Safety of Cosmetic Ingredients
Every cosmetic you use contains a number of ingredients, from preservatives to cleansing agents to fragrances. Health Canada is regularly reviewing these ingredients to make sure they are safe. Health Canada prohibits or limits the use of ingredients that present health risks.
Note: This document is created as guidance for consumers who are interested in how cosmetics and their ingredients are regulated as per the Cosmetic Regulations under the Food and Drugs Act. The information within is intended as guidance only. If there are any discrepancies between this document and the legislation, the legislation will supersede this document.
This topic includes the following information:
- About cosmetics
- How Health Canada protects you
- How Health Canada determines the safety of an ingredient
- Cosmetic ingredients that consumers often ask about
- For more information
Under the law, a cosmetic "includes 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." Cosmetics include beauty preparations (make-up, perfume, moisturizer, nail polish) and grooming aids (soap, shampoo, shaving cream, deodorant).
Always read the label and follow all directions when using cosmetics.
For more information on how to report health and safety incidents (including adverse reactions), see Report an Incident Involving a Consumer Product. For tips on what cosmetics are and using cosmetics safely, see Cosmetics and safety.
How Health Canada protects you
- Legislated protection: By law, manufacturers cannot sell cosmetics that contain any ingredient that may cause injury when used according to the directions on the label and under normal use. Health Canada can take appropriate compliance action if a product presents a hazard to the health or safety of Canadians.
- Mandatory notification: Manufacturers must disclose all cosmetic ingredients to Health Canada through a Cosmetic Notification Form. This lets Health Canada monitor ingredients and keep a record of all cosmetics sold in Canada.
- Continuous monitoring of scientific information: Health Canada monitors scientific literature on cosmetic ingredients, as well as information from the Chemicals Management Plan, the European Union and United States Food and Drug Administration (U.S. FDA). If any ingredients are found to present a risk to consumers, Health Canada will act quickly to prohibit or restrict the use of these ingredients and add them to the Cosmetic Ingredient Hotlist.
- Cosmetic Ingredient Hotlist: The Cosmetic Ingredient Hotlist is an administrative tool that Health Canada uses to communicate to manufacturers and others that certain substances, when present in a cosmetic, may contravene (a) the general prohibition found in section 16 of the Food and Drugs Act or (b) a provision of the Cosmetic Regulations. It lists ingredients that are intended to be prohibited or restricted for use in cosmetics in Canada. However, if an ingredient does not appear in the list, it does not necessarily mean that the ingredient is safe for use in cosmetics.
- Mandatory ingredient labelling: All cosmetics must disclose ingredients on the product label, which let consumers identify and avoid cosmetics with ingredients that are of concern to them.
- Monitoring of cosmetics on the marketplace: Health Canada has post-market surveillance processes in place to identify potential safety issues related to cosmetic products. Inspectors receive consumer and trade complaints made to Health Canada and investigate these cases to ensure the cosmetics are compliant with the law.
How Health Canada determines the safety of cosmetic ingredients
To determine if an ingredient is safe for use in cosmetics, Health Canada applies evidence-based decision making, and focuses on reducing any risks to consumers if an ingredient poses a hazard.
Health Canada scientists apply 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.
For example, formaldehyde may be hazardous when inhaled into the lungs. However, when used at small doses in products applied to the skin, the exposure to consumers is very low and therefore there is no health risk. This is why Health Canada considers formaldehyde in aerosol containers to be unsafe, but small amounts of formaldehyde in certain types of cosmetics to be safe, as outlined in the Cosmetic Ingredient Hotlist.
Cosmetic Ingredients that Consumers Often Ask About
Many of the ingredients in cosmetics have been the subject of news reports or have been topics of discussion on the internet. Health Canada regularly reviews these ingredients for their safety. The following represents their current status in cosmetics in Canada.
BHA and BHT
BHA (butylated hydroxyanisole) and BHT (butylated hydroxytoluene) are used as preservatives in many foods, cosmetic products and drugs. In cosmetics, these ingredients are found mainly in shampoos, deodorants, body lotions and make-up, usually at a concentration of 0.1% or less.
BHA and BHT play an important part in maintaining the quality and safety of products, and help to extend shelf life.
