product stewardship of electronic cigarettes 101 · 1. what is product stewardship? 2. product...

Ian Jones, PhD

ECig London Industry Conference

December 04, 2014

Product Stewardship of Electronic Cigarettes

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1. What is Product Stewardship?

2. Product Stewardship of e-cigarettes

a. Understanding ‘what goes in’

b. Understanding ‘what comes out’

c. Waste management & recycling

3. Product Stewardship & product standards

4. Summary

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Agenda

1. What is Product Stewardship?

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“Responsibly managing the health, safety,

and environmental aspects of raw materials,

intermediate, and consumer products

throughout their life cycle and across the

value chain in order to prevent or minimize

negative impacts and maximize value.”

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Product Stewardship

http://www.productstewards.org/resources/Pages/Core-Competencies.aspx

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Understand and ‘steward’ your product right

across the supply chain!

• What ‘goes in’

• What ‘comes out’

• Environmental considerations

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In other words….

2. Product Stewardship of electronic cigarettes

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1. Product development

2. Suppliers, materials &

ingredients

3. Manufacturing

4. Product testing, QA/QC

5. Logistics

6. After-sales support

EHS

EHS; Environment, Health & Safety

3. Understanding ‘what goes in’

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Know your suppliers (and sub-suppliers)

• Map your supply chain

• Know your suppliers and sub-suppliers

• Establish confidentiality agreements to

protect your assets

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• Know your product

• Qualitative (WHAT) and quantitative

(HOW MUCH) information to the single

chemical level

• Facilitates ‘fit for purpose assessments’

• e.g. regulatory & toxicological risk

assessments

• Facilitates compliance with CLP

regulations

• Will be required to be disclosed to

authorities under pending regulations

(TPDII and FDA)

• Change control

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Ensure full ingredient & material disclosures are received

CLP; Classification, Labelling and Packaging

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• Based on full ingredient and material disclosures from suppliers to the single chemical level

• Toxicological risk assessment of key materials

• E-liquid

• Components in direct contact with liquid / aerosol / consumer

• Regulatory compliance

• ROHS

• REACH

• E-liquid ingredients (e.g. TPDII)

• etc…

• Shelf life assessment

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‘Fit for purpose’ assessment of all ingredients & materials

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• Incoming material inspection

• QA / QC

• Manufacture to accredited standards if

appropriate

• ISO

• GMP?

• Health & safety

• Waste management

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Manufacturing standards

4. Understanding ‘what comes out’

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Understanding what consumers are exposed to during normal use

• Aerosol chemistry

• Constituent yields (e.g. nicotine, other

ingredients)

• Leachables & extractables (e.g. metals)

• Reaction products?

• Potential additional assessments

• In vitro toxicology

• Nicotine uptake (c.f. TPDII)

5. Waste management & recycling

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• Material sourcing logistics

• Manufacture

• Waste management / recycling

• Energy

• etc

• Finished good supply logistics

• Product disposal / recycling

• e.g. battery recycling schemes

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Environmental issues across supply chain

6. Product Stewardship & product standards

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An amalgamation of regulatory compliance & product standards

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• Several initiatives ongoing in EU & USA

• Proposal to set up a CEN technical

committee in 2015

Towards EU standard

• Possible scope:

• E-liquids

• Devices

• Product testing

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Product standards for e-cigarettes

Product Quality

Quality

conformance

Quality of

design

Proper

storage

Safety Reliability

7. Summary

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1. Know your suppliers

2. Know, and be prepared to justify, your

starting ingredients & materials

3. Identify manufacturing QA/QC procedures

4. Understanding what consumers are

exposed to

5. Waste management & recycling

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Take-home messages

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