Aerosols, sterilants, and miscellaneous uses › ozonaction › information › mmcfiles ›...

38
Aerosols, sterilants, carbon tetrachloride and miscellaneous uses Protecting the Ozone Layer Volume 5 UNEP 2001 UPDATE

Transcript of Aerosols, sterilants, and miscellaneous uses › ozonaction › information › mmcfiles ›...

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Aerosols, sterilants, carbon tetrachloride

and miscellaneous uses

Protecting the

Ozone Layer

V o l u m e 5

UNEP

2 0 0 1U P DAT E

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This booklet is one of a series of reports prepared by the OzonAction Programme of the United Nations Environment

Programme Division of Technology, Industry and Economics (UNEP DTIE). UNEP DTIE would like to give special thanks

to the following organizations and individuals for their work in contributing to this project:

United Nations Environment Programme (UNEP)

Ms. Jacqueline Aloisi de Larderel, Director, UNEP DTIE

Mr. Rajendra M. Shende, Chief, UNEP DTIE Energy and OzonAction Unit

Ms. Cecilia Mercado, Information Officer, UNEP DTIE OzonAction Programme

Mr. Andrew Robinson, Programme Assistant, UNEP DTIE OzonAction Programme

Editor: Geoffrey Bird

Design and layout: ampersand graphic design, inc.

© 2001 UNEP

This publication may be reproduced in whole or in part and in any form for educational and non-profit purposes without

special permission from the copyright holder, provided acknowledgement of the source is made. UNEP would appreciate

receiving a copy of any publication that uses this publication as a source.

No use of this publication may be made for resale or for any other commercial purpose whatsoever without prior

permission in writing from UNEP.

The technical papers in this publication have not been peer-reviewed and are the sole opinion of the authors. The

designations employed and the presentation of the material in this publication therefore do not imply the expression of

any opinion whatsoever on the part of the United Nations Environment Programme concerning the legal status of any

country, territory, city or area or of its authorities, or concerning delimitation of its frontiers or boundaries. Moreover, the

views expressed do not necessarily represent the decision or the stated policy of the United Nations Environment

Programme, nor does citing of trade names or commercial processes constitute endorsement.

ISBN: 92-807-2162-3

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Aerosols, sterilants, carbon tetrachloride

and miscellaneous uses

Protecting the

Ozone Layer

V o l u m e 5

UNEP

2 0 0 1U P DAT E

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Contents

Foreword 3

Acknowledgements 4

Executive summary 5

Ozone depletion: an overview 6

Requirements of the Montreal Protocol 8

CFC use in aerosol products 12

CFC use in sterilants 15

Carbon tetrachloride 16

Miscellaneous uses 18

Prospects for action: 20

• Aerosol products 20

• Sterilants 26

Resources: 29

• the implementing agencies 29

• contact points 30

• further reading 32

• glossary 33

About the UNEP DTIE OzonAction Programme 34

About the UNEP Division of Technology, Industry and Economics 36

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Foreword

When the Montreal Protocol on Substances that Deplete the Ozone Layer came into force, in 1989, it

had been ratified by 29 countries and the EEC, and set limits on the production of eight man-made

chemicals identified as ozone depleting substances (ODS). By July 2001 there were more than 170

Parties (i.e. signatories) to the Protocol, both developed and developing countries, and production

and consumption of over 90 substances were controlled.

Linking these two sets of figures, which attest to the success of the Montreal Protocol, is a process of

elimination of ODS in which ratification of the Protocol was only a first step. It was recognized from

the start that the Protocol must be a flexible instrument and that it should be revised and extended to

keep pace with scientific progress. It was also recognized that developing countries would face

special problems with phase out and would need assistance if their development was not to be

hindered. To level the playing field, the developing countries were given extra time to adjust

economically and to equip. A Multilateral Fund (MLF) was also set up early in the process to provide

financial and technical support for their phase out efforts.

Exchanges of information and mutual support among the Parties to the Montreal Protocol – via the

mechanisms of the MLF – have been crucial to the Protocol’s success so far. They will continue to be

so in the future. Even though many industries and manufacturers have successfully replaced ODS

with substances that are less damaging to the ozone layer or with ODS-free technology, lack of up-

to-date, accurate information on issues surrounding ODS substitutes continues to be a major

obstacle for many Parties, especially developing country Parties.

To help stimulate and support the process of ODS phase out, UNEP DTIE’s OzonAction Programme

provides information exchange and training, and acts as a clearinghouse for ozone related

information. One of the most important jobs of the OzonAction programme is to ensure that all those

who need to understand the issues surrounding replacement of ODS can obtain the information and

assistance they require. Hence this series of plain language reports – based on the reports of UNEP’s

Technical Options Committees (TOC) – summarizing the major ODS replacement issues for decision

makers in government and industry. The reports, first published in 1992, have now been updated to

keep abreast of technological progress and to better reflect the present situation in the sectors they

cover: refrigerants; solvents, coatings and adhesives; fire extinguishing substances; foams; aerosols,

sterilants, carbon tetrachloride and miscellaneous uses; and methyl bromide. Updating is based on

the 1998 reports from the TOCs and includes further information from the TOCs until 2000.

Updating of the reports at this point is particularly timely. The ‘grace period’ granted to developing

countries under the Montreal Protocol before their introduction of a freeze on CFCs came to an end in

July 1999. As developing countries now move to meet their Protocol commitments, accurate and up-

to-date information on available and appropriate technologies will be more important than ever if the

final goal of effective global protection of the ozone layer is to be achieved.

The publications in this series summarize the current uses of ODS in each sector, the availability of

substitutes and the technological and economic implications of converting to ODS-free technology.

Readers requiring more detailed information should refer to the original reports of the UNEP Technical

Options Committees (see Further Reading) on which the series is based.

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Acknowledgements

This report was written by Dr. Helen Tope (EPA Victoria, Australia) and Dr. Stephen O. Andersen (US

EPA), based on the work of TEAP and its ATOC. The report was peer reviewed by Mr. Jose Pons,

Prof. Ashley Woodcock, and members of the ATOC. Thanks are due to those members of the ATOC

who gave freely of their time to ensure that this publication, while written in plain language, reflects the

more detailed information available in the original report as accurately as possible.

MEMBERS OF THE 2001 UNEP AEROSOL PRODUCTS, STERILANTS, MISCELLANEOUS

USES AND CARBON TETRACHLORIDE TECHNICAL OPTIONS COMMITTEE

Co-chairs Affiliation Country

Jose Pons Spray Quimica Venezuela

Helen Tope Environment Protection Authority, Victoria Australia

Ashley Woodcock University Hospital of South Manchester UK

Members Affiliation Country

D. D. Arora Tata Energy Research Institute India

Paul Atkins Glaxo Wellcome USA

Olga Blinova Russian Scientific Centre "Applied Chemistry" Russia

Nick Campbell Elf-Atochem SA France

Hisbello Campos Ministry of Health Brazil

Christer Carling Astra Zeneca Sweden

Francis M. Cuss Schering Plough Research Institute USA

Chandra Effendy p.t. Candi Swadaya Sentosa Indonesia

Charles Hancock Charles O. Hancock Associates USA

Eamonn Hoxey Johnson & Johnson UK

Javaid Khan The Aga Khan University Pakistan

P. Kumarasamy Aerosol Manufacturing Sdn Bhd Malaysia

Robert Layet Ensign Laboratories Australia

Robert Meyer Food and Drug Administration USA

Hideo Mori Otsuka Pharmaceutical Company Japan

Robert F. Morrissey Johnson & Johnson USA

Geno Nardini Instituto Internacional del Aerosol Mexico

Dick Nusbaum Penna Engineering USA

Tunde Otulana Aradigm Corporation USA

Martyn Partridge Whipps Cross Hospital UK

Fernando Peregrin AMSCO/FINN-AQUA Spain

Jacek Rozmiarek Glaxo Wellcome SA Poland

Abe Rubinfeld Royal Melbourne Hospital Australia

Albert L. Sheffer Brigham and Women’s Hospital USA

Greg Simpson CSIRO, Molecular Science Australia

Roland Stechert Boehringer Ingelheim Pharma KG Germany

Robert Suber RJR-Nabisco USA

Ian Tansey Expert UK

Adam Wanner University of Miami USA

You Yizhong Journal of Aerosol Communication China

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Executive summary

The use of ozone-depleting substances in industry increased significantly until about 1990. The result

has been serious depletion of the ozone layer. The hole in the Antarctic ozone layer is now larger than

ever before and similar depletion frequently occurs over the Arctic.

The Montreal Protocol, drafted under the auspices of the United Nations Environment Programme

(UNEP), will phase out the production and consumption of the man-made substances that deplete

stratospheric ozone. This action will prevent further damage to the ozone layer, and should eventually

allow the ozone layer to repair itself.

This report considers CFC uses in aerosol products, as sterilants, and in a range of miscellaneous

applications including food freezing, tobacco expansion, fumigation and cancer therapy. It also covers

the use of carbon tetrachloride.

Aerosol products were, at one time, the source of 60 per cent of global CFC uses and emissions, as

much as 300,000 tonnes in 1986.

Substitutes for CFC aerosol products are readily available except for a few specialized medical and

industrial applications. CFC use in aerosol products will be reduced to insignificant amounts by 2005.

