Context and scope of the substance assessment

AuthorClemm, Christan; Löw, Clara; Baron, Yifaat; Moch, Katja; Möller, Martin; Köhler, Andreas R; Gensch, Carl-Otto; Deubzer, Otmar
Pages7-8
RoHS Annex II Dossier, final
TBBP-A (flame retardant)
7
CONTEXT and SCOPE of the Substance Assessment
The substance assessment of 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol or tetrabromobis-
phenol A (TBBP-A, flame retardant), respectively, is being performed as part of the “Study on the
review of the list of restricted substances and to assess a new exemption request under RoHS 2
Pack 15”. With contract No. 07.0201/2017/772070/ENV.B.3 implementing Framework Contract
No. ENV.A.2/FRA/ 2015/0008, a consortium led by Oeko-Institut for Applied Ecology has been as-
signed by DG Environment of the European Commission to provide technical and scientific support
for the review of the list of restricted substances and to assess a new exemption request under RoHS
2. This study includes an assessment of seven substances with a view to the review and amendment
of the RoHS Annex II list of restricted substances. The seven substances have been pre-determined
by the Commission for this task. The detailed assessment is being carried out for each of the seven
substances in line with a uniform methodology.1
In the course of the substance assessment, the 1st stakeholder consultation was held from 20 April
2018 to 15 June 2018 to collect information and data for the seven substances under assessment.
Information on this consultation can be found at Oeko-Institut’s project webpage at:
http://rohs.exemptions.oeko.info/index.php?id=289.
For TBBP-A, a total of 11 contributions were submitted by different stakeholders. An overview of the
contributions submitted during this consultation is provided in Appendix I. The contributions can be
viewed at http://rohs.exemptions.oeko.info/index.php?id=295.
Among these contributions, a study from the Fraunhofer Institutes ITEM and IPA has been submit-
ted, which is an assessment of TBBP-A performed according to the “Methodology for Identification
and Assessment of Substances for Inclusion in the List of Restricted Substances (Annex III) under
the RoHS 2 Directive, thus in the format of a RoHS dossier which was mandated and funded by
BSEF, the Bromine Science and Environmental Forum.2 Though no date on when the study was
conducted is indicated, it is understood as a very recent data compilation. In August 2018, after the
stakeholder consultation was closed, the BSEF provided an updated version of this assessment. It
is understood that the update overall covers the DNELs retrieved from the ECHA Registered Sub-
stance Database that has been lowered in the last years. In the following, this updated assessment
is referred to as Fraunhofer ITEM IPA, Wibbertmann and Hahn (2018).3
Nine different stakeholder contributions were received during the 2nd stakeholder consultation which
was held from 05th December 2019 to 13th February 2020. The contributions can be viewed at
http://rohs.exemptions.oeko.info/index.php?id=333.
1 This methodology includes a dossier template for substance assessment which had been prepared by the Austrian
Umweltbundesamt GmbH in the course of a previous study. The methodology for substance assessment has been
revised based on various proposals from and discussions with stakeholders. Among others, revisions have been made
to clarify when the Article 6(1) criteria are considered to be fulfilled and how the precautionary principle is to be applied.
The methodology has also been updated in relation to coherence to REACH and other legislation and publicly available
sources of relevance for the collection of information on substances have been updated and added. The methodology
is available at https://rohs.exemptions.oeko.info/index.php?id=341
2 Frauenhofer ITEM & IPA, Hesse, Susanne; Wibbertmann, Axel; Hahn, Stefan; Miehe, Robert; Müller, Sebastian (no
year): Assessment of TBBP-A (tetrabromopisphenol-A) according to the “Methodology for Identification and
Assessment of Substances for Inclusion in the List of Restricted Substances (Annex III) under the RoHS2 Directive”.
Update August 2018. Fraunhofer ITEM, Fraunhofer IPA, Stuttgart; submitted as part of the contribution submitted by
BSEF, aisbl The International Bromine Council during the TBBP-A stakeholder consultation conducted from 20 April
2018 to 15 June 2018
3 Fraunhofer ITEM IPA, Wibbertmann and Hahn (2018): Assessment of TBBP-A (tetrabromopisphenol-A) according to
the “Methodology for Identification and Assessment of Substances for Inclusion in the List of Restricted Substances
(Annex III) under the RoHS2 Directive”. Update August 2018. Fraunhofer ITEM, Fraunhofer IPA, Stuttgart.

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