The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019

Chapter 2 U.K.

4.—(1) Chapter 2 is amended as follows.

(2) In Article 4—

(a) in paragraphs 2(a) and 3(b) and (e), for “by the Authority” substitute “ in accordance with paragraph 8 ”;

(b) in paragraph 4, for “Article 29(6)” substitute “ Article 29(6)(a) which apply to each constituent territory to which approval of the active substance relates ”;

(c) in paragraph 7—

(i) in the third subparagraph—

(aa) for “Member States” substitute “ A competent authority ”;

(bb) for “their” substitute “ its constituent ”;

(ii) in the fourth subparagraph—

(aa) for “they” substitute “ the competent authority ”;

(bb) for “transmit that plan to the Commission” substitute “ publish that plan in a manner which the competent authority considers appropriate ”;

(d) after paragraph 7 insert—

“8.   For the purposes of paragraphs 2(a) and 3(b) and (e), scientific methods are accepted if they are accepted—

(a) in relation to England, by the Secretary of State;

(b) in relation to Wales—

(i) by the Secretary of State with the consent of the Welsh Ministers, or

(ii) by the Welsh Ministers;

(c) in relation to Scotland—

(i) by the Secretary of State with the consent of the Scottish Ministers, or

(ii) by the Scottish Ministers;

F1 (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .”.

(3) For Article 5 substitute—

“Article 5 U.K. First approval

1.   First approval must be for a period not exceeding—

(a) 10 years for an active substance, safener or synergist;

(b) 15 years for a low-risk active substance (see Article 22);

(c) 7 years for a candidate for substitution (see Article 24).

2.   Paragraph 1 is subject to Article 17.

3.   Approval for a basic substance (see Article 23) is for an unlimited period.”.

(4) In Article 6—

(a) the existing text becomes paragraph 1;

(b) in that paragraph, in point (f), for the words from “Member States” to “(the Authority)” substitute “ each specified competent authority within a specified period ”;

(c) after that paragraph insert—

“2.   A competent authority may request from a specified competent authority a copy of any confirmatory information received in accordance with paragraph 1(f), which the specified competent authority must provide as soon as reasonably practicable.

3.   In this Article, “specified” means specified in the condition referred to in paragraph 1(f).”.

(5) In Article 7—

(a) for paragraph 1 substitute—

“1.   An application for the approval of an active substance may be submitted by the producer of the active substance to a competent authority.

1A.   An application for an amendment to the conditions of an approval may be submitted by the producer of the active substance to a competent authority for a constituent territory to which the approval applies.

1B.   A joint application may be submitted under paragraph 1 or 1A by an association of producers designated by the producers for the purpose of compliance with this Regulation.

1C.   For the purposes of this Subsection, “the assessing competent authority” in relation to an application is the competent authority referred to in paragraph 1 or 1A respectively, except where a transfer has been agreed under Article 12A(1).

1D.   An application under paragraph 1 or 1A must be submitted together with a summary and a complete dossier as provided for in Article 8(1) and (2) or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4.”;

(b) omit paragraph 2;

(c) in paragraph 3, in the second subparagraph—

(i) in the first sentence for “Member States” substitute “ The assessing competent authority ”;

(ii) in the second sentence, for “rapporteur Member State” substitute “ assessing competent authority ”;

(d) for paragraph 5, substitute—

“5.   When assessing the application the assessing competent authority may obtain independent scientific advice, where the assessing competent authority considers it appropriate to do so.”.

(6) In Article 8—

(a) in paragraph 1—

(i) in point (a)—

(aa) for “widely grown crop in each zone” substitute “ crop grown in the United Kingdom ”;

(bb) omit “cover all zones or”;

(cc) omit “which is not widely grown”;

(ii) in point (b), after “substance” insert “ which apply in each of the constituent territories to which the application relates ”;

(iii) in point (c), after “product” insert “ which apply in each of the constituent territories to which the application relates ”;

(b) omit paragraph 3;

(c) for paragraph 4 substitute—

“4.   The appropriate authority may by regulations prescribe the data requirements for—

(a) one or more active substances, safeners and synergists for the purposes of paragraph 1(b);

(b) plant protection products for the purposes of paragraph 1(c).”;

(d) in paragraph 5, for “determined by the Authority” substitute “ described in guidance issued under Article 77 ”.

