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What GMP Requirements Apply to Resin and Colorant Manufacture?

June 9, 2014
Question 

We produce trays for smoked seafood out of HDPE FDA grade material. We have cleaning and sanitization processes to minimize the likelihood of the trays becoming contaminated by our manufacturing process. Our film supplier states they are not required to follow GMPs or any FDA requirements for their manufacturing processes and will only state in their certification that the resin and colorants meet FDA requirements- but not their process. Wouldn't they have to follow GMPs or FDA requirements? 

Answer 

Good Manufacturing Practices (GMPs) for food packaging materials are found in Title 21 of the Code of Federal Regulations (C.F.R.) Part 174.5. They are fairly general and include the following requirements: no more of an additive should be used than necessary to achieve the intended technical effect; the components of the package be suitably pure for their intended use and comply with other provisions of the Food, Drug and Cosmetic Act; and the package must not render food unfit for consumption. The regulation requires compliance with these provisions over and above compliance with any specific regulation. So, in order for a company to provide assurance of FDA compliance, it should also address Part 174.5 along with any other applicable clearances. A manufacturer may require a supplier to provide a customer assurance of regulatory compliance for food-contact substances as a condition of sale, but this is up to the manufacturer. For information on types of customer assurance requests, see the PackagingLaw.com article, Customer Assurance for Food Packaging Materials: Points to Consider.