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Commission Decision

of 23 February 2004

laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council

(notified under document number C(2004) 540)

(Text with EEA relevance)

(2004/204/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 2001/18/ECDirective 90/220/EEC1), and in particular Article 31(2) thereof,

Whereas:

(1)Different sets of information are required for the notification of genetically modified organisms, hereinafter ‘GMOs’, pursuant to Directive 2001/18/EC

(2)The information required in notifications concerning the deliberate release of GMOs is listed in Annex III to Directive 2001/18/ECDirective 2001/18/EC

(3)According to Article 31(2) of Directive 2001/18/EC

(4)That information should include, where appropriate, the lodging of samples of the GMO, as or in products, or of its genetic material, with the competent authority and details of nucleotide sequences or other types of information necessary for the identification of the GMO product and its progeny, including the methodology for detecting and identifying the GMO product, and the experimental data demonstrating the validation parameters of the method supplied.

(5)In establishing the list of information to be recorded in the registers, account has been taken of the fact that other sets of information - such as the environmental risk assessment, the scientific studies, including studies which demonstrate the safety of the product, including, where available, references to independent and peer-reviewed studies, and to methods for identification and detection, and all other information submitted by the notifier, methods and plans for monitoring the GMO(s) and for emergency response, and results of the post-market monitoring - are in principle accessible according to the relevant provisions of Directive 2001/18/ECRegulation (EC) No 1946/20032) and Regulation (EC) No 1049/20013), and therefore need not be recorded.

(6)For the sake of transparency and in conformity with Regulation (EC) No 1049/2001Directive 2001/18/ECRegulation (EC) No 1049/2001Directive 2001/18/EC

(7)The competent authorities, inspection services, control laboratories of the Member States and the Commission should have available, during the consent period and for an appropriate period after expiry of the consent, the methods for detection and identification, including detection methods relating to thresholds established pursuant to Directive 2001/18/EC

(8)At the time of submission of the data by the competent authority to the Commission for the sake of placing it on the registers, some data, such as the date of authorisation or the validation parameters for the identification and detection method, are or may be missing. Moreover, during the consent period, and even for some time after expiry of the consent, updates such as identification and detection methods, commercial names or responsible persons may be necessary. Provision should therefore be made for updating the registers.

(9)Future developments in the methodology of genetic modification or the corresponding detection and identification methods, including detection methods relating to thresholds established pursuant to Directive 2001/18/EC

(10)The measures provided for in this Decision are in accordance with the opinion of the Committee established pursuant to Article 30(1) of Directive 2001/18/EC

HAS ADOPTED THIS DECISION:

Article 1

This Decision lays down the detailed arrangements for the operation of registers (hereinafter referred to as ‘the registers’) to be established by the Commission pursuant to Article 31(2) of Directive 2001/18/ECGMOs’).

Article 2

The information referred to in Article 1 shall include, in accordance with the provisions of Article 3, details of nucleotide sequences or other types of information necessary to identify the GMO product and its progeny, such as the methodology for the detection and identification of the GMO product, including detection methods relating to thresholds established under Directive 2001/18/EC

The registers shall be consistent and compatible with those established under other relevant Community legislation.

Article 3

The following shall be recorded in the registers:

(adetails concerning the notifier and responsible persons:

(ithe name and full address of the notifier,

(iithe name and full address of the person established in the Community who is responsible for the placing on the market, whether it be the manufacturer, the importer or the distributor, if different from the notifier;

(bgeneral information concerning the GMO(s):

(ithe commercial name(s) of the GMO products and the names of the GMOs contained therein, including scientific name(s) and common name(s) of the recipient or, where appropriate, parental organism of the GMO,

(iithe unique identifier(s) of the GMO(s) contained in the product(s),

(iiithe Member State of notification,

(ivthe notification number,

(vthe decision authorising the GMO(s);

(cinformation on the insert:

(iinformation on the nucleotide sequence of the insert used to develop the detection method, including, where appropriate, the complete sequence of the insert as well as the number of base pairs of the host flanking sequences needed to establish an event-specific detection method and detection methods relating to thresholds established pursuant to Directive 2001/18/EC

(iia detailed map of the inserted DNA, including all genetic elements, coding and non-coding regions as well as the indication of their order and their orientation;

(dinformation concerning the detection and identification methods:

(idescription of identification and detection techniques for event-specific detection, including, where appropriate, detection methods relating to thresholds established pursuant to Directive 2001/18/EC

(iiinformation on detection and identification tools such as PCR primers and antibodies,

(iiiwhere appropriate, information on validation parameters, in accordance with international guidelines;

(einformation on the lodging, storage and supply of samples:

(ithe name and address of the person(s) responsible for the lodging, storage and supply of control samples,

(iiinformation on the stored samples such as the kind of material, the genetic characterisation, the amount of repository material, the stability, the conditions of appropriate storage and the shelf-life.

Article 4

The registers shall be available to the public in accordance with Article 25 of Directive 2001/18/ECRegulation (EC) No 1049/2001

The information recorded shall be divided as follows:

(aa set of data accessible to the public;

(ba set of data comprising additional confidential data, accessible only to the Member States, the Commission and the European Food Safety Authority.

Article 5

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Article 6

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Article 7

This Decision is addressed to the Member States.

Done at Brussels, 23 February 2004.

For the Commission

Margot WALLSTRÖM

Member of the Commission

(1)

OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003

(2)

OJ L 287, 5.11.2003, p. 1.

(3)

OJ L 145, 31.5.2001, p. 43.

(1)

OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.6.2003, p. 24).

(2)

OJ L 287, 5.11.2003, p. 1.

(3)

OJ L 145, 31.5.2001, p. 43.

Status: There are currently no known outstanding effects by UK legislation for Commission Decision of 23 February 2004 laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council (Text with EEA relevance) (notified under document number C(2004) 540) (Text with EEA relevance) (2004/204/EC).
Commission Decision (2004/204)

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Status of this instrument

footnotecommentarytransitional and savingsin force statusrelated provisionsgeo extentinsert/omitsource countin force adj
F1Art. 5 revoked (1.1.2024) by Retained EU Law (Revocation and Reform) Act 2023 (c. 28), ss. 1(1), 22(3), Sch. 1 Pt. 2 (with s. 1(3)(4)); S.I. 2023/1363, reg. 2this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F1Art. 5 revoked (1.1.2024) by Retained EU Law (Revocation and Reform) Act 2023 (c. 28), ss. 1(1), 22(3), Sch. 1 Pt. 2 (with s. 1(3)(4)); S.I. 2023/1363, reg. 2this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F2Art. 6 revoked (1.1.2024) by Retained EU Law (Revocation and Reform) Act 2023 (c. 28), ss. 1(1), 22(3), Sch. 1 Pt. 2 (with s. 1(3)(4)); S.I. 2023/1363, reg. 2this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F2Art. 6 revoked (1.1.2024) by Retained EU Law (Revocation and Reform) Act 2023 (c. 28), ss. 1(1), 22(3), Sch. 1 Pt. 2 (with s. 1(3)(4)); S.I. 2023/1363, reg. 2this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
Defined TermSection/ArticleIDScope of Application
GMOsart. Article 1GMOs_rtUSmwJ
the registersart. Article 1the_regist_rtyTEQN

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