The Biocidal Products Regulations 2001

Statutory Instruments

2001 No. 880

HEALTH AND SAFETY

The Biocidal Products Regulations 2001

Made

7th March 2001

Laid before Parliament

16th March 2001

Coming into force

6th April 2001

The Secretary of State, being the Minister designated(1) for the purpose of section 2(2) of the European Communities Act 1972(2) in relation to biocides, in the exercise of the powers conferred on him by the said section 2(2)(3) and by sections 15(1), (2), (3)(c), (5)(b), (8) and (9), 43(2), (4), (5) and (6) and 82(3)(a) of, and paragraphs 1(1)(b) and (c), (4) and (5), 2(1), 4(1), 13(1), 15(1) and 16 of Schedule 3 to, the Health and Safety at Work etc. Act 1974(4) (“the 1974 Act”) and of all other powers enabling him in that behalf and for the purpose of giving effect without modifications to proposals submitted to him by the Health and Safety Commission under section 11(2)(d) of the 1974 Act after the carrying out by the said Commission of consultations in accordance with section 50(3) of that Act, hereby makes the following Regulations:

PART I GENERAL

Citation and commencement

1.  These Regulations may be cited as the Biocidal Products Regulations 2001 and shall come into force on 6th April 2001.

Interpretation

2.—(1) In these Regulations—

“the 1974 Act” means the Health and Safety at Work etc. Act 1974;

“the 1994 Regulations” means the Chemicals (Hazard Information and Packaging for Supply) Regulations 1994(5);

“active substance” means a substance or micro-organism having a general or specific action on or against harmful organisms;

“approved supply list” has the same meaning as it has in the 1994 Regulations;

“biocidal product” means an active substance or a preparation containing one or more active substances, in the form in which it is supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on, any harmful organism by chemical or biological means;

“classified” means classified in accordance with regulation 5 of the 1994 Regulations and “classification” shall be construed accordingly;

“the Commission” means the Commission of the European Communities;

“Commission decision” means a decision taken in accordance with the procedures set out in Article 28(2);

“competent authority” means the authority appointed in a member State for the purpose of carrying out the duties of a competent authority under the Directive;

“the Directive” means Directive 98/8/EC of the European Parliament and the Council of 16th February 1998 concerning the placing of biocidal products on the market(6);

“existing active substance” means an active substance which was on the market in the European Community before 14th May 2000 for a purpose other than process-orientated research and development or scientific research and development;

“feedingstuff” means feedingstuff for animals, birds or fish;

“harmful organism” means an organism which has an unwanted presence or a detrimental effect for humans, their activities or the products they use or produce, or for animals or for the environment;

“letter of access” means a document—

(a)

permitting the use by the Ministers of information, which is—

(i)

subject to the provisions of regulation 23 or 24, and

(ii)

specified in that document; and

(b)

signed by the owner of that information;

“low-risk biocidal product” means a biocidal product—

(a)

which does not contain any active substance other than an active substance included only in Annex IA; and

(b)

which does not contain a substance of concern; and

(c)

which, under the conditions subject to which that biocidal product may be used, poses a low risk to humans, animals and the environment;

“member State” means a member State of the Communities, except the United Kingdom;

“micro-organism” includes a fungus and a virus;

“new active substance” means an active substance which is not an existing active substance;

“placing on the market” means—

(a)

any supply, whether in return for payment or not, within Great Britain, including importation into Great Britain; or

(b)

any subsequent storage,

other than a supply for storage followed by consignment from the customs territory of the European Community or followed by disposal, and “place on the market”, “placed on the market” and “on the market” shall be construed accordingly;

“preparation” means a mixture or solution of two or more substances;

“process-orientated research and development” means the further development of a substance or preparation in the course of which pilot plant or production trials are used to test the fields of application of that substance or preparation;

“product-type” means one of the product-types specified in column 1, and described in column 2, of Schedule 1;

“residue” means a substance present in a biocidal product which remains as a result of the use of that biocidal product, including the metabolites of, and products resulting from the degradation or reaction of, such a substance;

“scientific research and development” means scientific experimentation, analysis or chemical research carried out under controlled conditions including the determination of intrinsic properties, performance and efficacy as well as scientific investigation relating to product development;

“Scotland” has the same meaning as it has in the Scotland Act 1998(7).

“substance” means a chemical element and its compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition; and

“substance of concern” means a substance, other than an active substance, which has an inherent capacity to cause an adverse effect on humans, animals or the environment and is present in or produced in a biocidal product in sufficient concentrations to create such an effect.

(2) In the application of these Regulations—

(a) subject to sub-paragraph (b) of this paragraph, “the Ministers” means the Secretary of State and the Minister of Agriculture, Fisheries and Food, acting jointly;

(b) in or as regards Scotland, “the Ministers” means the Secretary of State and the Scottish Ministers, acting jointly, and the expression “the Ministers in or as regards Scotland” shall be construed accordingly.

(3) In these Regulations, any requirement to submit or provide information, including information comprising, or included in, a dossier, in support of an application for the authorisation or the registration of a biocidal product under these Regulations, may be satisfied in whole or in part by—

(a) the submission of a letter of access in respect of that information; or

(b) a reference to information which the Ministers or a competent authority already hold and which, by virtue of regulation 23 or 24, the Ministers or the competent authority are entitled to use for the benefit of persons other than the persons who submitted that information.

(4) In these Regulations, a reference to frame-formulation is a reference to specifications for a group of biocidal products which—

(a) have the same use;

(b) are used by the same type of user; and

(c) contain the same active substances of the same specification,

and whose composition, when compared, subject to paragraph (5), with the composition of a biocidal product which has been authorised or registered in accordance with these Regulations, is the same as the composition of that biocidal product.

(5) In carrying out the comparison referred to in paragraph (4), there shall be disregarded a variation which does not reduce the efficacy of, nor affect the level of risk associated with, the biocidal products in question.

(6) In paragraph (5), “variation” means one or more of the following, that is to say—

(a) a lower percentage of each active substance;

(b) a change in the percentage of each substance which is not an active substance;

(c) the replacement of pigments, dyes or perfumes by other pigments, dyes or perfumes having the same or a lower risk.

(7) In these Regulations, any reference to the name of an active substance is a reference to—

(a) the name of that active substance as listed in Part I of the approved supply list; or

(b) if the name is not listed in Part I of the approved supply list, the name of that substance as given in the European Inventory of Existing Chemical Substances(8); or

(c) if the name—

(i) is not listed in Part I of the approved supply list, nor

(ii) given in the European Inventory of Existing Chemical Substances,

the International Organisation for Standardisation common name of that active substance; or

(d) if the name—

(i) is not listed in Part I of the approved supply list, nor

(ii) given in the European Inventory of Existing Chemical Substances,

and there is no International Organisation for Standardisation common name for that active substance, the chemical designation of that active substance according to International Union of Pure and Applied Chemistry rules.

(8) In paragraph (7),

(a) “International Organisation for Standardisation” means the institution of that name founded in 1947 and currently having its headquarters at 1 rue de Varembé, CP56, 1211 Geneva 20, Switzerland; and

(b) “International Union of Pure and Applied Chemistry” means the institution of that name founded in 1919 and currently having its headquarters at Bank Court Chambers, 2-3 Pound Way, Templars Square, Cowley, Oxford OX4 3YF.

(9) In these Regulations, a reference to a biocidal product which contains an active substance shall include a reference to a biocidal product which is an active substance.

(10) In these Regulations, unless the context otherwise requires—

(a) a reference to a numbered regulation or Schedule is a reference to the regulation or Schedule in these Regulations so numbered;

(b) a reference to a numbered paragraph is a reference to the paragraph so numbered in the regulation or Schedule in which that reference occurs; and

(c) a reference to a numbered Article or Annex is a reference to the Article in or Annex to the Directive so numbered.

Application

3.—(1) These Regulations shall not apply to a biocidal product where and to the extent that the biocidal product is placed on the market or used for a purpose over which control is exercised under—

(a) any of the Regulations set out in Schedule 2;

(b) Council Regulation (EEC) No. 2309/93(9), laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products; or

(c) sections 32 to 39 or section 58B of the Medicines Act 1968(10).

(2) Subject to Schedule 13, these Regulations, except regulation 29, shall not apply to a biocidal product which contains an existing active substance.

(3) These Regulations shall not apply to a biocidal product which is a relevant plant protection product where and to the extent that that biocidal product is placed on the market or used for a purpose over which, but for the provisions of Schedule 3 to the 1995 Regulations, control under the 1995 Regulations would otherwise be exercisable.

(4) These Regulations shall not apply to a biocidal product which, by virtue of regulation 19(1) of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994(11), continues to have a product licence under section 7 of the Medicines Act 1968 so long as that licence remains in force.

(5) These Regulations shall not apply to the placing on the market of a biocidal product prepared extemporaneously in the circumstances described in regulation 5(1)(c) of the Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Regulations 1994(12).

(6) Regulations 30 to 32 shall not apply to the carriage of biocidal products by rail, road, inland waterway, sea or air.

(7) These Regulations shall not extend to Northern Ireland.

(8) In this regulation—

(a) “the 1995 Regulations” means the Plant Protection Products Regulations 1995(13); and

(b) “relevant plant protection product” shall have the meaning assigned to it in paragraph 8 of Schedule 3 to the 1995 Regulations.

PART II ACTIVE SUBSTANCES

Placing on the market of active substances

4.—(1) Subject to paragraph (2), no person shall place on the market for use in a biocidal product a new active substance unless—

(a) an application has been made to the Ministers or to a competent authority for the inclusion of that new active substance in Annex I, IA or IB; and

(b) the Ministers or that competent authority have agreed to the applicant forwarding a summary of the dossiers submitted in support of the application to the Commission and the member States.

(2) Paragraph (1) shall not apply to a new active substance intended for use in a biocidal product where that new active substance is placed on the market for use in an experiment or test for the purposes of—

(a) scientific research and development; or

(b) process orientated research and development.

(3) No person shall place on the market an active substance intended exclusively for use in a biocidal product for the purpose of any experiment or test in Great Britain which may involve or result in the release into the environment of that active substance unless that active substance has been authorised in accordance with regulation 17.

Applications concerning new active substances

5.  A person who applies to the Ministers for the inclusion of a new active substance in Annex I, IA or IB shall submit to the Ministers—

(a) a dossier relating to the new active substance satisfying the requirements of—

(i) Annex IVA, where the new active substance in question is a micro-organism, or

(ii) Annexes IIA and IIIA, where the new active substance in question is not a micro-oganism;

(b) a dossier satisfying the requirements of regulation 9(4) to (6) for at least one biocidal product containing the new active substance; and

(c) a declaration that the new active substance is intended for inclusion in a biocidal product.

Assessment of applications concerning new active substances

6.—(1) When the Ministers receive an application under regulation 5, they shall ensure that the dossiers submitted as part of that application satisfy the requirements of that regulation and, where those dossiers do so, the Ministers shall—

(a) accept the dossiers; and

(b) agree to the applicant forwarding a summary of the dossiers to the Commission and the member States.

(2) Subject to paragraph (5) and subject to regulation 39(2), within the period of 12 months of the Ministers accepting the dossiers in accordance with paragraph (1)(a), the Ministers shall—

(a) evaluate the dossiers submitted in accordance with regulation 5;

(b) make a recommendation as to whether the new active substance in question should, or should not, be included in Annex I, IA or IB; and

(c) send a copy of their evaluation and recommendation to the Commission, the member States and the applicant.

(3) Where necessary for the purpose of carrying out an evaluation required by paragraph (2)(a), the Ministers shall—

(a) request in writing the applicant to provide such additional information relating to the new active substance as they may specify; and

(b) at the same time inform the Commission and the member States of their request.

(4) Where the Ministers request additional information under paragraph (3), the period of time between the date when the Ministers request the information and the date when the applicant responds to their satisfaction shall not be taken into account in calculating the period of 12 months referred to in paragraph (2).

(5) After the Ministers have accepted the dossiers in accordance with paragraph (1)(a), they may make a request to the Commission for the evaluation of the dossiers to be carried out by a competent authority, and, in such a case—

(a) the Ministers shall not be under a duty to evalute those dossiers, unless and until there is a Commission decision to refuse their request; and

(b) where there is such a Commission decision to refuse, the Ministers shall evaluate the dossiers within the period of 12 months of the date of that Commission decision.

(6) Where there is a Commission decision that the Ministers shall evaluate the dossiers submitted to a competent authority in support of an application for the inclusion of a new active substance in Annex I, IA or IB, subject to regulation 39(2), within the period of 12 months of receiving the dossiers, the Ministers shall—

(a) evaluate the dossiers;

(b) make a recommendation as to whether the new active substance should, or should not, be included in Annex I, IA or IB; and

(c) send a copy of their evaluation and recommendation to the Commission, the member States and the applicant.

(7) Paragraphs (3) and (4) shall apply where the Ministers evaluate dossiers under paragraph (6)(a) as if the dossiers had been submitted under regulation 5.

Applications for variation or renewal of the inclusion of active substances in Annex I, IA or IB

7.—(1) A person may apply to the Ministers for a variation of the requirements subject to which an active substance was included in Annex I, IA or IB.

(2) Before the expiry of the initial period, or any renewed period, as the case may be, of the inclusion of an active substance in Annex I, IA or IB, a person may apply to the Ministers for the renewal of the inclusion of that active substance in Annex I, IA or IB for a period not exceeding 10 years.

(3) A person who applies to the Ministers under paragraph (1) or (2) shall submit dossiers in accordance with regulation 5.

(4) Regulation 6(1) to (5) shall apply to an application made under paragraph (1) or (2) as it applies to an application made under regulation 5, save that—

(a) in the case of an application made under paragraph (1), the recommendation to be made under regulation 6(2)(b) shall be as to whether the variation should, or should not, be made; and

(b) in the case of an application made under paragraph (2), the recommendation to be made under regulation 6(2)(b) shall be as to whether the inclusion of the active substance in Annex I, IA or IB should, or should not, be renewed.

(5) Where there is a Commission decision that the Ministers shall evaluate the dossiers submitted to a competent authority in support of an application for—

(a) a variation of the requirements subject to which an active substance was included in Annex I, IA or IB; or

(b) the renewal of the inclusion of an active substance in Annex I, IA or IB,

subject to regulation 39(2), within the period of 12 months of receiving the dossiers, the Ministers shall comply with the requirements specified in paragraph (6).

(6) The requirements referred to in paragraph (5) are that the Ministers shall—

(a) evaluate the dossiers;

(b) make a recommendation as to whether—

(i) the variation should, or should not, be made, or

(ii) the new active substance should, or should not, continue to be included in Annex I, IA or IB,

as the case may be; and

(c) send a copy of their evaluation and recommendation to the Commission, the member States and the applicant.

(7) Regulation 6(3) and (4) shall apply where the Ministers evaluate dossiers under paragraph (6)(a) as if the dossiers had been submitted under regulation 5.

PART III BIOCIDAL PRODUCTS

Prohibitions

8.—(1) Subject to paragraphs (3) and (4), no person shall place on the market a biocidal product unless that biocidal product—

(a) has been authorised or registered in accordance with these Regulations; and

(b) is placed on the market in accordance with any condition or restriction which is specified in that authorisation or registration.