(7) In Article 9—

(a) in paragraph 1, in the first sentence, for “rapporteur Member State” substitute “ assessing competent authority ”;

(b) in paragraph 2—

(i) for “rapporteur Member State” in both places it occurs substitute “ assessing competent authority ”;

(ii) in the second subparagraph, for “, the other Member States and the Commission” substitute “ and the other competent authorities ”;

(c) in paragraph 3—

(i) in the first subparagraph—

(aa) for “rapporteur Member State” substitute “ assessing competent authority ”;

(bb) for “, the other Member States, the Commission and the Authority” substitute “ and the other competent authorities ”;

(ii) in the second subparagraph—

(aa) for “shall immediately” substitute “ must on request ”;

(bb) for “Member States, the Commission and the Authority” substitute “ competent authorities ”.

(8) In Article 10, for “Authority” substitute “ assessing competent authority ”.

(9) In Article 11—

(a) in paragraph 1—

(i) for “rapporteur Member State” substitute “ assessing competent authority ”;

(ii) for “Commission, with a copy to the Authority,” substitute “ other competent authorities ”;

(b) in paragraph 2, in the second subparagraph, for “rapporteur Member State” substitute “ assessing competent authority ”;

(c) in paragraph 3—

(i) in the first subparagraph—

(aa) for “rapporteur Member State” in each place it occurs substitute “ assessing competent authority ”;

(bb) in the fourth sentence, for “Commission and the Authority” substitute “ other competent authorities ”;

(ii) in the second subparagraph—

(aa) for “rapporteur Member State” substitute “ assessing competent authority ”;

(bb) for “, the Commission and the Authority” substitute “ and the other competent authorities, ”;

(d) omit paragraph 4.

(10) Article 12 is amended in accordance with paragraphs (11) to (18).

(11) In the heading, for “Authority” substitute “ assessing competent authority ”.

(12) In paragraph 1—

(a) for the first subparagraph substitute—

“(a) The assessing competent authority must circulate the draft assessment report to the applicant and the other competent authorities at the latest 30 days after its completion. The assessing competent authority may ask the applicant to circulate any updated dossier to the assessing competent authority and the other competent authorities.”;

(b) the existing second and third subparagraphs become points (b) and (c);

(c) in those points (b) and (c), for “Authority” substitute “ assessing competent authority ”.

(13) In paragraph 2—

(a) omit the first subparagraph;

(b) in the second subparagraph—

(i) in the first sentence—

(aa) for “Authority” substitute “ assessing competent authority ”;

(bb) for “, the Member States and the Commission” substitute “ and the other competent authorities, ”;

(ii) for the second sentence substitute—

“In the event that independent scientific advice is obtained by the assessing competent authority in accordance with Article 7(5), the 120-day period must be extended by 90 days.”;

(c) in the third subparagraph, for “Authority” substitute “ assessing competent authority ”.

(14) In paragraph 3—

(a) the existing first subparagraph becomes point (a);

(b) in that point (a)—

(i) for “Authority” in the first place it occurs substitute “ assessing competent authority ”;

(ii) for “Member States, the Commission and the Authority” substitute “ assessing competent authority and the other competent authorities ”;

(c) for the second subparagraph, substitute—

“(b) The assessing competent authority must assess the additional information, and for that purpose the period provided for in paragraph 2 may be extended by a maximum of 60 days.”;

(d) the existing third subparagraph becomes point (c);

(e) in that point (c)—

(i) for “Authority” substitute “ assessing competent authority ”;

(ii) omit “ask the Commission to”;

(iii) omit “Community” in both places it occurs.

