Detailed assessment of substances

• Author: Clemm, Christan; Löw, Clara; Baron, Yifaat; Moch, Katja; Möller, Martin; Köhler, Andreas R; Gensch, Carl-Otto; Deubzer, Otmar
• Pages: 45-77

Methodology for Identification and Assessment of substances

for inclusion in Annex II under RoHS

45

3. Part III DETAILED ASSESSMENT OF SUBSTANCES

The aim of the detailed assessment is to conclude whether a substance or substance group67

should be recommended for restriction under RoHS or not.

The decision on which substances are to undergo a detailed assessment is to be taken by the

Commission. Prioritisation of substances, performed according to Part II, shall feed into such deci-

sions. Nonetheless, the Commission may decide to prioritise substances for assessment that were

not specified with the highest priority or with any priority for that matter. This may be the case for

example:

•when a RoHS assessment is initiated in the context of the various assessments performed un-

der REACH, for example under the risk management option analysis (RMOA) or under the re-

striction procedure; or

•when a Member State submits a proposal for a RoHS restriction.

Article 6(2) of RoHS stipulates which types of information shall be included in a proposal to review

and amend the list of restricted substances specified in Annex II of the Directive (see detail be-

low). It is thus concluded that an assessment may address both, new substances as well as pos-

sible changes to substances already specified in the Annex, for example when it becomes rele-

vant to change the scope of substances restricted or the conditions of the restriction (e.g. specified

threshold) in light of scientific and technical progress.

Article 6(1)(a-d) of RoHS specifies criteria which have to be taken into account while assessing a

possible amendment of the restriction list (see detail in “Background”, Section II.I.I). A substance

assessment shall thus focus on information of relevance to allow assessing whether the criteria

are fulfilled and whether a restriction would be justified.

Approach: The objective of the detailed assessment is to determine whether the Article 6(1) crite-

ria in connection with information requirements set out in Article 6(2) are fulfilled, justifying a re-

striction. The following guidance has been prepared to allow the documentation of the assessment

in the form of a RoHS dossier which fulfils the information requirements of Article 6(2) of the Di-

rective. This includes the following (interpretations follow the cited requirements and appear in

grey):

“(a) precise and clear wording of the proposed restriction;”

This element is interpreted to be the formulation of the recommended restriction and should in-

clude at least:

挑 The name of the substance/compound;

挑 A threshold above which the substance is restricted

挑 A date for application (category specific if relevant68)

Additionally, in some cases, it may be relevant to specify equipment groups or sub-groups to be

excluded from the scope of the restriction69.

67 For simplicity’s sake, within this manual, reference is always made to a substance, with substance groups being

implied

68 For example, in the case of the DEHP, BBP and DBP restriction under RoHS, longer transition periods were granted

to categories 8 and 9 (medical devices and monitoring and control instruments, respectively).

Methodology for Identification and Assessment

of substances for inclusion in Annex II under RoHS

46

“(b) references and scientific evidence for the restriction;”

If relevant, distinction should be made as to the certainty of information provided by various refer-

ences – harmonised classifications for example shall be assumed to have a higher certainty than

self-classifications70 made by suppliers in safety data sheets. Various sources may also differ in

their certainty and this should be taken into consideration and be communicated where relevant.

For the purpose of evaluating the certainty of various sources, the so-called weight of evidence

approach may be applied71. This approach involves an assessment of the relative values/weight of

different pieces of available information that have been retrieved and gathered in previous steps.

The quality and consistency of the data of cited references shall be given appropriate weight. It

shall be documented and justified in a clear and transparent manner. The principles of weighing of

evidence shall be considered in order to decide whether certain sources should be considered to

have a higher weight than others in light of their higher certainty. For further information as to data

quality and dealing with data gaps, see Appendix A.7.

“(c) information on the use of the substance or the group of similar substances in EEE;”

Such information should include detail of relevant products and components in which the sub-

stance (or group of substances) is used and/or present, detail of its function in applications in

which it is used and/or present and estimated volumes of use and/or presence in EEE in the EU

and globally. An estimated distribution of the total volume between typical uses in EEE should be

detailed.

“(d) information on detrimental effects and exposure in particular during waste EEE management

operations;”

Information should relate to impacts addressed under Article 6(1)(a-d), so as to clarify the types of

impacts and the range at which they are expected to occur and subsequently to what degree the

criteria specified under Article 6(1)(a-d) are fulfilled.

