This news update discussing the Memorandum of Understanding is brought to you by ECHA.



The memorandum sets out the working arrangements aiming to ensure coherence and consistency in the Agencies’ scientific opinions through active information exchange.


Helsinki, 14 May 2014 – ECHA’s Executive Director, Geert Dancet and EMA’s Executive Director, Guido Rasi signed a memorandum of understanding (MoU) in their meeting in Helsinki today. The purpose of the agreement is to strengthen the scientific dialogue between ECHA and EMA by sharing expertise, know-how and scientific data between their scientific committees, working groups and panels on matters of common interest. The Agencies also agreed to consult each other regularly in meetings, missions of technical experts and ad hoc consultations on emerging situations.


The  Memorandum of Understanding mainly focuses on the exchange of information on:


    • REACH and CLP: the evaluation, classification, restriction and authorisation of chemicals and other risk management activities where they are relevant to EMA;


    • Predictive methods and new approach methodologies for toxicological assessment such as read-across,  chemical categories and high throughput screenings;


    • Biocides: understanding better the differences between the classification of biocides  and veterinary products and the establishment of maximum residue limits (MLRs) for pharmacologically active substances used in animal husbandry;


    • Environmental risk assessment for both human and veterinary medicinal products and ecotoxicology.




To learn more about the memorandum of understanding, please visit the ECHA link above. Please contact Nexreg for our Regulatory Services.