Sodium Saccharin E954

Saccharin and Sodium Saccharin E954

Saccharin

Saccharin is not the same with Sodium Saccharin. Another name is insoluble Saccharin, it is mainly used to produce Sodium Saccharin. Chemical formula as follows:

Chemical Name: O-Benzoic Sulfimide
Molecular formula:C7H5N03S
Molecular Weight: 183.19

Sodium Saccharin E954

Sodium Saccharin E954 is the sodium salt of Saccharin. It is the first generation of artificial sweetener, its sweet degree is about 500 times than that of sugar. It is widely used in toothpaste, mouth wave, drinks, medicines, feed, electricity plating and etc. It’s harmless to the human body and it’s can not absorbed by the body as it can be discharged completely through body metabolism.

It has two Specifications in the market, Sodium Saccharin Dehydrate (with 15% water, CAS number 6155-57-3) and Sodium Saccharin Anhydrous(with 6% water, CAS number 128-44-9).

Sodium Saccharin Dehydrate

Another name of Sodium Saccharin Dehydrate is 15% water Sodium Saccharin. It has 4-6 mesh,5-8 mesh,6-10mesh, 8-12mesh,8-16mesh,10-20mesh,20-40 mesh and 40-80 mesh in the market.

Chemical Name: Sodium O-Benzoic Sulfimide
Molecular formula: C7H4N03SNa2H20
Molecular Weight: 241.20

CAS number 6155-57-3

Sodium Saccharin Anhydrous

Another name of Sodium Saccharin Anhydrous is Spray dried Sodium Saccharin or 6% water Sodium Saccharin. It has 100mesh in the market.
Chemical Name: Sodium O-Benzoic Sulfimide
Molecular formula:C7H4N03SNa
Molecular Weight: 205.17

CAS number 128-44-9

Regulatory History

Discovered in 1879, Sodium Saccharin E954 has been used to sweeten foods and beverages without calories or carbohydrates for over a century. Its use was considerable during the sugar shortages of the two world wars, particularly in Europe. For many people, it is an integral part of their lifestyle. It is particularly important to those whose diets require a restriction of caloric or carbohydrate intake, such as persons with diabetes. Most health practitioners favor using non-caloric sweeteners in weight reduction and for people with diabetes.

The regulation develops as follows:

1879 – A student researcher at Johns Hopkins University discovered it.

1907 – A top food safety official tried to ban it from using as a sweetener, but President Theodore Roosevelt adamantly opposed it.

1911 – A board of federal scientists called it “an adulterant” that should not be used in foods and limited its use to products intended for invalids. The restriction was lifted during World Wars I & II due to shortages of sugar.

1958 – The Delaney Clause was enacted into law prohibiting the use of any food additive shown to cause cancer in animals or humans.

1958 – Congress passed the Food Additives Amendment to the Food, Drug and Cosmetic Act requiring pre-market approval from the U.S. Food and Drub Administration (FDA) for food additives developed after 1958. This did not apply to Sodium Saccharin, which was classified by the FDA as “generally recognized as safe” (GRAS).

1969 – An FDA Ban on cyclamates, a sweetener similar to it, led to investigations of its carcinogenicity.

1970 – The FDA started to review GRAS substances to ensure that current scientific information backed the safety claims.

1972/73 – Toxicological rat studies indicated the possibility that Sodium Saccharin could cause bladder cancer. The data, however, suggested that impurities in sodium saccharin were actually causing the cancer.

1972 – The FDA removed it from the list of GRAS substances and issued an interim food additive regulation limiting use of in foods.

1974 – The National Academy of Science reviewed available data and stated that it could not be identified as the cause of tumors due to impurities and problems with research. FDA interim regulations remained in effect.

1977 – Canadian rat studies by Arnold D.L., et al., showed that it was causing bladder cancer in rats (primarily male); Based on these studies, the FDA proposed to ban all its uses except for over-the-counter (OTC) drugs for use by diabetics and/or those who would benefit from an artificial sweetener.

1977 – Congress passes two year moratorium preventing the proposed FDA ban on Sodium Saccharin.. Congress asks for additional research and institutes product labeling requirements.

1981 – The National Toxicology Program (NTP) and the International Agency for Research on Cancer (IARC) listed saccharin and its salts as “anticipated human carcinogen” based on Canadian rat studies.

1988 – Saccharin and its salt were added to the State of California’s Proposition 65 list as chemicals known to cause cancer.

1991 – The FDA formally withdraws its 1977 proposal to ban the use.

