Stakeholder = Contributions

(April 2008)

Dear Stakeholder,

During the stakeholder consultation we received = comments that=20 the timeline for the stakeholder consultation was considered too short.=20 Furthermore, the questions arose on the criteria that are applied to = select high=20 priority substances.

=D6ko-Institut e.V. started the stakeholder=20 consultation to the RoHS hazardous substance project on 17 December 2007 = by=20 sending out a questionnaire to manufacturers and suppliers of EEE asking = for=20 information on other hazardous substances contained in typical = components /=20 subgroups of EEE, and to quantify the concentration ranges. Only limited = information on the questions was received by manufacturers and = suppliers. In=20 order to be able to set up an inventory of hazardous substances used in = EEE=20 additional sources of information (i.e. existing studies, XRF-analyses = and other=20 information) were evaluated in addition to the questionnaire.
As a = first=20 result of these activities the hazardous substances were grouped in = classes of=20 different priority: Substances classified as CMR, PBT / vPvB or = endocrine=20 disruptors were allocated a high priority just as a number of other = substances=20 whose use in EEE and other consumer products is intensively discussed by = national authorities or which are included in the Water Frame Work = Directive,=20 OSPAR, etc. The resulting list of high priority substances comprised 46=20 substances/materials. Due to the fact that only limited information had = been=20 provided on hazardous substances in EEE during the first part of the = stakeholder=20 consultation, the consultation was continued by circulating the list of = high=20 priority substances to ask for details on these substances:
- = In=20 which specific components are the hazardous substances = contained
- =20 Their concentration ranges
- Information on possible = substitutes /=20 alternatives

The same questions were part of the original = questionnaires=20 sent to manufacturers/suppliers, NGOs, research institutes, et al. The = purpose=20 of the second part of the consultation was thus to get more detailed = information=20 on the pre-selected hazardous substances to be able to judge whether or = not=20 these substances need a further in-depth evaluation.
The consultation = ended=20 on 28 March 2008. Thus, the total consultation period was approximately = three=20 months.

All information on technical issues that we received = during the=20 consultation (e.g. substances that are not anymore used in EEE; = degree/nature of=20 coverage by other EU legislation; presence of the substances in the = final=20 product etc..) will be considered in the further evaluation resulting in = a much=20 more condensed list of hazardous substances in EEE. Unfortunately, the=20 manufacturers/supplier provided only very limited information on = concentrations=20 or quantity ranges of hazardous substances in electrical and electronic=20 components. Therefore, it will be difficult to estimate the relevance of = EEE for=20 the total consumption of the substances.

The criteria applied to = select=20 the high priority substances in a first step and candidate = substances for a=20 possible inclusion into the scope of RoHS in a next step can be = summarised as=20 follows:
In order to identify substances which are of high relevance = for=20 inclusion into the RoHS Directive, the substances have been = characterized=20 according to the following criteria:

1. Substances of very high = concern=20 (SVHC) as defined by REACH. The classification as substances of very = high=20 concern is introduced by REACH. (The use and the marketing of these = substances=20 can become subject of authorisation under REACH, if the substances are = included=20 in the REACH Annex XIV). These substances can cause a high risk to = humans and=20 the environment and should be replaced by suitable alternative = substances or=20 technologies as soon as possible. The criteria defined in REACH for = substances=20 of very high concern refer to three different properties: toxicity, = persistence=20 and bioaccumulation. Substances of very high concern are:
(a) = substances=20 meeting the criteria for classification as carcinogenic category 1 or 2 = in=20 accordance with directive 76/548/EE;
(b) substances meeting the = criteria for=20 classification as mutagenic category 1 or 2 in accordance with directive = 76/548/EE;
(c) substances meeting the criteria for classification as = toxic=20 for reproduction category 1 or 2 in accordance with directive = 76/548/EE;
(d)=20 substances which are persistent, bioaccumulative and toxic in accordance = with=20 the criteria set out in Annex XIII of this regulation;
(e) substances = which=20 are very persistent and very bioaccumulative in accordance with the = criteria set=20 out in Annex XIII of this regulation;
(f) substances =96 such as = those having=20 endocrine disrupting properties or those having persistent, = bioaccumulative and=20 toxic properties or very persistent and very bioaccumulative properties, = which=20 do not fulfil the criteria of points (d) or (e) =96 for which there is = scientific=20 evidence of probable serious effects to human health or the environment = which=20 give rise to an equivalent level of concern to those of other substances = listed=20 in points (a) to (e).

2. Substances which have been found in = humans and=20 biota. These substances not necessarily fulfil the strict criteria for=20 bioaccumulation and persistency as given in Annex XIII. Nevertheless = they have=20 been identified in humans and biota and raise concern regarding = long-term=20 harmful effects. These properties are at present not expressed by the = R-phrases=20 of Dir 67/548 neither the categories of GHS.

3. Substances which = can form=20 hazardous substances during the collection and treatment of electrical = and=20 electronical equipment. A number of substances and materials used in EEE = can=20 cause formation of hazardous substances during recycling and/or during=20 incineration. This property is not expressed by the classification of = the=20 substances resp. materials themselves. Therefore it is taken as an = additional=20 criterion in the selection process.

4. Substances classified as = dangerous=20 according to Annex I Dir 67/548, not fulfilling the REACH criteria for = SVHC. A=20 large number of hazardous substances contained in EEE are classified due = to=20 their physicochemical hazards (e.g. explosive substances) or due to=20 environmental hazards. Others are classified due to human health = hazards, but=20 the effects are not as serious as in case of substances which are = cancerogenic=20 or mutagenic or which can damage the reproductive system (CMR substances = as=20 characterized under Point 1 above). These substances can cause harm to = man and=20 the environment, but are not considered as substances of very high=20 concern.

5. Substances which are already excluded from electrical = and=20 electronical equipment by existing legislation. A large number of = hazardous=20 substances have already been regulated by European legislations. It has = been=20 checked whether this refers explicitly to the use in = EEE.

Substances with=20 a lower hazardous potential (criterion 4) and substances already = excluded by=20 existing legislation (criterion 5) have been documented, but are not = further=20 evaluated.
Substances which fulfil one of the criteria 1=963 have the = potential=20 to cause severe harm to humans and/or the environment. Therefore they = are given=20 the highest priority in this study.
These substances of highest = priority are=20 further evaluated. At this, the exposure situation, the relevance of EEE = for the=20 total consumption of the substances and the availability of substitutes = will be=20 taken into account. Based on the results of this analysis, a = recommendation will=20 be made which of the highest priority substances constitute significant = health=20 and environmental risks due to their use in electrical and electronical=20 equipment. These substances are discussed as =93potential candidates for = inclusion=20 into RoHS=94.

The draft final report summarising the results of = the study=20 and containing the list of potential candidates for inclusion into RoHS = will be=20 submitted to the EU Commission by 18 April 2008 and will be published by = the end=20 of April 2008.

Sincere regards,
The = project=20 team (=D6ko-Institut)