Intermediate substance: a substance manufactured, consumed or used to be transformed, through a chemical process, into another substance (hereinafter referred to as "synthesis"):
Non-isolated intermediates: are exempt from REACH registration: A substance that is manufactured solely for the purpose of being transformed into another substance (or synthesis) and is used up within this reaction. Non-isolated intermediate is not intentionally removed from the synthesizing equipment. Other intermediate other than non-isolated intermediate are called isolated intermediates, which can be divided into two sub groups: On-site isolated intermediate and transported intermediate.
On-site isolated intermediate: A substance manufactured for or used for chemical processing in order to be transformed into another substance, the synthesis of which takes places on the same site and which is operated by one or more legal entities.
Transported isolated intermediate: A substance(for example, pharmaceutical intermediate) manufactured for or used for chemical processing in order to be transformed into another substance, the synthesis of which is transported between or supplied to other sites.
For the use of a substance as a non-isolated intermediate, there are no obligations under REACH Regulation (Article 2, paragraph 1, point C).
ON SITE / TRANSPORTED ISOLATED INTERMEDIATE:
Manufacturers of isolated / transported intermediate products in quantities in excess of 1 tonne/year must submit a registration dossier unless the substance is exempt from the registration provisions.On site/transported isolated intermediate reporting agents may provide reduced registration information pursuant to Art. 17 (2) and art. 18 paragraph 4 if they confirm that the substance is manufactured and used under strictly controlled conditions.
Besides the available data on substance's intrinsic properties, the registrant still has to provide the following information:
According to REACH, two critical conditions need to be met for an on-site or transported isolated intermediate to benefit from the reduced data set provisions of articles 17 and 18 of REACH:
In view of these conditions, ECHA is asking registrants to collect and send:
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