Introduction to the management of registration of new chemical substances - exempted category substances
China New Chemical Substance Registration
2022-04-13

Exemption categories of the Registration Scheme for Environmental Management of New Chemical Substances:

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Chemical substances or products that meet the following requirements are exempted from registration for environmental management of new chemical substances



▌Naturally occurring substances



1. processed or treated by physical means such as unprocessed or only by hand, machinery, gravity, dissolution in water, flotation in water, heating and dehydration


2. extracted from the air in various ways


3. without chemical processing treatment of natural polymers;


4. without chemical processing treatment to change the chemical structure of living substances, such as RNA, DNA, proteins and other biological macromolecules. →Click to inquire about registration of new chemical substances



▌Categories for non-commercial purposes or unintended production


1. impurities, i.e. chemical substances that do not contribute to the function of the product, may come from raw materials or from side reactions or incomplete reactions in the production process, are not desired but are present in the final product, and the single content does not exceed 10% and the total amount does not exceed 20% (weight percentage);

2. chemical products, specifically:

(1) Chemical substances that react with other substances in incidental contact, or with environmental factors (such as air, water vapor, microorganisms, or sunlight, etc.) to generate chemical products; → Click to consult the registration of new chemical substances


(2) Chemical substances, mixtures, or articles that react incidentally during storage as chemical products;


(3) Chemical products generated by non-designed reactions of chemical substances, mixtures or articles at the time of end use;


(3) Waste water, exhaust gas, solid waste and by-products from the reaction process.



▌Other special categories


1. Material category

Glass category, glass material category, ceramic raw materials and ceramic ware, steel and its products, cement products (such as high alumina cement, Portland cement, etc.), etc.


2. Alloys

Two or more metals or one metal mixed with other non-metals to form homogeneous and heterogeneous solids or liquids. Intermetallic compounds, metal intercalation compounds with precise definition are excluded.


3. Non-separated intermediates

Intermediates are chemical substances that come out of the previous chemical reaction in the whole chemical reaction process and are consumed in the next chemical reaction process for the production of other chemical substances or products. Intermediates should not appear in the chemical substances or products produced, unless as impurities.


Non-separated intermediates are intermediates that do not leave the reaction vessel or reaction device, and also include the case where the reaction is put into the container for temporary storage and used for the next chemical reaction in the same plant.


Non-separated intermediates other than intermediates apply to the Measures.



4. Items

Items should meet the following three requirements at the same time:


(1) formed when manufacturing a specific shape or style;


(2) have the function and purpose of the end use, these functions and purposes depend in whole or in part on the shape or style it has;


(3) No chemical changes occur at the time of end use, or only chemical changes other than those of commercial value of the article.


(4) For example, fibers, films, leathers, yarns, etc. are articles.


Articles that are intentionally released new chemical substances during regular use under the following circumstances shall be registered as new chemical substances in articles in accordance with the Measures:


(1) The new chemical substance contained is released from the article is necessary to achieve the function of the article, i.e., it is intentionally released by human design, and the shape of the article is only equivalent to the container of the new chemical substance, such as pens, ink cartridges, fire extinguishers, etc;


(2) In the process of use, the new chemical substance contained will be released, i.e., the process is necessary to achieve the function of the article, and it is artificially designed and intentionally released, such as erasers containing fragrance, etc.



5) Chemical substances that are not themselves artificially produced, imported or sold, but are produced by chemical reactions in the realization of their specific functions in products or preparations with specific functions.


For example, surface treatment agents, chelating agents, flocculants, adhesion promoters, and other new chemical substances produced in accordance with the expected realization of specific functions, do not need to be registered.



6. A mixture of existing chemical substances that are artificially mixed and do not generate new chemical substances.



7. When chemical substances in anhydrous form are listed in the List or have been registered, their hydrates are considered to be managed equally, and vice versa.


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