Japan's Three Ministries Release CSCL Violation Cases: Unnotified New Chemical Substances Face Immediate Halt

On October 6, 2026, Japan's Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOEJ) jointly released a collection of violation cases and countermeasures under the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (CSCL), which reviews typical cases in recent years where companies manufactured or imported new chemical substances without the proper notification or confirmation procedures, together with countermeasures. The three ministries have entrusted industry associations to publicize the collection to member companies, with a view to deepening companies' understanding of the CSCL and strengthening their legal compliance management systems.

General Requirements

As companies have repeatedly manufactured or imported new chemical substances without completing the proper CSCL procedures, the collection uses illustrations to highlight two basic requirements:

1. New chemical substances must not be manufactured or imported without completing required procedures such as notification or application; once a violation is identified, the manufacture or import will be halted immediately;
2. Manufacture or import cannot start immediately after the notification or application is filed. A certain review period is required from submission to approval, and companies should allow sufficient time and complete the procedures well in advance.

Determination Process for New Chemical Substances and Simplified Procedures

The collection presents a determination process for new chemical substances, which can be summarized in five steps:

1. Determine whether the substance is a “chemical substance” under the CSCL, i.e., a compound generated through chemical reactions; natural products and elements are not covered, and radioactive substances, specified poisonous substances, stimulants, and narcotics are also excluded from the scope;
2. Determine whether the substance is regulated by other laws and regulations, such as those on pharmaceuticals, food, agricultural chemicals and fertilizers; such substances are not subject to the CSCL procedures, but the procedures still apply when they are used for purposes outside the scope regulated by those laws;
3. Search the Chemical Risk Information Platform (CHRIP) of the National Institute of Technology and Evaluation (NITE) and the CSCL database (J-CHECK) to check whether the substance already has a CSCL number (MITI number); substances with a number fall into five categories, each subject to different procedures;
4. If no number is found, determine whether the substance can be regarded as an “Existing Chemical Substance, etc.”, such as one listed in the List of Target Substances or treated as an “Existing Chemical Substance, etc.” under operational notices; such determinations are highly technical, and conclusions should be drawn only after consultation with the quality management department and other relevant units, with questions remaining referred to METI;
5. For substances determined to be new chemical substances, GLP tests on biodegradability, bioaccumulation, human health, etc. must in principle be completed before the notification is filed.

Simplified procedures apply to substances that fall under test and research use (including pilot plants) and reagents; intermediates, etc.; small amount new chemical substances (up to 1 tonne/year per company); low tonnage new chemical substances (up to 10 tonnes/year per company and determined to be difficult to degrade and not highly bioaccumulative); and polymers of low concern. The requirements and timeframes of each procedure are shown in the table below:

Six Typical Violation Cases

The collection analyzes six typical violation cases:

1. Insufficient understanding of the CSCL: The manufacturing department mistakenly believed that the polymer publicly announced in the official gazette under the name “A·B·C copolymer” remained within its scope even when the constituent monomers were added or removed; in fact, the announced name only covers copolymers containing all three monomers A, B and C as constituent units, and copolymers lacking any of them or containing other monomers are new chemical substances. The company had been manufacturing in violation of the Act over a long period, which was discovered only through an internal check of all its products [violation of Article 3, Paragraph 1 of the CSCL; unnotified manufacture];
2. Insufficient awareness of “on-site intermediates”: The company mistakenly believed that a new chemical substance processed directly into products within the company qualified as an on-site intermediate and required no notification; however, an on-site intermediate refers only to cases where the entire volume of the new chemical substance is chemically converted into other substances within the company. The substance in question remained in the products after processing that involves no chemical reaction, such as coating, and therefore does not qualify as an intermediate. The violation came to light only when the company planned to entrust manufacturing to an external party and consulted its quality management department [violation of Article 3, Paragraph 1];
3. Insufficient coordination between the manufacturing site and the quality management department: In the early stage of development, production started only after the manufacturing department and the quality management department jointly confirmed that the raw materials were existing chemical substances. After the person in charge changed, the new manager changed the formulation to improve the yield and manufactured without consulting the quality management department, resulting in the formation of a new chemical substance [violation of Article 3, Paragraph 1];
4. Overproduction caused by insufficient quantity management: A substance had obtained confirmation of 800 kg/year under the small amount new chemical substance scheme. Three plants each considered the quota ample and manufactured 300 kg, 200 kg and 400 kg respectively, totaling 900 kg company-wide and exceeding the confirmed quantity; this was noticed only when actual results were aggregated afterwards [violation of Article 3, Paragraph 1, Item 5];
5. Insufficient coordination with overseas business operators before importation: First, a substance the company had long imported as an existing chemical substance actually contained a new chemical substance (the overseas manufacturer had changed the production process and the composition had changed accordingly), which was discovered only when the company obtained the SDS [violation of Article 3, Paragraph 1; unnotified import] — even as an impurity, a new chemical substance present at 1% or more as a component is subject to notification and other procedures. Second, the arrival quantity of a substance confirmed under the small amount new chemical substance scheme exceeded the confirmed quantity (1,000 kg as stated on the invoice vs. 1,100 kg actually shipped) [possible violation of Article 3, Paragraph 1, Item 5]. Import performance should be managed by actual quantities rather than the figures on invoices and other documents; the portion exceeding the confirmed quantity may be excluded from performance records if it is properly disposed of promptly;
6. Insufficient confirmation of user change procedures: A case holding intermediate confirmation became effectively invalid when user Company B was absorbed by Company C through a merger. User change procedures must be completed by the manufacturer, but the manufacturer and the user had divergent understandings of the procedure and lacked coordination: Company C believed that no change was needed as long as the substance continued to be used at Company B’s facility, and kept manufacturing and using the substance even after the confirmation had become invalid [violation of Article 3, Paragraph 1, Item 4]. 

