Recital 20

(20) The manufacture of metered dose inhalers for the delivery of pharmaceutical ingredients uses a non-negligible proportion of all HFCs consumed in the Union today. Alternative options are available that include metered dose inhalers using lower GWP fluorinated greenhouse gases as propellants that have been newly developed by industry. This Regulation includes the metered dose inhalers sector in the HFC quota system, thereby creating an incentive for the industry to pursue its path towards cleaner alternatives. To enable a smooth transition, the quota mechanism envisaged for the metered dose inhalers sector will guarantee full quota, corresponding to the most recent market share of that sector, for the period from 2025 to 2026, and reach the full reduction rate of the other sectors covered under the quota system only in 2030. HFCs used as propellants in metered dose inhalers are critical for the health of patients suffering from respiratory conditions, such as asthma and chronic obstructive pulmonary disease. Metered dose inhalers are medicinal products subject to rigorous assessments, including clinical studies, in order to ensure patient safety. Cooperation between the Commission, competent authorities in Member States and the European Medicines Agency should facilitate the smooth approval process of metered dose inhalers using low GWP fluorinated greenhouse gases and alternatives to fluorinated greenhouse gases, thereby ensuring the transition to cleaner solutions.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-07 · Text as adopted (Official Journal); later amendments are not incorporated in this text.