Public consultation on a draft Scientific and technical guidance for the preparation and presentation of applications pursuant to Article 6 Paragraph 11 of Directive 2000/13/EC, as amended

Privacy statement(52.7 KB)

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’s Panel on Dietetic Products, Nutrition and Allergies (NDA) has launched an open consultation on a draft Scientific and technical guidance for the preparation and presentation of applications pursuant to Article 6 Paragraph 11 of Directive 2000/13/EC, as amended.

This guidance applies to food ingredients or substances with known allergenic potential listed in Annex IIIa of 2003/89/EC (as amended) or products thereof and aims for updating the Commission guidelines in view of assisting applicants in the preparation and presentation of well-structured applications for exemption from labelling. 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 application, the hierarchy of different types of data and study designs, reflecting the relative strength of evidence which may be obtained from different study types, and the key issues which must be addressed in the application in order to assess the likelihood of a food ingredient or substance to trigger adverse reactions in sensitive individuals under the proposed conditions of use.

Interested parties are invited to submit written comments by 13 September 2013. Please use exclusively the electronic template provided with the documents to submit comments and refer to the line and page numbers. Please note that comments submitted by e-mail or by post cannot be taken into account and that a submission will not be considered if it is:

• submitted after the deadline set out in the call
• presented in any form other than what is provided for in the instructions and template
• not related to the contents of the document
• contains complaints against institutions, personal accusations, irrelevant or offensive statements or material
• is related to policy or risk management aspects, which is 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.