Sweetener approval

The main intense sweeteners currently permitted for use in the major markets of Europe and the United States are not natural and have had to go through a food additive approval procedure. Within the European Union, approval is controlled by the EU Commission, with the aim of achieving harmonisation across member states. The current system allows for temporary national approval (and this was the mechanism by which sucralose was approved in the United Kingdom). This in turn allows the other EU countries time to review the data and either approve or reject each product within a specified period. Within the European Union, approved sweeteners are assigned an E number and can also be assigned a maximum use level within a specific application (e.g. soft drinks). The maximum use levels for sweeteners in soft drinks in the European Union are given in Table 4.2. 

When assigning maximum use levels, the regulators take into account a sweetener s likely intake across different population groups and its acceptable 

Sweetener EU E-Number Solubility Caloric Nutritive (g/1) value (kcal/g) ADI (mg/kg bw) Approval Approval inEU in USA 1 Max. use level (ppm) Relative sweetnessb 

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Nonnutritive Sweeteners. Consumer desire to reduce caloric iatake and protect dental health has created an enormous market for nonnutritive sweeteners (qv). As of this writing there are only three nonnutritive sweeteners approved for use ia the United States. 

Acesulfame-K was approved as a new artificial sweetener for Pepsi One. It was the first sweetener approved since aspartame in 1981. 

Donald Rumsfeld, the former Secretary of Defense, is instrumental in getting Aspartame, the most popular artificial sweetener, approved despite attempts by consumer groups to ban the product. 

These studies persuaded the Canadian and American authorities to suspend use of the sweetener in 1977. In the USA it was banned under the Delaney Clause of the Food, Drug, and Cosmetic Act which prohibits the use of any food additive that has been shown to produce cancer in laboratory animals. There was a public outcry against the ban, as saccharin was the only general purpose artificial sweetener approved for use and available to diabetics and those with an obesity problem as well as to people who wished to reduce their consumption of sugar. The result was a moratorium on the ban in the USA to allow the evidence to be examined. Further studies were carried out and, while they confirmed the findings, it proved possible to rationalize the results in relation to human safety, as we shall see in the next chapter. In 1991 the FDA eventually withdrew its proposal to ban the sweetener.The cloud hanging over it was finally removed in 2000 when official concerns were dropped. 

Properties White crystalline powder from water or alcohol odorless sweet taste. Mw 294.34 mp 190. Slightly soluble in water, alcohol. TM for a synthetic nonnutritive sweetener approved by FDA for table-top use and as a packaged food additive. The U.S., Canada, and South Africa permit its use in carbonated beverages. A combination of aspartic acid and l-phenylalanine, it is said to be 200 times sweeter than sugar. 

Thaumatin (also called thalin) is a mixture of sweet proteins extracted from the fruit of the tropical West African flowering plant Thaumatococcus danielli (Marantaceae), known as miracle fruit or miracle berry. It is the only protein sweetener approved in the EU (E957). The main components with sweet notes resembling... 

Some of the most common low-calorie sweeteners approved for use in the United States are ... 

Sucralose has the structure most similar to su crose Galactose replaces the glucose unit of sucrose and chlorines replace three of the hydroxyl groups Sucralose is the newest artificial sweetener having been approved by the U S Food and Drug Adminis tration in 1998 The three chlorine substituents do not dimmish sweetness but do interfere with the ability of the body to metabolize sucralose It there fore has no food value and IS noncaloric... 

Acesulfame K. Acesulfame K [55589-62-3] C H NO S -K, is an oxathia2iae derivative approximately 200 times as sweet as sucrose at a 3% concentration ia solutioa (70). It is approved for use as a nonnutritive sweeteaer ia 25 couatties (71), and ia the United States has approval for use in chewing gum, confectionery products, dry mixes for beverages, puddings, gelatins, and dairy product analogues, and as a tabletop sweetener (72). 

Other Sweeteners. Two other sweeteners, sucralose and cyclamates, are approved for use outside of the United States. Sucralose, a chlorinated derivative of sucrose which is 500—600 times as sweet as sugar, has received limited approval in Canada, and petitions for its approval are pending in the United States and Europe (71). Cyclamate sweeteners, once available in the United States, but now baimed because they caused bladder cancer in animals, are stiU available in Canada and Europe. Table 7 gives several examples of nonnutritive sweeteners that have been developed. 

Larch arabinogalactan is approved in 21 CFR 172.610 as a food additive for use as an emulsifier, stabilizer, binder or bodying agent for essential oils and noimutritive sweeteners, flavor bases, nonstandardized dressings, and pudding mixes. It has also been used in the preparation of cosmetic and pharmaceutical dispersions and as an emulsifier in oil—water emulsions (69). Industrially, the main use has been in Hthography as a gum arabic substitute. 

A chlorination process (20,21,44—46) converts sucrose into sucralose [56038-13-2] (4,l, 6 -trichloro-4,l, 6 -trideoxy-galactosucrose), a heat-stable, noncariogenic, noncaloric, high intensity sweetener. Sucralose is approved for food use in Canada, Australia, and Russia. It is not yet approved for use in the United States. 

