Derek Mariner

British American Tobacco,

Research & Development, Southampton UK

E-Cigarette Product Regulation and Standardisation

E-cigarette Workshop, Paper STW03

CORESTA Smoke Science and Product Technology Study Groups Meeting,

Jeju Island , S. Korea. 3-8 October 2015

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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

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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, www.globaltobaccocontrol.org)

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Banned

Tobacco

Permitted (e-cig specific)

EU consumer/2 tier/banned

Medicines regulation

No specific regs

2 tier (medicines/

zero nic permitted)

Unclear

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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 2017

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Impact of Standardisation on Regulation

Q1 2015

Q2 2015

Q3 2015

Q4 2015

Q1 2016

May 2016

Q3 2016

Q4 2014

Tech Stand refill

mechanism

Commission Implementing

Act 2

TPD National Transposition

Transposition Dead line

Q4 2016

May 2017

Commission Implementing

Act 1

Notification Template

Industry consult’n/impact

assessment

MS consult’n & adoption

Industry consultation/impact

assessment

AFNOR

BSI

CEN

Standards

Regulation

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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

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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)

1st meeting 26 October 2015 Berlin

WG16: Routine analytical e-cigarette vaping machine

Convenor: Derek Mariner (CORESTA)

1st meeting TBA

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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 2015

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Comité Européen de Normalisation (CEN)

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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

1st mtg 22 June 2015: business plan, proposed WGs, liaison with other TCs

eg Packaging, Household Electrical Appliance Safety, Elec. Equip. in Medical Practice

Current activity: Nominations to WGs

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

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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

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Association Française de Normalisation (AFNOR)

E-cigarettes and E-liquids (May 2014)

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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)

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Association Française de Normalisation (AFNOR)

Standard on electronic cigarettes – XP D90-300-1

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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 1.50-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 :

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Association Française de Normalisation (AFNOR)

Standard on e-liquids, with or without nicotine – XP D90-300-2

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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

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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

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CORESTA E-cigarette Task Force

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• 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

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Perspective on Standardization Activities

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Balance of interests

Ind

ust

ry

Co

nsu

me

r/ P

ub

lic He

alth

ISO

AFNOR BSI CEN

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Thank you

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