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

CHAPTER II U.K. PROCEDURE FOR APPLICATIONS FOR MRLS

SECTION 1 U.K. Submission of applications for MRLs

Article 6 U.K. Applications

[F1 1. Where a competent authority envisages granting an authorisation for the use of a plant protection product in accordance with Regulation (EC) No 1107/2009, the competent authority must consider whether, in relation to its constituent territory—

(a) as a result of such use an MRL listed in Part 2 or 3 of the MRLs register needs to be modified;

(b) as a result of such use it is necessary to set a new MRL;

(c) the active substance contained in the plant protection product does not require the setting of an MRL and therefore should be listed in Part 4 of the MRLs register.

1A. The competent authority referred to in paragraph 1 may require the person requesting the grant of that authorisation for the plant protection product to submit an application in accordance with Article 7.]

2. All parties demonstrating, through adequate evidence, a legitimate interest in health, including civil society organisations, as well as commercially interested parties such as manufacturers, growers, importers and producers of products [F2 listed in Part 1 of the MRLs register in relation to a constituent territory] may also submit an application to [F3 the competent authority for that constituent territory] in accordance with Article 7.

3. Where a [F4 competent authority] considers that the setting, modification or deletion of an MRL is necessary, that [F4 competent authority] may also compile and evaluate an application F5 ... in accordance with Article 7.

4. Applications for import tolerances shall be submitted to [F6 any competent authority]. Such applications shall be made in accordance with Article 7 of this Regulation.

Textual Amendments

F1 Art. 6(1)(1A) substituted for Art. 6(1) (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 6(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(2)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 6(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(2)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 6(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(2)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 6(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), 4(2)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 6(4) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(2)(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 7 U.K. Requirements relating to applications for MRLs

1. The applicant shall include in an application for an MRL the following particulars and documents:

(a) the name and address of the applicant;

(b) a presentation of the application dossier including:

(i)

a summary of the application;

(ii)

the main substantive arguments;

(iii)

an index of the documentation;

(iv)

a copy of the relevant GAP applying to the specific use of that active substance;

(c) a comprehensive overview of relevant concerns raised in the available scientific literature about the plant protection product and/or its residue;

(d) the data [F7 required under Article 8(4) of Regulation (EC) No 1107/2009] relating to data requirements for the setting of MRLs for pesticides [F8 in relation to the constituent territory to which the application relates] including, where appropriate, toxicological data and data on routine analytical methods for use in control laboratories, as well as plant and animal metabolism data.

However, where relevant data are already publicly available, in particular when an active substance has already been evaluated under [F9 Regulation (EC) No 1107/2009 in relation to that constituent territory] or when a CXL exists and such data are submitted by the applicant, a [F10 competent authority] may also use such information in evaluating an application. In such cases, the evaluation report shall include a justification for using or not using such data.

2. The evaluating [F11 competent authority] may, where appropriate, request the applicant to provide supplementary information in addition to information required under paragraph 1 within a time limit specified by the [F11 competent authority]. In no event may this period exceed two years.

Textual Amendments

F7 Words in Art. 7(1)(d) substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(3)(a)(i)(aa) (with Sch. 1 para. 10) (as amended by S.I. 2020/1376, regs. 1(4), 6(9)); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 7(1)(d) inserted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(3)(a)(i)(bb) (with Sch. 1 para. 10) (as amended by S.I. 2020/1376, regs. 1(4), 6(9)); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Art. 7(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(3)(a)(ii)(aa) (with Sch. 1 para. 10) (as amended by S.I. 2020/1376, regs. 1(4), 6(9)); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in Art. 7(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(3)(a)(ii)(bb) (with Sch. 1 para. 10) (as amended by S.I. 2020/1376, regs. 1(4), 6(9)); 2020 c. 1, Sch. 5 para. 1(1)

F11 Words in Art. 7(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(3)(b) (with Sch. 1 para. 10) (as amended by S.I. 2020/1376, regs. 1(4), 6(9)); 2020 c. 1, Sch. 5 para. 1(1)

Article 8 U.K. Evaluation of applications

1. A [F12 competent authority] to which an application complying with Article 7 is submitted pursuant to Article 6 shall immediately [F13 notify the other competent authorities] and draw up an evaluation report without undue delay.

[F14 1A. A competent authority notified in accordance with paragraph 1 may request from the notifying competent authority a copy of the application received, and where such a request is received the notifying competent authority must provide a copy as soon as reasonably practicable.]

[F15 2. Applications must be evaluated in accordance with—

(a) principles set by regulations made under paragraph 2A in relation to the constituent territory, or

(b) where there are no such regulations, the uniform principles for the evaluation and authorisation of plant protection products prescribed in accordance with Article 29(6) of Regulation (EC) No 1107/2009 in relation to the constituent territory.

2A. The appropriate authority may, by regulations, set evaluation principles for applications for MRLs.

2B. In paragraph 2A, “the appropriate authority” means—

(a) for regulations applying in relation to England, the Secretary of State;

(b) for regulations applying in relation to Wales, the Welsh Ministers;

(c) for regulations applying in relation to Scotland, the Scottish Ministers.

2C. But the appropriate authority is the Secretary of State if consent is given by—

(a) for regulations applying in relation to Wales, the Welsh Ministers;

(b) for regulations applying in relation to Scotland, the Scottish Ministers.

3. A competent authority may, by agreement, transfer the evaluation of an application to another competent authority, provided the relevant principles referred to in paragraph 2 are the same in relation to the constituent territory of each of those competent authorities.

3A. A transfer in accordance with paragraph 3 does not affect anything done by a competent authority prior to transfer.]

