Do you know what Annex XIV of REACH is and how to apply for an authorization?
One of the key mechanisms of the REACH Regulation is Annex XIV, which includes substances that, due to the risks associated with their use, require prior authorisation to continue being used or placed on the market.
These restrictions not only aim to protect human health and the environment, but also promote the substitution of hazardous substances with safer and more sustainable alternatives.
Which substances are included in Annex XIV?
Annex XIV, also known as the Authorisation List, contains certain Substances of Very High Concern (SVHCs) that were previously included in the Candidate List.
ECHA periodically reviews the Candidate List to identify substances that should be prioritised for inclusion in Annex XIV, based on criteria such as:
- Their intrinsic hazardous properties
- Their widespread use, which makes them difficult to control
- The large volumes in which they are placed on the market or used
Once a substance is included in Annex XIV, it may no longer be used or placed on the market without an explicit authorisation granted by the European Commission.
My company uses a substance subject to authorisation – what should I do?
If your company wants to continue using a substance listed in Annex XIV, it must obtain an authorisation for that specific use.
Since this is a lengthy and costly process, it’s essential to define a suitable strategy before starting the application work:
- Verify whether the use is exempt from authorisation
- Assess the availability of safer alternatives
- Evaluate the strategic importance of the substance for your company or supply chain
What if I don’t have an authorisation?
Using an Annex XIV substance without an authorisation can lead to penalties, trade restrictions, and even withdrawal of products from the market.
When must an authorisation be requested?
Each substance included in Annex XIV is assigned two key dates:
- The sunset date: after this date, the substance may no longer be used or placed on the market, unless an authorisation has been granted
- The latest application date: if the company submits its authorisation request before this date, it may continue using the substance temporarily, even beyond the sunset date, while the application is being evaluated
If the application is submitted after the latest application date, the company must stop using the substance once the sunset date is reached, and may only resume its use if the authorisation is granted.
What information must an authorisation application include?
The applicant company must submit a dossier that contains:
- A description of the use for which the authorisation is being requested
- A Chemical Safety Report (CSR) demonstrating adequate control of risks during use
- An analysis of alternatives, both technical and economic
- If suitable alternatives exist, a substitution plan detailing the actions, timelines, and conditions for replacement
- A socio-economic analysis, showing that the benefits of continued use outweigh the risks and the potential impact of a refusal
At ServiREACH we support you throughout the process:
- We identify whether the substances you are using are affected by Annex XIV (or could be in the near future)
- We assess the viability and safety of potential alternatives
- We prepare all necessary documentation to successfully apply for an authorisation