중국 화학물질 규제
중국 REACH(MEE Order 12)
China REACH Substance Registration and Compliance Services
Place New Chemical Substances on the Chinese Market with Confidence with China REACH (MEE) Registration Services by GPC
Before entering the Chinese market, companies must determine whether their substance is listed in the Inventory of Existing Chemical Substances in China, commonly known as the IECSC.
If a substance isn’t found in the IECSC, it’s usually thought of as a new chemical substance. What happens next depends on a few things: how much of it is made or imported each year, its properties, whether it’s a polymer, 그리고 what it’s going to be used for. Based on these factors, it might need to have a record filed, go through a simplified registration process, 또는 get a regular registration before it can be made 또는 brought into the country.
GPC helps companies for China REACH (MEE) Registration Services from other countries, like manufacturers, exporters, 그리고 traders, as well as Chinese importers, 와 함께 의 whole China REACH compliance process . China REACH substance registration includes checking if a substance is on the IECSC list, coming up with a registration plan, submitting 의 necessary documents, 그리고 managing everything after registration. They support these companies every step of the way, making sure they follow all the rules and regulations.
What Is China REACH?
중국 REACH: A Brief Overview – Industry terms – EuChemS
그리고 law for 중국 REACH 는 called Measures for the Environmental Management Registration of New Chemical Substances, MEE Order No. 12.
MEE Order No. 12 of 2020, which became effective on January 1, 2021, replaced the MEP Order No. 7 of 2009 for Environmental Management New Chemical Substances Registration and requires the filing or registration by 제조업체 또는 importers of new chemical 물질 prior to their production or introduction into the market in China.
중국 REACH 는 managed by 의 Chinese Ministry of Ecology and Environment (MEE).
Important 2026 Regulatory Update
MEE recently issued new measures for 의 registration of chemical 물질 for 공공 comment. The comment period for 의 proposed changes closes on 11 June 2026.
The proposed changes may affect areas such as:
- Registration applicants and China-based agents
- Registration and filing pathways
- Exemptions and exclusions
- Polymer requirements
- High-hazard substances
- Supply-chain obligations
- Post-registration supervision
- Legal liabilities and penalties
The consultation closed on 12 July 2026.
The revised measures have not yet been adopted by 의 MEE and we recommend that companies continue 에 operate in accordance with the existing measures as set out in MEE Order No. 12 whilst we monitor the progress of the proposed revision.
We continue 에 monitor the developments and inform you on 의 possible impact for future registrations, existing certificates and your polymer portfolio.
Who Must Comply with China REACH or MEE Order No. 12 registration ?
중국 REACH legislation apply to within organizations 관련 와 함께 new chemical substances in China (i.e., manufacturing, importing, exporting, using of new substances)
Potentially affected companies include:
- Chinese chemical manufacturers
- Chinese importers
- Overseas chemical manufacturers
- Overseas formulators
- Overseas trading companies
- Exporters supplying chemicals to China
- Companies introducing new polymers
- Importers of mixtures containing new substances
- Importers of articles designed to release new substances
Proposing a new industrial use for a controlled existing chemical substance.
그리고 obligations of 중국 REACH are defined by four elements: 의 chemical identity in question, 의 annual amount of the substance in question, 의 intended use or new function of the substance in question, 그리고 의 role of 의 company in the supply chain of that chemical substance in question.
IECSC Checking
The Inventory of Existing Chemical Substances in China (IECSC) 는 a list of chemical substances which have been recorded prior to the implementation of the law relating to the registration of new chemicals in China, and is used to distinguish between new chemicals and existing chemicals for purposes of chemical registration.
Substances listed on the IECSC are considered to be already existing in stock in China. These chemical 물질 는 usually not required 에 be registered as new chemical substances even if they are to be manufactured or imported into China. However, such existing chemical 물질 could be subject to environmental control measures for new use.
