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The information as to the ‘function of a cosmetic product’ which must appear on such a product’s container and packaging must be such as to inform consumers clearly as to the product’s purpose and method of use, in order to ensure that consumers can use that product safely.
The cost of labelling those products in a different language in order to market them in other Member States cannot in any case be regarded as justifying incomplete labelling of the product on its container and its packaging.
The information concerning particular precautions for use of a cosmetic product, its function and its ingredients may not appear in a company catalogue which also includes other products, where the symbol of a hand with an open book is placed on the cosmetic product’s packaging or container.
Key words: labelling requirements, cosmetic products, precautions, packaging, cost.
The cosmetic product safety assessment shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.
What shall be considered as a “similar discipline”?
The existence of a common body of scientific knowledge that is indispensable in order to assess, with the greatest certainty possible, the safety of a cosmetic product, in so far as concerns not only its ingredients, but also the finished product itself and, second, that the objective consisting in ensuring a high level of protection of human health cannot be properly attained unless that common body of knowledge includes both knowledge of the human body and its pathologies and knowledge of the substances used in the manufacture of cosmetic products and their physical and chemical properties. Each Member State has the power to assess the similarity.
Key words: Safety assessor, qualifications, similar discipline, human health, safety of cosmetic products
The Regulation No 1223/2009 on cosmetic products may prohibit the placing on the European Union market of cosmetic products containing some ingredients that have been tested on animals outside the European Union, in order to market cosmetic products in third countries, if the resulting data is used to prove the safety of those products for the purposes of placing them on the EU market.
Key words: animal testing, safety of cosmetic products, EU market
Non-corrective colour contact lenses featuring designs shall not be considered “cosmetic products” within the meaning of the Regulation No 1223/2009 on cosmetic products, as they do not satisfy the three criteria stated therein:
- they may be classified as ‘objects’, they cannot be regarded as a ‘substance’ or a ‘mixture’.
- they are placed on the eye’s cornea, which is not referred to in that exhaustive list of body parts that may come in contact with the cosmetic product at stake.
- their function is to change the appearance of the eye’s cornea, their sole or main function is not to clean, perfume, change the appearance of, protect or keep in good condition any of the parts of the body listed in the Regulation, or to correct body odours.
Key words: non-corrective contact lenses, cosmetic product
Supplies of services consisting in plastic surgery (such as breast augmentation and reduction, breast lifts, abdominoplasty, liposuction, face lifts, brow lifts, eye, ear and nose operations and other plastic surgery) and other cosmetic treatments (such as permanent hair removal and skin rejuventation by pulsed light, anti-cellulite treatments and botox and restylane injections), fall within the concepts of ‘medical care’ and ‘the provision of medical care’ where those services are intended to diagnose, treat or cure diseases or health disorders or to protect, maintain or restore human health. These services may be except from VAT, according to the VAT Directive.
Key words: cosmetic treatments, plastic surgery, VAT exemption, VAT Directive
For a substance to be regarded as exerting a ‘pharmacological action’, it is not necessary for there to be an interaction between the molecules of which it consists and a cellular constituent of the user’s body, as an interaction between that substance and any cellular constituent present within the user’s body may be sufficient.
For example, a mouthwash solution called in which chlorhexidine, an antiseptic, accounts for 0.12% of the product contents shall be considered as exerting a ‘pharmacological action’, and shall not be regarded as a cosmetic product.
Key words: cosmetic product, pharmacological action, mouthwash solution.
The proprietor of a trade mark may, by virtue of the exclusive right conferred by the mark, oppose the resale of perfumes and cosmetic products on the ground that the person reselling the goods has removed their packaging, when the consequence of that removal is that essential information, such as information relating to the identity of the manufacturer or the person responsible for marketing the cosmetic product, is missing. When the removal of the packaging has not resulted in the absence of that information, the trade mark proprietor may nevertheless oppose the resale of an unboxed perfume or cosmetic product bearing his trade mark, if he establishes that the removal of the packaging has damaged the image of the product and, hence, the reputation of the trade mark.
Key words: perfumes, cosmetic products, packaging, manufacturer, responsible person, trade mark.
Importers of cosmetic products are required to communicate to the competent authorities the name or corporate name of the manufacturer, its registered office and that of the manufacturing plant and a full and detailed list of the substances contained in the product being marketed. This obligation is proportionate to the objective of protecting human health.
Key words: cosmetic products, authorities, substances, proportionate, human health
Cosmetic products’ labels, putting up for sale and advertising should not include text, names, trade marks, pictures and figurative or other signs that might imply that those products have characteristics which they do not have. Any reference to expert medical opinions, in particular, use of the statement ‘dermatologically tested’ appearing on the packaging of a cosmetic product is likely to attribute to that product characteristics which it does not possess; it may be allowed only on condition that prior authorisation is granted by the competent Minister of a Member State.
Key words: dermatologically tested, expert medical opinions, labels, advertising