This report outlines a series of steps U.S. exporters active in the cosmetics sector may want to implement in anticipation of selling their products in the European Union (EU). U.S. exporters unfamiliar with EU regulations applicable to cosmetic products may also want to review MR – 179 on cosmetic products as it provides an overview of the EU Cosmetics Regulation.
Last Published: 2/22/2016
This report outlines a series of steps U.S. exporters active in the cosmetics sector may want to
implement in anticipation of selling their products in the European Union (EU). U.S. exporters
unfamiliar with EU regulations applicable to cosmetic products may also want to review MR – 179 on
cosmetic products as it provides an overview of the EU Cosmetics Regulation.

Steps to exporting cosmetic products to the European Union

1. Determine if the product is considered a cosmetic under EU law

The EU Cosmetics Regulation defines a “cosmetic product” as, “any substance or preparation
intended to be placed in contact with the various external parts of the human body 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, and/or correcting body odors, and/or protecting them
or keeping them in good condition.”

U.S. exporters selling cosmetic products that have characteristics of other product-types such as
pharmaceuticals, biocides or medical devices should take care when assessing whether EU
Cosmetics Regulation legislation applies to their product. U.S. exporters may find the EU “Manual
on the Scope of Application of the Cosmetics Directive” helpful in making this assessment:

http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/manual_borderlines_version50_en.pdf

2. Verify that no ingredients are subject to EU-wide bans or restrictions

The EU annexes to the EU Cosmetics Regulation identify substances used in cosmetic products that
are subject to prohibitions or restrictions. These annexes are:
  • Annex II: List of substances prohibited in cosmetic products
  • Annex III: List of substances which cosmetic products may contain only under the
  • restrictions and conditions laid down.
  • Annex IV: List of colorants permitted in cosmetic products
  • Annex V: List of preservatives permitted in cosmetic products
  • Annex VI: List of UV filters allowed in cosmetic products
  • In addition, the EU Cosmetics Regulation prohibits the:
  • Testing of finished cosmetic products and ingredients on animals (test ban);
  • Marketing of finished cosmetic products and ingredients which were tested on animals (marketing ban).
This ban went into effect on March 11, 2013. Ingredients used in cosmetic products before this date are exempt from the ban. A U.S. exporter wanting further information may consult the EC Communication, which provides information about its legislative history, the scope and guidance to Member States and companies for its implementation.

3. Prepare a Product Information File (PIF)

A Product Information File (PIF) must be prepared for each cosmetic product and made readily accessible to the Competent Authorities for inspections. The PIF documents that the product has met all requirements required by EU regulation.

When preparing a PIF, some U.S. exporters may find it helpful to review the UK guidance document discussing how to compile such a dossier and how to carry out a safety assessment. This document is available at: http://www.bis.gov.uk/assets/biscore/consumer-issues/docs/guide-to-cpsr.pdf

4. Appoint a Responsible Person (New Requirement as of July 11, 2013)

As of July 11, 2013, cosmetic products can only be placed on the EU market if they have a designated ‘responsible person’.The Responsible Person ensures that that the product meets all EU regulatory requirements and will serve as the primary contact should regulatory officials have questions about the product.
The Commercial Service at the U.S. Mission to the European Union maintains a list of Business Service Providers that offer responsible person services. This list is available at: http://export.gov/europeanunion/accessingeumarketsinkeyindustrysectors/eg_eu_044318.asp

5. Ensure that any claims about the product can be supported with evidence:

The EU published requirements regarding the use of cosmetic product claims were published on July 10, 2013. The detailed requirements, referred to as the “common criteria”, apply immediately, and:
  • Require that explicit and implicit claims are supported by adequate and verifiable evidence;
  • Prohibit claims that indicate that a cosmetic product has been authorized or approved by a competent authority within the EU;
  • Prevent the use of claims that attribute specific characteristics to a cosmetic product if similar cosmetic products possess the same characteristics or if a specific benefit is in mere compliance with minimal legal requirements;
  • Require that claims do not create confusion with competitor products, and do not denigrate competitors or ingredients legally used.
The responsibility for ensuring that a company’s claims comply with the common criteria is placed on the legal or natural person designated as the ‘responsible person’ for the cosmetic product concerned within the EU. The Commission Regulation setting forth the common criteria for product claims is available here.

