Cosmetic Regulations (C.R.C., c. 869)

Short Title

1 These Regulations may be cited as the Cosmetic Regulations.

Interpretation

• 2 (1) The following definitions apply in these Regulations.

  Act

  Act means the Food and Drugs Act. (Loi)

  Assistant Deputy Minister

  Assistant Deputy Minister[Repealed, SOR/2004-244, s. 1]

  botanical

  botanical means an ingredient that is directly derived from a plant and that has not been chemically modified before it is used in the preparation of a cosmetic. (substance végétale)

  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)

  ICI Dictionary

  ICI Dictionary[Repealed, SOR/2024-63, s. 1]

  importer

  importer means a person who imports a cosmetic into Canada for the purpose of selling it. (importateur)

  INCI name

  INCI name means the International Nomenclature Cosmetic Ingredient name assigned to an ingredient in the International Cosmetic Ingredient Dictionary and Handbook published by the Personal Care Products Council on its website, as amended from time to time. (appellation INCI)

  ingredient

  ingredient means any substance that is one of the components of a cosmetic and includes colouring agents, botanicals, fragrance and flavour, but does not include substances that are used in the preparation of the cosmetic but that are not present in the final product as a result of the chemical process. (ingrédient)

  inner label

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

  leave-on product

  leave-on product means any cosmetic that is intended to stay in prolonged contact with the skin, hair or mucous membranes. (produit sans rinçage)

  manufacturer

  manufacturer, in respect of a cosmetic, means one of the following persons:

  • (a) a person in Canada who sells the cosmetic under the person’s own name or under a trademark, design, trade name or other name or mark owned or controlled by the person; or

  • (b) a person in Canada who is authorized to act in Canada on behalf of another person who is not in Canada, if the other person sells the cosmetic under the other person’s own name or under a trademark, design, trade name or other name or mark owned or controlled by the other person. (fabricant)

  official method

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

  ornamental container

  ornamental container means a container that, except on the bottom, does not have any promotional or advertising material on it other than a trademark or common name, and that appears to be a decorative ornament because of a design that is on its surface or because of its shape or texture, and is sold as a decorative ornament in addition to being sold as the container of a cosmetic. (contenant décoratif)

  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)

  rinse-off product

  rinse-off product means any cosmetic that is intended to be removed after application to the skin, hair or mucous membranes. (produit à rincer)

  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.

Application

2.1 If, in respect of a cosmetic, no person meets the definition manufacturer, a reference in these Regulations to “manufacturer” is to be read as a reference to:

• (a) an importer of the cosmetic; or

• (b) if no person meets the definition importer, any person that manufactures or processes the cosmetic in Canada on behalf of another person.

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 [Repealed, SOR/2004-244, s. 2]

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 under subsection (1) unless the cosmetic is relabelled or modified in accordance with the Act and these Regulations within three months after its importation.

10 [Repealed, SOR/2004-244, s. 4]

Sampling

11 When an inspector takes a sample of a cosmetic under subsection 23(1) of the Act, the inspector shall inform the owner of the cosmetic or the person from whom the sample is taken that the inspector proposes to submit the sample or a part of it 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 Minister’s request, provides the Minister with the evidence described in subparagraph (i).

15.2 No person shall sell a cosmetic described in section 28.2 or 28.3 unless it is packaged in a child-resistant container.

• 15.3 (1) A person must not sell a cosmetic after the 10-day period beginning on the day on which the manufacturer or importer first sells that cosmetic if the Minister has not been provided with the documents required under subsection 30(1).

• (2) A person must not sell a cosmetic after the 10-day period referred to in paragraph 31(1)(a) unless the Minister has been provided with a revised notification, document or information.

• (3) If the Minister requests additional information under paragraph 31(1)(b) respecting a cosmetic, and the manufacturer or importer has not provided it, a person must not sell the cosmetic after the 10-day period beginning on the day on which the Minister requests the additional information.

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

Labelling

General

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 The information required by these Regulations to be provided on the label of a cosmetic must

• (a) be shown both in English and in French, except for the INCI name; and

• (b) be clearly legible and remain so throughout the useful life of the cosmetic, or in the case of a refillable container, throughout its useful life, under normal conditions of sale and use.

19 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.