Lead Added to EU REACH Candidate List of SVHCs

By Nicolas Robin, IPC Senior Director, Europe. 

Key Summary

• ECHA added lead metal to the EU REACH Candidate List due to its reprotoxic properties.
• Suppliers must inform customers when articles contain more than 0.1% lead by weight, applied per article in complex objects.
• Importers and producers must notify ECHA within 6 months of listing and provide updated safety data sheets.
• Lead may move toward Authorization as early as 2021, potentially requiring permission for continued use by 2024.
• IPC will advocate to prevent Authorization or seek exemptions while supporting R&D for lead-free alternatives.

The European Chemicals Agency (ECHA) added lead metal to its Candidate List of Substances of Very High Concern (SVHCs) on 27 June 2018, owing to its properties as a reprotoxic substance. What does Candidate Listing mean for IPC Members? Companies may have legal obligations resulting from the inclusion of lead metal in the Candidate List. Candidate Listing means that EU suppliers of articles containing more than 0.1% by weight of lead - including lead-based batteries, architectural lead sheet, engineered lead products, and those manufactured with lead-containing alloys - must provide information to the recipients which allows for safe use. Note that in the case of complex objects (i.e., objects made up of more than one article joined or assembled together), the 0.1% threshold applies to each article. As a minimum, the information provided by the article supplier must contain the name of the substance, if present above the 0.1% threshold. The information must be provided in writing and free of charge. There is also a requirement to notify ECHA. This notification must be submitted by the importer/producer no later than 6 months after the substance was included in the Candidate List. EU and EEA suppliers of substances on the Candidate List must provide their customers with a safety data sheet (SDS), including relevant exposure scenarios where applicable. Lead producers should already be doing so, but an update is recommended to notify their customers of the inclusion of lead metal in the Candidate List as a Substance of Very High Concern. The obligation to provide an SDS also applies to mixtures including solders and (pre-fabricated) alloys; however, if the mixture does not meet the criteria for classification as hazardous under CLP, the SDS needs only to be provided at the recipient’s request.

What are the next steps? The next regulatory step after Candidate Listing is the inclusion of the substances on the so-called Authorization List. Once included on the Authorization List, companies wishing to use the substance will have to apply for application-specific permissions from ECHA.

1. 2019: With lead metal included on the Candidate List in June 2018, it could be included in ECHA’s prioritization exercise in 2019, with a formal recommendation likely to be submitted by ECHA to the European Commission the same year.
2. 2021: If the REACH Committee of Member State representatives agrees to include lead metal in Annex XIV, the Authorization List, the substance could be added as early as 2021; a transitional period would apply, potentially giving rise to a ‘sunset date’ (after which REACH Authorization would be required to use lead metal, unless exemption applied) in 2024.
3. Before 2024: Companies applying for authorization to use lead metal in the EU would need to submit their application at least 18 months before the sunset date to prevent supply chain disruption. Authorization would only be granted if the risks to human health or the environment from the use of metallic lead on its own or in a mixture above the relevant concentration threshold are proven to be adequately controlled or, in the case where adequate control cannot be demonstrated, that the financial benefits of continued use outweigh the societal costs of the health and/or environmental impacts and that there are no suitable alternative substances or technologies for the use.

What can IPC and its members do? IPC will be engaged in an advocacy campaign in partnership with a Eurometaux/ILA cross-commodity platform. The goal of this campaign will be to stop the inclusion of lead in the authorization list, or if not possible, to advocate for exemptions.

Engage with the lead cross-commodity platform (September 2018-2019):

• Map out the use of lead across the industry and assess where the risk areas and potential adverse effects are and in which applications substitutions to lead are possible.
• If lead metal were to be prioritized for Authorization, a 90-day public consultation will be opened to gather views on transition periods, case studies, and examples highlighting where REACH Authorization would lead to regulatory overlap or inconsistency. Data will need to be collected from IPC membership to develop a socio-economic analysis.

Focus efforts on R&D funding for substitution: Both ECHA and the European Commission are very keen on fostering R&D efforts on substitution, for which the EU offers a specific budget line. IPC will assess the possibility of getting funding opportunities for research on lead-free electronics and has already initiated preliminary contacts with the European Commission service in charge of R&D. If you have any questions or comments, please contact me at NicolasRobin@IPC.org.