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Final scientific and technical guidance for applicants for preparation and presentation of the application for authorisation of a health claim
Following public consultation, the European Food Safety Authority (EFSA) has published its final guidance to applicants on the submission of health claims for authorisation. The guidance aims to help companies who want to submit health claims for authorisation. It addresses the types of information to include in the application, in particular concerning the scientific data and evidence required to support claims.
The guidance will be kept under review and will be amended and updated as appropriate in the light of experience gained from evaluation of health claim applications. EFSA advises applicants to check the most recent version before submitting an application
Working format of the application ready-to-use by applicants (Notes: You will need to open and save these documents in your computer prior using them. We strongly suggest NOT to change the order, numbering or structure of the documents. For questions or problems in opening the documents, please write to efsa-NDA-claims@efsa.europa.eu
Please note that the ready-to-use documents below have been modified to accomodate applications falling under the scope of Article 13 (5) of Regulation (EC) No 1924/2006 (Article 18 procedure). Additional "ticking boxes" reading "Application pursuant to Article 13 (5) of the Regulation (EC) 1924/2006" have been inserted in page 2 of "Appendix B: Summary of the Application" and in page 3 of "Part 1-4" and of "Appendix A: Application form". The document "Apendices C-I" has not been modified.
Part 1-4 
(0.2Mb)
Appendix A: Application form (0.2Mb)
Appendix B: Summary of the Application (0.1Mb)
Appendices C-I (0.4Mb)
Data di pubblicazione: 26 luglio 2007
Ultimo aggiornamento: 1 febbraio 2008
Ultimo aggiornamento: 1 febbraio 2008
