Cosmetics: Frequently Asked Questions

Introduction - Cosmetic Safety and the Consumer
Cosmetic or Drug?
What Safety Criteria and Good Manufacturing Practices (GMPs) Must a Cosmetic Meet?
How Reliable Are Manufacturer Claims and Advertisements?
What Information Must Be on Cosmetic Labels?
How Are Hair Colours Labelled?
What Is The Patch Test?
Are Hair Dyes Safe?
How Safe Are Eye Cosmetics?
Cosmetic Terms on Labels
Natural Versus Synthetic
Are Tanning Products Cosmetics?
Adverse Reactions to Cosmetics - Who Do I Call?
Conclusion - The Consumer and Cosmetic Safety

Cosmetic Safety and the Consumer

Cosmetics are a part of everyone's daily grooming routine. From the newborn's baby powder to grandpa's after-shave lotion. Estimated sales of cosmetics in Canada total over four billion dollars annually.

Regardless of whether the product is a beauty preparation (make-up, perfume, skin cream, nail polish) or a grooming aid (toothpaste, soap, shampoo, deodorant), all cosmetics sold to consumers must meet the requirements of the Food and Drugs Act and Cosmetic Regulations and the Consumer Packaging and Labelling Act and Regulations.

Cosmetic or Drug?

The law defines a cosmetic as a product which cleanses, improves or alters the complexion, skin, hair or teeth. A beauty product or grooming aid is usually categorized as a cosmetic, but will be legally classified as a drug if it makes any claims to modify body functions, to prevent or treat disease.

What Safety Criteria and Good Manufacturing Practices (GMPs) Must a Cosmetic Meet?

The Food and Drugs Act and the Cosmetic Regulations set safety requirements. All cosmetics sold in Canada must be:

• free from filth, foreign matter and substances that may injure the health of the user when the cosmetic is used according to label directions or customary ways of use;
• manufactured, prepared, preserved packed and stored under sanitary conditions; and
• on notification with the government as to the composition. (A manufacturer must disclose the composition of any cosmetic so that the acceptability of its ingredients can be monitored. If a safety concern arises, the cosmetic is prohibited from the market. Those "trade secrets" are considered confidential.)

There are currently no regulations specifying GMPs for cosmetics. However, products are expected to be manufactured with the general safety conditions specifed in Section 16 and 18 of the Cosmetics Regulations. For information on specific GMP guidelines, please read the United States Food and Drug Administration's document entitled Cosmetic Good Manufacturing Practice Guidelines or contact the Canadian Cosmetic, Toiletry and Fragrance Association.

How Reliable Are Manufacturer Claims and Advertisements?

Claims for a cosmetic on a label or in an advertisement must be accurate so that they do not mislead the public. Since certain claims, such as increased attractiveness or increased masculinity, can only be judged subjectively, some puffery (exaggeration of a kind which does not mislead the public) is tolerated. However, be doubtful of any therapeutic claims on a label that does not have a Drug Identification Number (DIN) or Natural Product Number (NPN) associated with it. Therapeutic claims are not acceptable for cosmetic products.

Radio or television advertising is previewed and cleared with Advertising Standards Canada before it is broadcast. Printed advertisements do not require pre-clearance review. Instead, a selection of popular Canadian magazines and newspapers are monitored and if an advertisement does not conform with the Regulations, the advertiser is asked to change or withdraw it.

What Information Must Be on Cosmetic Labels?

Labelling is regulated by the Food and Drugs Act, the Cosmetic Regulations and the Consumer Packaging and Labelling Act and Regulations.

To comply with these requirements, cosmetic labels must supply:

• an ingredient list
• the identity of the product, in English and French in terms of common or generic name or function;
• a statement of net quantity in metric units of measurement;
• the name and address of the manufacturer or distributor; and
• directions, warnings or cautions, in English and French where necessary for safe use of the product.

Specific regulations also exist for the safe use of special products, such as hair dyes. In addition, the statutes prohibit false and misleading representation or deceptive packaging.

More information on ingredient labelling

How Are Hair Colours Labelled?

Permanent and semi-permanent hair dyes, which employ coal tar dye bases and coal tar dye intermediates to produce the colour, are required by law to also carry on their labels:

• a warning that the product may cause skin irritation on certain individuals;
• a warning not to use the product for dyeing eyebrows and eyelashes because to do so may cause blindness; and
• instructions for carrying out a preliminary test for skin irritation called the patch test.

What Is The Patch Test?

The patch test is a way of determining an individual's sensitivity to products, including cosmetics.

To make the test, a small area of the skin behind the ear or upon the inner surface of the forearm is cleansed, then a small quantity of the cosmetics as prepared for use is applied to the area and allowed to dry. After 24 hours, the area is washed gently with soap and water.

If there is any redness, burning, itching, blistering or eruptions, the reaction is positive and the cosmetic should not be used.

The patch test should be performed whenever permanent or semi-permanent hair dyes are used. Sensitivity to these ingredients may not reveal itself until after these products have been used a number of times and therefore the patch test should be repeated before each application.

Other types of hair dyes are sold in Canada and these do not require routine use of the patch test because they do not cause skin irritations in most persons.

Are Hair Dyes Safe?

The Food and Drugs Act requires that cosmetics be safe under the intended condition of use. Health Canada's evaluation of current scientific data indicates there is no hazard associated with the proper use of hair dyes.

How Safe Are Eye Cosmetics?

Eye cosmetics must meet the same requirements as other cosmetics regarding safety and sanitary manufacturing. If contamination is found, the sale of such product is discontinued until corrective action is taken by the manufacturer. However, part of the responsibility for safety from microbiological contamination belongs to the individual consumer. In the area of eye cosmetics, much depends on the way a product is handled after purchase.

