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Requirements for Resins for Use in Food-Contact Articles

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Requirements for Resins for Use in Food-Contact Articles


If a post-consumer resin (PCR) is used to produce polyethylene (PE) resin for use in food-contact articles, what are the regulations/requirements that apply to the PCR packaging (i.e., such as contamination to PE resin)?


The U.S. Federal Food, Drug, and Cosmetic Act and the U.S. Food and Drug Administration’s (FDA) implementing regulations do not mandate any unique regulatory review or specific premarket clearance of recycled plastics intended for use in contact with food. Generally speaking, FDA regulates food-contact plastics based on their composition, and not on the specific process by which they are manufactured or the source of their raw materials. Recycled food-contact plastics must meet the same compositional and specification requirements that apply to the virgin plastics. And, manufacturers of food-contact articles made from recycled plastic are responsible for ensuring that, like virgin material, the recycled plastic material will meet all existing specifications that apply to the virgin material and will be suitably pure for its intended use. Companies engaged in the production of recycled plastics intended to be used in contact with food must adhere to FDA Good Manufacturing Practices (GMP) requirements that apply to the production of all food-contact materials and, in particular, 21 CFR § 174.5 (General provisions applicable to indirect food additives), subparagraph (a)(2), which states that “[a]ny substance used as a component of articles that contact food shall be of a purity suitable for its intended use.”
FDA has issued a Guidance document for industry regarding the Use of Recycled Plastics in Food Packaging (Chemistry Considerations). In addition, FDA has established a voluntary process by which recyclers can submit to the Agency an application that includes the following: (1) a complete description of the recycling process; (2) the results of any testing to establish that the recycling process removes potential incidental contaminants; and (3) a description of the proposed conditions of use for the recycled plastic. FDA considers each such submission on a case-by-case basis and may issue a “Letter of No Objection,” which is the Agency’s informal advice as to the ability of the recycling process to obtain post-consumer recycled plastic that is of a suitable purity for the intended use. For more details on the use of recycled plastics in food packaging, see the article, U.S. and EU Requirements for Recycled Food-Contact Materials.

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