AN UPDATE ON FLUOROCARBONS

Developments gather pace for the use of HFC-152a and HFO-1234ze(E) in MDIs

Developments gather pace for the use of HFC-152a and HFO-1234ze(E) in MDIs

HFC-152a and HFO-1234ze(E) have been identified as low GWP alternatives for HFC-134a and HFC-227ea propellants in pressurised metered dose inhalers (pMDIs). These new propellants for pMDIs are under development, with recent announcements indicating progress for manufacturing lines and medical trials. HFC-152a is flammable with a direct GWP of 124 (AR4, F-gas 2024/573 value) but it is not in scope of the current regulatory actions on PFAS in the EU. HFO-1234ze(E) is classed as non-flammable under the applicable test conditions for this application, with a direct GWP 1.37 [1] (AR6, F-gas 2024/573 value) and is included in the PFAS definition used to define the scope of the proposal for an EU restriction of PFAS. Both HFC-134a, non-flammable, GWP 1430 (AR4) and HFC-227ea, non-flammable, GWP 3220 (AR4) are also included in the PFAS definition used to define the scope of the proposal for an EU restriction of PFAS.

It should be noted that technical discussions are currently ongoing regarding the proposed PFAS restriction. The International Pharmaceutical Aerosol Consortium (IPAC) and the International Pharmaceutical Consortium on Regulation & Science (IPAC-RS) in their preliminary joint comments [2] to ECHA stated “We respectfully request a lengthier derogation for the two medical propellants currently used in MDIs: HFC-134a and HFC-227ea consistent with the one granted to other medical device sectors.” And “We respectfully request a permanent exemption for HFO 1234ze as a medical propellant for MDIs.” 

According to the MCTOC Assessment Report [3], the first pMDIs containing HFC-152a are expected to launch in 2025, and with the first anticipated product launch in 2025 for pMDIs containing HFO-1234ze(E). The report also discusses manufacturing of pMDIs using these propellants. Due to its flammability, safe manufacturing processes for HFC-152a would need to be developed for pMDIs. HFO-1234ze(E) is classified as non-flammable (per ASTM E-681 and ISO 10156) but possesses a flammable range of 8.0–8.5 volume percent in air (at one atmosphere under certain conditions), requiring consideration in manufacturing processes.

A contract research organization, dedicated to providing pressurized metered dose inhaler (pMDI) research and development (R&D), has announced the installation of a new low-GWP manufacturing line to meet global needs for pMDI investigation. The line will manufacture pMDIs containing HFO-1234ze (E) and HFC-152a propellants and will allow 2.5 -10-kilogram batches to be manufactured [4]. In the USA, the FDA has awarded a contract to provide the FDA with information related to the formulation, manufacture, device design and quality aspects related to low-GWP propellant MDIs and their utility to replace existing propellant MDIs [5]. Partnerships between pharmaceutical companies and MDI propellant manufacturers of HFO-1234ze(E) and HFC-152a have been announced and progress is being made on the required clinical trials with plans to file regulatory submissions assuming trials are successful [6-9].

Background on pMDIs and treatment of asthma and COPD (chronic obstruction pulmonary disease)

Pressurised metered dose inhalers (pMDIs), dry powder inhalers (DPIs), aqueous soft mist inhalers (SMIs), and other delivery systems such as nebulisers all play a role in the treatment of asthma and COPD. An inhalation propellant must be safe for human use and meet several other criteria relating to safety, efficacy, and quality. Traditionally the list would include: (i) liquefied gas, (ii) low toxicity, (iii) non-flammable, (iv) chemically inactive and stable, (v) acceptable to patients (in terms of taste and smell), (vi) appropriate solvency characteristics, and (vii) appropriate density. Not all these requirements may be essential for an alternative propellant, but careful study and justification would be required to support any significant change. It is, however, extremely difficult to identify new propellants fulfilling all these criteria, and which are also environmentally acceptable [2].

References

[1] See EFCTC Newsletter of January 2024, Update on the atmospheric degradation of HFOs and HCFOs for a discussion on indirect GWPs.

[2] International Pharmaceutical Aerosol Consortium (IPAC) and the International Pharmaceutical Consortium on Regulation & Science (IPAC-RS) Preliminary joint comments to ECHA REACH on proposal to restrict PFAS (May 2023) available at ECHA Comments submitted to date on restriction report on PFAS - ECHA (europa.eu) Part 6 Ref 4063 Attachment

[3] 2022 MCTOC Assessment Report, section 10.2.7 New propellants for pMDIs, available at MCTOC-Assessment-Report-2022.pdf (unep.org)

[4] PharmiWeb.com New low-GWP manufacturing line.

