The Biocidal Products Directive (BPD) came into force in March 1998 with the aim of removing barriers to trade in biocides by harmonising controls for the marketing and use of biocidal products across Europe, whilst maintaining a high level of protection for humans and the environment. The BPD is implemented in the United Kingdom through the Biocidal Products Regulations 2001 (BPR), which include the requirements for data sharing as given in the Directive. The Biocides and Pesticides Unit (BPU) of the Health and Safety Executive acts as the Competent Authority for the regulations in the United Kingdom.
For a product to be authorised under BPR, an extensive list of data requirements needs to be met, either by submission of studies or scientific justifications for the non-submission of specific data. BPR encourages co-operation in the use of data to ensure that unnecessary duplicate experiments are not carried out. In order to achieve data sharing, the BPR actually puts a duty on the data holder and subsequent applicants for product authorisation to take all reasonable steps to share data. The primary reason for this is to minimise animal testing, however, there are many other advantages to sharing data, such as reducing costs for the companies involved, both in relation to the generation of the data themselves, and for the assessment of the data when they are submitted to the BPU. A reduced number of studies being submitted for assessment will also help to reduce the amount of work that needs to be carried out by BPU, and help to improve the efficiency of the assessment programme.
This guidance document provides suggestions for applicants on some steps they can take to achieve data sharing when submitting information to the BPU in support of active substances or biocidal products:
Active substances
- Before deciding whether they need to carry out testing on vertebrate animals for the purpose of supporting an active substance under the BPD review programme, applicants should check whether or not the active substance they intend to apply for has already been notified for review or is undergoing review. They can do this by checking the European Chemicals Bureau website (http://ecb.jrc.it/biocides/) which lists all those substances for which a notification for review has been made and gives details of the companies involved.
- If it is found that the active substance of interest has already been notified, the prospective applicant should contact the notifier and try to reach an agreement on data sharing. The intention is that if the substance is sufficiently similar to one for which supporting data already exist, then further animal testing could be minimised by sharing the data. When negotiating an agreement, all parties involved in the discussions should keep in mind the other major advantages to data sharing as mentioned above, such as shared costs and improved efficiency of the review process.
- If the applicant finds that the substance is not already being supported under the review programme, they should check with the BPU as to whether the substance has been assessed previously under national rules (The Control of Pesticides Regulations 1986). If it has, the BPU will provide details of the companies involved and the applicant should contact those companies and try to reach an agreement on data sharing. The applicant should carry out an evaluation into the adequacy of existing data and make a decision on the need to conduct tests, taking into account, among other things, the requirement to minimise testing on animals.
- Before starting a testing programme and submitting an application, prospective applicants should try to find other parties who may also be interested in supporting the same active substance. Applicants should consider forming a task force in which members can work together and agree what data can be shared and where further data will need to be generated.
Biocidal products
- Before deciding on the need to carry out testing on vertebrate animals for the purpose of applying for authorisation or registration of a biocidal product under the BPR, applicants should contact the BPU and give details, as required, on the proposed product. The BPU will check whether similar products have already been authorised or registered, and will put the applicant in touch with the authorisation holder for those products.
- If it is found that a similar product has already been authorised, the prospective applicant should contact the authorisation holder and try to reach an agreement on data sharing. The intention is that if the new product is sufficiently similar to one for which supporting data already exist, then further animal testing could be minimised by sharing the data. When negotiating an agreement, all parties involved in the discussions should keep in mind the other major advantages to data sharing such as shared costs and improved efficiency. For example, if the BPU has already assessed the data, less resource is likely to be required to authorise the new product, which may then result in reduced costs being charged to industry.
General points
- The Regulations place an obligation on all parties to take all reasonable steps to reach an agreement on the sharing of data for the authorisation of biocidal products. Therefore applicants for product authorisation may be required to demonstrate to the BPU all the efforts they have made to find existing data and in trying to reach an agreement with other data owners.
- Situations in which data sharing may be possible, but an agreement between parties has not been possible, should be reported to the BPU who will investigate each dispute on a case-by-case basis, and may also refer certain disputes to the Home Office, the UK Government department that licenses animal tests.
This guidance is produced by the Biocides and Pesticides Unit to help industry comply with the requirements of the biocides regulatory system.
November 2006