Regulatory Process

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Senomyx Provides Additional Information Regarding Generally Recognized As Safe (GRAS) Determination for Sweetmyx S617
On March 11, 2014 Senomyx, Inc. issued a press release announcing the Generally Recognized As Safe (GRAS) determination for its new Sweetmyx S617 flavor ingredient. The press release was accurate; however, one of the statements in the release was misinterpreted by some members of the media, who reported that FDA made the GRAS determination and/or approved its use.

To clarify, the GRAS designation for Sweetmyx S617 was determined by the Expert Panel of the Flavor and Extract Manufacturers Association of the United States (FEMA). The FEMA Expert Panel GRAS assessment program for flavor ingredients has been in place since 1960, following the 1958 Food Additives Amendment to the U.S. Federal Food, Drug, and Cosmetic Act, which exempts from FDA food additive review those substances that are generally recognized as safe by qualified experts. GRAS determinations can be made without notifying FDA.

The FEMA Expert Panel is comprised of independent experts in the fields of chemistry, toxicology, pharmacology, medicine, pathology, and statistics; all are also experts in flavor safety assessment. The Expert Panel makes “generally recognized as safe” (GRAS) determinations for flavor ingredients that meet the Expert Panel’s well-defined and published criteria. FEMA’s GRAS determinations are widely recognized, with over 2,800 flavor ingredients gaining GRAS determinations by FEMA during the past 50 years. FDA is generally aware of FEMA’s GRAS determinations, which are published in the open literature. FEMA GRAS determinations are not routinely submitted as a notice under FDA‘s GRAS notification program.

Regulation of Flavor Ingredients
Flavor ingredients intended for use in foods and beverages in the United States are regulated under provisions of the Food, Drug, and Cosmetic Act. In accordance with the Food Additive Amendment of 1958, the Flavor and Extract Manufacturers Association (FEMA) established in 1960 a process under which an Expert Panel that is identified and convened by FEMA evaluates the safety data, physical and chemical properties, expected manufacturing processes, conditions of intended use, and other specifics of a flavor ingredient candidate. If the Expert Panel determines the product candidate to be Generally Recognized As Safe (GRAS) the conclusions of the Expert Panel are provided directly to the FDA and published in the journal Food Technology. The FEMA GRAS status allows the ingredient to be commercialized in the United States and several other countries and regions. FEMA GRAS status also facilitates regulatory determinations in a number of additional countries.

FEMA has a website,, which is a resource for information about flavors, flavor ingredients, and their safety.

Flavor ingredients sold in countries and regions outside of the United States are also subject to regulations imposed by national governments or regional regulatory authorities, as is the case in the European Union. These authorities include the Joint FAO/WHO Expert Committee on Food Additives (JECFA), an independent committee of international scientific experts that has been evaluating the safety of food additives and flavors since 1956. JECFA is jointly administered by the Food and Agricultural Organization (FAO) and World Health Organization (WHO) of the United Nations. JECFA performs assessments and provides advice to FAO, WHO and the member countries of both organizations. A positive assessment by JECFA allows immediate usage of new ingredients in many countries and also enables regulatory approvals in other countries around the world, particularly those that do not have independent regulatory approval systems.

Flavor ingredients are also evaluated by the European Food Safety Authority (EFSA). EFSA is an independent European agency governed by an independent Management Board whose members are appointed to act in the public interest and do not represent any government, organization or sector.

Following regulatory approval in a given country, foods and beverages containing our proprietary flavor ingredients can be commercialized immediately. Prior to product launches, however, Senomyx collaborators will most likely conduct pre-commercialization efforts including product development, scale-up and manufacturing, and sales and marketing activities.

Regulatory Determinations for Senomyx Ingredients
Senomyx has 13 flavor ingredients that have been granted FEMA GRAS regulatory determinations. Some of these ingredients have also received JECFA and EFSA regulatory approvals.

Four Senomyx Savory Flavors were granted FEMA GRAS determination in 2005. In 2007, the Chinese Ministry of Health granted official regulatory approval in China for the Company's Savory Flavors via the publication of the 2007 List of Flavors Intended for Use in Food (GB 2760). Also in 2007, the Savory Flavors received a positive review by JECFA, which determined that there were no safety concerns with the use of these ingredients in foods. The assessments enable incorporation of these Senomyx Savory Flavors into a variety of food products including sauces, frozen foods, processed cheese and snack foods in numerous countries. In October 2012 the four initial Savory Flavors received regulatory approvals in the European Union (EU) which allowed usage in EU countries as of end-April 2013.

Two additional Senomyx Savory Flavors, S9229 & S5456 received FEMA GRAS status in 2011. The FEMA GRAS status for S9229 and/or S5456 allows usage in a wide array of applications including snack foods, beverages, soups, seasonings, gravies, condiments and relishes, cereals, baked goods, gelatins and puddings, meat, poultry, fish, milk, and egg products.

Senomyx’s sucralose modifier, S2383, was granted FEMA GRAS status in November 2008 and received a positive determination by JECFA in July 2012. S2383 also received regulatory approval in the European Union (EU) in October 2012 and may be used in EU countries as of end-April 2013. S2383 is intended to restore the desired sweet taste in products with reduced sucralose, a high-intensity sweetener used in a wide variety of beverages and foods such as confectionaries, baked goods, desserts, and dairy products, as well as over-the-counter (OTC) healthcare products and dietary supplements. S2383 is effective in numerous products in which up to 75% of the sucralose has been reduced.

Sweetmyx® SR69 (S6973), Senomyx’s first sucrose (table sugar) modifier was granted FEMA GRAS status in October 2009 and received a positive determination by JECFA in July 2012. S6973 enables the reduction of up to 50% of the sucrose present in numerous products while maintaining the sweet taste of natural sugar. The GRAS designation allows usage of S6973 in baked goods, cereals, gum, condiments and relishes, confectioneries and frostings, frozen dairy offerings, fruit ices, gelatins and puddings, hard and soft candy, jams and jellies, milk products, and sauces. During the first quarter of 2010 the FEMA GRAS status for S6973 was extended to instant coffee and tea, and imitation dairy products. In March 2014, Senomyx announced that the European Food Safety Authority has completed its review of S6973, which can now be marketed in the European Union.

Sweetmyx® SR96 (S9632), Senomyx’s second sucrose (table sugar) modifier was granted FEMA GRAS status in September 2012. Sweetmyx® SR96 enables the reduction of up to 50% of the sucrose present in product prototypes while maintaining the sweet taste of natural sugar. The GRAS designation allows usage of Sweetmyx® SR96 in a broad range of non-alcoholic beverages including powdered and concentrated beverages, along with ready-to-drink and powdered forms of dairy, coffee and tea products. In addition, Sweetmyx® SR96 may be used with alcoholic beverages, as well as a variety of foods, including dairy products, confectioneries, snack foods, and sauces. Numerous individual product types are included in each of these product categories.

Two Senomyx Bitter Blockers, S6821 and S7958, were granted FEMA GRAS status in November 2010 and each received a positive determination by JECFA in July 2012. S6821 has demonstrated activity against bitter tasting foods and beverages that include soy and whey proteins, menthol, caffeine, cocoa, and Rebaudioside A (stevia). S7958, a related bitter blocker with similar functionality, has alternative desirable physical properties that may be useful for these or other product applications.

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