Please see below update from MedTech Europe on the harmonised Classification and labelling of Lead. If you use Lead metal or Lead powder or associated substances please find the below information that applies to products placed on the EU and NI markets.
We would like to share a recent communication from the Lead manufacturers (International Lead Association), which aims to support the value chain using lead metal to comply with its 2024 CLH classification.
Background:
The 21st Adaptation to Technical Progress (ATP) of the EU CLP includes an environmental classification for Pb metal, with 2 entries:
- Pb powder (particle diameter < 1mm): Aquatic Acute 1, M-factor 10 and Aquatic Chronic 1, M-factor 100
- Pb massive (particle diameter ≥1 mm): Aquatic Chronic 1, M-factor 10
The 21st ATP was published in the EU Official Journal on 05.01.2024 (EU 2024/197), entered into force on 25.01.2024 and has a transitional period of 18 months for mandatory application in all EU Member States. This transitional period ends on 01.09.2025 which means that, from that date, all manufacturers, importers and downstream users of Pb metal in the EU must classify Pb metal in accordance with the entries included in Annex VI to the EU CLP (Index No 082-013-00-1 for Pb powder and 082-014-00-7 for Pb massive). The classification applies to Pb metal as a substance but also as a constituent of Complex Inorganic Materials (CIM), which include alloys for example but also More than One Constituent Substances (MOCS2) such as UVCBs.
Value Chain Support:
In order to support the entire value chain – from producers, to users of lead – in complying with this classification, and to ensure consistency in application, the ILA together with its partners Eurometaux and ARCHE have prepared the following information that was shared with us. We are now sending this to MedTech Europe members who may be impacted, in case this information and tools may be of help to you.
We would like to note that this is a different regulatory path for lead than the potential REACH Authorisation listing of lead MedTech Europe has engaged on in the last few years. The potential inclusion of lead in the Authorisation list is delayed for more than a year. However, as previously communicated to members, it was indicated at political level of the Commission, that a REACH Authorisation of Lead is not likely. We are still monitoring closely in case this were to change.
Below is the information that was shared with us:.
In addition to direct impacts, classification under CLP may have downstream consequences under waste, transport and Seveso regimes. Eurometaux, working with ARCHE and a multi-metallic working group including ILA, has prepared the Guidance Note to support companies producing, using and recycling complex inorganic materials (CIMs) such as alloys, mixtures, or UVCBs containing Pb. It complements and refers to notes previously prepared by ILA, WV Metalle, IZA and others which anticipated the complexities of the Pb metal environmental classification.
Supporting the Guidance Note is a user-friendly Excel tool prepared by ARCHE for ADR/RID (Transport) classification. As explained in the note, self-classification under ADR/RID depends on the availability of data. Depending on whether Transformation/Dissolution protocol (T/Dp) data is available or not to the consignor, the note outlines two scenarios: a testing approach (when data on the transported materials is available) and a non-testing approach (where T/Dp data is not available). As the latter requires quite some calculations, ARCHE has designed the Excel tool to help companies when making their decisions under ADR/RID.
In time, the tool and the approach will be included in MeClas and also in the practical guide (toolkit) that will accompany a updated MERAG classification fact sheet (an ARCHE/ICMM/Eurometaux project).
In case members have questions or feedback we should provide to the ILA, please let us know.
