Registration

Current activity

The Consortium is committed to maintaing its registration dossiers, submitting updates in line with REACH Article 22 and the Commission Implementing Regulation (EU) 2020/1435.

Lead Registration dossier updates, including updates to the CSR Part B, were most recently submitted for the Lead REACH Consortium’s Pb compounds with active registrations in H1 2020.

These updates were made to:

• incorporate the results of the Consortium’s latest employee blood lead survey, covering the period 2015-2018,
• include the Consortium’s new chronic environmental toxicity study (OECD 243),
• update the mutagenicity section of the CSR with new information, and
• continue to make dossier quality improvements in light of the Consortium’s MISA commitments.

The M-factors for Pb metal powder have also been updated in light of its harmonised environmental classification (15th ATP to CLP), and the Pb metal Lead Registration dossier was updated in H1 2021 to revise key aspects of the Consortium’s environmental effects database.

If you are a co-registrant, please refer to Eurometaux’s 11-point checklist whenever the LR dossier is updated, and consider whether your own registration dossier needs to be updated. Please contact the Consortium manager if you have additional questions.

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.

In October 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 is 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. In the first instance, the Consortium reviewed its read-across rationale document for human health and environmental endpoints, and continues to improve dossier quality and consistency, where required, for lead metal and lead compounds. As part of its MISA commitment, the Lead REACH Consortium is also actively engaged in a project to refine the substance identity profiles (SIPs) for its UVCBs, a project that will continue during 2021. Further relevant actions will be defined under the MISA rolling action plan devised with Eurometaux.

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.