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.
Novel foods
Regulatory framework
- Regulation 2017/2469 on administrative and scientific requirements for novel foods applications
- Regulation 2017/2468 on administrative and scientific requirements concerning traditional foods from third countries
- Regulation 2017/2470 on establishing the Union list of novel foods
- Regulation 258/1997 concerning novel foods and novel food ingredients
- Regulation 2015/2283 on novel foods
- Regulation 1852/2001 laying down detailed rules for making certain information available to the public and for the protection of information
Administrative guidance
- Administrative guidance on the submission of applications for authorisation of a novel food pursuant to Article 10 of Regulation EU 2015/2283
Scientific guidance
- Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation EU 2015/2283
- Guidance on the preparation and presentation of the notification and application for authorisation of traditional foods from third countries in the context of Regulation EU 2015/2283
Other guidance
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
Scientific guidance
- Guidance on submission for safety evaluation of sources of nutrients or of other ingredients proposed for use in the manufacture of food (2001) (European Commission’s former Scientific Committee on Food)
- Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources
Other guidance
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 EU 1169/2011 on the provision of food information to consumers
- EU Register of Nutrition and health claims made on food
Administrative guidance
- EFSA scientific and technical guidance
- EC Guidance on the Regulation 1924/2006 on nutrition and health claims made on food approved by the Standing Committee on Food Chain and Animal Health
Scientific guidance
- General scientific guidance for stakeholders on health claim applications
- 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
Nutrition claims
Infant formulae and follow-on formulae
Regulatory framework
- Directive 2006/141/EC on infant formulae and follow-on formulae
- 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
Scientific guidance
- 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
- Explanatory note to the 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 (with a view to amend Regulation (EU) 2016/127)
Other guidance
Food allergies
Regulatory framework
Scientific guidance
- Guidance on the preparation and presentation of applications
- Outcome of a public consultation on the Draft Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on Scientific and technical guidance for the preparation and presentation of applications
