Cruelty Free International, R (on the application of) v Secretary of State for the Home Department

Animal testing required by REACH is not testing carried out in order to meet the requirements of the Cosmetics Regulation, even where the substance is used exclusively in cosmetics. The two regimes must be interpreted coherently. REACH addresses the safety of substances throughout their life-cycle, including risks to workers, whereas the Cosmetics Regulation focuses on the safety of cosmetic products for end users.

A long-standing policy does not ordinarily create an expectation of consultation before it is changed, absent a promise, established practice or exceptional unfairness. A policy remains operative until effectively withdrawn, but there is no general free-standing duty to notify the public of its withdrawal.

The claimant challenged the defendant’s revised policy on licensing animal testing of cosmetic products and ingredients. The policy had historically refused such licences, but from February 2019 the defendant permitted testing required by other legislation, including REACH, subject to the Animals (Scientific Procedures) Act 1986.

The claim alleged that the revised approach was legally erroneous, that the claimant should have been consulted before the policy changed, that the change should have been publicly notified, and that the defendant failed to conduct the statutory harm-benefit assessment. The central legal issue was whether testing required by REACH was prohibited by Article 18 of the Cosmetics Regulation.

1. Ground 4 dismissed. The court agreed with the EChA Board of Appeal in Symrise that animal testing required by REACH is undertaken to satisfy REACH, not the Cosmetics Regulation. That conclusion applies even where the substance is exclusively used in cosmetics.
2. The two regulatory regimes pursue different but compatible objectives. REACH requires information about a substance’s intrinsic properties and risks throughout its life-cycle, including risks to workers involved in manufacture and production. The Cosmetics Regulation concerns the safety of the finished cosmetic product for the end user.
3. Article 18 of the Cosmetics Regulation does not prohibit animal testing required by REACH. However, results of such testing cannot be relied upon in the cosmetic product safety report to demonstrate the safety of the cosmetic product. Mere inclusion of the data in the product information file does not trigger the marketing ban. If the results undermine the product’s safety, the product may have to be withdrawn.
4. Article 2(4)(b) of REACH does not create a general exemption for substances used exclusively in cosmetics. Exemptions are stated expressly in REACH, including the interaction between Article 14(5)(b) and section 3 of Annex XI.
5. Grounds 2 and 3 failed. The claimant had no legitimate expectation of consultation or notification before the policy changed. There was no promise, established practice or exceptional unfairness. The meetings with establishment licence holders were an exchange of information, not a consultation exercise. Save Britain’s Heritage required a policy to remain operative until effectively withdrawn, but did not establish a free-standing duty to notify the public.
6. Ground 1 also failed. The evidence established that the defendant carried out the statutory harm-benefit analysis for every application. There was no unlawful delegation to other regulators. The claim was dismissed.

First-instance judicial review in the Administrative Court. Permission was granted on Grounds 1 and 4 by May J and, on renewal, on Grounds 2 and 3 by Steyn J. The claim was dismissed by Linden J.