(2) Subject to paragraphs (3) and (4), no person shall use a biocidal product which has been placed on the market unless that biocidal product—

(a) has been authorised or registered in accordance with these Regulations; and

(b) is properly used.

(3) Paragraphs (1) and (2)(a) shall not apply to a biocidal product which is placed on the market for use in an experiment or test for the purposes of—

(a) scientific research and development; or

(b) process orientated research and development,

pursuant to regulation 16.

(4) Paragraphs (1) and (2) shall not apply to a biocidal product which does not contain any active substance other than an active substance included only in Annex IB.

(5) No person shall use a biocidal product containing an active substance which is included in Annex IB unless that biocidal product is used in a manner which involves the rational application of a combination of physical, biological, chemical or other measures as appropriate to limit the use of biocidal products to the minimum necessary for the effective control of target organisms.

(6) In this regulation, “properly used” means used both—

(a) in accordance with the conditions of use specified in the label of the biocidal product in question; and

(b) in a manner which involves the rational application of a combination of physical, biological, chemical or other measures as appropriate to limit the use of biocidal products to the minimum necessary for the effective control of target organisms.

Authorisation of a biocidal product

9.—(1) Subject to the following paragraphs of this regulation, the Ministers may authorise a biocidal product for placing on the market and use for a period of time which ends on a date not later than the earliest date on which the entry in Annex I of any active substance in that biocidal product expires.

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

(a) the following conditions are satisfied, namely—

(i) at least one active substance in the biocidal product is included in Annex I at the time the authorisation is granted,

(ii) any other active substances in the biocidal product are included in Annex I or Annex IA at the time the authorisation is granted, and

(iii) any requirements set out in Annex I or Annex IA relating to the active substances in the biocidal product have been fulfilled; and

(b) the Ministers have made the determinations referred to in Schedule 3.

(3) The Ministers 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.

(4) An applicant for the authorisation of a biocidal product under paragraph (1) shall submit his application to the Ministers and with that application shall include—

(a) a dossier for that biocidal product satisfying, in the light of current scientific and technical knowledge—

(i) the requirements set out in Annex IVB where that biocidal product is a micro-organism, or

(ii) the requirements set out in Annexes IIB and IIIB where that biocidal product is not a micro-organism; and

(b) a dossier for each active substance in that biocidal product satisfying, in the light of current scientific and technical knowledge, the requirements of—

(i) Annex IVA, where the active substance in question is a micro-organism, and

(ii) Annexes IIA and IIIA, where the active substance in question is not a micro-organism.

(5) A dossier submitted in accordance with paragraph (4) shall include—

(a) a detailed and full description of any studies referred to in that dossier; and

(b) either—

(i) a detailed and full description of the methods used in carrying out such studies, or

(ii) a bibliographical reference to such methods.

(6) The information in dossiers submitted to the Ministers in accordance with paragraph (4) shall be sufficient to enable the Ministers to make the determinations referred to in Schedule 3.

(7) The Ministers—

(a) shall evaluate dossiers submitted in accordance with paragraph (4) in accordance with the common principles set out in Annex VI; and

(b) subject to regulations 18(3) and 39(2), shall decide without undue delay whether or not to authorise the biocidal product in question.

(8) If the evaluation of a dossier shows that additional information, which may include data and results from further testing, is necessary for the purpose of evaluating the risks of the biocidal product in question, the Ministers shall request in writing the applicant to provide such additional information as they may specify.

(9) Where the Ministers request additional information under paragraph (8), the period of time within which the Ministers shall decide whether or not to authorise the biocidal product in question shall not commence until the dossier is complete.

(10) In an authorisation granted under paragraph (1), the Ministers 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 set out in Annex I or Annex IA relating to the 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.

(11) The Ministers may renew an authorisation granted under this regulation for a period of time which ends on a date not later than the earliest date on which the entry in Annex I of any active substance in the biocidal product the subject of the authorisation expires.

(12) Paragraphs (2) to (10) shall apply in the case of an application for the renewal of an authorisation under paragraph (11) as they apply in the case of an application for an authorisation under paragraph (1).

(13) Where an application for the renewal of an authorisation of a biocidal product granted under this regulation has been made, the Ministers may, where necessary, renew that authorisation for such further period as is required to enable the Ministers—

(a) to verify that the conditions specified in paragraph (2)(a) continue to be satisfied; and

(b) to confirm, or otherwise, the determinations referred to in paragraph (2)(b).

Registration of a low-risk biocidal product

10.—(1) Subject to the following paragraphs of this regulation, the Ministers may register a low-risk biocidal product for placing on the market and use for a period of time which ends on a date not later than the earliest date on which the entry in Annex IA of any active substance in that low-risk biocidal product expires.

(2) The Ministers shall not register a low-risk biocidal product under paragraph (1) unless—

(a) any requirements set out in Annex IA relating to the active substance in that low-risk biocidal product have been fulfilled; and

(b) the Ministers have made the determinations referred to in Schedule 3.

(3) The Ministers shall not register a low-risk biocidal product under paragraph (1) for use by the public, or for placing on the market for use by the public, where that low-risk biocidal product is classified as toxic or very toxic.

(4) Subject to paragraph (7), an applicant for the registration of a low-risk biocidal product under paragraph (1) shall submit his application to the Ministers and with that application shall include—

(a) a dossier containing the information set out in Schedule 4; and

(b) a dossier for each active substance in that low-risk biocidal product satisfying, in the light of current scientific and technical knowledge, the requirements of—

(i) Annex IVA, where the active substance in question is a micro-organism, and

(ii) Annexes IIA and IIIA, where the active substance in question is not a micro-organism.

(5) A dossier submitted in accordance with paragraph (4) shall include—

(a) a detailed and full description of any studies referred to in that dossier; and

(b) either—

(i) a detailed and full description of the methods used in carrying out such studies, or

(ii) a bibliographical reference to such methods.

(6) The information in dossiers submitted to the Ministers in accordance with paragraph (4) shall be sufficient to enable the Ministers to make the determinations referred to in Schedule 3.

(7) 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 low-risk biocidal product, or

(ii) its proposed uses;

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

(8) The Ministers—

(a) shall evaluate dossiers submitted in accordance with paragraph (4) in accordance with the common principles set out in Annex VI; and

(b) subject to regulation 39(2), shall decide within 60 days of their receiving an application whether or not to register the low-risk biocidal product in question.

(9) If the evaluation of a dossier shows that additional information, which may include data and results from further testing, is necessary for the purpose of evaluating the risks of the low-risk biocidal product in question, the Ministers shall request in writing the applicant to provide such additional information as they may specify.

(10) Where the Ministers request additional information under paragraph (9), the period of time referred to in paragraph (8)(b) shall not commence until the dossier is complete.

(11) In a registration granted under paragraph (1), the Ministers shall specify—

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

(i) compliance with any requirements set out in Annex IA relating to the active substance in that low-risk 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 registration is granted.

(12) The Ministers may renew a registration granted under this regulation for a period of time which ends on a date not later than the earliest date on which the entry in Annex IA of any active substance in the low-risk biocidal product the subject of the registration expires.

(13) Paragraphs (2) to (11) shall apply in the case of an application for the renewal of a registration under paragraph (12) as they apply in the case of an application for a registration under paragraph (1).

(14) Where an application for the renewal of a registration of a low-risk biocidal product granted under this regulation has been made, the Ministers may, where necessary, renew that registration for such further period as is required to enable the Ministers—

(a) to verify that the requirements referred to in paragraph (2)(a) continue to be fulfilled; and

(b) to confirm, or otherwise, the determinations referred to in paragraph (2)(b).

Mutual recognition of authorisations

11.—(1) Where a biocidal product has been authorised for placing on the market and use under the Directive in a member State, a person may apply to the Ministers for authorisation of that biocidal product for placing on the market and use under this regulation.

(2) Subject to the following paragraphs of this regulation and to regulations 18(3) and 39(2), within 120 days of the Ministers receiving an application in accordance with this regulation, they shall authorise the biocidal product in question subject to the conditions and restrictions imposed on authorisation of that biocidal product in the member State where authorisation was first granted.

(3) Subject to paragraphs (8) and (9), the Ministers shall not authorise a biocidal product under this regulation unless the following conditions are satisfied, namely—

(a) at least one of the active substances in the biocidal product is included in Annex I;

(b) any other active substances in the biocidal product are included in Annex I or Annex IA; and

(c) any requirements set out in Annex I or Annex IA relating to the active substance in the biocidal product have been fulfilled.

(4) Subject to paragraphs (8) and (9), the Ministers shall not authorise a biocidal product under this regulation if they consider that—

(a) the biocidal product does not satisfy the requirements referred to in paragraphs 1(a)–(d) and 4(b) of Schedule 3; or

(b) the nature and quantity of—

(i) the active substance in,

(ii) where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants in, or

(iii) the residues of toxicological or environmental significance which result from authorised uses of,

the biocidal product cannot be determined according to the relevant requirements in Annexes IIA, IIB, IIIA, IIIB, IVA and IVB.

(5) An applicant for authorisation of a biocidal product under this regulation shall submit with his application—

(a) a summary of the dossier submitted in support of the application for authorisation of that biocidal product in the member State in which the authorisation was first granted; and

(b) a certified copy of that authorisation.

(6) Where the Ministers are satisfied that—

(a) the target species is not present in harmful quantities;

(b) there is unacceptable tolerance or resistance of the target organism to the biocidal product; or

(c) the relevant circumstances of use differ significantly from those in the member State where the biocidal product was first authorised, such that an authorisation without additional conditions may present unacceptable risks to humans, animals or the environment,

they may propose conditions and restrictions relating to the matters referred to in Schedule 5 concerning the placing on the market and the use of the biocidal product in addition to those conditions and restrictions imposed in the member State in which the biocidal product was first authorised.

(7) The additional conditions and restrictions proposed pursuant to paragraph (6) shall be such as to ensure—

(a) compliance with any requirements set out in Annex I or Annex IA relating to the active substance in the biocidal product in question; and

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

(8) Where, under this regulation, the Ministers propose to refuse to authorise a biocidal product or to impose conditions or restrictions in addition to those imposed in the member State in which the biocidal product was first authorised, they shall—

(a) notify the Commission, member States and the applicant; and

(b) provide the Commission, member States and the applicant with an explanatory document setting out—

(i) the name and specification of the biocidal product, and

(ii) the grounds on which they propose to refuse authorisation, or to impose additional conditions or restrictions on authorisation.

(9) Where a Commission decision—

(a) confirms a proposed refusal, the Ministers shall refuse to authorise the biocidal product in question;

(b) confirms any of the proposed additional conditions and restrictions, the Ministers shall authorise the biocidal product in question subject to—

(i) the conditions and restrictions confirmed by the Commission decision, and

(ii) any conditions and restrictions imposed in the member State in which the biocidal product was first authorised;

(c) confirms that an authorisation, which the Ministers propose should be refused, should be granted, the Ministers shall authorise the biocidal product in question subject to any conditions and restrictions imposed in the member State in which the biocidal product was first authorised;

(d) confirms that none of the additional conditions and restrictions proposed by the Ministers should be imposed, the Ministers shall authorise the biocidal product in question subject to any conditions and restrictions imposed in the member State in which the biocidal product was first authorised but without imposing the additional conditions and restrictions which they proposed.

Mutual recognition of registrations

12.—(1) Where a biocidal product has been registered for placing on the market and use under the Directive in a member State, a person may apply to the Ministers for registration of that biocidal product for placing on the market and use under this regulation.

(2) Subject to the following paragraphs of this regulation and subject to regulation 39(2), within 60 days of the Ministers receiving an application in accordance with this regulation, they shall register the biocidal product in question subject to the conditions and restrictions imposed on registration of that biocidal product in the member State where registration was first granted.

(3) Subject to paragraphs (10) to (13), the Ministers shall not register a biocidal product under this regulation unless—

(a) the biocidal product is a low-risk biocidal product; and

(b) any requirements set out in Annex IA relating to the active substance in the biocidal product have been fulfilled.

(4) Subject to paragraphs (12) and (13), the Ministers shall not register a biocidal product under this regulation if they consider that—

(a) the biocidal product does not satisfy the requirements referred to in paragraphs 1(a)–(d) and 4(b) of Schedule 3; or

(b) the nature and quantity of—

(i) the active substance in,

(ii) where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants in, or

(iii) the residues of toxicological or environmental significance which result from authorised uses of,

the biocidal product cannot be determined according to the relevant requirements in Annexes IIA, IIB, IIIA, IIIB, IVA and IVB.

(5) Subject to paragraphs (6) and (7), an applicant for registration of a biocidal product under this regulation shall submit with his application—

(a) a dossier containing the information set out in Schedule 4; and

(b) a certified copy of the registration of that biocidal product in the member State in which registration was first granted.

(6) Where the applicant justifies the omission to the satisfaction of the Ministers, the applicant may omit from a dossier submitted in accordance with paragraph (5)(a) information which—

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

(i) the low-risk biocidal product, or

(ii) its proposed uses;

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

(7) The data referred to in paragraph 10 of Schedule 4 may be provided in summary form.

(8) Where the Ministers are satisfied that—

(a) the target species is not present in harmful quantities;

(b) there is unacceptable tolerance or resistance of the target organism to the biocidal product; or

(c) the relevant circumstances of use differ significantly from those in the member State where the biocidal product was first registered, such that registration without additional requirements or conditions may present unacceptable risks to humans, animals or the environment,

they may propose conditions and restrictions relating to the matters referred to in Schedule 5 concerning the placing on the market and the use of the biocidal product in addition to those conditions and restrictions imposed in the member State in which the first registration was granted.

(9) The additional conditions and restrictions proposed pursuant to paragraph (8) shall be such as to ensure—

(a) compliance with any requirements set out in Annex IA relating to the active substance in the biocidal product in question; and

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

(10) If the Ministers are satisfied that the biocidal product, in respect of which an application has been made under paragraph (1), is not a low-risk biocidal product, they—

(a) may provisionally refuse to register the biocidal product; and

(b) shall immediately communicate their concerns to the competent authority which verified the dossier submitted in support of the application for first registration.

(11) If, within 90 days of the Ministers communicating their concerns in accordance with paragraph (10)(b), the Ministers and the competent authority which verified the dossier submitted in support of the application for first registration cannot reach an agreement as to whether a biocidal product is a low-risk biocidal product, the Ministers shall notify the Commission of the lack of agreement.

(12) Notwithstanding paragraphs (10) and (11), where, under this regulation the Ministers propose to refuse to register a biocidal product, or to impose conditions or restrictions in addition to those imposed in the member State in which the low-risk biocidal product was first registered, they shall—

(a) notify the Commission, member States and the applicant; and

(b) provide the Commission, member States and the applicant with an explanatory document setting out—

(i) the name and specification of the biocidal product, and

(ii) the grounds on which they propose to refuse registration, or to impose additional conditions or restrictions on registration.

