Proposal for a Council Directive amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (97/C 356/09) COM(95) 640 final - 95/0340(SYN)

(Submitted by the Commission on 6 December 1995)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 130s thereof,

Having regard to the proposal from the Commission,

Acting in accordance with the procedure laid down in Article 189c of the Treaty, in cooperation with the European Parliament,

Having regard to the opinion of the Economic and Social Committee,

Whereas, pursuant to the Treaty, action by the Community relating to the environment should be based on the principle that preventive action is to be taken and to seek to preserve, protect and improve the environment and to protect human health;

Whereas activities involving genetically modified micro-organisms should be classified in relation to the risks they present, whereas such classification should be in line with international practice; whereas such classification should be based on an assessment of the risk;

Whereas appropriate containment and control measures should be applied to ensure a high level of safety; whereas the containment and control measures should be linked to the risk of the activities;

Whereas the following main weaknesses have been identified in Council Directive 90/219/EEC (1), as amended by Commission Directive 94/51/EC (2): the classification system is not in line with international practice, the administrative procedures and notification requirements are not linked to the real risk of activities; the administrative procedures for certain classes of activities involving genetically modified micro-organisms are unnecessarily restrictive; there is insufficient guidance as to the containment and control measures which should be applied in order to protect human health and the environment; Directive 90/219/EEC does not permit rapid adaptation to technical progress; technical parts of the Directive need to be adapted to technical progress;

Whereas there is now considerable experience and knowledge of the risks associated with the contained use of genetically modified micro-organisms;

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. Article 2 is amended as follows:

(a) the following words are added at the end of paragraph (a) 'including viruses, viroids and animal and plant cells in culture, but excluding naked nucleic acid molecules`;

(b) in paragraph (b), the references to 'Annex I A` in subparagraphs (i) and (ii) are replaced by 'Annex I`;

(c) paragraph (c) is replaced by the following:

'(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 or destroyed, 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; or any activity in which genetically modified micro-organisms are disposed of, for which physical or chemical or biological barriers, or any combination of these types, are used to limit their contact with the general population and the environment`;

(d) paragraphs (d) and (e) are deleted;

(e) the following paragraph (i) is added:

'(i) "significant changes" in the context of Article 6a (2) shall mean changes which could change the result of the risk assessment`.

2. Article 3 is replaced by the following:

'Article 3

This Directive shall not apply where genetic modification is obtained through the use of the techniques or methods listed in Annex II, or for contained-use activities involving other types of genetically modified micro-organisms known to be safe for human health and the environment. Such types of genetically modified micro-organisms and their characteristics are listed in Annex II, part B`.

3. Article 4 is deleted.

4. Article 5 is amended as follows:

(a) In the first sentence the words 'Articles 7 to 12` are replaced by the words 'Articles 6a and Articles 8 to 11`;

(b) The second sentence is replaced by the following:

'This Directive shall not apply to the storage, culture, transport, destruction, disposal or use of genetically modified micro-organisms which have been placed on the market in accordance with Directive 90/220/EEC or under any other Community legislation, which provides for a specific environmental-risk assessment similar to that laid down in Directive 90/220/EEC, provided always that the contained use is in accordance with the conditions, if any, of the marketing approval or consent`.

5. Article 6 is amended as follows:

(a) paragraphs 2 and 3 are replaced by the following texts:

'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 they may incur, taking due account of the principles set out in Annex III.

3. The assessment should result in the categorization of the contained-use activities in the following four classes of risk:

Class 1:

Activities of no, or negligible, risk, that is to say, activities for which level 1 containment is appropriate to protect human health as well as the environment that could be exposed to the genetically modified micro-organisms.

Class 2:

Activities of low risk, that are activities for which level 2 containment is appropriate to protect human health as well as the environment that could be exposed to the genetically modified micro-organisms in the absence of containment.

Class 3:

Activities of moderate risk, that are activities for which level 3 containment is appropriate to protect human health as well as the environment that could be exposed to the genetically modified micro-organisms in the absence of containment.

Class 4:

Activities of high risk, that are activities for which level 4 containment is appropriate to protect human health as well as the environment that could be exposed to the genetically modified micro-organisms in the absence of containment`.

(b) In paragraph 4, the words 'Articles 8, 9 and 10` are replaced by the words 'Articles 8 and 10`.

