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  Legal base
Art. 114 TFEU – “Approximation of laws” (Internal market Directive)
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)
- Activities: Deliberate release in the environment for any other purpose than for placing on the market and the placing on the market (art. 4)
- Object(s): GMOs, as or in products (art. 4)
- Scope related definitions:
- 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))
- Placing on the market: “making available to third parties, whether in return for payment or free of charge” (art. 2(4))
- 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))
- Organisms obtained through the techniques listed in Annex I B (art. 3.1)
- The carriage of GMOs by rail, road, inland waterway, sea or air (art. 3.2)
- Certain GMOs as medicinal and other products authorised under EU legislation (art. 5, 12.1, 12.2)
- Mechanism(s) for future exemptions: /
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)
- 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)
- 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)
- A differentiated procedure is possible for GMOs meeting the requirements in Annex V (art. 7)
- 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) 
- 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)
- 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)
- 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)
- 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)
- In the case of an unfavourable decision, the applicant may resort to appeal before the European courts.
- 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)
 Regulation (EC) No 1829/2003 provides for a single procedure for the placing of the market of a GMO that concerns food or feed, thus merging the procedures set out in Directive 2001/18/EC and in the Regulation. The single procedure under Directive 2001/18/EC for the placing on the market has not been used since the entry into force of the Regulation.
 In practice, these documents are only sent to the Commission, which in turn forwards these to the CAs of the MS. Refer to: http://ec.europa.eu/food/plant/gmo/new/authorisation/cultivation/index_en.htm
 Cf. supra, chapter “Commission implementing acts”
 The Directive refers to art. 5, 7 and 8 of Decision 1999/468/EC but this act has been repealed by Regulation (EU) No 182/2011. According to the old provisions, if no qualified majority can be reached on the Commission proposal in the Committee, it is submitted to the Council.
The Council decides within 3 months after referral of the proposal. If it fails to reach a majority to consent to the proposal, the Commission will re-examine it. The Commission in turn may amend the proposal and re-submit it to the Council, which again has 3 months to reach a qualified majority.
 The simplified procedure provides for a single notification dossier for more than one release of genetically modified plants which have resulted from the same recipient crop plant species but which may differ in any of the inserted/deleted sequences or have the same inserted/deleted sequence but differ in phenotypes.