Currently about 1500 tonnes of CFCs are used in the sterilization of equipment. The most widely used

sterilant is ethylene oxide, a substance that is toxic, mutagenic, a suspected carcinogen, flammable

and explosive. To reduce these risks, ethylene oxide can be used in a mixture that contains 88 per

cent CFC-12 by weight. The alternatives to CFCs include the use of undiluted ethylene oxide, steam,

formaldehyde, a mixture of ethylene oxide and carbon dioxide, and mixtures of ethylene oxide with

HCFCs. These techniques enabled CFC phase out in developed countries by 1995.

Carbon tetrachloride is used as a feedstock in the production of CFC-11 and CFC-12, in the

production of key pharmaceuticals and agricultural chemicals, and as a catalyst promoter. Its use in

the CFC industry will be progressively reduced as CFCs themselves are phased out. The Montreal

Protocol allows the use of carbon tetrachloride as a feedstock wherever carbon tetrachloride is

destroyed in the production process, or where it is used as a process agent. (for more information

see TEAP, 2001 at http://www.teap.org).

The miscellaneous uses of CFCs cover a wide variety of fields but use only small amounts of CFCs.

They are therefore not covered in detail in this publication.

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Ozone depletion: an overview

Most of the oxygen in the Earth’s atmosphere is in the form of molecules containing two oxygen

atoms, known by the familiar chemical symbol O2. In certain circumstances, three atoms of oxygen

can bond together to form ozone, a gas with the chemical symbol O3. Ozone occurs naturally in the

Earth’s atmosphere where its concentration varies with altitude. Concentration peaks in the

stratosphere at around 25–30 kilometres from the Earth’s surface and this region of concentration of

the gas is known as the ozone layer.

The ozone layer is important because it absorbs certain wavelengths of ultraviolet (UV) radiation from

the Sun, reducing their intensity at the Earth’s surface. High doses of UV radiation at these

wavelengths can damage eyes and cause skin cancer, reduce the efficiency of the body’s immune

system, reduce plant growth rates, upset the balance of terrestrial and marine ecosystems, and

accelerate degradation of some plastics and other materials.

A number of man-made chemicals are known to be harmful to the ozone layer. They all have two

common properties: they are stable in the lower atmosphere and they contain chlorine or bromine.

Their stability allows them to diffuse gradually up to the stratosphere where they can be broken down

by solar radiation. This releases chlorine and bromine radicals that can set off destructive chain

reactions breaking down other gases, including ozone, and thus reducing the atmospheric

concentration of ozone. This is what is meant by ozone depletion. The chlorine or bromine radical is

left intact after this reaction and may take part in as many as 100,000 similar reactions before

eventually being washed out of the stratosphere into the troposphere.

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Effects of CFCs on stratoshperic ozone

UV radiation CFCl3

CFCl2

chlorineradical

chlorinemonoxide free

chlorineradical

ozone(O3)

series of reactions

oxygenmolecule

(O2)

+

When gases containing chlorine,

such as CFCs, are broken down

in the atmosphere, each chlorine

atom sets off a reaction that may

destroy hundreds of thousands

of ozone molecules.

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Another important environmental impact of a gas is its contribution to global warming. Global

Warming Potential (GWP) is an estimate of the warming of the atmosphere resulting from release of a

unit mass of gas in relation to the warming that would be caused by release of the same amount of

carbon dioxide. Some ODS and some of the chemicals being developed to replace them are known

to have significant GWPs. For example, CFCs have high GWPs and the non-ozone-depleting

hydrofluorocarbons (HFCs) developed to replace CFCs also contribute to global warming. GWP is an

increasingly important parameter when considering substances as candidates to replace ODS.

During past decades, sufficient quantities of ODS have been released into the atmosphere to damage

the ozone layer significantly. The largest losses of stratospheric ozone occur regularly over the

Antarctic every spring, resulting in substantial increases in UV levels over Antarctica. A similar though

weaker effect has been observed over the Arctic.

At present, scientists predict that, provided the Montreal Protocol is implemented in full, ozone

depletion will reach its peak during the next few years and will then gradually decline until the ozone

layer returns to normal around 2050.

PROTECTING THE OZONE LAYER • TECHNICAL BROCHURE UPDATES • AEROSOLS AND STERILANTS

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number of carbon atoms minus one (omitted if 0)

CC

FF

FF

ClCl CFC 114

number of hydrogen atoms, plus one

number of flourine atoms in one molecule

Note: 1. All spare valencies filled by chlorine atoms2. Different isomers are indicated by a suffic of lower case letters3. Bromine atoms are indicated by a suffic B plus number of atoms4. Hundreds number = 4 or 5 for blends (e.g. R-502)

CFC numbers provide the information

needed to deduce the chemical structure

of the compound. The digit far right

provides information on the number of

fluorine atoms, the digit second from the

right provides information on hydrogen

atoms, and the digit on the left provides

information on carbon atoms. Vacant

valencies are filled with chlorine atoms.

Adding 90 to the number reveals the

numbers of C, H and F atoms more

directly.

How CFC Nomenclature Works

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The Montreal Protocol

The Montreal Protocol, developed under the management of the United Nations Environment

Programme in 1987, came into force on 1 January 1989. The Protocol defines measures that

Parties must introduce to limit production and consumption of substances that deplete the ozone

layer. The Montreal Protocol and the Vienna Convention – the framework agreement from which the

Protocol was born – were the first global agreements to protect the Earth’s atmosphere.

The Protocol originally introduced phase out schedules for five CFCs and three halons. However, it

was designed so that it could be revised on the basis of periodic scientific and technical

assessments. The first revisions were made at a meeting of the Parties in London, in 1990, when

controls were extended to additional CFCs and halons as well as to carbon tetrachloride and methyl

chloroform. At the Copenhagen meeting, in 1992, the Protocol was amended to include methyl

bromide and to control HBFCs and HCFCs. A schedule for phase out of methyl bromide was

adopted at the Vienna meeting in 1995, and this was later revised in 1997, in Montreal. In 1999, the

Parties met in Beijing, where they extended control to bromochloromethane (CBM). By July 2001,

there were 177 Parties to the Montreal Protocol and more than 90 chemicals are now controlled.

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Ozone-depleting Major uses Ozone-depletion substance (ODS) potential (ODP)

Ozone-depleting substances (ODS) covered by the Montreal Protocol and their ozone-depletion potential (ODP)*

* Where ranges of ODP are given, readers requiring the exact ODP for a given CFC, halon, HBFC or HCFCshould refer to the Handbook for the International Treaties for the Protection of the Ozone Layer, published by theUNEP Ozone Secretariat, or other accredited sources.

Chlorofluorocarbons

(CFC)

Refrigerants; propellants for spray cans, inhalers, etc.;

solvents, blowing agents for foam manufacture

0.6–1

Halons Used in fire extinguishers 3–10

Carbon tetrachloride Feedstock for CFCs, pharmaceutical and agricultural

chemicals, solvent

1.1

1,1,1-trichlorethane

(methyl chloroform) Solvent 0.1

Hydrobromofluorocarbons

(HBFCs) Developed as ‘transitional’ replacement for CFCs. 0.01–0.52

Hydrochlorofluorocarbons

(HCFCs) Developed as ‘transitional’ replacement for CFCs. 0.02–7.5

Methyl bromide Fumigant, widely used for pest control 0.6

Bromochloromethane (CBM) Solvent 0.12

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How regulation works

All ODS do not inflict equal amounts of damage on the ozone layer. Substances that contain only

carbon, fluorine, chlorine, and/or bromine – referred to as fully halogenated – have the highest

potential for damage. They include CFCs and halons. Other substances, including the

hydrochlorofluorocarbons (HCFCs), developed as replacements for CFCs, also contain hydrogen. This

reduces their persistence in the atmosphere and makes them less damaging for the ozone layer. For

the purposes of control under the Montreal Protocol, ODS are assigned an ozone-depletion potential

(ODP).

Each controlled chemical is assigned an ODP in relation to CFC-11 which is given an ODP of 1.

These values are used to calculate an indicator of the damage being inflicted on the ozone layer by

each country’s production and consumption of controlled substances. Consumption is defined as

total production plus imports less exports, and therefore excludes recycled substances. The relative

ozone-depleting effect of production of a controlled ODS is calculated by multiplying its annual

production by its ODP, results are given in ODP tonnes, a unit used in this series of publications and

elsewhere. The ODS currently covered by the Montreal Protocol are shown, with their ODPs, in the

table opposite.

Developing countries and the Montreal Protocol

From the outset, the Parties to the Montreal Protocol recognized that developing countries could face

special difficulties with phase out and that additional time and financial and technical support would

be needed by what came to be known as ‘Article 5’ countries. Article 5 countries are developing

countries that consume less than 0.3 kg per capita per year of controlled substances in a certain

base year. They are so called because their status is defined in Article 5 of the Protocol1.

Financial and technical assistance was provided under the 1990 London Amendment which set up

the Multilateral Fund (MLF). Activities and projects under the MLF are implemented by four

implementing agencies: UNDP, UNEP, UNIDO and the World Bank.

Article 5 countries were also granted a ‘grace period’ of 10 years to prepare for phase out. 1999

marked the end of that period for production and consumption of CFCs. Article 5 countries have,

since 1999, entered the ‘compliance’ period in which they will have to achieve specific reduction

targets.

The requirements of the Montreal Protocol as of December 2000 for both developed and Article 5

countries are shown in the table on page 10.

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1 This is often written Article 5(1), indicating that status is defined in paragraph 1 of Article 5 of the Protocol.‘Article 5 Parties’ is also used.

