The evaluation of active substance/product-type combinations which were still in the review programme on 7 June 2018 has been further delayed due to the need to generate new data to allow for the evaluation of the new scientific criteria for determining endocrine disrupting properties which became applicable on that date. Furthermore, since then, other new data also had to be generated at the request of the Member States’ evaluating competent authorities due to the quality of the initial data submitted in certain applications being insufficient and to the evolution of technical guidance and data requirements. As a consequence, and given the end date for data protection periods currently specified in Article 95(5) of Regulation (EU) No 528/2012, the protection period for such newly generated data for active substance/product-type combinations for which a decision on the approval had not been adopted by 7 June 2018 in accordance with Article 89(1), third subparagraph, of that Regulation would be considerably shorter than for data generated earlier. Therefore, the protection period for such newly generated data should be extended. In order to ensure that the implementation of such an extension by all parties is administratively simple, the extension of protection should cover all data for the active substance/product-type combinations concerned.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
