The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019

Regulation (EU) No 528/2012

102.  For Article 55, substitute—

“Article 55 Derogation from the requirements

1.   By way of derogation from Articles 17 and 19, the competent authority may permit, for a period not exceeding 180 days, the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in this Regulation, for a limited and controlled use under the supervision of the competent authority, if such a measure is necessary because of a danger to public health, animal health or the environment which cannot be contained by other means.

On receipt of a reasoned request from the competent authority, the Secretary of State or a Devolved Authority shall issue a decision, with or without conditions, on whether the action taken may be extended for a period not exceeding 550 days if they have competence to exercise the derogation within the meaning in paragraphs 4 to 8.

2.   By way of derogation from point (a) of Article 19(1) and until an active substance is approved, the competent authority may authorise, for a period not exceeding three years, a biocidal product containing a new active substance.

Such a provisional authorisation may be issued only if, after dossiers have been evaluated in accordance with Article 8, the competent authority has produced an assessment report and evaluation conclusions on the new active substance and consider that the biocidal product is expected to comply with points (b), (c) and (d) of Article 19(1) taking into account the factors set out in Article 19(2).

If the Secretary of State decides not to approve the new active substance, the competent authority shall cancel that authorisation.

Where a decision on the approval of the new active substance has not yet been made by the Secretary of State when the period of three years expires, the competent authority may extend the provisional authorisation for a period not exceeding one year, provided that there are good reasons to believe that the active substance will satisfy the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2).

3.   By way of derogation from point (a) of Article 19(1), the Secretary of State or a Devolved Authority shall issue a decision allowing the competent authority to authorise a biocidal product containing a non-approved active substance if the Secretary of State or a Devolved Authority is satisfied that that active substance is essential for the protection of cultural heritage and that no appropriate alternatives are available. To obtain such a derogation, the competent authority shall apply to the Secretary of State or a Devolved Authority providing due justification.

4.   The Secretary of State has competence to grant a derogation under paragraph 1 or 3 if, or to the extent that, the exercise of the function to take that measure—

(a) relates to England;

(b) relates to Scotland and is not within devolved competence (within the meaning of section 54 of the Scotland Act 1998(1));

(c) relates to Wales and is not within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006(2));

(d) relates to Northern Ireland and is not within devolved competence in Northern Ireland as set out in paragraphs 7 and 8.

5.   The Scottish Ministers have competence to grant a derogation under paragraph 1 or 3 if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 54 of the Scotland Act 1998).

6.   The Welsh Ministers have competence to exercise a derogation under paragraph 1 or 3 if, or to the extent that, the exercise of the function to take that measure is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006).

7.   A Department in Northern Ireland has competence to exercise a derogation under paragraph 1 or 3 if, or to the extent that, the function to take that measure is within devolved competence in Northern Ireland.

8.   For the purposes of paragraph 7, the exercise of the function of exercising a derogation is within devolved competence in Northern Ireland except so far as a provision of an Act of the Northern Ireland Assembly conferring the function of taking that provisional measure would be outside the legislative competence of the Assembly.

The references in this paragraph to provision being outside the legislative competence of the Northern Ireland Assembly are to be read in accordance with section 6 of the Northern Ireland Act 1998.

Any provision that would be outside the legislative competence of the Northern Ireland Assembly unless the Secretary of State consented to it is to be regarded, for the purposes of this paragraph, as outside legislative competence.

9.   Where the Secretary of State grants a derogation, the Secretary of State must immediately inform the Devolved Authorities giving reasons for the decision. Where a Devolved Authority exercises a derogation, it must immediately inform the other Devolved Authorities and the Secretary of State giving reasons for the decision.”

(1)

1998 c.46

(2)

2006 c.32; section 58A was inserted by the Wales Act 2017 (c.4).