Frequently Asked Questions

The major revisions include-

  • Adjusting the type and scope of registration
  1. Substances currently subject to scientific research record in volumes less than 100 kg/y are exempted from the requirements under the Draft;
  2. 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;
  3. New registration/notification types:
  • Record notification for substances (<1t/y) and PLCs or polymers new monomers <2% w/w;
  • Simplified registration for substances 1-10t/y;
  • Regular registration: for substances ≥10 t/y.

Details required to register polymer as a new substance in CHINA

1. Firstly, you need to check if all ingredients (including polymers) in your products are listed on IECSC or not. If not, you might need to submit new chemical substance notification by appointing a local agent.

2.  Exact IUPAC name of the polymer - "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."

3. Search the IECSC to confirm whether the polymer is listed in the inventory.

4. Quantity expected to be exported to CHINA

5. Molecular Weight of the Polymer -

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

a. Molecules must be distributed over a range of molecular weights;
b. The weight percentage of molecules containing three monomer units or above should exceed 50%;

c. 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). 

After successful registration of the substance, the authority issues a registration certificate containing the specific management category will be issued. The certificate holder needs to fulfil different post-notification obligations depending on the management category of the substance.

Based on the management category there are specific post registration obligations. 

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 following 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 purposes.

 

If the certificate holder fails to comply with any of these obligations, during the routine checks done by local government authority then the registration certificate can be revoked and the certificate holder will be penalized.

Firstly, you need to check if all ingredients (including polymers) in your products are listed on IECSC or not. If not, you might need to submit new chemical substance notification by appointing a local agent. Secondly, you need to check if your products contain any restricted or prohibited chemicals in China. Thirdly, you need to make sure your SDSs, packaging and labels are compliant with Chinese national standards (GHS and TDG).

China’s chemical inventory of existing chemical substances is IECSC, which stands for the Inventory of Existing Chemical Substances Produced or Imported in China (IECSC). There are two parts of IECSC, public part and classified/confidential part. Companies can check out the public part by themselves and shall only enquire Authorities for classified/confidential part. Notified new substances may be added to this inventory 5 years since the date of the first commencement of manufacturing or importation. If one substance is listed on China IECSC, that does not mean that it is free of any production or import and export control in China. For example, if it is a hazardous chemical, a drug precursor chemical or chemical weapons precursor, it will be subject to stringent license and registration requirements. Up to now, the inventory has been updated for three times. A total of 104 substances have been supplemented. Currently, 46716 substances are listed in the inventory. It should be noted that substances not listed in the inventory are new chemical substances and it is illegal to manufacture or import such substances into China before completing the new chemical substance notification.

China MEE is to supplement substances manufactured in or imported into China before 15 Oct. 2003 into the Inventory of Existing Chemical Substances. Manufacturers, importers, users, industrial associations, etc. can submit paper copies and electronic copies of application materials (application form and supporting documents) to MEE before 30 Sep. 2019 for IECSC supplementation. Manufacturers, importers, users of chemicals, industrial associations, etc. can also submit their applications for informational revision of existing chemical substances. MEE will check the compliance of the application materials and publish the application for public notification. If there is no objection to the application, related substances will be listed into the IECSC.

Categories of exemption from notification include: 

  • Finished products subject to other existing laws and regulations (pharmaceuticals, pesticides, veterinary medicines, cosmetics, foodstuffs, food additives, feed and feed additives, radioactive materials, military products, explosives, tobacco etc.);
  • Naturally occurring substances;
  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;
  • Substances of non-commercial purpose or non-intentional produced, e.g. impurities (content of a single impurity <10%w/w, total content of all impurities<20%w/w), waste or by-products, etc.;
  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
  • 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.
  10. Fertilisers are out of the Regulations scope

There are three types of notification under NCSN, depending on the purpose of manufacture/import and the quantities.

 

  • Scientific Research Record Notification:

Scientific Research Record has the lowest requirements among all the three notification types. To apply for a scientific research record, your substance should be manufactured/imported:

  1. for the purpose of scientific research and development (R&D), in very low quantities (<0.1 tonne per annum), or
  2. as samples used for a compulsory eco-tox test that must be performed in a verified Chinese laboratory (which is also viewed as the prerequisite to the Regular Notification for imported new substances).
  • Simplified Notification:

Simplified Notification applies for tonnage quantities <1 tonne per annum. There are special cases of Simplified Notification, by applying for which substances have less registration requirements than the general case of simplified notification.

  • General Case:

Manufactured/imported in quantities < 1 tonne per annum.

  • Special Case:
  1. Intermediates manufactured/imported < 1 tonne per annum) (“Intermediate”);
  2. Only for the purpose of exporting from China, in quantities < 1 tonne per annum (“Manufacture for Export Only”);
  3. Classified as the polymers of low concern (“Polymers of Low Concern”);
  4. Polymers with low new chemical substance concentration of monomer which are (<2 % w/w) (“New Chemical Substance Monomer<2%”);
  5. For the purpose of scientific research and development, in quantities of 0.1-1 tonne (not included) per annum (“Scientific Research”);
  6. For the purpose of product research or process technology <10 tonnes per annum for less than 2 years (“PPORD”).
  • Regular Notification

The general case of Regular Notification applies to tonnage quantities > 1 tonnes per annum. There are four tonnage bands:

  1. Band 1: 1-10 tonnes per annum
  2. Band 2: 10-100 tonnes per annum
  3. Band 3: 100-1000 tonnes per annum
  4. Band 4: 1000+ tonnes per annum

 

If an approved new substance is considered very hazardous, for example PBT or vBvP, the MEE will place restrictions on its use when it is added to the existing chemicals inventory. Also, as per the major revisions to MEP Order 7 proposed on 9 July, 2019, if new substances are considered persistent, bioaccumulative or toxic (PBTs) or very persistent and very bioaccumulative (vPvBs) – or substances of ‘equivalent concern’ – the government would only grant approval for use if registrants provide socio-economic analysis demonstrating its necessity. After these substances have been added to the existing chemicals list, companies would then only be able to use them for specific, ‘approved’ uses. If companies wanted to use them for a different purpose, they must be re-registered.

Foreign companies have to appoint a local Chinese agent to submit new chemical notifications and the local agent shall be knowledgeable enough to carry out the notification. The role of the agent is very similar to the role of "only representative" under EU REACH regulation. A qualified agent has to meet 7 criteria. One of them is that the minimum registered capital of the local Chinese agent is 3 million yuan (around 330,000 Euros). China REACH has set out this requirement to avoid so called "shell" companies.


Total 15 Record : 2 Page : 1 [ 2 ] Next>>