Strategic & Regulatory Support

The BPR (Regulation (EU) No 528/2012) offers a wide variety of different options when it comes to active substance or biocidal product authorisation:

  • active substance authorisation vs. provisional authorisation of active substances and biocidal products
  • membership in active substance task force vs. third party dossier
  • membership in task force or consortium vs. letter of access (LoA)
  • independent product dossier vs. membership in product consortium
  • single product authorisation vs. biocidal product family (BPF)
  • national authorisation vs. Union authorisation
  • same biocidal product authorisation (Commission Implementing Regulation (EU) 414/2013)
  • “normal” vs. simplified authorisation of biocidal products

While this offers the possibility to finding perfect-fit solutions for your company and product portfolio, the choice of options can also be overwhelming.

spectra’s employees have excellent knowledge of the European regulatory field of biocides and chemicals and good contacts with national and European regulatory bodies. Make use of our experience when planning authorisation strategies for your biocidal active substances or products.

We are ready to support you e.g. with

  • R&D strategies for active substances and biocidal products (e.g. opting for well-balanced efficacy and hazard profile, elimination of co-formulants with potential ED properties)
  • selection of appropriate task force or product consortium
  • finding the best authorisation strategy for new biocidal active substances and related products (e.g. selection of best suited eCA, simplified or provisional authorisation procedure)
  • data sharing and letter of access (LoA) negotiations (e.g. choice of relevant test data, independent technical review of studies in closed room, Article 62 requests, etc.)
  • defining authorisation strategies for your different biocidal products
  • optimising your biocidal product portfolio for BPR (Regulation (EU) No 528/2012) authorisation
  • ensuring access to market (e.g. national registration and notification according to transitional law)
  • identifying critical issues for biocidal products based on certain active substances at an early stage (e.g. due to revision of classification and labelling, critical reference values, formation of disinfection by-products or residues, new exposure models) so you can re-align your product portfolio early on