ECHA annuls its decision on enforced animal test for BASF ingredient

By Julia Wray 14-Dec-2017

The European chemicals agency had previously asked BASF to conduct a prenatal developmental toxicity study using rats or rabbits on a fatty acid derivative for cosmetic use

Animal rights activists are welcoming a decision by the European Chemicals Agency (ECHA) to annul an earlier ruling requiring a cosmetic ingredients company, BASF Personal Care and Nutrition, to conduct animal tests on a pipeline cosmetic ingredient.

The incident shines a spotlight on the somewhat confused requirements of two European regulations governing the cosmetics category: the REACH Regulation and the Cosmetics Regulation (EC) No 1223/2009.

Why did the ECHA demand a PNDT test?

In 2015, BASF submitted a registration dossier for a fatty acid derivative. Instead of proposing a pre-natal developmental toxicity (PNDT) test on its own substance, the ingredients supplier proposed a read-across adaptation based on data derived from a PNDT study on an analogous substance (L-glutamic acid, N-coco acyl derivs., disodium salts; EC No 269-085-1).

The ECHA rejected this proposal, despite BASF’s protestation that the substance is “solely used as a cosmetic ingredient” and that “there is still uncertainty with regard to the marketing ban laid down in the Cosmetics Regulation”.

The ECHA requested that BASF perform a PNTD study of the substance in question on a rat or rabbit via the oral route, citing Article 40 of the REACH Regulation.

The REACH Regulation applies without prejudice to the Cosmetics Regulation, which means the registrants of a substance registered for use as an ingredient in cosmetic products may not perform tests on animals under the REACH Regulation unless the substance also has non-cosmetic uses or there is potential worker exposure to that substance.

According to the agency, the registration dossier for the BASF ingredient showed potential worker exposure.

BASF's appeal

BASF expressed concern that performing a test on the substance using vertebrate animals could lead to a marketing ban under (EC) No 1223/2009.

It filed an appeal on 16 December 2016 asking for the decision to be annulled; both the PETA International Science Consortium (PISC) and The European Coalition to End Animal Experiments (ECEAE) were granted leave to intervene in this case in support of the appellant on 3 May 2017. The appellant (BASF) raised the following pleas in law against the contested decision:

• A breach of Articles 13 and 25 as well as Section 1.5. of Annex XI to the REACH Regulation, in conjunction with the principle of proportionality
• An error of assessment and a breach of the duty to state reasons
• A breach of the principle of good administration

It argued that the contested decision should have addressed the fact that the substance is registered exclusively for use as an ingredient in cosmetic products, and that any cosmetics containing the substance could no longer be placed on the market.

The ECHA counter argued a) that it did not need to address the relationship between REACH and the Cosmetics Regulation in the contested decision, because of potential worker exposure; and b) that it is not a competent authority to interpret the Cosmetics Regulation.

It likewise drew attention to a factsheet published in the agency’s name on its website stating “The Cosmetics Regulation does not restrict testing under [the REACH Regulation], if:
- this testing is required for environmental endpoints; or
- the substance is also registered for non-cosmetic uses.”

The Board of Appeal’s ruling

However, in a decision published 12 December 2017, the Board of Appeal rejected this argument, noting that the relationship between REACH and the Cosmetics Regulation was clearly relevant to the contested decision; that a more detailed statement of reasons (for the contested decision) should have been provided; that the ECHA did not explain how the interpretation set out in the factsheet applied in the present case; and that even if the agency had no competence to examine and interpret the Cosmetics Regulation, it should have explained the reasons for its alleged lack of competence.

It concluded that the contested decision was silent on the relationship between the REACH Regulation and the Cosmetics Regulation, and did not mention the use of the substance as an ingredient in cosmetic products or potential worker exposure.

For these reasons, the Board of Appeal found the ECHA to have breached ‘the duty to state reasons’.

PETA’s verdict

This final decision is being supported by animal rights groups, including the PISC, which intervened in the appeal.

Dr Julia Baines, a science policy advisor for the PETA International Science Consortium Ltd, said: “We welcome the ruling from the ECHA Board of Appeal to annul a decision by the ECHA requiring BASF Personal Care and Nutrition GmbH to conduct a prenatal developmental toxicity study using rats or rabbits, which was made following an intervention by the PETA International Science Consortium.

“For now, the ruling saves hundreds of animals, including pregnant females and their unborn offspring, from being force-fed high concentrations of a cosmetics ingredient.

“Going forward, registrants would be well advised to use only non-animal approaches to the hazard assessment of cosmetics ingredients, and where the ECHA has serious hazard concerns, these should be raised with the relevant member states in accordance with the law.”

Baines continued: “The PETA International Science Consortium intervened in this case, pointing out that the ECHA’s justification for the required test was neither ethical nor legally robust. The EU Court of Justice clarified last year that relying on new data derived from tests on animals can trigger the cosmetics marketing ban.

“Similarly, following a complaint filed by PETA UK, the European Ombudsman advised that animal testing data generated for the purpose of REACH cannot necessarily be relied upon for the safety assessment report required under the Cosmetics Regulation. Consequently, by barring the substance from the EU market, the requested test would serve no real purpose in protecting humans.

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“REACH applies without prejudice to the animal testing bans laid out in the Cosmetics Regulation. The Board has agreed with the Science Consortium, correctly recognising that ECHA has a duty to take into account the implications of the Cosmetics Regulation in its administration of REACH.”

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