Search for:

In brief

With a judgement dated 17 December 2020 (case C-667/19), the EU Court of Justice (CJEU) provided clarifications on the principles governing the manner in which certain mandatory indications must be shown on the labelling of cosmetic products.


In particular, the court ruled that the indication of the function of the product, which must appear on the container and packaging of cosmetics pursuant to article 19 of Regulation (EU) 1223/2009, must be suitable for clearly informing the consumer of the purpose and method of the use of the product. This is not confined to mentioning the purposes pursued by the use of the product itself. To this end, the above information must be given in a language that can be easily understood by the consumer, unless it can be effectively conveyed by the use of pictograms or signs other than words.

Lastly, the court clarified that the possibility of reporting indications relating to special precautions for use, function and ingredients on an adhesive tape, a label or a tag to be applied on the product itself, must be limited to cases where there is a practical impossibility to place them on the packaging and that in any case they cannot appear in a company catalogue referred to by the symbol placed on the packaging provided for in annex VII to the abovementioned regulation (i.e., the hand pointing to an open book). With specific reference to the practical impossibility — which justifies recourse to the attached documentation — the court established that the same cannot be found in the difficulty of preparing a multilingual label or in the costs incurred by the distributor who, by importing the products from another country, must translate these indications and draw up a new label in the language of the country of destination.

Case Background

Last 17 December 2020, CJEU issued a judgment in Case C-667/19 (A.M. and E.M.) on a reference for a preliminary ruling by the Warsaw regional court concerning the correct interpretation of article 19 (“labelling”) of Regulation (EC) No 1223/2009 of 30 November 2009 on cosmetic products (“Cosmetics Regulation“).

In the national proceedings giving rise to this question, the owner of a beauty salon (A.M.) terminated the sale-purchase agreement and sued the distributor of American cosmetic products (E.M.) on the grounds that the packaging of the creams, masks and powders did not give information in Polish about the function of the product (thus being impossible to identify it or know its effects) and that the symbol of a hand with an open book referring to the catalogue in Polish did not comply with the legal framework because that catalogue was not enclosed or attached to the product.

The Polish lower court dismissed the claim for reimbursement of purchasing costs, and the Warsaw regional court referred the following questions for a preliminary ruling, separately addressed by the CJEU in its judgment:

  1. Regarding the mention on the “function of the cosmetic product,” which must appear on the container and packaging of the cosmetic product according to Art. 19.1.f), the Cosmetics Regulation shall inform only about the purposes of art. 2 (cleaning, perfuming, changing the appearance, protecting, maintaining in good condition or correcting odors) or on the contrary it shall inform about all the functions that allow for the identification of the specific properties of the product.

    To assess this question, the CJEU argues that compliance with art. 19 of the Cosmetics Regulation requires information regarding the “indication of the most specific characteristics of the product” that make it possible to use it safely without harming health. In this regard, it is not enough to state the general purposes for which the product is used listed in art. 2.1.a) of the Cosmetics Regulation (e.g., cleaning or perfuming), which are only relevant for purposes of product regulatory classification.

    The CJEU explains that labelling requirements are closely linked to the safety of cosmetic products. The obligation to provide information about the function of the cosmetic product on the container and packaging guarantees that the consumer has complete information on the use and instructions for safe use. However, this obligation does not refer to the properties of the cosmetic product (function of the product is not to be confused with product claims).

  2. Whether the information concerning particular precautions for use of the cosmetic product, the function of the product and its ingredients regulated in Article 19.1.d), f) and g) of the Cosmetics Regulation can be included in a company catalogue that also includes other products, when the symbol of a hand with an open book is shown on the packaging or container of the cosmetic product.

    The CJEU starts by stressing that the practice of referring to external supporting documentation that contains the mandatory information on particular precautions for use and ingredients is only admissible in the event that it is impossible for practical reasons to indicate it on the label. The CJEU finds the referral to a separate company catalogue that includes various products unlawful for several reasons:

    1. The symbol of a hand with an open book constitutes a reference to information enclosed or attached to the product, and in the case at issue the CJEU does not consider the company catalogue containing a description of the product in question together with other products to be enclosed or attached to the purchased cosmetic products.

There is no practical impossibility to include mentions of particular precautions for use on the same product. In this regard, the costs arising from translating information in another language does not justify incomplete labeling. Likewise, the fact that the labelling is responsibility of the manufacturer does not constitute an impossibility. Ensuring a high level of protection for consumer’s health takes priority over the inconvenience of translating the labelling into the language that consumers can understand.

Author

Montserrat has extensive experience in pharmaceutical and health law, as well as in compliance, contract law, licensing, competition law and acquisitions in the pharmaceutical sector. She is the coordinator of the healthcare practice in the Barcelona office.
She assists healthcare companies throughout the life cycle of healthcare products (drugs, IVD and medical devices, combination products, cosmetics and food supplements), from R&D to commercialization and more specifically in the areas of clinical trials (agreements, regulatory procedures, processing of personal data), market access (pricing and reimbursement), products and companies regulations (MA/CE-marking, vigilances, required licenses, product classification, labelling), commercial relations between healthcare industries (distribution, (co)promotion, manufacturing, supply, licensing, partnership agreements), relations with healthcare professionals and/or patients including compliance (anti-gift and transparency laws); communication and advertising, e-health (connected devices, telemedicine, hosting of health data) and product liability. Her practice encompasses both advisory and litigation matters.
She also has considerable experience in the drafting of codes of professional ethics and conducting compliance audits, and advising on advertising and promotion of medicines and medical devices, including via the internet, online advertising and social media. Montserrat advises on a wide range of agreements related to the pharmaceutical industry, such as license and distribution agreements, clinical trial agreements, and supply and manufacturing agreements.

Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.