Solicitudes en materia de alimentación: reglamentos y documentos de orientación

La legislación de la UE y los documentos de orientación de la EFSA detallan la manera de elaborar expedientes para su presentación y la información y los estudios necesarios para la evaluación. Los documentos de orientación de la EFSA se actualizan periódicamente, por lo que los solicitantes deben comprobar que están utilizando la versión más reciente antes de presentar su solicitud.

Fuentes de nutrientes

Marco reglamentario

• 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

Orientación administrativa

Orientación científica

Otros documentos de orientación

Guidance on the review, revision and development of EFSA's cross-cutting guidance documents

Declaraciones de propiedades saludables

Marco reglamentario

• 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

Orientación administrativa

Applicable to all applications (submitted before or after 27 March 2021)

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

Orientación científica

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

Otros documentos de orientación

Guidance on the review, revision and development of EFSA's cross-cutting guidance documents

Preparados para lactantes y de continuación

Marco reglamentario

• 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

Orientación administrativa

Orientación científica

Applicable to all applications (submitted before or after 27 March 2021)

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)

Otros documentos de orientación

• Guidance on the review, revision and development of EFSA's cross-cutting guidance documents
• Food for infants and young children

Alergias alimentarias

Marco reglamentario

Regulation EU 1169/2011 on the provision of food information to consumers

Orientación administrativa

Orientación científica

Otros documentos de orientación

Guidance on the review, revision and development of EFSA's cross-cutting guidance documents

Alimentos para usos médicos especiales

Marco reglamentario

Regulation 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control

Orientación administrativa

Orientación científica

Otros documentos de orientación

Guidance on the review, revision and development of EFSA's cross-cutting guidance documents