CEPA's New CMR Substances Notice: Ingredient Checks Cosmetic, Biocide and Formulation Teams Should Make Before 2 December

On 3 October 2026, the Minister of the Environment and the Minister of Health published a notice in the Canada Gazette, Part I, confirming that they have started to develop new regulations under the Canadian Environmental Protection Act, 1999 (CEPA). The regulations will set out the criteria used to decide whether a substance is carcinogenic, mutagenic or toxic for reproduction. Those three properties are known together as CMR. A public comment period runs from 3 October to 2 December 2026.

For companies that formulate cosmetics, disinfectants and other biocides, natural health products, food packaging, and consumer chemical products, this notice is an early warning, not a new rule. The criteria themselves are still being written. The direction, however, is clear. Substances that meet CMR criteria are heading toward the highest risk track under the modernized Act, and that track carries the strongest controls CEPA can impose. The time to understand your ingredient exposure is now, while the criteria can still be shaped by the comments you file.

Executive summary

The CEPA CMR notice begins the process of defining, in regulation, what makes a substance carcinogenic, mutagenic or toxic for reproduction. Those criteria will feed Canada's highest risk classification for toxic substances. Formulators and importers should map their ingredients, track the consultation, and file written comments before 2 December 2026.

• What it is: a Gazette notice starting the development of CMR criteria regulations under section 67 of CEPA.
• Why it matters: the criteria will help decide which substances are classified as posing the highest risk, and therefore face the strongest controls.
• Who should act: cosmetic, biocide, natural health product, food contact and consumer chemical formulators, plus importers who rely on a supplier's formulation.
• The deadline: written comments are due by 2 December 2026.

What the CEPA CMR notice actually says

The notice confirms that the two Ministers are developing regulations under section 67 of CEPA. The regulations will set the criteria for carcinogenicity, mutagenicity and reproductive toxicity. They are being made for the purpose of subsection 77(3) of the Act, which deals with substances that pose the highest risk. The notice opens a 60 day comment window and asks that submissions cite CMR under CEPA.

The notice appears in Canada Gazette, Part I, Volume 160, Number 40. It is a consultation document, not a draft regulation, so it does not list the exact test thresholds or which substances would be captured. You can read the Government Notices in the 3 October 2026 Canada Gazette, Part I to see the Ministers' wording in full. Comments filed now shape the criteria before the proposed regulation is published for a second, formal consultation.

What are CMR substances?

CMR stands for carcinogenic, mutagenic and toxic for reproduction. A carcinogen can cause or increase the risk of cancer. A mutagen can cause heritable changes to genetic material. A reproductive toxicant can harm fertility or the development of a child before or after birth. These are among the most serious human health hazards a chemical can carry, which is why regulators worldwide treat them as a distinct, high-priority group.

CMR properties are already recognized in other frameworks. The United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and the European Union's CLP Regulation each have formal CMR categories, and agencies such as the International Agency for Research on Cancer publish carcinogenicity classifications. Canada's notice is about building a made-in-Canada set of criteria that fit the modernized CEPA. The practical point for formulators is simple. If an ingredient already carries a CMR classification elsewhere, it is a strong candidate to be captured once Canadian criteria exist.

Why the modernized CEPA raises the stakes

CEPA was modernized in 2023 by the Strengthening Environmental Protection for a Healthier Canada Act, often called Bill S-5. That reform restructured Schedule 1, the list of toxic substances, into two parts. Part 1 is reserved for substances that pose the highest risk, and Part 2 holds other toxic substances. Substances in Part 1 face the strongest controls the Act allows, with an emphasis on prohibition and virtual elimination. You can review the Canadian Environmental Protection Act, 1999 on the Justice Laws website to see the structure for yourself.

This is where the CMR criteria matter. Section 67 of CEPA now lets the Ministers make regulations that classify a substance as one that poses the highest risk, for the purpose of subsection 77(3). CMR properties are a core part of that highest-risk test. Once the criteria are set, a substance that meets them can be prioritized for assessment, added to Part 1 of Schedule 1, and then controlled. Environment and Climate Change Canada already signals which substances are in its sights through the CEPA Plan of Priorities, so the shift from criteria to action can move faster than many formulators expect.

Which sectors and products are in scope

CEPA governs substances, not products, so its reach crosses almost every regulated category MFLRC supports. If your formula contains an ingredient that could be captured by CMR criteria, the downstream product rules you already follow, whether for cosmetics, biocides or natural health products, will sit on top of a new chemicals-management layer. The table below shows where CMR exposure usually shows up and the first action for each sector.

Cosmetic teams should read the CEPA notice alongside Health Canada's 2026 Cosmetic Ingredient Hotlist changes, because an ingredient flagged as CMR under CEPA may also face Hotlist action. Biocide teams who are already adjusting to Canada's biocide labelling rules should treat CMR screening as the next step in the same workstream. Exporters balancing Canadian and United States rules can line this up with MoCRA registration and listing for cosmetic exporters, so one ingredient review serves several markets at once.

What the criteria could mean for your ingredients

Criteria on their own do not restrict anything. They are the yardstick. Once the yardstick exists, the government can measure specific substances against it, prioritize the ones that meet it, and move them through assessment toward control. For a formulator, the risk is not that a product is banned next month. The risk is that an ingredient you depend on becomes a candidate for prohibition two or three years from now, and you learn about it only when the proposed order is published.

Reformulation is slow and expensive. Finding a replacement ingredient, confirming it performs, running stability work, and updating specifications and labels can take a year or more. Companies that run disciplined change control, as they already do for biocides transition applications and for cosmetics GMP under ISO 22716, are best placed to absorb a CMR restriction without a supply interruption. The ones who wait until the order is final are the ones who scramble.

