Short Title

1 These Regulations may be cited as the Cosmetic Regulations.

Interpretation

• 2 (1) In these Regulations,

  Act

  Act means the Food and Drugs Act; (Loi)

  Assistant Deputy Minister

  Assistant Deputy Minister means the Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, of the Department of Health; (sous-ministre adjoint)

  child-resistant container

  child-resistant container has the same meaning as in section 2 of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001; (contenant protège-enfants)

  flame projection

  flame projection means the ability of the pressurized contents of an aerosol container to ignite and the length of that ignition, when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981; (projection de flamme)

  flashback

  flashback means that part of the flame projection that extends from its point of ignition back to the aerosol container when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981; (retour de flamme)

  inner label

  inner label means a label on or affixed to the immediate container of a cosmetic; (étiquette intérieure)

  manufacturer

  manufacturer means any person, partnership or unincorporated association that manufactures and, under its own name or under a trade mark, design, trade name or other name or mark owned or controlled by it, sells a cosmetic and includes any other person, partnership or unincorporated association that sells a cosmetic in such a manner; (fabricant)

  official method

  official method means a method of analysis or examination designated as such by the Assistant Deputy Minister for use in the administration of the Act and these Regulations; (méthode officielle)

  outer label

  outer label means a label on or affixed to the outside package of a cosmetic; (étiquette extérieure)

  practitioner

  practitioner means a person who is registered and licensed under the laws of a province to practise the profession of medicine in that province; (praticien)

  prescription

  prescription means a direction given by a practitioner; (ordonnance)

  principal display panel

  principal display panel has the same meaning as in the Consumer Packaging and Labelling Regulations; (espace principal)

  security package

  security package means a package having a security feature that provides reasonable assurance to consumers that the package has not been opened prior to purchase. (emballage de sécurité)

• (2) Where a cosmetic has more than one name, a reference in these Regulations to the cosmetic by any of its names is deemed to be a reference to the cosmetic by all of its names.

Inspectors

• 3 (1) An inspector shall perform the functions and duties and carry out the responsibilities in respect of cosmetics prescribed by the Act and these Regulations.

• (2) An inspector may, for the proper administration of the Act or these Regulations, take photographs of

  • (a) any cosmetic;

  • (b) any place where, on reasonable grounds, he believes any cosmetic is manufactured, prepared, preserved, packaged or stored;

  • (c) anything that, on reasonable grounds, he believes is used or capable of being used for the manufacture, preparation, preservation, packaging or storing of any cosmetic; and

  • (d) any labelling or advertising material relating to a cosmetic.

4 The certificate of designation required pursuant to subsection 22(2) of the Act shall

• (a) certify that the person named therein is an inspector for the purpose of the Act; and

• (b) be signed by the Assistant Deputy Minister and the person named in the certificate.

Importation into Canada

5 Subject to section 9, no person shall import into Canada for sale a cosmetic the sale of which in Canada would constitute a violation of the Act or these Regulations.

6 An inspector may examine and take samples of any cosmetic sought to be imported into Canada.

7 Where an inspector examines or takes a sample of a cosmetic pursuant to section 6, he may submit the cosmetic or sample to an analyst for analysis or examination.

8 Where an inspector, on examination of a cosmetic or sample thereof or on receipt of a report of an analyst of the result of an analysis or examination of the cosmetic or sample, is of the opinion that the sale of the cosmetic in Canada would constitute a violation of the Act or these Regulations, the inspector shall so notify in writing the collector of customs concerned and the importer.

• 9 (1) Where a person seeks to import a cosmetic into Canada for sale and the sale would constitute a violation of the Act or these Regulations, that person may, if the sale of the cosmetic would be lawful in Canada after relabelling or modification of the cosmetic, import the cosmetic into Canada on condition that

  • (a) he gives to an inspector notice of the proposed importation; and

  • (b) the cosmetic will be relabelled or modified under the supervision of an inspector in such a manner as to enable the sale of the cosmetic to be lawful in Canada.

• (2) No person shall sell a cosmetic that has been imported into Canada pursuant to subsection (1) unless the cosmetic has been relabelled or modified to the satisfaction of the inspector under whose supervision the relabelling or modification was carried out within three months after the importation of the cosmetic into Canada or within such longer period as the Assistant Deputy Minister may specify.

