Subject matter and scope
Article 1
Open ↗Regulation (EC) No 378/2005 is amended as follows: (1) Article 1 is replaced by the following: ‘Article 1 Subject matter and scope This Regulation lays down detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the duties and tasks of the Community Reference Laboratory (the CRL), which is the Joint Research Centre of the Commission located in Geel, Belgium.’ ; (2) Article 3(4) is amended as follows: (a) the introductory phrase is replaced by the following: ‘Unless the applicant is required to supply reference samples in accordance with paragraph 3, reference samples shall not be required for:’; (b) the following point (c) is added: ‘(c) an application for renewal of an existing authorisation submitted in accordance with Article 14 of Regulation (EC) No 1831/2003, provided the reference samples held by the CRL in relation to the existing authorisation of the feed additive are in the form in which the feed additive is intended to be placed on the market.’; (3) in Article 4, the following paragraph 4 is added: ‘4. Where the CRL considers that, due to developments following the submission of the application, additional duties and tasks are to be performed and the final fee rates relevant to the type of application concerned are to be higher than those calculated at the time of the submission of the application, it shall communicate those considerations and the corresponding additional fee to the applicant. The applicant shall notify the CRL about any disagreement on the additional fee within 15 days of receipt of the communication.’; (4) in Article 5(2), the following point (aa) is added: ‘(aa) an indication of which of the duties and tasks set out in Annex II to Regulation (EC) No 1831/2003 could not be carried out as a result of the disagreement notified by the applicant on additional fees as referred to in Article 4(4);’; (5) in Article 5(4), the second subparagraph is replaced by the following: ‘Notwithstanding paragraph 4, the Commission, the CRL or the Authority may, on the basis of legitimate factors relevant to the application, in particular the need to adapt the methods of analysis in the light of scientific and technological developments, consider that a new evaluation of the methods of analysis is necessary. In such cases the applicant shall be informed by the CRL and Article 4(4) shall apply.’; (6) Article 6 is replaced by the following: ‘Article 6 National reference laboratories 1. The CRL shall be assisted by a consortium of national reference laboratories (the consortium) for the duties and tasks set out in points 2.2, 2.4 and 3 of Annex II to Regulation (EC) No 1831/2003. 2. The Member States may designate national reference laboratories for the purpose of inclusion in the list of national reference laboratories participating in the consortium, provided that the designated national reference laboratories comply with the requirements set out in Annex I. The Member States shall communicate those designations to the CRL and the Commission. The CRL shall be responsible for the publication on its website of the list of the national reference laboratories designated by the Member States, including the name and address of each of them, and for the update of that list, whenever necessary, upon reception of the relevant information. The same procedure shall apply if a Member State wishes to withdraw from the consortium a national reference laboratory that it designated. 3. The first publication by the CRL of the list of national reference laboratories designated by the Member States to take part in the consortium shall be with effect from 5 February 2026. 4. The members of the consortium and the CRL shall make arrangements for defining the relations between them, particularly in financial matters. In particular, the arrangements may provide that the CRL is to distribute a share of the fees it receives to the members of the consortium. The arrangements between the members of the consortium and the CRL shall be adapted to reflect any changes to the consortium. Without prejudice to the provisions of those arrangements, the CRL may issue guidance to the members of the consortium as provided for in Article 12(2).’ ; (7) Article 9(2) is deleted; (8) Article 12(2) is replaced by the following: ‘2. The CRL may establish detailed guidance for national reference laboratories, including criteria for appointing rapporteur laboratories.’ ; (9) Annex I is amended as follows: (a) the title is replaced by the following: ‘ Requirements for laboratories participating in the consortium of national reference laboratories, as referred to in Article 6(2) ’; (b) point (a) of Annex I is replaced by the following: ‘(a) have been designated as a national reference laboratory by a Member State for the purpose of taking part in the consortium referred to in Article 21 and Annex II to Regulation (EC) No 1831/2003;’; (10) Annex II is deleted; (11) Annex IV, under the heading ‘Rates according to the type of application for authorisations of feed additives in accordance with Regulation (EC) No 1831/2003’, is amended as follows: (a) point 4 is replaced by the following: ‘4. Applications for changing the terms of an existing authorisation (Article 13(3) of Regulation (EC) No 1831/2003): — when Article 3(4), point (b) and Article 5(4), point (b) apply: Fee = EUR 0 — when only Article 3(4), point (b) applies, only Component 2 is applicable: Fee = EUR 4 000 — when neither Article 3(4), point (b) nor Article 5(4), point (b) applies: Fee = Component 1 + Component 2 = EUR 6 000 ’; (b) point 5 is replaced by the following: ‘5. Applications for renewal of an authorisation of a feed additive (Article 14 of Regulation (EC) No 1831/2003): — when Article 3(4), point (c) and Article 5(4), point (c) apply: Fee = EUR 0 — when only Article 3(4), point (c) applies, only Component 2 is applicable: Fee = EUR 4 000 — when neither Article 3(4), point (c) nor Article 5(4), point (c) applies: Fee = Component 1 + Component 2 = EUR 6 000.’.