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Requirements of the Montreal Protocol including amendments and adjustments to the end of 1999**

Controlled Substance Reduction in consumption Reduction in consumption and production for and production for developing developed countries (Article 5) countries

CFC-11, CFC-12, CFC- 113,

CFC-114, CFC-115

Base level: 1986

1989: Freeze

1994: 75 per cent

1996: 100 per cent

Base level: Average of 1995–1997

1999: Freeze

2005: 50 per cent

2007: 85 per cent

2010: 100 per cent

Halon 1211, halon 1301, halon

2402

Base level: 1986

1992: 20 per cent

1994: 100 per cent

Base level: Average of 1995–1997

2002: Freeze

2005: 50 per cent

2010: 100 per cent

Other fully halogenated CFCs Base level: 1989

1993: 20 per cent

1994: 75 per cent

1996: 100 per cent

Base level: Average of 1998–2000

2003: 20 per cent

2007: 85 per cent

2010: 100 per cent

Carbon tetrachloride Base level: 1989

1995: 85 per cent

1996: 100 per cent

Base level: Average of 1998–2000

2005: 85 per cent

2010: 100 per cent

1,1,1-trichloroethane

(methyl chloroform)

Base level: 1989

1993: Freeze

1994: 50 per cent

1996: 100 per cent

Base level: Average of 1998–2000

2003: Freeze

2005: 30 per cent

2010: 70 per cent

2015: 100 per cent

HCFCs Consumption

Base level: 1989 HCFC consumption +

2.8 per cent of 1989 CFC consumption

1996: Freeze

2004: 35 per cent

2010: 65 per cent

2015: 90 per cent

2020: 99.5 per cent

2030: 100 per cent

Production

Base level: 1989 HCFC consumption +

2.8 per cent of 1989 CFC consumption

2004: Freeze

Consumption

Base level: 2015

2016: Freeze

2040: 100 per cent

Production

Base level: 2015

2001: Freeze

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Requirements of the Montreal Protocol including amendments and adjustments to the end of 1999**

Controlled Substance Reduction in consumption Reduction in consumption and production for and production for developing developed countries (Article 5) countries

** The Protocol allows some exemptions, e.g. for "essential uses." Readers requiring full details of phase out for a given substanceshould refer to the Handbook for the International Treaties for the Protection of the Ozone Layer, published by the UNEP OzoneSecretariat, or other accredited sources.

HBFCs 1996: 100 per cent 1996: 100 per cent

Bromochloromethane 2002: 100 per cent 2002: 100 per cent

Methyl bromide Base level: 1991

1995: Freeze

1999: 25 per cent

2001: 50 per cent

2003: 70 per cent

2005: 100 per cent

Base level: Average of 1995-1998

2002: Freeze

2005: 20 per cent

2003: review of reduction schedule

2015: 100 per cent

0

50

100

150

200

Beijing Amendment

Montreal Amendment

Copenhagen Amendment

London Amendment

Montreal Protocol

Vienna Convention

Agreement

No. of CountriesRatifying

Progress in the ratification of the Montreal Protocol and its amendments

Source: Caleb Management Services, UK

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CFC use in aerosol products

Compressed gas propellants

were first used in 1923 as a

means of dispersing

insecticides. An aerosol

propellant must evaporate

quickly and disperse the active

ingredient effectively.

Compressed gas is of limited

use as a propellant since the

gas pressure in the container

falls as the container empties.

CFC-12 was introduced, during World War II, because it maintains constant pressure until all of the

product is dispensed. CFCs are also not explosive, flammable or toxic, can be produced in very pure

form and are good solvents. These properties made them the preferred propellant in an industry that

expanded rapidly after World War II. By 1987, more than 8000 million aerosol cans were being

produced annually – the equivalent of 15,000 per minute.

CFCs have been used to dispense a wide variety of sprays, including lacquers and paints,

deodorants, shaving foam, perfume, insecticides, window cleaners, oven cleaners, pharmaceutical

and veterinary products, glues and lubricating oils. CFC-12 was the most widely used propellant but

CFC-114 was also used to disperse products containing alcohol. CFC-11 is not a propellant, but was

added to some formulations as a solvent and carrier.

The fact that CFCs were both good propellants and good solvents accounted for many of their uses

in aerosol products. In some formulations, CFCs had the added advantage of suppressing the

flammability of other ingredients.

CFCs are also used in aerosol products designed to produce a chilling effect that occurs when

compressed gases are sprayed. Aerosol chilling products include local anaesthetic and sprain

treatment, freezing of liquids in leaking pipes to cut off flow while repairs are made, freezing of

chewing gum so that it can be removed from fabrics, and identification of electronic circuit faults by

cooling solder joints so that the electrical circuit is interrupted. CFCs can also be used to remove dust

from photographs, disks and tapes because they evaporate quickly and leave no residues. And,

finally, the sudden escape of CFCs from a small orifice is used to create noise in fog and sports

horns, and alarm equipment.

In the mid-1970s, aerosol products accounted for 60 per cent of all the CFC-11 and CFC-12 used

worldwide. By the end of the decade, however, countries were beginning to ban or restrict the use of

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others7%

foams

aerosols 27%

refrigeration 25%

solvents 16%

Aerosol product uses

currently account for about

27 percent of all CFC

usage but reductions are

being rapidly introduced in

most countries.

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CFCs in aerosol products and, after the introduction of the Montreal Protocol in 1987, CFC use in

aerosol products began to decline rapidly. Overall consumption was about 300,000 tonnes in 1986

but was reduced to some 180,000 tonnes in 1989. Progress since then has been rapid. There are

now no technical barriers to global transition to alternatives. In 1991 about 115,000 tonnes of CFCs

were used in aerosol products. By 1999 this had fallen to about 9000 tonnes (excluding MDIs –

metered-dose inhalers). The table below summarizes regional consumption in 1999.

How countries reduced CFC use in aerosol products

There have been four distinct stages in phasing out CFCs from convenience and cosmetic aerosol

products:

Stage 1: Stage 2: Stage 3: Stage 4:

Before 1987 1987 to 1990 1990 to 1992 1992 to 2001

Canada, Sweden, Australia, Austria, Brazil, Egypt, Finland, All countries except

and the United States Denmark, Germany, Hungary, Norway, some developing

Mexico, New Zealand, Switzerland, and countries and some

United Kingdom, and Trinidad and Tobago CEITs

Venezuela

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Regional use of CFCs in aerosol products (excluding MDIs)

CFC Used (tonnes) 1999

ASEAN countries 900

China 2300

Indian subcontinent countries* 1000

Latin America 500

Middle East and Africa 400

Russian Federation 3500

Ukraine 500

Other CEIT, including CIS** 100

Total 9200

* India, Pakistan, Sri Lanka, Bangladesh, Nepal and Bhutan** Other countries with economies in transition, including the Commonwealth of Independent States

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CFC use in metered dose inhalers

CFC-containing metered dose inhalers (MDIs) provide reliable and effective therapy for respiratory

diseases such as asthma and chronic obstructive pulmonary disease (COPD). MDIs generally use

CFC-12 as a propellant. To suspend or dissolve medication, most use CFC-11 and CFC-114, either

alone or in a mixture. Approximately 500 million MDIs were used annually worldwide in 1998, using

approximately 10,000 tonnes of CFCs.

The prevalence of asthma and COPD is increasing worldwide. In 1998 there were estimated to be

300 million patients with asthma and COPD throughout the world. Evidence confirms that asthma

prevalence is increasing as urbanization of developing countries continues. There is international

consensus that primary treatment of these diseases should be by the inhaled route. Inhalation permits

fast and efficient delivery of treatment to the airways with minimal risk of adverse reactions. Therapy

requires regular treatment, often with more than one drug. MDIs remain the dominant inhaled delivery

system in most countries and for all categories of drugs.

Overall, use of inhaled medication is increasing because of increased prevalence of disease. World

Health Organization/US National Heart, Lung and Blood Institute (WHO/NHLBI-GINA) guidelines on

asthma management also encourage the inhaled route as the preferred method of administering

medicine. Therapy administered by the inhaled route is likely to remain the mainstay of therapy for

asthma/COPD.

An MDI is a complex system designed to provide a fine mist of medicament for inhalation directly to

the lungs to treat respiratory diseases such as asthma and COPD. The active ingredient may be

dissolved in the propellant but is more often present as a suspension of particles, the majority of

which are less than 5 micrometers in diameter. A surface-active agent may be included to ensure that

the drug is well suspended and to help lubricate the metering valve. When a patient uses an MDI, the

drug/propellant mixture in the metering chamber of the valve is expelled by the vapour pressure of the

propellant through the exit orifice in the actuator. As droplets of drug in propellant leave the spray

nozzle the propellant gases expand, with very rapid evaporation, resulting in a fine aerosol cloud of

drug particles.

Alternatives to CFC-based MDIs are primarily hydrofluorocarbon (HFC) based MDIs, dry powder

inhalers (DPIs) (single or multi-dose), nebulizers (hand held or stationary), orally administered drugs

(tablets, capsules or oral liquids) and injectable drugs. It is likely that a wide range of reformulated

products will be available in many developed countries and transition to these products away from

CFCs will be making good progress by the year 2005.

