It is unwise to assume that a cosmetic product in one territory, will automatically be defined as a cosmetic in another. The complexities of legislation and consumer perception mean the same product may reclassified as a drug or interface.
When developing personal care products, manufacturers must understand the way their product will be defined in the target market to ensure consumer acceptance and compliance.
The same personal care product can be categorized differently in different markets. It is important to understand the way the target market will define the product, in order to ensure acceptance by consumers and compliance with regulations, such as labeling.
To understand how the product will be received by the target market, manufacturers must view their personal care products from three distinct angles. They must consider:
- Consumer perception
- Active Ingredients
In many cases, using these three criteria for assessing a product will help the manufacturer define and market their product. In some cases, however, the complexity inherent in the product means that classification is not always straight-forward. In this article we will consider definition, consumer perception and the active ingredients, along with some borderline products where classification can be difficult.
In the European Union (EU), ‘cosmetic product’ is defined, according to Article 2(1) of (EC) 1223/2009 Cosmetic Regulation, as:
“Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors”
The cosmetic definition defines its scope by looking at its state, application area, and intended function. This can create issues with some borderline products, such as:
- False eyelashes
Due to their function as appearance changers, it might seem that false eyelashes should be considered cosmetic products. In fact, the categorization is reliant upon the definition of cosmetic:
- EU: false eyelashes are not cosmetics because the definition only considers ‘substance and mixture’ within its scope
- USA: Food and Drug Administration (FDA) considers false eyelashes, eyelash extensions, and their adhesives, to be cosmetic products. The Federal Food, Drug and Cosmetic (FD&C) Act defines cosmetics as, “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance”
- Wet razors
Razors will not automatically be cosmetics in the EU. However, if a razor contains a chemical strip that slowly releases a substance or mixture, bringing a cosmetic effect – e.g. a moisturizer, it must meet the requirements of the Cosmetic Regulation
- Hand sanitizers
Hand sanitizers that protect the skin against infection by being antiseptic or antibacterial, may be classified as medicinal products rather than cosmetic products:
- EU: any substance or mixture with properties for treating or preventing disease in humans; or being used in or administered to human beings, either with a view to restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to assist in the making a medical diagnosis, falls under the scope of a medicinal product. If the hand sanitizer claims antiseptic or antibacterial properties, it will probably fall under the scope for biocidal products, meaning it should follow the biocide directive
- USA: the definition is different because ‘drug’ is defined as - ‘articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease...and articles (other than food) intended to affect the structure or any function of the body of man or other animals’. Hand sanitizer is therefore considered an over-the-counter (OTC) drug and does not require a doctor's prescription
- Nasal sprays
These are not considered cosmetic products in the EU because the definition of cosmetics does not cover the nasal cavity, only the external parts of the human body and teeth/mucous membrane in the oral cavity
A cosmetic product must not use print, images, illustrations, or package design to alter the consumer’s perception of the product that the function is anything other than purely cosmetic. For example, a bath product cannot take the characteristic form, color, and/or size of a cake, because it may be mistaken for a foodstuff. In the EU, products may not comply with the Cosmetic Products Regulation (EC) 1223/2009 and the requirements of Directive 87/357/EEC if they appear to be other than they are and endanger the health or safety of consumer.
Classification of a product as drug or medicinal product often relates to the active ingredient contained within the product. This can lead to borderline products, such as:
Toothpaste is generally considered to be a cosmetic product, except when it contains an active ingredient like fluoride at an active level. This will prevent dental decay and so it will not be considered as a cosmetic. In the US, it is likely to fall under the scope of OTC
- Sunscreen products
- EU: falls under the scope of cosmetics, as defined in (EC) 1223/2009 Cosmetic Regulation
- USA: OTC drug product, with permitted active ingredients for sunscreen function defined in 21 CFR Part 352 (subpart B). This applies whether the product is purely a sunscreen, or has sunscreen as a secondary function
- Australia: only products having primary cosmetic function and secondary sunscreen function, but under certain conditions, are classified as a cosmetic product and are regulated by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
Looking at these borderline products, it is clear that for a product to successful enter its target market, the manufacturer must consider how regulatory definitions, consumer perception, and the active ingredients in the product, will affect access to the market. Without this understanding, a product may accidentally come to market without the correct labeling and safety requirements being applied. The costs of failing to comply with the requirements of a target market can be high, with expensive product recalls, reformulations and extended time-to-market periods.
For more information on how SGS can assist with understanding international personal care product regulations, contact:
Consumer and Retail
Cosmetics, Personal Care and Household (CPCH)
t: +852 2765 3672 ext. 1672