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

CHAPTER I U.K. SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1 U.K. Subject matter

This Regulation establishes, in accordance with the general principles laid down in Regulation (EC) No 178/2002, in particular the need to ensure a high level of consumer protection F1 ... relating to maximum levels of pesticide residues in or on food and feed of plant and animal origin.

Textual Amendments

F1 Words in Art. 1 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(2); 2020 c. 1, Sch. 5 para. 1(1)

Article 2 U.K. Scope

1. This Regulation shall apply to products of plant and animal origin or parts thereof [F2 listed in Part 1 of the MRLs register in relation to a constituent territory] to be used as fresh, processed and/or composite food or feed in or on which pesticide residues may be present.

2. This Regulation shall not apply to the products [F3 listed in Part 1 of the MRLs register in relation to a constituent territory] where it may be established by appropriate evidence that they are intended for:

(a) the manufacture of products other than food or feed; or

(b) sowing or planting; or

(c) activities authorised by national law for the testing of active substances.

3. Maximum residue levels for pesticides set in accordance with this Regulation shall not apply to products [F4 listed in Part 1 of the MRLs register in relation to a constituent territory] intended for export F5 ... and treated before export, where it has been established by appropriate evidence that the F6 ... country of destination requires or agrees with that particular treatment in order to prevent the introduction of harmful organisms into its territory.

F7 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F2 Words in Art. 2(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(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 2(2) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 3(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

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

F5 Words in Art. 2(3) 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(3)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F6 Word in Art. 2(3) 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(3)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F7 Art. 2(4) 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(3)(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 3 U.K. [F8 Definitions: general]

1. For the purpose of this Regulation, the definitions in Regulation (EC) No 178/2002, and the definitions in [F9 Article 2(1) and (2) of Regulation (EC) No 1107/2009] shall apply.

2. The following definitions shall also apply:

[F10 (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 [F11 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 [F12 , 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 F13 ..., which are present in or on the products [F14 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 [F15 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 F16 ... 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

F8 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)

F9 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)

F10 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)

F11 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)

F12 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))

F13 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)

F14 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)

F15 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)

F16 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)

[F17 Article 3A U.K. Definitions: “competent authority” and “constituent territory”

1. In this Regulation, a reference to a competent authority or a constituent territory is to be interpreted in accordance with the provisions of this Article.

2. The Secretary of State is the competent authority for the constituent territory of England.

3. The Welsh Ministers are the competent authority for the constituent territory of Wales.

4. The Scottish Ministers are the competent authority for the constituent territory of Scotland.]

Textual Amendments

F17 Art. 3A inserted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 3(5) (as amended by S.I. 2020/1376, regs. 1(4), 6(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

[F19 Article 4 U.K. List of groups of products for which F18 ... MRLs shall apply

1. The products, product groups and/or parts of products referred to in Article 2(1) to which [F20 MRLs apply in relation to a constituent territory must be established and maintained by the competent authority in a list in Part 1 of the MRLs register]. F21 ... [F22 A list in Part 1 of the MRLs register in relation to a constituent territory] shall include all products for which MRLs are set, as well as the other products for which it is appropriate to apply F23 ... MRLs, in particular in view of their relevance in the diet of consumers or in trade. Products shall be grouped in such a way that MRLs may as far as possible be set for a group of similar or related products.]

[F24 2. A competent authority may add, amend or remove an entry from the list in Part 1 of the MRLs register accordingly as the competent authority considers appropriate.

3. The Secretary of State may exercise a function under this Article instead of the competent authority—

(a) in relation to Wales, with the consent of the Welsh Ministers;

(b) in relation to Scotland, with the consent of the Scottish Ministers.]

Textual Amendments

F18 Word in Art. 4 heading 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(6)(a); 2020 c. 1, Sch. 5 para. 1(1)

F19 Substituted by Regulation (EC) No 299/2008 of the European Parliament and of the Council of 11 March 2008 amending Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin, as regards the implementing powers conferred on the Commission.

F20 Words in Art. 4(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(6)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F21 Words in Art. 4(1) 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(6)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F22 Words in Art. 4(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(6)(b)(iii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F23 Word in Art. 4(1) 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(6)(b)(iii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F24 Art. 4(2)(3) substituted for Art. 4(2) (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 3(6)(c) (as amended by S.I. 2020/1376, regs. 1(4), 6(2)(c)); 2020 c. 1, Sch. 5 para. 1(1)

[F25 Article 5 U.K. Active substances for which no MRLs are required

1. A competent authority must establish and maintain a list in Part 4 of the MRLs register of active substances evaluated under Regulation (EC) No 1107/2009 for which MRLs are not required in relation to its constituent territory, taking into account the uses of those active substances and the matters referred to in Article 14(2)(a), (c) and (d).

2. A competent authority must update the MRLs register accordingly as soon as reasonably practicable—

(a) after first establishing a list in accordance with paragraph 1, and

(b) after adding to or removing an entry from that list.

3. The Secretary of State may exercise a function under this Article instead of the competent authority—

(a) in relation to Wales, with the consent of the Welsh Ministers;

(b) in relation to Scotland, with the consent of the Scottish Ministers.]

Textual Amendments

F25 Art. 5 substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 3(7) (as amended by S.I. 2020/1376, regs. 1(4), 6(2)(c)); 2020 c. 1, Sch. 5 para. 1(1)