China New Chemical Substance Notification - China REACH - MEE Order No.12

Updated on 29 Jun. 2020

The Provisions on Environmental Administration of New Chemical Substances were first published in 2003. In 2010, the Provisions (MEP Order No.7) were revised for the first time. Then, after nine years of implementation, the second revision on the Provisions was made in 2020. The revised Measures forthe Environmental Management Registration of New Chemical Substances (MEE Order No. 12) were released on the 29^th April, 2020 and will take effect on 1st January, 2021. The MEP Order No. 7 will be repealed simultaneously.

Under the Provisions, companies shall submit new chemical substance registration for substances not listed in Inventory of Existing Chemical Substances in China (IECSC). The registration not only applies to new substances, substances in a preparation or substances contained in articles which are intended to be released; but also applies to new substances used as ingredients or intermediates for pharmaceuticals, pesticides, veterinary drugs, cosmetics, food additives, feed, feed supplements, etc.

In terms of the substances are listed in IECSC and are subject to new uses management, if these substances are to be used for purposes other than the registered uses, then new uses registration shall be carried out.

IECSC Access

The IECSC is made up of two parts; the public part and classified/confidential part. You may check the public part of the IECSC for free via the following two ways:

• Download Official Version in pdf format.
• Quickly search IECSC by using CIRS's ChemRadar.

There are 3,270 substances listed in the confidential part of IECSC (2013). The substances are presented as category names, neither CAS number nor molecular structure is given. Companies must submit a formal enquiry in order to check whether a substance is listed in the confidential part of IECSC. The SCC then issues a letter of confirmation (usually within 2 weeks) and a 3,000 RMB fee will be charged by SCC for the enquiry. CIRS can assist by submitting the enquiry to SCC on your behalf. Please contact a CIRS representative to avail of this service.

Note: Polymers are not exempt from notification. Even if all monomers are listed on the IECSC, notification is still required. More information regarding polymer notification in China can be found under simplified notification under special conditions and here.

The IECSC has been updated for several times, please click here to know the detailed information of the substances added into IECSC.

Who Shall Register

• Manufacturers of new substances in China;
• Importers of new substances in China;
• Companies who intend to apply for new uses registration or to change the registered uses of the preparations managed by other laws and regulations to other industrial uses;
• Foreign companies selling new substances to China;

Companies in China can submit a new substance notification or appoint a local agent to do so. Foreign companies must appoint a local Chinese agent to submit new chemical notifications. The local agent should be knowledgeable and qualified to carry out the registration. The role of the agent is similar to the role of "only representative" under EU REACH.

Registration Types under China REACH

There are three types of registrations under China REACH: regular registration, simplified registration and record

Registratio n Type	Applicable Scope
Regular Registration	New chemical substances to be manufactured or imported above the annual volume of 10 ton.
Simplified Registration	New chemical substances to be manufactured or imported above the annual volume of 1 ton, yet no more than 10 ton.
Record	1. New chemical substances with tonnage no more than 1 ton per year; 2. Monomers of new substances, polymers containing less than 2%w/w new substances; 3. Polymers of low concern;

Post-Registration Obligations

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

Regist ration Type	Post-registration Obligation
Regular Registration	1. Communicate relevant information, including registration certificate number, registered applications, hazard characteristics, risk control measures as well as environmental management requirements; 2. Establish new chemical substance activity situation record system; 3. Keep documents on file for over 10 years; 4. Disclose the implementation situations of the environmental risks control measures and environmental management requirements; 5. Submit first-activity report; 6. Report the situation of the new chemical substances of last year; 7. Submit updates if new hazards or risks arises and take measures to eliminate or reduce the risks;
Simplified Registration	1. Communicate relevant information, including registration certificate number, registered applications, hazard characteristics, risk control measures as well as environmental management requirements; 2. Establish new chemical substance activity situation record system; 3. Keep documents on file for over 10 years; 4. Submit first-activity report; 5. Submit updates if new hazards or risks arises and take measures to eliminate or reduce the risks;
Record	1. Communicate relevant information, including record receipt, registered applications, hazard characteristics, risk control measures as well as environmental management requirements; 2. Establish new chemical substance activity situation record system; 3. Keep documents on file for over 3 years; 4. Submit updates if new hazards or risks arises and take measures to eliminate or reduce the risks;

Supervision

China MEE may require further information, including environmental or health hazards information and exposure information, based on the registration situations, the actual import or manufacture volume and the emission status, or if there is any newly founded environmental/ health risks or increasing environmental risks;

The Cost of China REACH

The total cost consists of three major parts: 1) Administration fee, 2) Testing fee, and 3) Consulting fee.

The testing fee accounts for a large proportion of the total costs. Tests must be carried out by certified laboratories, and are determined by the registration type and the substance property. It can typically cost several hundred thousand RMB to obtain a full data set, but it may be possible to waive some high-cost tests through analysing the results of more basic test items.

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

Note1: Some ecotoxicological tests must be carried out in certified local Chinese laboratories, while other data generated in GLP labs outside of China is acceptable. If your company owns data, the total costs could be reduced significantly. QSAR and READ Across are also accepted under China REACH.

Note2: For typical registration, the required data is based on the PBT property of the substance. For example, if the substance is suspected to be PBT, more data besides basic data set shall be provided.

Our Services

CIRS China fulfils all the qualifications and requirements of being a local agent (registered capital, expertise, etc). We provide all the necessary services in one package to complete registration 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 correct registration type.

New Chemical Substance Registration

Data evaluation, data gap analysis, and 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-registration Maintenance

Reporting the trade/manufacture activities of the new substance to local enforcement authorities, fulfillment of other post-registration obligations after the registration certificate has been issued.

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