Cosmetic Regulations (C.R.C., c. 869)
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Regulations are current to 2024-06-19 and last amended on 2019-06-17. Previous Versions
AMENDMENTS NOT IN FORCE
— SOR/2024-63, s. 1
1 (1) The portion of subsection 2(1) of the Cosmetic RegulationsFootnote 1 before the first definition is replaced by the following:
Return to footnote 1C.R.C., c. 869
2 (1) The following definitions apply in these Regulations.
(2) The definition ICI Dictionary in subsection 2(1) of the Regulations is repealed.
(3) The definitions INCI name, inner label, manufacturer, practitioner and prescription in subsection 2(1) of the Regulations are replaced by the following:
- 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)
- inner label
inner label means a label on or affixed to the immediate container of a cosmetic. (étiquette intérieure)
- 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)
- 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)
(4) The definitions Act, botanical, child-resistant container, flame projection, flashback, ingredient, official method, ornamental container, outer label and principal display panel in subsection 2(1) of the English version of the Regulations are replaced by the following:
- Act
Act means the Food and Drugs Act. (Loi)
- 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)
- 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)
- 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)
- principal display panel
principal display panel has the same meaning as in the Consumer Packaging and Labelling Regulations. (espace principal)
(5) The definition emballage de sécurité in subsection 2(1) of the French version of the Regulations is replaced by the following:
- security package
emballage de sécurité Emballage doté d’un dispositif de sûreté qui offre au consommateur une assurance raisonnable que l’emballage n’a pas été ouvert avant l’achat. (security package)
(6) Subsection 2(1) of the Regulations is amended by adding the following in alphabetical order:
- importer
importer means a person who imports a cosmetic into Canada for the purpose of selling it. (importateur)
- 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)
- 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)
— SOR/2024-63, s. 2
2 The Regulations are amended by adding the following after section 2:
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.
— SOR/2024-63, s. 3
3 The Regulations are amended by adding the following after section 15.2:
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.
— SOR/2024-63, s. 4
4 The portion of section 20 of the Regulations before paragraph (b) is replaced by the following:
20 Subject to these Regulations, a person must not sell a cosmetic unless its inner label contains
(a) 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
— SOR/2024-63, s. 5
5 Subsection 21.2(4) of the Regulations is replaced by the following:
(4) An ingredient that is included in the schedule may be listed
(a) by its European Union (EU) technical name set out in column 1 of the schedule;
(b) 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
(c) by all three names.
— SOR/2024-63, s. 6
6 (1) Subsection 21.4(1) of the Regulations is replaced by the following:
21.4 (0.1) The following definitions apply in this section.
- European Restricted Substances List
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
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)
(1) Subject to subsections (2) to (4), ingredients must be listed in descending order of predominance, in their concentration by weight.
(2) Subsection 21.4(3) of the Regulations is replaced by the following:
(3) 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.
(4) A fragrance allergen must be listed if
(a) in the case of a rinse-off product, the concentration of the fragrance allergen in the cosmetic is greater than 0.01%; or
(b) in the case of a leave-on product, the concentration of the fragrance allergen in the cosmetic is greater than 0.001%.
(5) Despite subsection (4), a fragrance allergen is not required to be listed in a cosmetic’s list of ingredients before the later of
(a) 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
(b) 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.
— SOR/2024-63, s. 7
7 Subsection 21.5(1) of the Regulations is replaced by the following:
21.5 (1) 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
(a) on a tag, tape or card affixed to the container or package; or
(b) 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.
— SOR/2024-63, s. 8
8 Section 29 of the Regulations is replaced by the following:
29 (1) 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.
(2) 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.
(3) 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
(a) has submitted further evidence to the Minister; and
(b) has been notified in writing by the Minister that the further evidence is sufficient.
— SOR/2024-63, s. 9
9 (1) The portion of subsection 30(1) of the French version of the Regulations before paragraph (a) is replaced by the following:
30 (1) Le fabricant ou l’importateur remet au ministre, dans les dix jours suivant la vente initiale d’un cosmétique par le fabricant ou l’importateur, les documents suivants :
(2) Paragraph 30(2)(a) of the Regulations is replaced by the following:
(a) the contact information that appears on the inner label of the cosmetic in accordance with paragraph 20(a);
(3) Paragraphs 30(2)(c) and (d) of the Regulations are replaced by the following:
(c) the function of the cosmetic, including whether the cosmetic is a leave-on product or a rinse-off product;
(d) 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;
(4) Paragraphs 30(2)(f) and (g) of the Regulations are replaced by the following:
(f) the name and address in Canada of the manufacturer or importer;
(g) 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
(5) The table to section 30 of the Regulations is replaced by the following:
TABLE
Column 1 Column 2 Item Concentration Range Corresponding Number 1 More than 80%, up to 100% 1 2 More than 65%, but not more than 80% 2 3 More than 50%, but not more than 65% 3 4 More than 40%, but not more than 50% 4 5 More than 30%, but not more than 40% 5 6 More than 20%, but not more than 30% 6 7 More than 10%, but not more than 20% 7 8 More than 3%, but not more than 10% 8 9 More than 1%, but not more than 3% 9 10 More than 0.3%, but not more than 1% 10 11 More than 0.1%, but not more than 0.3% 11 12 More than 0.001%, but not more than 0.1% 12 13 More than 0%, but not more than 0.001% 13
— SOR/2024-63, s. 10
10 Section 31 of the Regulations is replaced by the following:
31 (1) A manufacturer or importer who has provided the Minister with a notification under section 30 must
(a) 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
(b) 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.