F16 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F12 Words in Art. 8(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(4)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Art. 8(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(4)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F14 Art. 8(1A) inserted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F15 Art. 8(2)-(3A) substituted for Art. 8(2) (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(4)(c) (as amended by S.I. 2020/1376, regs. 1(4), 6(3)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F16 Art. 8(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), 4(4)(d); 2020 c. 1, Sch. 5 para. 1(1)

[F17 Article 8A U.K. The competent authority's opinion on applications concerning MRLs

1. An evaluation report under Article 8 must include the competent authority's reasoned opinion on, in particular, the risks to the consumer and where relevant to animals associated with the setting, modification or deletion of an MRL.

2. The reasoned opinion must include—

(a) an assessment of whether the analytical method for routine monitoring proposed in the application is appropriate for the intended control purposes;

(b) the anticipated LOD for the pesticide/product combination;

(c) an assessment of the risks of the acceptable daily intake or acute reference dose being exceeded as a result of the modification of the MRL;

(d) the contribution to the acceptable daily intake due to the residues in the product for which the MRL was requested;

(e) any other element relevant to the risk assessment.

3. The reasoned opinion must clearly define the basis for each conclusion reached.

4. The competent authority may request supplementary information from the applicant where necessary for the giving of a reasoned opinion.]

Textual Amendments

F17 Art. 8A inserted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(5); 2020 c. 1, Sch. 5 para. 1(1)

[F18 Article 9 U.K. Notification of evaluated applications

1. After completion of the evaluation report under Article 8 the competent authority must without delay—

(a) forward the application, evaluation report and supporting dossier to the other competent authorities;

(b) forward a copy of its reasoned opinion to the applicant;

(c) make a copy of the reasoned opinion public, subject to paragraphs 2 and 3.

2. The duty in paragraph 1(c) does not apply to third party confidential information received by the competent authority for which confidential treatment has been requested and justified.

3. Paragraph 2 does not apply to—

(a) information which must be made public in order to protect public health;

(b) the conclusions of the reasoned opinion relating to foreseeable health effects.]

Textual Amendments

F18 Art. 9 substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(6); 2020 c. 1, Sch. 5 para. 1(1)

SECTION 2 U.K. [F19 Assessment of existing MRLs by the competent authority]

F20 Article 10 U.K. The Authority's opinion on applications concerning MRLs

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F20 Art. 10 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(8); 2020 c. 1, Sch. 5 para. 1(1)

F21 Article 11 U.K. Time limits for the Authority's opinion on applications concerning MRLs

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F21 Art. 11 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(8); 2020 c. 1, Sch. 5 para. 1(1)

[F22 Article 12 U.K. Assessment of existing MRLs by the competent authority

1. A competent authority must produce a reasoned opinion within a period of 36 months beginning with the date on which an active substance approval decision is made in respect of an active substance in relation to its constituent territory, except where paragraph 2 applies.

2. Where at the end of the 36 month period described in paragraph 1 there are outstanding renewals of authorisations under Article 43 of Regulation (EC) No 1107/2009 relating to that active substance in relation to its constituent territory, a competent authority must instead produce a reasoned opinion before the end of the period of 6 months beginning with the date on which the last of those outstanding renewals is concluded.

3. The reasoned opinion must be based in particular on the relevant assessment report prepared under Regulation (EC) No 1107/2009, and must include—

(a) existing MRLs for that active substance set out in Part 2 or 3 of the MRLs register in relation to the competent authority's constituent territory;

(b) the necessity of setting a new MRL for that active substance, or its inclusion in Part 4 of the MRLs register;

(c) specific processing factors as referred to in Article 20(2) that may be needed for that active substance;

(d) MRLs which the competent authority may consider including in Part 2 or 3 of the MRLs register and those MRLs related to that active substance which may be deleted.

4. In paragraph 1, an “active substance approval decision” means a decision by the competent authority under Article 13(1) or 20(1) of Regulation (EC) No 1107/2009.

5. The Secretary of State may produce a reasoned opinion under this Article 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 produces a reasoned opinion in accordance with paragraph 5—

(a) a reference in paragraphs 1 to 3 to the competent authority is to be read as a reference to the Secretary of State;

(b) the Secretary of State must send a copy of the produced reasoned opinion to the competent authority.]

Textual Amendments

F22 Art. 12 substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(9) (with Sch. 1 para. 11) (as amended by S.I. 2019/1410, regs. 1(2), 7(3)(b) and S.I. 2020/1376, regs. 1(4), 6(3)(b)(9)(e)); 2020 c. 1, Sch. 5 para. 1(1)

F23 Article 13 U.K. Administrative review

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F23 Art. 13 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(10); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F19 Ch. 2 Section 2 heading substituted (31.12.2020) by The Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/557), regs. 1(1), 4(7); 2020 c. 1, Sch. 5 para. 1(1)

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

Article 14 U.K. Decisions on applications [F24 or opinions] concerning MRLs

[F25 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. [F26 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 [F27 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 [F28 competent authority] may request at any time that supplementary information be provided by the applicant or [F29 , 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 [F28 competent authority] shall make available any supplementary information received to the [F30 other competent authorities].

[F31 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

F24 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)

F25 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)

F26 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)

F27 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)

F28 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)

F29 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)

F30 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)

F31 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)

[F32 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

F32 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. [F33 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 [F34 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 [F35 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 [F36 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 [F37 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 F38 ....

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 [F39 Part 3 of the MRLs register].

[F40 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

F33 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)

F34 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)

F35 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)

F36 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)

F37 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)

F38 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)

F39 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)

F40 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)

[F41 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

F41 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)

[F41 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

F41 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)