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CFC use in sterilants

A mixture of ethylene oxide and CFC-12 is used to sterilize medical equipment. The CFC is used to

reduce the flammability and explosive risk of ethylene oxide. The most common mixture contains 88

per cent CFC-12 by weight, and is commonly known as 12/88. Use of CFC-12 in sterilization has

been successfully phased out in most developed countries and in some countries with economies in

transition; it is still used in developing countries. Worldwide, use of CFC-12 for this purpose was

estimated to be less than 1500 tonnes in 1998 (compared with approximately 25,000 tonnes in 1989).

Ethylene oxide penetrates packaging materials, destroys microorganisms and diffuses away from the

package leaving almost no residues. It is used to sterilize medical and surgical equipment and

devices such as catheters and fibre optic medical equipment that are sensitive to heat and moisture.

Since ethylene oxide is toxic, mutagenic, a suspected carcinogen, flammable and explosive, its use

requires stringent safety precautions and is strictly regulated in some countries. This has led to widely

differing sterilization practices in different countries. Great efforts have been made to replace ethylene

oxide as a sterilant, particularly in hospitals, owing to concerns about exposure of personnel. The fact

that ethylene oxide is still widely used as a sterilant is evidence that, in numerous applications, the

benefits of its use outweigh these disadvantages.

Consumption patterns vary globally so that while no use of 12/88 is reported for China, its use has

been reported in more than 40 other developing countries. There are also indications of increasing

use of CFC-12 in sterilization in some developing countries. Some manufacturers of surgical

equipment may even be shipping products from developed to developing countries for sterilization

with 12/88.

A range of sterilization methods is available. Some use ethylene oxide, others do not. Ethylene oxide

can be used as a sterilant either alone or diluted with other gases such as CFC-12, HCFCs or carbon

dioxide (CO2). Methods that do not rely on ethylene oxide include steam sterilization, dry heat,

formaldehyde, radiation and ionized gas plasma.

HCFC replacement mixtures for 12/88 are used mostly in the United States and in some European

countries. The European Union has legislation restricting the use of HCFCs in emissive applications

such as sterilization. Mixtures of HCFCs and ethylene oxide are virtual drop-in replacements for

12/88. HCFCs have been found to be important as transitional products in sterilization in those

countries that previously employed 12/88 extensively. The use of HCFC replacement mixtures was

estimated to be less than 3000 metric tonnes in 1998 (some 90 ODP tonnes).

KEY FACTS

Ethylene oxide can beused to sterilize medicalequipment, either aloneor diluted with othergases such as CFC-12,HCFCs or carbondioxide (CO2). Mixturesof CFC-12 and ethyleneoxide are used in somedeveloping countries.Mixtures of HCFCs andethylene oxide are usedin some developedcountries. Methods thatdo not rely on ethyleneoxide include steamsterilization, dry heat,formaldehyde, radiationand ionized gas plasma.Health and safetyregulations on ethyleneoxide in some countrieshave led to the use ofprocesses such assteam, formaldehydeand radiation.

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Carbon tetrachloride

Carbon tetrachloride (CCl4) – a controlled substance under the Montreal Protocol – is used as a

feedstock for the production of other chemicals, as a process agent, and for other uses.

As a feedstock, carbon tetrachloride is the basic chemical building block in the production of other

CFCs, notably CFC-11 and CFC-12. The carbon tetrachloride undergoes transformation in the

process and is converted from its original composition. Only insignificant trace emissions, allowed

under the Montreal Protocol, remain.

When used as a process agent, carbon tetrachloride’s unique chemical or physical properties

facilitate an intended chemical reaction and/or inhibit an unintended one. Carbon tetrachloride is used

as a process agent in a variety of applications including the chlorination of rubber and the production

of ibuprofen (a basic drug used for analgesic formulations in painkillers). Some products can be

produced without the use of carbon tetrachloride, for others, carbon tetrachloride cannot be replaced

for reasons of health, safety, environment, quality, yield, cost effectiveness, technical and economic

feasibility. The Montreal Protocol allows specific uses of carbon tetrachloride as a process agent (for

elaboration see TEAP, 2001 at http://www.teap.org).

The use of carbon tetrachloride as a solvent includes simple solvent extraction, such as caffeine

extraction and palm oil extraction, and cleaning applications such as metal degreasing and textile

spotting. Substitutes are commercially available and economic. These uses should therefore be

discontinued to protect the ozone layer and safeguard the health and safety of people using carbon

tetrachloride. Carbon tetrachloride can also be used in miscellaneous applications such as fire

extinguishers, grain insecticide fumigation, and as an anti-helminthic agent (especially for the

treatment of liver fluke in sheep).

In 1996, estimated atmospheric emissions of carbon tetrachloride were 41,000 tonnes. The primary

source of atmospheric emissions of carbon tetrachloride is its use as a feedstock in the production of

CFCs. Emissions have been estimated at around 28,000 tonnes for 1996, about 70 per cent of total

emissions. The majority of feedstock use emissions originate from CFC production in developing

countries and countries with economies in transition. As production of CFCs is phased out under the

Montreal Protocol, carbon tetrachloride emissions will continue to decline. Atmospheric levels of

carbon tetrachloride have already reduced as a result of the phasing out of CFC consumption in

developed countries.

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KEY FACTS

Carbon tetrachloride is acontrolled substanceunder the MontrealProtocol.

Its main use is as afeedstock for theproduction of CFCs – ause that will disappearalong with CFCs.

Other uses are as aprocess agent in thechemical industry, as asolvent and for graininsecticide fumigation.The Montreal Protocolallows the use of carbontetrachloride as afeedstock and specificuses as a processagent.

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There are a number of measures that can lead to reductions in carbon tetrachloride emissions to the

environment:

• closure of CFC manufacturing facilities;

• conversion of facilities using carbon tetrachloride as process agents to alternatives;

• further use of improved emission control technology in carbon tetrachloride and CFC

manufacturing facilities;

• further use of improved containment and emission control technology in manufacturing facilities

using carbon tetrachloride as process agents.

As the bulk of carbon tetrachloride production is for use as a feedstock for CFC production this use

will be eliminated along with CFCs. Carbon tetrachloride is not dealt with further in this publication (for

more information see TEAP, 2001 at http://www.teap.org).

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Miscellaneous uses

CFCs have been used in small amounts in many different ways in many different industries. The minor

uses described below now consume insignificant amounts of CFC. In 1998, tobacco expansion was

thought to be the largest of these small uses. Laboratory and analytical uses of CFCs are perhaps the

most widespread of these uses globally.

• CFC-11 has been used to expand dried tobacco to its original size to provide low tar cigarettes.

Worldwide use is difficult to estimate. About 4050 tonnes was used in China in 1996. Carbon dioxide

is an alternative expansion agent used in many countries. Others used less commonly are nitrogen,

propane, and iso-pentane. The principal difficulty for developing countries is the high capital cost of

conversion to alternative technologies. Most are converting to carbon dioxide expansion technologies.

• Laboratory and analytical uses of ozone depleting substances such as CFC-113 and carbon

tetrachloride include: equipment calibration; extraction solvents, diluents, or carriers for specific

chemical analyses; inducing chemical-specific health effects for biochemical research; as a carrier

for laboratory chemicals; and other critical purposes in research and development where

substitutes are not readily available or where standards set by national and international agencies

require specific use of the controlled substances. The Montreal Protocol allows a global exemption

for laboratory and analytical uses for developed countries until the end of 1995 under strict

conditions (see Decisions VI/9)2. International and national organizations are working to eliminate

the use of ozone depleting substances in many laboratory and analytical uses. Decision XI/193

eliminates three major uses from the global exemption from 1 January 2002: testing of oil, grease

and total petroleum hydrocarbons in water; testing of tar in road paving materials; and forensic

finger-printing.

• Food can be frozen through contact with liquid CFC-12, which boils at -30 °C at normal pressure.

CFC consumption has been totally eliminated from this application using available alternative

freezing methods.

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fahrenheit

celsius

3020

10

0-1

0

-20

8070

60

50

408570

55

4025

10-5

160145

130

115

10020°

25°30°5°

10°

15°

GLACIER

FROZEN SHRIMPS

123005700150004

alternatives:liquid nitrogen and air blast freezing

Food freezing

Thermostats/thermometers Double glazingMetal purification

little used: abandon technique? new formulations being developed

Tobacco expansion

alternatives: HCFC-123, propane, steam, liquid N2 and CO2

Fumigation

Radiation therapy

alternatives: conventional fumigation

temporary exception

KEY FACTS

There are manymiscellaneous uses ofCFCs in industry butnone use substantialamounts.

The two remainingconsumers are theexpansion of curedtobacco to provide lowtar cigarettes, andlaboratory and analyticaluses.

Substitute chemicalsand processes areavailable for allmiscellaneous uses.

With the phase out ofCFCs in developingcountries, thesesubstitutes will be usedor the processesabandoned.

2 Decision VI/9 adopted by the 6th Meeting of the Parties to the Montreal Protocol. For details, see the Handbookfor the International Treaties for the Protection of the Ozone Layer (UNEP Ozone Secretariat).

3 Decision XI/19 adopted by the 11th Meeting of the Parties to the Montreal Protocol. For details, see theHandbook for the International Treaties for the Protection of the Ozone Layer (UNEP Ozone Secretariat).

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• Fumigation with CFC/ethylene oxide mixtures can be used to treat an assortment of objects,

including spices, rare books and manuscripts, and beehives. Consumption of CFCs for this

application in developed countries has been eliminated. Consumption would be minimal, if any, in

developing countries.

• CFC-12 and a halide detector can be used to detect leaks in pressure vessels. A combination of

HCFC-22 and nitrogen is one alternative, another is the use of helium with helium detectors.

