EU Transparency Regulation now applicable

Be compliant with the new requirements of notification of studies according to the “Transparency Regulation” (Regulation (EU) 2019/1381) which became applicable on 27 March 2021.

The Transparency Regulation (notification under Article 32b and Article 32c(1)) introduces the new requirement to pre-notify to EFSA all studies planned to be carried out in support of EU applications of active substances (and representative plant protection products) in one submission for each application. This obligation applies to Business Operators i.e. the notifiers/applicants. In addition, Contract Research Organizations (e.g. laboratories) who are carrying out these studies and are based in the European Union have the duty to co-notify the studies to EFSA.

The aim of the new regulation is to increase transparency of the approval/renewal process of active substances, i.e. the EU risk assessment in the food chain, strengthen the reliability, objectivity and independence of the scientific studies used by EFSA for this purpose and to reinforce the governance of EFSA to ensure the Authority’s long-term sustainability.

knoell is EFSA registered, meaning we can act as Business Operator on your behalf to support you in this new task.  

Questions? Contact us. We develop solutions tailored to your needs.