FDA 21 CFR 177 Disposable Plastics Food Contact Compliance Testing
Eurolab Testing Services Polymer & Plastics TestingDisposable Plastics Testing

FDA 21 CFR 177 Disposable Plastics Food Contact Compliance Testing

FDA 21 CFR 177 Disposable Plastics Food Contact Compliance Testing

FDA 21 CFR 177 Disposable Plastics Food Contact Compliance Testing

The FDA’s 21 Code of Federal Regulations part 177 (21 CFR 177) sets forth the safety standards for materials and articles intended to come into contact with food. This regulation ensures that all materials used in or around food are safe and do not transfer harmful substances to the food during processing, packaging, storage, or distribution.

For disposable plastics designed to come into direct contact with food, compliance with 21 CFR 177 is mandatory. This service involves a comprehensive suite of tests that ensure the plastic materials used in disposable items like cutlery, plates, and containers meet both physical and chemical safety standards. The testing process includes:

  • Material identification and characterization
  • Determination of leachables
  • Evaluation of thermal stability under simulated use conditions
  • Assessment of migration of additives into food simulants
  • Microbial resistance evaluation
  • Physical property measurement (stiffness, flexibility)

The testing methods employed are based on recognized standards such as ASTM D884, ISO 17651, and EN 12399. These tests simulate real-world conditions to ensure that the disposable plastics not only meet regulatory requirements but also perform effectively in their intended use.

Our laboratory uses state-of-the-art equipment to conduct these tests. Our experienced team of scientists ensures accurate and precise testing, providing you with reliable data for your compliance documentation.

Test Method Description
ASTM D884 Determination of tensile properties of plastics
ISO 17651 Determination of leaching from plastic materials into food simulants
EN 12399-2 Evaluation of the effect of heat on migration from plastics to food

In summary, our FDA 21 CFR 177 testing service ensures that your disposable plastics meet all necessary safety and performance criteria. This is critical for maintaining compliance with regulatory standards while ensuring consumer safety.

Quality and Reliability Assurance

The integrity of our FDA 21 CFR 177 testing service is underpinned by rigorous quality assurance practices. We adhere to strict procedural guidelines that are regularly reviewed and updated to meet the latest regulatory requirements. Our laboratories are equipped with advanced instrumentation and calibrated to international standards, ensuring accurate and consistent test results.

Our team of highly skilled scientists and engineers ensures that every aspect of your disposable plastic products is thoroughly evaluated. From material selection through to final product testing, we follow a systematic approach that guarantees reliability and consistency in our findings.

We also provide detailed reports that outline the results of each test conducted. These reports are comprehensive and include all relevant data points from the testing process. This transparency allows you to make informed decisions about your product development and compliance strategy.

Environmental and Sustainability Contributions

In addition to ensuring food safety, our FDA 21 CFR 177 testing service contributes positively to environmental sustainability. By helping manufacturers produce safe disposable plastics that are free from harmful chemicals, we support a cleaner environment.

We also offer additional services that focus on the environmental impact of your products. These include lifecycle assessments and recommendations for more sustainable materials. Our goal is not only to meet regulatory requirements but also to promote responsible manufacturing practices.

Use Cases and Application Examples

  • Testing single-use containers used in fast-food chains
  • Evaluation of disposable cutlery for use in catering services
  • Assessment of plastic packaging for food delivery services
  • Quality control checks on custom-made medical devices with food-contact surfaces
What is the difference between leachables and extractables?
Leachables refer to substances that are released into a material when it comes into contact with a substance, such as food. Extractables are components of a material that can be removed by coming into direct contact with another substance.
How long does the testing process usually take?
The duration of our FDA 21 CFR 177 testing service depends on the complexity of your product and the number of tests required. Typically, the process can be completed within 4-6 weeks.
Can you test custom products that are not listed in FDA guidelines?
Yes, our laboratory is equipped to handle custom materials and products. We work closely with your team to develop a tailored testing plan.
What certifications will I receive upon successful completion of the tests?
Upon successful completion, you will receive detailed reports that include all relevant test results and compliance information. These reports are essential for maintaining FDA compliance.
Do I need to provide samples before testing begins?
Yes, providing samples is necessary so that our laboratory can begin the appropriate tests. Samples should ideally be representative of your product line.
Is there a minimum order quantity for this service?
There is no minimum order quantity, but providing multiple samples allows us to conduct more thorough testing and analysis.

Frequently Asked Questions

What is the difference between leachables and extractables?
Leachables refer to substances that are released into a material when it comes into contact with a substance, such as food. Extractables are components of a material that can be removed by coming into direct contact with another substance.
How long does the testing process usually take?
The duration of our FDA 21 CFR 177 testing service depends on the complexity of your product and the number of tests required. Typically, the process can be completed within 4-6 weeks.
Can you test custom products that are not listed in FDA guidelines?
Yes, our laboratory is equipped to handle custom materials and products. We work closely with your team to develop a tailored testing plan.
What certifications will I receive upon successful completion of the tests?
Upon successful completion, you will receive detailed reports that include all relevant test results and compliance information. These reports are essential for maintaining FDA compliance.
Do I need to provide samples before testing begins?
Yes, providing samples is necessary so that our laboratory can begin the appropriate tests. Samples should ideally be representative of your product line.
Is there a minimum order quantity for this service?
There is no minimum order quantity, but providing multiple samples allows us to conduct more thorough testing and analysis.

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