The Future of the
European Aerosol Directive
in the Context of
Global Harmonization
Dr. Hartmut Schiemann - Wella AG
at the
XVII. FEA International Aerosol Congress in Athens
Contents
•
Introduction
•
EU and Europe in global economies
•
Global Aerosol Production and Global Harmonization
•
GHS (Globally Harmonized System of classification and labelling of
chemicals)
•
Revision of ADD - Examples for Harmonization and no
Harmonization at all
•
Conclusions
•
Future Aspects
The Future of the European Aerosol Directive in the
2
Introduction
•
•
•
•
•
•
The European Aerosol Dispensers Directive 75/324/EEC (ADD) is
currently being revised
In history there was only one amendment 94/1/EC
Alterations of the Directive are possible by:
• Co-decision procedure (involving the European Parliament and
the Council), which takes a long time
• Adaptation to Technical Progress (ATP) with revision of the
technical aspects only, normally on shorter terms
Timeline for current revision probably early in 2006
Will this revision consider global harmonization ?
What might follow after this revision, thinking globally ?
The Future of the European Aerosol Directive in the
3
Contents
•
Introduction
•
EU and Europe in global economies
•
Global Aerosol Production and Global Harmonization
•
GHS (Globally Harmonized System of classification and labelling of
chemicals)
•
Revision of ADD - Examples for Harmonization and no
Harmonization at all
•
Conclusions
•
Future Aspects
The Future of the European Aerosol Directive in the
4
EU in a Global Context
•
Global Gross Domestic Product (GGDP) shares in 2004*
1,7%
21,1%
21,7%
1,8%
1,8%
20,9%
2,5%
2,7%
6,0%
6,7%
13,1%
EU (5 Major countries
=15,2% of global GDP)
Germany
4,2
UK
3,2
France
3,1
Italy
2,9
Spain
1,7
United States
EU
China
Japan
India
Brazil
Russia
Canada
Mexico
South Korea
ROW
* Source: CIA World Factbook, March 2005
The Future of the European Aerosol Directive in the
5
Europe and the EU - relevant facts
•
50 countries in Europe
•
25 countries in EU
• Majority of the European Population
• 80% of European GDP
• 2nd rank in global GDP (GGDP)
• Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, UK
• Home of the Aerosol Dispensers Directive 75/324/EEC
The Future of the European Aerosol Directive in the
6
Contents
•
Introduction
•
EU and Europe in global economies
•
Global Aerosol Production and Global Harmonization
•
GHS (Globally Harmonized System of classification and labelling of
chemicals)
•
Revision of ADD - Examples for Harmonization and no
Harmonization at all
•
Conclusions
•
Future Aspects
The Future of the European Aerosol Directive in the
7
Global Aerosol Production
•
Global Aerosol Production in 2004*
2%
2%
5%
6%
36%
2%
42%
5%
Argentina
Australia
Brazil
China
Europe
Japan
South Africa
USA
Europe is No 1 worldwide
* Source: FEA statistics 2004
The Future of the European Aerosol Directive in the
8
5000
Global Aerosol Production*
4500
4000
CFC ban
3500
3000
2500
VOC reduction by CARB
2000
80% for HS
55% for HS
1500
1000
500
0
1974 1976 1978 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004
Argentina
Australia
Brazil
China
Europe
Japan
South Africa
USA
* Source: FEA statistics 2004
The Future of the European Aerosol Directive in the
9
Global Thinking
•
•
•
•
•
•
Europe and North America are the major markets in the world, not
only for Aerosols
Since the prohibition of 1st CFCs and 2nd the VOC programs in the
US, production quantities did not grow much in US
Standards on Aerosols are sometimes different but a sort of
industrial standard already exists
In case of Aerosols the principles of European and North American
standards can be found globally, US standards were adopted first
Transportation issues are globally harmonized at the UN Committee
of Experts for Transport of Dangerous Goods (UN-CETDG)
Growing importance of Asia with Japan and China both economically
and potentially concerning Aerosol production (both are voting
members of the UN-CETDG)
The Future of the European Aerosol Directive in the
10
•
•
•
•
•
•
•
UN Committee of Experts for the
Transport of Dangerous Goods
Responsible for transport regulation
Home of ADR/RID
27 voting countries globally (representing 80% of global GGDP), 22
observers
13 voting countries in EU (representing 19% of GGDP), 4 observers
15 voting countries in total Europe (representing 22 % of GGDP), 8
observers
EU alone does not have the majority of votes
A unified European Opinion could be one of the keys to
harmonization although the economical power is not balanced
The Future of the European Aerosol Directive in the
11
UN Committee of Experts for the
Transport of Dangerous Goods
•
Influencing Transport Regulations:
