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The Future of the European Aerosol Directive in the Context of Global Harmonization Dr. Hartmut Schiemann - Wella AG at the XVII. FEA International Aerosol.

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Presentation on theme: "The Future of the European Aerosol Directive in the Context of Global Harmonization Dr. Hartmut Schiemann - Wella AG at the XVII. FEA International Aerosol."— Presentation transcript:

1 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

2 2The Future of the European Aerosol Directive in the Context of Global Harmonization 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 3The Future of the European Aerosol Directive in the Context of Global Harmonization 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 4The Future of the European Aerosol Directive in the Context of Global Harmonization 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 5The Future of the European Aerosol Directive in the Context of Global Harmonization EU in a Global Context Global Gross Domestic Product (GGDP) shares in 2004* EU (5 Major countries =15,2% of global GDP) Germany4,2 UK3,2 France3,1 Italy2,9 Spain1,7 * Source: CIA World Factbook, March 2005

6 6The Future of the European Aerosol Directive in the Context of Global Harmonization 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 7The Future of the European Aerosol Directive in the Context of Global Harmonization 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 8The Future of the European Aerosol Directive in the Context of Global Harmonization Global Aerosol Production Global Aerosol Production in 2004* Europe is No 1 worldwide * Source: FEA statistics 2004

9 9The Future of the European Aerosol Directive in the Context of Global Harmonization Global Aerosol Production* * Source: FEA statistics 2004 CFC ban VOC reduction by CARB 80% for HS55% for HS

10 10The Future of the European Aerosol Directive in the Context of Global Harmonization 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)

11 11The Future of the European Aerosol Directive in the Context of Global Harmonization 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 12The Future of the European Aerosol Directive in the Context of Global Harmonization 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 13The Future of the European Aerosol Directive in the Context of Global Harmonization 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 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

14 14The Future of the European Aerosol Directive in the Context of Global Harmonization 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 15The Future of the European Aerosol Directive in the Context of Global Harmonization 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 => consequences for aerosols and the ADD

16 16The Future of the European Aerosol Directive in the Context of Global Harmonization 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 Paragraph 23 (c)

17 17The Future of the European Aerosol Directive in the Context of Global Harmonization 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 18The Future of the European Aerosol Directive in the Context of Global Harmonization 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.

19 19The Future of the European Aerosol Directive in the Context of Global Harmonization 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 20The Future of the European Aerosol Directive in the Context of Global Harmonization 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:Vapour pressure at 50°C >300 kPa or Completely gaseous at 20°C and 101.3kPa Compressed gas:Entirely gaseous at -50°C Liquefied gas: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

21 21The Future of the European Aerosol Directive in the Context of Global Harmonization Revision of the ADD 75/324/EEC Example - Cans = Containers, Receptacles ADD containers ml brimful volume, made out of metal ml brimful volume, made out of coated glass or plastic that does not splinter (also filled with gas only) ml brimful volume, made of glas or plastic that splinters ADR 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 22The Future of the European Aerosol Directive in the Context of Global Harmonization Revision of the ADD 75/324/EEC Example - Cans = Containers, Receptacles European Aerosol Production Can Materials A consequence of current legislation ? Harmonization between ADR and ADD possible ?

23 23The Future of the European Aerosol Directive in the Context of Global Harmonization 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

24 24The Future of the European Aerosol Directive in the Context of Global Harmonization 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

25 25The Future of the European Aerosol Directive in the Context of Global Harmonization 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 26The Future of the European Aerosol Directive in the Context of Global Harmonization 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

27 27The Future of the European Aerosol Directive in the Context of Global Harmonization 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.

28 28The Future of the European Aerosol Directive in the Context of Global Harmonization 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 !

29 29The Future of the European Aerosol Directive in the Context of Global Harmonization Revision of the ADD 75/324/EEC Example - Alternatives to the Hot Water Bath Test (hWBT) Complete revision of the paragraph 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)

30 30The Future of the European Aerosol Directive in the Context of Global Harmonization 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/cm 2 Japan e.g. requires maximum pressure of 8 kp/ cm 2 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

31 31The Future of the European Aerosol Directive in the Context of Global Harmonization 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 32The Future of the European Aerosol Directive in the Context of Global Harmonization 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 33The Future of the European Aerosol Directive in the Context of Global Harmonization 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 34The Future of the European Aerosol Directive in the Context of Global Harmonization 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 !


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