Every company that produces a chemical substance in quantities over one ton in the EU or imports it into the EU, is required to register the respective substance under REACH. Here, the general principle is “one substance, one registration”. This means, that all manufacturers and importers of the same substance are asked to submit their registration jointly. The registration may be related to a substance, a substance in a mixture or, in certain cases, to a substance in articles.
If a substance to be registered has not been pre-registered by 31 May 2018 you have a duty to inquire with ECHA whether a registration has already been submitted for your substance. We can advise you on questions about creating an inquiry dossier.
To register a substance, it is necessary to collect and assess information on the properties and uses of the substance. Based on this information, the potential hazards and risks of the substance have to be determined. However, the information requirements may vary to considerable degree depending on the substance to be registered. Although according to REACH regulation generally the information requirements are dependent on the amount produced or imported per year, there are also exceptions for distinct substances that admit a minimization of the information requirements. Upon, request we can check whether these reduced information requirements are also applying on your substance.
This information must be entered into IUCLID 6 Software and submitted to ECHA as a registration dossier (technical dossier). For substances at a tonnage of more than 10 tons per year, a chemical safety report (CSR) is required in addition to the technical dossier. This CSR shall contain detailed information on the physico-chemical, toxicological and ecotoxicological properties of the substance and, in case that the substance is hazardous, an additional estimation of the likely exposure as well as a respective risks characterization.
The REACH regulation also claims data sharing with third parties to reduce registrations fees and to avoid unnecessary animal testing. For this purpose, either Substance Information Exchange Forums (SIEF) or consortia are used. Even after the last deadline for preregistration (31 May 2018) continuance of data sharing and cooperation is claimed as for registration of a new substance an inquiry has to be submitted.
CFCS provided services for its customers in more than 100 registrations under REACH. In many cases, we have prepared the entire set of documents required for registration like the technical dossier and the CSR. If requested, we also take over the entire management of consortia and SIEF co-operations.
You want to join an existing registration? No problem. Upon request, we take over all necessary steps to register your substance as a member of a joint registration. If you want to hide your identity form other competitors, the registration may be performed by CFCS as a “Third Party” on your behalf.
We provide our services according to your specific needs and help you both with single tasks like the creation of entries in IUCLID 6 dossier as well as with the entire process until final registration of a substance.
Through our experience, we ensure that the entire process is transparent, projectable and cost-efficient.
Our services at a glance:
Technical services:
Literature research and review
Data gap analysis
Planning of test strategies, including read-across and QSAR
Evaluation of hazard potential of substances to man and the environment
Classification and labelling according to GHS and CLP
Development of exposure scenarios for exposure assessment
Exposure assessment with various models, such as e.g. Chesar, EasyTRA, ECETOC TRAM, EUSES, ART, ConsExpo, ECPA OWB, MEASE
Qualitative and quantitative risk characterization
Preparation of all documents required for registration, such aus the technicals dossier in IUCLID 6 and the Chemical Safety Report (CSR)
Services for joining an existing registration and – if you wish- performance of all necessary steps up to registration
Communication and Management:
Support for the preparation of an inquiry dossier
Support for the preparation of consortium agreements
Support for data and cost sharing
Organisation and execution of Conference Calls and face-to-face meeting