•
•
•
•
•
•
Russia, rank 11 in GGDP is a country in Europe, not member of EU but a
voting member in UN Committee of Experts for the Transport of
Dangerous Goods (UN-CETDG)
Norway, rank 43 in GGDP is also a voting member of UN-CETDG
Having an alignment within EU and both countries would decide any
future vote in UN-CETDG
UN Model Regulations are important and are the base for
harmonized provisions in the different modes (air, rail, road and sea)
The harmonization of the transport regulations is still ongoing
But, if we want to sell globally, we still have to consider the
respective local regulations (e.g. Japan)
The Future of the European Aerosol Directive in the
12
Global Harmonization
•
•
•
•
•
Transport Regulations have been harmonized for years, published in
ADR (European Agreement for Transport of Dangerous Goods on the
Road), RID, IATA and others
Recognition of ADD in ADR/RID via acceptance clause (ADR 6.2.4.4
Reference to standards) => direct adoption of European law in ADR
member states
GHS (Globally Harmonized System of classification and labelling of
chemicals) as new approach to harmonize labelling and declaration
aspects globally (revised in 2005)
Harmonization of transport and supply (as far as possible)
Harmonization of the 3 major systems (US, Canada, EU) and others
The Future of the European Aerosol Directive in the
13
Contents
•
Introduction
•
EU and Europe in global economies
•
Global Aerosol Production and Global Harmonization
•
GHS (Globally Harmonized System of classification and labelling of
chemicals)
•
Revision of ADD - Examples for Harmonization and no
Harmonization at all
•
Conclusions
•
Future Aspects
The Future of the European Aerosol Directive in the
14
What is the GHS?
•
•
•
•
•
A common and coherent approach to defining and classifying hazards,
and communicating information on labels and safety data sheets
Target audiences include workers, consumers, transport workers, and
emergency responders
Internationally-comprehensible system for hazard communication
Physical hazards: The UN Experts on Transport of Dangerous Goods
were selected as the lead for work on physical hazards, in cooperation
with the International Labor Organization ILO.
The UN Committee of Experts for the Transport of Dangerous Goods
adopted the Globally Harmonized Systems of Classification and
Labelling of Chemicals (GHS) formally in December 2002.
=> consequences for aerosols and the ADD
The Future of the European Aerosol Directive in the
15
GHS Implementation
The Plan of Implementation includes:
Encourage countries to implement the new globally
harmonized system for the classification and labelling of
chemicals as soon as possible with a view to having the
system fully operational by 2008.
Paragraph 23 (c)
The Future of the European Aerosol Directive in the
16
Contents
•
Introduction
•
EU and Europe in global economies
•
Global Aerosol Production and Global Harmonization
•
GHS (Globally Harmonized System of classification and labelling of
chemicals)
•
Revision of ADD - Examples for Harmonization and no
Harmonization at all
•
Conclusions
•
Future Aspects
The Future of the European Aerosol Directive in the
17
Revision of the ADD 75/324/EEC
Example - Definition of Aerosols
• GHS - Chapter 2.3
Aerosols, this means aerosol dispensers, are any non-refillable
receptacles made of metal, glass or plastics and containing a gas
compressed , liquefied or dissolved under pressure with or without a
liquid, paste or powder, and fitted with release device allowing the
contents to be ejected as solid or liquid particles in suspension, in a gas,
as a foam, paste or powder in a liquid state or in a gaseous state.
(this includes the current definition in ADR)
•
ADD - Article 2
For the purpose of this Directive, the term ‘aerosol dispenser’ shall
mean any non-reusable container made of metal, glass or plastic and
containing a gas compressed, liquefied or dissolved under pressure,
with or without a liquid, paste or powder, and fitted with a release
device allowing the contents to be ejected as solid or liquid particles in
suspension in a gas, as a foam, paste or powder or in a liquid state.
The Future of the European Aerosol Directive in the
18
Revision of the ADD 75/324/EEC
Example - Definition of Aerosols
• Non-reusable in ADD is a stricter provision.
• Refillable aerosol cans are not covered by the definition in GHS,
ADR/RID and ADD
•
All other types of pressure receptacles are covered by the definition:
• common sprays and mousses (2-phase, 3-phase ore more)
• multi-chamber receptacles
• products where the pressure is created by activation (shaking,
membrane break aso.)