The IECSC includes:
- A publicly available inventory
- Confidentially listed substances
- Substances subject to new-use controls
- Eligible substances added following regular registration
- The MEE periodically updates the IECSC 인벤토리 of chemical substances that have already been registered in China and publishes lists of newly added substances 그리고 of substances that are proposed for addition after the update has been conducted.
- Public IECSC search
- The initial search may use:
- CAS 번호
- Chinese chemical name
- English chemical name
- Molecular formula
- Substance identity information
- Confidential IECSC inquiry
- Even if a substance 는 not in 의 공공 IECSC list, it might be in the confidential part of the inventory.
- Distinguishing between 물질 included in 의 기밀 part of 의 인벤토리 그리고 those not included in the inventory at all even if publicly unknown is sometimes necessary and can prevent unnecessary efforts for new chemical registration, testing, 그리고 related work as well as avoid associated expenses and delays.
GPC IECSC services
GPC can support:
- Public inventory screening
- Substance identity review
- Confidential IECSC inquiry
- Interpretation of search results
- New-use control screening
- Written regulatory status confirmation
Can an Overseas Company Register?
- A supplier from overseas, be it a manufacturer or trading company, can be the registration applicant for a new chemical for export to China.
- In cases where a single overseas manufacturer or trading company wants to register a 새로운 화학 물질 for export to China, they can act as the registration applicant. However, 의 overseas manufacturer or trading company has to appoint a registered legal entity in mainland China as 그들의 agent. The overseas applicant and 의 agent registered in mainland China jointly carry out the registration and post-registration procedures and their obligations afterwards.
- An overseas manufacturer or trading company would typically register through their overseas company. 그리고 overseas company would then appoint a China-based entity (e.g. GPC) as 그들의 agent 그리고 의 overseas applicant and their 중국-based agent would jointly 등록 의 chemical substance 그리고 perform 의 subsequent post-registration obligations.
GPC can assist with:
- 중국 REACH Only Representative
- Power of Attorney documentation
- Application preparation
- Regulatory submission
- Authority communication
- Certificate management
- Post-registration reporting
- Supply-chain communication
등록 유형
MEE Order No. 12 establishes three main registration pathways, together with specific compliance routes for qualifying polymers and new uses of certain IECSC-listed substances.
| Compliance Pathway | Application Scope / Description |
|---|---|
| General Application | |
| Record filing | New chemical substances manufactured or imported in quantities of less than 1 tonne per year. |
| Simplified registration | New chemical substances manufactured or imported in quantities from 1 tonne to less than 10 tonnes per year. |
| Regular registration | New chemical substances manufactured or imported in quantities of 10 tonnes or more per year. |
| Polymer record filing | Polymers containing no more than 2% by weight of new monomers or reactants, and qualifying polymers of low concern that meet the applicable criteria. |
| New-use registration | IECSC-listed substances are subject to new-use environmental management controls when they are intended for a use outside the permitted scope. |
알림 requirements 는 not only determined by the amount of tonnage of a substance, 하지만 also by several additional criteria.
- Substance identity
- Polymer composition
- Intended use
- Hazard profile
- Persistence and bioaccumulation
- Environmental exposure
- Existing test data
- Confidentiality requirements
- Supply-chain structure
Article 10 of MEE Order No. 12 of 의 MEPC sets out 의 thresholds for 의 relevant categories as well as the principal registration categories.
등록 문서
인벤토리
The Inventory of Existing Chemical Substances in China (IECSC) was introduced in 2013. The list has been regularly updated since then. Currently, there are 46,192 listed chemical substances as of the latest updates (Latest reference date 2020-11-17). Substances in the inventory are presented as category names, neither CAS number nor molecular structure is given. Substances that are not listed in the Inventory are considered 새로운 화학 물질.
