In these conjoined appeals, the appellants (collectively, BASF) challenged a decision of the European Chemicals Agency (ECHA) that they must provide certain missing data. The appeals were heard by ECHA’s Board of Appeal, which gave its decision on 9 November 2021.
Cruelty Free Europe and PETA International Science Consortium were given permission to intervene in the appeals in support of BASF. Advocates for Animals acted for both organisations.
Both BASF Colors & Effects and BASF SE registered a particular substance, albeit at different times. They registered it at Annex IX tonnage (100 to 1000 tonnes a year) because that was the tonnage at which they expected to market it in the EU. For a short time some years ago, the annual tonnage did indeed exceed 100, albeit only just.
In March 2019, ECHA initiated a compliance check. Three months later, it sent the registrants a draft compliance check decision requiring them to fill data gaps at both Annexes VIII and IX, including via an Annex IX long-term toxicity test involving several hundred fish force-fed the substance.
The draft decision triggered a multi-step procedure set out in Articles 50 and 51 of REACH. This included an opportunity for the registrants to comment on the draft decision. They did so by updating their registration dossier: they changed the tonnage band from Annex IX to Annex VIII. They explained that their original projections had proved overoptimistic; indeed, they intended ceasing manufacture before too long. They accepted that they had to provide the Annex VIII data in the meantime.
ECHA declined to accept the registrants’ arguments and its final decision confirmed the requirement to provide the missing Annex XI data. Data had to follow the tonnage at which a substance was registered at the time of the draft decision and any changes after that could not be taken into account. Article 50(2) and (3) dealt with the consequences of cessation of manufacture (under different scenarios): those provisions apart, the registered tonnage at the time of a draft decision was determinative.
Subject to some exceptions, companies (‘registrants’) wishing to manufacture or place on the market (collectively, ‘marketed’) in the EU a chemical (‘substance’) must register them with ECHA. They must hold a complete data set. If they do not, they cannot market the substance. This is under Regulation (EU) No 1907/2006, commonly known as ‘REACH’, which seeks to protect human health and the environment.
The data required depends on the tonnage at which the substance is marketed. So, substances marketed at between 1-10 tones a year must hold the data required by Annex VII; substances marketed at between 10 and 100 tonnes a hear must also hold the data required by Annex VIII; substances marketed at between 100 tonnes and 1000 tones must also hold the data required by Annex IX; and substances marketed at over 1000 tonnes a year must also hold the data required by Annex X. Annexes VII to X are known as ‘the testing annexes’. The obligations under each successive tonnage band are cumulative.
The rationale is that the higher the tonnage at which a substance is marketed the greater the risk to human health and the environment. That is a blunt policy instrument, but it is the one which EU legislators have chosen to adopt.
Many of the types of data (endpoints) within a testing annex prima facie require animal tests. However, registrants can ‘adapt’ the endpoints if there is an alternative way of generating the data. The permissible adaptations are set out both in the testing annexes and in Annex XI, which sets out alternative approaches. ‘Alternatives’ encompass not only non-animal methods and approaches but also methods and approaches involving fewer animals or less suffering.
It is a fundamental principle of REACH (Article 25(1) that animal tests should only be carried out as a last resort.
ECHA is given the power by REACH to conduct a compliance check to ensure that the requisite data is held. At Annexes IX and X, a registrant must make a testing proposal which ECHA must then accept before carrying out animal tests. Third parties can then come forward with data obviating the need for an animal test.
The Board of Appeal’s Decision
The Board of Appeal decided that ECHA should have taken into account the change in tonnage. That was capable of constituting ‘substantial new information’. As the Board of Appeal had decided in previous cases, ECHA was in principle entitled to set administrative cut-off points – here, the issue of the draft decision. However, those cut-off points could not be inflexible. In exercising its discretion on a case-by-case basis (at it had to), it was required to take other factors into account as well – in particular, the last resort principle. ECHA itself had a duty to avoid the need for animal testing.
The Board of Appeal said that the fact that the registrants had been dilatory in meeting their obligation under Article 22(1)(c) to inform ECHA of changes in tonnage band did not matter.
It added that, if ECHA concluded, after proper examination, that the downgrade was being done as an impermissible way of avoiding providing data, that was something it could take into account. One had to look at the industrial and commercial realities in each case.
The Board of Appeal remitted the case to ECHA, as it normally does. It is difficult to see that, in the circumstances, ECHA can do anything other than remove the requirement to carry out the Annex IX tests.
If that is right, hundreds of fish will be spared potentially significant suffering and that is clearly important in itself. More generally, the decision reiterates the principle which the Board of Appeal had established in previous cases, albeit in different contexts, that ECHA cannot place administrative convenience over its obligation to avoid unnecessary animal tests. Given the reality that the substance in question was not marketed at Annex XI tonnage and was never likely to again, and given the legislative philosophy that tonnage correlates to risk, there was nothing to be gained for human health or the environment from insisting on Annex IX data for a substance which was in reality an Annex VIII one.
ECHA could challenge the Board of Appeal decision at the EU General Court.
Post-Brexit, the EU has its own version of REACH, largely following the EU version. The UK does not have to follow the Board of Appeal decision but it would be surprising if it did not.
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