Japan Chemical Law Update: Streamlined Import Procedures

I.Background and Overview of Update Content

Historical Background and Importance of the Chemical Substances Control Law

Output:

Japan’s "Chemical Substances Review and Manufacturing Management Law" (abbreviated as "Chemical Review Law") is an important regulation enacted by the Japanese government to control the production and circulation of chemical substances and ensure environmental and public health safety.Since its promulgation,the review and management of chemical substances have always been an important aspect of Japanese government supervision.On June 26,2024,the Japanese Ministry of Economy,Trade and Industry issued a notice on the update of customs clearance procedures for the Chemical Review Law,with the new regulations taking effect from July 1,2024.The original notice will be repealed from June 30,2024.

Main Contents of This Update

Output:

The content of this update mainly includes three aspects:

• RationalizationofCustomsClearanceProceduresforSubstances(forExperimentalResearchPurposes):Simplifiedthecustomsclearanceprocessfornewsubstancesusedforexperimentalresearchpurposes.
• UnificationofSomeTerms:Unifiedandstandardizedthetermsintheregulations.
• UpdateofDeclarationTemplate:Updatedthedeclarationtemplateusedforcustomsclearancetomakeitmoreinlinewithactualoperationrequirements.

II.Specific Requirements for Experimental Research Purposes

Definition of Experimental Research Purposes

Output:

According to the Chemical Substances Control Law,if a new substance is used for compliant experimental research purposes,it may be exempt from new substance notification and can be cleared through the submission of a self-declaration.Based on the "General Principles for the Application of the Chemical Substances Control Law," REACH24H has provided the following interpretation of the exemptible "experimental research purposes" and "reagent purposes":

a.Experimental Research Purposes

• Scope:Includesnewsubstancesforexperiments,research,development,andinspectionsinallpublicorprivateinstitutions(suchasschools,researchinstitutes,andinspectionagencies),aswellassamplesusedforthepracticalapplicationofresearchresultsinindustry,andthesesamplesarenotforsale.
• requirements:Thesenewsubstancesshallallbeusedforexperimentalresearchactivitiesandshallnotflowintothemarketforcommercialsales.

b.Reagent Purposes

• Definition:Chemicalsubstancesusedforsubstancedetection,quantification,substancesynthesisexperiments,ordeterminationofphysicalpropertiesbychemicalmethods.
• Judgmentprinciple:Judgmentshallbemadebasedonthepackagingandmanufacturingformofthesubstance.Industrialdrugsandrawmaterialsdonotfallwithinthecategoryofreagents.

Requirements for Self - Declaration

Output:

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:

• Detaileddescriptionofthesubstance:Includingchemicalname,CASnumber,use,etc.
• Descriptionoftheplaceofuseandpurpose:Specifyindetailwhichinstitutionthesubstanceisusedforandwhatpurpose.
• Usageamountandtimelimit:Theexpectedamountandtimeofuse.

III.Customs Clearance Requirements for Chemical Substances and Enterprise Responses

Customs Clearance Requirements of the Japanese Customs

Output:

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

• OfficialGazettenoticenumber:Thecategorysortingnumberofthesubstanceshallbeprovided.
• Documentstobesubmitted:Generally,noadditionaldocumentsarerequiredtobesubmitted.

b.Publicly Notified Chemical Substances

• Noticenumber:Thenoticenumberandthecategorysortingnumbershallbeprovided.

c.Monitored Chemical Substances and Priority - Evaluated Chemical Substances

• Noticenumber:Thenoticenumberandthecategorysortingnumbershallbeprovided.

d.First - Class Specified Chemical Substances

• Specificpurpose:Acopyofthepermitshallbeprovided.
• Experimentalresearchpurpose:Aself-declarationformshallbesubmitted.

e.Second - Class Specified Chemical Substances and New Substances

• Categorysortingnumber:ThenumberspecifiedinArticle2oftheChemicalSubstancesControlLaw.
• Afterthedeclarationofanewsubstance:Acopyofthejudgmentnoticeshallbeprovided.

Enterprise Response Strategies

Output:

a.Customs Clearance Preparation

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

• OfficialGazettesortingnumber(MITInumber):EnterprisescanqueryonthewebsiterecommendedbytheofficialwiththeCASnumber.Ifrelevantinformationcannotbedirectlyqueried,othermethodssuchasscreeningbymainfunctionalgroupsandcategoryscreeningshallbeusedforquerying.Declarationandpermit
• Accordingtothespecificclassificationofthesubstance,preparecorrespondingself-declarationforms,permitsandotherdocuments.:EnterprisesshalloperateinstrictaccordancewiththeprovisionsoftheChemicalSubstancesControlLawtoensurethatallsubmitteddocumentsanddeclarationsaretrueandvalid,andavoidcustomsclearancedelaysorrejectionsduetoincompleteorfalseinformation.

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

Output:

Substance description and purpose explanation

• Includingthechemicalname,CASnumber,detailedpurposeandplaceofuseofthesubstance.:Self-declarationform
• Specifyindetailwhichinstitutionthesubstanceisusedforandwhatpurpose,aswellastheexpectedamountandtimeofuse.:Enterprisesshallsubmitthepreparedself-declarationformandrelevantmaterialstotheJapanesecustoms.ThecustomswillreviewaccordingtotherequirementsoftheChemicalSubstancesControlLaw.Ifthematerialsarecompleteandcomplywiththeregulations,customsclearancewillbeallowed.Throughouttheprocess,enterprisesshallensuretheauthenticityandeffectivenessofthesubmittedmaterialstoavoidcustomsclearancedelaysduetomaterialproblems.

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

Output:

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.Through 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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