인벤토리는 두 부분으로 구성됩니다(공공 그리고 기밀). 현재 3,270개의 기밀 물질이 있습니다. 기업은 기밀 물질에 해당되는지 확인하려면 공식 문의서를 제출해야 합니다. 그러면 MEE의 한 부서인 중국 고체 폐기물 및 화학물질 관리 센터(SCC)에서 확인서를 발급하며(보통 2주 이내), 3,000위안의 수수료가 부과됩니다. GPC는 고객을 대신하여 문의를 지원할 수 있습니다.
모든 단량체가 인벤토리에 등재되었지만 폴리머는 여전히 등록이 필요합니다.
연례 보고서
첫 번째 활동 보고서
등록 유형에 관계없이 인증서 보유자 또는 그 OR은 해당 화학물질의 첫 번째 활동(제조 및 수입/하위 사용자에게 이전) 이후 60일 이내에 첫 번째 활동 보고서를 제출해야 합니다.
보고서에는 다음 정보가 포함되어야 합니다:
- 국내 수입 또는 생산 업체 정보
- 첫 번째 활동의 시간, 장소, 볼륨
- 전송된 사용자 정보
- 환경 위험 관리 조치
- 환경 관리 요구 사항 구현
연례 보고서
일반 등록 인증서 보유자 또는 인증서에 연례 보고서 제출 의무가 명시된 인증서의 OR은 등록 2년차부터 4월 30일까지 연례 보고서를 제출해야 합니다.
연례 보고서에는 다음 정보가 포함되어야 합니다:
- 지난해 신규 화학물질의 생산 또는 수입량, 이전 이력 및 처리 사용자 정보 등 활동 기록
- 정보 통신에 관한 기록
- 환경으로의 배출
- 환경 위험 관리 조치
- 환경 관리 요구 사항 구현
참고: 처리 사용자는 인증서 소유자가 연례 보고서 의무를 이행할 수 있도록 지원할 의무가 있습니다.
Are Polymers Exempt?
No. Unlike EU REACH polymers are not automatically excluded from new chemical substance requirements in China for existing substances not listed in IECSC.
For chemicals 그 는 not listed in the IECSC a polymer assessment needs to be performed in order to determine the corresponding measures to be taken in order to fulfill the legal requirements for new chemical substances.
Certain polymers may qualify for record filing, including:
Polymers 그 contain no more than 2% by weight of new monomers or of reactants used in the polymerisation.
A polymer assessment may require information on:
- Monomers and reactants
- Weight percentages
- Number-average molecular weight
- Molecular-weight distribution
- Oligomer content
- Functional groups
- Cationic properties
- Polymer stability
- Residual monomers
- Structural information
Information obtained from the GPC measurement can be used to assess whether a polymer has a degree of concern low enough to enable record filing or whether it will require simplified or full registration.
China REACH Compliance Process
1. Confirm the substance identity
Define the substance (chemical name) 그리고 provide identifiers for 의 substance such as the CAS number, molecular formula and 2D structure. Also, provide information on the substance’s purity, and any impurities 또는 additives that are present in the substance.
2. Search the IECSC
Public database search (IECSC public inventory). Is a confidential inquiry required?
3. Confirm the regulatory scope
Are the substance and intended 사용 covered by the scope of the MEE Order No. 12 or 는 they excluded 또는 subject to another exception or special case?
4. Identify the compliance pathway
Determine whether a substance has to be registered by record filing, simplified registration, regular registration or new-use registration.
5. Conduct a data-gap analysis
Compare the information you have with the technical requirements for registration in 의 relevant category of registration.
6. Develop a testing strategy
Determine whether it is possible to rely on existing knowledge (e.g. reports, literature) or whether a read-across, a QSAR calculation, a weight-of-evidence assessment 등 has 에 be performed before new tests can be conducted.
7. Prepare the dossier
Application forms; Information on 의 registered substance; Study summaries; Evaluations; Assessments as required by the appropriate registration procedure.
8. Appoint the China-based agent
Overseas applicants would also need to prepare agent appointments and Power of Attorney documentation.