(13) Where a Commission decision—

(a) confirms a proposed or provisional refusal, the Ministers shall refuse to register the biocidal product in question;

(b) confirms any of the proposed additional conditions or restrictions, the Ministers shall register the biocidal product in question subject to—

(i) the conditions and restrictions confirmed by the Commission decision, and

(ii) any conditions and restrictions imposed in the member State in which the biocidal product was first registered;

(c) confirms that a registration, which the Ministers propose should be refused or have provisionally refused, should be granted, the Ministers shall register the biocidal product in question subject to any conditions and restrictions imposed in the member State in which the biocidal product was first registered;

(d) confirms that none of the additional conditions and restrictions proposed by the Ministers should be imposed, the Ministers shall register the biocidal product in question subject to any conditions and restrictions imposed in the member State in which the biocidal product was first registered but without imposing the additional conditions and restrictions which they proposed.

Provisional authorisation

13.—(1) Subject to the following paragraphs of this regulation, the Ministers 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 Ministers under regulation 5.

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

(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 and have recommended that that new active substance should be included in Annex I; and

(b) the Ministers have made the determinations referred to in Schedule 3.

(3) The Ministers 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) that objection has been upheld by a Commission decision.

(4) The Ministers 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 substance 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 occurence of resistance in organisms targeted by that biocidal product,

(ii) the Ministers do 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 Ministers 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 Ministers 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 they have 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 Ministers 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 Ministers shall inform the Commission and the member States of every authorisation granted in accordance with paragraph (8).

Provisional registration

14.—(1) Subject to the following paragraphs of this regulation, the Ministers may register, for a period not exceeding three years, a biocidal product for placing on the market and use which—

(a) contains a new active substance which is not included in Annex IA but in respect of which an application has been made to the Ministers under regulation 5;

(b) does not contain a substance of concern;

(c) does not contain an active substance included in Annex I; and

(d) under the conditions under which that biocidal product may be used poses a low risk to humans, animals and the environment.

(2) The Ministers shall not register a biocidal product under paragraph (1) unless—

(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 and have recommended that the new active substance should be included in Annex IA; and

(b) the Ministers have made the determinations referred to in Schedule 3.

(3) The Ministers shall not register 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) that objection has been upheld by a Commission decision.

(4) The Ministers shall not register a biocidal product under paragraph (1) where the new active substance contained in that biocidal product which is not included in Annex IA—

(a) is classified as carcinogenic, mutagenic, sensitising or toxic for reproduction; or

(b) is bioaccumulative and does not readily degrade.

(5) The Ministers shall not register 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 substance 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 Ministers do 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.

(6) The Ministers shall not register 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 toxic or very toxic.

(7) Paragraphs (4) to (10) of regulation 10 shall apply in the case of an application for a registration granted under paragraph (1) as they apply in the case of an application for a registration granted under paragraph (1) of that regulation, and, in the application of this paragraph, a reference to a low-risk biocidal product in paragraphs (4) to (10) of regulation 10 shall be deemed to be a reference to a biocidal product.

(8) In a registration granted under paragraph (1), the Ministers shall specify—

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

(i) compliance with any requirements which they have recommended should attach to the inclusion in Annex IA of the new active substance in the 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 registration is granted.

(9) If, on the expiry of the period for which a registration has been granted under paragraph (1), a decision has not been taken concerning the inclusion in Annex IA of the new active substance in the biocidal product referred to in that registration, the Ministers may register that biocidal product for placing on the market and use for a further period of one year.

(10) Paragraphs (2) to (8) shall apply to an application for a registration under paragraph (9) as they apply to an application for registration under paragraph (1).

(11) The Ministers shall inform the Commission and the member States of every registration granted under paragraph (9).

Emergency authorisation

15.—(1) Where a person submits an application to the Ministers for the authorisation of an unauthorised biocidal product under this regulation, the Ministers may authorise, for a period not exceeding 120 days, the placing on the market of an unauthorised biocidal product for a limited and controlled use if such authorisation appears necessary because of an unforeseen danger which cannot be contained by any other means.

(2) The Ministers shall immediately inform the Commission and the member States of an authorisation granted in accordance with paragraph (1) and the justification for it.

(3) An authorisation granted under paragraph (1) shall specify such conditions and restrictions relating to the placing on the market and the use of the biocidal product in question as the Ministers consider appropriate.

(4) If there is a Commission decision that—

(a) the period in respect of which an authorisation granted pursuant to paragraph (1) may be extended; or

(b) such an authorisation may be renewed,

the Ministers may extend that period or renew that authorisation.

(5) Where the Ministers extend the period of, or renew, an authorisation under paragraph (4), they shall at the same time specify any conditions referred to in the Commission decision subject to which the period may be extended or the authorisation may be renewed, as the case may be.

(6) In this regulation, “unauthorised biocidal product” means a biocidal product which—

(a) has not been authorised in accordance with regulation 9, 11, 13 or 17 or registered in accordance with regulation 10, 12 or 14; or

(b) has been authorised in accordance with regulation 9, 11, 13 or 17 or registered in accordance with regulation 10, 12 or 14, but which, by virtue of the conditions or restrictions to which the authorisation, or, as the case may be, the registration, is subject, cannot be used to deal with an unforeseen danger referred to in paragraph (1).

Research and development

16.—(1) This regulation shall not apply to the placing on the market of a relevant product for use in an experiment or test in Great Britain which may involve or result in the release into the environment of that relevant product.

(2) No person shall place on the market a relevant product for use in an experiment or test for the purposes of scientific research and development, or process-orientated research and development, unless that person compiles a dossier containing all available information on the possible effects of the relevant product on human or animal health and on the environment.

(3) No person shall place on the market a relevant product for use in an experiment or test for the purposes of scientific research and development unless that person draws up and maintains a written record of the following information relating to that relevant product, namely—

(a) its identity;

(b) any data on which the information on its label should be based;

(c) the quantity placed on the market; and

(d) the name and address of the person who receives it.

(4) A person, who places on the market a relevant product for use in an experiment or test for the purpose of scientific research and development, which is to be conducted in Great Britain, shall provide to the Ministers on request the written record and dossier relating to that relevant product which he is required to compile and maintain in accordance with paragraphs (2) and (3).

(5) A person, who intends to place on the market a relevant product for use in an experiment or test for the purpose of process-orientated research and development in Great Britain, shall provide to the Ministers before the relevant product is placed on the market—

(a) the dossier relating to the relevant product which he is required to compile in accordance with paragraph (2); and

(b) the following information relating to the relevant product, namely—

(i) its identity,

(ii) any data on which the information on its label should be based,

(iii) the quantity of the relevant product to be placed on the market, and

(iv) the name and address of the person who is to receive the relevant product.

(6) If an experiment or test referred to in paragraph (2) or (3) is liable to have harmful effects on human or animal health or an unacceptable adverse influence on the environment, the Ministers may—

(a) prohibit the experiment or test; or

(b) impose such conditions regarding the conduct of the experiment or test as they consider necessary to prevent such harmful effects or such adverse influence.

(7) No person shall conduct an experiment or test which the Ministers have prohibited under paragraph (6)(a).

(8) Where the Ministers have imposed conditions regarding the conduct of an experiment or test under paragraph (6)(b), the person conducting the experiment or test shall comply with the conditions, or shall ensure that the conditions are complied with.

(9) In this regulation—

(a) “unauthorised biocidal product” means a biocidal product which—

(i) has not been authorised in accordance with regulation 9, 11, 13 or 17 or registered in accordance with regulation 10, 12 or 14, or

(ii) has been authorised in accordance with regulation 9, 11, 13 or 17 or registered in accordance with regulation 10, 12 or 14, but which, by virtue of the conditions or restrictions to which the authorisation, or, as the case may be, the registration is subject, cannot be used in the experiment or test in question;

(b) “relevant product” means—

(i) an unauthorised biocidal product, or

(ii) an active substance intended exclusively for use in a biocidal product.

Experimental authorisation

17.—(1) Subject to the following paragraphs of this regulation, the Ministers may authorise a biocidal product, or an active substance intended exclusively for use in a biocidal product, for placing on the market for the purpose of any experiment or test in Great Britain which may involve or result in the release into the environment of that biocidal product or active substance, as the case may be.

(2) An authorisation granted under this regulation—

(a) shall contain conditions limiting—

(i) the quantity of biocidal product or active substance, as the case may be, to be used, and

(ii) the area to be treated with that biocidal product or active substance; and

(b) may contain such further conditions, including any conditions necessary to prevent harmful effects on human or animal health or unacceptable adverse influence on the environment, as the Ministers consider necessary.

(3) An authorisation granted under this regulation may relate to more than one experiment or test and, if it does so, shall—

(a) be granted to one person;

(b) specify the experiments or tests to which it relates; and

(c) specify the conditions under which those experiments and tests shall be undertaken.

(4) An applicant for an authorisation under this regulation shall submit his application to the Ministers together with a dossier setting out, in relation to each experiment or test—

(a) the identity of the biocidal product or active substance in question;

(b) any data on which the information on the label of that biocidal product or active substance should be based;

(c) the quantity of the biocidal product or active substance to be placed on the market;

(d) the name and address of each person who is to receive the biocidal product or active substance in question; and

(e) all available information on the possible effects on human or animal health and on the environment of the biocidal product or active substance concerned.

(5) Subject to regulation 39(2), the Ministers shall assess the information provided by the applicant before deciding whether or not to grant an authorisation under this regulation.

Frame-formulations

18.—(1) At the same time the Ministers grant an authorisation in respect of a biocidal product under regulation 9 or 13, or grant a registration in respect of a biocidal product under regulation 10 or 14—

(a) they shall, when requested to do so by the applicant for that authorisation or that registration; or

(b) they may, without being requested to do so,

issue a frame-formulation which includes that biocidal product and they shall communicate that frame-formulation to that applicant.

(2) Where an application is made under regulation 9, 10, 13 or 14 in respect of a biocidal product within an issued frame-formulation, the Ministers shall take that issued frame-formulation into account in evaluating the dossiers submitted with the application in question.

(3) Where a person makes an application for an authorisation under regulation 9 or 13 and that person has a letter of access in respect of the information relating to the biocidal products within an issued frame-formulation, the Ministers shall decide whether or not to grant the authorisation within 60 days of their receiving the application.

(4) In this regulation, “issued frame-formulation” means a frame-formulation issued by the Ministers in accordance with paragraph (1).

Revocation of authorisations and registrations

19.—(1) The Ministers shall revoke an authorisation granted under regulation 9 or 11 where—

(a) an active substance in the biocidal product to which the authorisation relates—

(i) is removed from Annex I, or

(ii) is removed from Annex IA and that active substance is not included in Annex I; or

(b) a requirement laid down in Annex I or Annex IA in respect of an active substance in the biocidal product to which the authorisation relates is no longer satisfied.

(2) The Ministers shall revoke an authorisation—

(a) granted under regulation 9, 11 or 13, where the biocidal product, the subject of the authorisation, no longer satisfies one or more of the requirements referred to in paragraphs 1(a)–(d) and 4(b) of Schedule 3;

(b) granted under regulation 9, 11, 13, 15 or 17, where false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted.

(3) The Ministers shall revoke an authorisation of a biocidal product 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.

(4) The Ministers shall revoke a registration granted under regulation 10 or 12 where—

(a) an active substance in the low-risk biocidal product to which the registration relates is removed from Annex IA; or

(b) a requirement laid down in Annex IA in respect of an active substance in the low-risk biocidal product to which the registration relates is no longer satisfied.

(5) The Ministers shall revoke a registration granted under regulation 10 if—

(a) there is a Commission decision referred to in regulation 20(4); and

(b) following a review of the registration in accordance with regulation 20(4), the Ministers decide that the biocidal product in question is not a low-risk biocidal product.

(6) The Ministers shall revoke a registration granted under regulation 10, 12 or 14 where—

(a) the biocidal product, the subject of the registration, no longer satisfies one or more of the requirements referred to in paragraphs 1(a)–(d) and 4(b) of Schedule 3;

(b) false or misleading information was supplied concerning the facts on the basis of which the registration was granted.

(7) The Ministers shall revoke a registration of a biocidal product for use by the public or for placing on the market for use by the public, where that low-risk biocidal product is classified as toxic or very toxic.

(8) The Ministers shall revoke an authorisation granted under regulation 13 where there is a Commission decision that an active substance in the biocidal product to which the authorisation relates shall not be included in Annex I, and no decision is made to include that active substance in Annex IA.

(9) The Ministers shall revoke a registration granted under regulation 14 where there is a Commission decision that an active substance in the biocidal product to which the registration relates shall not be included in Annex IA.

(10) The Ministers shall revoke an authorisation granted under regulation 15 where a Commission decision does not uphold it.

(11) The Ministers may revoke an authorisation granted under regulation 17 if the experiment or test in question is liable to have harmful effects on human or animal health or an unacceptable adverse effect on the environment.

(12) The Ministers may revoke an authorisation or registration granted under these Regulations at the written request of the holder, who shall state the reasons for that request.

(13) Before revoking an authorisation or a registration, except following a request made in accordance with paragraph (12), the Ministers shall—

(a) give to the holder a notice in writing stating that—

(i) they are considering revoking that authorisation or registration and the reasons why, and

(ii) within a period specified in the notice, the holder may make written representations to the Ministers or, if the holder so requests, may make oral representations to the Ministers; and

(b) consider any representations which are duly made and not withdrawn.

(14) Before refusing to revoke an authorisation or a registration following a request made in accordance with paragraph (12), the Ministers shall—

(a) give to the holder a notice in writing stating that—

(i) they are considering not revoking that authorisation or that registration and the reasons why, and

(ii) within a period specified in the notice, the holder may make written representations to the Ministers or, if the holder so requests, may make oral representations to the Ministers; and

(b) consider any representations which are duly made and not withdrawn.

(15) When the Ministers revoke—

(a) an authorisation or a registration granted under these Regulations in respect of a biocidal product; or

(b) an authorisation granted under regulation 17 in respect of an active substance intended exclusively for use in a biocidal product,

they may grant a period of grace for the disposal, storage, placing on the market or use of existing stocks of the biocidal product to which the authorisation or the registration relates, or the active substance to which the authorisation relates, as the case may be.

(16) The period of grace referred to in paragraph (15) shall be of a length commensurate with the reason for the revocation, but shall be without prejudice to any period provided for in connection with the removal from Annex I or Annex IA of an active substance in the biocidal product in question or the active substance in question, as the case may be.

(17) In this regulation, “holder” means a person to whom an authorisation or a registration has been granted in accordance with these Regulations.

Modification and review of authorisations and registrations

20.—(1) The Ministers shall modify the conditions of use, subject to which an authorisation or a registration is granted under these Regulations, where they consider that, on the basis of developments in scientific and technical knowledge, such modification is necessary to protect human or animal health or the environment.

(2) Subject to regulation 39(3), the Ministers may modify the conditions of use, subject to which an authorisation or a registration is granted under these Regulations, at the written request of the holder, who shall state the reasons for that request.

(3) The Ministers may review an authorisation of a biocidal product granted under regulation 9, 11 or 13 or a registration of a biocidal product granted under regulation 10, 12 or 14 at any time if there are indications that—

(a) the biocidal product in question no longer satisfies one or more of the requirements referred to in paragraphs 1(a)–(d) or 4(b) of Schedule 3;

(b) there is a change in the classification of the biocidal product; or

(c) the conditions or restrictions, subject to which the biocidal product has been authorised or registered, as the case may be, and imposed to ensure that the requirements referred to in paragraphs 1(a)–(d) or 4(b) of Schedule 3 remain satisfied, are no longer appropriate for ensuring that such requirements remain satisfied.

