A new report from the European Commission’s Health and Food Safety Directorate-General has identified the many challenges faced by Member States in processing applications for biocidal products.
Under the BPR (Biocidal Products Regulation, (EU) No 528/2012), a reference Member State evaluates biocidal products on behalf of itself and other concerned Member States to which the applicant has applied for authorisation. The new report summarises a series of fact-finding missions in 2017-18 in five Member States: Belgium, Germany, Hungary, the Netherlands and Spain.
Among the difficulties identified were poor quality dossiers submitted by applicants, resulting in multiple requests for additional data, as well as complex applications for biocidal product families that represent an unmanageable workload. The high burden on Member State staff resources is added to by other challenges such as a lack of synchronised procedures (for example, harmonised classification) and the fact that previously finalised evaluations of active substances have to be revisited for evaluation of possible endocrine-disrupting properties.
The report identifies a number of potential good practices that can be introduced to minimise delays, including the use of planning and forecasting tools, and improving dossier quality via awareness-raising activities and additional pre-submission meetings with applicants.
At Kerona Scientific, we can help you prepare your application for a biocidal product authorisation, from study commissioning to dossier submission. Contact the team at firstname.lastname@example.org or call us on +353 1 849 5284.