the history and challenges faced by the coresta evap sub ... · proficiency study: determination of...

The History and Challenges

Faced by the CORESTA EVAP Sub-Group in Developing

Testing Standards for E-liquids and E-aerosols

Eduardo Berea, Dr Derek Mariner, Dr Gene Gillman, Dr Stéphane Colard

ENDS US 2019 – December 9-11, 2019 | Arlington, VA, USA

Outline

❖ Introduction to CORESTA

❖ CORESTA work on E-Vapour products

❖ Process for Development of Recommended Methods

❖ Proficiency study for metals in e-liquids

❖ Challenges and Opportunities

❖ Participation to standardization activities

2www.coresta.orgENDS US 2019

December 9-11, 2019 | Arlington, VA, USA

CORESTA

www.coresta.org

Cooperation Centre for Scientific Research Relative to Tobacco

A non-profit organisation created in 1956

governed by French law

Purpose*To promote cooperation in scientific research relative

to tobacco and its derived products

*Legally bindingENDS US 2019

December 9-11, 2019 | Arlington, VA, USA3

www.coresta.org

FEELING OPINION FACT

ENDS US 2019


CONSENSUS

4

To be recognised by our members

and relevant external bodies

as an authoritative source of publicly available

credible science and best practices

related to tobacco and its derived products

The Vision

www.coresta.org

“

”ENDS US 2019


Membership

>600 participants across 26 Sub-Groups and Task Forces

162 members (September 2019)

www.coresta.orgENDS US 2019


Governance & Structure

General

Assembly

Board

Scientific

Commission

Agronomy &

Leaf Integrity

General

Secretariat

Smoke

Science

Product

Technology

Phytopathology &

Genetics

Agrochemical

Advisory Committee

26 subject or

product-specific

Working Groups

(Sub-Groups or

Task Forces)

~ 600 experts

Strategy and Policy:

14 elected/co-opted

organisations

Technical Oversight:

20 elected experts162 Member

organisations

Administration

3.5 people

Workshops &

Annual Conferences



Spectrum of Scientific Cooperation Topics

www.coresta.org

• Integrated Pest Management

• Virus Diseases

• Extended Diagnostic Expert System

• Efficacy of Biological & Eco-Friendly Crop Protection Agents

• Collaborative Study Black Shank

• Tobacco Alkaloid Genetics

• Tobacco Biotechnology and Omics

• Routine Analytical Chemistry

• Physical Test Methods

• Cigar Smoking Methods

• Tobacco and Tobacco Products Analytes

• E-Vapour

• Cigarette Variability

• Heated Tobacco Products

• Product Use Behaviour

• Smoke Analytes

• In Vitro Toxicity Testing

• Biomarkers

• Consumer Reported Outcome

Measures Consortium

• 21st Century Toxicology for

Next Generation Tobacco and

Nicotine Products

• Agrochemicals Analysis

• Pest and Sanitation Management in Stored

Tobacco

• Proficiency Testing for Detection of

Transgenic Tobacco

• TSNA in Air-cured and Fire-cured Tobacco

• Agrochemical Residue Field Trials

• Collaborative Study of Low Nicotine

Tobacco Agronomic Production Practices

26Current

Working

Groups

ENDS US 2019


Spectrum of Scientific Cooperation Topics

www.coresta.org

• Integrated Pest Management

• Virus Diseases

• Extended Diagnostic Expert System

• Efficacy of Biological & Eco-Friendly Crop Protection Agents

• Collaborative Study Black Shank

• Tobacco Alkaloid Genetics

• Tobacco Biotechnology and Omics

• Routine Analytical Chemistry

• Physical Test Methods

• Cigar Smoking Methods

• Tobacco and Tobacco Products Analytes

• E-Vapour

• Cigarette Variability

• Heated Tobacco Products

• Product Use Behaviour

• Smoke Analytes

• In Vitro Toxicity Testing

• Biomarkers

• Consumer Reported Outcome

Measures Consortium

• 21st Century Toxicology for


Nicotine Products

• Agrochemicals Analysis

• Pest and Sanitation Management in Stored

Tobacco

• Proficiency Testing for Detection of

Transgenic Tobacco

• TSNA in Air-cured and Fire-cured Tobacco

• Agrochemical Residue Field Trials

• Collaborative Study of Low Nicotine

Tobacco Agronomic Production Practices

26Current

Working

Groups

Tobacco Biotechnology and Omics

Collaborative Study of Low Nicotine

Tobacco Agronomic Production

Practices

Heated Tobacco Products

21st Century Toxicology for


Nicotine Products

Consumer Reported Outcome

Measures Consortium

Tobacco Alkaloid Genetics

ENDS US 2019


The Process (Simplified)

CORESTA

Members

Working

Groups

Scientific

Commission

Board

General

Secretariat



Publications

Guides Methods

Technical

Reports

Abstracts &

Presentations

~ 9000 abstracts/presentations

www.coresta.org



http://www.coresta.org/

CORESTA Study Groups

Agronomy & Leaf Integrity

Agronomy & Breeding

Curing

Sustainability

Product Technology

Technical specifications

Methods for component

analysis

Phytopathology & Genetics

Pests & plant diseases

Agrochemical issues

Smoke Science

Methods emissions analysis

Consumer behaviour

In Vitro Toxicology

ENDS US 2019

December 9-11, 2019 | Arlington, VA, USAwww.coresta.org 12

CORESTA work relative to ENDS products

• Conduct studies to characterisee-liquids, emissions and device

• Develop/publish methods/guides

• Organise and conduct periodic proficiency/collaborative studies

• Develop an approach and adopt validation guidelines for CROM for use in the assessment of products with reduced risk potential.

