OpenLegislation

Annex APPLICATION/REQUEST FOR THE ESTABLISHMENT OF MAXIMUM RESIDUE LIMITS

United Kingdom

Original text. Later amendments are not shown.

  1. 1..

    The application or the request shall include all administrative information and scientific documentation necessary for demonstrating the safety of the residues of the substance in question and risk management considerations.

  2. 2..

    All volumes of the dossier shall be clearly numbered and paginated. Particular care shall be taken to ensure that there is adequate cross-referencing between volumes and between the detailed and critical summaries and the original data. Electronic submissions shall comply with guidance on veterinary e-Submissions published by the F1appropriate authority.

  3. 3..

    Where reference is made to published information, complete copies of the relevant articles should be inserted in the relevant section of the dossier.

  4. 4..

    The application or the request shall be submitted in accordance with the requirements specified below respecting the order of presentation indicated.

  5. 5..

    Pharmacological, toxicological and residue tests, results of which are accompanying an application or a request for the establishment of MRLs, shall be carried out in conformity with Directive 2004/10/EC of the European Parliament and of the Councilf1 and Directive 2010/63/EU of the European Parliament and of the Councilf2.

  1. 1ADMINISTRATIVE INFORMATION
  2. 2DATA FOR SCIENTIFIC RISK ASSESSMENT
  3. 3RISK MANAGEMENT CONSIDERATIONS

Annotations

Textual amendments

F1

Words in Annex para. 2 substituted (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 8(5)(a); 2020 c. 1, Sch. 5 para. 1(1)

Footnotes

f1

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).

f2

Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).