Making and scaling balms

What must a cosmetic label carry in Canada?

The Cosmetic Regulations and packaging law applied to a balm: bilingual text, INCI list, metric net quantity, small pack options and the fragrance allergen dates.

A cosmetic sold in Canada needs, in English and French, a contact detail and the product's identity on the container, an INCI ingredient list on the outer label, a metric net quantity on the principal display panel, and the dealer's name and principal place of business. Since 12 April 2026 the list must also name any listed fragrance allergen above 0.001% in a leave-on product or 0.01% in a rinse-off one. Which allergens depends on when the product reached the market, because Canada borrows the European Union's list and its deadlines.

Short answer

Inner label: a phone, email, website or postal contact, and the identity. Outer label: the INCI list, with allergens above 0.001% leave-on. Principal display panel: metric net quantity and identity. All of it bilingual except INCI names. A product first sold from 1 August 2026 declares the full expanded EU allergen list; older products declare the original 24 now and the rest by 1 August 2028.

  • C.R.C., c. 869 as amended by SOR/2024-63
  • Allergens in force 12 April 2026
  • 0.001% leave-on, 0.01% rinse-off
  • English and French, INCI excepted
  • Ingredient list may go on a website
Not legal advice

Trebalm is a reference site, not a law firm, and this page is orientation for a small maker rather than legal advice. It quotes the federal texts on the Justice Laws website and Health Canada's explanation of the 2024 amendment, and does not cover provincial law. Last checked 24 October 2026.

Two laws, one label

A Canadian cosmetic label is built from two federal regimes. The Cosmetic Regulations (C.R.C., c. 869), made under the Food and Drugs Act and run by Health Canada, set the contact detail, the identity on the container, the ingredient list, the fragrance allergens and any warnings. The Consumer Packaging and Labelling Act (CPLA) and its regulations (CPLR) set the net quantity, the dealer's name and place of business, and type sizes. Health Canada's impact statement for the 2024 amendment says so directly: "Cosmetics are subject to the Consumer Packaging and Labelling Act (CPLA) and its regulations", and the amendment does "not change the requirements of the CPLA".

Every label element for an ordinary cosmetic balm sold in Canada, the provision that requires it and where it goes. C.R.C., c. 869 is the Cosmetic Regulations. Consolidated texts as at October 2026.
ElementProvisionWhereLanguage
Contact detail for consumer questionsC.R.C., c. 869, s. 20(a)Inner label (the container itself)Both, where it contains words
Identity (common or generic name, or function)s. 20(b); CPLA s. 10(b)(ii); CPLR s. 12(b)Inner label, unless obvious, and the principal display panelEnglish and French
Ingredient list, INCI namesss. 21.2 to 21.4Outer label, or the only label (s. 19)INCI names exempt
Fragrance allergens above the thresholds. 21.4(4) and (5)Inside the ingredient listINCI names
Net quantity, metricCPLA s. 4; CPLR ss. 14, 21 to 27Principal display panelUnit symbols
Dealer's identity and principal place of businessCPLA s. 10(b)(i); CPLR s. 13Anywhere except the bottomMay be in one language (CPLR s. 6(2))
Directions for safe uses. 24Only where there is an "avoidable hazard"English and French
Batch code, expiry dateNone in either regimeNot requiredNot applicable

The last row surprises makers who learned the European rules first. Print a batch code anyway: it is the only way to trace a complaint to one production run, the argument made in batch records.

Three prohibitions in the same regulations are easy to break with marketing copy. Section 17 bans any reference to the Act or the Regulations unless the reference is itself required, so "complies with Health Canada regulations" is out. Section 12 bans anything implying the product was compounded to a prescription. Section 21 requires evidence for any claim that the product will "influence the chemistry of the skin", or that the user "will not suffer injury". Where a claim stops being cosmetic at all is covered in cosmetic versus drug claims.

Inner label and outer label: which one holds what

An inner label is "on or affixed to the immediate container"; an outer label is on "the outside package". A boxed tube has both. A naked tube or an unboxed tin has one, and section 19 settles it: "If a cosmetic has only one label, that label must contain all the information required by these Regulations to be shown on both the inner and outer labels." Most small makers sell unboxed, so most need everything on the tube or tin.