(4) Where a Commission decision confirms the refusal of a member State to register a biocidal product in respect of which the Ministers have granted a registration under regulation 10, if considered appropriate by the Standing Committee, the Ministers shall review that registration, taking the refusal of the member State into consideration.

(5) Where the Ministers review an authorisation or a registration under paragraph (3), or a registration under paragraph (4), the Ministers—

(a) may extend the authorisation or registration in question for the period necessary to enable them to complete the review; and

(b) may require the holder to provide further information necessary for the review.

(6) Where the Ministers require further information in accordance with paragraph (5), the Ministers shall extend the authorisation or registration for the period necessary to enable the holder to provide such information.

(7) In this regulation—

(a) “holder” has the same meaning as it has in regulation 19;

(b) “the conditions of use” means the conditions relating to the use of a biocidal product, including, but without prejudice to the generality of the foregoing, the manner of use and the amounts used; and

(c) “the Standing Committee” means the Standing Committee on Biocidal Products referred to in Article 28(1).

Notification of new information

21.—(1) A person to whom an authorisation or a registration has been granted in accordance with these Regulations shall immediately notify the Ministers of any information of which he is aware or may reasonably be expected to be aware concerning—

(a) the biocidal product; or

(b) an active substance contained in the biocidal product,

to which the authorisation or the registration relates, which may affect that authorisation or registration.

(2) The information referred to in paragraph (1) shall include—

(a) new knowledge or information on the effects of that biocidal product, or the active substance which the biocidal product contains, on humans, animals or the environment;

(b) changes in the source or composition of the active substance which the biocidal product contains;

(c) changes in the composition of the biocidal product;

(d) development of resistance to the biocidal product in the harmful organisms which it is intended to control;

(e) changes of an administrative nature; or

(f) changes in the nature of the packaging.

(3) A notification made pursuant to paragraph (1) shall include—

(a) a statement that the notification is made in compliance with this regulation; and

(b) the number of the authorisation or registration relating to the biocidal product with which the notification is concerned.

(4) The Ministers shall immediately notify member States and the Commission of any information they receive by virtue of paragraph (1) relating to—

(a) potentially harmful effects for humans, animals or the environment of—

(i) a biocidal product,

(ii) an active substance, an impurity or a co-formulant which a biocidal product contains, or

(iii) a residue of a biocidal product; and

(b) changes in the composition of a biocidal product, including changes in the active substance which a biocidal product contains.

Emergency prohibition or restriction

22.—(1) The Ministers may prohibit or restrict the sale or use of a biocidal product which has been authorised or registered under these Regulations, where they have valid reasons to consider that the biocidal product constitutes an unacceptable risk to human or animal health or to the environment.

(2) Where the Ministers prohibit or restrict the sale or use of a biocidal product pursuant to paragraph (1), they shall immediately inform the Commission and member States of that prohibition or restriction and of the reasons for it.

(3) No person shall sell a biocidal product—

(a) whose sale has been prohibited pursuant to paragraph (1); or

(b) in a manner which contravenes any restriction on the sale of that biocidal product imposed pursuant to paragraph (1).

(4) No person shall use a biocidal product—

(a) whose use has been prohibited pursuant to paragraph (1); or

(b) in a manner which contravenes any restriction on the use of that biocidal product imposed pursuant to paragraph (1).

(5) The Ministers shall revoke a prohibition or restriction issued under this regulation where a decision made in accordance with the procedures set out in Article 28(3) does not uphold the prohibition or restriction.

PART IV USE OF INFORMATION

Data protection for active substances

23.—(1) Subject to the following paragraphs of this regulation, the Ministers shall not make use of relevant information relating to an active substance for the benefit of a person making an application under these Regulations other than—

(a) the person who submitted; or

(b) the person on whose behalf was submitted,

that relevant information.

(2) The Ministers may make use of relevant information relating to an active substance for the benefit of a person making an application under these Regulations who has a letter of access to that relevant information.

(3) In the case of relevant information relating to a new active substance which was submitted other than for a purpose referred to in paragraph (4), paragraph (1) shall not apply after the expiry of the period of 15 years from the date on which that new active substance was first included in either Annex I or Annex IA.

(4) In the case of relevant information relating to a new active substance which was submitted for the first time for the purpose of an application under regulation 7 to renew the inclusion of that new active substance in Annex I or Annex IA or to vary the requirements subject to which the new active substance was included in Annex I or Annex IA, paragraph (1) shall not apply after either—

(a) the expiry of the period of 5 years from the date of the decision relating to the application under regulation 7; or

(b) the expiry of the period of 15 years from the date on which that new active substance was first included in either Annex I or Annex IA,

whichever is the later.

(5) In the case of relevant information relating to an existing active substance which was also submitted in support of an application for an approval (except an approval in the form of an experimental permit) under the 1986 Regulations, paragraph (1) shall not apply after either—

(a) the expiry of the period of 10 years from the date on which the approval was first given on the basis of that relevant information; or

(b) 14th May 2010,

whichever is the sooner.

(6) Subject to paragraph (10), in the case of relevant information relating to an existing active substance which was also submitted in response to a requirement imposed under section 16(11) of the 1985 Act to supply information relating to the review, revocation or suspension of, or the amendment of the conditions of, an approval given under the 1986 Regulations (except an approval in the form of an experimental permit), paragraph (1) shall not apply after either—

(a) the expiry of the period of 5 years from the date of the decision to continue, revoke or suspend, or amend the conditions of, the approval in question; or

(b) 14th May 2010,

whichever is the sooner.

(7) Subject to paragraph (11), in the case of relevant information relating to an existing active substance which was also submitted in support of an application for approval in the form of an experimental permit under the 1986 Regulations, paragraph (1) shall not apply after 14th May 2010.

(8) In the case of relevant information relating to an existing active substance which was not submitted in the specified circumstances but which was submitted for the first time in support of an application for the first inclusion in Annex I or Annex IA of that existing active substance or of an additional product-type for that existing active substance, paragraph (1) shall not apply after the expiry of the period of 10 years from the date on which that existing active substance, or additional product-type for that existing substance, as the case may be, was first included in either Annex I or Annex IA.

(9) In the case of relevant information relating to an existing active substance which was not submitted in the specified circumstances but which was submitted for the first time for the purpose of an application under regulation 7 to renew the inclusion of that existing active substance in Annex I or Annex IA, or to vary the requirements subject to which the existing active substance was included in Annex I or Annex IA, paragraph (1) shall not apply after either—

(a) the expiry of the period of 5 years from the date of the decision relating to the application under regulation 7; or

(b) the expiry of the period of 10 years from the date on which that existing active substance was first included in either Annex I or Annex IA,

whichever is the later.

(10) Paragraph (6) shall not apply where the relevant information submitted in response to a requirement imposed under section 16(11) of the 1985 Act is also submitted in support of an application referred to in paragraph (5).

(11) Paragraph (7) shall not apply where the relevant information submitted in support of an application referred to in that paragraph is also submitted in support of an application referred to in paragraph (5).

(12) In this regulation—

(a) “the 1985 Act” means the Food and Environment Protection Act 1985(14);

(b) “the 1986 Regulations” means the Control of Pesticides Regulations 1986(15);

(c) “submitted in the specified circumstances” means—

(i) submitted under the 1986 Regulations, as described in paragraphs (5) or (7), or

(ii) submitted in response to a requirement imposed under section 16(11) of the 1985 Act, as described in paragraph (6); and

(d) “relevant information” means information submitted to the Ministers under these Regulations.

Data protection for biocidal products

24.—(1) Subject to the following paragraphs of this regulation, the Ministers shall not make use of relevant information relating to a biocidal product for the benefit of a person making an application under these Regulations other than—

(a) the person who submitted; or

(b) the person on whose behalf was submitted,

that relevant information.

(2) The Ministers may make use of relevant information relating to a biocidal product for the benefit of a person making an application under these Regulations who has a letter of access to that relevant information.

(3) In the case of relevant information relating to a biocidal product containing a new active substance which was submitted other than for a purpose referred to in paragraph (4), paragraph (1) shall not apply after the expiry of the period of 10 years from the date on which that biocidal product was first authorised or registered, as the case may be, under these Regulations.

(4) In the case of relevant information relating to a biocidal product containing a new active substance which was submitted for the first time in connection with a modification under regulation 20 of a condition of use subject to which was granted the authorisation or registration, as the case may be, relating to that biocidal product, or for the first time in connection with an application under regulation 7 to renew the inclusion of that new active substance in Annex I or Annex IA, paragraph (1) shall not apply after either—

(a) the expiry of the period of 5 years from the date on which the Ministers first received that relevant information; or

(b) the expiry of the period of 10 years from the date on which that biocidal product was first authorised or registered, as the case may be, under these Regulations,

whichever is the later.

(5) In the case of relevant information relating to a biocidal product containing an existing active substance which was also submitted in support of an application for an approval (except an approval in the form of an experimental permit) under the 1986 Regulations, paragraph (1) shall not apply after either—

(a) the expiry of the period of 10 years from the date on which the approval was first given on the basis of that relevant information; or

(b) 14th May 2010,

whichever is the sooner.

(6) Subject to paragraph (10), in the case of relevant information relating to a biocidal product containing an existing active substance which was also submitted in support of an application for approval in the form of an experimental permit under the 1986 Regulations, paragraph (1) shall not apply after 14th May 2010.

(7) In the case of relevant information relating to a biocidal product containing an existing active substance which was not submitted under the 1986 Regulations as described in paragraphs (5) or (6) but which was submitted for the first time in support of an application for the first inclusion in Annex I or Annex IA of that existing active substance or of an additional product-type for that existing active substance, paragraph (1) shall not apply after the expiry of the period of 10 years from the date on which that existing active substance, or additional product-type for that existing substance, as the case may be, was first included in either Annex I or Annex IA.

(8) In the case of relevant information relating to a biocidal product containing an existing active substance which—

(a) was not submitted under the 1986 Regulations as described in paragraphs (5) or (6); nor

(b) submitted for the first time in support of an application for the first inclusion in Annex I or Annex IA of that existing active substance or of an additional product-type for that existing active substance,

but which was submitted in support of an application for the grant of an authorisation or a registration under these Regulations, paragraph (1) shall not apply after 14th May 2010.

(9) In the case of relevant information relating to a biocidal product containing an existing active substance which was not submitted under the 1986 Regulations as described in paragraphs (5) or (6), but which was submitted for the first time in connection with a modification under regulation 20 of a condition of use subject to which was granted the authorisation or registration, as the case may be, relating to that biocidal product, or for the first time in connection with an application under regulation 7 to renew the inclusion of that existing active substance in Annex I or Annex IA, paragraph (1) shall not apply after either—

(a) the expiry of the period of 5 years from the date on which the Ministers first received that relevant information; or

(b) after the expiry of the period of 10 years from the date on which that existing active substance was first included in either Annex I or Annex IA,

whichever is the later.

(10) Paragraph (6) shall not apply where the relevant information submitted in support of an application referred to in that paragraph was also submitted in support of an application referred to in paragraph (5).

(11) In this regulation, “the 1986 Regulations” and “relevant information” have the same meaning as they have in regulation 23.

Co-operation in the use of information

25.—(1) Subject to paragraph (2), the Ministers may give their consent to a new applicant referring to the information contained in the dossiers included in the application submitted to the Ministers in respect of an approved biocidal product.

(2) The Ministers shall not give their consent under paragraph (1) unless—

(a) the new applicant can provide evidence to the satisfaction of the Ministers that—

(i) the biocidal product to which his application relates is sufficiently similar to, and

(ii) the active substance contained in that biocidal product is the same as that contained in,

the approved biocidal product, including in relation to the degree of purity and the nature of the impurities; and

(b) the information referred to in paragraph (1) is information—

(i) in respect of which the new applicant has a letter of access, or

(ii) which the Ministers already hold and, by virtue of regulation 23 or 24, are entitled to use for the benefit of that new applicant.

(3) Notwithstanding the obligations contained in these Regulations to submit dossiers in support of an application for the authorisation of a biocidal product under regulation 9, 11, 13 or 17, or the registration of a biocidal product under regulation 10, 12 or 14, before carrying out an experiment on vertebrate animals, a new applicant shall ask the Ministers—

(a) whether an authorisation or registration has been granted under these Regulations in respect of a biocidal product similar to that which the new applicant intends to use in such an experiment (whether or not that authorisation or registration has been revoked); and

(b) for the name and address of the authorisation holder in respect of that biocidal product.

(4) When a new applicant makes an enquiry pursuant to paragraph (3), he shall provide evidence that—

(a) he intends to apply on his own behalf for an authorisation of a biocidal product under regulation 9, 11, 13 or 17 or a registration of a biocidal product under regulation 10, 12 or 14; and

(b) the other information, which he has to provide with such an application in accordance with these Regulations, is available.

(5) If the Ministers are satisfied that the new applicant intends to apply for an authorisation or a registration referred to in paragraph (4)(a), they shall provide him with the name and address of the authorisation holder and shall inform the authorisation holder of the name and address of the new applicant.

(6) The authorisation holder and the new applicant shall take all reasonable steps to reach agreement on the sharing of information in order to avoid, if possible, the duplication of testing on vertebrate animals.

(7) The Ministers shall encourage the authorisation holder to co-operate in the provision of information, with a view to limiting the duplication of testing on vertebrate animals.

(8) In this regulation—

(a) “approved biocidal product” means a biocidal product which has been authorised under regulation 9, 11 or 13 or registered under regulation 10, 12 or 14;

(b) “authorisation holder” means the person to whom—

(i) an authorisation of a biocidal product has been granted under regulation 9, 11, 13 or 17, or

(ii) a registration of a biocidal product has been granted under regulation 10, 12 or 14,

as the case may be;

(c) “dossier” includes a summary of a dossier;

(d) “new applicant” means a person who intends to apply for an authorisation or registration of a biocidal product under these Regulations.

Confidentiality

26.—(1) Information provided to the Ministers under these Regulations shall not be treated as relevant information for the purposes of section 28 of the 1974 Act.

(2) Subject to the following paragraphs of this regulation, where a person indicates to the Ministers in writing that information provided by him to them under these Regulations should be kept confidential because the disclosure of that information might harm his industrial and commercial position—

(a) he shall provide to the Ministers full written justification for that indication; and

(b) the Ministers shall decide which information shall be kept confidential on the basis of that justification.

(3) Information which a person has indicated should be kept confidential and in relation to which the Ministers have not made a decision under paragraph (2)(b) shall not be disclosed except—

(a) to the Commission or to a competent authority;

(b) where the information is provided in support of an application made under these Regulations, to the extent necessary to enable the Ministers to deal with the application in question.

(4) Where the Ministers have made a decision under paragraph (2)(b) that certain information shall not be kept confidential, that information shall not be disclosed until there has elapsed a period of 14 days following the day on which the Ministers informed the person providing the information of their decision except—

(a) to the Commission or to a competent authority;

(b) where the information is provided in support of an application made under these Regulations, to the extent necessary to enable the Ministers to deal with the application in question.

