(fra kommisjonsforordningen)

(1) As from January 2027, point 7(b) of Annex IV to Regulation (EU) 2024/573 prohibits the placing on the market of chillers with a rated capacity of up to and including 12 kW that contain fluorinated greenhouse gases with a global warming potential (‘GWP’) of 150 or more, or whose functioning relies upon those gases, except if required to meet safety requirements at the site of operation.

(2) Pursuant to Article 11(5) of Regulation (EU) 2024/573, on 26 June 2026, the German competent authority submitted to the Commission a request to authorise an exemption (the exemption request) allowing the placing on the Union market of certain medical stationary chillers, whose placing on the market is to be prohibited under point 7(b) of Annex IV to Regulation (EU) 2024/573 as from 1 January 2027.

(3) The medical chillers covered by the exemption request are used for precise thermoregulation of heat-transfer fluids during critical care and life-supporting medical procedures such as open-heart surgeries. As they ensure that the patient's blood is safely warmed and cooled, they are vital for reducing adverse events related to cardiovascular surgical procedures.

(4) According to the exemption request, medical chillers that would not fall under the placing on the market prohibition set out in point 7(b) of Annex IV are not available in the Union market. Despite ongoing research and development efforts, alternatives using refrigerants with a GWP below 150 are not yet sufficiently mature to be applied. In order to ensure that alternatives are going to be used safely and the transition does not result in avoidable costs, further time is needed to facilitate the switch to refrigerants with a GWP value below 150.

(5) The Commission has assessed the exemption request and considers that the conditions set out in points (a) and (b) of Article 11(5) of Regulation (EU) 2024/573 are fulfilled. In particular, no suitable alternatives are available in the Union market and the absence of an exemption would lead to disproportionate costs.

(6) The Commission also considers that under such exceptional circumstances it is appropriate to grant a time-limited exemption to avoid market disruption in the supply of such essential equipment while allowing sufficient time for the development and deployment of suitable alternatives. The Commission considers that a period of two years for the equipment listed in point 7(b) of Annex IV to Regulation (EU) 2024/573 is appropriate and proportionate to achieve those objectives.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Committee on fluorinated greenhouse gases, established by Article 34(1) of Regulation (EU) 2024/573,