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

Type Statutory-Instrument

Publication 2019-03-20

Last updated 2023-12-31

State In force

Department King's Printer of Acts of Parliament

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(1) The labelling of plant protection products must include— (a) the classification, labelling and packaging requirements of Regulation (EC) No 1272/2008 of the European Parliament and of the Council, and (b) any requirements contained in regulations made under paragraph 1A which apply in relation to the constituent territory in which the product is to be placed on the market or used. (1A) The appropriate authority may, by regulations, specify additional requirements for the labelling of plant protection products, including (but not limited to) standard phrases for special risks and safety precautions which supplement the phrases provided for in Regulation (EC) No 1272/2008 of the European Parliament and of the Council.

(b) in paragraph 2, for “Member States” substitute “ A competent authority ”;

(4) In Article 66(3)—

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

(b) for “Community” substitute “ retained EU ”.

Chapter 8

10

(1) Chapter 8 is amended as follows.

(2) In Article 67—

(a) in paragraph 1—

(i) in the second subparagraph—

(aa) in the first sentence, for “the competent authority” substitute “ a competent authority ”;

(bb) in the second sentence, after “addressing the” insert “ relevant ”;

(ii) in the third subparagraph, omit “or Community”;

(b) in paragraph 2—

(i) in the first sentence, for “the competent authorities” substitute “ a competent authority ”;

(ii) in the second sentence, for “authorities” substitute “ authority ”;

(i) omit “of the Member States”;

(ii) for the words from “in accordance” to the end substitute “ for the purposes of establishing and maintaining risk indicators in accordance with Annex 4 to Directive 2009/128/EC ”;

(d) omit paragraph 4.

(3) For Article 68 substitute—

Acompetent authority shall publish by 31 August each year a report, for the previous year, on the scope and the outcome of the official controls performed in order to verify compliance with this Regulation.

Chapter 9

11

(1) Chapter 9 is amended as follows.

(2) For Article 69 substitute—

(1) Where a competent authority is satisfied that the conditions in paragraph 2 are met, the competent authority may— (a) in the case of an active substance, safener or synergist approved in relation to its constituent territory— (i) amend the conditions of approval, or (ii) suspend approval; (b) in the case of a co-formulant, add that co-formulant to the unacceptable co-formulants register in relation to its constituent territory; (c) in the case of a plant protection product authorised in its constituent territory— (i) amend the authorisation for that product; (ii) suspend the authorisation for that product. (2) The conditions referred to in paragraph 1 are— (a) the approved active substance, safener, synergist, co-formulant or plant protection product is likely to constitute a serious risk to human or animal health or the environment, and (b) that risk cannot be contained satisfactorily by means of other measures taken by the competent authority. (3) In performing a function under paragraph 1, the competent authority may obtain independent scientific advice, where the competent authority considers it appropriate to do so. (4) As soon as reasonably practicable after acting in accordance with paragraph 1(a), (b) or (c), the competent authority must— (a) update the approvals register or unacceptable co-formulants register accordingly; (b) in relation to an amendment or suspension under paragraph 1(a), begin a review of the active substance, safener or synergist in accordance with Article 21 or that Article as applied by Article 25A(4); (c) in relation to a register addition under paragraph 1(b), begin a review of the co-formulant under Article 27(3); (d) in relation to an amendment or suspension under paragraph 1(c), begin a review of the plant protection product authorisation under Article 44. (5) An amendment or suspension under paragraph 1(a) expires upon the completion of the review described in paragraph 4(b). (6) A register addition under paragraph 1(b) expires upon the completion of the review described in paragraph 4(c). (7) An amendment or suspension under paragraph 1(c) expires upon the completion of the review described in paragraph 4(d). (8) Following the expiry of an amendment or suspension under paragraph 1(a), or a register addition under paragraph 1(b), the competent authority must update the approvals register or unacceptable co-formulants register accordingly. (9) The Secretary of State may perform a function 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; (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (10) Where the Secretary of State performs a function in accordance with paragraph 9, a reference to the competent authority in paragraphs 3 , 4 and 8 is to be read as a reference to the Secretary of State.

(3) Omit Articles 70 and 71.

Chapter 10

12

(1) Chapter 10 is amended as follows.

(2) Omit Article 72.

(3) In Article 73, for “the Member States” substitute “Great Britain”.

(4) Omit Article 74.

(5) In Article 75—

(a) omit paragraphs 1 and 2;

(b) in paragraph 3, for “Member States shall ensure that competent authorities have” substitute “ A competent authority must ensure that it has ”;

(6) For Articles 77 and 78 substitute—

(1) A competent authority may issue, amend or withdraw technical and other guidance documents relating to the implementation of this Regulation, including (but not limited to)— (a) guidance relating to the format of the summary or complete dossiers to be used for the purposes of Article 8; (b) guidance relating to the format of the draft assessment report for the purposes of Article 11; (c) guidance relating to the format of the assessment for the purposes of Article 36; (d) guidance regarding the rules and procedure for the assessment of equivalence under Article 38; (e) guidelines on the coordination of compliance checks to be undertaken in accordance with Article 43(3); (f) guidance on the application of Article 54, including on— (i) the maximum quantities of plant protection products that may be released during experiments or tests; (ii) the minimum data to be submitted in accordance with Article 54(2); (g) guidance concerning the content of the application concerning micro-organisms, pheromones and biological products. (2) A competent authority must publish any guidance document issued or amended, or a notice specifying any guidance document withdrawn, under paragraph 1 in a manner which that competent authority considers appropriate. (3) Before issuing, amending or withdrawing a guidance document under paragraph 1 a competent authority may obtain independent scientific advice, where the competent authority considers it appropriate to do so. (4) The Secretary of State may issue, amend or withdraw a guidance document 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; (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (5) Where the Secretary of State issues, amends or withdraws a guidance document in accordance with paragraph 4, a reference in paragraphs 2 and 3 to the competent authority is to be read as a reference to the Secretary of State. (6) In complying with any obligation under this Regulation, a person or competent authority must have regard to any guidance issued in accordance with paragraph 1. The appropriate authority may by regulations— (a) amend the Annexes to take account of current scientific and technical knowledge; (b) make further provision as necessary for the implementation of this Regulation. (1) Regulations made by the Secretary of State or Welsh Ministers under this Regulation are to be made by statutory instrument. (2) For regulations made under this Regulation by the Scottish Ministers, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 . (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (4) A statutory instrument containing regulations made by the Secretary of State under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament. (5) A statutory instrument containing regulations made by the Welsh Ministers under this Regulation is subject to annulment in pursuance of a resolution of the National Assembly for Wales. (6) Regulations made by the Scottish Ministers under this Regulation are subject to the negative procedure (see section 28 of the Interpretation and Legislative Reform (Scotland) Act 2010). (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (8) Such regulations may— (a) contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments); (b) make different provision for different purposes.

(7) Omit Article 79.

Chapter 11

13

(1) Chapter 11 is amended as follows.

