Safety

On the basis of numerous scientific studies and national and international regulatory agencies have classified Ace-K as safe for human consumption.

The internationally recognized Joint FAO/WHO Expert Committee on Food Additives (JECFA) has repeatedly examined and evaluated data from Ace-K studies and deemed it harmless for use in food. Similarly, the U.S. Food and Drug Administration (FDA) has approved Ace-K as safe for consumption as a food additive. The European Food Safety Authority has also come to a positive assessment, as have national health authorities in Canada, Australia, and Japan, and elsewhere.

Discovered in 1967 by Hoechst scientists in Frankfurt, Germany, Ace-K Ace-Khas been used in food and beverages since 1983 and now is approved in more than 100 countries around the world.

Approval milestones

1967 – Ace-K Ace-Kdiscovered by Hoechst AG
1983 – Approval in Great Britain
1984 – Approval in Australia
1986 – Approval in Belgium, Italy, and South Africa
1987 – Approval in Switzerland
1988 – Approval in USA and France
1990 – Approval in Germany
1998 – Approval for soft drinks in USA
2000 – Approval in Japan
2003 – General purpose approval in USA1

References

1 Since 2003, Ace-K Ace-Khas been used as a general purpose sweetener adding approval for numerous products in addition to the already approved categories of chewing gum, dry beverage mixes, dry desserts mixes, dry dairy analog bases, tabletop sweeteners, confections, soft candy, hard candy (including breath mints, cough drops and lozenges), baked goods, dairy products, carbonated beverages and alcoholic beverages. In addition, Ace-K Ace-Kcan also be used as a flavor enhancer.

How has the safety of Ace-K been established?

On the basis of over 90 scientific studies, the relevant national and international regulatory agencies have classified Acesulfame Potassium as safe for human consumption. The internationally recognized Joint Expert Committee on Food Additives of the Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO) repeatedly examined and evaluated data from Acesulfame Potassium studies and deemed it safe for use in food. Similarly, the U.S. Food and Drug Administration (FDA) has approved Acesulfame Potassium as safe for consumption as a food additive. The Scientific Committee on Food of the European Union has also come to a positive assessment along with national health authorities in various countries such as Canada, Australia and Japan. Acesulfame Potassium is approved in more than 100 countries and is used in over 5,000 food and beverage products worldwide.

Does Ace-K cause cancer?

No. All substances that are intended to be added to food must undergo extensive tests to ensure their safety. At the center of these studies are tests to determine whether the substances have any carcinogenic or cancer-promoting effect. Only substances not suspected of having such an effect are approved for use in food by the relevant agencies.

Does Ace-K cause headaches?

No. In today’s society, headaches are commonplace. Headaches can have many causes, such as stress, long hours in front of a computer screen, etc. There are no indications that Acesulfame Potassium could be responsible for the occurrence of headaches.

Does Ace-K increase the appetite and cause weight gain?

No. Although this accusation is repeated time and again, there is no proof that this is the case. Studies on this subject have shown no relationship between the consumption of Acesulfame Potassium and increased appetite. Acesulfame Potassium is not metabolized or broken down in the body but is excreted unchanged. As a result, consumption of products sweetened with Acesulfame Potassium does not cause an increase in insulin nor a resulting drop in blood sugar level, which could trigger hunger pangs. Additionally, there are no known complaints from consumers that the consumption of products containing Acesulfame Potassium has resulted in increased appetite. Health experts agree that weight loss is best achieved by a combination of reducing caloric intake and increasing exercise/activity but can be accomplished more slowly by a reduction in caloric intake or exercise alone. Weight management results from balancing food intake with energy expenditure. Calorie-free sweeteners do not make people lose weight. They are, however, tools that those trying to lose or maintain weight may incorporate as part of an overall healthy lifestyle that includes exercise and nutritious food.

Does Ace-K cause gastrointestinal effects?

Acesulfame Potassium does not cause gastrointestinal effects. It is not metabolized by the body and is excreted essentially unchanged. Many products contain a combination of Acesulfame Potassium and other sweeteners such as polyols. Polyols are only partially digested, like beans and other high fiber foods. For most consumers, polyols do not cause a problem. In some people, excessive consumption of these sweeteners may cause gastrointestinal symptoms, such as gas or bloating experienced with consumption of high fiber foods. Such symptoms depend on an individual’s sensitivity and the other foods eaten at the same time.

Does Ace-K cause sensitivity to light?

Hypersensitivity to sunlight can occur after contact with various substances. No such hypersensitivity has been observed to date with Acesulfame Potassium.

How is Ace-K metabolized?

Ace-K is not metabolized by the body and is excreted unchanged.

May pregnant women consume Ace-K?

