Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 13
The registration provisions require manufacturers and importers to collect or generate data on
the substances they manufacture or import, to use these data to assess the risks related to
these substances and to develop and recommend appropriate risk management measures to
control these risks. To ensure that they actually meet these obligations, as well as for
transparency reasons, manufacturers and importers are required to prepare a registration
dossier (in IUCLID format) and submit it to ECHA via REACH IT (see section 5).
When a substance is intended to be or is actually being manufactured or imported by more
than one manufacturer or importer, certain data must be shared (see section 4) and submitted
jointly (see section 3.3.1) with the purpose of increasing the efficiency of the registration
system, saving costs and reducing testing on vertebrate animals. A registrant may opt-out
from some information requirements and submit the information separately to ECHA in certain
specified cases (see section 3.3.2).
Unless the REACH Regulation indicates otherwise, registration obligations apply to substances
manufactured or imported in quantities of one tonne or more per year per manufacturer or
importer (see section 2.2). Normally, the registration must be successfully completed and a
registration number assigned to the registrant before a substance can be manufactured,
imported or placed on the market.
However, for most substances that are already being manufactured or imported (so called
‘phase-in substances’) a special transition regime applies provided the substances have been
pre-registered. This allows their manufacture or import to continue without registration until
the corresponding deadlines are met (see section 2.3). If a manufacturer or importer does not
register by the appropriate deadline, the substance may not be manufactured in the EU or
placed on the EU market until after it has been registered.
Registered substances can in principle circulate freely on the internal market.
1.3 Substances, mixtures and articles
REACH lays down obligations which apply to the manufacture, import, placing on the market
and use of substances on their own, in mixtures or in articles. Before continuing to explain
which substances require registration it is important to have a clear understanding of these
terms and how mixtures and articles are dealt with.
Substance means a chemical element and its compounds. The term substance includes both
substances obtained by a manufacturing process (for example formaldehyde or methanol) and
substances in their natural state. The term substance also includes its additives and impurities
where these are part of its manufacturing process, but excludes any solvent which can be
separated without affecting the stability of the substance or changing its composition. Detailed
guidance on substances and substance identity can be found in the <strong>Guidance</strong> on substance
identification.
Mixture means a mixture or solution composed of two or more substances. Typical examples
of mixtures under REACH include paints, varnishes and inks. REACH obligations apply
individually to each of the substances contained in the mixture depending on whether the
individual substances are within the scope of REACH.
When contained in a mixture, each individual substance needs to be registered if the threshold
of one tonne per year is reached (for additional information on how to calculate the tonnage
for registration for substances in mixtures please refer to sections 2.2.6.3 and 2.2.6.4) The
registration obligation applies to the manufacturer or importer of each individual substance, or
in case that the mixture is imported as such, to the importer of the mixture. The formulator,
i.e. the natural or legal entity that mixes the individual substances to produce the mixture,
does not have registration obligations under REACH unless he is at the same time a
manufacturer or importer of the individual substances contained in the mixture or an importer
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