Citation and commencement

1.  These Regulations may be cited as the Biocidal Products (Amendment) Regulations 2007 and shall come into force on 6^th April 2007.

Amendment of the Biocidal Products Regulations 2001

2.  The Biocidal Products Regulations 2001 are amended as follows.

3.  In regulation 2(1)—

(a) for the definition of “the 1994 Regulations” substitute—

““the 2002 Regulations” means the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002(7);”;

(b) in the definition of “approved supply list”, for “the 1994 Regulations” substitute “the 2002 Regulations”;

(c) in the definition of “classified”, for “regulation 5 of the 1994 Regulations” substitute “regulation 4 of the 2002 Regulations”;

(d) in the definition of “the Directive”, after “16^th February 1998” insert “as from time to time amended,”;

(e) for the definition of “existing active substance”, substitute—

““existing active substance” means an active substance on the market in the European Community before 14th May 2000 as an active substance of a biocidal product for a purpose other than process-orientated research and development or scientific research or development(8);”;

(f) in the definition of “first review regulation”, after “Commission Regulation (EC) 1896/2000” add “as from time to time amended”;

(g) for the definition of “new active substance” substitute —

““new active substance” means an active substance which is not an existing active substance, but in regulations 13 and 14 shall not include any active substance that is deemed not to have been placed on the market in the European Community for biocidal purposes before 14th May 2000 by virtue of the second review regulation;”; and

(h) after the definition of “Scotland”, insert—

““the second review regulation” means Commission Regulation (EC) No. 2032/2003 as from time to time amended;”.

4.  In regulation 3—

(a) omit paragraph 3(2);

(b) in paragraph (3), for “Schedule 3 to the 1995 Regulations” substitute “Schedule 4 to the 2005 Regulations”;

(c) in paragraph (5), for “regulation 5(1)(c) of the Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Regulations 1994” substitute “paragraph 2(c) of Schedule 4 to the Veterinary Medicines Regulations 2005(9)”; and

(d) in paragraph (8)—

(i) for sub-paragraph (a), substitute—

“(a) the 2005 Regulations” means the Plant Protection Products Regulations 2005(10); and”, and

(ii) in sub-paragraph (b), for “Schedule 3 to the 1995 Regulations” substitute “Schedule 4 to the 2005 Regulations”.

5.  After regulation 3, insert—

“3A.—(1) .–(1) Subject to Schedule 13 and paragraphs (2) and (3) below, these Regulations shall not apply to a biocidal product which contains no active substances other than existing active substances.

(2) Paragraph (1) shall cease to apply on 14^th May 2010.

(3) Notwithstanding paragraph (1) above but subject to regulation 3, regulations 29, 33, 39A and Schedule 12A shall apply to all biocidal products.”

6.  In regulation 5, in paragraph (a)(ii) for “micro-oganism” substitute “micro-organism”.

7.  In regulations 4, 5, 6 and 7, for each reference to “new active substance” substitute a reference to “active substance”.

8.  In regulation 9—

(a) at the beginning of paragraph (4), insert “Subject to paragraph (6A)”; and

(b) after paragraph (6), insert—

“(6A) Where the applicant justifies the omission to the satisfaction of the Ministers, the applicant may omit from a dossier submitted in accordance with paragraph (4)(a) information which—

(a) is not necessary owing to the nature of—

(i) the biocidal product, or

(ii) its proposed uses; or

(b) it is not scientifically necessary or technically possible to supply.”.

9.  In regulation 10(7)(a)(ii), after “its proposed uses;” insert “or”.

10.  In regulation 13—

(a) in paragraph (1), after “regulation 5” add “, or to a competent authority under Article 11”;

(b) for paragraph (2), substitute—

“(2) The Ministers shall not authorise a biocidal product under paragraph (1) unless the Ministers have made the determinations referred to in Schedule 3 and either—

(a) in accordance with regulation 6(2), they have evaluated the new active substance contained in that biocidal product which is not included in Annex I or Annex IA; or

(b) they are satisfied that an evaluation has been carried out by a competent authority of the new active substance contained in that biocidal product which is not included in Annex I or Annex IA.”; and

(c) in paragraph (4)—

(i) omit “and”, and

(ii) omit sub-paragraph (b).

11.  In regulation 14—

(a) in paragraph (1)(a), after “regulation 5” add “, or to a competent authority under Article 11;”;

(b) for paragraph (2), substitute—

“(2) The Ministers shall not register a biocidal product under paragraph (1) unless the Ministers have made the determinations referred to in Schedule 3 and either—

(a) in accordance with regulation 6(2), they have evaluated the new active substance contained in that biocidal product which is not included in Annex IA; or

(b) they are satisfied that an evaluation has been carried out by a competent authority of the new active substance contained in that biocidal product which is not included in Annex IA.”; and

(c) in paragraph (5)—

(i) omit “and”, and

(ii) omit sub-paragraph (b).

12.  In regulation 15(6), in sub-paragraphs (a) and (b) after “regulation 9, 11, 13” insert “,15A”.

13.  After regulation 15, insert—

“Essential use authorisation

15A.—(1) Where a person submits an application under this regulation to the Ministers for the authorisation of an essential use biocidal product, the Ministers may authorise the placing on the market of that product(11).

(2) In this regulation, an “essential use biocidal product” means a biocidal product containing an active substance listed in column 1 of the table in Schedule 5A for the use listed in column 2 of that table.

(3) The Ministers shall grant an authorisation under paragraph (1) only if they are satisfied that the essential use biocidal product has no unacceptable effect on human or animal health or on the environment.