(2) For Article 80, substitute—

(1) The following application is taken to have been made under Article 7(1) on the date it was made—

Common Name, CIPAC Identification Number	Applicant	Date of application
EthametsulfuronCIPAC-No: 834	DuPont de Nemours GmbH	29th June 2010

(1A) For the determination of the application described in paragraph 1, this Regulation is to be read subject to the modifications in paragraphs 1B to 1F. (1B) Article 4(1) is to be read as if— (a) in the first subparagraph— (i) “in accordance with Annex II” were omitted; (ii) the words from “, taking into account” to “that Annex,” were omitted; (b) the second subparagraph were omitted. (1C) Article 4(2)(a) is to be read as if the words from “, taking into account” to “available,” were omitted. (1D) Article 4(3) is to be read as if— (a) point (a) were omitted; (b) in point (b), the words from “or consequences” to “effects are available;” were omitted; (c) points (c), (d) and (e)(iii) were omitted; (1E) Article 4(7) is to be ignored. (1F) Article 11(2) is to be read as if the third subparagraph were omitted. (1G) Anything done before IP completion day in relation to the application described in paragraph 1— (a) by the United Kingdom — (i) under Directive 91/414/EEC, as the member State described in Article 6 of that Directive; (ii) as the rapporteur Member State under Regulation 188/2011; (b) by the European Food Safety Authority under Directive 91/414/EEC or Regulation 188/2011, is taken to have been done by the relevant competent authority as the assessing competent authority. (1H) If the application described in paragraph 1 is approved in accordance with Article 13— (a) Article 13(1) to (4) of Directive 91/414/EEC applies in relation to that approval for a period of 10 years beginning with the date of approval; (b) Regulation 544/2011 and Regulation 545/2011 apply in relation to that approval as if, in Article A1(1)(a) of each Regulation, for the words from “as it had effect” in the first place it occurs to the end there were substituted “ as read with Article 80(1) of that Regulation ”. (1I) In paragraph 1G— (a) “rapporteur Member State” has the meaning given by Article 2(1) of Regulation 188/2011; (b) the “relevant competent authority” is the Secretary of State. (2) Paragraphs 2A to 2E apply to an active substance— (a) included in Annex 1 to Directive 91/414/EEC; (b) approved in accordance with paragraph 1 of this Article as it had effect immediately before IP completion day . (2A) Article 13(1) to (4) of Directive 91/414/EEC applies— (a) for active substances covered by Article 8(2) of Directive 91/414/EEC, for a period of five years beginning with the date of the inclusion or approval of the active substance; (b) for active substances which were not on the market in the European Union, an EEA state or the United Kingdom on 26th July 1993, for a period of 10 years from the date of the inclusion or approval of the active substance. (2B) In paragraph 2A(b), “on the market” means any supply, whether in return for payment or free of charge, other than for storage followed by consignment from the territory of the European Union, an EEA state or the United Kingdom or disposal. (2C) In paragraphs 2A(b) and 2B, the “European Union” does not include the Republic of Croatia. (2D) Regulation 544/2011 applies to the active substance, and is to be read as if, in Article A1(1) of that Regulation— (a) point (a) were omitted; (b) for point (c)(i) there were substituted— (i) described in Article 80(2) of Regulation (EC) No 1107/2009, and (2E) Regulation 545/2011 applies to the active substance, and is to be read as if, in Article A1(1) of that Regulation— (a) point (a) were omitted; (b) in point (c)(ii), for “to which point (a) applies” there were substituted “ described in Article 80(2) of Regulation (EC) No 1107/2009 ”. (2F) In this Article— (a) “assessing competent authority” has the same meaning as in Subsection 2 of Section 1 of Chapter 2; (b) “Directive 91/414/EEC” means Council Directive 91/414/EEC concerning the placing of plant protection products on the market, as it had effect by virtue of paragraph 1 and 2 of this Article as those paragraphs had effect immediately before IP completion day , read in accordance with paragraph 2G; (c) “Regulation 188/2011” means Commission Regulation (EU) No 188/2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive as it had effect immediately before IP completion day; (d) “Regulation 544/2011” means Commission Regulation (EU) No 544/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances; (e) “Regulation 545/2011” means Commission Regulation (EU) No 545/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products. (2G) For the purposes of this Article, Article 13(1) to (4) of Directive 91/414/EEC is to be read as if— (a) a term used in those paragraphs which is defined in this Regulation has the meaning given in this Regulation; (b) in paragraph 1— (i) in the words before point (a), for “Without prejudice to Article 10, Member States” there were substituted “ A competent authority ”; (ii) in point (a), for “Annex III” there were substituted “ Regulation 545/2011 ”; (iii) in point (b), for “Annex II” there were substituted “ Regulation 544/2011 ”; (c) in paragraph 3— (i) for “Member States” there were substituted “ a competent authority ”; (ii) for “Annex II” there were substituted “ Regulation 544/2011 ”; (iii) in point (b), for the words from “two years” to the end there were substituted “ by 26th July 1993 ”; (iv) point (c) (and the “or” immediately preceding it) were omitted; (v) in point (d), for “paragraphs 3(b) and (c)” there were substituted “ paragraph 3(b) ”; (d) in paragraph 4— (i) for “Member States” there were substituted “ a competent authority ”; (ii) for “Annex III” there were substituted “ Regulation 545/2011 ”; (iii) point (c) (and the “or” immediately preceding it) were omitted.

(3) Omit Article 81.

(4) In Article 83—

(a) in the first paragraph—

(i) omit “by the Acts listed in Annex V”;

(ii) omit the words from “, without prejudice” to the end;

(b) in the second paragraph, omit “in other Community legislation, such as Regulation (EC) No 1782/2003,”.

(5) Omit Article 84.

(6) After Article 84, omit the words from “This Regulation” to “all Member States”.

Annexes

14

(1) The Annexes are amended as follows.

(2) Omit Annex 1.

(3) In Annex 2—

(a) in point 1.1, for “rapporteur Member State and the Authority” substitute “ assessing competent authority ”;

(b) in point 1.2, for “Authority and the rapporteur Member State” substitute “ assessing competent authority ”;

1.2A. In this Annex, “the assessing competent authority” has the meaning given by Article 7(1C) or 15(1A) as the case may be.

(d) omit point 1.3;

(e) in point 2.1, for “in at least one Member State” substitute “ by at least one competent authority ”;

(f) in point 2.3—

(i) in the first paragraph, for “Article 6” substitute “ Article 6(1) ”;

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

(g) in point 3.1, in the first, second and fourth paragraphs, for “Article 7(1)” substitute “ Article 7(1D) ”;

(h) in points 3.2 and 3.5.3, for “Article 29(6)” substitute “ Article 29(6)(a) in relation to the relevant constituent territory ”;

(i) in point 3.6.2, omit “, reviewed by the Authority”;

(j) in point 3.6.3—

(i) after “synergist” in the second place it appears insert “ in relation to the relevant constituent territory ”;

(ii) omit “, reviewed by the Authority”;

(k) in point 3.6.4—

(i) after “synergists” insert “ in relation to the relevant constituent territory ”;

(ii) omit “, reviewed by the Authority”;

(l) in point 3.6.5—

(i) in the first paragraph—

(aa) for “Community” substitute “nationally”;

(bb) for “Authority” substitute “competent authority”;

(ia) omit the third and fourth paragraphs;

(ii) in the sixth paragraph, in point (1)—

(aa) in point (a), for the words from “the Commission” to “products,” substitute “ guidance issued ”;

(bb) in point (b), for the words from “which is” to “products” substitute “ issued ”;

(m) in point 3.8.1, for “Article 29(6)” substitute “ Article 29(6)(a) in relation to the relevant constituent territory ”;

(n) in point 3.8.2—

(i) in the first paragraph, for “Community” substitute “nationally;”

(ii) in the third paragraph, in point (1)(a) and (b), for the words from “the Commission” to “products,” substitute “ guidance issued ”;

(o) in point 3.8.3, for “Community” substitute “ nationally ”;

(p) in point 3.10, for “Article 29(6)” substitute “ Article 29(6)(a) in relation to the relevant constituent territory ”;

(q) in point 4, in the seventh indent—

(i) for “Community” substitute “ nationally ”;

(ii) omit “, reviewed by the Authority”;

(r) in point 5.1.1(b), for “under” substitute “ and is listed in Annex 10 to ”.