• Wind tunnels are sometimes filled with CFCs because the velocity of sound is much lower in CFC

than in the air. This means that supersonic conditions can be reached with much lower circulation

rates. Possible alternatives are sulphur hexafluoride and HFC-134a.

• In the United Kingdom, graphite rods for nuclear reactors used to be purified by heating them in a

furnace filled with CFC-12. The process is no longer used. A similar process has been used in the

Middle East to refine aluminium.

• Refrigerator and central heating thermostats and thermometers have made use of the rate at

which CFCs expand as temperature rises to operate on/off switches and turn dials on rotary

thermometers. Other fluorinated chemicals are alternatives for this application.

• Double glazing sometimes uses a gas mixture that includes CFC-12 to lower thermal conductivity

and increase transparency. Other insulating gases such as argon are used as alternatives.

European insulating window manufacturers sometimes use sulphur hexafluoride – one of the most

potent greenhouse gases known – but this use may be environmentally counterproductive and

could be banned under new regulations to protect the climate.

• Linear accelerators used for radiation therapy have used CFC-12 as a dielectric medium in the

transmission of energy at radio frequencies. Sulphur hexafluoride is used as an alternative.

• Solar tracking systems have made use of CFC expansion to tilt solar panels towards the sun. HCFC-

22 is a substitute and mechanically driven systems are also available. The latter, however, are more

prone to wind damage and are less energy efficient since they use tracking motors.

Other minor uses of CFCs may exist. However, with phase out of CFCs, most have either been

abandoned or replaced by alternative substances and processes. A few very minor uses, such as

laboratory and analytical uses have required temporary exemption in developed countries since 1996.

As these minor uses of CFCs are relatively insignificant, they are not considered further in this

publication.

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Laboratory analysis

temporary exeption

Leak testing

temporary exemption

Wind tunnels

little used: abandon technique?

Ice plugs in piping

alternatives: HCFC-22 and HCFC-152

Drug manufacturing

substitutes by the year 2000

Solar tracking systems

HCFC-22 and mechanical systems

19.26

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Aerosol products

CFCs are used in aerosol products as propellants, as solvents, as a means of reducing the

flammability of the active ingredient and as the active ingredient itself in aerosol products designed to

chill and to produce noise. Substitutes for CFCs are chosen with these properties in mind. Many

different substitutes have been adopted and proposed to replace CFCs.

One approach involves finding a substitute for the aerosol concept itself – such as the use of solid

sticks for deodorants. The range of possibilities is shown in the table below.

Substitutes for propellants

Hydrocarbons and dimethyl ether

The hydrocarbons, propane, normal butane and isobutane are the most common substitutes for CFC

propellants. They are cheap and efficient, but highly flammable. Operators can minimize risks by

installing fire detection and extinguishing systems, reinforcing buildings to reduce explosion damage,

and providing safety training. The average cost of converting a filling plant to hydrocarbons varies

according to the location and size of the facility. Hydrocarbons generally cost between one-third and

one-fifth as much as CFCs, and the savings obtained soon pay back the conversion costs. However,

if the hydrocarbons need to be purified, operating costs may increase considerably.

Dimethyl ether is used extensively as a propellant, particularly in Europe. It has excellent solvency and

compatibility with water. Although it is flammable it can be used in aerosol filling plants if the usual

safety procedures for flammable propellants are followed.

Hydrocarbons and dimethyl ether share the same disadvantage: they are volatile organic compounds

(VOCs) that take part in chemical reactions in the atmosphere in the presence of sunlight resulting in

the production of toxic ground-level ozone. However, dimethyl ether has been used to produce low

VOC formulations with a high water content, which replaces organic solvents.

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Aerosol products: currently available alternatives

alternative propellants alternative solvents alternative delivery systems

• hydrocarbons (propane, butane)

• dimethyl ether

• compressed gases

(CO2, N2, N2O, air)

• HFC-152a

• HFC-134a

• HFC-227ea

• HCFC-22

• water

• alcohols (ethanol, iso-

and n-propanol)

• chlorinated solvents

(methylene chloride,

trichloroethylene,

perchloroethylene)

• pentane, hexane, white spirits,

acetone, methyl ethyl ketone

• HCFC-141b, HFC-43-10mee,

volatile silicones

• finger and trigger pumps

• mechanical pressure dispensers

• sticks (for deodorants, anti-

perspirants, insect repellents)

• rollers, brushes and cloths

• bag-in-can and piston-in-can

systems

KEY FACTS

The aerosol productsindustry can eliminateCFC usage byconverting to alternativepropellants, including:

• hydrocarbons;

• dimethyl ether;

• compressed air, CO2or nitrous oxide; and

• HFCs and HCFCs.

HFC-134a, which isnon-flammable and hasan ODP of zero, alsohas a high GWP. Its usewill therefore be limited.

Some products can beredesigned to eliminatethe use of propellantaerosols.

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Compressed gas

If a coarse spray is acceptable, air, nitrogen, carbon dioxide and nitrous oxide can be used instead of

CFC propellants. The main limitation with these compressed gases is that the pressure inside the

container falls as it empties reducing the delivery rate, spray quality and even the quantity of spray

dispensed. Careful quality control is needed to avoid propellant leaks. Carbon dioxide can produce

corrosion in the can if the formula and can specifications are not carefully chosen. The percentage of

aerosol products using compressed gases is currently 7–9 per cent of all products.

HFCs and HCFCs

HFC-134a and HFC-227ea are new replacements for CFCs. Both of these are non-flammable and

both have an ODP of zero. HFC-134a is the principal replacement of CFC-12 in pharmaceutical

inhalants, HCFC-22 for certain industrial products. HFC-227ea is also being used for pharmaceutical

inhalants. These substances have a high global warming potential. Their use will be limited.

Use of HCFC-22 is not permitted in either the United States or the European Union. HCFC-22 has

been used in place of CFCs for some industrial and technical uses where non-flammable propellants

are essential. HCFC-22 has also been used in some personal products, such as hair sprays and

aerosol fragrances, although use in this category is minimal. HCFC-22 has a higher pressure than

CFC-12.

Substitutes for solvents

Methyl chloroform, CFC-113 and carbon tetrachloride have all been used as solvents in aerosol

formulations and they are still used in some developing countries and countries with economies in

transition. These substances are all non-flammable, have large evaporation rates, high density, low

viscosity and surface tension, and are reasonably low cost where they are still available. Their

solvency power varies from very high (carbon tetrachloride and methyl chloroform) to very low (CFC-

113). CFC-113 has generally been considered safe for most uses. However methyl chloroform has

much lower exposure levels and should be used only in well-ventilated places. Carbon tetrachloride is

a well-known carcinogen; for that reason alone it should not be used in aerosols. It is possible to

replace these solvents with non-ODS alternatives. However, in developed countries, particularly in

some parts of the United States, VOC regulations have made replacement more difficult by limiting

the amount of VOCs that could be used in each product category.

The two properties that are most difficult to duplicate simultaneously are high evaporation rate and

non-flammability. Where VOC regulations do not limit available options, formulators can usually use

mixtures of chlorinated solvents, such as non-ozone-depleting methylene chloride and

perchloroethylene, with alcohols, ketones, and aliphatic and/or aromatic hydrocarbons. In other cases

it may be possible to replace the ozone-depleting solvent with a mixture of dimethyl ether and water.

The multiplicity of aerosol products requires that each formulation has to be carefully analysed in each

case to determine which characteristics are more desirable.

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Alternative non-aerosol methods

Improvements in the design of finger pumps and trigger pumps have allowed these mechanical

dispensing devices to increase their market share. Modern pumps are capable of dispensing fine

mists of low viscosity products at any angle of operation. The disadvantages of pump sprays are that

they produce larger droplets, and the spray penetrates less than that produced by aerosol products.

Aerosol products still offer some unique advantages over these mechanical devices, such as total

enclosure that prevents tampering with the product or oxidation due to air intake (in pumps, air is

admitted to replace the liquid that is dispensed). Total investment will be lower than for an aerosol

facility with similar throughput. The cost of the package for pumps is highly dependent on the style of

the bottle and pump, degree of construction, order quantity, local supply and economics. However, in

most cases pumps will be at least as expensive as aerosol products or even more so. On the other

hand, pump dispensers can be refilled many times, thus saving cost and reducing waste.

The solid stick dispenser is a non-spray dispenser for deodorant or antiperspirant. Pack costs for

solid sticks vary with the degree of package sophistication and will, in some cases, exceed the price

of an aerosol can and valve. However, the finished product will last longer than an aerosol product,

with substantial savings to the customer. Capital costs for filling and assembling of roll-on dispensers

are lower than those for an aerosol line of similar capacity (typically half the investment cost).

In two compartment aerosol (or “pressurized”) products the concentrate and propellant inside the

aerosol package are separated, either by use of a piston, an inner bag containing the product, or an

expanding bag containing propellant. A number of systems are available, some of which have been

commercialized for a long time. Designed originally for dispensing of viscous products (gels, pastes,

cheese spreads, etc.) they can be used with liquids to provide a propellant free spray. A two

compartment pressurized can costs about twice as much as a normal aerosol product. Special filling

machines that are more expensive than normal aerosol fillers are needed for these systems.

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product

piston

propellant

product

propellant in bag

product in bag

propellant

suction created by trigger action

product drawn up dip tube

Alternatives to propellant aerosol products.

