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Commission Directive 94/51/EC of 7 November 1994 adapting to technical progress Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms Official Journal L 297 , 18/11/1994 P. 0029 - 0030 Finnish special edition: Chapter 15 Volume 13 P. 0248 Swedish special edition: Chapter 15 Volume 13 P. 0248

COMMISSION DIRECTIVE 94/51/EC of 7 November 1994 adapting to technical progress Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms THE COMMISSION OF THE EUROPEAN COMMUNITIES, 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 20 thereof, Whereas Directive 90/219/EEC classifies genetically modified micro-organisms into two groups having regard to the risks they present, whereas Annex II to the said Directive sets out the criteria for determining such classification; Whereas, having regard to the experience gained with the contained use of genetically modified micro-organisms, and to technical progress generally in the field of biotechnology, and on the basis of an evaluation of the risks currently presented, it is appropriate to revise the classification of genetically modified micro-organisms; Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 21 of Directive 90/219/EEC, HAS ADOPTED THIS DIRECTIVE: Article 1 Annex II to Directive 90/219/EEC is replaced by the Annex hereto. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 April 1995. They shall immediately 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. Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Done at Brussels, 7 November 1994. For the Commission Yannis PALEOKRASSAS Member of the Commission (1) OJ No L 117, 8. 5. 1990, p. 1. ANNEX 'ANNEX II CRITERIA FOR CLASSIFYING GENETICALLY MODIFIED MICRO-ORGANISMS INTO GROUP I A genetically modified micro-organism is classified as falling within Group I when all the following criteria are fulfilled: (i) the recipient or parental micro-organism is unlikely to cause disease to humans, animals or plants; (ii) the nature of the vector and the insert is such that they do not endow the genetically modified micro-organism with a phenotype likely to cause disease to humans, animals or plants, or likely to cause adverse effects in the environment; (iii) the genetically modified micro-organism is unlikely to cause disease to humans, animals or plants and is unlikely to have adverse effects on the environment.'

COMMISSION DIRECTIVE 94/51/EC of 7 November 1994 adapting to technical progress Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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 20 thereof,

Whereas Directive 90/219/EEC classifies genetically modified micro-organisms into two groups having regard to the risks they present, whereas Annex II to the said Directive sets out the criteria for determining such classification;

Whereas, having regard to the experience gained with the contained use of genetically modified micro-organisms, and to technical progress generally in the field of biotechnology, and on the basis of an evaluation of the risks currently presented, it is appropriate to revise the classification of genetically modified micro-organisms;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 21 of Directive 90/219/EEC,

HAS ADOPTED THIS DIRECTIVE:

Annex II to Directive 90/219/EEC is replaced by the Annex hereto.

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 April 1995. They shall immediately 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.

This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.

Done at Brussels, 7 November 1994.

For the Commission

Yannis PALEOKRASSAS

Member of the Commission

(1) OJ No L 117, 8. 5. 1990, p. 1.

ANNEX

'ANNEX II

CRITERIA FOR CLASSIFYING GENETICALLY MODIFIED MICRO-ORGANISMS INTO GROUP I

A genetically modified micro-organism is classified as falling within Group I when all the following criteria are fulfilled:

(i) the recipient or parental micro-organism is unlikely to cause disease to humans, animals or plants;

(ii) the nature of the vector and the insert is such that they do not endow the genetically modified micro-organism with a phenotype likely to cause disease to humans, animals or plants, or likely to cause adverse effects in the environment;

(iii) the genetically modified micro-organism is unlikely to cause disease to humans, animals or plants and is unlikely to have adverse effects on the environment.'