2003/701/EC: Commission DecisionShow full title

Commission Decision

of 29 September 2003

establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market

(notified under document number C(2003) 3405)

(Text with EEA relevance)

(2003/701/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC(1), and in particular the second sentence of Article 10 thereof,

Whereas:

(1)

With regard to the deliberate release of genetically modified organisms (GMOs) for any purpose other than placing on the market, Article 10 of Directive 2001/18/EC requires the notifier of such a release, to send the competent authority, after completion of a release, and thereafter, at any intervals laid down in the consent on the basis of the results of the environmental risk assessment, the results of the release in terms of any risk to human health or the environment, with, where appropriate, particular reference to any kind of product that the notifier intends to notify at a later stage.

(2)

To date, most GMOs deliberately released in the Community pursuant to Part B of Directive 2001/18/EC are genetically modified higher plants (GMHP). It is necessary, therefore, with regard to those plants, to establish the format to be used by the notifier when presenting the results of the release to the competent authority. That format should reflect the need to enable the fullest possible exchange of relevant information, presented in a standardised and easily comprehensible manner. The format should be kept as general as possible so that, where appropriate, multi-sites, multi-annual releases or releases of several GMOs can be covered by a single report.

(3)

Since genetic engineering is not restricted to higher plants, it will be necessary to establish formats for other types of GMOs, such as genetically modified (GM) animals (including GM insects), veterinary and medicinal products (containing or consisting of GMOs) or GM plants which could produce pharmaceutical products. Future developments may also make it necessary to adapt the report formats which have already been established.

(4)

The measures provided for in this Decision are in accordance with the opinion of the Committee established under Article 30 of Directive 2001/18/EC,

HAS ADOPTED THIS DECISION:

(1)

OJ L 106, 17.4.2001, p. 1.