FDA No Objection Letter (NOL) for Recycled Plastics in the U.S.

Regulatory Framework for Recycled Plastics in the U.S.

The regulation of food-contact recycled plastics in the United States is overseen by the U.S. Food and Drug Administration (FDA). Similar to virgin plastics, recycled plastics must meet the requirements outlined in the Federal Food, Drug, and Cosmetic Act (FFDCA) and Title 21 of the Code of Federal Regulations (21 CFR). In addition, the FDA has published Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations), which provides voluntary recommendations to help industry stakeholders ensure the safety of recycled plastics for food-contact applications.

What is an FDA No Objection Letter (NOL)?

An FDA No Objection Letter (NOL) is an official statement from the FDA confirming that the agency has reviewed a product or material and found no objections to its safety or compliance. FDA starts the evaluation for a product when the technical data is submitted. If the product meets the safety requirements of the Guidance and does not pose a risk to consumer health, an NOL will be issued by the FDA.

Who Needs to Apply for an FDA No Objection Letter (NOL)?

The eligible applicants for a No Objection Letter (NOL) include recycled plastic equipment suppliers and recycled plastic manufacturers. The FDA allows equipment suppliers to authorize material manufacturers to use the NOL associated with their equipment. In such cases, if the manufacturer can ensure that the recycled plastic materials, process conditions, and equipment used are identical to those specified in the supplier’s NOL application, then the existing NOL can be licensed to the manufacturers to use without submitting a new one.

Which Plastics Can Apply for an FDA NOL?

According to the Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations), recycled plastics are classified into three categories, each of which can apply for an NOL:

1. Primary Recycled Plastics
   Offcuts from the production of food-contact plastics, also known as post-industrial recycled plastics. To apply for an NOL, companies only need to demonstrate overall facility compliance with Good Manufacturing Practices (GMP) and prove that the material’s properties have not significantly changed after recycling.
2. Secondary Recycled Plastics
   Plastics that have undergone mechanical processes such as crushing, cleaning, melting, and extrusion to remove most contaminants. The structure and composition of the plastics remain unchanged after recycling, so this process is also called “physical recycling.”
3. Tertiary Recycled Plastics
   Plastics have been chemically degraded to monomers or oligomers, then purified through distillation, refined, and finally polymerized into virgin plastic pellets. This process is also called chemical recycling, which is able to manufacture materials with higher purity compared to secondary recycling.

FDA’s Safety Assessment of Plastics Recycling Processes

Since different companies use different recycling processes, the FDA requires a comprehensive evaluation of the decontamination efficiency of the recycling process. For a recycled plastic product to be considered safe for food-contact use, the estimated daily intake of contaminants migrating from the plastic into food should not exceed 1.5 micrograms per person per day. Therefore, companies must conduct a surrogate contamination test to demonstrate the effectiveness of their recycling process.

Surrogate Contamination Test (Challenge Test)

Surrogate contamination test is essential for assessing the decontamination efficiency of the recycling process. The general procedure involves:

1. Contamination Simulation: Plastic pellets are immersed in a specific formulation of contaminants, simulating the contamination of the recycled plastics.
2. Initial Contaminant Detection: The initial level of contaminants is measured.
3. Recycling Process operation: The contaminated plastic is processed using the company’s recycling method to remove contaminants.
4. Final Contaminant Detection: The final level of contaminants in the final product is measured to confirm the decontamination effectiveness.

FDA NOL Application Process

Application Types and Process:
Depending on the intended use of the recycled plastic in food packaging, applicants must submit NOL application documents under two different types:

• Specific use:
  The recycled plastic is intended to contact with specific food types such as fresh vegetables, fruits, and shell eggs, or not directly contact with food without heat treatment. (This aligns with the FDA’s classification of food contact types and use conditions.) Applications based on specific use are generally exempt from surrogate contaminant testing.
• General use:
  The recycled plastic is intended to contact with a variety of food types, and the application may involve heat treatment such as high temperature sterilization. Applications for general use must undergo a surrogate contamination test.

The FDA NOL application process can be summarized in the following steps:

1. Identify Recycled Plastic Category:
   The applicant needs to determine whether the recycled plastic is primary, secondary, or tertiary.
2. Data Gap Analysis:
   Evaluate whether existing data meets the FDA’s requirements. Determine whether additional testing (such as a surrogate contamination test) is necessary.
3. Testing Arrangement:
   Arrange for third-party laboratories to conduct a surrogate contamination test.
4. Dossier Preparation:
   Prepare and compile the application dossiers, including scientific data and process descriptions.
5. Dossier Submission:
   Submit the completed dossiers to the FDA, ensuring compliance with FDA guidelines.
6. Technical Review by FDA:
   FDA reviews the scientific data and the manufacturing process information. FDA may request additional information or clarification.
7. Supplementary Data Submission:
   If necessary, submit additional data or attend technical meetings with the FDA to clarify any issues.
8. FDA Issues NOL:
   Once the dossiers fulfill the requirements of the FDA, an NOL will be issued, which can be used as proof of compliance when marketing the product.

Why Do Companies Need an FDA NOL?

1. Compliance with Regulatory Requirements:
   Obtaining an FDA NOL ensures that the product complies with the FDA guidelines for recycled plastics, thus gaining strong recognition within the industry.
2. Enhanced Customer Trust and Market Competitiveness:
   An FDA NOL signifies that a product has passed stringent scientific reviews and complies with FDA chemical safety guidelines, enhancing trust among customers (e.g., food companies, packaging manufacturers) and improving market competitiveness.

Our Services

We offer the following services for FDA NOL applications for recycled plastics:

• FDA NOL Application for Recycled Plastics
• Official Communication with the FDA
• Surrogate Contamination Test Oversight
• Specific/General Use NOL Applications

Why Choose Us?

At REACH24H, our Food Contact Materials Compliance Team specializes in U.S., European, and global compliance services. We have extensive experience handling regulatory submissions for food-contact materials, including recycled plastics, and have successfully helped companies achieve compliance in markets worldwide. With a strong network of certified laboratories and streamlined communication with regulatory authorities, we offer tailored compliance solutions to meet the needs of your business.