Cold comfort pharm
Brexit has resulted in divergence over rules governing refrigerated equipment, says Judith Evans, who offers an overview on the legislation, regulations and compliance requirements to bear in mind.
In today’s market it is important for companies to understand their legal obligations. Manufacturers need to comply with a plethora of regulations and also take into account standards which are continually being developed.
A hot topic at the moment in the area of refrigerated equipment is the F-gas regulations. These cover the use of fluorinated refrigerants and restrict the application of high global warming potential (GWP) refrigerants. Since Brexit regulations for Europe and Great Britain (i.e. the UK excluding Northern Ireland) have diverged.
The European fluorinated greenhouse gases regulation (F-gas regulation) was updated just over a year ago [1]. This update included some significant changes, including prohibiting of certain refrigerants from 1 January 2025. It also extended the previous prohibitions on hydrofluorocarbons (HFCs) above a GWP of 150 to all fluorinated greenhouse gases.
Specifically, the following prohibitions are now in force which are relevant to laboratory equipment:
- Clause 4. From 1 January 2025: Placing on the market of self-contained refrigeration equipment (except chillers) using a fluorinated refrigerant with a GWP of above150 is prohibited.
- Clause 5. From 1 January 2025: Placing on the market of refrigeration equipment (except chillers, self-contained refrigeration equipment and multipack centralised refrigeration systems for commercial use) except equipment intended for application designed to cool products to temperatures below -50°C, with a fluorinated greenhouse gas with a GWP of 2,500 or more is prohibited. The same clause will not allow fluorinated greenhouse gases with a GWP of above 150 to be placed on the market after 1 January 2030 (except if required to meet safety requirements at the site of operation).
- Clause 21. From 1 January 2025: Equipment used for cooling the skin using a fluorinated greenhouse gas with a GWP of 150 or less must not be placed on the market, except if the use is for medical applications.
The European fluorinated greenhouse gases regulation (F-gas regulation)… update included some significant changes, including prohibiting of certain refrigerants
Although there are derogations for low temperature equipment, these only apply to non-self-contained equipment (i.e. equipment where refrigerant gas-containing parts are connected on site). Therefore, most smaller laboratory equipment will fall within Clause 4 and will be required to operate with a refrigerant with a GWP of <150. This means that most laboratory equipment put on the market will need to contain either a natural refrigerant or a low GWP option. Refrigerants such as R134a, R245fa, R404A, R407A, R407C, R407F, R410A or R452A are no longer legally allowed.
Equipment sold in Great Britain must comply with the Fluorinated Greenhouse Gases (Amendment) (EU Exit) Regulations 2021, based on the original EU F-gas regulation. Therefore, Great Britain does not align with the current EU F-gas regulation. The Department for Environment Food and Rural Affairs (Defra) is the responsible department and has been consulting on changes to the regulation, which are not required to mirror the EU regulation. It is unlikely that any changes to legislation will be introduced before late in 2026.
In the Great Britain legislation, most laboratory equipment will fall under the stationary refrigeration equipment clause. This states that: “Stationary refrigeration equipment, that contains, or whose functioning relies upon, HFCs with GWP of 2,500 or more except equipment intended for application designed to cool products to temperatures below -50°C” cannot be placed on the market. Therefore, in Great Britain, stationary refrigeration equipment with refrigerants with a GWP of <2,500 are allowed to be placed on the market and there is a derogation which allows higher GWP refrigerants if products are cooled to <-50°C. However, despite the more relaxed GWP threshold in Great Britain, it is unlikely that manufacturers will trade only here and not the EU, so EU regulations should be considered to allow compliance across both markets.
Most of the low GWP alternatives that would be suitable for laboratory equipment are either flammable, such as propane (R290) or mildly flammable, such as HydroFluoroOlefin (HFO) or blends containing them. This adds some extra challenges, as the equipment needs to be designed to be safe in case of refrigerant leakage. Laboratory equipment with a refrigerant charge of less than 150g is within the scope of BS EN 61010 (safety requirements for electrical equipment for measurement, control and laboratory use).
This prescribes specific refrigerant safety requirements and practical testing to assess safety of components. Such testing is relatively specialised and is carried out in laboratories such as RD&T.
Despite the more relaxed GWP threshold in Great Britain, it is unlikely that manufacturers will trade only here and not the EU, so EU regulations should be considered to allow compliance across both markets
Converting equipment to operate on low GWP refrigerants is not just about safety. There are opportunities to also reduce energy consumption and to further optimise the equipment. Some of this work is relatively specialised and requires equipment to measure temperature, pressure and energy consumption as well as environmentally controlled rooms for the testing.
In some cases, test standards are available to allow performance comparison of different pieces of equipment. A new test standard for laboratory equipment is at the final preliminary (Fpr) stage. The standard (FprEN 18151) covers: refrigerators and freezers for laboratory and medical applications – terminology, requirements, testing.
This includes electrically operated medical refrigerating appliances intended for the cold storage of blood components, biological specimen, vaccines, medicines, reagents, or other laboratory preparations used in medical practice and research. The standard divides equipment into six different categories which can be categorised for use in four different climate classes (ambient conditions for use). As well as general design considerations, the standard covers a methodology to measure temperature and energy performance of equipment.
References:
Regulation (EU) 2024/573 of The European Parliament and of the Council of 7 February 2024 on fluorinated greenhouse gases, amending Directive (EU) 2019/1937 and repealing Regulation (EU) No 517/2014
- Judith Evans is director of Refrigeration Developments and Testing Ltd (RD&T). She was part of the committee which developed the new test standard