EU REACH authorisation
As substances of very high concern (SVHC) are added to Annex XIV of REACH (Regulation (EC) No 1907/2006), companies need to decide whether to seek authorisation from the European Commission.
Once an SVHC is added to Annex XIV, otherwise known as the authorisation list, it is assigned a ‘sunset date’ after which its use will be illegal, unless an authorisation is granted for a definite period of time.
Companies manufacturing, importing or using chemical substances included in Annex XIV will need to decide how to proceed. Is it best to apply for authorisation or choose another route? What are the advantages of applying alone or with others in a joint application? Are there other appropriate risk management options?
The authorisation procedure is complex and TSG can provide strategic advice to help you evaluate the options available and decide the best way forward. Should you decide to proceed with authorisation, our experienced regulatory consultants can guide you through this challenging process.
Addressing the challenges of REACH authorisation
- Viable alternatives – TSG can identify those technically viable alternatives to the SVHC on the market (if any), crucial for a successful analysis of alternatives
- Application strategy – we can help you understand which actor in your supply chain can submit an application to ensure the best chances of success, as well as coverage for downstream users
- Sufficient data in the application dossier – TSG will ensure that ECHA is provided with sufficient information to make sure that the benefits of continued use of the substance outweigh the risks. We can assist with the required Chemical Safety Report, Socio-Economic Analysis and Analysis of Alternatives
- Time – typically, companies have 18 to 24 months to create and submit an authorisation application. TSG will guide you through the timeline so that key milestones are met. Our proven data collection techniques can improve the quality of data generated and accelerate timescales
- Engagement from stakeholders – the authorisation process typically requires information from suppliers and customers. With no legal obligation to provide this data, it can be difficult and time consuming to get what is needed. TSG can engage your supply chain to support you in this critical step
TSG – REACH authorisation consultants
We can support you in all aspects of your REACH authorisation strategy and REACH compliance.