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Commission Regulation (EU) No 546/2011Show full title
Commission Regulation (EU) No 546/2011 of 10 June 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 (Text with EEA relevance)
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- Revised 24/05/20180.50 MB
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Changes over time for: Division 2.
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Changes and effects yet to be applied to Annex Part I Division A Division 2:
- Annex Pt. 1 Pt. C point 1.6 word substituted by S.I. 2025/82 Sch. 15 para. 95(2)(a)
- Annex Pt. 1 Pt. C point 2.4.1.2 word substituted by S.I. 2025/82 Sch. 15 para. 95(2)(b)
- Annex Pt. 2 Pt. C point 1.6(b) word substituted by S.I. 2025/82 Sch. 15 para. 95(2)(c)
- Annex Pt. 2 Pt. C point 2.6.1.3 word substituted by S.I. 2025/82 Sch. 15 para. 95(2)(d)
Changes and effects yet to be applied to the whole legislation item and associated provisions
- Annex Pt. 1 Pt. C point 1.6 word substituted by S.I. 2025/82 Sch. 15 para. 95(2)(a)
- Annex Pt. 1 Pt. C point 2.4.1.2 word substituted by S.I. 2025/82 Sch. 15 para. 95(2)(b)
- Annex Pt. 2 Pt. C point 1.6(b) word substituted by S.I. 2025/82 Sch. 15 para. 95(2)(c)
- Annex Pt. 2 Pt. C point 2.6.1.3 word substituted by S.I. 2025/82 Sch. 15 para. 95(2)(d)
2.In evaluating applications and granting authorisations [F1competent authorities] shall:U.K.Textual Amendments
F1Words in Annex Pt. 1.A points 1, 2, 4 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F1Words in Annex Pt. 1.A points 1, 2, 4 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
(a)
ensure that the dossier supplied is in accordance with the requirements of the Annex to Commission Regulation (EU) No 545/2011(1), at the latest at the time of finalisation of the evaluation for the purpose of decision-making, without prejudice, where relevant, to the provisions of Articles 33, 34 and 59 of Regulation (EC) No 1107/2009,
ensure that the data submitted are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier,
evaluate, where relevant, justifications submitted by the applicant for not supplying certain data;
(b)
take into account the data concerning the active substance in the plant protection product of the Annex to Commission Regulation (EU) No 544/2011(2), submitted for the purpose of approval of the active substance under Regulation (EC) No 1107/2009, and the results of the evaluation of those data, without prejudice, where relevant, to the provisions of Article 33(3) and Articles 34 and 59 of Regulation (EC) No 1107/2009;
(c)
take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its residues.
(1)
See page 67 of this Official Journal.
(2)
See page 1 of this Official Journal.
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