Authorisation of Biocidal Products

The approval of a biocidal active substance is a complex process. Activities towards registering an active substance and the biocidal product – or various types of products - will be managed and steered by the regulatory affairs team, which takes on responsibilities that are at the centre of any project: all procedures and actions are coordinated, from data analysis, to the final dossier and authority contacts, both for approvals at EU level, and for those at EU-internal and -external national level.

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Dr. Knoell Consult has been involved in the creation of 25 active substance dossiers for 15 product types under Directive 98/8/EC. Well over a hundred product dossiers have been submitted so far in connection with the authorization of biocidal products. The entry-into-force of the Biocidal Products Regulation (BPR) (EU) No 528/2012/EC  brings changes such as the concept of the product family, and the need for risk assessments for “Substances of Concern.”
Biocidal products also have to be approved in non-EU countries according to national requirements. Here, we establish which national guidelines apply for a particular active substance or product, and we support the registration process with the help of our local partners in each country.

For products that fall within the scope of both the BPR and other legislation such as that covering veterinary pharmaceuticals and cosmetic products, synergies can be realized, because Dr. Knoell Consult is capable to advise on such borderline cases.

Our services for the authorisation of biocidal products

  • Global project management
  • Data analysis, Check of Completeness
  • Identification of data gaps
  • Preliminary risk assessments
  • Designing and developing a global registration strategy
  • Study management and Quality Assurance
  • Dossier compilation for the European Union
  • IUCLID 6 data set (DOC III-A), DOC II-A, DOC I for the active substance according to Regulation (EU) 528/2012
  • IUCLID 6 data set (DOC III-B), DOC II-B, DOC II-C, DOC I for the Biocidal Product according to EU guidelines.
  • Creation of individual dossier parts or individual documents (such as risk assessments)
  • Dossier compilation for non-EU countries
  • Determination of the regulatory status according to national legislation
  • Identification of data requirements applying at national level
  • Regional support through cooperation with local partners around the world
  • Support for submissions
  • Close contacts with national und EU authorities
  • Pre- und post-submission support
Ángeles Rico Rico Managing Director
+34 91 112 60 80 +34 91 112 60 75 send mail

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