Biocides
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)
- Study design and study monitoring to fill identified data gaps
- Liaison with Member State and evaluating competent authorities
- Preparation and submission of biocidal product dossiers, including Product Assessment Report (PAR) and IUCLID 6 dossiers, including Biocidal Product Family (BPF) applications and Union Authorisations (UA)
- Risk assessments (human health, environmental, EUSES, CONSEXPO)
- Preparation of efficacy summaries and testing strategies
- Submission of applications using the R4BP 3 platform
- Determination of technical equivalence
- Preparation of supporting documentation (SDS, product labels, SPC – summary of product characteristics)
- Reclassification of products to CLP
- Notification of biocidal products on the Irish market and national application under transitional measures throughout EU
- Assistance with data access negotiations and inclusion on the Article 95 list
- Consortia management
- Approval of in-situ generated active substances
- Advice on the marketing of treated articles
Upcoming Deadlines
Biocidal Authorisations
According to the Biocidal Products Regulation (BPR), prior to marketing your biocidal products in the EU, notification, registration and/or authorisation are required. The authorisation holder must be a legal entity based in one of the EU Member States. For UK based authorisation holders, after Brexit, in order to maintain the validity of your biocidal product authorisations, they must be transferred as a matter of priority to a legal entity established in the remaining EU 27 Member States, EEA countries or Switzerland by using the relevant case types in R4BP 3 (NA-TRS, SA-TRS or UA-TRS).
Please note that the transfers must be notified and implemented before the UK withdrawal. Similarly, all applicants should transfer, by using the transfer functionality embedded in the cases, all their ongoing R4BP 3 cases for which the prospective authorisation holder is a UK-based company.
At Kerona Scientific we have all the necessary skills, resources and experience to meet your Only Representative and Authorisation Transfer requirements.
Please send an email to info@kerona.ie or contact our team on +353 1 849 5284 if you would like to discuss this further.
