Latest Regulatory Trends for Food Contact Materials and Elastomers: A Comprehensive Overview of Japan, U.S., EU, and China
Food contact materials are strictly regulated in each country, and in particular, Japan's new positive list system (fully implemented in June 2025) has made monomer-level management essential. This guide compares the regulatory systems of four countries: Japan, the United States, the EU, and China, and explains the requirements of each regulation. It also describes Mitsubishi Chemical's product lineup, focusing on the styrene-based thermoplastic elastomer "Tefabloc™".
Table of Contents [hide]
- 1.The role and regulatory environment of food contact elastomers
- 2.Comparison Table of Current Food Contact Regulations in Various Countries
- 2.1.Japan: Establishment of a national positive list and JCII voluntary standards
- 2.2.United States: Regulations by the FDA
- 2.3.Europe (EU): The need for a Declaration of Conformity and Transition Testing
- 2.4.China: Regulation based on national standards
- 3.Food Elastomer Lineup
- 4.Points to note when implementing
- 5.ReferenceURL
The role and regulatory environment of food contact elastomers
Contact materials in food manufacturing and distribution (bottle caps, gaskets, seals, hoses, etc.) are at the forefront of maintaining food quality and hygiene. Elastomer materials, in particular, combine flexibility and durability, making them essential for applications requiring dynamic sealing performance.
However, supplying raw materials from material manufacturers to final product manufacturers requires compliance with complex international regulations. Compliance standards differ across markets—Japan, the United States, Europe, and China—and a single product may not be suitable for all markets. This article explains the current state of food-contact elastomers and selection criteria from the perspective of a material manufacturer.
Comparison Table of Current Food Contact Regulations in Various Countries
The table below summarizes the regulatory systems of various countries, including Japan, the US FDA, the European EU-PIM, and the Chinese GB.
item | Japan | US | European Union (EU) | China |
Main regulatory framework | Positive list system for food utensils, containers, and packaging based on the Food Sanitation Act | Food contact substance regulations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR, etc. | Regulation (EC) No 1935/2004 and Plastics Regulation (EU) No 10/2011 | National food safety standards for food contact materials (e.g., GB 4806, GB 9685) |
Regulatory approach | Positive list system for base resins and additives | For each food contact substance used, check for applicable regulations, Food Contact Notifications (FCNs), or exemptions. | Positive list system based on a union list of approved substances | Positive list system for base resins, additives, etc. |
Main restrictions and requirements | Confirm usage conditions and additive usage limits according to application, operating temperature, food category, etc. | Confirm the usage conditions, food classification, contact conditions, and regulatory scope for each substance. | Check the specific migration limit (SML), overall migration limit (OML), and usage conditions for each substance. | Confirm the specific migration limit (SML), scope of use, and limits on the amount of additives used for each substance. |
The entity responsible for confirming conformity | Each business in the supply chain confirms compliance within its own area of responsibility. | The manufacturer and distributor of the final product confirms its suitability for its intended food contact application. | Each business in the supply chain must verify compliance with its scope of responsibility and communicate this information to the final product stage. A Declaration of Conformity (DoC) is required except at the retail stage. | The manufacturer and distributor of the final product confirms its suitability for its intended food contact application. |
Required actions from raw material manufacturers | This provides information on the listing status, application conditions, and usage limits of base resins and additives. | Provide information on the regulatory basis for raw materials, applicable usage conditions, and restrictions. | Provides information to assist in union list inclusion status, SML and other restrictions, terms of use, and creation of DoCs. | Provides information on positive list inclusion status, usage conditions, and restrictions on the amount of additives used. |
Japan: National positive list establishment and JCII voluntary standards
In Japan, the positive list system was fully implemented on June 1, 2025. The inclusion status of base polymers is determined at the monomer level, while that of additives is determined on a substance-by-substance basis.
Japan's positive list is a standard in which only listed substances are permitted for use, and it is a system in which the manufacturer of the final product is responsible for determining compliance themselves.
Furthermore, even before the establishment of the national positive list in Japan, JCII (Japan Food Contact Materials Safety Center: formerly the Japan San-ei Association) had been creating and operating a positive list based on industry voluntary standards. If a product conforms to these voluntary standards, JCII issues a certificate of confirmation upon application, and this certificate has been widely used as the de facto basis for safety assurance. Following the introduction of the national positive list system, JCII also reviewed its voluntary positive list and is proceeding with its restructuring to align with the national system. Currently, JCII's voluntary standards remain one of the effective means of determining the conformity of food contact materials in Japan.
