The Natural and Non-prescription Health Products Directorate (NNHPD) circulated emails to NPN product licence and DIN owners regarding the risks of benzene in carbomers of concern based on information in their possession. If you did not receive this notification and you have any of the carbomers detailed below in your formulations or are planned for any of your future formulations, reach out to Cosmetics Alliance (regulatory@cosmeticsalliance.ca) to receive the details.
- Ingredients Removed: Carbomer 934, 934P, 940, 941, and 1342 (as these may be manufactured using benzene).
- Generic Entry Removed: The generic “carbomer” entry is now insufficient; specific viscosity grades must be identified.
- Regulatory Alignment: The USP and NF have proposed omitting these specific carbomer monographs effective August 1, 2026.
The NNHPD contacted approximately 865 NHP licence holders and 70 non-prescription drug licence holders to request the removal of these carbomers from formulations by an August 2026 deadline. Here is the summary of the Carbomer changes in the NHPID.
As part of “their ongoing commitment to openness and transparency”, the NNHPD notified these licensees that several ingredient entries in the Natural Health Products Ingredients Database (NHPID) have been recently removed or revised. These revisions follow the United States Food and Drug Administration’s alert on the risk of benzene contamination in certain drugs. Benzene is a Class I solvent and should not be used in the manufacture of health products due to its unacceptable toxicity and deleterious environmental effects. Based on this information, several modifications were made to the carbomer entries in the NHPID as certain carbomers may be manufactured with the use of benzene. Specifically, the ingredient entries for Carbomer 934, 934P, 940, 941, and 1342 were removed. In addition to the removal of the five carbomers, the generic ‘carbomer’ entry was also removed, as the term ‘carbomer’ is insufficient to identify the specific viscosity grade used as an NMI.
Revisions to omit the Carbomer 934, Carbomer 934P, Carbomer 940, Carbomer 941, and Carbomer 1342 monographs (the documentary standards for carbomers manufactured with the use of benzene) from the United States Pharmacopeia (USP) and the National Formulary (NF) are proposed for August 1, 2026.
We would like to remind you of the following details regarding NHP & DIN labelling:
- Non-Prescription Drug Action Plan Solution 6 – Application of INCI® names on NHP labelling from April 2024 and
- Labelling of Natural Health Products Guidance Document (specifically Table 6, section 6.
