Brussels, 21.01.2003
DG SANCO/D/3/KN/km D 430007 (2003)

Dear Mr Hasslberger,

Thank you for your e-mail dated 31 December 2002 to Commissioner David Byrne concerning the approval process of aspartame in the United States. The Commissioner has asked me to reply on his behalf.

In the European Union, food additives such as aspartame may only be authorised if a reasonable case of technological need can be demonstrated, if they present no hazard to the health of the consumer at the level of use proposed and provided they do not mislead the consumer. The European Commission is required to consult the Scientific Committee on Food prior to submission of any proposals for legislation on food additives where these may have an effect on health.
Aspartame has been evaluated by the Scientific Committee on Food in 1988 and has been found acceptable for use as a sweetener in food. An Acceptable Daily Intake (ADI) of 40 mg/kg bodyweight has been set by the Committee. Accordingly, this sweetener has been authorised under Community legislation in 1994 for a restricted range of foods and with maximum usage levels [1].

Recently, the Scientific Committee on Food has reviewed all new scientific information on aspartame not having been examined by the Committee previously [2]. The Committee concluded that there was no need to revise the outcome of the earlier risk assessment or the ADI previously established for aspartame. For your information, the framework of core tests required for the safety evaluation of a food additive has been outlined by the Scientific Committee on Food and is available on the internet.
The Commission would like to reassure you that the size or the area of activity of the manufacturer neither influence evaluations of food additives carried out by the Scientific Committee on Food [3], nor evaluations of substances for use as ingredients in food supplements.

Yours sincerely,

Robert J. Coleman

  1. European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs, OJ L 237, 10.9.1994, p. 3!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=31994L0035&model=guichett

  2. Opinion of the Scientific Committee on Food: Update of the Safety of Aspartame, expressed on 4 December 2002

  3. Guidance on submissions for food additive evaluations by the Scientific Committee on Food, opinion expressed on 11 July 2001

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