Data protection

The data protection provisions in the Biocidal Products Directive 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 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 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 date of entry into Annex I or IA for information submitted for the first time in support of the first inclusion in Annex I or IA of either the active substance or an additional product type for that active substance
• 5 years from the date of decision for further information submitted for the first time for variation of the requirements of the entry on Annex I or IA or maintenance of the entry (5-year period can be extended to expire at the same time as the 10-year period)
• In the case of data protected already protected under existing national legislation, the protection applies up to the end of the period under the national legislation or the end of the transitional period under the BPD (i.e. which ever is earlier).

New active substances

• 15 years from the date of first inclusion into Annex I or IA
• 5 years from the date of decision for further information submitted for the first time for variation of the requirements of the entry on Annex I or IA or maintenance of the entry (the 5-year period can be extended to expire at the same time as the 15-year period)

Biocidal products containing existing actives

• 10 years from the date of entry into Annex I or IA for information submitted for the first time in support of the first inclusion in Annex I or IA of either the active substance or an additional product type for that active substance
• 5 years from the date of first receipt of any data with further information submitted for the first time for variation of the conditions of authorisation of the biocidal product or maintenance of the entry of the active substance onto Annex I or IA (the 5-year period can be extended to expire at the same time as the 10 year period);
• In the case of data protected already protected under existing national legislation, the protection applies up to the end of the period under the national legislation or the end of the transitional period under the BPD (i.e. which ever is earlier).

Biocidal products containing new actives

• 10 years from the date of first authorisation in any Member State;
• 5 years from the date of first receipt of any data with further information submitted for the first time for variation of the conditions of authorisation of a biocidal product or maintenance of the entry of an active substance in Annex I or IA (the 5-year period can be extended to expire the same time as the 10-year period).

Frequently asked questions relating to data protection

If I withdraw from the review process, is my data still protected from other potential applicants who may wish take over support for the same active substance?

The withdrawal of an active substance from the BPD review does not render the relevant protection provisions under regulation 23 of BPD void, the information may still be protected.

If another company produces data on the same active substance as me, after my submission, will their data protection expire after mine?

If a second company produce a data set identical to one already submitted (foreseen if letter of access is unattainable), the second company will get data protection that will expire at the same date as the data submitted by the first applicant.

More detailed information is available in the European Commission document ‘General Note on Data Protection in the framework of Directive 98/8/EC’