EIGA - European Industrial Gases Association

EIGA propose the following areas for the final version of the MDR: We support the creation of expert panels to provide timely guidance in case of divergent interpretation on classification by Notified Bodies and ensure regulatory consistency in interpretation of regulatory requirements.

Dear Members of the Commission, on behalf of EIGA -European Industrial Gases Association, we wish to express our full support for the initiative to revise the MDR Regulation. EIGA is a safety and technically oriented organization representing the vast majority of European and also non-European companies producing and distributing industrial, medical and food gases.

EIGA welcomes the opportunity to provide input on the revision of benchmark values for free allocation under the EU Emissions Trading System (EU ETS). EIGA supports a robust and predictable EU ETS that drives industrial decarbonisation while maintaining competitiveness and preventing carbon leakage.

EIGA welcomes the Commissions commitment to improving the Carbon Border Adjustment Mechanism (CBAM) and the opportunity to provide input. Downstream products A CBAM-related issue arises because hydrogen is a CBAM good, whilst many of its derivatives, and precursors from which hydrogen can be recovered, are not.

The EU achieved a remarkable 13% reduction in electricity-related CO emissions, reaching its lowest level on record in 2024. Furthermore, Europe continues to lead efforts to decarbonize its power sector. This progress is driven by a strong shift toward clean energy, with renewables and nuclear accounting for over 70% of electricity generation.

Grid Costs: The cost of grids for power, natural gas, hydrogen, and CO2 should ultimately be borne by the users of these networks. Effective network planning is essential to prevent excessive, costly investments. Network tariffs and connection charges must be designed in a way that does not compromise consumer competitiveness.

As an energy intensive sector itself, the cost of energy is a major component of the total cost structure of the IG sector - as recognized by the CEEAG. Industrial gases are essential for hard-to-abate sectors, our key customers.

The European Industrial Gases Association represents providers/operators of carbon capture technologies. Our members have expertise in both the merchant CO2 market and major carbon capture and storage (CCS) projects, giving us a deep understanding of the challenges and opportunities in decarbonising hard-to-abate industries.

The Industrial Gas (IG) sector is strongly integrated into the value chains of industries it serves, such as steelmaking, chemical manufacturing and oil refining. In mature economies, IG consumers may decide either to self- produce (i.e. insourcing business model) or to outsource their IG needs to IG producers (i.e. outsourcing business model). Outsourcing to a company like an EIGA member has significant benefits.

Related to Dinitrogen Oxide: The European Industrial Gases Association (EIGA) has been monitoring the evolution of the dossier on nitrous oxide (N2O) and recognises the European Commissions commitment to regulatory action. We welcome the Commissions proposal for a REACH restriction, including the targeted derogation for culinary applications in small volumes.

EIGA believe that there is no need to include in the proposed Annex to the regulation a full copy of the GMP Annex 6, but instead it is more effective to only refer in this Annex to the regulation, to the existing regulation on GMP Annex 6 Medicinal Gases. Indeed, by referring to an existing regulation, - Legislators and Inspectors only have to manage & update 1 set of applicable regulation on GMP.