{
  "url": "https://openlegislation.uk/draft-plant-protection-products-miscellaneous-amendments-eu-exit-regulations-2019/regulation-16",
  "json_url": "https://openlegislation.uk/draft-plant-protection-products-miscellaneous-amendments-eu-exit-regulations-2019/regulation-16.json",
  "legislation": "ukdsi/2019/9780111176931",
  "legislation_title": "The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/draft-plant-protection-products-miscellaneous-amendments-eu-exit-regulations-2019",
  "path": "regulation/16",
  "kind": "regulation",
  "number": "16",
  "heading": "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",
  "text": "(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.\n(2) Before Article 1, insert—\n“Article A1\nScope and interpretation\n1. This Regulation applies in relation to—\n(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 exit day where—\n(i) paragraph 6 of Schedule 1 to the Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 applies to that application, and\n(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 exit day;\n(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 exit day where—\n(i) paragraph 7 of Schedule 1 to the Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 applies to that application, and\n(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 exit day;\n(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, to the submission of data concerning an active substance—\n(i) to which point (a) or (b) applies, or\n(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 exit day.\n2. 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.\n3. 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—\n(a) Article 1 of that Regulation, or\n(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.\n4. 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).”.\n(3) Omit Article 2.\n(4) After Article 2, omit the words from “This Regulation shall” to “Member States”.\n(5) In the Annex—\n(a) in the Introduction—\n(i) in point 1.2, for the words from “the entry” to “Annex,” substitute “14th June 2011”;\n(ii) in point 1.3, for “Member States” substitute “the competent authority”;\n(iii) in point 1.6, for “Council Directive 86/609/EEC” substitute “the Animals (Scientific Procedures) Act 1986”;\n(iv) in point 2.1, after “laid down in” insert “Annex 1 to”;\n(v) in point 2.2, in the first paragraph—\n(aa) for “Member States” substitute “the competent authority”;\n(bb) after “their” insert “constituent”;\n(vi) in point 2.3, in the first paragraph—\n(aa) for “Member States” substitute “the competent authority”;\n(bb) after “their” insert “constituent”;\n(cc) for “2 years after notification of the Directive 91/414/EEC” substitute “on or before 25th July 1993”;\n(b) in Part A—\n(i) in point 1.1, in the second paragraph, for the words from “Member State” in the first place it occurs to “Commission” substitute “United Kingdom”;\n(ii) in point 1.2, in the third sentence, for “the Commission and the Member States” substitute “each competent authority which granted approval”;\n(iii) in point 1.5, in the second sentence, omit “Member States or”;\n(iv) in point 1.9, in the second paragraph for “the Commission and the Member States” substitute “each competent authority which granted approval”;\n(v) in point 4.2.1, for “Member States” substitute “competent authorities”;\n(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”;\n(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”;\n(viii) in point 6.10, omit “of the Member States”;\n(ix) in point 7.1, in the fourth paragraph, for “EU” substitute “UK”;\n(x) in point 7.1.1.2.1, under “Aerobic degradation”, under “Test conditions”, in the second paragraph, omit “EU”;\n(c) in Part B—\n(i) in point 1.1, in the second paragraph, for the words from “Member State” in the first place it occurs to “Commission” substitute “United Kingdom”;\n(ii) in point 1.2, for “the Commission and the Member States” substitute “each competent authority which granted approval”;\n(iii) in point 1.4.1, in the second paragraph for “the Commission and the Member States” substitute “each competent authority which granted approval”;\n(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”;\n(v) in point 7.1.1, for “EU” substitute “UK”;\n(vi) in point 9, omit “of the Member States”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No L 358, 18.12.1986, p 1, which was repealed by Directive 2010/63/EU of the European Parliament and of the Council (OJ No L 276, 20.10.2010, p 33)."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "1986 c. 14."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "OJ No L 230, 19.8.1991, p. 1, which was repealed by Regulation (EC) No 1107/2009 of the European Parliament and of the Council."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "See for example: S.I. 2002/2676, 2677, 2776, 2010/330 and 2012/632; and in relation to Northern Ireland, S.R. 2003 No. 152 and 2012 No. 179."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2019/9780111176931/regulation/16",
    "retrieved_at": "2026-10-30T15:02:33.823613+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}