• Create a repository of measurement and validation approaches.

• Review published papers and publish critical reviews in peer-reviewed journals.

• Examine unpublished reports and recommend work and publication

• Review emerging technologies and application and identify appropriate approaches to NGP testing.

• Provide guidance documents to support assay using toxicity testing in the 21st century

Toxicology for NGP Products

Product Use

Behaviour

E-vapour productsTesting

Consumer Reported Outcome Measures

ENDS US 2019

December 9-11, 2019 | Arlington, VA, USAwww.coresta.org 13

❖ Approach used for the development of robust methods

➢ Consensus-based process

➢ Discussions during process provide insight into causes/reduction of intra- and inter-laboratory

variability

➢ Methods and Reports are made available on the CORESTA website

Development of Recommended Methods

Define

purpose

Paper-based

assessment of

available

methods

Preliminary

practical

assessment

Method

optimization

Collaborative study:

draft CRM

10-20 labs

multiple products

Data evaluation

using ISO 5725

Publish

CRM



❖ Currently 35 member organisations: e-cig and e-liquid manufacturers, academia,

regulators, equipment suppliers, and testing laboratories

❖ Information documents available on CORESTA website:

➢ E-Cigarettes: A Brief Description of History, Operation and Regulation. Reference Report - February 2014

➢ E-Cigarettes: Assessment of Analytical Literature from 55 Studies Published Worldwide prior to November

2013 on Commercial E-Cigarettes. Reference Report - May 2014

➢ Guide No. 18: Sample Handling and Sample Collection of E-Cigarettes and E-Vapour Generating Products –

November 2016

➢ Guide No. 22: Technical Guide for the Selection of Appropriate Intense Vaping Regimes for E-Vapour Devices

❖ In development:

➢ Guide for Designing E-Vapor Product Stability Studies

➢ Collection Strategies and Considerations When Testing E-Vapour Product Technologies

➢ LOD/LOQ values for the determination of metals in aerosol

E-Vapour Sub-Group



❖ Analytical Methods and Technical Reports

➢ E-Liquid Preliminary Proficiency Study. Technical Report - March 2015

➢ Electronic Cigarette Aerosol Parameters Study. Technical Report - March 2015

➢ CRM 81: Routine analytical machine for e-cigarette aerosol generation and collection - definitions and

standard conditions – June 2015

➢ Collaborative Study for Determination of Glycerin, Propylene Glycol, Water and Nicotine in Collected

Aerosol of E-Cigarettes. Technical Report - March 2017

➢ CRM 84: Determination of Glycerin, propylene glycol, water, and nicotine in the aerosol of e-cigarettes by

gas chromatographic analysis – March 2017

➢ 2017 Collaborative Study on Carbonyl Containing Compounds in Electronic Cigarette Liquids – May 2017

❖ In progress:

➢ Proficiency Study: Determination of Metals in e-liquids (reporting stage)

➢ Collaborative Study: Determination of Carbonyls in Aerosol

➢ Collaborative Study: Aerosol delivery of Nicotine, PG and Glycerin from a reference e-cigarette

E-Vapour Sub-Group













❖ In progress:

➢ Proficiency Study: Determination of Metals in e-liquids (reporting stage)



E-Vapour Sub-Group

Basis for ISO 20768:

“Vapour products - Routine

analytical vaping machine –

Definitions and standard

conditions”













❖ In progress:

➢ Proficiency Study: Determination of Metals in e-liquids



E-Vapour Sub-Group

Development has informed ISO 20714/FDIS:

“E-liquid — Determination of nicotine,

propylene glycol and glycerol in liquids used

in electronic nicotine delivery devices — Gas

chromatographic method”



Metals in e-liquid proficiency study

Objective: To assess

whether harmonisation

necessary

• 4 blank/fortified e-liq

• 8 labs using µwave

digestion, 6 using

dilution only

• ICP-MS analysis

• As, Cd, Cr, Cu, Fe,

Pb, Ni, Ag, Sn, Zn



Challenges

❖ Range of member needs

➢ Testing requirements vary according to local regulations

➢ Scope of testing and target analytes are not harmonized eg EU vs US

❖ Range of ENDS products

➢ Rapid advances in ENDS technology

➢ Members do not have experience with all types

➢ Studies cannot cover all products on the worldwide market

❖ Collaborative studies

➢ Device availability for collaborative studies, members cite liability and logistics

➢ Shipping of study samples worldwide complicated by varied local customs requirements, eg

nicotine content and tank capacity



Opportunities

❖ Global interdisciplinary expertise from different sectors – non-members can get

involved

❖ Focus on sharing and advancing scientific knowledge

❖ Conduct of inter-laboratory studies during development of analytical methods

❖ Track record supporting development of International Standards

❖ Emphasis on collaboration





CORESTA

and International Standards

24



❖ ISO (International)

➢ CORESTA Liaison with TC 126 Tobacco and Tobacco Products and

⚫ SC1 Physical and Dimensional Tests

⚫ SC2 Leaf tobacco

⚫ SC3 Vape and Vapour Products

➢ CORESTA led SC3-WG2 on Vaping machine parameters

❖ CEN (Europe)

➢ CORESTA Liaison with TC 437 Vape and Vapour Products

➢ CORESTA-nominated experts in WG1, WG3 and WG4

Participation to

standardization activities

25

❖ Thank you for your attention

❖ Questions?

❖ More information available at www.coresta.org



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