The grouping approach in risk management
Claudio Mereu and Selma Abdel-Qader of FieldFisher take a look at a change in approach to REACH from the European Commission
The Chemicals Strategy for Sustainability ( CSS ), which was adopted by the European Commission ( EC ) in 2020 , sets a new vision for sustainability for the EU chemicals policy in order to achieve a toxic-free environment and promote toxic-free material cycles . 1 In it , the EC indicated , among other things , its intention to extend the generic approach to risk management provided for in Article 68 ( 2 ) of REACH . The generic risk approach to risk management allows the EC to restrict substances without seeking the opinions from the Committees for Risk Assessment ( RAC ) and Socio- Economic Analysis ( SEAC ). This procedure , however , can only be used for substances that are carcinogenic , mutagenotoxic or reprotoxic ( CMR ) categories 1A or 1B and which are present in consumer products . To ensure that consumer products do not contain hazardous chemicals , the EC now wants to extend the generic approach to risk management to substances that affect the reproductive or the endocrine system or the immune , neurological or respiratory systems , or are persistent , bioaccumulative or toxic ( PBT ) to specific organs . In the meantime , while the generic approach to risk management is not in place , the EC decided to prioritise all the above-listed substances for restrictions for all uses and through grouping , instead of regulating them one by one , through the development of a REACH Restrictions Roadmap that should be adopted in the next months . It can be expected that the grouping approach will be soon codified in the Roadmap and the review of REACH in the context of risk management . However , the question arises of ‘ Under what circumstances can the grouping approach in risk management be legally sound ?’
Grouping approach in risk management
The REACH Regulation only explicitly refers to the grouping of substances in Article 13 and Section 1.5 of Annex XI . More specifically , in order to promote the use of alternatives to vertebrate animal testing , Article 13 provides that information on the intrinsic properties of substances may be generated by means other than tests , such as grouping or read-across from structurally related substances . Annex XI , on the general rules for adaptation of the standard testing regime , provides that structurally similar substances can be considered as a group so that their physicochemical properties , human health effects and environmental effects or environmental fate can be predicted from data for the reference substance within the group . Annex XI also states that the results of the grouping approach should be , among other things , adequate for the purpose of classification and labelling and / or risk assessment . On this basis , it can be argued that REACH provides for the grouping of substances for the purposes of fulfilling the data requirements set out in Annexes VII-X . However , over the years , and consistent with ECHA ’ s Guidance on Annex XV for restrictions , ECHA and Member State competent authorities have increasingly started to use the grouping approach for the purposes of risk assessment and risk management in order to increase efficiency and to include in the scope of the proposed restrictions substances that could be unwanted alternatives . 2 Against this background , ECHA and Member States have progressively moved from a substance-bysubstance approach to addressing groups of structurally similar substances for other purposes , including restriction measures . The lawfulness of the grouping approach for risk management purposes has been dealt with in a recent case brought before the EU General Court , ( the lower court of the Court of Justice of the European Union ), against the inclusion of 1-bromoproprane ( nPB ) in Annex XIV ( i . e . authorisation process ). 3 The applicants , who were the registrants of nPB , lodged an action for the annulment of Regulation 2017 / 999 , arguing , amongst other things , that the EC was not entitled to rely on considerations relating to
72 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981