9. Submit the application
Step 9: Submit the filing or registration application (for overseas applicants’ agents to submit on their behalf through the MEE system(s) as required, respond to any MEE review queries and follow up until the processing is completed).
10.Complete post-registration obligations
Complete post registration requirements i.e. reporting, communicating, keeping records 그리고 managing risks as required by applicable requirements.
Data and Documentation Requirements
Record filing
Typical information includes:
- Filing form
- Applicant and agent information
- Substance identity
- Annual quantity
- Intended use
- Available hazard and risk information
- Evidence supporting filing eligibility
- Polymer information, where applicable
- Confidentiality request, where required
그리고 applicant can go ahead 와 함께 의 intended activity 와 함께 의 정보 which has been filed. The MEE can afterwards check the filing that has been submitted by the applicant in full.
Simplified registration
Typical requirements include:
- Registration application
- Substance identity information
- Physicochemical information
- Persistence information
- Bioaccumulation information
- Aquatic toxicity information
- Available environmental and health hazard data
- Testing-institution documentation
- Risk-control commitment
Regular registration
Typical requirements include:
- Registration application
- Detailed substance identity information
- Physicochemical data
- Toxicological data
- Ecotoxicological data
- Environmental exposure assessment
- Environmental risk assessment report
- Environmental risk-control measures
- Testing-institution information
- Commitment letter
Socio-economic analysis for high-hazard substances
Confidentiality justification, where applicable
For any data-gap needed for 의 required testing, GPC will recommend to 사용 의 available 정보 if this 는 appropriate from scientific 그리고 legal point of view.
How Long Does Registration Take?
The overall timeline depends on:
- Registration pathway
- Availability and quality of existing data
- Need for laboratory testing
- Substance complexity
- Polymer status
- Environmental risk assessment
- Authority questions
- Requests for additional information
According 에 MEE Order No. 12 the technical-review periods are as follows:
Up to 30 days for simplified registration
Up to 60 days for regular registration
Time spent by the applicant to compile supplementary 정보 (such information is not part of the formal review period granted by MEE Order No. 12) 그리고 time required 에 carry out any necessary laboratory testing plus time required 에 complete 의 registration dossier.
Companies should start to assess the required substances for 그들의 products before the first manufacture or import date.
중국 REACH does not cease to require actions of compliance after a registration certificate or a filing receipt has been obtained.
Supply-chain communication
Information of registered or filed use of substances of very high concern (SVHC) by manufacturer, 수입자 또는 processing user has 에 be communicated to other parties in the supply chain after registration certificate or filing receipt has been obtained by such manufacturer, 수입자 or processing user.
- Registration certificate or filing receipt number
- Registered or filed use
- Environmental and health hazards
- Environmental risk-control measures
- Applicable environmental management requirements
Record keeping
Companies must maintain records of:
- Activity dates
- Manufactured or imported quantities
- Uses
- Risk-control measures
- Environmental management requirements
Records must generally be retained for:
- 10 years for substances subject to registration under simplified 또는 regular procedure.
- At least three years for record filings
First activity reporting
그리고 first activity report of holders of simplified or regular registration certificates has 에 be submitted within 60 days of the following events:
- First manufacture; or
- First import and transfer to a processing user
- A first activity report as required for registered 물질 under Article 41 is not required for 물질 filed under Article 40.
Annual reporting
Annual reporting for registered substances does not apply 에 all of them.
Annual reporting for substances registered on 의 basis of regular registration 는 only required if 의 regular registration certificate includes environmental management requirements for annual reporting. In such cases the report must be submitted by 30 April of 의 year following the previous calendar year.
New hazard information
Any new information concerning potential health 또는 environmental effects has 에 be reported immediately to REACH if in the notifier’s opinion this information indicates an increased risk for the environment. Appropriate action has 에 be taken by 의 notifier in 의 case of such increased risk.