(15) In paragraph 4, for “Authority” substitute “ assessing competent authority ”.

(16) Omit paragraph 5.

(17) In paragraph 6, for the words from “limits for the Authority's” to “Article 11 and” substitute “limit”.

(18) Omit paragraphs 7 and 8.

(19) After Article 12 insert—

“Article 12A U.K. Application for approval: transfer of assessment functions

1.   The assessing competent authority may by agreement transfer the functions listed in paragraph 2 in relation to an application for approval to another competent authority for a constituent territory in relation to which the same application has been made, and upon transfer that competent authority is the assessing competent authority for the purposes of this Subsection.

2.   For the purposes of paragraph 1 the functions are the functions of the assessing competent authority under Articles 7(3) and (5), 9, 10, 11 and 12.

3.   Following a transfer under paragraph 1, the assessing competent authority must notify the applicant of the transfer.

4.   A transfer in accordance with paragraph 1 does not—

(a) affect anything done by the assessing competent authority prior to transfer;

(b) affect the timing of any requirements placed on the assessing competent authority under this Subsection.”.

(20) For Article 13, substitute—

“Article 13 U.K. Approval Decision

1.   Within six months of the relevant conclusion date, a competent authority for a constituent territory to which the application relates must decide to do one of the following—

(a) approve the active substance, subject to conditions or restrictions, as referred to in Article 6(1), where appropriate;

(b) amend the conditions of the approval; or

(c) refuse to approve the active substance.

2.   In making a decision under paragraph 1, the competent authority must have regard to—

(a) the conclusion of the assessing competent authority;

(b) any comments received by the assessing competent authority in relation to the application, including any environmental monitoring information submitted by an appropriate agency;

(c) where the competent authority considers it appropriate to obtain it, any independent scientific advice obtained;

(d) where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety are relevant, the precautionary principle;

(e) any other matters which the competent authority considers relevant to the competent authority's decision.

3.   As soon as reasonably practicable after making a decision under paragraph 1, the competent authority must—

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

(b) update the approvals register accordingly.

4.   The Secretary of State may make a decision under paragraph 1 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;

F2 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.   Where the Secretary of State makes a decision in accordance with paragraph 4—

(a) a reference in paragraphs 2 and 3 to the competent authority is to be read as a reference to the Secretary of State;

(b) paragraph 3(a) is to be read as if “other” were omitted.

6.   In paragraph 1, the “relevant conclusion date” means—

(a) where the competent authority is the assessing competent authority, the date on which the competent authority adopts a conclusion under Article 12(2);

(b) otherwise, the date on which the competent authority receives the conclusion of the assessing competent authority in accordance with Article 12(2).

7.   In paragraph 2(b), “appropriate agency” means one of the following—

(a) the Environment Agency;

(b) the Natural Resources Body for Wales;

(c) the Scottish Environment Protection Agency;

F2 (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .”.

(21) In Article 14—

(a) in paragraph 1, in the third subparagraph, for “Article 6” substitute “ Article 6(1) ”;

(b) for paragraph 2 substitute—

“2.   The renewal of the approval must be for a period not exceeding—

(a) where the active substance is covered by Article 4(7), 5 years;

(b) for a candidate for substitution (see Article 24), 7 years;

(c) otherwise, 15 years.

3.   Paragraph 2 is subject to Article 17.”.

(22) In Article 15—

(a) in paragraph 1, for the words from “Member State” to “and the Authority” substitute “ competent authority for a constituent territory in relation to which the active substance is approved ”;

(b) after paragraph 1 insert—

“1A.   For the purposes of this Subsection, “the assessing competent authority” in relation to an application is the competent authority referred to in paragraph 1, except where a transfer has been agreed under Article 15A(1).”;

(c) after paragraph 2 insert—

“3.   The assessing competent authority must notify the other competent authorities as soon as reasonably practicable after receipt of an application under paragraph 1.

4.   A competent authority which receives a notification under paragraph 3 may request in writing from the applicant a copy of the application and any accompanying information, which the applicant must provide as soon as reasonably practicable.”.

