Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
be submitted and within which tonnage band. However if certain exemptions to
registration apply (such as in food or medicinal products or for PPORD purposes as in the
examples below) the potential registrant does not need to include those quantities in his
calculation to determine the volume he has to register. For details on the different exemptions,
please, refer to the previous sections.
Example 1: Use in medicinal products
If a company manufactures a substance to be used in a medicinal product, it does not need
to register the substance for that use. However, this company or its customers may at the
same time make other uses of the same substance. To determine its registration obligation
under REACH, it must determine the quantities for the other uses. E.g., company A
manufactures 120 tonnes of magnesium hydroxide in year X. 70 tonnes are used in
medicinal products and 50 tonnes are used for the formulation of a mixture. The 50 tonnes
used for the formulation of the mixture will be subject to the provisions of the REACH
Regulation, while the 70 tonnes used in medicinal products are exempted from registration
under the REACH Regulation.
Example 2: Use for PPORD purposes
If a company manufactures 11 tonnes per year of a substance, of which 2 tonnes are for
PPORD, the registration obligation is defined by the 9 tonnes per year which are not for
PPORD. The company will also have to submit a PPORD notification dossier for the 2 tonnes
used for PPORD purposes.
2.2.6.2 Calculation of the volume for intermediates
In addition to the exemptions from registration, the potential registrant should consider
whether the substance he intends to register is used as an intermediate and is manufactured
and used under strictly controlled conditions (see previous section 2.2.5). If this is the case he
can benefit from the limited information requirements defined for intermediates and need not
comply with the full set of information required for a standard registration. If the manufacture
or use of the intermediate does not take place under strictly controlled conditions, the potential
registrant will have to submit a standard registration dossier and comply with the information
requirements established for the tonnage band in which he intends to register the
intermediate.
Where a dossier contains both the use of a substance as an intermediate under strictly
controlled conditions and as an intermediate where strictly controlled conditions are not met,
and/or as a non-intermediate, the information requirements will depend on the volume of the
non-intermediate and of the intermediate use that is not taking place under strictly controlled
conditions.
Example: Volume to consider for the registration dossier in the case of
intermediates
A company manufactures 2300 tonnes per year of substance A, of which 1700 tonnes are
used as intermediate in strictly controlled conditions and the other 600 tonnes are used for
other purposes not exempted from registration. This company will submit only one
registration dossier for substance A, covering the 1700 tonnes used as intermediates and the
600 tonnes for the other purposes. However the information requirements of the registration
dossier will be determined by the 600 tonnes, since for the intermediate use under strictly
controlled conditions only a limited set of information is required This means that the
information requirements defined under REACH for the 100-1000 tonnage band will be used
as a basis for this dossier. The fact that the substance is also used as an intermediate under
strictly controlled conditions should be indicated in the dossier and the volume of 1700
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