Updates: RoHS exemptions and other chemical files

Please see the below update from MedTech Europe:

We would like to share updates on RoHS exemptions and other files, based on the publicly available minutes that were published Friday 22 November, from the 18 September 2024 RoHS Expert Group.

The Commission Expert Group on RoHS is comprised of the EU Member State authorities responsible for RoHS and the Commission. It is usually a closed door gathering, however, they may on an ad-hoc basis invite external stakeholders, e.g. exemption applicants. The last meeting of this group was held on 18 September and the minutes have now been released (link here). In these minutes, we find some relevant updates and indications of the direction of the pending draft delegated acts, but also other chemical files, namely:

1. RoHS exemptions:
2. 1. Draft delegated directive – lead as an alloying element in steel, aluminium and copper (exemption 6a), extracts from the public minutes:

1. “The impression that can arise that the industry applying for exemptions did not want to come forward with substantial data enabling a deeper scrutiny of the market situation. In view of the supposedly insufficient information, the MS expert asked on which grounds the relevant criteria were met and whether short validity periods and splitting entries can be seen as appropriate measures to incentivize cooperation.”
2. “Another MS expert supported the Commission’s proposal partly on the proposed short validity periods and the reduction of lead as an alloying element in aluminium casting alloys”.

1. 1. Draft delegated directive – lead in high melting temperature solders (exemption 7a), extracts from the public minutes:

1. “In general, it seems that the applicants have problems to come up listing all relevant applications under the scope, which let the size of the scope appear problematic, if the applicant is not even capable to do so. This would be in particular valid for the exemptions 6(c), 7(a) and 7(c) of Annex III to the RoHS Directive. Hence, creating sub-entries and narrowing down the broad scope is welcomed.”
2. “However, renewing the old entry with a broader scope for a short period, leaves room for industry to re-apply and ensure that no application falls outside. The Commission was asked to share intentions and instructions to the industry directly within the draft acts, if possible, so that there is a clear signal to the industry…Creating more specific sub-entries should contribute to achieve a more meaningful technical assessment.” 

1. 1. Draft delegated directive – lead in glass or ceramic components (exemption 7c-I), extracts from the public minutes:

1. “In view of the expert, there is more industry commitment for the exemption 7(c) needed.”
2. “The Commission had several exchanges with the applicant before, during and after the technical assessment under the Pack 27. In view of the Commission, all provided category-specific information were considered but, in the end, no substantiated, specific and reliable information could be provided to support a renewal with a maximum validity period. The applicant was unable to justify a divergent approach for EEE from the category 9 ‘industrial monitoring and control instruments’ (IMCI)”

Finally, the minutes do not indicate a specific timeline as to when the draft delegated acts will be published, however, agenda item 6.2 states “the draft delegated directives discussed today are foreseen as the next ones.” This information is consistent with our previous information that the Pack 22/27 delegated acts with the Annex III 6, 7 series are expected by the end of this year.

1. RoHS revision:
2. • At the time of the meeting, it was indicated that the Council and Parliament need to discuss the targeted amendment to RoHS via the One Substance, One Assessment package and that the Council General Approach was presented à this is (at this stage) no longer new information, as by now the Parliament has begun drafting its report.
   • The draft amendments proposed by the MEP leading this file were sent to members last week and an e-mail with MedTech Europe proposed next steps will circulate in the next days.

 TBBP-A:

• The Commission indicated that there is no progress on restriction efforts under RoHS Directive (the potential inclusion of TBBP-A in the RoHS Annex II, restricted substances list) neither under the REACH Regulation. However,  “there is intention to prepare a  restriction dossier under the REACH Regulation covering aromatic brominated flame retardants, but no decision will be taken under REACH before the end of the year”.
• It is interesting to note that the Commission announced in these minutes that there is an intention for a REACH Restriction of Aromatic Brominated Flame Retardants (ABFR), as the ECHA recommendation on whether such a Restriction is needed is due by 31 December 2024 latest. In this ABFR report, TBBP-A is considered.
• By way of reminder, MedTech Europe participated in the second ECHA call for evidence on the ABFR file and we are waiting for the ECHA report by 31 December to read if ECHA will recommend to the Commission to open a Restriction. If that is the case, the Commission will then need to issue such an official mandate to begin the work on a Restriction dossier (Q1 2025).