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NM-Carbomer 10G, 974P ,934P: the current regulatory requirements of toothpaste

2024-02-03 19:57:46

The State Administration for Market Regulation promulgated the Measures for the Supervision and Administration of Toothpaste on March 16, 2023, which came into effect on December 1, 2023, in order to regulate the production and operation activities of toothpaste, strengthen the supervision and administration of toothpaste, ensure the quality and safety of toothpaste, safeguard the health of consumers, and promote the healthy development of the toothpaste industry. 

It stipulates that before the record of toothpaste, the record holder shall carry out safety assessment by himself or entrust professional institutions, and there are mandatory ability requirements for the personnel engaged in safety assessment. At the same time, it is emphasized that the toothpaste record holder shall be responsible for the safety of the toothpaste raw materials used by him/her and shall clarify the source of raw materials and the relevant information of raw materials safety through the record information service platform. For the record of imported toothpaste, the free sales certificate and the quality management standard certificate of overseas production enterprise or other relevant certification materials shall be submitted.

The requirements for raw materials, especially new raw materials, have also been clearly stipulated. 

New raw materials for toothpaste shall comply with the relevant provisions on the administration of new raw materials for cosmetics. New raw materials for toothpaste with anticorrosion and coloring functions shall be registered with the State Medical Products Administration before use, and other new raw materials for toothpaste shall be subject to record management. The safety monitoring system shall be implemented for the new toothpaste raw materials that have obtained registration and completed the filing. The safety monitoring period shall be three years. The new toothpaste raw materials that have not experienced safety problems after the safety monitoring period shall be included in the list of toothpaste raw materials in use formulated by the National Medical Products Administration. Currently, the list of Used raw materials for toothpaste has not been published. 

As the toping leading manufacturer of carbomers, NM-Carbomer as excipients have been used extensively in oral care applications for toothpastes, denture care products, mouth rinses, and whitening products.

NM-Carbomers as excipient in pharmaceutical fields are approved by CENTER FOR DRUG EVALUATION of National Medical Products, among which.

1)    Carbomer homopolymer TYPE A mainly includes NM- Carbomer 971P, 981G, 71G, 941G.

2)     Carbomer homopolymer TYPE B mainly includes NM- carbomer 934P, 974P.

3)    Carbomer homopolymer TYPE C mainly includes NM- carbomer 980G, 940G.

4)    Carbomer Copolymer: carbomer copolymer type A such as NM-Carbomer TR-2 P, and Carbomer copolymer type B such as NM-Carbomer TR-1P, and 1342G, and carbomer Copolymer Type C.

5)  Carbomer interpolymer: Carbomer interpolymer Type A, such as NM-Carbomer 10G, Carbomer interpolymer type B such as carbomer 2020 G. 

Initially used in aqueous toothpaste formulations as a thickener and co-binder.

NM-Carbomer products are now preferred thickeners for anhydrous toothpaste formulations such as NM-Carbomer 974P , carbomer 956.They are also used in a variety of other toothpastes, mouth rinses, and denture adhesive products, including those with natural ingredients, whitening capabilities, and long acting or retention properties.

They primarily function as efficient thickeners and binders and provide suspension of non-soluble actives or excipients. The viscoelastic structure of NM-Carbomer product imparts shear-thinning rheology and low thixotropy which enables a clean ribbon of toothpaste to be extruded from the tube.



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