Health Canada is Seeking Stakeholders’ Comments
Health Canada is seeking stakeholder’s comments and feedback regarding potential amendments to the Cosmetic Regulations. Comments are open from July 16, 2021 to August 30, 2021.
Cosmetic Alliance Canada is happy to report that the Forward Regulatory Plan clearly establishes HC’s post Covid-19 commitment to Self-Care Framework as a priority.
- Phase I – Targeting spring 2021: Introduce, for consultation, targeted amendments to the Natural Health Products Regulations to improve labeling of natural health products. This proposal will require essential risk information to be presented in a standardized format, with minimum font size and black-on-white contrast, making it easier to read, understand and compare with that for other similar self-care products, such as non-prescription drugs, on store shelves. The use of plain language will also ensure that information on labels can be easily understood by Canadians. (These changes are necessary to eventually align labelling requirements for all cosmetic, natural health and drug products regulated together in each self-care risk category)
- Phase II – Targeting spring 2022: Targeted amendments to introduce for consultation a risk-based approach to regulatory oversight for non-prescription drugs. These include: expedited pathways for lower-risk products. These changes are intended to align the oversight for non-prescription drugs with other self-care products of comparable level of risk. Regulations amending the Food and Drug Regulations, Part C (Agile Regulations for Licensing Drugs, including Self-Care Framework Phase 2 and the Use of Foreign Decisions)
- Phase III – Introduce for consultation, regulatory amendments to address: evidence standards for similar health claims; extending risk-based regulatory oversight; and, seeking additional powers for Health Canada such as the ability to require a recall or label change for all self-care products.
Are your cosmetic ingredients acceptable by Health Canada standards?
To determine if an ingredient is safe for use in cosmetics, Health Canada applies evidence-based decisions on reducing any risks to consumers if an ingredient poses a hazard.
Health Canada uses the principles of toxicology, which means that they look carefully at both the characteristics of the ingredients of a product as well as how consumers are exposed to those ingredients. Under these principles, a particular ingredient can be considered hazardous, but safe at low doses, because the exposure is low. It is a case by case scenario.
Cosmetics Regulations may seem clear-cut, however, the regulations that influence cosmetics contain underlying complications, particularly in the areas of classification and claims one can make. We have acquired the experience a manufacturer or distributor will need to successfully register your cosmetic products.
Do I need to register my products with Health Canada prior to sale?
Prior to Sales Notification is a mandatory requirement for the sale of cosmetics in Canada, according to section 30 of the Cosmetic Regulations. This entails submitting a fully completed Cosmetic Notification Form (CNF) to Health Canada within the first 10 days that a cosmetic is available for sale. There is no fee associated with the cosmetic notification process.
In Canada, cosmetic products are defined as “any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes.”
A cosmetic product, its ingredients, claims, and labelling must all comply with the Canadian Food and Drugs Act and its Cosmetic Regulations.
Cosmetic Classification and Cosmetic claims
The classification of a product as either a drug or a cosmetic can present a challenge. This section attempts to indicate, through examples and explanation, some current practices in classification. Cases are, however, considered on an individual basis.
Two factors are considered in the classification of cosmetic products: composition of the product, and the proposed use of the product.
The composition of a product does not necessarily determine its classification. However, it is quite possible that an ingredient, or the concentration of an ingredient, may make the product unsuitable for classification as a cosmetic.
According to the definitions of the terms “cosmetic” and “drug”, the key consideration for the classification of a product is its proposed use. The claims made in package inserts, in advertisements, and especially in product labels, indicate the intended use of the product.
It is also important to consider the context in which the product is marketed.
Claims that indicate that a product is a drug cannot be made for a product marketed as a cosmetic. If the manufacturer or importer chooses to remove the drug-related claim, the product may be classified as a cosmetic. If a manufacturer or importer chooses not to remove a drug-related claim, the product may be regulated as a drug. (Information on regulatory requirements for cosmetics and drugs is available from the Cosmetics Program and from the Therapeutic Products Directorate.
Examples of Classifications
A product that has only a cosmetic use, but must be swallowed to achieve the cosmetic effect (i.e., it is transported through the body to perform its cosmetic action), is regulated as a drug (e.g., preparations containing chlorophyll to deodorize breath).
