A successful registration starts with a proper substance identification, which ECHA considers to be a key element of the dossier. We will evaluate the analytical data of your substance and, based on the composition and impurities , determine the SIP (Substance Identification Profile) that best fits your substance. We will also check the registration status, possible identified uses and can even do an enquiry with ECHA on your behalf.
2. SIEF communication
Data have to be shared amongst all registrants of the same substance. We will support you in the SIEF communication, advise on strategic issues and perform initial data evaluation including valuation of the studies.
3. Data evaluation
The available data will be evaluated and summarized in IUCLID. We will draw robust conclusions on the EU classification and labelling, PBT status and derive DNELs and PNECs. For endpoints where no data is available, we will assess the possibilities for waiving statements and read across to other substances by use of an integrated approach, trying to avoid testing where possible. Based on our experience we know which arguments work and don’t work, enabling us to prepare an advice that perfectly fits your position.
4. Identified uses and Exposure Scenarios
A complete overview of the identified uses of your substance will be created based on information from your company (e.g. sales department), your customers and open sources. The identified uses will be condensed to comprehensive Exposure Scenarios and presented in a use tree, which is the basis for the compilation of Exposure Scenarios.
5. Exposure assessment
For each of the exposure scenarios, exposure of workers and consumers as well as emission to the environment will be assessed by use of the latest versions of the applicable tools like Chesar, EASY TRA, EUSES, Advanced REACH tool. With our long history in the field of exposure assessment, we build scenarios with a proper justification of safe use and exposure conditions and controls that fit the real conditions from your and your customers companies as much as possible.
6. Chemical Safety Report
As a final step in the risk assessment, the Chemical Safety Report will be prepared, in which all assumptions, calculations and evaluations are described in a comprehensive way.
7. Testing plans
In case data is not available for a certain endpoint, the dossier will be completed by waiving statements, by justifying why a certain study is not necessary, and testing proposals in case a test is needed to draw conclusions. We can provide you with quotations for all possible studies and monitor them on your behalf.
8. (Extended) Safety Data Sheets
We will extract the necessary information for your Safety Data Sheet, since information on the safe use of chemicals will need to be summarized in your SDS, which is extended with Exposure Scenarios in case a substance is classified as hazardous and produced in amounts exceeding 10 tons per year.
9. Dossier completion
We will prepare your technical dossier in IUCLID and make sure that is passes the obligatory completeness check. If you like so, we can also create the company dossier and do the submission on your behalf.
10. Follow up
Once your dossier is submitted and the substance is registered, it may become subject to several evaluation processes or new data may become available. We will take care of the accompanying communication and update the dossier on the requested topics.