The REACh Regulation defines an intermediate as a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (Article 3(15)). Intermediates fall into the following categories and have differing registration requirements:
- Non-isolated Intermediates
- Isolated Intermediates:
(a) On-site (non-transported) Intermediates
(b) Transported Intermediates
A non-isolated intermediate is 'an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place.' (Article 3 (15)(a)). Under REACH, non-isolated intermediates are completely exempt.
An on-site isolated intermediate is 'an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities' (Article 3(15)(b)).
A transported isolated intermediate is 'an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites' (Article 3(15)(c)).
Isolated intermediates benefit from reduced registration requirements, provided their manufacture and use take place under the conditions set in Article 17 and 18. For on-site isolated intermediates used under strictly controlled conditions, neither dossier nor substance evaluation apply (Article 49). On-site isolated intermediates and transported isolated intermediates are exempt from Authorisation (Title VII).
The revised ECHA Guidance on Intermediates (version 2) is available here.
