EU REACH
We provide complex services to ensure your compliance with the REACH Regulation (EC 1907/2006). From Registration to Authorization.
Registration
We will prepare a registration dossier for your substances according to Regulation EC no. 1907/2006 REACH. From registration strategy to submission of the dossier to ECHA. Simply and comprehensively.
REACH is the EU Regulation for Registration, Evaluation, Authorisation, and Restriction of Chemicals, based on the principle that substances as such or in mixtures and certain cases in articles may not be manufactured or marketed in the EU if they are not registered (No data, No market).
Under registration duties, EU manufacturers and importers are obliged to inquire ECHA whether the registration has already been made for that substance and prepare and submit the Registration Dossier to ECHA via REACH-IT (for each substance manufactured or imported in quantities equal to or greater than 1 ton per year). Following successful registration and getting a registration number from ECHA, the Registration Dossier must be kept up to date for any change and, in some cases, updated without undue delay!
The complexity of the Registration Dossier will depend on the tonnage of the substance placed on the EU market per year as well as on the substance intrinsic properties, while the preparing of registration dossier may include data compilation by literature search, LoA purchase, generation of new data by substance testing, or using alternative methods such as in vitro or in chemical methods, grouping or read-across of properties from another substance.
If you plan to register a substance in a tonnage band equal to or higher than 10 tonnes per year, a Chemical Safety Report must be included in the registration dossier, and the relevant exposure scenario(s) communicated to downstream users via the extended safety data sheets.
REACH has a very wide scope and applies to all chemical substances – not only those used in industrial processes but also in our daily lives. Therefore, the regulation has an impact on most companies across the EU, but not every company will have registration duties. It is necessary to recognize your role under REACH and understand your duties and responsibilities. You will need to consider how you use chemicals and what your obligations may be. In the end – any infringements or failing to comply with the REACH Regulation can lead to serious penalties!
REGARTIS s.r.o. provides a wide range of services for complying with the REACH registration duties.
Whether you need help with:
- Product/portfolio regulatory assessment
- Procurement of chemical analysis or LoA purchase
- Literature search
- Data Gap Analysis
- Inquiry Dossier compilation
- Registration dossier compilation for JSM or LR
- REACH-IT monitoring and management
- SIEF/Consortium monitoring and communication
- Only Representative service
- Registration dossier updates
- Chemical Safety Assessment/Report
- Exposure Scenario(s) generation, their update, and integration into a dossier
- REACH consultation or
- Specific training for your staff
you are at the right place. Our enthusiastic team of experts can support you in all REACH registration procedures and situations, assist with all monitoring, communications, and updates obligations, and finally guide you to your full REACH compliance!
Authorisation of SVHC substances
Several applications for authorizations were prepared by our team and authorization was successfully granted to our clients. We are able to prepare all parts of the application including analysis of alternatives, social-economic analysis, and risk assessment.
Chemical substances properties testing
We have a number of reliable partnerships with laboratories and universities. We can coordinate testing strategy and performance in both GLP and non-GLP environments.
Only Representative
Every non-EU company that supplies chemicals to the EU must appoint Only Representative – a natural person or legal entity established physically in the EU and equipped with sufficient knowledge to comply with REACH regulation. Companies, which are not established in the EU, cannot supply chemicals or articles to the EU unless they appoint Only Representative or their customer in the EU complies with REACH by himself.
The Only Representative takes over the tasks and responsibilities of importers for complying with the REACH regulation and can be appointed by a manufacturer, formulator, or article producer outside the EU.
REGARTIS offers complete Only Representative services, including registration, authorization, SDS management, SVHC management, and any other activities, which our customers need our assistance with.