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SUCCES FOR THE REPLACEMENT OF CFCS BY HFCS IN PHARMACEUTICAL AEROSOLS

SUCCES FOR THE REPLACEMENT OF CFCS BY HFCS IN PHARMACEUTICAL AEROSOLS

04.10.2015

Since the start of the Montreal Protocol, the use of CFCs for Metered dose inhalers (MDIs) for the treatment of respiratory illnesses, such as asthma and chronic obstructive pulmonary disease (COPD), has dropped from a 1997 peak of around 10,000 tonnes to about 300 tonnes in 2013.

According to IPAC (International Pharmaceutical Aerosol Consortium), 2015 will be the final year of essential use exemptions for metered dose inhalers (MDIs).

MDIs were CFC based, but the Montreal Protocol Parties decided to leave them outside the CFC ban decisions and place them under the regime of “Essential Use Exemptions”

CFCs have been replaced by HFCs (95 per cent HFC-134a, 5 per cent HFC-227ea) in new MDIs formulations. For an approximate 630 million HFC based MDIs manufactured annually worldwide, 9,400 tonnes HFCs were used in 2014.

By moving from CFC MDIs to HFC MDIs, besides the suppression of their action on the ozone layer, their climate impact has dropped by 90 %.

Alternatives to HFC based MDIs do exist but the Montreal Protocol Technical Options Committee considers that “it is not yet technically or economically feasible to avoid HFC MDIs completely.” EFCTC Comment : According to Annex III Point 17 of the F-Gas Regulation EU 517/2014, HFC based medical aerosols are exempt from the “Placing On The Market Prohibitions”

Source : 2014 REPORT OF THE MEDICAL TECHNICAL OPTIONS COMMITTEE