Earlier in 2026, Health Canada has sent out an update on the Carbomer ingredient to align with the US Food and Drug Agency’s alerts about benzene risk.
The US FDA published in 2025 an alert reminding industry that benzene should not be used as it is a Class 1 solvent which has an unacceptable toxicity to consumers. All products should meet a benzene level of 2 ppm. Alongside this alert, the US Pharmacopeia has plans to omit specific Carbomer monographs that include unacceptable levels of benzene.
Carbomers (used as thickening agents in gels, creams, hand sanitizers, and some topical drug products) were identified as a potential indirect source of benzene contamination because some manufacturing processes historically used benzene as a solvent or could introduce trace contamination.
To align with international standards such as the ICH Q3C, the NNHPD has updated some ingredient listings to minimize risk from benzene contamination.
The following are the key changes that they made:
- Ingredients Removed: Carbomer 934, 934P, 940, 941, and 1342 (as these may be manufactured using benzene).
- Generic Entry Removed: The generic “carbomer” entry is not enough, and specific viscosity grades must be identified.
Health Canada has provided an August 2026 deadline to remove the carbomers from product license formulations. The reformulation deadline for products containing carbomers of concern is August 1, 2026, meaning any products manufactured with the carbomers of concern before this date can still be sold until all stock is depleted.
However, certain changes will need to be made for any products that currently have carbomer as ingredients. Updating the ingredient “carbomer” to the correct type will be required, and the ingredient must have test results showing they are well below 2 ppm which is the limit for benzene. This also has further effects to industry members as labels must be updated to list the revised carbomer name.
If you have any products containing carbomers or intend to import any formulations with this listed as an ingredient, we here at Dell Tech perform formulation and label reviews. Our Product Safety team will be able to lend support for any cosmetics, Natural Health Products, or drug products that need to be updated before this deadline.
Blog Author
Matthew Lai, H.BSc.
Matthew Lai is a Regulatory Affairs Specialist with expertise in natural health products, GMP requirements, and Health Canada site licensing. With experience in regulatory affairs and quality assurance, he supports clients in achieving compliance and ensuring product safety in the Canadian market.
