CO2_2016 - page 58

Chimica Oggi - Chemistry Today
- vol. 34(2) March/April 2016
KEYWORDS: REACH, (EC) No 1907/2006, Registration Evaluation Authorisation and restriction of Chemicals.
The phasing in of REACH’s provisions began on 1 June 2007, now after two of the three registration
deadlines in 2010 and 2013; the next major registration milestone, 31 May 2018, is looming. Various
measures have been taken and are due to be applied as REACH is progressing through its eleven year transitional period. Some of the
recent developments are discussed herein with a focus on their impacts on obligations for data requirements and the synergies
between the developments.
Test data in REACH:
requirements and developments
Examining developments in REACH and their impact on
information requirements
More than eight years ago, REACH entered into force with
the objectives of generating information on chemicals
in order to allow for better protection of human health
and the environment whilst enhancing competitiveness
and innovation. In this period, EU REACH – Registration,
Evaluation, Authorisation and restriction (the silent ‘r’
in the acronym) of CHemicals – Regulation (1) has
made a significant impact both in terms of immediate
costs to industry and volume of information generated
consequently. Registration is often considered to be
the most resource demanding aspect, in part, because
of the significant data requirements legal entities can
be obliged to meet. The complexity of the Regulation
coupled with unforeseen issues and dissenting views
instigates a dynamic environment in which new
regulations, software updates and enforcement actions
are necessary for addressing shortcomings, practicalities
and non-compliance. Equipping the agency, industry and
the authorities with these tools is deemed necessary in
order to meet an overarching aim of REACH: to identify
the chemicals of the highest concern and substitute them
with safer alternatives in the interests of human health and
the environment whilst avoiding unnecessary vertebrate
animal testing.
This article assesses REACH’s provisions and developments
concerning the aforementioned in the context of
analytical data, data submission and sharing. The
Implementing Act on Joint Submission of Data and Data-
Sharing; IUCLID 6 and the updated REACH-IT; as well as
restrictions and RAPEX are also discussed.
A central provision of REACH “No data, no market” (2)
applies to substances on their own, in mixtures and in
articles, subject to registration. Registration applies to
manufacturers and importers in the European Economic
Area (EEA) where aggregate annual manufacture or
import of a substance (can be in mixtures or, in some
cases, in articles) equals or exceeds 1 metric tonne
per legal entity. Therefore even small quantities of
substances (1-10 tpy) require at least physico-chemical
analysis as well as the least extensive toxicological and
ecotoxicological tests, if they have not already been
completed, to yield data to permit placing on the market.
There are currently two ways to register, the first is for
phase-in substances that are now subject to the next
registration deadline (31 May 2018) and proceeds through
formation of a Substance Information Exchange Forum
(SIEF) (3) and the second is for non-phase-in substances,
which proceeds through making an Inquiry to ECHA (4).
Non-phase in substances are, generally, new substances,
or existing substances for which a pre-registration is no
REACHReady Ltd, Kings Buildings, Smith Square, London SW1P 3JJ, United Kingdom
Peter B. Walters
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