1998 – The International Agency for Research on Cancer (IARC) downgraded rating of saccharin and its salts from “possibly carcinogenic to humans” to “not classifiable as to its carcinogenicity to humans”.

2000 – The NTP removed Sodium Saccharin from its 9th Edition of the Report on Carcinogens.

2000 – President Clinton signed a bill to remove the warning label from its products.

2001 – The Carcinogen Identification Committee of the State of California issued a request for data and comments from professionals and the public regarding new information on sodium saccharin. Currently, sodium saccharin products still carry the warning label.

2003 – The Department published the Antidumping Duty order on saccharin from the PRC \1\

2009 – At the conclusion of the first sunset review, the Department published a notice of continuation of the Antidumping Duty order on it from the PRC.\2\

2014 – the Department initiated a second sunset review of the Antidumping Duty order on it from the PRC, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). As a result of its review, the Department determined that revocation of the Antidumping Duty order on it from the PRC would likely lead to a continuation or recurrence of dumping and notified the ITC of the magnitude of the margins of dumping likely to prevail were the order revoked.\3\

2015 – Revocation of the Antidumping Duty Order From the People’s Republic of China. AGENCY: Enforcement and Compliance, International Trade Administration,
Department of Commerce. SUMMARY: As a result of the determination by the International Trade Commission (ITC) that revocation of the antidumping duty (AD) order on saccharin from the People’s Republic of China (PRC) is not likely to lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time, the Department
of Commerce (the Department) is revoking the AD order on saccharin from the PRC.

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\1\ Notice of Antidumping Duty Order: from the People’s Republic of China, 68 FR 40906 (July 9, 2003). 
\2\ Continuation of Antidumping Duty Order from the People’s Republic of China, 74 FR 27089 (June 8, 2009) (“Continuation”). 
\3\ Saccharin from the People’s Republic of China: Final Results of Expedited Second Sunset Review of Antidumping Duty Order, 79 FR 51139 (August 27, 2014). 

Application & Use

In low-calorie and sugar-free food & beverage

Research also has shown that health professionals believe it is especially beneficial to obese individuals and persons with diabetes. Additionally, research indicates that Sodium Saccharin E954 may help to reduce risk of dental caries. It continues to be important for a wide range of low-calorie and sugar-free food & beverage applications.

It is used in such products as soft drinks, tabletop sweeteners, baked goods, jams, chewing gum, canned fruit, candy, dessert toppings and salad dressings. Additionally, personal care products such as toothpastes, mouthwash, hygiene/cosmetic products, vitamins and pharmaceuticals contains Sodium Saccharin E954.

Sweeteners blends

The current availability of Sodium Saccharin and other low-calorie sweeteners, such as aspartame, acesulfame potassium, neotame and sucralose, allows manufacturers to utilize a “multiple sweetener approach” — using the most appropriate sweetener, or combination of sweeteners, for a given product. Blending a variety of low-calorie sweeteners provides products with increased stability, improved taste, lower production costs and more choices for the consumer.

Additionally, blending sodium saccharin e954 with one or more low calorie sweeteners can result in sweetness synergy (the resulting sweetness is greater than the sum of the sweetness of the individual sweeteners), which can decrease the total amount of sweetener.

Sodium Saccharin E954 is stable when heated, even in the presence of acids, does not react chemically with other food ingredients, and stores well. In its acidic form, Saccharin is not particularly water-soluble. The form used as an artificial sweetener is usually its sodium salt, Sodium Saccharin. People restricting their dietary sodium intake sometimes use he calcium salt, Calcium Saccharin.

What is the use of Sodium Saccharin in toothpaste?

Sodium Saccharin E954 is a sugar substitute for toothpaste, mouthwash, beverages, table-top sweeteners, confectionery, electro-plating and etc. From our observing, there are lot oftoothpaste that contains E954. The use quantity of sodium saccharin in toothpaste is more than 50% in its total consumption in the market.

It does not promote tooth decay in toothpaste while sugar can. Toothpaste must have thickeners to stay on the toothbrush, and squeeze out of the tube. It must have detergents to remove fatty films, and water softeners to make the detergents work better, and sweeteners, preferably non-nutritive, so bacteria are not encouraged.

What is the use of Sodium Saccharin in feed?

Sodium saccharin E954 is intended to be used as a sweetener in feed and water for drinking for piglets, pigs for fattening and veal calves. The Panel on Additives and Products or Substances used in Animal Feed(FEEDAP) considers the proposed maximum use level of 150 mg sodium saccharin/kg feed as safe forcalves and pigs for fattening.

