Decision 2001/204 - 2001/204/EC: Council Decision of 8 March 2001 supplementing Directive 90/219/EEC as regards the criteria for establishing the safety, for human health and the environment, of types of genetically modified micro-organisms - Main contents

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Legal instrument	Decision
Number legal act	Decision 2001/204
Original proposal	COM(2000)627
CELEX number i	32001D0204

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2001/204/EC: Council Decision of 8 March 2001 supplementing Directive 90/219/EEC as regards the criteria for establishing the safety, for human health and the environment, of types of genetically modified micro-organisms (Text with EEA relevance)

Official Journal L 073 , 15/03/2001 P. 0032 - 0034

Council Decision

of 8 March 2001

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

(Text with EEA relevance)

(2001/204/EC)

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), and in particular Article 20a thereof,

Having regard to the proposal from the Commission,

Whereas:

• (1) 

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

• (2) 

  By virtue of Article 20a of Directive 90/219/EEC, the criteria establishing the safety, for human health and the environment, of types of genetically modified micro-organisms to be included in Part C of Annex II to that Directive should be adopted. In order to facilitate the application of those criteria, it should be made possible for the Commission to adopt detailed guidance notes, in accordance with the procedure referred to in Article 21 of that Directive.

• (3) 

  Directive 90/219/EEC should be supplemented accordingly,

HAS ADOPTED THIS DECISION:

Article 1

Part B of Annex II to Directive 90/219/EEC shall be replaced by the text in the Annex to this Decision.

Article 2

This Decision shall be published in the Official Journal of the European Communities.

Article 3

This Decision shall apply from the day of its publication in the Official Journal of the European Communities.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 8 March 2001.

For the Council

The President

• K. 

  Larsson

• (1) 

  OJ L 117, 8.5.1990, p. 1. Directive as last amended by Directive 98/81/EC (OJ L 330, 5.12.1998, p. 13).

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 for human health and the environment and their suitability for inclusion in Part C. It will be supplemented by guidance notes for the easy application of such criteria, such notes being developed and, if necessary, amended by the Commission in accordance with the procedure referred to in Article 21.

• 1. 

  INTRODUCTION

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

• 2. 

  GENERAL CRITERIA

2.1. Strain verification/authentication

Identity of the strain must be precisely established. Modification must be 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....

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