Japan Market Access | Food Contact Material Compliance
Positive List screening, inclusion applications, testing strategy, supply chain documentation, and JCII support
Compliance with Japan's food contact material (FCM) requirements is a key market access consideration for materials and articles supplied to Japan. The regulatory framework covers raw material controls, product specifications and testing, good manufacturing practices, and compliance information transfer throughout the supply chain.
Japan's Positive List (PL) system for synthetic resins took effect on June 1, 2020. After the five-year transition period ended on May 31, 2025, the system became fully applicable on June 1, 2025. REACH24H supports suppliers and manufacturers with Japan PL screening, product and formulation assessment, unlisted-substance pathway review, testing strategy, supply chain documentation, and JCII-related procedures.
Quick Navigation
Japan FCM Compliance Services at a Glance
| Item | Key Information |
|---|---|
| Target market | Japan |
| Core legal framework | Food Sanitation Act; Specifications and Standards for Foods, Food Additives, etc. (MHLW Notification No. 370 of 1959); synthetic resin Positive List |
| Main regulatory bodies | Consumer Affairs Agency (CAA); Food Safety Commission of Japan (FSCJ); MHLW and quarantine stations for import procedures |
| Primary scope | Synthetic resins, monomers and starting substances, additives, intermediate materials, utensils, containers, and packages |
| Key compliance work | PL and restriction screening, product/formulation assessment, unlisted-substance pathway review, testing strategy, supply chain documents, and JCII-related support |
| Important boundary | A test report alone does not establish full compliance, and JCII services do not replace Japan's statutory Positive List obligations. |
Who May Need Japan FCM Compliance Support?
Upstream suppliers: Suppliers of synthetic resins, monomers or starting substances, additives, and intermediate materials intended for food-contact applications in Japan.
Article manufacturers: Food packaging, container, utensil, kitchenware, or tableware manufacturers that need to identify applicable material specifications and testing requirements.
Overseas manufacturers and exporters: Companies responding to Japanese customer requests for PL status, use restrictions, testing evidence, or conformity documentation.
Importers and procurement teams: Importers, distributors, brand owners, and procurement teams reviewing whether supplier evidence is sufficient for Japan market entry or customer qualification.
Companies handling unlisted substances: Businesses whose substances cannot be matched to the current PL, or whose intended use does not fit the listed conditions.
Companies receiving JCII requests: Businesses asked to provide a JCII document, join JCII, or distinguish a national PL compliance statement from JCII-related documentation.
What Are Food Contact Materials in Japan?
Japan's Food Sanitation Act defines food-contact utensils, containers, and packages (UCP) that come into contact with food or food additives. Utensils are instruments, tools, or implements that directly contact food or food additives. Containers and packages are articles used to contain or package them and that come into direct contact with them.
Food packaging and containers
Plastic films, bags, boxes, cups, trays, bottles, closures, gaskets, and similar articles.
Kitchenware and food-service articles
Cups, plates, cutlery, cookware, cutting boards, storage containers, and other direct-contact components.
Upstream materials
Synthetic resins, monomers, additives, masterbatches, colorants, coatings, adhesives, and related inputs.
Scope note: Glass, ceramic, enamel, metal, rubber, wood, and other non-synthetic-resin materials are outside the core synthetic resin PL, but may still be subject to the Food Sanitation Act and applicable material- or product-specific standards.
Key Regulatory Bodies and Industry Systems
| Authority or System | Primary Role | What Companies Should Review |
|---|---|---|
| Consumer Affairs Agency (CAA) | Develops and amends food sanitation standards for utensils, containers, and packaging, including the PL, and manages relevant consultation and application procedures for new substances. | Scope determination; PL screening; official test methods and limits; pathways for list amendments or new substances. |
| Food Safety Commission of Japan (FSCJ) | Conducts independent scientific risk assessments of food-related chemical substances and provides scientific opinions to the relevant authorities. | Safety data expectations; migration and dietary exposure; toxicological and risk-assessment criteria. |
| MHLW and quarantine stations | Handle sanitary oversight and import notification procedures for imported foods, utensils, containers, and packaging. | Commercial import procedures and supporting compliance information that may be reviewed during import processes. |
| JCII and other industry organizations | Operate voluntary industry lists and management systems and may provide conformity-related documents, testing, and consultation to eligible members. | Membership eligibility, requested customer documentation, and transfer of conformity documents through the supply chain. |
Japan's FCM Regulatory Framework and Positive List
Japan's FCM framework is founded on the Food Sanitation Act and the specific measures established in the Specifications and Standards for Foods, Food Additives, etc. (MHLW Notification No. 370 of 1959). The statutory synthetic resin Positive List is complemented by GMP requirements, test methods, import procedures, information-transfer obligations, and voluntary industry management systems.
