Cabinet Approves Amendments to the Enforcement Order of the Act on the Evaluation and Regulation of Chemical Substances

On May 19, 2026, Japan’s Cabinet approved amendments to the Enforcement Order of the Act on the Evaluation and Regulation of Chemical Substances. This significant regulatory change designates long-chain perfluoroalkyl carboxylic acids (LC-PFCA) and related substances as Class I specified chemical substances. For foreign entrepreneurs, understanding these regulations is crucial for compliance and to avoid potential legal issues when importing or manufacturing chemical products in Japan.

Background & Context

The Act on the Evaluation and Regulation of Chemical Substances (Kagaku Busshitsu no Shinsa oyobi Seizō nado no Kisei ni kansuru Hōritsu 1973) establishes a framework for the evaluation and regulation of chemical substances in Japan. The recent amendments, approved by the Cabinet on May 19, 2026, introduce new classifications for certain chemicals, specifically long-chain perfluoroalkyl carboxylic acids (LC-PFCA), their salts, chlorpyrifos, and medium-chain chlorinated paraffins (MCCP). These substances are now classified as Class I specified chemical substances, which imposes stricter regulations on their manufacture, import, and use. The regulatory framework aims to mitigate environmental and health risks associated with these chemicals. The amendments reflect Japan’s commitment to aligning its chemical regulations with international standards, particularly in light of growing global concerns over persistent organic pollutants. The Ministry of Economy, Trade and Industry (METI) is the issuing agency responsible for enforcing these regulations.

How This Affects Your Business in Japan

Item	Cost (JPY)	Cost (USD approx)	Notes
Company Registration	¥150,000	$1,050	Standard fee
Notary Fee	¥50,000	$350	For document notarization
Visa Application	¥4,000	$28	Business Manager visa

1. Foreign Residents Already Operating a Business in Japan
If you currently manufacture or import chemicals that fall under the new classifications, you must review your compliance status immediately. Ensure that your products are registered and that you have the necessary permits. Failure to comply can result in penalties or product recalls. You may need to submit documentation to METI, and it is advisable to consult with a legal expert familiar with Japanese chemical regulations.

2. Foreign Nationals Planning to Establish a New Company
If you are considering starting a business that involves the manufacture or import of chemical substances, familiarize yourself with the new regulations. You will need to ensure that your products comply with the Class I specifications. Prepare to submit a registration application to METI, which may require detailed information about your products and their safety assessments.

3. Foreign Investors Who Are NOT Residents of Japan
If you are looking to invest in Japanese chemical manufacturing or import businesses, understanding these regulations is critical. Ensure that any potential investment complies with the new classifications to avoid future liabilities. Conduct thorough due diligence on the companies you are considering investing in to assess their compliance with the new regulations.

Step-by-Step: What You Need to Do

Step 1: Review your current chemical products
Assess whether any of your products fall under the new Class I specified chemical substances.
Office: Your internal compliance team or a legal advisor (English Support: Yes)
Cost: Varies by consultant
Time: 1-2 weeks
Pitfall: Overlooking lesser-known substances

Step 2: Prepare necessary documentation
Gather all required documents for registration with METI, including safety data sheets and product specifications.
Office: Ministry of Economy, Trade and Industry (METI) (English Support: Limited)
Cost: ¥100,000 (~$700 USD) for translation services
Time: 2-4 weeks
Pitfall: Incomplete documentation

Step 3: Submit registration application
File your application with METI for the new classifications.
Office: METI (English Support: Limited)
Cost: ¥50,000 (~$350 USD)
Time: 4-6 weeks
Pitfall: Delays due to missing information

Step 4: Monitor compliance
Regularly check for updates on regulations and ensure ongoing compliance with any changes.
Office: METI and industry associations (English Support: Varies)
Cost: Minimal; mainly time investment
Time: Ongoing
Pitfall: Failing to stay updated on regulatory changes

Key Contacts
www.jetro.go.jp/en/
www.moj.go.jp/isa/
www.meti.go.jp/english/

Expert Analysis: Japan vs. Regional Competitors

Metric	Japan	Singapore	Hong Kong	South Korea
Incorporation Time	14 days	3 days	5 days	10 days
Minimum Capital Requirement	¥0	S$1	HK$0	₩0
Annual Filing Cost	¥60,000	S$60	HK$105	₩50,000
Corporate Tax Rate	30%	17%	16.5%	22%

What to Expect Next

Looking ahead, businesses should keep an eye on potential further amendments to the chemical regulations as Japan continues to align with global standards. The government may introduce additional classifications or stricter compliance measures in response to international treaties or domestic environmental concerns. Stakeholders should watch for announcements from METI regarding upcoming consultations or changes to the regulatory framework, particularly in late 2026 and early 2027.

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Sources & References

This article is based on the following source and enhanced with professional analysis for foreign business owners.
Source: 化学物質の審査及び製造等の規制に関する法律施行令の一部を改正する政令が閣議決定されました

⚠️ This article is for informational purposes only and does not constitute legal advice. Please consult a qualified Japanese attorney (bengoshi) or judicial scrivener (shiho shoshi) for advice specific to your situation.