E-Cigarette Product Regulation and Standardisation

Transcription

1 E-Cigarette Product Regulation and Standardisation Derek Mariner British American Tobacco, Research & Development, Southampton UK E-cigarette Workshop, Paper STW03 CORESTA Smoke Science and Product Technology Study Groups Meeting, Jeju Island, S. Korea. 3-8 October 2015

2 Outline Current Regulatory Status - Regulatory developments in EU - Impact of standardisation on regulation Standardisation Activities - International ISO - Regional CEN - National BSI, AFNOR CORESTA E-cigarette TF Perspective

3 Current Regulatory Status (Based on Country Laws Regulating E-cigarettes: A Policy Scan by John Hopkins Bloomberg School of Public Health Institute for Global Tobacco Control, May 2015, Permitted (e-cig specific) EU consumer/2 tier/banned Medicines regulation No specific regs Banned Tobacco 2 tier (medicines/ zero nic permitted) Unclear 3

4 Regulatory Development in the EU Revised Tobacco Products Directive (TPD II) adopted May 2014 TPD II provides e-cigarette manufacturers with two options 1. E-cigarettes with nicotine below 20 mg/ml will be regulated as a non-tobacco products within the TPD, albeit with similar restrictions as to traditional tobacco products (advertising bans etc) 2. E-cigarettes with nicotine above 20mg/ml or with product claims (health) will require a Market ing Authorisation under medicines regulation Member States have 24 months to transpose into national legislation ie new rules apply from May 2016 Member States may extend e-cigarette grace period for a further 12 months until May

5 Impact of Standardisation on Regulation Q Q Q Q Q Q May 2016 Q Q May 2017 TPD National Transposition Transposition Dead line Commission Implementing Act 1 Industry consult n/impact assessment MS consult n & adoption Notification Template Regulation Commission Implementing Act 2 AFNOR Industry consultation/impact assessment Tech Stand refill mechanism BSI CEN Standards 5

6 International Organization for Standardization (ISO) TC126 Tobacco and Tobacco Products (1968) Scope: Standardization of terminology and test methods for unmanufactured tobacco, all types of tobacco products, materials used for manufacturing tobacco products and tobacco smoke including environmental tobacco smoke aspects; specifications and questions of handling, storage, packaging and transport are included as appropriate. Proposed addition/clarification: Tobacco product means any product made or derived from tobacco that is intended for human use and products that are used in a manner similar to smoking or smokeless products. Currently on hold pending decision by ISO Technical Management Board over proposed new TC: Vape and Vapour products 6

7 International Organization for Standardization (ISO) Existing TC126 Tobacco and Tobacco Products (1968) Current activities with e-cigarettes: WG15: Determination of substances in e-liquids Convenors: Thomas Schmidt (Germany), Liu Huimin (China) 1 st meeting 26 October 2015 Berlin WG16: Routine analytical e-cigarette vaping machine Convenor: Derek Mariner (CORESTA) 1 st meeting TBA 7

8 International Organization for Standardization (ISO) Proposed new TC: Vape and Vapour Products Proposed scope: Standardization of requirements and test methods of vape and vapor products. Standardization of product information and services related to the use of vape and vapor products Currently subject to ISO Member Body vote/comment concludes 3 October

9 Comité Européen de Normalisation (CEN) TC437 Electronic cigarettes and e-liquids (2015) Scope: Standardization in the field of electronic cigarettes and related e-liquids (consumable), including or not nicotine, for which no other technical committee exists 1 st mtg 22 June 2015: business plan, proposed WGs, liaison with other TCs eg Packaging, Household Electrical Appliance Safety, Elec. Equip. in Medical Current activity: Nominations to WGs Practice WG1: Terminology and definitions; WG2: Requirements and test methods for electronic cigarette devices, WG3: Requirements and test methods for e-liquids, WG4: Requirements and test methods for emissions Decided not to work on: manufacturing reqts, product information, refill mechanisms 9

10 British Standards Institution (BSI) Production of Publically Available Specification 54115: Vaping products, including electronic cigarettes, e-liquids, e-shisha and directly-related products Manufacture, importation, testing and labelling Guide Published July 2015 Steering group comprised consumer groups, E-cig industry, public health, government (Trading standards + DoH comment on final draft) Focus on safety and quality All requirements have to be achievable and enforceable Technological neutrality Uses existing standards and guides 10

11 Association Française de Normalisation (AFNOR) E-cigarettes and E-liquids (May 2014) 60+ individuals/organisations involved, many new to standardisation process High work rate, broad output 3 Standards developed: 1: E-cigarette devices (March 2015) 2: E-liquids (March 2015) 3: E-cigarette emissions (draft) 11

12 Association Française de Normalisation (AFNOR) Standard on electronic cigarettes XP D Includes: The risks of overheating cutting, injuring or exploding The coatings used must not release any allergenic or toxic substances, or cause burns. Electronic cigarettes must be shock-resistant, and a metre drop test protocol is recommended. Chemical risks must be minimized, and the metals in the atomizer's heating element must not contain mercury. Two icons : 12

13 Association Française de Normalisation (AFNOR) Standard on e-liquids, with or without nicotine XP D Includes: Bottle safety Grade of the ingredients used List of banned ingredients Label and information leaflet Nicotine dosage: reliable information Clear information about ingredients An exhaustive information leaflet 13

14 Association Française de Normalisation (AFNOR) Part 3: Requirements and test methods pertaining to emissions (in draft) Includes: Heat and chemical risks (inc inhalation and toxicity) Characterisation Reference e-liquids, vaporisation machine, reference e-cigarette, operating conditions, puffing parameters Limits for some constituents Analytical methods (outline) Consistency of nicotine yield 14

15 CORESTA E-cigarette Task Force CRM 81: Routine Analytical Machine for E-Cigarette Aerosol Generation and Collection - Definitions and Standard Conditions (June 2015) Development of CRMs for nicotine, glycerol, PG, water in e-liquid and aerosol (ongoing) Propose to work on guidance documents Product handling and sample preparation Collection strategies: tank systems vs cigalike products 15

16 Industry Perspective on Standardization Activities Balance of interests ISO BSI CEN AFNOR Consumer/ Public Health 16

17 Thank you