Yes. The Scientific Committee on Food of the European Union (SCF) published an opinion on the applicability of the ADI (Acceptable Daily Intake) for food additives and stated, “The ADI covers adequately exposure during all live stages including special emphasis on reproductive cells, on the fetus and on the young and old organism”. Although calorie-free sweeteners can be safely used by pregnant women, caloric restriction is not generally encouraged during pregnancy due to increased energy needs of pregnant women. However, those women who relegate intake of calories to foods that supply appropriate nutrition can utilize calorie-free sweeteners to satisfy sweet cravings. The FDA approved use of Acesulfame Potassium without restrictions for any segment of the population. Pregnant women, however, should follow the advice of their physician regarding their nutrition, including the use of low-calorie sweeteners.

How many studies have been carried out with Ace-K?

Altogether, over 90 studies have been conducted on Acesulfame Potassium.

Which authorities have approved Ace-K?

Numerous studies have thoroughly established the safety of Ace-K. In addition, the world’s leading scientific institutions and regulatory bodies have reviewed these studies and repeatedly confirmed its safety. Ace-K is permitted in XXX countries around the world. Some expert reviews include those from:

    • SCF (EU Scientific Committee on Food)
    • Food and Agriculture Organization (FAO)/World Health Organization (WHO)
    • Joint Expert Committee on Food Additives (JECFA)
    • US Food and Drug Administration (FDA)
    • Nordic Council of Ministers
    • Commission of the European Communities

    The following are statements from regulatory bodies regarding the safety of Ace-Ky

    • “Under the conditions of this 9-month study, there was no evidence of carcinogenic activity(from) Acesulfame Potassium in male or female p53 haploin sufficient mice exposed to 0.3%, 1%, or 3%.”(National Toxicology Program Board of Scientific Counselor’s Technical Reports Review Subcommittee on May 22, 2003)

    “FDA has evaluated the data in the petition, published scientific literature, and other relevant material from its files and concludes that the use of ACK in non-alcoholic beverages is safe”(Food and Drug Administration in the Federal Register Vol.63, No. 128, Monday, July 6, 1998, page 36,361))

    “FDA has evaluated the data in the petition and other relevant material and concludes that the use of Acesulfame Potassium in alcoholic beverages is safe”.(Food and Drug Administration, Federal Register Vol. 60, No. 85, May 3, 1995, page 21,701)

    “FDA has evaluated the data in the petition and other relevant material and concludes that the proposed use of Acesulfame Potassium in yogurt and yogurt-type products, frozen and refrigerated desserts, and in syrups, sweet sauces and toppings is safe….”(Food and Drug Administration, Federal Register Vol. 59, No. 230, December 1, 1994, page 61,540)

    “FDA has evaluated the data in the petition and other relevant material and concludes that the proposed uses of Acesulfame Potassium in baked goods, baking mixes, and frostings, icings, toppings, and fillings for baked goods are safe….”(Food and Drug Administration, Federal Register Vol. 59, No. 230, December 1, 1994, page 615,424)

    “FDA has evaluated the data in the petition and other relevant material and concludes that Acesulfame Potassium is safe under the conditions of use …”(Food and Drug Administration, Federal Register Vol. 53, No. 145, July 28, 1988, page 28,382)

    “…the agency…concludes that Acesulfame Potassium is safe for the additional uses requested…”(Food and Drug Administration, Federal Register Vol. 57, No. 236, December 8, 1994, page 57,961)

    “The committee was provided with extensive toxicological data including metabolic, long‑term, reproduction and teratology studies. The long‑term studies in rat and mouse did not show any dose‑related increase in specific tumors nor any treatment‑related pathological changes of significance.”(Commission of the European Communities, “Sweeteners.” Reports of the Scientific Committee for Foods No. 16, Luxembourg, 1985)

    “The safety of acesulfame K is well documented by the studies reviewed by the SCF (EU Scientific Committee on Food), JECFA (Joint Expert Committee for Food Additives of the WHO and FAO) and national authorities: A re-evaluation is not recommended as the compound was recently reviewed by the SCF.” (Food Additives in Europe 2000 – Status of Safety Assessments of Food Additives Presently Permitted in the EU, Nordic Council of Ministers, Tema Nord 2002:56)

    “More than 90 safety studies, including four long‑term animal feeding studies, conducted over the last 20 years were submitted to the FDA. FDA addressed the question of tumors found in some rats fed acesulfame K during one of the long‑term studies. A detailed analysis of the tumors showed that they were typical of what could be routinely expected in rats and were not related to acesulfame K. (American Dietetic Association, “Position of The American Dietetic Association: Use of nutritive and non-nutritive sweeteners,” ADA Reports)

    “Currently, there are three non-nutritive sweeteners…approved for use in the United States: saccharin, aspartame, and Acesulfame Potassium – – These products undergo rigorous scrutiny from the FDA and are not allowed on the market unless they are safe for the public, including people with diabetes, to consume.” (Technical Review, Vol. 17, Number 5, May 1994, Diabetes Care) (Note: there are currently five non-nutritive sweeteners approved for use in the United States – Acesulfame Potassium, aspartame, neotame, sucralose and saccharin.)

Can I Have Too Much Ace-K?

As consumers look to reduce the amount of added sugars and total calories in their diet, low- and no- calorie sweeteners (LNCS) may be considered to help achieve this goal. Click here to learn more about how much you can have without posing a health risk.