(23) After Article 15 insert—

“Article 15A U.K. Applications for renewal: transfer of assessment

1.   The assessing competent authority may by agreement transfer the function of assessing an application for renewal to another competent authority for a constituent territory in relation to which the active substance to be renewed is approved, and upon transfer that competent authority is the assessing competent authority for that application for the purposes of the renewal provisions.

2.   The application for renewal and any supporting dossiers or information must be transferred at the same time as the transfer under paragraph 1.

3.   Following a transfer under paragraph 1, the assessing competent authority must notify the applicant of the transfer.

4.   A transfer in accordance with paragraph 1 does not—

(a) affect anything done by the assessing competent authority prior to transfer;

(b) affect the timing of any requirements placed on the assessing competent authority under the renewal provisions.

5.   In this Article, the “renewal provisions” means the provisions of—

(a) this Subsection, and

(b) Commission Implementing Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances.”.

(24) In Article 16, for “Authority” substitute “ assessing competent authority ”.

(25) In Article 17—

(a) for the first paragraph, substitute—

“1.   Where for reasons beyond the control of the applicant it appears to a competent authority that the approval is likely to expire before a decision has been taken on renewal, the competent authority must extend the approval period by a further period sufficient to examine the application.”;

(b) omit the second paragraph;

(c) the existing third paragraph becomes paragraph 3;

(d) after that paragraph 3, insert—

“4.   As soon as reasonably practicable after extending the approval period in accordance with the first paragraph, the competent authority must—

(a) notify the applicant and the other competent authorities of the extension, and

(b) update the approvals register accordingly.

5.   The Secretary of State may extend approval under paragraph 1 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;

F3 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.   Where the Secretary of State extends approval in accordance with paragraph 5, paragraph 4 is to be read as if—

(a) in the words before point (a), the reference to the competent authority were a reference to the Secretary of State;

(b) in point (a), “other” were omitted.”.

(26) In Article 18—

(a) the existing first paragraph becomes paragraph 1;

(b) in that paragraph 1—

(i) in the first sentence, for “The Commission” substitute “ A competent authority ”;

(ii) in the second sentence, for “Member States, the Commission and the Authority” substitute “ competent authority ”;

(c) the existing second paragraph becomes paragraph 2;

(d) in that paragraph 2, omit point (f);

(e) after that paragraph 2, insert—

“3.   The competent authority may vary or withdraw a work programme established by it.

4.   The competent authority must publish the work programme and notice of any variation or withdrawal of a work programme in such manner as the competent authority thinks appropriate.

5.   The Secretary of State may establish, vary or withdraw a work programme under paragraph 1 or 3 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;

F4 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.   Where the Secretary of State establishes, varies or withdraws a work programme in accordance with paragraph 5, a reference in paragraph 4 to the competent authority is to be read as a reference to the Secretary of State.

7.   Where the Secretary of State establishes, varies or withdraws a work programme in accordance with paragraph 5 in respect of one or more competent authorities, the programme must also include an allocation of evaluation of active substances to the Secretary of State and those competent authorities, taking into account a balance in the responsibilities and work to be done among the Secretary of State and those competent authorities.

8.   A competent authority may request in writing from the competent authority which receives data relating to an active substance in accordance with a work programme under this Article a copy of that data, which the competent authority must provide as soon as reasonably practicable.”.

(27) For Articles 19 to 21 substitute—

“Article 19 U.K. Implementing measures

The appropriate authority may, by regulations, make provision necessary for the implementation of the renewal procedure.

Article 20 U.K. Renewal decision

1.   Within six months of the relevant conclusion date, a competent authority for a constituent territory to which the application relates must decide to either—

(a) renew the approval of the active substance, subject to conditions or restrictions, as referred to in Article 6(1), where appropriate; or

(b) refuse to renew approval of the active substance.