6. The following Article 6a is inserted:

'Article 6a

1. The user shall apply the containment and control measures from the appropriate table(s) in Annex IV corresponding to the risk-class of the activity, so as to keep workplace and environmental exposure to any genetically modified micro-organisms at the lowest reasonably practicable level, and so that a high level of safety is ensured.

2. The risk assessment and the containment and control measures applied shall be periodically reviewed forthwith if:

(a) there has been a significant change in the activity(ies) to which the assessment relates, or

(b) there is reason to suspect that the assessment is no longer adequate as judged in the light of new scientific or technical knowledge`.

7. Article 7 is deleted.

8. Articles 8, 9 and 10 are replaced by the following:

'Article 8

When premises are to be used for the first time for activities involving the contained use of genetically modified micro-organisms, the user shall be required to submit to the competent authorities a notification containing at least the information listed in Annex V, part A.

Article 9

For class 1 activities to be carried out, no further notification shall be needed. Such activities shall be able to commence immediately following the notification referred to in Article 8. Users of genetically modified micro-organisms in class 1 activities shall be required to keep the record of each assessment referred to in Article 6 (4), which shall be made available to the competent authority on request.

Article 10

1. For the first and subsequent class 2 activities to be carried out in premises notified in accordance with Article 8, a notification containing the information listed in Annex V, part B shall be submitted.

2. If no previous notification has been submitted for class 2 or a higher class of activities, the contained use may, in absence of any indication to the contrary from the competent authority, proceed 45 days after submission of the notification referred to above, or earlier with the agreement of the competent authority.

3. If a previous notification has been submitted for class 2 activities or higher and the associated consent requirements have been satisfied, the contained use may proceed immediately following the new notification`.

9. The following Article 10a is inserted:

'Article 10a

1. For first and subsequent class 3 or class 4 activities to be carried out in premises notified in accordance with Article 8, a notification containing the information listed in Annex V, part C shall be submitted.

2. If no previous notification has been submitted for class 3 or a higher class of activities, 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.

3. If a previous notification has been submitted for class 3 or a higher class of activities and the associated consent requirements have been satisfied, the contained use may in absence of any indication to the contrary from the competent authority proceed 45 days after submission of the new notification, or earlier with the agreement of the competent authority`.

10. Article 11 is amended as follows:

(a) the words 'Article 8, Article 9 (2) and Article 10` in paragraph 1 are replaced by the words 'Articles 8, 10 and 10a`;

(b) in paragraph 2, the word 'classification` is replaced by the words 'risk assessment and the class of risk`;

(c) in point (a) of paragraph 3, the second sentence is replaced by the following:

'in this case the competent authority may require that the contained use, if proposed, does not begin or, if in progress, is halted, 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`;

(d) paragraphs 4 and 5 are deleted;

(e) in paragraph 6, the words 'paragraphs 4 and 5` are replaced by the words 'Articles 10 and 10a`.

11. Paragraph 1 of Article 12 is replaced by the following:

'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 it, the competent authority shall be informed as soon as possible and the notification pursuant to Articles 8, 10 and 10a modified`.

12. Article 13 is replaced by the following:

'Article 13

Where a Member State considers it appropriate, it may provide that groups or the public shall be consulted on aspects of the proposed contained use, in accordance with Article 19`.

13. Article 14 is replaced by the following:

'Article 14

The competent authorities shall ensure that, where necessary, before an activity commences:

(a) an emergency plan is drawn up for class 3 and class 4 activities where failure of the containment measures could lead to serious danger, immediate or delayed, to humans outside the premises and/or to the environment;

(b) information on emergency plans 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`.

14. Paragraph 1 of Article 15 is amended as follows:

(a) in the second indent, the word 'released` is replaced by the word 'concerned`;

(b) in the fourth indent, the word 'emergency` is deleted.

15. In point (b) of paragraph 1 of Article 16, the phrase 'the identity and quantities of the genetically modified micro-organisms released, the emergency response measures employed and their effectiveness` is replaced by 'the identity and quantities of the genetically modified micro-organisms concerned, the response measures employed and their effectiveness`.

16. In Article 18, paragraph 1 is replaced by the following:

'1. Member States shall send to the Commission, at the end of each year, a summary report on the class 3 and class 4 contained uses notified pursuant to Article 10a, including the description, purpose and risks of the activity or activities`.

