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United Kingdom
The Biocidal Products Regulations 2001

The Biocidal Products Regulations 2001

In forceThis text since 7 Mar 2001law://uk/uksi/2001/880@2026-11-12

Version in force on

Where

EnglandNorthern IrelandScotlandWales

Contents

Part I General
Part II Active substances
Part III Biocidal products
Part IV Use of information
Part V Packaging, labelling and advertisements
Part VI Miscellaneous and general
Schedule 1 Biocidal product-types and their descriptions
Schedule 2 Regulations relating to biocidal products
Schedule 3 Determinations of the ministers
Schedule 4 Information to be contained in a dossier submitted in support of an application for the registration of a biocidal product
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
Schedule 6 Non-confidential information
Schedule 7 Information relating to biocidal products to be given to the commission and to the competent authorities
Schedule 8 Information to be notified to the national poisons information service
Schedule 9 Information to be included on labels
Schedule 10 Appeals
Schedule 11 Enforcement, offences and civil liability
Schedule 12 Fees
Schedule 13 Transitional provisions

Contents

Part I General
Part II Active substances
Part III Biocidal products
Part IV Use of information
Part V Packaging, labelling and advertisements
Part VI Miscellaneous and general
Schedule 1 Biocidal product-types and their descriptions
Schedule 2 Regulations relating to biocidal products
Schedule 3 Determinations of the ministers
Schedule 4 Information to be contained in a dossier submitted in support of an application for the registration of a biocidal product
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
Schedule 6 Non-confidential information
Schedule 7 Information relating to biocidal products to be given to the commission and to the competent authorities
Schedule 8 Information to be notified to the national poisons information service
Schedule 9 Information to be included on labels
Schedule 10 Appeals
Schedule 11 Enforcement, offences and civil liability
Schedule 12 Fees
Schedule 13 Transitional provisions

Contents

1,034 provisions, too many to show on one page. Open a part or section to read it with its history and connections, or search inside the text.

Part I · General
Part II · Active substances
Part III · Biocidal products
Part IV · Use of information
Part V · Packaging, labelling and advertisements
Part VI · Miscellaneous and general
Schedule 1 · Biocidal product-types and their descriptions
Schedule 2 · Regulations relating to biocidal products
Schedule 3 · Determinations of the ministers
Schedule 4 · Information to be contained in a dossier submitted in support of an application for the registration of a biocidal product
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
Schedule 6 · Non-confidential information
Schedule 7 · Information relating to biocidal products to be given to the commission and to the competent authorities
Schedule 8 · Information to be notified to the national poisons information service
Schedule 9 · Information to be included on labels
Schedule 10 · Appeals
1. Part I
2. Part II
Schedule 11 · Enforcement, offences and civil liability
Schedule 12 · Fees
Schedule 13 · Transitional provisions

Key facts

Type: Statutory instrument · UKSI 2001/880
Made by: UK Government (statutory instrument)
Extent: England, Wales, Scotland and Northern Ireland

History · 1 version

7 Mar 2001Reading

Connections

Amended by 10: The Legislative Reform (Health and Safety Executive) Order 2008; The Cosmetic Products Enforcement Regulations 2013; The Human Medicines Regulations 2012; The Plant Protection Products Regulations 2011; The Chemicals (Hazard Information and Packaging for Supply) Regulations 2009; The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005; The Biocidal Products (Amendment) Regulations 2005; The Biocidal Products (Amendment) Regulations 2003; The Biocidal Products (Amendment) Regulations 2007 (revoked); The Biocidal Products (Amendment) Regulations 2010 (revoked)
Repealed by 2: The Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013; The Biocidal Products (Fees and Charges) Regulations 2013 (revoked)
Applied by 1: The Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 (revoked)

Defined terms · 66

Show every defined term

active substance
means a substance or micro-organism having a general or specific action on or against harmful organisms;
appeal
means an appeal under regulation 36;
appellant
means a person who has brought an appeal;
applicant
means an applicant for—
appointed person
means a person appointed in accordance with paragraph 2;
appropriate person
has the same meaning as it has in regulation 36;
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;
approved supply list
has the same meaning as it has in the 1994 Regulations;
authorisation holder
means the person to whom— as the case may be;
authorised biocidal product
has the same meaning as it has in regulation 30.
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;
certificate of exemption
means a certificate of exemption referred to in Schedule 13.
classified
means classified in accordance with regulation 5 of the 1994 Regulations and “classification” shall be construed accordingly;
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;
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);
dossier
includes a summary of a dossier;
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;
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;
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;
hearing
means a hearing to which Part II of this Schedule applies;
holder
has the same meaning as it has in regulation 19;
inspector
means an inspector appointed under section 19 of the 1974 Act;
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;
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.
issued frame-formulation
means a frame-formulation issued by the Ministers in accordance with paragraph (1).
justice
means— (a) in relation to England and Wales, a justice of the peace;
letter of access
means a document— (a) permitting the use by the Ministers of information, which is— (a) subject to the provisions of regulation 23 or 24, and (ii) specified in that document;
local authority
means— (a) 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;
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;
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;
new applicant
means a person who intends to apply for an authorisation or registration of a biocidal product under these Regulations.
placing on the market
means— (a) any supply, whether in return for payment or not, within Great Britain, including importation into Great Britain;
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;
properly used
means used both—
quarter
means the periods in each year— and “end of each quarter” shall be construed accordingly.
relevant information
means information submitted to the Ministers under these Regulations.
relevant product
means—
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. • “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;
submitted in the specified circumstances
means—
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;
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.
the 1974 Act
means the Health and Safety at Work etc.
the 1985 Act
means the Food and Environment Protection Act 1985;
the 1986 Regulations
means the Control of Pesticides Regulations 1986;
the 1994 Regulations
means the Chemicals (Hazard Information and Packaging for Supply) Regulations 1994;
the 1995 Regulations
means the Plant Protection Products Regulations 1995;
the 1998 Regulations
means the Health and Safety (Enforcing Authority) Regulations 1998;
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.”
the appropriate person
means—
the Commission
means the Commission of the European Communities;
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;
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;
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.
the parties
means the appellant and the Ministers;
the Standing Committee
means the Standing Committee on Biocidal Products referred to in Article 28(1).
unauthorised biocidal product
means a biocidal product which—
unlisted active substance
means an existing active substance which is not included in Annex I, IA or IB.
variation
means one or more of the following, that is to say—

uk/uksi/2001/880