Cosmetic Product or not?
For some products, the definition is pretty clear: they are easily identified as cosmetic products. But in some cases, a definite classification is a lot harder. Christina Klima from Lemikos takes a closer look at the so called borderline products in cosmetics.
The Regulation (EC) No 1223/2009 defines the properties a product must meet to be claimed a cosmetic product and the needed requirements for bringing a cosmetic product on the EU market. The definition for a cosmetic product in the Regulation is stated in Article 2(1)(a) as followed: “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours”. But in some cases, it’s unclear if a product falls under the scope of this regulation or another one. To help deciding if a product is a cosmetic product or not, the Working Group on Cosmetic Products has published a tool to help differentiate between these so-called borderline products1.
These products make it hard to distinguish if you are looking at a cosmetic product, medical device, medicinal product, or maybe even a toy. In this article we will look at some of these borderline products and their definition in the Borderline Manual as well as current court judgements.
Eyelash serums containing prostaglandin (derivates)
A borderline product which everyone discusses right now are eyelash serums which are used to help eyelashes grow by using prostaglandins and prostaglandin derivates. These serums are normally applicated like an eyeliner (contact with external body part) and used for eyelash growth and thickening (changing the appearance), hence they could fulfil the criteria for the classification as a cosmetic product.
The active components in the product are the prostaglandins. Prostaglandins are physiologically active substances that are built in human tissues with hormone-like activity. While using prostaglandins as a treatment for open angle glaucoma, a patient reported growing and darker eyelashes as a side effect2. That effect is now used in special serums which are applied to the lashes to make them longer, which induces the questions if it can be considered a cosmetic product or if it is still a medicinal product. As per definition in Article 2(1) of the Directive 2001/83/EC a medicinal product is “any substance or combination of substances presented for treating or preventing disease in human beings” or “any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings”. Also, according to Article 2(2) of the Directive 2004/27/EC “a product may fall within the definition of a “medicinal product” and within the definition of a product covered by other Community legislation” is considered a medicinal product. Which means that a product can’t be a cosmetic product and a medicinal product at the same time. As prostaglandins are used in medicine, it suggests that products with prostaglandins used for eyelash growth therefore could be medicinal products. However, the Borderline Manual stated that the sole use of a substance that is equally used in medicinal products is not an indicator that the product is also a medicinal product, and the classification of the eyelash serums must be done on a case-by-case basis2. For the assessment of the product, many factors as the presentation of the product (e.g., claims), application mode, ingredients and composition, as well as pharmacological, immunological or metabolic properties must be taken into consideration.
This year, the Administrative Court of Cologne had to make such classification during a lawsuit between an eyelash serum manufacturer and the Federal Republic of Germany. In the opinion of the court, the product to be evaluated, although it contains a pharmacological active substance (methylamido-dihydro-noralfaprostal), cannot be considered a medicinal product. Moreover, the general perception of the customers classifies this product as a cosmetic product. These two reasons, among others, have led the court to rule that the product in question should be classified as a cosmetic product. The court finds that the risks of using prostaglandin as an ingredient for cosmetic products can be addressed by including it and its analogues on the list of banned substances or restricting their use3. Additionally, it must be noted that Scientific Committee on Consumer Safety (SCCS) recently published an opinion which stated their concern for the use of prostaglandin and their analogues in cosmetic products4. Entrepreneurs wanting to bring eyelash serums with prostaglandin(-analogues) to the EU market need to keep an eye on the current legal situation and should consult an expert if there is any uncertainty about the classification.
Colouring contact lenses
Another borderline product is colouring contact lenses. The contact lenses are usually non-corrective and are used to change the appearance of the user. The European Court of Justice has dealt with such a product in 2015. On the outside of the product packaging following information could be found: “cosmetic eye accessory, subject to the EU Cosmetics Directive”. Such a statement led to the presumption that the customer would have the impression that the product issued was indeed a cosmetic product within the meaning of the said regulation, the Krefeld Regional Court ruled in an earlier hearing. In the case of this product, the court decided that the customers perception of the product is not the main criteria to determine if it is a cosmetic product or not, but the fulfilment of all the criteria for the definition of the term “cosmetic product” referred to in Article2(1)(a) in the Regulation (EC) No 1223/2009.
