Cosmetic Regulations

Regulations Respecting Cosmetics These Regulations may be cited as the Cosmetic Regulations. The following definitions apply in these Regulations. Act means the Food and Drugs Act. (Loi) Assistant Deputy Minister[Repealed, SOR/2004-244, s. 1] botanical means an ingredient that is directly derived from a plant and that has not been chemically modified before it is used in the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 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 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 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 (retour de flamme) ICI Dictionary[Repealed, SOR/2024-63, s. 1] importer means a person who imports a cosmetic into Canada for the purpose of selling it. (importateur) 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 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 means a label on or affixed to the immediate container of a cosmetic. (étiquette intérieure) 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, in respect of a cosmetic, means one of the following persons: 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 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 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 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 means a label on or affixed to the outside package of a cosmetic. (étiquette extérieure) 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 means a direction given by a practitioner. (ordonnance) principal display panel has the same meaning as in the Consumer Packaging and Labelling Regulations. (espace principal) 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 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) 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. 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: an importer of the cosmetic; or if no person meets the definition importer, any person that manufactures or processes the cosmetic in Canada on behalf of another person. An inspector shall perform the functions and duties and carry out the responsibilities in respect of cosmetics prescribed by the Act and these Regulations. An inspector may, for the proper administration of the Act or these Regulations, take photographs of any cosmetic; any place where, on reasonable grounds, he believes any cosmetic is manufactured, prepared, preserved, packaged or stored; 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 any labelling or advertising material relating to a cosmetic. [Repealed, SOR/2004-244, s. 2] 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. An inspector may examine and take samples of any cosmetic sought to be imported into Canada. 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. 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. 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 he gives to an inspector notice of the proposed importation; and 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. 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. [Repealed, SOR/2004-244, s. 4] 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 where, in the opinion of the inspector, division of the procured quantity would not interfere with analysis or examination, he shall divide the quantity into three parts, 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, seal each part in such a manner that it cannot be opened without breaking the seal, and 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 where, in the opinion of the inspector, division of the procured quantity would interfere with analysis or examination, he shall identify the entire quantity as the sample, seal the sample in such a manner that it cannot be opened without breaking the seal, and forward the sample to an analyst for analysis or examination. 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. 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. 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. 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. No manufacturer or importer shall sell a cosmetic that contains chloroform as an ingredient; or an estrogenic substance. No manufacturer or importer shall sell a cosmetic that contains mercury or a salt or derivative thereof unless the cosmetic is intended for use in the area of the eye; the mercury or its salt or derivative thereof is used in the cosmetic as a preservative; and the manufacturer or importer 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 at the Minister’s request, provides the Minister with the evidence described in subparagraph (i). No person shall sell a cosmetic described in section 28.2 or 28.3 unless it is packaged in a child-resistant container. 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). 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. 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. No person shall sell a cosmetic unless it is labelled in accordance with these Regulations. 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. The information required by these Regulations to be provided on the label of a cosmetic must be shown both in English and in French, except for the INCI name; and 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. 