1. General Introduction Evaluation Manual Biocides
The general introduction of the present Evaluation Manual provides background information on the Biocidal Products Regulation (BPR) for products based on active substances already approved as well as active substance approval, and the Dutch transitional law for products based on active substances that are still under review. This general introduction chapter explains the differences between both legislations and makes clear under which legislations products must be notified. Specific details on legislation and information requirements are described in the BPR and transitional parts of this evaluation manual. The specific NL information requirements or NL aspect specific assessments is described in the NL-part of the current evaluation manual.
The BPR-part furthermore provides generic information about legislation, information requirements, and assessments. Furthermore, new elements (as e.g. Biocidal Product Families and Comparative Assessment) concerning the technical and scientific assessment described in the BPR not pertained to a specific aspect as physical chemical, efficacy, human toxicology, and environment are described in a separate paragraphs.
1. General introduction (this page)
5. New elements concerning the scientific assessment described in the regulation and relevant for two or all aspects
In the Technical Agreements for Biocides (TAB) general agreements of the Working Groups of the Biocidal Products Committee (WGs) are provided in concise format which have not yet been included in any other BPR related guidance documents. In this document a general database of questions where an agreement has been reached is presented. The general relevance is focused on methodological decisions with respect to risk assessment and questions on the implementation of the Biocides Regulation 528/2012. TAB-entries that concerns editorial changes of existing guidance or entries that provides clarification of existing guidance are applicable from the date of publication. However, the approach as agreed in the BPC document named Applicability time of new guidance and guidance-related documents in active substance approval or CA document CA-July12-Doc.6.2d (products) should be followed for TAB entries that require new data. The cut-off date is six months (active substance) or two years (products) before the date of submission of a first application, and three and a half years before the expiry of the current application in case of a renewal unless scientific progress shows that the reliance on old guidance gives rise to serious concern.
Besides the guidance on the BPR and the document TAB agreements there are also relevant CA documents that should be used for the scientific assessment for the different aspects. A list of finalised CA documents is available on the CIRCABC (part European Commission > Health and Food Safety>Biocides – BPR 528/2012 – Public > Library > Documents finalised at CA meetings). New (BPR) elements concerning the technical and scientific assessment not pertained to a specific aspect as physical chemical, efficacy, human toxicology and environment are described beneath (e.g. BPF, SoC etc). The relevant CA documents per aspect are presented for that specific aspect.
5.1. Biocidal product family (BPF)
5.2. Candidates for substitution / Comparative assessment
5.3. Substance of concern
5.4. In situ generation of biocides and active substances
5.8. Treated articles
5.10. Harmonised sentences SPC
5.11. Label claims
5.12. Endocrine disruptors