As a key European biocide consultancy, Kerona Scientific provides a range of regulatory services from dossier preparation to risk assessments for Annex I inclusion and national Member State applications for many product types.
The Biocidal Products Regulation, BPR, Regulation (EU) No 528/2012 aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment. Mandatory data sharing obligations apply, and alternative testing methods are encouraged. As in the previous Directive (Directive 98/8/EC), the approval of active substances takes place at EU level, and the subsequent authorisation of the biocidal products at the Member State level. An authorisation can be extended to other Member States by mutual recognition (MR), and the new Regulation also provides for biocidal product family (BPF) and Union Authorisation (UA) approvals. Applications are prepared in IUCLID 6 and submitted using the dedicated IT platform, the Register for Biocidal Products (R4BP 3).
Our full range of services for the biocide sector includes:
- Project management of biocide registrations projects
- Strategic regulatory advice
- Data gap analysis (completeness checks)
- Biocidal product testing advice
- Study design and study monitoring to fill identified data gaps
- Assistance with data sharing negotiations
- Liaison with regulatory authorities
- Preparation of IUCLID 6 dossiers
- Preparation of efficacy summaries and testing strategies
- Submission of applications using the R4BP 3 platform
- Determination of technical equivalence
- Risk assessments (human health, environmental, EUSES, CONSEXPO)
- Preparation of SDS and product labels
- Reclassification of products to CLP
- Submission of Biocidal Product Family (BPF) applications and Union Authorisations (UA)
- Notification of biocidal products on the Irish market and throughout EU
- Article 95 Assistance
- Biocidal Consortia management
- Approval of in-situ generated active substances
- Treated Articles Authorisation
There are a number of upcoming deadlines that may be applicable to your products under the BPR. We can help you meet your obligations under this Regulation to ensure you maintain your product positioning in the market place. Please follow this link for a list of upcoming active substance approval dates.
If you have any queries relating to biocides and our services, please send an email to email@example.com or contact the team on +353 1 849 5284.
The revised and updated second edition of our BPR Vademecum on the Biocidal Products Regulation (BPR) (EU) No 528/2012 is now available in both print and electronic forms. Our intention in publishing this Vademecum is to provide you with a handy reference guide on all aspects of the Regulation.
Since the 1st September 2015, a biocidal product can only be made available on the EU market for sale, supply and use where the active substance(s) contained in the product is supplied by a supplier that is included in the Article 95 list for the product type to which the product belongs.
Since the introduction of the EU Biocidal Product Regulation (EU) No 528/2012 (BPR), a number of consortia have been set up between manufacturers of active substances or biocidal product formulators to submit joint dossiers for biocidal product authorisations.
If biocidal active substances are generated from one or more precursors at the place of use, they are known as in situ generated active substances. The approval process for such substances involves the evaluation of the generated active substance and of the precursor(s) it is generated from, in the context of each product type.
According to article 3(1)(l) of the BPR, a treated article is any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products. As a general rule, articles can only be treated with biocidal products containing active substances approved in the EU.