Published: 23 October, 2018
All Biocidal Products must be authorised in the EU before they are placed on the market in accordance with the Biocidal Products Regulation No. 528/2012 (BPR). A condition for Product authorisation is that all active substances in the biocidal product must be approved at EU level before product authorisation applications can be sought. After Approval companies will have almost 2 years to prepare a dossier for biocidal product authorisation. However, preparation of the dossier can be costly especially for Small Medium Enterprises (SMEs). Therefore, companies must start budgeting as early as possible in the process, before the active substance is approved.
There are a number of product authorisation routes available; National Authorisation, Mutual Recognition, Union Authorisation and Simplified Authorisation. These routes of authorisation can apply to single biocidal products, same biocidal products and biocidal product families. Costs and fees associated with each one of these route are different and will depend on a number of factors. With the introduction of BPR biocidal product authorisation application evaluation fees are payable to the Member State evaluating Competent Authority (eCA) and ECHA for the overall management of biocidal product application.
The fee structure is harmonised across Member States, however, fees vary between Member States. Although the choice of an eCA can have a significant impact on the total fees payable, opting for an eCA with relatively low fees and costs is not always the best solution for companies. Each Member State has specific criteria for accepting the role as the eCA and some eCAs may not have the resources and right expertise to evaluate your product applications dossier.
Our experts can help you identify the best authorisation route for your product to minimise costs and support you in preparing to fulfil your obligations for product authorisation. To discuss your requirements with one of our experts, contact us on firstname.lastname@example.org or call +44 (0)1524 510278.