Food Contact Regulatory Compliance

  • Overview
  • Services
  • Why Work With NSF?

For products sold in the U.S. and European Union, all food contact materials must comply with applicable regulations including FDA 21 CFR and the EU Framework Regulation No. 1935/2004. NSF has the technical expertise and laboratory capabilities to provide comprehensive services to ensure product compliance and speed to market.

Services

Food contact material compliance is required in many countries to ensure there is no transfer of constituents to food in quantities that could endanger human health or bring about an unacceptable change or deterioration in food composition. In the U.S., materials are often required to comply with 21 CFR. Similarly, all food contact materials (FCMs) manufactured or sold in the European Union must comply with EU Framework Regulation No. 1935/2004.

NSF provides a full range of services to help you comply with the requirements necessary to sell your food industry product. We can help you determine the appropriate steps to secure regulatory approval, while assisting with the submission of the necessary paperwork to the U.S. Food and Drug Administration and other regulatory agencies.

Specific services include:

21 CFR Material Formulation Review

Our team of toxicologists reviews material formulations to determine whether the ingredients are FDA compliant to 21 CFR regulations for the intended end use of the material.

21 CFR End Testing

Scientists in our 130,000-square-foot laboratory conduct the appropriate analyses for food contact materials to determine potential leaching at varying conditions of exposure.

EU Legislation Compliance

NSF's expert staff and toxicologists can assist manufacturers in navigating the complex legislation and developing supporting documents to demonstrate compliance to the Framework Regulation EC 1935/2004, material-specific measures and the national legislation of the EU member states.

Food Contact Notifications (FCNs)

Our staff helps compile and submit food contact notifications as a requirement of the Federal Food, Drug and Cosmetic Act and Title 21, Code of Federal Regulations (CFR) for indirect food additive and secondary additive substances that are not generally recognized as safe (GRAS) or not previously authorized by the FDA for the intended end use.

Safety Assessments

NSF’s experienced toxicologists conduct safety and risk assessments on various substances. We review and evaluate comprehensive scientific literature, identify and resolve any data gaps and apply various toxicology and exposure modeling tools to support risk-management decisions.

Why Work With NSF?

At NSF, we have the expertise to assist your company with a variety of regulatory support services. Our international network of quality and regulatory professionals can help your company meet domestic and international requirements, providing technical guidance to increase your product’s speed to market. Our scientists and regulatory specialists have the knowledge and experience to provide guidance on the regulatory framework for various manufacturers in the food ingredient and food-contact material industries.

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  • We’ve worked with NSF for 18 years and have had almost all our products NSF certified. The widely accepted NSF mark, easy-to-navigate listings and dedication of our project manager have saved us time and money, and helped our products stand out.Jim Tuyls, Automatic Bar Controls
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