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French Agency for Food, Environmental and Occupational Health & Safety

Sweeteners: ANSES analyses the results of two recent studies

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News of 11/01/2011

11 January 2011

Aspartame is an intense sweetener that has been authorised in Europe since 1994 by Directive 94/35/EC(1), after assessment by the European Commission's Scientific Committee on Food (SCF) in 1985. The committee set an Acceptable Daily Intake (ADI) of 40 mg/kg body weight (2). The SCF reassessed aspartame in 1989, 1997 and 2002 and more recently the European Food Safety Authority (EFSA) did so in 2006.

Aspartame was also authorised as a sweetener in the United States after having been assessed by the US Food and Drug Administration (FDA) in 1974. The FDA reassessed aspartame in 1981, 1983, 1998 and more recently in 2007.

The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has also assessed aspartame several times since the 1980s and, like the SCF, established an ADI of 40 mg/kg body weight.

In 1995, a study raised the possibility of a relationship between an increase in the frequency of brain tumours and the consumption of aspartame(3). This study was criticised by many scientists for faulty methodology. The SCF issued a first opinion on the results of this study in 1997. In 2002(4), based principally on work by AFSSA and by England's Food Standard Agency (FSA), the SCF concluded that the scientific data did not provide proof of a link between aspartame and brain tumours; the Acceptable Daily Intake for aspartame was consequently maintained.

AFSSA had indeed concluded in its contribution dated 2002, after assessing approximately 80 referenced scientific papers, that the available scientific data did not support the hypothesis put forward by Olney and colleagues (5).

In 2005 and 2006, the European Foundation of Oncology and Environmental Sciences “B. Ramazzini” in Bologna published the results of a study on rats whose conclusions suggested an increase in the incidence of lymphomas, leukaemia and other types of cancer in animals exposed to aspartame(6)((7). The European Commission referred the matter to EFSA, which requested the raw data from the Ramazzini Foundation in order to be able to examine them itself(8). The data were then analysed by EFSA(9).

EFSA concluded that there was nothing to justify questioning its previous assessments nor the ADI for aspartame of 40 mg/kg body weight(10). Furthermore, similar conclusions concerning the study published by the Ramazzini Foundation were issued by the US FDA on 20 April 2007(11).

A new article by the Ramazzini Foundation published in 2007(12) again noted an increase in the incidence of leukaemia, lymphomas and cancers of the mammary glands in rats after exposure to aspartame in utero. In February 2009, EFSA issued two opinions on this new article(13) which concluded that the available data obtained did not indicate any genotoxic or carcinogenic effects following exposure to aspartame in utero. The Acceptable Daily Intake (ADI) of 40 mg/kg body weight established for aspartame was therefore maintained. This ADI is still valid today.

New scientific studies have recently been published on the possible effects of sweeteners on health: in particular, a study carried out on mice on the link between aspartame and certain tumours (again from the Ramazzini Foundation), and a Danish epidemiological study on the relationship between the consumption of artificially sweetened soft drinks and the risk of giving birth prematurely(14). As part of its continual monitoring of health issues, ANSES will immediately examine these new studies with a view to making any necessary recommendations to the French authorities, and if necessary will alert the European Food Safety Authority (EFSA), which is the competent European authority for reassessing this risk.

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(1) Directive 94/35/EC of the European Parliament and Council dated 30 June 1994 on sweeteners for use in foodstuffs. OJ no. L 237 of 10.9.1994, p.3.

(2) The ADI is the estimated dose found in foods or drinking water, expressed as a function of body weight, that can be consumed every day of one's life, with no appreciable risk to the health of the consumer, taking account of all factors known at the time of evaluation. It is expressed in milligrams of substance per kilo of body weight.

(3) Olney JW, Farber NB, Spitznagel E, Robins LN. Increasing brain tumor rates: is there a link to aspartame? J. Neurpathol. Exp. Neurol. (1996) 55: 1115-1123.

(4) Opinion of the Scientific Committee on Food: Update on the Safety of Aspartame - 10 December 2002

(5) Report by the French Food Safety Agency on a possible link between exposure to aspartame and brain tumours. AFSSA. 7 May 2002.

(6) Soffritti M, Belpoggi F, Degli Esposito D, Lambertini L. Aspartame induces lymphomas and leukaemias in rats. Eur. J. Oncol 10: 107-116, 2005.

(7) Soffritti M, Belpoggi F., Dogli Esposito D., Lambertini L., Tibaldi E., Rigano A. First experimental demonstration of the multipotent carcinogenic effects of aspartame administered in the feed of Sprague-Dawley rats. Environmental Health Perspectives 114:379-385, 2006.

(8) Press release. New research data on the sweetener aspartame to be considered by EFSA's scientific experts. 14 July 2005.

(9) Press release. Aspartame: EFSA receives the data requested from the Ramazzini Institute. The scientific experts will start their assessment. 19 December 2005.

(10) Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC) on a request from the Commission related to a new long-term carcinogenicity study on aspartame. The EFSA Journal 356:1-44, 2006.

(11) FDA Statement on European Aspartame Study. April 20, 2007.

(12) Soffritti M., Belpoggi F., Tibaldi E., Dogli Esposito D., Lauriola M. Life-Span Exposure to low doses of aspartame beginning during Prenatal life increases cancer effects in rats. Environmental Health Perspectives 115:1293-1297, 2007.


(14) Halldorsson T. et al. Intake of artificially sweetened soft drinks and risk of preterm delivery: a prospective cohort study in 59,334 Danish pregnant women. Am. J. Clin.Nutr. 92:626-633, 2010; 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.