3. Information requirements

The BPR Evaluation Manual (EU or NL) describes the procedures following the information requirements as laid down in BPR 528/2012 Annex II and Annex III (title I chemical substances) for active substances and for products respectively . These information requirements apply for active substances submitted after 1 September 2013 (see CA-March14-Doc.4.1 Final Principles for substance approval.doc available on the CIRCABC Public Biocides Regulation Page (on CIRCABC Public Biocides Regulation Page (Circabc public > categories > European Commission > Health and Food Safety>Biocides – BPR 528/2012 – Public > Library > Documents finalised at CA meetings).

Biocidal products based on micro-organisms

The technical advice on the information requirements for micro-organisms in accordance with Annex II, Title 2 and Annex III, Title 2 of the BPR for micro-organisms for all aspects as physical chemical, efficacy, human toxicology, and environment are listed in the Guidance on the Biocidal Products Regulation Volume V, Guidance on Active Micro-organisms and Biocidal Products for which 2.1 (March 2017) is the current version. The guidance is published on ECHA’s website under the BPR regulation. No additional information requirements for product authorisation are obligated by the Ctgb. Because the assessment contains at least the core data set (CDS), a valid Letter of Access to the relevant dossier is sufficient to fulfil the information requirements unless additional information requirements are listed in the BPR opinion and/or product specific parameters are required.

Low risk active substances

Active substances for Annex I of the BPR are identified as presenting a low risk/low concern. At the ECHA website an amendment is provided for the data requirements for these substances for all aspects. Information on the former information requirements is laid down in Biocides Directive 98/8 for active substances and products.

Note further that at the ECHA website transitional (REACH) guidance on Data Sharing is available for use until they are incorporated into the BPR guidance structure.

The TL Evaluation Manual describes the information requirements for products. In general for all aspects comparable information requirements as already available in the EU-part, and in the NL part of the BPR Evaluation Manual are used. A separate application form is available on the Ctgb website explaining the minimum data that should be submitted.

For some aspects data filing requirements will not be assigned to applicants. Applicants retain the right to voluntary submit a data dossier, because new information requirements for applications will have a transitional period. For the different aspects, specific situations are described in the relevant chapters.