Three Major Causes of Violations and Countermeasures

The collection groups the causes of violations into three categories and provides countermeasures for each:

1. Making judgments without sufficient understanding of the CSCL. Typical situations include no regular training, compliance work depending on specific individuals, and failure to recognize notification obligations. Countermeasures: conduct regular in-house education, with the quality management department familiar with the CSCL working with business departments to deliver training, and provide chemical substance management training for new personnel after they take up their posts;
2. Insufficient coordination between departments and with business partners. Typical situations include the absence of dedicated regulatory staff, a lack of checking rules, failure to manage manufacturing and import quantities in a unified manner, and overseas trading partners unfamiliar with CSCL restrictions. Countermeasures: establish systems and rules that require the participation of the quality management department, prohibit the manufacturing site from unilaterally changing manufacturing processes or imported products, explain quantity and content rate restrictions to overseas business operators, and build a unified management system covering manufacturing, import, and shipment;
3. Violations remaining undetected for long periods. Typical situations include no longer regularly confirming the CSCL status of substances manufactured or imported over the long term, and failure to confirm compliance status when manufacturing processes or procurement sources are changed. Countermeasures: incorporate regular audits by the quality management department into internal company rules to confirm manufacturing compliance and review whether past determinations remain valid under the current CSCL.

12 Additional Specific Violation Cases

The collection also compiles 12 additional specific violation cases in three categories: six cases of misjudging whether a substance is a new chemical substance (e.g., substances of similar composition managed as existing chemical substances over the long term that were in fact new chemical substances, misreading of the names given in the list, and confirmation applications interrupted by staff transfers or retirement without handover); four cases of exceeding the confirmed quantities under the special schemes (e.g., combined production by multiple departments exceeding the limit, errors in quantity calculation methods, and imports from countries outside the scope of confirmation causing the total to exceed the limit); and two cases of insufficient confirmation of CSCL applicability (e.g., mistaking a substance generated during the manufacturing process for an on-site intermediate, and wrongly assuming that the substance fell under other laws and regulations).

ChemRadar Insights

For companies exporting chemical products to Japan or engaged in the manufacture or import of new chemical substances in Japan, CIRS offers the following recommendations:

1. Allow sufficient lead time. GLP tests must be completed before a new chemical substance is notified; a standard notification takes about 4 months from the preliminary review, and simplified procedures such as the small amount scheme take about 1.5–2 months. Moreover, once a failure to complete the procedures is identified, manufacture or import will be halted immediately, so never plan to start production right after filing the notification or obtaining the confirmation;
2. Substance determination should not be made by the manufacturing site or a business department alone. Determining whether a substance is a new chemical substance is highly technical and should be reviewed and finalized by dedicated departments such as the quality management department; before consulting METI, companies should first search for candidate CSCL numbers on their own (METI does not provide a number lookup service on behalf of companies), and it may take considerable time to receive a response to such consultations;
3. Strengthen supply chain coordination. When an overseas supplier changes the production process or the composition, a substance previously managed as an existing chemical substance may become a new chemical substance, and such changes should be promptly communicated to the Japanese importer; shipment quantities to Japan should match the quantity confirmed by the Japanese side to avoid over-shipment;
4. Manage quantities on an actual and unified basis. Manufacturing and import quantities across all plants and departments of the company should be consolidated and managed so as not to exceed the confirmed quantity; import performance should be based on actual quantities rather than invoice figures, and the quantity arriving in excess, once properly disposed of promptly, may be excluded from the performance record;
5. Conduct regular audits and review past determinations. For substances manufactured or imported over the long term and substances previously determined to be outside the scope of the CSCL, their status under the current CSCL should be confirmed periodically, so that personnel changes, process changes or regulatory updates do not render existing determinations invalid.

CIRS Services

The compliance work described above is highly specialized and wide-ranging: from new chemical substance determination, GLP testing and notification, to quantity management and supply chain coordination, an oversight at any stage may lead to a violation. CIRS has years of in-depth experience in Japan’s chemical control regulations and can help companies implement the above compliance requirements. Our services are listed below, and inquiries are welcome:

• Japan New Chemical Substance Search Service
• Japan New Chemical Substance Notification Service
• Overall Registration Strategy Development (Data Assessment / Gap Analysis / Exemption Analysis)
• Laboratory Testing Supervision Service
• Communication and Consultation with Competent Authorities and Experts
• Regulatory Training Service
• SDS (Safety Data Sheet) and Label Preparation

Further information

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