Sweeteners
carcinogenic pathways, thus supporting a scientific hypothesis of its potential carcinogenicity. When such concerns arise, the food industry – and consumers – may look to regulatory bodies to clarify matters. At the moment, however, there seems to be a lack of clarity about the safety of aspartame.
Voices from IARC and the FDA In July 2023, the International Agency for Research on Cancer (IARC), which is part of the World Health Organisation (WHO), classified aspartame as ‘possibly carcinogenic’. This followed a recommendation in 2019 by an external expert advisory group of independent scientists that aspartame be a high priority for cancer hazard identification.
The initial recommendation arose from findings of increased tumours in some studies of animals that were exposed pre- and postnatally to aspartame, and also some positive findings for cancer in humans. In 2023, an expert Monographs Working Group of independent scientists at the IARC reviewed all human cancer, animal cancer and mechanistic evidence related to aspartame in the publicly available literature, including unpublished industry studies that were made publicly available by the European Food Safety Authority. “The Working Group concluded that there was ‘limited’ evidence for cancer in humans, specifically for hepatocellular carcinoma, the main type of liver cancer; ‘limited’ evidence for cancer in experimental animals; and ‘limited’ mechanistic evidence that aspartame displays the key characteristics of carcinogens,” remarks Dr Mary Schubauer-Berigan, branch head for evidence synthesis and classification at the IARC Monographs programme.
On the surface, the IARC – working with the WHO and the Food and Agriculture Organisation (FAO) Joint Expert Committee on Food Additives (JECFA) – seems to have flagged aspartame as a carcinogenic substance. Nevertheless, the JECFA did not change its recommendations for the acceptable daily intake (ADI) of 40mg/kg body weight. The IARC and JECFA conducted independent but complementary reviews to assess the potential carcinogenic hazard and other health risks associated with aspartame consumption. For the IARC, this was the first evaluation of aspartame, though for the JECFA it was the third time assessing its health risks. Both bodies reviewed the available scientific literature, and both found that there were limitations in the evidence available concerning the risk of cancer and other health effects.
A spokesperson for the European Food Safety Authority (EFSA) confirmed that “the findings of JECFA are in line with the previous conclusions of EFSA’s latest assessment on aspartame,
Ingredients Insight /
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reconfirming the ADI of 40mg/kg per body weight for this food additive previously set by EFSA in 2013. It is important to underline that EFSA and the IARC carry out separate types of assessments, which are different in their scope. While IARC’s mission is to assess and identify potential sources of carcinogenicity, EFSA’s role, as well as JECFA, is to evaluate risks to human and animal health.” While the IARC and JECFA did highlight some risk of cancer from their analyses, on the same day that they announced their findings the US Food and Drug Administration (FDA) adopted a slightly different tone, saying that aspartame is safe to consume. Specifically in response to the IARC assessment, the FDA reconfirmed its previous conclusions that aspartame is safe to consume, with a statement noting that it was aware of the IARC and JECFA conclusions about aspartame, but wished to clarify that labelling aspartame is ‘possibly carcinogenic to humans’ does not mean that it is actually linked to cancer. “The FDA disagrees with IARC’s conclusion that these studies support classifying aspartame as a possible carcinogen to humans,” read the statement, adding that “FDA scientists reviewed the scientific information included in IARC’s review in 2021 when it was first made available and identified significant shortcomings in the studies on which IARC relied.” The FDA further noted that the JECFA did not raise safety concerns for aspartame under the current levels of use and did not change the ADI. The regulatory backed up its position by noting that aspartame is one of the most studied food additives in the human food supply chain and that its scientists have no safety concerns when it is used under the approved conditions. Indeed, regulatory bodies in Canada and the EU consider aspartame safe to use at currently permitted levels.
Aspartame’s carcinogenic potential has been extensively studied, yet still remains disputed.
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