Does the legislation apply to you?

Biocidal products (as defined in BPD/BPR) are:

'Active substances and preparations containing one or more active substances, put up in the form in which they are 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.'

The bold words and phrases are further defined below:

'Active substance' - 'a substance or micro-organism having a general or specific action on or against harmful organisms'

'Harmful organism' - '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'

'Chemical means' - ' A substance controlling harmful organisms is regarded as an active substance acting by chemical means when the control is linked to the interference of that substance in biological/physiological processes through direct chemical interaction (inside or outside the target organisms) or indirect modifications because of the physical/chemical properties of the substance (chemical means)'

'Biological means' -  'A substance controlling harmful organisms is considered as an active substance acting by biological means when the control action directly involves living micro-organisms (biological means)'

These are very broad definitions and the scope of BPD/BPR is further defined by a list of product types and a number of exclusions.

The BPD excludes:

The non-biocidal uses of products and active substances - the active substance may be used in other products not for biocidal purposes. For example:

• the use of citronella as a fragrance rather than as an insect repellent.

Products that destroy, deter, render harmless, etc by a 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;
• human medicines;
• veterinary medicines;
• medical devices;
• cosmetics.

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

When considering if your product falls under scope of BPD/BPR, ask yourself:

• 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 by falling under one of the other pieces of European legislation? For example:
  • Is it a plant protection product? Contact PSD
  • Is it a human medicinal product? Contact MHRA
  • Is it a veterinary medicine? Contact VMD
  • Is it a cosmetic? Contact BERR
  • 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.

For most products, the question of scope is relatively straightforward. However, sometimes scope can be unclear and in these cases, issues are discussed at EU level. When the EU Commission finalises decisions on scope issues they are included in the ‘Manual of Decisions'. This 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 relevant to the BPD.

If after considering scope, you think your product may come under the exempting legislation then you need to check with the relevant UK regulatory authority who deals with that piece of legislation for confirmation. We have made available some contact details for some of the Government Departments.

If they consider your product is out of the scope of their legislation then contact HSE who can then consider if the product is within the scope of BPD/BPR.

(These have been discussed at EU level or are taken from the borderline guidance documents.)

(These have been discussed at EU level or are taken from the borderline guidance documents.)

If you consider your product is a biocidal product then you also need to consider if your product falls within the scope of the Control of Pesticides Regulations (COPR) as some of the products covered under BPD/BPR also fall within the scope of COPR that HSE administers.

• A list of product types covered under COPR which HSE regulates
• Definition of a pesticide under COPR (as amended 1997)
  1. any pesticide; or
  2. any substance, preparation or organism prepared or used for any of the following purposes:
     1. protecting plants or wood or other plant products from harmful organisms;
     2. regulating the growth of plants;
     3. giving protection against harmful creatures;
     4. rendering such creatures harmless;
     5. controlling organisms with harmful or unwanted effects on water systems (including sewage treatment works), buildings or other structures, or on manufactured products;
     6. protecting animals against ectoparasites.

In COPR (as amended 1997) there is a list of exemptions where COPR does not apply. Some examples include:

• substances, preparations or organisms whose use or sale within the UK is controlled under any of the following legislation:
  • the Medicines Act 1968;
  • Part IV of the Agriculture Act 1970;
  • the Food Safety Act 1990;
  • the Cosmetic Products (Safety) Regulations 1984;
  • the Water Supply (Water Quality) Regulations 1989;
  • the Water Supply (Water Quality) (Scotland) Regulations 1990;
• substances, preparations or organisms that are used or sold for the purpose over which control under that legislation is exercised;
• substances, preparations or organisms prepared or used for the purpose of disinfecting, bleaching or sterilising any substance (including water), other than soils, compost or other growing medium;
• substances, preparations or organisms designed and used for destroying or controlling pests by purely physical means;
• pesticides –
  • used in adhesive pastes, decorative paper or textiles;
  • intended solely for exportation from the United Kingdom;
  • used in preparations for insect repellent that people can apply to their skin;
  • used in paint for the sole purpose of preserving the paint;
  • used in water-based cooling or heating systems, humidifying systems or swimming pools.

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

What to do next:

• If your product is within the scope of BPD but not within the scope of COPR.
• If your product is within the scope of both BPD and COPR.
• If your product is not within the scope of either BPD or COPR, you should establish whether it is under the scope of any other legislation.