It was decided by the court that the discussed product could not be classified as a cosmetic product, as it is not a substance or mixture according to the definition in the regulation but an article, nor it is placed on the external parts of the human body but on the cornea. Since the product was finally not classified as cosmetic product the printed statement on the packaging could be considered misleading commercial practice.5
Creams for healing of the skin
But what about products that are often used for cosmetic purposes like lotions, gels and oils but for skin with special needs? For this type of products, we can usually expect that they are a substance or mixture which are intended to be placed in contact with the external body part (here the epidermis). Nevertheless, the compliance with these conditions must be verified. Furthermore, it must be evaluated, among other aspects, if the main purpose is to clean, perfume, change the appearance, protect or keep the body part in good condition or correct body odours, as well as the ingredients, the packaging and the general view of the consumer. The purpose of lotions usually is to keep the skin in good condition, but some also have other functions. One of which is to treat injured skin. While the Borderline Manual does not classify products with skin-healing claims as cosmetic products but as medicinal products or medical devices1, there are also exceptions. According to a judge at the Higher Regional Court in Karlsruhe, a wound care cream marketed as a cosmetic product which was presented as a curative is not considered a medicinal product. The reasons were that the healing statement only appeared once in the context of a professional journal. The term wound care cream and the indication “for sensitive and irritated skin” are not sufficient to identify a product as a medicinal product.6
Razors releasing substances
Razors are usually made up of blades and a framework with a handle. They do not fall within the scope of application of the EU cosmetic regulation because they are neither a substance nor a mixture but an article. Some of these razors have a sliding strip or a formulation attached which releases substances or mixtures to the shaving area. Can these substances or mixtures be claimed a cosmetic product according to the Regulation (EC) No 1223/2009? First, these substances or mixtures are intended to be placed in contact with external parts of the human body (in this case the epidermis). Then, we need to check their (main) purpose. A cosmetic product is used on the external parts of the human body “with the main view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours”.
This main purpose must be determined on a case-by-case basis. The Borderline Manual states that a strip used for lubrication of the skin can have the main purpose to support the gliding of the blades. Therefore, a lubricating strip is not necessarily a cosmetic product according to Article 2(1)(a) of the Regulation. But the Borderline Manual further states that a formulation next to the blades could have a main cosmetic function like cleaning, moisturising or perfuming which could make it a cosmetic product. In addition, other points such as the general perception of consumers or the presentation of the product also must be taken into consideration for the classification1. In 2014, a court in Germany had to rule if a razor whose blades are framed by a soap block is considered a cosmetic product and therefore needs a date of minimum durability or an indication of the period after opening for which the product can be safely used. The court ruled that the soap is in fact a cosmetic product according to the Regulation (EC) No 1223/2009 as it is a mixture which is intended to be used on the human skin for the sole purpose to clean it or to keep it in a good condition. This purpose is reinforced by the advertising of the company. They claimed that the product provides foam, shaves, and moisturises in one step for naturally beautiful skin.7
Conclusion
The presented cases show that the legal classification as a cosmetic product in the EU is not always easy and clear and has to be decided on a case-by-case basis. Staying informed about changings in the legal situation of cosmetic products will help you classify your products. The Borderline Manual and as well as existing court rulings can be used as a tool for orientation. Nevertheless, it is important to consult an expert on this topic if there are doubts to avoid misclassification and the resulting legal problems.
References:
- Manual of the Working Group on Cosmetic Products (Sub-group on Borderline Products) on the Scope of Application of the Cosmetic Regulation (EC) No. 1223/2009 (Art. 2(1)(A)). Version 5.2, September 2020.
- Alm, A., & Stjernschantz, J. (1995). Effects on Intraocular Pressure and Side Effects of 0.005% Latanoprost Applied Once Daily, Evening or Morning. Ophthalmology, 102(12), 1743–1752. doi: 10.1016/s0161-6420(95)30798-1
- Administrative Court Cologne. (2023). ECLI:DE:VGK:2023:0425.7K14623.17.00. https://www.justiz.nrw.de/nrwe/ovgs/vg_koeln/j2023/7_K_14623_17_Urteil_20230425.html
- SCCS (Scientific Committee on Consumer Safety), Opinion on Prostaglandins and prostaglandin-analogues used in cosmetic products, preliminary version of 27 September 2021, final version of 3 February 2022, SCCS/1635/21
- European Court of Justice. (2015). ECLI:EU:C:2015:540. https://eur-lex.europa.eu/legal-content/DE/TXT/PDF/?uri=CELEX:62014CJ0321
- Higher Regional Court Karlsruhe. (2016). ECLI:DE:OLGKARL:2016:0128.4U134.15.0A. https://www.landesrecht-bw.de/bsbw/document/JURE160002611
- Regional Court Wuppertal. (2014). ECLI:DE:LGW:2014:0616.12O38.13.00. https://www.justiz.nrw.de/nrwe/lgs/wuppertal/lg_wuppertal/j2014/12_O_38_13_Urteil_20140616.html
