The Court of Justice of the European Union (“CJEU”) has confirmed that Article 18(1)(b) of the Cosmetics Regulation (EC) No 1223/2009 (“Cosmetics Regulation”) must be interpreted as meaning that it may prohibit the placing on the EU/EEA market of cosmetic products containing some ingredients that have been tested on animals outside the EU/EEA, in order to market cosmetic products in third countries, if the resulting data is used to prove the safety of those products for the purposes of placing them on the EU/EEA market. However, as long as the resulting data has not be relied on to prove the safety of the cosmetic product pursuant to the Cosmetics Regulation, access to the EU/EEA market shall not be prohibited.
Background
The so called “marketing ban” in Article 18(1)(b) of the Cosmetics Regulation prohibits the placing on the market of cosmetic ingredients that ‘in order to meet the requirements of this Regulation, have been the subject of animal testing …’.
In the context of national judicial review proceedings, the High Court of Justice of England and Wales made a request for a preliminary ruling to the CJEU in order to clarify the meaning of this provision. The main aim of the referral was to establish whether or not this provision prohibits the placing on the Community market of cosmetic products containing ingredients, or a combination of ingredients, which have been the subject of animal testing where that testing was performed outside the EU/EEA to meet the legislative or regulatory requirements of third countries in order to market cosmetic products containing those ingredients in those countries.
Ruling
The CJEU ruled on 21 September 2016 in Case C 592/14 that:
“Article 18(1)(b) of [the Cosmetics Regulation] must be interpreted as meaning that it may prohibit the placing on the European Union market of cosmetic products containing some ingredients that have been tested on animals outside the European Union, in order to market cosmetic products in third countries, ifthe resulting data is used to prove the safety of those products for the purposes of placing them on the EU market.” (emphasis added)
The CJEU’s ruling is in-line with the AG Opinion. In his Opinion delivered on 17 March 2016, AG Bobek opined that Article 18(1)(b) has a narrow meaning, namely, it only prevents reliance on the results of animal testing for the purpose of meeting the requirements of the Cosmetics Regulation, subject to the relevant cut-off dates.
Helpfully for industry, the CJEU’s ruling sets out how companies who wish to market a cosmetic product in the EU/EEA can comply with the “marketing ban” in Article 18(1)(b) in practice. Namely, and long as the cosmetic product safety report (as required by Article 10 of the Cosmetics Regulation) does not include the results of animal tests, such tests will not be regarded as having been carried out “in order to meet the requirements of [the Regulation]” and hence the “marketing ban” in Article 18(1)(b) of the Regulation will not be contravened.
Furthermore, the CJEU confirmed that such compliance will not be jeopardised by the inclusion elsewhere in the cosmetic product information file (known as the ‘PIP’) of data resulting from animal testing. In fact, it follows from Article 11 of the Cosmetics Regulation that the data on any animal testing performed inter alia by the manufacturer to meet the legislative or regulatory requirements of third countries must be included in the PIP.
Comment
This ruling confirms that where cosmetics manufacturers conduct animal testing outside the EU/EEA in order to establish the safety of ingredients (or a combination of ingredients) as required for the use of those ingredients in cosmetics sold in non-EU/EEA countries, those ingredients can be incorporated in cosmetic products placed on the EU market without contravening the so called “marketing ban” in Article 18(1)(b) of the Cosmetics Regulation. This interpretation helps to keep the EU/EEA cosmetics consumer market open to cosmetic products developed for sale in third countries.