On September 13, 2017, the European Commission ("EC") published a "Notice to business operators in the field of Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products." The notice provides guidance to companies operating in the biocides sector on the steps to be taken prior to Brexit. In particular, the EC notes that business operators should be mindful of ongoing and/or planned regulatory procedures involving the United Kingdom (e.g., active substance approval, renewal of an active substance approval, Union authorization, simplified authorization procedure, mutual recognition in parallel, renewal of product authorizations, etc.) when evaluating a Member State or reference Member State, including with regards to the expected timelines for such procedures in view of the United Kingdom's withdrawal from the EU on March 29, 2017, and the consequent cease of applicability of EU laws by March 30, 2019 (provided that the EU-UK withdrawal agreement does not establish another date or the period is extended by the European Council). In this respect, the EC advises that "where there are clear indications that the procedure will not be concluded by the withdrawal date, taking account of the uncertainties as well as the regulatory framework, business operators should consider taking the relevant actions. For example, business operators may consider changing to another evaluating Member State."
The EC further reminds companies operating in the biocides sector that holders of product authorizations and active substance or product suppliers included on the list referred to in Article 95 of the Biocidal Products Regulation (EU) No 528/2012 must be established in the European Union (or, for active substance and product suppliers, have an EU representative). In order to provide further clarifications and practical guidance, the EC has also drafted a document in the form of "Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to the Biocides sector," addressing the above-mentioned consequences. The EC intends to further update and complement the Q&A to reflect any changes or additional clarifications.
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