The Biocidal Products Regulations 2001

Publication Date:January 01, 2001
 
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2001No. 880

HEALTH AND SAFETY

The Biocidal Products Regulations 2001

7thMarch2001

16thMarch2001

6thApril2001

General

Active Substances

Biocidal Products

Use of Information

Packaging, Labelling and Advertisements

Miscellaneous and general

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;

"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,...

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