Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 17
EU producers and importers of articles in case that the article contains a substance
in quantities over 1 tonne per year and the substance is intended to be released under
normal or reasonably foreseeable conditions of use.
‘Only representatives’ established in the EU and appointed by a manufacturer,
formulator or article producer established outside the EU to fulfil the registration
obligations of importers (see section 2.1.2.5).
Examples of when registration is needed
A manufacturer of a substance who uses the manufactured substance himself has a duty
to register each substance manufactured in quantities of 1 tonne or more per year, unless
exemptions apply, and will have to include information on his own use(s) and any
identified uses of his customers in his registration.
An importer of a mixture has to register those substances which are present in the
imported mixture in quantities of 1 tonne or more per year, unless exemptions apply. He
will have to include information in his registration on the identified use(s) of the
substance(s) in the mixture. There is no obligation for importers of mixtures to register the
mixtures as such; indeed mixtures cannot be registered.
Examples of when registration is not needed
Any user of substances not manufactured or imported by himself, is a downstream user
and has no obligation to register these substances.
An importer of a substance, a mixture or an article, who is importing from a non-EU
company who has appointed an ‘only representative’ will be considered as a downstream
user and therefore does not need to register.
A manufacturer or importer of a substance which is exempted from registration under
REACH has no obligation to register that substance.
2.1.2.1 Legal personality
Only a natural or legal person established in the EU can be a registrant. REACH-IT and IUCLID
as well as the current guidance use the term ‘legal entity’ to refer to such a natural or legal
person having rights and obligations under REACH.
Although what constitutes a natural and a legal person is defined by the national laws of each
EU Member State, the following principles may be of interest:
A ‘natural person’ is a concept applied in many legal systems to refer to human beings
who are capable and have the right to engage into contracts or commercial
transactions. These are usually people who have reached the age of legal maturity and
are in full possession of their rights (meaning that these rights have not been taken
away from them, for example due to a criminal conviction).
A ‘legal person’ is a similar concept, applied in many legal systems to refer to
companies who have been endowed with legal personality by the legal system
applicable to them (the law of the Member State where they are established) and
therefore are capable of carrying rights and obligations, independently of the people or
other companies behind them (in the case of a ‘société anonyme’ or ‘limited company’,
their shareholders). In other words, the company usually has its own existence and its
assets do not coincide with those of its owners. One legal person can work on different
sites. It can also open so-called ‘branch offices’ which do not have separate legal
personality from the main or head office. In such a case, it is the head office that has
the legal personality and that has to respect the provisions of REACH if it is established
in the EU. On the other hand, a legal person can also open ‘daughter companies’ or
‘subsidiaries’ in the EU in which it holds shares or another type of ownership. Such EU
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