Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
daughters have a different legal personality and therefore qualify as a ‘legal person
established in the Community’ for the purposes of REACH. They are to be considered as
different manufacturers and importers who each may be obliged to register for the
respective quantities they manufacture or import. Often operators do not use the terms
‘branch’ and ‘office’ in this technical-legal sense and therefore it should be ascertained
in detail whether the entity being referred to has legal personality or not.
In principle each legal entity must submit its own registration for each individual substance. In
the case of a company group which is composed of several legal entities (e.g. a parent
company and its subsidiaries), each of those legal entities must submit its own registration. On
the other hand, if one legal entity has two or more production plants which are not separate
legal entities, then only one registration covering the different sites needs to be submitted by
the legal entity.
Example
International companies sometimes have several daughters in the EU acting as importers,
often spread over several Member States. Each of those daughters, if it has legal
personality, is a legal person within the meaning of REACH. Depending on the distribution of
work within the group, each of them can be an ‘importer’ responsible for import. It is for the
group or the individual companies to assign the tasks and the responsibilities to companies
in the group.
2.1.2.2 Customs boundaries for manufacturing and import
REACH applies to the European Economic Area (EEA), i.e. the 27 EU Member States and
Iceland, Liechtenstein and Norway. This means that imports from Iceland, Liechtenstein and
Norway are not considered imports for the purposes of REACH.
Therefore, an importer of a substance from Iceland, Liechtenstein or Norway is not required to
register the substance under REACH and is simply regarded as a distributor or downstream
user. However if the manufacturer of the substance is established in Iceland, Liechtenstein or
Norway, he will be subject to the same registration obligations as all EU manufacturers.
Importers of a substance from Switzerland (a non-EU country not belonging to the EEA) will
have the same obligations under REACH as any other importers.
Examples
A formulator purchasing his substances in Germany or Iceland will be considered as a
Downstream User.
A formulator purchasing his substances in Switzerland or Japan and introducing them into
the EU customs territory will be considered as an Importer.
Please note that whenever the term EU is used in this guidance document, Iceland,
Liechtenstein and Norway are also included.
2.1.2.3 Who is responsible for the registration in case of manufacturing?
In case of manufacturing (see definition in section 2.1.1), the registration should be made by
the legal entity who undertakes the process of manufacturing. It is important to bear always in
mind that only manufacturers established in the EU are required to submit a registration for
the substance they manufacture. The registration obligation also applies in the case that the
substance is not marketed in the EU but exported outside the EU after manufacturing.
Who is the registrant in case of toll manufacturing?
A toll manufacturer (or subcontractor) is normally understood to be a company that
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