The Future of the European Aerosol Directive in the Context of Global Harmonization

1

• The Future of theEuropean Aerosol Directivein
  the Context ofGlobal Harmonization

Dr. Hartmut Schiemann - Wella AG at the XVII. FEA
International Aerosol Congress in Athens
2
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

3
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 ?

4
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

5
EU in a Global Context

• Global Gross Domestic Product (GGDP) shares in
  2004

EU (5 Major countries 15,2 of global
GDP) Germany 4,2 UK 3,2 France 3,1 Italy 2,9 S
pain 1,7
Source CIA World Factbook, March 2005
6
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

7
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

8
Global Aerosol Production

• Global Aerosol Production in 2004Eu
  rope is No 1 worldwide

Source FEA statistics 2004
9
Global Aerosol Production
CFC ban
VOC reduction by CARB
80 for HS
55 for HS
Source FEA statistics 2004
10
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)

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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

12
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)

13
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) gt
  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

14
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

15
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.gt
  consequences for aerosols and the ADD

16
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)

17
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

18
Revision of the ADD 75/324/EEC

• Example - Definition of Aerosols
• GHS - Chapter 2.3Aerosols, 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 2For 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.

19
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

20
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
  GHSGas Vapour pressure at 50C gt300 kPa
  or Completely gaseous at 20C and
  101.3kPaCompressed gas Entirely gaseous at
  -50CLiquefied gas Partially liquid at
  Temperatures gt -50CLiquid Not a gas, but
  initial melting point ?20C Solid All
  othersSame criteria applied to Substances
  Preparations

21
Revision of the ADD 75/324/EEC

• Example - Cans Containers, Receptacles
• ADD containers
• 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
• ADR 6.2.4.1.1 receptacles
• 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)

22
Revision of the ADD 75/324/EEC

• Example - Cans Containers, Receptacles
• European Aerosol Production 2004 - Can
  Materials
• A consequence of current legislation ?
• Harmonization between ADR and ADD possible ?

23
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 gt additional requirements necessary
• Consumer safety first gt
• Separate set of criteria for materials that
  splinter versus materials that do not splinter
• Separate set of criteria for material that
  softens at 50C as described in current ADR ?
• Set of definitions, test methods and criteria for
  cans made of synthetic material required

24
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 gt contradiction
• 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

25
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

26
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
  20C
• 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 50C in ADD
• ADR still allows 95, different regulations in
  other parts of the world
• but 90 filling level at 50C is pragmatic and
  always on the safe side

27
Revision of the ADD 75/324/EEC

• Example - Definition of flammable contents
• Current ADDFlammable 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.

28
Revision of the ADD 75/324/EEC

• Example - Definition of flammable contents
• Future ADDFor 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 !

29
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 appliedgt only alternatives according to UN
  Model Regulations may be used (different from
  ADR)

30
Revision of the ADD 75/324/EEC

• Example - Maximum pressure
• ADR maximum pressure of 13,2 bar at 50C 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 35C
• DOT pressure levels for cans, e.g. 2P (240 psig
  16,55 bar burst pressure) and 2Q (270 psig
  18,62 bar burst pressure) cansmaximum pressure
  at 130F 54,4C 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

31
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

32
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

33
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

34
Future Aspects

• The future of the ADD is related to the
  implementation of GHSgt 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 gt
• 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 !