United States: Regulations by the FDA
The US Positive List of Food Contact Materials is under the jurisdiction of the FDA (Food and Drug Administration) and is defined section by section in Title 21 CFR. Food contact materials are regulated by the part concerning food additives (particularly Parts 170-189).
Because temperature conditions and usage categories are also strictly defined, it is necessary to determine whether the ingredients used are suitable for the target food product by combining multiple conditions.
There is also the FCN (Foreign Carrier Network) system, which requires companies to submit safety data to the authorities and obtain individual approval. In recent years, the required safety data has become more stringent, and the difficulty of obtaining approval has been increasing.
Europe (EU): The need for a Declaration of Conformity and Transition Testing
The EU's Positive List of Food Contact Materials (Union List) is defined in Regulation (EU) No 10/2011 (Plastic Regulation). In principle, materials not included in the Union List are prohibited from use, however, NIAS (Non-Intentionally Added Substances), impurities, and reaction products are permitted for use on the condition that their safety is individually assessed.
While the creation of a Declaration of Compliance (DoC) is the responsibility of the final product manufacturer, raw material manufacturers have an obligation to provide information necessary for the creation of the DoC, such as SML (Specific Migration Limit) and QM (Quality Limit).
Transition testing is mandatory when creating a DoC (Developmental Document), and the manufacturer of the final product must conduct the testing before creating the DoC. Furthermore, since the positive list is frequently revised, it is important to regularly gather the latest information.
China: Regulations based on national standards
China's positive lists for food contact materials are defined in GB4806 and GB9685. The standards are further subdivided by material category, with plastics covered by GB4806.7 and additives by GB9685.
In addition to usage limits for each substrate, additives also have specific migration limits (SML) set for each substance. The manufacturer of the final product must confirm compliance with these limits through migration testing.
Food Elastomer Lineup
Features and Applications of Tefabloc™
Features:
• Hardness range: From approximately Durohardness A15 to high hardness (flexural modulus of elasticity 500 MPa)
• Excellent rubber elasticity, weather resistance, and heat resistance
• Easy to process with general-purpose molding machines; sprue and runner are recyclable.
• Food hygiene compliant grades are available in our lineup.
Application example:
• Tubing/hoses for delivering beverages
• Kitchen tools such as cutting boards and knife grips
• Bottle caps, gaskets, and seals
• Food conveying belt
• Dental care products (toothbrushes, interdental brushes)
• Medical devices for dentistry and digestive systems
Grade quick reference chart
When selecting materials for food contact applications, it is necessary to comprehensively consider the type of food, contact temperature, contact time, product shape, processing method, and regulatory requirements of the applicable region. This table summarizes the recommended processing methods, hardness/modulus, appearance, and compliance with Japan's Positive List System for Food Contact Materials for representative grades of thermoplastic elastomers and olefin-based elastomers intended for food contact applications.
Whether or not a material can be used in oily foods depends particularly on temperature conditions, so selecting the appropriate grade for the application is crucial. Suitability as a final product should be individually confirmed based not only on the material grade, but also on additives, colorants, processing conditions, final product shape, food contact conditions, and applicable regulations.
Material type/ grade | Recommended molding method | Durometer hardness A | Flexural modulus (MPa) | exterior | Special notes | Japan's Product Liability System | Other than oily foods | Oily foods: below 100°C | Oily foods: over 100°C |
TPS/ ME5309C | Extrusion Molding | 55 | ― | translucent | ― | Compatibility | correspondence | ― | ― |
TPS/ ME5302C | Extrusion Molding | 60 | ― | translucent | ― | Compatibility | correspondence | ― | ― |
TPS/ ME6301C | Extrusion Molding | 65 | ― | translucent | ― | Compatibility | correspondence | ― | ― |
TPS/ MP7204C | Extrusion Molding | 70 | ― | transparent | High transparency, softener-free | Compatibility | correspondence | ― | ― |
TPS/ MP8202C | Extrusion Molding | 80 | ― | transparent | High transparency, softener-free | Compatibility | correspondence | ― | ― |
TPS/ MJ4300C | Injection molding | 38 | ― | translucent | ― | Compatibility | correspondence | ― | ― |
TPS/ MJ5302C | Injection molding | 46 | ― | translucent | ― | Compatibility | correspondence | ― | ― |
TPS/ MJ6301C | Injection molding | 52 | ― | translucent | ― | Compatibility | correspondence | ― | ― |
TPS/ MJ7301C | Injection molding | 66 | ― | translucent | ― | Compatibility | correspondence | ― | ― |
TPS/ MJ8301C | Injection molding | 76 | ― | translucent | ― | Compatibility | correspondence | ― | ― |
TPS /MJ9301C | Injection molding | 84 | ― | translucent | ― | Compatibility | correspondence | ― | ― |
TPS/ OC-19 (Product under development) | Injection molding | 92 | ― | milky white | For oil-based food applications | Compatibility | correspondence | correspondence | ― |
TPO/ TX504N | Injection molding | ― | 530 | translucent | For olefin-based and oily food applications. | Compatibility | correspondence | correspondence | correspondence |
*The Japanese Positive List System for Food Contact Materials refers to the system that came into effect on June 1, 2025.
