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Subject: REACH authorisation and innovation, Follow-up of meeting Commission
CHEMTrust 4th of June on chemicals strategy
Dear
thank you again for the meeting on 4th of June and for your questions.
Concerning the issues with the REACH authorisation procedure and its
impacts on innovation, we would like to follow-up involving our colleagues
from ChemSec,
, who are in copy to this email.
ChemSec is supporting REACH implementation since two decades and working
closely with companies to foster the substitution of hazardous chemicals with
safer alternatives.
Authorisation, a driver for innovation towards safer substances and
technologies
The authorisation procedure is a new and modern instrument introduced by
REACH. Its aim is to identify Substances of Very High Concern (SVHCs) and to
progressively replace them by suitable alternative substances or technologies.
SVHCs include substances that are carcinogenic, mutagenic and reprotoxic, or
persistent, bioaccumulate and toxic as well as substances of equivalent levels
of concerns like endocrine disruptors. SVHCs on Annex XIV of REACH are
banned unless the Commission authorised a specific use, either because i) the
risks are managed or ii) no suitable alternatives are available and the
socioeconomic benefits outweigh the risk of use. The applicant for an
authorisation has to provide the proof that above conditions, in particular that
no safer alternatives are available, are met. If applied correctly, this approach
would give a clear direction and planning certainty for all parties and promote
substitution and innovation towards safer alternatives. ChemSec is working
with companies and experts to promote safer alternatives(
How to find and
analyse alternatives in the Authorisation Process).
Implementation has gone wrong, protecting incumbents and frustrating
alternative providers
So far the Commission has always granted authorisations to all applicants. It
has done so systematically based on insufficient evidence provided by the
applicants and a very narrow interpretation of what constitutes an “available
alternative”, reducing it to substances which deliver identical performance like
for example the shade of a colour. This systematic misapplication of the
authorisation procedure has been exposed by the General Court judgment
from 7th of March 2019 which annulled the Commission's decision to authorise
a use of lead chromate in paints. Also the European Parliament issued several
resolutions highlighting the same or similar problems, for example in the case
of sodium dichromate 2018, chromium trioxide 2019 and DEHP 2019.
The current implementation of the authorisation procedure has damaged the
market for alternative providers. Many of them are left disappointed after
having planned to expand their operations anticipating a substitution, which
then did not materialise.
The Commission can fix the problem and boost innovation
We believe the European Commission should change its approach to
authorisation to deliver protection in line with the REACH requirements and to
boost innovation for safer alternatives. The General Court's judgement
provides guidance for necessary changes in the process: 1) the applicant for
authorisation bears the risk of a possible impossibility to determine whether
to conclude on the unavailability of alternatives and in case of remaining
uncertainties the applicant has not med the burden of proof and cannot be
granted an authorisation; and 2) the Commission cannot rely on conditions
attached to the authorisation, like shorter review periods, to remedy
deficiencies of the assessment.
In most cases this means that the Commissions will have to judge whether a
safer alternative, which usually will have different performance
characteristics, i.e. different shade of colour, is acceptable considering the
economic (change in products and trade) and health and environmental
impacts (deaths per year etc..). In case it is, the authorisation would not be
granted and the innovation towards safer alternatives would effectively be
rewarded.
Please do not hesitate to get back to us for any questions you may have.
Kind regards,
--
EU Policy Advocate
CHEM Trust
www.chemtrust.org
tel +32 (0)
mob +32 (0)
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