The Department of Agriculture, Environment and Rural Affairs (DAERA) Northern Ireland (NI) is preparing to launch a consultation on the draft Fluorinated Greenhouse Gases Regulations (NI) 2025. This is because the EU recently introduced new legislation on F-gases – EU Regulation (EU) 2024/573 on fluorinated greenhouse gases (F-gases) – and as this applies to NI, new laws must be drafted for NI to incorporate the provisions of the new EU Regulation.
The new EU Regulation has implications for companies involved in producing metered dose inhalers. You can find relevant sections in the EU Regulation:
- Article 12(1), (3) and (6) – labelling of products/equipment containing F-gases
- Article 16 – reduction of the quantity of HFCs placed on the market
- Article 18(2) – HFC quota allocations
- Article 19(1), (2), (3) and (6) – products/equipment pre-charged with HFCs
- Article 28(8) – trade controls
You can find out more information on fluorinated greenhouse gases on DAERA’s website here.
The European Medicines Agency (EMA) has published guidance on labelling requirements for metered dose inhalers containing fluorinated greenhouse gases, which can be accessed here.
The consultation is not open yet but if you have any initial concerns or questions, please contact the PAGB regulatory team – regulatory@pagb.co.uk.
