I. Background and Overview of Update Content

Historical Background and Importance of the Chemical Substances Control Law

Japans Chemical Substances Control Law (abbreviated as CSCL) is an important regulation enacted by the Japanese government to control the production and distribution of chemical substances and ensure environmental and public health safety. Since its promulgation, the review and management of chemical substances have been key aspects of Japanese government oversight. On June 26, 2024, Japans Ministry of Economy, Trade and Industry issued a notice regarding updates to CSCL customs clearance procedures, with the new regulations taking effect from July 1, 2024, and the original notice being abolished from June 30, 2024.

Main Contents of This Update

The content of this update mainly includes three aspects:

• Rationalization of Customs Clearance Procedures for Substances (for Experimental Research Purposes): Simplified the customs clearance process for new substances used for experimental research purposes.
• Unification of Some Terms: Unified and standardized the terms in the regulations.
• Update of Declaration Template: Updated the declaration template used for customs clearance to make it more in line with actual operation requirements.

II. Specific Requirements for Experimental Research Purposes

Definition of Experimental Research Purposes

Under the CSCL, if a new substance is used for compliant test research purposes, it may be exempt from new substance declaration and cleared by submitting a self-declaration. Based on the General Principles for CSCL Application, REACH24H has provided the following interpretation of test research purposes and reagent purposes that qualify for exemption:

a. Experimental Research Purposes

• Scope: Includes new substances for experiments, research, development, and inspections in all public or private institutions (such as schools, research institutes, and inspection agencies), as well as samples used for the practical application of research results in industry, and these samples are not for sale.
• RequirementsThese new substances shall all be used for experimental research activities and shall not flow into the market for commercial sales.

b. Reagent Purposes

• DefinitionChemical substances used for substance detection, quantification, substance synthesis experiments, or determination of physical properties by chemical methods.
• Judgment principleJudgment shall be made based on the packaging and manufacturing form of the substance. Industrial drugs and raw materials do not fall within the category of reagents.

Requirements for Self - Declaration

For new substances that meet the experimental research purpose, enterprises can go through customs clearance by means of self - declaration. The self - declaration shall include the following contents:

• Detailed description of the substanceIncluding chemical name, CAS number, use, etc.
• Description of the place of use and purposeSpecify in detail which institution the substance is used for and what purpose.
• Usage amount and time limitThe expected amount and time of use.

III. Customs Clearance Requirements for Chemical Substances and Enterprise Responses

Customs Clearance Requirements of the Japanese Customs

The customs clearance requirements of the Japanese customs for substances of different classifications under the Chemical Substances Control Law vary. Reachchem Technology has compiled a detailed list of customs clearance requirements for enterprises reference:

a. Existing Substances

• Official Gazette notice numberThe category sorting number of the substance shall be provided.
• Documents to be submittedGenerally, no additional documents are required to be submitted.

b. Publicly Notified Chemical Substances

• Notice numberThe notice number and the category sorting number shall be provided.

c. Monitored Chemical Substances and Priority - Evaluated Chemical Substances

• Notice numberThe notice number and the category sorting number shall be provided.

d. First - Class Specified Chemical Substances

• Specific purposeA copy of the permit shall be provided.
• Experimental research purposeA self - declaration form shall be submitted.

e. Second - Class Specified Chemical Substances and New Substances

• Category sorting numberThe number specified in Article 2 of the Chemical Substances Control Law.
• After the declaration of a new substanceA copy of the judgment notice shall be provided.

Enterprise Response Strategies

a. Customs Clearance Preparation

When enterprises go through customs clearance for chemical substances, they should prepare the required documents and materials in advance, including:

• Official Gazette sorting number (MITI number)Enterprises can query on the website recommended by the official with the CAS number. If relevant information cannot be directly queried, other methods such as screening by main functional groups and category screening shall be used for querying.NITE-CHRIP websiteDeclaration and permit
• According to the specific classification of the substance, prepare corresponding self - declaration forms, permits and other documents.Enterprises shall operate in strict accordance with the provisions of the Chemical Substances Control Law to ensure that all submitted documents and declarations are true and valid, and avoid customs clearance delays or rejections due to incomplete or false information.

b. Compliance Operations

A certain chemical enterprise plans to export a batch of new chemical substances for experimental research purposes to Japan. According to the provisions of the Chemical Substances Control Law, the enterprise needs to prepare the following materials:

IV. Case Analysis and Practical Operations

Case Analysis

Substance description and purpose explanation

• Including the chemical name, CAS number, detailed purpose and place of use of the substance.Self - declaration form
• Specify in detail which institution the substance is used for and what purpose, as well as the expected amount and time of use.Enterprises shall submit the prepared self - declaration form and relevant materials to the Japanese customs. The customs will review according to the requirements of the Chemical Substances Control Law. If the materials are complete and comply with the regulations, customs clearance will be allowed. Throughout the process, enterprises shall ensure the authenticity and effectiveness of the submitted materials to avoid customs clearance delays due to material problems.

Customs clearance process

Enterprises should prepare all the required materials and documents in advance before exporting chemical substances to ensure the integrity and accuracy of the materials.

Practical Operation Suggestions

a. Prepare in Advance

Enterprises need to pay close attention to the latest developments and requirements of the Chemical Substances Control Law, regularly update relevant materials and declaration templates to ensure compliance with the latest regulations.

b. Update Regularly

During the customs clearance process, enterprises can seek the consultation and assistance of professional institutions to ensure the smooth progress of the customs clearance process. For example,

c. Seek Professional Advice

It can help enterprises accurately understand and implement customs requirements and avoid customs clearance delays.ZhongShen International TradeThrough the detailed interpretation and analysis of this article, it is hoped that it can help enterprises better understand and respond to the customs clearance requirements of the Japanese Chemical Substances Control Law, ensuring the safe and smooth export of chemical substances. At the same time, enterprises should constantly pay attention to the latest developments in the international market, adjust strategies in a timely manner, and enhance their international competitiveness.

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