Noting with appreciation the work done by the Technology and Economic Assessment Panel and its Medical Technical Options Committee,

Mindful that, according to decision IV/25, the use of chlorofluorocarbons for metered-dose inhalers does not qualify as an essential use if technically and economically feasible alternatives or substitutes are available that are acceptable from the standpoint of environment and health,

Noting the Panel's conclusion that technically satisfactory alternatives to chlorofluorocarbon-based metered-dose inhalers are available for some therapeutic formulations for treating asthma and chronic obstructive pulmonary disease,

Taking into account the Panel's analysis and recommendations for essential-use exemptions for controlled substances for the manufacture of metered-dose inhalers used for asthma and chronic obstructive pulmonary disease,

Noting that the Medical Technical Options Committee continued to have difficulty assessing some nominations submitted by parties in accordance with the criteria of decision IV/25 and subsequent relevant decisions owing to a lack of certain information,

Noting also that, notwithstanding the insufficient information referred to in the preceding paragraph, the Medical Technical Options Committee gave due consideration to the health and safety of patients with regard to the amounts recommended,

Welcoming the continued progress in several parties operating under paragraph 1 of Article 5 in reducing their reliance on chlorofluorocarbon-based metered-dose inhalers as alternatives are developed, receive regulatory approval and are marketed for sale,

Welcoming also the announcements by India and the Islamic Republic of Iran that they will not require pharmaceutical-grade chlorofluorocarbons under essential-use nominations for 2011 or beyond for the manufacture of metered-dose inhalers, and acknowledging their efforts in their phase-out of chlorofluorocarbons in metered-dose inhalers,

Acknowledging Bangladesh's efforts in its phase-out of chlorofluorocarbons in metered-dose inhalers, and taking into account the economic difficulties faced by that party,

Welcoming the announcement by Bangladesh that it will not, in the future, submit essential-use nominations for the use of chlorofluorocarbons in salbutamol, beclomethasone or levosalbutamol metered-dose inhalers,

1. To authorize the levels of production and consumption for 2011 necessary to satisfy essential uses of chlorofluorocarbons for metered-dose inhalers for asthma and chronic obstructive pulmonary disease as specified in the annex to the present decision;
2. To request nominating parties to supply to the Medical Technical Options Committee information to enable assessment of essential-use nominations in accordance with the criteria set out in decision IV/25 and subsequent relevant decisions as set out in the handbook on essential-use nominations;
3. To encourage parties with essential-use exemptions in 2011 to consider sourcing required pharmaceutical-grade chlorofluorocarbons initially from stockpiles where they are available and accessible;
4. To encourage parties with stockpiles of pharmaceutical-grade chlorofluorocarbons potentially available for export to parties with essential-use exemptions in 2011 to notify the Ozone Secretariat of such quantities and of a contact point by 31 December 2010;
5. To request the Secretariat to post on its website details of the potentially available stocks referred to in the preceding paragraph;
6. That the parties listed in the annex to the present decision shall have full flexibility in sourcing the quantity of pharmaceutical-grade chlorofluorocarbons to the extent required for manufacturing metered-dose inhalers, as authorized in paragraph 1 above, from imports, from domestic producers or from existing stockpiles;
7. To approve the authorization given to the Dominican Republic by the Secretariat, in consultation with the Technology and Economic Assessment Panel, of the emergency essential use of 1.832 metric tonnes of CFC-113 as a diluter for silicon grease during the manufacture of medical devices, to cover the period 2010-2011;

Annex to decision XXII/4

Essential-use authorizations for 2011 of chlorofluorocarbons for metered-dose inhalers (in metric tonnes)