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Regulatory Compliance of U.S. Post-Consumer Recycled (PCR) Plastics for Food-Contact Articles

Sustainable development has become a hot topic throughout the world, stimulating packaging companies and plastic manufacturers to meet sustainability initiatives by using recycled plastics for food contact articles. Simultaneously, the safety of recycled plastics has aroused widespread concern. The U.S. is one of the pioneers in the safety assessment of recycled plastics and makes a great effort in helping enterprises demonstrate their recycled plastics are of suitable purity for their intended use in food-contact applications.

U.S. Recycled Plastics Regulation and Supervision

In the United States, the regulation of food contact recycled plastics is regulated by the Food and Drug Administration (FDA). The regulatory requirements for food contact recycled plastics are the same as those for virgin food contact plastics, that is, recycled plastics also need to comply with the Federal Food, Drug, and Cosmetic Act and Title 21 of the Code of Federal Regulations (21CFR) requirements.

The 21 CFR permits, in principle, recycled plastics for use in food packaging. FDA has also published a corresponding Guidance for Industry on the assessment of recycled processes. Companies related to recycled plastics can voluntarily apply to the FDA for the evaluation of their recycling process.

Enterprise Compliance Practice for Recycled Plastics

As per U.S. regulations, FDA does not establish legally enforceable responsibilities for the enterprises to certify their recycling process of the recycled plastic. However, to become more competitive in the U.S. market, many companies take the initiative to submit applications for certification of recycled plastics to the FDA. In the meanwhile, many of their downstream customers also push them to get an official assessment of their recycling process.

After submitting the technical dossier, the FDA will evaluate the entire recycling process. If the FDA concludes that the recycled plastic products produced by this recycling process are safe, the agency will issue a No Objection Letter (NOL) to the applicant confirming that the capability of the recycling process in producing relevant recycled plastics is suitable for food-contact applications.

Based on the enterprise compliance practice for recycled plastics, we conclude two typical cases. One common case is that enterprises set up their own recycling process for recycled plastics. As mentioned before, under this circumstance, enterprises can carry out FDA Post-Consumer Recycled (PCR) Plastic for Food-contact Articles Registration, and it is necessary to carry out surrogate contamination testing to demonstrate its decontamination efficiency. After passing the evaluation, the FDA will issue an NOL to the applicant.

Besides, some foresighted process equipment manufacturers have already gotten the NOL from the FDA, and many enterprises purchase their certified recycling equipment and run it in accordance with the same recycling process and intended use conditions of recycled plastics described in the NOL. On this occasion, the enterprises obtain the sublicense from the equipment manufacturer. And there is no need for the sublicensing enterprises to obtain a new NOL issued to their name as the process has already been FDA-reviewed.

In this case, enterprises can conduct Prenotification Consultation (PNC) to the FDA regarding the official feedback of the recycling process and will receive a reply of PNC, serving as a supporting document that is shown to downstream customers for the efficiency of the recycling process. However, if the recycling process is sufficiently different such that the original opinion letter would not apply, then the manufacturer is recommended to conduct their own surrogate contaminant testing in support of their process and apply for new registration.

Our Services

Our FCM team of REACH24H consulting group, the founder of ChemLinked, can provide FDA Post-Consumer Recycled (PCR) Plastic for Food-contact Articles Registration Service, including pre-registration compliance analysis, application dossier preparation, submission and follow-up, communication with FDA, assistance with additional information supplementation, and so forth.

Moreover, we can also provide FDA Prenotification Consultation (PNC) Service for those enterprises who purchase certified machines for recycled plastics. Please feel free to contact if you need any help.

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