Authorisation

Current activity

The Lead REACH Consortium has an extensive workplan relating to Authorisation. The Consortium is also an active participant in the work of the Eurometaux Risk Management Taskforce and is a member of the Cross-Industry Initiative for better regulation in chemicals management and of ASMoR, the Alliance for Sustainable Management of Chemical Risk.

Pb metal

Lead metal is not included in REACH Annex XIV, the Authorisation List.

The European Commission stated in 2024 that it does not intend to ban the use of lead or include it the REACH Authorisation List. Prior to this development, in view of the 11th Recommendation of the European Chemicals Agency, ILA and the Pb REACH Consortium published an Open Statement, co-signed by more than 40 organisations representing downstream users of lead, warning of severe consequences for a broad range of strategically important European industries and applications.

Pb compounds

A number of the Consortium’s Pb compounds have been recommended by the European Chemicals Agency for Authorisation but have not been included in REACH Annex XIV.

There is no current indication that the European Commission will seek to include the Consortium’s Pb compounds in the REACH Authorisation List.

Advocacy and Communications

ILA and the Pb REACH Consortium are fully committed to coordinating and delivering a comprehensive advocacy and communications campaign on Pb substances. The Consortium continues to defend against the use of REACH Authorisation to further regulate Pb substances, on the grounds of a lack of effectiveness and proportionality, and in light of the extensive existing framework of specific EU legislation designed to manage risk. It also engages with downstream user sectors, communicating the regulatory situation and highlighting the Commission statement.

The Consortium established a Pb Metal Advocacy and Communications Taskforce designed to provide support to downstream users and other sectors reliant on lead. Lead Matters, a collaborative campaign website showcasing the essentiality of lead, was launched in October 2020. Developed by the Pb REACH Consortium, this a voluntary initiative supports over 40 sectors in highlighting the vital, safe and sustainable use of lead in their industries. The Consortium also funded a pilot advocacy campaign in France supported by an external public affairs partner, and has contributed to the ongoing ILA-CBI EU advocacy campaign.

For more information, please contact us.

What is Authorisation?

Authorisation is one of two key REACH mechanisms designed to address chemicals of concern. It aims to identify and manage the risks from “substances of very high concern (SVHCs)”, substances which:

• meet the criteria for classification as carcinogens, mutagens, reproductive toxicants, or
• are persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) in accordance with the criteria of Annex XIII to REACH, or
• pose an equivalent level of concern to human health or the environment.

Where a substance is identified as an SVHC it is included in the Candidate List for eventual inclusion in Annex XIV to REACH, commonly known as the Authorisation List.

Authorisation seeks to ensure that SVHCs are progressively replaced with safer alternatives where feasible. Once a substance is added to Annex XIV a sunset date will apply, after which it cannot be used or placed on the EU market without Authorisation unless an exemption applies.

Companies wishing to continue to use, import or supply a substance included in Annex XIV will need to make an Application for Authorisation (AfA), demonstrating either that the risks are adequately controlled or that the socio-economic benefits of continued use outweigh the risk. Applicants must also analyse whether there are safer suitable alternative substances or technologies and prepare substitution plans, or provide information on appropriate activities to research and develop such alternatives.

An Application for Authorisation can be made individually or collectively by a group of applicants. An AfA is much more comprehensive than a REACH Registration dossier, but some aspects will again require companies to have legitimate access to Consortium data. The AfA dossier will normally contain:

1. Application summary
2. Substance identity
3. Applicant information
4. Uses for which the AfA is made
5. Chemical Safety Report
6. Socio-economic analysis (optional, but recommended)
7. Analysis of alternatives (optional, but recommended)
8. Substitution plan (optional, but recommended where alternatives exist)

Subject to a review period, authorisation is granted by the European Commission, with input from Member States and ECHA. The Commission may amend or withdraw any authorisation on review if suitable substitutes become available.

Find out more about Authorisation.