China New Chemical Substance Notification - China REACH - MEP Decree No.7

Updated on 1 December 2015

On 19 January 2010, the Ministry of Environmental Protection (MEP) of China released the revised version of the Provisions on Environmental Administration of New Chemical Substances (MEP Decree No. 7)(China REACH). The new regulation replaced the old regulation issued in 2003 and entered into force on 15 October 2010. This regulation is also named ‘China REACH’ for short, although it only requires new substance notification rather than EU REACH requires all chemical registration.

Under this regulation, companies shall submit new chemical substance notification to the Chemicals Management Center (SCC) of MEP for the new chemicals irrespective of annual tonnage, ie chemicals other than the approximately 45,000 substances currently listed on the Inventory of Existing Chemical Substances Produced or Imported in China (IECSC). The notification not only applies to new substance on its own, in preparation or articles intended to be released, but also applies to new substances used as ingredients or intermediates for pharmaceuticals, pesticides, veterinary drugs, cosmetics, food additives and feed additives, etc.


IECSC Access

There are 45,612 substances in IECSC (2013). Chinese government updated this inventory on 31 January 2013. IECSC includes two parts of existing chemical substances, public part and classified/confidential part. 

For the public part:

There are 3,270 substances listed in the confidential part of IECSC (2013). They are shown in category names. Neither CAS number nor molecular structure is given for those confidential substances. Companies have to submit a formal enquiry to SCC to check whether a substance is listed in the confidential part of IECSC or not. SCC usually issues a letter of confirmation within 2 weeks after an enquiry is submitted. a 3,000 RMB fee will be charged by SCC for the enquiry. CIRS can provide the service to help you submit the enquiry to SCC.

Note: Polymer is not exempted from notification. Even if all monomers are listed in IECSC, notification is still required if the polymer itself is not listed in IECSC. More info can be found at simplified notifications under special conditions. More info about polymer notification in China can be found here.


What can be Exempted ?

There are four major categories of chemical substances being exempted from this regulation:

Category I: Chemicals subject to other existing laws and regulations;

Radioactive substances, military industry products, pyrotechnics, biotic substances, pesticides, veterinary drugs, pharmaceuticals, cosmetics, foods, food additives, feed, feed additives, tobacco and tobacco products.

Category II: Substances existing in nature

1. Substances that are unprocessed, or that are manufactured or processed only through the methods listed below: 1) Manual; 2) Mechanical; 3) Gravitational; 4) Soluble in water; 5) Floatation in water; 6) Heat dehydration.

2. Extracted from the atmosphere through various means;

3. Natural polymers, except for ones that are chemically modified;

Category III: Substances of noncommercial purpose or unintentionally produced

1. Impurities; 2. Products of random reactions; 3. Products of random reactions that occur when a chemical substance, mixture, or article is in storage; 4. Products of reactions that occur when a chemical substance, mixture, or article is in final use; 5. Waste water, waste gas, solid waste, and by-products.

Category IV: Special categories

1. Glass; 2.Frit; 3. Pottery raw materials and ceramic ware; 4. Steel and steel products; 5. High-alumina cement; 6. Portland cement; 7. Articles 8. Homogeneous and heterogeneous alloys, except for metal compounds and precisely defined intermetallic compounds 9. Non-isolated intermediates.


Who can Apply?

  • Manufacturer of new substance in China;
  • Importer of new substance in China;
  • Foreign companies selling new substances to China.

Companies in China can submit new substance notification on their own or appoint a local agent to do so. Foreign companies have to appoint a local Chinese agent to submit new chemical notifications and the local agent shall be knowledgeable and qualified enough to carry out the notification. The role of the agent is very similar to the role of "only representative" under EU REACH regulation.

Note: the minimum registered capital of the local Chinese agent is 3 million yuan (around 330,000 Euros).  Chinese REACH has set this requirement to avoid the so called "shell" companies. 



Notification Types under China REACH

There are three types of notifications under China REACH: typical notification, simplified notification (under basic or specific condition) and scientific research record.

