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
Published date | 21 March 2008 |
Subject Matter | ravvicinamento delle legislazioni,ambiente,ricerca e sviluppo tecnologico,Mercato interno - Principi,rapprochement des législations,environnement,recherche et développement technologique,Marché intérieur - Principes,aproximación de las legislaciones,medio ambiente,investigación y desarrollo tecnológico,Mercado interior - Principios |
Official Gazette Publication | Gazzetta ufficiale delle Comunità europee, L 106, 17 aprile 2001,Journal officiel des Communautés européennes, L 106, 17 avril 2001,Diario Oficial de las Comunidades Europeas, L 106, 17 de abril de 2001 |
02001L0018 — EN — 27.03.2021 — 007.001
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►B | 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 (OJ L 106 17.4.2001, p. 1) |
Amended by:
Official Journal | ||||
No | page | date | ||
►M1 | REGULATION (EC) No 1829/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2003 | L 268 | 1 | 18.10.2003 |
►M2 | REGULATION (EC) No 1830/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2003 | L 268 | 24 | 18.10.2003 |
►M3 | DIRECTIVE 2008/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2008 | L 81 | 45 | 20.3.2008 |
►M4 | DIRECTIVE (EU) 2015/412 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2015 | L 68 | 1 | 13.3.2015 |
►M5 | COMMISSION DIRECTIVE (EU) 2018/350 of 8 March 2018 | L 67 | 30 | 9.3.2018 |
►M6 | REGULATION (EU) 2019/1243 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 | L 198 | 241 | 25.7.2019 |
►M7 | REGULATION (EU) 2019/1381 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 | L 231 | 1 | 6.9.2019 |
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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
PART A
GENERAL PROVISIONS
Article 1
Objective
In accordance with the precautionary principle, the objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States and to protect human health and the environment when:
Article 2
Definitions
For the purposes of this Directive:
(1) | ‘organism’means any biological entity capable of replication or of transferring genetic material; |
(2) | ‘genetically modified organism (GMO)’ means 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; Within the terms of this definition: (a) genetic modification occurs at least through the use of the techniques listed in Annex I A, part 1; (b) the techniques listed in Annex I A, part 2, are not considered to result in genetic modification; |
(3) | ‘deliberate release’means 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; |
(4) | ‘placing on the market’ means making available to third parties, whether in return for payment or free of charge; The following operations shall not be regarded as placing on the market: — making available genetically modified microorganisms for activities regulated under Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified microorganisms ( 1 ) including culture collections, — making available GMOs other than microorganisms referred to in the first indent, to be used exclusively for activities where appropriate stringent containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment, the measures should be based on the same principles of containment as laid down in Directive 90/219/EEC, — making available GMOs to be used exclusively for deliberate releases complying with the requirements laid down in part B of this Directive; |
(5) | ‘notification’means the submission of the information required under this Directive to the competent authority of a Member State; |
(6) | ‘notifier’means the person submitting the notification; |
(7) | ‘product’means a preparation consisting of, or containing, a GMO or a combination of GMOs, which is placed on the market; |
(8) | ‘environmental risk assessment’means 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 and carried out in accordance with Annex II. |
Article 3
Exemptions
Article 4
General obligations
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PART B
DELIBERATE RELASE OF GMOs FOR ANY OTHER PURPOSE THAN FOR PLACING ON THE MARKET
Article 5
Articles 6 to 11 shall not apply to medicinal substances and compunds for human use consisting of, or containing, a GMO or combination of GMOs provided that their deliberate release for any purpose other than that of being placed on the market is authorised by Community legislation which provides:
for a specific environmental risk assessment in accordance with Annex II and on the basis of the type of information specified in Annex III without prejudice to additional requirements provided for by the said legislation;
for explicit consent prior to release;
for a monitoring plan in accordance with the relevant parts of Annex III, with a view to detecting the effects of the GMO or GMOs on human health or the environment;
in an appropriate manner for requirements relating to treatment of new items of information, information to the public, information on the results of releases, and exchanges of information at least equivalent to those contained in this Directive and in the measures taken in accordance therewith.
Article 6
Standard authorisation procedure
The notification referred to in paragraph 1 shall include:
a...
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