Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 35
2.2.3.6 Re-imported substance
In cases where a substance is first manufactured in the EU, then exported – for example, to be
formulated into a mixture – and then brought back into the EU again – for example, to be
marketed or for further processing – this could lead to a double registration obligation if it
happens within the same supply chain: first at the stage of original manufacture, by the
original manufacturer, and a second time at the stage of import back into the EU, by a reimporter
down in the same supply chain (who may or may not be the original manufacturer).
Therefore, substances which have been registered, exported and then re-imported are
exempted from registration under certain conditions.
The following conditions must be fulfilled to benefit from this exemption:
(1) The substance must have been registered before it was exported from the EU. This means
that if, for some reason, the substance was not registered at the manufacturing stage, the
substance has to be registered upon re-import.
(2) The substance already registered and exported must be the same, as the substance being
re-imported, on its own or in a mixture (the sameness of the substance must be assessed
according to the criteria defined in the <strong>Guidance</strong> on substance identification). For example,
if the exported substance itself was modified outside the EU and therefore it is not the
same substance as that which is now being re-imported, the re-imported substance has to
be registered.
Again, the reason is clear; if the substance is not the same, it has not yet been registered
(the registration information will be different), and therefore there will not be duplication of
registrations.
(3) The substance must not only be the same but it must actually proceed from the same
supply chain in which the substance was registered.
(4) The re-importer must have been provided with information on the exported substance, and
that information must comply with the requirements established under REACH for the
provision of information down the supply chain. The required information is described in
detail in section 6.1.1 and 6.1.2 of this guidance.
Legal reference: Article 2 (7) (c)
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