Regulation (EC) No 396/2005 of the European Parliament and of the CouncilShow full title

Article 3 U.K. [F1 Definitions: general]

1. For the purpose of this Regulation, the definitions in Regulation (EC) No 178/2002, and the definitions in [F2 Article 2(1) and (2) of Regulation (EC) No 1107/2009] shall apply.

2. The following definitions shall also apply:

[F3 (za) ‘Regulation (EC) No 1107/2009’ means Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market;

(zb) ‘MRLs register’ means the register maintained in accordance with Article 46A;]

(a) ‘good agricultural practice’ (GAP) means the nationally recommended, authorised or registered safe use of plant protection products under actual conditions at any stage of production, storage, transport, distribution and processing of food and feed. It also implies the application [F4 of the principles of integrated pest management referred to in Article 14 of and Annex 3 to Directive 2009/128/EC of the European Parliament and of the Council establishing a framework for Community action to achieve the sustainable use of pesticides], as well as using the minimum quantity of pesticides and setting MRLs/temporary MRLs at the lowest level which allows the desired effect to be obtained [F5 , and for these purposes Directive 2009/128/EC is to be read as if—

(i) Article 3(10)(b) were omitted;

(ii) in Article 14—

• obligations on Member States were obligations on the competent authorities;

• paragraph 3 were omitted];

(b) ‘critical GAP’ means the GAP, where there is more than one GAP for an active substance/product combination, which gives rise to the highest acceptable level of pesticide residue in a treated crop and is the basis for establishing the MRL;

(c) ‘pesticide residues’ means residues, including active substances, metabolites and/or breakdown or reaction products of active substances currently or formerly used in plant protection products F6 ..., which are present in or on the products [F7 listed in Part 1 of the MRLs register in relation to a constituent territory], including in particular those which may arise as a result of use in plant protection, in veterinary medicine and as a biocide;

(d) ‘maximum residue level’ (MRL) means the upper legal level of a concentration for a pesticide residue in or on food or feed set in accordance with this Regulation, based on good agricultural practice and the lowest consumer exposure necessary to protect vulnerable consumers;

(e) ‘CXL’ means an MRL set by the Codex Alimentarius Commission;

(f) ‘limit of determination’ (LOD) means the validated lowest residue concentration which can be quantified and reported by routine monitoring with validated control methods;

(g) ‘import tolerance’ means an MRL set for imported products to meet the needs of international trade where:

• (g) the use of the active substance in a plant protection product on a given product is not authorised in [F8 a constituent territory] for reasons other than public health reasons for the specific product and specific use; or

• a different level is appropriate because the existing F9 ... MRL was set for reasons other than public health reasons for the specific product and specific use;

(h) ‘proficiency test’ means a comparative test in which several laboratories perform analyses on identical samples, allowing an evaluation of the quality of the analysis performed by each laboratory;

(i) ‘acute reference dose’ means the estimate of the amount of substance in food, expressed on a body weight basis, that can be ingested over a short period of time, usually during one day, without appreciable risk to the consumer on the basis of the data produced by appropriate studies and taking into account sensitive groups within the population (e.g. children and the unborn);

(j) ‘acceptable daily intake’ means the estimate of the amount of substances in food expressed on a body weight basis, that can be ingested daily over a lifetime, without appreciable risk to any consumer on the basis of all known facts at the time of evaluation, taking into account sensitive groups within the population (e.g. children and the unborn).

Textual Amendments

F1 Art. 3 heading substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 3(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 3(1) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 3(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Art. 3(2)(za)(zb) inserted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 3(4)(c)(i) (as amended by S.I. 2020/1376, regs. 1(4), 6(2)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 3(2)(a) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 3(4)(c)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 3(2)(a) inserted (31.12.2020) by S.I. 2019/557, reg. 3(4)(c)(ii)(bb) (as substituted by The Pesticides (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1410), regs. 1(2), 7(2); 2020 c. 1, Sch. 5 para. 1(1))

F6 Words in Art. 3(2)(c) omitted (31.12.2020) by virtue of The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 3(4)(c)(iii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 3(2)(c) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 3(4)(c)(iii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 3(2)(g) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 3(4)(c)(iv)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F9 Word in Art. 3(2)(g) omitted (31.12.2020) by virtue of The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 3(4)(c)(iv)(bb); 2020 c. 1, Sch. 5 para. 1(1)