(4) Omit Annexes 3 and 5.

CHAPTER 2 — Amendment of other EU Regulations

Commission Regulation (EU) No 1141/2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances

15

(1) Commission Regulation (EU) No 1141/2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances is amended as follows.

(2) For Article 1, substitute—

(1) This Regulation lays down the procedure for the determination of the existing renewal application by the relevant competent authority as assessing competent authority. (2) The “existing renewal application” is the application for the renewal of the approval of the active substance famoxadone which— (a) was made to the United Kingdom as rapporteur Member State in accordance with Article 4 as it had effect immediately before IP completion day , and (b) is taken as being made under this Regulation and Article 15(1) of Regulation (EC) No 1107/2009 on the date on which it was made. (3) Anything done under this Regulation as it had effect immediately before IP completion day in relation to the existing renewal application— (a) by the United Kingdom as rapporteur Member State; (b) by the European Food Safety Authority; is taken to have been done by the relevant competent authority as the assessing competent authority. (4) In this Article— (a) “rapporteur Member State” has the meaning given in Article 2(c) as it had effect immediately before IP completion day ; (b) the “relevant competent authority” is the Secretary of State.

(3) In Article 2—

(a) for point (b) substitute—

(b) ‘applicant’ means the producer who made the existing renewal application;

(b) omit points (c) to (f);

(g) ‘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; (h) ‘assessing competent authority’ has the meaning given by Article 15(1A) of Regulation (EC) No 1107/2009; (i) ‘existing renewal application’ has the meaning given by Article 1(2).

(4) After Article 2 insert—

(1) Where the assessing competent authority considers that additional data from the applicant is necessary to finalise the relevant conclusion, the assessing competent authority may set a period of up to one month for the applicant to supply that data. (2) The assessing competent authority must notify the other competent authorities— (a) as to the data received in accordance with paragraph 1, or (b) where no data is received during the period described in paragraph 1. (3) On request from a competent authority, the assessing competent authority must provide a copy of data received in accordance with paragraph 1. (4) The assessing competent authority must send the other competent authorities a finalised conclusion as soon as reasonably practicable after the conclusion is finalised. (5) Article 20 of Regulation (EC) No 1107/2009 applies to the determination of an existing renewal application, and for the purpose of that Article an existing renewal application is taken to relate to each constituent territory. (6) In paragraph 1, “relevant conclusion” means the conclusion of the European Food Safety Authority in respect of the existing renewal application, delivered in accordance with the second subparagraph of Article 16(2) as it had effect immediately before IP completion day . (7) In this Article, “competent authority” and “constituent territory” have the meanings given in Article 3A of Regulation (EC) No 1107/2009.

(5) Omit Articles 3 to 21.

(6) After Article 21, omit the words from “This Regulation” to “Member States”.

(7) Omit Annexes 1 and 2.

Commission Regulation (EU) No 544/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances

16

(1) Commission Regulation (EU) No 544/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances is amended as follows.

(2) Before Article 1, insert—

(1) This Regulation applies in relation to— (a) an application under Article 7 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market as it had effect immediately before IP completion day where— (i) paragraph 6 of Schedule 1 to the Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 applies to that application, and (ii) on or before 31st December 2013 dossiers were submitted in accordance with Article 8(1) and (2) of Regulation (EC) No 1107/2009 as it had effect immediately before IP completion day; (b) an application under Article 15 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market as it had effect immediately before IP completion day where— (i) paragraph 7 of Schedule 1 to the Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 applies to that application, and (ii) on or before 31st December 2013 dossiers were submitted in accordance with Article 9 of Commission Regulation (EU) No 1141/2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances as it had effect immediately before IP completion day; (c) an application for authorisation of a plant protection product, as referred to in Article 28 of Regulation (EC) No 1107/2009, which was submitted before 31st December 2015, as regards the submission of data concerning an active substance— (i) to which point (a) or (b) applies, or (ii) for which approval has not been renewed in accordance with Article 14 of Regulation (EC) No 1107/2009 or Commission Implementing Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, whether before or after IP completion day. (2) Paragraph 1(b) does not apply where the applicant for the authorisation notifies the competent authority in writing when submitting the application that the data requirements of Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances apply instead. (3) Paragraph 4 applies where Commission Regulation (EU) No 284/2013 setting out the data requirements for active substances applies in relation to an application by virtue of— (a) Article 1 of that Regulation, or (b) Article A1(2) of Commission Regulation (EU) No 545/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products. (4) Where this paragraph applies, a reference in this Regulation to Commission Regulation (EU) No 545/2011, or a specified part of Commission Regulation (EU) No 545/2011, is to be read in relation to the application as a reference to Commission Regulation (EU) No 284/2013, or the equivalent part of Commission Regulation (EU) No 284/2013 (as the case may be).

(3) Omit Article 2.

(4) After Article 2, omit the words from “This Regulation shall” to “Member States”.

(5) In the Annex—

(a) in the Introduction—

(i) in point 1.2, for the words from “the entry” to “Annex,” substitute “ 14th June 2011 ”;

(ii) in point 1.3, for “Member States” substitute “ the competent authority ”;

(iii) in point 1.6, for “Council Directive 86/609/EEC ” substitute “ the Animals (Scientific Procedures) Act 1986 ”;

(iv) in point 2.1, after “laid down in” insert “ Annex 1 to ”;

(v) in point 2.2, in the first paragraph—

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

(bb) after “their” insert “ constituent ”;

(vi) in point 2.3, in the first paragraph—

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

(bb) after “their” insert “ constituent ”;

(cc) for “2 years after notification of the Directive 91/414/EEC ” substitute “ on or before 25th July 1993 ”;

(b) in Part A—

(i) in point 1.1, in the second paragraph, for the words from “the Member State” to “Commission” substitute “Great Britain”;

(ii) in point 1.2, in the third sentence, for “the Commission and the Member States” substitute “ each competent authority which granted approval ”;

(iii) in point 1.5, in the second sentence, omit “Member States or”;

(iv) in point 1.9, in the second paragraph for “the Commission and the Member States” substitute “ each competent authority which granted approval ”;

(v) in point 4.2.1, for “Member States” substitute “ competent authorities ”;

(vi) in point 5.9, in the first paragraph, in the first sentence, after “the provisions of” insert “ the EU-derived domestic legislation which transposed ”;

(vii) in the Introduction to Section 6, in point (iii), for “the EU Guidelines for” substitute “ guidance issued under Article 77 of Regulation (EC) No 1107/2009 regarding ”;

(viii) in point 6.10, omit “of the Member States”;

(ix) in point 7.1, in the fourth paragraph, for “EU regions” substitute “regions of Great Britain”;

(x) in point 7.1.1.2.1, under “Aerobic degradation”, under “Test conditions”, in the second paragraph, omit “EU”;

(i) in point 1.1, in the second paragraph, for the words from “the Member State” to “Commission” substitute “Great Britain”;

(ii) in point 1.2, for “the Commission and the Member States” substitute “ each competent authority which granted approval ”;

(iii) in point 1.4.1, in the second paragraph for “the Commission and the Member States” substitute “ each competent authority which granted approval ”;

(iv) in point 5.1.1, in the first paragraph, in the first sentence, after “the provisions of” insert “ the EU-derived domestic legislation which transposed ”;

(v) in point 7.1.1, for “EU regions” substitute “regions of Great Britain”;

(vi) in point 9, omit “of the Member States”.

Commission Regulation (EU) No 545/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products

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(1) Commission Regulation (EU) No 545/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products is amended as follows.

