Solicitudes de autorización de ingredientes alimentarios: reglamentos y documentos de orientación
La legislación de la UE y los documentos de orientación de la EFSA detallan cómo elaborar expedientes de solicitud de autorización de ingredientes alimentarios y qué tipo de datos científicos y de otra índole deben incluirse. La EFSA actualiza regularmente sus documentos de orientación. Se recuerda a los solicitantes que se cercioren de que están utilizando la última versión antes de presentar su solicitud.
Aditivos alimentarios
Marco reglamentario
Procedimiento de autorización común
- 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
Reevaluación
- 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
Orientación administrativa
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)
- 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
Orientación científica
Applicable to applications submitted as of 27 March 2021
Guidance on submission for food additive evaluations (update 2021)
Applicable to applications submitted until 26 March 2021
Otros documentos de orientación
Guidance on the review, revision and development of EFSA's cross-cutting guidance documents
Aromas alimentarios
Marco reglamentario
Procedimiento de autorización común
- 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
Group evaluation
Orientación administrativa
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)
- 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 for group evaluation
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)
Otros documentos de orientación
Guidance on the review, revision and development of EFSA's cross-cutting guidance documents
Smoke flavouring primary products
Marco reglamentario
- 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
Orientación administrativa
Applicable to applications submitted as of 27 March 2021
- Administrative guidance for the preparation of applications on smoke flavouring primary products
- 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
Orientación científica
Scientific Guidance for the preparation of applications on smoke flavouring primary products
Otros documentos de orientación
Guidance on the review, revision and development of EFSA's cross-cutting guidance documents
Enzimas alimentarias
Marco reglamentario
Procedimiento de autorización común
- 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
Orientación administrativa
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)
- 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
Orientación científica
Applicable to all applications as of 21 April 2022
- Scientific Guidance for the submission of dossiers on Food Enzymes (published on 21 October 2021)
This new Guidance will become mandatory as of 21 April 2022.
During the six-month transition period to the new guidance, EFSA is still using the sets of guidance documents listed above. Starting from 21 April 2022, this new Guidance supersedes those guidance documents.
In view of the new scientific requirements becoming mandatory as of 21 April 2022, applicants are encouraged to start using already the new guidance when preparing data.
Otros documentos de orientación
Guidance on the review, revision and development of EFSA's cross-cutting guidance documents
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Disolventes de extracción
Marco reglamentario
- 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