On 3 September 2015, the Court of Justice of the European Union (CJEU) delivered its ruling in case C-321/14 Colena AG v Karnevalservice Bastian GmbH following a reference from the Landgericht Krefeld (Regional Court Krefeld, Germany) as whether non-corrective colour contact lenses fell within the scope of Regulation (EC) No 1223/2009 (the "Cosmetic Regulation").
The effect of the ruling is that the Cosmetic Regulation must be interpreted such that contact lenses marketed purely to alter the user's appearance (rather than to correct vision) will not be within its scope even if the outer packaging declares that the product is a cosmetic, subject to the EU Cosmetics Directive.
The CJEU's decision is discussed in this article together with the changing legislative framework for medical devices in Europe.
Karnevalservice Bastian GmbH (“Karnevalservice") marketed non-corrective colour contact lenses in Germany. The purpose of these lenses were to alter the user's appearance and not for correcting visual deficiencies. The outer packaging of these lenses also included the following statement: "cosmetic eye accessory, subject to the EU Cosmetics Directive".
In October 2013, Colena AG commenced proceedings in the Landgericht Krefeld (Regional Court Krefeld, Germany) against Karnevalservice seeking an injunction prevent the company from marketing the contact lenses in issue unless the packaging provided certain information required by Article 19(1) of the Cosmetic Regulation. However, the Court refused to grant the injunction on the basis that the lenses could not be classified as 'cosmetic products' within the meaning of the Cosmetic Regulation and therefore the legislation was not applicable.
Colena appealed to the Oberlandesgericht Düsseldorf (Düsseldorf Higher Regional Court). The Court reversed the earlier decision and granted the injunction. The Court held that notwithstanding the fact that the lenses could not be classified as 'cosmetic products' within the meaning of the Cosmetics Regulations, they would still fall within its scope because of the statement on the outer packaging that the lenses were a 'cosmetic eye accessory, subject to the EU Cosmetics Directive'. This statement, in the Court's opinion, would give the 'average consumer, who is reasonably well informed and reasonably observant and circumspect' under German law the impression that the product was in fact a cosmetic product within the meaning of the Cosmetics Regulations.
In January 2014, Karnevalservice challenged the injunction before the Landgericht Krefeld, which stayed the proceedings and make a reference to the CJEU seeking clarification on the following questions:
(1) Must the Cosmetics Regulation be interpreted as meaning that a product which does not come under that Regulation must nonetheless comply with the requirements of that Regulation solely by reason of a statement on the outer packaging that the product is a “cosmetic eye accessory, subject to the EU Cosmetics Directive”?
(2) Must the Cosmetics Regulation be interpreted as meaning that “non-corrective contact lenses featuring designs” come within the scope of that Regulation?’
The CJEU's Ruling
The CJEU held that since the contact lenses were not 'cosmetic products' within the meaning of the Cosmetic Regulation, they fell outside the scope of the Regulation.
Article 2(1)(a) of the Cosmetic Regulation defines 'cosmetic product' as meaning "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". In light of that definition, the CJEU considered that the definition of 'cosmetic product' was based on three cumulative criteria: (i) the nature of the product in question (substance or mixture); (ii) the part of the human body with which it is intended to be placed in contact; and (iii) the purpose of its use.
The CJEU held that cosmetic contact lenses of the type in suit were not 'cosmetic products' because they do not satisfy all 3 criteria required in Article 2(1)(a) of the Cosmetic Regulation. First, the lenses could not be classified as a "substance" or a "mixture" as defined in the Cosmetic Regulation. Second, the eye's cornea is not among the parts of the human body referred to in the exhaustive list provided in Article 2(1)(a) or any other provision of the Cosmetic Regulation. Third, the function of these lenses is to change the appearance of the cornea, so they do not fall within the third criterion.
Accordingly, the CJEU held that the lenses could not be classified as ‘cosmetic products’ as defined in that regulation and therefore fall outside the scope of the regulation. That conclusion was unaffected by the statement on the outer packaging. The Cosmetic Regulation did not contain a category of cosmetic products defined by reference to their 'presentation' such that it was possible to categorise a product as a 'cosmetic product' as a matter of law for the sole reason that it was presented as such.
The CJEU stated, however, that its decision was without prejudice to the application, where appropriate, of rules enabling competent authorities to verify whether or not the statement on the outer packaging of the lenses at issue amounted to misleading commercial practice.
Non-corrective colour contact lenses: a matter of classification
The CJEU appears to have lost an important opportunity to clarify its position with respect to the regulation of non-corrective contact lenses. They do not fall within the Cosmetic Regulation. They generally do not fall within the scope of medical device legislation either.
Contact lenses for aesthetic purposes are generally not considered to be medical devices under the Directive 93/42/EEC (the "Medical Device Directive"), as they are not intended to have a medical purpose . Article 1(2) of Medical Device Directive bases the definition of a medical device on the "purpose of use" of the devices. Indeed, the European Commission's Manual on Borderline and Classification specifies that non-corrective contact lenses that have specific medical purposes (e.g. used to treat congenital or traumatic conditions or they are used in clinical practice or post-surgical as a medical prosthesis) will be considered to be medical devices. However, non-corrected contact lenses without specific claims (as those listed in the Manual) would be regarded as having no medical purpose and therefore were not medical devices.
Notwithstanding this classification, contact lenses due to their direct contact with the eye may pose a risk for human health. This is clearly explained by the CJEU in the decision Ker-Optika bt v. ANTSZ Dél-dunàntùli Regionàlis Intézete -concerning corrective contact lenses classified as medical devices that, as seen, may be compared to aesthetic contacts lenses insofar safety is concerned -the Court held that "contact lenses come into direct contact with the eyes… the use of which may, in individual cases, cause eye inflammations and even lasting visual impairment, medical conditions which may be caused by the mere wearing of contact lenses". It follows that "given the risk to public health which thus exist, a Member State may impose requirement that contact lenses are to be supplied by qualified staff who are to alert the consumer to those risks, carry out an examination of the customer and recommend or advise against the wearing of lenses (…)".
Although such lenses currently fall outside the scope of medical device legislation, Member States have implemented laws or rules governing their use. For example, in Italy the marketing of contact lenses, both corrective and cosmetic, shall be accompanied by the delivery of a booklet warning about the risk related to contact lenses use . In the UK, section 27 of the Opticians Act 1989 provides that zero power contact lenses can only be sold by or under the supervision of a registered medical practitioner, registered optometrist or registered dispensing optician.
The Proposed Medical Devices Regulation
European legislators are set to replace the current regulatory framework governing medical devices with two new EU Regulations: In Vitro Diagnostic Medical Devices Regulation and the Medical Devices Regulation.
The inclusion of cosmetic contact lenses among medical devices is among the issues considered text for proposed Medical Device Regulation . The proposed Regulation (which is currently under discussion within the Trialogue phase ) extends of the scope of the current medical device legislation to include implantable or other invasive products without a medical purpose that are similar to medical devices in terms of characteristics and risk profile. This includes non-corrective contact lenses.
This extension would affect the freedom of economic operators to conduct business, introducing also for cosmetic lenses the pre-marketing product safety and post-marketing vigilance requirements already forecast for corrective lenses, which are already classified as medical devices. Moreover cosmetic contact lenses would be subject to technical requirements sets forth by the Medical Devices Directive. This reclassification has been largely supported by practitioners and governing bodies as a means to improve public protection.