10 No person shall import a cosmetic into Canada for sale unless the information and materials required by section 30 have been filed with the Assistant Deputy Minister in respect of that cosmetic.

Sampling

11 Where an inspector takes a sample of a cosmetic pursuant to paragraph 22(1)(a) of the Act, he shall inform the owner thereof or the person from whom the sample is taken that he proposes to submit the sample or a part thereof to an analyst for analysis or examination and

• (a) where, in the opinion of the inspector, division of the procured quantity would not interfere with analysis or examination, he shall

  • (i) divide the quantity into three parts,

  • (ii) identify the three parts as the owner’s portion, the sample and the duplicate sample and where only one part bears the label, identify that part as the sample,

  • (iii) seal each part in such a manner that it cannot be opened without breaking the seal, and

  • (iv) deliver the part identified as the owner’s portion to the owner or the person from whom the sample was obtained and forward the sample and the duplicate sample to an analyst for analysis or examination; or

• (b) where, in the opinion of the inspector, division of the procured quantity would interfere with analysis or examination, he shall

  • (i) identify the entire quantity as the sample,

  • (ii) seal the sample in such a manner that it cannot be opened without breaking the seal, and

  • (iii) forward the sample to an analyst for analysis or examination.

Sales

12 No person shall sell a cosmetic if any label or advertisement of the cosmetic contains any symbol or statement that implies that the cosmetic has been compounded in accordance with a prescription.

13 No person shall sell a cosmetic recommended for removing stains from the teeth that has a measure of acidity greater than that represented by a pH of 4.

• 14 (1) No person shall sell a cosmetic for use in the area of the eye that contains any coal tar dye, coal tar dye base or coal tar dye intermediate.

• (2) For the purpose of subsection (1) and section 15.1, “area of the eye” means the area bounded by the supraorbital and infraorbital ridges and includes the eyebrows, the skin underlying the eyebrows, the eyelids, the eyelashes, the conjunctival sac of the eye, the eyeball and the soft tissue that lies below the eye and within the infraorbital ridge.

15 No manufacturer or importer shall sell a cosmetic that contains

• (a) chloroform as an ingredient; or

• (b) an estrogenic substance.

15.1 No manufacturer or importer shall sell a cosmetic that contains mercury or a salt or derivative thereof unless

• (a) the cosmetic is intended for use in the area of the eye;

• (b) the mercury or its salt or derivative thereof is used in the cosmetic as a preservative; and

• (c) the manufacturer or importer

  • (i) has in his possession evidence demonstrating that the only satisfactory way to maintain the sterility or stability of the cosmetic is to use mercury or a salt or derivative thereof as a preservative, and

  • (ii) at the request of the Assistant Deputy Minister, furnishes the Assistant Deputy Minister with the evidence referred to in subparagraph (i).

15.2 No person shall sell a cosmetic described in sections 28.2 to 28.4 unless it is packaged in a child-resistant container.

16 No person shall sell a cosmetic unless it is labelled in accordance with these Regulations.

Labelling

17 No reference, direct or indirect, to the Act or these Regulations shall be made on any label or in any advertisement of a cosmetic unless the reference is a specific requirement of the Act or these Regulations.

18 All information required by these Regulations to appear on the label of a cosmetic shall be

• (a) clearly and prominently displayed thereon; and

• (b) readily discernible to the purchaser or consumer under the customary conditions of purchase and use.

19 Where a cosmetic has only one label, that label shall contain all the information required by these Regulations to be shown on both the inner and outer label thereof.

20 Subject to these Regulations, the inner label of a cosmetic shall show

• (a) the name of the manufacturer or distributor of the cosmetic and the address of his principal place of business; and

• (b) the identity of the cosmetic in terms of its common or generic name or in terms of its function, unless the identity is obvious.

• 21 (1) No manufacturer shall, on any label or in any advertisement for a cosmetic, make any claim respecting

  • (a) the ability of the product or any ingredient thereof to influence the chemistry of the skin, hair or teeth, or

  • (b) product formulation, manufacture or performance that would imply that the user of the product will not suffer injury to health,

  unless the manufacturer is in possession of evidence validating the claim.

• (2) The manufacturer shall, on request, furnish the Assistant Deputy Minister with the evidence referred to in subsection (1).

