Case-Law

The General Court annulled Commission Delegated Regulation (EU) 2020/217 of October 4, 2019, as regards the classification as CMR substance of titanium dioxide in powder form containing 1% or more of particles with a diameter equal to or below 10 μm.

In Febraury 2023, France has appealed the General Court decision annulling the classification of Titanium Dioxide as a CMR substance. The French government argued that the court exceed the limits of its judicial review by interpreting scientific data. Lastly, it highlighted that the classification will continue to apply until the conclusion of the appeal procedure.

Key words: CMR substances, Omnibus Act, REACH, Titanium Dioxide, cosmetic ingredients restrictions

National authorities may, for the purpose of classifying a product as a ‘medicinal product’, establish the pharmacological properties of that product by relying on scientific knowledge relating to a structural analogue of that substance, where no scientific study of the substance of which that product consists is available, if the degree of analogy is such that it may be assumed on the basis of an objective scientific assessment that a substance present in a product with a given concentration has the same properties as an existing substance for which the required studies are available.

Moreover, a product which modifies physiological functions may be classified as a ‘medicinal product’ only if it has specific health-promoting effects. In that regard, an improvement in appearance, which gives rise to an indirect benefit through an increase in self-esteem or well-being, is sufficient where it permits the treatment of a recognised pathological condition. By contrast, a product which improves appearance without having harmful properties and which has no beneficial effects on health cannot be classified as a ‘medicinal product’, within the meaning of that provision.

Key words: classification, borderline product, medicinal product, cosmetic product, improvement in appearance, pharmacological properties, structural analogues, eyelash serum

Article 27(1) of the EU Cosmetics Regulation must be interpreted as not allowing the competent authority of a Member State to adopt general provisional measures applying to a category of products containing the same substance. The safeguard clause applies only to one or more individually identified cosmetic products available on the market.

Key words: Article 27(1), national safeguard clause, Phenoxyethanol, national competent authorities, serious risk to human health, recall, withdrawal

Article 1(2) of Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers must be interpreted as meaning that it is not necessary to demonstrate by objective and substantiated data that placing in the mouth, sucking or ingesting products which, although not foodstuffs, possess a form, odour, colour, appearance, packaging, labelling, volume or size, such that it is likely that consumers, especially children, will confuse them with foodstuffs and in consequence place them in their mouths, or suck or ingest them may entail risks such as suffocation, poisoning, or the perforation or obstruction of the digestive tract. Nevertheless, the competent national authorities must assess on a case-by-case basis whether a product meets the conditions listed in that provision and justify their assessment that that is the case.

Key words: foodstuff, products that look like food, health and safety of consumers, bath bomb

The Annual Report contains a detailed review of the judicial activity of the Court of Justice and the General Court, providing an analysis of the case law with links to full texts, and presenting the year’s judicial statistics.

The Annual Report contains a detailed review of the judicial activity of the Court of Justice and the General Court, providing an analysis of the case law with links to full texts, and presenting the year’s judicial statistics.

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 regarding the product’s purpose and method of use, in order to ensure that consumers can use it 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. 

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. 

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. 

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. 

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. 

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.  

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. 

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. 

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.