The central PL principle is that synthetic resins and relevant raw materials used for food-contact applications should be composed of substances permitted under the Positive List and should comply with the applicable polymer group, conditions of use, maximum use levels, and other restrictions.
Table 1: Synthetic resins
Solid synthetic resins with a molecular weight of at least 1,000 Da. The list classifies materials into 21 groups based on material characteristics and identifies permitted monomers, starting substances, and related constituents for each group.
Table 2: Additives for synthetic resins
Specifies maximum use levels and conditions of use for additives in relevant base material categories.
Important: Being outside the synthetic resin PL does not mean that a material is outside Japan's FCM regulatory framework. Rubber, glass, ceramic, enamel, metal, wood, and other materials may still be subject to applicable specifications and testing requirements. Non-intentionally added substances, surface-treatment systems, and functional migrants should also be assessed based on their source, intended function, and conditions of use.
What If a Substance Is Not Listed on Japan's Positive List?
If a monomer, starting substance, or additive within the PL scope cannot be matched to an existing entry, the first step is to verify the substance identity, component name, CAS number, applicable entry, polymer group, and conditions of use. This helps determine whether the substance is truly unlisted or whether the proposed use falls outside the restrictions of an existing entry.
Depending on the substance category and regulatory issue, the pathway may involve:
An application to amend the additives list or the relevant table entry;
A safety review application supported by safety data requested by the competent authority;
A request to amend a monomer-related notification or list; or
A technical justification that the substance is outside the PL scope or is subject to another applicable rule under defined conditions.
A technical feasibility and data-gap assessment is generally recommended before a formal application. Where an official safety assessment is required, the overall timeline will depend on dossier completeness, additional testing, supplementary questions, and the authority's review progress.
What Do Customers Mean by "JCII Certification"?
In procurement and supply chain discussions, customers may use "JCII certification" or "JCII Certificate" as an umbrella term for a PL conformity determination, conformity-related documentation, testing, or other services provided within JCII's membership framework. These services are not the same as Japan's statutory national Positive List and do not replace legal compliance obligations. JCII documents may nevertheless be requested or recognized by Japanese customers as supplementary supply chain evidence.
| Comparison | Japan National Positive List | JCII Industry Services |
|---|---|---|
| Nature | Mandatory compliance requirement under the Food Sanitation Act framework. | Membership, PL conformity assessment, documentation, testing, and consultation services provided by an industry organization. |
| Administrator | Consumer Affairs Agency. | JCII's Food Contact Materials Safety Center. |
| Core assessment | Whether a substance is permitted for the relevant synthetic resin FCM and complies with the applicable restrictions. | Conformity review or documentation based on membership eligibility, submitted information, and applicable JCII rules. |
| Is it mandatory? | Yes, when the material or substance falls within the statutory scope. | Usually depends on customer specifications, procurement requirements, or the company's internal compliance program. |
| Overseas companies | FCM materials and articles exported to Japan should comply with the applicable statutory requirements. | Foreign companies may apply for membership, but a contact point in Japan is required and the relevant procedures are conducted in Japanese. |
Confirm the requested deliverable first: Determine whether the customer needs a national PL compliance statement, a JCII conformity document, or both. Only then can the project team accurately assess membership, testing, documentation, timeline, and cost requirements.