• Aerosols only containing gas
•
Minimum pressure that makes an aerosol an aerosol =
any pressure, created by a propellant, to eject the contents
The Future of the European Aerosol Directive in the
19
Revision of the ADD 75/324/EEC
Example - Definition of Aerosols
• The definition will not change, as it is a part of the Articles and may
not be amended by ATP
• Clear definitions of what are actually gases, liquids or solids are
neither included in ADD nor in the current revision, but we might
obtain from GHS:
Gas:
Compressed gas:
Liquefied gas:
Vapour pressure at 50°C >300 kPa or
Completely gaseous at 20°C and 101.3kPa
Entirely gaseous at -50°C
Partially liquid at Temperatures > -50°C
Liquid:
Not a gas, but initial melting point 20°C
Solid:
All others
Same criteria applied to Substances & Preparations
The Future of the European Aerosol Directive in the
20
Revision of the ADD 75/324/EEC
Example - Cans = Containers, Receptacles
• ADD containers
•
•
•
•
ADR 6.2.4.1.1 receptacles
•
•
•
•
50 - 1000 ml brimful volume, made out of metal
50 - 220 ml brimful volume, made out of coated glass or plastic that
does not splinter (also filled with gas only)
50 - 150 ml brimful volume, made of glas or plastic that splinters
up to 1000 ml brimful volume, made out of metal
Aerosol receptacles containing gas only have to be made of metal (other
material is possible up to 100 ml)
up to 500 ml brimful volume, made out of glass or synthetic material
Containers in the US, DOT (US Department of Transport)
•
•
Test methods are comparable, Definitions and Criteria are different
Volumes are different, especially concerning plastic containers
(exemptions for larger sizes than 100 ml)
The Future of the European Aerosol Directive in the
21
Revision of the ADD 75/324/EEC
Example - Cans = Containers, Receptacles
• European Aerosol Production 2004 - Can Materials
0,2%
37,1%
Tin Plate
Aluminum
Glass&Plastic
62,7%
•
•
A consequence of current legislation ?
Harmonization between ADR and ADD possible ?
The Future of the European Aerosol Directive in the
22
Revision of the ADD 75/324/EEC
Example - Cans = Containers, Receptacles
• ADR: no difference between test criteria of metal cans and others
• ADD: Provisions for Plastic Cans are not subject to revision now
• Safety of aerosols for both consumer and transport =>
additional requirements necessary
• Consumer safety first =>
• Separate set of criteria for materials that splinter versus
materials that do not splinter
• Separate set of criteria for material that softens at 50°C as
described in current ADR ?
•
Set of definitions, test methods and criteria for cans made of
synthetic material required
The Future of the European Aerosol Directive in the
23
Revision of the ADD 75/324/EEC
Example - Cans = Containers, Receptacles
• Dimensions
•
•
No restrictions for dimensions (diameter, wall thickness) in ADD or ADR
Requirement for cans with diameter of 40 mm and larger shall have a
concave bottom. Not required in ADD => contradiction
1. Explicit requirements concerning maximum diameter (3 inches = 76,2
mm) and minimum wall thickness (0,007 inch = 0,178 mm for 2P and
0,008 inch = 0,203 mm for 2Q) in DOT-regulations
•
Harmonization of the different systems is currently not possible
•
•
Set of definitions, criteria and test methods, reflecting the state of the
art for plastic cans is not available
No future amendments concerning sizes and construction discussed for
the current ADD revision
The Future of the European Aerosol Directive in the
24
Revision of the ADD 75/324/EEC
Example - Filling levels
• Current situation
•
•
•
ADD does not contain standard filling levels
Article 8 of ADD requires labelling of net volume and weight
Standard filling levels are in ANNEX III of directive 80/232/EEC
(derogation concerning double labelling of volume and weight)
•
Currently maximum filling levels are established in ADD
• 87% for metal containers having no concave bottom
• 95% for metal containers with concave bottom
• 90% for glass and plastic containers
•
Maximum filling levels in all relevant safety regulations for aerosols
worldwide
The Future of the European Aerosol Directive in the
25
Revision of the ADD 75/324/EEC
Example - Filling levels
• Future ADD (focus on consumer safety)
•
•
•
Complete deregulation of nominal filling quantities/volumes likely,
labelling of nominal quantity and the total capacity of the container
Nominal quantity is the liquid phase volume at 20°C
Standards concerning minimum filling are found in different regulations
worldwide, e.g. minimum filling of 70%, not only for aerosols, in Latin
America, Russia and others, but not as a part of safety regulations
•
Watchout: All laws concerning deceiving or misleading packaging
have to be considered, but they are not part of ADD
•
•
•
Maximum filling level would be 90% at 50°C in ADD
ADR still allows 95%, different regulations in other parts of the world
but 90% filling level at 50°C is pragmatic and always on the safe side
The Future of the European Aerosol Directive in the
26
Revision of the ADD 75/324/EEC
Example - Definition of flammable contents
• Current ADD
‘Flammable contents’ means the substances and preparations
corresponding to the criteria laid down for the categories ”extremely
flammable”, ”highly flammable” and ”flammable” and listed in Annex
VI to Council Directive 67/548/EEC.
