Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
2.2 What to register?
Aim:
This chapter provides an outline of which substances are subject to registration
requirements and a detailed explanation of the circumstances under which the
various exemptions from registration are applicable. Because the tonnage of
manufacture or import of each substance is critical in determining whether and
how to register, this chapter also outlines methods for calculating the volume to
be registered.
Structure: The structure of this chapter is as follows:
2.2.1 Overview of the registration scope
Registration is required for all substances manufactured or imported in quantities of one tonne
or more per year per manufacturer or importer unless they are exempted from the scope of
registration. The registration requirement applies to all substances irrespective of whether they
are hazardous or not. This includes substances on their own, in mixtures or substances in
articles when they are intended to be released under normal or reasonably foreseeable
conditions of use.
For all registrations, a registration dossier has to be prepared and submitted electronically to
ECHA. The information that the registrant has to provide in the registration dossier will depend
on the volume (tonnes manufactured or imported per year) of the substance to be registered.
The definition of a substance under REACH (see section 1.3) is very broad and includes not
only chemicals whether hazardous or not, but every type of substance manufactured in or
imported into the EU. It includes substances which are already closely regulated by other
legislation such as radioactive substances, medicines, food or feedingstuffs, biocides or
pesticides. These substances are completely or partially exempted from REACH or from the
registration requirements (see following sections below). Other substances within the scope of
specific pieces of legislation, e.g. food-packaging and cosmetics, although subject to
registration, have reduced risk assessment requirements under REACH (see section 3.2.1).
When the registrant manufactures or imports the substance in the nanoform as well as in the
bulk form, the registration dossier should include the information of the substance in both the
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