Cosmetic ingredient hotlist for Canadian cosmetic compliance

Canada's Cosmetic Ingredient Hotlist is Health Canada's non-exhaustive list of prohibited or restricted substances in cosmetics sold in Canada. Prohibited ingredients should not be present, while restricted ingredients must meet their listed conditions.

Azelaic acid and its salts, for example, have a maximum concentration of 14%. They are not categorically banned. These Canadian requirements concern cosmetics sold in Canada, including products a US manufacturer supplies into that market, so do not apply the Hotlist as if it were a US rule.

What the Health Canada hotlist means

The Hotlist communicates requirements under the Food and Drugs Act and Cosmetic Regulations. It is an administrative tool, not an ingredient approval list. Health Canada can enforce those requirements even when a substance does not appear on the list. Its explanatory page makes that distinction explicit.

An ingredient's absence doesn't establish safety or legal approval. Section 16 of the Food and Drugs Act prohibits selling a cosmetic that has in or on it a substance that may injure the user. That test applies when the product is used according to directions on the label or accompanying the cosmetic, or in the customary way.

A Hotlist addition does not create a statutory grace period. The underlying legal requirements already apply. Health Canada says there is no legislated coming-into-force or transition period when substances are added.

How to read prohibited and restricted entries

Start with the separate prohibited and restricted tables on the cosmetic hotlist. Check the ingredient name and related compounds, then read the full row. A concentration limit alone does not capture product-type conditions or required warnings.

Blank cells have defined meanings. A blank product-type conditions cell means no condition of use is specified and the restriction applies to all cosmetic products. A blank warnings cell means no warning or cautionary statements are specified. Neither removes the general safety requirements. Where the restricted table requires cautionary statements, they must appear on the label in English and French. These instructions accompany the restricted table.

Do not turn the tables into a homemade count of banned ingredients. Read the row for the substance in the formula.

Is azelaic acid banned in Canada?

Azelaic acid is restricted, not categorically banned in Canadian cosmetics. The current entry sets a maximum concentration of 14% for azelaic acid and its salts. The row lists nonanedioic acid, disodium azelate and dipotassium azelate, and CAS numbers 123-99-9, 52457-54-2, 132499-85-5, 17265-13-3 and 27825-99-6. The CAS and synonym columns say "including but not limited to," so those identifiers are examples rather than a closed set. The entry specifies no product-type conditions or entry-specific warnings.

Health Canada's August 2022 changes record explains why it added the restriction: known therapeutic properties and skin-irritation risk above 14%. But that ceiling is not blanket permission for therapeutic claims, or proof that every finished formulation is safe.

For a formulation check, include the salts rather than searching only for "azelaic acid." Read the maximum alongside the entry's scope and the general safety requirements.

What changed most recently?

Health Canada's changes page, dated 14 August 2025, shows August 2025 as its latest final update. That update amended two cannabis-related entries to reflect changes to the Cannabis Exemption (Food and Drugs Act) Regulations and the Industrial Hemp Regulations. It did not introduce the azelaic-acid restriction.

The preceding February 2025 update added retinal to restricted substances and thioglycolic acid esters to prohibited substances, among other revisions. Consult the current operative entries for their conditions rather than using a change summary as a formulation specification.

RegAffairs AI's answer on Canada's Cosmetic Ingredient Hotlist explains the list with source citations.

Keep proposals separate from final changes. Health Canada's update process distinguishes stakeholder notices from formal consultations and final updates. A stakeholder notice is not a formal consultation. Formal consultations have a 60-day comment period.