Guidance on the restrictions relating to research under BPR
Research is required to:
- understand how biocidal products are used, eg where they are used, how many people use them, what happens to them after use;
- understand how chemicals interact with humans and the environment, eg 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, ie 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.
More information on research
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.
Guidance on the restrictions relating to research under BPR
This guidance:
- has no legal standing;
- does not advise industry of any additional responsibilities under other legislation.
Introduction to the scope of BPR with respect to research
BPR applies to:
- a biocidal product placed on the UK market specifically for the purposes of research and development, by means of an experiment or test where that product contains:
- a new active substance (ie one that was not on the market as a biocide before 14 May 2000);
- an existing active substance that has been included on Annex I etc of the Biocidal Products Directive; or
- an existing active substance where a decision not to include that substance onto Annex I etc, of the Biocidal Products Directive has come into effect;
- an active substance placed on the UK market specifically for the purposes of research and development, by means of an experiment or test, where that active substance;
- is a new active substance (ie one that was not on the market as a biocide before 14 May 2000); and
- it is intended exclusively for use in biocidal products.
BPR does not apply to:
- testing of new active substances and biocidal products, where there is no act of supply (ie if you manufacture your own active ingredient and test it yourself on your own site then there is no placing on the market and BPR does not apply).
As stated previously under BPR, if a substance is placed on the market for research and development purposes it will fall into one of the categories below.
Scientific research and development(R&D)
Means scientific experimentation, analysis or chemical research carried out under controlled conditions. It includes the determination of intrinsic properties, performance and efficacy as well as scientific investigation relating to product development. Full details of the specific requirements can be found under BPD research R&D
Process-oriented research and development (PORD)
under the Biocidal Products Regulations 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. Full details of the specific requirements can be found under BPD research PORD and the BPD PORD application form.
Experimental authorisations (EA)
Means that an authorisation is required as the experiment or test may result in the release into the environment of the active substance or product. Full details of the specific requirements can be found under BPD research EA
The flow diagram below is a guide to help determine the most appropriate approach before embarking on any research in relation to BPR. The areas of study for which BPR may apply are also listed below.
Are you placing an active substance/product on the market for the purpose of research and development?
Charges relating to research activities
The competent authority is required to charge a fee for the work done to assess the information provided by the applicant before deciding whether or not to grant an authorisation under this regulation. The charges can be found on the main BPD fees page.