On 3 September 2015, the Court of Justice of the European Union (the “Court”) delivered its ruling in Case C-321/14 (the “ruling”) confirming that Regulation (EC) No 1223/2009 on cosmetic products (the “Cosmetics Regulation”) must be interpreted as meaning that non-corrective colour contact lenses featuring designs do not fall within the scope of that regulation, notwithstanding the fact that their outer packaging bears the statement ‘cosmetic eye accessory, subject to the EU Cosmetics Directive’.


Cosmetic contact lenses (also known as plano or zero-powered lenses) do not have a corrective function but are used to change the appearance of the eye in fashion, fancy dress or films.

Following conflicting judicial decisions in Germany concerning the classification of cosmetic lenses, the Landgericht Krefeld (a German regional court) referred the following questions to the Court for preliminary ruling:

  1. Must Regulation No 1223/2009 be interpreted as meaning that a product which does not come under Regulation No 1223/2009 must none the less 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 Regulation No 1223/2009 be interpreted as meaning that “non-corrective contact lenses featuring designs” come within the scope of that regulation?’

The Court’s answer to both questions was no.

Definition of ‘Cosmetic product’

The ruling observes that merely labeling a product as a ‘cosmetic’ will not automatically mean that the product falls within scope of the Cosmetics Regulation.  Rather, the product must satisfy the legal definition of a cosmetic as set out in the Cosmetics Regulation.  The legal definition is based on three cumulative criteria:

  1. The nature of the product in question

In order to qualify as a cosmetic, the product must be a ‘mixture’ or a ‘substance’ as opposed to an ‘object’.  The Court found that in light of the objective characteristics of cosmetic lenses, on the basis of which they may be classified as ‘objects’, they cannot be regarded as a ‘mixture’ or a ‘substance’.
Of note, this literal interpretation would also exclude objects such as specialised face cleaning brushes, leaving them in the territory of more general consumer protection law.

  1. The part of the human body with which the product is intended to be placed in contact

If the product is not intended to be placed in contact with certain listed parts of the human body - i.e. external parts of the body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity - then it will not qualify as a cosmetic.  The Court found that the list of body parts is exhaustive and hence excludes the eye’s cornea.

  1. The purpose of use

The definition provides that the product is placed into the contact with the listed body parts 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.  The Court found that since the function of the cosmetic lenses was to change the appearance of the eye’s cornea, their sole or main function was not to clean, perfume, change the appearance of, protect or keep in good condition any of the listed body parts.

In light of the above, the Court’s clear conclusion was that the Cosmetics Regulation must be interpreted as meaning that cosmetic lenses do not fall within the scope of that regulation.  The Court noted that, unlike for medicinal products, the definition of a ‘cosmetic product’ does not contain a category of cosmetic products defined by reference to their ‘presentation’, whereby it is possible to categorise a product as a ‘cosmetic product’ as a matter of law for the sole reason that it is presented as such.
Not only does the ruling answer the questions posed by the German court in relation to the classification of cosmetic lenses, it offers general interpretation of the definition of ‘cosmetic product’ in the Cosmetics Regulation.  The literal interpretation offered by the Court leaves no room to broaden the definition of a ‘cosmetic product’ to cover cosmetic lenses.  However, the Court indicates that, in the particular instance, the labelling may constitute misleading commercial practice by stating that the lenses fall within the cosmetics legislation in violation of Directive 2005/29/EC concerning unfair business-to-consumer commercial practices and Directive 2006/114/EC concerning misleading and comparative advertising.
National laws that regulate the supply of contact lenses should also be considered.  In the UK, cosmetic lenses can only be sold by or under the supervision of a registered medical practitioner, a registered optometrist or a registered dispensing optician.  There are also obligations in relation to arranging appropriate aftercare. - See more at: http://www.bristows.com/articles/european-court-of-justice-rules-on-cosmetic-contact-lenses#sthash.2QsLC0M0.dpuf