EU F-Gas Regulation 2024/573: Strategic Guidance For MDI Manufacturers

The European Union’s intensified climate policy agenda is reshaping regulatory expectations across multiple industries including pharmaceutical manufacturers of metered dose inhalers (MDIs). With the adoption of Regulation (EU) 2024/573 on fluorinated greenhouse gases (F-gases), effective February 2024, companies developing and marketing MDIs must now balance environmental sustainability, regulatory compliance, and patient safety more carefully than ever.

At Maven Regulatory Solutions, we support pharmaceutical organizations in translating complex environmental regulations into clear regulatory strategies that protect both market access and product continuity. This blog provides a comprehensive, practical guide to the new EU F-Gas Regulation and its implications for MDI manufacturers.

Why the EU F-Gas Regulation Matters to the Pharmaceutical Sector

Metered dose inhalers remain essential medicinal products for patients with asthma, COPD, and other chronic respiratory diseases. Most MDIs rely on hydrofluorocarbons (HFCs) such as HFA-134a and HFA-227ea as propellants. While clinically indispensable, these substances are also high-global warming potential (GWP) greenhouse gases.

Under the EU Green Deal and the Kigali Amendment to the Montreal Protocol, the EU is committed to achieving climate neutrality by 2050, with aggressive reductions in fluorinated greenhouse gas emissions.

Although MDIs represent a relatively small share of total EU HFC consumption (approximately 2–3%), Regulation (EU) 2024/573 formally integrates the pharmaceutical sector into the broader HFC phase-down framework while recognizing the critical public health role of inhaled medicines.

Key Objectives of Regulation (EU) 2024/573 for MDIs

• Reduce overall HFC emissions across the EU
• Incentivize development of low-GWP inhaler technologies
• Maintain uninterrupted patient access to essential medicines
• Ensure regulatory predictability for pharmaceutical manufacturers
• Align environmental compliance with EMA and medicinal product regulation

Inclusion of MDIs in the EU HFC Quota System

A Phased and Health-Sensitive Approach

For the first time, HFCs used in MDIs are explicitly included within the EU HFC quota system, which limits the quantity of HFCs placed on the EU market, expressed in CO?-equivalent values.

Transition Protection for Pharma Manufacturers

This transition period is designed to give pharmaceutical companies sufficient time to reformulate products, conduct clinical studies, and secure regulatory approvals without disrupting patient supply.

Strategic Insight
HFC reference values are recalculated every three years. Active monitoring of quota allocations via the EU F-Gas Portal is critical for long-term supply planning.

Driving Innovation: Low-GWP and Sustainable Inhaler Technologies

Regulation (EU) 2024/573 explicitly encourages a shift toward:

• Lower-GWP HFC alternatives (e.g., HFC-152a)
• Non-fluorinated propellant technologies
• Improved inhaler efficiency and dose delivery systems

Regulatory Alignment with EMA

The regulation emphasizes that MDIs remain medicinal products subject to rigorous clinical and quality assessment. Importantly, it calls for enhanced coordination between the European Commission, Member States, and the European Medicines Agency (EMA) to facilitate approval of environmentally improved inhales.

Potential regulatory advantages include:

• Optimized variation pathways
• Streamlined scientific advice
• Alignment with lifecycle management strategies
• ESG-aligned product positioning

Early movers toward low-GWP MDIs may gain both regulatory goodwill and commercial advantage.

Mandatory Labelling Requirements for MDIs (Effective 1 January 2025)

New F-Gas Labelling Obligations

All MDIs containing fluorinated greenhouse gases must comply with Article 12 labelling requirements under Regulation (EU) 2024/573.

Advertising Rule
If the propellant has GWP ≥150, the same F-gas information must appear in promotional and advertising materials.

Bulk Propellant Containers
Manufacturing-scale containers must include quota-related labelling, including exemption wording where applicable.

Compliance Obligations Beyond Labelling

Key Regulatory Requirements

• Annual HFC Reporting via the EU F-Gas Portal
• Independent verification of submitted data
• Five-year record retention
• Import/export documentation aligned with the EU Single Window Environment
• Supply chain compliance, including recovery and handling obligations

Non-compliance may result in financial penalties, market restrictions, or product withdrawal at Member State level.

How Maven Regulatory Solutions Supports Compliance

At Maven Regulatory Solutions, we help MDI manufacturers proactively manage environmental and medicinal regulatory convergence.

Recommended actions:

1. Portfolio Impact Assessment
   Map current propellant usage, GWPs, and reformulation feasibility.
2. Regulatory Pathway Planning
   Align EMA lifecycle strategies with F-Gas compliance timelines.
3. Labeling & Artwork Updates
   Update SmPC, PIL, packaging, and promotional materials.
4. Quota & Supply Chain Strategy
   Secure quota continuity and diversify sourcing strategies.
5. R&D and ESG Integration
   Support low-GWP inhaler development aligned with sustainability goals.

Turning Compliance into Competitive Advantage

Regulation (EU) 2024/573 is not merely a constraint, it is a strategic inflection point for the pharmaceutical industry. Manufacturers that integrate environmental compliance, regulatory strategy, and innovation planning will be best positioned to lead the future of respiratory care.

Maven Regulatory Solutions partners with life sciences organizations to ensure regulatory confidence, sustainability alignment, and uninterrupted patient access in an evolving EU regulatory landscape.

Frequently Asked Questions (FAQs)

Q1. Are MDIs banned under the new EU F-Gas Regulation?
No. MDIs are explicitly recognized as critical medicinal products and are not subject to outright bans.

Q2. When do labeling changes become mandatory?
From 1 January 2025 for all MDIs containing fluorinated greenhouse gases.

Q3. Will EMA approvals be required for reformulated inhalers?
Yes. Any propellant change requires appropriate regulatory submissions and clinical justification.

Q4. Can companies receive incentives for low-GWP MDIs?
Early adopters may benefit from quota flexibility, ESG positioning, and potential EU funding opportunities.

Q5. How often are HFC quotas recalculated?
Every three years, based on recent market activity.