What to do before 2 December 2026

You do not need the final criteria to start. The best comment you can file is grounded in your own ingredient data, and the work you do to prepare that comment doubles as your reformulation early-warning system. Here is a practical sequence.

• Step 1. Build a complete ingredient inventory. List every substance in every formula, with its CAS number, function and supplier. Include excipients, solvents and processing aids, not just actives.
• Step 2. Screen each substance against existing CMR classifications, such as the EU CLP list, IARC carcinogen groups and authoritative safety data. Flag anything with a current or proposed CMR classification.
• Step 3. Rank your flagged substances by how central they are to the product and how hard they would be to replace. This becomes your reformulation watch list.
• Step 4. Ask suppliers for data. Where a substance is proprietary or poorly characterized, request composition and hazard information in writing, and record any gaps.
• Step 5. Prepare and file a comment by 2 December 2026. Explain how the proposed approach would affect your products, where data is uncertain, and what transition time industry would need. Cite CMR under CEPA as the notice directs.
• Step 6. Keep watching. Track the Plan of Priorities and future Gazette postings so a proposed restriction never arrives as a surprise.

CEPA CMR compliance checklist

Use this checklist to brief your quality and regulatory teams and to confirm you are ready for both the comment deadline and the longer transition that will follow.

• A master ingredient inventory exists, with CAS numbers, functions and suppliers.
• Each ingredient has been screened against current and proposed CMR classifications.
• High-concern ingredients are ranked on a reformulation watch list.
• Supplier data requests are documented, with gaps recorded.
• A written comment is drafted and submitted before 2 December 2026, citing CMR under CEPA.
• Change-control procedures can handle a substance substitution, including stability and label updates.
• A named owner tracks the CEPA Plan of Priorities and future Gazette postings.
• Downstream product obligations, such as the Cosmetic Ingredient Hotlist or biocide rules, are cross-referenced to the same ingredient list.

Common mistakes to avoid

• Treating the notice as finished law. It is a consultation. The window to influence the criteria closes on 2 December 2026, and it will not reopen at this stage.
• Screening only the active ingredient. CMR concern often sits in a solvent, preservative or plasticiser that nobody thinks of as the star of the formula.
• Assuming a Canadian product is safe because it is sold here. CEPA applies to the substance regardless of which product framework the finished good falls under.
• Relying on a single market's classification. A substance not yet classified in one jurisdiction may already be a CMR in another, which is a signal, not an all-clear.
• Leaving suppliers out of the loop. If you cannot get composition data now, you will not be able to reformulate quickly later.

Frequently asked questions

What does CMR stand for under CEPA?

CMR stands for carcinogenic, mutagenic and toxic for reproduction. The 3 October 2026 notice begins developing the criteria that Canada will use to decide whether a substance has one or more of these properties, under section 67 of CEPA.

Is anything banned by this notice?

No. The notice sets no restrictions. It starts the development of criteria. Restrictions, if any, would come later through separate proposals that classify specific substances and, where warranted, add them to Schedule 1 of CEPA.

When is the comment deadline?

The public comment period runs from 3 October to 2 December 2026, a 60 day window. Submissions should cite CMR under CEPA as set out in the Gazette notice.

Does this apply to cosmetics and natural health products?

Yes, indirectly. CEPA regulates substances rather than product categories, so any ingredient in a cosmetic, natural health product, biocide or food contact material could be affected if it meets the CMR criteria. The product-specific rules you already follow would then apply on top of the CEPA controls.

How are CMR substances controlled once identified?

Under the modernized CEPA, a substance that meets the highest-risk criteria can be placed in Part 1 of Schedule 1, which carries the strongest controls, including prohibition and an emphasis on virtual elimination. Lower-risk toxic substances are managed under Part 2.

What should a small formulator do first?

Build an ingredient inventory with CAS numbers and screen it against existing CMR classifications. That single step tells you where your exposure is, gives you the facts to file a useful comment, and starts your reformulation watch list.

How MFLRC can help

MFLRC helps regulated businesses turn a notice like this into a plan. We run ingredient-risk screening across your formulas, build the inventory and CMR watch list, and prepare evidence-backed comments that reflect your operational reality. Our regulatory affairs, licensing and import and export support connects the CEPA layer to your product obligations, and our cosmetics and personal care regulatory support keeps formulation, labelling and claims aligned as the rules evolve. We also support gap assessments, SOP development, supplier qualification and reformulation change control.

If you are not sure which of your ingredients could be caught by CMR criteria, that is exactly the question to answer before the comment window closes.

Conclusion

The CEPA CMR notice is a quiet document with a long shadow. It does not restrict a single ingredient today, yet it sets the measuring stick that will decide which substances face Canada's strongest chemical controls in the years ahead. Formulators who map their ingredients, screen them against known CMR classifications and file a thoughtful comment before 2 December 2026 give themselves two advantages at once: a voice in the criteria, and an early warning for the reformulation that may follow. The companies that treat this as a scheduling problem now will avoid treating it as a crisis later.

Sources and references

• Canada Gazette, Part I, Volume 160, Number 40, Government Notices, 3 October 2026
• Canadian Environmental Protection Act, 1999 (S.C. 1999, c. 33), Justice Laws Website
• Environment and Climate Change Canada, CEPA Plan of Priorities (priority substances)
• Health Canada, Cosmetic Ingredient Hotlist of prohibited and restricted ingredients