Information to Prepare for a Japan FCM Assessment
The information needed depends on whether the project concerns PL screening, a finished-product assessment, testing, a JCII procedure, or an inclusion application. The following information helps define the regulatory pathway and identify data gaps.
Substance and product identity
Material or product name and CAS number, where available;
Formulation summary, composition range, and layer structure;
Structural formula, molecular weight, purity, impurities, and residual monomers;
Manufacturing process and batch-quality information.
Intended use and restrictions
Technical function and intended material;
Maximum use level and proposed restrictions;
Food type, contact temperature, and contact time;
Applicable customer specifications and required deliverable.
Existing evidence and safety data
SDS, supplier statements, specifications, and test reports;
Authorizations or uses in other markets;
Migration or dietary exposure assessment;
Toxicological or other safety data proportionate to the risk level.
Practical Japan FCM Compliance Pathway
Product identification
Confirm whether the subject is an FCM raw material, component, or finished article; establish the substance or product identity, structure, intended use, and downstream deliverable.
Scope determination
Identify which components fall within the synthetic resin PL and which are governed by other material- or product-specific standards.
PL and restriction screening
Review monomers, starting substances, additives, permitted use levels, polymer groups, and use restrictions; identify information gaps and determine whether material-specific or product testing is needed.
Pathway selection
For a substance that is not listed or does not match the listed specifications, assess a list inclusion or amendment route, a safety review, a monomer-related procedure, or another applicable pathway.
Compliance information transfer
Prepare documentation describing substance status, restrictions, test evidence, intended uses, and precautions so downstream customers can confirm compliance. Where requested, separately assess the appropriate JCII conformity or documentation route.
Japan FCM Services Provided by REACH24H
01
Japan PL Screening and Status Determination
Screen monomers or starting substances used in base materials and relevant additives against the current PL. Review entries, polymer groups, restrictions, and substance identity, including polymers, UVCBs, salts, mixtures, or substances without a clear CAS number.
02
Product and Formulation Compliance Assessment
Assess the applicable Positive List, material specifications, product testing, and documentation requirements based on layer structure, formulation, food type, temperature, contact time, and intended use.
03
Support for Unlisted Substances and PL Inclusion Applications
Conduct pathway and data-gap assessments; assist with materials for additive-list amendments, safety reviews, or monomer-related procedures; and support pre-consultation, authority questions, and supplementary submissions.
04
Japan Food Contact Material Testing Strategy
Determine appropriate test items based on material type and intended use, coordinate qualified laboratories, monitor testing, and review whether reports are suitable for the intended product and market scenario.
05
Compliance Information and Supply Chain Documentation
Organize PL status, restrictions, intended uses, test basis, and precautions into customer-ready conformity statements, confirmation materials, technical packages, or supplier-questionnaire responses.
06
JCII Membership and Conformity-Document Support
Assess the appropriate membership type and requested deliverable; support JCII membership and applications for relevant conformity documentation, including certificates where applicable; and act as the project liaison for Japanese-language communication, testing supervision, and dossier coordination.
07
Communication with Authorities and Industry Organizations
Support pre-consultation, technical inquiries, and supplementary information relating to substance identity, scope, application procedures, or other project-specific issues.
08
Extended Japan Market Access Support
Provide regulatory update interpretation and customized training where needed, helping project teams implement material-compliance requirements for the Japanese market.
Japan FCM Timeline and Cost Factors
There is no universal fixed timeline or price for Japan FCM work. A single PL screening, product assessment, test program, JCII procedure, and PL inclusion application involve substantially different scopes. A phased timeline and quotation can be prepared after reviewing the following factors.
| Factor | Why It Matters |
|---|---|
| Project and deliverable type | PL screening, testing, JCII support, and inclusion applications require different workstreams and outputs. |
| Substance or product complexity | Polymers, UVCBs, mixtures, multilayer materials, coatings, and unclear identities may require additional matching or assessment. |
| Intended use and restrictions | Food type, contact temperature and time, maximum use level, layer structure, and customer specifications affect the assessment. |
| Existing information and data gaps | Available formulations, supplier statements, test reports, exposure assessments, and safety data influence the work required. |
| Testing and external review | Laboratory scheduling, additional testing, supplementary questions, and authority or industry-organization review may affect the timeline. |
| Confidentiality and supply-chain coordination | Separate data submissions, access controls, translation, and coordination among suppliers and customers can affect project sequencing. |
Why Choose REACH24H?
