How to assess whether a substance is used as an intermediate under strictly controlled conditions and how to report the information for the intermediate registration in IUCLID : Practical Guide 16

This practical guide aims to assist registrants of intermediates and the downstream users in assessing if the use of a substance complies with the definition of intermediate according to Article 3(15) of REACH. In addition it will assist the registrants to identify the relevant information to include in their registration dossiers in order to comply with their legal obligations. It also explains the information needed to document that an intermediate is used under strictly controlled conditions, as defined in Article 18(4)(a) to (f) of REACH. This practical guide has been developed on the basis of: - information provided to ECHA in the registration dossiers of intermediates, - experience gathered from the evaluation of responses to requests for information from ECHA (Article 36 decisions) provided by the registrants of intermediates and - input from the Forum for Exchange on Information on Enforcement – the body composed of representatives from the European national enforcement authorities for REACH (Article 86). - Good practices in the area of intermediates’ registration are emerging and developing, as experience in the implementation of REACH grows. This document will be reviewed and revised as necessary in the future to incorporate new developments