REGULATION & COMPLIANCE registration process . However , its use in the restriction process is questionable if it does not take into account all of the relevant factors and circumstances of each individual case or substance ( e . g . specific uses , manufacturing process , risk management measures implemented at industrial sites , exposure routes and pathways , etc .). Such approach would go against general principles of EU law such as the principle of proportionality , the duty to examine each case carefully on its own merits and the registrant ’ s right of defence , as well as REACH principles , such as OSOR . Grouping of substances on the basis of their intrinsic ( hazard ) properties alone would also depart from the risk-based approach on which the restriction process replies upon .
Notwithstanding , the grouping of substances may be justified under specific circumstances , for example , when there are at least scientifically documented similarities in the hazard , risk profiles and uses of the covered substances . The grouping may also be justified by the principle of economies of administrative procedures and the need to ensure coherence and consistency , provided that the criteria for grouping are not purely hazardbased , are clearly defined , and that circumstances and opportunities for not being included in the group are provided for . This would be the case for example where substances do not meet the relevant criteria for the group categorisation , notably in terms of their specific toxicological and ecotoxicological properties , uses and related exposure scenarios and risk management measures as reported in the relevant CSR , and socioeconomic impact . Furthermore , if applied , the grouping approach needs to follow a scientifically and legally sound and transparent process involving all relevant stakeholders ( i . e . both the authorities and the registrants ). •
Claudio Mereu
PARTNER
FIELDFISHER k + 32 2 742 70 60 J claudio . mereu @ fieldfisher . com j www . fieldfisher . com
References :
1 : https :// eur-lex . europa . eu / legal-content / EN / TXT /? uri = COM % 3A2020 % 3A667 % 3AFIN # document2 2 : ECHA , Recommendations of the Task Force on Restriction Efficiency , 3 December 2020 : https :// echa . europa . eu / documents / 10162 / 17233 / report-task-force-on-restriction-efficiency-en . pdf / 68ba2a4f-5c93-4b55-a061-b69fd2795a21 3 : Case T610 / 17 , ICL-IP Terneuzen BV v . Commission
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