Regolamento cinese sulle sostanze chimiche
Cina REACH (ordine MEE 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, e 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, or get a regular registration before it can be made or brought into the country.
GPC helps companies for China REACH (MEE) Registration Services from other countries, like manufacturers, exporters, e traders, as well as Chinese importers, con il 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 il necessary documents, e 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?
Cina REACH: A Brief Overview – Industry terms – EuChemS
Il law for Cina REACH is 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 manufacturers or importers of new chemical substances prior to their production or introduction into the market in China.
Cina REACH is managed by il Chinese Ministry of Ecology and Environment (MEE).
Important 2026 Regulatory Update
MEE recently issued new measures for il registration of chemical substances for pubblico comment. The comment period for il 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 il MEE and we recommend that companies continue to 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 to monitor the developments and inform you on il possible impact for future registrations, existing certificates and your polymer portfolio.
Who Must Comply with China REACH or MEE Order No. 12 registration ?
Cina REACH legislation apply to within organizations involved con 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.
Il obligations of Cina REACH are defined by four elements: il chemical identity in question, il annual amount of the substance in question, il intended use or new function of the substance in question, e il role of il company in the supply chain of that chemical substance in question.
IECSC Checking
The Inventory of Existing Chemical Substances in China (IECSC) is 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 substances are usually not required to be registered as new chemical substances even if they are to be manufactured or imported into China. However, such existing chemical substances 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 inventario of chemical substances that have already been registered in China and publishes lists of newly added substances e of substances that are proposed for addition after the update has been conducted.
- Public IECSC search
- The initial search may use:
- Numero CAS
- Chinese chemical name
- English chemical name
- Molecular formula
- Substance identity information
- Confidential IECSC inquiry
- Even if a substance is not in il pubblico IECSC list, it might be in the confidential part of the inventory.
- Distinguishing between substances included in il riservato part of il inventario e 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, e 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 nuova sostanza chimica for export to China, they can act as the registration applicant. However, il overseas manufacturer or trading company has to appoint a registered legal entity in mainland China as their agent. The overseas applicant and il 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. Il overseas company would then appoint a China-based entity (e.g. GPC) as their agent e il overseas applicant and their Cina-based agent would jointly register il chemical substance e perform il subsequent post-registration obligations.
GPC can assist with:
- Cina REACH Only Representative
- Power of Attorney documentation
- Application preparation
- Regulatory submission
- Authority communication
- Certificate management
- Post-registration reporting
- Supply-chain communication
Tipo di registrazione
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. |
Notifica requirements are not only determined by the amount of tonnage of a substance, but 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 il MEPC sets out il thresholds for il relevant categories as well as the principal registration categories.
Documento di registrazione
Inventario
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 Nuova sostanza chimica.
L'Inventario è composto da due parti (pubblico e riservato). Attualmente sono presenti 3.270 sostanze riservate. Le aziende devono presentare una richiesta formale per verificare se una sostanza è elencata nella parte riservata. Il China Solid Waste and Chemicals Management Center (SCC), una divisione del MEE, emetterà una lettera di conferma (di solito entro 2 settimane) e verrà addebitato un costo di 3.000 RMB. GPC può assistere la richiesta per conto del cliente.
Nonostante tutti i monomeri siano elencati nell'inventario, i polimeri devono ancora essere registrati.
Rapporto annuale
Primo rapporto di attività
I titolari di certificati o i loro RUP, indipendentemente dal tipo di registrazione, devono presentare le prime relazioni sulle attività entro 60 giorni dalla prima attività (fabbricazione e importazione/trasferimento all'utilizzatore a valle) delle sostanze chimiche in questione.
Il rapporto deve contenere le seguenti informazioni:
- Informazioni sull'azienda importatrice o produttrice nazionale
- Ora, luogo e volume della prima attività
- Informazioni sull'utente trasferite
- Misure di controllo del rischio ambientale
- Attuazione dei requisiti di gestione ambientale
Rapporto annuale
I titolari di certificati di registrazione regolari o i loro RUP di coloro che sono stati segnalati con l'obbligo di presentare relazioni annuali sui loro certificati devono presentare relazioni annuali entro il 30 aprile a partire dal secondo anno di registrazione.
La relazione annuale deve contenere le seguenti informazioni:
- Registro delle attività relative alle nuove sostanze chimiche dell'ultimo anno, compresi i volumi di produzione o importazione, la storia dei trasferimenti e le informazioni sugli utilizzatori del trattamento.
- Registrazione della comunicazione delle informazioni
- Emissione nell'ambiente
- Misure di controllo del rischio ambientale
- Attuazione dei requisiti di gestione ambientale
Nota: gli utenti del trattamento sono tenuti ad assistere i titolari dei certificati nell'adempimento dell'obbligo di rendicontazione annuale.
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 that are 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 that 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) e provide identifiers for il substance such as the CAS number, molecular formula and 2D structure. Also, provide information on the substance’s purity, and any impurities or 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 use covered by the scope of the MEE Order No. 12 or are they excluded or 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 il 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 ecc. has to be performed before new tests can be conducted.
7. Prepare the dossier
Application forms; Information on il 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 e 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
Il applicant can go ahead con il intended activity con il information 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 il required testing, GPC will recommend to use il available information if this is appropriate from scientific e 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 to 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 information (such information is not part of the formal review period granted by MEE Order No. 12) e time required to carry out any necessary laboratory testing plus time required to complete il registration dossier.
Companies should start to assess the required substances for their products before the first manufacture or import date.
Cina 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, importer or processing user has to be communicated to other parties in the supply chain after registration certificate or filing receipt has been obtained by such manufacturer, importer 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 or regular procedure.
- At least three years for record filings
First activity reporting
Il first activity report of holders of simplified or regular registration certificates has to 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 substances under Article 41 is not required for substances filed under Article 40.
Annual reporting
Annual reporting for registered substances does not apply to all of them.
Annual reporting for substances registered on il basis of regular registration is only required if il regular registration certificate includes environmental management requirements for annual reporting. In such cases the report must be submitted by 30 April of il year following the previous calendar year.
New hazard information
Any new information concerning potential health or environmental effects has to be reported immediately to REACH if in the notifier’s opinion this information indicates an increased risk for the environment. Appropriate action has to be taken by il notifier in il case of such increased risk.
Confidential Business Information Protection
Applicants can apply for the protection of their confidential information as filed during il Registrazione or 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 il protection of il 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 con 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 e, after registration, also supporting you after registration.
Support for overseas exporters
Overseas exporters need advice on the requirements for China-based agents, importers e information on substances that are subject to the MEE Order No. 12 and the IECSC.
Practical data strategy
Our experts will assess your current data e advise if further testing is required or if an alternative route to 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:
- Numero CAS
- 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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