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Nutrition applications: regulations and guidance

EU legislation and EFSA guidance documents detail how to compile dossiers for submission and the information and studies required for the evaluation. EFSA’s guidance is updated regularly so applicants should check they are using the latest version before applying.

Nutrient sources

Regulatory framework

Administrative guidance and support initiatives

Applicable to applications submitted until 26 March 2021 Applicable to applications submitted as of 27 March 2021
Administrative guidance for the processing of applications for regulated products Administrative guidance for the processing of applications for regulated products (update 2021)
EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products (update 2021)

Scientific guidance

Applicable to applications submitted until 26 March 2021 Applicable to applications submitted as of 27 March 2021
Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources

Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources (Revision 1) (update 2021)

Other guidance

Health claims

Regulatory framework

Administrative guidance and support initiatives

Applicable to applications submitted until 26 March 2021 Applicable to applications submitted as of 27 March 2021
Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 2) Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 3) (update 2021)
Administrative guidance for the processing of applications for regulated products Administrative guidance for the processing of applications for regulated products (update 2021)
EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products (update 2021)
Applicable to all applications (submitted before or after 27 March 2021)

Scientific guidance

Applicable to applications submitted until 26 March 2021 Applicable to applications submitted as of 27 March 2021
General scientific guidance for stakeholders on health claim applications General scientific guidance for stakeholders on health claim applications (Revision 1) (update 2021)
Applicable to all applications (submitted before or after 27 March 2021)

Other guidance

Infant formulae and follow-on formulae

Regulatory framework

Administrative guidance and support initiatives

Applicable to applications submitted until 26 March 2021 Applicable to applications submitted as of 27 March 2021
Administrative guidance for the processing of applications for regulated products Administrative guidance for the processing of applications for regulated products (update 2021)
EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products (update 2021)

Scientific guidance

Applicable to applications submitted until 26 March 2021 Applicable to applications submitted as of 27 March 2021
Scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow-on formula manufactured from protein hydrolysates

Scientific and technical guidance for the preparation and presentation of a dossier for evaluation of an infant and/or follow‐on formula manufactured from protein hydrolysates (Revision 1) (update 2021)

Applicable to all applications (submitted before or after 27 March 2021)

Other guidance

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