Q.01

What must cosmetic labels include in Canada?

Under the Cosmetic Regulations (C.R.C., c. 869) and the Consumer Packaging and Labelling Act, a cosmetic sold in Canada needs five things on its label: the product's identity, a net quantity in metric units, the dealer's name and principal place of business, a consumer contact point on the inner label, and an INCI ingredient list on the outer label. All of it must be in English and French and stay legible. Some products also need set warnings: aerosols, hair dyes, genital deodorants, mouthwash, and products containing methyl alcohol, bromates or mercury.

Approach: I read the full Cosmetic Regulations and the cosmetics sections of the Food and Drugs Act (Justice Laws consolidations). The Consumer Packaging and Labelling Act and Regulations aren't in the datasets, so those points come from the official Justice Laws pages and Health Canada's labelling guide, cited as links.

Mandatory elements on every cosmetic

ElementWhere it goesSource
Identity: the common or generic name, or the functionInner label, unless the identity is obvious; principal display panel under CPLR s. 12Cosmetic Regs s. 20(b); CPLR
Consumer contact: a telephone number, email, website, postal address or other way to reach a contact personInner labelCosmetic Regs s. 20(a)
Ingredient listOuter label [1]Cosmetic Regs s. 21.2
Net quantity, in metric units: by volume for liquids, gases or viscous products, by weight for solidsPrincipal display panel, shown clearly and prominentlyCPLA s. 4; CPLR ss. 21 and 27
Dealer identity and principal place of businessAny part of the label except the bottom of the containerCPLA s. 10; CPLR s. 13
  • Single label: if the product has only one label, that label must carry everything required on both the inner and outer labels [2].
  • Language and legibility: required information must be in English and French, except INCI names. It must be clearly legible and stay that way for the product's useful life (or the refillable container's) under normal conditions of sale and use [3]. Under CPLR s. 6(2), the dealer's name and address may appear in only one official language.
  • Selling an unlabelled product: "No person shall sell a cosmetic unless it is labelled in accordance with these Regulations" [4].

Ingredient list rules

  • Naming:
    • Use the INCI name only [1].
    • Use the chemical name if there is no INCI name [5].
    • Botanicals need at least the genus and species parts of the INCI name.
    • Ingredients in the Schedule may instead be listed by their EU technical name, or by INCI name plus French equivalent [1].
  • Order:
    • List in descending order of predominance by weight.
    • Ingredients at 1% or less, and all colouring agents, may follow in any order after the ingredients above 1% [6].
  • Shade ranges: makeup and nail polish sold in a range of shades may list every colourant used in the range after "+/–", "±" or "may contain/peut contenir" [1].
  • Fragrance and flavour: "parfum" and "aroma" may be used at the end of the list.
  • Fragrance allergens must be named individually. These are the allergens in EU Annex III (Regulation (EC) No 1223/2009) whose entry says they must appear in the ingredient list. The thresholds are:
    • more than 0.01% in rinse-off products;
    • more than 0.001% in leave-on products.
  • Fragrance allergen timing: naming is not required before the later of two dates: the date the EU amendment adding that allergen comes into force, and the EU's own deadline for listing it, if one applies [6].
  • Small, ornamental or awkward containers:
    • If the container or package is too small to label legibly, the list may go on an attached tag, tape or card.
    • Alternatively it may go on a website, if the outer label says the list is there and gives the website's location.
    • Ornamental containers with no outside package may use a tag, tape or card.
    • Where even a tag is impractical, a leaflet must accompany the product at the point of sale [7].
  • Exclusion: these ingredient rules don't apply to products whose ingredient labelling is regulated under the Food and Drug Regulations or the Natural Health Products Regulations [8].

Product-specific warnings

  • Any avoidable hazard: the label must include directions for safe use. An avoidable hazard is one that can be predicted from the composition, toxicology and site of application, can reasonably be expected in normal use, and can be removed by usage limits [9].
  • Aerosols (disposable metal pressurised containers):
    • Principal display panel: the hazard symbol, "CAUTION / ATTENTION" and "CONTAINER MAY EXPLODE IF HEATED…".
    • Another panel: the bilingual "Contents under pressure…" statement [10].
    • Flammability symbols and signal words depend on flame projection: under 15 cm, 15 to under 45 cm, 45 cm or more, or flashback. Flammable aerosols also need "Do not use in presence of open flame or spark" [11].
    • Small aerosols get reduced labelling. The hazard symbol must be at least 6 mm across below 30 mL/30 g, and inner-label content is reduced at up to 60 mL/g and at over 60 up to 120 mL/g [12].
  • Hair dyes with paraphenylenediamine or other coal tar dye bases or intermediates:
    • The set bilingual CAUTION on both inner and outer labels, covering the skin-irritation and patch-test warning and the eyelash/eyebrow blindness warning.
    • Accompanying patch-test instructions [13].
  • Pressurised genital-area deodorants: set bilingual Directions and Caution text on both labels [14].
  • 5 mL or more of methyl alcohol (not in an aerosol): hazard symbol, signal word and statements on the principal display panel [15]. These products must also be in child-resistant containers [16].
  • Liquid products with 600 mg or more of sodium bromate, or 50 mg or more of potassium bromate:
    • A statement on both labels that the product contains the bromate, is poisonous, must be kept out of reach of children, and that a Poison Control Centre or physician should be contacted immediately if swallowed [17].
    • Child-resistant packaging is also required [16].
  • Mercury preservative (allowed only in eye-area products): the outer label shall name the preservative and its concentration [18].
  • Mouthwash sold from open self-selection areas or as samples: a security package. Unless the security feature is self-evident and part of the container, the label must carry a statement or illustration drawing attention to it [19].

What a label must not say

  • Prescriptions: no symbol or statement implying the product was compounded to a prescription [20].
  • References to the law: no reference to the Food and Drugs Act or the Regulations unless they specifically require it [21].
  • Claims needing evidence: the manufacturer must hold evidence for claims that the product affects the chemistry of skin, hair or teeth, or that imply the user will not suffer injury [22].
  • "Not tested on animals": these claims need evidence that no such testing occurred after the relevant date.
  • Disease claims: a label must not present the product as a treatment, preventative or cure for the diseases in Schedule A.1 [23].
  • False or misleading content: prohibited under CPLA s. 7.

Type size (CPLR)

  • Net quantity numerals: minimum height runs from 1.6 mm (display surface of 5 sq in or less) to 12.7 mm (over 400 sq in) (CPLR s. 14).
  • Very small containers: where the principal display surface is 10 cm² or less and all required information is on the principal display panel, everything except the net quantity may be as small as 0.8 mm (CPLR s. 16).

The label also feeds the Cosmetic Notification Form. The form must repeat the inner-label contact information, and labels needing ss. 22 to 24 information must be sent in copy within 10 days of first sale [24].

Sources:

Q.02