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
Four Senomyx Savory Flavors were granted 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. The European Food Safety Authority (EFSA) has provided a 'favorable opinion' for Senomyx's S336 and S807 Savory Flavors, which means that no further evaluation is required. Final regulatory approval and commercialization in the EU is contingent upon the ingredients being included in the EFSA Union List, which has not yet been published.
Two additional Senomyx Savory Flavors, S9229 & S5456 received GRAS stats in 2011. The 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-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. S2383 can be used in numerous products to enable up to a 75% reduction in the concentration of sucralose, which in some applications also improves taste.
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.
Two Senomyx Bitter Blockers, S6821 and S7958, received FEMA GRAS regulatory status in November 2010. 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.