BHA was evaluated under the Government of Canada's Chemicals Management Plan and was found to not present a risk at current levels of exposure. In 2002, the U.S. Cosmetic Ingredient Review Expert Panel (with the support of the U.S. Food and Drug Administration) reviewed BHT in cosmetic products and found that BHT is safe as currently used in cosmetics.
Coal Tar Dyes
Coal tar dyes are colour ingredients that were originally made from chemicals extracted from coal tar, and the distillation process was not 100% effective so harmful impurities were often left in the product.
Although the coal tar dyes in use today are no longer made from coal tar, but made synthetically, the name has stuck. These ingredients have a high level of quality and purity, as they undergo a refining process to remove any unacceptable impurities. Some coal tar dyes, like para-phenylenediamine (also known as PPD), and others used in oxidative hair dyes still pose a health risk because they are known sensitizers when used on the skin (they cause allergic reactions upon repeat exposure).
The Cosmetic Regulations set out the prohibitions and other restrictions for coal tar dyes such as PPD. Most coal tar dyes are safe for use in cosmetics; however those coal tar dyes that have been found to be unsafe are prohibited. For example, sensitizing coal tar dyes are not permitted in the area of the eye. Also, coal tar dyes used in permanent and semi-permanent hair dyes must have cautionary statements on the inner and outer labels to warn consumers that the ingredients may cause skin irritation in certain individuals, and that a patch test should be done before every use.
The Government of Canada is currently reviewing many colourants under the Chemicals Management Plan (CMP). If any of these ingredients are found to be unsafe for human health and are relevant to cosmetic uses, Health Canada will add them to the Cosmetic Ingredient Hotlist. For example, as a result of a CMP assessment, Solvent Red 23 is proposed to be added to the Cosmetic Ingredient Hotlist as a substance that is not permitted in cosmetics intended to be used on or around mucosal membranes such as eyes, nose or mouth. Additionally, hair dye products containing Solvent Red 23 must contain cautionary statements to inform users not to use the products in the above specified areas.
Diethanolamine (DEA) and other ethanolamines
Diethanolamine (DEA) is unacceptable for use in cosmetics in Canada. This is because DEA and similar compounds like diisopropanolamine (DIPA) can form harmful nitrosamines (known carcinogens) upon reacting with nitrosating agents found in the cosmetic formulation or airborne nitrogen oxides. DEA and DIPA, along with any ingredients that can cause the formation of nitrosamines, when included in a cosmetic, may cause injury to the user, and should not be present in cosmetics sold in Canada. This is reflected in the Cosmetic Ingredient Hotlist.
Cocamide DEA, Cocamide DIPA and other fatty acid ethanolamines are currently permitted for use in cosmetics as they do not have the same nitrosamine-forming potential as DEA on its own. However, to mitigate the risk associated with the potential presence of DEA impurities, their use in combination with nitrosamine-forming agents is unacceptable for cosmetics.
The U.S. Cosmetic Ingredient Review Expert Panel is of the opinion that triethanolamine (TEA), diethanolamine (DEA) and monoethanolamine (MEA) (in rinse-off formulations only) are acceptable for use in cosmetics that are formulated to be non-irritating as long as they are not used in combination with nitrosating agents, as this may give rise to carcinogenic nitrosamines.
Formaldehyde (and Formaldehyde-releasing preservatives)
Formaldehyde is used in small amounts in hair and skin cosmetics as a preservative, to maintain the integrity of the product and prevent growth of microorganisms. Formaldehyde is a gas, but in liquid form, it is referred to as "formaldehyde", "methylene glycol" or "formalin". Formaldehyde-releasing ingredients slowly release very small amounts of formaldehyde to act as a preservative for the product or as a denaturant in the case of hair straightening products. Formaldehyde use has declined in recent years.
Formaldehyde is produced commercially but also occurs naturally in fruits and some foods. As well, it is formed endogenously in humans as a normal result of metabolism. When inhaled at high levels, however, formaldehyde is anticipated to be a human carcinogen.
Health Canada has reviewed the scientific information available on formaldehyde and considers formaldehyde to be safe when used in small concentrations on the skin. It is permitted at a concentration of 5% or less in nail hardeners but should carry cautionary labels and directions for safe use to indicate the potential to cause skin sensitivity. Formaldehyde is also permitted in oral cosmetics at a concentration of 0.1% or less and at a concentration of 0.2% or less in non-oral cosmetics as a preservative only. These are the lowest possible amounts that still have an effective anti-microbial effect. However, because formaldehyde may cause sensitivity in some individuals, Health Canada concluded that formaldehyde is not permitted in aerosol cosmetics due to inhalation hazards.