17. In Article 19, paragraph 4 is replaced by the following:

'4. In no case may the following information, when submitted according to Articles 8, 9 or 10, be kept confidential:

- the characteristics of the genetically modified micro-organisms, name and address of the notifier, and location of use,

- the level and measures of containment,

- the evaluation of foreseeable effects, in particular any harmful effects on human health and the environment`.

18. In Article 20, the words 'Annexes II to V` are replaced by the words 'Annexes I to V`.

19. The Annexes are amended as 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 by 1 January 1999. They shall forthwith inform the Commission thereof.

When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted 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 shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.

Article 4

This Directive is addressed to the Member States.

(1) OJ L 117, 8. 5. 1990, p. 1.

(2) OJ L 297, 18. 11. 1994, p. 29.

ANNEX

The Annexes to Directive 90/219/EEC are amended as follows:

1. Former Annex I A becomes Annex I and is amended as follows:

(a) In part 1, point (1) is replaced by the following:

'(1) recombinant-nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation.`

(b) Part 2 is amended as follows:

(i) in the introductory phrase, the term 'DNA` is replaced by the words 'nucleic acid`, and the following words are added: 'made by techniques or methods other than those excluded by Annex II`;

(ii) point 2 is replaced by the following:

'(2) natural processes such as: conjugation, transduction, transformation`.

2. Annex I B is deleted.

3. Annex II is replaced by the following:

'ANNEX II

A. Techniques or methods of genetic modification yielding micro-organisms to be excluded from the Directive on the condition that they do not involve the use of recombinant-nucleic acid molecules or genetically modified micro-organisms other than those produced by one or more of the techniques/methods listed below:

1. mutagenesis;

2. cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic material by known physiological processes, where the resulting micro-organism is unlikely to cause disease to humans, animals or plants;

3. cell fusion (including protoplast fusion) of cells of any eukaryotic species, including production of hybridomas and plant cell fusions, where the resulting micro-organism is unlikely to cause disease to humans, animals or plants;

4. self-cloning consisting in the removal of nucleic acid sequences from a cell of an organism which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent) with or without prior enzymic or mechanical steps, into cells of the same species or into cells of phytogenetically closely related species which can exchange genetic material by natural physiological processes, where the resulting micro-organism is unlikely to cause disease to humans, animals or plants.

Self-cloning may include the use of recombinant vectors with an extended history of safe use in the particular micro-organisms. The following are non-exhaustive examples of safe host/vector systems:

- E-coli K 12 strains/pBR 322,

- Eukaryotic cells/defective Simian virus 40 (SV 40).

B. Types of genetically modified micro-organisms which have been shown to be safe for human health and the environment and which are, therefore, excluded from the Directive`.

4. Annex III is replaced by the following:

'ANNEX III

PRINCIPLES TO BE FOLLOWED FOR THE ASSESSMENT REFERRED TO AT ARTICLE 6

Elements of assessment

1. The following should be considered as potentially harmful effects:

- disease to humans, animals or plants,

- adverse effects resulting from the inability to treat disease or offer effective prophylaxis,

- adverse effects resulting from establishment or dissemination in the environment.

- adverse effects resulting from transfer of genes to other organisms.

2. (a) The assessment referred to in Article 6 should be based on the following:

(i) the recipient micro-organism,

(ii) the inserted (donated) genetic material,

(iii) the vector,

(iv) the donor micro-organism (if the donor micro-organism is used during the operation),

(v) the resulting genetically modified micro-organisms,

(b) the severity of the potentially harmful effects,

(c) the likelihood of the potentially harmful effects being realized.

Procedure

3. In order to arrive at the categorization of a particular activity, as referred to in article 6, the user may take into consideration the risk class of the recipient, the vector and, if applicable, donor micro-organism as given in other Community legislation, international or national schemes (e.g. WHO, NIH, etc.).

These classification schemes concern natural micro-organisms and are usually based on the ability of micro-organisms to cause disease to humans or animals, and on the severity and transmissibility of the disease likely to be caused. The user may also take into consideration classification schemes referring to plant pathogens (which are usually established on a national basis). The above mentioned classification schemes give only a provisional indication of the risk class of the activity and the corresponding set of containment and control measures required.

