European Commission 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

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

European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive

European Commission opens a public consultation on hazardous chemicals – deadline 31 July

The European Commission has opened a public consultation on hazardous chemicals and a potential prohibition of production for export of chemicals banned in the EU (regulated under the Prior Informed Consent Regulation), which will run until 31 July 2023. Members are encouraged to participate if they think they will be impacted by this prohibition

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

European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive

European Commission amends ANNEX XVII of REACH regulation

On 3 May, the European Commission adopted a regulation that modifies Annex XVII to the REACH Regulation, specifically with respect to lead and its compounds in PVC. This Commission Regulation aims to limit the use and the placing on the market of Lead in PVC articles. It is added on entry 63, column 2 of Annex XVII. Although, several exceptions…

TeheljMay 12, 2023

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

SCHEER call for information on phthalates in medical devices – deadline 17 July

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has received a request for updating the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical device covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting properties. To ensure all relevant scientific information is available to the Scientific Committee for its assessment,…

AshleighMay 5, 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

European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive European Commission Updates Regulatory Affairs Newsletter European Commission Updates Regulatory Affairs Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive MedTech Europe Updates Regulatory Affairs Newsletter MedTech Europe Updates Regulatory Affairs Newsletter Archive

Public consultation on proposed Ecodesign for Sustainable Products Regulation (ESPR)

There is an ongoing public consultation on priorities under the Ecodesign for Sustainable Products Regulations (ESPR). This consultation is open until 12 May. It is possible that this could affect certain medical devices such as adult incontinence products or substances used in production of medical devices and IVDs. Members are encouraged to review this consultation and provide feedback directly by…

AshleighMarch 17, 2023