For piglets (sucking and weaned piglets), a lower level of 100 mg sodium saccharin/kg complete feed is considered safe. The corresponding maximum safe concentrations in water for drinking are 30 mg/L for piglets and 50 mg/L for pigs for fattening, respectively.

Source: Safety and efficacy of sodium saccharin when used as a feed flavour for piglets, pigs for fattening, calves for rearing and calves for fattening 

Benefits

Zero glycemic index and beneficial to diabetes

It may be useful for people with diabetes. Saccharin produces no glycemic response and may help control caloric intake. Sodium Saccharin is both calorie and carbohydrate free. It is appropriate to use it for medical and nutrition therapy (MNT) for people with diabetes, and dietetic professionals may incorporate saccharin into the individualized meal plans of their patients who have diabetes.

Zero calories

Sodium Saccharin E954 produce zero calories and is useful for people trying to control their weight. It may assist in weight management, control of blood glucose and prevention of dental caries. Replacing full-calorie products with it may help promote modest weight loss and may facilitate long-term maintenance of weight loss.

It has a long history (more than 100 years) of safe use. Sodium Saccharin contributes no calories to the diet because human body cannot metabolized it. (It is excreted in the same form it is ingested.)

Tooth health

Does not contribute to tooth decay. It is also inexpensive when compare with second generation artificial sweeteners (aspartame and acesulfame k) and third generation artificial sweeteners (sucralose).

Heat Stable

Sodium Saccharin E954 is 500 times sweeter than sucrose. It has the ability to synergize the sweetening power of both nutritive and nonnutritive sweeteners, and its sweetening power is stable with heating. These factors make it an excellent food additive in manufactured products. During such blending of sweeteners, sodium saccharin can provide stability to maintain the product’s sweetness over a prolonged period of time. It also has a long shelf life.

As a tabletop sweetener, E954 is available in granular form (mostly 20-40 mesh and 40-80 mesh).

Sodium Saccharin is useful for consumers who want to create lower-calorie, lower sugar versions of their favorite recipes. Because it is heat stable it is a good choice for use in cooking, baking and canning/preserving. Depending on the type of recipe, e951 may be used to replace 50-100 percent of the sugar without sacrificing taste or other aspects of palatability.

Source: saccharin.org 

Safety

Sodium Saccharin E954 has been the subject of extensive scientific research. It is one of the most studied ingredients in the food supply. Although the totality of the available research indicates it is safe for human consumption, there has been controversy over its safety. The basis for the controversy rests primarily on findings of bladder tumors in some male rats fed high doses of sodium saccharin. Considerable research, however, indicates safety at human levels of consumption.

In addition, the level of human consumption of sodium saccharin E954 is very small compared to the levels used in rat studies. Further, although past research found increased risk of bladder tumors in male rats ingesting high amounts of sodium saccharin, additional research has discovered that the mechanism by which the tumors developed was specific to male rats and does not apply in humans.

The average user ingests less than one ounce of the sweetener each year. The following scientific data demonstrates its safety:

Extensive research on human populations has established no association between sodium saccharin and cancer. More than 30 human studies indicated sodium saccharin’s safety at human levels of consumption. These studies include multiple generations of users.

In 14 single-generation animal studies involving several species of animals, sodium saccharin did not induce cancer in any organ, even at exceptionally high dose levels.

The body does not metabolize it and does not react with DNA (nucleic acid present in all living cells).

Sodium Saccharin E954 is approved in more than 100 countries around the world and has been determined to be safe by regulatory agencies around the world, including the U.S. Food and Drug Administration (FDA), Health Canada, the European Food Safety Authority (EFSA) and the Joint Expert Committee on Food Additives (JECFA) of the World Health Organization (WHO). In summary, research conducted over the past 25 years and a history of human use of over 100 years overwhelmingly demonstrates that it does not cause cancer in humans.

Safety supported

1993 – World Health Organization (WHO) Confirmed as a safe artificial sweetener for human consumption

1998 – International Agency for Research on cancer (iARc) Deleted from list of carcinogen

2000 – National Toxicology Program (nTP) Deleted from list of carcinogens

2001 – Food and Drug Administration (FDA) Declared safe for human consumption

2010 – Environmental Protection Agency (ePA) Deleted from list of toxic materials

2011 – The Wall street Journal (WsJ) Us President Barack Obama commented that the ePA’s decision to eliminate the regulation on saccharin was wise.

