Article 38 Assessment of equivalence under Article 29(1)(b)F1

United Kingdom

This Article applies where it is necessary in relation to an application to establish for an active substance, safener or synergist whether a different source or, for the same source a change of the manufacturing process or location complies with Article 29(1)(b).

1A.

Where this Article applies, equivalence—

(a)

may be assessed by a competent authority examining the application, where—

(i))

each of the other competent authorities examining the application consents to that competent authority assessing equivalence, and

(ii))

in relation to the active substance, safener or synergist for which equivalence is to be assessed, any data requirements specified in regulations made under Article 8(4)(a) and (b), any uniform principles for evaluation and authorisation of plant protection products prescribed in regulations made under Article 29(6)(a) and any guidance issued under Article 77 relating to those requirements or principles are the same in relation to the constituent territory of each competent authority examining the application;

(b)

otherwise, must be assessed by each competent authority examining the application.

1B.

The applicant must submit all necessary data to each competent authority assessing equivalence.

A competent authority assessing equivalence must—

(a)

give the applicant the opportunity to submit comments,

(b)

prepare a report on the competent authority's conclusion on equivalence within 60 days from receiving the application, and

(c)

provide a copy of that report to—

(i))

the applicant, and

(ii))

where the assessment is undertaken in accordance with paragraph 1A(a), the other competent authorities examining the application.

Where an assessment is undertaken in accordance with paragraph 1A(a), a competent authority examining the application which does not agree with the conclusion in the report provided in accordance with paragraph 2(c)(ii) must notify the competent authority which assessed equivalence, the other competent authorities examining the application and the applicant, stating its reasons for not agreeing.

3A.

Following a notification under paragraph 3, the competent authorities concerned must—

(a)

give the applicant the opportunity to submit comments, and

(b)

try to reach agreement on whether Article 29(1)(b) is complied with.

Article 29(1)(b) is deemed not to be complied with where the competent authorities concerned under paragraph 3A do not reach agreement within 45 days of the latest date on which a notification from a competent authority is communicated in accordance with paragraph 3.

Annotations

Textual amendments

F1: Art. 38 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(14) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)

Notes on Section 1

Textual amendments

F1: Words in Ch. 3 Section 1 Subsection 3 heading inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(16)(a) (with Sch. 1); 2020 c. 1, Sch. 5 para. 1(1)
F2: Ch. 3 Section 1 Subsection 3A inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 5(21) (with Sch. 1) (as amended by S.I. 2020/1376, regs. 1(4), 3(5)(f)); 2020 c. 1, Sch. 5 para. 1(1)