• 22 (1) Subject to subsection (2), no person shall sell a hair dye that contains paraphenylenediamine or other coal tar dye base or coal tar dye intermediate unless

  • (a) both the inner and the outer labels thereof carry the following warning:

    “CAUTION: This product contains ingredients that may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows. To do so may cause blindness”

    “MISE EN GARDE : Ce produit contient des ingrédients qui peuvent causer de l’irritation cutanée chez certaines personnes; il faut donc d’abord effectuer une épreuve préliminaire selon les directives ci-jointes. Ce produit ne doit pas servir à teindre les sourcils ni les cils; en ce faisant, on pourrait provoquer la cécité”; and

  • (b) instructions to the following effect, in both official languages, accompany each package of the hair dye;

    • (i) the preparation may cause serious inflammation of the skin in some persons and a preliminary test should always be carried out to determine whether or not special sensitivity exists, and

    • (ii) to make the test, a small area of skin behind the ear or on the inner surface of the forearm should be cleansed, using either soap and water or alcohol, and a small quantity of the hair dye as prepared for use should be applied to the area and allowed to dry. After 24 hours, the area should be washed gently with soap and water. If no irritation or inflammation is apparent, it is usually assumed that no hypersensitivity to the dye exists. The test should, however, be carried out before each application. On no account should the hair dye be used for dyeing eyebrows or eyelashes as severe inflammation of the eye or even blindness may result.

• (2) [Repealed, SOR/89-228, s. 3]

22.1 The outer label of a cosmetic, where that cosmetic contains mercury or a salt or derivative thereof as a preservative, shall indicate the name of the preservative and its concentration in the cosmetic.

23 A deodorant that is intended for use in the genital area and that is sold in a pressurized container shall carry the following information on both its inner and outer labels:

“Directions: For external use only. Use sparingly and not more than once daily. Spray external skin surface while holding nozzle at least eight inches from the skin”

“Mode d’emploi : Pour usage externe seulement. Employer modérément, pas plus d’une fois par jour. Vaporiser sur la surface externe de la peau en tenant le bec à une distance d’au moins huit pouces”

“Caution: Do not apply internally or to broken, irritated or itching skin. Do not use when wearing a sanitary napkin. Discontinue use immediately if a rash or irritation develops. Consult a physician if the rash or irritation persists or if there is any unusual odour or discharge at any time”

“Mise en garde : Ne pas appliquer sur une surface interne ou sur une surface éraflée, irritée ou en proie à la démangeaison. Ne pas utiliser avec des serviettes hygiéniques. Cesser immédiatement l’emploi en cas d’éruption ou d’irritation. Consulter un médecin si l’éruption ou l’irritation persiste ou en cas d’odeur ou de sécrétion inhabituelle”

• 24 (1) No person shall sell a cosmetic presenting an avoidable hazard unless the label carries, in both official languages adequate directions for safe use.

• (2) For the purpose of subsection (1), avoidable hazard means a threat of injury to the health of the user of a cosmetic that can be

  • (a) predicted from the composition of the cosmetic, the toxicology of the ingredients and the site of application thereof;

  • (b) reasonably anticipated during normal use; and

  • (c) eliminated by specified limitations on the usage of the cosmetic.

• (3) [Repealed, SOR/89-228, s. 5]

Cosmetics in Pressurized Containers

• 25 (1) Subject to subsection (3) and section 27, in the case of a cosmetic packaged in a disposable metal container designed to release pressurized contents by use of a manually operated valve that forms an integral part of the container, the principal display panel of the inner and outer labels of the cosmetic shall display, in accordance with sections 15 to 18 of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following information:

  • (a) the hazard symbol set out in column II of item 10 of Schedule II to those Regulations, accompanied by the signal word “CAUTION / ATTENTION”; and

  • (b) the primary hazard statement “CONTAINER MAY EXPLODE IF HEATED. / CE CONTENANT PEUT EXPLOSER S’IL EST CHAUFFÉ.”.

• (2) Subject to subsection (3) and section 27, one panel of the inner and outer labels of a cosmetic referred to in subsection (1) shall display, in the size required by paragraph 19(1)(b) of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following additional hazard statement:

  “Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50°C.

  Contenu sous pression. Ne pas mettre dans l’eau chaude ni près des radiateurs, poêles ou autres sources de chaleur. Ne pas percer le contenant, ni le jeter au feu, ni le conserver à des températures dépassant 50°C.”

