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.

Pb metal and ECHA’s 11th recommendation

Following a proposal by the Swedish Chemicals Agency, Pb metal was included in the ECHA Candidate List of substances of very high concern (SVHC) for Authorisation on 27 June 2018. In consequence, the Consortium published an updated set of Frequently Asked Questions addressing the implications of Candidate Listing.

In April 2023, ECHA included Pb metal in its 11th Recommendation for Authorisation, following a Member State Committee Opinion adopted by consensus. Two Member State representatives abstained from voting, as noted in the ECHA MSC-81 meeting minutes. ILA was active during the ECHA MSC process, submitting comments on behalf of the Consortium in both the ECHA consultation and European Commission call for information, coordinating the input and responses of downstream users and other sectors reliant on Pb metal, and intervening in MSC meetings as the invited expert of the metals industry accredited stakeholder, Eurometaux.

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. The Consortium’s secretariat then met with the European Commission’s REACH Unit within DG DROW to discuss the Commission’s thinking in respect of Pb metal and REACH Authorisation Listing. For more information, please contact us.

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 actively 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.

The Consortium has 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 which showcases 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 is also funding a pilot advocacy campaign in France supported by an external public affairs partner.

The Consortium’s advocacy and communications work continues in partnership with relevant downstream user organisations for Pb metal and Pb compounds, including EUROBAT.

Previous ECHA recommendations

Four lead compounds – lead oxide, lead tetroxide, pentalead tetraoxide sulphate and tetralead trioxide sulphate – were included in ECHA’s 7th Recommendation for Authorisation. The Consortium response to the related public consultation and in debates by Member States, addressed four key concerns: prioritisation, scope of authorisation, transitional arrangements, and uses exempted from Authorisation.

Another six Lead REACH Consortium compounds were included in ECHA’s 9th Recommendation for Authorisation. During the public consultation, the Consortium facilitated registration dossier updates to clarify tonnages and EU uses, and responded to the public consultation, in particular commenting on the aspect of effectiveness and proportionality.

ECHA’s 11th Recommendation brings Pb metal to the same regulatory status in the REACH Authorisation process as these compounds.

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The Consortium continues to assess the most effective organisational structure for Applications for Authorisation (AfA), and would develop a specific AfA workplan, in the event that its substances are included in Annex XIV to REACH. Subject to approval from the General Assembly, an AfA template would be prepared by the Consortium for use by all members that have paid relevant fees.

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.