2.   In making a decision under paragraph 1, the competent authority must have regard to—

[F5 (a) the conclusion of the assessing competent authority and the opinion of the Agency, if any, referred to in Article 37(4) of Regulation (EC) No 1272/2008;]

(b) any comments received by the assessing competent authority in relation to the application, including any environmental monitoring information submitted by an appropriate agency;

(c) where the competent authority considers it appropriate to obtain it, any independent scientific advice obtained;

(d) where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council are relevant, the precautionary principle;

(e) any other matters which the competent authority considers relevant to the competent authority's decision.

3.   Where the reasons for not renewing the approval of an active substance—

(a) relate to immediate concerns for the protection of human or animal health or the environment, plant protection products containing that active substance must be withdrawn from the market immediately;

(b) do not fall within point (a), the competent authority must set a grace period in respect of existing stocks of the plant protection products containing that active substance.

4.   The grace period—

(a) for the sale and distribution of the plant protection products must take into account the normal period of use of those plant protection products but must not exceed six months;

(b) for the disposal, storage, and use of the plant protection products must be consecutive to the period described in point (a) and must not exceed one year.

5.   As soon as reasonably practicable after making a decision under paragraph 1, the competent authority must—

(a) notify the applicant and the other competent authorities in writing of the decision under paragraph 1, the reasons for that decision and the details of any grace period set in accordance with paragraphs 3 and 4, and

(b) update the approvals register accordingly.

6.   The Secretary of State may make a decision under paragraph 1 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;

F6 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7.   Where the Secretary of State makes a decision in accordance with paragraph 6, a reference in paragraphs 2, 3 and 5 to the competent authority is to be read as a reference to the Secretary of State.

8.   In paragraph 1, the “relevant conclusion date” means—

(a) where the competent authority is the assessing competent authority, the date on which the competent authority adopts a conclusion under Article 13(1) of Commission Implementing Regulation (EU) No 844/2012;

(b) otherwise, the date on which the competent authority receives the conclusion of the assessing competent authority in accordance with Article 13(1) of Commission Implementing Regulation (EU) No 844/2012.

9.   In paragraph 2(b), “appropriate agency” has the meaning given by Article 13(7).

Article 20A U.K. Review of further information submitted

1.   Where an approval is subject to a condition in accordance with Article 6(1)(f), any confirmatory information received within the period specified in the condition must be assessed by the reviewing authority.

2.   Within 6 months of receipt of the confirmatory information, the reviewing authority must—

(a) assess that information, and

(b) submit its assessment to the other competent authorities.

3.   For the purposes of this Article, the “reviewing authority” is—

(a) the competent authority specified in the condition to which the approval is subject, or

(b) a competent authority to which the function of reviewing the confirmatory information is transferred in accordance with paragraph 4.

4.   The reviewing authority may by agreement transfer the function of reviewing confirmatory information received to another competent authority.

5.   Any confirmatory information received must be transferred at the same time as the transfer under paragraph 4.

6.   Following a transfer under paragraph 4, the competent authority to which the function is transferred must notify the applicant of the transfer.

7.   A transfer in accordance with paragraph 4 does not—

(a) affect anything done by the reviewing authority prior to transfer;

(b) affect the timing of the requirement in paragraph 2.

Article 21 U.K. Review of approval

1.   A competent authority may review the approval of an active substance in relation to its constituent territory at any time.

2.   The competent authority must review the approval of an active substance in relation to its constituent territory where—

(a) the competent authority has assessed confirmatory information as reviewing authority in accordance with Article 20A(1),

(b) the competent authority receives the assessment of the reviewing competent authority in accordance with Article 20A(2)(b), or

(c) further information required in accordance with a condition under Article 6(1)(f) has not been provided within the period specified in the condition.

3.   Where the competent authority considers that—

(a) in light of new scientific and technical knowledge or the assessment of the reviewing authority in accordance with Article 20A, there are indications that the active substance no longer satisfies the approval criteria provided for in Article 4, or

(b) further information required in accordance with a condition under Article 6(1)(f) has not been provided

the competent authority must inform each of the other competent authorities and the producer of the active substance accordingly, setting a period for the submission of comments.