(2) Before Article 1, insert—

(1) This Regulation applies— (a) in relation to an application under Article 7 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market as it had effect immediately before IP completion day where— (i) paragraph 6 of Schedule 1 to the Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 applies to that application, and (ii) on or before 31st December 2013 dossiers were submitted in accordance with Article 8(1) and (2) of Regulation (EC) No 1107/2009 as it had effect immediately before IP completion day ; (b) in relation to an application under Article 15 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market as it had effect immediately before IP completion day where— (i) paragraph 7 of Schedule 1 to the Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 applies to that application, and (ii) on or before 31st December 2013 dossiers were submitted in accordance with Article 9 of Commission Regulation (EU) No 1141/2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances as it had effect immediately before IP completion day ; (c) in relation to an application for authorisation of a plant protection product, as referred to in Article 28 of Regulation (EC) No 1107/2009, where— (i) the application was submitted before 31st December 2015, and (ii) the plant protection product contains at least one active substance to which point (a) or (b) applies; (d) in relation to the renewal of the authorisation of a plant protection product in accordance with Article 43(2) of Regulation (EC) No 1107/2009 following the renewal (whether before or after IP completion day ) of an active substance in accordance with Commission Regulation (EU) No 1141/2010. (2) Paragraph 1(c) or (d) does not apply where the applicant for the authorisation notifies the competent authority in writing when submitting the application that the data requirements of Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products apply instead. (3) Paragraph 4 applies where Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances applies in relation to an application by virtue of— (a) Article 1 of that Regulation, or (b) Article A1(2) of Commission Regulation (EU) No 544/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances. (4) Where this paragraph applies, a reference in this Regulation to Commission Regulation (EU) No 544/2011, or a specified part of Commission Regulation (EU) No 544/2011, is to be read in relation to that application as a reference to Commission Regulation (EU) No 283/2013, or the equivalent part of Commission Regulation (EU) No 283/2013 (as the case may be).

(3) Omit Article 2.

(4) After Article 2, omit the words from “This Regulation shall” to “Member States”.

(5) The Annex is amended in accordance with paragraphs (6) to (8).

(6) In the Introduction—

(a) in point 1.2, for the words from “the entry” to “Annex,” substitute “ 14th June 2011 ”;

(b) in point 1.3, for “Member States” substitute “ competent authorities ”;

(d) in point 2.1, after “laid down in” insert “ Annex 1 to ”;

(e) in point 2.2, in the seventh indent, for “the Union” substitute “Great Britain”;

(f) in point 2.3—

(i) in the first indent, for “to the relevant national authority” substitute “ in accordance with the official recognition scheme ”;

(ii) in the second indent—

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

(bb) after “on its” insert “ constituent ”;

(g) in points 2.4 and 2.5—

(i) for “Member States” substitute “ the competent authority ”;

(ii) after “their” insert “ constituent ”;

(h) in point 3, omit the words from “Directive 1999/45/EC” to “or with”;

(i) in point 4, in the first indent, for “EU legislation” substitute “ retained EU law ”.

(7) In Part A—

(a) in point 1.1, in the second paragraph, for the words from “the Member State” to “sought” substitute “Great Britain”;

(b) in point 1.4.1, for “Directive 1999/45/EC” substitute “ Regulation (EC) No 1272/2008 of the European Parliament and of the Council ”;

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

(ii) for “territory of this Member State” substitute “ constituent territory of that competent authority ”;

(d) in points 7.1, 7.1.1 and 7.1.2, omit “Directive 1999/45/EC or”;

(e) in point 7.2, after “the requirements of” insert “ the EU-derived domestic legislation which transposed ”;

(f) in point 7.2.1.1, omit “Directive 1999/45/EC or”;

(g) in points 7.2.1.2 and 7.2.3.2, after “in accordance with” insert “ the EU-derived domestic legislation which transposed ”;

(h) in point 7.3, in the second paragraph, in the second indent, after “in accordance with” insert “ the EU-derived domestic legislation which transposed ”;

(i) in point 8.9, in the first paragraph, omit “of the Member States”;

(j) in section 11, omit “of the Member States”;

(k) in point 12.3, in the heading, omit “and Directive 1999/45/EC”.

(8) In Part B—

(a) in point 1.1, in the second paragraph, for the words from “ the Member State ” to “sought” substitute “ Great Britain ”;

(b) in point 1.4(ii), in the third subparagraph, for “Directive 1999/45/EC” substitute “ Regulation (EC) No 1272/2008 of the European Parliament and of the Council ”;

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

(ii) for “territory of this Member State” substitute “ constituent territory of that competent authority ”;

(d) in points 7.1, 7.1.1 and 7.1.3, omit “Directive 1999/45/EC or”;

(e) in Section 11, omit “of the Member States”.

Commission Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products

18

(1) Commission Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products is amended as follows.

(2) Before Article 1, insert—

(1) Paragraph 2 applies where Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances applies in relation to an application by virtue of— (a) Article 1 of that Regulation, or (b) Article A1(2) of Commission Regulation (EU) No 544/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances. (2) Where this paragraph applies, a reference in this Regulation to Commission Regulation (EU) No 544/2011, or a specified part of Commission Regulation (EU) No 544/2011, is to be read in relation to that application as a reference to Commission Regulation (EU) No 283/2013, or the equivalent part of Commission Regulation (EU) No 283/2013 (as the case may be). (3) Paragraph 4 applies where Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products applies in relation to an application by virtue of— (a) Article 1 of that Regulation, or (b) Article A1(2) of Commission Regulation (EU) No 545/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products. (4) Where this paragraph applies, a reference in this Regulation to Commission Regulation (EU) No 545/2011, or a specified part of Commission Regulation (EU) No 545/2011, is to be read in relation to the application as a reference to Commission Regulation (EU) No 284/2013, or the equivalent part of Commission Regulation (EU) No 284/2013 (as the case may be).

(3) In Article 1, for “Article 29(6)” substitute “ Article 29(6)(a) ”.

(4) Omit Article 2.

(5) After Article 2, omit the words from “This Regulation shall” to “Member States”.

(6) The Annex is amended in accordance with paragraphs (7) to (9).

(7) In the heading, for “Article 29(6)” substitute “ Article 29(6)(a) ”.

(8) In Part 1—

(a) in Part A—

(i) in points 1, 2 and 4, for “Member States” substitute “ competent authorities ”;

(ii) in point 5—

(aa) in the first paragraph, for “Member States” substitute “ competent authorities ”;

(bb) in the second paragraph, for “Member States” substitute “ Competent authorities ”;

(iii) in point 6, omit “of the Member States”;

(b) in Part B—

(i) in points 1.1, 1.2, 1.3 and 1.4, for “Member States” in each place it occurs substitute “ competent authorities ”;

(ii) in Section 2, in the text before point 2.1, for “Member States” substitute “ Competent authorities ”;

(iii) in points 2.1.1 and 2.1.2, for “Member States” substitute “ competent authorities ”;

(iv) in point 2.1.3, for “Member States” substitute “ Competent authorities ”;

(v) in point 2.1.4—

(aa) in the first paragraph, for “Member States” substitute “ Competent Authorities ”;

(bb) in the second paragraph, for “Member States” substitute “ competent authorities ”;

(vi) in point 2.1.5, for “Member States” in each place it occurs substitute “ competent authorities ”;

(vii) in point 2.2.1, in the words before point (a), for “Member States” substitute “ Competent authorities ”;

(viii) in points 2.2.2 and 2.3, for “Member States” substitute “ competent authorities ”;

(ix) in points 2.4.1.1, 2.4.1.2, 2.4.1.3, 2.4.1.4, and 2.4.2.1 for “Member States” substitute “ Competent authorities ”;

