1- The identification of constraints
2- The creation of technical dossiers
3- The administrative management of the registration process
4- Necessary update of your files
REACh did not stop on 31 May 2018. A new cycle is taking place with control reinforcement from January 2019, with the aim of accelerating the updates (according to Art. 22 of REACh).
5- Evaluation: follow up and compliance
6- Authorisation – support during the different steps of the process
- maps all the uses and the exposure steps
- helps you in implementing monitoring campaigns
- builds specific scenarios for health and environment
- characterises the exposure and the risks for the uses of the application
- supports you in the communication with the ECHA’s experts of the risk assessment committee
7- With our partners
8- Case studies
EQUITOX was contacted at that time. The requirements were clear: to produce a registration dossier without missing data, that would pass the technical completeness check and was scientifically robust. All of this needed to be done in a short period of time. The strategy we developed was based on the physico-chemical properties of the substance (hydrolysis) and a read-across approach with well-known degradation products. We then completed with a weight-of-evidence using some information from the abandoned sub-acute toxicological study.
We submitted, on-time, a reliable and valid registration dossier.
Indeed, a lot of IT-tools and experimental data are available. However, when making a prediction or an extrapolation, one must go back to the basics: a well-defined endpoint, a robust dataset, an understandable relationship between the data source and the newly generated value/parameter. It takes shape in the assessment of the applicability domain for a QSAR prediction or the adequacy of a database for a read-across (analogy, category approach). Once a reliable value is generated, the second main task is to report it in order to pass the evaluation by Regulatory Bodies. For this purpose, official templates are available meeting the OECD/ECHA principles (QPRF, Read-Across Assessment Framework – RAAF). Thanks to their dual skills (scientific and regulatory), experts from EQUITOX drive the scientific assessment of the data source, the relevance of the prediction/extrapolation and the reporting in a formal way. EQUITOX applies this approach to comply with the REACH registration requirements, especially QSARs for the Annex VII tonnage band (1-10 tons), the read-across justification for any tonnage band. In addition, non-testing methods are used for projects related to the Cosmetics regulation.
The main difficulty in this type of project is to allow two different worlds to work together, the regulatory experts and the on-site operators (usually the HSE department). EQUITOX benefits from its strong experience in both worlds to support the deployment of these projects in industrial plants.
In a project where 7 intermediates were audited, the compliance with the SCC was demonstrated for 4 chemicals. Therefore, EQUITOX prepared the simplified REACH registration dossiers, and provided the Plant Manager with the relevant documentation. This set of proof justifies the regulatory decision in the case of a control by Local Authorities. In the same way, EQUITOX trained and deployed an efficient methodology to comply with the duties related to the e-SDSs for raw materials (prioritisation, ES conformity, DU CSR, exemption…).