Some products present on the market are often considered by consumers as cosmetic products (that fall under the category of utility articles), although in reality they are medicinal products, medical devices or biocidal products.
However, in order to protect public health, it is important that products be assigned to their correct category.
Accordingly, the present document focuses on the demarcation of cosmetic products from medicinal products, medical devices or biocidal products.
Food Legislation, Therapeutic Produc tLegislation (medicinal products and medical devices) and Chemicals Legislation govern differently the requirements for production, treating, publicity, purpose, distribution, supply and monitoring of a product.
Moreover, those authorities responsible for enforcement are different; likewise measures and sanction possibilities available to them also differ.
In particular, in contrast to cosmetic products, those authorisation procedures required for placing on the market therapeutic products and biocidal products involve enormous economic resources.
For these reasons the correct classification of a product is highly significant for the manufacturer or distributor.
It should also be noted that in the European Union (EU) certain raw materials used for therapeutic products, cosmetic products and other utility articles are subject to the regulations on chemicals (REACHRegulation (EC) no 1907/20061, CLPRegulation (EC) no 1272/20082).
Of particular concern here are propellants and technical auxiliaries, precursors or carrier substances for cosmetic products and medicinal products as well as utility articles or medical devices, which contain substances of very high concern.
The present document provides a review of the relevant legal bases in Switzerland and Europe and summarises the Swiss and European jurisprudence in regard to the demarcation issues on cosmetic products.
The report then presents the working group’s indication of significant procedures, typical classification indications as well as a reference to the “Borderline Manual”, recently published by the European Commission, on the scope of application of the Cosmetics Regulation with practical examples (cf Chapter V and Annex).
It is intended to serve as a common basis for collaboration between Swissmedic, FOPH and FSVO so as to clearly define the legislation to be applied in a given case.
Cosmetic products sold in Switzerland do not require an authorisation from the cantonal or federal authorities. However, the products have to fulfil the requirements of food law. Whosoever manufactures, treats, stores, places on the market, imports, exports or carries in transit cosmetic products must ensure that the statutory requirements are complied with (obligation to self-supervision).
But medicinal products may only be commercialised if they have been authorised by Swissmedic and if the legal or natural person who has manufactured, imported, exported or carried out wholesale trade or traded them abroad possesses an operating license from Swissmedic.
In principle, biocidal products may be placed on the market in Switzerland or used professionally or commercially only when they have been granted a valid authorisation in Switzerland.
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Resource Person: BARBARA PIROLA
