Statutory Instrument 2001 No. 880

      The Biocidal Products Regulations 2001


      © Crown Copyright 2001

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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 


ARRANGEMENT OF REGULATIONS


PART I

General
1. Citation and commencement
2. Interpretation
3. Application

PART II

Active Substances
4. Placing on the market of active substances
5. Applications concerning new active substances
6. Assessment of applications concerning new active substances
7. Applications for variation or renewal of the inclusion of active substances in Annex I, IA or IB

PART III

Biocidal Products
8. Prohibitions
9. Authorisation of a biocidal product
10. Registration of a low-risk biocidal product
11. Mutual recognition of authorisations
12. Mutual recognition of registrations
13. Provisional authorisation
14. Provisional registration
15. Emergency authorisation
16. Research and development
17. Experimental authorisation
18. Frame-formulations
19. Revocation of authorisations and registrations
20. Modification and review of authorisations and registrations
21. Notification of new information
22. Emergency prohibition or restriction

PART IV

Use of Information
23. Data protection for active substances
24. Data protection for biocidal products
25. Co-operation in the use of information
26. Confidentiality
27. Treatment of confidential information
28. Exchange of information
29. Notification of information to the National Poisons Information Service

PART V

Packaging, Labelling and Advertisements
30. Packaging
31. Labelling
32. Samples, models and drafts
33. Advertisements

PART VI

Miscellaneous and general
34. General provisions on applications for authorisations and registrations
35. Files on applications
36. Appeals
37. Tests
38. Enforcement, offences and civil liability
39. Fees
40. Transitional provisions
41. Extension outside Great Britain
42. Amendments

SCHEDULES

  1. Biocidal product types and their descriptions

  2. Regulations relating to biocidal products

  3. Determinations of the Ministers

  4. Information to be contained in a dossier submitted in support of an application for the registration of a biocidal product

  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

  6. Non-confidential information

  7. Information relating to biocidal products to be given to the Commission and to the competent authorities

  8. Information to be notified to the National Poisons Information Service

  9. Information to be included on labels

  10. Appeals

  11. Enforcement, offences and civil liability

  12. Fees

  13. Transitional provisions

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;

    "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 - 

    (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 - 

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 - 

    (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 - 

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

    (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 - 

    (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 - 

    (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 - 

    (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 - 

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 - 

    (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 - 

    (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 - 

    (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 - 

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

    (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 - 

    (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 - 

    (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 - 

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 - 

    (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 - 

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

    (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 - 

    (8) The Ministers - 

    (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 - 

    (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 - 

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 - 

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

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

    (6) Where the Ministers are satisfied that - 

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 - 

    (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 - 

    (9) Where a Commission decision - 

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 - 

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

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

    (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 - 

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

    (8) Where the Ministers are satisfied that - 

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 - 

    (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 - 

    (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 - 

    (13) Where a Commission decision - 

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 - 

    (3) The Ministers shall not authorise a biocidal product under paragraph (1) where - 

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

    (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 - 

    (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 - 

    (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 - 

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

    (3) The Ministers shall not register a biocidal product under paragraph (1) where - 

    (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 - 

    (5) The Ministers shall not register a biocidal product under paragraph (1) where the evaluation required by paragraph (2)(a) shows that - 

    (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 - 

    (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 - 

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 - 

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 - 

    (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 - 

    (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 - 

    (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 - 

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 - 

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

    (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 - 

    (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 - 

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 - 

    (2) The Ministers shall revoke an authorisation - 

    (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 - 

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

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

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

    (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 - 

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

    (15) When the Ministers revoke - 

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 - 

    (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 - 

    (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 - 

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 - 

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 - 

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

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

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 - 

    (4) No person shall use a biocidal product - 

    (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 - 

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 - 

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 - 

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 - 

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 - 

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 - 

    (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 - 

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

    (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 - 

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 - 

    (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 - 

    (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 - 

    (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 - 

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 - 

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 - 

    (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 - 

    (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 - 

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 - 

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 - 

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 biocid