Why the EU Standard Leads in Consumer Safety
Comparing FDA and EU regarding Epoxy resins, which are versatile compounds used across
industries, from aerospace to electronics to food packaging. Their high adhesive strength and chemical resistance make them invaluable — but also potentially hazardous. In particular, concerns have been raised about substances like Bisphenol A (BPA), a key component in many epoxy resins, which can migrate into food and beverages, posing health risks.
When it comes to regulating these materials for use in food contact applications, two of the most influential standards come from the United States Food and Drug Administration (FDA) and the European Union (EU). While both aim to protect public health, the EU framework is widely considered to be more stringent and precautionary. This article explores the differences between the FDA and EU, comparing FDA and EU regulations for epoxy resin and why the EU’s approach is generally regarded as superior in safeguarding consumer health.
FDA Regulations: Broad and Less Restrictive
The FDA governs epoxy resins for food contact under its Code of Federal Regulations (CFR), particularly Title 21. Substances used in coatings, such as epoxy resins, are often regulated under 21 CFR 175.300, which permits specific resinous and polymeric coatings as indirect food additives.
Notably, the FDA evaluates materials based on intended use and migration testing, but it does not maintain a specific positive list for all possible chemical constituents. For instance, BPA is still permitted by the FDA for use in food-contact applications (except baby bottles and sippy cups, from which manufacturers voluntarily removed it). Instead of banning BPA outright, the FDA maintains that current exposure levels are safe — a position that has attracted criticism from independent researchers and public health organizations.
Weaknesses of the FDA Approach
Reactive rather than proactive: The FDA often evaluates chemicals based on industry-supplied data and tends to act only when overwhelming evidence demands it.
Limited scope: There's a lack of comprehensive assessment for combination effects or endocrine-disrupting properties.
Outdated assumptions: Many FDA rules were written decades ago and have not been sufficiently updated to reflect modern toxicology and risk assessment techniques.
EU Regulations: Precautionary and Specific
Comparing FDA and EU regulations. In contrast, the European Union applies a much stricter and more transparent framework. Epoxy resins used in food contact materials are regulated under Regulation (EC) No 1935/2004, which states that materials must not transfer their constituents into food in quantities that could endanger human health.
For epoxy derivatives specifically, Directive 2002/16/EC and Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food include detailed migration limits and substance-specific restrictions. These include:
Specific Migration Limits (SMLs) for epoxy derivatives such as BADGE (bisphenol A diglycidyl ether) and its related compounds.
Positive list system: Only substances that have undergone rigorous safety evaluations by the European Food Safety Authority (EFSA) are permitted.
Ban on BPA: Several EU member states, including France and Denmark, have banned BPA in food contact materials for infants and young children. The EU has also proposed a union-wide ban on BPA in all food packaging as of 2024, citing its classification as a substance of very high concern (SVHC) due to its endocrine-disrupting effects.
Strengths of the EU Approach
Precautionary principle: The EU favours caution in the face of scientific uncertainty, especially concerning vulnerable populations.
Regular updates: EFSA frequently revisits scientific data and updates migration limits and safety assessments accordingly.
Comprehensive oversight: The EU takes into account cumulative exposure and low-dose effects, particularly for endocrine disruptors.
Conclusion: Why the EU Standard Is Superior
While the FDA continues to rely on outdated assumptions and voluntary industry compliance, the EU has adopted a modern, science-based, and precautionary approach to regulating epoxy resins. The EU’s focus on specific migration limits, mandatory substance evaluations, and its willingness to act against substances like BPA demonstrates a more substantial commitment to consumer safety.
For manufacturers and consumers alike, aligning with the EU standard not only ensures compliance with some of the world’s most rigid safety rules but also reflects a proactive stance on health and environmental responsibility. As global awareness around chemical safety grows, the EU’s framework stands out as a model for effective, science-driven regulation — one that other jurisdictions, including the United States, may need to follow more closely.
Comparing FDA and EU regulations, Passionart and Resinzwood Products follow the guidelines of both the FDA and the EU regulations. By purchasing from our company, you can rest assured that our Highest Quality Epoxy Resins are EU-approved