[5] OINDP News   FDA contracts for LGWP propellant study

[6] finance.yahoo.com Collaboration for Low GWP Propellant Conversion for HFC-152a

[7] OINDP News Partners on development of HFO-1234ze MDIs

[8] OINDP News Partnership on development of MDIs using HFO-1234ze(e) propellant

[9] OINDP News Upcoming Phase 3 trials of HFA 152a version of an MDI

Illegal Trade Round-up

In this round-up: New measures in revised F-gas Regulation 2024/573 together with the EU Single Window Environment for Customs will help combat illegal trade.  In addition to seizures at EU borders, international co-ordinated action resulted in record seizures of Montreal Protocol related substances. The first prosecution in the United States include charges for the importation of HFCs, related to the American Innovation and Manufacturing Act of 2020 (AIM Act).

In the EU, use the anonymous European Anti-Fraud Office (OLAF) Fraud Notification System to report illicit HFC activity, see Home - Fluorocarbons and https://fns.olaf.europa.eu/  , anybody with information on illegal trade can provide information to OLAF.

F-Gas Regulation 2024/573 came into force on 11 March 2024, with new measures to help combat illegal trade in Article 24  Measures to monitor illegal trade, and a complementary requirement set out in Article 23 Trade Controls para 5 to enter into force from 3 March 2025:  Where relevant, customs authorities shall communicate information regarding the customs clearance of goods to the F-gas Portal via the EU Single Window Environment for Customs. And para 13: Member States shall designate or approve customs offices or other places and shall specify the route to those offices and places, in accordance with Articles 135 and 267 of Regulation (EU) No 952/2013, for the presentation to customs authorities of the fluorinated greenhouse gases listed in Annex I to, and of the products and equipment referred to in Article 19 of this Regulation, at their entry into or at their exit from the customs territory of the Union. Controls shall be carried out by customs office personnel or by other authorised persons in accordance with national rules, who are knowledgeable about matters related to the prevention of illegal activities covered by this Regulation and have access to suitable equipment to carry out the relevant physical controls based on risk analysis. Under Article 24 On the basis of regular monitoring of trade in fluorinated greenhouse gases and assessment of the potential risks of illegal trade linked to the movements of fluorinated greenhouse gases, and products and equipment containing those gases or whose functioning relies upon those gases, the Commission is empowered to adopt delegated acts. The EU Single Window Environment for Customs, enables customs authorities to automatically verify the legitimacy of F-Gas imports at the border, confirming whether importers are legally registered and have sufficient quota for the import of their goods. Measures set out in Article 11 para 3, further restrict non-refillable containers, which are typically used for illegal imports: the import, any subsequent supply or making available to other persons within the Union for payment or free of charge, use or export of non-refillable containers for fluorinated greenhouse gases …. empty, or fully or partially filled, shall be prohibited. This restriction also applies to containers which could be refilled but are imported or placed on the market without provision having been made for their return for refilling.

Seizures of HFCs have been recently reported in Bulgaria, Italy and Romania.  Bulgaria: A shipment of nearly one tonne of smuggled HFC refrigerants in disposable cylinders have been seized by Bulgarian customs officials (see Cooling Post). Italy: Customs officers at the port of Naples report the interception and seizure of 150 tons of HFC refrigerants (see Cooling Post). Romania: Authorities in Romania have blocked the importation of over 4,000 cylinders of R134a refrigerant from China at the Black Sea port of Constanta (see Cooling Post).

Refrigerant analysers: To support customs authorities in Romania: In an effort to crack down on illegal imports, the newly-established Association of F-Gas Companies Romania has supplied refrigerant analysers and offered training to customs authorities in Romania (see Cooling Post).

Record number of Montreal Protocol-related seizures under WCO’s Global Customs Operation DEMETER IX: This operation was led by the World Customs Organisation (WCO) Secretariat, financially backed by China Customs, and technically supported by the Regional Intelligence Liaison Office for Asia/Pacific (RILO A/P). International partners included UNEP OzonAction, Basel Convention Secretariat, European Anti-Fraud Office (OLAF), UNODC Unwaste Project, INTERPOL, European Union Network for the Implementation and Enforcement of Environmental Law (IMPEL), and the WCO RILO network. All WCO Member States were invited to join the operation. A record number of customs agencies – 106 – from both Article 5 and non-Article 5 countries participated in this edition of DEMETER, whose operational phase took place between 1-31 October 2023. Based on preliminary findings, national customs agencies seized almost 70 tonnes of substances controlled under the Montreal Protocol and 6,046 pieces of pre-charged equipment (unweighed). Most of the seizures concerned HFCs, but there were also ODS such as hydrochlorofluorocarbons (HCFCs) and even chlorofluorocarbons (CFCs).  The WCO reports: “There was a significant increase in illegal trade cases involving Montreal Protocol substances and related equipment (over 250% compared to the previous edition). See UNEP.

