| Proposed Banning of Import of Chlorofluorocarbons (CFC) Metered-Dose Inhalers (MDI) Consultation Document 1. Proposal | 1.1 | It is proposed that the following legislative amendments will be made to the Ozone Layer Protection (Products Containing Scheduled Substances) (Import Banning) Regulation [Cap. 403C] by end 2003 and come into effect from 2005 - | | | - removing the existing exemption of "pharmaceutical product or medicine" from the definition of "controlled products" (Annex 2, item c); and
- extending the import banning to all countries or places, whether or not bound by the terms of the Montreal Protocol.
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2. Background | 2.1 | The Hong Kong Special Administrative Region (HKSAR) has been in full compliance with the obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer, which aims to restore the ozone concentration in the stratosphere as soon as reasonably practicable. | | 2.2 | At present, the importation of products containing certain ozone depleting substances such as chlorofluorocarbons (CFC) is governed under the Ozone Layer Protection (Products Containing Scheduled Substances) (Import Banning) Regulation [Cap. 403C]. This Regulation prohibits the importation of such controlled products from a country or place that is not a Party to the Montreal Protocol. (The definitions of CFCs and controlled products are available in Annexes 1 and 2 respectively.) | | 2.3 | As a manufactured product, CFC metered dose inhalers (MDIs) for treatment of asthma and/or chronic obstructive pulmonary disease have been exempted from the import prohibition for "essential use" in the HKSAR. Under the Pharmacy and Poisons Regulations, such pharmaceutical products still need to be registered with the Pharmacy and Poisons Board before they can be sold and distributed in the HKSAR. | | 2.4 | To facilitate a speedier restoration of ozone layer, the Decision XII/2 of the 12th Meeting of Parties to the Montreal Protocol requires a transition strategy to phase out CFC MDIs. Many advanced countries such as the European Union, Japan, Australia and Canada have already established 2005 or before as their phasing out targets. | | 2.5 | The HKSAR has to fulfill this international obligation under the Montreal Protocol, which is applicable to the HKSAR, and is developing measures to facilitate transition to CFC free products, including legislative amendment to ban the importation of CFC MDIs in a time frame similar to those adopted by the above-mentioned advanced countries. |
3. Transition to CFC Free MDIs | 3.1 | All MDIs supplied in the HKSAR are imported products. According to a consultancy study commissioned by the Environmental Protection Department in 2001, transition to CFC free MDIs is feasible. Initial feedback from the major medical product suppliers also shows that CFC MDI can be phased out by 2005. | | 3.2 | Major alternatives to CFC MDIs available on the market are non-CFC (such as hydrofluorocarbon) MDIs and dry powder inhalers (DPIs). The cost of non-CFC MDI is comparable with conventional CFC MDI, whereas DPI is of a higher cost . It is expected that the cost of these alternatives would become more competitive in the near future with the emergence and registration of more products and economy of scale. | | 3.3 | At present, there are more than 20 non-CFC MDIs and some other 20 DPIs registered in the HKSAR. More alternatives are expected to emerge in the HKSAR as many pharmaceutical companies have been developing them in line with the international trend. The Government will also continue to encourage these companies to source and submit more alternatives for registration. | | 3.4 | In view of the above, the Government considers that it is possible for the HKSAR to facilitate the transition to CFC free MDIs by banning the importation of CFC MDIs in 2005 by amending the Ozone Layer Protection (Products Containing Scheduled Substances) (Import Banning) Regulation [Cap. 403C] in 2003. |
4. Views Sought | 4.1 | You are welcomed to send your comments, if any, in writing on the proposed banning to the Air Management Group, Environmental Protection Department, 33/F Revenue Tower, 5 Gloucester Road Wan Chai, Hong Kong, on or before 16 May 2003. Should you have any query on the above, please call Mr. Eric HO at 2594 6234. |
Air Management Group
Environmental Protection Department
April 2003
Annex 1 Chlorofluorocarbons (CFCs) as Scheduled Substances under Ozone Layer Protection Ordinance Part 1 of Schedule | Chemical Name | Common Name | | CFCl3--Trichlorofluoromethane | CFC-11 | | CF2Cl2--Dichlorodifluoromethane | CFC-12 | | C2F3Cl3--Trichlorotrifluoroethane | CFC-113 | | C2F4Cl2--Dichlorotetrafluoroethane | CFC-114 | | C2F5Cl--Chloropentafluoroethane | CFC-115 |
Part 3 of Schedule | Chemical Name | Common Name | | CF3Cl--Chlorotrifluoromethane | CFC-13 | | C2FCl5--Pentachlorofluoroethane | CFC-111 | | C2F2Cl4--Tetrachlorodifluoroethane | CFC-112 | | C3FCl7--Heptachlorofluoropropane | CFC-211 | | C3F2Cl6--Hexachlorodifluoropropane | CFC-212 | | C3F3Cl5--Pentachlorotrifluoropropane | CFC-213 | | C3F4Cl4--Tetrachlorotetrafluoropropane | CFC-214 | | C3F5Cl3--Trichloropentafluoropropane | CFC-215 | | C3F6Cl2--Dichlorohexafluoropropane | CFC-216 | | C3F7Cl--Chloroheptafluoropropane | CFC-217 |
Annex 2 "Controlled Product" under the Ozone Layer Protection (Products Containing Scheduled Substances) (Import Banning) Regulation "Controlled product" means any of the following things which contain certain ozone depleting substance (including CFCs): | (a) | an air-conditioner or heat pump designed to cool the driver's or passengers' compartment of a motor vehicle (whether or not installed in the motor vehicle); | | (b) | refrigeration equipment or air-conditioning or heat pump equipment (whether for domestic or commercial use); | | (c) | an aerosol product other than an aerosol product containing a pharmaceutical product or medicine as defined in section 2 of the Pharmacy and Poisons Ordinance (Cap. 138) *; | | (d) | (Already repealed in 1996) | | (e) | insulation panel, insulation board or insulation pipe cover; | | (f) | a pre-polymer |
* proposed to be deleted |