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Potential problems

Specialized aerosol product uses

CFCs are difficult to replace for some specialized uses of aerosol products. Propellants in medical

aerosol products must be neither toxic nor flammable. Propellants and solvents in aerosol products

used for many industrial purposes must be non-flammable and inert.

CFCs are still being used as propellants in some developing countries, for medical aerosol products

containing substances such as anaesthetics and antiseptics. Medical aerosol products that are not

inhaled can be converted to alternative propellants, dispensed by mechanical pump sprays, or

produced as powders. The CFC-free products will need to be approved by local health authorities.

This can be a lengthy process.

CFCs are also used as propellants and solvents in aerosol products for lubricating, cleaning and fault-

checking of electrical equipment. Most of these products have been converted to use HFC-134a as

propellant. HCFC-141b can be used in developing countries as a partial replacement for CFC-113,

but its use for this purpose is not allowed in developed countries.

Developing countries’ perspective

Use of CFC in aerosols in developing countries is declining slowly. A faster decline will not occur

unless the specific problems of reformulation of medical aerosols and industrial and technical aerosols

are solved. Where lack of availability of hydrocarbons is stopping conversion of non-metered dose

inhaler medical aerosols, availability problems need to be solved. Final phase out of the use of CFCs

will also require conversion of small users, overcoming any potential public safety issues for small

aerosol fillers operating in congested areas.

Final phase out

As most aerosol products have been converted to non-ODS propellants and solvents, an accelerated

phase out of CFCs would be relatively simple. In 2000, it was estimated that less than 10,000 tonnes

of ozone-depleting substances were used worldwide in the manufacture of aerosols (excluding MDIs).

Most of this amount was used for the manufacture of non-MDI medical aerosols in developing

countries and countries with economies in transition.

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Metered dose inhalers

Currently available alternatives to CFC-based metered dose inhalers (MDIs) are, primarily:

• CFC-free MDIs;

• dry powder inhalers (DPIs) (single or multi-dose);

• nebulizers (hand held or stationary);

• orally administered drugs (tablets, capsules or oral liquids);

• and injectable drugs.

All the CFC-free MDIs under development contain the same components as the CFC products, but

the very different physical properties of the HFC propellants have meant that significant changes have

had to be made. CFC-free MDIs will contain the new propellants HFC-134a or HFC-227ea, and some

products may contain both. The HFCs have very different properties to the CFCs. This has resulted in

new formulations being developed. The CFC-free MDI may superficially look the same as the CFC

MDI, but it will have a different taste and mouth feel that will be obvious to the user.

In the future, alternatives are likely to include non-CFC MDIs, new DPIs, new nebulizers, novel non-

inhaled treatments, and new propellant-free inhalation devices. Some of these are already on the

market, and many others are in the late stage of development or under regulatory evaluation. They

will reach the market place in the next few years.

DPIs can now be used successfully for most anti-asthma drugs. These inhalers are an immediately

available alternative for a large proportion of patients, although they may not represent a satisfactory

alternative to the pressurized MDIs for all patients or for all drugs. Currently available DPIs are

lightweight and portable like MDIs; they require less coordination to use than most MDIs; they have

the potential to use pure drugs without additives; they are difficult for patients with very low inspiratory

flow, e.g. small children and the elderly; they may require special packaging for use in humid climates;

some require special handling during use; the cost compared with MDIs varies between products and

countries; patient acceptability is not uniform. In some countries, over 85 per cent of inhalers used

are DPIs.

There is an increasing use of the multi-dose dry powder inhaler and this is likely to accelerate as new

multiple dose devices are produced, particularly as they may be more suitable for young children,

provided their inspiratory flow is sufficient. DPI usage globally, as a percentage of all inhaled

medication, is estimated to be around 17 per cent. This figure varies considerably from country to

country. For example, it is currently 85 per cent in Sweden, less than 2 per cent in the USA, and no

DPIs are available yet in Japan. It seems unlikely that uptake of DPIs in most countries will be at the

levels seen in Scandinavian countries.

Nebulizers are devices that are filled with a drug that is dissolved or suspended in aqueous solution

and that is converted to inhalable droplets using compressed air or ultrasonic waves. Nebulizers are

generally not considered to be alternatives to MDIs. They are mainly restricted to the treatment of

infants and severely ill patients where patient cooperation is minimal, or to situations when larger

doses of drug and/or prolonged administration times are desired.

Oral medications include tablets, capsules, and oral liquids and have been the standard form of

therapy for most diseases for many years. For existing products such as steroids and

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bronchodilators, tablet therapies involve higher doses and greater risk of side effects. Regulatory

authorities in some countries have approved novel oral compounds (e.g. leukotriene modifiers) for the

treatment of asthma. These may be of value to certain asthma sufferers, but it is unlikely that they will

be a full substitute for the current inhaled preventive therapy.

Some drugs used for the treatment of asthma and COPD are also available in injection form.

However, injection is not practical for general use in ambulatory patients. It is therefore reserved for

the treatment of hospitalized patients.

Continued provision of MDIs in developing countries will depend either on import of products or local

production. Local production of CFC MDIs is likely to continue for some time after cessation of their

use in developed countries and will overlap with the importation and local production of CFC-free

MDIs by multinational and national companies. Local production of CFC-free MDIs by a local

producer, a multinational company, or by a local producer in collaboration with a multinational

company will require the transfer of new technologies and may require new licensing arrangements

and transfer of intellectual property. The costs of local production of CFC-free inhalers will include

capital costs and licensing arrangements. Multinational companies operating in Article 5 countries

should be encouraged to make the technology transfer as soon as possible. One company is already

committing resources to set up manufacturing capacity for HFC MDIs in Latin America (Brazil) and

Eastern Europe (Poland). The manufacturing plants will be operational in the next couple of years and

will serve local and regional market needs.

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Sterilants

Ethylene oxide mixed with CFC-12 (a mixture known as 12/88) is used to sterilize medical equipment.

Hospitals, medical equipment manufacturers and commercial sterilizing facilities also use a range of

other sterilizing substances and processes for particular products.

Methods for sterilization of medical and surgical equipment and devices have developed differently in

each country, influenced by country-specific codes and regulations for fire protection, occupational

safety, validation of results, liability considerations, availability of sterilization equipment and materials,

and medical practices.

Quality health care is dependent on ensuring the sterility of medical devices. Validation of processes

for an intended application is important to avoid problems of incompatibility with certain materials or

deficiencies in the level of sterility. Not every process or sterilant will be compatible with all products.

However, once a technology is validated for a specific application it becomes a viable alternative for

that application.

Alternative sterilization processes

The alternative processes listed below can be used to reduce or replace the use of ozone-depleting

substances in sterilization.

Steam sterilization

Steam sterilization is the least expensive of all sterilization methods and is widely used by medical

equipment manufacturers and hospitals. This process is non-toxic, economical and safe. It can be

used for equipment that can withstand high humidity and temperatures of at least 113 °C. Steam

sterilization cannot be used to sterilize certain heat and moisture-sensitive medical equipment, e.g.

the equipment used for operations such as organ transplants.

Hospital practice can minimize the use of mixtures of ozone-depleting substances with ethylene

oxide by separating the majority of equipment that can be sterilized with steam (and/or formaldehyde)

from the heat- and moisture-sensitive equipment sterilized with the ethylene oxide mixture.

Formaldehyde

Formaldehyde has been used as a sterilant for many years. However, as it is toxic and a suspected

carcinogen, its use is restricted in some countries. The most common formaldehyde sterilization

process can be used on equipment that can withstand temperatures of 80–85 °C, with some

operating temperatures as low as 60–65 °C.

It is cheaper to sterilize with steam than formaldehyde. However, the formaldehyde process is

cheaper than 12/88 and, where regulations allow, it is a viable alternative for the sterilization of

equipment that can withstand the required operating temperatures.

Ethylene oxide

Medical equipment manufacturers and hospitals use undiluted ethylene oxide to sterilize heat-

sensitive materials and equipment. This flammable gas can be used where safety requirements can

be met. Sterilization is usually carried out at atmospheric pressure, or below, to reduce the risk of fire

and explosion. Equipment varies from large industrial units to small hospital units that use canisters

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KEY FACTS

Commercial sterilizationplants can reduce CFC-12 use by convertingfrom 12/88 totechniques based on100 per cent ethyleneoxide, HCFC andethylene oxide mixtures,10/90 and radiation.

For smaller units, suchas those used inhospitals, 12/88 usecan be reduced oreliminated by acombination of steam,formaldehyde, ethyleneoxide or HCFC/ethyleneoxide mixtures.

Techniques for reducingor eliminating 12/88 usein hospitals

• sterilizing heat-resistant equipmentwith steam;

• sterilizing heat-sensitive equipmentwith formaldehyde;

• using 100 per centethylene oxidesterilizers in unitswhere this is safe andpractical;

• using HCFC/ethyleneoxide mixtures;

• recovering andrecycling 12/88.

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containing less than 200 g of ethylene oxide. Safety precautions are necessary for the storage and

handling of ethylene oxide.

In hospitals, steam and formaldehyde are used to sterilize most equipment. Ethylene oxide is used

only for heat-sensitive equipment that cannot withstand sterilization by other methods. Ethylene

oxide, used in conjunction with other sterilization processes, is a possible alternative to use of 12/88

in hospitals.