• (3) Where the Assistant Deputy Minister has determined, at the request of the manufacturer, that the materials used in the construction of a container described in subsection (1) or the incorporation in that container of a safety device has eliminated the hazards presented by the container, subsections (1) and (2) do not apply to the cosmetic packaged in that container.

• (4) and (5) [Repealed, SOR/81-615, s. 2]

• 26 (1) Subject to section 27, if a cosmetic is packaged in a container described in subsection 25(1) and has a flame projection of a length set out in column I of any of items 1 to 3 of the table to this subsection or has a flashback as set out in column I of item 4 of that table, as determined by official method DO-30, Determination of Flame Projection, dated October 15, 1981, the principal display panel of the inner label of and outer label for the cosmetic shall display, in accordance with sections 15 to 18 of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following information:

  • (a) the hazard symbol set out in column II of the same item;

  • (b) in both official languages, the signal word set out in column III of the same item; and

  • (c) in both official languages, the primary hazard statement set out in column IV of the same item.

  Item Article	Column I Colonne I	Column II Colonne II	Column III Colonne III	Column IV Colonne IV
  	Flame Projection Length — Flashback Projection de la flamme — Retour de flamme	Hazard Symbol Signal de danger	Signal Word Mot indicateur	Primary Hazard Statement Mention de danger principale
  1	Less than 15 cm moins de 15 cm		Caution Attention	Flammable Inflammable
  2	15 cm or more but less than 45 cm 15 cm et plus mais moins de 45 cm		Warning Avertissement	Flammable Inflammable
  3	45 cm or more 45 cm et plus		Danger Danger	Extremely Flammable Extrêmement inflammable
  4	Flashback Retour de flamme		Danger Danger	Extremely Flammable Extrêmement inflammable

• (2) In addition to the requirements of subsection (1), one panel of the inner and outer labels of a cosmetic referred to in that subsection shall display, in the size required by paragraph 19(1)(b) of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following additional hazard statements:

  “Do not use in presence of open flame or spark.

  Ne pas utiliser en présence d’une flamme nue ou d’étincelles.”

• 27 (1) Where the labelled net quantity of a container of a cosmetic described in subsection 25(1) or 26(1) does not exceed 60 millilitres or 60 grams, the inner label may show only the information described in paragraph 25(1)(a) or paragraphs 26(1)(a) and (b), as the case may be.

• (2) Where the labelled net quantity of a container of a cosmetic described in subsection 25(1) or 26(1) exceeds 60 millilitres or 60 grams but does not exceed 120 millilitres or 120 grams the inner label may show only the information described in subsection 25(1) or subsection 26(1), as the case may be.

• (3) Where the labelled net quantity, in a container, of a cosmetic described in subsection 25(1) or 26(1) is less than 30 mL or 30 g, the hazard symbol shall be of such size as to be capable of being circumscribed by a circle with a diameter of at least 6 mm.

• (4) Where a container of a cosmetic described in subsection (1) or (2) is sold in a package, the outer label may show only the information described in subsection 25(2) and where applicable, subsection 26(2).

28 [Repealed, SOR/93-243, s. 2]

Security Packaging

• 28.1 (1) Subject to subsection (2) no person shall sell a mouthwash for human use unless it is contained in a security package.

• (2) Subsection (1) applies only to mouthwash that is available to the public in an open self-selection area or that is distributed as a sample.

• (3) Unless the security feature of a security package referred to in subsection (1) is self-evident and is an integral part of the immediate product container, the inner label of the security package shall carry a statement or illustration drawing attention to the security feature of the package and, if the security feature is part of an outer package, the outer label shall also carry the statement or illustration.

28.2 The principal display panel of the inner label and the outer label of the container of a cosmetic, other than a disposable metal container designed to release pressurized contents by the use of a manually operated valve that forms an integral part of the container, that contains an amount of methyl alcohol equal to or greater than 5 mL, shall display

• (a) the hazard symbol set out in column II of item 1 of Schedule II to the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, in accordance with paragraphs 16(a) and (b) of those Regulations; and

• (b) for each of the particulars set out in column I of items 1 to 5 of the table to section 46 of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the signal word and statements set out in columns III and IV of those items, which shall be located on the labels in accordance with paragraphs 15(2)(a) and (c) of those Regulations and printed in accordance with paragraphs 17(a) and (b), 18(a) and (b) and 19(1)(a) and (b) and subsection 19(2) of those Regulations.

