The Court of Justice Rules: Contact Lenses Do Not Fall Under the Cosmetics Regulation

On the 3rd of September 2015, the European Court of Justice, delivering the case C-321/14, ruled that corrective color contact lenses do not fall within the scope of the Regulation (EC) No 1223/2009 on cosmetic products. This is despite the outer packaging possibly stating the following: “cosmetic eye accessory, subject to the EU Cosmetics Directive.”

The dispute in the main proceeding and the questions referred to the Court

The subject of the dispute before the Regional German Courts was the classification given to the contact lenses that are used for altering the eye’s appearance, before being placed on the beauty products market.

In those circumstances, the Regional German Court, the Landgericht Krefeld, referred two crucial questions to the European Court of Justice with the aim of clarifying the scope of the beauty products regulation. They were:

  • Should a beauty product, which does not come under the EU Cosmetics Regulation, comply with its requirements for the sole reason that on the packaging it states, “cosmetic eye accessory, subject to the European Cosmetics Directive”?
  • Do non-corrective contact lenses featuring designs fall under the scope of the European Cosmetics Regulation?

Consideration of the questions referred

The Court considered it necessary to examine whether or not the lenses met the three cumulative criteria set out in the cosmetics products definition given by Article 2 (1) of the Regulation (EC) No 1223/2009.

  • The nature of the product in question:
  • According to the definition, ‘cosmetic product’ means any substance or mixture, ‘substance’ being a chemical element and ‘mixture’ being a mixture or solution composed of two or more substances. In light of the objective characteristics, the lenses can be classified as ‘objects’ and they cannot be regarded as a ‘substance’ or a ‘mixture’;
  • The part of the human body with which it is intended to be placed in contact:
  • The definition gives an exhaustive list, including the external parts of the human body (epidermis, hair system, nails, lips and external genital organs), the teeth and the mucous membranes of the oral cavity. The lenses are placed on the eye’s cornea and as such they have no connection with the list mentioned above;
  • The purpose of its use:
  • Following the definition, the cosmetic product is used with a view to exclusively or mainly cleaning the lenses, filling them with perfume, changing their appearance, protecting them, keeping them in good condition or correcting body odors. The purpose of the lenses is to change the appearance of the eye’s cornea and as such they do not satisfy the third criterion.


The Court offers a literal interpretation concluding that the contact lenses do not meet any of the three criteria to fall under the definition of a cosmetic product. Contact lenses are not classified as cosmetic products and they do not fall under the scope of application of the Regulation (EC) No 1223/2009. This conclusion is not affected by the fact that the outer packaging claims something different. The cosmetics industry should be aware of the fact that the Regulation (EC) No 1223/2009 does not contain a category of beauty products defined by reference to their ‘presentation’.

If you want to know more about product regulatory compliance and product safety regulations please contact us.

Get in touch

Share This

Copy Link to Clipboard