With a carton, the contact detail and identity stay on the container, which outlives the box, and the ingredient list goes on the outer label (s. 21.2(1)). The net quantity and identity go on the principal display panel of the label "applied to the container in which the product is displayed for sale" (CPLR s. 7(1)), which for a boxed tube is the box.

The contact detail after SOR/2024-63

Section 20(a) was rewritten by SOR/2024-63 and has applied since 9 October 2024, the 180th day after registration on 12 April 2024. The inner label must carry "a telephone number, email address, website address, postal address or any other information that enables communication with a contact person to whom consumers may direct questions about the cosmetic." Health Canada's reason was that product questions "are often received through companies' websites and the postal address is used infrequently", and it notes the contact "may include the foreign manufacturer". The same detail goes on the notification form (s. 30(2)(a)).

The postal address did not disappear

A website satisfies the Cosmetic Regulations, not the packaging law. CPLA s. 10(b)(i) still requires "the identity and principal place of business of the person by or for whom the prepackaged product was manufactured or produced for resale". So a tin reading only "questions: example.ca" meets section 20 and still lacks a name and place of business.

If the product is made wholly outside Canada and the label names the Canadian business it was made for, that name must be preceded by "imported by / importé par" or "imported for / importé pour", unless the label states the geographic origin (CPLR s. 31(2)). "Made in USA" beside a stockist's name, in letters at least as large as the address, meets it.

The ingredient list: INCI names, in one order

Section 21.2(1) requires the list on the outer label "with each ingredient listed only by its INCI name", the name in the Personal Care Products Council's International Cosmetic Ingredient Dictionary and Handbook. Botanicals need "at least the genus and species portions of the INCI name", and an ingredient with no INCI name takes its chemical name. The INCI list builder keeps names consistent across a range.

The schedule to the regulations lists 58 ingredients by EU technical name, INCI name and French equivalent, and section 21.2(4) lets you use the EU name alone, the INCI name with the French, or all three. Beeswax is item 12, so "Cera Alba" alone is acceptable, as is "Beeswax / Cire d'abeille". The schedule also covers tallow, lard, honey, mineral oil, candelilla, carnauba, lanolin wax and water. The EU forms are the shortest, one reason a European list moves to Canada with few edits. The wax itself is covered in beeswax in balms.

Order, and the 1% line

Section 21.4 sets "descending order of predominance, in their concentration by weight", then relaxes it: ingredients "present at a concentration of 1% or less and all colouring agents, regardless of their concentration, may be listed in random order after the ingredients that are present at a concentration of more than 1%." In Canada an ingredient at exactly 1% is in the free part of the list. New Zealand draws the line the other way, as set out in New Zealand cosmetic labelling.

Section 21.4(3) allows "parfum" and "aroma" at the end of the list for fragrance and flavour, but only for ingredients "other than fragrance allergens". The allergens come out of the collective word and are named.

For a 4.25 g lip balm at castor oil 40%, beeswax 25%, shea 20%, jojoba 13.5%, peppermint flavour 1% and tocopherol 0.5%, with no allergen over the line: "Ingredients / Ingrédients : Ricinus Communis (Castor) Seed Oil, Cera Alba, Butyrospermum Parkii (Shea) Butter, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Aroma." If the flavour carried a listed allergen above 0.001% of the balm, that name would join the list. How a buyer reads the result is in reading a balm label.

Fragrance allergens: which list, and which date

This is where the search results get muddled, so here is the text. SOR/2024-63 added three things to section 21.4, and its section 14(2) brought them into force "on the second anniversary of the day on which these Regulations are registered", which is 12 April 2026.

  • The definition. A fragrance allergen is a fragrance or flavour "included in the European Restricted Substances List" that column h of that list requires to be named. That list is Annex III of Regulation (EC) No 1223/2009 "as amended from time to time". Canada prints no list of its own.
  • The thresholds. An allergen must be listed above 0.01% in a rinse-off product and above 0.001% in a leave-on one (s. 21.4(4)). Leave-on means "intended to stay in prolonged contact with the skin, hair or mucous membranes": every balm, salve and lip product. A rinse-off cleansing balm takes the higher figure.
  • The timing. An allergen is not required "before the later of" the day the EU provision adding it comes into force and, where applicable, the day it must be listed "in order for the cosmetic to be made available on the European Union market" (s. 21.4(5)).

