Safety of sweeteners in the EU
Before being authorised for use in food and drinks all low-calorie sweeteners come under rigorous scrutiny of national and international scientific expert committees. These independent bodies include the Joint FAO/WHO Expert Committee on Food Additives (JECFA) at international level, the European Food Safety Authority (EFSA) at European level, as well as national agencies; they are responsible for evaluating the safety of low-calorie sweeteners that have been petitioned for use in a given market. The careful and detailed approval procedure for these products, and the extensive testing done to obtain and maintain approval, have ensured that sweeteners are among the most thoroughly tested food additives in use today.
Authorisation for the use of a low-calorie sweetener in food and drinks in the EU is given in response to a petition from a sponsor, on the recommendation of EFSA, and on the basis of a proposal by the European Commission and a joint decision by the European Parliament and the European Council. The role of EFSA is that of a risk assessor and its independence is crucial, to regulators, decision makers, industry and consumers alike.
Sponsors apply or petition for approval after extensive safety tests have been completed and the sponsor itself is convinced of the product's safety and utility. The petition provides technical details about the product and comprehensive data obtained in safety studies. At any time, questions raised by EFSA must be answered by the sponsors. Sometimes this may require additional studies. Obtaining approval is often a very lengthy process. Completing and analysing the safety studies may take from seven to fifteen years and the cost are carried fully by the petitioner. Only if the regulators are fully satisfied that the product is safe will approval be given and authorisation for use recommended. In the case of low-calorie sweeteners and other additives currently on the EU market, this means that they are thoroughly safe for human consumption.
Low-calorie sweeteners like all additives remain under continuous evaluation during their use in order to remain approved. For instance, it is EU policy that: "All food additives must be kept under continuous observation and must be re-evaluated whenever necessary in the light of changing conditions of use and new scientific evidence." EFSA, as an independent scientific body, is responsible for any re-evaluation that might be required.
Acceptable daily intake
Once a sweetener has been found safe by an independent scientific body it is given an Acceptable Daily Intake (ADI). The ADI is the amount of a food additive that can be consumed in the diet every day throughout life without health risks. It is in fact a safe intake level. The granting of an ADI and the approval of a substance signifies that a product is safe.
According to JECFA "the ADI relates to lifetime use and provides a safety margin large enough for toxicologists not to be particularly concerned about short-term use at exposure levels exceeding the ADI providing the average intake over long periods of time does not exceed it." The ADI is the most important practical tool for legislators in ensuring the appropriate and safe use of food additives. The amounts of food additives permitted in different foods and beverages are established so that even the average daily intake by high consumers over prolonged periods of time would not exceed the ADI value. Different international scientific bodies such as JECFA and EFSA use the same method of deriving the ADI independently. This guarantees consistency of food safety worldwide. Dietary surveys have shown that intakes of low-calorie sweeteners are generally well below the ADI.
The safety of sweetener blends
Different low-calorie sweeteners show differences in properties such as perceived sweetness, "mouth feel", duration of sweet taste, aftertaste, solubility and stability at various pH values and temperatures. Not only is a single low-calorie sweetener safe but also combined low-calorie sweeteners are safe. The scientific basis on which food ingredients, including low-calorie sweeteners, are approved includes a thorough understanding of how each ingredient is handled by the body. They have a different metabolic route, meaning that a low-calorie sweetener cannot have an effect on another low-calorie sweetener in the body. This also means there is no combined effect for low-calorie sweeteners.
Most recent SCF (now EFSA) safety evaluation on individual low calorie sweeteners
- E950: Acesulfame-K – 9 March 2000: ADI 0-9mg/kg bw
- E951: Aspartame – 4 December 2002: ADI 0-40mg/kg bw
- E962: Aspartame-acesulfame salt – 8-9 March 2000 (see section 9.4): the aspartame and acesulfame moieties in aspartame-acesulfame salt are covered by the acceptable daily intake (ADI) values previously established for aspartame and acesulfame-K (respectively 0-40 mg/kg body weight per day for aspartame and 0-9 mg/kg bodyweight per day for acesulfame-K).
- E952: Cyclamate – 9 March 2000: ADI 0-7mg/kg bw
- E959: Neohesperidine DC – 10 November 1988 (see section on sweeteners): ADI 0-5mg/kg bw
- E954: Saccharin – 2 June 1995: ADI 0-5mg/kg bw (In July 2001, SCF saw no reason to undertake a review of saccharin “at this stage”)
- E955: Sucralose – 7 September 2000: ADI 0-15mg/kg bw
- E957: Thaumatin – 10 November 1988 (see section on sweeteners): “acceptable”
Aspartame safety
Low-calorie sweeteners, including aspartame, are among the most comprehensively investigated food additives ever and the scientific databases have been submitted to, and assessed by national and international regulatory bodies throughout the world. Despite the uniform conclusion by all such bodies that aspartame is safe, allegations continue to arise from a relatively small number of individuals. When new allegations have arisen, these have been carefully considered by regulatory bodies, and in all cases they have concluded that aspartame is safe. The reader is therefore left with a choice between accepting the conclusions of internationally recognised scientific and regulatory bodies, or the conspiracy theories of those who seem to believe that it is in the interests of regulators to behave irresponsibly. These allegations try to discredit the integrity of some of the world’s most respected scientific and regulatory experts. Yet the fact remains that aspartame today is approved in over one hundred countries, only after having gone through the most stringent evaluations.
Fact sheet on aspartame: Aspartame facts (pdf)
Aspartame in more detail: Aspartame – its components and safety (pdf)
Websites on aspartame safety: http://www.aspartame.info and http://www.aspartame.org