Type of Notification

Applicable Scope

Typical notification

8~36 months;

New chemical substances to be manufactured or imported at or above the annual volume of 1 ton. Based on tonnage band, there are four notification levels:

- First level (110 tons)

- Second level (10100 tons)

- Third level (1001,000 tons)

- Forth level (>1,000 tons))

Simplified notification basic condition

6~8 months

New chemical substance with tonnage under 1 ton per year;

Simplified notification specific condition

2~3 months

 

New chemical substance

- for export only with tonnage under 1 ton per year;

- for scientific research with tonnage between 0.1 to 1 ton per year;

- for technological research with tonnage less than 10 ton per year

- for polymer consisting of monomers already listed in IECSC(if the polymer itself is not listed in IECSC);

- for polymers containing less than 2% new chemical substance weight by weight; and

- for low concern polymers(if the polymer itself is not listed in IECSC);.

Scientific research record

3~10 working days

New chemical substances used for scientific research with an annual quantity lower than 0.1 ton or if the sample is to be tested in laboratories in China.

The difference between Scientific Research Record and other two types of notification is that for the former the related activities could be started once the notification form is submitted and for the latter related activities (manufacturing or importation) can only be started after the applicant receives the registration certificate issued by SCC.

For more information about the specific data requirements for new chemical notification in China and other types of notification (joint notification, repeated notification and serial notification), please click here.


Post-Notification Obligations

After notification is completed, a registration certificate containing specific management category will be issued. Certificate holder needs to fulfill different post-notification obligations depending on the management category of the substance.

Chemical substances will be categorized as general new chemical substances or hazardous new chemical substances. Hazardous new chemical substances possessing persistent, bioaccumulative properties or are harmful to ecological environment and human health will be further classified as priority hazardous new chemical substances for environmental management.

Category

Post-notification Obligations

General new chemical substances

(6 Requirements)

1. Communicate MSDS to downstream users;

2. Implement risk management measures;

3. Submit first-activity report;

4. Keep documents on file for over 10 years;

5. Do not sell chemicals to downstream users who are not capable of implementing risk management measures;

6. Submit updates if new hazard arises;

Hazardous new chemical substances

(8 Requirements)

7. Submit annual report (for previous year);

8. Comply with <<The Measures for The Administration of Registration of Hazardous Chemicals>>;

Priority hazardous new chemical substances for environmental management

(11 Requirements)

9. Submit report on disposal information;

10. Submit substance flow chart;

11. Submit annual plan (for next year);

Simplified Notification
(2 Requirements)
1. Submit annual plan (for previous year);
2. Keep documents on file for over 10 years;
Scientific Research Record
(2 Requirements)
1.Requirements of professionals and facilities;
2. Can only be used for scientific research purpose;


The Cost of China REACH

The total cost consists of three major parts: the administration fee, the testing fee and the consulting fee.

The testing fee accounts for a large proportion of the total costs and it is charged by certified laboratories. The testing fee is tonnage based. It typically costs several hundred thousand RMB to carry out testing to obtain a full set of data. Some high level testing items could be waived by analyzing the results of the basic testing items and thus the corresponding testing fee would be lower.

The consulting fee charged by CIRS is fixed depending on the type of notification.

Note: Some ecotoxicological tests must be carried out on Chinese specific creatures in certified local Chinese laboratories. Other data generated in GLP labs outside of China is acceptable. If your company owns available data, the total costs could be reduced significantly. QSAR and READ Across are also accepted.


Our Services

CIRS China has all the qualifications of being a local agent (registered capital, expertise, etc). We provide all services in one package to help you complete notification at the most competitive price in the market. Our services include:

IECSC Search

  • Evaluation of whether a substance is within the scope of China REACH and determination of right notification type;

New Chemical Substance Notification

  • Data evaluation, data gap analysis, and resorting to non-testing methods such as literature search, QSAR and Read Across to minimize data costs;
  • Writing testing proposal, sending sample to certified labs and waving high-level testing items based on the results of low-level testing;
  • Dossier preparation and submission;

Post-Notification Maintenance

  • Updating the notification dossier if tonnage band has changed, reporting the trade/manufacture activities of the new substance to local enforcement authorities, fulfillment of other post-notification obligations after the Registration Certificate has been issued.

If you are interested in our service, please contact us at Service@cirs-reach.com.