Page 24 - CTPA Annual Report 2011

Basic HTML Version

07. Science, Innovation and the Cosmetics Industry
What is a Cosmetic?
Cosmetics today are more than just decorative products. Indeed, they have long been more than
just decorative products: in 1541 BC Queen Hatshepsut of Egypt was buried with a skin balm,
clearly showing that she used some cosmetics for their skin protective and restorative properties
as well as others for their decorative effect. Today, cosmetics are much more tightly regulated than
they were three-and-a-half thousand years ago and there is a legal definition of what is a cosmetic
product. So, today, we know that in Europe cosmetics may protect, keep in good condition and
restore as well as decorate. Thus, the definition today includes fragrances and personal care
products, or toiletries, within the legal classification of cosmetics.
When is a Cosmetic not a Cosmetic?
Medicinal products may also be applied to the skin with a view to protecting, restoring or keeping
in good condition, raising the possibility of a product falling under both definitions. An example
might be a cream or lotion to be applied to irritated or inflamed skin. However the legislation
covering each category makes clear that a product may be either a medicine or a cosmetic but
may not be both at the same time. Thus, it is necessary to make a choice when faced with such
a borderline situation. In practice, this initially seems relatively straightforward since medicines take
precedence. In other words, if a product falls within the definition of a medicine, it is a medicine
and not a cosmetic, even if it also complies with the definition of a cosmetic. A consequence of
this is that products often described in marketing or media terms as ‘cosmeceuticals’ are legally
cosmetics and must comply with the requirements of the EC Cosmetics Regulation, unless they are
actually medicines; there is no middle legal category.
However, although the Medicines and Healthcare Products Regulatory Agency (MHRA) issues
guidance in this area, there are times when it is not so easy to determine on which side of the
borderline a particular product falls. A product may be a medicine by function or by presentation,
which means the product is a medicine either because it works (functions) as a medicine or
because it is presented as a medicine.
The latter situation is relatively straightforward. For example, if you make medicinal claims for
the product (claims to diagnose, prevent or treat disease or the product is presented as doing
any of these things) or if the presentation of the product as a whole gives the impression that
the product is a medicine, it will be judged as being one and treated accordingly. It will for
example, require marketing authorisation from the MHRA.