22 January 2021 by David Thomas
Esso Raffinage (Esso) registered its chemical with the European Chemicals Agency (ECHA), an EU agency, as it was required to do before it could sell it in the EU. This was under Regulation (EC) No 1907/2006, known as REACH.
Under REACH rules, given the volume at which it sold the chemical Esso had to provide data about (amongst other things) its potential pre-natal toxicity. Normally, this would be done via an animal test - a pre-natal developmental toxicity (PNDT) study - but a non-animal approach method could be used instead if it gave the equivalent information. This is known as an ‘adaptation’. Esso argued that the weight of existing evidence, an alternative approach recognised by Annex XI to REACH, provided the equivalent information.
However, ECHA disagreed and ordered the company to provide the animal data, using hundreds of rabbits. Esso nevertheless persisted and provided the available evidence instead. ECHA sent a ‘statement of non-compliance’ (SONC) to the French Government, which was responsible for issuing sanctions against Esso, since it is based in France. Under Article 5 of REACH, a company which has not provided required data is unable to sell its chemical in the EU.
Esso applied to the General Court (the GC), the lower of the two EU courts, to annul the SONC. The case was against ECHA. A number of member states, including Germany, intervened.
The GC ruled in Esso’s favour. ECHA accepted the decision but Germany appealed to the Court of Justice of the European Union (CJEU). The European Coalition to End Animal Experiments (ECEAE) was given permission to intervene along with two companies. Other member states supported Germany, including France.
There were related procedural issues: was the SONC a justiciable decision under Article 263 of the Treaty of the Functioning of the European Union and did Esso have the standing to bring the case? Only if both questions were answered in the affirmative should the GC have heard it.
The substantive issue was whether the principle under Article 25(1) of REACH that animal tests should be a last resort continued to apply even after ECHA had made its initial decision. Linked to this, when considering whether a company had complied with that decision, should ECHA evaluate whether an alternative approach adopted by a company at that stage passed muster and should it accord the company the same procedural rights (including the right of appeal to its Board of Appeal) as it had for the initial decision?
Decision The CJEU held that the SONC was a justiciable decision. It had binding legal effect and changed Esso’s legal position. The company had standing to bring the case.
On the substantive issue, the Court said that a registrant could propose an alternative approach even after ECHA had ordered it to carry out an animal test. Indeed, it was bound to do so, where it thought that such an approach was available. ECHA then had to consider whether information using that approach was equivalent to the animal data. Its role was not confined to considering whether a registrant had provided data in the form ECHA had required (as Esso clearly had not).
As well as Article 25(1), the Court referred to Article 13(1) of REACH which says: ‘… information on intrinsic properties of substances may be generated by means other than [animal] tests, provided that the conditions set out in Annex XI are met’. Weight of evidence is one of the non-animal approaches recognised by Annex XI. The Court also cited recital (47) which says that ‘it is necessary to replace, reduce or refine testing on vertebrate animals’.
The use of alternatives, the Court added, contributed to the attainment of the principal REACH objectives of the protection of human health and the environment.
The GC had been right to hold that, save where a registrant was abusing the system in order to buy time, ECHA had to prepare a decision under Article 42(1) of REACH at this second stage with all the procedural safeguards for registrants contained in Articles 50 and 51.
This is an important decision because it underlines the importance of the REACH principle that animal tests should only be carried out as a last resort. Companies and ECHA itself had to apply that principle at all stages, even after ECHA had decided that an animal test was needed.
The last resort principle is no panacea for animals because in many cases companies are unable to show that there is an alternative approach. Millions of animal tests have taken place under REACH. Animal protection organisations complain that the principle is honoured more in its breach than the observance.
But the CJEU’s decision puts the principle firmly at the centre of decision-making. The Advocate-General, who advises the Court, said that it would be a ‘devastating result’ if animal tests were carried out in these circumstances when there was an available adaptation. In fact, ECHA did eventually accept Esso’s weight of evidence approach, underlining just how important the company’s persistence was.
Advocates for Animals acted for ECEAE.