The flammability and flash point of the contents of the container
shall be determined using the specific methods described in Part A
of Annex V to the above mentioned Directive.
The Future of the European Aerosol Directive in the
27
Revision of the ADD 75/324/EEC
Example - Definition of flammable contents
• Future ADD
For the purpose of this directive an aerosol, which may be a single
component or a mixture of different components, is considered as
‚flammable‘ if the aerosol is classified as ‚flammable‘ or ‚extremely
flammable‘ according to the criteria laid down in the most recent
edition of the Manual of Tests and Criteria of the UN
Recommendations on the Transport of Dangerous Goods.
This is total harmonization !
The Future of the European Aerosol Directive in the
28
Revision of the ADD 75/324/EEC
Example - Alternatives to the Hot Water Bath Test (hWBT)
• Complete revision of the paragraph 6.1.4 of ADD
• No change concerning the Hot Water Bath Test
• Addition of 2 alternative routes:
•
•
•
•
Alternatives using heat (modification of the hWBT)
Alternatives not using heat (full reference to UN model regulations /
ADR requirements)
Requirements to use alternatives to hWBT
•
•
an approval by the Competent Authority for Application of the ADR
a technical file and the approval available on demand
For Aerosols with contents that undergo a physical or chemical
transformation before use, the hWBT or an alternative using heat
shall not be applied
=> only alternatives according to UN Model Regulations may be
used (different from ADR)
The Future of the European Aerosol Directive in the
29
Revision of the ADD 75/324/EEC
Example - Maximum pressure
•
•
ADR: maximum pressure of 13,2 bar at 50°C for all can types and materials
ADD: different maximum pressures for metal, glass and plastic cans
•
International standards are different, because of the used dimensions,
related temperatures, but also because of definition and criteria
• Dimensions are sometimes Fahrenheit (°F) instead of Celsius (°C)
• Pressure is sometimes measured in psig (1 bar =14,5 psig) or kp/cm2
• Japan e.g. requires maximum pressure of 8 kp/ cm2 at 35°C
• DOT pressure levels for cans, e.g. 2P (240 psig =16,55 bar burst
pressure) and 2Q (270 psig = 18,62 bar burst pressure) cans;
maximum pressure at 130°F = 54,4°C is 180 psig = 12,41 bar
•
Increase of the maximum pressure to 15 bars for non flammable aerosols in
the meaning of point 1.8. of the ADD is likely
The Future of the European Aerosol Directive in the
30
Contents
•
Introduction
•
EU and Europe in global economies
•
Global Aerosol Production and Global Harmonization
•
GHS (Globally Harmonized System of classification and labelling of
chemicals)
•
Revision of ADD - Examples for Harmonization and no
Harmonization at all
•
Conclusions
•
Future Aspects
The Future of the European Aerosol Directive in the
31
Conclusions
•
Future ADD covers all necessary aspects
• Consumer safety is respected (criteria, tests)
• Product liability aspects are well covered (e.g. communication,
labelling, tests aso.)
•
ADD is going to be more related to UN transport regulations in the
global context of harmonized standards
With the acceptance clause in ADR, ADD will be automatically part
of the worlds most wide spread transport regulations
The way of harmonization can also work the other way round (e.g.
Flammabilty of Aerosols and Hot Water Bath Test)
•
•
•
•
In the context of Global Harmonization, there is still a lot to do !
Especially on Aerosols: Harmonization of current standards of
Europe and North America and adoption in other parts of the world
The Future of the European Aerosol Directive in the
32
Contents
•
Introduction
•
EU and Europe in global economies
•
Global Aerosol Production and Global Harmonization
•
GHS (Globally Harmonized System of classification and labelling of
chemicals)
•
Revision of ADD - Examples for Harmonization and no
Harmonization at all
•
Conclusions
•
Future Aspects
The Future of the European Aerosol Directive in the
33
Future Aspects
•
•
•
The future of the ADD is related to the implementation of GHS
=> the current revision might have an update by 2008
Frequent adaptations to technical progress (ATP) for ADD likely ?
What we do locally (working with the experts) has to take place in a
global context
=>
• work via the national associations with the local experts
• work via international associations to share the local and global
experiences with others
Europe can be a key driver of Global Harmonization !
The Future of the European Aerosol Directive in the
34