You need to register a new substance you have added to your portfolio? EcoMundo’s experts handle the Registration of your substances from A to Z, starting with a detailed Registration budget estimate.
DOSSIER REGISTRATION – LEAD REGISTRANT
Our experts are there to guide you through registering a substance for you as Lead Registrant, in particular to:
- handle the Inquiry procedure with ECHA
- manage the SIEF of the substance and the election as Lead Registrant
- optimise the technical and economic aspects for the test strategy
- complete the Chemical Safety Report (CSR), if necessary
- carry out and submit the Registration dossier (both joint and individual parts) to ECHA
- manage the Letters of Access (LoA) for the new members who join the SIEF and the cost-sharing mechanism
Each SIEF has a Lead Registrant who prepares and submits the ‘joint dossier’ to ECHA. When this ‘joint dossier’ is complete, the other registrants may submit their member dossiers. One of REACH’s prerequisites is that all registrants share all the detailed and reliable scientific information they possess concerning the substance.
If you are the registrant for a currently inactive SIEF and for which the Registration dossier has not been started yet, it can prove very advantageous to take on the role of Lead Registrant, with EcoMundo acting as the SIEF Manager. In this way you have control over the Registration strategy and optimisation of costs.
As the SIEF Manager, EcoMundo manages the Registration dossier from A to Z, organises the cost-sharing and ensures the continuity of the SIEF.
Bonus : Once you are the Lead Registrant for a substance and a new Member Registrant wishes to join, you need to provide them with a Letter of Access. See how our experts take charge of managing this Letter of Access request without any further charge.
REGISTRATION DOSSIER – MEMBER REGISTRANT
Our experts are there to guide you through registering a substance as Member Registrant and, in particular, to:
- assess the Registration budget taking into account the LoA cost
- handle the Inquiry procedure with ECHA
- purchase the LoA from the Lead Registrant or from the Consortium
- complete and submit the Registration dossier to ECHA
We represent your company within the SIEF and/or the existing Consortium and manage the Registration of your substances through to submission to ECHA.
EcoMundo handles the Letters of Access, the equitable split of costs, the exchange of data as well as the preparation of your member dossier in the IUCLID format.
If the joint Registration dossier to which you refer via the LoA does not include the Chemical Safety Report (CSR) or does not cover one or more of your uses, we also prepare the CSR specific to your company to complete your Registration dossier.
MONITORING YOUR TONNAGE BANDS AND ISSUING ALERTS
REACH Registration has a life beyond May 2018! Specifically, when the quantity of one of your chemical substances manufactured in, or imported into, a European country exceeds the 1 tonne/year threshold, you need to register the substance with REACH.
Similarly, when a substance exceeds any of the 10, 100 or 1,000 tonnes/year thresholds, your Registration dossier must be updated, and the change in tonnage band must be declared to the ECHA.
EcoMundo monitors the tonnage of the full portfolio of your substances and warns you when a threshold is about to be exceeded so that the necessary resulting administrative tasks concerning REACH Registration can be handled in time (creation or update of the appropriate dossier).
ONLY REPRESENTATIVE (OR) SERVICE
EcoMundo is, in the eyes of REACH, your Only Representative (OR) and takes responsibility for ensuring compliance with all the legal requirements imposed by REACH.
EcoMundo operates within the European Union and is recognised as an expert establishment dealing with requirements under the REACH umbrella. In this capacity, it is able to fulfil your REACH obligations for the Inquiry and the Registration in order to maintain your market capability, in addition to managing your Registration dossier, whether that be for Lead Registrant or Member Registrant.
Our commitment: : The OR “assumes the responsibilities and is responsible for carrying out the REACH obligations for importing companies concerning the quantities of the substance(s) for which it is nominated, and which are exported into the European Union by manufacturers who are not established in the EU. Other importers of substances manufactured by the same manufacturer become downstream users for the REACH regulations.”