Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
an only representative has been appointed to cover the registration obligations, this importer
will be regarded as a downstream user of the only representative for the tonnage covered by
the registration of the only representative. This change of status from importer to downstream
user only pertains to the same supply chain, i.e. to the tonnage imported from the ‘non-EU
manufacturer’ having appointed the only representative. If this importer also imports the
substance from other non-EU suppliers, he still has to register the tonnage imported from this
or these non-EU suppliers unless the latter has/have appointed an only representative(s) to
cover the respective imports.
Although the importer will receive confirmation from his ‘non-EU manufacturer’ on the
appointment of the only representative, he should preferably also obtain confirmation in
writing from the only representative that his imported tonnage and use is indeed covered by
the registration submitted by the only representative. This would not only provide the importer
with the contact point to whom he, acting as a downstream user, can make his use known, but
would also give the importer a clear documentation that the imports are indeed covered by the
registration of the only representative, as otherwise he remains responsible for the imports.
The importer may decide, as can any downstream user, to perform his own chemical safety
assessment (see the <strong>Guidance</strong> on downstream users for further information). This requires
considerable effort so it is advisable for the importer to consider carefully to what extent it
may be necessary.
Obligations of the only representative regarding the registration of substances
An only representative is fully responsible and liable for fulfilling all obligations of importers for
the substances he is responsible for. These do not only pertain to registration but also to all
other obligations of importers under REACH.
The following paragraphs describe the role of the only representatives in regard to their
registration obligations. The reader is reminded that other only representative obligations,
such as pre-registration, data-sharing, etc. are described in the corresponding sections of this
guidance under the obligations of importers. Where the only representative obligations differ
from those of the importers, they are specifically mentioned.
The only representative registers the imported quantities depending on the contractual
arrangements between the ‘non-EU manufacturer’ and the only representative.
REACH does not distinguish between direct and indirect imports into the EU and therefore such
terms are not used in this guidance. It is essential that there is a clear identification of:
who in the supply chain of a substance outside the EU is the manufacturer, formulator
or producer of an article;
who has appointed the only representative;
which imports the only representative has responsibility for.
As long as the above conditions are met, it does not matter what the steps or supply
chain are outside the EU between the manufacturer, formulator or producer of an
article and the importer into the EU.
It should, however, be pointed out that the appointment of an only representative by the ‘non
EU manufacturer’ creates the need for importers to keep exact documentation on which
imported quantities of the substance are covered by the only representative registration and
which imported quantities are not In case of import of mixtures the importers will also need to
know what quantity of the substance in a mixture is covered by an only representative
registration, as he would otherwise be subject to a registration requirement himself. This
documentation will need to be presented to the enforcement authorities upon request.
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