28.3 The inner label and the outer label of a cosmetic, in liquid form, that contains an amount of sodium bromate (NaBrO₃) equal to or greater than 600 mg or an amount of potassium bromate (KBrO₃) equal to or greater than 50 mg, shall carry a statement to the effect that the product contains sodium bromate or potassium bromate, as the case may be, is poisonous, is to be kept out of reach of children and, in the case of accidental ingestion, a Poison Control Centre or physician is to be contacted immediately.

28.4 The inner label and the outer label of a cosmetic, in liquid form, that contains an amount of acetonitrile equal to or greater than 500 mg shall carry a statement to the effect that the product contains acetonitrile, is poisonous, is to be kept out of reach of children and, in the case of accidental ingestion, a Poison Control Centre or physician is to be contacted immediately.

Evidence of Safety of Cosmetics

• 29 (1) The Assistant Deputy Minister may, in writing, request the manufacturer of a cosmetic to submit to him, on or before a specified day, evidence to establish the safety of the cosmetic under the recommended conditions of use of the cosmetic or when used under such methods of use as are customary or usual therefor.

• (2) Where the manufacturer of a cosmetic is requested by the Assistant Deputy Minister pursuant to subsection (1) to submit evidence of the safety with respect to a cosmetic, the manufacturer shall cease to sell that cosmetic after the day specified in the request unless he has duly submitted the evidence requested.

• (3) Where the Assistant Deputy Minister is of the opinion that the evidence submitted by a manufacturer pursuant to subsection (1) is not sufficient, he shall notify the manufacturer in writing to that effect and the manufacturer shall not thereafter sell the cosmetic unless

  • (a) he has submitted further evidence to the Assistant Deputy Minister; and

  • (b) he has been notified in writing by the Assistant Deputy Minister that the further evidence is sufficient.

Notification

• 30 (1) Every manufacturer of a cosmetic shall within 10 days from the day on which he first sells the cosmetic, furnish the Assistant Deputy Minister with

  • (a) a notification on a form obtained from the Assistant Deputy Minister and signed by the manufacturer or a person authorized on his behalf, advising whether he intends to continue sales of the cosmetic in Canada and including the information described in subsection (2); and

  • (b) a copy or facsimile of the labels and inserts used in conjunction with the cosmetic where the labels and inserts require the information set out in sections 22 to 24.

• (2) For the purpose of paragraph (1)(a), the information described in this subsection is

  • (a) the name and address of every person, firm, partnership or corporation appearing on the label of the cosmetic sold by the manufacturer;

  • (b) the name under which the cosmetic is sold;

  • (c) the purpose of the cosmetic;

  • (d) a list of ingredients contained in the cosmetic and, for each ingredient, the exact concentration or the concentration range that includes the concentration of that ingredient which may be shown by the numbers indicated as applying to the concentration range on the table to this section;

  • (e) the form of the cosmetic;

  • (f) the name and address of the Canadian distributor;

  • (g) where the cosmetic was not manufactured or formulated by the person whose name appears on the label of the cosmetic, the name and address of the person who manufactured or formulated the cosmetic; and

  • (h) the name and office of the person who signed the notification referred to in paragraph (1)(a).

  Number/Chiffre		Range/Concentration
  1	over	30% to 100%/
  	de	30% à 100%
  2	over	10% to 30%/
  	de	10% à 30%
  3	over	3% to 10%/
  	de	3% à 10%
  4	over	1% to 3%/
  	de	1% à 3%
  5	over	0.3% to 1%/
  	de	0.3% à 1%
  6	over	0.1% to 0.3%/
  	de	0.1% à 0.3%
  7		0.1% or less/
  		0.1% ou moins

31 The manufacturer of a cosmetic who has furnished the Assistant Deputy Minister with a notification pursuant to section 30 shall, where any information or material furnished therewith becomes no longer accurate, furnish the Assistant Deputy Minister, within 10 days, with a revised notification together with such revised materials as may be applicable.

32 Any manufacturer who has furnished the Assistant Deputy Minister with a notification pursuant to section 30 shall promptly furnish the Assistant Deputy Minister with such additional information respecting the cosmetic as the Assistant Deputy Minister may from time to time request.