The law

If you want to place a product which may be biocidal on the UK market, you must first determine whether it falls within the scope of the above legislation. To do this, you need to understand the definition of a ‘biocidal product’; which is defined in the Directive / Regulations as:

‘…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’.

See the biocides glossary for definitions of the terms in bold above.

If you are unsure whether this applies to your product, see the following sections for details of product types both within scope of, and excluded from, the Directive / Regulations.

The scope of the Directive is very wide, with four main groups containing 23 different product types. The four main groups are:

• disinfectants, for home and industrial use
• preservatives, for manufactured and natural products
• pest control products
• other biocidal products, eg vertebrate control and other specialised products

A full list of product types can be found in Annex V of the Biocidal Products Directive and Schedule 1 of the Biocidal Products Regulations.

BPD/R excludes:

• The non-biocidal uses of products and active substances. This is where the active substance is used in other products but not for biocidal purposes, for example:
  • the use of an essential oil as a fragrance rather than as an insect repellent
• Products that destroy, deter, render harmless, etc by physical means (ie their mode of action does not involve chemical or biological activity). For example:
  • fly swats
  • UV fly killers
  • sticky boards for rodents
• Products regulated under certain other European legislation, for example:
  • plant protection products (eg algaecides applied on soil or water to protect plants; products to protect trees or plants from damage by wildlife)
  • human medicines (eg anti-lice shampoo)
  • veterinary medicines
  • medical devices
  • cosmetics (eg anti-dandruff shampoo)

A full list of the exempting legislation / Directives can be found in Article 1 of BPD and in Schedule 2 of BPR.

The Directive's Fifth Review Regulation provides a derogation for food and feedstuffs used as repellents or attractants, which may be applicable in some circumstances.

When considering if your product falls under the scope of BPD / BPR, you should consider:

• Does it fall within the definition of a biocidal product, in that it:
  • makes biocidal claims / has an intended biocidal action?
  • acts by chemical or biological means?
• Does it fall within one of the 23 different product types?
• Is it exempted from BPD/R by falling under one of the other pieces of European legislation? For example:
  • Is it a plant protection product? CRD (Pesticides)
  • Is it a human medicinal product? Contact MHRA
  • Is it a veterinary medicine? Contact VMD
  • Is it a cosmetic? Contact BIS
  • Is it raw milk, heated milk and milk product? Contact FSA and DEFRA
• Is it being placed on the EU market? ‘Placing on the market’ is defined in Article 2(1) (h) of BPD and Regulation 2 (1) of BPR.

For most products, the question of scope is relatively straightforward. However, when the scope is unclear, these issues are discussed at EU level. When the EU Commission finalises decisions on scope issues, these are included in the BPD Manual of Decisions. The Manual should be regarded as a living document; ­it is not exhaustive and further decisions will be added in the course of time as they are agreed between the Commission and the member states.

There are also borderline documents available on specific scope issues that are relevant to BPD for example the borderlines between biocides and the exempting legislation.

If, after considering scope, you think your product may come under the exempting legislation, you need to check with the relevant UK authority which regulates that legislation for confirmation. If the authority considers your product to be outside the scope of the legislation they regulate, then contact HSE. HSE will then consider if the product is within the scope of BPD / BPR.

Flow chart of questions to ask when considering whether a product is within the scope of BPD / BPR

Some of the products covered under the Biocidal Products Directive (BPD) / Biocidal Products Regulations (BPR) also fall within the scope of the Control of Pesticides Regulations (COPR). COPR covers various pest control products which contain active substances that are not yet regulated under BPR.

If yours is a biocidal product – therefore falling within the scope of BPD / BPR – you will also need to consider if your product falls within the scope of COPR.

HSE is the regulatory authority for COPR, covering pesticides as defined as:

• any pesticide; or
• any substance, preparation or organism prepared or used for any of the following purposes:
  • protecting plants or wood or other plant products from harmful  organisms;
  • regulating the growth of plants;
  • giving protection against harmful creatures;
  • rendering such creatures harmless;
  • controlling organisms with harmful or unwanted effects on water systems (including sewage treatment works), buildings or other structures, or on manufactured products;
  • protecting animals against ectoparasites.

There is a list of exemptions where COPR does not apply. The main exemptions are

• disinfectant products,
• products that act purely by physical means,
• products for export outside the United Kingdom and
• insect repellents that people can apply to their skin.

However you should read the exemption in the Regulation to see if you product is exempted from the requirements of COPR.

If your product is within the scope of COPR, you will need to apply to HSE for an approval before your product can be advertised, sold, supplied, stored or used in the UK.

Click on any of the following links, as applicable, for further guidance on what you must do to comply with the law:

• If your product is within the scope of BPR but not within the scope of COPR.
• If your product is within the scope of both BPR and COPR.
• If your product is not within the scope of either BPR or COPR, you do not need to comply with their requirements.