The Biocidal Products (Amendment) Regulations (Northern Ireland) 2007

EXPLANATORY NOTE

(This note is not part of the Regulations)

1.  These Regulations amend the Biocidal Products Regulations (Northern Ireland) 2001 (S.R. 2001 No. 422) (“the 2001 Regulations”) to make further provision as regards Northern Ireland for the implementation of Directive 98/8/EC of the European Parliament and Council (OJ No. L123, 24.4.98, p.1.) concerning the placing of biocidal products on the market (“the Directive”).

2.  These Regulations —

(a) take account of the effects of three Commission Regulations on the transitional provisions in Schedule 12 to the 2001 Regulations for biocidal products on the market before 14 May 2000—

(i) Commission Regulation (EC) No. 1896/2000 (OJ No. L228, 8.9.2000, p. 6.) (“the First Review Regulation”),

(ii) Commission Regulation (EC) No. 2032/2003 (OJ No. L307, 24.11.2003, p.1.), (“the Second Review Regulation”), and

(iii) Commission Regulation (EC) No. 1048/2005, (OJ No. L178, 9.7.2005, p.1.) (“the Third Review Regulation”);

(b) update references and make minor corrections in the 2001 Regulations; and

(c) take account of developments within the Directive that require further amendment to the 2001 Regulations.

3.  The main changes made by these Regulations are as follows.

4.  Regulation 3 amends the definitions of “existing active substance” and “new active substance”—

(a) the definition of “existing active substance” now reflects the definition in the First Review Regulation. A footnote refers to the effects of Article 4.3 of the Second Review Regulation. This deems those existing active substances, which have been neither identified nor notified to the European Commission, not to have been on the market before 14th May 2000. Consequently these substances should not be treated as existing active substances.

(b) the definition of “new active substances” has been amended so to include substances deemed by Article 4.3 of the Second Review Regulation not to be existing active substances; however note that provisional authorisations and registrations under regulations 13 and 14 of the 2001 Regulations should not be granted for biocidal products containing such active substances.

5.  Regulation 5 inserts a new regulation 3A into the 2001 Regulations. The effect of this is that—

(a) a biocidal product can remain on the UK market under its existing national authorisation only if all active substances within it are existing active substances. The transitional provisions provide that when a decision takes effect as to whether to include the active substance(s) in that product in the Directive’s annexes, the 2001 Regulations will then apply to that product;

(b) the transitional provisions will cease to apply on 14th May 2010; and

(c) the transitional provisions do not apply to regulation 33 (advertisements) in the same way as they do not apply to regulations 29 and 39A of, and Schedule 11A to, the 2001 Regulations.

6.  Regulation 6 amends regulations 4, 5, 6 and 7 of the 2001 Regulations, in line with the Second Review Regulation, so that they apply to all active substances.

7.  Regulation 7 amends regulation 9 of the 2001 Regulations so that it now contains the qualification contained in Article 8(5) of the Directive. This allows an applicant to omit from the dossier information that they consider unnecessary or not technically possible to supply.

8.  Regulations 9 and 10 amend regulations 13 and 14 of the 2001 Regulations to allow the Executive to grant provisional authorisations or registrations where an application has been made to another competent authority. Certain conditions attached to granting these authorisations or registrations have been removed.

9.  In order to implement a Commission Decision(1) regulation 12 inserts a new regulation 15A into the 2001 Regulations to allow the Executive to grant an authorisation to place a product on the market where the active substance in the product has been approved for an essential use under Article 4a.3 of the Second Review Regulation. A number of consequential amendments have been made to the 2001 Regulations as a result, including—

(a) regulation 21, inserting a new Schedule 5A, showing the essential use authorised for each substance;

(b) regulation 24, amending Schedule 11 to allow a fee to be charged for the processing of these applications; and

(c) regulation 25, amending Schedule 11A to make such applicants for essential use authorisations subject to the General Industry Charge.

10.  Regulation 15(1) amends regulation 20 of the 2001 Regulations to ensure that where the Executive proposes to extend the uses to which a biocidal product can be put, it must ensure that any requirements on the use of the active substance set out in Annex I or IA remain satisfied. Furthermore, when the Executive proposes to modify any conditions of use in an authorisation, it must ensure that the requirements of Schedule 3 remain satisfied.

11.  Regulation 19 amends regulation 37 of the 2001 Regulations so as to require an applicant, before he carries out any testing, to evaluate the existing data and to take into account among other things the need to minimise testing on animals.

12.  Regulation 26(a) amends paragraph 2 of Schedule 12 to reflect the effect of Article 4(2) of the Second Review Regulation, as amended by the Third Review Regulation. From 1st September 2006, existing active substances that have been identified but not notified to the Commission can no longer be placed on the market.

13.  Regulation 26(b) amends paragraph 4 of Schedule 12 to clarify that the transitional provisions cease to apply to biocidal products containing more than one existing active substance–

(a) either after a decision is made not to include one of those substances in Annex I, IA or IB, or

(b) after the decision has been taken to include all of those substances in Annex I, IA or IB.

14.  In Great Britain the corresponding Regulations are the Biocidal Products (Amendment) Regulations 2007 (S.I. 2007/293).

(1)

Commission Decision of 20/XII/2006 addressed to the United Kingdom, concerning the extension of the deadline for placing on the market of biocidal products containing ammonia for use as a veterinary hygiene biocidal product for the prevention of infections by coccidian, cryptosporidium and nematodes in livestock, (C (2006) 6707)