Key Points
- Global regulatory framework for Food Contact Materials (FCM)
- EU, US, China, and Japan compliance requirements comparison
- Positive List regulatory approach explained
- Japan FCM regulatory reform fully implemented in 2025
- PFAS restrictions and emerging chemical compliance risks
- Migration limits (OML/SML) and testing considerations
- Sustainable packaging and recycled material compliance trends
- Key compliance strategies for global market access
In today’s society, food safety has become a major public concern. From pesticide residues to food additives, consumers are increasingly attentive to the quality and safety of food itself. However, compared with food safety, the safety of Food Contact Materials (FCMs) is often overlooked, despite being closely related to food safety.
FCMs include materials such as plastics, rubber, paper, metals, and coatings used in food packaging, containers, and utensils. These materials may release harmful substances when in contact with food, potentially affecting food safety. According to EU FCM regulations, materials must not transfer harmful substances to food in quantities that could endanger human health, change the composition of food, or negatively affect its sensory properties.
Globally, regulatory control of FCMs is becoming increasingly stringent. Among different regulatory approaches, the positive list system has become the dominant model. This article reviews global FCM regulatory frameworks with a particular focus on Japan’s recent reform, highlighting key trends shaping the future of FCM compliance.
Global Overview of FCM Regulations
Globally, FCM regulatory frameworks can be broadly categorized into two main approaches:
- The flexible premarket notification system represented by the United States
- The stricter positive list system represented by the European Union
The positive list system requires that only substances which have undergone safety evaluation and are included on an approved list may be used in the manufacture of FCMs. This approach provides stronger risk control but may also increase compliance costs for industry. Many countries and regions have adopted or partially adopted this system.
The European Union is among the earliest and most comprehensive adopters of the positive list approach. Regulation (EU) No 10/2011 establishes the Union List, which includes all authorized monomers, additives, and polymer production aids permitted in plastic FCMs. Only substances included on the list may be used. The regulation also defines Specific Migration Limits (SML) and Overall Migration Limits (OML). Since its implementation in 2011, the regulation has been continuously updated, including the 2025 revision introducing new substances and updated migration requirements.
China also applies a positive list-based framework. In 2016, National Health Commission of the People’s Republic of China issued the National Food Safety Standard: General Safety Requirements on Food Contact Materials and Articles (GB 4806.1-2016), together with a series of related standards.1 These include general safety requirements, technical requirements for specific materials, and testing methods. Appendix A of GB 4806.6-2016 lists a detailed positive list, while GB 9685-2016 lists all the standards for the use of additives in FCM.
Regulatory authorities such as State Administration for Market Regulation (SAMR) and China National Center for Food Safety Risk Assessment (CFSA) periodically review and approve new substances2, reflecting China’s increasing focus on FCM safety as a major global manufacturing hub.
Japan introduced its positive list system in 2020, with full implementation effective on 1 June, 20253. The system mainly applies to synthetic resins, requiring safety assessment of substances prior to use. The positive list is structured as appended tables, specifying permitted polymers4, additives5, usage limits, and conditions. Certain thermosetting elastomers such as rubber remain regulated under a negative list approach. Japan’s reform aims to align its regulatory framework with international standards and enhance product safety.
Other countries adopting positive list systems include:
- India – Food Safety & Standards (Packaging) Regulations 20186
- Indonesia – BPOM Regulation No. 20 of 20197
MERCOSUR – GMC resolutions harmonized these regulatory developments demonstrate a global trend toward proactive risk control through pre-evaluation of materials.
In contrast, the U.S. FDA applies a hybrid system combining existing substance listings under 21 CFR and the Food Contact Notification (FCN) process for new substances. This approach allows greater flexibility and innovation, though preventive control may be less stringent than under the positive list system.
Evolution of Japan’s FCM Regulatory Framework
Japan has a long history of regulating FCMs. In 1959, the Ministry of Health, Labour and Welfare issued Notification No. 370, establishing Standards and Standards for Food, Additives, etc. specifications and standards for foods, food additives, containers, and packaging. Initially, the regulatory approach relied primarily on a negative list system, prohibiting certain hazardous substances without comprehensive pre-approval requirements.
For several decades, regulatory development remained limited, resulting in a gap between Japan and other developed regions. On 12 June, 2018, Japan amended the Food Sanitation Act and introduced the positive list system8, marking a significant regulatory shift.
The positive list system officially took effect on 1 June, 20209, with a five-year transition period.
The system applies mainly to plastic materials and additives, with authorized substances listed in Appended Table 110 along with an implementation notice11, which serves as an elaboration and explanatory note. Only listed substances may be used unless evaluated and approved by the Ministry of Health, Labour and Welfare (MHLW).
Following the transition period, full implementation began on 1 June, 2025. Additional structural changes reorganized regulatory provisions and removed certain physical testing requirements for high-temperature sterilized packaging. Importantly, Japan strengthened Overall Migration Limits for plastic FCMs12, creating a dual regulatory structure combining positive and negative list controls. The amendments, except the Overall Migration requirement that will become effective on 1 June 2026, have come to effective on 1 June, 2025.
