Food improvement agents applications: regulations and guidance
EU legislation and EFSA guidance documents detail how to compile dossiers for food improvement agents 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 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation 1333/2008
Re-evaluation
- Regulation 257/2010 setting up a programme for the re-evaluation of approved food additives
- Regulation 1169/2011 on the provision of food information to consumers
Administrative guidance and support initiatives
Applicable to applications submitted as of 27 March 2021
- Administrative guidance for the preparation of applications on food improvement agents (food enzymes, food additives and food flavourings) (update 7 July 2023)
- EC practical guidance for applications containing a check list, useful addresses, contact points and relevant documents (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
Scientific guidance
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Food 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
- EU Register of food flavourings
Administrative guidance and support initiatives
Applicable to applications submitted as of 27 March 2021
- Administrative guidance for the preparation of applications on food improvement agents (food enzymes, food additives and food flavourings) (update 7 July 2023)
- EC practical guidance for applications containing a check list, useful addresses, contact points and relevant documents (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
- Administrative information is available in the Guidance on the data required for the risk assessment of flavourings to be used in or on foods
- Administrative guidance for the processing of applications for regulated products
- EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products
Scientific guidance
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Smoke flavouring primary products
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 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
Administrative guidance and support initiatives
Applicable to applications submitted as of 27 March 2021
- Administrative guidance for the preparation of applications on smoke flavouring primary products (update 13 December 2022)
- 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
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
Administrative guidance
Applicable to applications submitted as of 27 March 2021
- Administrative guidance for the preparation of applications on food improvement agents (food enzymes, food additives and food flavourings) (update 7 July 2023)
- EC practical guidance for applications containing a check list, useful addresses, contact points and relevant documents (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
Scientific guidance
- Scientific Guidance for the submission of dossiers on Food Enzymes (update on 26 July 2023 – applicable as of 21 April 2022)
- Scientific Guidance for the submission of food manufacturing processes and technical data used in the exposure assessment of food enzymes (published on 25 July 2023 – applicable as of 25 January 2024)
Two scientific guidance documents are complementary to each other and, therefore shall be consulted in parallel for the submission of a dossier on food enzymes.
The updated Guidance for the submission of dossiers on food enzymes is applicable as of 21 April 2022, while the Guidance on food manufacturing processes and technical data used in the exposure assessment of food enzymes becomes applicable six months after its publication, i.e. as of 25 January 2024.
During the six-month transition period to the new guidance on food manufacturing processes and technical data used in the exposure assessment of food enzymes, EFSA is still using the sets of guidance documents listed below.
In view of the new scientific requirements becoming mandatory as of 25 January 2024, applicants are encouraged to start using already the new guidance when preparing data.
For applications submitted by 25 January 2024 the below versions of the EFSA guidance documents apply, depending on the submission date of the application.
Applicable to applications submitted as of 21 April 2022
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Extraction solvents
Regulatory framework
- Directive 2009/32/EC on extraction solvents used in the production of foodstuffs and food ingredients
- Regulation (EU) 234/2011 implementing Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings
- DG SANTE Extraction solvents web section