Blends of ethylene oxide and CO2Non-flammable mixtures of ethylene oxide and carbon dioxide (CO2) are sometimes suitable

alternatives to ODS mixtures with ethylene oxide. Common mixtures are 10 percent ethylene oxide

and 90 percent CO2 (known as 10/90), and 8.5 percent ethylene oxide and 91.5 percent CO2. These

mixtures are non-flammable, not explosive or environmentally damaging, and are also currently

available. However, operating pressures are about ten times higher than for 12/88, requiring more

expensive equipment. They also have other disadvantages, such as composition changes during the

progressive use of a single tank or cylinder, increased polymerization problems, and compatibility and

corrosion problems caused by the acidity of CO2. Flammable mixtures of ethylene oxide and CO2 are

also used in some countries, with safety precautions necessary to reduce operating risks.

Blends of ethylene oxide and HCFC-124

Blends of ethylene oxide and HCFC-124 are virtual drop-in replacements for 12/88. HCFCs are good

flame-retardants; have low ODP, GWP and toxicity; are compatible with medical equipment; and

blend with ethylene oxide. With minor control adjustments, these mixtures allow continued use of

expensive 12/88 sterilizing equipment. The gas mixture requires validation for the particular

application before use. Product and packaging compatibility needs to be established.

Radiation

Two radiation processes are used, one based on gamma radiation the other on electron beam

irradiation. Both processes are well established and used in large facilities. Globally, a large proportion

of all single-use medical products is sterilized by irradiation. Product manufacturers usually have their

own on-site equipment for irradiation, whereas hospitals usually send equipment to specialized

facilities for irradiation. Hospitals do not have their own facilities because of construction costs and

the complexities of irradiation. For example, processes using gamma radiation need to dispose of

spent isotopes and are therefore generally not acceptable for hospitals.

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Sterilization techniques: alternatives to 12/88

suitable for cheaper heat-sensitive non- non-

than 12/88 equipment toxic flammable comments

steam • • • cheapest sterilization method

formaldehyde • some • use restricted in some countries

ethylene oxide • • conversion costs; safety procedures

essential

ethylene oxide/ • • • operating problems

carbon dioxide

radiation • • • safety procedures essential

dry heat • • • sterilized equipment must be

used immediately

ethylene oxide/ • • virtual drop-in replacement

HCFC 124 for 12/88

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Radiation is a very reliable sterilization technique. Irradiated equipment can be released as sterile

without holding it under quarantine to conduct sterility tests. However, radiation is not compatible with

all materials. Some products and packaging are irreversibly damaged by radiation.

Dry heat

Metal and other items that can withstand temperatures up to about 190° C can be sterilized by

exposure to dry heat. A wide selection of dry heat equipment is available worldwide, and is cheap to

buy, operate and maintain. Items sterilized by this technique must be used immediately as they are

not protected by a sterilized package. Dry heat sterilization would therefore, for instance, be a suitable

technique for a small dental surgery, but not for a large hospital where equipment is unlikely to be

used immediately after it is sterilized.

Ionized Gas Plasma

Several ionized gas plasma processes have been commercialized. In one process the plasma is

generated in a hydrogen peroxide atmosphere, while in another it is generated in a peracetic acid

environment. Many ionized gas plasma units have been sold worldwide, mostly to hospitals. One of

these processes (using peracetic acid plasma)–and which had not received FDA approval for this

application–was recently associated with patient injuries when ophthalmic surgical instruments

sterilized with this system were used. A global recall of equipment using this particular ionized gas

process was issued.

Developing countries

In 1998, total global use of blends of ethylene oxide and CFC-12 was estimated to be 1500 tonnes,

consumed almost exclusively in developing countries. Most developing countries have some hospitals

using advanced medical techniques and equipment. A few developing countries have at least one

commercial sterilization facility, and many have one or more hospital sterilization units. To reduce CFC

use, commercial sterilization facilities are phasing out 12/88 and converting to other sterilization

methods. However, in some developing countries there have been indications of increased use of

CFC-12, with the possibility that some surgical equipment manufacturers are shipping products from

developed to developing countries for sterilization.

Developing countries can take steps to minimize CFC use. Hospital practice can minimize the use of

mixtures of ethylene oxide with CFC-12 by separating the majority of equipment that can be sterilized

with steam (and/or formaldehyde) from the heat- and moisture-sensitive equipment sterilized with the

ethylene oxide mixture. Units using 12/88 should be identified, and assistance provided to convert to

100 per cent ethylene oxide or HCFC/ethylene oxide mixtures. Developing countries can convert

12/88 equipment to the virtual drop-in replacement HCFC/ethylene oxide mixtures with no changes

to operating procedures and at reasonable cost. Developing countries can also: ensure that no new

commercial facilities using 12/88 are built in the country; provide commercial sterilization facilities and

hospitals with technical information and financial assistance to help them convert from 12/88; train

personnel in commercial facilities and hospitals in alternative techniques; and encourage hospitals to

choose non-CFC technology when purchasing new sterilizers.

Forecast of usage

By 1998, CFC use in sterilization had been successfully eliminated in most developed countries. In

1998, use in developing counries and in some countries with economies in transition was estimated

to be less than 1500 tonnes. In these countries, 12/88 can be eliminated from commercial and

hospital units if financial and technical assistance is available.

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Resources

PROTECTING THE OZONE LAYER • TECHNICAL BROCHURE UPDATES • AEROSOLS AND STERILANTS

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Secretariats and Implementing Agencies

Multilateral Fund Secretariat

Dr. Omar El Arini

Chief Officer

Secretariat of the Multilateral Fund for

the Montreal Protocol

27th Floor, Montreal Trust Building

1800 McGill College Avenue

Montreal, Quebec H3A 6J6

Canada

Tel: 1 514 282 1122

Fax: 1 514 282 0068

E-mail: [email protected]

Web site: www.unmfs.org

UNEP Ozone Secretariat

Mr. Michael Graber

Acting Executive Secretary

UNEP Ozone Secretariat

PO Box 30552

Gigiri, Nairobi

Kenya

Tel: 2542 623-855

Fax: 2542 623-913

Email: [email protected]

Web site: www.unep.org/ozone

UNEP

Mr. Rajendra M. Shende, Chief

Energy and OzonAction Unit

United Nations Environment Programme

Division of Technology, Industry and Economics

(UNEP DTIE)

39-43 quai Andre Citroen

75739 Paris Cedex 15

France

Tel: 33 1 44 3714 50

Fax: 33 1 44 3714 74

Email: [email protected]

Web site: www.uneptie.org/ozonaction

UNDP

Dr. Suely Carvalho, Deputy Chief

Montreal Protocol Unit, EAP/SEED

United Nations Development Programme

(UNDP)

304 East 45th Street

Room FF-9116,New York, NY 10017

United States of America

Tel: 1 212 906 6687

Fax: 1 212 906 6947

Email: [email protected]

Web site: www.undp.org/seed/eap/montreal

UNIDO

Mrs. H. Seniz Yalcindag, Chief

Industrial Sectors and Environment Division

United Nations Industrial Development

Organization (UNIDO)

Vienna International Centre

P.O. Box 300

A-1400 Vienna

Austria

Tel: (43) 1 26026 3782

Fax: (43) 1 26026 6804

E-mail: [email protected]

Web site: www.unido.org

World Bank

Mr. Steve Gorman, Unit Chief

Montreal Protocol Operations Unit

World Bank, 1818 H Street NW

Washington DC 20433

United States of America

Tel: 1 202 473 5865

Fax: 1 202 522 3258

Email: [email protected]

Web site: www.esd.worldbank.org/mp/home.cfm

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Contact points

PROTECTING THE OZONE LAYER • TECHNICAL BROCHURE UPDATES • AEROSOLS AND STERILANTS

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American Hospital Association

840 North Lakeshore Drive

Chicago, IL 60675

United States

Tel: 1 312 280 6360

Fax: 1 312 280 5923

http://www.aha.org

Asociación Española de Aerosoles

Loreta 2-Entresuelo 4°, 08029

Barcelona, Spain

Tel: +34 93 410 60 65

Fax: +34 93 419 37 56

[email protected]

Associação Portuguesa de Aerossois

Avenida Antonio José d’Almeida Nº 7-2º

1000 Lisbon, Portugal

Tel: +351 1 799 1550

Fax: +351 1 799 1551

[email protected]

Association for the Advancement of Medical

Instrumentation

3330 Washington Boulevard

Suite 400

Arlington, VA 22201-4598

United States

Tel: 1 703 525 4890

Fax: 1 703 276 0793

http://www.aami.org/

British Aerosol Manufacturers Association

King’s Buildings

16 Smith Square

London SW1P 3JJ

United Kingdom

Tel: 71 828 5111

Fax: 71 834 8436

http://www.bama.co.uk/

(includes directory of global aerosol associations and

government departments)

Suomen Aerosoliyh

(Finnish Aerosol Association)

PO Box 073

SF-00131 Helsinki

Finland

Tel/Fax: 358 01 3451400

E-mail: [email protected]

American Chemistry Council

(Formerly the Chemical Manufacturers Association)

703-741-5000 phone

703-741-6000 fax

1300 Wilson Blvd.

Arlington, VA 22209

http://www.cmahq.com/

Comité Français des Aérosols

32 rue de Paradis

F-75484 Paris Cedex 10

France

Tel: 1 47 70 26 42

Fax: 1 47 70 34 84

http://www.aerosols-info.org/index.html

European Council of Chemical Manufacturers

Federations

Avenue E. Van Nieuwenhuyse, 4

B-1160 Brussels

Belgium

Tel: 322 676 7211

Fax: 322 676 7300

http://www.cefic.org/

Federation of European Aerosol Associations

Square Marie-Louise, 49

B-1040 Brussels

Belgium

Tel: 322 238 9711

Fax: 322 231 1301

http://www.aerosol.org/

Health Industry Manufacturers Association

1200 G Street, NW

Washington, DC 20005

United States

Tel: 1 202 783 8700

Fax: 1 202 783 8750

Hellenic Aerosol Association

Eleftherias & Melpomenis str

15th Klm Nat.Rd Athens-Lamia, 14564

Kifissia-Athens, Greece

Tel: +30 1 80 77 403

Fax: +30 1 80 76 084

E-mail: [email protected]

International Aerosol Association

Waisenhausstrasse, 2

CH-8001 Zurich

Switzerland

Tel: 01 211 5255

Fax: 01 221 2940

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31

Brandberg et al. Sterilisering med etylenoxid (EO).

