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New Polymer Notification in China

Under China REACH, any polymer that is not listed on the Inventory of Existing Chemical Substances Produced or Imported in China (IECSC) will be regarded as a new chemical substance. Domestic companies shall notify the new chemical substance to the Chemical Registration Centre (CRC) prior to the manufacturing or importation. Foreign companies can notify the new substance by appointing a local Chinese agent. Please note that even if all monomers are listed on IECSC, notification is still required if the polymer itself is not listed on IECSC.

Please note that in China, a polymer must meet the following three criteria:

(1) Molecules must be distributed over a range of molecular weights;
(2) The weight percentage of molecules containing three monomer units or above should exceed 50%;
(3) The weight percentage of any molecule of the same molecular weight shall not exceed 50%.

The preferred method to determine whether a substance falls under the definition of a polymer is Gel Permeation Chromatography (GPC).

Nomenclature Rules for Polymers in China and How to Search Polymers on IECSC

Before searching IECSC, it is very important for a company to know the nomenclature rules in China. The Chinese name of a polymer should be named in accordance with <Chinese Nomenclature in Polymer Chemistry (2005 edition)>. English name shall follow IUPAC or CAS nomenclature rules. Chinese name must match English name precisely.

Polymers with defined molecular and structural formula should be named after their molecular structure, for example, polyethylene, polystyrene, otherwise, be named on the basis of starting monomer (s) and reactants. Only the starting monomer(s) and reactants with 2 % weight by weight (w/w) or more need to be included in the name of the notified polymers, which is the so-called “2% rule of polymer”.

Searching for polymers by name on online IECSC is very difficult as the names are long and chemical names are sometimes in different formats (sequence matters). Therefore searching for polymers on IECSC using the CAS number is the best option. However, if no CAS number is available, submitting enquiry to CRC is the best way. Do not waste your time by searching the names of monomers or trying different names.

Types of Notification

There are three types of notifications for new polymers in China: simplified notification under special conditions, simplified notification under basic conditions and typical notification. The following picture shows how to determine right type of notification for polymers in China.

new polymer notification china

Simplified Notification under Special Conditions

Polymers listed below qualify for simplified notifications under special conditions.

  •  polymer consisting of monomers or building blocks that are already listed in IECSC(if the polymer itself is not listed on IECSC);
  •  polymers containing less than 2% new chemical substance weight by weight (if the polymer itself is not listed on IECSC); and
  •  polymer of low concern (if the polymer itself is not listed on IECSC);.

 

China has adopted the concept of PLC proposed by OECD even though China is not a member of OECD. China’s PLC criteria are very similar to USEPA PLC criteria. In China, polymer that meets any one of the following three criteria will be regarded as PLC: 

  •  The average molecular weight (MW) of the polymer is between 1,000~10,000 Da. At the same time, the weight percentage of oligomer with MW<500 is less than 10 percent, and the weight percentage of oligomer with MW<1000 is less than 25 percent. Besides, the polymer shall not contain functional groups of high concern (for example, heavy metals) and highly reactive functional groups;
  •  The average molecular weight (MW) of the polymer is greater than10,000 daltons. At the same time, the weight percentage of oligomer with MW<500 is less than 2 percent, and the weight percentage of oligomer with MW<1000 is less than 5 percent;
  •  Polyester polymer;

 

The following information shall be submitted for the simplified notification of polymers:

  • List of monomer (s)/reactants, including the name, CAS number, the content of monomer (s)/reactants as well as whether if monomer (s)/reactants are listed in IECSC;
  • Molecular weight and its distribution, including GPC or other testing results to indicate molecular weight and its distribution;
  • Description of the mechanism of polymerization process, manufacturing process or flow chart;

 

Please note that no mandatory toxicology or eco-toxicology data are required for simplified notification under special conditions in China. Many new polymers placed on Chinese market meet the criteria of simplified notification under special conditions.

Simplified Notification under Basic Conditions

For polymers that are not listed on IECSC and not eligible for simplified notification under special conditions, simplified notification under basic conditions shall be submitted if the volume of the polymers is less than or equal to 1 ton per year. If the volume is above 1 ton per year, typical notification shall be submitted.

The following information shall be submitted for the simplified notification under basic conditions for polymer:

  • Composition information about the polymer and GPC data;
  • Existing physio-chemical data (Melting point, partition coefficient n-octanol/water and water solubility are mandatory);
  • 1~3 of the following tests must be carried out in Chinese labs approved by MEP: ready biodegradability, acute toxicity study with Brachydanio rerio, acute toxicity test with earthworms depending on substance properties;

 

Typical Notification

For polymers that are not listed in IECSC and do not meet the conditions of simplified notification under special conditions, typical notifications shall be submitted if the volume of the polymers exceeds 1 ton per year. More data will be required for typical notification depending on the tonnage band. However, the overall data requirement is still less than the requirement for a regular substance because chemical risk assessment report is not required for polymers. Besides, a series of identification procedures could be used to determine if the data requirements could be reduced further (solubility and stability are the key factors).

More info about new polymer notification can be found here.

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Our Services

Initially set up by China Inspection and Quarantine Bureau, CIRS has a strong presence in China and close links with Chinese Government Agencies including the Chemical Registration Center and state testing laboratories such as Shanghai Environmental Academy of Sciences and Shenyang Research Institute of Chemical Industry Testing Center. As the largest REACH only representative in the world, our expertise with REACH has given us extra advantages of using non-testing method to generate data and minimize costs. CIRS has become the leading provider of comprehensive chemical compliance services in China.

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 Polymer 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.
  • IECSC Inclusion
    • Application for IECSC inclusion for substances manufactured or imported before 15 Oct 2003.

If you are interested in our services, please don't hesitate to contact us. We offer free consultation on the right type of notification and initial data gap analysis. Confidentiality agreement can be signed if necessary.

We also offer one-stop solutions to your chemical compliance in China and our services include new substance notification, registration of the import and export of toxic chemicals, and classification and labelling in according to China GHS and the Chinese SDS. We also deliver the most up-to-date regulatory information about chemical control laws in China.

Contact Us

  • Mr. Eric Xiong, China Office
    11F Building 1, Dongguan Hi-Tech Park, 1288 Chunbo Road, Binjiang District, Hangzhou 310052, China
    Tel: +86-571 8720 6555 | Fax: +86-571 8720 6533
    Email: eric.xiong@cirs-reach.com
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