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The low-GWP propellant transition
How F-Gas regulations impact our industry
Meeting the challenge of today’s decarbonising healthcare market requires support across the whole supply chain. As regulators tighten controls on hydrofluorocarbon (HFC) supply and use, inhaler manufacturers and pharma partners must transition from legacy HFAs to next-generation, low-GWP propellants — without compromising dose performance, patient safety or regulatory compliance. Our expertise spanning 30 years in MDI propellant science, formulation, support services and early-stage development enables us to help you in accelerating that transition with confidence.
Regulatory snapshot — what’s changing and why it matters
The EU updated its F-Gas rules (Regulation (EU) 2024/573). The previously excluded MDI sector is now included within the HFC quota system. This change brings the sector into the phasedown of HFCs and creates specific reporting obligations for volumes used in MDIs.
In practice this means for our industry:
A lower level of permitted HFC volumes available on the EU market and earlier, steeper reductions in supply.
New documentation, product allocation, and reporting requirements for placing HFCs on the market.
Our approach — regulatory-aware, science-led and patient-focused
Orbia Fluor & Energy Materials combines industrial-scale propellant manufacturing know-how with formulation development to support our customers throughout every step of the low-GWP propellant transition:
Regulatory and market insight
We monitor F-gas developments and associated impact so your development decisions reflect the latest obligations and market constraints.
Propellant expertise
Early-stage formulation and pilot-scale testing for HFA-152a are core competencies found within our UK Technology Centre; we have dedicated facilities and handling protocols for low-GWP propellants.
Device-compatible formulation
Aerosol performance is tested in parallel with materials compatibility assessments, so reformulations integrate with existing device platforms where possible.
Analytical & safety support
Trace-level analytical strategies, impurity profiling, Regulatory and Nitrosamine statements for risk considerations are regularly updated and provided to assist customers with their regulatory submissions.
What we offer in terms of our “targeted services”
Early-stage formulation development (bench & pilot 5 L) with HFA-152a
Spray characterisation, and dose uniformity testing
Materials compatibility screening for canisters, valves, elastomers and seals
Stability and impurity profiling (GC, HPLC, GC-MS methods tailored to new propellants)
Safety and manufacturability advice for flammable propellant handling and ATEX-aligned processes
Regulatory support packages: technical dossiers, risk assessments and supply-chain planning aligned with EU/UK F-gas requirements
These services build on our established formulation capabilities and recent investments in advanced propellant facilities.
Why partner with Orbia Fluor & Energy Materials now?
Move from uncertainty to strategy
With MDIs inside the EU quota system since 2025, early planning preserves market access and helps to avoid supply bottlenecks.
Mitigate technical risk
Reformulation work up front reduces device modifications and clinical risk later — we help you choose the propellant that best meets your product, device and regulatory objectives.
Practical, hands-on capability
Dedicated facilities and experienced teams expedite iteration cycles and get you to a robust solution faster.
Ready to transition?
Orbia Fluor & Energy Materials’ team is actively supporting partners on HFA-152a programmes — from concept through pilot-scale demonstration. Contact our Technology Centre to discuss your product objectives, regulatory footprint and a staged development plan that keeps patients and compliance front-and-centre.
Discover more about the low-GWP transition
Speak with one of our experts
Do you have a question regarding medical propellants for one of our experts?
Document downloads
Here you can download additional support materials for our medical propellants and other informative resources such as flyers, white papers and guides.
Sources and further reading
- European Commission — F-gas legislation and key measures (Regulation (EU) 2024/573). EU-Rules – Fluorinated Greenhouse Gases – Climate Action
- Industry briefings on MDI inclusion in the HFC quota (e.g., Fluorocarbons.org, Danfoss analysis). F-Gas Regulation – Fluorocarbons
- Peer-reviewed and technical literature on HFA-152a and HFO-1234ze(E) for pMDIs; materials compatibility and aerosol performance studies. Materials Compatibility Considerations for the Transition to Low Global Warming Potential Propellants for Pressurized Metered Dose Inhalers | AAPS PharmSciTech
- Practical analytical and trace-impurity considerations for next-generation propellants. ONdrugDelivery
- Guidance for users, producers and traders Fluorinated gas (F gas) -GOV.UK
- Considerations for the Transition to Low-GWP Propellants – Materials Compatibility Considerations for the Transition to Low Global Warming Potential Propellants for Pressurized Metered Dose Inhalers | AAPS PharmSciTech