Why the search results say "24 now, 80 later"

Subsection (5) is the source of both numbers. The original EU allergens were long past both EU dates by April 2026, so they applied in Canada at once. Health Canada counts them as 24: of the EU's original 26, lilial and lyral are now banned outright in the EU and so "would not be required to be disclosed" in Canada. The expanded list from Regulation (EU) 2023/1545, which Health Canada records as "81 entries in Annex III", carries the EU's transition of "three years (July 31, 2026) for new products placed on the market, and five years (July 31, 2028) for existing products to sell through." Health Canada's impact statement reads that into two stages:

When each obligation applies in Canada, from SOR/2024-63 s. 14 and section 21.4(5) as read in Health Canada's Regulatory Impact Analysis Statement. Status as at 24 October 2026.
DateWhat appliesTo which productsStatus
9 October 2024New contact rule, website option for small packs, notification changesAll cosmeticsIn force
12 April 2026Declare the original 24 EU allergens above the thresholdsAll cosmeticsIn force
1 August 2026Declare the full expanded EU listProducts introduced from this dateIn force
1 August 2028Declare the full expanded EU listProducts on the market before 1 August 2026Not yet

So both figures are true, for different products. A lip balm launched in September 2026 must name every allergen on the expanded list it carries above 0.001%. A balm sold since 2025 must already name any of the original 24, and has until 1 August 2028 for the rest. For a small maker the practical answer is simpler: write every new label to the full list now. A European label already carries it, so one artwork serves both. The substances, and how to read a supplier's allergen statement, are in fragrance allergen labelling and fragrance allergens.

The arithmetic, by use level

The threshold is a share of the finished product, and the allergen arrives inside an oil. The table turns it round: the share of the oil above which a listed constituent must be named.

The share of a fragrance or essential oil above which a listed allergen in it must be declared, by the oil's use level. Calculated here from s. 21.4(4): share = threshold divided by use level.
Oil in the productLeave-on (0.001%)Rinse-off (0.01%)
0.25%0.4% of the oil4% of the oil
0.5%0.2% of the oil2% of the oil
1%0.1% of the oil1% of the oil
2%0.05% of the oil0.5% of the oil
3%0.033% of the oil0.33% of the oil

At 1% in a leave-on balm, any listed constituent above a thousandth of the oil goes on the label, which is why an essential oil balm nearly always declares several names and why the figures must come from the supplier. The essential oil dilution calculator does the multiplication, and essential oils in balms lists the constituents that usually cross the line.

The amendment also changed the notification, which now records leave-on or rinse-off and the allergens. The form and its 10 day deadline after first sale are covered in notification portals; section 15.3 bars any sale after that period if it has not been filed.

English and French: what has to be bilingual

Section 18 requires the information the Cosmetic Regulations demand to "be shown both in English and in French, except for the INCI name", and to be "clearly legible" for the product's useful life. That covers the identity, any directions under section 24, any words around the list such as its heading, and the small pack statement pointing to a website. A phone number or web address is not a phrase in either language.

The packaging regulations have their own bilingual rule (CPLR s. 6(2)), with a "local product" exemption for goods sold only in a local government unit where one official language is the mother tongue of less than 10% of residents (s. 6(3)). It applies to information the packaging law requires. Section 18 of the Cosmetic Regulations has no such exemption, so a maker selling at one local market still prints the identity in both languages: "Lip balm / Baume à lèvres".

Net quantity: metric, by weight, in type of a set height

The CPLA requires a metric net quantity (s. 4(1)), "clearly and prominently displayed" on the principal display panel (s. 4(2)). The regulations fix the form. A product is declared "by weight, when the product is solid" (s. 21), so a set balm takes grams by default, even in a tin sold as 15 ml. Grams apply below 1,000 g (s. 27), to three figures, or two below 100 g (s. 25). Ounces are optional, but if shown they must sit with the metric figure (s. 17), which a US style "Net Wt 0.15 oz (4.25 g)" does.

Type size depends on the principal display surface. For a container whose lid is what shows on the shelf, that is the top of the lid. For one with no particular display side, such as a round tube, it is "any 40 per cent of the total surface area of the container, excluding the top and bottom". Net quantity numerals must be bold and at least 1.6 mm high up to 32 cm2, 3.2 mm from 32 to 258 cm2 (s. 14(2)). Other packaging law text must be at least 1.6 mm (s. 15), or 0.8 mm where the surface is 10 cm2 or less and everything is on the principal display panel (s. 16).

