REGULATION & COMPLIANCE
chemicals . Currently , a substance can be restricted under REACH if it poses an ‘ unacceptable risk ’.
In addition , the regulation also sets out generic restrictions that apply irrespective of the risk . However , such generic restrictions currently only apply to substances that have a harmonised classification as carcinogenic , mutagenic , and reprotoxic ( CMR ), and exclusively to consumer uses .
The revised REACH will extend the scope of the generic restrictions to professional uses , as well as to additional hazard classes : endocrine disruptors ( EDs ), substances that are persistent , bioaccumulative , and toxic ( PBTs ) or very persistent and very bioaccumulative ( vPvB ), persistent , mobile and toxic ( PMT ) or very persistent and very mobile ( vPvM ). 2 There will be another significant change to REACH restrictions : under the current regime , exemptions from restrictions can be granted based on a risk assessment and a socio-economic analysis . After the revision , exemptions will only be granted for ‘ essential uses ’, which are yet to be defined by the European Commission ( EC ), irrespective of the level of risk .
The EC also intends to increase the number of substances identified as SVHCs significantly , from the current number of 224 to more than 10,000 . 3 The focus will again be on EDs , PBT / vPvB and PMT / vPvM substances . Such SVHCs will likely be further prioritised for restrictions .
Currently , not many substances have been identified by their REACH registrants as EDs , PBT / vPvB , or PMT / vPvM . By way of example , only 101 have been identified as PBT / vPvB substances . To reverse this trend , the revised REACH will probably introduce an obligation for REACH registrants to generate new hazard data related to the ED endpoint .
In addition , the EU is in the process of adopting an amendment to the EU Classification , Labelling & Packaging Regulation ( CLP ) that implements the GHS rules . The amended CLP revision will introduce ED , PBT / vPvB , and PMT / vPvM as new hazard classes . 2 This will lead to the need for the operators to carry out a hazard evaluation and potentially generate new data if necessary .
Finally , the REACH revision intends to stop the current practice whereby different types of products are riskassessed by separate EU bodies . Such practice , according to the EU , is inconsistent and often brings contradictory results .
To break this status quo , the EU wants to introduce a ‘ one substance , one assessment ’ approach , whereby the risk assessment would be carried out primarily by the European Chemicals Agency ( ECHA ). There is a concern that such risk assessment will probably focus on hazard data because ECHA mainly manages this type of data .
Food packaging will probably continue to be assessed by the European Food Safety Authority ( EFSA ). However , the European Commission has already announced that its ongoing revision of food contact materials legislation will focus on the risk management of EDs and PBT / vPvB substances , potentially leading to their being banned .
Regarding the timing of the REACH revision , the EC is currently working on a legislative proposal that should be published by the end of 2023 . After the publication , the proposal will move to the European Parliament and to the European Council for the full legislative procedure . The final regulation amending REACH is expected in 2026 . ●
References : 1 : https :// www . epa . gov / assessing-and-managing-chemicalsunder-tsca / final-risk-evaluation-cyclic-aliphatic-bromidecluster # documents 2 : https :// ec . europa . eu / info / law / better-regulation / have-yoursay / initiatives / 13578-Hazardous-chemicals-updated-rules-onclassification-labelling-and-packaging _ en ( Section ‘ Annex ’) 3 : https :// echa . europa . eu / candidate-list-table
David Fischer
COUNSEL
KELLER AND HECKMAN k + 1 202 434 4224 J fischer @ khlaw . com j
www . khlaw . com
38 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981