(4) An authorisation granted under paragraph (1) shall include the following conditions—

(a) that the biocidal product is placed on the market only for the essential use set out in column 2 of the table in Schedule 5A;

(b) all risk reduction measures that the Ministers consider appropriate for that product are imposed;

(c) that the label of the biocidal product shows that it is intended only for the essential use set out in column 2 of the table in Schedule 5A.

(5) An authorisation granted under paragraph (1) shall expire on the date specified in column 3 of the table in Schedule 5A.

(6) The Ministers may extend an authorisation granted under paragraph (1) if the Commission makes a decision or adopts a regulation to that effect.”.

14.  In regulation 16(9)(a), after “regulation 9, 11, 13” wherever it appears insert “, 15A”.

15.  In regulation 19—

(a) in paragraph (2)—

(i) in sub-paragraph (a), for “or 13” substitute “, 13 or 15A”, and

(ii) in sub-paragraph (b), after “15” add “, 15A”;

(b) after paragraph (10), insert—

“(10A) The Ministers shall revoke an authorisation made under regulation 15A where—

(a) they consider that the biocidal product no longer satisfies the requirement referred to in regulation 15A(3);

(b) they consider that any of the conditions set out in regulation 15A(4) and contained in the authorisation are not being complied with; or

(c) a Commission decision requires the authorisation to be revoked.”.

16.—(1) In regulation 20, after paragraph (2) insert—

“(2A) Where a modification of the conditions of use, proposed under paragraphs (1) or (2) above, would result in an extension of uses to which the biocidal product can be put, the Ministers, in modifying the conditions of use, shall ensure that any requirements set out in Annex I or Annex IA relating to the active substance in the biocidal product remain satisfied.

(2B) The Ministers, in modifying the conditions of use subject to which an authorisation or a registration is granted under these Regulations, shall ensure that the requirements referred to in paragraphs 1(a)-(d) and 4(b) of Schedule 3 remain satisfied.”.

(2) After paragraph (3), insert—

“(3A) The Ministers may review an authorisation of a biocidal product granted under regulation 15A at any time if there are indications that—

(a) the biocidal product no longer satisfies the requirement referred to in regulation 15A(3); or

(b) any of the conditions contained in the authorisation set out in regulation 15A(4) are not being complied with;” and

(3) In paragraph (5), after “paragraph (3)” insert “an authorisation under paragraph (3A)”.

17.  In regulation 29(6) omit “NHS Trust”.

18.  In regulation 32, for “regulations 9 to 15” substitute “regulations 9 to 15A”.

19.  In regulation 34—

(a) in paragraphs (2) and (5), after “in paragraph (1)” insert “or made under regulation 15A”; and

(b) in paragraph (7)(a), after “regulation 9, 11, 13, 15”, insert “,15A”.

20.  In regulation 36(1) in sub-paragraphs (d) to (g), for “regulations 9 to15” wherever it appears substitute “regulations 9 to15A”.

21.  For regulation 37, substitute—

“37.—(1) Every test carried out in support of an application under regulations 9 to 15A and 17 shall be conducted in accordance with such guidance as may be issued by the Ministers.

(2) Before any tests referred to in paragraph (1) are carried out the applicant must carry out an evaluation into the adequacy of existing data and make a decision on the need to conduct tests, taking into account, among other things, the need to minimise testing on vertebrate animals.”.

22.  In paragraph 13 of Schedule 4, for “the 1994 Regulations” substitute “the 2002 Regulations”.

23.  After Schedule 5, add the Schedule set out in the Schedule to these Regulations.

24.  In paragraph 6 of Schedule 6—

(a) for “the 1994 Regulations”, substitute “the 2002 Regulations”; and

(b) for “paragraph 18(1)” substitute “paragraph 6(1)”.

25.  In paragraph 4 of Schedule 7, for “the 1994 Regulations” substitute “the 2002 Regulations”.

26.  In paragraph 3 of Schedule 12, after sub-paragraph (h) insert—

“(ha) an application under regulation 15A for the authorisation of a biocidal product for an essential use;”

27.  In Schedule 12A—

(a) in paragraph 4(a)(i), after “regulations 9 to 14” insert “or 15A”.

(b) in paragraph 17, after “regulations 9 to 14” insert “or 15A”.

28.  In Schedule 13—

(a) after paragraph 2 insert—

“2A  In relation to those active substances to which the first sub-paragraph of Article 4.2 of the second review regulation(12) refers, a decision referred to in paragraph 2(b) of this Schedule not to include those active substances in Annex I, IA or IB shall be deemed to have taken effect, and these Regulations shall apply to a biocidal product which contains any of those active substances.”;

(b) for paragraph 4 substitute—

“4.  Where there is more than one unlisted active substance in a biocidal product, these Regulations shall not apply to that biocidal product until either—

(a) a decision referred to in paragraph 2(a) to include the last of those unlisted active substances in Annex I, IA or IB takes effect, provided that such a decision has been made to include all other active substances in that biocidal product in either Annex I, IA or IB; or

(b) a decision referred to in paragraph 2(b) not to include an unlisted active substance present in the biocidal product in Annex I, IA or IB takes effect.”;

(c) in paragraph 14—

(i) in sub-paragraph (a), for “paragraph 10” substitute “paragraph 13” and omit “and” at the end; and

(ii) omit sub-paragraph (b); and

(d) in paragraph 15—

(i) after “other than regulation 29,” insert “33, 39A or Schedule 12A,”; and

(ii) omit sub-paragraph (c).