Guidance on registration - ECHA - Europa

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46 <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) Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
<strong>Guidance</strong> on registration Version 2.0 May 2012 47 2.3 When to register? Aim: Structure: The aim of this chapter is to inform potential registrants when they should submit their registrations to ECHA. It explains in detail what are phase-in and not phase-in substances and what the deadlines for registration are. The structure of this chapter is as follows: 2.3.1 Phase-in substances vs. non phase-in substances 2.3.1.1 Phase-in substances The REACH Regulation creates a special transition regime for substances which, under certain conditions, were already being manufactured or placed on the market before the entry into force of the REACH Regulation on 1 st June 2007 and were not notified according to Directive 67/548/EEC. For these substances, the registration can be submitted within deadlines foreseen by the REACH Regulation and described in section 2.3.2. Such substances are called phase-in substances because they are being subjected to the registration system in different phases over time, rather than immediately in one go. A precondition to benefit from the transitional regime for registration is that the phase-in substance has been pre-registered between the 1 st June 2008 and the 1 st December 2008. Phase-in substance which are manufactured or imported for the first time after 1 st December 2008 can benefit from a later pre-registration under special conditions. Further information on pre-registration of phase-in substances is included in section 4.2. Phase-in substances are substances which fall under at least one of the following criteria: The substance is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS) (Article 3 (20)(a)). The EINECS list contains, in principle, all substances on the Community market on 18 September 1981. These are the so-called Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
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