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How the European Commission dealt with concerns raised about the research and development information related to active substances in pesticides that it approves

The case concerns how the European Commission deals with research and development information related to active substances in pesticides that it approves. Under the applicable rules, sensitive commercial information concerning active substances is protected for a period of ten years. However, according to the complainant, some manufacturers essentially apply for new authorisations for existing approved active substances towards the end of this ten-year period, with a view to preventing the disclosure of this important research and development information for an additional ten years. This means smaller manufacturers are prevented from developing generic products, using this information. The complainant is concerned that the Commission has not addressed its concerns.

The Ombudsman opened an inquiry and asked the Commission to provide a more detailed reply to the complainant. The Commission sent a detailed reply to the complainant, addressing its concerns about the protected commercial information and outlining possible means of redress.