(x) in points 2.4.2.2 and 2.4.2.3, for “Member States” substitute “ competent authorities ”;

(xi) in points 2.4.2.4, 2.4.2.5 and 2.4.2.6, for “Member States” substitute “ Competent authorities ”;

(xii) in point 2.5.1, for “Member States” substitute “ competent authorities ”;

(xiii) in point 2.5.1.1, in the first paragraph, for “Member States” substitute “ Competent authorities ”;

(xiv) points 2.5.1.2 and 2.5.1.3 are amended as follows;

(xv) in the first paragraph—

(aa) for “Member States” substitute “ Competent authorities ”;

(bb) for “suitable calculation model validated at EU level” substitute “ suitable validated calculation model ”;

(xvi) in the second paragraph—

(aa) omit “EU” in the first place it occurs;

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

(xvii) in points 2.5.1.4 and 2.5.1.5, for “Member States” substitute “ Competent authorities ”;

(xviii) in point 2.5.2, for “Member States” substitute “ competent authorities ”;

(xix) in points 2.5.2.1, 2.5.2.2, 2.5.2.3, 2.5.2.4, 2.5.2.5, 2.5.2.6, 2.6, 2.7.1 and 2.7.2, for “Member States” substitute “ Competent authorities ”;

(i) in point 1.1, for “Member States” substitute “ competent authorities ”;

(ii) in point 1.2—

(aa) for “Member States” substitute “ Competent authorities ”;

(bb) for “Member State” substitute “ constituent territory of the competent authority ”;

(iii) in points 1.3 and 1.4, for “Member States” substitute “ Competent authorities ”;

(iv) in point 1.5, for “Member States” substitute “ competent authorities ”;

(v) in point 1.6—

(aa) the first paragraph is amended as follows;

(bb) in the words before the first indent, for “Member States” substitute “ competent authorities ”;

(cc) in the second indent, for “EU legislation” substitute “ retained EU law ”;

(dd) in the second paragraph, for “Directive 1999/45/EC of the European Parliament and of the Council” substitute “ Regulation (EC) No 1272/2008 ”;

(vi) in point 1.7—

(aa) in the words before point (a), for “Member States” substitute “ competent authorities ”;

(bb) in point (a), for “Directive 1999/45/EC” substitute “ Regulation (EC) No 1272/2008 ”;

(vii) in point 1.9—

(aa) in the first paragraph, for “Member States” substitute “ competent authorities ”;

(bb) in the second paragraph, for “Member States” substitute “ Competent authorities ”;

(viii) in point 2.1.4, for “Member State” substitute “ constituent territory of the competent authority ”;

(ix) in point 2.1.5, in the second paragraph, for “Member States” substitute “ competent authorities ”;

(x) in point 2.4.1.1, in the second paragraph, after “in accordance with” in both places it occurs insert “ the EU-derived domestic legislation which transposed ”;

(xi) in point 2.4.1.2, for “EU provisions” substitute “ retained EU law ”;

(xii) in point 2.4.1.4, omit “EU”;

(xiii) in points 2.4.2.2 and 2.4.2.3, for “Member States” substitute “ competent authorities ”;

(xiv) in point 2.4.2.4, for “Member State” substitute “ constituent territory of the competent authority ”;

(xv) in point 2.5.1.2(i), after “laid down by” insert “ the EU-derived domestic legislation which transposed ”;

(xvi) in point 2.5.1.3, in the first indent, after “in accordance with” insert “ the EU-derived domestic legislation which transposed ”;

(xvii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(9) In Part 2—

(a) in Part A—

(i) in points 1, 2 and 4, for “Member States” substitute “ competent authorities ”;

(ii) in point 5—

(aa) in the first paragraph, for “Member State” substitute “ competent authority ”;

(bb) in the second paragraph, for “Member States” substitute “ Competent authorities ”;

(iii) in point 6, omit “of the Member States”;

(iv) in point 8—

(aa) for “Member States” substitute “ Competent authorities ”;

(bb) for the words from “taken note” to the end substitute “ issued in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council or Regulation (EC) No 1107/2009 of the European Parliament and of the Council ”;

(v) in point 9—

(aa) in the first sentence, after “micro-organisms,” insert “ the EU-derived domestic legislation which transposed ”;

(bb) in the second sentence, for “Directive” substitute “ legislation ”;

(b) in Part B—

(i) in point 1.1, in the words before point (a), for “Member States” substitute “ competent authorities ”;

(ii) in point 1.3, for “Member States” substitute “ competent authorities ”;

(iii) in point 1.4—

(aa) for “Member States” in both places it occurs substitute “ Competent authorities ”;

(bb) for “in that Member State” substitute “ to that competent authority ”;

(iv) in points 1.5 and 1.6, for “Member States” in each place it occurs substitute “ competent authorities ”;

(v) in Section 2, in the words before point 2.1, for “Member States” substitute “ Competent authorities ”;

(vi) in point 2.1.2, for “Member States” substitute “ Competent authorities ”;

(vii) in point 2.2.1.2, for “Member States” substitute “ competent authorities ”;

(viii) in point 2.2.2.3, for “Member States” substitute “ Competent authorities ”;

(ix) in point 2.4.1, for “Member States” substitute “ competent authorities ”;

(x) in points 2.4.2 and 2.4.3, for “Member States” substitute “ Competent authorities ”;

(xi) in points 2.4.4—

(aa) in the first paragraph, for “Member States” substitute “ Competent authorities ”;

(bb) in the second paragraph, for “Member States” substitute “ competent authorities ”;

(xii) in point 2.4.5, for “Member States” substitute “ Competent authorities ”;

(xiii) in points 2.4.6, 2.4.7 and 2.4.8, for “Member States” in each place it occurs substitute “ competent authorities ”;

(xiv) in points 2.5, 2.5.1.1, 2.5.1.2, 2.5.2.1, and 2.5.2.2, in the first paragraph, for “Member States” substitute “ Competent authorities ”;

(xv) in point 2.6, in the words before point (a), for “Member States” substitute “ competent authorities ”;

(xvi) in point 2.6.1.1, in the words before point (a)—

(aa) in the first sentence, for “Member States” substitute “ Competent authorities ”;

(bb) omit the third sentence;

(xvii) in points 2.6.1.2, 2.6.1.3 and 2.6.1.4, for “Member States” substitute “ Competent authorities ”;

(xviii) in points 2.6.2.1 and 2.6.2.2, in points (a) and (b), for “Member States” substitute “ Competent authorities ”;

(xix) in point 2.7, in the fourth paragraph, for “Member States” substitute “ competent authorities ”;

(xx) in point 2.7.1—

(aa) in the first paragraph, for “Member States” substitute “ Competent authorities ”;

(bb) in the second paragraph, for “Member States” substitute “ competent authorities ”;

(xxi) in point 2.7.2—

(aa) in the first paragraph, for “Member States” substitute “ Competent authorities ”;

(bb) in the second paragraph, in point (f), after “provided for in” insert “ the EU-derived domestic legislation which transposed ”;

(xxii) in points 2.7.3, 2.7.4, 2.8, 2.8.1, 2.8.2, 2.8.3, 2.8.4, 2.8.5, 2.8.6, 2.8.6.2, and 2.9, for “Member States” in each place it occurs substitute “ Competent authorities ”;

(i) in point 1.1, for “Member States” substitute “ competent authorities ”;

(ii) in point 1.2—

(aa) in the first sentence, for “Member States” substitute “ Competent authorities ”;

(bb) in the second sentence, for “Member State in question” substitute “ constituent territory of the competent authority ”;

