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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) and its name.

EU framework

Under European legislation, additives must be explicitly authorised at European level before they can be used in foods. Before authorisation they must undergo a safety evaluation for using the additive as intended. The legislation consists of a framework Directive (Council Directive 89/107/EEC) covering additives in general and three specific Directives on three categories of additive - colours, sweeteners and other food additives - which list the permitted additives and their conditions of use. All authorised additives also have to comply with approved purity criteria, which are laid down in three other Directives (for more information see related links below).

In EU legislation, food additives are defined as "any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose results in it or its by-products becoming directly or indirectly a component of such foods".

In December 2008, a new regulatory package on Food Improvement Agents was adopted which will replace the current legislation. The package includes regulations on food additives (1333/2008), food enzymes (1332/2008), and flavourings, and food ingredients with flavouring properties (1334/2008) as well as an additional fourth regulation establishing a common authorisation procedure for these (1331/2008). The Regulation on food additives (1333/2008) brings together the provisions on additives currently in different Directives and will enter into force in January 2010. The Regulation on the common authorisation procedure for additives, flavourings and enzymes will enter into force in December 2010. The Regulation requires that these substances have to undergo a safety assessment by EFSA before they can be authorised for use in the EU.

In accordance with the new legislation, food additives which were permitted before 20 January 2009 are foreseen to be re-evaluated by December 2020 by EFSA.

The Joint Expert Committee on Food Additives (JECFA), the Food and Agriculture Organisation of the United Nations (FAO) and World Health Organisation (WHO) has been active since 1956 in performing evaluations of food additives, contaminants and residues of veterinary drugs in food. A summary of these evaluations is available online.

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 significant new scientific information and/or changing conditions.
  • Carry out a systematic re-evaluation of all authorised food additives in the EU.

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 including genotoxicity 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. This statement defines the general data requirements for applications. Specific scientific approaches are detailed in the SCF’s guidance on submitting applications, which the Panel will begin reviewing in autumn 2009. The new guidance is expected to 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: aspartame and steviol glycosides

EFSA has been working on the safety assessment of sweeteners, such as aspartame and steviol glycosides.

EFSA has reviewed on several occasions the safety of the sweetener aspartame. In 2009, EFSA’s ANS Panel concluded that on the basis of all the evidence currently available, including the study by the European Ramazzini Foundation published in 2007, there was no indication of any genotoxic or carcinogenic potential of aspartame and no reason to revise the previously established Acceptable Daily Intake for aspartame of 40 mg/kg body weight. An earlier opinion, following the first study on aspartame by the European Ramazzini Foundation, was adopted by the former AFC Panel in 2006.

The Panel is also looking at steviol glycosides, sweeteners prepared from the stevia leaf. Their safety assessment is expected to be finalised in the first quarter of 2010.

Re-evaluation of authorised additives: colours

As part of the process of re-evaluating all authorised food additives in the EU, EFSA is giving top priority to colours in line with the European Commission’s request. Colours were among the first additives to be evaluated under European legislation and several new studies have become available since the original assessments were done.

EFSA is re-evaluating all food colours which are authorised for use in the EU on a case-by-case basis. The first colour to be re-evaluated was Red 2G in July 2007. The European Commission and the Member states subsequently withdrew the authorisations for the use of this colour, following the concerns expressed by the AFC Panel. Lycopene was also re-evaluated in January 2008. The AFC Panel established an Acceptable Daily Intale (ADI) of 0.5 mg per kg of body weight from all sources. However, the Panel also pointed out that some high consumers of food containing lycopene, such as pre-school and school children, may exceed this ADI.

In September 2009, the ANS Panel provided scientific advice on six food colours. It lowered the ADIs in three cases (Quinoline Yellow, Sunset Yellow and Ponceau 4R). For these colours, the Panel found that exposure could go above the new ADIs for both adults and children. The Panel also concluded that the existing ADIs did not need to be changed for the other three colours which were assessed (Tatrazine, Azorubine/Carmoisine and Allura Red AC). The Panel pointed out that only some children consuming large amounts of food and drink containing Azorubine/Carmoisine or Allura Red AC could exceed the ADIs for these colours.

The European Commission asked EFSA to prioritise the evaluation of these six colours after a study was published by Southampton University in 2007 (McCann et al, 2007), suggesting a link between certain mixtures of these colours and the preservative sodium benzoate with hyperactivity in children. In March 2008, EFSA’s AFC Panel completed an assessment of this study, concluding that its findings could not be used as a basis for altering the ADIs of these individual food colours or sodium benzoate. The opinions published in November 2009 concluded that the currently available data – including the McCann et al study – did not substantiate a causal link between these individual colours and possible behavioural effects.

The re-evaluation of all food colours is expected to be completed in the middle of 2011.

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.

Scientific Documents  
Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive

Published: 12 November 2009  Adopted: 23 September 2009

Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive

Published: 12 November 2009  Adopted: 23 September 2009

Scientific Opinion on the re-evaluation Tartrazine (E 102)

Published: 12 November 2009  Adopted: 23 September 2009

Data requirements for the evaluation of food additive applications [1]

Published: 4 August 2009  Adopted: 9 July 2009

Food Additives