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What Are the Requirements for Additives Used in Packaging in China?

February 2, 2010
Question 

There is an article on PackagingLaw.com about China publishing a positive list of approved substances for use in food packaging. Is there an FDA equivalent of this list?

Answer 

While the United States has lists of substances cleared for use in food packaging materials, these lists are not equivalent to China's "positive list" of approved substances for use in food packaging. In the U.S., substances used in packaging that are reasonably expected to become components of food, when used as intended, are considered indirect food additives. They must be the subject of: an applicable Food and Drug Administration (FDA) food additive regulation, an FDA Threshold of Regulation (TOR) exemption, an effective Food Contact Notification (FCN), or subject to exemption or exclusion under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Exemptions include substances that are generally recognized as safe (GRAS) and prior sanctioned substances, which are substances whose use in or on food is the subject of a letter issued by FDA or the U.S. Department of Agriculture prior to September 6, 1985 offering no objection to a specific use.

Lists of substances cleared by FDA for use in food-contact packaging under a food additive regulation can be found in Title 21 of the U.S. Code of Federal Regulations (CFR). The specific lists are: adhesives and components of coatings (Part 175), paper and paperboard components (Part 176); polymers (Part 177); adjuvants, production aids, and sanitizers (Part 178); and packaging materials cleared for use during the irradiation of pre-packaged foods (Part 197.45). Part 186 contains a list of packaging materials that FDA considers GRAS for food packaging or other food-contact applications, however, this list is not a comprehensive list of all GRAS substances. In addition, FDA maintains a GRAS Notice Inventory that includes information about all GRAS notices filed since 1998, including the Agency's response letters.

Food-contact materials that involve very low human exposure can be cleared through the threshold of regulation (TOR) exemption process. FDA maintains a list of substances subject to TOR exemptions on its website (click here to access the list). These exemptions are not proprietary and, therefore, anyone can manufacture or use the cleared substance under the conditions specified in the TOR. Some prior sanctioned substances are listed in Part 181.

The FCN program was implemented in 2000. Under this program, a manufacturer or supplier of a food-contact material may submit a notification to FDA regarding the identity and use of a new food-contact substance, along with information supporting the conclusion that the substance is safe for the intended use. FCNs become effective 120 days from the date of receipt, unless FDA considers the submission incomplete or objects to the notification. FCNs are proprietary and may be relied upon only by the submitter and its customers. FDA maintains an Inventory of Effective Food Contact Substances Notifications on its website.

For more information on how packaging materials are regulated in the U.S., see the PackagingLaw.com article, Fathoming Food Packaging Regulation Revisited.