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

Publication Date21 March 2008
Subjectravvicinamento 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 publicationGazzetta 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
Consolidated TEXT: 32001L0018 — EN — 27.03.2021

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




▼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



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:

carrying out the deliberate release into the environment of genetically modified organisms for any other purposes than placing on the market within the Community,
placing on the market genetically modified organisms as or in products within the Community.

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

1.
This Directive shall not apply to organisms obtained through the techniques of genetic modification listed in Annex I B.
2.
This Directive shall not apply to the carriage of genetically modified organisms by rail, road, inland waterway, sea or air.

Article 4

General obligations

1.
Member States shall, in accordance with the precautionary principle, ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs. GMOs may only be deliberately released or placed on the market in conformity with part B or part C respectively.
2.
Any person shall, before submitting a notification under part B or part C, carry out an environmental risk assessment. The information which may be necessary to carry out the environmental risk assessment is laid down in Annex III. Member States and the Commission shall ensure that GMOs which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment are taken into particular consideration when carrying out an environmental risk assessment, with a view to identifying and phasing out antibiotic resistance markers in GMOs which may have adverse effects on human health and the environment. This phasing out shall take place by the 31 December 2004 in the case of GMOs placed on the market according to part C and by 31 December 2008 in the case of GMOs authorised under part B.
3.
Member States and where appropriate the Commission shall ensure that potential adverse effects on human health and the environment, which may occur directly or indirectly through gene transfer from GMOs to other organisms, are accurately assessed on a case-by-case basis. This assessment shall be conducted in accordance with Annex II taking into account the environmental impact according to the nature of the organism introduced and the receiving environment.
4.
Member States shall designate the competent authority or authorities responsible for complying with the requirements of this Directive. The competent authority shall examine notifications under part B and part C for compliance with the requirements of this Directive and whether the assessment provided for in paragraph 2 is appropriate.
5.
Member States shall ensure that the competent authority organises inspections and other control measures as appropriate, to ensure compliance with this Directive. In the event of a release of GMO(s) or placing on the market as or in products for which no authorisation was given, the Member State concerned shall ensure that necessary measures are taken to terminate the release or placing on the market, to initiate remedial action if necessary, and to inform its public, the Commission and other Member States.

▼M2 —————

▼B



PART B

DELIBERATE RELASE OF GMOs FOR ANY OTHER PURPOSE THAN FOR PLACING ON THE MARKET

Article 5

1.

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:

(a)

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;

(b)

for explicit consent prior to release;

(c)

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;

(d)

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.

2.
Assessment of the risks to the environment presented by such substances and compounds shall be carried out in coordination with the national and Community authorities mentioned in this Directive.
3.
Procedures ensuring conformity of the specific environmental risk assessment and equivalence with the provisions of this Directive must be provided for by the said legislation, which must refer to this Directive.

Article 6

Standard authorisation procedure

1.
Without prejudice to Article 5, any person must, before undertaking a deliberate release of a GMO or of a combination of GMOs, submit a notification to the competent authority of the Member State within whose territory the release is to take place.
2.

The notification referred to in paragraph 1 shall include:

(a)

a...

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