WHAT IS A COSMETIC PRODUCT?
It is unreasonable to assume that a cosmetic product in one area will automatically be identified as a cosmetic product in another. The complexity of legislation and consumer perception means that the same product can be reclassified as a drug or interface.
When developing personal care products, manufacturers need
to understand how their product will be defined in the target market to ensure
consumer acceptance and compliance.
The same personal care product may be classified differently
in different markets. It is important to understand how the target market will
define the product to ensure consumer acceptance and compliance with regulatory
requirements such as labeling.
To understand how the target market will perceive a product,
manufacturers must view their personal care products from three different
angles. They should consider.
DEFINITION
In the European Union (EU), a "cosmetic product"
is defined in accordance with Article 2 (1) of Regulation (EC) 1223/2009 on
cosmetics as:
“Any substance or mixture intended to come into contact with
the external parts of the human body (epidermis, capillary system, nails, lips
and vulva) or with teeth and oral mucous membranes for a single or primary
purpose. cleanse them, flavor them, change their appearance, protect them, keep
them in good condition or eliminate body odors "
A cosmetic definition determines its scope by looking at its
condition, scope, and intended function. This can create problems with some
questionable products such as.
CONSUMER PERCEPTION
A cosmetic product must not use printed materials, images,
illustrations, or packaging designs to alter the consumer's perception of the product that the function is not purely cosmetic. For example, a bath product
cannot have the characteristic shape, color, and/or size of a cake because it
could be mistaken for food. In the EU, products may not comply with Cosmetic
Products Regulation (EC) 1223/2009 and Directive 87/357 / EEC if they appear to
be different from what they are and pose a health or safety hazard to the
consumer.
ACTIVE INGREDIENTS
The classification of a product as a medicine or drug is
often related to the active ingredient contained in the product. This can lead
to the appearance of questionable products, for example:
Tubes of toothpaste
Toothpaste is generally considered a cosmetic product unless
it contains an active ingredient such as fluoride at an active level. This will
prevent tooth decay and therefore will not be considered a cosmetic product. In
the US, this is likely to fall into the realm of over-the-counter
Sun protection
EU: subject to cosmetics as defined in Regulation (EC)
1223/2009 on cosmetics.
USA: Non-prescription drug with active ingredients approved
for use as sunscreen as defined in 21 CFR Part 352 (Subpart B). This is
applicable if the product is purely sunscreen or has sunscreen as a secondary
function.
Australia: Only those products that have a primary cosmetic
function and a secondary sunscreen function, but under certain conditions, are
classified as cosmetic products and are regulated by the National Industrial
Chemicals Assessment and Notification System (NICNAS).
Looking at these frontier products, it is clear that in
order for a product to successfully enter a target market, a manufacturer must
consider how regulatory definitions, consumer perceptions, and active
ingredients in a product will affect market access. Without this knowledge, a
product could accidentally enter the market without proper safety and labeling
requirements. The costs of not meeting target market requirements can be high
due to costly product recalls formulation changes and extended time-to-market.