Side Effects

Discovered in 1879 and 500 times sweeter than table sugar, sodium saccharin is added to some foods to reduce the calorie count without stripping the food of its sweet flavor. Though there is some controversy about the use of artificial sweeteners and health, it is recognized as safe by the U.S. Food and Drug Administration. Certain diet and low-calorie foods contain saccharin, and they include the artificial sweetener in the ingredient list.

It is approved for use in food as a non-nutritive sweetener. It is 500times sweeter than table sugar (sucrose), and it does not contain any calories.

First discovered and used in 1879, sodium saccharin is currently approved for use, under certain conditions, in beverages, fruit juice drinks, and bases or mixes when prepared for consumption in accordance with directions, as a sugar substitute for cooking or table use, and in processed foods. It is also approved for use for certain technological purposes.

In the early 1970s, sodium saccharin was linked with the development of bladder cancer in laboratory rats, which led Congress to mandate additional studies of sodium saccharin and the presence of a warning label on saccharin-containing products until such warning could be shown to be unnecessary. Since then, more than 30 human studies demonstrated that the results found in rats were not relevant to humans, and that it is safe for human consumption.

In 2000, the National Toxicology Program of the National Institutes of Health concluded that it should be removed from the list of potential carcinogens. Products containing saccharin no longer have to carry the warning label.

Source: Additional Information about High-Intensity Sweeteners Permitted for Use in Food in the United States. 

Sodium Saccharin VS Aspartame

Its strength over aspartame is not only limited to its economical value. It can also be preserved for a long period of time without decomposition and can also act as an effective stabilizer. Moreover, it is thermal resistant. In an experiment, Sodium Saccharin and Aspartame were heated for 30 minutes.

In the final results, Sodium Saccharin did not show any change in its composition, regardless of temperature. On the other hand, aspartame started to decompose at 150°C, became 91% decomposed at 170°C, and decomposed completely after 180°C. The final results appear that aspartame is not appropriate as a sweetener for high temperature usage in food such as baked goods.

Thermal resistance Comparison Between Sodium Saccharin and Aspartame

Decomposition Rate According to Temperature

Market Trend

Sodium Saccharin is one of the oldest artificial, non-nutritive sweeteners. It has no caloric value and our body does not metabolize it and excrete unchanged. It is also better for oral health (such as toothpaste, mouth wave) as compared to table sugar since it does not promote tooth decay.

We can easily find Sodium saccharin in the food and beverage industry in diet carbonated drinks and other low-calorie products. According to the latest report by IMARC Group, titled “Saccharin Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2018-2023”, the global saccharin market reached a value of US$ 260 Million in 2017. The market is further expected to reach a value of US$ 339 Million by 2023, growing at a CAGR of 6% during 2018-2023.

The rising health consciousness among the consumers regarding the negative effects of sugar consumption has led to an increase in the demand for artificial sweeteners. Since sodium saccharin is cheaper as compared to most other artificial sweeteners (aspartame, acesulfame k, sucralose), it is used extensively in its end-use sectors. The use of sodium saccharin is also important for people who require a diet with restriction on caloric or carbohydrate intake, such as diabetics.

Source: Saccharin Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2018-2023 

With the popular of plant-based sweeteners and other artificial sweeteners, we think the use of sodium saccharin may decrease especially in food and drink application, can sodium saccharin market keep go up? It’s hard to say.

Manufacturers

The capacity from China manufacturers takes a large number of global sodium saccharin market share, the manufacturers like Keifeng, Tianjin North Food (TNF), Changjie and Shanghai Fortune who are in the market for years, China manufacturers export Sodium Saccharin Dehydrate (with 15% water, CAS number 6155-57-3) 20-40mesh and 40-80mesh much, other mesh sizes like 4-6 mesh,5-8 mesh,6-10mesh, 8-12mesh,8-16mesh,10-20mesh are little; also with Sodium Saccharin Anhydrous(with 6% water, CAS number 128-44-9). There is also a manufacturer in Korea, named JMC.

Shanghai Fortune won the antidumping case for USA market so it had more advantages than other China manufacturers. Shanghai Fortune together with JMC take over more than 80% market share in USA during the antidumping.

Manufacturing process

The manufacturing process of Sodium Saccharin is from chemical synthesis. The raw materials used in producing sodium saccharin as follows: Phthalic Anhydride, Ammoonia, Sodium Hydroxide, Methyl Alcohol, Sodium Hydroxide, Hydrochloric Acid, Sodium Nitrite, Copper Sulphate, Sulphur Dioxide, Toluene, Liquid Chlorine, Ammonia, Sodium Bicarbonate, Potassium Permanganate, Sodium Pyrosulfite.