4. The final classification and selection of control measures must be made in the light of:

(i) any harmful properties (see above) which the vector or inserted material might confer on the recipient, or any alteration of the recipient's existing properties;

(ii) the characteristics of the operation (e.g. its nature, scale);

(iii) the characteristics of the environment likely to be exposed to the genetically modified micro-organisms (e.g. whether in the environment likely to be exposed to the genetically modified micro-organisms there are known biota which can be adversely affected by the micro-organisms used in the contained-use activity).

5. The analysis carried out as described under paragraph 4 may lead to a categorization of the risk of the activity higher or lower than the provisional one. The check foreseen in paragraph 4 should be repeated, until the final classification is stable.`

5. Annex IV is replaced by the following:

'ANNEX IV

CONTAINMENT AND CONTROL MEASURES

Preface

These tables present the normal minimum requirements and measures necessary for each level of containment.

Containment is achieved through the use of good workpractices, containment equipment and special installation design.

The titles of the Tables are indicative.

Table Ia presents minimum requirements for laboratory activities.

Table Ib presents additions to and modifications of Table Ia for glasshouse/growthroom activities involving genetically modified micro-organisms (GMMs).

Table Ic presents additions to and modifications of Table Ia for activities with animals involving genetically modified micro-organisms (GMMs).

Table II presents minimum requirements for other activities than laboratories activities.

In some particular cases, it might be necessary to apply a combination of measures from Table Ia and Table II of the same level.

In some exceptional cases (e.g. for plant pathogens), it also might be appropriate, following consultation with the competent authority not to apply a specification under a particular containment level or to combine specifications from two different levels.

In these tables:

>TABLE>

Table Ia

Containment and control measures for laboratory activities

>TABLE>

Table Ib

Containment and control measures for glasshouses and growthrooms

The terms glasshouse and growthroom refer to a structure with walls, a roof and a floor designed and used principally for growing plants in a controlled and protected environment.

All provisions of Table Ia shall apply with the following additions/modifications:

>TABLE>

Table Ic

Containment and control measures for activities in animal units

All provisions of Table Ia shall apply with the following additions/modifications:

>TABLE>

Table II

Containment and control measures for other activities

>TABLE>

`

6. Annex V is replaced by the following:

'ANNEX V

PART A

Information required for the notification referred to at Article 8:

- name of user(s) including those responsible for supervision and safety information on their training and qualifications,

- details of any biological committees or subcommittees,

- address of installation,

- general description of the premises,

- a description of the nature of the work will be undertaken,

- the class of risk of the activities,

- a summary of the risk assessment referred to at Article 6 (2) and (3) (only for class 1 activities).

PART B

Information required for the notification referred to at Article 10:

- the date of submission of the notification referred to in Article 8,

- the recipient, donor and/or parental micro-organism(s) used and, where applicable, the host-vector system(s) used,

- the source(s) and the intended function(s) of the genetic material(s) involved in the manipulation(s),

- identity and characteristics of the genetically modified micro-organism(s),

- the purpose of the contained use including the expected results,

- approximate culture volumes to be used,

- description of the containment and control measures to be applied, including information about the wastes to be generated, their treatment, ultimate form and destination,

- a summary of the risk assessment referred to at Article 6 (2) and (3).

PART C

Information required for the notification referred to at Article 10a:

(a) - the date of submission of the notification referred to at Article 8,

- name fo the responsible person,

(b) - the recipient or patental micro-organism(s) to be used;

- the host-vector system(s) to be used (where applicable),

- the source(s) and intended function(s) of the genetic material(s) involved in the manipulation(s),

- identity and characteristics of the genetically modified micro-organism,

- the culture volumes to be used;

(c) - description of the containment and control measures to be applied, including information about the type and form of wastes to be generated, their treatment, ultimate form and destination,

- the purpose of the contained use including the expected results,

- description of the sections of the installation;

(d) information about accident prevention and emergency response plans, if any:

- the sources of hazards and conditions under which accidents might occur,

- any specific hazards arising from the location of the installation,

- the preventive measures applied such as safety equipment, alarm systems and containment methods,

- procedures and plans for verifying the continuing effectiveness of the containment measures,

- a description of information provided to workers,

- the information necessary for the competent authority to evaluate any emergency response plans prepared in accordance with Article 14;

(e) a copy of the risk assessment referred to at Article 6 (2) and (3).`