MedTech Europe Updates Environmental Newsletter Archive – Page 7

European Chemicals Agency Updates Environmental Newsletter European Chemicals Agency Updates Environmental Newsletter Archive European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

Potential inclusion of Lead in REACH Annex XIV

The EU have proposed to add Lead to the EU REACH Annex XIV Substances subject to authorization. Background: In 2022, ECHA launched a public consultation on whether Lead should be included in the REACH Authorisation list. MedTech Europe submitted its feedback advising against such a listing, mainly because most of the uses are already covered under RoHS (exemptions) and the…

adminJanuary 24, 2024

Update on EU RoHS Pack 27 questionnaire consultations

MedTech Europe recently sent a letter to the Commission and the Consultant BIOIS on the RoHS Pack 27 Annex III lead exemption consultations (launched by the Consultant in Q4 2023). DG Environment responded to MTE’s arguments and noted that “Electrical and electronic equipment (EEE) under category 8 ‘medical devices’ is often not comparable with EEE from other categories. As you…

adminJanuary 9, 2024

ECHA recommendation report on PVC and its additives

MedTech Europe are collecting feedback on ECHA’s report advising the Commission that regulatory action is needed at EU level on PVC and its additives and responding to this EC proposal. The Annexes to the report are available at here. BIVDA members are invited to review the report and share with us your findings. The MedTech Europe Secretariat have reviewed the…

adminDecember 15, 2023

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ECHA calls for evidence for UV-328 – deadline 18 August

After its inclusion into Annex A to the Stockholm Convention, ECHA has opened a call for comments and evidence for UV-328. This call will remain open until 18 August. This call aims to ‘gather comments on the draft screening report prepared according to REACH Article 69(2)’, and to gather information on the following points: Uses of the four phenolic benzotriazoles…

adminJune 2, 2023

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Inclusion of Dechlorane Plus in Annex A to the Stockholm Convention

Following the proposal in September 2022, Dechlorane Plus has been included in Annex A (Elimination) to the Stockholm Convention on 15 May. This Annex requests Parties to ‘take measures to eliminate the production and use of the chemicals listed’. In the UK, this falls under the POPs legislation. This information is kindly provided by MedTech Europe.

adminMay 19, 2023

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Outcome of consultation on RoHS exemption for the use of lead in PVC

Following a consultation on a new RoHS exemption for the use of lead in PVC used as a base material in sensors for IVDs (category 8), the European Commission has adopted its decision, which is for the exemption to expire on 31 December 2023. BIVDA members did not provide feedback on this topic. This information is kindly provided by MedTech Europe.

adminMay 19, 2023

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Request: Feedback on Glutaral

MedTech Europe are requesting feedback on Glutaral and associated information. If your organisation uses this substance, we would appreciate your feedback on: The intermediate use definition stated in REACH in relation to Glutaral, and whether is it an appropriate definition What impact would result from the use of Glutaral as a cross-linker or auxiliary in the manufacturing process Members are…

adminMay 19, 2023

Safe and Sustainable by Design (SSbD) framework testing phase – deadline 30 June

The EU Framework for Safe and Sustainable by Design is aimed at those researching and manufacturing chemicals and materials. The first reporting period of the Safe and Sustainable by Design (SSbD) framework testing phase is open until 30 June 2023. If applicable, members are invited to fill in the reporting template, which can be found and submitted via this link.…

adminMay 12, 2023

Feedback request 10 May: RoHS mercury lamps

MedTech Europe have previously requested information on mercury lamps used in the medical device and IVD sectors. It was noted previously that under RoHS exemption 1(f)-II and 2(b)4-I for neonatal jaundice treatment, we have no uses of mercury lamps in these exemptions. Further information has been requested by LightingEurope as to the reason for this, primarily whether this is due…

adminApril 28, 2023

Amendment made to EU CLP Regulation

The European Commission adopted an amendment to the CLP Regulation on 25 April. These additions can be summarised as follows: A ‘Note X’ has been added to Part 1, section 1.1.3.1 of Annex VI, which indicates that: ‘The classification of hazard class(es) in this entry is based only on the hazardous properties of the part of the substance which is…

adminApril 28, 2023