(iii) in point 1.3, for “Member States” substitute “ Competent authorities ”;

(iv) in point 1.4—

(aa) for “Member States” substitute “ Competent authorities ”;

(bb) for “control” substitute “ management ”;

(v) in point 1.5, for “Member States” substitute “ competent authorities ”;

(vi) in point 1.6—

(aa) in the words before point (a), for “Member States” substitute “ competent authorities ”;

(bb) in point (b), for “EU legislation” substitute “ retained EU law ”;

(cc) in point (d), for “Article 10(1.2), (2.4), (2.5) and (2.6) of Directive 1999/45/EC” substitute “ Articles 19, 21 and 22 of, and part 4 of Annex 2 to Regulation (EC) No 1272/2008 of the European Parliament and of the Council ”;

(vii) in point 1.7—

(aa) in the words before point (a), for “Member States” substitute “ competent authorities ”;

(bb) in point (a), for “Directive 1999/45/EC” substitute “ Regulation (EC) No 1272/2008 ”;

(viii) in point 1.9—

(aa) in the first paragraph, for “Member States” substitute “ competent authorities ”;

(bb) in the second paragraph, for “Member States” substitute “ Competent authorities ”;

(ix) in point 1.10, for “Member States” substitute “ Competent authorities ”;

(x) in point 1.11, after “in accordance with” in both places it occurs insert “ the EU-derived domestic legislation which transposed ”;

(xi) in point 1.12, after “in accordance with” in the second place it occurs insert “ the EU-derived domestic legislation which transposed ”;

(xii) in point 1.14, for “Member States” substitute “ Competent authorities ”;

(xiii) in point 2.1, for “Member States” substitute “ competent authorities ”;

(xiv) in point 2.2.1, in the third sentence, for “Member States” substitute “ Competent authorities ”;

(xv) in point 2.4.1.4, for “Member State” substitute “ constituent territory ”;

(xvi) in point 2.4.1.5, for “Member States” substitute “ competent authorities ”;

(xvii) in point 2.4.1.6, for “Member State” substitute “ competent authority ”;

(xviii) in point 2.6.1.2, for “Member States” substitute “ competent authorities ”;

(xix) in point 2.6.1.3, for “EU provisions” substitute “ retained EU law ”;

(xx) in point 2.6.1.9, after “in compliance with” in each place it occurs insert “ the EU-derived domestic legislation which transposed ”;

(xxi) in point 2.7.2, after “provided for in” insert “ the EU-derived domestic legislation which transposed ”;

(xxii) in point 2.7.3(a), after “laid down by” insert “ the EU-derived domestic legislation which transposed ”;

(xxiii) in point 2.7.3(b) and 2.7.4, after “in accordance with” in each place it occurs insert “ the EU-derived domestic legislation which transposed ”;

(xxiv) in point 2.8, for “Member States” in both places it occurs substitute “ Competent authorities ”.

Commission Regulation (EU) No 547/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products

19

(1) Commission Regulation (EU) No 547/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products is amended as follows.

(2) Before Article 1, insert—

(1) Paragraph 2 applies where Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances applies in relation to an application by virtue of— (a) Article 1 of that Regulation, or (b) Article A1(2) of Commission Regulation (EU) No 544/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances. (2) Where this paragraph applies, a reference in this Regulation to Commission Regulation (EU) No 544/2011, or a specified part of Commission Regulation (EU) No 544/2011, is to be read in relation to the application as a reference to Commission Regulation (EU) No 283/2013, or the equivalent part of Commission Regulation (EU) No 283/2013 (as the case may be). (3) Paragraph 4 applies where Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products applies in relation to an application by virtue of— (a) Article 1 of that Regulation, or (b) Article A1(2) of Commission Regulation (EU) No 545/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products. (4) Where this paragraph applies, a reference in this Regulation to Commission Regulation (EU) No 545/2011, or a specified part of Commission Regulation (EU) No 545/2011, is to be read in relation to the application as a reference to Commission Regulation (EU) No 284/2013, or the equivalent part of Commission Regulation (EU) No 284/2013 (as the case may be).

(3) Omit Article 2.

(4) After Article 2, omit the words from “This Regulation shall” to “Member States”.

(5) In Annex 1—

(a) in point (1)(c), in the first sentence, for “Article 10(2.3) of Directive 1999/45/EC of the European Parliament and of the Council” substitute “ Article 18(3) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council ”;

(b) for point (4) substitute—

(4) A competent authority may make the placing of plant protection products on the market in its constituent territory subject to the additional labelling of the product in a language other than English.

(6) In Annex 2—

(a) in the words before point 1, in the first paragraph—

(i) in the first sentence, for “Directive 1999/45/EC” substitute “ Regulation (EC) No 1272/2008 ”;

(ii) in the second sentence, for “Directive” substitute “ Regulation ”;

(b) for point 1.1 substitute—

1.1. Special risks related to humans (RSh) RSh 1 — Toxic by eye contact. RSh 2 — May cause photosensitisation. RSh 3 — Contact with vapour causes burns to skin and eyes and contact with liquid causes freezing.

(c) in point 2.1, for “risk phrases R34 or R35, as set out in Directive 1999/45/EC” substitute “ hazard statement H314 in Regulation (EC) No 1272/2008 of the European Parliament and of the Council ”.

(7) In Annex 3—

(a) in the words before point 1, in the first paragraph—

(i) in the first sentence, for “Directive 1999/45/EC” substitute “ Regulation (EC) No 1272/2008 ”;

(ii) in the second sentence, for “Directive” substitute “ Regulation ”;

(b) for point 1 substitute—

(1) General provisions All plant-protection products shall be labelled with the following phrase, which shall be supplemented by the text in parentheses, as appropriate: SP 1 — Do not contaminate water with the product or its container (Do not clean application equipment near surface water/Avoid contamination via drains from farmyards and roads).

2.1 Safety precautions for operators (SPo) General provisions (1) Competent authorities may identify suitable personal protective equipment for operators and prescribe specific elements of this equipment (e.g. coveralls, apron, gloves, sturdy shoes, rubber boots, face protection, face shield, tightly fitting glasses, hat, hood or respirator of a specified type). Such supplementary safety precautions are without prejudice to the standard phrases applicable according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council. (2) Competent authorities may further identify the specific tasks which require particular protective equipment, such as mixing, loading or handling the undiluted product, applying or spraying the diluted product, handling recently treated materials like plants or soil or entering recently treated areas. (3) Competent authorities may add specifications of engineering controls, such as: - — a closed transfer system must be used when transferring the pesticide from the product container to the spray tank, - — the operator must work within a closed cabin (with an air conditioning/air filtration system) during spraying, - — engineering controls may replace personal protective equipment if they provide an equal or higher standard of protection. Specific provisions SPo 1 — After contact with skin, first remove product with a dry cloth and then wash the skin with plenty of water. SPo 2 — Wash all protective clothing after use. SPo 3 — After igniting the product, do not inhale smoke and leave the treated area immediately. SPo 4 — The container must be opened outdoors and in dry conditions. SPo 5 — Ventilate treated areas/greenhouses thoroughly/time to be specified/until spray has dried before re-entry. 2.2 Safety precautions related to the environment (SPe) SPe 1 — To protect groundwater/soil organisms do not apply this or any other product containing (identify active substance or class of substances, as appropriate) more than (time period or frequency to be specified). SPe 2 — To protect groundwater/aquatic organisms do not apply to (soil type or situation to be specified) soils. SPe 3 — To protect aquatic organisms/non-target plants/non-target arthropods/insects respect an unsprayed buffer zone of (distance to be specified) to non-agricultural land/surface water bodies. SPe 4 — To protect aquatic organisms/non-target plants do not apply on impermeable surfaces such as asphalt, concrete, cobblestones, railway tracks and other situations with a high risk of run-off. SPe 5 — To protect birds/wild mammals the product must be entirely incorporated in the soil; ensure that the product is also fully incorporated at the end of rows. SPe 6 — To protect birds/wild mammals remove spillages. SPe 7 — Do not apply during the bird breeding period. SPe 8 — Dangerous to bees./To protect bees and other pollinating insects do not apply to crop plants when in flower./Do not use where bees are actively foraging./Remove or cover beehives during application and for (state time) after treatment./ Do not apply when flowering weeds are present./ Remove weeds before flowering./Do not apply before (state time). 2.3 Safety precautions related to good agricultural practice (SPa) SPa 1 — To avoid the build-up of resistance do not apply this or any other product containing (identify active substance or class of substances, as appropriate) more than (number of applications or time period to be specified). 2.4 Specific safety precautions for rodenticides (SPr) SPr 1 — The baits must be securely deposited in a way so as to minimise the risk of consumption by other animals. Secure bait blocks so that they cannot be dragged away by rodents. SPr 2 — Treatment area must be marked during the treatment period. The danger from being poisoned (primary or secondary) by the anticoagulant and the antidote against it should be mentioned. SPr 3 — Dead rodents must be removed from the treatment area each day during treatment. Do not place in refuse bins or on rubbish tips.

