Biocidal products regulation (BPR): data protection
The GB Biocidal Products Regulation (GB BPR) and EU Biocidal Products Regulation (EU BPR) specify protection periods for data submitted for the first time in support of active substance approvals and biocidal product authorisations. This is intended to protect the interests of companies that have submitted proprietary information. It also allows them to recover some of the cost of generating data from other companies who wish to use the data in support of their own applications.
Under these protections, the data may only be used by HSE or another relevant competent authority for the benefit of another applicant if one of the following conditions is met:
- that applicant provides a letter of access from the original data submitter
- the data protection has expired
The data protection periods begin when the data are submitted for the first time and vary in length depending on the circumstances of the data submission.
Once the data protection has expired, HSE or another relevant competent authority may grant permission for subsequent applicants to refer to the data. However, data which are no longer protected are still the property of the original data owner and HSE, or other competent authorities, will not give copies of such data to other applicants.
GB and EU BPR data protection periods
| Data submitted for | Active substance is | Data protection ends |
|---|---|---|
| Active substance approval | New | 15 years from the first day of the month following the date of approval or inclusion onto the GB Simplified Active Substance List or Annex I of EU BPR |
| Existing | 10 years from the first day of the month following the date of approval or inclusion onto the GB Simplified Active Substance List or Annex I of EU BPR | |
| Renewal of an active substance approval | New or existing | 5 years from the first day of the month following the date of renewal |
| Product authorisation | New | 15 years from the first day of the month following the date of authorisation |
| Existing | 10 years from the first day of the month following the date of authorisation | |
| Renewal of a product authorisation | New or existing | 5 years from the first day of the month following the date of renewal |
| Change of a product authorisation | New or existing | 5 years from the first day of the month following the date of authorisation of the change |
When data protection cannot be granted
Data protection cannot be granted for:
- data that are published/available in the public domain
- data that are already protected under the relevant regulation – for example, data that have already been submitted under EU BPR cannot be protected again under EU BPR
Consequences of the UK leaving the EU
For data that were already protected under EU BPR before 31 December 2020, the existing protection periods remain valid under GB BPR. Extensions to the existing expiry dates or new data protection periods will not be granted if that data is resubmitted to HSE under GB BPR.