USA: California man arrested for smuggling potent greenhouse gases into the United States. This is the first prosecution in the United States to include charges related to the American Innovation and Manufacturing Act of 2020 (AIM Act). The AIM Act prohibits the importation of hydrofluorocarbons (HFCs), commonly used as refrigerants, without allowances issued by the U.S. Environmental Protection Agency (see EPA). EPA announced a settlement, for the attempted illegal import of hydrofluorocarbons (HFCs), which is the latest in a series of enforcement actions EPA has taken recently against importers of HFCs (see EPA).

New heat pumps using R-32 or R-454B for the European Market

New heat pumps have become available on the market that use low GWP R-32 or R-454B and offer improved heating and cooling efficiency for a wide range of commercial applications, such as office buildings and hotels. One new series of R-32 units are factory-filled supporting installation by engineers for sanitary, heating and air conditioning technology without any problems. Available from 15 to 41 kW they achieve improved efficiencies with SCOP values of up to 4.76 for low-temperature applications and SCOP 3.48 for medium temperatures.

Two new air-to-water heat pump ranges, using mildly flammable R-454B refrigerant (GWP 466), cover the capacity range 45 to 700 kW. One range is optimised with the combination of an inverter scroll compressor, EC fans and a control system to adjust capacity output to changes in building load, has increased seasonal efficiencies up to 4.06 heating and 4.72 cooling, and is designed to function at ambient temperatures down to -25ºC and up to 60ºC hot water. The second range of packaged air-to-water scroll heat pumps is specifically designed for low ambient heating solutions thanks to its vapour and liquid injection large scroll compressors.

A new series of heat pump chillers, available with capacities of 50kW/75kW/100kW, use mildly flammable R-32 refrigerant (GWP 675).  Proprietary technologies, such as an advanced "e-3D scroll" compressor, contribute to the energy saving performance and environmental protection by delivering the industry's top-tier SCOP of 4.59 by the 50kW-class, combined with an approximately 43% reduction in refrigerant charge volume, compared to R-410A. The compressor and water pump are inverter controlled which enables optimal operation control depending on the load. The remote control allows setting and adjustment of up to 20 air-cooled heat pump chillers with intuitive touch operation.

SCOP: Seasonal Coefficient of Performance: It is the performance indicator during the heating season. The higher the value, the greater the energy saving.

Sources:

Refrigeration Industry

Cooling Post

Manufacturer’s information and Refrigeration Industry

R-32 Chillers used for high-efficiency cooling and heating for world’s largest vertical farm

Air-cooled scroll chillers operating on lower global warming potential (GWP) refrigerant R-32 are providing high-efficiency cooling and heating for the world’s largest vertical farm in the UK. The vertical farm, the size of seventy tennis courts, offers about 13,700 square metres of growing space for stacking crops 15 layers high, and is expected to supply 1,000 tonnes of fresh produce a year to UK supermarkets.

One of the key challenges was the requirement to achieve four different temperature and humidity set points. The compact air-cooled scroll chillers with refrigerant R-32, operate from -10°C up to +48°C, and have variable-speed pumps to reduce pumping energy consumption by up to two-thirds. The chillers have a heat recovery system that enables waste heat to be captured and used for various heating applications on site, saving energy while maintaining optimum growing conditions. The four chillers deliver a total of 2.2 megawatts of cooling and heating to the growing room. By October 2023 the entire growing area was fully planted, allowing the operator to harvest a tonne in weight of basil and leafy greens every 19 days.

Source

Manufacturer’s information reported in Refrigeration Industry and ACR Journal.

Ozone Secretariat launches App to track and review avoided ODS and HFC emissions

The CO2e app aims to raise awareness and enhance understanding of the contributions of the Montreal Protocol on Substances that Deplete the Ozone Layer and its Kigali Amendment to climate change mitigation. It allows for the tracking of production and consumption of ten groups of ODSs & HFCs. The app generates customized reports and allows for aggregation by Annex group, party, or reporting period.

The app allows users to track production and consumption of ODSs in CO2e tonnes or metric tonnes per country and region in the period from 1986 to 2023. It allows for further refinement depending on EU membership and Article 5 status (developing or developed country). The app generates customized reports and allows for aggregation by Annex group, party, or reporting period.

The app shows that nearly 10 billion tonnes CO2e emissions have been avoided until 2023, with HFCs avoided emissions accounting for 6.7% of the total so far.

Sources

Ozone Secretariat Launches App to Track and Review Avoided ODS Emissions | News | SDG Knowledge Hub | IISD

Avoided CO2e by the Montreal Protocol | Ozone Secretariat (unep.org)