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Commission Regulation (EC) No 1981/2006Dangos y teitl llawn
Commission Regulation (EC) No 1981/2006 of 22 December 2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms (Text with EEA relevance)
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Changes over time for: Article 3
Changes to legislation:
There are outstanding changes not yet made to Commission Regulation (EC) No 1981/2006. Any changes that have already been made to the legislation appear in the content and are referenced with annotations.
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Changes and effects yet to be applied to Article 3:
- Regulation revoked by S.I. 2019/705 reg. 390 (This amendment not applied to legislation.gov.uk. Reg. 390 substituted by regs. 389-477 immediately before IP completion day by virtue of S.I. 2020/1504, regs. 1(2), 17(21)(22))
- Regulation revoked by S.I. 2019/705, reg. 477 (as substituted) by S.I. 2020/1504 reg. 17(22)
[F1Article 3 U.K. Contributions
1. For each application for a GMO containing a single transformation event, a flat-rate contribution of EUR 40 000 shall be paid by the applicant to the CRL.
2. The CRL shall request the applicant to pay an additional contribution of EUR 65 000 where a full validation procedure of a method of detection and identification for a GMO containing a single transformation event is required in accordance with the following provisions:
(a) Annex III to Implementing Regulation (EU) No 503/2013, when the application is related to:
(i)
genetically modified plants for food or feed uses;
(ii)
food or feed containing or consisting of genetically modified plants;
(iii)
food produced from or containing ingredients produced from genetically modified plants or feed produced from such plants; or
(b) Annex I of Regulation (EC) No 641/2004 in all other cases.
3. For each application for a GMO containing stacked transformation events, where the method of detection and identification of each single transformation event that constitutes the GMO has been validated by the CRL or where the validation is pending, the flat-rate contribution depends on the number (N) of single transformation events that constitute the GMO and shall be calculated as EUR 20 000 + (N × EUR 5 000 ). Only the GMO containing stacked transformation events with the highest number of single transformation events is to be considered in this calculation.
4. For each application for a GMO containing stacked transformation events that consists of one or more single transformation event(s) for which the method of detection and identification has not been validated by the CRL or for which no validation is pending, the contribution shall be calculated as follows: Article 3(1) and 3 (2) shall apply to single transformation event(s) for which no validated method exists and Article 3(3) shall apply to the GMO containing stacked transformation events, N corresponding to the number of single transformation events composing the GMO for which a validated method exists.
5. The CRL shall reduce the amount of the additional contribution referred to in paragraph 2, in proportion of the costs saved:
(a) where the material needed to perform the full validation procedure is supplied by the applicant; and/or
(b) where the applicant provides data that refers to modules, such as DNA extraction protocols and species specific reference systems, already validated and published by the CRL.
6. Where the costs of the validation of the method of detection and identification proposed by the applicant exceed by at least 50 % the amount of the financial contributions mentioned under paragraphs 1, 2 and 3, a further contribution shall be requested. The further contribution shall cover 50 % of the part of the costs exceeding the amount of the contributions referred to in paragraphs 1, 2 and 3.
7. The contributions provided for in paragraphs 1 to 6 remain due in case of withdrawal of the application, without prejudice to Article 5(3).]
Textual Amendments
F1 Substituted by Commission Implementing Regulation (EU) No 120/2014 of 7 February 2014 amending Regulation (EC) No 1981/2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and the Council as regards the Community reference laboratory for genetically modified organisms (Text with EEA relevance).
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