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) (c. 546)

ANNEX U.K. UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS, AS PROVIDED FOR IN [F1 ARTICLE 29(6)(a)] OF REGULATION (EC) No 1107/2009

Textual Amendments

F1 Words in Annex heading substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(7); 2020 c. 1, Sch. 5 para. 1(1)

PART I U.K. Uniform principles for evaluation and authorisation of chemical plant protection products

C. DECISION-MAKING U.K.

1. General principles U.K.

1.1. Where appropriate, [F2 competent authorities] shall impose conditions or restrictions with the authorisations they grant. The nature and severity of these measures must be selected on the basis of, and be appropriate to, the nature and extent of the expected advantages and the risks likely to arise. U.K.

Textual Amendments

F2 Words in Annex Pt. 1.C point 1.1 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

1.2. [F3 Competent authorities] shall ensure that, where necessary, decisions taken with respect to the granting of authorisations take account of the agricultural, plant health or environmental (including climatic) conditions in the areas of envisaged use. Such considerations may result in specific conditions and restrictions of use, and, where necessary, in authorisation being granted for some but not other areas within the [F4 constituent territory of the competent authority] in question. U.K.

Textual Amendments

F3 Words in Annex Pt. 1.C point 1.2 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Annex Pt. 1.C point 1.2 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

1.3. [F5 Competent authorities] shall ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effect even where higher amounts would not result in unacceptable risks to human or animal health or to the environment. The authorised amounts must be differentiated in accordance with, and be appropriate to, the agricultural, plant health or environmental (including climatic) conditions in the various areas for which an authorisation is granted. However, the rates and the number of applications may not give rise to undesirable effects such as the development of resistance. U.K.

Textual Amendments

F5 Words in Annex Pt. 1.C points 1.3, 1.4 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(iii); 2020 c. 1, Sch. 5 para. 1(1)

1.4. [F5 Competent authorities] shall ensure that decisions respect the principles of integrated control if the product is intended to be used in conditions where these principles are relied on. U.K.

1.5. Since the evaluation is to be based on data concerning a limited number of representative species, [F6 competent authorities] shall ensure that use of plant protection products does not have any long-term repercussions for the abundance and diversity of non-target species. U.K.

Textual Amendments

F6 Words in Annex Pt. 1.C point 1.5 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(iv); 2020 c. 1, Sch. 5 para. 1(1)

1.6. Before issuing an authorisation, [F7 competent authorities] shall ensure that the label of the product: U.K.

Textual Amendments

F7 Words in Annex Pt. 1.C point 1.6 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(v)(bb); 2020 c. 1, Sch. 5 para. 1(1)

• fulfils the requirements setting out in the Commission Regulation (EU) 547/2011(1),

• also contains the information on protection of users required by [F8 retained EU law] on worker protection,

• specifies in particular the conditions or restrictions under which the plant protection product may or may not be used as referred to in points 1.1, 1.2, 1.3, 1.4 and 1.5 above.

Textual Amendments

F8 Words in Annex Pt. 1.C point 1.6 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(v)(cc); 2020 c. 1, Sch. 5 para. 1(1)

The authorisation shall mention the particulars indicated in [F9 Regulation (EC) No 1272/2008] and in Regulation (EU) No 547/2011.

Textual Amendments

F9 Words in Annex Pt. 1.C point 1.6 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(v)(dd); 2020 c. 1, Sch. 5 para. 1(1)

1.7. Before issuing authorisations, [F10 competent authorities] shall: U.K.

Textual Amendments

F10 Words in Annex Pt. 1.C point 1.7 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(vi)(aa); 2020 c. 1, Sch. 5 para. 1(1)

(a)

ensure that the proposed packaging is in accordance with the provisions of [F11 Regulation (EC) No 1272/2008];

(b)

ensure that:

• the procedures for destruction of the plant protection product,

• the procedures for neutralisation of the adverse effects of the product if it is accidentally dispersed, and

• the procedures for the decontamination and destruction of the packaging,

are in accordance with the relevant regulatory provisions.

Textual Amendments

F11 Words in Annex Pt. 1.C point 1.7 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(vi)(bb); 2020 c. 1, Sch. 5 para. 1(1)

1.8. No authorisation shall be granted unless all the requirements referred to in Section 2 are satisfied. However: U.K.

(a)

when one or more of the specific decision-making requirements referred to in points 2.1, 2.2, 2.3 or 2.7 are not fully satisfied, authorisations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweigh the possible adverse effects of its use. Any restrictions on use of the product relating to non-compliance with some of the aforementioned requirements must be mentioned on the label, and non-compliance with the requirements referred to in point 2.7 must not compromise proper use of the product. These advantages can be in terms of:

• advantages for and compatibility with integrated control measures or organic farming,

• facilitating strategies to minimise the risk of development of resistance,

• the need for a greater diversity of types of active substances or biochemical modes of action, e.g. for use in strategies to avoid accelerated breakdown in the soil,

• reduced risk for operators and consumers,

• reduced contamination of the environment and reduced impact on non-target species;

(b)

where the criteria referred to in point 2.6 are not fully satisfied because of limitations in current analytical science and technology, authorisation shall be granted for a limited period if the methods submitted prove adequate for the purposes intended. In this case the applicant shall be given a time limit in which to develop and submit analytical methods that are in accordance with those criteria. The authorisation shall be reviewed on expiry of the time limit accorded to the applicant;

(c)

where the reproducibility of the submitted analytical methods referred to in point 2.6 has only been verified in two laboratories, an authorisation shall be granted for 1 year to permit the applicant to demonstrate the reproducibility of those methods in accordance with agreed criteria.

1.9. Where an authorisation has been granted in accordance with the requirements provided for in this Annex, [F12 competent authorities] may, by virtue of Article 44 of Regulation (EC) No 1107/2009: U.K.

Textual Amendments

F12 Words in Annex Pt. 1.C point 1.9 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(vii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

(a)

define, where possible, preferably in close cooperation with the applicant, measures to improve the performance of the plant protection product; and/or

(b)

define, where possible, in close cooperation with the applicant, measures to reduce further the exposure that could occur during and after use of the plant protection product.

[F13 Competent authorities] shall inform applicants of any measures identified under (a) or (b) and shall invite applicants to provide any supplementary data and information necessary to demonstrate performance or potential risks arising under the changed conditions.

Textual Amendments

F13 Words in Annex Pt. 1.C point 1.9 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(8)(c)(vii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

(1)

See page 176 of this Official Journal.