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FDA Letter of No Objection

Tuesday, 07. April 2020

Posted by Mike Horrocks

The FDA regulates recycled plastics for food-contact applications. They  manage how companies in the recycled plastics and related plastic recycling technology industries  can ensure that recycled plastics destined for food packaging are safe for use in the US.

Consumer demand for the responsible use of plastics is increasing, as we all see the outcomes of irresponsible plastics management in the environment, such as the Great Pacific Garbage Patch. Leading consumer brands are responding to this surge in pressure by instituting aggressive goals to utilize recycled plastics in their packaging and products. Food products businesses in particular are realizing that the continued application of singly-use plastic containers ultimately is going to harm their brands and businesses and are responding.

PepsiCo has initiated its Global Sustainable Packaging Policy which has a stated goal of reducing the use of virgin plastic use across their beverage portfolio by 35% by 2025. If you think of the scale that a PepsiCo operates at globally, you can begin to imagine the impact that just this one company will have on the global plastics supply chain. They’ve also, as a sophisticated user of plastics, initiated aggressive Post-Industrial plastic recycling internally by aiming to achieve Best-in-Class recycled content for their internal processes buy practicing post-industrial recycling of trimmings, scraps and rejects. 

Similarly, Proctor & Gamble  has set the goal of reducing their global use of virgin petroleum plastic in their packaging by 50% by 2030. 

"By 2025, PepsiCo will reduce virgin plastic use across our beverage portfolio by 35%, equating to the elimination of 2.5 million metric tons of cumulative virgin plastic when taking into account business growth. On an absolute basis, this includes a 20% virgin plastic reduction vs a 2018 baseline."

These commitments raise a question, what are the safety implications of producing recycled plastic packaging at large scale that will be used as containers for food products?

Most recycling systems gather and segregate plastics by plastic type, HDPE, PP etc. These systems are not organized to discern what the plastic intended for recycling was used for. Even sorting out beverage containers into lots still leaves a lot of room for having contamination across a broad spectrum of food products and contaminants. 

PepsiCo is smart to try to raise the awareness of post-industrial recycling efforts. While still a technical challenge, recycling plastic scraps and rejects in-house diverts waste from landfills, can be done profitably and avoids the technical challenge of decontaminating plastics between the bale of post-consumer plastics and pellets usable for new products. 

In order to manage food safety, the FDA has established a process for independent regulatory review, or “premarket clearance” for plastics produced by post-consumer recycling processes. The FDA process is designed to manage the composition of the plastic at the end of the process, as opposed to dictating what process was used to manufacture the end product. Under this standard, recycled plastics destined for food-contact must meet the same regulatory requirements that they have in place for virgin plastics bound for food-contact.

Under the FDA regulations, all food-contact materials, like plastics packaging must be of a purity suitable for their intended use as defined by GMPs or Good Manufacturing Practices. The FDA has established guidelines for the use of post-consumer recycled plastics to establish their safety for food packaging. 

In setting their guidelines, the FDA is worried about three things. Their first worry is that contaminants from post-consumer plastic may end up in the post-consumer recycled product and may contact food. The second worry is that post-consumer plastics being recycled may not themselves be regulated and approved for food use. The third worry is that adjuvants (products used in the production process not suitable for food contact) might be introduced as part of the recycling process. 

The FDA has made clear that the plastics products recycler and packaging manufacturer must demonstrate that the contaminants from prior use of the plastic to be recycled are sufficiently removed in the recycling process.

Which leads us to the FDA Letter of No Objection.

In this process, companies take their determinations of the suitability of their food-contact quality recycled plastics process to the FDA for review. 

A satisfactory Letter of No Objection (sometimes called an “NOL” or No Objection Letter”) specifies the identity of the plastic being evaluated and whether the recycling process is physical or chemical. The FDA will determine whether they’ve imposed conditions or limitations on the use of the post-consumer recycled material. 

In evaluating processes for a Letter of No Objection, the FDA requires:

  • A complete description of the recycling process, the source of recycled plastic and controls that are used to ensure the process meets applicable regulations.
  • A description of the steps taken to ensure that the post-consumer recycled plastic is not contaminated before collection or during the recycling process.
  • Data to support the claim that the recycling process removes possible contaminants.
  • A description of the intended use for the post-consumer recycled plastic, such as the expected food it will be in contact with, the temperature of use, how long it will be in contact with the food product and whether the post-consumer recycled plastic is intended for single-use or may be recycled again. 

The FDA is particularly concerned about post-consumer plastics that have been through a recycling process multiple times, picking up a range of contaminants along the way, or which might have carried hazardous chemicals such as pesticides, automotive chemicals, fuels, solvents or whatever else a consumer might have temporarily used a container for. 

The FDA provides guidelines for testing a virgin polymer that is first exposed to a range of ‘surrogate contaminants’. These surrogate contaminants are selected to represent a range of chemicals that are used by, or would be accessible to consumers. When the virgin polymer samples are exposed to the range of potential contaminants (now called a ‘challenged’ plastic, or polymer) it is run through the manufacturer’s recycling process for testing of the process’s ability to remove this range of contaminants. 

As an additional precaution, most consumer brands are limiting the amount of post-consumer recycled plastics in their food-contact packaging to less than 50%. This dilution with virgin material is a way to further dilute any miniscule contaminants that might make their way through even a robust decontamination process. 

EREMA has received a Letter of No Objection from the FDA for it’s “secondary recycling process (a so-called as “super clean” process) in producing post-consumer recycled high-density polyethylene (PCR-HDPE) material that is suitable for food-contact. The PCR-HDPE material is intended for use at levels of up to 100% recycled content in manufacture of milk and juice bottles, meat trays, disposable tableware and cutlery under Conditions of Use (COU) E - F, as described in Table 2, which can be accessed from the Internet in the Packaging and Food Contact Substances section under the Food topic at”

You can access the FDA Letter of No Objection for EREMA here.

Since EREMA’s process has been accepted by the FDA for 100% recycled content use in food-contact packaging. As the industry grows more comfortable with the ability to consistently deliver post-consumer recycled plastics suitable for food contact, we expect that higher limits will be embraced and more and more post-consumer plastics can be used in recycling processes and not make their way into the environment. 

Additionally, the European Union has expressed similar confidence in EREMA’s processes for producing food-contact grade post-consumer recycled plastics.


If you’re curious about what producing recycled plastics FDA approved for food-contact looks like, you can see video of EREMA’s post-consumer packaging decontamination and de-coloring technologies here.


If you’d like to understand how post-consumer plastics can be efficiently recycled at massive scale to be food-contact compliant, you can read about an integrated system here.


To learn the details of EREMA’s technology for producing food-contact grade recycled pellets, you can read here.


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