If you wish to manufacture or import a non phase-in substance into the EU you must complete non phase-in registration. The REACH24H Consulting Group can assist you with this process.
1. Registration strategy –Inquiry Dossier to ECHA
There are 4 types of Inquiry Dossier:
- Type 1 – Inquiry for non-phase-in substance
- Type 2 - Inquiry for non-phase-in substance legally on the market before June 2008
- Type 3 – Inquiry for phase-in substance that has not been pre-registered
- Type 4 – Inquiry for tonnage band increase
The inquiry dossier is submitted either in REACH-IT directly or as an IUCLID dossier in REACH-IT. If the inquiry dossier submission is successful, you will receive an inquiry number and information on other potential and previous registrants of the same substance as well as details of (robust) study summaries, as appropriate.
2. Technical Dossier Preparation
The next step is preparation of the dataset for the technical dossier in IUCLID5. There are two options:
(i) Previous registrants may have already accumulated the required dataset(s) (for a specific tonnage band), so it is possible to purchase a Letter of Access (LoA) from the data holder(s). The LoA grants permission to use/ refer to a single/set of study (ies) by a data holder.
(ii) If a suitable LoA is not available then it is necessary to perform a comprehensive review of all available data. This review includes:
(a) Data gap analysis: Review of existing data packages to identify data gaps and suitability of data for submission
(b) Suggestions to address data insufficiencies (using publicly available data, scientific waivers, QSARs, read-across).
3. Testing Requirements
If testing is required, then REACH24H can co-ordinate and manage the process through:
(i) Sourcing of GLP-certified laboratories to conduct test studies
(ii) Co-ordination and monitoring of cost-effective test programmes
4. Chemical Safety Assessment (required for >10 tonnes per annum)
(i) Creation of the Chemical Safety Assessments with the related Chemical Safety Reports (CSR)
(ii) Exposure scenario(s) building associated with CSA
(iii) Risk characterisation and Risk Management Measures (RMM) identified
5. Communication with ECHA authorities and throughout the Supply Chain
(i) Registration dossier submission
(ii) Communication with supply chain actors through RSCC System
Please This e-mail address is being protected from spambots. You need JavaScript enabled to view it for a quotation for registering your non-phase in substance.
