Data protection
The data protection provisions in the Biocidal Products Directive (BPD) and the new EU Regulation (528/2012) allow applicants to recover some of the costs of generating the data. Member States may only use data for the benefit of an applicant if the applicant has access to the data (and provides a letter of access) or the data protection has expired for the data.
Data protection duration varies according to whether the data is in support of active substances or biocidal products, whether the active substances are considered to be 'existing' or ‘new’ and the reason for submission/stage in the approval/authorisation process at which submission occurs. An explicit timescale for each of the available options is given below:
Existing active substances
- 10 years from the first day of the month following the date of inclusion in a Union list of approved active substances, for data submitted for the first time in support of the approval of an existing active substance.
- 5 years from the first day of the month following the date of inclusion in a Union list of approved active substances, for data submitted for the first time in support of the renewal or review of the approval of an active substance.
New active substances
- 15 years from the first day of the month following the date of first inclusion in a Union list of approved active substances, for data submitted for the first time in support of the approval of a new active substance.
- 5 years from the first day of the month following the date of inclusion in a Union list of approved active substances, for data submitted for the first time in support of the renewal or review of the approval of an active substance.
Biocidal products containing existing actives
- 10 years from the first day of the month following the first decision concerning the authorisation of the biocidal product, for data submitted for the first time in support of the authorisation of a biocidal product containing only existing active substances.
- 5 years from the first day of the month following the decision concerning the renewal or amendment of the authorisation of the biocidal product, for data submitted for the first time in support of the renewal or amendment of the authorisation.
Biocidal products containing new actives
- 15 years from the first day of the month following the first decision concerning the authorisation of the biocidal product, for data submitted for the first time in support of the authorisation of a biocidal product containing a new active substance;
- 5 years from the first day of the month following the decision concerning the renewal or amendment of the authorisation of the biocidal product, for data submitted for the first time in support of the renewal or amendment of the authorisation.