“(e) information on possible substitutes and other alternatives, their availability and reliability;”

Information should allow understanding in which applications substitutes or alternative technolo-

gies are already applied and subsequently to what degree the substance (or substance group) has

been phased-out. Where differences occur related to substitute or alternative technology imple-

mentation, such as between manufacturers of certain regions, product or component categories,

etc., this should be specified. It should also be specified whether substitutes or alternative tech-

nologies can be considered to have less negative impacts (interpreted in comparison with the im-

pacts of the substance in relation to the Article 6(1)(a-c) criteria).

69 As performed in the case of the DEHP, BBP and DBP restriction under RoHS and its applicability to toys, for which a

restriction for use in toys was already valid at the time of recommendation through entry 51 of Annex XVII to Regula-

tion (EC) No 1907/2006 (REACH), see http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015L0863 for

detail.

70 The CLP Regulation requires suppliers of substances and mixtures to decide on the classification of a substance or

mixture to be placed on the market. This information needs to be taken into consideration for example in the labelling

of the substance, in its safety data sheets, etc. This is called a self-classification.

71 The so-called weight of evidence approach is described more precisely in ECHA’s practical guide: “How to report

weight of evidence?” (published in 2010) as well as in Annex I of the CLP regulation (EC) No 1272/2008 and is also

outlined in the general approach for prioritisation of SVHC substances for inclusion in the list of substances subject

to authorisation. It is also well described in the 2012 memorandum of the Scientific Committees on Emerging and

Newly Identified Health Risks (SCENIHR).

Methodology for Identification and Assessment of substances

for inclusion in Annex II under RoHS

47

“(f) justification for considering a Union-wide restriction as the most appropriate measure;”

The assessment should detail the rationale for recommending a restriction under the RoHS Di-

rective and why legislation at this level is understood to have benefits over the alternative of na-

tional legislation.

“(g) socioeconomic assessment.”

Information should analyse whether the benefits related to a restriction scenario under RoHS are

considered proportionate in relation to costs expected to arise through the enforcement of the re-

striction. Proportionality is interpreted to mean that while some costs may be acceptable and justi-

fied as improving the protection of environment and of health can be assumed to have a price,

where costs are significantly higher than expected benefits this relation is to be considered for the

purpose of establishing whether the benefits justify the restriction and its costs. For this purpose,

the following socio-economic impacts should be considered (non-exhaustive- see further detail in

Section 3.12):

•Impact on chemicals industry (EU and non-EU, substance manufactures and substitute manu-

facturers);

•Impact on EEE-producers, industry (EU and non-EU), suppliers and manufacturers of sub-

stance and substitute-based technologies);

•Impact on EEE users (private users, commercial users);

•Impact on waste management (impacts related to EEE containing the substance or EEE con-

taining substitutes or alternative technologies);

•Impact on public administration (for regulators at EU level and national level);

•Impacts on environment (during use, during waste management; impacts on different media,

e.g. air, water, soil);

•Impacts on health (consumers, workers, residents in proximity of waste management facilities)

•Total socio-economic impact (relation of costs and benefits);

It is stated in the Directive (Recital 10, Article 6,) that the amendment of the list of restricted sub-

stances in Annex II shall be coherent with other legislation related to chemicals, in particular the

REACH Regulation and shall use publicly available knowledge obtained from the application of

such legislation. Therefore, the methodology for assessment of substances under RoHS relies on

existing data from the REACH Regulation, and will take into account, inter alia, Annexes XIV and

XVII to that Regulation and documents established in relation to their entries. Further, Annex XV

dossiers for Restriction and other documents prepared for regulatory purposes under REACH will

be considered. Impact Assessments and Risk Assessment Reports of the European Commission

(in the framework of Council Regulation (EEC) No793/93 also known as Existing Substances

Regulation (ESR), scientific opinions of any of the European scientific committees e.g. SCHER,

SCENIHR, SCCP, SCCS, RAC, SEAC, SCOEL72 shall be considered. International guidelines and

recommendations and other relevant available scientific and technical information shall be taken

into account. In general, the main principles of a risk assessment as implemented by ECHA shall

72 SCHER: Scientific Committee on Health and Environmental Risks; SCENIHR: Scientific Committee on Emerging

and Newly Identified Health Risks; SCCS: Scientific Committee on Consumer Safety; RAC: Committee for Risk As-

sessment; SEAC: Socio-Economic Analysis Committee, SCOEL: Scientific Committee on Occupational Exposure

Limits