EU Regulatory Framework

Economic operators are facing a number of practical and legal questions as EU and national authorities work to facilitate the supply of biocidal products.

By Cesare Milani and Federica Rizzo

The COVID-19 crisis has increased demand for disinfectants, hand cleaners, and other biocidal products, resulting in general shortages across most EU Member States. Many companies are currently working to increase the supply of such products and are considering shifting production.

EU companies and non-EU economic operators (through their EU importers) and regulatory authorities are striving to make fast-track procedures fully available via derogation to the lengthy pre-market authorisation procedures established under the EU Biocidal Products Regulation (BPR) and other relevant regulations. In this respect, many questions have arisen surrounding: (i) which legislation applies; (ii) what is the competent regulatory body; and (iii) how to deal in practice with the legal and technical requirements in a timely and cost-effective manner.