After reviewing new scientific data, a new limit has been added to the Cosmetic Ingredient Hotlist to address health concerns with the inhalation of formaldehyde in non-aerosol cosmetics that release formaldehyde vapours when used according to the directions of use. Hair straightening products that are intended to undergo forced convection (for example, blow-drying) and/or heating (for example flat-ironing), processes which cause formaldehyde vapours to be created and released, must not contain formaldehyde at concentrations of more than 0.01%.
Health Canada reviews fragrance ingredients like all other cosmetic ingredients. If a fragrance ingredient is found to be unsafe for use in cosmetics, it cannot be used in cosmetics sold in Canada, as per the law. Cosmetic ingredients that Health Canada determines may cause injury are reflected on the Cosmetic Ingredient Hotlist.
Canada uses the international naming convention for cosmetics, called "International Nomenclature for Cosmetic Ingredients" (INCI). Under this naming convention, components of a fragrance can be listed as individual ingredients or can be listed under the term "parfum" (in the E.U. and Canada) or "fragrance" (in the U.S.).
The fragrance industry is predominantly self-regulating. Most global fragrance suppliers are members of the International Fragrance Association (IFRA). IFRA develops and implements a Code of Practice and safety standards used worldwide to protect the consumer and the environment.
IFRA's standards for use and restrictions on fragrance ingredients are based on safety assessments by the Research Institute for Fragrance Materials (RIFM). RIFM is an independent non-profit institute that evaluates safety data on fragrance ingredients. RIFM's Panel of Experts is made up of toxicologists, pharmacologists and dermatologists who have no commercial ties to the fragrance industry. RIFM publishes its findings and conclusions in a peer-reviewed and accredited scientific journal.
Lead and other heavy metals
Due to health concerns, heavy metals such as lead, arsenic, cadmium, mercury and antimony are considered unsafe and should not be used as cosmetic ingredients in Canada. Yet impurities exist due to the persistent nature of these substances and the fact that they are found in the natural environment. Health Canada has set impurity limits for heavy metals in a guidance document. For example, the impurity limit for lead (Pb) is 10 parts per million (ppm).
These impurity limits are generally much lower than the limits known to cause harm in humans as used in cosmetics, but are technically feasible levels for manufacturers to achieve. Health Canada conducts routine testing in cosmetics for concentrations of heavy metal impurities. Health Canada will take compliance and enforcement actions as deemed appropriate for cosmetic products that contain heavy metal impurities beyond the acceptable limits.
Parabens are used as preservatives in many cosmetic and personal care products, including make-up, moisturizers, hair care products and shaving products. They are generally used at concentrations of 0.5% or less.
All commercially used parabens are synthetically produced, although some parabens also occur naturally as preservatives in certain fruits (for example, blueberries and carrots).
Parabens have been found to weakly mimic estrogens in in vitro studies and some, but not all, parabens have been found to have effects on the development of the male reproductive system in animal studies. While this raises a concern, there is currently no clear evidence that, at current levels of use in cosmetics, parabens cause similar effects in humans. In 2008, the U.S. Cosmetic Ingredient Review Expert Panel concluded that parabens are "safe as used" in cosmetics. In 2012 the Panel re-examined its previously published safety assessment of parabens and reaffirmed the safety of parabens as preservatives in the present practices of use and concentration in cosmetics. The European Union's Scientific Committee on Consumer Safety has published multiple opinions on parabens that state the use of some parabens in cosmetics is safe, within limits. The U.S. Food and Drug Administration has also made a statement on parabens in cosmetics.
Health Canada is currently conducting an assessment of parabens in all uses, to be published as a draft in Summer 2019. We will continue to monitor and review any new scientific data on parabens.
PEG, or poly(ethylene glycol) compounds are used to make non-ionic surfactants (surfactants allow for easier spreading of cosmetics, among other purposes). There are hundreds of different types of PEG compounds used in cosmetics. PEGs have low oral (taken by mouth) and dermal (used on the skin) toxicity. The U.S. Cosmetic Ingredient Review Expert Panel found that cosmetics containing PEGs should not be used on compromised skin (such as skin that is broken or has a rash), but there was no evidence of problems with healthy, intact skin. The final safety assessment, in 2012, of Alkyl PEG Sulfosuccinates and other PEG related compounds confirmed that these compounds are safe as used in cosmetic products, when formulated to be non-irritating.