*Test No. 370 is a standard test for utensils, containers, and packaging made of synthetic resins mainly composed of polyethylene and polypropylene, based on Ministry of Health and Welfare Notification No. 370.
*The information in this table is representative of the information available at the time of creation and does not guarantee final compliance with product specifications or regulations. When applying to food contact applications, please check the latest regulations, usage conditions, final product composition, and required testing requirements for the target region.
Grade Introduction
Mitsubishi Chemical's Tefabloc™ for food contact is broadly classified into the following three categories depending on the application:
• Extrusion molding grades suitable for molding tubes, hoses, etc. (ME/MP series)
• Injection molding grade (MJ series) suitable for cap liners, gaskets, etc.
• Oil-based food grade suitable for food applications containing high levels of fat and oil.
Recommended grade:
• Applications requiring softness and high flexibility: MJ4300C and ME5309C
• Applications where transparency is important: MP7204C and MP8202C
• Low elution (softener-free): MP7204C and MP8202C
Main suitable series for each application:
- Injection molding applications such as cap liners and gaskets: MJ series
• Extrusion molding applications such as beverage delivery tubes and hoses: ME series and MP series
For applications where contact with oily foods is expected: We recommend considering TX504N and OC-19 (development product) as oily food-compatible grades.
Status of responses in each country:
• In Japan: The grades that have been confirmed to comply with the positive list system based on the Food Sanitation Act are those listed above.
- Outside of Japan (US FDA, European EU-PIM, China GB, etc.): Individual investigations are required for each ingredient used to confirm compliance with regulations in each country. If you are considering food contact applications overseas, please contact us separately.
Points to note when implementing
Compliance with regulations for food-contact elastomers requires an understanding of market-specific standards and accurate information dissemination within the internal supply chain. Since food-contact material regulations in each country and region are frequently revised, be sure to check the latest public information and guidelines before implementation.
As a compound manufacturer, Mitsubishi Chemical verifies product compliance through surveys with various raw material manufacturers and provides responses and grade recommendations based on the latest regulations in each country. However, since regulations and interpretations may change in the future, please contact your sales representative individually for specific regulatory confirmations and grade selections.
Due to the nature of compound products, it may take some time to confirm the formulation and raw materials used. We ask for your understanding that we require sufficient lead time in advance when inquiring about and responding to inquiries regarding compliance with regulations in various countries.
This article is a general explanation based on publicly available information and market and regulatory information obtained by our company, and does not guarantee suitability for specific products or applications or compliance with laws and regulations. We assume no responsibility whatsoever for the results of decisions or actions taken by customers based on this article. When actually applying this information, please be sure to check the latest laws, standards and public guidelines and evaluate and judge it at your own responsibility.
Reference URL
- Consumer Affairs Agency: "Regarding the Positive List System for Food Utensils, Containers, and Packaging (from June 2025 onwards)"
https://www.caa.go.jp/policies/policy/standards_evaluation/appliance/positive_list_new - JCII "Food Contact Materials Safety Center"
https://www.jcii.or.jp/pages/65/ - US Government Publishing Office, “Title 21 – Food and Drugs, Vol.3 (Contains Parts 170–199, including 174–178)”
https://www.govinfo.gov/content/pkg/CFR-2023-title21-vol3/pdf/CFR-2023-title21-vol3.pdf - European Commission, “Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food”
https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32011R0010 - The National Health Commission of the People's Republic of China (NHC) issued a public announcement (No. 15 of 2016) regarding 53 national food safety standards, including the "National Standard for Food Safety: General Safety Requirements for Food Contact Materials and Products" (GB 4806.1-2016).
https://www.nhc.gov.cn/wjw/c100175/201611/f2cf66762b054f7b87b26da7a620533c.shtml
