Electronic submissions introduced for regulated product applications
Applications for regulated products such as feed additives, food enzymes and health claims should now be submitted to the European Food Safety Authority (EFSA) by electronic means. The initiative, which requires applicants to use electronic mediums such as CD ROMs or USB keys to submit technical dossiers, will cut bureaucracy and streamline the risk assessment process, said EFSA.
Under the new rule, applicants can also send updates to their applications and respond to requests for additional information from EFSA using electronic submissions. While it is still possible to also send paper copies of technical dossiers to EFSA, the electronic copy is now considered as the formal submission.
Technical dossiers must be submitted on a standard electronic medium such as a CD ROM, DVD or USB key. All applications submitted to EFSA, either by an applicant, Member State or the European Commission, should include the original of a signed cover letter listing annexes, their tables of content and the mandate.
Karine Lheureux, head of EFSA’s Applications Helpdesk, said: “The introduction of E-submissions is the first step in developing a complete IT tool for the electronic management of applications. This is part of EFSA’s ongoing customer-oriented approach to strengthen the support it provides to applicants. It will reduce the administrative burden for applicants and deliver efficiency gains by streamlining the risk assessment process.”
Regulated products require scientific risk assessment by EFSA before they can be authorised for use on the EU market. These include substances used in feed and food (such as additives, enzymes, flavourings, nutrient sources), food contact materials and pesticides as well as GMOs, food manufacturing processes and processing aids. EFSA's regulated products mandate also includes the scientific substantiation of nutrition and health claims.