Currently, there are no restrictions or prohibitions on cosmetic PEG compounds in Canada, the European Union or the U.S.
Small amounts of 1,4 dioxane, a by-product of ethoxylation, may be found in PEG and Sodium Lauryl Sulfate (SLS) ingredients. Exposure to high levels of 1,4 dioxane is linked to kidney and liver damage, and to cancer in some laboratory animals. The potential presence of dioxane in this material is well known, and can be controlled through purification steps. Dioxane exposure via cosmetic products was evaluated in Canada's Chemicals Management Plan and found to be safe. Health Canada advises industry to follow the recommendations set out by the U.S. FDA. If a product was found to have unacceptable levels of this impurity, Health Canada would take action to remove the product from sale.
Petrolatum (mineral oil jelly) is used widely in cosmetics as a moisturizer as well as in over-the-counter drugs as a skin protectant. Its safety has been reviewed by the U.S. FDA and Health Canada for these purposes. Food, drug and cosmetic petrolatum products are made from highly refined petrolatum at pharmaceutical or cosmetic grade. In the E.U., petrolatum is acceptable in cosmetics if the full refining history is known.
In Canada, if an ingredient is susceptible to impurities, the manufacturer must make sure the ingredients and products are of good quality and safe when used as directed. It is recommended that manufacturers follow Good Manufacturing Practices (GMPs) and use acceptable quality materials (for example, pharmaceutical grade). At this time, there have been no reports of unacceptable impurities (such as polycyclic aromatic hydrocarbons) in petrolatum found in products regulated by Health Canada.
Phthalates are used in cosmetics as plasticizers (to keep nail polish supple), perfume solvents, fixatives and antifoam ingredients. Many scientific reviews in Canada, the U.S. and the E.U. have shown that the phthalates most commonly used in cosmetics (DEP–diethyl phthalate and to a lesser extent, DBP–dibutyl phthalate) are safe at the levels at which they are currently used in cosmetics. Available studies looked at the typical routes of exposure through normal use of cosmetics (skin absorption and inhalation).
- In 2012, the U.S. Cosmetic Ingredient Review Expert Panel reaffirmed its original safety assessment, stating that DBP and DEP are "safe as used" in cosmetics.
- In 2007, the Scientific Committee on Consumer Products (the European Union's top scientific body) published its opinion on phthalates in cosmetic products. DEP in cosmetics was found to be safe at current levels of use. DBP however, is prohibited for use in cosmetic products in the European Union.
- The European Chemicals Bureau completed an in-depth risk assessment on DEP in 2004. In addition to a thorough evaluation of toxicity, the Bureau assessed exposure to DBP from cosmetics, focussing on nail polish in particular. The risk assessment found that there was no need for further risk reduction measures for consumers.
- In 2011, the Government of Canada published a study on concentrations and possible dermal exposure of phthalates in cosmetics and personal care products, in which it concluded: "that only DEP and DBP are present in significant quantity in cosmetic products. The overall exposure to phthalates from the use of cosmetic and personal care products was low and therefore unlikely to pose health risks to Canadian consumers".
- In 2004, Koo et. al. estimated exposure (inhalation and dermal) to phthalates in cosmetics and concluded that estimated exposure is relatively small.
Diethylhexyl phthalate (DEHP) was assessed by the Government of Canada, and was deemed that DEHP "may enter the environment in a quantity or concentration or under conditions that may constitute a danger in Canada to human health." While the phthalate DEHP has not been notified in any cosmetics with Health Canada, it is used in other countries as a cosmetic ingredient. It was added to the Cosmetic Ingredient Hotlist to communicate to manufacturers that it should not be used in cosmetic products.
As part of the chemical grouping initiative, under the CMP, the Government of Canada will be evaluating 14 substances which are part of the phthalate substance grouping. Fourteen additional substances are under consideration to be included in the grouping as well. The draft screening assessment is anticipated for release in 2016.
Para-phenylenediamine (PPD) is a coal tar dye commonly used in permanent and semi-permanent hair dyes, colours and tints. It is used with oxidizing agents like hydrogen peroxide to create colourant molecules. Hair colouring products have been used all over the world for decades with very few reports of adverse effects.
