When is a cosmetic no longer a
cosmetic?
The borderline with pharmaceuticals, medical
devices, biocides, toys …
Gerald Renner
Cosmetics Europe
TAIEX Ankara, April 26, 2013
The Cosmetic Valley
Medicinal
Product Massive
TAIEX Ankara, April 26, 2013
…is placed in a bigger landscape
Medicinal
Product Massive
Mount
Biocide
Medical Device
Hills
Cosmetic Valley
Food
Forrest
TAIEX Ankara, April 26, 2013
Toy
Planes
Be careful, or you may find yourself in
alien territory
TAIEX Ankara, April 26, 2013
Who are our most important
legislative neighbours ?
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•
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Medicinal products (pharmaceuticals)
Medical Devices
Biocides
Toys
Food
TAIEX Ankara, April 26, 2013
Assessment Criteria
Is my product (still) a cosmetic ?
TAIEX Ankara, April 26, 2013
Definition of cosmetics
Article 2 of Regulation 1223/2009
‘cosmetic product’ means 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 …
TAIEX Ankara, April 26, 2013
Cleaning them
TAIEX Ankara, April 26, 2013
Perfuming them
TAIEX Ankara, April 26, 2013
Changing their Appearance
TAIEX Ankara, April 26, 2013
Protecting them
TAIEX Ankara, April 26, 2013
Keeping them in Good Condition
TAIEX Ankara, April 26, 2013
Correcting Body Odours
TAIEX Ankara, April 26, 2013
Three fundamental criteria
‘cosmetic product’ means 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 …
TAIEX Ankara, April 26, 2013
Three fundamental criteria
”A cosmetic product shall mean any substance
or mixture intended to be placed in contact with
the various 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...”
TAIEX Ankara, April 26, 2013
Three fundamental criteria
substance or mixtureintended to ed in
intended contact with certain defined 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...”
TAIEX Ankara, April 26, 2013
Three fundamental criteria
substance or mixtureintended to ed in
intended contact with certain defined parts of
the human body
with a certain defined exclusive or main
functions
TAIEX Ankara, April 26, 2013
Three fundamental criteria
Physical/chemical form
Intended application site
Primary function
TAIEX Ankara, April 26, 2013
Physical/Chemical Form
Cosmetics must be substances or mixtures
Articles are not cosmetic products - even if they are
applied to the skin and fulfil a cosmetic function
Substances or preparations intentionally released
from an article can be cosmetics (e.g. lotion in a
cosmetic wipe)
The article part of such a composite product falls
under the General Products Safety Directive (GPSD)
TAIEX Ankara, April 26, 2013
Physical/Chemical Form
Some examples
Wigs 
False eyelashes 
Glue-on artificial nails 
Hair extensions 
Cosmetic Wipes 
+
Cosmetic Patches  + 
Clothes releasing substances  + possibly 
Tooth picks and tooth floss  + possibly 
TAIEX Ankara, April 26, 2013
Intended application site
Clearly specified and limited.
In addition – Article 2.2 clarifies :
a substance or mixture intended to be ingested, inhaled,
injected or implanted into the human body shall not be
considered to be a cosmetic product.
However, certain degree of dermal penetration,
inhalation or accidental ingestion is acknowledged
and accepted for cosmetics
TAIEX Ankara, April 26, 2013
Intended application site
Some examples
Tattoos 
Slimming pills 
Nutro-cosmetics 
Products applied by iontophoresis  or 
Tooth whitener injected in tooth 
TAIEX Ankara, April 26, 2013
Primary Function
Exclusive or main function (primary function) must
be cosmetic
However, cosmetic products can have certain
secondary, non-cosmetic functions
To determine the primary function it is necessary to
consider :
- Manfacturer intention
- Presentation / Labelling / Advertising / Claims
- Mode of action / composition
- Consumer perception
TAIEX Ankara, April 26, 2013
Primary Function
Some examples
Washable, temporary “tattoos” 
Body Paint 
Nail Glue remover 
Toy make-up 
Leave-on hand sanitiser 
Products to detect dental plaque 
Cream to stimulate sexual arousal 
TAIEX Ankara, April 26, 2013
Characteristics of Specific
Bordelines
TAIEX Ankara, April 26, 2013
Cosmetics/Biocides
Biocides legislation (BPR) and cosmetics legislation
are not cumulative (i.e. the BPR excludes cosmetic
products from its application scope)
A cosmetic product with secondary biocidal function
remains regulated only by the Cosmetics Regulation
Sometimes difficult to demonstrate that the biocidal
function is secondary to the cosmetic function
TAIEX Ankara, April 26, 2013
Cosmetics/Toys
Toy directive and cosmetics legislation are not
mutually exclusive
A cosmetic product with secondary function as toy is
regulated by the Cosmetics Regulation and by the
Toy Directive
It needs to comply with both sets of requirements.
