Biocidal products

We have extensive experience with applications under the Biocidal Products Regulation (BPR, 528/2012/EC) as well as transitional law, and can assist you with:

Biocidal product authorisation

Biocidal products must be authorised before being placed on the EU 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) , using the SPC Editor
  • Submission of data sharing inquiry to ECHA
  • Assessment of technical equivalence
  • Assessment of chemical similarity
  • Product efficacy assessment
  • (Eco-) toxicological assessments
  • Classification, labelling and packaging in accordance to CLP

Active substance approval

Active substances must be approved by the European Commission before an authorisation for a biocidal product containing them can be granted.  We can support you in the application process, and offer assistance with:

IUCLID and R4BP 3 support

The R4BP 3 (Register for Biocidal Products version 3) is ECHA’s central hub through which all biocides applications and notifications are made. IUCLID is the software in which the required application dossiers must be prepared. 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@thechemicalcompliancecoach.com

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