For Articles 77 and 78 substitute—

“Article 77Guidance documents

1.

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.

2.

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competent authority must publish any guidance document issued or amended, or a notice specifying any guidance document withdrawn, under paragraph 1 in a manner which that competent authority considers appropriate.

3.

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.

4.

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;

F2(c)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.

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.

6.

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.

Article 78Amendments and implementing measures

The appropriate authority may by regulations—

(a)

amend the Annexes to take account of current scientific and technical knowledge;

(b)

make further provision as necessary for the implementation of this Regulation.

Article 78ARegulations

1.

Regulations made by the Secretary of State or Welsh Ministers under this Regulation are to be made by statutory instrument.

2.

For regulations made under this Regulation by the Scottish Ministers, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 M1.

F23.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.

A statutory instrument containing regulations made by the Secretary of State under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.

5.

A statutory instrument containing regulations made by the Welsh Ministers under this Regulation is subject to annulment in pursuance of a resolution of the National Assembly for Wales.

6.

Regulations made by the Scottish Ministers under this Regulation are subject to the negative procedure (see section 28 of the Interpretation and Legislative Reform (Scotland) Act 2010).

F27.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8.

Such regulations may—

(a)

contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments);

(b)

make different provision for different purposes.”.