6. Ensure that the container and packaging comply with EU requirements
Cosmetic products do not require a CE mark. However, both the container and packaging must
bear, the following information:
  • The name and EU address of the responsible person ;
  • The weight or volume expressed in metric units at the time of packaging;
  • The durability of the cosmetic product. Companies may use the open jar or hour glasssymbol as appropriate. Both symbols are depicted below;
    • The open jar symbol indicates the durability of the product after it as been opened. This symbol should only be used on products with a shelf life of 30 months or more.
    • The hour glass symbol should be used for products that have a durability shoarter than30 months. The symbol must be accompanied by the date of minimum durability. This date should be expressed either in the day/month/year or month/year format (in that order).
  • Any necessary warnings and conditions of use
  • Batch number
  • Product function (unless it is clear from the product presentation)
  • List of ingredients (U.S. exporters must use the European version of the International
  • Nomenclature of Cosmetics Ingredients (INCI)). This can be found at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:097:0001:0528:EN:PDF
  • Country of origin
  • In addition, if a product uses nanomaterials, their presence must be indicated by the word [nano] in brackets (as shown).
  • This information must be found in indelible, easily legible, and visible characters on both the container and the package of the cosmetic product
  • Other notes on labeling:
  • Language: Label information must be in the national or official language (or languages) of the respective Member State where the product is marketed. The only exception is the list of ingredients, which must use INCI ingredient names.
  •  Small Packaging: For products where it is not practical to print warnings, ingredients, and product use information on the packaging or container itself, a leaflet, label, or card must be provided including this information. The container and packaging must make reference to this leaflet, label, or card, through use of the symbol located on the left (ie.hand inside an open book as shown below).
For more information on how to label products, see pages 13-24 of the UK guidance document: http://www.bis.gov.uk/assets/biscore/consumer-issues/docs/guide-to-cpsr.pdf.

7. Notify using the Cosmetic Product Notification Portal (CPNP)

The previous system of national notification has been replaced by a centralized European electronic notification system. U.S. exporters must rely on their Responsible Person to submit the notification.

8. Implement your marketing strategy

U.S. exporters should take into consideration that the European Union and the Member States have strict rules for certain types of marketing techniques including on-line sales and marketing, and direct sales. U.S. exporters may want to review the following legislation before deploying those practices:

E-commerce Directive (2000/31/EC):
http://ec.europa.eu/internal_market/e-commerce/index_en.htm
Directive on Distance Selling to Consumers (97/7/EC)
For more information, please see:
http://ec.europa.eu/consumers/cons_int/safe_shop/dist_sell/index_en.htm
http://ec.europa.eu/consumers/rights/gen_rights_en.htm
Council Directive (85/577/EEC) on protection of consumers in contracts negotiated off business premises:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1985:372:0031:0033:EN:PDF

For more information:
  • Link to the Cosmetics Regulation (1223/2009): http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF
  • European Commission Website (DG Consumer Affairs):
  • http://ec.europa.eu/consumers/sectors/cosmetics/index_en.htm
  • Link to EU communication and regulation on Animal Testing:
  • http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/animal_testing/com_at_2013_en.pdf
  • Link to EU communication and regulation on Product Claims: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:190:0038:0053:EN:PDF

More questions? E-mail Office.BrusselsEC@trade.gov

For More Information
The U.S. Commercial Service at the U.S. Mission to the European Union, can be contacted via email at: Matthew A. Kopetski, matthew.kopetski@trade.gov; Fax: +32 2 811 5151; or visit our website: http://www.export.gov/europeanunion.

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Disclaimer: The information provided in this report is intended to be of assistance to U.S. exporters. While we make every effort to ensure its accuracy, neither the United States government nor any of its employees make any representation as to the accuracy or completeness of the information in this or any other United States government document. Readers are advised to independently verify any information prior to reliance thereon. The information provided in this report does not constitute legal advice. The U.S. Commercial Service reference to or inclusion of material by a non-U.S. Government entity in this document is for informational purposes only and does not constitute an endorsement by the U.S. Commercial Service of the entity, its materials, or its products or services.

International copyright, U.S. Department of Commerce, 2013. All rights reserved outside of the United States.

Prepared by our U.S. Embassies abroad. With its network of 108 offices across the United States and in more than 75 countries, the U.S. Commercial Service of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide. Locate the U.S. Commercial Service trade specialist in the U.S. nearest you by visiting http://export.gov/usoffices.



European Union 28 Cosmetics and Toiletries Export Regulations