Decision XIX/13: Essential-use nominations for Parties not operating under paragraph 1 of Article 5 for controlled substances for 2008 and 2009
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 (CFCs) 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 Technology and Economic Assessment Panel's conclusion that technically satisfactory alternatives to chlorofluorocarbon-based metered-dose inhalers are available for short‑acting beta-agonists and other therapeutic categories for asthma and chronic obstructive pulmonary disease,
Mindful that paragraph 8 of decision XII/2 allows the transfer of CFCs between metered-dose inhaler companies,
Welcoming the continued progress in several Parties not operating under paragraph 1 of Article5 in reducing their reliance on CFC-containing metered‑dose inhalers as alternatives are developed, receive regulatory approval and are marketed for sale,
- To authorize the levels of production and consumption for 2008 and 2009 necessary to satisfy essential uses of CFCs for metered-dose inhalers for asthma and chronic obstructive pulmonary disease specified in the annexes to the present decision;
- That Parties not operating under paragraph 1 of Article 5 of the Montreal Protocol, when licensing, authorizing or allocating essential-use exemptions for a manufacturer of metered-dose inhalers, shall ensure, in accordance with paragraph 1 (b) of decision IV/25, that pre- and post-1996 stocks of controlled substances are taken into account such that no more than a one‑year operational supply is maintained by the manufacturer;
- That Parties not operating under paragraph 1 of Article 5 of the Montreal Protocol will request each company, consistent with paragraph 1 of decision VIII/10, to notify the relevant authority, for each metered-dose inhaler product for which the production of CFCs is requested, of:
- The company’s commitment to the reformulation of the concerned products;
- The timetable in which each reformulation process may be completed;
- Evidence that the company is diligently seeking approval of any chlorofluorocarbon-free alternative(s) in its domestic and export markets and transitioning those markets away from its chlorofluorocarbon products;
- The Parties listed in Annex A to the present decision shall not nominate for the production of essential use volumes of CFCs for the manufacture of metered-dose inhalers in 2010 or any year thereafter.
Annex A to decision XIX/13
Essential-use authorizations for 2008 of CFCs for metered‑dose inhalers approved by the Nineteenth Meeting of the Parties (in metric tonnes)
Party |
2008 approved amount |
European Community |
200 |
Russian Federation |
212 |
Annex B to decision XIX/13
Essential-use authorizations for 2009 of CFCs for metered-dose inhalers approved by the Nineteenth Meeting of the Parties (in metric tonnes)
Party |
2009 approved amount |
United States of America |
282 |