Record keeping and reporting
The UK has left the EU, new rules from January 2021
The transition period after Brexit comes to an end this year.
This page provides information about the record keeping and reporting requirements under the EU Biocides Regulation 528/2012 (EU BPR), which apply from 1 September 2013
Article 65 of the EU Biocides Regulations (EU BPR) introduces the requirement for manufacturers of biocidal products placed on the Union market to keep appropriate documentation (paper or electronic format) in relation to the quality and safety of the biocidal product to be placed on the market. The documentation shall include as a minimum:
- safety data sheets and specifications of active substances and other ingredients used for manufacturing the biocidal product;
- records of the various manufacturing operations performed;
- results of internal quality controls;
- identification of production batches.
Manufacturers of biocidal products shall store production batch samples.
Manufacturers of biocidal products shall make available the relevant information contained in their records following a request from a competent authority.
Authorised biocidal products
Article 68 of EU BPR introduces the requirement for authorisation holders to keep a record of the biocidal products they have placed on the market.
The records must be kept for at least 10 years after placing on the market, or 10 years after the date on which the authorisation was cancelled or expired, whichever is the earlier.
The Commission will draw up guidance to specify the form and content of the information required to comply with the requirements in Article 68.
Authorisation holder shall make available the relevant information contained in their records following a request from a competent authority.