Japan CSCL & ISHL Compliance Services for New Chemical Substance Notification

Confirm Regulatory Scope

Identify whether the item is a chemical substance, mixture, polymer, UVCB, reaction product, article or finished product. Products regulated by other laws, such as pharmaceuticals, cosmetics, pesticides or food additives, may require a separate assessment.

Clarify Substance Identity

Review the CAS number, chemical structure, composition, monomer information, manufacturing process, impurities, molecular weight distribution and intended use.

Conduct the CSCL Inventory Search

Check J-CHECK, NITE-CHRIP and relevant substance-identity information to determine whether the substance is existing or new under CSCL.

Select the CSCL Route

For new chemical substances, assess whether exemption, special confirmation, SVE, LVE, standard notification, PLC confirmation or another polymer-specific option is appropriate.

Assess ISHL in Parallel

Confirm whether the substance is manufactured or imported in Japan, used at workplaces and may cause worker exposure. Then assess ISHL inventory status, exemptions and notification or confirmation routes.

Maintain Post-Market Obligations

Review annual reporting, quantity or use changes, hazard-information communication, Japan SDS/GHS, recordkeeping and regulatory updates.

Information Collection

Collect the CAS number, structure, composition, intended use, annual tonnage, supply-chain role, SDS and available test data.

CSCL / ISHL Inventory Search

Check official databases and substance-identity information to assess the substance's CSCL and ISHL inventory status.

Existing/New Substance and Exemption Review

Confirm whether the substance is existing or new and whether an exemption or special-confirmation pathway may apply.

Route Confirmation

Determine whether SVE, LVE, standard notification, PLC, special confirmation or an ISHL route is appropriate.

Testing and Data-Gap Analysis

Assess whether existing data can be used and develop a route-specific testing strategy where new data are required.

Dossier Preparation and Submission Support

Prepare application forms, use certificates, structure files, test reports, environmental-emission explanations and supporting documents.

Authority Communication

Follow up on authority questions and prepare supplementary explanations, documents and formal responses.

Post-Market Maintenance

Support annual reporting, use or volume changes, SDS/GHS updates, supply-chain information transfer and regulatory monitoring.

9

global branches

300+

specialists

15,000+

enterprises served

20+

certified toxicologists

Full-Process Regulatory Support

From substance identity and inventory search to route selection, testing strategy, dossier preparation and post-market maintenance, REACH24H delivers coordinated support backed by global chemical regulatory compliance capabilities.

Experience with Difficult Substances

Our team supports assessments involving CAS/MITI/ISHL mismatch, polymers, UVCBs, complex reaction products, unstable substances and uncertain composition, where database results alone may not provide a reliable conclusion.

Technical and Multilingual Capability

Professionals with backgrounds in chemistry, chemical engineering, toxicology, biology, pharmacology and environmental science provide multilingual support for international projects, including SDS/GHS and hazard communication needs.

Japan-Local and Global Coordination

REACH24H helps coordinate communication among overseas suppliers, Japanese importers, laboratories and relevant stakeholders, reducing information gaps and supporting efficient Japanese-language documentation and authority follow-up.

If a substance has no MITI number, is it automatically a new chemical substance under CSCL?

Not necessarily. MITI number is important, but CAS number and MITI number are not always one-to-one. A substance may require further identification based on name, structure, composition, monomer information, manufacturing process and use before a reliable conclusion can be made.

Are there registration or reporting requirements for existing chemical substances under CSCL?

Yes, potentially. Existing chemical substances may still be subject to annual quantity reporting, use reporting, information communication, hazard investigation or stricter control depending on whether they are general chemical substances, priority assessment chemical substances, monitoring chemical substances, Class II specified chemical substances or Class I specified chemical substances.

If a substance has a MITI number under CSCL, do we still need to check ISHL?

Yes. MITI status supports CSCL assessment, but it does not replace ISHL assessment. Companies should separately review whether the substance is existing under ISHL and whether worker-exposure obligations are triggered in Japan.

Do new substances in articles need to be notified under CSCL or ISHL?

This depends on the product form and whether the substance is intentionally released or used as a chemical substance in Japan. Articles or finished products may be outside new chemical notification in some cases, but chemical substances, mixtures and raw materials supplied for industrial use should be assessed carefully. If worker exposure may occur during workplace use, ISHL should also be reviewed.

What are the minimum tonnage thresholds for new substance notification in Japan?

For CSCL, common routes include Small Volume Exemption (SVE) for substances with annual manufacture/import volume below 1 t/y in Japan and Low Volume Exemption (LVE) for substances below 10 t/y, while standard notification is used when these routes are not suitable. For ISHL, small quantity confirmation may be available when the planned annual manufacture/import quantity is below 100 kg/y. The final route should consider not only actual volume but also environmental emission volume, use and exposure conditions.

How are SVE and LVE volumes assessed?

SVE and LVE volume assessment should consider environmental emission volume, use certification and emission coefficients. It should not be simplified as actual import or manufacturing volume only. Early preparation is recommended because filing windows and national-level volume management may affect approval quantity.

Can overseas suppliers protect CBI when Japanese importers are involved in SVE or LVE?

Japan’s system should not be assumed to work like a TSCA Letter of Support model. For SVE and LVE, the applicant is generally the Japanese importer or manufacturer, and substance identity must be provided for authority assessment. Companies should use carefully designed information-sharing arrangements and route selection to manage CBI risks. For some routes, such as standard notification or certain polymer routes, overseas exporters may have more direct involvement, but the strategy must be assessed case by case.

What are the differences between Japanese and OECD biodegradation or bioaccumulation requirements?

Japan often refers to OECD test guidelines, but regulatory acceptance may involve Japan-specific expectations on test design, laboratory qualification, reporting format and interpretation. Existing OECD data should be reviewed for route-specific acceptability before being used in a CSCL submission.

Do polymers always require CSCL new chemical substance notification?

No. Polymers may follow different routes, including existing polymer interpretation, PFS, PLC confirmation or new chemical substance notification. Monomer composition, molecular weight distribution, oligomer content, stability, solubility and functional groups should be reviewed.

What information should we prepare for an initial Japan CSCL / ISHL assessment?

Useful information includes CAS number, chemical name, structure, composition, monomer information, manufacturing process, intended use, annual volume, SDS, existing test data and details of the Japan-side importer or manufacturer.