Case law: classification of a borderline product between cosmetic and medicinal

May 24, 2022 – On April 7, 2022, Advocate General Ćapeta, from the Court of Justice of the European Union, delivered his opinion on the classification of an eyelash serum borderline between cosmetic and medicinal products.

 

The case

A beauty brand marketed an eyelash serum, claimed to lengthen eyelashes by using an ingredient, methylamido-dihydro-noralfaprostal (MND), as a cosmetic product.

MND is a structural analogue of bimatoprost (BMP), a prostaglandin analogue used in medicinal products for glaucoma treatment. However, BMP has a particular side effect: it boosts eyelash growth. Hence, bimatoprost and its analogues have been used in cosmetic products to improve eyelash growth.

In 2014, the German Federal Institute for Drugs and Medicinal Devices classified the eyelash serum as a medicinal product by function. Therefore, it required the beauty brand to apply for the related authorisation. The beauty brand objected to the decision and, in 2017, brought the case in front of the Court of Justice of the European Union.

 

Definitions    

According to the EU Cosmetics Regulation, a cosmetic product:

  • Is a solution;
  • Applied to the external part of the human body or oral mucosa;
  • With the function of cleaning, perfuming, changing the appearance, protecting, keeping in good condition, or masking body odours.

Conversely, as per Article 1(2) of the Medicinal Products Directive, a medicinal product is:

  • “Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
  • Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological, or metabolic action or to making a medical diagnosis” (EC, 2001).

The first part describes medicinal products by presentation, and the latter refers to medicinal products by function.

It is necessary to understand under what definitions the eyelash serum falls to settle this case.

 

The Advocate General’s opinion

In his opinion, Advocate General (AG) Ćapeta firstly highlighted that the competent national authority must classify borderline products case-by-case, considering their composition, properties, and any other characteristics.

Moreover, AG stated that medicinal products by function must have a beneficial health effect: the mere improvement of eyelash appearance cannot be considered as such.

Lastly, Advocate General added that on February 3, 2022, the Scientific Committee on Consumer Safety (SCCS) issued an opinion on prostaglandins and prostaglandin-analogues used in cosmetic products. The SCCS concluded that these substances have strong pharmacological effects even at low concentrations; thus, they raise safety concerns.

AG recommended to the Court of Justice to take into account all the above considerations in adopting the preliminary ruling.

 

Impact

The Court of Justice is the highest legal authority for interpreting EU law, and in many cases, the Court follows AG opinions. Furthermore, it proves essential to follow the SCCS opinion, not only to ensure safe cosmetics, but also as it is taken into consideration by AG and potentially the Court of Justice!

The COSlaw team will monitor the case and update you on its status. Subscribe to our monthly newsletter not to miss any news.

 

Update from 08/11/2022

The judgement of the Court 

On October 13, 2022, the Court of Justice of the European Union (CJEU) issued a preliminary ruling in the case M2Beauté Cosmetics GmbH against the Federal Republic of Germany (Bundesrepublik Deutschland).

Firstly, the CJEU explained that competent national authorities can use data on substances with a similar chemical structure (structural analogue) to classify a product as a medicinal product if:

  • There are no scientific studies on the substance of which the product consists;
  • An objective scientific assessment confirms that the properties of the two substances can be considered the same at a given concentration.

Secondly, according to the definition, a medicinal product must modify the physiological functions; namely, it has a beneficial effect on human health. In light of this, the CJEU clarified that a product can be classified as a medicinal product by function when it improves the human appearance under certain conditions. The Court concluded that “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” (InfoCuria, 2022).

 

 

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