Regulation (EC) No 396/2005 of the European Parliament and of the CouncilDangos y teitl llawn

SECTION 3 U.K. Setting, modifying or deletion of MRLs

Article 14 U.K. Decisions on applications [F1 or opinions] concerning MRLs

[F2 1. Within 3 months of completing the evaluation of an application under Article 8 or producing or receiving a reasoned opinion under Article 12, a competent authority must decide to take one of the actions set out in paragraph 1B(a) to (c).

1A. Within 3 months of receiving an evaluation report under Article 9(1)(a), a competent authority may decide to—

(a) take the action outlined in paragraph 1B(a) or (b), or

(b) take no action.

1B. The actions are—

(a) set a new MRL in relation to its constituent territory,

(b) modify or delete an existing MRL, or

(c) reject the application, or take no further action in respect of the reasoned opinion.

1C. A new MRL set under paragraph 1B(a) applies from a date set by the competent authority.

1D. The modification or deletion of an MRL under paragraph 1B(b) applies from a date set by the competent authority in accordance with paragraph 1E.

1E. The date described in paragraph 1D must be at least 6 months after the day on which the decision under paragraph 1 or 1A is made, except where the competent authority considers that an earlier date is necessary to avoid endangering human or animal health.]

2. [F3 In making a decision under paragraphs 1 or 1A, the competent authority must take account of—]

(a) the scientific and technical knowledge available;

(b) the possible presence of pesticide residues arising from sources other than current plant protection uses of active substances, and their known cumulative and synergistic effects, when the methods to assess such effects are available;

(c) the results of an assessment of any potential risks to consumers with a high intake and high vulnerability and, where appropriate, to animals;

(d) the results of any evaluations and decisions to modify the uses of plant protection products;

(e) a CXL or a GAP implemented in [F4 another] country for the legal use of an active substance in that country;

(f) other legitimate factors relevant to the matter under consideration.

3. The [F5 competent authority] may request at any time that supplementary information be provided by the applicant or [F6 , where the Secretary of State provided the reasoned opinion to the competent authority in accordance with Article 12(6)(b), the Secretary of State]. The [F5 competent authority] shall make available any supplementary information received to the [F7 other competent authorities].

[F8 4. As soon as reasonably practicable after making a decision under paragraph 1 or 1A, the competent authority must—

(a) notify the other competent authorities and any applicant in writing of the decision and the reasons for it, and

(b) update the MRLs register accordingly.

5. The Secretary of State may make a decision under paragraph 1 or 1A instead of a 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.

6. Where the Secretary of State makes a decision in accordance with paragraph 5, a reference in paragraphs 1C to 4 to the competent authority is to be read as a reference to the Secretary of State.]

Textual Amendments

F1 Words in Art. 14 heading inserted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(11)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Art. 14(1)-(1E) substituted for Art. 14(1) (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(11)(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 14(2) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(11)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F4 Word in Art. 14(2)(e) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(11)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 14(3) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(11)(d)(i); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 14(3) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(11)(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 14(3) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(11)(d)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F8 Art. 14(4)-(6) inserted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(11)(e) (as amended by S.I. 2020/1376, regs. 1(4), 6(3)(c)); 2020 c. 1, Sch. 5 para. 1(1)

[F9 Article 15 U.K. Setting of new MRLs

1 This Article applies where the competent authority decides to set a new MRL in accordance with Article 14(1B)(a).

2 The competent authority—

(a) may set a temporary MRL in relation to its constituent territory—

(i) for an active substance which is not approved under Regulation (EC) No 1107/2009 in relation to that territory, or

(ii) in the circumstances described in Article 16(1);

(b) otherwise, must set an MRL in relation to its constituent territory.

3 A temporary MRL set in accordance with paragraph 2(a)(i) expires after 12 months unless—

(a) deleted in accordance with Article 14(1B)(b), or

(b) extended in accordance with paragraphs 4 or 5.

4 A competent authority may extend a temporary MRL set in accordance with paragraph 2(a)(i) by a further 12 months where confirmation is pending that any scientific studies necessary for supporting an application for setting an MRL have been undertaken.

5 Where the confirmation described in paragraph 4 is received, a competent authority may extend the temporary MRL by a further 24 months provided that no unacceptable safety concerns for consumers have been identified.

6 Where the competent authority extends the period of the temporary MRL in accordance with paragraph 4 or 5, the competent authority must update the MRLs register accordingly.

7 Where the Secretary of State makes a decision under Article 14(5) to set a new MRL in accordance with Article 14(1B)(a), a reference to the competent authority in paragraphs 1 and 2 is to be read as a reference to the Secretary of State.

8 The Secretary of State may extend a temporary MRL in accordance with paragraphs 4 or 5 instead of a 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.

9 Where the Secretary of State extends a temporary MRL in accordance with paragraph 8, a reference in paragraph 6 to the competent authority is to be read as a reference to the Secretary of State.]

