EU legislation and EFSA guidance documents detail how to compile dossiers for food ingredient applications and what type of scientific data and other information must be included. EFSA regularly updates its guidance documents. Applicants are reminded to ensure they are using the latest version before applying.
Food additives
Regulatory framework
Common authorisation procedure
- Regulation 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings
- Regulation 234/2011 establishing a common authorisation procedure for food additives, food enzymes and food flavourings
- Regulation 1333/2008 on food additives
- Regulation 1129/2011 establishing a Union list of food additives
- Regulation 1130/2011 on food additives by establishing a Union list of food additives approved for use in food additives, food enzymes, food flavourings and nutrients
- Regulation 1131/2011 on steviol glycosides
- Regulation 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation 1333/2008
Re-evaluation
Administrative guidance
Scientific guidance
- EFSA data requirements for the evaluation of food additive applications
- Guidance on submission for food additive evaluations
Other guidance
Food enzymes
Regulatory framework - Common authorisation procedure
- Regulation 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings
- Regulation 234/2011 establishing a common authorisation procedure for food additives, food enzymes and food flavourings
- Regulation 1332/2008 on food enzymes
- Regulation 562/2012 on specific data required for risk assessment of food enzymes
- Regulation 1056/2012 on food enzymes with regard to transitional measures
Administrative guidance
- EC practical guidance for applications containing a check list, useful addresses, contact points and relevant documents
- Administrative guidance to applicants on the suitability check of applications for authorisation of food enzymes
Scientific guidance
- Guidance on the submission of a dossier on food enzymes
- Characterisation of microorganisms used for the production of food enzymes
- Exposure assessment of food enzymes
- Explanatory note for the guidance on the submission of a dossier on food enzymes
Other guidance
Flavourings
Regulatory framework
Common authorisation procedure
- Regulation 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings
- Regulation 234/2011 establishing a common authorisation procedure for food additives, food enzymes and food flavourings
- Regulation 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods
- Regulation 872/2012 adopting the list of flavouring substances
- Regulation 873/2012 on transitional measures concerning the Union list of flavourings and source materials set out in Annex I to Regulation 1334/2008
- Regulation 246/2014 amending Annex I to Regulation 1334/2008 as regards removal from the Union list of certain flavouring substances
Group evaluation
- Regulation 2232/96 laying down a Community procedure for flavouring substances used or intended for use in or on foodstuffs
- Regulation 1565/2000 laying down the measures necessary for the adoption of an evaluation programme
- 1999/217/EC: Commission Decision adopting a register of flavouring substances used in or on foodstuffs
- EU Register of food flavourings
Administrative guidance
Scientific guidance for group evaluation
- Guidance on the data required for the risk assessment of flavourings to be used in or on foods
- Proposed template to be used in drafting scientific opinion on flavouring substances (explanatory notes for guidance included)
Other guidance
Smoke flavouring
Regulatory framework
- Regulation 2065/2003 on smoke flavourings used or intended for use in or on foods
- Regulation 627/2006 on quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke products
- Regulation 596/2009 adapting a number of instruments with regard to the regulatory procedure
- Regulation 1321/2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings
Scientific guidance
- Guidance on submission of a dossier on a smoke flavouring primary product for evaluation by EFSA
- EFSA statement on the safety evaluation of smoke flavourings primary products: interpretation of the margin of safety
- EFSA guidance on dietary exposure assessment methods for smoke flavouring primary products
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)
