Regulation (EC) No 1107/2009 of the European Parliament and of the CouncilShow full title

Article 29 U.K. Requirements for the authorisation for placing on the market

1. Without prejudice to Article 50 a plant protection product shall only be authorised where following the uniform principles referred to in paragraph 6 [F1 for the constituent territory of authorisation] it complies with the following requirements:

(a) its active substances, safeners and synergists [F2 are approved in the constituent territory of authorisation, and approval is not suspended in accordance with Article 69];

(b) where its active substance, safener or synergist is produced by a different source, or by the same source with a change in the manufacturing process and/or manufacturing location:

(i)

the specification, pursuant to Article 38, does not deviate significantly from the specification [F3 of that substance, safener or synergist as approved in the constituent territory of authorisation]; and

(ii)

the active substance, safener or synergist has no more harmful effects within the meaning of Article 4(2) and (3) due to its impurities than if it had been produced in accordance with the manufacturing process specified in the dossier that supported the approval;

(c) its co-formulants are not included [F4 on the unacceptable co-formulants register in relation to the constituent territory of authorisation];

(d) its technical formulation is such that user exposure or other risks are limited as much as possible without compromising the functioning of the product;

(e) in the light of current scientific and technical knowledge, it complies with the requirements provided for in Article 4(3);

(f) the nature and quantity of its active substances, safeners and synergists and, where appropriate, any toxicologically, ecotoxicologically or environmentally relevant impurities and co-formulants can be determined by appropriate methods;

(g) its residues, resulting from authorised uses, and which are of toxicological, ecotoxicological or environmental relevance, can be determined by appropriate methods in general use in [F5 Great Britain], with appropriate limits of determination on relevant samples;

(h) its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product;

(i) for plants or plant products to be used as feed or food, where appropriate, the maximum residue levels for the agricultural products affected by the use referred to in the authorisation have been set or modified [F6 in relation to the constituent territory of authorisation] in accordance with Regulation (EC) No 396/2005.

2. The applicant shall demonstrate that the requirements provided for in points (a) to (h) of paragraph 1 are met.

3. Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the [F7 areas of Great Britain] where the product is intended to be used.

F8 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F8 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6. [F9 (a) The appropriate authority may, by regulations, prescribe uniform principles for the evaluation and authorisation of plant protection products.]

[F10 (b)] Following these principles, interaction between the active substance, safeners, synergists and co-formulants shall be taken into account in the evaluation of plant protection products.

Textual Amendments

F1 Words in Art. 29(1) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(3)(a)(i) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 29(1)(a) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(3)(a)(ii) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 29(1)(b)(i) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(3)(a)(iii) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 29(1)(c) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(3)(a)(iv) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 29(1)(g) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(3)(a)(v) (with Sch. 1) (as amended by S.I. 2020/1376, regs. 1(4), 3(5)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 29(1)(i) inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(3)(a)(vi) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 29(3) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(3)(b) (with Sch. 1) (as amended by S.I. 2020/1376, regs. 1(4), 3(5)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F8 Art. 29(4)(5) omitted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(3)(c) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

F9 Art. 29(6)(a) substituted for words in Art. 29(6) (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(3)(d)(i) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in Art. 29(6) renumbered as Art. 29(6)(b) (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(3)(d)(ii) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)