Proposal for a COUNCIL DECISION amending Directive 90/219/EEC as regards the criteria for establishing the safety to human health and the environment of types of genetically modified micro-organisms

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. Directive 98/81/EC, amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms, was adopted on 26 October 1998.

2. The Directive provides the regulatory framework for activities with genetically modified micro-organisms (GMMs) under appropriate conditions of containment used to limit their contact with the general population and the environment.

3. Article 3 of Directive 90/219/EEC provides that types of GMMs may be excluded from the Directive if criteria establishing their safety to human health and the environment are met.

4. This exclusion only applies when the GMM is used under conditions of contained use as defined in Article 2(c) of the Directive.

5. The criteria are to be listed in Annex II, Part B, which is to be adopted before 5 December 2000, by the Council acting by a qualified majority on a proposal from the Commission on the basis of Article 20a of the Directive.

6. These criteria include both general and specific criteria, which have been considered in conjunction with the competent authorities, established under the Directive, of Member States and through consultation of the Scientific Committee(s).

7. In order to facilitate the application of these criteria the Commission should be able to adopt detailed guidance notes in accordance with the procedure set out in Article 21 of the Directive.

Proposal for a

COUNCIL DECISION

amending Directive 90/219/EEC as regards the criteria for establishing the safety to human health and the environment of types of genetically modified micro-organisms

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms [1], as last amended by Directive 98/81/EC [2], and in particular Article 20a thereof,

[1] OJ L 117, 8.5.1990, p. 1.

[2] OJ L 330, 5.12.1998, p. 13.

Having regard to the proposal from the Commission [3],

[3] OJ C

Whereas:

(1) According to Article 3 of Directive 90/219/EEC, that Directive is not to apply for contained uses involving only types of genetically modified micro-organisms (GMMs) meeting the criteria listed in Annex II, Part B, which establish their safety to human health and the environment.

(2) By virtue of Article 20a of Directive 90/219/EEC, the criteria establishing the safety to human health and the environment of types of genetically modified mircro-organisms to be listed in Annex II, Part C, to that Directive should be adopted before 5 December 2000. In order to facilitate the application of those criteria the Commission should be able to adopt detailed guidance notes in accordance with the procedure referred to in Article 21 of that Directive.

(3) The provisions of Directive 90/219/EEC should be adapted to take account of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [4].

[4] OJ L 184, 17.7.1999, p. 23.

(4) Directive 90/219/EEC should be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

Directive 90/219/EEC is amended as follows:

1. In Article 20, "decided in accordance with the procedure defined in Article 21" is replaced by "adopted in accordance with the procedure referred to in Article 21(2)."

2. Article 21 is replaced by the following:

"Article 21

1. The Commission shall be assisted by a committee composed of representatives of the Member States and chaired by the representative of the Commission.

2. Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Council Decision 1999/468/EC* shall apply, in compliance with Article 7 thereof.

3. The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months.

__________

* OJ L 184, 17.7.1999, p. 23."

3. Annex II, Part B, is replaced by the text in the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels,

For the Council

The President

ANNEX

"PART B

Criteria establishing the safety of GMMs for human health and the environment

This annex describes in general terms the criteria to be met when establishing the safety of types of GMMs to human health and the environment and their suitability for inclusion in Part C. It will be supplemented by guidance notes to be developed and, if necessary, amended by the Commission in accordance with the procedure referred to in Article 21(2).

1. Introduction

Types of genetically modified micro-organisms (GMMs) listed in Part C in accordance with the procedure referred to in Article 21(2) of the Directive are excluded from the scope. GMMs will only be added to the list on a case-by-case basis and the exclusion will only relate to the clearly identified GMM. This exclusion only applies when the GMM is used under conditions of contained use as defined in Article 2(c) and does not apply to the deliberate release of GMMs. For a GMM to be listed in Part C, it must be proven to meet the criteria given below.

2. General Criteria

2.1 Strain verification/authentication

Identity of the strain must be precisely established and the modification known and verified.

2.2 Documented and established evidence of safety

Documented evidence of the safety of the organism must be provided.

2.3 Genetic stability

Where any instability could adversely affect safety, evidence of stability is required.

3. Specific Criteria

3.1 Non-pathogenic

The GMM should not be capable of causing disease or harm to a healthy human, plant or animal. Pathogenicity includes both toxigenicity and allergenicity, accordingly the GMM should also be:

3.1.1 Non-toxigenic

The GMM should not produce increased toxigenicity as a result of the genetic modification nor be noted for its toxigenic properties.

3.1.2 Non-allergenic

The GMM should not produce increased allergenicity as a result of the genetic modification nor be a noted allergen, having for example allergenicity comparable with those micro-organisms identified in Directive 93/88/EEC [5].

[5] OJ L 268, 29.10.1993, p. 71."

3.2 No harmful adventitious agents

The GMM should not harbour known adventitious agents such as other micro-organisms, active or latent, existing alongside/inside the GMM that could cause harm to human health and the environment.

3.3 Transfer of genetic material

The modified genetic material must not give rise to harm if transferred nor should it be self transmissible or transferable at a frequency greater than other genes of the recipient or parental micro-organism.

3.4 Safety for the environment in the event of an escape from control

GMMs must not produce adverse effects on the environment, immediate or delayed, should any incident involving a significant and unintended release occur.

GMMs that do not meet the above criteria will not be suitable for inclusion into Part C.