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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.

Scientific guidance

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

Submission of Health claims dossiers: List of competent authorities of the Member States

Scientific guidance

  1. Applicable to applications submitted as of 27 March 2021

  2. Applicable to applications submitted until 26 March 2021

Scientific guidance

Food allergies

Regulatory framework

Regulation EU 1169/2011 on the provision of food information to consumers

Administrative guidance and support initiatives

Scientific guidance 

  1. Applicable to applications submitted as of 27 March 2021

  2. Applicable to applications submitted until 26 March 2021

Foods for special medical purposes (FSMPs)

Regulatory framework

Regulation 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control

Administrative guidance and support initiatives

Scientific guidance