Textual Amendments

F9 Art. 15 substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(12) (as amended by S.I. 2020/1376, regs. 1(4), 6(3)(d)); 2020 c. 1, Sch. 5 para. 1(1)

Article 16 U.K. Procedure for setting temporary MRLs in certain circumstances

1. [F10 The competent authority may set a temporary MRL in the following circumstances—]

(a) in exceptional cases, in particular where pesticide residues may arise as a result of environmental or other contamination or from uses of plant protection products pursuant to [F11 Article 53 of Regulation (EC) No 1107/2009]; or

(b) where the products concerned constitute a minor component of the diet of consumers, and do not constitute a major part of the diet of relevant subgroups, and, where relevant, of animals; or

(c) for honey; or

(d) for herbal infusions; or

(e) where essential uses of plant protection products have been identified by [F12 the competent authority in deciding to refuse approval or the renewal of approval, or to withdraw approval, for an active substance under Regulation (EC) No 1107/2009]; or

(f) where new products, product groups and/or parts of products have been included in [F13 the list in Part 1 of the MRLs register in relation to its constituent territory], in order to allow any scientific studies necessary for supporting an MRL to be undertaken and evaluated, provided that no unacceptable safety concerns for the consumer have been identified.

2. The inclusion of temporary MRLs as referred to in paragraph 1 shall be based on the opinion of the [F14 competent authority], monitoring data and an assessment demonstrating that there are no unacceptable risks to consumers or animals.

The continued validity of the temporary MRLs referred to in paragraphs 1(a), (b), (c) and (d) shall be reassessed at least once every 10 years F15 ....

The MRLs referred to in paragraph 1(e) shall be reassessed at the expiry of the period for which the essential use was authorised. The MRLs referred to in paragraph 1(f) shall be reassessed when the scientific studies have been completed and evaluated, but no later than four years after their inclusion in [F16 Part 3 of the MRLs register].

[F17 3. Upon reassessment of a temporary MRL in accordance with paragraph 2, the competent authority—

(a) may modify or delete the temporary MRL, and

(b) where the competent authority does so, must update the MRLs register accordingly.

4. Where the Secretary of State makes a decision in accordance with Article 15(2)(a)(ii), a reference to the competent authority in paragraphs 1 and 2 is to be read as a reference to the Secretary of State.

5. The Secretary of State may reassess a temporary MRL in accordance with the second or third subparagraph of paragraph 2 instead of a 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.

6. Where the Secretary of State reassesses a temporary MRL in accordance with paragraph 5, a reference in paragraph 3 to the competent authority is to be read as a reference to the Secretary of State.]

Textual Amendments

F10 Words in Art. 16(1) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(13)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F11 Words in Art. 16(1)(a) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(13)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F12 Words in Art. 16(1)(e) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(13)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Art. 16(1)(f) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(13)(a)(iv); 2020 c. 1, Sch. 5 para. 1(1)

F14 Words in Art. 16(2) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(13)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F15 Words in Art. 16(2) 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), 4(13)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in Art. 16(2) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(13)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F17 Art. 16(3)-(6) inserted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(13)(c) (as amended by S.I. 2020/1376, regs. 1(4), 6(3)(e)); 2020 c. 1, Sch. 5 para. 1(1)

[F18 Article 17 U.K. Modifications of MRLs following withdrawal of authorisations of plant protection products

1. Where a competent authority withdraws an authorisation for a plant protection product, the competent authority—

(a) may modify or delete a MRL, and

(b) where the competent authority does so, must update the MRLs register accordingly.

2. The Secretary of State may modify or delete an MRL in accordance with paragraph (1)(a) 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.

3. Where the Secretary of State modifies or deletes an MRL in accordance with paragraph 2, the Secretary of State must update the MRLs register accordingly.]

Textual Amendments

F18 Arts. 17, 17A substituted for Art. 17 (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(14) (as amended by S.I. 2020/1376, regs. 1(4), 6(3)(f)); 2020 c. 1, Sch. 5 para. 1(1)

[F18 Article 17A U.K. Transitional provision for modified MRLs

1. Paragraph 2 applies where a competent authority modifies an MRL in relation to its constituent territory for a pesticide residue by lowering it, under Article 14(1B)(b), 16, 17 or 18(6).

2. The competent authority may exempt one or more products produced before the relevant date from the application of the modified MRL where—

(a) the competent authority considers it necessary to allow for the normal marketing, processing or consumption of each product exempted, and

(b) the competent authority is satisfied that in doing so a high level of consumer protection can be ensured.

3. Where the competent authority exempts a product from the application of a modified MRL for a pesticide residue in accordance with paragraph 2—

(a) an entry in Parts 2 to 5 of the MRLs register in relation to the competent authority's constituent territory which immediately before the relevant date applied in respect of that product and pesticide residue continues to apply in respect of that product and pesticide residue on and after the relevant date, and

(b) the competent authority must update the MRLs register accordingly.

4. Where the Secretary of State modifies an MRL for a pesticide residue by lowering it in accordance with Article 14(5), 16(6) or 17(2), a reference in paragraphs 1 to 3 to competent authority is to be read as a reference to Secretary of State.

5. In this Article, “relevant date” means the date from which the modified MRL applies in accordance with Article 14(1D).]

Textual Amendments

F18 Arts. 17, 17A substituted for Art. 17 (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(14) (as amended by S.I. 2020/1376, regs. 1(4), 6(3)(f)); 2020 c. 1, Sch. 5 para. 1(1)