We at REACh ChemConsult GmbH offer consulting and auditing regarding the implementation of strictly controlled conditions for intermediate registrations under REACH.

For intermediates e.g. for the synthesis of fine chemicals such as active pharmaceutical ingredient (API) a registration with less data requirements is allowed provided that the provisions of Art. 17(3) and 18 (4) of REACH are met respectively. There are two types of isolated intermediates, on-site isolated and transported isolated intermediates. It is necessary to prove the existence of control as required by Art. 17(3)/ 18 (4) in the registration dossier. These strictly controlled conditions have to be installed for every handling step of the substance such as filling, discharging, bottling and emptying, sampling. Documentation needs to be provided within the registration dossier. Documents need to be attached to section 13 of the IUCLID dossier.

We at REACh ChemConsult GmbH have many years of experience in the documentation and establishing of strictly controlled conditions for intermediates handling. We utilise the existing documentation in your company that results from hazardous substance regulations and operational safety. The requirements of the relevant REACH guidelines are taken into account. In 2014, we already held a symposium on intermediates under REACH (in German).

Our experts are happy to come on site to audit or to recommend measures to achieve the conditions. We are also happy to take on the preparation of inquiry and registration dossiers in IUCLID.

Contact us for further information or for a non-binding offer.