Testing plays a crucial role in the cosmetic product manufacturing process. Compliance with specific testing requirements is essential to ensure that cosmetic products are safe for use under reasonably foreseeable conditions.
How it is working in other parts of the world?
USA
FFDCA defines a “cosmetic” as an article intended to be “applied to the human body … for cleansing, beautifying, promoting attractiveness, or altering the appearance.” The term covers a broad range of FDA-regulated products that may be used externally and internally. Cosmetics include products for the eyes, face, nails, hair, skin, and mouth, such as makeup, nail polish, hair dyes and coloring, suntan preparations, fragrances, oral care, and bath products. Although soap was explicitly exempted from the definition of a cosmetic, it may be regulated by the FDA as a cosmetic product in certain instances. In addition, coal-tar hair dye was provided a limited exemption from the FFDCA’s adulteration provisions. Inks used for tattooing are also classified as cosmetics under the FFDCA. Under MoCRA, FFDCA will separately define a “cosmetic product” as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”
Although the term “cosmeceutical” has been used to refer to combination cosmetic/drug products, such products have no statutory or regulatory definition. Historically, FDA has indicated that cosmetic/drug combinations are subject to FDA’s regulations for both cosmetics and drugs. Determining whether a cosmetic is also a drug, and therefore subject to the additional statutory requirements that apply to drugs, depends on the distributor’s claims regarding the drug’s intent or intended use. A product’s intended use may be established in several ways, such as claims on the label or in advertising or promotional materials, customer perception of the product, and the inclusion of ingredients that cause the product to be considered a drug because of a known therapeutic use. For example, if a lipstick (a cosmetic) contains sunscreen (a drug), historically, the mere inclusion of the term “sunscreen” in the product’s labeling required the product to be regulated as a drug as well as a cosmetic. The text box below provides examples of other cosmetic/drug combinations and compares cosmetic and drug classifications.
According to the MoCRA, products require an adequate safety justification, which is further defined as « tests, studies, studies, analyses, or other evidence or information, sufficient to support a reasonable assurance that the product is safe, which are then evaluated by qualified experts (through experience) performing a safety assessment of cosmetic products and their ingredients. »
However, the legislation does not provide for a specific set of tests or documents demonstrating the safety of individual products or ingredients. It is up to cosmetics manufacturers to prove the safety of their products.
The manufacturer should keep appropriate documentation – product safety dossier.
Cosmetic products must also comply with ingredient restrictions, there are prohibitions and requirements for coloring additives (there is a specific list of FDA approved and exempt from approval). Other coloring additives require FDA approval/certification before they can be used in cosmetics.
Canada
Cosmetics sold in Canada are regulated by Health Canada, which monitors production and distribution in several sectors. Cosmetic products placed on the Canadian market must comply with the Food and Drugs Act, with the Cosmetic Regulation as well as the Consumer Packaging and Labelling Act.
The Food and Drugs Act provides a definition of a cosmetic product in Canada. Cosmetic products include “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”.
Cosmetic claims in Canada are regulated under the Consumer Packaging and Labelling Act and the Competition Act and are overseen by Competition Bureau. They can take action in cases of false or misleading marketing claims.
There are common criteria for cosmetic claims, which are shared among many countries. The claims have to be true, verifiable and not misleading to the consumers.
It is important to avoid any drug-type claims as those are not permitted for cosmetics. By using such claims, which imply that the cosmetic product has a physiological effect, you would risk the product to be classified as a drug. Some drug-type claims include the words ‘restores, repairs, prevents, stimulates, eliminates, stops, heals, etc. Products that claim to have an SPF, even if this is a secondary function (e.g. moisturiser with an SPF), would be considered a drug in Canada. However, products, which include sunscreen ingredients but do not claim to have an SPF, would be considered cosmetics. Products that claim to have skin lightening/whitening effects and products with antiseptic properties (sanitisers, disinfectants) are also considered drugs in Canada.
There are also some defined criteria for the special claims such as:
- Hypoallergenic claim – this claim can be made for products, which have a minimum potential for causing allergies. However, this is not considered to be a legal term, so there are also no requirements for manufacturers in regard to the use of this claim. It is important to note that products with a hypoallergenic claim can still cause an allergenic reaction in some individuals.
- Dermatologically tested – this claim can be used on products sold in Canada. It means that the product was tested to make sure that the product is not (or is less) irritating to the skin and that this test involved a dermatologist at some point during the study. However, there are no regulations for the type of test needed in order to support this claim.
- Not tested on animals – similar to the US, this claim is allowed to be used on products sold in Canada. It usually means that the cosmetic product was not tested on animals, but it does not necessarily mean that this applies to the individual ingredients as well. Canada is, however, working towards a ban on animal testing for cosmetics.
As we can see, cosmetic testing all over the world is a multi-faceted process that prioritizes consumer safety, claims support, and Regulatory compliance. With its firm commitment to safeguarding public health we are slowly gaining confidence that the cosmetic products available to consumers are safe and effective.
References:
https://cosmeticsbusiness.com/how-to-make-claims-for-cosmetics-sold-in-canada-166030
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