Regulatory Compliance of Recycled Plastics for Food Contact in the US

In the United States, food contact plastics are regulated by the Food and Drug Administration (FDA). Food contact recycled plastics, similar to virgin plastics, should fulfill the requirements under the Federal Food, Drug, and Cosmetic Act and Title 21 of the Code of Federal Regulations (21 CFR).

The US does not require an independent "pre-market clearance" for recycled plastics used in food contact applications. Actually, the FDA has established a relatively complete regulatory system for food contact recycled plastics and provides companies with official channels to evaluate the applicability and safety of their recycling processes. Additionally, the FDA has issued specific guidance on recycled plastics that offers advice to plastic recycling and regeneration enterprises.

Relevant enterprises can submit an application to the FDA for review of their recycling processes and the FDA will start to review the entire recycling process upon receiving the application. This process is wholly voluntary and, if the FDA considers the recycled plastics produced under the process are safe, the Agency will issue a No Objection Letter (NOL) to the applicant on the suitability of a specific process for producing PCR plastic for food-contact uses.

Who shall apply?

• Recycled plastic manufacturers;
• Recycled plastic users; and
• Recycled plastic equipment manufacturers

When shall apply?

• Recycled plastics to be used for food contact; and
• There are changes to the recycling process (changes to materials, process procedures, product applications, etc.).

Requirements for the application dossier

• A complete description of the recycling process;
• Proof to show the recycling process removes decontamination (challenge tests);
• Expected use conditions and dietary exposure assessment for the recycled plastics; and
• Routine compliance tests under 21 CFR.

Application process and timeline

Note: It takes about six months to arrange tests and prepare dossiers. Generally, it takes about three to six months for FDA to complete the review.

About No Objection Letter (NOL)

A No Objection Letter should cover the following information

• Applicant information;
• Type of plastics;
• Type of the recycling process;
• Applicable food contact categories, and
• Conditions of use.

Our services

• Regulatory compliance for recycled plastics
• Dossier preparation and submission; and
• Coordination and communication with FDA officials.

CIRS provides one-stop services for the regulatory compliance of food contact materials and recycled plastics for food contact, to assist enterprises in fulfilling the market access requirements.