QUESTIONS & ANSWERS regarding REACH-Evaluation of HDI Trimer
According to the draft Community Rolling Action Plan (CoRAP), which was recently
published by the European Chemicals Agency (ECHA), HDI trimer (more precisely: HDI
oligomers, isocyanurate type) will be subject to a substance evaluation process in 2014.
The inclusion of a substance in the CoRAP does not in itself have any immediate legal
impact and does not necessarily mean that the substance causes risks to human health
or the environment. The following Q&A aim to provide more detailed information about
this process and possible consequences.
What is a “substance evaluation” under REACH?
Substance evaluation is a process within REACH to evaluate all available information
for a certain substance in order to clarify if there is a risk to human health or the
environment. The evaluation is carried out by a Member State, in our case Slovenia.
What are possible consequences of a substance evaluation process?
The Member State can either conclude that the available information is sufficient to
evaluate possible risks related to the substance, or that additional information is needed
for evaluation. In the latter case the Member State will draft a legally binding decision
requesting further information from the registrants of the substance. If the available
information is sufficient for evaluation, the Member State may conclude that no further
actions are needed, or may recommend additional measures (e.g. set up/modify OEL,
modify classification & labelling, initiate restriction or authorization).
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What is the “CoRAP”?
CoRAP stands for ”Community Rolling Action Plan”. This plan is updated and finally
published by ECHA each year in March and indicates substances for evaluation by the
Member States in the next three years. It lists substances, responsible Member State,
year of evaluation and initial grounds for concern.
Why was HDI trimer chosen for substance evaluation?
Substances are selected and prioritized for evaluation based on hazard information,
exposure information and tonnages. Based on these criteria the CoRAP lists for all
substances so-called “initial grounds for concern”. For HDI trimer these grounds are:
high aggregated tonnage, potential for wide dispersive use from professional uses and
suspect to be a “vPvB” (very persistant, very bioacculumative) substance.
The manufacturers of HDI trimer have concluded in their registration dossier that HDI
trimer is neither a vPvB nor a PBT and are confident that the vPvB suspicion will be
clarified in the course of the evaluation.
It has to be noted, however, that the initial concern does not limit the evaluation of the
Member State and other concerns could possibly be identified by the Member State
during its evaluation.
Are other HDI polyisocyanates also subject to this evaluation process?
Only HDI trimer (more precise: HDI oligomer, isocyanurate type) with REACH
registration numbers 01-2119485796-17-XXXX is subject to the current evaluation. The
registration numbers are provided in current safety data sheets. Other HDI
polyisocyanates (e.g. HDI biuret), even if the same CAS no. (28182-81-2) or NLP no.
(500-060-2) is assigned to them, are not affected (CAS and NLP numbers are not
always sufficient to describe the substance identity under REACH).
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Tel : +32 2 676 74 75
Fax : +32 2 676 74 79
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What is the time schedule for the evaluation process?
Publication of the final CoRAP for 2014-2016 is expected in March 2014. For all
substances due in 2014 (like HDI trimer) the evaluating Member States have to notify
ECHA about the outcome within 12 months, i.e. until March 2015. If further information
is needed, finalization of the respective decision may require about a further year. Then
the registrants will be given a certain deadline to deliver the additional information,
which will be taken into account for a final evaluation by the Member State. So, in many
cases, a substance evaluation process will last several years.
What is the role of the HDI trimer manufacturers?
In accordance with the legislation registrants are formally consulted at the stage of a
draft decision prior to a final decision being taken. There is no formal involvement of the
registrants in the evaluation before the draft decision is available. However, ECHA
recommends that evaluating Member States contact the (lead) registrant as early as
possible in the process and get into dialogue.
The HDI trimer manufacturers will offer any appropriate support to the evaluating
Member State and stay ready to provide information as required. The HDI trimer
manufacturers remain convinced that HDI trimer is safe in its intended applications, if
the current safety recommendations are followed. It is therefore expected that any
possible concern can be clarified during the evaluation process.
Av. E. Van Nieuwenhuyse Laan 4
B – 1160 Brussels
Tel : +32 2 676 74 75
Fax : +32 2 676 74 79
info@alipa.org
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