Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 21
Who can appoint an only representative?
According to Article 8(1) a ‘non-EU manufacturer’ being a natural or legal person who is
manufacturing a substance, formulating a mixture or producing an article that is imported into
the EU, can appoint an only representative to fulfil the registration obligations of the importers.
‘Non-EU distributors’ 3 are not mentioned in Article 8(1) and can therefore not appoint an only
representative. An only representative must be able to document who he is representing and is
advised to attach a document from the ‘non-EU manufacturer’ appointing him as only
representative in his registration dossier. Although it is not mandatory to include this
information in the registration dossier, it needs to be presented to the enforcement authorities
upon request.
Who can be an only representative?
An only representative is a legal entity established in the EU which has sufficient background in
the practical handling of substances and the information related to them to be able to fulfil the
obligations of importers.
It should be noted that an only representative is not the same as a third party representative
(Article 4). A third party representative can be appointed by a manufacturer, importer or
where relevant downstream user to allow this potential registrant or data holder to remain
anonymous vis-à-vis other stakeholders in the data sharing process. It is neither necessary nor
advisable for an only representative to appoint a third party representative because an only
representative is not obliged to disclose to the other participants in the data sharing process
the identity of the ‘non-EU manufacturer’ he is representing (for more guidance on this see the
<strong>Guidance</strong> on data sharing).
What should a ‘non-EU manufacturer’ do when appointing an only representative?
When appointing an only representative, it is recommended that the ‘non-EU manufacturer’
provides his only representative with up to date information on the list of EU importers which
should be covered by the registration of the only representative and the quantities imported
into the EU. This information may also be supplied by other means (e.g. it may be notified
directly to the only representative by the EU importers) depending on the arrangements made
between the ‘non-EU manufacturer’ and the only representative.
The ‘non-EU manufacturer’ needs to inform all the EU importers in the same supply chain that
he has appointed an only representative to conduct the registration thus relieving the
importers from their registration obligations. A ‘non-EU manufacturer’ can only appoint one
only representative per substance. The only representative’s registration should clearly specify
which quantity of the imported substance it covers – be it the entire import into the EU from a
given ‘non-EU manufacturer’, or only specified quantities within that total. In cases where an
importer is also importing quantities of the same substance from other non-EU sources, then
both the only representative and the importer must be able to clearly document to
enforcement authorities which imports are covered by the registration of the only
representative; and which are covered by the importer; otherwise, the importer remains
responsible for all his imports. In other words, an importer has to submit a registration for the
quantity of a substance he imports, but does not have to cover the volume of the substance
that is covered by the registration of the only representative.
What are the consequences for the EU importers?
When an importer receives information from a ‘non-EU manufacturer’ in his supply chain that
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Please note that a ‘non-EU distributor’ is not a distributor for the purposes of REACH as he is not a natural or legal
person established in the EU (as defined in Article 3(14)). An EU-based distributor cannot, of course, in any case
appoint an only representative.
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