4.   The competent authority may obtain independent scientific advice, where the competent authority considers it appropriate to do so.

5.   Where the competent authority concludes, having considered comments received during the period set in accordance with paragraph 3 and any other information or matters that the competent authority considers relevant to the review, that paragraph 3(a) or (b) apply, the competent authority must decide to either—

(a) amend the conditions or restrictions of the approval, or

(b) withdraw the approval.

6.   Where the reasons for withdrawing the approval of an active substance—

(a) relate to immediate concerns for the protection of human or animal health or the environment, plant protection products containing that active substance must be withdrawn from the market immediately;

(b) do not fall within point (a), the competent authority must set a grace period in respect of existing stocks of the plant protection products containing that active substance.

7.   The grace period—

(a) for the sale and distribution of the plant protection products must take into account the normal period of use of those plant protection products but must not exceed six months;

(b) for the disposal, storage, and use of the plant protection products must be consecutive to the period described in point (a) and must not exceed one year.

8.   As soon as reasonably practicable after making a decision under paragraph 5, the competent authority must—

(a) notify the producer of the active substance and the other competent authorities in writing of the decision, the reasons for that decision, and the details of any grace period set in accordance with paragraphs 6 and 7, and

(b) update the approvals register accordingly.

9.   The Secretary of State may review an active substance under paragraph 1 or 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;

F6 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10.   Where the Secretary of State reviews an active substance in accordance with paragraph 9, a reference in paragraphs 3 to 6 and 8 to the competent authority is to be read as a reference to the Secretary of State.”.

(28) For Article 22 substitute—

“Article 22 U.K. Low-risk active substances

1.   An active substance complying with the criteria provided for in Article 4 must be approved as a low-risk active substance where—

(a) that substance complies with the criteria in point 5 of Annex 2, and

(b) it may be expected that plant protection products containing that substance will pose only a low risk to human and animal health and the environment as provided for in Article 47(1).

2.   Articles 4 to 21 apply.

3.   The appropriate authority may, by regulations, amend point 5 of Annex 2 to specify new criteria for approving an active substance as a low-risk active substance.”.

(29) In Article 23—

(a) in paragraph 1—

(i) for “paragraphs 2 to 6” in both places it occurs substitute “ this Article ”;

(ii) in the first subparagraph, omit the second sentence;

(b) in paragraph 2, omit “Community”;

(c) in paragraph 3—

(i) in the first subparagraph—

(aa) omit “by a Member State or”;

(bb) for “Commission” substitute “ the competent authority for the constituent territory in relation to which approval is sought ”;

(ii) in the second subparagraph, in point (a) omit “Community”;

(d) omit paragraph 4;

(e) for paragraph 5 substitute—

“5.   Article 6 applies to the approval of a basic substance.

5A.   Within the decision period following receipt of the application and accompanying information, the competent authority must decide to either—

(a) approve the basic substance, subject to conditions or restrictions, as referred to in Article 6(1), where appropriate, or

(b) refuse to approve the basic substance.

5B.   In paragraph 5A, the “decision period” is—

(a) where the competent authority obtains independent scientific advice in respect of the application, nine months;

(b) otherwise, six months.

5C.   In making a decision under paragraph 5A, the competent authority must have regard to—

(a) the application and accompanying information,

(b) where the competent authority considers it appropriate to obtain it, any independent scientific advice obtained,

(c) where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council are relevant, the precautionary principle, and

(d) any other matters which the competent authority considers relevant to the competent authority's determination of the application.

5D.   As soon as reasonably practicable after making a decision under paragraph 5A, the competent authority must—

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

(b) update the approvals register accordingly.

5E.   Article 20A applies to an approval of a basic substance which is subject to a condition in accordance with Article 6(1)(f) as it applies to an approval of an active substance.

