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published on 11 November 2020 | Approx. reading time 5 minutes
Currently the impression may be that there are no noteworthy developments with regard to cosmetics law. And contrary to the case in areas such as foodstuffs, medical products and fertilisers as a result of new EU directives or national legislation, there are indeed no fundamental changes to cosmetics law pending. However, you can read the details of the latest developments here. This article sheds some light on the EU legal framework of the Cosmetics Regulation and takes a quick look at the latest developments.
In the past, measures aimed at regulating the ingredients in cosmetics have usually been met with a great deal of interest from the media. The debate on the content of microplastics in cosmetics in spring 2019 is one such example. When looking more closely at what the term “cosmetic product” entails, it is easy to see why this attracted such interest. The legal definition of a cosmetic product, as per Article 2(1)(a) of Regulation (EC) no. 1223/2009 is:
Cosmetics are therefore products that are ever-present in our everyday lives: Every consumer uses cosmetics, which therefore means that consumers are exposed to a large quantity of chemicals used as ingredients in cosmetics. As a result of the new chemicals strategy that was adopted by the European Commission on 14 October 2020, besides impacting on other consumer products like toys, detergents, furniture and textiles, developments are now also expected with regard to cosmetics. The European Commission has announced, in particular, measures to protect against harmful chemicals, such as those that cause cancer or genetic mutation, or that can have a negative effect on the reproduction or endocrine system. Companies in the life science sector in general and specifically in the cosmetics sector, should therefore keep track of the developments relating to the European Commission’s Green Deal and, where appropriate, start to plan and carry out any necessary changes to their products in plenty of time.
Cosmetic products were one of the first product categories whose marketing requirements were harmonised at EU level (Directive 76/768/EEC). This was followed by a revision of the EU cosmetics law a few years ago through Regulation (EC) no. 1223/2009 on cosmetic products (referred to here as the Cosmetics Regulation). In addition, Regulation (EU) no. 655/2013 lays down common criteria for the justification of claims used in relation to cosmetic products (referred to here as the Cosmetic Claims Regulation). The general competition law, and in particular the prohibition of misleading statements, otherwise applies to the advertising of cosmetics. The provisions were rounded off by the Commission Implementing Decision 2013/674/EU of 25 November 2013 with guidelines for creating product information files and safety reports for cosmetics. Furthermore, the German Cosmetics Regulation (D-KosmetikV) must also be complied with in Germany. This regulation addresses aspects that are not regulated at EU level, such as the obligation to notify the supervisory authorities for cosmetics manufactured domestically.
In its Annexes, the Cosmetics Regulation contains provisions regarding which substances may not be used in cosmetics (Annex II) or whose use may possibly be approved with restrictions (Annexes III-VI). First and foremost, the Cosmetics Regulation is continuously updated by the Commission in these Annexes. This is always the case, in particular, when new or existing substances are assessed and categorised on the basis of scientific assessments by the Risk Assessment Committee of the European Chemicals Agency. Most recently, the Annexes of the Cosmetics Regulation were amended at the end of 2019 by Regulation (EU) no. 2019/1966, which came into effect on 1 May 2020. Essentially, this regulation amendment deals with the use of salicylic acid and other substances or substance groups in cosmetic products. If substances – such as salicylic acid – are assigned to Category 2 as being carcinogenic, mutagenic or toxic to reproduction (CMR substances) in accordance with Regulation (EC) no. 1272/2008, they may only be used in cosmetics according to Article 15(1)(2) of the Cosmetics Regulation if they have been assessed by the Scientific Committee on Consumer Safety (SCCS) and found to be safe for use in such products. To this end, a request must be submitted to the European Commission to grant an exception to use the corresponding substance in cosmetic products. The SCCS has undertaken such an assessment and classification for salicylic acid, which meant that the Annexes to the Cosmetics Regulation had to be amended accordingly. If a company uses a new substance or a newly assessed substance in its products, it has the possibility for the substance to be listed in the Cosmetics Regulation, provided that the substance concerned is safe for use in cosmetics. In other words, that dangers to the consumer can be excluded. The associated procedure should not be underestimated however, since it involves a (very time-consuming) approvals procedure whereby – if concluded successfully – the substance may be used in cosmetics throughout the EU. The approvals procedure includes, e.g. a detailed toxicology examination of the substance. It should also be noted that in order for this substance to be used in compliance with the law, the company must wait until the substance has been explicitly listed in the corresponding Annex to the Cosmetics Regulation.
A preliminary ruling procedure (C-667/19) is currently pending with the European Union court of law. It was instigated by a Polish court of law in September 2019. As part of this procedure, two issues relating to the interpretation of the labelling information requirement of Article 19 of the Cosmetics Regulation are to be clarified: Firstly, what is understood by the wording “the function of the cosmetic product” as information on the container and packaging (referred to in 19(1)(f) of the Cosmetics Regulation), and secondly whether it is possible to only specify certain mandatory information in a separate catalogue that is not provided together with the product but is instead available for purchase. The conclusions of Advocate General Campos Sánchez-Bordona from 9 July 2020 include extensive reasoning for how these questions could be answered. The Advocate General points out, with regard to the reference for a preliminary ruling, that the specification of the function – which is mandatory information – should not be limited to stating the intended purpose (e.g. cleaning, perfuming or protecting) in accordance with Article 2(1)(a) of the Cosmetics Regulation, as the function (consumer information) and the intended purpose (differentiation from other product categories such as pharmaceuticals or medical devices) do not systematically pursue the same objective. In the opinion of the Advocate General, the term “function” is usually not to be equated with the term “claims” from Article 20(1) of the Cosmetics Regulation in connection with the Cosmetic Claims Regulation, as the latter are intended to provide a greater amount of information. With regard to the second issue, the Advocate General explains that in his opinion (in accordance with the statements of the governments involved in the procedure), the specification of mandatory information in a separate catalogue, which is neither associated with the product, nor is supplied together with the product to the buyer, does not fulfil the requirements of Article 19(2) of the Cosmetics Regulation. According to this principle, mandatory information must be specified directly on the packaging and may only be stated on accompanying documentation in exceptional cases where this is not possible due to insurmountable technical reasons (e.g. size of the packaging). Reasons that are purely organisational or financial do not fulfil the requirements to benefit from an exemption. In order to be able to conclusively answer the questions, the decision of the ECJ remains to be seen, however.
Companies in the cosmetics sector need to keep an eye on the latest developments in cosmetics law, to make sure they are able to quickly and successfully adapt their products, where necessary, in line with the new harmonised provisions.
Dr. Barbara Klaus
Partner
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