(5) A person who receives information by virtue of paragraph (3)(b), (4)(b) or (11)(b) shall not use that information except for the purposes of the Ministers.

(6) After a biocidal product has been authorised or registered under these Regulations, the Ministers shall not keep the information specified in Schedule 6 relating to that biocidal product confidential.

(7) If—

(a) the applicant for the authorisation or registration of a biocidal product; or

(b) the manufacturer or the importer of that biocidal product or an active substance contained in that biocidal product,

discloses any information relating to that biocidal product or that active substance which the Ministers have decided under paragraph (2)(b) shall be kept confidential, that applicant shall inform the Ministers accordingly, and such information shall no longer be treated as being confidential for the purposes of these Regulations.

(8) Subject to paragraph (9), where, pursuant to paragraph (2), a person has indicated that he has provided confidential information, he shall forthwith inform the Ministers in writing of any change in circumstances which may affect the justification given by him under paragraph (2)(a).

(9) Paragraph (8) shall not apply if the Ministers have informed the person in question that the information he has provided shall not be kept confidential.

(10) Where—

(a) the Ministers have decided to keep information confidential pursuant to paragraph (2)(b); and

(b) a person has informed them of a change in circumstances pursuant to paragraph (8),

after consulting that person as appropriate, the Ministers shall review whether the information in question should continue to be kept confidential and shall inform that person of the result of that review.

(11) If, following a review referred to in paragraph (10), the Ministers decide that the information in question shall not be kept confidential, that information shall not be disclosed until there has elapsed a period of 14 days following the day on which the Ministers informed the person providing the information of their decision except—

(a) to the Commission or a competent authority;

(b) where—

(i) the information is provided in support of an application made under these Regulations, and

(ii) the Ministers have not finally disposed of that application,

to the extent necessary to enable the Ministers to deal with the application.

(12) This regulation is without prejudice to the provisions of the Environmental Information Regulations 1992(16).

Treatment of confidential information

27.—(1) The Ministers shall inform the competent authorities and the Commission of the information they have decided shall be kept confidential in accordance with regulation 26.

(2) When the Ministers receive information from a competent authority which that competent authority has decided shall be kept confidential, they shall treat that information as confidential and shall not disclose it except to the Commission or to another competent authority.

Exchange of information

28.—(1) The Ministers shall inform the Commission and the competent authorities within one month from the end of each quarter of the information, including the information specified in Schedule 7, relating to every biocidal product in respect of which, in that quarter, an authorisation or, as the case may be, a registration has been granted, refused, modified, renewed or revoked under these Regulations.

(2) When the Ministers receive a summary of a dossier submitted in support of an application in a member State for inclusion, or for changes to the inclusion, of an active substance in Annex I, IA or IB and are of the opinion that the dossier is incomplete, they shall—

(a) immediately communicate that opinion to the competent authority which is responsible for the evaluation of that dossier; and

(b) without undue delay inform the Commission and the member States of that opinion.

(3) The Ministers shall draw up annually a list of the biocidal products authorised or registered under these Regulations and shall send a copy of that list to the Commission and the member States.

(4) In this regulation, “quarter” means the periods in each year—

(a) commencing on 1st January and ending on 31st March;

(b) commencing on 1st April and ending on 30th June;

(c) commencing on 1st July and ending on 30th September; and

(d) commencing on 1st October and ending on 31st December,

and “end of each quarter” shall be construed accordingly.

Notification of information to the National Poisons Information Service

29.—(1) This regulation shall not apply to a biocidal product on the market in Great Britain on 14th May 2000 until 6th May 2003.

(2) The person responsible for first placing a biocidal product on the market in Great Britain shall submit to the National Poisons Information Service written notification of the information specified in Schedule 8 relating to that biocidal product.

(3) Subject to paragraph (4), the notification referred to in paragraph (2) shall be submitted to the National Poisons Information Service—

(a) within three months after the date on which these Regulations come into force; or

(b) within one month after the date on which the biocidal product in question was first placed on the market in Great Britain,

whichever is the later.

(4) In the case of a biocidal product which is on the market in Great Britain on 14th May 2000, the notification referred to in paragraph (2) shall be submitted to the National Poisons Information Service by 13th May 2003.

(5) A person who has submitted a notification under paragraph (2) shall also submit to the National Poisons Information Service written notification of any change to the information notified by him in accordance with that paragraph.

(6) Notifications to be submitted in accordance with this regulation shall be sent to the National Poisons Information Service at NPIS Birmingham Centre, City Hospital NHS Trust, Dudley Road, Birmingham B18 7QH.

(7) In the event of an emergency referred to in paragraph 4(c) of Schedule 8, the individual to be contacted shall provide such further information relating to the biocidal product in question as the National Poisons Information Service may require.

(8) The National Poisons Information Service shall not disclose any information notified to it in pursuance of this regulation except to, and at the request of—

(a) a registered medical practitioner; or

(b) a person working under the direction of a registered medical practitioner,

in connection with the medical treatment of a person who may have been affected by the biocidal product in question.

PART V PACKAGING, LABELLING AND ADVERTISEMENTS

Packaging

30.—(1) No person shall place on the market an authorised biocidal product which may be mistaken for food, drink or feedingstuff unless—

(a) it is packaged to minimise the likelihood of such a mistake being made; and

(b) where that authorised biocidal product is available to the public, it contains a substance or preparation to discourage its consumption.

(2) In this regulation, “authorised biocidal product” means a biocidal product which has been authorised or registered in accordance with these Regulations.

Labelling

31.—(1) No person shall place on the market an authorised biocidal product whose label—

(a) is misleading or gives an exaggerated impression of the authorised biocidal product; or

(b) contains, in relation to the authorised biocidal product, the descriptions “low-risk biocidal product”, “non-toxic” or “harmless”, or similar descriptions.

(2) Subject to paragraph (3), no person shall place on the market an authorised biocidal product unless—

(a) that authorised biocidal product is labelled clearly and indelibly with the information specified in Schedule 9; and

(b) that information is in English, whether or not it is also in any other language.

(3) Subject to paragraph (4), the information referred to in paragraphs 3, 5 to 12 and 14 of Schedule 9 may be given on the packaging of the authorised biocidal product or in an accompanying leaflet integral to the packaging of that authorised biocidal product.

(4) Where any information referred to in paragraph (3) is given in an accompanying leaflet, the authorised biocidal product shall be labelled clearly and indelibly with the words “Read attached instructions before use.”.

(5) In this regulation, “authorised biocidal product” has the same meaning as it has in regulation 30.

Samples, models and drafts

32.  When required to do so by the Ministers, a person who has submitted an application under regulations 9 to 15 or 17 or a person who places, or has placed, a biocidal product on the market shall provide them with—

(a) a sample or model of the packaging of, or a sample or draft of the labelling of, the biocidal product in question;

(b) a sample or draft of any accompanying leaflet integral to the packaging of the biocidal product in question.

Advertisements

33.—(1) A person who places a biocidal product on the market shall ensure that—

(a) any advertisement for that biodical product—

(i) subject to paragraph (2), contains the sentences “Use biocides safely. Always read the label and product information before use.”,

(ii) does not refer to the biocidal product in a manner likely to mislead in respect of the risks of that biocidal product to humans, animals or the environment,

(iii) does not contain, in relation to the biocidal product, the descriptions “low-risk biocidal product”, “non-toxic” nor “harmless”, nor similar descriptions; and

(b) the sentences referred to in sub-paragraph (a)(i) of this paragraph (1) shall be clearly distinguishable from the rest of the advertisement.

(2) The word “biocides” in the first sentence required by sub-paragraph (a)(i) of paragraph (1) may be replaced by the product-type of the biocidal product being advertised.

PART VI MISCELLANEOUS AND GENERAL

General provisions on applications for authorisations and registrations

34.—(1) An application for—

(a) an authorisation of a biocidal product under regulation 9, 11, 13, 15 or 17; and

(b) a registration of a biocidal product under regulation 10, 12, or 14,

shall be made to the Ministers by, or on behalf of, the person responsible for first placing the biocidal product in question on the market in Great Britain.

(2) An application referred to in paragraph (1), and information submitted in support of such an application, shall be in English.

(3) An applicant shall have a permanent office within the Community.

(4) When requested to do so by the Ministers, an applicant shall submit to them samples of—

(a) the biocidal product in question; and

(b) its ingredients.

(5) The Ministers shall communicate their decision in respect of an application referred to in paragraph (1) to the applicant.

(6) Every authorisation and every registration granted under these Regulations shall be in writing.

(7) In this regulation, “applicant” means an applicant for—

(a) an authorisation of a biocidal product under regulation 9, 11, 13, 15 or 17; or

(b) a registration of a biocidal product under regulation 10, 12 or 14.

Files on applications

35.—(1) The Ministers shall ensure that a file is compiled in respect of each application made under regulations 9 to 15 and 17.

(2) A file referred to in paragraph (1) shall include—

(a) a copy of the application to which it relates;

(b) a record of the decision relating to the application taken by the Ministers;

(c) a record of the decision concerning the dossiers submitted in support of that application taken by the Ministers; and

(d) a summary of those dossiers.

(3) The Ministers shall, on request, make available to the competent authorities and the Commission—

(a) a copy of a file compiled in accordance with paragraph (1); and

(b) all information necessary for the full comprehension of the application to which the file relates.

(4) When requested to do so by a competent authority or the Commission, the Ministers shall require an applicant under regulations 9 to 15 and 17, to forward copies of the dossiers submitted in support of his application to that competent authority or to the Commission, as the case may be, and the applicant shall comply with that requirement.

Appeals

36.—(1) Subject to paragraph (3), a person may appeal to the appropriate person if that person is aggrieved by a decision of the Ministers—

(a) not to grant his application for—

(i) the authorisation, or the renewal of an authorisation, of a biocidal product under regulation 9 or 13,

(ii) the authorisation of a biocidal product under regulation 17, or

(iii) the registration, or the renewal of a registration, of a biocidal product under regulation 10 or 14;

(b) to impose a condition or restriction when granting his application for—

(i) an authorisation of a biocidal product under regulation 9, 13 or 17, or

(ii) a registration of a biocidal product under regulation 10 or 14;

(c) made pursuant to regulation 16(6), to prohibit him from conducting an experiment or test or to impose conditions regarding the conduct by him of an experiment or test;

(d) made pursuant to regulation 20(1), to modify a condition of use subject to which an authorisation or registration has been granted to him under regulations 9 to 15 or 17;

(e) not to modify a condition of use, subject to which an authorisation or registration has been granted to him under regulations 9 to 15 or 17, when requested by him to do so under regulation 20(2);

(f) made pursuant to regulation 19, other than paragraph (12) of that regulation, to revoke an authorisation or a registration granted to him under regulations 9 to 15 or 17;

(g) not to revoke an authorisation or registration granted to him under regulations 9 to 15 or 17, when requested by him to do so under regulation 19(12);

(h) not to issue a frame-formulation, when requested by him to do so under regulation 18(1)(a);

(i) made pursuant to regulation 25, not to give their consent to him referring to information; or

(j) made pursuant to regulation 26(2)(b), not to keep confidential information submitted by him to the Ministers.

(2) A person may appeal to the appropriate person if that person is aggrieved by a decision of the Ministers—

(a) not to grant him a period of time longer than 3 months in which to make an application under regulation 9, 10, 11 or 12 pursuant to paragraphs 5 or 8 of Schedule 13;

(b) not to grant him a certificate of exemption;

(c) to impose a condition when granting him a certificate of exemption;

(d) to revoke a certificate of exemption granted to him;

(e) relating to the period of time for which a certificate of exemption is granted to him,

and in this paragraph, “certificate of exemption” means a certificate of exemption referred to in Schedule 13.

(3) Paragraph (1) shall not apply where the decision of the Ministers in question is made to give effect to a Commission decision.

(4) The provisions of Schedule 10 shall apply where an aggrieved person appeals to the appropriate person.

(5) Where an appeal is brought under paragraphs (1)(d), (1)(f) or (2)(d), the decision in question shall be suspended pending the final determination of the appeal.

(6) Where an appeal is brought under paragraph (1)(j), pending final determination of the appeal, the Ministers shall not disclose the information except—

(a) to the Commission or a competent authority; and

(b) to the extent necessary to enable the Ministers to deal with the application in question made under these Regulations.

(7) A person who receives information by virtue of paragraph (6)(b) shall not use that information except for the purposes of the Ministers.

(8)  In this regulation, “the appropriate person” means—

(a) in the case of a decision of the Secretary of State and the Minister of Agriculture, Fisheries and Food, acting jointly, the Secretary of State; and

(b) in the case of a decision of the Ministers in or as regards Scotland, the Secretary of State and the Scottish Ministers, acting jointly.

Tests

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

Enforcement, offences and civil liability

38.  Schedule 11 shall have effect.

Fees

39.—(1) Schedule 12 shall have effect.

(2) The period of time within which the Ministers must—

(a) comply with the provisions of regulation 6(2) when dealing with an application under regulation 5, 7(1) or 7(2);

(b) make a decision relating to an application submitted under regulations 9 to 14 or 17; or

(c) comply with the provisions of regulation 6(6) or 7(5),

shall not begin until there have been paid all fees payable under these Regulations in respect of the application or evaluation in question, other than those fees payable in accordance with paragraph 10 of Schedule 12.

(3) The Ministers shall not be bound to consider a request made under regulation 20(2) until there have been paid the fee or fees payable under paragraph 6 of Schedule 12, other than those payable in accordance with paragraph 10 of that Schedule.

Transitional provisions

40.  Schedule 13 shall have effect.

Extension outside Great Britain

41.  These Regulations shall apply outside Great Britain as sections 1 to 59 and 80 to 82 of the 1974 Act apply by virtue of the Health and Safety at Work etc. Act 1974 (Application Outside Great Britain) Order 1995(17).

Amendments

42.—(1) At the end of regulation 3(2) of the Control of Pesticides Regulations 1986(18) there shall be added the following sub-paragraph—

“(j) any biocidal product—

(i) authorised or registered under the 2001 Regulations,

(ii) placed on the market for use in an experiment or test in accordance with regulation 16 of the 2001 Regulations, or

(iii) the placing on the market and use of which are subject to any of the prohibitions specified in regulation 8 of the 2001 Regulations,

and in this sub-paragraph, “the 2001 Regulations” means the Biocidal Products Regulations 2001 and “biocidal product” shall have the meaning assigned to it in regulation 2(1) of the 2001 Regulations.”

(2) In regulation 5(6) of the 1994 Regulations, after the words “the Food and Environment Protection Act 1985”, there shall be inserted the words “or a biocidal product which has been authorised or registered under the Biocidal Products Regulations 2001”.