Confidential Business Information Protection
Applicants can apply for the protection of 그들의 confidential information as filed during 의 등록 또는 Filing process.
A confidentiality request should:
- Identify the information requiring protection
- Explain why confidentiality is necessary
- Describe the potential commercial harm caused by disclosure
- Include the required supporting justification
- Currently 의 protection of 의 substance name and other identifying information as stipulated in MEE Order No. 12 shall be limited to a maximum period of five (5) years from the date of the first registration or filing.
GPC can assist with:
- Confidentiality strategy
- CBI justification
- Generic substance naming
- Confidential IECSC inquiries
- Communication between suppliers, agents and importers
GPC China REACH (MEE) Registration Services
GPC provides end-to-end support for MEE Order No. 12 registration :
- China REACH applicability assessments
- Public IECSC searches
- Confidential IECSC inquiries
- Substance identity assessments
- Polymer eligibility assessments
- Registration strategy
- China-based agent support
- Data-gap analysis
- Testing strategy
- Laboratory coordination
- Read-across and alternative-data assessment
- Record filing
- Simplified registration
- Regular registration
- New-use registration
- Confidential Business Information protection
- MEE submission and authority communication
- First activity reporting
- Annual reporting, where required
- Downstream communication
- Record-keeping support
- Registration amendment assessments
- Regulatory monitoring
Why Work with GPC?
End-to-end regulatory support
We can fully support you in your compliance 와 함께 the list of substances of MEE Order No. 12 by first checking whether any substances from your product range need to be registered, then developing a registration strategy for you, registering the substances on your behalf 그리고, after registration, also supporting you after registration.
Support for overseas exporters
Overseas exporters need advice on the requirements for China-based agents, importers 그리고 정보 on substances that are subject to the MEE Order No. 12 and the IECSC.
Practical data strategy
Our experts will assess your current 데이터 그리고 advise if further testing 는 required or if an alternative route 에 compliance is acceptable.
Support for complex substances
Our services cover:
- Individual substances
- Polymers
- UVCBs
- Intermediates
- Specialty chemicals
- Pigments and dyes
- Additives
- Mixtures
- Intentionally released substances in articles
- Ongoing regulatory monitoring
We monitor the current development of MEE Order No. 12, IECSC and proposed revision 2026.
Start Your China REACH Assessment
Don’t wait until your shipment leaves for China to find out if registration of your substance is required.
GPC can help you:
- Verify the IECSC status
- Identify the correct compliance pathway
- Assess polymer eligibility
- Review available data
- Plan testing requirements
- Coordinate a China-based agent
- Prepare and submit the dossier
- Manage post-registration obligations
- Monitor the 2026 regulatory revision
Frequently Asked Questions
1. What is China REACH?
China REACH is the commonly used industry term for China’s regulatory framework governing new chemical substances.
The principal legislation currently in force is the Measures for the Environmental Management Registration of New Chemical Substances, commonly known as MEE Order No. 12.
MEE Order No. 12 was issued in 2020 and entered into force on 1 January 2021, replacing the former MEP Order No. 7 of 2010.
2. How can I check whether a substance is listed in the IECSC?
The Inventory of Existing Chemical Substances in China, or IECSC, is used to determine whether a chemical is considered existing or new in China.
A public IECSC search can be conducted using available identifiers such as:
- CAS 번호
- Chinese or English chemical name
- Molecular formula
- Other relevant substance identity information
If the public search result is unclear or the substance cannot be found, a formal confidential IECSC inquiry may be required. This is important because some substances are included in the confidential portion of the inventory and cannot be identified through the public list.
3. What happens if a substance is not listed in the IECSC?
A chemical substance that is not listed in the IECSC is generally considered a new chemical substance in China.
The substance must complete the applicable record-filing or registration procedure before it is manufactured in or imported into China.
The required compliance pathway depends on factors such as:
- Annual manufacture or import quantity
- Polymer status
- Intended use
- Hazard characteristics
- Applicable new-use controls
4. Does a substance below one tonne per year require China REACH compliance?
Yes.