På 4:e året i Göteborgs sjukvård, Sjukhuset, nr 2/1985, årgång 62.

‘CFC Replacement, Are we Ready?’ Deposition, Clearance and Effects in the Lung, Consensus Seminars on Issues

of Aerosol Therapy. Davos, Switzerland, April 1991. Journal of Aerosol Medicine, Vol 4 No 3 1991.

Chest, The Environmental Impact of Chlorofluorocarbon Use in Metered Dose Inhalers. 100, No. 4 October 1991.

CMA reporting companies. Grant Thornton Report 1991. Chlorofluorocarbons (CFCs) 11 and 12 – Cumulative

Production through 1979 and Annual Production and Sales for the years 1980–l989. CMA, Washington D.C., United

States.

Figurama, Metal Box Aerosols, l987.

Independent Committee on Smoking and Health. Developments in Tobacco Products and the Possibility of ‘Lower

Risk’ Cigarettes. Second Report, page 7, 1979.

Midwest Research Institute. Addenda to EPA Regulatory Impact Analysis Document, Miscellaneous Uses, vol III, part 5.

October 1987.

Midwest Research Institute. Addenda to EPA Draft Regulatory Impact Analysis, vol III, part 6, Sterilants. October 1987.

National Swedish Environmental Protection Board. CFCs/Freons – Proposals to Protect the Ozone Layer. Report

3410.

Radian, Essential Aerosols Update.

EPA Contract No. 68-02-4288, January 1989.

UNEP. Report of the Aerosol Products, Sterilants, Miscellaneous Uses and Carbon Tetrachloride Technical Options

Committee, 1992.

UNEP. Report of the Aerosol Products, Sterilants, Miscellaneous Uses and Carbon Tetrachloride Technical Options

Committee, 1994.

UNEP. Report of the Aerosol Products, Sterilants, Miscellaneous Uses and Carbon Tetrachloride Technical Options

Committee, 1998.

UNEP. Report of the Technology and Economic Assessment Panel, 2001.

USEPA. Future Concentrations of Stratospheric Chlorine and Bromine. USEPA, 1989.

Further reading

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Glossary

CFC chlorofluorocarbon

carcinogen causing cancer in animals and humans

compressed gas a high pressure propellant that behaves like a gas inside the aerosol

DPI dry powder inhaler

DME dimethyl ether

GWP global warming potential

HCFC hydrochlorofluorocarbon

HFC hydrofluorocarbon

hydrocarbon organic substance made of hydrogen and carbon

MDI metered dose inhaler

mutagenic causes mutation

ODP ozone-depletion potential

OAIC OzonAction Information Clearinghouse

ozone gas formed from three oxygen atoms

propellant a liquid or gas inside an aerosol product that provides pressure to expel the contents

VOC volatile organic compound – constituents will evaporate at temperature of use, and may react

photochemically with atmospheric oxygen to produce toxic and smog-producing tropospheric

ozone

12/88 a mixture of ethylene oxide and CFC-12 in the proportion 12:88 per cent

10/90 mixture of ethylene oxide and CO2 in the proportion 10:90

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About the UNEP DTIE OzonAction Programme

Nations around the world are taking concrete actions to reduce and eliminate production and

consumption of CFCs, halons, carbon tetrachloride, methyl chloroform, methyl bromide and HCFCs.

When released into the atmosphere these substances damage the stratospheric ozone layer – a

shield that protects life on Earth from the dangerous effects of solar ultraviolet radiation. Nearly every

country in the world has committed itself under the Montreal Protocol to phase out the use and

production of ODS. Recognizing that developing countries require special technical and financial

assistance in order to meet their commitments under the Montreal Protocol, the Parties established

the Multilateral Fund and requested UNEP, along with UNDP, UNIDO and the World Bank, to provide

the necessary support. In addition, UNEP supports ozone protection activities in Countries with

Economies in Transition (CEITs) as an implementing agency of the Global Environment Facility (GEF).

Since 1991, the UNEP DTIE OzonAction Programme has strengthened the capacity of governments

(particularly National Ozone Units or “NOUs”) and industry in developing countries to make informed

decisions about technology choices and to develop the policies required to implement the Montreal

Protocol. By delivering the following services to developing countries, tailored to their individual needs,

the OzonAction Programme has helped promote cost-effective phase out activities at the national and

regional levels:

Information Exchange

Provides information tools and services to encourage and enable decision makers to make informed

decisions on policies and investments required to phase out ODS. Since 1991, the Programme has

developed and disseminated to NOUs over 100 individual publications, videos, and databases that

include public awareness materials, a quarterly newsletter, a web site, sector-specific technical

publications for identifying and selecting alternative technologies and guidelines to help governments

establish policies and regulations.

Training

Builds the capacity of policy makers, customs officials and local industry to implement national ODS

phase out activities. The Programme promotes the involvement of local experts from industry and

academia in training workshops and brings together local stakeholders with experts from the global

ozone protection community. UNEP conducts training at the regional level and also supports national

training activities (including providing training manuals and other materials).

Networking

Provides a regular forum for officers in NOUs to meet to exchange experiences, develop skills, and

share knowledge and ideas with counterparts from both developing and developed countries.

Networking helps ensure that NOUs have the information, skills and contacts required for managing

national ODS phase out activities successfully. UNEP currently operates 8 regional/sub-regional

Networks involving 109 developing and 8 developed countries, which have resulted in member

countries taking early steps to implement the Montreal Protocol.

Refrigerant Management Plans (RMPs)

Provide countries with an integrated, cost-effective strategy for ODS phase out in the refrigeration and

air conditioning sectors. RMPs have to assist developing countries (especially those that consume

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low volumes of ODS) to overcome the numerous obstacles to phase out ODS in the critical

refrigeration sector. UNEP DTIE is currently providing specific expertise, information and guidance to

support the development of RMPs in 60 countries.

Country Programmes and Institutional Strengthening

Support the development and implementation of national ODS phase out strategies especially for

low-volume ODS-consuming countries. The Programme is currently assisting 90 countries to develop

their Country Programmes and 76 countries to implement their Institutional-Strengthening projects.

For more information about these services please contact:

Mr. Rajendra Shende, Chief, Energy and OzonAction Unit

UNEP Division of Technology, Industry and Economics

OzonAction Programme

39-43, quai André Citroën

75739 Paris Cedex 15 France

E-mail: [email protected]

Tel: +33 1 44 37 14 50

Fax: +33 1 44 37 14 74

www.uneptie.org/ozonaction.html UNEP�

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About the UNEP Division of Technology, Industryand Economics

The mission of the UNEP Division of Technology, Industry and Economics is to help decision-makers

in government, local authorities, and industry develop and adopt policies and practices that:

• are cleaner and safer;

• make efficient use of natural resources;

• ensure adequate management of chemicals;

• incorporate environmental costs;

• reduce pollution and risks for humans and the environment.

The UNEP Division of Technology, Industry and Economics (UNEP DTIE), with its head office in Paris,

is composed of one centre and four units:

• The International Environmental Technology Centre (Osaka), which promotes the adoption and use

of environmentally sound technologies with a focus on the environmental management of cities

and freshwater basins, in developing countries and countries in transition.

• Production and Consumption (Paris), which fosters the development of cleaner and safer

production and consumption patterns that lead to increased efficiency in the use of natural

resources and reductions in pollution.

• Chemicals (Geneva), which promotes sustainable development by catalysing global actions and

building national capacities for the sound management of chemicals and the improvement of

chemical safety world-wide, with a priority on Persistent Organic Pollutants (POPs) and Prior

Informed Consent (PIC, jointly with FAO).

• Energy and OzonAction (Paris), which supports the phase out of ozone depleting substances in

developing countries and countries with economies in transition, and promotes good management

practices and use of energy, with a focus on atmospheric impacts. The UNEP/RISØ Collaborating

Centre on Energy and Environment supports the work of the Unit.

• Economics and Trade (Geneva), which promotes the use and application of assessment and

incentive tools for environmental policy and helps improve the understanding of linkages between

trade and environment and the role of financial institutions in promoting sustainable development.

UNEP DTIE activities focus on raising awareness, improving the transfer of information, building

capacity, fostering technology cooperation, partnerships and transfer, improving understanding of

environmental impacts of trade issues, promoting integration of environmental considerations into

economic policies, and catalysing global chemical safety.

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www.unep.orgUnited Nations Environment Programme

P.O. Box 30552 Nairobi, KenyaTel: (254 2) 621234Fax: (254 2) 623927

E-mail: [email protected]: www.unep.org