China REACH Substance Registration Service
Highlights on China REACH
Under the Chinese “Measures on Environmental Management of New Chemical Substances”, in force since 15 October 2010, companies placing on the Chinese market new chemical substances as such, in preparations, or in articles intended to be released, must comply with a number of obligations. These obligations depend on the nature of the product and of the volumes put on the market.
New substances are substances not listed in the Inventory of Existing Chemical Substances in China.
The principal categories of obligations are:
- Registration of substances as such, in preparations or articles intended to be released
- Implementation of Safety measures and communication to users and processors:
• Documentation of Risk Management Measures
• Chemical Safety instructions for processors and users
• Monitoring of hazardous emissions of Substances of Environmental Concern
- Production of annual manufacturing and impact reports
As the substance registration obligation is legal entity specific (EU REACH-like), the regulation applies for by every importing company.
The Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP) until 2018, and prior to 2008 known as the State Environmental Protection Administration (SEPA), is a department of the State Council of the People's Republic of China.
Some measures under China REACH
Legislation aim :
The current Regulations are enacted for the purpose of controlling environmental risks posed by new chemical substances, ensuring human health and protecting the environment in accordance with the Decision of the State Council on Establishing Administrative License for the Administrative Examination and Approval Items Really Necessary to Be Retained as well as other relevant laws and administrative regulations.
Application scope :
The current Regulations are applicable to environmental management of the activities in relation to the research，manufacture, import, process and utilization of new chemical substances within the customs territory of the People’s Republic of China. The current Regulations shall also apply to the environmental management of the activities relating to new chemical substances in bonded areas and export processing zones.
The management of pharmaceuticals, pesticides, veterinary medicine, cosmetics, food addictive and feed addictive shall comply with relevant laws and regulations.
However, environmental management of the activities relating to the new chemical substances as the raw materials and intermediates of the above products shall comply with the current Regulations.
Items that are designed to deliberately release the contained new chemical substances during their regular utilization shall be managed in accordance with the current Regulations.
Based on the standards on the identification and classification of the hazard characteristics of chemicals, new chemical substances shall be classified into general new chemical substances and hazardous new chemical substances.
Among the hazardous new chemical substances, those with enduring and bioaccumulative characteristics harmful to the ecological environment and human health shall be taken as key hazardous new chemical substances for environmental management.
“New chemical substances” mentioned in the current Regulations refer to the chemical substances not in the China Inventory of Existing Chemical Substances.
China Inventory of Existing Chemical Substances is developed, adjusted and published by Ministry of Environmental Protection.
Basic System :
The State shall carry out risk classified management and adopt the systems of notification and registration as well as follow-up control.
Registration certificate :
The producers or importer of a new chemical substances shall make a notification and obtain the registration certificate for environmental management of new chemical substances (hereinafter referred to as the “registration certificate”) before the production or import.
The production, import, processing and utilization of any new chemical substance without the registration certificate shall be prohibited.
No new chemical substance without the registration certificate or without being recorded and notified shall be allowed to be used in scientific researches.
Encouraging new technologies :
The State shall support the scientific researches on environmental risk and health risk assessment and control technology for new chemical substances, promote advanced and applicable environmental risk control technology for new chemical substances, encourage the researches, production, import, processing and utilization of alternative chemical substances that are environment-friendly and encourage appliers to share the data on the notification and registration of new chemical substances.
Any person engaged in environmental management of new chemical substances shall keep commercial and technical secrets for the appliers.
Public Supervision :
Any institution and individual has the right to expose, denounce and file a charge against any behavior violating the current Regulations.
Types of notification :
The notification of new chemical substances is divided into regular notification, simplified notification and scientific research record notification.
Requirements for regular notification :
The manufacturer or importer that produces or imports new chemical substances with the amount exceeding 1,000 kg per year shall submit to the Chemical Registration Center of the Ministry of Environmental Protection (herein after referred to as the “Registration Center”) the report on notification of new chemical substances to apply for a notification before the production or import.
Where the conditions for a simplified notification are met, however, the manufacturer or importer may apply for a simplified notification.
The report on notification of new chemical substances shall contain:
(1) Regular notification form for new chemical substances, attached with the classification, based on the relevant national standards such as the Safety Regulations on the Classification of Chemicals, Warning Labels and Warning Instructions , label and chemical safety data sheet;
(2) Risk assessment report: It includes such contents as the assessment of the hazards of the application substance, forecast assessment of its exposure and risk control measures and results of the assessment of environmental and health risks;
(3) Test report or relevant materials on the physical and chemical property, toxicity and eco-toxicological characteristics, and the qualification certificate of the testing institution. The eco-toxicological test report must include the testing data using Chinese target organism within the territory of the People’s Republic of China.
Amount grades for regular notification :
Regular notification follows the principle of “the higher the notification amount, the higher requirement for test data” The appliers shall provide relevant test data or materials according to the Guidelines for notification and registration of new chemical substances developed by the Ministry of Environmental Protection.
The amount of new chemical substances for regular notification is divided into the following four grades from the low to high:
(1) Grade 1, annual production or import amount more than 1 ton but less than 10 tons;
(2) Grade 2, annual production or import amount more than 10 tons but less than 100 tons;
(3) Grade 3, annual production or import amount more than 100 tons but less than 1000 tons; and
(4) Grade 4, annual production or import amount more than 1000 tons.
General circumstances for simplified notification :
Where the annual production or import amount of new chemical substances is less than 1 ton (not including 1 ton), the manufacturer or importer shall apply to the Registration Center for simplified notification.
For simplified notification, the following documents shall be submitted:
(1) Simplified notification form for new chemical substances;
(2) The report on the eco-toxicological test carried out within the territory of the People’s Republic of China by using Chinese target organism.
