Regulatory Process
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 administered by the United States Food and Drug Administration (FDA). 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.
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 is expected to expedite regulatory approvals in additional countries, particularly those that do not have independent regulatory approval systems.
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’s four savory flavor ingredients obtained a FEMA GRAS determination in the U.S. in March 2005. In March 2007, the Chinese Ministry of Health granted official regulatory approval in China for the Company’s savory flavor ingredients via the publication of the 2007 List of Flavors Intended for Use in Food (GB 2760). In July 2007, the savory flavor ingredients received a positive review by JECFA, which determined that there were no safety concerns with the use of these ingredients in foods. These assessments enable incorporation of Senomyx’s savory flavor ingredients into a variety of food products including sauces, frozen foods, processed cheese and snack foods in numerous countries.
Senomyx’s sucralose-enhancing flavor ingredient, S2383, was granted FEMA GRAS status in November 2008. S2383 is intended to enhance the taste of 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.
S6973, Senomyx’s enhancer of sucrose (table sugar) received a FEMA GRAS designation in October 2009. Taste tests have demonstrated that S6973 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 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 GRAS status for S6973 was extended to instant coffee and tea, and imitation dairy products.
