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
- Regulation 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods
- Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements
- Directive 2006/37/EC on the inclusion of certain substances
- Regulation 1170/2009 of EC on the lists of vitamin and minerals and their forms that can be added to foods, including food supplements
- Regulation 1161/2011 on the lists of mineral substances that can be added to foods
- Regulation 119/2014 on chromium enriched yeast used for the manufacture of food supplements and chromium(III) lactate tri-hydrate added to foods
- Regulation 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control
- Regulation 953/2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses
- Regulation 307/2012 on the addition of vitamins and minerals and of certain other substances to foods
- EC list of authorised nutrient sources
Administrative guidance and support initiatives
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Scientific guidance
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Health claims
Regulatory framework
- Regulation 1924/2006 on nutrition and health claims made on foods
- Regulation 353/2008 establishing implementing rules for applications for authorisation of health claims
- Regulation 1169/2009 establishing implementing rules for applications for authorisation of health claims
- Decision 2013/63/EU adopting guidelines for the implementation of specific conditions for health claims
- Regulation 432/2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health
- Regulation 1169/2011 on the provision of food information to consumers
- EU Register of Nutrition and health claims made on food
Administrative guidance and support initiatives
Applicable to applications submitted as of 27 March 2021
- 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 (update 2021)
- EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products (update January 2024)
Applicable to applications submitted until 26 March 2021
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
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Applicable to all applications (submitted before or after 27 March 2021)
- Guidance on the scientific requirements for health claims related to functions of the nervous system, including psychological functions
- Guidance on the scientific requirements for health claims related to physical performance
- Guidance on the scientific requirements for health claims related to bone, joints, skin and oral health
- Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations
- Guidance for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms
- Guidance on health claims related to antioxidants, oxidative damage and cardiovascular health
Other guidance
Guidance on the review, revision and development of EFSA's cross-cutting guidance documents
Infant formulae and follow-on formulae
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
- Regulation 2016/127 as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding
Administrative guidance and support initiatives
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Scientific guidance
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Applicable to all applications (submitted before or after 27 March 2021)
Other guidance
Food allergies
Regulatory framework
Regulation EU 1169/2011 on the provision of food information to consumers
Administrative guidance and support initiatives
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Scientific guidance
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Foods for special medical purposes (FSMPs)
Regulatory framework
Administrative guidance and support initiatives
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Scientific guidance
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021