Regulatory & Safety

Our flavor ingredients and natural high intensity sweetener go through robust safety testing before they are added to foods. This testing is conducted by independent research entities and the results are reviewed by several third party organizations. Reviewing scientists are independent to ensure an objective evaluation.

•  Flavor Ingredients

Senomyx’s strategy is to pursue global regulatory approval for our flavor ingredients. Each regulatory organization has a slightly different process and time table for their review of flavor ingredients, and all of our offerings have either completed, or are in various stages of evaluation by these groups.

In the United States, the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA) grants a Generally Recognized as Safe (GRAS) designation to flavor ingredients that meet their standards. Since the Expert Panel was formed in 1960, the GRAS process has been used for over 2,800 flavor ingredients that are included in countless products around the world. For more information on the FEMA GRAS Program, visit www.flavorfacts.org.

GRAS determination by the Expert Panel allows immediate usage of flavor ingredients in the U.S. It also permits use in numerous other countries in the Americas, Asia, and Africa. All of the Senomyx flavor ingredients used in foods and beverages have been granted FEMA GRAS designation. Several have also been determined to be safe by the European Food Safety Authority (EFSA), which allows for usage in the European Union. In addition, many Senomyx flavor ingredients have been reviewed successfully by the Joint Food and Agricultural Organization (FAO) / World Health Organization of the United Nations (WHO) Expert Committee on Food Additives (JECFA), which allows immediate use in a number of countries and enables regulatory approvals elsewhere. Additionally, other countries such as China and Japan, have their own review process for flavor ingredients, enabling their use in food and beverage products.

•  High Intensity Sweeteners

In the United States, an independent, qualified panel of experts from pertinent scientific disciplines may be formed by a company to evaluate the safety of a specific ingredient for GRAS status.  A summary of the GRAS determination may be submitted to the FDA for evaluation.  If the FDA is satisfied with the data, it may issue a “letter of no questions”. The current commercialized forms of Stevia have gone through this process.  Senomyx’s goal is to attain regulatory approval through this FDA GRAS notification process for our lead novel sweetener, siratose and any future natural HIS candidates that we discover.   While we always first pursue regulatory approval in the United States, we are working on developing our regulatory strategy for EFSA and JECFA approvals, as well as for China and other major countries.

Senomyx Flavor Safety and Regulations