China Regulation on New Chemical Substance Notification will be Significantly Changed

China,Chemical,China REACH,New Chemical Substance, Notification,IECSC

China MEE has released the amended Provisions on Environmental Administration of New Chemical Substances for public comments. Comments can be made before 16 Aug. 2019 via chem@mee.gov.cn.

The current Provisions on Environmental Administration of New Chemical Substances (MEP Decree No.7)(China REACH) took effect on 19 Jan. 2010  and it has been implemented for nearly 9 years. 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) for the new chemicals irrespective of annual tonnage. 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.

Compared with the current Regulation, the Draft has been significantly changed in the following aspects:

Adjusting the type and scope of registration

  • Substances currently subject to scientific research record in volumes less than 100 kg/y are exempted from the requirements under the Draft;
  • Substances currently subject to simplified notification will be subject to record under the Draft; Enterprises can carry out business activities once they submit the completed record materials; 
  • Substances currently subject to first level of typical notification (in volumes between 1-10t/y) will be subject to simplified registration under the Draft; the data requirements as well as the registration process for simplified registration will be reduced under the Draft; 
  • Under the Draft, substances currently subject to second, third or fourth level of typical notification (in volumes over 10t/a) will be subject to regular registration; data requirements for substances subject to regular registration substance will be variable depending on the environmental risks of these substances and the actual needs; if the new substances are considered persistent or bio-accumulative with exposure risks, then enterprises shall also submit long-term chronic toxicity test report.

Comparison of Registration Type and Scope between the Current Regulation and the Draft

Current Regulation

Draft

Notification Type

Notification Scope

Notification Type

Notification Scope

Scientific Research Record

For scientific research; less than 0.1t/y

Exempted

Simplified Notification Specific Condition

1. Intermediates, less than 1t/y;

2. For export only, less than 1t/y;

3. Scientific research, 0.1-1t/y

4. Monomers of Substances, polymers containing less than 2%w/w new substances and polymers of low concern;

Record

1. Less than 1t/y;

2. Monomers of Substances, polymers containing less than 2%w/w new substances and polymers of low concern;

Simplified Notification Basic Condition

Less than 1t/y

Typical Notification First Level

1-10t/y

 Simplified Registration

1-10t/y

Typical Notification Second Level

10-100t/y

Regular Registration

More than 10t/y

Typical Notification Third Level

100-1000 t/y

Typical Notification Fourth Level

Over 1000t/y

Optimizing the registration criteria

The registration criteria are more detailed under the Draft:

Amended Notification Type

(Current Notification Type)

Registration Standard

Current Regulation

Draft

Regular Registration

(Typical Notification Second Level and above)

If there are appropriate risk control measures, registration is approved; otherwise registration is rejected;

If there is no unreasonable risks after appropriate risk control measures are in place and it is necessary to perform such activity, registration is approved; otherwise registration is rejected;

Simplified Registration

(Typical Notification First Level)

If there are appropriate risk control measures, registration is approved; otherwise registration is rejected;  

If the substances are not considered persistent, bio-accumulative and toxic and environmental risks are not accumulated, registration is approved; otherwise registration is rejected;

Record

(Simplified Notification)

If eco-toxicology test reports are required, the expert committee shall perform technical review. Registration will be approved after passing the technical review.

 

Existing hazard data of the new substances is required. Activities can be carried out based on the record after the completed material is submitted;

 

Optimizing the procedures for supplementation of IECSC

Procedures for supplementation of Inventory of Existing Chemical Substances in China (known as IECSC) are optimized under the Draft:

  • Under the current regulation, new substances will be added into IECSC and be regulated as existing substances five years after the date they are first imported or produced;
  • Under the Draft, new substances will be added into IECSC and be regulated as existing substances five years after the date they are first registered.

Highly toxic substances must demonstrate the necessity of activity

China is now paying more attention to substances with environmental risks. If substances that are considered persistent, bio-accumulative or toxic (PBT); or substances that are considered very persistent and very bio-accumulative (vPvB) shall complete regular registration, enterprises need to provide socio-economic analysis demonstrating its necessity.

New applications of existing substances will be managed

New uses of substances that are considered persistent and bio-accumulative (PB), persistent and toxic (PT), bio-accumulative and toxic (BT) or highly hazardous will be managed.

  • In terms of substances that are considered PB, PT or BT, when these substances are included into IECSC, the government will rule the approved uses of these substances. If enterprises need to use these substances for different purposes, they must apply for new use registration to the competent authority.
  • In terms of highly toxic substances, all uses of these substances are under management. That is to say, enterprises need to apply for new use registrations for any use of these substances. Besides, these enterprises also need to provide socio-economic analysis demonstrating its necessity.  

Annual Report

Under the draft, first activity report and annual report is required. Enterprises subject to regular registration need to submit annual report before 30 April each year only when the government specifically requires them to submit it.  

Confidentiality

Under the Draft, if enterprises need to apply for protection of CBI, they must submit documents demonstrating the necessity. The period for the CBI protection is limited to 5 years at most. Currently, there is no expiration date for CBI protection.

In addition, the Draft also makes some changes to the conditions for re-registration and clarifies the random checking measures as well as the responsibilities of enterprises

CIRS Comments

China is now trying to reinforce its management on high risk substances and reduce the registration requirements for substances of low risks. The supporting documents which detailedly rules the data requirements has not been amended yet. It is estimated that the supporting documents will also be amended in the near future.

If you have any needs or questions, please contact us at service@cirs-reach.com.

[Hot!] Chemical Inspection and Regulation Service Limited (CIRS) together with Helsinki Chemicals Forum is to host the Asian Helsinki Chemical Forum and the 4th Summit Meeting on Chemical Regulations in Asia Pacific (HCF&SMCR 2019) in Shanghai on 24th -25th October 2019. The Asian HCF will be a shorter version of the 2019 HCF taking place in Helsinki on 23rd-24th May with high-level keynote speeches and open debate among speakers and public on hot topics in chemicals regulation globally. The three topics will be taken from the five presented in Helsinki as they are equally relevant to Asia. The compositions of the panels and the audience will be different so that the content and conclusions will be suitable and unique to the Asian context. HCF&SMCR 2019 also will invite government officials and company regulatory experts from China, Japan, Korea and Southeast Asia to make presentations on updated chemical regulations and compliance issues in those countries.

As the amended Provisions on Environmental Administration of New Chemical Substances has been released for public comments, officials in China will give an introduction to the amended provisions during the conference.