Customized Assessment
We evaluate materials against applicable FDA food contact regulations, authorizations, exemptions, and guidance documents to identify regulatory obligations, support compliance efforts, and highlight potential gaps.
Food Contact Material Evaluation Support
Navigate FDA Requirements and Market Expectations with Confidence
Successfully bringing food contact materials to the U.S. market requires a thorough understanding of FDA regulations, regulatory clearances, and chemical safety considerations. Our customized Food Contact Material (FCM) evaluation services help organizations identify compliance obligations, determine appropriate regulatory pathways, and support successful market access.
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Regulatory
ExpertiseOur experts assess food contact materials against applicable U.S. Food and Drug Administration (FDA) regulations, Food Contact Notifications (FCNs), Threshold of Regulation (TOR) exemptions, and other relevant regulatory requirements. We help organizations understand regulatory expectations and develop strategies that support their compliance objectives.
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Tailored
SolutionsWe evaluate raw materials, additives, formulations, and intended food contact applications to develop compliance strategies aligned with each product’s composition, intended use, and business objectives.
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Comprehensive
SupportOur team reviews material compositions, supplier documentation, manufacturing processes, intended use conditions, and relevant regulatory requirements to support compliance throughout the product lifecycle.
Food Contact Material Evaluation Overview
We help manufacturers, suppliers, and brand owners assess food contact materials against applicable U.S. regulatory requirements while supporting product performance, customer expectations, and market access goals.
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What Is a Food Contact Material Evaluation?
A Food Contact Material Evaluation involves assessing materials and substances intended to come into direct or indirect contact with food to determine whether their intended use is supported under applicable FDA requirements.
Evaluations may include reviews of:
- Material composition
- Regulatory status and clearances
- Intended food contact conditions
- Migration potential
- Supplier documentation
- Manufacturing processes
- Intended end-use applications
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Why Are Food Contact Material Evaluations Important?
Organizations introducing food contact materials into the U.S. market are responsible for ensuring their products are suitable for their intended use and supported by applicable regulatory requirements.
A comprehensive evaluation can help organizations:
- Support FDA compliance objectives
- Facilitate market access in the United States
- Identify regulatory risks early in product development
- Meet customer, retailer, and supply chain requirements
- Support food safety and consumer confidence
- Streamline supplier qualification and approval processes
- Reduce potential compliance and business risks
Our Food Contact Material Evaluations Solutions
Personalized Guidance
Our experts combine knowledge of food contact regulations, chemistry, toxicology, materials science, and product stewardship to provide practical, risk-based recommendations tailored to your products and business goals.
Ongoing Support
Regulatory requirements and industry expectations continue to evolve. We help organizations monitor regulatory developments, evaluate the impact of regulatory changes, and support ongoing compliance throughout the product lifecycle.
Meet Our Food Contact Compliance Expert
Dedicated Professionals Supporting Your U.S. Compliance Journey
![1[1]](https://h2compliance.com/wp-content/uploads/2025/01/11.png)
Adrienne Black |PhD, DABT|
Senior Consultant: Product Stewardship & Compliance
Vonore, TN, USA
Frequently Asked Questions
Food contact materials include packaging, containers, processing equipment, utensils, coatings, adhesives, inks, plastics, rubber materials, paper products, and other materials intended to come into direct or indirect contact with food during manufacturing, processing, storage, transportation, or consumer use.
We review the material composition, intended use, food contact conditions, applicable FDA regulations, existing authorizations and exemptions, and supporting documentation to determine whether the intended application is supported under applicable regulatory requirements.
Typical information includes:
- Material composition details
- Supplier declarations and supporting documentation
- Intended food types
- Food contact conditions
- Processing and use conditions
- Product specifications
- Manufacturing information, when relevant
Yes. We support both existing commercial products and new product development initiatives. Early-stage evaluations can help identify regulatory requirements, potential compliance challenges, and data needs before commercialization.