Recycled Plastics in Food Contact Applications: FDA Submission Process

FDA compliance for recycled plastics in food packaging comes down to one requirement written into 21 CFR 174.5: the recycled material must be of a purity suitable for its intended use, meaning as pure as the virgin plastic it replaces.¹ The FDA does not formally approve recycled plastics. Instead, it reviews the technical data a manufacturer submits about a specific recycling process and, if the data supports a safety finding, issues an informal advisory known as a No Objection Letter. Getting that letter requires the right data package, submitted through the right pathway, for the right polymer and method.

The Purity Standard and Why It Matters

Food packaging is a “food contact substance” under federal law: any material that touches food during manufacturing, packaging, or storage without being intended to change the food falls under FDA jurisdiction.²³⁴ Introducing adulterated food into interstate commerce is a prohibited act under 21 U.S.C. § 331(a).⁵

That chain makes 21 CFR 174.5 the operative rule for recyclers. How you achieve virgin-equivalent purity — through strict source control, aggressive cleaning, or both — is your choice. The end result has to meet the standard, and the FDA’s review of your process is how the agency decides whether you have.

When You Do Not Need a Submission

Chemical (tertiary) recycling of PET and PEN sits outside the review process. The FDA has determined that tertiary recycling produces these polymers at suitable purity for food contact and no longer evaluates individual tertiary processes for PET or PEN or issues No Objection Letters for them.⁶ Surrogate contaminant testing is no longer considered necessary for these processes either. You still have to ensure the finished polymer meets all existing specifications for virgin material, but you skip the submission.

Physical (mechanical) recycling of PET, and all recycling of other polymers, still requires the standard review.

What the FDA Looks At

Reviews are case-by-case, and four factors drive how demanding the data package will be.⁶

Source Material

Post-consumer plastic carries higher risk than industrial scrap. A bottle that once held pesticide in someone’s garage is a different problem than clean manufacturing cutoffs that never left the factory floor. The agency wants to see the source of the feedstock, the sorting procedures used to exclude non-food containers, and any steps that prevent contamination between collection and processing. Strict source control can reduce the scope of testing required. Most post-consumer streams cannot guarantee that level of control, so surrogate testing usually stays in the package.

Recycling Method

Chemical recycling breaks the polymer down to its molecular building blocks and reassembles it, which generally produces higher-purity output because contaminants are destroyed or separated during depolymerization. Physical recycling melts and reforms the plastic without breaking the chain, so absorbed contaminants have to be driven out through washing, heating, and vacuum treatment.⁷

Polymer Type

PET resists absorbing contaminants better than polyolefins like HDPE and polypropylene. For PET, the FDA does not recommend including a heavy metal surrogate in challenge testing, because metal salts wash out of PET readily. For polyolefins, heavy metal surrogate testing is still recommended: there is not enough data to draw general conclusions about how metals behave in those materials.⁷

Intended Conditions of Use

Heat accelerates migration from packaging into food, so plastic destined for hot-fill liquids faces more scrutiny than plastic holding room-temperature dry goods. Submissions should specify the intended temperature of use, the type of food (acidic, fatty, aqueous, or dry), the duration of contact, and whether the container is single-use or reusable. A recycled plastic cleared for cold water is not automatically cleared for microwaveable soup.

Building the Technical Data Package

The FDA’s “Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations)” is the template for organizing your submission.⁷

Surrogate Challenge Testing

This is the centerpiece of most submissions. You deliberately contaminate feedstock with chemicals that represent different contaminant classes — volatile organic compounds, non-volatile polar and non-polar substances, and (for polymers other than PET) heavy metals — then run that material through your recycling process and measure how much gets removed. Each surrogate yields a cleaning efficiency: the percentage of contamination the process eliminates. Reviewers compare those numbers against the acceptable residual levels for your specific polymer.

Residual Contaminant Thresholds

The safety benchmark is the threshold of regulation: a dietary concentration at or below 0.5 parts per billion, which corresponds to an estimated daily intake of no more than 1.5 micrograms per person per day.⁸ If migration studies show individual contaminants below this level, the FDA generally considers the risk negligible. The maximum acceptable residual in the plastic itself varies by polymer and thickness. For a standard 0.50 mm thickness at a consumption factor of 0.05, the guidance sets the limit at 220 micrograms per kilogram for PET and 320 micrograms per kilogram for polyolefins.⁷

Process and Supporting Documentation

The rest of the package describes the operation itself: the entire recycling process from collection to final pelletization, a flow diagram identifying contamination risk points, migration study results simulating real food contact conditions, estimated daily intake calculations for any identified migrants, wash temperatures and solvent types used during decontamination, and whether the finished product is intended for single-use or repeated-use applications. Independent laboratory validation of your internal testing strengthens the submission.

