Highest EU Court To Interpret Cosmetic Animal-Test Ban’s Scope

The European Federation for Cosmetic Ingredients awaits a ruling from the European Court of Justice – expected in about two years – as to whether the ban in the EU necessarily prohibits the marketing of cosmetic ingredients tested on animals to meet regulatory requirements in third countries. Animal-welfare groups claim EFfCI’s aim is to “severely weaken” the ban and “herald a return to the dark days of animals suffering.”

The European Court of Justice will rule on whether cosmetic ingredients tested on animals to meet third country regulatory requirements – such as those in China and Japan – can be marketed lawfully in the EU, addressing what has been a gray area in the ban implemented under the European Cosmetics Regulation.

The case stems from a claim filed in the High Court of England’s Queen’s Bench Division, in which the European Federation for Cosmetic Ingredients seeks declarations to resolve legal uncertainty around the EU animal-testing ban for cosmetics.

Specifically, EFfCI – a trade group representing 90% of the EU cosmetic ingredients industry – says that since the European marketing ban’s enactment in 2009 for testing across most health endpoints, three EFfCI member companies have conducted animal tests on ingredients to satisfy regulatory requirements in China and Japan.

China has begun taking steps to phase out its required animal testing for selected cosmetic products, but foreign manufacturers remain subject to the mandate and no alternative testing methods have been accepted for regulatory purposes by the China Food and Drug Administration to date (Also see "Animal-Test Alternatives Progress In China Despite Regulatory Uncertainty" - HBW Insight, 12 Nov, 2014.).

EFfCI questions whether its member companies with ingredients tested on animals in markets outside of the EU would be in violation of the European ban, and potentially subject to criminal action at the national level, if products containing their ingredients launched in the U.K. or other European markets.

The U.K. Secretary of State for Business, Innovation and Skill and Attorney General, both responsible for enforcing EU law domestically, are defendants in the case, and the British Union for Abolishment of Vivisection and European Coalition to End Animal Experiments were admitted as interveners to provide their expertise and perspective.

In a Dec. 12 judgment, High Court Justice Clive Lewis determined that there is a “real issue of law that needs to be resolved in this case,” referring the case to the European Court of Justice for preliminary ruling, which serves to clarify points of interpretation in European law to enable their proper application.

Notably, according to the official EU website, Court of Justice decisions are “binding not only on the national court on whose initiative the reference for a preliminary ruling was made, but also on all of the national courts of the Member States.”

Legality Hinges On Wording

At issue in the case is Article 18 of the Cosmetics Regulation, which prohibits the marketing of cosmetic products tested on animals “in order to meet the requirements of this regulation.”

That wording has been central to speculation among stakeholders as to the ban’s applicability to cosmetic products tested on animals to substantiate safety under European law outside of the Cosmetics Regulation – such as the EU’s Registration, Authorization, Evaluation and Restriction of Chemicals program – or products that undergo animal testing to meet requirements under third-country regulations.

An Oct. 29 clarification from the European Chemicals Agency, which oversees REACH, highlighted a number of exceptions to the cosmetic animal-testing ban. Among them, ECHA cited cases where a cosmetic ingredient is used in other product categories subject to REACH requirements – such as in pharmaceuticals, household goods or food products – in which event animal testing may be necessary to fulfil data obligations (Also see "ECHA Clarifies Exceptions To Cosmetic Animal-Test Ban; NGOs Regroup" - HBW Insight, 30 Oct, 2014.).

The animal-welfare community reacted with outrage to the release, with a BUAV spokesperson saying the group plans to challenge ECHA’s interpretation “at the first opportunity.”

However, ECHA’s position was consistent with a communication issued by the EC in March 2013 when the full animal-testing ban entered into force, which noted: “Animal testing that has clearly been motivated by compliance with non-cosmetics-related legislative frameworks … should not trigger the marketing ban and could subsequently be relied on in the cosmetics safety assessment” (Also see "EU Animal-Test Ban Exceptions Offer Wiggle Room – Cosmetics Europe" - HBW Insight, 22 Apr, 2013.).

In the same communication, the EC said that that animal testing undertaken to comply with regulations in third countries “cannot be relied on in the Union for the safety assessment of cosmetics.”

That isolated phrasing may still lead firms to question whether such testing is permissible if its results are not being used to substantiate product safety according to the European Cosmetics Regulation’s standards.

The EC went on to say that “testing carried out for cosmetics-relevant endpoints on ingredients that have been specifically developed for cosmetic purposes and are exclusively used in cosmetic products would in the Commission’s view always be assumed to be carried out ‘in order to meet the requirements of this Directive/Regulation.’”

EFfCI is challenging the EC’s assumption, emphasizing that its member companies carried out animal testing on their cosmetic ingredients expressly to comply with third-country regulations and are not relying on that data to support the safety of their products under the European Cosmetics Regulation.

The EC’s seemingly contradictory statement – that “the marketing ban is triggered by the reliance on the animal data for the safety assessment under the Cosmetics Directive/Regulation, not by the testing as such” – leaves the door open for interpretation regarding third-country testing, which now will be in the hands of the EU’s highest court.

In his judgment, Justice Lewis notes that without a declaration resolving legal uncertainty, firms’ only option is to place questionable products on the market and run the risk of prosecution, subsequently raising the defense that their actions were not unlawful under a strict reading of the animal-testing ban.

“It would not, in my judgment, be appropriate to compel the manufacturer of a cosmetic product to run that risk in order to enable this issue to be resolved,” he says.

BUAV Wary Of “Watered Down” Ban

BUAV Director of Policy Nick Palmer suggested in a Dec. 16 interview that EFfCI is attempting to circumvent the EU’s cosmetic animal-testing ban via semantics. “What they are seeking to do is water down the European ban,” he said, adding that it isn’t the first time the group has attempted such a tactic.

In a Dec. 12 post on its website, BUAV notes that EFfCI and the French government were unsuccessful 10 years ago when they tried to have the ban declared unlawful by the European courts.

“If it can’t get the bans declared unlawful, EFfCI is trying to persuade the courts that companies should be allowed to sell in the EU cosmetics tested on animals under the laws of other countries,” BUAV says.

The group maintains that “such a move would severely undermine [the ban] and herald a return to the dark days of animals suffering simply to produce a new hairspray or deodorant.”

According to Palmer, the animal-welfare community is not overly concerned that the industry trade group will prevail in its argument, and it doesn’t expect the Court of Justice to give a ruling on the issue for two years, at which time the case will be remanded back to the U.K. court for its judgment.

“We are nervous when any kind of challenge appears for the ban, but in principle, we’re confident the challenge will be defeated and will give us the opportunities to clarify the ban in a helpful way,” said Palmer.