Special circumstances for simplified notification :
Where the manufactured or imported new chemical substances meet one of the following special circumstances, simplified notification shall be applied for:
(1) New chemical substances as intermediate or only for export with annual production or import amount less than 1 ton;
(2) New chemical substances for scientific research with annual production or import amount more than 0.1 ton but less than 1 ton;
(3) New chemical substances being the polymer with monomer concentration lower than 2% or belonging to low concern polymers;
(4) New chemical substances aiming at research and development for processes and products with annual production or import amount less than 10 tons and within two years.
For the application for simplified notification under the special circumstances, the simplified notification form for new chemical substances and the materials proving the compliance with the corresponding circumstances shall be submitted.
Requirements for notification of scientific research ...
The scientific research record form for new chemical substances shall be submitted to the Registration Center to apply for a notification of scientific research record before the manufacture or import under any of the following circumstances:
(1) In case that the annual production or import amount of new chemical substances is less than 100 kg, which aims at scientific research;
(2) Where the test sample of the new chemical substance is imported for the eco-toxicological test on the substance carried out within the territory of the People’s Republic of China by using Chinese target organism.
Serial notification, joint notification and repeated ... :
Appliers for regular notifications with any of the following circumstances may go through the notification procedures as prescribed below:
(1) In case that the same notifier applies for several new chemical substances with similar molecular structure, same or similar use and similar testing data, he may present serial notification of new chemical substances;
(2) In case that two or more notifiers apply for the same new chemical substances at the same time and jointly submit notification materials, they may present joint notification for new chemical substances; and
(3) In case that two or more notifiers apply for the same new chemical substances one after another, the later notifiers using the testing data of the previous notifier upon his agreement, the later notifiers may present repeated notification. The way to share the test costs for the data shall be negotiated about and determined discretionally by the notifiers.
Qualification of the applicant :
The applicant for new chemical substances or its agent shall be a registered institution within the territory of China.
Any applier that is not for the first time to apply for notification of new chemical substances shall not have the bad record of being punished for violation against the regulations on the environmental management of new chemical substances over the past three years.
Substance Registration Services with Regard to China REACH
Service 01: Substance Evaluation Process
- ¤ IECSC Checking
- • Checking substances listed on the Inventory of Existing Chemical Substances Produced or Imported in China
- ¤ Extended IECSC Checking
- • Inventory of Existing Chemical Substances in China includes registered substances which have “confidentially protection”
- • These substances can not be found through a standard assessment
- • Following the initial assessment, for substances identified as not currently listed on IECSC, we proceed to double checking via a search mechanism which identifies substances listed with confidentiality protection
- ¤ Extended IECSC Checking includes the followings
- • Preparation of the substance inquiry dossiers
- • Dossier submissions to the Chemical Registration Center (CRC - Chinese authority)
- • Verifications by CRC and disclosure on each substance status
Service 02: Simplified Substance Registration Process [Tonnage < 1T/y]
- ¤ Simplified Registration Dossier Generation
- • A simplified notification form for the new chemical substance
- • A report on eco-toxicological testing conducted on Chinese test species within the territory of China
- • Certification materials in line with relevant volume thresholds [Art. 12, 13]
- ¤ Simplified Registration Dossier Submission & Follow up
- • Dossier submission
- • Dossier follow up
- ¤ Mandatory Reports Submission
- • Annual activity reports building
- • Submission of the reports to the Chemical Registration Center (CRC)
- ¤ Translation Service Pack
- • Translation of client documents in Chinese
Service 03: Standard Substance Registration Process [Tonnage bands: 1+T/y, 10+T/y, 100+T/y, 1000+T/y]
- ¤ Step-01: Record Application for Scientific Research
- 01: Record application form for Scientific Research for new chemical substances
- 02: Application form, including copies of the entity legal documents
- 03: Record application for Scientific Research dossier submission (Electronic (CD) support and papery files)
- 04: Record application for Scientific Research dossier follow up
- Note: if required Eco-toxicological tests have been carried out in China, Service Step-01 can be altogether skipped
- ¤ Step-02: General Registration (Tonnage ≥ 1T/y)
- 01: Cover of General Registration dossier
- 02: Total catalogue of General Registration dossier
- 03: General Registration application form for new chemical substances
- 04: Attachment of application form (in Chinese), including the copies of artificial person’s certificate and business licence, labelling, MSDS, and the result and basis of classification according to the safety rules for classification, precautionary labelling and precautionary statements of chemicals and other relevant national standards, etc.
- 05: Risk Assessment Report, including hazard assessment of the notified substance, exposure scenarios assessment and risk control measures, assessment results of environment and health risks, etc
- 06: List of test reports and materials
- 07: Competency Certificates for test lab and/or experts
- 08: Test reports and/or materials (in Chinese or English) of the substance’s physicochemical properties and toxicological and eco-toxicological properties, and the eligibility testimonial of the relevant testing institutions. The eco-toxicological testing report must include the data of test conducted on a Chinese test species within the territory of China according to the relevant standards
- 09: Regular Registration dossier submission (electronic (CD) and papery files)
- 10: Regular Registration dossier follow up
- 11: For hazardous new chemical substance of priority environmental management
- 11-1: Annual activity reports generation and submission to CRC
- 11-2: Within 30 days from the date of each delivery to different processors or users, report the flow to the CRC
- 12: Report the first business activity report to the CRC, within 30 days of its first manufacturing, importing and transferring to users
- ¤ Translation Pack
- • Translation of client documents in Chinese
China-REACH Full Services Portfolio ...
When time is of the essence...
- Within the shortest possible delays
- With more than 10 years of experience in the régulatory industry, our services are provided speedy and effectively in accordance with the target legislations and rules of procédures; as well as the rules within that govern the handling of business confidential informations.