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Importance of Vape Product Standards and their Relevance to the Vaping Industry in Prague

Learn about the significance of vape product standards and how they contribute to safety, quality, and innovation in the rapidly growing vaping industry. Explore the AFNOR and British PAS standards as the foundation for European vape regulations.

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Importance of Vape Product Standards and their Relevance to the Vaping Industry in Prague

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  1. Setting standards and their relevance to t.p.d Praha (Prague) – 08/12/16 Charly PAIRAUD Vice-President

  2. What is fivape? • Initially the French Independent Vapingtrade association (founded in 2012) Now the biggest independent vape trade federation in Europe More than 350 members (Producers, Shops & distributors networks) • Our mission : To protect the Vape innovation, How ?- by promoting our profession and expertise, • by constituting the vape loby, • by being the privileged institutions’ interlocutor (Health, Economy, etc…) • Our Team : President (Jean MOIROUD) and VP (CP)- Secretaries : Producers, Distributors, International Relationships, Vapers Relationships and our Coordinator : Remi PAROLAremi.parola@fivape.org who is: - The FIVAPE and ECIV (European Coalition for Independent Vape) Board Member - CEN/TC 437 “Electronic cigarettes and e-liquids” Chairman - ISO 126/SC3 “Vape and Vapour Products” Chairman www.fivape.org

  3. ABOUT THE EUROPEAN COALITION FOR INDEPENDENT VAPE • ECIV is a cooperationat the European Union and wider international levelbetween IBVTA (Independent British Vape Trade Association) and FIVAPE • Independent from the tobacco and pharmaceutical industries • Helping the independent industry to provide a coordinated response to the European and International challenges threatening the sector • ECIV plans to hold its first open meeting in Brussels later this year. Anyone interested in getting involved with this event or finding out more should contact ECIV at contact@eciv.eu • Vape products are neither tobacco nor pharmaceutical products and should therefore be regulated as a product set in their own right. ECIV believes that such regulation needs to be proportionate and based on the fact that vaping is at least 95% less harmful than smoking. www.fivape.org

  4. Why product standards? • The need for a nascent industry to bring solutions to a public concern: safety & quality • Product standards elaborated for and by the vaping industry • Proven track record method: all interests represented through consensus • Give consumers confidence without stifling innovation • These product standards aren’t law, but provide a framework for regulators. • Evolution: product standards evolve regularly & innovation (XP) • Help structure a new market www.fivape.org

  5. French AFNOR & BRITISH PAS standards: the europeanbase AFNOR - Association Française de Normalisation XP D90-300-1: Requirements and test methods for electroniccigarettes (published in March 2015) XP D90-300-2: Requirements and test methods for e-liquids(March 2015) XP D90-300-3: Requirements and test methods for emissions(July 2016) BSI – British Standards Institution PAS 54115:2015 - Vapingproducts, includingelectronic cigarettes, e- liquids, e-shisha and directly-relatedproducts. Manufacture, importation, testing and labelling (July 2015) www.fivape.org

  6. How do standards work? Others Ex : AFNOR (France) CEN (Europe) ISO (Worldwide) Each country has its own national product standards body. They can draft and elaborate product standards that can be applied to that specific country. European product standards bodies find consensus amongst the existing local product standards + new expertise at the European level. European standards once drafted overrule national standards. A network of National Standards Bodies. Each NSB has influence and represents ISO in their respectful countries. ISO standards are applied worldwide. www.fivape.org

  7. Ecig Standard XP D90-300-1 General requirements: for electronic cigarettes rechargeable or not (open or closed systems), the devices should not: • Cause overheating of the energy source or the vapor chamber (tank), • This is the main risk that must me mitigated by the security mechanisms and an information leaflet, • Electronic cigarettes (battery) must be equipped with a 10 seconds cutoff mechanism. • Have a risk of cutting, injuring or exploding. • The coatings should not release allergenic or toxic substances, or cause any kind of burns. www.fivape.org

  8. Ecig Standard XP D90-300-1 The 7 tests described in paragraphs 5, 6 and 7 must be on representative samples of a production lot. The 11 chapters of the electronic cigarette information leaflet shall provide all necessary information; • Instruction pertaining to voltage/resistance combinations, depending on the surface of the resistance (to prevent overheating). • Identify the entity responsible for placing the product on the market. Shock resistance: pass the 1.5 meter high drop test protocol. Limit chemical risks: metals constituting the atomizer resistance cannot not contain mercury. (NB: The emission control allows the final control, but double safety was always sought out when possible). www.fivape.org

  9. Ecig Standard XP D90-300-1 Refilling is a risky operation if badly done (? is not my opinion ) • We have taken into account that the volume of the vapor chamber will be reduced to 2 ml with the European directive (TPD), requiring the more than one refill per day. • Two icons were created: • Indicates the maximum diameter of an eliquid dropper to fill the electronic cigarette • Indicates the diameter of the dropper of the eliquid bottle so as not to be used with an electronic cigarette that has a smaller refill diameter. www.fivape.org

  10. Eliquid StandardXP D90-300-2 Unlike electronic cigarettes, e-liquids sold in France are mainly made in France (expertise within the Standards Working Group Commission in aromatherapy, making e-liquids and controlling eliquids). E-liquids with and without nicotine were considered. The requirements are very high on the ingredients that can be used as well as those that cannot not be used. For e-liquid bottles, only what is written on the label will be controlled. Hence, eliquid controls only cover what is useful. There will be more controlled parameters in emissions. (NB: if the ingredients are well controlled and emissions meet the requirements, there is no need to multiply, besides reported alerts, systematic inspections on the bottle of eliquiditself) www.fivape.org

