BAKGRUNN (fra kommisjonsforordningen) 

(1) Point 4 of Annex IV to Regulation (EU) 2024/573, prohibits from 1 January 2025 the placing on the market of self-contained refrigeration equipment, except chillers, that contains fluorinated greenhouse gases with a GWP of 150 or more, except if required to meet safety requirements at the site of operation.

(2) Pursuant to Article 11(5) of Regulation (EU) 2024/573, on 15 May 2024, the Dutch competent authorities submitted to the Commission a request for the authorisation of an exemption allowing the placing on the Union market of mechanical cryogenic freezers (– 150o C), that fall within the scope of Annex IV, point 4, to Regulation (EU) 2024/573.

(3) Mechanical cryogenic freezers (– 150 oC) are used for cryopreservation, namely the storage of living organisms, cells and tissues at ultra-low temperatures, and are intended for critical applications mostly in the fields of science and healthcare.

(4) The exemption request states that, at present, mechanical cryogenic freezers (– 150 oC) heavily rely on fluorinated greenhouse gases with a GWP of more than 150 and that there are many technical challenges involved in identifying an alternative substance for equipment with such low temperature without compromising safety, energy efficiency and reliable performance of the equipment. Full reliability of such equipment is essential for the preservation. The development of the equipment that can use alternative substances requires more time, due to the changes in design needed to accommodate refrigerants with a GWP below 150 while also addressing safety concerns in relation to flammable refrigerants and safeguarding reliability. In order to ensure that alternatives are going to be used safely and to retain costs at a proportionate level, time is needed to facilitate the switch to refrigerants with a GWP value below 150. Moreover, there is also a risk to the availability of products on the market, in case manufacturers of such equipment can no longer supply equipment. In the absence of an exemption, such equipment will also not be allowed for export as from 12 March 2025 in accordance with Article 22(3) of Regulation (EU) 2024/573.

(5) The exemption request asks for the maximum period of time authorised under Article 11(5) of Regulation (EU) 2024/573, namely 4 years, due the complexity of the transition to alternative refrigerants for such types of equipment.

(6) The Commission has assessed the request submitted by the Dutch competent authority and considers that the conditions set out in points (a) and (b) of Article 11(5) of Regulation (EU) 2024/573 are fulfilled. The Commission also considers that under such exceptional circumstances, sufficient time should be granted to avoid market disruption in the supply of such essential equipment. The Commission considers that a period of 4 years would be justified in this exceptional case.

(7) Considering that the prohibition for the placing on the Union market of the type of equipment referred in the exemption applies from 1 January 2025, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union.

(8) 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,