Principal display surface and minimum type heights under CPLR ss. 14 to 16 for common balm containers. Dimensions are typical examples and the areas are calculated here, so measure your own pack.
ContainerDisplay surface basisSurfaceNet quantity numeralsOther CPLA text
Lip tube, 16 by 68 mm40% of the wall13.7 cm21.6 mm bold1.6 mm
Small tin, 35 mm lidTop of the lid9.6 cm21.6 mm bold0.8 mm if all on the lid
15 ml tin, 50 mm lidTop of the lid19.6 cm21.6 mm bold1.6 mm
30 ml tin, 58 mm lidTop of the lid26.4 cm21.6 mm bold1.6 mm
60 ml tin, 68 mm lidTop of the lid36.3 cm23.2 mm bold1.6 mm

Two consequences follow. A standard lip tube gets no small type concession, because 40% of its wall exceeds 10 cm2. And the 1.6 mm floor binds the net quantity, identity and dealer details, not the ingredient list: the Cosmetic Regulations set no type height for the list, only that it be "clearly legible". That legibility test triggers the small pack options below. The container decides most of this before any artwork, as argued in lip balm tube versus tin.

How close the fill has to be

CPLA s. 7(3) treats a declaration as not misleading if the contents are, "subject to the prescribed tolerance, not less than the declared net quantity". Schedule I, Part III sets that tolerance. It is an inspection allowance, not a target.

The prescribed tolerance for common balm fills, from CPLR Schedule I, Part III (9% up to 50 g, 4.5 g from 50 to 100 g, 4.5% from 100 to 200 g). The last column is calculated here.
DeclaredToleranceLowest content inside tolerance
4.25 g lip tube9%, 0.38 g3.87 g
15 g tin9%, 1.35 g13.65 g
50 g tin9%, 4.5 g45.5 g
60 g tin4.5 g55.5 g
120 g jar4.5%, 5.4 g114.6 g

Fill to the declared weight on a scale you trust; what a given scale can reliably weigh is worked out in weighing and calibration.

Small packs: tag, card or website

Section 21.5, widened by SOR/2024-63, applies where the container or package "is too small for the label to comply with paragraph 18(b)", meaning the list cannot be printed legibly. The list may then appear:

  1. On a tag, tape or card affixed to the container or package (s. 21.5(1)(a)).
  2. On a website, "provided that the outer label contains a statement specifying that the list of ingredients appears on that website and includes the location of the website" (s. 21.5(1)(b)). The impact statement says the statement is bilingual.
  3. On a tag, tape or card for an ornamental container with no outside package (s. 21.5(2)).
  4. In a leaflet that must accompany the product at the point of sale, where even a tag is impractical (s. 21.5(3)).

There is no area threshold. Health Canada looked at the US tear-away sheet for packages under 12 square inches (77.4 cm2) and chose legibility instead, and it refused to open the website route to all sizes: "Health Canada is only adding flexibility for disclosure of ingredients on a website when the package size limits the legibility of the labelling information." A 60 ml tin with room for the list cannot send it online.

For a lip tube the website is the cleanest answer to a long allergen list. "Ingredients / Ingrédients : example.ca/ingredients" leaves room for the identity, net quantity and dealer. Health Canada "encourages" access without an account, and another route for buyers without internet. Neither is a legal condition, but both are cheap.

Using a US or EU label in Canada

Canada has no clause accepting foreign labels. An imported product that would break the regulations may come in only if it is relabelled "under the supervision of an inspector", and it may not be sold unless that is done within three months (s. 9). The useful question is what each foreign label lacks.

What a label built for the United States or the European Union usually needs before sale in Canada. Home market rules are summarised from Trebalm's pages for each jurisdiction.
ElementUS labelEU label
FrenchAdd for identity and any directionsAdd, unless already French and English
Contact detail (s. 20)The adverse event website or phone works if it reaches a contact personThe responsible person's address works
Ingredient namesCheck every name is INCI; use "parfum" for undeclared fragranceUsually fine: Cera Alba and Parfum are accepted forms
Fragrance allergensAdd: the US does not require themAlready to the expanded list if placed on the EU market from 31 July 2026
Net quantity"Net Wt 0.15 oz (4.25 g)" meets the metric ruleGrams meet it
Name and place of businessPresent; add "imported by" or the originPresent; same

A US label needs more work than a European one. The US elements, including the adverse event contact that now overlaps with section 20, are in US cosmetic labelling; the European label and its small pack symbol are in EU cosmetic labelling; the British divergence on allergens is in UK cosmetic labelling.