  11. Eliquid Standard XP D90-300-2 Security of the eliquid bottle • A safety cap + dripper + pictothe diameter of the dropper of the eliquid bottle so as not to be used with an electronic cigarette that has a smaller refill diameter. • Prohibition of all materials suspected to release monomers like bisphenoland others. The quality of ingredients used, strong requirements • Pharmaceutical Quality or more when these qualities exist, Propylene glycol, glycerol, nicotine, water (> 90% of e-liquid) • Food quality for alcohol and flavors The list of prohibited ingredients • Carcinogenic, mutagenic or toxic to reproduction 1 and 2 or STOT 1 for breathing; vegetable or animal oils; sugars; conservatives, particularly those likely to release formaldehyde, energizing substances, drug, etc ... Label and information leaflet: • Composition. Consumption limit (date), safety instructions, population at risk ... www.fivape.org

  12. E-liquid Standard XP D90-300-3 • New technicals definitions : ex : heat surfacic power, vaping machine, vaping profile… • 2 “stallion” e-liquides “A” and “B” for testing devices. • Vaping machine and vaporisation requirements • Power, resistance, flow, • puff volume, duration… • Trapping efficiency • Substances screening and analysis Nicotine (and delivery), diacetyl, aldhehydes heavy metals, others… • Results and repporting www.fivape.org

  13. CEN/TC 437 Electronic cigarettes and e-liquids • 1st plenary meeting: June 2015 in Paris • 3rd plenary meeting: June 2016 in Warsaw • 4 working groups : Terminology and definitions (WG1), Requirements and test methods for electronic cigarettes devices (WG2), Requirements and test methods for e-liquids (WG3), Requirements and test methods for emissions (WG4) • More than 20 European countries participate at the CEN/TC 437 • Setting the standards for the European vaping industry • Contribute to the European regulation and the implementation of the EU Tobacco Products Directive – article 20 www.fivape.org

  14. EU STANDARDS AND EU TPD REGULATION: (MAY 2016  2018) • Tobacco Products Directive, article 20: notification scheme (6 months), max 20 mg/ml nicotine, technical requirements and obligations, leaflet & consumers information, packaging and health warning, check of monitoring and reporting obligations, market survey, 10 ml bottles - 2ml tanks, ingredients (0.1%) and high purity, toxicological data, emissions, constant delivery of nicotine, uptake, child safety and refilling mechanisms … • For almost each element of the EU Tobacco Products Directive, European (and international) standards will matter! www.fivape.org

  15. THE European commission is already using eu standards • Commission implementing decision (EU) for the refill mechanism of electronic cigarettes (2016/04/16) : • "Refill mechanisms": it entails the use of a refill container possessing a securely attached nozzle at least 9 mm long (...) into the opening of the tank of the electronic cigarette with which it is used and possessing a flow control mechanism that emits no more than 20 drops of refill liquid per minute when placed vertically and subjected to atmospheric pressure alone at 20 °C ± 5 °C(AFNOR XP D90-300-2) • Many elements required by the TPD will be declarative…until the publication of the first EU CEN/TC 437 standards www.fivape.org

  16. ISO 126/SC3 VAPE AND VAPOUR PRODUCTS • In March 2016, following a French proposal, creation of the new ISO 126/SC 3 Vape and vapour products • 2 Working groups:Determinationof substances in e-liquids(WG1) and Routine analytical e-cigarette vaping machine (WG2) • Next meeting: October 2016, Osaka (Japan) • Participating Countries (19): Austria (ASI), Belgium(NBN), Brazil (ABNT), Canada (SCC), Denmark (DS), Egypt (EOS), France (AFNOR), Germany (DIN), India(BIS), Italy (UNI), Japan (JISC), Korea, Republic of (KATS), Luxembourg (ILNAS), Netherlands (NEN), Spain (AENOR), Sweden (SIS), Switzerland (SNV), United Kingdom (BSI), United States (ANSI). • Observing Countries (8): Argentina (IRAM),CzechRepublic (UNMZ), Finland (SFS), Iran, IslamicRepublic of (ISIRI), Ireland (NSAI), Mongolia(MASM), Singapore (SPRING SG). www.fivape.org

  17. CONCLUSIONS • Standards are technical requirements for building a national transcription of the TPD in each state member. • Vape loby helps national institutions to understand the meaning of vaping, who are the professionals, and… who are the vapers ! • In France, the market is growing up now • Now , french products are distributed around the world for their qualities • European and national consumers will be confident • Following the studies (against or for) and answering to critics are our jobs ! www.fivape.org www.fivape.org 10/08/2016

  18. Thank you ! Charly PAIRAUD • Vice president of FIVAPE • General Manager of « Vincent dans les Vapes » (Vincent Vapes) • President of French Laboratory of e-liquids (www.LFEL.fr) www.fivape.org

  19. How can I CONTACT THE FIVAPE? Rémi PAROLA Email: remi.parola@fivape.org Address: 37, rue des Mathurins – 75 008 Paris Site internet : www.fivape.org Facebook/Twitter : Fivape European Coalition for Independent Vape : www.eciv.eu www.fivape.org

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