Market Challenges
According to China's REACH regulation (Environmental Management Regulations for New Chemical Substances), polymers not listed in the "Inventory of Existing Chemical Substances Produced or Imported in China" (IECSC) are considered new chemical substances. Relevant entities must comply with the relevant declaration requirements and declare to the Chemical Registration Centre (CRC) before manufacturing or importing them. Companies outside of China may designate a domestic agency to handle the declaration process. It is important to note that even if all monomers in a polymer are listed in the "Inventory of Existing Chemical Substances Produced or Imported in China," but the polymer itself is not, declaration is still required.
In China's new regulations for the environmental management of chemical substances, polymers are defined as follows:
- Molecular weight is not a fixed value; it must be distributed within a certain range.
- In a molecule comprising more than 50% (w/w), there are at least three monomers, which are covalently linked to at least one other monomer or other reactant.
- Molecules with the same molecular weight do not exceed 50% (w/w) of all molecules.
The most common method is to use a gel permeation chromatography (GPC) instrument to test the sample to determine whether the sample belongs to the category of polymers.
When searching in the "Inventory of Existing Chemical Substances in China," the first thing to pay attention to is the naming convention of polymers. The Chinese names of polymers follow the "Principles of Nomenclature in Polymer Chemistry (2005 Edition)," while the English names follow IUPAC or CAS rules. The Chinese and English names must correspond. Basically, polymers are named after the starting monomers and reactants, but monomers and reactants accounting for less than 2% (w/w) may be omitted from the polymer name.
Searching for polymers using their names in the "Inventory of Existing Chemical Substances in China" is difficult because the names are often very long and come in different orders. Therefore, if a CAS number is available, searching using that number will be easier; if no CAS number is available, you can try contacting the Chemical Registration Center.
Classification of New Chemical Applications
There are three categories: simplified declaration under special circumstances, simplified declaration under general circumstances, and regular declaration.
The relevant regulations are detailed in the table below:
|
condition
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Application content
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Simplified declaration (special circumstances)
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One or more monomers in the imported polymer are new chemical substances, and this monomer is less than or equal to 2% (w/w). (The polymer itself is not in the List.)
The polymer itself is a polymer of low concern (PLC)*. (The polymer itself is not in the List.)
All monomers are in the List. (The polymer itself is not in the List.)
|
Monomer list, including monomer name, CAS number, monomer content, and monomer inclusion in the catalog.
Molecular weight distribution diagram, including colloidal permeation chromatography (GPC) chromatograms or other results representing the polymer's molecular weight and its distribution.
Polymerization reaction mechanism, including a graphical description of the monomers, process, conditions, and mechanism of the polymerization reaction.
|
Simplified declaration (general situation)
| Polymers that do not meet the requirements for "simplified declaration under special circumstances"
Production or import of less than 1 ton per year
| Polymer composition information, including GPC spectra.
Existing physicochemical property information.
Depending on the specific substance, reports on acute toxicity tests for aquatic organisms, median lethal concentration (LD50), and acute toxicity tests for terrestrial organisms may be required.
These tests must be conducted by a local Chinese laboratory authorized by the Ministry of Environmental Protection of China. |
Regular declaration
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For other polymers, if they do not meet the simplified declaration requirements, regular declarations must be made according to different production/import tonnage.
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According to the usual declaration regulations, depending on the tonnage, you may need to submit documents such as a risk assessment report, physicochemical property report, toxicological and ecological report, and ecotoxicological characteristic test report.
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*Note: The definition of low-interest polymer (PLC) is as follows:
- The average molecular weight of the polymer is between 1,000 and 10,000 Da, the content of oligomers with a molecular weight of less than 500 Da is less than 10%, and the content of oligomers with a molecular weight of less than 1,000 Da is less than 25%, but it does not contain high-interest or highly reactive groups.
- The content of oligomers with an average molecular weight greater than or equal to 10,000 Da and a molecular weight less than 500 Da is less than 2%, and the content of oligomers with a molecular weight less than 1,000 Da is less than 5%.
- It belongs to polyester polymers.
Source: Intertek (2011-10-04)