Signed by authority of the Secretary of State

Whitty

Parliamentary Under-Secretary of State,

Department of the Environment, Transport and the Regions

7th March 2001

Regulation 2(1)

SCHEDULE 1 BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS

Column 1	Column 2
Product-type	Description
MAIN GROUP 1
Disinfectants and general biocidal products These product-types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products.
1  Human hygiene biocidal products	Products used for human hygiene purposes.
2  Private area and public health area disinfectants and other biocidal products	Products (which are not used for direct food or feedingstuff contact) used for the disinfection of air, surfaces, materials, equipment and furniture in private, public and industrial areas, including hospitals, as well as products used as algaecides. Usage areas include swimming pools, aquariums, bathing and other waters; air-conditioning systems; walls and floors in health and other institutions; chemical toilets, waste water, hospital waste, soil or other substrates (in playgrounds).
3  Veterinary hygiene biocidal products	Products used for veterinary hygiene purposes, including products used in areas in which animals are housed, kept or transported.
4  Food and feed area disinfectants	Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food, feed or drink (including drinking water) for humans and animals.
5  Drinking water disinfectants	Products used for the disinfection of drinking water (for both humans and animals).
MAIN GROUP 2	Preservatives
6  In-can preservatives	Products used for the preservation of manufactured products, other than food or feedingstuff, in containers by the control of microbial deterioration to ensure their shelf life.
7  Film preservatives	Products used for the preservation of films or coatings by the control of microbial deterioration in order to protect the initial properties of the surface of materials or objects such as paints, plastics, sealants, wall adhesives, binders, papers, art works.
8  Wood preservatives	Products (both preventive and curative) used for the preservation of wood, from and including the saw-mill stage, or wood products by the control of wood-destroying or wood-disfiguring organisms.
9  Fibre, leather, rubber and polymerised materials preservatives	Products used for the preservation of fibrous or polymerised materials, such as leather, rubber or paper or textile products and rubber by the control of microbiological deterioration.
10  Masonry preservatives	Products used for the preservation and remedial treatment of masonry or other construction materials other than wood by the control of microbiological and algal attack.
11  Preservatives for liquid-cooling and processing systems	Products used for the preservation of water (other than drinking water) or other liquids used in cooling and processing systems by the control of harmful organisms such as microbes, algae and mussels.
12  Slimicides	Products used for the prevention or control of slime growth on materials, equipment and structures, used in industrial processes, such as on wood and paper pulp or porous sand strata in oil extraction.
13  Metalworking-fluid preservatives	Products used for the preservation of metalworking fluids by the control of microbial deterioriation.
MAIN GROUP 3	Pest control
14  Rodenticides	Products used for the control of mice, rats or other rodents.
15  Avicides	Products used for the control of birds.
16  Molluscicides	Products used for the control of molluscs.
17  Piscicides	Products used for the control of fish except products for the treatment of fish diseases.
18  Insecticides, acaricides and products to control other arthropods	Products used for the control of arthropods (including insects, arachnids and crustaceans).
19  Repellents and attractants	Products used to control harmful organisms (invertebrates such as fleas, vertebrates such as birds), by repelling or attracting, including those that are used for human or veterinary hygiene either directly or indirectly.
MAIN GROUP 4	Other Biocidal products
20  Preservatives for food or feedstocks	Products used for the preservation of food or feedstocks by the control of harmful organisms.
21  Antifouling products	Products used to control the growth and settlement of fouling organisms (microbes and higher forms of plant or animal species) on vessels, aquaculture equipment or other structures used in water.
22  Embalming and taxidermist fluids	Products used for the disinfection and preservation of human or animal corpses, or parts thereof.
23  Control of other vertebrates	Products used for the control of vermin.

Regulation 3(1)

SCHEDULE 2 REGULATIONS RELATING TO BIOCIDAL PRODUCTS

The Regulations referred to in regulation 3(1)(a) are—

(a) the Materials and Articles in Contact with Food Regulations 1987(19);

(b) the Flavourings in Food Regulations 1992(20);

(c) the Food Additive Labelling Regulations 1992(21);

(d) the Active Implantable Medical Devices Regulations 1992(22);

(e) the Egg Products Regulations 1993(23);

(f) the Medicines (Homoeopathic Medicinal Products For Human Use) Regulations 1994(24);

(g) the Medical Devices Regulations 1994(25);

(h) the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994(26);

(i) the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(27);

(j) the Plant Protection Products Regulations 1995(28);

(k) the Dairy Products (Hygiene) Regulations 1995(29);

(l) the Dairy Products (Hygiene) (Scotland) Regulations 1995(30);

(m) the Miscellaneous Food Additives Regulations 1995(31);

(n) the Cosmetic Products (Safety) Regulations 1996(32);

(o) the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997(33);

(p) the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations 1998(34);

(q) the Medicated Feedingstuffs Regulations 1998(35);

(r) the Feedingstuffs (Zootechnical Products) Regulations 1999(36);

(s) the Feeding Stuffs Regulations 2000(37);

(t) the Feeding Stuffs (Scotland) Regulations 2000(38);

(u) the Feeding Stuffs (Wales) Regulations 2001(39);

Regulations 9(2), (6) and (10), 10(2), (6) and (11), 11(4) and (7), 12(4) and (9), 13(2) and (7), 14(2) and (8), 19(2) and (6) and 20(3) and Schedules 6 and 7

SCHEDULE 3 DETERMINATIONS OF THE MINISTERS

1.  Subject to paragraph 2, the Ministers have determined that the biocidal product satisfies the following requirements, namely—

(a) the biocidal product is sufficiently effective;

(b) the biocidal product has no unacceptable effects on the target organisms, such as unacceptable resistance, cross-resistance, or unnecessary suffering and pain for vertebrates;

(c) the biocidal product and its residues have no unacceptable effects on human or animal health, surface water or groundwater, whether directly or indirectly; and

(d) the biocidal product, and its residues, have no unacceptable effects on the environment, having particular regard to—

(i) its fate and distribution in the environment, including in particular contamination of surface water (including estuarian and sea water), ground water and drinking water, and

(ii) its impact on non-target organisms.

2.  In making the determinations referred to in paragraph 1, the Ministers shall have regard to—

(a) current scientific and technical knowledge;

(b) the evaluation, according to the common principles for the evaluation of dossiers laid down in Annex VI, of the dossiers submitted with the application in question;

(c) all normal conditions under which the biocidal product may be used;

(d) the ways in which any material treated with the biocidal product may be used; and

(e) the consequences of use and disposal of the biocidal product.

3.  The Ministers have determined, according to the relevant requirements in Annexes IIA, IIB, IIIA, IIIB, IVA and IVB—

(a) the nature and quantity of—

(i) the active substance, and

(ii) where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants,

contained in the biocidal product; and

(b) the nature and quantity of the residues of toxicological or environmental significance which would result from the uses of the biocidal product if such biocidal product were authorised or registered.

4.  The Ministers have determined—

(a) the physical and chemical properties of the biocidal product; and

(b) that such properties are acceptable for the purposes of the intended use, storage and transport of the biocidal product.

Regulations 10(4) and 12(5) and (7)

SCHEDULE 4 INFORMATION TO BE CONTAINED IN A DOSSIER SUBMITTED IN SUPPORT OF AN APPLICATION FOR THE REGISTRATION OF A BIOCIDAL PRODUCT

1.  The name and address of the applicant.

2.  The name and address of the manufacturer of the biocidal product.

3.  The name and address of the manufacturer of the active substance in the biocidal product, and the location of manufacture.

4.  The trade name of the biocidal product.

5.  The name of each substance in the biocidal product, including the name of its active substance, and the amount of each substance, as a percentage of the whole.

6.  The physical and chemical properties of the biocidal product relating to use, storage and transport.

7.  The product-type and field of use of the biocidal product.

8.  The intended category of users.

9.  The intended method of use.

10.  Efficacy data.

11.  Analytical methods.

12.  The classification, packaging and labelling of the biocidal product, including a draft label.

13.  Where the biocidal product is a substance or preparation dangerous for supply within the meaning of regulation 2(1) of the 1994 Regulations, a safety data sheet for that biocidal product prepared in accordance with regulation 6 of those Regulations.

Regulations 11(6) and 12(8)

SCHEDULE 5 MATTERS IN RESPECT OF WHICH ADDITIONAL CONDITIONS MAY BE IMPOSED ON THE MUTUAL RECOGNITION OF AN AUTHORISATION OR A REGISTRATION OF A BIOCIDAL PRODUCT

1.  Directions for use of the biocidal product in question, including its dose rate expressed in metric units.

2.  Particulars of any likely direct or indirect adverse side effects and any directions for first-aid.

3.  Directions for safe disposal of the biocidal product in question and its packaging, including any prohibition on the re-use of packaging.

4.  The period of time needed for the biocidal effect.

5.  The interval to be observed between—

(a) applications of the biocidal product;

(b) application and the next use of the article, material or substance treated by the biocidal product; or

(c) application and the next access by humans or animals to the area where the biocidal product has been used,

including particulars of decontamination means and measures and duration of necessary ventilation of treated areas.

6.  Particulars for adequate cleaning of equipment.

7.  Particulars concerning precautionary measures during use, storage and transport, such as personal protective equipment to be used, measures for protection against fire, covering of furniture, removal of food and feedingstuff and directions to prevent animal exposure to the biocidal product in question.

8.  Information on any specific dangers to the environment, including protection of non-target organisms and avoidance of contamination of water.

Regulation 26(6)

SCHEDULE 6 NON-CONFIDENTIAL INFORMATION

1.  The name and address of the applicant for the authorisation or registration of the biocidal product.

2.  The name of the biocidal product.

3.  The name and address of the manufacturer of the biocidal product.

4.  The name and address of the manufacturer of the active substance in the biocidal product.

5.  The name and content of the active substance in the biocidal product.

6.  The name of any other substance in the biocidal product which—

(a) is listed in Part I of the approved supply list; or

(b) is classified as being in one or more of the categories of danger specified in column 1 of Schedule 1 to the 1994 Regulations,

except a substance of which no account would be taken in the classification of that biocidal product by virtue of paragraph 18(1) of Part I of Schedule 3 to those Regulations.

7.  Physical and chemical data concerning the biocidal product and the active substance contained in that biocidal product.

8.  Any ways of rendering harmless the biocidal product and the active substance contained in that biocidal product.

9.  A summary of the results of the tests, referred to in the dossiers submitted in support of an application under these Regulations, to establish—

(a) the efficacy;

(b) the effects on humans, animals and the environment; and

(c) where applicable, any ability to promote resistance,

of the biocidal product and the active substance contained in that biocidal product.

10.  Recommended methods and precautions to reduce dangers from handling, storage, transport, use, fire or other hazards.

11.  Safety data sheets.

12.  Methods of analysis necessary to enable the Ministers to make the determination referred to in paragraph 3 of Schedule 3.

13.  Methods of disposal of the biocidal product and its packaging.

14.  Procedures to be followed and measures to be taken in the case of spillage or leakage of the biocidal product and the active substance contained in that biocidal product.

15.  First aid and medical advice to be given in the case of injury to persons.

Regulation 28(1)

SCHEDULE 7 INFORMATION RELATING TO BIOCIDAL PRODUCTS TO BE GIVEN TO THE COMMISSION AND TO THE COMPETENT AUTHORITIES

1.  The name of the applicant for, or the person to whom, the authorisation or registration was granted.

2.  The trade name of the biocidal product.

3.  The name and amount of each active substance which the biocidal product contains.

4.  The name and amount of each substance which the biocidal product contains which is a substance dangerous for supply within the meaning of regulation 2(1) of the 1994 Regulations and its classification.

5.  The product-type for the biocidal product and the use for which it is authorised or registered, as the case may be.

6.  The type of formulation of the biocidal product, namely whether it is in the form of a powder, granules, a solid, a liquid concentrate or some other form.

7.  Any proposed limits on residues which have been determined by the Ministers in accordance with paragraph 3(b) of Schedule 3.

8.  Any conditions subject to which the authorisation or registration was granted.

9.  The reasons for the modification or cancellation of an authorisation or registration.

10.  Whether the biocidal product is a low-risk biocidal product or within a frame-formulation.

Regulation 29(2) and (7)

SCHEDULE 8 INFORMATION TO BE NOTIFIED TO THE NATIONAL POISONS INFORMATION SERVICE

1.  The name of the biocidal product.

2.  If the biocidal product is authorised or registered under these Regulations—

(a) the use for which it is so authorised or registered; and

(b) the name, address and telephone number and any e-mail address and any fax number of the person to whom the authorisation or registration was granted.

3.  The date on which the biocidal product was first placed on the market in Great Britain.

4.  The name, address and telephone number and any e-mail address and any fax number of—

(a) the manufacturer of the biocidal product;

(b) any importer of the biocidal product; and

(c) the individual to be contacted in an emergency in the event of an individual being affected by the biocidal product.

5.  A description of the packaging of the biocidal product, including its size and type.

6.  The pH, physical state and colour of the biocidal product.

7.  The identity of the ingredients of the biocidal product, and their concentration in metric units.

8.  The effects on human health of contact with the biocidal product.

9.  Particulars of the likely direct or indirect adverse side effects of the biocidal product and any directions for first aid.

10.  Any other information relating to the health and safety of humans which is given on the label of the biocidal product.

Regulation 31(2) and (3)

SCHEDULE 9 INFORMATION TO BE INCLUDED ON LABELS

1.  The identity of the active substance in the biocidal product and its concentration in metric units.

2.  The authorisation or registration number allocated to the biocidal product by the Ministers.

3.  The type of formulation of the biocidal product, namely whether it is in the form of a powder, granules, a solid, a liquid concentrate or some other form.

4.  The use for which the biocidal product is authorised or registered.

5.  Directions for use of the biocidal product, including its dose rate in metric units.

6.  Particulars of likely direct or indirect adverse side effects and any directions for first aid.

7.  Directions for safe disposal of the biocidal product and its packaging, including any prohibition on the re-use of packaging.

8.  The number or other reference assigned by the manufacturer of the biocidal product to the batch of biocidal products with which that biocidal product was made and the expiry date relevant to normal conditions of storage.

9.  The period of time needed for the biocidal effect.

10.  The interval to be observed between—

(a) applications of the biocidal product;

(b) application and the next use of the article, material or substance treated by the biocidal product; or

(c) application and the next access by humans or animals to the area where the biocidal product has been used,

including particulars of decontamination means and measures and duration of necessary ventilation of treated areas.

11.  Instructions for adequate cleaning of equipment for use with the biocidal product.

12.  Instructions concerning precautionary measures during use, storage and transport, such as personal protective equipment to be used, measures for protection against fire, covering of furniture, removal of food and feedingstuff and directions to prevent animal exposure to the biocidal product.

13.  Any restriction on the category of persons who may use the biocidal product.

14.  Information on any specific dangers to the environment, including protection of non-target organisms and avoidance of contamination of water.

Regulation 36(4)

SCHEDULE 10 APPEALS

PART I

1.  In this Schedule—

(a) “appeal” means an appeal under regulation 36;

“appellant” means a person who has brought an appeal;

“appointed person” means a person appointed in accordance with paragraph 2;

“appropriate person” has the same meaning as it has in regulation 36;

“hearing” means a hearing to which Part II of this Schedule applies;

“the parties” means the appellant and the Ministers;

(b)

a reference to “government department” includes, in the case of an appeal relating to a decision of the Ministers in or as regards Scotland, a reference to the Scottish Administration or any part thereof; and

(c)

a reference to a numbered sub-paragraph is a reference to the sub-paragraph so numbered in the paragraph in which that reference occurs.

2.  The appropriate person shall direct that an appeal shall be determined by a person appointed by him for the purpose and the appropriate person shall notify the parties in writing of the name of the appointed person.

