EFSA has launched an open consultation on its draft scientific and technical guidance for the assessment of products notified as food for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013. The guidance is for assisting in the preparation and presentation of well-structured dossiers for food products notified as foods for special medical purposes (FSMPs). It presents a common format for the organisation of the information to be provided and outlines the information and scientific data which must be included in the dossier, as well as the key issues which should be addressed in the dossier in order to assess the extent to which a food product notified as FSMP falls under the scope of Regulation (EU) No 609/2013, under the proposed use.
In line with EFSA’s policy on openness and transparency and in order for EFSA to receive comments from the scientific community and stakeholders, EFSA has launched a public consultation on the draft document developed by the NDA Panel of EFSA.
Interested parties are invited to submit written comments by 11 September 2015. Please use the electronic template provided to submit comments and refer to the line and page numbers. Kindly note that after 2 hours of non-activity your working session will expire and comments submitted after that time will not be recorded and transmitted. Therefore, if the page is left inactive for more than 2 hours, please re-open it from the link before restarting to comment. If you would like to submit additional data to support your comments or files send an email to: NDA.PublicConsult.email@example.com.Please note that comments will not be considered if they:
- are submitted after the closing date of the public consultation;
- are not related to the contents of the document;
- contain complaints against institutions, personal accusations, irrelevant or offensive statements or material;
- are related to policy or risk management aspects, which are out of the scope of EFSA's activity.
EFSA will assess all comments from interested parties which are submitted in line with the criteria above. The comments will be further considered by the relevant EFSA Panel and taken into consideration if found to be relevant.
All comments submitted will be published. Comments submitted by individuals in a personal capacity will be presented anonymously. Comments submitted formally on behalf of an organisation will appear with the name of the organisation.