R4BP 3 now available

Now that the BPR is in operation (as of 1 September 2013), R4BP 3, the central hub through which biocides applications will be made, is now officially open.



ECHA releases biocides submission manuals

Accompanying R4BP 3, ECHA’s series of biocides submission manuals, providess users with technical assistance on building IUCLID dossiers for biocides applications, and submitting and managing applications in R4BP 3. The series currently comprises the following parts:

1: using IUCLID for biocide applications

2: using R4BP 3 for biocide applications

3a: active substances, initial submissions

3b: active substances, technical equivalence

4a: biocidal products, initial submissions

4b: biocidal products, national authorisation changes on request

5: invoicing in R4BP 3

6: confidentiality requests for biocide applications

European Chemicals Agency. Biocides submission manuals. Dated June to August 2013.



Emission scenario documents now hosted by ECHA

Finalised emission scenario documents for biocidal products are now hosted on ECHA’s website. These are used to estimate the initial environmental releases of substances from biocidal products or treated materials.

European Chemicals Agency. Emission scenario documents.



ECHA guidance on technical equivalence for biocides

ECHA’s new guidance provides assistance on applying for an assessment of technical equivalence for a biocidal active substance. Under the BPR, such assessments will be performed by ECHA, rather than the Member State competent authority (as previously).

European Chemicals Agency. Guidance on applications for technical equivalence. ECHA-13-G-05-EN. Version 1.0. August 2013.




ECHA releases explanatory note on data sharing

ECHA’s explanatory note on data sharing highlights the chapters of its (2012) guidance on data sharing which are of particular relevance to BPR applicants.

European Chemicals Agency. Explanatory note, related to Biocidal Products Regulation (EU) No. 528/2012. How to read the guidance on data sharing. Released August 2013.



The above items were taken from the October 2013 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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