(d) in point 3.1. for the words from “Annex to Regulation (EU) No” to “products]” substitute “ Annex to Commission Regulation (EU) No 546/2011 ”;

(e) in point 3.3, for “Member States” in both places it occurs substitute “ competent authorities ”.

Commission Implementing Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market

20

(1) Commission Implementing Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market is amended as follows.

(2) In Article 1—

(a) in paragraph 1—

(i) for the first subparagraph substitute—

An application for the renewal of an approval of an active substance must be submitted by a producer of the active substance to a competent authority for a constituent territory in relation to which the active substance is approved (in this Regulation, the “assessing competent authority”) no later than three years before the expiry of the approval.

(ii) omit the fourth to sixth subparagraphs;

(b) omit paragraph 2.

(3) In Article 3—

(a) in paragraph 1—

(i) in the first subparagraph—

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

(bb) for “, the co-rapporteur Member State, the Commission and the Authority” substitute “ and the other competent authorities ”;

(ii) in the second subparagraph, for “rapporteur Member State” in both places it occurs substitute “ assessing competent authority ”;

(b) in paragraph 2—

(i) in the first subparagraph—

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

(bb) for “Rapporteur Member State and to the co-rapporteur Member State” substitute “ assessing competent authority ”;

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

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

(ii) for the words from “, the co-rapporteur” to “Authority” substitute “ and the other competent authorities ”;

(d) in paragraph 4, for “Authority” in both places it occurs, substitute “ assessing competent authority ”;

(e) in paragraph 5—

(i) after “separately” insert “ to the same assessing competent authority ”;

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

(f) in paragraph 6, for “Commission” substitute “ assessing competent authority ”.

(4) In Article 4, for “rapporteur Member State and the co-rapporteur Member State” substitute “ assessing competent authority ”.

(5) In Article 5, for “Authority” substitute “ assessing competent authority ”.

(6) In Article 6—

(a) in paragraph 1—

(i) for “rapporteur Member State” in the first place it occurs substitute “assessing competent authority";

(ii) for the words from “rapporteur Member State" in the second place it occurs to the end substitute “ assessing competent authority ”;

(b) after paragraph 1 insert—

(1A) The assessing competent authority must notify the other competent authorities as soon as reasonably practicable after receipt of the supplementary dossiers under paragraph 1. (1B) A competent authority which receives a notification under paragraph 1A may request in writing from the applicant a copy of supplementary dossiers, which the applicant must provide as soon as reasonably practicable.

(7) In Article 7(1)—

(a) in point (c)—

(i) for “widely grown crop in each zone” substitute “ crop grown in Great Britain ”;

(ii) for the words from “cover all zones” to “widely grown” substitute “ concern a ";

(b) in points (e) and (f)—

(i) for “a Regulation” substitute “ legislation ”;

(ii) after “Regulation (EC) No 1107/2009” insert “ in relation to each constituent territory to which the application for renewal relates ”.

(8) In Article 8—

(a) in paragraph 1—

(i) in the first subparagraph—

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

(bb) for the words from “, the co-rapporteur” to “Authority” substitute “ and the other competent authorities ”;

(ii) in the second subparagraph, for “rapporteur Member State” in both places it occurs substitute “ assessing competent authority ”;

(b) in paragraph 2—

(i) in the first subparagraph—

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

(bb) for “rapporteur Member State and co-rapporteur Member State” substitute “ assessing competent authority ”;

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

(i) omit the first subparagraph;

(ii) in the second subparagraph—

(aa) for “At the same time” substitute “ Before the end of the period stated in paragraph 1 ”;

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

(d) in paragraph 4, for “Authority” substitute “ assessing competent authority ”;

(e) in paragraph 5, for “the Authority or a Member State” substitute “ a competent authority ”;

(f) in paragraph 6—

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

(ii) for the words from “, the co-rapporteur” to “Authority” substitute “ and the other competent authorities ”.

(9) In Article 9—

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

(b) in the second sentence, for the words from “co-rapporteur” to “Authority” substitute “ other competent authorities ”.

(10) For Article 10 substitute—

Where all of the applications submitted for renewal of the approval of an active substance in relation to a constituent territory are inadmissible in accordance with Article 3(3) or 8(6), the competent authority for that constituent territory must refuse to renew approval of the active substance in accordance with Article 20(1)(b) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council.

(11) In Article 11—

(a) in the heading, for “rapporteur Member State and the co-rapporteur Member State” substitute “ assessing competent authority ”;

(b) in paragraph 1—

(i) for “rapporteur Member State shall, after consulting the co-rapporteur Member State” substitute “ assessing competent authority must ”;

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

(d) in paragraphs 3 and 4, for “rapporteur Member State” substitute “ assessing competent authority ”;

(e) in paragraph 5—

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

(ii) omit the second sentence,

(f) after paragraph 5 insert—

(5A) The 13 month period provided for in paragraph 1 is extended by any additional period set in accordance with paragraph 5. (5B) The additional period described in paragraph 5 must be for no more than 6 months and ceases at the earlier of— (a) the date on which the assessing competent authority receives the additional information; (b) the expiry of the additional period.

(g) for paragraph 6 substitute—

(6) The assessing competent authority may, as it considers appropriate— (a) obtain independent scientific advice; (b) consult with the other competent authorities.

(h) in paragraph 8—

(i) for the first subparagraph substitute—

When submitting the draft renewal assessment report to the other competent authorities, the assessing competent authority must require the applicant to notify the other competent authorities of the existence of any updated supplementary summary dossiers. Article 15(4) of Regulation (EC) No 1107/2009 applies to a notification under this paragraph as it applies to a notification under Article 15(3) of that Regulation.

(ii) in the second subparagraph, in the second sentence, for “Authority” substitute “ assessing competent authority ”.

(12) In Article 12—

(a) in paragraph 1—

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

(ii) omit “received from the rapporteur Member State”;

(iii) for “Member States” substitute “ competent authorities ”;

(b) in paragraph 2, for “Authority” substitute “ assessing competent authority ”;

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

(ii) for “Commission” substitute “ other competent authorities ”;

(d) in paragraph 4, for “Authority” substitute “ assessing competent authority ”.