What this page cannot settle

Section 21.1 removes the ingredient list rules for a product "whose ingredient labelling is regulated under the Food and Drug Regulations or the Natural Health Products Regulations", so a balm that becomes a drug or natural health product, by claim or by active, is labelled under rules this page does not cover. Balms built on actives such as camphor or menthol raise that question, discussed in menthol, camphor and actives.

Three judgements stay with you. Whether a label is "clearly legible" on your container is a call no regulation quantifies. Whether your French reads correctly is for a French speaker. And whether a product was "introduced" before 1 August 2026 is Health Canada's reading of an EU rule; if a product was relaunched or reformulated around that date, write the label to the full list and the question disappears. Provincial law, including Quebec's language legislation, is outside this page.

Frequently asked questions

Do cosmetic labels in Canada have to be bilingual?

Yes. Section 18 of the Cosmetic Regulations requires the information they demand to be shown in English and French, except INCI ingredient names, which are not translated. That covers the identity on the container, any directions for use and the words around the ingredient list. The packaging law's local product exemption does not extend to the Cosmetic Regulations, so a balm sold only locally still needs both languages.

Is a website address enough as the contact on a Canadian cosmetic label?

For the Cosmetic Regulations, yes. Since 9 October 2024 section 20(a) accepts a telephone number, email address, website address, postal address or other means of reaching a contact person, on the inner label. The Consumer Packaging and Labelling Act separately requires the dealer's name and principal place of business on the label, so the website does not replace that.

When do fragrance allergens have to be on cosmetic labels in Canada?

Since 12 April 2026, listed allergens above 0.001% in leave-on products and 0.01% in rinse-off products must be named in the ingredient list. Health Canada reads the EU dates into two stages: products introduced from 1 August 2026 declare the full expanded EU list, while products already on the market declared the original 24 from April 2026 and must declare the rest by 1 August 2028.

Why do some sources say Canada requires 24 allergens and others say more than 80?

Both describe the same rule at different dates. The Cosmetic Regulations adopt whatever Annex III of the EU Cosmetics Regulation lists, together with the EU's own transition dates. The original EU list counts as 24 in Canada because lilial and lyral are now banned in the EU. The 2023 EU expansion took Annex III to 81 allergen entries, applying to new products from August 2026 and to all products from August 2028.

Can the ingredient list on a lip balm be on a website in Canada?

Yes, if the container or package is too small to show the list legibly. Section 21.5 then allows the list on a tag, tape or card attached to the pack, or on a website named on the outer label in a statement saying the list is there. The website option does not apply to larger packs that have room for the list.

Does a Canadian cosmetic label need a batch code or expiry date?

No. Neither the Cosmetic Regulations nor the Consumer Packaging and Labelling Regulations require a batch code or a durability date on an ordinary cosmetic. Printing a batch code is still good practice, because without one a complaint or a reformulation cannot be traced to a production run, and EU and New Zealand rules do require one.

Sources and further reading

  1. Government of Canada, Cosmetic Regulations, C.R.C., c. 869, consolidated text current to October 2026, Justice Laws website. Sections 2, 9, 12, 15.3 to 21.5, 24 and 30, and the schedule.
  2. Government of Canada, Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients, SOR/2024-63, Canada Gazette Part II, vol. 158, no. 9, registered 12 April 2024, with the Regulatory Impact Analysis Statement.
  3. Government of Canada, Consumer Packaging and Labelling Act, R.S.C. 1985, c. C-38, Justice Laws website. Sections 2, 4, 7 and 10.
  4. Government of Canada, Consumer Packaging and Labelling Regulations, C.R.C., c. 417, Justice Laws website. Sections 2, 6, 7, 12 to 17, 21 to 27, 31 and Schedule I, Part III.

Reviewed and updated 24 October 2026. Spotted an error? Tell us and we will fix and log it.