Similarities and Differences in EU and US Food Contact Material Regulations

As overseas distributors and OEM brands, you face the complex task of ensuring your products comply with diverse regulatory landscapes. Food contact materials (FCMs), those intended to come into contact with food, are subject to stringent regulations in both the European Union (EU) and the United States (US). Understanding the similarities and differences between EU and US FCM regulations is crucial for market access, minimizing compliance risks, and ensuring consumer safety. This article provides a detailed comparison to help you navigate these requirements.

Key Regulatory Bodies and Frameworks

Both the EU and US have established regulatory bodies and frameworks to govern FCMs. While their approaches differ, the ultimate goal is the same: to protect public health by ensuring that materials in contact with food do not release harmful substances into the food.

European Union (EU)

• European Food Safety Authority (EFSA): EFSA provides scientific advice and risk assessments on food safety matters, including FCMs.
• European Commission: The Commission is responsible for drafting and implementing EU legislation, including FCM regulations.
• Framework Regulation (EC) No 1935/2004: This overarching regulation sets out the general principles for all FCMs, requiring them to be safe, inert, and not to deteriorate food quality.
• Specific Measures: Specific regulations exist for certain materials like plastics (Regulation (EU) No 10/2011), active and intelligent packaging (Regulation (EC) No 450/2009), and recycled plastics (Regulation (EC) No 282/2008).

United States (US)

• Food and Drug Administration (FDA): The FDA is the primary regulatory body responsible for overseeing the safety of food, including FCMs.
• Federal Food, Drug, and Cosmetic Act (FFDCA): This Act provides the FDA with the authority to regulate FCMs.
• Food Contact Substances (FCS): The FDA regulates substances intended for use as components of FCMs under the FCS notification program.
• Food Additive Regulations: Some FCMs or components thereof may be regulated as food additives, requiring pre-market approval.

Similarities in Regulatory Objectives and Principles

Despite differences in their regulatory structures, the EU and US share fundamental objectives and principles regarding FCMs.

• Safety and Inertness: Both regions require FCMs to be safe for their intended use and not to transfer harmful substances into the food in quantities that could endanger human health or cause unacceptable changes to the food’s composition or sensory characteristics.
• Good Manufacturing Practices (GMP): Both the EU and US mandate GMP for the manufacturing of FCMs to ensure quality control and minimize contamination risks.
• Overall Migration Limit (OML): Both regulatory systems utilize OMLs to limit the total amount of substances that can migrate from the FCM into the food.
• Specific Migration Limits (SML): Both also use SMLs to restrict the migration of particular substances known to be of concern.
• Risk Assessment: Both rely on scientific risk assessments to evaluate the safety of FCMs and establish appropriate regulatory controls.

Key Differences in Regulatory Approaches and Requirements

While the objectives are similar, the EU and US differ significantly in their regulatory approaches, testing requirements, and permitted substances.

Scope and Coverage

• EU: The EU employs a list-based (positive list) approach for many FCMs, especially plastics. Only substances explicitly listed in the regulations are authorized for use. This list is regularly updated based on scientific evidence.
• US: The US relies on a more flexible approach, allowing substances to be used if they are Generally Recognized as Safe (GRAS) for their intended use or have received pre-market approval through the FCS notification program or food additive petition process. GRAS status can be based on scientific procedures or experience based on common use in food.

Pre-Market Approval

• EU: For plastics, pre-market authorization is mandatory for new substances or uses not already covered by existing regulations. This requires a submission to EFSA for a scientific assessment.
• US: The FDA’s FCS notification program provides a pathway for manufacturers to notify the agency of their intent to use a new FCS. If the FDA does not object within a specified timeframe, the substance can be used as intended. Food additive petitions are required for substances that don’t meet FCS definition or when significant questions about safety exists.

Testing Requirements

• EU: The EU provides detailed guidance on migration testing methods and conditions, specifying simulants, time, and temperature depending on the intended use of the FCM.
• US: The FDA provides general guidelines on migration testing. However, specific test methods and conditions may be determined based on the nature of the FCM and the intended use.

Information Requirements and Declaration of Compliance (DoC)

• EU: The EU requires a Declaration of Compliance (DoC) for FCMs, providing information on the materials used, compliance with relevant regulations, and intended use. This DoC must be provided to customers and updated as necessary.
• US: While a formal DoC is not mandated, manufacturers are responsible for ensuring that their FCMs comply with applicable FDA regulations and must be able to provide supporting documentation upon request.

Enforcement

• EU: Enforcement is carried out by individual member states, leading to potential variations in interpretation and implementation.
• US: The FDA has nationwide enforcement authority, ensuring more consistent application of regulations.

Navigating Dual Compliance

For businesses targeting both the EU and US markets, the differences in FCM regulations can pose significant challenges. A robust strategy for achieving dual compliance is essential:

• Thorough Material Selection: Choose materials that comply with both EU positive lists and FDA regulations. Opt for materials with extensive toxicological data available.
• Comprehensive Testing: Conduct migration testing under both EU and US conditions to ensure compliance with both sets of requirements.
• Detailed Documentation: Maintain thorough documentation of materials used, manufacturing processes, and testing results. Prepare a DoC that satisfies EU requirements, even if not formally required by the FDA, as a best practice.
• Expert Consultation: Engage with regulatory experts who are familiar with both EU and US FCM regulations to ensure accurate interpretation and compliance.
• Supply Chain Management: Implement robust supply chain controls to ensure that all suppliers comply with the necessary requirements.
• Stay Updated: Regularly monitor changes in both EU and US FCM regulations to ensure ongoing compliance.

Summary

While both the EU and US aim to ensure the safety of FCMs, their regulatory approaches differ significantly. The EU relies on a positive list system and mandatory pre-market authorization for plastics, while the US utilizes a more flexible approach based on GRAS status and the FCS notification program. Understanding these differences, conducting thorough testing, and maintaining detailed documentation are crucial for distributors and OEM brands seeking to access both markets successfully. By implementing a proactive compliance strategy, businesses can minimize risks, protect consumers, and ensure seamless market access for their products.