Brussels, 30 July 2002
Commission Decision of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC ( notified under document number C(2002) 15) (OJ L200/22 30.7.2002). Full text [NB link expires 45 days from publication date]
ANNEX: Guidance notes on the objective, elements, general principles and methodology of the environmental risk assessment referred to in Annex II to Directive 2001/18/EC
1. INTRODUCTION
Environmental risk assessment (ERA) is defined in Article 2(8) of Directive 2001/18/EC as 'the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose'. As one of the general obligations under the Directive, Article 4(3) requires Member States and, where appropriate, the Commission to ensure that potential adverse effects on human health and the environment, which may occur in particular directly or indirectly, are accurately assessed on a case-by-case basis taking into account the environmental impact according to the nature of the organism introduced and the receiving environment. ERA is carried out in accordance with Annex II to the Directive, and is also referred to in Parts B and C thereof.
Annex II describes in general terms the objective to be achieved, the elements to be considered and the general principles and methodology to be followed to perform the ERA, taking into account the impact on human health and the environment according to the nature of the organism introduced and the receiving environment.
Notifiers must submit a notification including an ERA for deliberate release under Article 6(2) or for placing on the market under Article 13(2).
This guidance note supplements Annex II to Directive 2001/18/EC and outlines the objectives and principles as well as the methodology for the ERA, in order to assist notifiers, to facilitate the performance by the competent authorities of a comprehensive and appropriate ERA under Directive 2001/18/EC and to make the process of ERA transparent to the general public.
The six steps in the ERA are set out in Chapter 4.2.
Official Journal of the EC, L200/22 30.7.2002 http://europa.eu.int/eur-lex/en/oj/inde x.html