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Research involving biocidal products and active substances

Research is required to:

• understand how biocidal products are used, e.g. where they are used, how many people use them, what happens to them after use;
• understand how chemicals interact with humans and the environment, e.g. how long it takes a liquid to be absorbed by the skin, how long an aerosol spray remains in the air;
• develop exposure scenarios for risk assessment, i.e. to understand how much of a product humans and the environment are going to come into contact with. The risk assessment then considers whether this amount of contact has the potential to do harm.

Guidance for applicants on the regulation of research under BPR

This guidance:

• has no legal standing;
• does not advise industry of any additional responsibilities under other legislation (e.g. COSHH).

Regulations 16 and 17 of the Biocidal Products Regulations 2001 (BPR) apply to biocidal products which are supplied or placed on the market in the UK for the purpose of process orientated research and development or experimental testing and are:

• based on a new active substance (i.e. one that was not on the market as a biocide before 14 May 2000); or
• based on an active substance that has been included on Annex I of the Biocidal Products Directive; or
• based on an active substance where an Annex I non-inclusion decision has come into effect

Placing a biocide on the market means a transfer of ownership to another legal entity, whether in return for payment or not.

For example:

• a company manufactures a biocide and supplies it free of charge to a UK contract research laboratory for testing/research and development
• a company imports a biocide into the UK for testing/research and development

BPR does not apply to research into active substances and biocidal products, where there is no act of supply (e.g. if you manufacture your own active ingredient and test it yourself on your own site).

Our flow diagram helps explain the requirements of UK biocides legislation in relation to experimental testing and research into the safety and efficacy of biocidal products or active substances.  

Research not involving or resulting in biocidal release into the environment

In some cases a biocidal product/active substance may be placed on the market for use in an experiment or test for the purposes of research and development where there is no release to the environment (Regulation 16 of BPR). Where such a product/active substance is placed on the market for this use in UK the company must have the following information package:

• A dossier of information containing all available information on the possible effects of the product/active substance on human and animal health and on the environment.
• An up to date written record of information relating to that product/active substance
  • its identity
  • any data on which the information on its label should be based
  • the quantity placed on the market
  • the name and address of the persons receiving it

Where the product/active substance is placed on the market for scientific research and development* this information package must be made available to HSE on request.

Where the product/active substance is intended for process-orientated research and development** this information package must be provided to HSE along with a completed Biocidal Products Research application form for assessment before it may be placed on the market.

In both cases if HSE consider that the experiment or test is liable to have harmful effects on humans or animals or an unacceptable adverse influence on the environment then it may prohibit the experiment or test or impose conditions considered necessary to prevent those effects.

*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/active substance development

**means the further development of a substance or product in the course of which pilot plant or production trials are used to test the fields of application of that substance or product

Research involving or resulting in biocidal release into the environment

Where a biocidal product/active substance is intended for use in any experiment or test in UK which may involve or result in the release of that product/active substance into the environment, then an experimental authorisation is required. The applicant must submit a completed Biocidal Products Research application form together with the following information to HSE:

• A dossier of information containing all available information on the possible effects of the product on human and animal health and on the environment.
• An up to date written record of information relating to that product
  • its identity
  • any data on which the information on its label should be based
  • the quantity placed on the market
  • the name and address of the persons receiving it

If the application is successful the authorisation will detail conditions limiting the quantity of the biocidal product that can be used and the area that can be treated, as well as any other conditions considered necessary.

Authorisation is typically granted for a period of 12-18 months, with discretion to allow it for shorter or longer periods as appropriate.

Biocides and research commissioned by HSE

Some examples of the areas of research that HSE has been involved in include;

• carrying out boat surveys in order to determine the exposure of coastal waters to antifouling paints that are used to limit the growth of algae/seaweed etc on boat hulls;
• investigations to develop and apply new instrumental techniques for the assessment of risks from toxic and harmful substances in the workplace;
• looking at the effects of environmental variables on biocide leaching rates (ie how quickly biocides move down through soil) in order to establish how measurements obtained by laboratory tests should be interpreted when used in environmental risk assessment.

It is worth considering HSE’s previously commissioned research before embarking upon any independent research.

Search the website to find research commissioned by HSE to assist in their role as the UK CA under the Biocidal Products Regulations 2001 (BPR).

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