Article 77 Guidance documentsF1

United Kingdom

A competent authority may issue, amend or withdraw technical and other guidance documents relating to the implementation of this Regulation, including (but not limited to)—

(a)

guidance relating to the format of the summary or complete dossiers to be used for the purposes of Article 8;

(b)

guidance relating to the format of the draft assessment report for the purposes of Article 11;

(c)

guidance relating to the format of the assessment for the purposes of Article 36;

(d)

guidance regarding the rules and procedure for the assessment of equivalence under Article 38;

(e)

guidelines on the coordination of compliance checks to be undertaken in accordance with Article 43(3);

(f)

guidance on the application of Article 54, including on—

(i))

the maximum quantities of plant protection products that may be released during experiments or tests;

(ii))

the minimum data to be submitted in accordance with Article 54(2);

(g)

guidance concerning the content of the application concerning micro-organisms, pheromones and biological products.

A competent authority must publish any guidance document issued or amended, or a notice specifying any guidance document withdrawn, under paragraph 1 in a manner which that competent authority considers appropriate.

Before issuing, amending or withdrawing a guidance document under paragraph 1 a competent authority may obtain independent scientific advice, where the competent authority considers it appropriate to do so.

The Secretary of State may issue, amend or withdraw a guidance document under paragraph 1 instead of a competent authority—

(a)

in relation to Wales, with the consent of the Welsh Ministers;

(b)

in relation to Scotland, with the consent of the Scottish Ministers.

Where the Secretary of State issues, amends or withdraws a guidance document in accordance with paragraph 4, a reference in paragraphs 2 and 3 to the competent authority is to be read as a reference to the Secretary of State.

In complying with any obligation under this Regulation, a person or competent authority must have regard to any guidance issued in accordance with paragraph 1.

Annotations

Textual amendments

F1: Arts. 77-78A substituted for Arts. 77, 78 (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 12(6) (with Sch. 1) (as amended by S.I. 2020/1376, regs. 1(4), 3(10)(b) (which amendment includes the omission of Art. 78A(3)(7))); 2020 c. 1, Sch. 5 para. 1(1)