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Only 8 days left until USP regulations come into effect: Omitting carbomer 940, 941 etc. with benzene solvent

Source:本站 Author:Lily Release:2025/7/23 Modify:2025/7/23

Affiliation:Company News Hots:218

Carbomer is a cross-linked acrylic (ester) polymer, which is extensively applied as a rheological modifier in the pharmaceutical, personal care products, and other industrial fields. However, some traditional carbomer products such as 940, 941, 1342 , etc. used benzene as solvent during their production, resulting in residual benzene content that could be as high as 5000 ppm, far exceeding the 2 ppm safety limit stipulated by ICH Q3C and USP <467>. Since 2020, the US Food and Drug Administration (FDA) has evaluated the safety of carbomer, and ultimately the US Pharmacopeia (USP) decided to officially omit  five type carbomer 940,941,1342, 934, 934P with benzene content greater than 2 ppm from the monograph on August 1, 2025.

Earlier than the US Pharmacopeia (USP), the Chinese Pharmacopeia stipulated in the 2020 edition that the safety limit of benzene in carbomer is 2 ppm. And on August 28, 2023, the National Medical Products Administration's notice: a management limit of 2mg/kg for the prohibited component benzene in cosmetics was added (2mg/kg), and "if benzene as an impurity is inevitably introduced into cosmetics due to technical reasons, its limit should not exceed 2mg/kg" was included in Chapter 2 of the "Cosmetics Safety Technical Specifications (2015 Edition)" and came into effect from the date of release.

In the 1950s, traditional carbomer 940, 941, 1342, 996, 676 had harmful impurities remaining during the synthesis process due to the use of benzene solvents. Benzene, as a known carcinogen, even a very small residual amount may pose a potential threat to human health during long-term use. Especially in fields such as personal care and medicine where there is close contact with the human body, this risk cannot be ignored.

Anhui Newman Fine Chemicals Co., Ltd., are the top leading manufacturer of carbomer and acrylates copolymer. With its profound technological accumulation and unwavering pursuit of quality, it has launched the "Toxicology Preferred" carbomer product series, providing safer and more efficient option for customers.

We have not only launched "benzene-free" carbomer products using cosolvents instead of benzene solvents, such as Newman Carbomer 970, 20, 21, 990, 981, 1382, 934, 10, 30, etc., which do not use benzene as the solvent system. At the same time, we have already ensured that the content of the risk impurity benzene in carbomer not only meets industry standards, but also meets the requirements of major pharmacopoeias of no more than 2mg/kg, such as our pharmaceutical-grade and oral care-grade carbomer 934P, 974P and 971P, 71G and 10G, etc.The concern about "benzene content" among everyone ultimately stems from considerations of safety and health. Of course, the safety of raw materials is the prerequisite for the safety of cosmetic products. Regarding the control of the risk substance benzene in carbomer, we have conducted inspections and checks at every stage, from the raw materials used in production, the production process, to packaging, to ensure that the impurity benzene content in Newman Carbomer not only meets industry standards, but also complies with the requirements of Chinese Pharmacopoeia (chP.), United States Pharmacopeia (USP/NF), European Pharmacopoeia (Ph.Eur.), British Pharmacopoeia (BP), Indian Pharmacopoeia (IP), Japanese Pharmacopoeia (JPE), and relevant regulations.

Carbomer/Carbopol 934P/941/974P/990, , pemulen tr-1, Pemulen EZ-4U ,Carbomer/Carbopol Aqua SF-1/30,Acrylates/ Steareth-20 Methacrylate Copolymer ,benzene free carbomer 940/340,

For sensitive skin, we have specially launched new products with unique features: Acrylates/C10-30 Alkyl Acrylate Cross polymer ,Polymer emulsifier NM-Carbomer TR series products, Such as NM-Carbomer TR-1, TR-2 and TR-3,This product is a polymer emulsifier without PEG/-EO chains, featuring multiple functions such as thickening, suspending, and emulsifying. It is free of preservatives and is suitable for sensitive skin with stable emulsification. It is free of preservatives and is suitable for sensitive skin with gentle emulsification stability. It is a versatile, non-ethoxylated polymer designed to create stable and mild oil-in-water emulsions at low use levels. It is a great choice for use in many skin care formulations.

At the same time, the liquid carbomer NM-Carbomer SF-1, NM-Carbomer Aqua10,Aqua 30,and NM-Carbomer Aqua 20 with INCI name Acrylates/ Steareth-20 Methacrylate Copolymer are also introduced, which are easy to use liquid forms and have good synergic thickening effect with surfactants, micelles and hydrophobic raw materials due to special chemical structure. Excellent salt resistance. We also specially launched the NM-Carbomer Aqua 25, INCI name: Acrylates/ Steareth-20 Methacrylate Crosspolymer, NM-Carbomer Aqua 25 is an anionic hydrophobically modified alkali-soluble acrylic polymer emulsion (HASE) with unusually high aqueous thickening and stabilizing efficiency. This thickener is a liquid, cold-processable product that instantaneously thickens upon neutralization providing ease of handling and increased manufacturing efficiency. NM-Carbomer Aqua 25 specifically imparts efficient thickening properties for amino acid surfactant systems, and has excellent clarity gels , which can be extensively applied for formulations containing high levels of surfactant.

Our heath care and Oral care grade carbomer are focused on, such as NM-Carbomer 934P as a thickener and co-binder for Aqueous toothpaste formulations s NM-Carbomer 974P are now preferred thickeners for anhydrous toothpaste formulations. NM-Carbomer 971P for mouth rinses.

Anhui Newman has continuously obtained the certifications of IS09001 quality system, IS014001 environmental system and IS045001 occupational health and safety system since 2015. Moreover, in January 2023, it successfully passed the assessment and evaluation conducted by the global social responsibility assessment company EcoVadis. It actively complies with the SA8000 social responsibility standards, reduces pollution emissions, makes rational use of resources, ensures continuous environmental compliance, and continuously improves the company's social responsibility management system. It effectively fulfills social responsibilities, strengthens communication and exchanges with partners and other stakeholders, thereby promoting the company to better fulfill its social responsibilities and support social welfare causes, achieving harmonious development of itself, society and the environment.

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