Food Additives

Food Additives

Food additives are substances added intentionally to foodstuffs to perform certain technological functions, for example to colour, to sweeten or to help preserve foods. All food additives are identified by an E number. Food additives are always included in the ingredient lists of foods in which they are used. Some of the additives that you are likely to come across on food labels are antioxidants (to prevent deterioration caused by oxidation), colours, emulsifiers, stabilisers, gelling agents and thickeners, preservatives and sweeteners. When food additives are used in foods in Europe, product labels must identify both the function of the additive in the finished food (eg colour, preservative etc.) and the specific substance used either by referring to the appropriate E number (such as E415) or its name.

EU framework

Under European legislation, food additives must be authorised before they can be used in foods. This authorisation by the risk managers follows the safety assessment carried out by EFSA.
EU legislation consists of a framework Directive (89/107/EEC) covering additives in general and three specific Directives on colours (94/36/EC), sweeteners (94/35/EC) and other food additives (95/2/EC), which list the permitted additives and their conditions of use. All authorised additives also have to comply with the approved purity criteria laid down in three other Directives.

In December 2008, a new regulatory package on Food Improvement Agents was adopted which includes, among others, regulations on:

The Regulation on food additives, which entered into force in January 2010, consolidates all food additives legislation previously covered by different Directives.
The Regulation on the common authorisation procedure for additives, enzymes and flavourings and enzymes will start becoming fully applicable in the course of 2011 when its implementing measures will enter into force.

In accordance with the new legislation, by December 2020 EFSA has to re-evaluate food additives which were authorised before 20 January 2009. In Regulation 257/2010 the Commission set a timeline for the re-evaluation of all food additives, the details of which are contained in Annex II. As sweeteners were evaluated most recently, these additives will be re-evaluated last. This timetable can be adjusted should a safety concern arise for an individual additive and/or new data be made available requiring further review ahead of the agreed deadline.

EU priorities for re-evaluation of certain food additives (Reg. 257/2010)

Deadlines Food additives
15 Apr 2010 Food colours 1: E 123, E 151, E 154, E 155, E 180
31 Dec 2010* Food colours 2: E 100, E 127, E 131, E 132, E 133, E 142, E 150a, E 150b, E 150c, E 150d, E 161b, E 161g, E 170
31 Dec 2015 Food colours 3: E 101, E 120, E 140, E 141, E 153, E 160b, E 160a, E 160c, E 160e, E 160f, E 162, E 163, E 171, E 172, E 174, E 175
31 Dec 2015 Preservatives and antioxidants: E 200-203; E 210-215, E 218-252, E 280-285; E 300-E 321, E 586 (priorities: E 310-312, E 320, E 321, E 220-228, E 304, E 200-203, E 284, E 285, E 239, E 242, E 249, E 250, E 251, E 252, E 280-283, E 306, E 307, E 308, E 309)
31 Dec 2016 Emulsifiers, stabilisers, gelling agents: E 322, E 400-E 419, E 422-E 495, E 1401-E 1451 (priorities: E 483, E 491-495, E 431, E 432-436, E 444, E 481, E 482, E 414; E 410, E 417, E 422, E 475)
31 Dec 2016 E 551, E 620-625, E 1105, E 1103
31 Dec 2018 All remaining food additives other than colours and sweeteners (priorities: E 552, E 553a, E 553b, E 558, E 999, E 338-343, E 450-452, E 900, E 912, E 914, E 902, E 904, E 626-629, E 630-633, E 634-635, E 507-511, E 513)
31 Dec 2020 All sweeteners and remaining colours

* Re-evaluations of E 131, E 132 and E 170 were not met by the specified deadline and are still in progress following the publication of calls for data on these additives.

EFSA’s role

EFSA has three main activities in the area of food additives:

  • Carry out safety evaluations of new food additives before they can be authorised for use in the EU.
  • Respond to ad-hoc requests from the European Commission to review certain food additives in the light of new scientific information and/or changing conditions.
  • Carry out the re-evaluation of all food additives that were already permitted in the European Union before 20 January 2009.

This work is carried out by the Panel on food additives and nutrient sources added to food (ANS). The Panel’s safety evaluations involve a review of all available, relevant scientific studies and data on toxicity as well as human exposure, from which the Panel draws conclusions regarding the safety of the substance. Formerly this work was the responsibility of the   Panel on food additives, flavourings, processing aids and materials in contact with food   (AFC).