TAIEX Ankara, April 26, 2013
Cosmetics / Food
Food legislation and cosmetics legislation are
mutually exclusive at the level of their basic definition
(intended ingestion vs. not intended to be ingested)
Borderline issues can arise from accidental ingestion
(i.e. at what stage does large accidental ingestion
become intended ingestion ?)
A secondary food function for a cosmetic is not
possible.
TAIEX Ankara, April 26, 2013
Cosmetics/Medical Device
Medical Device legislation and cosmetics legislation
are not cumulative (i.e. the Medical Device legislation
excludes cosmetic products from its scope)
A product with secondary medical device function
remains regulated only by the Cosmetics Regulation
Difficult to demonstrate that the medical device
function is secondary to the cosmetic function.
(Mainly : diagnosis, prevention, monitoring, treatment or
alleviation of disease, injury or handicap )
TAIEX Ankara, April 26, 2013
Cosmetics/Medicinal Products
Perspective of the Cosmetics Regulation
Not applicable to products that … are exclusively intended to
protect from disease.
Secondary medicinal product function remains in
principle in line with the definition of a cosmetic.
BUT : Often difficult/impossible to demonstrate that
the medicinal function is secondary to the cosmetic
function
TAIEX Ankara, April 26, 2013
Cosmetics/Medicinal Products
Perspective of Medicinal Products Legislation
Definition of a medicinal product :
• presented as having properties for treating or
preventing disease OR
• may be used with a view to restoring, correcting or
modifying physiological functions by pharmacological,
immunological or metabolic action, or to making a
medical diagnosis.
TAIEX Ankara, April 26, 2013
Cosmetics/Medicinal Products
Perspective of Medicinal Products Legislation
Definition of a medicinal product :
• presented as having properties for treating or
preventing disease OR
• may be used with a view to restoring, correcting or
modifying physiological functions by
pharmacological, immunological or metabolic action, or
to making a medical diagnosis.
significantly
TAIEX Ankara, April 26, 2013
Cosmetics/Medicinal Products
Assessment parameters for medicinal product
definition :
• Presentation / Labelling / Advertising / Claims for treating
or preventing disease
Medicinal product
by virtue of
presentation
• Mode of action / composition / pharmacological properties
/ use pattern / exposure / safety risks
Medicinal product
by virtue of
function
TAIEX Ankara, April 26, 2013
Cosmetics/Medicinal Products
Assessment may conclude that the product falls
under the definition of both, cosmetics and medicinal
products.
However - Medicinal Products legislation and
Cosmetics legislation are non cumulative,
i.e. a product cannot fall under both regimes.
In this case : Medicinal Product legislation prevails.
TAIEX Ankara, April 26, 2013
Cosmetics/Medicinal Products
Some examples
Lip plumpers working by inflammation/irritation :
 significant physiological impact
Skin exfoliation vs. Skin peels
few cell layers removed : insignificant impact
stratum corneum fully removed : significant impact
Anti-dandruff shampoo advertised with pictures of psoriatic
skin (and containing corticosteroids)
 medicinal product by virtue of presentation
 pharmacological activity & significant physiol. Impact
 use of banned ingredient
TAIEX Ankara, April 26, 2013
Cosmetics/Medicinal Products
Many products situated on the
Cosmetics/Medicinal Products Borderline are
“Damned if they do – Damned if they don’t”
If the product works, it is challenged for having a
significant metabolic action
If the product does not have a significant metabolic
action - it challenged for not working and thereby
misleading the consumer
TAIEX Ankara, April 26, 2013
Further Information
TAIEX Ankara, April 26, 2013
European Commission
Standing Working Group with industry and
competent authorities meeting twice per year to :
• develop general guidelines
• assess specific borderline cases
• keep a manual of decisions
Documents are available under :
http://ec.europa.eu/consumers/sectors/cosmetics/cosmeticproducts/borderline-products/index_en.htm
TAIEX Ankara, April 26, 2013
Thank you for your attention !
TAIEX Ankara, April 26, 2013