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. Subject to these Regulations, a person must not sell a cosmetic unless its inner label contains 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; and the identity of the cosmetic in terms of its common or generic name or in terms of its function, unless the identity is obvious. No manufacturer shall make any claim on a label of or in an advertisement for a cosmetic respecting either of the following, unless the manufacturer has evidence that validates the claim: the ability of the cosmetic or any of its ingredients to influence the chemistry of the skin, hair or teeth; or the formulation, manufacture or performance of the cosmetic that would imply that the user of the cosmetic will not suffer injury to their health. The manufacturer shall, on request, provide the Minister with the evidence referred to in subsection (1). Sections 21.2 to 21.5 do not apply to any product whose ingredient labelling is regulated under the Food and Drug Regulations or the Natural Health Products Regulations. Subject to subsection (4), a list of ingredients must appear on the outer label of a cosmetic, with each ingredient listed only by its INCI name. In the case of makeup and nail polish and enamel sold in a range of colour shades, all colouring agents used in the range may be listed if they are preceded by the symbol “+/–” or “±” or the phrase “may contain/peut contenir”. Botanicals must be listed by specifying at least the genus and species portions of the INCI name. An ingredient that is included in the schedule may be listed by its European Union (EU) technical name set out in column 1 of the schedule; by its appropriate INCI name set out in column 2 of the schedule and its appropriate French equivalent set out in column 3 of the schedule; or by all three names. An ingredient that has no INCI name must be listed by its chemical name. The following definitions apply in this section. European Restricted Substances List means Annex III, titled List of Substances Which Cosmetic Products Must Not Contain Except Subject To The Restrictions Laid Down, of Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, published by the European Union on its website, as amended from time to time. (Liste européenne de substances à usage restreint) fragrance allergen means a fragrance or flavour that can cause an allergic reaction and that is included in the European Restricted Substances List and for which the restrictions set out in column h of that list provide that its presence must be indicated in a cosmetic’s list of ingredients. (allergène de parfum) Subject to subsections (2) to (4), ingredients must be listed in descending order of predominance, in their concentration by weight. Ingredients that are 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 the case of fragrance and flavour, other than fragrance allergens, the words “parfum” and “aroma”, respectively, may be inserted at the end of the list of ingredients to indicate that such ingredients have been added to the cosmetic to produce or to mask a particular odour or flavour. A fragrance allergen must be listed if in the case of a rinse-off product, the concentration of the fragrance allergen in the cosmetic is greater than 0.01%; or in the case of a leave-on product, the concentration of the fragrance allergen in the cosmetic is greater than 0.001%. Despite subsection (4), a fragrance allergen is not required to be listed in a cosmetic’s list of ingredients before the later of the day on which a provision of a regulation, published by the European Union on its website and amending the Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products by adding the fragrance allergen to the European Restricted Substances List, comes into force; and if applicable, the day on which the fragrance allergen must be listed in the list of ingredients of a cosmetic in order for the cosmetic to be made available on the European Union market, as set out or referred to in the entry in the European Restricted Substances List for that fragrance allergen. Despite subsection 21.2(1), in the case of a cosmetic whose immediate container or outside package is too small for the label to comply with paragraph 18(b), the list of ingredients may appear on a tag, tape or card affixed to the container or package; or 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. Despite subsection 21.2(1), in the case of a cosmetic in an ornamental container that has no outside package, the list of ingredients may appear on a tag, tape or card affixed to the container. Despite subsection 21.2(1), in the case of a cosmetic that has no outside package and whose size, shape or texture, or that of its immediate container, makes it impractical for a tag, tape or card to be affixed to the container, the list of ingredients may instead appear in a leaflet that must accompany the cosmetic at the point of sale. A hair dye that contains paraphenylenediamine or other coal tar dye base or coal tar intermediate must carry the following warning on both the inner and outer labels: “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 be accompanied by instructions to the following effect: the preparation may cause serious inflammation of the skin in some persons, and a preliminary test should always be made to determine whether special sensitivity exists, and 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 may be assumed that no hypersensitivity to the dye exists. The test should be made before each application. The hair dye should never be used for dyeing eyebrows or eyelashes, as severe inflammation of the eye or even blindness may result. 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. 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” The label of a cosmetic that presents an avoidable hazard must include directions for safe use. 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 predicted from the cosmetic’s composition, the toxicology of its ingredients and the site of its application; reasonably anticipated during normal use; and eliminated by specified limitations on the usage of the cosmetic. 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: 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 the primary hazard statement “CONTAINER MAY EXPLODE IF HEATED. / CE CONTENANT PEUT EXPLOSER S’IL EST CHAUFFÉ.”. 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.” If the Minister determines, at the request of the manufacturer, that the materials used in the construction of a container described in subsection (1) or the incorporation in such a 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. [Repealed, SOR/81-615, s. 2] 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: the hazard symbol set out in column II; the signal word set out in column III; and the primary hazard statement set out in column IV. 