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Japan CSCL regulations and ISHL regulations
Legal overview

The Chemical Substance Control Law (CSCL), promulgated on October 16, 1973, is the world's first regulation to control the risk of chemical substances.

In 2017, the 17th amendment to the Japanese Modernization Law was passed by a Cabinet resolution and will be implemented in phases from April 1, 2018 and January 1, 2019. The Chemical Review Act regulates the risk management of industrial chemicals produced or imported into Japan and is jointly supervised by the Ministry of Health and Social Security (MHLW), the Ministry of Environment (MOE) and the Ministry of Economy, Trade and Industry (METI) of the Central Ministry of Japan.

 
Japanese Code CSCL

1. Subject of declaration:

Production/import enterprises in Japan overseas enterprises exporting to Japan.

2, declaration requirements:

List of Existing and new chemicals in Japan:

The Japan Existing and New Chemical Substances List (ENCS List) includes chemicals produced, imported and used in Japan, and both new and existing chemical substances are subject to regulation.

The ENCS list can confirm whether it is a new substance, and the existing substance is included in the list and assigned a MITI number, otherwise it is regarded as a new chemical substance.

Exemptions:

• Scientific research or reagent use

• Non-compliance with regulations “ Chemicals ” Defined: such as natural products, alloys, etc.

• Items and mixtures that can be sold over the counter (e.g. household detergents)

• Impurities (including byproducts, residual raw materials, indicators, catalysts, etc.)

• All self-produced and consumable intermediates

• Not considered as new substances: such as double salts, intermolecular compounds, solid solutions, etc.

• Other substances regulated by law (food, pesticides, fertilizers, feed and feed additives, drugs, cosmetics, cosmeceuticals, etc.), but still required to be declared if used for industrial purposes.

 
Japanese Security Law ISHL

1. Subject of declaration:

Production/import enterprises in Japan

2, Japan Security Law ISHL declared substance scope:

The chemicals that need to be declared under the Safety and Health Act are manufactured in Japan or imported into Japan and used in the workplace, creating new chemical exposures for workers.

Existing chemical substances under the Japanese Safety and Health Law include: existing chemical substances specified by the current government order, new chemical substances whose names have been announced by the Minister of Health and Labor (i.e. chemical substances with official registration numbers), specific chemical substances treated as existing chemical substances, and specific polymer compounds treated as existing chemical substances.

Exemptions

• For experimental research

• Products used by ordinary consumers in their daily lives

• Mechanical seal for entry and use

• Free or promotional samples

The services we provide
  • Japan New Chemical Discovery Service
  • Japan's new Chemical Substance Declaration Service
  • Overall registration plan development (data evaluation/gap analysis/exemption analysis)
  • Communication and consultation with competent authorities/experts
  • Legal Training Service
  • Safety Technical Specification (SDS) and label making
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Zhongbang is one of the earliest institutions in China to engage in compliance consulting services. It has a senior expert team composed of PhDs, Masters, and Bachelor's degrees, and has established branches in the UK, the United States, South Korea, Beijing, Shanghai, Suzhou, Fuzhou, Shenzhen, and other places, forming a global service network layout.
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  • Rich compliance experience:
    With years of experience in global product and regulatory research in multiple fields, we are able to provide comprehensive and high-level compliance consulting support to various customers
  • Localized service capabilities:
    Having multiple branch offices in the UK, USA, South Korea, Beijing, Shanghai, Suzhou, Fuzhou, Shenzhen, etc., we can provide you with services nearby
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About Us
Zhongbang Consulting (Shandong Zhongbang North Management Consulting Co., Ltd.) focuses on product registration and compliance consulting services. With its professional technology, diverse resources, and global network, we are committed to providing regulatory consulting and environmental regulation response services for pharmaceutical, chemical, consumer goods production enterprises, and large multinational corporations. To solve the environmental, health and safety laws and regulations, product quality standards, and other issues faced by enterprises in production, sales, and global trade processes.
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If you have any issues related to environmental health and safety laws and regulations, product quality standards, etc. that need to be resolved in import and export trade, you can contact us for assistance.
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