Directive 2001/18/EC

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. Legal base

Art. 114 TFEU – “Approximation of laws” (Internal market Directive)

2. Objective

To approximate the laws, regulations and administrative provisions of the MS (art. 1)

To protect human health and the environment (art. 1)

To clarify Directive 90/220/EC and its scope (recital 2 and 3)

To establish a common methodology to carry out environmental risk assessments (recital 20)

3. Scope

I.          Covered:

o          Activities: Deliberate release in the environment for any other purpose than for placing on the market and the placing on the market (art. 4)

o          Object(s): GMOs, as or in products (art. 4)

II.         Scope related definitions:

o          Deliberate release: “any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment” (art. 2(3))

o          Placing on the market: “making available to third parties, whether in return for payment or free of charge” (art. 2(4))

o          GMO: “an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination” (art. 2(2))

III.        Exemptions:

o          Organisms obtained through the techniques listed in Annex I B (art. 3.1)

o          The carriage of GMOs by rail, road, inland waterway, sea or air (art. 3.2)

o          Certain GMOs as medicinal and other products authorised under EU legislation (art. 5, 12.1, 12.2)

IV.        Mechanism(s) for future exemptions: /

4. Main regulatory mechanism(s)

Harmonised authorisation procedure for the deliberate release in the environment for any other purpose than for placing on the market (Part B: art. 5 to 11)

o          The applicant notifies the CA of the MS within whose territory the release is to take place and supplies the information determined by art. 6.2. (art. 6.1)

o          The CA consults the public and notifies other MS through the Commission. The CA consents to or rejects the application within 90 days of receipt based on an ERA. (art. 6.3 to 6.9)

o          A differentiated procedure is possible for GMOs meeting the requirements in Annex V (art. 7)

o          In the case of an unfavourable decision, the applicant may resort to administrative appeal under the domestic framework.

Harmonised authorisation procedure for the placing on the market (Part C: art. 12 to 24)

o          The applicant notifies the CA of the MS within whose territory the placing on the market is to take place for the first time and supplies the information determined by art. 13.2. (art. 13)

o          Within 90 days, the CA carries out a preliminary assessment and forwards the assessment report with the application to the CAs of the MS and the Commission.  In the case of a negative assessment report, the application will be rejected. (art. 14)

o          Within 60 days from the date of circulation of the assessment report, the CAs and the Commission may make comments or object. Outstanding issues are to be resolved within 105 days after the date of circulation. The application will be approved if there are no objections, nor unresolved outstanding issues at the end of the respective time frames. (art. 15)

o          In the case of objections or unresolved outstanding issues, the Commission and the competent Committee assess the dossier and a decision will be taken within 120 days in accordance with the examination procedure laid down in art. 5, 10 and 11 of Regulation (EU) No 182/2011     (art. 30(2)). (art. 18)

o          In the case of an unfavourable decision, the applicant may resort to appeal before the European courts.

o          A simplified procedure is possible for the deliberate release for any other purpose than for placing on the market of certain genetically modified plants   (art. 6(5) jº Commission Decision 94/730/EC)