FDA 21 CFR Part 177 Food Contact Material Compliance
The FDA’s 21 CFR Part 177 regulations govern the safety of materials, articles, and components that come into contact with food. Compliance with these regulations is essential for any company involved in the production or supply chain of food contact materials (FCMs). This service focuses on ensuring that FCMs are safe for use, do not leach harmful substances into food, and meet strict FDA requirements.
Our laboratory adheres to rigorous testing protocols and utilizes state-of-the-art equipment to evaluate the migration of chemicals from packaging into food products. We provide comprehensive compliance testing services tailored to help you navigate the complexities of 21 CFR Part 177. Our team of experts ensures that your FCMs are thoroughly assessed, ensuring safety and regulatory compliance.
The importance of FDA 21 CFR Part 177 cannot be overstated. Non-compliance can lead to product recalls, legal issues, and significant financial losses. Our service is designed to minimize these risks by providing accurate and reliable testing results that meet the stringent requirements set forth by the FDA.
Our approach begins with a thorough evaluation of your FCMs. This includes understanding the materials used, the intended use of each material, and any potential food contact scenarios. We then develop a tailored testing plan to address these specific needs. Our comprehensive suite of tests covers various aspects such as chemical migration, physical properties, and durability.
Chemical migration is one of the key concerns when it comes to FCMs. Our laboratory uses advanced analytical techniques to detect even trace amounts of chemicals that might migrate into food products. This ensures that any potential risks are identified early in the process. We also conduct tests for physical properties, such as tensile strength and flexibility, which are crucial for ensuring the durability and integrity of your packaging materials.
Our testing methods comply with international standards, including ISO 21579, ASTM E1086, and EN 14362. These standards provide a framework for consistent and reliable testing, ensuring that our results are comparable and valid across different laboratories worldwide. By adhering to these standards, we ensure that your FCMs meet not only FDA requirements but also international best practices.
Our team of experts works closely with you throughout the testing process. We provide detailed reports that outline all test results and recommendations for improving product safety. These reports are invaluable tools for quality managers, compliance officers, R&D engineers, and procurement teams to make informed decisions about your FCMs.
We understand that regulatory requirements can be complex and ever-evolving. Our service is designed to keep you up-to-date with the latest changes in FDA regulations. By working with us, you can rest assured that your FCMs are always compliant with current standards.
Applied Standards
The testing protocols we follow for 21 CFR Part 177 compliance are rooted in a variety of international and industry-specific standards. These include:
- FDA 21 CFR Part 177
- ISO 21579:2013 – Food Contact Surfaces – Determination of Migratable Matter from Packaging into Foodstuffs
- ASTM E1086-14(2019) – Standard Test Method for Migration of Materials from Single-Layer Containers into Food Simulants by the Use of Headspace Gas Chromatography-Mass Spectrometry (GC-MS)
- EN 14362:2015 – Packaging and packaging waste – Determination of leachable substances into food simulants
These standards provide a comprehensive framework for evaluating the safety of materials that come into contact with food. By adhering to these standards, we ensure that our testing methods are both robust and reliable.
| Test Method | Description | Acceptance Criterion |
|---|---|---|
| FDA 21 CFR Part 177 | Detailed regulations for food contact materials. | All regulated chemicals must not migrate into food at levels exceeding the limits set by FDA. |
| ISO 21579:2013 | Standard method for determining migratable matter from packaging into food simulants. | Migratable substances should be below specified limits to ensure safety. |
| ASTM E1086-14(2019) | Method for migration testing using headspace gas chromatography-mass spectrometry (GC-MS). | Migratable substances must be below the detection limit set by ASTM. |
| EN 14362:2015 | Detailed procedure for determining leachable substances into food simulants. | Leachable substances should not exceed specified levels to ensure safety and compliance. |
These tests are conducted in a controlled environment, using a range of food simulants that mimic real-world conditions. This ensures that the results accurately reflect how your FCMs will perform under actual use conditions.
Scope and Methodology
The scope of our FDA 21 CFR Part 177 compliance testing encompasses a wide range of food contact materials. This includes plastics, metals, glass, paper, and any other material that comes into direct or indirect contact with food.
Our methodology involves several key steps:
- Sample Preparation: We carefully prepare your samples according to the specified conditions outlined in 21 CFR Part 177. This includes determining the type of food simulant and the duration of contact.
- Migration Testing: Using advanced analytical techniques, we test for the migration of chemicals into the food simulants. Our methods ensure that even trace amounts are detected.
- Analytical Methods: We employ a variety of analytical tools to analyze the samples. These include gas chromatography-mass spectrometry (GC-MS), inductively coupled plasma mass spectrometry (ICP-MS), and other cutting-edge technologies.
- Reporting: Once all tests are completed, we provide detailed reports that summarize our findings. These reports include recommendations for improving the safety of your FCMs if necessary.
The accuracy and reliability of our testing methods are critical to ensuring FDA compliance. We use only the latest technology and follow strict quality control procedures to maintain the highest standards in our work.
Industry Applications
| Food Contact Material | Testing Requirements |
|---|---|
| Polyethylene (PE) | Migration testing for plasticizers such as phthalates. |
| Polystyrene (PS) | Migration testing for monomeric styrene and other solvents used in production. |
| Cellophane | Migration testing for leachable substances such as alcohols and esters from the material itself. |
| Paperboard | Migration testing for lignin, phenolic compounds, and other potential leachates from paper materials. |
| Aluminum Foil | Metallic migration tests to ensure that aluminum does not leach into food products. |
| Glass Jars | Migration testing for leachable substances such as silicates and boron compounds from the glass itself. |
| Silicone Rubber | Metallic migration tests to ensure that silicone does not release harmful compounds into food products. |
Our testing services are designed to meet the specific needs of various industries. Whether you are in packaging, food manufacturing, or any other sector where FCMs play a crucial role, our expertise can help ensure compliance with FDA regulations and international standards.
