The History and Challenges Faced by the CORESTA EVAP Sub ... · Proficiency Study: Determination of...
Transcript of 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
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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
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www.coresta.org
FEELING OPINION FACT
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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
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Membership
>600 participants across 26 Sub-Groups and Task Forces
162 members (September 2019)
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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
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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
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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
Tobacco Biotechnology and Omics
Collaborative Study of Low Nicotine
Tobacco Agronomic Production
Practices
Heated Tobacco Products
21st Century Toxicology for
Next Generation Tobacco and
Nicotine Products
Consumer Reported Outcome
Measures Consortium
Tobacco Alkaloid Genetics
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The Process (Simplified)
CORESTA
Members
Working
Groups
Scientific
Commission
Board
General
Secretariat
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Publications
Guides Methods
Technical
Reports
Abstracts &
Presentations
~ 9000 abstracts/presentations
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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
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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
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❖ 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
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❖ 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
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❖ 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
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❖ 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
Basis for ISO 20768:
“Vapour products - Routine
analytical vaping machine –
Definitions and standard
conditions”
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❖ 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
➢ 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
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”
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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
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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
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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
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CORESTA
and International Standards
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www.coresta.orgENDS US 2019
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❖ 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
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❖ Thank you for your attention
❖ Questions?
❖ More information available at www.coresta.org
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