Impact and risk evaluation

• Author: Clemm, Christan; Löw, Clara; Baron, Yifaat; Moch, Katja; Möller, Martin; Köhler, Andreas R; Gensch, Carl-Otto; Deubzer, Otmar
• Pages: 47-50

RoHS Annex II Dossier, final

TBBP-A (flame retardant)

47

7. IMPACT AND RISK EVALUATION

The substance evaluation of the human health and environment hazards of TBBP-A under REACH

is currently ongoing. EU wide, no conclusion is reached so far on whether TBBP-A has endocrine

disruptive properties and whether it is to be considered as PBT, respectively. Any evidence regarding

one of these properties may affect the impact and risk evaluation here at hand because as a result

of either properties, the current DNELs and PNEC may no longer be applicable:

• As pointed out in section 3.3, there are substantial structural similarities of TBBP-A and bisphenol

A. In the document on the identification of bisphenol A as an SVHC due to its endocrine disrupting

properties, the structural alerts have been described that are necessary for the different modes of

action for BPA, the estrogenic activity, the anti-androgenic activity and the thyroid hormone

activity. Having in mind that TBBP-A is currently under review by the ED expert group of ECHA

concerning its possible endocrine disrupting properties, it is suggested here that similar hazards

are to be expected for TBBP-A as for BPA.

• Though the evaluation whether TBBP-A is a PBT substance is still ongoing, substances with PBT

properties have the potential to persist and accumulate in the environment. ECHA (2017b)

emphasises that the effects of such accumulation are unpredictable in the long–term and that such

accumulation is in practice difficult to reverse as cessation of emission will not necessarily result

in a reduction in chemical concentration. They circulate in the global environment for long times

and if further released the environmental concentration is constantly increasing.

As explained below, workers and consumers as well as the environment are subjected to exposure,

which, however, on the basis of the threshold values, is not assessed as posing a risk. However, the

risk characterisation ratios provided by the study of the Fraunhofer ITEM IPA, Wibbertmann and

Hahn (2018) would no longer be valid if TBBP-A were to be recognised as endocrine disrupter and

as a type of PBT substance.

As for human health it should further be noted that according to the Fraunhofer ITEM IPA,

Wibbertmann and Hahn (2018), the DNELs available were provided by the REACH registrants

(industry). These DNELS have not been officially reviewed by ECHA or by an EU expert group.

However, they have decreased significantly in recent years.

As pointed out earlier, exposure is mainly due to the additive use of TBBP-A in plastic enclosures

and housings. Stakeholders, e.g. the ZVEI (2018) pointed out that the manufacture of EEE

containing additive applications of TBBPA would not take place in Europe. Based on this information,

it is assumed that plastic containing additive TBBP-A occurs solely in imported goods.

7.1. Impacts on WEEE management as specified by Article 6(1)a

Article 6(1)a demands for a potential Annex II candidate the assessment of whether a substance/

substance group “could have a negative impact during EEE waste management operations,

including on the possibilities for preparing for the reuse of WEEE or for recycling of materials from

WEEE”.

According to Annex VII of the WEEE Directive,121 plastics used in EEE containing brominated flame-

retardants have to be removed from any separately collected WEEE. It is understood that the

presence of a restricted BFR causes disproportionate costs for plastic recyclers because expensive

testing techniques, such as XRT/XRF technologies, are necessary to distinguish plastic parts

121 Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic

equipment (WEEE) (recast)