A new chemical substance manufactured or imported in a quantity of less than one tonne per year is not automatically exempt from China REACH.
It will generally require record filing before manufacture or import, unless a specific exemption or exclusion applies.
5. Does an overseas company need a China-based agent?
Yes.
An overseas manufacturer or trading company acting as the registration applicant must appoint a legally established entity in mainland China as its agent.
The overseas applicant and the China-based agent are responsible for fulfilling the applicable registration and post-registration obligations.
The China-based agent is sometimes commercially referred to as a China REACH Only Representative, although MEE Order No. 12 formally uses the term agent.
6. Are polymers exempt from China REACH?
No. Polymers are not automatically exempt from China REACH.
A polymer that is not listed in the IECSC must be assessed to determine the applicable compliance pathway.
Certain polymers may qualify for record filing, including:
- Polymers containing no more than 2% by weight of new monomers or reactants
- Qualifying polymers of low concern
- Polymers that do not meet the record-filing criteria may require simplified or regular registration, depending on the annual quantity and other relevant factors.
7. Are mixtures covered by China REACH?
Mixtures are generally assessed at the individual substance level.
Each chemical substance contained in a mixture should be checked against the IECSC. Any component that is considered a new chemical substance must complete the applicable filing or registration procedure before the mixture is manufactured in or imported into China.
8. Is testing always required?
Not necessarily.
The testing and data requirements depend on the applicable compliance pathway and the information already available for the substance.
existing information may be considered where it is sufficiently reliable and relevant, including:
- Existing study reports
- Scientific literature
- Read-across data
- QSAR results
- Weight-of-evidence assessments
- Other scientifically justified information
However, simplified and regular registrations have specific data requirements. Certain ecotoxicological data may also need to meet Chinese testing requirements and include studies conducted using Chinese test organisms.
A data-gap analysis should therefore be completed before commissioning new studies.
9. How long does China REACH registration take?
Under MEE Order No. 12, the formal technical-review periods are generally:
- Up to 30 days for simplified registration
- Up to 60 days for regular registration
These periods do not include the time required to:
- Confirm the substance identity
- Conduct an IECSC inquiry
- Generate laboratory data
- Prepare the registration dossier
- Translate supporting documents
- Respond to requests for supplementary information
The total project timeline may therefore be considerably longer, particularly when new testing is required.
10. What happens after China REACH registration?
Post-Registration Obligations
Compliance obligations continue after a registration certificate or record-filing receipt has been obtained.
Depending on the applicable registration pathway and the conditions specified in the certificate, companies may be required to fulfil the following obligations.
Communicate Information Downstream
Manufacturers, importers and processing users must communicate relevant information to downstream recipients, including:
- Registration certificate or record-filing receipt number
- Registered or filed use
- Environmental and health hazard information
- Environmental risk-control measures
- Applicable environmental management requirements
Maintain Activity Records
Companies must maintain records of activities involving the new chemical substance, including:
- Manufactured or imported quantities
- Uses of the substance
- Downstream recipients
- Implementation of environmental risk-control measures
- Compliance with applicable environmental management requirements
Records must generally be retained for:
- At least 10 years for simplified and regular registrations
- At least 3 years for record filings
Submit a First Activity Report
A holder of a simplified or regular registration certificate must generally submit a first activity report within 60 days of:
- The first manufacture of the substance; or
- The first import and transfer of the substance to a processing user
Submit Annual Reports Where Required
Annual reporting is not required for every registered substance.
It applies where an annual-reporting obligation is specifically included in the regular registration certificate. Where required, the annual report must generally be submitted by 30 April and cover activities conducted during the previous calendar year.
Report New Hazard Information
Any newly identified environmental or health hazard information relating to the substance must be reported promptly.
Where the new information indicates an increased environmental risk, the company must take appropriate measures to control or reduce that risk.
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