Ombudsman Clarifies Ruling On Animal Testing Case

« ECHA told how to ensure registrants take account of ‘last resort’ principle.
The European ombudsman has clarified how ECHA should respond to her ruling, last December, that the agency’s interpretation of its obligations to ensure REACH registrants do not perform unnecessary animal tests has been “excessively restrictive”.

The ruling addressed a complaint by animal welfare NGOs that Echa was failing to fulfil the REACH Regulation’s requirement, as stated in Article 25, that animal testing be conducted only as a « last resort ».
The ombudsman, Emily O’Reilly, broadly agreed with the NGOs and Echa accepted most of her recommendations.

The key recommendations were that Echa:

• systematically require registrants to show that (i) they have considered alternative testing methods to generate the missing information and (ii) have found that the information gap cannot reasonably be filled through such methods; and

• share with the registrant any relevant information, concerning the potential availability of alternative testing methods for the registered substance. If a registrant does not adopt the non-animal testing method in question, Echa should require them to explain to its satisfaction why they do not consider it useful or possible to do so.

Echa said it would ask the European Commission and member states if they supported moves to use the compliance check procedure as a means of ensuring REACH registrants were doing all they could to minimise animal testing .

Decision sheds light

The ombudsman’s Decision, made on 11 September but only published recently, sheds more light on what Echa’s new approach will be.
The document says that on the first key recommendation, Echa agreed it would systematically ask for this information, for all new testing proposals involving vertebrate animals, submitted after the ombudsman’s Decision in this case.

But Echa warned that it was not in a position to assess whether a registrant has adequately considered all viable alternative methods, nor to reject a testing proposal for a standard REACH information requirement on the grounds that the registrant had not considered these.

It also said the new approach should not push registrants to provide invalid adaptations, which the agency could only verify by a compliance check.
This response from Echa failed to satisfy the complainant, the European Coalition to End Animal Experiments (ECEAE), which asked the ombudsman to clearly set out what would, and what would not, constitute implementation of her recommendations.

Responding to ECEAE’s request, the ombudsman’s Decision says Echa “must” request registrants to show that they have tried to achieve both human health protection and the avoidance of animal testing, and could not reasonably do so; it also means that if an applicant does not show that it considered alternative methods to generate the missing data, “Echa must reject the application.”

Echa, it adds, “must be aware that requesting the relevant information from the registrants, without drawing any conclusions if it is not provided is a useless exercise”.

Similarly, “it would be absurd” for Echa to grant prior authorisation for the performance of an animal test under REACH Article 40 on testing proposal evaluation [which does not explicitly oblige Echa to verify whether the information submitted by registrants fulfils the requirements of the last resort principle], when it would not subsequently validate such a test in the context of Article 41 on whether the information submitted by the registrants fulfils the last resort principle requirements. »

Article by  Geraint Roberts
Ombudsman Decision :
Echa press release :
ECEAE press release :

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