2000/608/EC: Commission Decision of 27 September 2000 concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified micro-organisms (notified under document number C(2000) 2736) (Text with EEA relevance)

• Published date: 12 October 2000
• Official Gazette Publication: Gazzetta ufficiale delle Comunità europee, L 258, 12 ottobre 2000,Diario Oficial de las Comunidades Europeas, L 258, 12 de octubre de 2000,Journal officiel des Communautés européennes, L 258, 12 octobre 2000

|

2000/608/EC: Commission Decision of 27 September 2000 concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified micro-organisms (notified under document number C(2000) 2736) (Text with EEA relevance)

Official Journal L 258 , 12/10/2000 P. 0043 - 0048

Commission Decision

of 27 September 2000

concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified micro-organisms

(notified under document number C(2000) 2736)

(Text with EEA relevance)

(2000/608/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms(1), as last amended by Council Directive 98/81/EC(2), and in particular Article 5 paragraph 2 thereof,

Whereas:

(1) According to Article 5(2) of this Directive, the user is required to carry out an assessment of the contained uses of genetically modified micro-organisms (GMMs), using as a minimum the principles set out in Annex III supplemented by guidance notes.

(2) Annex III requires that these guidance notes be developed by the Commission in accordance with the procedure set out in Article 21.

(3) The measures provided for in this Decision are in accordance with the opinion of the Committee established under Article 21 of Directive 90/219/EEC,

HAS ADOPTED THIS DECISION:

Article 1

When an assessment of the contained uses of genetically modified micro-organisms is made under Article 5 of Directive 90/219/EEC, the annexed guidance notes for risk assessment shall be used to supplement Annex III of the Directive.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 27 September 2000.

For the Commission

Margot Wallström

Member of the Commission

(1) OJ L 117, 8.5.1990, p. 1.

(2) OJ L 330, 5.12.1998, p. 13.

ANNEX

GUIDANCE NOTES FOR RISK ASSESSMENT OUTLINED IN ANNEX III OF COUNCIL DIRECTIVE 90/219/EEC ON THE CONTAINED USE OF GENETICALLY MODIFIED MICRO-ORGANISMS

1. INTRODUCTION

The elements of the risk assessment outlined in points 1 and 2 of Annex III requires consideration of potentially harmful effects to human health and the environment. Potentially harmful effects are defined as those effects which may give rise to disease, render prophylaxis or treatment ineffective, promote establishment and/or dissemination in the environment which gives rise to harmful effects on organisms or natural populations present or harmful effects arising from gene transfer to other organisms. The assessment requires that the risk of these potentially harmful effects are considered for each activity and allocated to a class as defined in Article 5, taking into account both the nature and scale of operations, to determine the final containment facilities required. The degree of risk arising from contained uses with a genetically modified micro-organism (GMM), and their construction, is determined by consideration of the severity of the potential harmful effects, to human health or the environment, with the possibility of those effects occurring. The risk assessment considers the exposure of humans or the environment to GMMs during the operation of, or possible unintended release from, a contained use facility. The classification level determined by the risk assessment defines the containment requirements for the activities involving GMMs in accordance with Annex IV.

2. RISK ASSESSMENT

The full risk assessment process consists of two procedures outlined below:

2.1. Procedure 1

Identify potential harmful properties (hazard) of the GMM and allocate the GMM to an initial class (class 1 to class 4) taking into account the severity of the potential harmful effects.

and

Assessment of possibility of harmful effects occurring by consideration of exposure (both human and environmental) taking into account the nature and scale of the work, with containment measures appropriate to the initial class allocated.

2.2. Procedure 2

Determination of final classification and containment measures required for the activity. Confirm final classification and containment measures are adequate by revisiting Procedure 1.

3. PROCEDURE 1

3.1. Identification of harmful properties (hazard) of the GMM

The risk assessment process requires the identification of any potentially harmful properties of the GMM as a result of the genetic modification or any alteration of the recipient organisms' existing properties. Potentially harmful properties associated with the GMM...