Since infection of eye tissue can have very serious consequences, possibly even blindness, always follow these basic safety precautions:

• Wash your hands before applying eye cosmetics
• Never use saliva to moisten mascara or other eye make-up.
• Never borrow or share your eye make-up.
• Discontinue the use of an eye cosmetic immediately if its use results in irritation or inflammation.

Cosmetic Terms on Labels

Fragrance Free or Unscented
This means that there have been no fragrances added to the cosmetic product, or that a masking agent has been added in order to hide the scents from the other ingredients in the cosmetic.

Hypoallergenic
"Hypoallergenic" is neither a legal nor a scientific term. It simply means that the manufacturer has selected ingredients with the objective of producing a finished product with minimum potential for causing allergy. This does not guarantee that the product will not cause an allergic reaction in some individuals as people are allergic to a wide array of substances. There are no non-allergenic cosmetics.

If you experience an allergic reaction to a cosmetic, try switching to a different brand.

Ophthalmologist Tested/Dermatologist Tested
These terms usually mean that a test on the product was conducted to ensure that the product is not (or less) irritating to eyes or skin, and that this test involved a skin or eye doctor at some point during the study. It is the safety of the product that has been tested and not the efficacy of the product. There are no regulations that standardize the type or number of tests needed to use this claim on labels.

Not Tested on Animals
The cosmetic product was not tested on animals. This does not guarantee that the individual ingredients were not tested on animals. For new ingredients, testing is sometimes essential to determine that the ingredient is safe. The scientific community is moving toward using fewer animals and is gradually producing valid tests that do not use live animals but use cell cultures instead called "in vitro testing" as well as predictive computer models, however these new methods, cannot completely replace animal testing at this time for the risk assessment of most substances.

Preservative-Free
We have all heard how preservatives are supposed to be bad for you. In most cases, they are actually good and very essential for most cosmetics. The warm and damp area of your bathroom, where people use and store many cosmetic products, can be an ideal environment for microorganisms to grow in your cosmetics. Microorganisms can also find their way into cosmetics through cross-contamination when a cosmetic or its applicator touches your skin or hair and then touches the cosmetic again. Fortunately, most cosmetics contain preservatives to keep harmful bacteria, mold and yeast from finding its way in and growing on your cosmetics.

Natural Versus Synthetic

There is a general assumption among consumers that "natural" products are better or healthier than similar ones using synthetic ingredients. Often, however, these "natural" ingredients are no different in chemical composition than their synthetic counterparts. In fact, a synthetic substance which mimics a natural one can sometimes provide a purer, more stable ingredient which gives the product a longer usable life.

Health Canada considers both natural and synthetic ingredients to be equally suitable for use in cosmetics.

Are Tanning Products Cosmetics?

It is important to be aware that there is no such thing as a "healthy tan". Excessive exposure to the sun or to tanning beds can cause skin damage, eye damage and even skin cancer. Certain medications, including antibiotics and diuretics, can increase an individual's sensitivity to the sun. More information on preventing skin cancer.

Tanning lotions, oils or creams are considered cosmetics. They help moisturize the skin during exposure to the sun and thereby increase the opportunity for the user to get a tan. The suitability of a particular product is dependent on the individual's melanin (dark pigment) production.

On the other hand, sun blocks or screens are considered drugs because the product claims to prevent sunburn by shielding the skin from the sun's ultraviolet radiation. They can easily be differentiated from suntan lotions by the SPF or UVA/UVB designations on the label.

Self-tanners are considered cosmetics because these contain substances which are absorbed by the topmost layer of skin. Oral tanning products are drugs since they are ingested. These synthetic colouring agents, often identical to natural ones, are taken in large amounts so that the extra colouring agents become stored in the body's fatty tissue including the tissue under the skin. Both self-tanners and oral products do not provide a "sun" tan nor do they provide any protection from the sun's radiation. The "tan" will fade if the product is discontinued and as the colouring agents are eliminated from the skin or body.

Adverse Reactions to Cosmetics - Who Do I Call?

While the use of most cosmetic products have little or no risk associated with them, some people may occasionally encounter adverse, or unwanted effects. The effects noted are normally in the form of irritation or mild allergic reactions, but there have been cases of accidental ingestion of cosmetics by children, as well as a few isolated cases of hair loss associated with some hair dyes.

So what do you do if you suspect that you've experienced an adverse reaction?

1. Discontinue the use of the cosmetic.
2. Use good judgement to determine whether you should seek medical attention for the adverse effect. If it is an accidental ingestion by a child, immediately call the poison control centre nearest you. The number is located in the first few pages of your local telephone directory.
3. Keep the product that may have caused the effect at hand. This will enable your doctor and the Bureau to better help you. Remind your physician to report the problem to the Cosmetics Program. Information you may need to provide.
4. After medical attention has been sought (if needed), call or write your regional Product Safety Bureau if your physician has not done so already. We will do our best to help you out. Contact the Office Nearest You.

The Consumer and Cosmetic Safety

Laws and regulations provide the consumer with an increasing degree of protection, but cannot prevent misuse of cosmetics by the consumer. It is extremely important to read and follow exactly any directions for use provided by the cosmetic product. This information is provided to assist the user in avoiding potential hazards and is a vital factor in the safe use of cosmetics.

It is also important to remember that:

• Cosmetics should not be shared with someone else as there is the possibility of cross-contamination by skin bacteria.
• Cosmetics should not be stored for a long time (over one year) since the product's properties may alter with age and no longer be satisfactory.
• Cosmetics should be kept out of the reach of children to avoid accidental ingestion.