BORDERLINE CLASSIFICATIONS & COSMETICS
An area of great confusion within the cosmetic market is the classification of products as cosmetics when the ingredients within them may also be present in other products such as foods or biocidal products. Similarly, the way the product is held out for sale and its site of application may also impact its classification as a cosmetic, biocidal, medicine, medical device or within some other legislative framework. In this brief review we will take a look at one of these areas the borderline classification between cosmetics vs. medicine and how best judge where your product sits.
What is a cosmetic?As with all discussions in law of the identity of a product we must first consider its definition in law and to that end a cosmetic is defined (Article 2(1)(a) of Regulation 1223/2009) is defined as:
“…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.”
We have emphasised certain sections here of the legal definition within the European cosmetic regulation as these are key in the general interpretation of a products classification.
In addition to the definition there are a number of resources for a cosmetic company to seek clarity on where their product may fit in the UK or European legislative framework. Outside of the regulation you may have member state competent authority guidance (e.g. MHRA in the UK), European level guidance from the working group on borderline products and case law (from the European and member state courts). In the remaining discussion we will provide out main analysis on case law as guidance although influential on what maybe a view on general issue – Member States and trade associations alike accept that such guidance is not legally binding and it is only the UK courts (post Brexit) or the Court of Justice of the European Union (CJEU) than can give an authoritative interpretation of Union or UK law.
Making the grey clear
Borderline classification issues are often considered as the GREY area where we don’t know really where the classification of a product may fall. However, they court opinions from the EU may help turn the grey to black and white. The courts in essence look at 2 main factors when it comes to defining the difference between a medicine and cosmetic based on the definition of a medicine under Directive 2001/83/EC implemented into UK law by the Human Medicines Regulations 2012);
Article 1(2)(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or [Presentation Limb ‘our emphasis’]
Article 1(2)(b) 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. [Function Limb ‘our emphasis’]
Thus, we need to ensure the Cosmetic is not held out for sale where a consumer may view that product as ‘presented’ as delivering a medicinal effect or containing an ingredient that delivers a ‘function’ on the body that would be akin to a medicine.
Now this may seem simple but it can be complex – Is a tooth past a cosmetic if some of it can be swallowed? What about a dermal patch delivering high dose vitamin? What about a cosmetic that moisturises the skin but also uses a technology that allows the ingredient to reach the circulation? What about an eye lash product that has an ingredient that may influence the growth of eyelashes but you make no claims about it?
These are example of where a judgement needs to be made in the context of the regulation, guidance, case law and experience of interpretation and enforcement provisions by member state or the UK. The following is a brief of some interesting cases that fell before the European courts.
Case C-290/90 – Commission vs. Germany
In one of the earliest cases in borderline cosmetics over 30 years ago and involved eye lotion (drops) to clear dust out of eyes at work. The case was complex but the take home was that the Commission who did not believe the German government where right in its medicinal classification failed in demonstrating such to the courts (In essence due to lack of evidence on functional (medicinal) effects and the eye even though the court did not believe the product were presented as medicines (not requirement for a doctor to prescribe, not sold in pharmacies etc). In addition the courts also stated the requirement to require such products to apply for a marketing authorisation was also not correct and other public protection methods of a less restrictive nature could have been implemented.
C-315/92 - Verband Sozialer Wettbewerb v Clinique Laboratories and Estée Lauder
In January 1999 the CJEU delivered its opinion on a case better known as “Clinique” relates to the placing on the market in Germany cosmetics with the name Clinique and that this name may mislead consumers into believing that the product in question had medicinal properties (curative medical effects on the skin as stated in the AGs opinion). Note in German phonetically it is similar to the work Klinik meaning “Hospital”. Thus it should be prohibited for sale as a cosmetic.
There are a number of important factors resulting in the outcome of the case such as Clinique was not sold in pharmacies, the product is sold as a lip-stick or face-cream not as a Clinique, its marketing was as that for other cosmetics, it was not a restricted brand name in other member states. Thus, on the weight of the evidence it was not held to be viewed by the average consumer as suggesting the products were medicinal by presentation.
Case C-308/11 - Chemische Fabrik Kreussler & Co. GmbH v. Sunstar Deutschland GmbH
This case involved the marketing of a mouthwash solution containing chlorhexidine, an antiseptic. The plaintiff asserts that the mouthwash is medicinal by function as it has been demonstrated to have a therapeutic or clinical effect (pharmacological action) in cases of gingivitis.
The take home from the judgement was more one of a recognition of guidance in helping provide consistency in opinion yet not being legally binding. In addition the definition of medicinal by function is broad and cannot be confined to the action of say a molecule (ingredient) and a receptor but due regard must be given to the definition in law. Again the courts supported the view that and consideration of what constitutes a pharmacological effect must be based on the latest science and thus the area is fluid and open to change and interpretation over time.
Case 616/20 - M2Beauté Cosmetics GmbH v. Germany
At this time we do not have a judgement on this case but a request for a preliminary ruling. Whilst we don’t have a judgement the request contains some interesting arguments that may impact the future classification of cosmetics.
The case revolves around the use of an ‘eyelash activating serum’ that is to result in increased number of hair shafts and thicker longer lashes. The question of note is 2-fold:
1. Is an indirect effect medicinal e.g. one that by altering appearance results in a change in self-esteem, wellbeing and social relations?
2. If no evidence exists on the properties of the substance (potential pharmacological effects) could a classification be determined based on a “structural analogy” e.g. a similar chemical shown to deliver pharmacological effects.
Our view on this is that on point one we would expect the court to refer again to the definition under limb one which includes, “….exerting a pharmacological, immunological or metabolic action”. Therefore, if the effect is not based on these actions then it would not be medicinal. In this case the effect of the product is physiological so consideration would be given to state of the science in making this determination and that is for the member state courts (or UK courts) to make such a judgement.
On point 2 we would see that it would be for the company placing the product on the market to demonstrate the product is not medicinal by function and in the absence of any data from them the data from a member state in whatever form would be justification of a medicinal classification.
Conclusions
This is only a very brief view of a large body of work from the courts on what constitutes a borderline assessment. They key is to assess your product prior to placing it on the market to ensure it would not be at risk of a medicinal classification by presentation of function.
Offences under UK law and Human Medicines Regulations can include on conviction an unlimited fine and/or imprisonment for a term not exceeding two years. Therefore, caution is needed.