However, PPD is known to be a sensitizer when used on the skin (causes allergic reactions upon repeat exposure in some people), and a certain number of Canadians experience adverse allergic reactions to the ingredient. For this reason, the Cosmetic Regulations require cautionary statements and specific directions of use on the labels of all hair dyes containing PPD or other coal tar dyes. This is also specified in the Cosmetic Ingredient Hotlist. The labels must warn people that the product has the ability to cause skin sensitivity in some individuals and that a "patch test" should be done before using the product. Also, people are warned not to use the dye on eyebrows and eyelashes. Eyelash and eyebrow tinting should only be done by a professional.
PPD and other dye constituents are acceptable for use only in oxidative hair dyes at specific concentrations. Adverse reactions to this ingredient in hair dyes are rare when used as directed. This is because the oils on the scalp give some protection from the dye, and the product is rinsed off after no more than 30 minutes of use.
Both the European Union and U.S. have studied the use of PPD and found it is safe for use in hair dyes at the current concentrations by people who are not sensitive. They place similar restrictions as Canada on the use of PPD in hair dyes with cautions on the label.
The use of PPD on the skin in cosmetic products like black henna tattoos is unsafe because when applied to the skin, PPD can be a strong sensitizer.
Cyclomethicone and siloxanes are used in cosmetics to soften, smooth and moisten. Siloxanes are found in the vast majority of hair care and skin conditioning products on the market and leave hair and skin with a soft and silky feeling. Disclosure of ingredients on product labels of cosmetics is mandatory in Canada. Among the ways you can identify siloxanes in cosmetics is by looking for the term "siloxane" or "cyclomethicone" in the ingredient list.
Siloxanes were evaluated for risks to human and environmental health under the Chemicals Management Plan. An analysis of exposure through cosmetic products showed that the substances do not present a risk to human health as currently used.
After reviewing information on bioaccumulation of certain siloxanes, the Government of Canada concluded that Siloxane D5 and D6 are not harmful to human health. However, Siloxane D4 may cause harm to the environment or its biological diversity. The Government of Canada is developing measures to control the potential risks posed by Siloxane D4. Environment Canada will review and consider the development of additional risk management controls for Siloxane D4, if required, as more information becomes available.
Sodium Lauryl Sulfate (SLS)
Sodium Lauryl Sulfate (SLS) is most often used as a cleansing and foaming agent in rinse-off products like shampoos, bath products, shaving creams and skin cleansers. It is also sometimes found in other cosmetics like creams and lotions.
At high levels, SLS can cause skin or eye irritation in some individuals, which is why it is important to follow label instructions when using a cosmetic product. In skin absorption studies, it was found that there was little or no skin penetration with high levels of SLS. However, many baby products do not contain SLS in order to create a milder formula with less potential for skin irritation.
The U.S. Cosmetic Ingredient Review (CIR) Expert Panel reviewed the safety of SLS in 1983 and again in 2004. They found that SLS is safe in rinse-off products like soaps and shampoos. In products intended for prolonged contact with skin, concentrations should not exceed 1 percent. A final review amendment was done in 2010 based on new data. The U.S. CIR Expert Panel continues to maintain its position on the safety of SLS and related salts.
This ingredient is considered acceptable in cosmetics by the E.U. and the U.S. FDA. At this time, there is no evidence to show that SLS causes an undue safety risk to consumers when used as directed in cosmetics.
Triclosan is used in cosmetics as a preservative to prevent or slow down microbial growth and protect products from spoilage. This ingredient is also used in over-the-counter drugs and other consumer products.
Health Canada considers triclosan to be safe when used in cosmetics at a concentration of up to 0.03% in mouthwashes and 0.3% in other cosmetic products like soaps (see the Cosmetic Ingredient Hotlist for more details about triclosan limits). These cosmetic limits are consistent with those of the European Union, which allows triclosan in cosmetic products at 0.3% as a preservative.
The Government of Canada has completed the assessment of triclosan as part of the Chemicals Management Plan. The review concluded that triclosan is not harmful to human health but can cause harm to the environment when used in significant amounts. This preliminary assessment confirms that Canadians can continue to safely use products such as toothpaste, shampoo and soap containing triclosan.
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