When swallowing is secondary to the cosmetic purpose, but is an integral part of the product’s use, the product is considered to be a food and not a cosmetic (e.g., a breath mint or a lozenge sits in the mouth to deodorize breath, but as it dissolves, the components are swallowed). When swallowing is incidental to the cosmetic’s use, the product is a cosmetic (e.g., dentifrice or spray or drops to freshen breath).
Certain products may be classified in two categories. For example, a disposable toothbrush that contains a dentifrice may be classified as both cosmetic and a medical device.
“Cosmeceutical” is a term used in the cosmetic industry for cosmetic products that have drug-like qualities. The definitions under the Food and Drugs Act do not allow a product to be both a cosmetic and a drug. Therefore, “cosmeceuticals” fall under either cosmetics or drugs, depending on the ingredients and claims made.
It is important to note that the rejection of a product as a cosmetic does not necessarily ensure its acceptance as a drug since safety and efficacy must be demonstrated.
Products must have both outer and inner labels and specific requirements apply to each type of label.
What information do I need on my label?
On the outer label, the declaration of product identity must appear in both English and French on the principal display panel. The declaration must clearly contrast both with the background of the label and all the other information on the label.
Official Bilingual Exemptions Exemptions concerning official bilingual labelling may be granted in certain cases. Sections 6(3) and 6(7) of the Consumer Packaging and Labelling Regulations allow temporary exemptions (one year maximum) for products undergoing bona fide test marketing and for local or specialty products. Under these circumstances, the product may be identified in either of the two official languages.
Additional Panels: The labels of some prepackaged products are composed of one or more additional panels of the same size and prominence as the principal display panel. The product identity may be given on the principal display panel in only one of the two official languages, provided that it is also given in the other language on one of the other panels.
Inner Label Requirements
A declaration of identity must appear in English and in French on the principal display panel. The declaration must contrast clearly with the background and all other information that appears on the label.
Single Expressions The requirements are the same as those for the outer labels of products that have both an outer and inner label.
Obvious Identity In certain cases the identity of a product such as a lipstick, an eyebrow pencil, an automatic mascara applicator, or a compact including powder and puff may be considered obvious. A written declaration of product identity would not be necessary. If the product is in an opaque container, the identity of the product must be expressed.
Cosmetics sold in Canada must submit a notification to Health Canada within 10 days of first sale within Canada, and ensure that none of the ingredients are restricted as shown on the Hot List due to allergic and other adverse effects.
Failure to notify may result in a product being refused entry into Canada or removed from sale. Notification is not a product evaluation nor an approval procedure, and acceptance of the completed CNF by Health Canada does not constitute in any way agreement that the product is classified as a cosmetic or is in compliance with all regulatory requirements.
In addition, labels must not have any health claims so as not to be categorized as either a NHP or a drug. Health Canada indicates that a cosmetic product should be held accountable even though no regulatory body is in place just yet.
In addition to the Canadian Cosmetic Regulations, considerations must be made for the Canadian Environmental Protection Act (CEPA), the New Substances Notification (NSN) Regulations, and the Consumer Packaging and Labelling Act and Regulations in order to ensure regulatory compliance prior to the marketing of a cosmetic in Canada.
Changes are coming for these products, but to date, no regulations are established.
If something is approved by the FDA, does that mean it is also approved in Canada?
No. The United States Food and Drug Administration (or FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation in the United States.
Canada has an equivalent regulatory body called Health Canada. Although both bodies agree and work together on many of the same issues, they are not one and the same. Each country has its own rules and regulations that must be followed.
Can I sell a natural insect repellent?
No. All pest control products, including personal insect repellents, are regulated in Canada under the Pest Control Products Act. Before a product is registered for use, it must undergo a comprehensive and rigorous scientific assessment to ensure the product does not pose unacceptable risks to human health or the environment and to assess its efficacy to ensure that the lowest effective rate is used. If the assessment does not indicate that a product can be used safely, it is not registered for use in Canada. The same approach is taken during the re-evaluation of registered pesticides.
Companies that wish to have the right to sell a pest control product in Canada must submit detailed information and data to be evaluated by the PMRA. Companies must provide all the scientific studies necessary for determining that the product is acceptable in terms of safety, merit and value. Depending on the complexity of the submission, a complete evaluation can take anywhere from a number of weeks, to a year or more. The evaluation results either in the product being granted registration and allowed for sale and use in Canada, or in the product being refused registration.
We can help file your cosmetics notification form and ensure you have a compliant label.