HELSINKI – The European Chemicals Agency has added lead to its candidate list, following the SVHC identification process with the involvement of the Member State Committee.

Companies may have legal obligations resulting from the inclusion of lead in the candidate list. 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 recipients that allows for safe use.

In addition, importers and producers of products containing lead have six months from the date of its inclusion in the candidate list (June 27) to notify ECHA.
Eight other substances were added, including TMA and DCHP, having been identified as SVHCs by the European Commission due to their respiratory sensitizing properties and toxic for reproduction and endocrine-disrupting properties, respectively.

The commission’s decision follows the referral of the MSC opinions on these SVHC proposals in 2016.

Substances included in the candidate list for authorization June 27, 2018, include lead, Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5), Dodecamethylcyclohexasiloxane (D6), Disodium octaborate, Benzo[ghi]perylene, Terphenyl hydrogenated, Ethylenediamine (EDA), Benzene-1,2,4-tricarboxylic acid 1,2 anhydride (trimellitic anhydride) (TMA), and Dicyclohexyl phthalate (DCHP).  

The candidate list includes substances that may have serious effects on human health or the environment. Substances on the candidate list are known as substances of very high concern and are candidates for eventual inclusion in the authorization list. Once on the authorization list, industry will need to apply for permission to continue using the substance after the sunset date, which will be as soon as 2024.

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 relevant, says IPC. 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 an SVHC.

The obligation to provide an SDS also applies to mixtures including solders and (pre-fabricated) alloys, says IPC. 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.

Once included on the authorization list, companies wishing to use the substance will have to apply for application-specific permissions from ECHA.

With lead metal included on the candidate list, 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, according to IPC.

“For the time being, we don’t know what will happen,” said Nicolas Robin, IPC’s Europe senior director. ECHA will look at volume and use.

It doesn’t mean lead it will be automatically on the prioritization list, but we “expect it to be,” Robin added. “If the commission prioritizes lead, it will happen next summer. Then REACH Committee of Member State representatives will assess to see if it will be fully put on the list as early as 2021. A transitional period would apply, potentially giving rise to a ‘sunset date’ in 2024. If something happens, it will be 2021. If it happens, then [companies] will look for exemption.”

He stressed, “It is a long process.”

The European Union is focused on “a non-toxic environment and circular economy. They want to recycle and reuse more materials.”

They look at chemicals and waste and are interested in what’s “safe for consumers. There is a big push in Europe to look at what substances are in the public.

There is a push for substitutions,” which pushes companies to innovate, and “America has to comply.”

As of now, IPC’s broad membership must look at which applications use lead. “It’s very difficult,” and “It is just the beginning. A lot will happen before the end of the process. It’s not like deadline is happening now. A lot of things can happen with exemptions, and the EU may not work on lead first.”

But the “industry has to be organized ahead of time.” If lead metal were to be prioritized for Authorization, a 90-days public consultation will be opened, probably in Summer 2019.

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 is 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.

Now that lead metal is candidate listed, ECHA could recommend its inclusion in REACH Annex XIV as early as late 2019, according to IPC. If member states and
the European Commission agree, REACH Annex XIV would be amended.

The candidate list of SVHCs for possible inclusion in the authorization list now contains 191 substances.

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