REACH authorisation – recent developments
REACH never stands still – a new decision here, a final opinion or recommendation there – the impact of every change to the regulation must be carefully considered and, if needed, managed. Substances of Very High Concern are regularly recommended for inclusion to Annex XIV of REACH (Regulation (EC) No 1907/2006) and, if included, become subject to authorisation. Authorisation can lead to substantial new technical and commercial risks for businesses that must be actively managed.
Authorisation is a REACH process that aims to manage the risks associated with use of hazardous substances by driving their replacement with safer alternatives. Substances that are subject to authorisation must not be used after their ‘sunset date’, or placed on the market for a use, unless that use has been authorised or an exemption applies. Annex XIV of REACH contains the list of substances that are subject to authorisation. This list is updated every 2 years or so.
Some Annex XIV substances have limited use or can be readily replaced, but this isn’t always the case - the inclusion of chromium trioxide on Annex XIV in 2013 resulted in major changes across companies and sectors that are still playing out. The use of very small quantities of Annex XIV substances in niche uses or formulations can be far more difficult to unearth and just as costly to resolve. Businesses need to understand and act where they or others in their supply chain rely on substances on Annex XIV to avoid business interruption.
On 2 February 2022, the European Chemicals Agency (ECHA) launched a public consultation on its proposals to include eight more substances to Annex XIV of EU REACH, including lead metal. The European Commission has opened a call for information in parallel on the possible economic, social, health and environmental impacts (costs and benefits) of the proposals. The eight substances are as follows:
The consultation and call for information run until 2nd May 2022, after which ECHA will finalise its recommendation in Spring 2023, following an opinion from the Member State Committee. The European Commission will ultimately decide which of the substances will be included in Annex XIV with corresponding conditions.
Meanwhile, in Great Britain, the Health & Safety Executive (HSE) has proposed that two substances be added to Annex XIV of UK REACH:
The impact of authorisation can be very significant to companies and supply chains, from breaching the regulation to unplanned obsolescence. We explore the consequences of this further in our articles on lead metal and on lead solder as examples.
TSG Consulting can help
Led by Sue Bullock and TSG Consulting’s experienced REACH consultants, our industry and regulatory experts can support you through the public consultation process and beyond. We can help you:
- Understand how and when you might be impacted by the proposed changes to include these ten substances on the EU and UK REACH Authorisation Lists
- Bring into focus the health, social and economic consequences of the proposed inclusion for your products
- Map concerns through your supply chain, from supplier to customer
- Work with you to assess potential options and identify the preferred strategy, based on available regulatory, technical and commercial considerations
- Track and keep you up-to-date on regulatory developments
- Ensure your business risks are minimized in the event of authorisation listing
If you’d like to have an informal chat with our team, please get in touch at [email protected]