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

Medicinal Product Massive The Cosmetic Valley Medicinal Product Massive

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

Be careful, or you may find yourself in alien territory

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

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

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 …

Cleaning them

Perfuming them

Changing their Appearance

Protecting them

Keeping them in Good Condition

Correcting Body Odours

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 …

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...”

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...”

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

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

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)

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 

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

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

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

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 

Characteristics of Specific Bordelines

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

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.

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.

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 )

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

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.

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

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

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.

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

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

Further Information

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/cosmetic-products/borderline-products/index_en.htm

Thank you for your attention !