3.  Before the determination of an appeal, the appointed person shall ask the parties whether they wish to appear and be heard on the appeal and—

(a) the appeal may be determined without a hearing if the parties express a wish not to be heard as aforesaid;

(b) the appointed person shall, if either of the parties expresses a wish to appear and be heard, afford both of them an opportunity of so doing, in which case the provisions of Part II of this Schedule shall apply.

4.  An appointed person may give such directions as he thinks appropriate to give effect to his determination.

5.  The appropriate person may pay to an appointed person such remuneration and allowances as the appropriate person may, with the approval of the Minister for the Civil Service, determine.

PART II

6.  An appeal brought pursuant to regulation 36(1)(j) shall be heard in private.

7.—(1) Subject to the following sub-paragraphs of this paragraph, a date, time and place for the holding of the hearing shall be fixed, and may be varied, by the appointed person, who shall give not less than 42 days' notice in writing of such date, time and place to the parties.

(2) With the consent of the parties, the appointed person may give such lesser period of notice as shall be agreed with the parties and in that event he may specify a date for service of the statement referred to in paragraph 8(1) later than the date determined in accordance with that paragraph.

(3) Where it becomes necessary or advisable to vary the time or place fixed for the hearing, the appointed person shall give such notice of the variation as may appear to him to be reasonable in the circumstances.

(4) Without prejudice to the foregoing provisions of this paragraph, the appointed person may require the Ministers to take one or more of the following steps, namely—

(a) to serve such notice of the hearing, in such form and on such persons or classes of persons as he may direct;

(b) to give such other notice of the hearing and in such form as he may direct,

and the requirements as to the period of notice contained in sub-paragraph (1) shall not apply to any such notices.

8.—(1) Not later than 28 days before the date of the hearing, or such later date as the appointed person may specify in accordance with paragraph 7(2), the Ministers shall serve on the appellant a written statement of any submission which the Ministers propose to put forward at the hearing and shall supply a copy of the statement to the appointed person.

(2) Where a government department has expressed in writing to the Ministers a view in support of the decision of the Ministers and the Ministers propose to rely on such expression of view in their submission at the hearing, the Ministers shall include the expression of view in their statement and shall supply a copy of the statement to the government department concerned.

(3) Where the Ministers intend to refer to, or put in evidence at the hearing, documents (including photographs), the statement of the Ministers shall be accompanied by a list of such documents, together with a written notice stating the times and place at which the documents may be inspected by the appellant; and the Ministers shall afford the appellant a reasonable opportunity to inspect and, where practicable, to take copies of the documents.

(4) If so required by the appointed person, the appellant shall—

(a) serve on the Ministers and on the appointed person, within such time before the hearing as the appointed person may specify, a written statement of the submissions which he proposes to put forward at the hearing; and such statement shall be accompanied by a list of any documents (including photographs) which the appellant intends to refer to or put in evidence at the hearing; and

(b) afford the Ministers a reasonable opportunity to inspect and, where practicable, to take copies of such documents as are referred to in the foregoing provision.

9.—(1) The parties shall be entitled to appear at the hearing.

(2) Any other person may appear at the discretion of the appointed person provided that he has, not later than 7 days before the date of the hearing, served on the Ministers a statement of his proposed submissions.

(3) The Ministers shall send a copy of every statement served on them in accordance with sub-paragraph (2) to the appointed person and to the appellant.

(4) A body corporate may appear by its clerk or secretary or by any other officer appointed for the purpose by that body, or by counsel or a solicitor.

(5) A person may appear on his own behalf or be represented by counsel, a solicitor or any other person.

(6) Where there are two or more persons having a similar interest in the subject matter of the hearing, the appointed person may allow one or more persons to appear for the benefit of some or all persons so interested.

10.—(1) Where a government department has expressed in writing to the Ministers a view in support of the decision of the Ministers and the Ministers have included this view in the statement referred to in paragraph 8(1), the appellant may apply in writing to the appointed person, not later than 14 days before the date of the hearing, for a representative of the government department concerned to be made available at the hearing.

(2) The appointed person shall send an application made to him under sub-paragraph (1) to the government department concerned who shall make a representative of the department available to attend the hearing.

(3) A representative of a government department who, in pursuance of this paragraph, attends a hearing shall be called as a witness by the Ministers and shall state the reasons for the view expressed by his department and included in the statement of the Ministers under paragraph 8(1) and shall give evidence and be subject to cross-examination to the same extent as any other witness.

(4) Nothing in the last foregoing paragraph shall require a representative of a government department to answer any question which in the opinion of the appointed person is directed to the merits of government policy or to matters which affect the safety of the State and the appointed person shall disallow any such question.

11.—(1) Except as otherwise provided in this Part of this Schedule, the procedure at the hearing shall be such as the appointed person shall in his discretion determine and the appointed person shall state at the commencement of the hearing the procedure which, subject to consideration of any submission by the parties, he proposes to adopt.

(2) Unless in any particular case the appointed person with the consent of the appellant otherwise determines—

(a) in the case of an appeal to the Secretary of State, the appellant shall be heard first and shall have the right of final reply; and

(b) in the case of an appeal to the Secretary of State and the Scottish Ministers, acting jointly—

(i) the appellant shall be heard first,

(ii) the other persons entitled or permitted to appear shall be heard in such order as the appointed person may determine, and

(iii) any closing statements shall be made in the same order, unless the appointed person otherwise determines.

(3) The parties shall be entitled to make an opening statement, to call evidence and to cross-examine persons giving evidence, but any other person appearing at the hearing may do so only to the extent permitted by the appointed person.

(4) Subject to sub-paragraph (5), any evidence may be admitted at the discretion of the appointed person, who may direct that documents tendered in evidence may be inspected by any person entitled or permitted to appear at the hearing and that facilities be afforded him to take or obtain copies thereof.

(5) The appointed person shall not require or permit the giving or production of any evidence, whether written or oral, which would be contrary to the public interest.

(6) The appointed person may allow the Ministers or the appellant, or the parties, to alter or add to the submissions contained in any statement served under paragraph 8(1) or (4), or to any list of documents which accompanied such statement, so far as may be necessary for the purpose of determining the questions in controversy between the parties, but shall (if necessary by adjourning the hearing) give the appellant or the Ministers, as the case may be, an adequate opportunity of considering any such fresh submission or document.

(7) If any person entitled to appear at the hearing fails to appear, the appointed person may proceed with the hearing at his discretion.

(8) The appointed person shall be entitled (subject to disclosure thereof at the hearing) to take into account any written representations or statements received by him before the hearing from any person.

(9) The appointed person may from time to time adjourn the hearing, and where he does so, shall give reasonable notice to every person entitled or permitted to appear at the hearing of the date, time and place of the adjourned hearing.

12.—(1) Where, after the close of the hearing, the appointed person proposes to take into consideration—

(a) any new evidence, including expert opinion on a matter of fact; or

(b) any new issue of fact, not being a matter of government policy or a matter affecting the safety of the State,

which was not raised at the hearing and which he considers to be material to his decision, he shall not come to a decision without first notifying the parties of the substance of the new evidence or of the new issue of fact and affording them an opportunity of making representations thereon in writing within 21 days or of asking within that time for the re-opening of the hearing.

(2) If he thinks fit, the appointed person may cause the hearing to be re-opened and shall cause it to be re-opened if asked to do so in accordance with sub-paragraph (1).

(3) Where the hearing is re-opened, paragraphs 7(1) and 7(4) shall apply as they applied to the original hearing with the substitution in paragraph 7(1) of “28” for “42”.

13.  The appointed person shall notify the determination on the appeal, and the reasons therefor, in writing to the parties and to any person who, having appeared at the hearing, has asked to be notified of the decision.

Regulation 38

SCHEDULE 11 ENFORCEMENT, OFFENCES AND CIVIL LIABILITY

Interpretation

1.  In this Schedule—

(a) “the 1998 Regulations” means the Health and Safety (Enforcing Authority) Regulations 1998(40);

“domestic premises” means premises occupied as a private dwelling (including any garden, yard, garage, outhouse or other appurtenance of such premises which is not used in common by the occupants of more than one such dwelling);

“inspector” means an inspector appointed under section 19 of the 1974 Act;

“justice” means—

(i)

in relation to England and Wales, a justice of the peace;

(ii)

in relation to Scotland, a sheriff, stipendiary magistrate or justice of the peace:

“local authority” means—

(i)

in relation to England, a county council so far as they are the council for an area for which there are no district councils, a district council, a London borough council, the Common Council of the City of London, the Sub-Treasurer of the Inner Temple, the Under-Treasurer of the Middle Temple or the Council of the Isles of Scilly;

(ii)

in relation to Scotland, the council for a local government area; and

(iii)

in relation to Wales, a county council or a county borough council;

“work” shall be construed in accordance with section 52 of the 1974 Act; and

(b)

a reference to a numbered sub-paragraph is a reference to the sub-paragraph so numbered in the paragraph in which that reference occurs.

Application of the 1974 Act

2.—(1) Sections—

(a) 16 to 26 (approval of codes of practice and enforcement);

(b) 33 to 42 (provisions as to offences); and

(c) 47(2) (civil liability),

of the 1974 Act shall, subject to the following provisions of this Schedule, and to the extent that they would not otherwise do so, apply to these Regulations as if they were health and safety regulations for the purposes of that Act.

(2) Any function of the Health and Safety Commission under any other provision of the 1974 Act which is exercisable in relation to any function of the Health and Safety Executive under or in respect of health and safety regulations (including their enforcement) shall be exercisable as if these Regulations were, to the extent they would not otherwise be so, health and safety regulations for the purposes of that Act.

(3) The sections of the 1974 Act which are applied to these Regulations by sub-paragraph (1) shall so apply as if any reference to—

(a) danger, or danger to health and safety, were a reference to danger to the health or safety of humans or animals or to danger to the environment; and

(b) harm were a reference to harm to humans, animals or the environment.

(4) Sections 22 and 25 of the 1974 Act, as applied to these Regulations by sub-paragraph (1), shall apply as if the reference in those sections to serious personal injury were a reference to—

(a) serious personal injury to humans;

(b) a breach of the Regulations and serious injury to animals; or

(c) a breach of the Regulations and serious harm to the environment.

Offences

3.  A failure to discharge a duty—

(a) placed on the Ministers by these Regulations; or

(b) placed on any person by regulation 5, 7(3), 9(4) to (6), 9(8), 10(4) to (6), 10(9), 11(5), 12(5), 17(4), 26(2), 34(1) to (4) and 37,

shall not be an offence under section 33(1)(c) of the 1974 Act.

Limitation on entry to domestic premises in certain circumstances

4.—(1) An inspector may not enter domestic premises in the exercise of his powers under the 1974 Act, as applied to these Regulations by virtue of paragraph 2, in respect of an activity which is not, or is not related to, an activity involving work, unless a justice has issued a warrant authorising him to enter and exercise his powers in those domestic premises.

(2) A justice may not issue such a warrant, unless on an application made by the inspector, he is satisfied—

(a) that the inspector has reasonable grounds for believing that there is present in the domestic premises anything to which those powers relate; and

(b) that—

(i) it is not practicable to communicate with any person entitled to grant entry to the domestic premises,

(ii) a person entitled to grant entry to the domestic premises has unreasonably refused an inspector entry,

(iii) entry to the domestic premises is unlikely to be granted unless a warrant is produced, or

(iv) the purpose of entry may be frustrated or seriously prejudiced unless an inspector arriving at the domestic premises can secure immediate entry to them.

Allocation of enforcement responsibility

5.—(1) Notwithstanding the 1998 Regulations, and subject to sub-paragraphs (2) to (7), the enforcing authority for these Regulations shall be the Health and Safety Executive.

(2) Where an active substance is placed on the market—

(a) in or from any shop, mobile vehicle, market stall or other retail outlet; or

(b) otherwise to members of the public, including by way of free sample, prize or mail order,

the enforcing authority for regulation 4 shall be the local weights and measures authority.

(3) Where a biocidal product is placed on the market—

(a) in or from any shop, mobile vehicle, market stall or other retail outlet; or

(b) otherwise to members of the public, including by way of free sample, prize or mail order,

the enforcing authority for regulations 8(1), 30 and 31 shall be the local weights and measures authority.

(4) Where a biocidal product is sold—

(a) in or from any shop, mobile vehicle, market stall or other retail outlet; or

(b) otherwise to members of the public, including by way of free sample, prize or mail order,

the enforcing authority for regulation 22(3) shall be the local weights and measures authority.

(5) The enforcing authority for regulation 33 shall be the local weights and measures authority.

(6) The 1998 Regulations shall apply to the enforcement of regulations 8(2), 8(5) and 22(4).

(7) The enforcing authority for regulations 8(2), 8(5) and 22(4)—

(a) in respect of any use not related to an activity involving work; or

(b) in respect of any use by a domestic servant in a private household,

shall be the local authority for the area in which the use occurs.

Regulation 39(1), (2) and (3)

SCHEDULE 12 FEES

1.  On the making of an application to the Ministers under regulation 5 for the inclusion of an active substance in Annex I, IA or IB, there shall be payable by the applicant to the Ministers—

(a) for ensuring that the dossiers submitted as part of that application satisfy the requirements of regulation 5 in accordance with regulation 6(1); and

(b) for determining the application in accordance with regulation 6(2),

a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

2.  There shall be payable by the applicant to the Ministers in connection with the determination of an application to the Ministers specified in paragraph 3, a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

3.  The applications to the Ministers referred to in paragraph 2 are—

(a) an application under regulation 7(1) for a variation of the requirements subject to which an active substance is included in Annex I, IA or IB;

(b) an application under regulation 7(2) for the renewal of the inclusion of an active substance in Annex I, IA or IB;

(c) an application under regulation 9 for the authorisation of, or the renewal of an authorisation of, a biocidal product;

(d) an application under regulation 10 for the registration of, or the renewal of the registration of, a biocidal product;

(e) an application under regulation 11(5) for the authorisation of a biocidal product;

(f) an application under regulation 12(5) for the registration of a biocidal product;

(g) an application under regulation 13 for the provisional authorisation of, or the renewal of the provisional authorisation of, a biocidal product;

(h) an application under regulation 14 for the provisional registration of, or the renewal of a provisional authorisation of, a biocidal product;

(i) an application for an authorisation under regulation 17.

4.  There shall be payable by the applicant to the Ministers in connection with the evaluation of dossiers following a decision referred to in regulation 6(6) or regulation 7(5), a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

5.  There shall be payable by a person who provides information under regulation 16(5) or 20(5)(b) a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

6.  There shall be payable by a person who requests a modification under regulation 20(2) a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

7.  On receipt of—

(a) an application referred to in paragraph 1;

(b) an application specified in paragraph 3;

(c) dossiers referred to in paragraph 4;

(d) information referred to in paragraph 5; or

(e) a request referred to in paragraph 6,

the Ministers shall prepare and send to the applicant, the person providing the information or the person making the request, as the case may be, an estimate of the cost of the work necessary for the determination of the application, the evaluation of dossiers, or the consideration of the information or the request.

8.  The amount estimated in accordance with paragraph 7 shall be paid forthwith by the person to whom the estimate is sent.

