1. When is a cosmetic no longer a cosmetic
When is a cosmetic no longer a cosmetic? The borderline with pharmaceuticals, medical devices, biocides, toys …
Gerald Renner
Cosmetics Europe 1 1

2. Medicinal Product Massive
The Cosmetic Valley
Medicinal Product Massive

3. …is placed in a bigger landscape
Medicinal Product Massive
Mount Biocide
Medical Device Hills
Cosmetic Valley
Toy Planes
Food Forrest

4. Be careful, or you may find yourself in alien territory

5. Who are our most important legislative neighbours ?
Medicinal products (pharmaceuticals)
Medical Devices
Biocides
Toys
Food

6. Is my product (still) a cosmetic ?
Assessment Criteria
Is my product (still) a cosmetic ?

7. Article 2 of Regulation 1223/2009
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 …

8. Cleaning them

9. Perfuming them

10. Changing their Appearance

11. Protecting them

12. Keeping them in Good Condition

13. Correcting Body Odours

14. 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 …

15. 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...”

16. 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...”

17. 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

18. Three fundamental criteria
Physical/chemical form
Intended application site
Primary function

19. 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)

20. 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 

21. 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

22. Intended application site
Some examples
Tattoos 
Slimming pills 
Nutro-cosmetics 
Products applied by iontophoresis  or 
Tooth whitener injected in tooth 

23. 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

24. 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 

25. Characteristics of Specific Bordelines

26. 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

27. 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.

28. 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.

29. 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 )

30. 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

31. 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.

32. 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

33. Cosmetics/Medicinal Products
Assessment parameters for medicinal product definition :
Presentation / Labelling / Advertising / Claims for treating or preventing disease
Mode of action / composition / pharmacological properties / use pattern / exposure / safety risks
Medicinal product by virtue of presentation
Medicinal product by virtue of function

34. 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.

35. 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

36. 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

37. Further Information

38. 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 :

39. Thank you for your attention !