# Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (Text with EEA relevance), Article 8: Application for a maximum residue limit

Extent: E+W+S+N.I.

1. An application under these Regulations for a new or amended maximum residue limit for a substance intended for use in a veterinary medicinal product must be made to the Secretary of State.
2. An application must include all necessary administrative information, and all scientific documentation necessary for demonstrating the safety of the substance.
3. The applicant must pay to the Secretary of State the application fee, which is—
a) for a new maximum residue limit in respect of a substance, £62,300;
b) for an amended maximum residue limit in respect of a substance, £18,850.
4. The Secretary of State must ensure that where a valid application is received, the substance is classified under Article 14 within 210 days.
5. For the purposes of paragraph 4 an application is valid when both the requirements in paragraphs 2 and 3 have been complied with.
6. As soon as practicable after the substance is classified under Article 14, the Secretary of State must publish—
a) a notice setting out the classification;
b) the assessment report that has been prepared, with any commercially confidential or personal information deleted.
7. If the Secretary of State classifies a substance under Article 14(2)(b) or (d), the Secretary of State must notify the applicant accordingly, and the applicant may appeal to the Veterinary Products Committee under regulation 29 of the Veterinary Medicines Regulations 2013.

---
Source: https://www.legislation.gov.uk/eur/2009/470/article/8 (the official version)
Page: https://openlegislation.uk/eu-regulation-2009-470/article-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.