Registration

Current activity

The Consortium is committed to maintaining its registration dossiers, submitting updates in line with REACH Article 22 and the Commission Implementing Regulation (EU) 2020/1435. A project is currently underway to review the available aquatic effects and bioaccumulation information on lead, with Lead Registrant dossier updates, including updates to the CSR Part B, anticipated in 1H 2024.

Lead Registrant dossier updates were most recently submitted in 2022 for the Lead REACH Consortium’s Pb compounds with active registrations.

These updates were made to:

• review the lifecycle trees and related exposure scenarios,
• update the blood lead data reported for lead compounds manufacture and key use sectors to the period 2016-2020,
• include publications arising from the Study for Promotion of Health in Recycling Lead (SPHERL) and other recent sources, and
• update the chronic aquatic toxicity information, in particular providing a critical review of chronic toxicity data and study records related to algae and to the snail L. stagnalis, and for key species such as C.dubia.

The Pb metal Lead Registration dossier was most recently updated in H3 2021.

Prior to these most recent LR dossier updates, an extensive review of the available environmental effects data and the PNECs for freshwater, saltwater, sediment, and soil secondary poisoning led to a substantiative update of the Consortium’s datasets and CSRs in 2018.

Also in 2018, the Consortium signed a ‘Framework for Cooperation’ with the European Chemicals Agency (ECHA), signalling its commitment to the Metals and Inorganics Sectorial Approach (MISA). MISA was a voluntary initiative established by ECHA and Eurometaux aiming to further improve the completeness and quality of REACH dossiers and to advance technical and scientific issues related to metal compounds and inorganic substances. Since the MISA initiative formally concluded, the Consortium has been an active sponsor of the Eurometaux Metals Environmental Exposure Data (MEED) programme.

Future work

The Consortium will launch a new worker blood lead survey in 2024 to collect employee blood lead data, for the years 2020 to 2023 inclusive, from manufacturing and key use sectors. Updates to Lead Registrant dossiers will also be scheduled in light of a review of available information on possible endocrine activity of lead.

Co-registrants

If you are a co-registrant, please consider whether your own registration dossier needs to be updated whenever the LR dossier is updated. Please contact the Consortium Manager if you have additional questions.

What is Registration?

REACH Registration is a duty placed on manufacturers and importers of substances at one tonne and above per year per legal entity. In order to register, such companies must have detailed information on the composition of their substance, its uses, and on its hazard properties; the amount of information required on hazards increases with increasing tonnage band (1-10 tpy, 10-100 tpy, 100-1000 tpy, >1000 tpy).

To reduce the testing burden, particularly on vertebrate animals, data sharing is required by REACH. For each substance, a ‘Lead Registrant’ submits shared information on behalf of all ‘co-registrants’ of the same substance; in a minority of cases a registrant may opt out of this joint submission of shared data, provided that this action is justified in accordance with the legislation.

 To facilitate the registration and assessment of risks in supply chain uses, downstream users may provide information to their suppliers.

As a consequence of registration, improved information on hazards and risks and how to manage them is available to registrants which must be passed down their supply chain to downstream and end users.

Find out more about Registration.