9.  On the determination of the application, completion of the evaluation of dossiers or consideration of the information or request, the Ministers shall prepare a detailed statement of the work carried out in relation to that determination, evaluation or consideration, as the case may be, and of the cost reasonably incurred by the Ministers or any person acting on their behalf in carrying out that work.

10.  If the cost referred to in paragraph 9 is greater than the amount estimated in accordance with paragraph 7, the amount of the difference shall be—

(a) notified by the Ministers to the applicant or the person providing the information or making the request, as the case may be;

(b) the amount of the final fee payable; and

(c) paid by the applicant or that person forthwith.

11.  If the cost referred to in paragraph 9 is less than the amount estimated in accordance with paragraph 7, the fee shall be adjusted accordingly and the amount of the difference shall be paid forthwith by the Ministers to the applicant or the person providing the information or making the request, as the case may be.

12.  In estimating or stating the cost of carrying out any work, the Ministers may take into account the cost to them, or to any person acting on their behalf, of employing an officer for any period to perform the work concerned and shall determine that cost by reference to the average cost of employing an officer of the grade appropriate for that work for that period.

Regulations 3(2), 36(2) and 40

SCHEDULE 13 TRANSITIONAL PROVISIONS

1.  In this Schedule—

“COPR 1986” means the Control of Pesticides Regulations 1986(41);

“COPR approval” means an approval granted under COPR 1986;

“COPR biocidal product” means a biocidal product to which COPR 1986 applies; and

“unlisted active substance” means an existing active substance which is not included in Annex I, IA or IB.

2.  Subject to paragraphs 3 and 4, where a decision is made under Article 16(2) that—

(a) an unlisted active substance shall be included in Annex I, IA or IB; or

(b) an unlisted active substance shall not be included in either Annex I, IA or IB,

these Regulations shall apply to every biocidal product which contains the unlisted active substance to which the decision in question relates when that decision takes effect.

3.  These Regulations shall not apply to a biocidal product—

(a) when a decision referred to in paragraph 2(a) relating to an unlisted active substance in that biocidal product takes effect, if that biocidal product is not within a product-type in which the unlisted active substance may be used in accordance with any requirement to which the inclusion of the unlisted active substance in Annex I, IA or IB, as the case may be, is subject;

(b) when a decision referred to in paragraph 2(b) relating to an unlisted active substance in that biocidal product takes effect, if the biocidal product is not within a product-type in which, in accordance with that decision, the unlisted active substance may not be used.

4.  Where there is more than one unlisted active substance in a biocidal product, these Regulations shall not apply to that biocidal product until a decision referred to in paragraph 2 is made in relation to the last of those unlisted active substances to be considered for inclusion in Annex I, IA or IB, provided that such a decision has been made to include all the other active substances in that biocidal product in either Annex I, IA or IB.

5.  Where—

(a) there is made a decision referred to in paragraph 2(a); and

(b) by virtue of that paragraph, these Regulations apply to a biocidal product containing the unlisted active substance in question,

the person responsible for first placing the biocidal product on the market in Great Britain may make an application under regulation 9 or regulation 10, as the case may be, in respect of that biocidal product not later than 3 months after that decision takes effect, or such longer period as the Ministers may determine.

6.  Where—

(a) there is made a decision referred to in paragraph 2(a); and

(b) by virtue of that paragraph, these Regulations apply to a biocidal product containing the unlisted active substance in question,

the Ministers may grant a certificate of exemption in accordance with paragraph 15 where a person informs the Minister in writing that he intends to make an application to the Ministers under regulation 11 or regulation 12 after a competent authority in another member State has authorised or registered that biocidal product for placing on the market and use under the Directive.

7.  During—

(a) the period of time in which an application may be made in accordance with paragraph 5; and

(b) the period of time between such application being made and the Ministers deciding whether or not to authorise or register the biocidal product in question,

the Ministers may grant a certificate of exemption in accordance with paragraph 15.

8.  Where—

(a) there is made a decision referred to in paragraph 2(a);

(b) by virtue of that paragraph these Regulations apply to a biocidal product containing the unlisted active substance in question; and

(c) the competent authority of a member State has authorised or registered that biocidal product for placing on the market and use,

the person responsible for first placing the biocidal product on the market in Great Britain may make an application under regulation 11 or 12, as the case may be, in respect of that biocidal product not later than 3 months after that authorisation or registration was granted, or such longer period as the Ministers may determine.

9.  During—

(a) the period of time in which an application may be made in accordance with paragraph 8; and

(b) the period of time between such application being made and the Ministers deciding whether or not to authorise or register the biocidal product in question,

the Ministers may grant a certificate of exemption in accordance with paragraph 15.

10.  Where—

(a) no application is made in accordance with paragraph 5 or 8; or

(b) such an application is made but the Ministers refuse to authorise or register the biocidal product in question,

the Ministers may grant a certificate of exemption in accordance with paragraph 15.

11.  Where—

(a) an application is made in accordance with paragraph 8;

(b) the Ministers refuse to authorise or register the biocidal product, as the case may be; and

(c) such refusal is upheld by a Commission decision,

the Ministers may grant a certificate of exemption in accordance with paragraph 15.

12.  Where—

(a) there is made a decision referred to in paragraph 2(b); and

(b) by virtue of that paragraph these Regulations apply to a biocidal product containing the unlisted active substance in question,

the Ministers may grant a certificate of exemption in accordance with paragraph 15.

13.  Where—

(a) there is made a decision referred to in paragraph 2; and

(b) by virtue of that paragraph these Regulations apply to a COPR biocidal product containing the unlisted active substance in question,

COPR 1986 shall cease to apply to that COPR biocidal product when that decision takes effect.

14.  The Ministers shall—

(a) notify in writing the holder of a COPR approval in respect of a COPR biocidal product to which paragraph 10 applies that COPR 1986 no longer applies to that biocidal product; and

(b) at the same time, revoke that COPR approval.

15.  A certificate of exemption granted pursuant to paragraph 6, 7, 9, 10, 11 or 12 shall be in writing and may exempt any person or class of persons or any biocidal product or class of biocidal products from all or any of the requirements or prohibitions imposed by these Regulations, other than regulation 29, relating to—

(a) placing on the market;

(b) use;

(c) advertisements;

(d) packaging and labelling; or

(e) storage (including storage for disposal).

16.  An exemption certificate granted in accordance with paragraph 15—

(a) may be granted subject to conditions;

(b) may be revoked by a certificate in writing at any time; and

(c) shall be granted for a period not exceeding three years.

Explanatory Note

(This note is not part of the Regulations)

1.  These Regulations have effect with a view, first, to enabling applications to be made for agreement at Community level that an active substance can be used in a biocidal product and, secondly, to authorising the placing on the market and use of biocidal products to which these Regulations apply.

2.  These Regulations implement as regards Great Britain Directive 98/8 of the European Parliament and the Council of 16 February 1998 concerning the placing of biocidal products on the market (O.J. No. L 123, 24.4.98), (“the Directive”). Schedule 1 of these Regulations is based on Annex V of that Directive. The principle provisions are as follows.

3.  These Regulations do not apply to certain biocidal products nor to the carriage of biocidal products by rail, road, inland waterway, sea or air. (Regulation 3 and Schedule 2.)

4.  No person shall place on the market a new active substance for use in a biocidal product unless an application to a competent authority has been made for inclusion of that new active substance in Annex I, IA or IB of the Directive. The Ministers are designated as the competent authority in Great Britain. An application must be accompanied by dossiers containing information which the Ministers must evaluate, following which they must recommend to the European Commission whether or not an active substance should be included in Annex I, IA or IB of the Directive. (Regulations 4, 5 and 6.) (The terms “active substance”, “biocidal product”, “competent authority”, “new active substance” and “place on the market” are defined in regulation 2(1). “The Ministers” is defined in regulation 2(2).)

5.  No person shall place on the market or use a biocidal product unless that biocidal product has been authorised in accordance with the provisions of the Regulations. Where a biocidal product is a low-risk biocidal product, then a registration is required. Where a biocidal product contains an active substance which is included in Annex IB of the directive then that biocidal product may only be used in a particular manner. (Regulation 8.) (The term “low-risk biocidal product” is defined in regulation 2(1).)

6.  To obtain an authorisation or a registration, a person must submit an application to the Ministers together with the information specified in the Regulations. The Ministers may grant a mutual authorisation or registration where another member State has granted an authorisation or a registration in respect of the same biocidal product and the Ministers may also grant provisional authorisations and registrations. An authorisation and a registration may be granted subjected to conditions. (Regulations 9 to 14.)

7.  The Ministers may grant an emergency authorisation where such authorisation appears necessary because of an unforeseen danger. (Regulation 15.)

8.  Provision is made for a biocidal product to be placed on the market for use in tests and experiments, including those involving the release into the environment of a biocidal product. (Regulations 16 and 17.)

9.  The Ministers may revoke an authorisation or a registration in certain circumstances. They may also modify the conditions of use subject to which an authorisation or a registration is granted and review an authorisation or a registration. (Regulations 19 and 20.)

10.  Provision is made requiring a person to whom an authorisation or a registration has been granted to notify the Ministers of information of which he is aware relating to the biocidal product in question. (Regulation 21.)

11.  The Ministers may prohibit or restrict the sale or use of a biocidal product if they consider that the biocidal product constitutes an unacceptable risk to human or animal health or to the environment. (Regulation 22.)

12.  The Ministers shall not make use of information submitted to them under the Regulations except in certain circumstances. A person providing information to the Ministers may claim confidentiality in respect of that information if he considers that disclosure might harm his industrial or commercial position. (Regulations 23, 24 and 26.)

13.  Provision is made for co-operation between applicants for, and the holders of, authorisations or registrations regarding information relating to biocidal products. Provision is also made for the exchange of information between the Ministers and the European Commission and the competent authorities in other member States. (Regulations 25 and 28.)

14.  The person responsible for first placing a biocidal product on the market is responsible for providing information to the National Poisons Information Service. The information may only be disclosed for the purposes of medical treatment of a person affected by the biocidal product. (Regulation 29.)

15.  The Regulations impose obligations concerning the packaging, labelling and advertisement of a biocidal product. (Regulations 30, 31 and 33.)

16.  An application for an authorisation or a registration of a biocidal product is to be made by, or on behalf of, the person who first places the biocidal product on the market. An applicant must have a permanent office within the Community and the application must be in English. (Regulation 34.)

17.  The Ministers must ensure that a file is kept in respect of every application for an authorisation or a registration made under the Regulations. (Regulation 35.)

18.  There is a right of appeal for any person aggrieved by certain decisions of the Ministers made under the Regulations. (Regulation 36 and Schedule 10.)

19.  Provision is made for the enforcement of the Regulations, for the payment of fees and for transitional measures. (Regulations 38, 39, and 40 and Schedules 11, 12 and 13.)

20.  A copy of the regulatory impact assessment prepared in respect of these Regulations can be obtained from the Health and Safety Executive, Economic Adviser’s Unit, Rose Court, 2 Southwark Bridge, London SE1 9HS. A copy has been placed in the Library of each House of Parliament.

(1)

S.I. 1999/2788.

(2)

1972 c. 68.

(3)

As regards Scotland, see also section 57(1) of the Scotland Act 1998 (c. 46), which provides that, despite the transfer to the Scottish Ministers by virtue of that Act of functions in relation to observing and implementing obligations under Community law, any function of a Minister of the Crown in relation to any matter shall continue to be exercisable by him as regards Scotland for the purposes specified in section 2(2) of the European Communities Act 1972.

(4)

1974 c. 37; sections 11(2), 15(1), 43(6) and 50 were amended by the Employment Protection Act 1975 (c. 71), Schedule 15, paragraphs 4, 6, 12 and 16 respectively.

(5)

S.I. 1994/3247, amended by S.I. 1996/1092, 1997/1460, 1998/494, 1998/3106, 1999/197, 1999/3165, 1999/3194, 1999/3232 and 2000/2381.

(6)

OJ No. L123, 24.4.98, p. 1.

(7)

1998 c. 48.

(8)

A copy of the European Inventory of Existing Chemical Substances may be obtained from the European Communities Information Office, 8 Storey’s Gate, London SW1P 3AT.

(9)

OJ No. L214, 24.8.93, p. 1.

(10)

1968 c. 67; section 58B was added by the Medicines Act 1968 (Amendment) (No. 2) Regulations 1992 (S.I. 1992/3271).

(11)

S.I. 1994/3142, to which there are amendments not relevant to these Regulations.

(12)

S.I. 1994/2987, to which there are amendments not relevant to these Regulations.

(13)

S.I. 1995/887, as amended by S.I. 1997/7, 1997/2499, 1999/3430.

(14)

1985 c. 48.

(15)

S.I. 1986/1510, as amended by S.I. 1997/188.

(16)

S.I. 1992/3240, amended by S.I. 1998/1447.

(17)

S.I. 1995/263.

(18)

S.I. 1986/1510, amended by S.I. 1997/188.

(19)

S.I. 1987/1523, amended by S.I. 1990/2487, 1991/1476, 1994/979.

(20)

S.I. 1992/1971, amended by S.I. 1994/1486, 1996/1499.

(21)

S.I. 1992/1978, amended by S.I. 1995/3123, 1995/3124, 1995/3187, 1996/1499, 1999/1136, 2000/1799.

(22)

S.I. 1992/3146, amended by S.I. 1995/1671.

(23)

S.I. 1993/1520, amended by S.I. 1995/1763, 1996/1499, 2000/656 and SS.I. 2000/62.

(24)

S.I. 1994/105, amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574, 1999/566, 2000/592.

(25)

S.I. 1994/3017, amended by S.I. 2000/1315.

(26)

S.I. 1994/3142, amended by S.I. 1997/654, 1997/1729, 1997/2884, 1998/1048, 1999/1540, 1999/3142, 2000/776.

(27)

S.I. 1994/3144, amended by S.I. 1996/1499, 1997/2884, 1998/3105, 1999/1540, 2000/292.

(28)

S.I. 1995/887, as amended by S.I. 1997/7, 1997/2499, 1999/3430.

(29)

S.I. 1995/1086, amended by S.I. 1995/1763, 1996/1499, 1996/1699, 1997/1729, 1998/2424, 2000/656.

(30)

S.I. 1995/1372, amended by S.I. 1995/1763, 1996/1499, 1996/2465, 1997/1729, 1998/2424 and SS.I. 2000/62.

(31)

S.I. 1995/3187, amended by S.I. 1997/1413, 1999/1136, 2000/1799.

(32)

S.I. 1996/2925, amended by S.I. 1997/2914, 1998/1727, 1999/1552, 2000/1679.

(33)

S.I. 1997/322, amended by S.I. 1997/2884, 1999/3142.

(34)

S.I. 1998/994, amended by S.I. 1999/399, 1999/1585, 2000/656 and SS.I. 2000/62.

(35)

S.I. 1998/1046, amended by S.I. 2000/1686.

(36)

S.I. 1999/1871, amended by S.I. 2000/1686.

(37)

S.I. 2000/2481.

(38)

SS.I. 2000/453.

(39)

S.I. 2001/343.

(40)

S.I. 1998/494, amended by S.I. 1999/2024, 1999/3232.

(41)

S.I. 1986/1510, as amended by S.I. 1997/188.