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Parliamentary questions
25 March 2009
E-1020/2009
Answer given by Ms Vassiliou on behalf of the Commission

The use of sweeteners in the Community is tightly regulated under Directive 94/35/EC(1). Food additives are only permitted if they have been evaluated for their safety by the European Food Safety Authority (EFSA) or by its predecessor the Scientific Committee on Food (SCF).

The SCF reviewed the toxicity of cyclamic acid and its sodium and calcium salts (E952; ‘cyclamate’) in 1985 and established a temporary ADI of 0‑11 mg/kg bodyweight (bw)(2). The ADI was based on a no-observed-adverse-effect-level (NOAEL) of 100 mg/kg bw in the rat for testicular toxicity of cyclohexylamine (CHA), the metabolite of cyclamate. A conversion factor was applied to account for the amount of CHA likely to be formed from cyclamate. The ADI was temporary because of uncertainties relating to the relevance for man of the testicular damage found in rats fed cyclohexylamine.

The Committee reviewed cyclamate again in 1988, 1991 and 1995(3) and maintained the temporary ADI of 0‑11 mg/kg bw. At international level the Joint FAO/WHO Expert Committee on Food Additives (JECFA) has established in 1982 an ADI of 0‑11 mg/kg bw for cyclamates.

In March 2000(4) the SCF revised its opinion. Although the new epidemiological data revealed no indications of harmful effects of cyclamate on humans, scientific evidence showed that the conversion rate of cyclamate in the body was higher than previously thought, so the SCF decided to lower the ADI for this substance from 11 to 7 mg/kg bw.

As a result of the reduced ADI the conditions of use of cyclamate were revised in Directive 2003/115/EC of the Parliament and of the Council(5), notably the maximum permitted levels of cyclamate in soft drinks and fruit-juice based drinks were reduced from 400 mg/l to 250 mg/l.

Finally it should be noted that all permitted food additives in the EU are under continuous observation and are evaluated whenever necessary in the light of new scientific information. If as a consequence, the European Food Safety Authority (EFSA) would advise at any point that the additive is not safe for consumers, then the Commission would take appropriate action.

(1)Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs, OJ L 237, 10.9.1994.
(2)Commission of the European Communities (1985). Report of the Scientific Committee for Food on Sweeteners (opinion expressed on 14 September 1984). Reports of the Scientific Committee for Food (Sixteenth Series). CEC, Luxembourg, EUR 10210 EN.
(3)Commission of the European Communities (1989). Report of the Scientific Committee for Food on Sweeteners (opinion expressed on 11 December 1987 and 10 November 1988).Reports of the Scientific Committee for Food (Twenty-first Series). CEC, Luxembourg, EUR 11617 EN.Commission of the European Communities (1992). Recommendation on cyclamates(opinion expressed on 21 June 1991). Reports of the Scientific Committee for Food (Twenty-seventh Series). CEC, Luxembourg, EUR 14181 EN.Commission of the European Communities (1998). Cyclamic acid and its sodium and calcium salts (opinion expressed on 14 December 1995). Reports of the Scientific Committee for Food (Thirty-eighth Series). CEC, Luxembourg, ISBN92-828-1514-7.
(4)http://ec.europa.eu/food/fs/sc/scf/out53_en.pdf
(5)http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:024:0065:0071:EN:PDF

OJ C 189, 13/07/2010
Última actualización: 7 de abril de 2009Aviso jurídico