Authorisation of new food additives

When applying for authorisation of a new food additive, the applicant submits a formal request to the European Commission with a file of information on the substance including scientific data concerning safety. If the application is accepted, the Commission will formally ask EFSA to issue an opinion on the safety of the substance for its intended uses.

A guidance document is available on how to prepare an application. This guidance was prepared by the former Scientific Committee on Food (SCF) and was  provisionally endorsed by the AFC in July 2003. Following new EU legislation on the common authorisation procedure of additives, flavourings and enzymes, the ANS Panel adopted in July 2009 a statement specifying the type of data that industry should provide for the safety assessment of food additives. Specific scientific approaches are detailed in a guidance by the former SCF on submissions for food additives applications, which the Panel is currently reviewing. The new guidance will be finalised by mid-2011.

Once a request for an opinion has been accepted by EFSA it is included in the Register of requested opinions where its status is can be monitored including date of reception and anticipated timing of finalisation and adoption.

Sweeteners  

EFSA works on the safety assessment of sweeteners, such as aspartame and steviol glycosides.

Aspartame

With respect to aspartame, EFSA has reviewed on several occasions the safety of this sweetener.

In May 2011, the European Food Safety Authority (EFSA) was asked by the European Commission to bring forward the full re-evaluation of the safety of aspartame (E 951) to 2012. Previously planned for completion by 2020, the review of this individual sweetener is part of the systematic re-evaluation of all food additives authorised in the European Union prior to 20 January 2009, foreseen by Regulation (EU) No 257/2010.

EFSA accepted the mandate for the re-evaluation of aspartame, stipulating the need for a public call for scientific data as well as a thorough literature review. Following a public call for scientific data on aspartame, which closed on 30 September 2011, EFSA received access to a large number of both published and unpublished scientific studies and datasets. Reaffirming its commitment to openness and transparency, EFSA has published the full list of studies that have been made available to EFSA. The Authority has also made publicly available previously unpublished scientific data including the 112 original studies on aspartame which were submitted to support the request for authorisation of aspartame in Europe in the early 1980s.

EFSA will liaise closely with the French Agency for Food, Environmental and Occupational Health Safety (ANSES) on their nutritional risk/benefit assessment of sweeteners. After its completion in 2012, EFSA’s risk assessment of aspartame will be the most comprehensive and up-to-date available. 

 Steviol glycosides  

The ANS Panel has also looked at steviol glycosides, sweeteners extracted from the leaves of the stevia plant. In an opinion published in April 2010, it concluded that these substances are neither genotoxic, nor carcinogenic and established an ADI of 4 mg per kg body weight per day. The Panel also noted that this ADI could be exceeded by both adults and children if these sweeteners were used at the maximum levels proposed by the applicants. Following a request from the European Commission, in January 2011, EFSA also reviewed its previous assessment of consumer exposure to these sweeteners based on the revised levels of use proposed by the applicants.

In order to ensure that the use of such sweeteners would be safe for consumers, the Commission therefore asked industry to revise the uses proposed for the substances and EFSA to carry out a new exposure assessment on the revised uses. In January 2011, EFSA concluded that although the revised exposure estimates are slightly lower than those of the April 2010 opinion, adults and children who are high consumers of foods containing these sweeteners, could still exceed the ADI established by the Panel if the sweeteners are used at maximum levels. 

[1] Soffritti M. et al., Aspartame administered in feed, beginning prenatally through life span, induces cancers of the liver and lung in male Swiss mice, Am. J. Ind. Med. 2010, 53, 1197-1206.

[2] Halldorsson T.I. et al., Intake of artificially sweetened soft drinks and risk of preterm delivery: a prospective cohort study in 59334 Danish pregnant women. Am. J. Clin. Nutr. 2010, 92: 626-633.

[3] Further information on the work initiated by Anses can be found at: http://www.anses.fr/PM910058I0.htm

 

Food colours 

Safety of parabens (E214-219) 

In September 2004, EFSA issued an opinion on the safety of parabens used as preservatives in foods (additives E 214-219). The withdrawal of the ADI for one type, propyl paraben led to, the exclusion of E216 (propyl p-hydroxybenzoate) and E217 (sodium propyl p-hydroxybenzoate) from the list of substances permitted for use in the EU. The AFC Panel concluded that a group ADI (Acceptable Daily Intake) of 0-10 mg/kg body weight per day could be established for methyl and ethyl parabens and their sodium salts. However, propyl paraben could not be included in this group ADI due to recent research demonstrating its effects on certain reproductive parameters in rats, and the panel was unable to recommend a specific ADI based on current evidence. See the press release for more information.

Last updated: 30 January 2012

See also