REACH24H combines local support in Japan, professional communication with JCII, regulatory and material expertise, and coordinated multi-market FCM services. Our Japan subsidiary helps companies manage Japanese-language communication and project coordination across the supply chain.
Japan
Local subsidiary and Japanese-language support
JCII
Professional communication and project liaison
CRAC 2025
Regulatory exchange on recycled plastics and synthetic resins
Multi-Market
Coordinated FCM compliance support
Local Support in Japan
REACH24H has a subsidiary in Japan. The local team can support communication with Japanese customers, industry organizations, and other project stakeholders.
Professional Communication with JCII
REACH24H maintains professional communication with JCII. Mr. Takeshi Kajiwara, Director of JCII's Planning Office, participated in the CRAC China 2025 recycled plastics and synthetic resin compliance session and shared insights on Japan's Positive List system.
Regulatory and Material Expertise
Projects are assessed at the product, polymer, monomer or starting-substance, and additive levels, rather than relying only on product names or CAS-number searches.
Integrated Project Coordination
PL screening, product assessment, inclusion applications, testing strategy, supply chain documents, and JCII support can be coordinated within one project.
Multi-Market FCM Network
Where required, the Japan assessment can also connect with FCM compliance support for South Korea, ASEAN markets, the EU, and the United States.
Frequently Asked Questions
Does every substance that is not found on Japan's Positive List require an inclusion application?
No. First determine whether the substance is within the PL scope, covered under another name or entry, treated as part of a monomer or base material, or eligible for another applicable pathway. An amendment or safety-review route should be assessed only after confirming that the substance is not covered by the current PL and is intended for use within the statutory synthetic resin PL scope.
Is a polymer with a molecular weight above 1,000 Da automatically compliant with Japan's PL?
No. Molecular weight is only one factor in classifying the material and determining data needs. The polymer composition, monomers or starting substances, additives, polymer group, use levels, and restrictions still need to be reviewed.
Do glass, ceramic, metal, wood, or rubber products need to comply with the synthetic resin PL?
These materials are generally outside the core synthetic resin PL, but may still be subject to material- or product-specific specifications and testing requirements under the Food Sanitation Act. Plastic gaskets, coatings, liners, or other direct-contact components should be assessed separately.
Does a Japan FCM test report prove that the entire product is compliant?
No. A test report only covers the tested sample, parameters, and conditions. Companies should also confirm raw material PL status, applicable restrictions, formulation and manufacturing consistency, and whether the report covers the actual intended use.
What is the difference between Japan's national PL and JCII?
Japan's national Positive List is a statutory requirement for applicable synthetic resin food contact materials. JCII is an industry organization that may provide membership-based conformity documents, testing, and consultation. JCII documentation does not replace statutory PL compliance.
Can an overseas company join JCII?
According to JCII's current public information, a foreign company may apply for membership, but it should establish a contact point in Japan, such as an agent or branch, and conduct the application and subsequent procedures in Japanese. Eligibility and membership type should be confirmed based on the company's role.
How long does a Japan FCM project take, and what affects the cost?
The work required for a single PL screening, product assessment, test program, JCII procedure, or PL inclusion application differs substantially. A phased timeline and quotation can be prepared after reviewing the product or substance identity, intended use, available data, confidentiality arrangements, and required deliverables.
Assess Your Japan FCM Compliance Pathway
Whether you need to confirm one substance, assess a masterbatch or coating, address an unlisted substance, plan testing, or prepare JCII-related documentation, submit the information already available. REACH24H can identify the next information requirements, proposed service scope, estimated timeline, and cost factors.
Submit Your Japan FCM InquiryRecommended Reading
Navigating Japan's FCM Positive List and Compliance Strategies
CRAC China 2025: Recycled Plastics and Synthetic Resin Compliance
浙公网安备 33011002014301号