Food additives
Food additives are substances added to food and drinks for various reasons, such as to maintain or improve their safety, freshness, taste, texture or appearance.
Many substances used as additives occur naturally, such as vitamin Næringsstof, som mennesker og dyr har brug for i meget små mængder i kosten for at vokse normalt og være sunde. De fleste vitaminer er "essentielle", da de ikke dannes i kroppen. C (E 300) and pectin (E 440) in fruit, lycopene (E 160d(ii)) in tomatoes, and lecithin (E 322), which is present in a range of foods, such as egg yolks, soya beans, peanuts and maize.
Food additives can also be derived from animals (e.g. carminic acid or E 120, obtained from cochineal insects) or minerals (e.g. calcium carbonate or E 170, obtained from ground limestone), or they can be chemically synthesised (e.g. synthetic lycopene or E 160d(i)).
In the European Union (EU) all food additives are identified by an E number, and their safety is evaluated before they can be permitted for use in food.
More than 300 substances are authorised for use as food additives in the EU. The European Food Safety Authority (EFSA) has evaluated the safety of the majority of these, while the remainder were assessed by the European Commission’s Scientific Committee on Food before EFSA was established. Our scientists are re-evaluating the safety of those remaining substances in line with the latest scientific knowledge.
Food additives must always be included in the ingredients list of food and drinks in which they are used.
Food and drink labels must identify both the function of the additive in the finished food (e.g. colour or preservative) and the specific substance used, either by referring to the appropriate E number or its name (e.g. E 415 or Xanthan gum).
Common additives that appear on food labels include antioxidants (to prevent deterioration caused by oxidation), colours, emulsifiers, stabilisers, gelling agents and thickeners, preservatives and sweeteners.
All food additives on the EU market must comply with legal specifications, which include minimal purity criteria among other parameters that allow for their identification.
The list of all the food additives authorised in the EU, their E numbers and conditions of use can be accessed through the European Commission’s food additives database.
EFSA's role
EFSA provides scientific advice to support the authorisation process of food additives overseen by the European Commission.
The European Commission and EU Member States decide on the approval of food additives on the EU market and their conditions of use (such as labelling and maximum permitted limits).
Our experts carry out risk assessments of food additives in accordance with requests from the European Commission.
Our assessments consider all the data available on the chemical and biological properties, potential toxicity and dietary exposure estimates of food additives.
We have three main tasks in relation to food additives:
- Evaluating the safety of new food additives or proposed modifications to already authorised food additives submitted by applicants under Regulation (EC) No 1331/2008
- Re-evaluating the safety of all food additives already permitted for use in the EU before 20 January 2009 as required by Regulation (EU) No 257/2010
- Responding to ad-hoc requests from the European Commission to review the safety of certain food additives in the light of new scientific information
Since July 2018, our expert Panel on Food Additives and Flavourings (FAF) has been responsible for carrying out the safety evaluations and re-evaluations of food additives in the EU.
Before that date the scientific opinions on food additives were issued by EFSA’s Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) and previously by the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC Panel).
New food additives or new uses
We developed a guidance document in 2012 on the data required for the risk assessment of food additive applications.
Data requirements relate to:
- The characterisation of the food additive, including the description of its identity, manufacturing process, chemical composition, specifications, stability, reaction and fate in foods
- The proposed uses and use levels, and the assessment of dietary exposure
- The safety data, including information on the genotoxic potential of the food additive, toxicological data other than genotoxicity, and other information that is relevant to its safety
Our experts are planning to update the guidance document by the end of 2024.
The latest authorised food additives that have been included in the Union list following EFSA risk assessments are:
E 960d Glucosylated steviol glycosides
E 1210 Carbomer
E 246 Glycolipids
See: Food improvement agent applications: regulations and guidance
Re-evaluation of authorised food additives
Under Regulation (EU) No 257/2010, EFSA is required to re-evaluate all food additives authorised for use in the EU prior to 20 January 2009.
This task was scheduled for completion by 2020. However, more time was needed due to the large volume of work and the need to request additional data to complete the assessments.
We have so far re-evaluated more than 70% of the 315 food additives that were approved in the EU before 20 January 2009.
For re-evaluations of authorised food additives, EFSA’s experts check all the data – available through calls for data or updated literature searches – against the latest scientific requirements since EFSA or the Scientific Committee on Food performed an evaluation.
Interested parties (e.g. food business operators, national food authorities, research institutions and academia) and/or other stakeholders play a pivotal part in the re-evaluation programme by submitting published or unpublished information for the safety assessments.
The latest food additives re-evaluated by EFSA under this programme are:
E 968 Erythritol
E 959 Neohesperidine dihydrochalcone
E 957 Thaumatin
All scientific opinions on the re-evaluation of food additives are available in the EFSA Journal.
Follow-up activities
During the re-evaluation of food additives our scientists may identify issues or data gaps that require follow-up action, such as when:
- EFSA is not able to re-evaluate, and therefore to reconfirm, the safety of an additive and/or derive an Acceptable Daily Intake ( ADI Det acceptable daglige indtag (ADI) er et skøn over den mængde af et stof i fødevarer eller drikkevand, der kan indtages dagligt livet igennem uden at udgøre en nævneværdig sundhedsrisiko. Det udtrykkes normalt i milligram af stoffet pr. kg kropsvægt og gælder for kemiske stoffer såsom fødevaretilsætningsstoffer, pesticidrester og veterinærlægemidler.) due to the lack of relevant scientific data
- EFSA lowers the ADI of an additive due to the limited availability of toxicological data
- The exposure assessment carried out by EFSA suggests a potential exceedance of the ADI for one or more population Gruppe af mennesker, dyr eller planter fra samme art. groups
- EFSA raises issues concerning the specifications of some additives as laid down in Regulation EU 231/2012
For such cases, the European Commission has established a follow-up programme to collect additional data from interested business operators. These new data are requested by the European Commission through follow-up calls.
Once the requested data become available, the European Commission may request EFSA to prepare new opinions on the previously re-evaluated food additives.
These follow-up opinions may cover only certain aspects of the risk assessment (e.g. assessing data on impurities, performing risk assessments for the population of infants below 16 weeks of age, updating dietary exposure) whereas in other cases a full updated scientific assessment may be needed.
The latest scientific opinions issued by EFSA to follow up on previously re-evaluated food additives are:
E 170 Calcium carbonate
E 132 Indigo carmine
E 445 Glycerol esters of wood rosins
EU framework
- Regulation (EC) No 1333/2008 lays down general requirements for the safe use of food additives and contains the EU list of authorised food additives and their conditions of use.
- Regulation (EU) No 231/2012 lays down specifications for the food additives authorised in the EU.
- Regulation (EC) No 1331/2008 describes a common authorisation procedure for food additives, food enzymes and food flavourings.
EU legislation on food additives – European Commission
State of play of the re-evaluation of safety of permitted food additives by EFSA – European Commission
For applicants
EFSA has published guidance documents to support applicants in submitting information for its safety evaluations.