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Biocidal Products Regulations (Northern Ireland) 2001

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13.—(1) Subject to the following paragraphs, the Executive may authorise, for a period not exceeding three years, a biocidal product for placing on the market and use which contains a new active substance which is not included in Annex I or Annex IA but in respect of which an application has been made to the Executive under regulation 5.

(2) The Executive shall not authorise a biocidal product under paragraph (1) unless—

(a)in accordance with regulation 6(2), it has evaluated the new active substance contained in that biocidal product which is not included in Annex I or Annex IA and has recommended that that new active substance should be included in Annex I; and

(b)the Executive has made the determinations referred to in Schedule 3.

(3) The Executive shall not authorise a biocidal product under paragraph (1) where—

(a)a member State has made an objection in accordance with Article 18(2) to the completeness of the dossiers submitted in support of the application under regulation 5; and

(b)objection has been upheld by a Commission decision.

(4) The Executive shall not authorise a biocidal product under paragraph (1) where the evaluation required by paragraph (2)(a) shows that—

(a)under normal conditions under which the new active substance may be used in the biocidal product, there are risks to the health of humans or animals or to the environment which give rise to concern; and

(b)there is another active substance included in Annex I for the same product-type which, having regard to current scientific and technical knowledge, presents significantly less risk than the new active substances to the health of humans or animals or to the environment when used under normal conditions in biocidal products authorised in accordance with these Regulations, provided that—

(i)the chemical diversity of all the active substances included in Annex I is adequate to minimise the occurrence of resistance in organisms targeted by that biocidal product,

(ii)the Executive does not consider that it is necessary to acquire experience of using the new active substance in practice, and

(iii)the active substance included in Annex I can be used on the target organism with similar efficacy as the new active substance without significant economic and practical disadvantages for the user and without an increased risk to the health of humans or animals or to the environment.

(5) The Executive shall not authorise a biocidal product under paragraph (1) for use by the public, or for placing on the market for use by the public, where that biocidal product is classified as—

(a)toxic;

(b)very toxic;

(c)carcinogenic category 1;

(d)carcinogenic category 2;

(e)mutagenic category 1;

(f)mutagenic category 2;

(g)toxic for reproduction category 1; or

(h)toxic for reproduction category 2.

(6) Paragraphs (4) to (9) of regulation 9 shall apply in the case of an application for an authorisation under paragraph (1) as they apply in the case of an application for an authorisation under paragraph (1) of that regulation.

(7) In an authorisation granted under paragraph (1), the Executive shall specify—

(a)the conditions and restrictions relating to the placing on the market and use of the biocidal product referred to in the authorisation necessary to ensure—

(i)compliance with any requirements which it has recommended should attach to the inclusion in Annex I of the new active substance in that biocidal product, and

(ii)that the requirements referred to in paragraphs 1(a)–(d) and 4(b) of Schedule 3 remain satisfied; and

(b)any other conditions or restrictions subject to which the authorisation is granted.

(8) If, on the expiry of the period for which an authorisation has been granted under paragraph (1), a decision has not been taken concerning the inclusion in Annex I of the new active substance in the biocidal product referred to in that authorisation, the Executive may authorise that biocidal product for placing on the market and use for a further period of one year.

(9) Paragraphs (2) to (7) shall apply in the case of an application for an authorisation under paragraph (8) as they apply in the case of an application for an authorisation under paragraph (1).

(10) The Executive shall inform the Commission and the member States of every authorisation granted in accordance with paragraph (8).

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