5F.   The Secretary of State may make a decision under paragraph 5A 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;

F7 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5G.   Where the Secretary of State makes a decision in accordance with paragraph 5F, a reference in paragraphs 5A to 5D to the competent authority is to be read as a reference to the Secretary of State.”;

(f) omit paragraph 6.

(30) After Article 23 insert—

“Article 23A U.K. Review of basic substance approval

1.   A competent authority may review the approval of a basic substance at any time.

2.   A competent authority must review the approval of a basic substance where—

(a) the competent authority has received and assessed confirmatory information in accordance with Article 20A (as applied by Article 23(5E));

(b) further information required in accordance with a condition under Article 6(1)(f) has not been provided within the period specified in that condition.

3.   Where the competent authority considers that there are indications that the substance no longer satisfies the criteria provided for in Article 23(1) to (3), the competent authority must inform the other competent authorities and the interested party referred to in Article 23(3) accordingly, setting a period for the submission of comments.

4.   The competent authority may obtain independent scientific advice, where the competent authority considers it appropriate to do so.

5.   Where the competent authority concludes that, having considered comments received during the period set in accordance with paragraph 3 and any other information or matters that the competent authority considers important and relevant to the review, the substance no longer satisfies the criteria provided for in Article 23(1), the competent authority must decide to either—

(a) amend the conditions of the approval, or

(b) withdraw the approval.

6.   As soon as reasonably practicable after making a decision under paragraph 5, the competent authority must—

(a) notify the other competent authorities and the interested party referred to in Article 23(3) in writing of the decision and the reasons for it, and

(b) update the approvals register accordingly.

7.   The Secretary of State may review an active substance under paragraph 1 or 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;

F8 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8.   Where the Secretary of State reviews an active substance in accordance with paragraph 7, a reference in paragraphs 3 to 6 to the competent authority is to be read as a reference to the Secretary of State.”.

(31) In Article 24—

(a) in paragraph 1—

(i) in the first sentence, omit “, for a period not exceeding seven years,”;

(ii) omit the second sentence;

(b) in paragraph 2, omit the second sentence.

(32) Omit Article 25(3).

(33) After Article 25 insert—

“Article 25A U.K. Safeners and synergists on the market on or before 14th June 2011

1.   A safener or synergist is deemed to be approved for the purposes of this Regulation in each constituent territory if on or before 14th June 2011 it was—

(a) held for the purpose of sale within the European Union, an EEA state or the United Kingdom, including being offered for sale or other form of transfer, whether free of charge or not;

(b) sold, distributed or otherwise transferred within the European Union, an EEA state or the United Kingdom, but not including return to the previous seller; or

(c) released for free circulation into the territory of the European Union, an EEA state or the United Kingdom.

2.   For the purposes of paragraph 1, “the European Union” does not include the Republic of Croatia.

3.   A safener or synergist is deemed to be approved in accordance with paragraph 1 in a constituent territory until—

(a) where an application for approval of that safener or synergist is received in accordance with Article 7 (as applied by Article 25(2)), the date on which a decision is made by the competent authority for that constituent territory or the Secretary of State in accordance with Article 13 (as applied by Article 25(2));

(b) otherwise, the earliest of the following dates—

(i) the date on which the competent authority or the Secretary of State decides to withdraw approval of the safener or synergist for that constituent territory in accordance with Article 21 as applied by paragraph 4;

(ii) the date on which the first regulations made under Article 8(4)(a) in respect of safeners or synergists (as the case may be) which apply to that constituent territory come into force.

4.   Article 21 applies to a safener or synergist deemed to be approved in accordance with paragraph 1 as if—

(a) a reference to an active substance were a reference to that safener or synergist;

(b) paragraph 2 were omitted;

(c) in paragraph 3—

(i) in point (a), the words from “or the assessment” to “Article 20A,” were omitted;

(ii) point (b) (and the “or” immediately preceding it) were omitted;

(d) in paragraph 5, for “or (b) apply” there were substituted “ applies ”;

(e) paragraph 8(b) (and the “and” immediately preceding it) were omitted;

(f) in paragraph 9, in the words before point (a) “or 2” were omitted.”.

