Cosmetics in the Spotlight: Regulation 1223/2009 on cosmetic products sets new barriers for animal testing

Cosmetics in the Spotlight: Regulation 1223/2009 on cosmetic products sets new barriers for animal testing
  • 20/09/2017
  • Michalopoulou & Associates

The current European legislation on cosmetic products adequately regulates the legal status of cosmetics within the European Union. However, besides the safety measures that their manufacturers have to take to ensure compliance with the requirements of the Regulation having as primary concern consumer safety, cosmetic manufacturers must also never conduct any testing of product’s ingredients to animals.  This issue has been recently addressed by many companies and organizations worldwide, given that even though there is an explicit ban of animal testing under the Cosmetics Regulation, however, in some markets outside Europe, such as China and Japan, allowing testing of cosmetic products or ingredients in animals is surprisingly allowed.

What does the Cosmetics Regulation foresee?

Article 18 of the Cosmetics Regulation prohibits the placing on the market of cosmetic products the final composition of which has been subjected to animal testing using a method other than an alternative method after the validation and adoption of this alternative method at Community level, due consideration to the development of validated methods within the OECD. Furthermore, it is prohibited to place on the market cosmetic products containing ingredients or combinations of ingredients which, in order to meet the requirements of this Regulation, have been subjected to animal testing using a method other than an alternative method after the validation and adoption of that alternative method at Community level, taking due account of the development of validated methods within the OECD, while it is also forbidden to carry out trials in the territory of the Community animals which are ultimately cosmetic products in order to meet the requirements of the Regulation.

What happens when animal testing takes place outside the EU?

Although in Europe the testing of ingredients of cosmetic products in animals is prohibited under the Regulation, in some countries, such as Japan and China, animal testing is permissible for cosmetic products to be marketed in these countries. However, such issue has raised questions on whether cosmetic products tested in animals outside Europe can be lawfully marketed in Europe, in compliance with the provisions of the Regulation. In particular, the EU Court has recently adjudicated in regards to the content of the ban on animal testing, as defined in Article 18 of the Cosmetics Regulation. This decision came following a legal action brought by the European Federation for Cosmetic Ingredients (EFfCI), a trade association representing the manufacturers within the EU of ingredients for use in cosmetic products. Members of this federation carried out animal testing outside the territory of the European Union to verify that certain cosmetic ingredients were safe for human health. The data collected from these tests were required to be used in cosmetic products for sale on the Japanese or Chinese markets. By filing its action, the EFfCI sought to establish whether criminal penalties could be imposed against the three companies involved if they placed on the United Kingdom market cosmetic products containing ingredients tested on animals outside the territory of the Union. The EU Court of Justice concluded that according to the meaning of Article 18 (1) (b) of Regulation No 1223/2009 the placing on the EU market of cosmetic products containing some ingredients that have been tested on animals outside the EU in order to market those products in third countries may be prohibited if the data resulting from that testing is used to prove the safety of the products concerned for the purposes of placing them on the EU market.

 What criminal sanctions are threatened for companies / offenders?

According to the Explanatory Memorandum of the Cosmetics Regulation, it is for the Member States to lay down provisions on penalties to be imposed in the event of infringement of the provisions of this Regulation. In Greece, the circulation/distribution of any cosmetic product contrary to the applicable provisions on altered products, poor manufacturing or maintenance, as well as overall labeling and security formalities, is subject to a penalty of between 1,400€ and 11,000€, depending on the gravity and type of the infringement.

Our law firm’s comment:

The EU Court’s of Justice ruling leads to the conclusion that the Union law protects the European market from cosmetic products the ingredients of which have been tested in animals. Hence, legislation on cosmetic products is of great importance and therefore cosmetic manufacturers who must comply with the provisions of the Regulation at all times must pay careful attention in regards to its application when manufacturing and/or distributing cosmetic products. In this context, we also await for new legal rulings in regards to other provisions of the Cosmetics Regulation, such as those on advertising and its limits.

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