1 / 34

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

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

sebastien
Télécharger la présentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

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

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

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

  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 Spain 1,7 * Source: CIA World Factbook, March 2005 The Future of the European Aerosol Directive in the Context of Global Harmonization

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

  7. Contents • Introduction • EU and Europe in global economies • Global Aerosol Productionand 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 Context of Global Harmonization

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

  9. Global Aerosol Production* CFC ban VOC reduction by CARB 80% for HS 55% for HS * Source: FEA statistics 2004 The Future of the European Aerosol Directive in the Context of Global Harmonization

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

  11. 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 Context of Global Harmonization

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

  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) => 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 Context of Global Harmonization

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

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

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

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

  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-reusablecontainer 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 Context of Global Harmonization

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

  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 GHS:Gas: Vapour pressure at 50°C >300 kPa or Completely gaseous at 20°C and 101.3kPaCompressed gas: Entirely gaseous at -50°CLiquefied gas: Partially liquid at Temperatures > -50°CLiquid: Not a gas, but initial melting point 20°CSolid: All othersSame criteria applied to Substances & Preparations The Future of the European Aerosol Directive in the Context of Global Harmonization

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

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

  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 => 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 Context of Global Harmonization

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

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

  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 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 Context of Global Harmonization

  27. 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 Context of Global Harmonization

  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 ! The Future of the European Aerosol Directive in the Context of Global 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 applied=> only alternatives according to UN Model Regulations may be used (different from ADR) The Future of the European Aerosol Directive in the Context of Global Harmonization

  30. 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 Context of Global Harmonization

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

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

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

  34. 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 Context of Global Harmonization

More Related