Global Importance and Future Trends of FCM Regulation
Although large-scale incidents directly caused by FCMs are relatively rare13, their impact is often long-term and cumulative14. Positive list systems offer a preventive approach by ensuring only assessed substances enter the supply chain. This explains why regions such as the EU, China, and Japan have adopted this regulatory model.
Key future regulatory trends include:
- Expansion of regulatory scope: EU, as an example, suggests extending the coverage to paper, metals, glass, coatings, silicone, and inks, as well as escalate the regulation from member states’ level to EU’s level15; while China has been updating the FCM specifications for newly added materials;
- Increased scrutiny on key chemical residues: with perfluorinated and polyfluoroalkyl substances (PFAS) showing the most significant trend. The US FDA began phasing out PFAS compounds from certain food packaging in 202416, and many states have enacted legislation to completely ban them; on the other hand, the EU has explicitly banned PFAS in food packaging materials after 12 August, 2026, in its Packaging Materials Directive17. It is expected that more and more regions will join the ranks of those banning PFAS in food packaging materials in the future;
- Recycling and reuse: For example, one of the EU’s recent development directions is to support innovation and sustainability18 by promoting safe, reusable, and recyclable solutions; while China is also actively exploring regulations for recycled FCMs (such as rPET materials)19, and it is expected that regulations in this area will become increasingly stringent in the future.
For consumers, understanding FCM regulations helps ensure safer product choices. For businesses, compliance is essential for market access. Japan’s reform demonstrates how regulatory systems are evolving toward more scientific and comprehensive approaches to ensure food safety.
1 Announcement on the Issuance of 53 National Food Safety Standards Including General Safety Requirements for Food Contact Materials and Articles (GB 4806.1-2016) (Announcement No. 15 of 2016)
https://www.nhc.gov.cn/sps/c100088/201611/6f792a23fc294c1a90bebbbac1edf288.shtml
2 These standards include:
- GB 4806.14-2023 – National Food Safety Standard: Inks for Food Contact Materials and Articles
- GB 4806.15-2024 – National Food Safety Standard: Adhesives for Food Contact Materials and Articles
- GB 4806.16-2025 – National Food Safety Standard: Silicone Rubber Materials and Articles for Food Contact Use
3 Integration update conducted on 13 November 2023
4 Appended Table 1 – Table 1 (Permitted Polymers)
5 Appended Table 1 – Table 2 (Permitted Additives and Restrictions)
6 Schedule III of the regulation specifies technical requirements for certain materials, but does not explicitly prohibit the use of plastics outside the listed materials.
7 BPOM Regulation No. 20 of 2019 and its amendments. Annex 3 lists authorized substances, while Annex 4 specifies prohibited substances.
8 Official announcement on amendments to Japan’s Food Sanitation Act
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000197196.html
9 Following implementation in 2020, multiple technical updates and refinements were introduced
https://www.mhlw.go.jp/stf/newpage_05148.html
10 Official website of the Positive List system
11 Monomers, etc. constituting the base materials specified in Table 1 of Appended Table 1 of Specifications and Standards for Foods, Food Additives, etc.
Japanese version:
English version (notification only, excluding annex tables):
12 Previously, Overall Migration Limits (OML) requirements were only applicable to certain specific plastic materials.
13 Although large-scale incidents directly caused by FCM are rare, smaller incidents occasionally occur. For example, in 2024, multiple lawsuits were filed against Hershey Company alleging the presence of per- and polyfluoroalkyl substances (PFAS) in chocolate packaging, which may migrate into food. Additionally, in 2012, the EU warned about the potential presence of harmful mineral oil residues in recycled paper-based food packaging.
https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2012.2704
14 Studies conducted in the 2010s identified migration of Bisphenol A (BPA) from baby bottles and can linings, leading to regulatory bans on BPA in infant products across the EU, Canada, and the United States.
EU restriction:
https://www.europarl.europa.eu/doceo/document/P-7-2010-3848_EN.html
Canada restriction:
https://laws-lois.justice.gc.ca/eng/acts/C-1.68/page-7.html#h-44890
FDA announcement:
https://abcnews.com/Business/fda-officially-bans-bpa-bisphenol-baby-bottles/story?id=16799087
15 See final page of the official report
https://www.europarl.europa.eu/RegData/etudes/STUD/2016/581411/EPRS_STU(2016)581411_EN.pdf
16 FDA: Authorized Uses of PFAS in Food Contact Applications
https://www.fda.gov/food/process-contaminants-food/authorized-uses-pfas-food-contact-applications
Other contact materials, such as non-stick cookware, may still contain PFAS due to low migration potential.
17 Regulation (EU) 2025/40 (PPWR), Article 5(5), defines PFAS restrictions applicable to food packaging materials
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R0040
18 Revision of EU rules on Food Contact Materials
19 Report on upcoming updates to GB 4806.1
https://www.complianceandrisks.com/blog/key-takeaways-from-the-food-contact-asia-conference-2025/
