Article 3 Principles for extrapolation

United Kingdom

F1(1.)

The F2appropriate authority shall consider the extrapolation of MRLs where there is MRL or ‘No MRL required’ status established for the pharmacologically active substance and one of the following circumstances applies to the concerned species:

(1)
It is related to a major reference species for which MRLs have been established or a ‘No MRL required’ status exists for the concerned tissue/food commodity;
(2)
It is related to a minor reference species for which MRLs have been established or a ‘No MRL required’ status exists for the concerned tissue/food commodity;
(3)
It is unrelated to the reference species for which MRLs have been established or a ‘No MRL required’ status exists for the concerned tissue/food commodity;
(4)
MRL has been established for the concerned species but not for the concerned tissue/food commodity.

F3( 2.)

In paragraph 1, “appropriate authority” means—

(a)

in relation to England, Wales and Scotland, the Secretary of State;

(b)

in relation to Northern Ireland, the Department of Agriculture, Environment and Rural Affairs.

(3.)

But the appropriate authority is the Secretary of State if consent is given in relation to Northern Ireland by the Department of Agriculture, Environment and Rural Affairs.

Annotations

Textual amendments

F1: Art. 3 renumbered as Art. 3(1) (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), 9(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in Art. 3(1) 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), 9(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
F3: Art. 3(2)(3) inserted (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), 9(3)(c); 2020 c. 1, Sch. 5 para. 1(1)