(2) 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.
— SOR/2024-63, s. 11
11 The schedule to the Regulations is replaced by the schedule set out in the schedule to these Regulations.
SCHEDULE(Subsection 21.2(4))
EU Technical Names and Their INCI Names and French Equivalents
Column 1 Column 2 Column 3 Item EU Technical Name INCI Name French Equivalent 1 Acetum Vinegar Vinaigre 2 Adeps Bovis Tallow Suif 3 Adeps Suillus Lard Saindoux 4 Aqua Water Eau 5 Bombyx Lipida Silkworm Extract Extrait de ver à soie 6 Brevoortia Oil Menhaden Oil Huile de menhaden 7 Bubulum Oil Neatsfoot Oil Huile de pied de bœuf 8 Butyris Lac Powder Buttermilk Powder Babeurre en poudre 9 Butyrum Butter Beurre 10 Candelilla Cera Euphorbia Cerifera (Candelilla) Wax Cire de candelilla 11 Caprae Lac Goat Milk Lait de chèvre 12 Cera Alba Beeswax Cire d’abeille 13 Cera Microcristallina Microcrystalline Wax Cire microcristalline 14 Colophonium Rosin Colophane 15 Copernicia Cerifera Cera Copernicia Cerifera (Carnauba) Wax Cire de carnauba 16 Dromiceius Oil Emu Oil Huile d’émeu 17 Faex Lactic Yeasts Levures lactiques Yeast Levure Yeast Extract Extrait de levure 18 Gadi Lecur Oil Cod Liver Oil Huile de foie de morue 19 Hoplostethus Oil Orange Roughy Oil Huile d’hoplostète orange 20 Lac Milk Lait Whole Dry Milk Lait entier en poudre 21 Lactis Lipida Milk Lipids Lipides du lait 22 Lactis Proteinum Milk Protein Protéine du lait Whey Protein Protéine du petit-lait 23 Lanolin Cera Lanolin Wax Cire de lanoline 24 Maris Aqua Sea Water Eau de mer 25 Maris Limus Extract Sea Silt Extract Extrait de limon marin 26 Maris Sal Sea Salt Sel marin 27 Mel Honey Miel 28 Mel Extract Honey Extract Extrait de miel 29 Montan Cera Montan Wax Cire de Montan 30 Mustela Cera Mink Wax Cire de vison 31 Mustela Oil Mink Oil Huile de vison 32 Olus Oil Vegetable Oil Huile végétale 33 Ostrea Edulis Extract Oyster Extract Extrait d’huître 34 Ostrea Shell Extract Oyster Shell Extract Extrait de coquille d’huître 35 Ostrea Shell Powder Oyster Shell Powder Poudre de coquille d’huître 36 Ovum Dried Egg Yolk Poudre de jaune d’œufs Egg Œuf Egg Yolk Extract Extrait de jaune d’œuf 37 Ovum Oil Egg Oil Huile d’œufs 38 Ovum Powder Egg Powder Poudre d’oeufs 39 Paraffinum Liquidum Mineral Oil Huile minérale 40 Pellis Lipida Skin Lipids Lipides cutanés 41 Pisces Extract Fish Extract Extrait de poisson 42 Piscum Cartilage Extract Fish Cartilage Extract Extrait de cartilage de poisson 43 Piscum Lecur Oil Fish Liver Oil Huile de foie de poisson 44 Pix Tar Oil Huile d’anthracène 45 Propolis Cera Propolis Wax Cire de propolis 46 Salmo Oil Salmon Oil Huile de saumon 47 Salmo Ovum Extract Salmon Egg Extract Extrait d’œufs de saumon 48 Sepia Extract Cuttlefish Extract Extrait de seiche 49 Serica Silk Soie 50 Serica Extract Silk Extract Extrait de soie 51 Serica Powder Silk Powder Poudre de soie 52 Shellac Cera Shellac Wax Cire de laque 53 Sine Adipe Colostrum Nonfat Dry Colostrum Poudre de colostrum écrémé 54 Sine Adipe Lac Nonfat Dry Milk Poudre de lait écrémé 55 Solum Diatomeae Diatomaceous Earth Terre de diatomées 56 Solum Fullonum Fuller’s Earth Terre à foulon 57 Sus Extract Pigskin Extract Extrait de peau de porc 58 Tallol Tall Oil Tallöl
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