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The EU Cosmetics Regulation

General

The cosmetics sector is particularly attractive to U.S. exporters due to the low import tariffs imposed by the EU. For example, there is a zero tariff charged on hair products, manicure and pedicure products, perfumes, many essential oils and lip and eye makeup.

The EU Cosmetics Regulation applies to:

“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 other words, the regulation applies to a different, but in many cases overlapping, range of products than those regulated in the United States under equivalent legislation. Products covered by the EU regulation include not only traditional cosmetic products such as perfumes, fragrances and make-up, but also personal care products (i.e. lotions, skin products, soaps, facemasks, toiletries, bath products, deodorants, hair care products and sunscreen).

U.S. exporters may want to review Annex I of the EU Cosmetics Directive obsolete as it contains an extensive but illustrative list of products covered by the new regulation.

Marketing Requirements

All cosmetic and personal care products may be marketed freely within the EU provided that they:

  • are subject to the oversight of a Responsible Person;
  • are supported by a Product Information File (PIF);
  • have been notified on the Cosmetic Products Notification Portal (CPNP); and
  • have the correct labeling.

The Responsible Person

By default, the Cosmetics Regulation designates the importer as the Responsible Person in the event the non-EU based manufacturer fails to appoint one. Many U.S. exporters choose to retain a specialized consultant or law firm rather than rely on their importer(s) for commercial reasons.

U.S. exporters interested in retaining a professional Responsible Person should consult our registered list of Business Service Providers located at the bottom of this page.

Ingredients

U.S. Exporters should also bear in mind that the EU has rules that different from those in force in the United States that regulate ingredients used commonly found in cosmetics. These permissions/restrictions/prohibitions are contained Annexes II, III, IV, V and VI of the EU Cosmetics Regulation. These Annexes are often updated; therefore, U.S. exporters should take care to monitor them so as to ensure that their products will not be caught by a recent regulatory change.

The EU requires that products containing nano-scale ingredients identify such substances with the word “[nano]” in brackets.

In addition, the EU prohibits the sale of any product that contains an ingredient where safety data was obtained through animal testing if the test(s) occurred post March 11, 2013.

Contact Information:

If you have additional questions not covered on this website, please send an email to the following address: Office.BrusselsEC@trade.gov and reference "Cosmetics Inquiry" in the subject line. One of our specialists will respond to your inquiry as soon as possible.

Business Service Providers

Below is a list of consultants for those seeking assistance in ensuring compliance with the Cosmetics Regulation. Those marked with an asterisk also provide “Responsible Person” services.

EcoMundo *

CE.way Regulatory Consultants Ltd *

Obelis s.a. *

Compliance Services International (CSI) *

*Last updated 18 September 2014