Details of the registration of new chemical substances of polymers

Release time:

2021-03-19 09:53

In accordance with the "New Chemical Substances Environmental Management Registration Measures" and "New Chemical Substances Environmental Management Registration Guidelines" requirements, polymers as a special type of polymer substances, because of their own may cause less harm, registration conditions and general substances Different, and in most cases there are different degrees of data relief.

Starting today, we will launch a detailed series of polymer registration, which will analyze the requirements and process of polymer registration. In this issue, we focus on the basic concepts of polymers, registration strategies, resolution of polymer filing situations, and exclusion conditions.

Definition of polymer:

Polymer refers to a substance molecule composed of one or more monomer units in sequence, the molecular weight distribution of such molecules is within a certain range, and the difference in molecular weight mainly depends on the difference in the number of monomer units. The polymer shall meet the following three conditions simultaneously:

(1) The molecular weight is not a fixed value, but a dispersed distribution;

(2) More than 50% (weight percentage) of the molecule contains at least 3 monomer units, which are linked to at least one other monomer unit or other reactant in the form of a covalent bond;

(3) Molecules with the same molecular weight do not exceed 50% (weight percentage) of all molecules.

At the same time, substances that meet the above three conditions can be registered as new chemical substances according to the requirements of polymers. According to the nature of the polymer, the types of registration that may be involved are filing, simple registration and regular registration, the three types of registration data requirements gradually increase, we can gradually determine according to the registration strategy, select the appropriate registration type.

Polymer Registration Policy:

Polymer Filing Situation

The annual production or import of new 1. chemical substances is less than 1 ton;

2. new chemical monomer or reactant content of not more than 2% of the polymer or is a low concern polymer.

For the filing of the first case, only the annual production or import volume is less than 1 ton, and the filing data requirements are the same as those of general substances.

The second case of the record only for the polymer, the polymer in addition to the need to meet one of the two polymer conditions, at the same time need not belong to the record exclusion situation, the record does not limit the annual production or import.

Polymer filing information requirements:

Preparation Case Capital Material	New Chemical Substance Filing Form
	1 legal person certificate or business license, agency contract or agreement (with agent), power of attorney (with authorization)
	Certificate of compliance with polymer filing *: a List of monomers/reactants B Molecular weight distribution c polymerization reaction mechanism process D the application substance does not belong to the discrimination and explanation materials for the exclusion of polymer filing.
	Additional information on the characteristics of environmental and health hazards and environmental risks

* According to the first filing situation for filing, no need to provide relevant supporting materials.

Polymers that meet the second filing scenario:

Type	Definition
2% polymer	(1) The polymer itself is not in the List, but the weight percentage of all new chemical monomers/reactants of the polymer is less than or equal to 2%.
2% polymer	(2) The polymer itself is not in the List, but all monomers/reactants of the polymer are in the List.
Low Concern Polymer	(1) The number average molecular weight of the polymer is between 1,000 and 10,000. The content of oligomers having a molecular weight of less than 500 is less than 10%, and the content of oligomers having a molecular weight of less than 1,000 is less than 25%. At the same time, it must not contain high-interest or high-reactive functional groups, such as heavy metals, cyano (except non-conjugated), acrylate, aziridine, isocyanate (except blocked isocyanate), thioisocyanate, vinyl sulfone, alkoxysilane (alkyl is methyl or ethyl), amine, spiroenamine, halosilane, hydrazine, α/β lactone, methacrylate, etc.
	(2) The number average molecular weight of the polymer is 10,000 or more. The content of oligomers having a molecular weight of less than 500 is less than 2%, and the content of oligomers having a molecular weight of less than 1,000 is less than 5%.
	(3) Polyester polymer: The main chain is a polymer in which monomers are bonded by ester bonds or a polymer in which the main chain exhibits the characteristics of ester bonds.

Polymer Exclusion:

1	Cationic polymers (e. g., polymers containing covalent bonds with phosphonium ions, sulfonium ions, ammonium ions), or which are expected to be cationic polymers in natural water environments (amine-containing, isocyanate-containing polymers).
2	Degraded or unstable polymers include polymers that are susceptible to degradation, decomposition, depolymerization, and polymers that decompose after production or use.
3	Water-absorbing polymers having a number average molecular weight of 10,000 Dalton or more * *.
4	Fluoropolymers containing perfluoroalkyl sulfonic acid groups, perfluoroalkyl carboxylic acid groups or fluorine telomer structural fragments in the structure; Fluoropolymers containing perfluoroalkyl moieties covalently bonded to carbon or sulfur atoms in the polymer molecule.
5	Containing, in addition to impurities, elements other than the following permitted elements: The polymer component must contain at least two elements of carbon, hydrogen, nitrogen, oxygen, sulfur, or silicon (C,H,N,O,S, or Si). Additional elements: fluorine, chlorine, bromine and iodine (F,Cl,Br and I) covalently bound to carbon, and chloride, bromide and iodide in the form of single ions (Cl- , Br-and I-). Other allowed mono-ionic elements are sodium, magnesium, aluminium, potassium and calcium (Na ,Mg 2 +, Al 3 +, K and Ca 2 +) and less than 0.20 weight percent of lithium, boron, phosphorus, titanium, manganese, iron, nickel, copper, zinc, tin and zirconium (Li,B,P,Ti,Mn,Fe,Ni,Cu,Zn, sn and Zr) and other elements.

* Degradation, decomposition or depolymerization refers to the chemical changes that decompose polymers into simpler and smaller molecular weight substances through oxidation, hydrolysis, heat, light, solvents or microorganisms.

**Water-absorbing polymer means a polymer capable of absorbing its own weight of water, and does not include water-soluble polymers and water-dispersible (including self-dispersible or already-dispersed) polymers.

For the filing of both cases, after the data is submitted, the receipt automatically sent by the system will be received, and the activity can be started without waiting for the approval of the Ministry of Ecology and Environment. For the registration materials that have been filed, the solid management center will conduct random spot checks on compliance at a later stage, and scientific judgment shall be made when filing.

If the polymer cannot be filed, it is necessary to choose simple registration or regular registration according to the amount of activity. We will introduce the relevant requirements for simple and regular registration of polymers in the next issue.

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