By Jessica Lawrence
What is the scope of the marketing ban on cosmetics containing ingredients that were tested on animals? Does it include cosmetics that were tested on animals because of the requirements of a third country’s laws? This was the question the CJEU addressed in its decision in the European Federation for Cosmetic Ingredients case. The Court’s 21 September 2016 judgment goes some way toward resolving the lack of clarity of the animal testing provisions of the Cosmetics Regulation (which Advocate General Bobek’s Opinion referred to as ‘not well drafted’ and ‘not a paragon of clarity’ (AG’s Opinion paras 74 & 24)). But it also continues a recent line of cases in which the Court approves of EU rules with important extraterritorial effects.
Facts and Judgment
The EU has for some time had in place rules that seek to curtail the use of animal testing in the cosmetics industry. To that end, Article 18 of the Cosmetics Regulation prohibits the placing on the EU market of products that were tested on animals ‘in order to meet the requirements of this Regulation.’ The marketing ban is not limited to products tested within the EU, but rather applies to all cosmetic products marketed on the EU internal market, wherever their safety testing may have occurred (Judgment para 41). As such, it extends its protection extraterritorially to animals located outside EU borders.
This marketing ban is to be enforced in the Member States through ‘effective, proportionate and dissuasive’ penalties (Cosmetics Regulation Article 37). The UK—the Member State from which the preliminary reference was submitted—elected to implement the Regulation’s penalty provisions by imposing criminal sanctions on those who sell cosmetics in violation of the marketing ban. Article 18’s lack of clarity was therefore particularly troubling from the perspective of legal certainty.
The European Federation for Cosmetic Ingredients (EFfCI), a trade association representing EU manufactures of cosmetic ingredients, reported that third states such as Japan and China require them to conduct animal testing on cosmetics that will be sold in those markets. Fearing sanctions, EFfCI members had not yet incorporated such ingredients into products sold in the EU. The point of this case was, therefore, to determine whether they would face criminal and/or civil penalties if they began to market in the UK products containing ingredients that had been tested on animals outside of the EU, because third state laws (such as those of China and Japan) require such testing.
The CJEU, following Advocate General Bobek’s Opinion, determined that the prohibition on marketing products that were tested on animals ‘in order to meet the requirements of’ the Cosmetics Regulation meant that products could not rely on data from animal tests in order to prove the safety of cosmetics products. EU safety standards would therefore have to be met using data from alternative sources. However, neither the existence of animal testing data as such, nor its inclusion in a cosmetic product information file prevents a cosmetic product from being marketed in the EU (Judgment paras 43 & 45).
This rule is more restrictive than EFfCI’s proposed test, which would have looked at whether the animal testing was done for the purpose of complying with the EU’s Cosmetics Regulation. The Court rejected this test as being improperly focused on the ‘intent’ behind any such testing (Judgment para 30). As Advocate General Bobek explained, even though ‘[t]he first port of call in any interpretative exercise is the text of the provision,’ which here would seem to support EFfCI’s reading, and although one cannot ‘simply ignore the text and set sail on the foggy sea of effet utile,’ in this case the context and purpose of the Cosmetics Regulation confirmed the fact that it was intended to discourage more than just animal testing done with the ‘intent’ of complying with EU rules (AG’s Opinion paras 77-78).
On the other hand, the Court did not interpret the marketing ban as extending to all products that had been tested on animals per se, as advocated by some animal rights organizations (see also Judgment para 18). Had it done so, it would have created a situation in which cosmetics manufacturers would have to choose whether to market their products in countries that require animal testing—such as Japan and China in this case—or in countries that forbid it—such as the EU Member States. Instead, the CJEU determined that data from animal testing could simply not serve as the basis for determining whether or not a cosmetics product meets EU safety standards.
The CJEU’s ‘reliance’ test helpfully clarifies the scope of Article 18 of the Cosmetics Regulation. But it also continues the Court’s trend of accepting EU rules with important extraterritorial effects, so long as there is sufficient ‘territorial connection’ with the EU. The animals at issue in this case do not live in the EU. The animal testing does not take place within EU borders. But the EU’s animal welfare laws extend their reach extraterritorially, in the Court’s words, ‘actively promoting use of non-animal alternative methods to ensure the safety of products in the cosmetics sector’ (Judgment para 34), no matter where in the world that testing happens. For the CJEU, the focus of the analysis is the use of animal testing data in EU safety assessments—an activity that properly falls within EU jurisdiction—regardless of where any such testing may have taken place.
In this sense, European Federation for Cosmetic Ingredients parallels the 2015 Zuchtvieh case (see comment on this blog). In Zuchtvieh, the CJEU found that Regulation 1/2005 on the protection of animals during transport applied outside of EU borders to protect animals in transit between the EU and third states. This meant that animals whose transport originated in the EU would have to be fed, watered, and unloaded for rest breaks on a schedule determined by EU rules long after they left EU territory. Even though the animals would be moving through third states, the Court focused on the fact that EU authorities were the ones who had to issue the permit for their transport. In Zuchtvieh, as in European Federation for Cosmetic Ingredients, permitting or safety decisions by EU regulators act as the jurisdictional hook for EU rules that affect conduct taking place in third states.
While European Federation for Cosmetic Ingredients does not go so far as some other cases in this respect (see, e.g. Ebony Maritime), it continues the CJEU’s recent trend of being generally undeterred by the extraterritorial regulatory effects of EU law. For many, this will be seen as a positive development. Indeed, from an animal welfare perspective, a narrower reading would have effectively gutted the Cosmetics Regulation’s animal testing rules (though some would argue that allowing products tested on animals into the EU at all is still a huge blow). However, it also provides further evidence of the CJEU’s interpretation of international jurisdictional norms.
In his opinion on Zuchtvieh, Advocate General Bot expressed concern about the extraterritorial aspect of the case, arguing that the scope of Regulation 1/2005 should be limited to the portion of transport taking place within the EU. The CJEU was unmoved, however, noting only that ‘should it nevertheless be the case that the law or administrative practice of a third country through which the transport will transit verifiably and definitely precludes full compliance,’ then it would be within the competent authority’s margin of discretion to make allowances for such conflict.
Precisely such a case of preclusion could be said to have arisen here, where the EU’s prohibition on animal testing is directly contrary to the cited rules in China and Japan that require animal testing for cosmetic products. Perhaps this explains the CJEU’s reluctance to extend the reach of Article 18 of the Cosmetics Regulation to prohibit per se the marketing of products that have undergone animal testing, instead requiring only that such testing not factor into the EU’s safety determination.
The CJEU’s judgment in European Federation for Cosmetic Ingredients might thus be read as a concession to global pluralism, balancing the ‘external dimension’ of EU law that seeks to export its social and environmental norms abroad, against the regulatory sovereignty of third states. The CJEU here, and in cases such as Zuchtvieh, continues the process of crafting its own interpretation of the appropriate limits on the extraterritorial reach of EU authority. In European Federation for Cosmetic Ingredients, the Court confirms that EU safety determinations are a sufficient hook on which to hang EU regulatory authority. In doing so, the CJEU is making an intervention into the international legal conversation about jurisdiction and the meaning of territorial borders in a world of globalized production and consumption.