Regulatory Guidance

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BASF reasoned that they decided to reduce the tonnage band to < 100 t/a, since the production volumes were far below the initially estimated business forecast of max. 1000 t/a. ECHA refused to take the tonnage downgrade into account for its final compliance check, requesting new studies for Annex IX (in vivo mammalian alkaline comet assay, long term toxicity on aquatic invertebrates, long term fish, identification of degradation products).

After examination, the BoA overruled ECHA’s decision, arguing that:

• “There is no provision in the REACH Regulation that excludes the possibility for ECHA to take into account a tonnage downgrade during a compliance check process.
• ECHA failed to take into account substantial new information by not taking into account the tonnage downgrade.
• ECHA breached its duty to avoid animal testing.
• ECHA cannot presume that a registrant which downgrades its tonnage band after receiving a draft compliance check decision uses that tonnage downgrade as a means to escape its responsibilities; this presumption would be in contradiction with the duty of ECHA to examine each case individually”.