Food Ingredient Regulatory Compliance

Each food ingredient or additive must be scrutinized carefully by the end user to understand legal status, regulatory limits and requirements. Certain ingredients enjoy broad usage applications and quantities, while others are limited, monitored and controlled. Of particular concern are ingredients which share both food and non food applications or applications within the food industry. It is the shared responsibility of supplier and customer to clearly identify the characteristics, “grade”, suitability criteria, item number and other identifying and limiting criteria in order to avoid the risk of ingredient regulatory non-compliance.

Compliance Criteria

End users must be aware of all conditions and circumstances under which ingredients and additives are regulated and controlled. Examples of general and specific food ingredients and additives suitability criteria and monograph (including descriptions, status, limits and controls and caveats) information may be found in:

  • The Federal Food, Drug and Cosmetic Act and the Code of Federal Regulations, Title 21
  • The United States Pharmacopeia Food Chemicals Codex
  • FDA/CFSAN (Center for Food Safety and Applied Nutrition) EAFUS (Everything Added to Food in the United States) list
  • The U.S. FDA GRAS (Generally Recognized as Safe) list
  • The U.S. FDA GRAS notices inventory
  • GRAS Self Determination or Affirmation database
  • The FEMA (Flavor and Extract Manufacturers) GRAS list
  • The SCOGS (Select Committee on GRAS Substances) database
  • WHO (World Health Organization)/FAO (Food and Agriculture Organization) Codex Alimentarius
  • WHO/FAO Expert Committee on Food Additives Reports

Not all ingredient information in the listed references are relevant to use in the United States and some of the information may be confusing to even the most experienced safety and regulatory representative.

EHA’s expert technologists assist clients to fully understand the risks and benefits related to specific ingredients and additives. EHA explains and clarifies ingredient related terms, descriptors, grades and suitabilities, as well as criteria that clients must use to evaluation and qualify suppliers.

The category of additives and ingredients for use in food is daunting and laden with food safety risks and dangers if the proper controls and understandings are not known and applied. Clients depend on EHA’s experience and knowledge to guide them to safe food ingredients, safe handling of same and identify reputable sources of supply.

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