The ‘What to do next’ section of this page will direct you to helpful information if your product falls within the scope of one or both pieces of legislation above.
Please note that the EU BPR only applies from 1st September 2013, if you have a question on the Biocidal Products Directive (98/8/EC)/UK Biocidal Products Regulations 2001 that applied until the 31st August 2013, please contact us.
What is a biocidal product?
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 EU BPR as:
“ - any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action,
- any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action
A treated article that has a primary biocidal function shall be considered a biocidal product.”
This definition is broader than the old BPD and specifically includes in-situ generation of biocides (such as ozone generated from the air) and articles that are primarily biocidal, (such as disinfecting wipes).
The EU BPR also introduces specific controls on articles that have been treated with biocides but which are not themselves biocidal products (such as wood that has been treated with a wood preservative to protect the wood itself from decay) and more details are available on the Treated Articles webpage.
What types of product are covered under the EU BPR?
The scope of the EU BPR is very wide, with four main groups containing 22 different product types. The four main groups are:
- disinfectants, for home and industrial use
- preservatives, for manufactured and natural products
- pest control products
- other specialist biocidal products, e.g. antifouling products
A full list of product types can be found in Annex V of the Biocidal Products Regulation and our Product Type page.
What products are excluded from EU BPR?
The EU BPR 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 only by physical means (i.e. their mode of action does not involve chemical or biological activity). For example:
- fly swats
- UV fly killers
- sticky boards for rodents
- Uses of Products that are regulated under certain other European legislation, for example:
- plant protection products (e.g. algaecides applied on soil or water to protect plants; products to protect trees or plants from damage by wildlife)
- human medicines (e.g. anti-lice shampoo)
- veterinary medicines
- medical devices
- cosmetics (e.g. anti-dandruff shampoo)
A full list of the exempting legislation / Directives can be found in Article 2 of EU Biocides Regulation .
However, where a product has dual use, for example as a biocidal product to kill insects in the home and as a plant protection product to kill insects on garden plants, then the requirements of both sets of legislation will apply. The European Commission is drawing-up guidance on specific issues relating to the borderlines for products and we will include links on this page as they become available.
The Fifth Review Regulation provides a derogation for food and feedstuffs used as repellents or attractants, which may be applicable in some circumstances.
Questions to ask when considering scope
When considering if your product falls under the scope of the EU 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?
- only acts by physical/mechanical means?
- Does it fall within one of the 22 different product types?
- Is it exempted from EU BPR by falling under one of the other pieces of European legislation? For example:
- Is it only used as a plant protection product? CRD (Pesticides)
- Is it only used as a human medicinal product? Contact MHRA
- Is it only used as a veterinary medicine? Contact VMD
- Is it only used as a cosmetic? Contact BIS
- Is it being made available on the EU market? This is defined in the EU Biocides Regulation as “any supply of a biocidal product or of a treated article for distribution or use in the course of a commercial activity, whether in return for payment or free of charge”.
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 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 for example the borderlines between biocides and the exempting legislation.
Both the borderline documents and the Manual of Decisions were originally drawn up for the BPD, and whilst many of the decisions will remain valid for the EU BPR, if you have found an entry in these document that you believe is relevant to your product, you should check that entry is still valid by contacting us.
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 the EU BPR.
Is my product within the scope of the UK Control of Pesticides Regulations?
Some of the products covered under the EU 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 fully regulated under the EU BPR.
If yours is a biocidal product – therefore falling within the scope of the EU 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 are only for application to human 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.
What to do next?
Click on any of the following links, as applicable, for further guidance on what you must do to comply with the law: