Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
2.2.6.4 Calculation of the amount of substance in a mixture or in articles
Specific situations may occur for substances present in mixtures or in articles:
Amount of a substance in a mixture
In order to be able to calculate the amount of a substance in a mixture, the total volume of the
mixture is multiplied by the fraction of the constituent substance. This value can, for example,
be obtained from the safety data sheet of the mixture. When only a range of concentrations of
a substance in a mixture is available, then the maximum volume of the substance is calculated
using the highest possible content of that substance in the mixture. Without more precise
information on the composition, this may be the only way to ensure that the registration
requirements are being respected.
Amount of a substance in an article
In the case of articles which contain a substance that is intended to be released under normal
or reasonably foreseeable conditions of use, then:
If the weight by weight content of that substance is known, then this value is multiplied
by the total mass of the produced and/or imported article; or
If the weight of substance per unit article is known then this value is multiplied by the
total number of imported articles.
More detailed guidance can be found in the <strong>Guidance</strong> for articles.
2.2.6.5 Calculation of the volume for phase-in and non phase-in substances
For the registration, the registrant must report the volume in tonnes he manufactures or
imports per year. REACH defines different methods to determine the tonnes per year (Article 3
(30)) depending on whether a substance is a phase-in substance or a non phase-in substance.
For the definition of phase-in substances and non phase-in substances please refer to sections
2.3.1.1 and 2.3.1.2 respectively.
Calculation of the tonnes per year for the registration of non phase-in substances
The tonnes per year of a non-phase-in substance to be reported in a registration dossier is the
estimated quantity in tonnes that is expected to be manufactured and/or imported in the
calendar year (1 January - 31 December) of registration. In case manufacturing starts only
later in a particular calendar year, registration dossiers could cover the expected tonnes for a
full calendar year rather than the remaining months of the first calendar year, in order to avoid
the need for a very quick update of the registration dossier for the second year.
Calculation of the tonnes pe year for the registration of phase in-substances
In the case of a phase-in substance that has been imported or manufactured for at least three
consecutive years, the tonnes per year shall be calculated on the basis of the average tonnes
manufactured or imported in the three preceding calendar years. If the substance has not been
manufactured or imported for three consecutive years then the tonnes manufactured or
imported in a calendar year should be used. This provision has been put in place to avoid
situations where a sudden increase in demand would lead to the impossibility to comply with
the registration obligations.
Note that in the case of pre-registered phase-in substances the tonnes per year determine the
deadline for registration. Detailed examples on how to determine the tonnes per year and the
registration deadline for phase-in substances are provided in section 2.3.2.
Legal Reference: Article 3 (30)
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