If you wish to manufacture or import a phase-in substance into the EU then the REACh24H Consulting Group can provide you with the following services:
1. Registration Strategy development and SIEF Management Service Package
(i) Registration strategy advice/ Development of REACH registration strategy
(ii) Representation in the related SIEF(s) and/or Consortium
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 and data suitability 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 we 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
(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 and follow-up
(ii) Communication with supply chain actors through RSCC System
Please
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for a quotation for registering your phase-in substance.
