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:

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:

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.

 
Updated 2021-08-04