FDA NOL vs EU Rules for Food-Contact Recycled Plastics

FDA NOL and EU Requirements at a Glance

What Does an FDA NOL Establish?

FDA's recycled plastics framework focuses on whether a process can produce post-consumer recycled (PCR) plastic of suitable purity for the proposed food-contact use. A NOL records FDA's favorable opinion within the reviewed scope.

The letter does not replace the applicable regulatory basis for the material's components, such as relevant provisions in Title 21 of the Code of Federal Regulations (21 CFR) or effective Food Contact Notifications (FCNs). It also does not establish suitability for every food type, temperature or packaging structure. A resin intended for chilled food packaging, for example, should be assessed against that application rather than a different use covered by a supplier's letter.

The voluntary nature of the NOL route also does not remove the manufacturer's responsibility for food-contact compliance. FDA's chemistry guidance distinguishes recycling routes and evidence needs. Tertiary recycling involves chemical breakdown of the polymer followed by purification and rebuilding of the plastic. FDA no longer evaluates or issues individual opinion letters for these processes producing PCR polyethylene terephthalate (PET) or polyethylene naphthalate (PEN).

For projects seeking a favorable FDA opinion, REACH24H provides FDA NOL application support for recycled plastics, including data-gap assessment, surrogate contaminant test oversight and FDA communication.

Which EU Route Applies to Your Recycling Technology?

The EU distinguishes a recycling technology, the detailed process using it, and the installation operating that process. This distinction matters when selecting a route under Regulation (EU) 2022/1616, as amended. The recycling route sits alongside the food-contact safety framework in Regulation (EC) No 1935/2004, Regulation (EU) No 10/2011 on plastics, and Good Manufacturing Practice (GMP) requirements under Regulation (EC) No 2023/2006.

Mechanical PET Recycling

Post-consumer mechanical PET recycling is listed as a suitable technology requiring individual process authorization. EFSA assesses the process; the Commission decides on authorization. For an existing supplier, verify its authorization or any applicable transitional status.

Closed and Controlled Product Loops

Recycling within qualifying closed and controlled product loops is also listed as suitable, without individual process authorization. It requires a recycling scheme and compliance with its input, collection and reuse conditions. The suitable technology currently listed in Annex I excludes collection from consumers and requires the recycled articles to be used for the same purpose and under the same conditions as those circulated within the scheme. Calling a waste stream "closed loop" does not establish eligibility.

Novel Recycling Technologies

Within the scope of Regulation (EU) 2022/1616, a recycling technology that has not yet been subject to a decision on its suitability under Articles 15 or 16 is treated as a novel technology. This route involves notification, scientific evidence, operational controls and monitoring obligations. It is not an automatic extension of the PET process-authorization route.

A U.S. NOL for mechanically recycled polypropylene (PP) or polyethylene (PE) therefore does not identify the applicable EU route. Review the actual technology and collection system.

Certain substance-recovery routes fall outside 2022/1616 under Article 1(3) and remain subject to Regulation (EU) No 10/2011. Chemical recycling should not be treated as a blanket exemption.

The Commission's plastic recycling overview explains the technology–process–installation relationship. REACH24H's EU recycled plastic compliance support includes pre-application analysis, challenge-test supervision and support for EFSA scientific assessment applications.

Can the Same Challenge-Test Data Support Both Markets?

Potentially, but reuse should be assessed before testing begins. Similar scientific questions do not make the protocols, evaluation criteria or submission requirements interchangeable.

For mechanical PET, EFSA's scientific guidance evaluates decontamination efficiency using surrogate contaminants and a defined assessment model. FDA's approach considers contaminant exposure for the proposed use. A result considered acceptable in one assessment does not automatically establish acceptability in the other.

A challenge test evaluates a recycling process's ability to remove contaminants. Finished-article migration evidence addresses a different part of the assessment. One generic report should not be assumed to cover every process, formulation or use.

Administrative requirements also affect reuse. EFSA's application procedure requires studies supporting an application that were commissioned or carried out after March 27, 2021 to be notified before they start. An existing FDA study therefore needs an EU review covering both scientific suitability and study-notification obligations.

What Should a Dual-Market Compliance Plan Include?

Build a common technical file, then identify the additional requirements for each market.

1. Define the commercial application. Record the polymer, feedstock source, recycling method, recycled content, layer structure, food type and contact conditions.

2. Select the routes separately. Assess the role of an FDA NOL and identify the applicable EU technology route. Verify the relevant Union register entries, the applicable process status and the decontamination installation's status. The applicable EU requirements also extend to installations outside the EU producing recycled plastic for the EU market.

3. Review existing evidence before ordering tests. Identify usable information, technical gaps and study-notification requirements. Agree the target uses before finalizing the protocol.

4. Align supply-chain documents with the assessed scope. In the EU, recyclers and converters have specific declaration-of-compliance requirements. Customer documents should accurately communicate applicable restrictions.

For packaging manufacturers, the final check is whether the selected resin, process and supporting documents match the packaging actually being supplied. Changes to feedstock, equipment, operating conditions or intended use should trigger a review of the existing evidence.

How Does the PPWR Fit into This Comparison?

The EU Packaging and Packaging Waste Regulation (PPWR) adds packaging sustainability obligations, including phased recycled-content requirements. It does not replace food-contact safety requirements or authorize a recycling process.

Plan the intended PCR percentage alongside the applicable food-contact route. A recycled-content certificate alone does not demonstrate that the resin is suitable for the intended food-contact application. Companies can assess the packaging obligations separately through REACH24H's EU PPWR packaging compliance services.

How REACH24H Can Help

REACH24H supports food-contact recycled plastic projects through:

• Recycling-process compliance analysis and pathway selection for the intended material, feedstock and food-contact application.

• Data-gap assessment and challenge-test supervision to help align the evidence with the applicable assessment requirements.

• Application dossier preparation for U.S. FDA NOL requests and applicable EU recycled plastic process safety assessment submissions.

• Technical communication with competent authorities during the relevant review procedures.

These capabilities support U.S. FDA NOL applications and EU recycled plastic compliance and process safety assessment projects.

REACH24H's publicly reported projects include recycled polypropylene (rPP) and recycled linear low-density polyethylene (rLLDPE), as well as recycled high-density polyethylene (rHDPE).

As of October 2026, REACH24H has helped clients worldwide obtain 15 FDA NOLs during 2026, covering different recycled materials and food-contact applications. The applicable food types and conditions of use depend on each project's assessment and the scope of its FDA letter.

Recommended Reading

• FDA PCR Plastics NOL Trends: What Food-Grade Recycled Plastic Suppliers Should Know

• EU, US and ASEAN Food Contact Materials: Compliance Routes for Exporters

Official References

• FDA: Use of Recycled Plastics in Food Packaging — Chemistry Considerations

• Regulation (EU) 2022/1616 — consolidated text

• EFSA: Plastic Recycling Process Application Procedure

• Regulation (EU) 2025/40 — Packaging and Packaging Waste Regulation