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

EU Adopts New Regulation to eliminate 500M Tonnes of Greenhouse Gas Emissions

On 29 January, the EU Council announced that they have adopted a new legislation aimed at phasing down the emissions of highly potent greenhouse gases including fluorinated gases (F-gases) and ozone depleting substances (ODSs). This will result in the elimination of 500 million tonnes of CO2-equivalent emissions by 2050. The new rules will enter into force 20 days after publication…

adminJanuary 31, 2024

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

EU Harmonised Classification and Labelling update

The EC have adopted updated Harmonised classification and labelling – adding 28 and revising 24 entries under EU CLP. The scientific assessment for these substances was done in collaboration between ECHA, its Committee for Risk Assessment and Member State authorities for decision-making at the Commission. This impacts, Chemicals labelling, packaging, SDS and potentially triggers actions under EU CMR (Carcinogen, Mutagen,…

adminJanuary 31, 2024

FDA updates Regulatory Affairs Newsletter FDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 22 Jan)

Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) Page Summary: On January 26, 2024, the FDA held the second in a series of medical device sterilization town halls to: Describe the FDA’s early actions to help assure sterilization capacity in the U.S. and recent activities to reduce overall EtO reliance while maintaining…

adminJanuary 31, 2024

UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

DEFRA Resources and Waste Newsletter (WC 22 Jan)

Please note this is an extract of the original bulletin. EPR Scheme Administrator steering group We are pleased to confirm the full membership of the packaging EPR Scheme Administrator Steering Group.

adminJanuary 31, 2024

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

ECHA calls for evidence for proposal to ban UV-328

UV stabilisers commonly found in plastics are: UV-328 (EC: 247-384-8; CAS: 25973-55-1), UV-327 (EC: 223-383-8; CAS: 3864-99-1), UV-350 (EC: 253-037-1; CAS: 36437-37-3), UV-320 (EC: 223-346-6; CAS: 3846-71-7) ) After its inclusion into Annex A to the Stockholm Convention, ECHA opened a call for comments and evidence for UV-328. This consultation closed on 18 August 2023. ECHA published its screening report…

adminJanuary 31, 2024

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

EU Harmonised Classification and Labelling for Silver

Ahead of this week’s meetings of the REACH and CLP Competent Authorities (CARACAL) 24-26 January, the European Commission made available its draft delegated act on the proposed Silver metal classification. The key elements for us from this proposal on Silver metal are summarized as follows: Silver massive: Repro. 2 Silver powder: Repro. 2 Silver nano: Repro. 2 This is a…

adminJanuary 31, 2024

European Commission Updates Regulatory Affairs Newsletter European Commission Updates Regulatory Affairs Newsletter Archive

European Commission publishes a proposal amending the EU MDR and EU IVDR

A proposal for amending Regulations (EU) 2017/745 (EU MDR) and (EU) 2017/746 (EU IVDR) has been published by the European Commission (EC) on 23 January. The European Commission propose a gradual roll-out of the European database on medical devices (EUDAMED), obligations in case of supply interruption, and transitional provisions for certain in vitro diagnostic medical devices (IVDs). This proposal includes:…

adminJanuary 24, 2024

UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

UKRI weekly update (WC 15 Jan)

Please note this is an extract of original bulletin UKRI research and innovation in action Production of plastic packaging alternatives aimed at reducing 10,000 tonnes of single-use plastic coatings can now be scaled up thanks to an Innovate UK Smart Grant. Next generation Xampla and the 2M Group of Companies have been awarded the funds, to support scaled up manufacturing…

adminJanuary 24, 2024

UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 15 Jan)

Please note this is an extract of the original bulletin. Notify the MHRA about a clinical investigation for a medical device Page summary: How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Added template for submitting Quarterly Summary Reports. Medical devices: UK approved bodies Page summary: UK approved bodies listed…

adminJanuary 24, 2024

UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 15 Jan)

Please note this is an extract of the original bulletin. Code on Genetic Testing and Insurance Page summary: The agreement between the government and the Association of British Insurers (ABI) on the use of genetic test results in underwriting insurance policies. Change made: First published. Code on Genetic Testing and Insurance: annual report 2023 Page summary: Annual report on agreement…

adminJanuary 24, 2024