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What are the FDA Requirements for LLDPE Food Packages?

September 18, 2012
Question 

We import plastic pouches from China that are subsequently used for food packaging here in U.S. The pouches are usually a composite of different types of material with the inner-most layer (that touches the food) being LLDPE. How do we go about getting this LLDPE certified so that it complies with FDA requirements? Or, does this even needed to be certified? Which FDA regulation governs this particular material?

Answer 

Title 21 of the Code of Federal Regulations (C.F.R.) Part 177 applies to Indirect Food Additives: Polymers. More specifically, Part 177.1520 applies to "olefin polymers" and includes a list of olefin polymers that "may be safely used as articles or components of articles intended for use in contact with food," subject to certain limitations. Certification is not required to comply with this regulation. An important consideration is, even if a polymer is listed in Part 177 and complies with all applicable specifications and limitations, the good manufacturing practices (GMP) requirements applicable to food-contact materials (found in Section 174.5) state that all packaging materials must be "of a purity suitable for [their] intended use." This "suitable purity" requirement means that any unavoidable residues or impurities that may migrate to food must be present at such low levels as to not render the food adulterated (i.e., harmful to human health or having an off taste or odor).

You should work with your suppliers to obtain assurances that their products comply with applicable regulations and relevant quality specifications, including any required end tests. (For more information on customer assurances, see the PackagingLaw.com article, Customer Assurances for Food Packaging Materials: Points to Consider.) Please consult legal counsel to determine your specific legal obligations.