Biocidal products
We have extensive experience with applications under the EU and GB Biocidal Products Regulations (BPR) as well as transitional law. We can assist you with:
Biocidal product authorisation
Biocidal products must be authorised before being placed on the EU or UK market. Depending on your needs, we can assist you with (parts of) the authorisation application process, including:
- Application for national authorisation, mutual recognition or Union authorisation
- Grouping of similar biocidal products into product families
- Compiling of biocidal product dossiers in IUCLID
- Application submission (via R4BP 3)
- Summary of the product characteristics (SPC)
- Submission of data sharing inquiry
- Assessment of technical equivalence
- Assessment of chemical similarity
- Product efficacy assessment
- (Eco-) toxicological assessments
- Classification, labelling and packaging in accordance with CLP
Active substance approval
Active substances must be approved before an authorisation for a biocidal product containing them can be granted. We can support you in the application process, and offer assistance with:
- Compiling of active substance dossiers in IUCLID
- Application submission (via R4BP 3)
- Submission of data sharing inquiry to ECHA
- Test strategy and monitoring
- Efficacy assessment
- Exposure estimation
- (Eco-) toxicological assessment
- Classification, labelling and packaging in accordance with CLP
IUCLID and R4BP 3 support
The R4BP 3 (Register for Biocidal Products version 3) is ECHA’s central hub through which all EU biocides applications and notifications are made. IUCLID is the software used for the praparation of all EU and UK application dossiers. The Chemical Compliance Coach can assist you with, among others:
- Dossier preparation and submission
- Article 95 inclusion application
- Notification of an experiment or test (ET-NOT)
- Notification of a product in a product family (NA-NPF)
- Notification of unexpected or adverse effects (NE-NOT)
- Application for a parallel trade permit (PP-APP)
Need assistance?
CONTACT US
info[at]thechemicalcompliancecoach.com
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