MedTech Europe Updates Environmental Newsletter

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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…

TeheljJune 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.

TeheljMay 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.

TeheljMay 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…

TeheljMay 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.…

AshleighMay 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…

AshleighApril 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…

AshleighApril 28, 2023

Derogations proposed for D4/D5/D6

The restriction proposal for D4/D5/D6 is expected to be discussed within REACH Committees in June 2023. ECHA has proposed derogations for medical technologies, including for certain uses or increased allowable concentrations: Dental impression materials Medical devices for scar and wound management, and stoma care More information can be found on the Silicones Europe website. This information was kindly provided…

AshleighApril 28, 2023

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Request for information on labelling

There is work ongoing within MedTech Europe on labelling of medical devices. To support in this work, MedTech Europe have requested the following information from industry by 28 April. Data on financial impact of additional labelling requirements arising from any jurisdiction. Costs of label development/production per major jurisdiction are welcome (e.g. to prepare a specific label for certain region/country; percentage of…

AshleighApril 21, 2023

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Joint industry statement on the PPWR Single Market Legal Basis

The joint industry statement on the PPWR Single Market Legal Basis has now been made public. This urges co-legislators to preserve the internal market legal basis for the Packaging and Packaging Waste Regulation as the best way to achieve proposed environmental and economic objectives. The document is planned to be circulated amongst various key stakeholders, including the European Commission. …

AshleighApril 21, 2023