Acesulfame-K. Acesulfame-K [55589-62-3] (4), the potassium salt of acesulfame [33665-90-6] (6-methyl-l,2,3-oxathiaziQ-4(3ff)-one 2,2-dioxide), is a sweetener that resembles saccharin in stmcture and taste profile. 5,6-Dimethyl-l,2,3-oxathiazine-4(3ff)-one 2,2-dioxide, the first of many sweet compounds belonging to the dihydrooxathia2inone dioxide class, was discovered accidentally in 1967 (63). From these many sweet compounds, acesulfame was chosen for commercialisation. To improve water solubiUty, the potassium salt was made. Acesulfame-K (trade name Sunette) was approved for dry product use in the United States in 1988 and in Canada in October, 1994. Later, it was approved by the FDA for additional food categories such as yogurts, frosen and refrigerated desserts, and baked goods. 

In 1969, a chronic toxicity study on a cyclamate saccharin (10 1) blend indicated bladder cancer problems in rats. Cyclamate was soon banned by the FDA, but saccharin remained an approved sweetener. In 1977, the FDA proposed a ban on saccharin because of the discovery of bladder tumors in some male rats fed with high doses of saccharin. Because no other nonnutritive sweetener was available at that time, the proposed ban faced strong opposition. 

The main utihty of saccharin had been in beverages and as a table-top sweetener. Upon the approval of aspartame for carbonated beverages in 1983, aspartame displaced saccharin in most caimed and bottied soft drinks. However, saccharin is stiU used, usually blended with aspartame, in carbonated soft drinks dispensed from soda fountains. 

Sucralose. Sucralose [56038-13-2] is a trichlorodisaccharide sweetener developed by the British sugar company Tate Lyle during the 1970s (87—89). It was Hcensed to McNeil Specialty Products Company (a Johnson Johnson subsidiary) in the United States. A food additive petition was filed with the FDA in 1987 (90). As of December, 1996, the petition was still pending. Sucralose was approved for use as a sweetener by Canada in 1991, by Austraha, Mexico, and Russia in 1993, by Romania in 1994, and by New Zealand in 1996. 

Thaumatin (trade name Talin) is a very potent sweetener (ca 2000X, 10% sucrose solution sweetness equivalence). However, its potency is overshadowed by inferior taste quaUties. The onset of sweetness is very slow, and after reaching the maximum sweetness, a very long-lingering sweetness combined with an unpleasant aftertaste follows. Primarily owing to this poor taste quaUty, thaumatin is not considered a practically useflil sweetener. It is, however, used as a flavor enhancer, especially in products such as chewing gum. Thaumatin and thaumatin B-recombinant were affirmed GRAS flavors (EEMA no. 3732 and 3814, respectively). They are not approved as sweeteners in the United States. 

To meet consumer demands, manufacturers are developing new nonnutritive sweeteners that more closely match the taste and mouthfeel of sucrose. There are several nonnutritive sweeteners currentiy pending FDA approval for use in soft drinks. They include sucralose [56038-13-2] aUtame [80863-62-3] encapsulated aspartame, cyclamates, and acesulfame-K [55589-62-3] also known as paUtinit. 

FDA Approves New High-Intensity Sweetener Sucralose. FDA Talk Paper T98-16, April 1,1998, The Diabetes Monitor, http //www.diabetesmonitor.com/sucralos.htm... 

No studies have shown yet humans can develop cancer from exposure to sweeteners. ACSH the enormous doses necessary for such experiments. .. may overwhelm the animal s natural defenses. Saccharin still available, but its use has decreased since 1983 (aspartame approval s year)... 

Approved in 1981 as a table top sweetener and for dry foods, aspartame was permitted in carbonated soft drinks in 1983, and in 1996 its approval was extended to all foods and beverages. There has been controversy over the role a Public Board of Inquiry played in the approval process, but this has been discounted in reports by the American Medical Association (Council of Scientific Affairs, 1985) and Stegink (1987). Reports of adverse reactions began almost immediately after approval in the 1980s, and by mid-1984 more than 600 complaints had been received by the FDA. Reports of adverse reactions peaked in 1985, when over 1,500 complaints were received by ARMS, and have been declining since then. As of June 2000, ARMS had received a total of 7,335 complaints about aspartame, with 47% of complaints linked to diet soft drinks, followed by 27% of complaints attributed to table top sweeteners. All other product categories were mentioned in fewer than 10% of complaints. 

Sweeteners are food additives by definition in almost all countries and need approval for use by food laws, food regulations, decrees or certificates released and issued by the national government or other responsible governmental institutions. Generally three prerequisites must be fulfilled to obtain an approval for use ... 

The extent of safety studies necessary to obtain food additive approval can be demonstrated by the studies carried out on acesulfame K (trade name Sunett ), one of the sweeteners developed in course of the last 25 years,7 which has been endorsed for food use by the Joint Expert Committee on Food Additives (JECFA) of the WHO and FAO and the Scientific Committee for Foods (SCF) of the EU and has meanwhile been approved in more than 100 countries. This program shows the wide range of studies necessary. 

Some countries approve cyclamate and the EU Sweetener Directive lists cyclamate for a number of applications, while others still ban cyclamates. Attempts to get a re-approval in the USA have remained unsuccessful so far. 

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