Submitting and Getting the Letter

Send the technical package to the FDA’s Office of Food Additive Safety. Questions and submissions go to premarkt@fda.hhs.gov.⁶ The agency does not publish a fixed review timeline for recycled plastics submissions, so plan for an extended review. Reviewers may request additional testing data or clarifications during that period.

If the agency identifies problems, it will explain why the current data does not support a safety finding, giving you the chance to refine the process or improve testing before resubmitting. If it issues a favorable response, that letter is what the industry calls a No Objection Letter; the FDA also refers to it as a “favorable opinion letter.”⁹

The letter is informal advice, not a formal approval or a food additive regulation. It carries less legal weight than an effective Food Contact Notification, but it does two useful things: it documents that the FDA reviewed your process and did not object, and it gives retailers and brand owners the assurance they need to source from you. It also applies to the process itself rather than to your company. A licensee running the same recycling method for the same intended use conditions can rely on the same letter without submitting their own.⁹

Note that the No Objection Letter pathway is separate from the Food Contact Notification pathway used for authorizing new food contact substances. If your recycled plastic incorporates a novel additive or polymer that itself requires premarket authorization, you may need both a Food Contact Notification for the substance and a No Objection Letter for the recycling process. Sending the recycled plastics data through the FCN system, or vice versa, wastes months.

Consequences of Getting It Wrong

If recycled plastic contaminates food, that food is adulterated under 21 U.S.C. § 342(a)(2)(C), and moving it into interstate commerce triggers the prohibited acts provision of the Federal Food, Drug, and Cosmetic Act.³⁵ The FDA can pursue product seizures, injunctions, and criminal prosecution. A first offense is a misdemeanor carrying up to one year of imprisonment and a fine of up to $1,000. A second conviction, or a first offense committed with intent to defraud or mislead, is a felony punishable by up to three years and a fine of up to $10,000.¹⁰ Manufacturers carry the primary responsibility for ensuring recycled material meets purity requirements, and “we didn’t know” is not a defense the agency accepts.

After the Letter

Receiving a No Objection Letter does not end your compliance obligations. The FDA does not currently require ongoing safety data submissions from food contact substance manufacturers, but it can issue a formal Request for Information asking for unpublished safety and use data at any time.¹¹ You need to be able to answer with current data.

Keep thorough records of feedstock sources, surrogate testing results, cleaning efficiency data, and any changes to your recycling process. If a contamination issue surfaces later, the quality of that documentation is what determines whether the agency treats the problem as an isolated event or concludes your process is fundamentally flawed. Facilities that manufacture only food contact substances are not required to register under Section 415 of the FD&C Act, so they do not fall onto the FSMA routine inspection calendar.¹² That makes internal quality control the primary check on your process.

One boundary worth naming: FDA clearance covers food safety only. If you market the packaging as containing recycled content, the Federal Trade Commission’s Green Guides at 16 CFR Part 260 govern the claim, including how you state the percentage of recycled content by weight and how you distinguish pre-consumer from post-consumer material.¹³ A No Objection Letter satisfies the FDA. It does not authorize the marketing language on the label.

1
eCFR. 21 CFR 174.5 – General Provisions Applicable to Indirect Food Additives
2
U.S. Food and Drug Administration. Food Packaging and Other Substances That Come in Contact with Food: Information for Consumers
3
Office of the Law Revision Counsel. 21 USC 342 – Adulterated Food
4
Office of the Law Revision Counsel. 21 USC 348 – Food Additives
5
Office of the Law Revision Counsel. 21 USC 331 – Prohibited Acts
6
U.S. Food and Drug Administration. Recycled Plastics in Food Packaging
7
U.S. Food and Drug Administration. Guidance for Industry: Use of Recycled Plastics in Food Packaging – Chemistry Considerations
8
eCFR. 21 CFR 170.39 – Threshold of Regulation for Substances Used in Food-Contact Articles
9
U.S. Food and Drug Administration. Submissions on Post-Consumer Recycled Plastics for Food Contact
10
Office of the Law Revision Counsel. 21 USC 333 – Penalties
11
U.S. Food and Drug Administration. Understanding How the FDA Regulates Substances That Come into Contact with Food
12
U.S. Food and Drug Administration. Guidance for Industry: Registration of Food Facilities
13
eCFR. 16 CFR 260.13 – Recycled Content Claims