1. General Registration
Any manufacturer or importer (and to a certain extent producer of articles) of substances with a yearly tonnage of more than one tonne needs to submit a registration dossier within certain time limits. After the sign up of the company at the Agency it should either have pre-registered until December 1st 2008, late pre-registered (for late comer) or inquired before submitting a registration dossier. A joint submission of certain data is necessary for substances that are manufactured or imported by more than one company.
For new substances that do not fulfill phase-in character or substances that were not pre-registered on time a complete registration of the substance is needed once exceeding 1 t/y.
Data requirements for the registration:
Data requirements depend on the registrant’s yearly tonnage, upon intrinsic properties, uses and exposures.
Additionally a Chemical Safety Report (CSR) is required for substances with volumes higher than 10 tonnes per year. It documents the chemical safety assessment. It is mandatory to perform the chemical safety assessment by competent person(s) who have appropriate experience (Annex 1 (0.1)).
Therefore, be on the safe side and use the competence of REACh ChemConsult GmbH for the preparation of registration dossiers and chemical safety reports. Our qualified team prepares the dossiers with a maximum quality control for each endpoint study record for physicochemical and (eco)toxicological information.
For a quotation on our competent registration service please contact us.
2. Registration for Intermediates
A full registration means to provide all necessary data according to the standard data requirements and to prepare the technical dossier (if >10t/y additional Chemical Safety Report) in IUCLID 5 format. No registration is required for non-isolated intermediates provided that the definition of Art. 3 (15) is met.
A minor registration is required for isolated intermediates: e.g. for the registration of key intermediates 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) are met respectively. There are two types of isolated intermediates, on-site isolated and transported isolated intermediates.
Data requirements for the registration of isolated intermediates:
Less data than for a complete registration are required for isolated intermediates. Potential registrants are required to submit, to the ECHA, certain information in IUCLID 5 format such as the companies identity, the detailed identity of the substance, classification, existing information on physicochemical, human health or environmental properties and information on use and risk management measures applied.
Additional information requirements for transported isolated intermediates if > 1000 t/year:
For a transported isolated intermediate in yearly quantities of more than 1000 tonnes per manufacturer or importer the informations of Annex VII on the substance physicochemical and (eco)toxicological properties shall be included for a registration.
Be on the safe side and use the competence of REACh ChemConsult GmbH for the preparation of Registration dossiers for on-site isolated or transported isolated intermediates.
For a quotation on our competent Registration service on isolated intermediates please contact us.