Exports and Plastic Packaging: Why EU Compliance Is Not Enough for the US, Japan and China

European food producers and packaging manufacturers operating in global markets face a compliance challenge that is easy to underestimate: the EU’s framework for plastic food contact materials, while among the most demanding in the world, does not transfer to other jurisdictions. A plastic packaging that fully complies with EU Regulation 10/2011, the PPWR and the relevant substance restrictions may still require significant reformulation, retesting and re-documentation to enter the US, Japanese or Chinese market. And the differences are not merely procedural. In several areas, the underlying substance authorization lists, testing methodologies and migration limits are genuinely incompatible.

 

The United States: FDA Authority and a Positive System Based on Notifications

Food contact materials in the United States are regulated primarily by the Food and Drug Administration (FDA), under authority derived from the Federal Food, Drug and Cosmetic Act. The US system differs from the EU framework in a fundamental structural respect: rather than a centralized positive list of authorized substances with specific migration limits (as in EU Regulation 10/2011), the US operates through a combination of regulations, Food Contact Notifications (FCNs), Threshold of Regulation (ToR) exemptions and Generally Recognised as Safe (GRAS) determinations (note: the GRAS program is currently under legislative review).

The practical implication is that a substance authorized under the EU’s Annex I positive list for food contact plastics is not automatically considered safe or approved for use in the US. Each substance must have a separate basis for use under US law, either a prior sanctioned use, an applicable FDA regulation, a Food Contact Notification filed with and accepted by the FDA. Where the basis does not exist, the substance is not lawfully usable in food contact packaging for the US market, regardless of its EU status.

Migration limits also diverge. While the EU uses specific migration limits (SMLs) expressed in mg/kg food or mg/6 dm², the US system uses extraction tests, which is a more generic but also stringent approach to material’s analysis. A migration level that is compliant under EU 10/2011 may not satisfy the corresponding US exposure calculation.

On sustainability, the US picture is fragmented at the federal level but increasingly active at state level. California, Oregon, Colorado and Maine have enacted packaging EPR laws with varying scope, timelines and recycled content requirements. European producers exporting packaged goods to the US must track state-level obligations alongside federal FDA requirements, a two-tier compliance task with no single coordinating framework. Several US states have enacted packaging EPR laws that include specific recycled content targets for plastic packaging, with California’s SB-54 being the most notable example.

 

Japan: A Completed Transition to a Mandatory Positive List

Japan completed its transition to a mandatory positive list system for food contact materials in June 2025, following reforms introduced by the Food Sanitation Act in 2020. The transition is significant because it represents a fundamental change in the legal logic of the system: Japan moved from a negative list to a positive list model where only substances evaluated and approved by the Ministry of Health, Labour and Welfare (MHLW) may be used.

The positive list was initially implemented for synthetic resins, a key material category in packaging, utensils and multilayer structures. The change creates a direct risk for European exporters. For example, a substance on the EU’s Annex I positive list for food contact plastics is not automatically on Japan’s MHLW-approved list. Where a substance used in EU-compliant packaging does not appear on the Japanese list, it cannot lawfully be present in packaging intended for the Japanese market, even in trace quantities, unless a specific exemption applies.

Japan’s food contact system also applies through a different administrative structure. The MHLW sets standards at national level, but enforcement is carried out through a combination of national and prefectural authorities. The documentation and testing expectations, including the specific test conditions, simulants and methods, differ from EU practice, meaning that EU-standard migration test reports are typically not directly transferable to Japan compliance files.

 

 

China: GB Standards and an Evolving Framework

China’s food contact materials framework is built around the national food safety standards (GB standards) administered by the National Health Commission (NHC). The general framework is set by GB 4806.1-2016, which covers all food contact materials, while GB 4806.7-2023 sets specific requirements for plastics. GB 9685-2016 governs authorized additives and GB 31604.1-2023 establishes migration testing methods.

The Chinese system operates as a positive list for the main material categories. Substances not on the relevant GB list may not be used, regardless of their status under EU or US frameworks. The lists are not identical to either the EU’s Annex I or FDA’s authorised substance lists. This means that establishing compliance for the Chinese market requires a fresh assessment against the applicable GB standards, not a cross-reference from EU documentation.

China’s regulatory framework for food contact materials is not static. GB 4806.7-2023, which consolidated and expanded previous plastics standards, only took effect in September 2024 and the NHC issued three new testing standards and revised two existing ones in 2025 alone. For packaging containing recycled plastics, China’s standards include specific requirements for decontamination processes and quality control that parallel but do not mirror the EU’s Regulation 2022/1616. As with all major export markets, compliance documentation for China requires periodic review rather than a single assessment.

 

Conclusion

Meeting EU plastic packaging requirements is the starting point for selling in Europe, but does not guarantee access to other markets. The US, Japan and China each operate with their own substance authorization lists, testing methodologies and documentation requirements. Compliance must be assessed separately for each market.

Pack-Lab provides regulatory consulting for producers and exporters managing multi-market packaging compliance, including food contact materials assessment, migration testing and market-specific documentation preparation. Contact us to discuss your export markets.