EN Official Journal of the European Union CE 88/630

(2004/C 88 E/0648)

WRITTEN QUESTION E-2957/03

by Mogens Camre (UEN) to the Commission

(8 October 2003)

Subject: Commission's proposed amendment of Directive 94/35/EC

A report in the scientific journal ‘Headache’ (May 2003, p.555) indicates that people with a predisposition to migraine may suffer an attack if they take a substance known as sucralose.

This substance is being considered for possible inclusion on the EU's list of approved additives. The Commission has accordingly submitted, in a document of 16 May 2003, a revised amendment to Directive 94/35/EC (1) of 30 June 1994 on sweeteners for use in foodstuffs. The amendment proposes that the active substance ‘Splenda’ (sucralose) be approved in the EU as E955.

The amendment also relates to substance E962 (aspartame-acesulphame salt). Aspartame is a well-known migraine-inducing substance, but there are no studies on aspartame-acesulphame salt.

Will the Commission take the initiative of having both these substances (together with other food additives) thoroughly investigated for possible migraine-inducing effect before they are included on the list of approved additives?

Supplementary answer given by Mr Byrne on behalf of the Commission

(11 November 2003)

The Commission wishes to reassure the Honourable Member that all food additives including sweeteners were examined for their safety by the Scientific Committee on Food prior to their authorisation. This task is now carried out by the European Food Safety Authority.

Indeed, two new sweeteners are proposed for authorisation in the current amendment of Directive 94/35/EC of the Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs (2): sucralose and the salt of aspartame and acesulfame. Both substances were examined for their safety by the Scientific Committee on Food before they were proposed for authorisation by the Commission.

The opinion on sucralose was adopted by the Scientific Committee on Food in September 2000. The Committee concluded that sucralose is acceptable as a sweetener for general food use and established an Acceptable Daily Intake of 0-15 milligramme per kilogramme (mg/kg) bodyweight.

The salt of aspartame and acesulfame was examined by the Scientific Committee on Food in March 2000. The Committee concluded that the salt does not raise additional safety considerations since it only represents an alternative source of aspartame and acesulfame. Aspartame and acesulfame are both already authorised as sweeteners under Directive 94/35/EC.

At the request of the Commission, aspartame has been re-evaluated by the Scientific Committee on Food in collaboration with the British and French Food Safety Agencies. To this end, the scientists have reviewed all the scientific literature published since the last opinion on aspartame amounting to around 150 articles. The resulting opinion, adopted in December 2002, fully reconfirmed the safety of aspartame and that the intake of this sweetener, also in consumers with a high intake, including adults, children and diabetics of all ages, remains well below the Acceptable Daily Intake. The data on headaches examined by the Committee varied in quality, but the one well controlled double-blind, cross-over trial showed that aspartame was no more likely than placebo to be associated with headaches.

Moreover, during the 2nd reading of the amendment of Directive 94/35/EC, the Commission has committed to present within two years of entry into force of this amendment a progress report about the re-evaluation of food additives, in particular concerning the two newly authorised sweeteners.

For the reasons outlined above, the Commission does not consider it necessary to proceed with further re-evaluations of these sweeteners.

(1) OJ L 237, 10.9.1994, p. 3.

(2) OJ L 237, 10.9.1994, p. 3.