Stakeholders expect a ruling in 2016 from the EU's highest court on whether the cosmetic animal-testing ban applies to testing conducted to meet requirements outside of the European Cosmetics Regulation, such as other European chemicals programs and third-country regulations.

Cruelty Free International announced Dec. 5 that it and other animal-rights advocates recently presented arguments at a hearing held by the European Court of Justice, which is considering the matter following a referral from a division of the High Court of Justice of England.

A Cruelty Free rep told "The Rose Sheet" that the ECJ's advocate general is slated to furnish his opinion on the case by March 17, 2016. At that point, the court can agree with that opinion or take other steps, such as holding another hearing.

"One way or another, we do expect a ruling on this case in 2016," the spokesperson said.

Cruelty Free says it is "pleased with how the hearing went and that we were given the opportunity to make our argument," while acknowledging that the animal-welfare community has no further legal recourse if the ECJ sides with industry.

The European Federation for Cosmetic Ingredients – which represents roughly 90% of the European cosmetic ingredients industry – is the plaintiff in the case, while the U.K. Secretary of State for Business, Innovation and Skill and Attorney General, both responsible for enforcing EU law domestically, are defendants Also see "Highest EU Court To Interpret Cosmetic Animal-Test Ban’s Scope" - HBW Insight, 18 December, 2014..

EFfCI seeks legal clarification as to whether the EU ban fully implemented in March 2013 extends to products containing ingredients tested on animals for example in China, which often requires such testing as part of the country's premarket regulatory process, or generally under any circumstances beyond compliance with safety-substantiation criteria built into the European Cosmetics Regulation.

At issue 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."

On its face, the language suggests that cosmetic animal testing performed for any other reason, in the EU or elsewhere, would not violate the European ban and bar associated products from the market.

However, NGOs contend that the legislative intention behind the ban was to prohibit the sale of cosmetics in the EU that contain ingredients tested on animals under any scenario.

Any other reading "would make a nonsense of the bans, which took 20 years of hard-fought campaigning to achieve," Cruelty Free says.

Industry holds that the animal-welfare community's interpretation of the ban poses an oppressive quandary for multinationals with business in China, Brazil and other markets around the world where cosmetic animal testing is mandatory in many cases currently.

European authorities have issued communications addressing the scope of the ban that seem to support industry's case – to an extent.

When the full marketing ban on animal-tested cosmetic ingredients first went into effect, the European Commission stated: "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 April, 2013..

That position does not clear the way for products to enter the EU with ingredients tested on animals under Chinese cosmetic regulations, but substances that undergo animal testing to satisfy data needs under the EU's Registration, Evaluation, Authorization and Restriction of Chemicals law, for example, ostensibly can be used in cosmetics marketed in Europe, based on that statement.

The European Chemicals Agency, which oversees REACH, issued further clarification in October 2014 in partnership with the EC, specifying that animal testing is permitted under REACH, "as a last resort," to assess the human health effects of ingredients used for multiple purposes – i.e., not solely in cosmetic contexts – as well as risks to workers and the environment. Such instances would not constitute violations of the cosmetic animal-testing ban, they said Also see "ECHA Clarifies Exceptions To Cosmetic Animal-Test Ban; NGOs Regroup" - HBW Insight, 30 October, 2014..

Animal-rights groups reacted with outrage to the notice, arguing that “in practice, the animal tests bans would have virtually no application" if such exemptions were upheld.

Decision Could Remove Fetters On Innovation

The case before the ECJ could result in a decision that opens even larger gaps for cosmetic companies to animal-test ingredients, not only in markets where it's required but in any regulatory compliance context not directly related to the European Cosmetics Regulation.

For example, in the US, FDA expects companies to substantiate the safety of cosmetic products by "whatever testing is appropriate and effective" before placing them on the market. Firms that test ingredients on animals to meet that open-ended requirement would be able to market the same ingredients in the EU if the court agrees with industry that the animal-testing ban applies exclusively to testing germane to the European Cosmetics Regulation.

The Cruelty Free rep said the organization was "pleased with how the hearing went and that we were given the opportunity to make our argument." Cruelty Free and the European Coalition to End Animal Experiments are serving as interveners in the case to provide expertise and perspective.

He acknowledged that the issue's fate hangs in the balance of ECJ's decision next year.

"There are no further legal options if the ECJ sides with EFfCI, as the European Court of Justice is the most authoritative court," he said.

For industry, a favorable decision would help to resolve a predicament that it says has hamstrung innovation in the sector. With no validated alternative methods at present to assess repeated-dose systemic toxicity, cosmetic ingredient R&D has taken a hit under the EU ban on animal testing, stakeholders say ([A#02151221002]).

The Personal Care Products Council has noted that companies now only consider animal testing when mandated by government bodies "or for safety evaluations of new ingredients when no viable alternative is available."

Meanwhile, the Humane Cosmetics Act, introduced by Rep. Martha McSally, R-Ariz., in the US House in June, would help to remedy what NGOs have viewed as unintended loopholes being exploited in the European animal-testing ban.

As currently worded, H.R. 2858 not only would prohibit cosmetic animal testing on US soil one year after enactment, but also ostensibly would bar cosmetics from the U.S. market two years later "if the final product or any component thereof was developed or manufactured using cosmetic animal testing conducted or contracted for after the effective date," no matter where it occurs in the world ([A#02150824003]).

The proposed legislation has garnered 140 cosponsors and resides currently with the Energy and Commerce Subcommittee on Health.

Highest European Court To Rule On Animal-Testing Ban's Scope In 2016

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