Speciality Chemicals Magazine MAY / JUN 2022 | Page 73

REGULATION & COMPLIANCE the grouping of nPB with another substance , trichloroethylene , since its findings as to the alternative nature of those substances were purely speculative and hypothetical . The General Court , however , rejected all arguments seeking to call into question the EC ’ s considerations related to this grouping , with the result that the grouping approach for the purposes of the authorisation process can now be considered validated by the EU judicature . It is important to note that the use of the grouping approach in the context of a restriction process , despite having been used and relied on to restrict several substances , has not been challenged before the EU courts yet . Therefore , whether the grouping approach is legally sound in the context of the restriction process has not been addressed yet .
Some considerations
As explained above , the use of the grouping approach for the purposes of risk management finds no explicit legal basis in REACH . As a matter of fact , REACH implies that each substance should be assessed on its own on the basis of its properties , uses and exposure scenarios . A case-by-case risk assessment should therefore be conducted . Within that context , the grouping of substances for restriction purposes raises four main issues . First , the grouping of the substances relies on the structural similarities of substances based on their intrinsic ( hazard ) properties , whereas the purpose of the restriction process under REACH is to assess the possible unacceptable risks of substances to human health and the environment stemming from their actual use and related risk management measures . As substances are normally grouped on the basis of their structural similarity , but not their uses , exposure routes and pathways , a restriction of a group of chemicals that would not take into account differences related to all these would be flawed and would therefore depart from the risk-based approach on which REACH relies upon . An example directly on point relates to the PFAS substances , for which there is an ongoing restriction process , which will need to take into account the vast number of different PFAS substances and related uses ( more the 4,700 ). The need for any restriction should be assessed on the basis of a sound exposure-based safety assessment . A generic group restriction would not necessarily consider the specific
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