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 Less than 15 cm moins de 15 cm Caution Attention Flammable Inflammable 15 cm or more but less than 45 cm 15 cm et plus mais moins de 45 cm Warning Avertissement 45 cm or more 45 cm et plus Danger Extremely Flammable Extrêmement inflammable Flashback Retour de flamme 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.” When the labelled net quantity of a cosmetic described in subsection 25(1) or 26(1) is less than 30 mL or 30 g, the hazard symbol must be of such a size that it is capable of being circumscribed by a circle with a diameter of at least 6 mm. When the labelled net quantity of a cosmetic described in subsection 25(1) or 26(1) is not greater than 60 mL or 60 g, 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. When the labelled net quantity of a cosmetic described in subsection 25(1) or 26(1) is greater than 60 mL or 60 g but not greater than 120 mL or 120 g, the inner label may show only the information described in subsection 25(1) or 26(1), as the case may be. When a cosmetic described in subsection (2) or (3) is sold in an outside package, the outer label may show only the information described in subsection 25(2) and, if applicable, subsection 26(2). [Repealed, SOR/93-243, s. 2] Subject to subsection (2) no person shall sell a mouthwash for human use unless it is contained in a security package. 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. Unless the security feature of a security package is self-evident and is an integral part of the immediate container, the inner label of the security package must carry a statement or illustration that draws attention to the security feature of the package and, if the security feature is part of an outside package, the outer label must also carry the statement or illustration. The principal display panel of the inner and outer labels of a cosmetic, other than one in a container described in subsection 25(1), that contains 5 mL or more of methyl alcohol must display all of the following information: 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 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 must be located on the labels in accordance with paragraphs 15(2)(a) to (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. The inner and outer labels of a cosmetic in liquid form that contains 600 mg or more of sodium bromate (NaBrO3) or 50 mg or more of potassium bromate (KBrO3 ) must 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 the reach of children and, in the case of accidental ingestion, a Poison Control Centre or physician is to be contacted immediately. [Repealed, SOR/2004-244, s. 19] The Minister may request in writing that a manufacturer or importer submit to the Minister, on or before a specified day, evidence to establish the safety of a cosmetic under the recommended or the normal conditions of use. A manufacturer or importer who does not submit the evidence requested under subsection (1) must cease to sell the cosmetic on the day after the day specified in the request. If the Minister determines that the evidence submitted by a manufacturer or importer under subsection (1) is not sufficient, the Minister must notify the manufacturer or importer in writing to that effect, and the manufacturer or importer must cease to sell the cosmetic until the manufacturer or importer has submitted further evidence to the Minister; and has been notified in writing by the Minister that the further evidence is sufficient. Every manufacturer and importer shall provide the Minister with the following documents, at the latest 10 days after the manufacturer or importer first sells a cosmetic: a notification on a form obtained from the Minister and signed by the manufacturer or importer, as the case may be, or a person authorized on their behalf, advising whether they intend to continue sales of the cosmetic in Canada and including the information specified in subsection (2); and if the labels and inserts used in conjunction with the cosmetic require the information set out in any of sections 22 to 24, a copy or facsimile of the labels and inserts The following is the information required for the purpose of paragraph (1)(a): the contact information that appears on the inner label of the cosmetic in accordance with paragraph 20(a); the name under which the cosmetic is sold; the function of the cosmetic, including whether the cosmetic is a leave-on product or a rinse-off product; a list of the cosmetic’s ingredients, according to their INCI name — or, in the absence of such a name, their chemical name — and, for each ingredient, either its exact concentration or the concentration range that includes the concentration of that ingredient, the latter of which may only be indicated by setting out either the applicable concentration range set out in column 1 of the table to this section or the number in column 2 that corresponds to the applicable concentration range set out in column 1; the form of the cosmetic; the name and address in Canada of the manufacturer or importer; if the cosmetic was not manufactured or formulated by the person referred to in paragraph (f), the name and address of the person who manufactured or formulated it; and the name and title of the person who signed the notification referred to in paragraph (1)(a). A manufacturer or importer who has provided the Minister with a notification under section 30 must provide the Minister with a revised notification, together with any applicable revised document or information within 10 days after the day on which the document or information becomes inaccurate; and provide the Minister with any additional information that the Minister requests respecting the notification within 10 days after the day of the Minister’s request. For the purposes of paragraph (1)(a), an inaccurate document or inaccurate information includes a document or information in respect of a cosmetic that is no longer sold in Canada. [Repealed, SOR/2004-244, s. 22]