(13) In Article 13—

(a) in the heading, for “Authority” substitute “ assessing competent authority ”;

(b) in paragraph 1—

(i) in the first subparagraph—

(aa) for “Committee for Risk Assessment” substitute “Agency” in both places it occurs;

(bb) for “37(4)” substitute “37A(4)”;

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

(dd) for the second sentence, substitute—

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

(ee) in the third sentence, for “, the Member States and the Commission” substitute “and the other competent authorities”;

(ii) omit the second subparagraph

(d) in paragraph 3, in the first subparagraph—

(i) in the first sentence—

(aa) for “Authority” in both places it occurs substitute “ assessing competent authority ”;

(bb) omit “, in consultation with the rapporteur Member State,”;

(cc) for “one month” substitute “ 90 days ”;

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

(ii) in the second sentence—

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

(bb) omit “and send its evaluation to the Authority”;

(e) in paragraph 4—

(i) in the first sentence—

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

(bb) omit “ask the Commission to”;

(cc) omit “European Union”;

(ii) in the second sentence, omit “European Union”.

(14) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(15) In Article 15, for the words from “renewal” to the end substitute “ existing renewal applications within the meaning of Article 1(2) of that Regulation ”.

(16) Omit Article 16.

(17) After Article 16, omit the words from “This Regulation” to “Member States.”.

(18) In the Annex—

(a) in the “Format for applications, as provided for in Article 2(1)” section—

(i) in the first paragraph, for “rapporteur Member State and to the co-rapporteur Member State” substitute “ assessing competent authority ”;

(ii) omit the second paragraph;

(b) in the “Model” section, in point 2.5, for “Annex to Commission Implementing Regulation (EU) No 540/2011” substitute “ approvals register in relation to each constituent territory to which the application relates ”.

Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market

21

(1) Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market is amended as follows.

(2) In Article 1—

(a) the existing text becomes paragraph 1;

(b) after that paragraph insert—

(2) Paragraph 1 does not apply where Regulation (EU) No 544/2011 applies (see Article A1 of that Regulation).

(3) Omit Articles 2 to 5.

(4) After Article 5, omit the words from “This Regulation” to “Member States”.

(5) In the Annex—

(a) in the Introduction—

(i) in points 1.6 and 1.7, omit “European”;

(ii) in point 1.10, for “Directive 2010/63/EU of the European Parliament and of the Council” substitute “ the Animals (Scientific Procedures) Act 1986 ”;

(iii) in point 1.13, for “accepted by European Food Safety Authority, (the Authority)” substitute “ set out in guidance issued in accordance with Article 77 of Regulation (EC) No 1107/2009 ”;

(iv) in point 2, omit “at national level”;

(v) in point 3.1, after “laid down in” insert “ Annex 1 to ”;

(vi) in point 3.2.3, for “the application of this Regulation” substitute “ 1st January 2014 ”;

(vii) omit point 6;

(b) in Part A—

(i) in point 1.2, for “Commission, the Authority and the Member States” substitute “ competent authorities ”;

(ii) in point 1.5, omit “Member States or”;

(iii) in point 3.9, for “Council Directive 94/67/EC ” substitute “ the EU-derived domestic legislation which transposed Directive 2010/75/EU of the European Parliament and of the Council on industrial emissions (integrated pollution prevention and control) ”;

(iv) in point 4.2, in the first paragraph, in point (a) for “Member States” substitute “ competent authorities ”;

(v) in point 5.8.3, in the second paragraph for “Union” substitute “ national ”;

(vi) in point 5.9, in the first paragraph, in the first sentence, after “prejudice to” insert “ the EU-derived domestic legislation which transposed ”;

(vii) in point 6.3, under “Test conditions”—

(aa) for the fourth paragraph substitute—

For the evaluation of residue behaviour and the setting of maximum residue levels (MRLs) according to Regulation (EC) No 396/2005, residues trials data relevant to the agricultural practices in the UK must be provided. The trials must correspond to the critical GAP and the production conditions (such as cultural practices, climatic conditions) must be comparable to the UK. Differences in agricultural production methods (for example outdoor versus indoor uses), seasons of production, and types of formulation shall be taken into account.

(bb) in the fifth paragraph, omit “for each residue zone”;

(cc) omit the sixth paragraph;

(dd) in the seventh paragraph, in the second sentence, omit “per zone” in both places it occurs;

(ee) in the ninth paragraph, for “different zones” substitute “ growing areas representative of those in Great Britain ”;

(ff) omit the tenth paragraph;

(viii) in point 6.5.3, in the third paragraph, for “European” substitute “ relevant ”;

(ix) in point 6.6.2, in the sixth paragraph—

(aa) in the fifth sentence, for “the Union” substitute “ areas relevant to Great Britain ”;

(bb) in the sixth sentence, for “across the Union” substitute “ relevant to Great Britain ”;

(cc) in the eighth sentence, for “national competent authorities in the Member States” substitute “ competent authorities ”;

(x) in point 6.10.1, in the second paragraph, omit “national”;

(xi) in point 7.1, in the third paragraph, for “ the Union ” substitute “ Great Britain ”;

(xii) in points 7.1.2.2.2 and 7.1.3.2—

(aa) omit the words from “being included” to “introduction”;

(bb) omit “national” in each place it occurs;

(xiii) in points 7.1.4.3, 7.2.2.4, 7.2.3 and 7.3.2, omit “national” in each place it occurs;

(xiv) in Section 8, in the Introduction, in paragraph 1, in the third sentence, omit “national”;

(xv) in point 8.1.5—

(aa) in the first sentence, for “Union” substitute “ national ”;

(bb) in the fourth sentence, omit “national”;

(xvi) in points 8.2 and 8.2.2.2, omit “national”;

(xvii) in point 8.2.3—

(aa) in the first sentence, for “Union” substitute “ national ”;

(bb) in the third sentence, omit “national”;

(xviii) in points 8.2.7, 8.2.8, 8.3.2 and 8.4.2, omit “national” in each place it occurs;

(i) in point 1.1, in the second paragraph, for the words from “the Member State” to “Commission” substitute “Great Britain”;

(ii) in points 1.2 and 1.4.1, for “Commission and the Member States” substitute “ competent authorities ”;

(iii) in point 5.1.1, in the first paragraph, in the first sentence, after “provisions of” insert “ the EU-derived domestic legislation which transposed ”;

(iv) in point 7.1.1, in the first sentence omit “EU”;

(v) in point 8.6, in the fifth sentence, for “crop management (ICM)” substitute “ pest management (IPM) ”;

(vi) in Section 9, in the first sentence, omit “of the Member States”.

Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market

22

(1) Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market is amended as follows.

(2) In Article 1—

(a) the existing text becomes paragraph 1;

(b) after that paragraph insert—

(2) Paragraph 1 does not apply where Regulation (EU) No 545/2011 applies (see Article A1 of that Regulation).

(3) Omit Articles 2 to 5.

(4) After Article 5, omit the words from “This Regulation” to “Member States”.

(5) In the Annex—

(a) in the Introduction—

(i) in point 1.6, omit “European”;

(ii) in point 1.8, for “Directive 2010/63/EU of the European Parliament and of the Council” substitute “ the Animals (Scientific Procedures) Act 1986 ”;

(iii) in point 1.11, for “Union legislation” substitute “ retained EU law ”;

(iv) in point 1.14, for “accepted by the European Food Safety Authority (the Authority)” substitute “ set out in guidance issued in accordance with Article 77 of Regulation (EC) No 1107/2009 ”;

(v) in point 2, omit the second sentence;

(vi) in point 3.1, after “laid down in” insert “ Annex 1 to ”;

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