(34) In Article 27—

(a) in paragraph 2, for the words from “in Annex III” to the end substitute “ on the unacceptable co-formulants register ”;

(b) in paragraph 3—

(i) for the first sentence substitute—

“A competent authority may review co-formulants which are not accepted in the competent authority's constituent territory for inclusion in a plant protection product at any time.”;

(ii) in the second sentence—

(aa) for “It” substitute “ The competent authority ”;

(bb) for “Member States” substitute “ the other competent authorities ”;

(c) omit paragraph 4;

(d) for paragraph 5 substitute—

“5.   The appropriate authority may, by regulations, make provision necessary for the implementation of this Article.”.

(35) After Section 3, insert—

“SECTION 4 U.K. Registers

Article 27A U.K. Approvals register

1.    

The competent authorities must jointly establish and maintain a register of active substances, safeners, synergists, low-risk active substances, basic substances and candidates for substitution approved in accordance with this Regulation.

2.    

The entry on the register for each substance must contain the following information—

(a) the common name and identification numbers of the substance;

(b) the IUPAC name of the substance, where available;

(c) the minimum purity of the substance;

(d) in respect of each constituent territory to which the entry relates—

(i) whether the substance has been approved as an active substance, safener, synergist, low-risk active substance, basic substance or candidate for substitution;

(ii) the date of the approval decision;

(iii) except in relation to approved basic substances, the expiration date of approval;

(iv) information on any specific provisions, conditions or requirements in respect of the approved substance.

3.    

The register must contain a search facility.

4.    

The competent authorities must jointly make the register available for inspection by the public on a website maintained by one or more of the competent authorities.

Article 27B U.K. Unacceptable co-formulants register

1.    

The competent authorities must jointly establish and maintain a register of co-formulants which are not acceptable for inclusion in a plant protection product in accordance with Article 27.

2.    

The entry on the register for each co-formulant must contain the following information—

(a) the common name of the co-formulant;

(b) the IUPAC name of the co-formulant (where available);

(c) the CAS number of the co-formulant (where available);

(d) the EC number of the co-formulant (where available);

(e) in respect of each constituent territory to which the entry relates—

(i) the date of the decision that the co-formulant was not acceptable for inclusion in a plant protection product;

(ii) the sunset date for the co-formulant;

(iii) any conditions of restriction relating to the co-formulant;

(iv) any other information regarding the co-formulant that the competent authority considers relevant.

3.    

The register must contain a search facility.

4.    

The competent authorities must jointly make the register available for inspection by the public on a website maintained by one or more of the competent authorities.”.

Textual Amendments

F1 Words in reg. 4(2)(d) omitted (31.12.2020 immediately before IP completion day) by virtue of The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(4), 3(4)(a)

F2 Words in reg. 4(20) omitted (31.12.2020 immediately before IP completion day) by virtue of The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(4), 3(4)(b)

F3 Words in reg. 4(25)(d) omitted (31.12.2020 immediately before IP completion day) by virtue of The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(4), 3(4)(c)

F4 Words in reg. 4(26)(e) omitted (31.12.2020 immediately before IP completion day) by virtue of The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(4), 3(4)(c)

F5 Words in reg. 4(27) substituted (31.12.2020 immediately before IP completion day) by The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(4), 3(4)(d)(i)(aa)

F6 Words in reg. 4(27) omitted (31.12.2020 immediately before IP completion day) by virtue of The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(4), 3(4)(d)(ii)

F7 Words in reg. 4(29)(e) omitted (31.12.2020 immediately before IP completion day) by virtue of The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(4), 3(4)(e)

F8 Words in reg. 4(30) omitted (31.12.2020 immediately before IP completion day) by virtue of The Pesticides (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1376), regs. 1(4), 3(4)(f)

Commencement Information

I1 Reg. 4 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(1)