Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 87
The registrant has to update his registration as a consequence of an ECHA or a
Commission decision under the evaluation 18 procedure but also, when relevant, following
any decision made in accordance with the authorisation and the restriction processes.
These updates have to be performed within the deadline specified by ECHA/the
Commission in the decision (Article 22(2)).
For substances regarded as registered because a notification according to Directive
67/548/EEC has been submitted, registrants need to submit updates of their dossier when any
of the situations mentioned above occurs, including updates following decisions taken
according to Directive 67/548/EEC and now regarded as Agency decisions.(Article 135).
However, the update does not have to meet the full information requirements under REACH
corresponding to the respective tonnage band, unless the quantity manufactured/ imported of
the notified substance by the registrant reaches the next tonnage threshold.
There is no requirement to update a registration dossier for substances in plant protection and
biocidal products (Article 16(2)).
The next sections explain in further detail the different situations a registrant may encounter
as a consequence of which an update of his registration dossier may be required.
Note that an update will in certain cases be subject to the payment of a fee in accordance with
the Commission Regulation (EC) No 340/2008 (Fee Regulation) (see section 9.2).
Legal references: Article 22, Article 20 (2), Article 20 (6), Article 16 (2), Article 135
7.2 Required update on the registrant's own initiative
A registrant is responsible on his own initiative for updating his registration information without
undue delay. The following cases are identified (Article 22(1)):
a) Any change in his status, such as being a manufacturer or an importer or a producer of
articles, or in his identity, such as his name or address
The registrant must inform ECHA of any change in his identity and contact details. These
changes can be made directly in REACH-IT without submitting an update of the registration
dossier.
Further duties may arise in cases where a change in identity involves a change in the legal
personality of the company. This might be the case when a merger, takeover or split takes
place or in case a company sells its assets related to a registration. It also applies to the
appointment of a new only representative by a non-EU manufacturer as a replacement for a
previous one.
As a general rule, a registration may be transferred from one legal entity to another legal
entity following a change of legal personality. It is important to note that one registration
cannot be owned by more than one legal entity.
In the case of a merger or takeover where the individual legal entities have previously
registered the same substance, attention has to be paid to the total tonnage of the
manufactured/imported substance after the merger or takeover. If the total tonnage reaches a
higher tonnage band, then the registration dossier has to be updated accordingly.
Detailed information on how to report changes in the identity of legal entities can be found in
Practical guide 8: How to report changes in identity of legal entities . Additionally, any change
18
For further information on the evaluation procedures, refer to the <strong>Guidance</strong> on dossier and substance evaluation
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu