans for monitoring of the genetically modified micro-organisms and for emergency response;
- the evaluation of foreseeable effects, in particular any pathogenic and/or ecologically disruptive effects.
5. If, for whatever reasons, the notifier withdraws the notification, the competent authority must respect the confidentiality of the information supplied.
Article 20
Amendments necessary to adapt Annexes II to V to technical progress shall be decided in accordance with the procedure defined in Article 21.
Article 21
1. The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission.
2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case
of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
(b) If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority.
Article 22
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 23 October 1991. They shall forthwith inform the Commission thereof.
Article 23
This Directive is addressed to the Member States.
Done at Luxembourg, 23 April 1990.