Guidance on groups of similar substances

• Author: Clemm, Christan; Löw, Clara; Baron, Yifaat; Moch, Katja; Möller, Martin; Köhler, Andreas R; Gensch, Carl-Otto; Deubzer, Otmar
• Pages: 96-99

Methodology for Identification and Assessment

of substances for inclusion in Annex II under RoHS

96

A.6 Guidance on groups of similar substances

This guidance is based on discussions of the Commission expert group accompanying future sub-

stance reviews under Directive 2011/65/EU and a proposal prepared as guidance on the definition

of groups of similar substances in which some adjustments have been made.

A.6.1 Introduction

Article 6(1) of the RoHS Directive (2011/65/EU) requires the European Commission to consider

reviews and amendments of the list of restricted substances in Annex II. The directive gives the

possibility to review and assess both single substances as well as groups of similar substances.

The term ‘grouping’ or ‘substance grouping’ is interpreted to describe the general approach for

considering more than one substance at the same time in an assessment. Assessing a group of

substances could in some cases provide an alternative to the individual assessment of substanc-

es, mainly in order to maximise efficiency.

This annex thus aims to provide implementing guidance, describing an approach that is to be ap-

plied in the grouping of substances under RoHS, to simplify where possible the assessment pro-

cess. It is intended as an indicative list of guiding criteria for the selection of substances that can

be better assessed together.

A.6.2 Grouping of substances under RoHS

Under RoHS, a group of substances subject to assessment for potential restriction in EEE should

be composed of substances sharing one or a combination of the following similarities:

• Common structure, functional group(s) constituents or chemical classes;

• Common (eco-)toxicological effects, hazard classification or toxicokinetics;

• Common physico-chemical properties;

• Common mode or mechanism of action;

• Common adverse outcome pathway;

• Common environmental fate/behaviour;

• Likelihood of common precursors and/or breakdown products via physical or biological pro-

cesses that result in similar substances;

• Constant pattern or trend across the group in the potency of the properties;

• Comparable type and duration of exposure due to either the use of the EEE or the management

operations of the related WEEE;

• Similar or same purpose/use/function in specific applications

• Presence in EEE, or reasonable expectation of presence in EEE according to the substance’s

characteristics, for the same purpose/use/function;

The above list is not exhaustive, but rather provides example criteria that can be used to group

substances for assessment and potential restriction. The listed criteria can in some cases be used

alone, but in general, the more criteria apply, the more robust the definition of the group. Selection