Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
which were substances not appearing on the European Inventory of Existing Commercial
Chemical Substances (EINECS). The EINECS list contains, in principle, all substances on the
Community market on 18 September 1981.
Notifications made in accordance with Directive 67/548/EEC contain much of the technical
dossier information which the REACH Regulation aims to have assembled by registrants
through the registration requirement. This is the reason why such notifications are
regarded as registrations. Notified substances according to Directive 67/548/EEC are
generally referred to as NONS (Notification of New Substances) in the context of REACH.
ECHA has assigned registration numbers to all notifications and distributes them electronically
upon request of the notification’s owner. Detailed instructions on how to request a registration
number for a notified substance is available on the ECHA website at
http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/nons. Please, note
that the registration is assigned for the tonnage band referred to in the notification of the
substance. As soon as the actual volume differs from this initial tonnage band the registrant
will have to update his registration dossier as described in section 7.4 of this document.
Legal entities are advised to check whether they submitted a notification for their substance to
a Member State competent authority in accordance with the national legislation implementing
Directive 67/548/EEC. If this is the case, they have an official notification number on file which
was allocated by the Member State competent authority. The substance will in that case also
appear on the European List of Notified Chemical Substances (ELINCS).
Notification under Directive 67/548/EEC was only required if a substance was placed on the EU
market or imported into the EU. If a substance was merely manufactured in the EU, but not
placed on the market, a notification would not have been made. These substances will have to
be registered under REACH.
Manufacturers or importers of polymers which were notified according to Directive 67/548/EEC
are advised to read the <strong>Guidance</strong> for polymers where the specific steps to claim a registration
number for a notified polymer are explained in detail.
It is important to remark that a notification under Directive 67/548/EEC is nominal
so that only the notifier benefits from being considered registered; any other parties
manufacturing or importing the substance but who have not notified it, must
register, unless there is another exemption that applies to them.
Legal reference: Article 24
2.2.5 Obligations related to registration of intermediates
REACH establishes specific obligations for intermediates as previously explained in section
2.2.5. While non-isolated intermediates are not covered by REACH, isolated intermediates
have reduced requirements depending on the conditions of manufacture and use.
The following types of isolated intermediates are defined under REACH:
On-site isolated intermediate
Transported isolated intermediates
An on-site isolated intermediate is an intermediate not meeting the criteria of a nonisolated
intermediate and where the manufacture of the intermediate and the synthesis of
(an)other substance(s) from that intermediate take place on the same site, operated by one or
more legal entities (Article 3(15)(b)).
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