All additives in the EU must be authorised and listed with conditions of use in the EU's positive list based on:
A safety assessment
The technological need
Ensuring that use of the additive will not mislead consumers
Regulation EC 1333/2008 sets the rules on food additives: definitions, conditions of use, labelling and procedures.
Annex I: Technological functions of food additives
Annex II: Union list of food additives approved for use in food additives and conditions of use
Annex III: Union list of food additives approved for use in food additives, food enzymes and food flavourings, and their conditions of use
Annex IV: Traditional foods for which certain EU countries may continue to prohibit the use of certain categories of food additives
Annex V: Additives labelling information for certain food colours
Other pieces of EU legislation relevant to food additives are the following:
Regulation (EC) No 178/2002 lays down the general principles and requirements of food law.
Regulation (EC) No 1331/2008 establishes the common authorisation procedure for food additives, food enzymes and food flavourings.
Both Regulation (EC) No 178/2002 and Regulation (EC) No 1331/2008 were amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain amended with effect from 27 March 2021. Further information on the implementation of that Regulation can be found on DG SANTE’s website.
Regulation (EU) No 234/2011 implements the common authorisation procedure and applies from 11 September 2011. That Regulation has been amended by Commission Implementing Regulation (EU) No 562/2012 which lays down derogation from submitting toxicological data in some specific cases and the possibility of grouping food enzymes under one application under certain conditions. It has also been adjusted by Commission Implementing Regulation (EU) 2020/1823 to accommodate the changes linked to Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain. These new provisions are applicable to applications submitted from 27 March 2021.
The Commission will change the EU lists of food additives with regulations through regulatory procedure with scrutiny (Decision 1999/468/EC).
Producers must inform the Commission of new information which may affect the safety assessment of the food additive.
Rules for use of additives in food additives, food enzymes, food flavourings and nutrients
The list of authorised food additives approved for use in food additives, enzymes and flavourings can be found in the Annex of Commission Regulation (EU) No 1130/2011 which amends Annex III to Regulation (EC) No 1333/2008. The additives approved for use in flavourings can be found in part 4 of this Annex.
Food additives must comply with specifications which should include information to adequately identify the food additive, including origin, and to describe the acceptable criteria of purity.
Regulation (EU) No 231/2012 laid down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.
- Guidance document describing the food categories in Part E of Annex II to Regulation (EC) No 1333/2008 on Food Additives - The guidance document describing the food categories was elaborated by Commission services after consultation with the EU countries' experts on food additives and the relevant stakeholders. The descriptions of the categories can be useful for an EU country control authorities and food industry to assure correct implementation of the food additives legislation.