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Can Additives Approved in Europe be Exported Elsewhere?

May 21, 2007
Question 

In our factory in Europe we work with a plastic additive that it is been approved by European Community but it has not been approved by FDA. What will happen if we export  this additive to the U.S. or South America?

Answer 

In the United States, materials used in packaging that are reasonably expected to become components of food are by definition food additives under the Federal Food, Drug, and Cosmetic Act (FFDCA), and must be subject to a food additive regulation or effective Food Contact Notification, if not exempt or excluded. Food additives that are used without the appropriate clearance are considered to be adulterated food, per se, and in violation of the Act.

Most of the counties in South America also have laws regulating the use of materials in packaging.

The legal status of any particular plastic additive is largely dependent upon its chemical identity and intended use. Your legal counsel can provide you with more specific advice with this information in hand.