Product Stewardship of Electronic Cigarettes 101 Stewardship of...Ian Jones, PhD ECig Germany Industry Conference February 2015 Product Stewardship of Electronic Cigarettes 2

Ian Jones, PhD

ECig Germany Industry Conference

February 2015

Product Stewardship of Electronic Cigarettes 2

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1. Recap

• What is Product Stewardship?

• Product Stewardship of e-cigarettes

2. Product Stewardship & TPDII

• TPDII notification requirements for

electronic cigarettes

3. Summary

ECig Germany Industry Conference; February 2015 2

Agenda

1. What is Product Stewardship?

3ECig Germany Industry Conference; February 2015

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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

ECig Germany Industry Conference; February 2015

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


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Product development (PD)

• Product stewardship approaches can support PD activities by;

Guiding supplier selection

Guiding ingredient & material selection

Proactively addressing regulatory compliance

(e.g. leak-free refill mechanism)

Advising on prototype analysis

• Addressing such issues early on in the product development process can save time and

effort later on!


Suppliers, materials & ingredients

• Supply chain mapping

• Confidentiality agreements

• Ingredient & material disclosures

• Ingredient & material ‘fit-for-purpose’ assessments

• Regulatory compliance

• Additional assessments; e.g.

• Food-contact certification for key components

• E-liquid neat ingredient assessments (see next slide)


Suppliers, materials & ingredientsE-liquid neat ingredient assessments

• Ingredient identity

• Necessary for gathering relevant chemical, toxicological and regulatory status information for the ingredient under review.

• Physicochemical properties

• Provides information concerning properties that may influence exposure and fate of the ingredient under intended conditions of use.

• Regulatory status and assessment by relevant authorities

• Provides information on the pre-existing regulatory status of the ingredient and identifies permitted usage levels and/or acceptable intake levels.

• Toxicological information

• Provides an overview of the potential toxicological hazards associated with an ingredient. In particular, determination of whether an ingredient is known to be, and regulated as, a carcinogen, genotoxicant, reproductive/developmental toxicant, and/or human allergen.

• Exposure assessment

• Provides an expected exposure dose and compares estimates of ingredient intake to diet and toxicological reference values.

• Auxiliary studies

• As required.


Manufacturing

• Production process

• Manufacturing standards

• Incoming material inspections

• Storage

• Health & safety


Product testing, QA/QC

• QA/QC procedures

• Batch analyses

• Vapor chemistry (emissions)

• Other assessments

• Claim substantiation


Logistics

• Documentation

• Storage

• Handling


After-sales support

• Quality complaints procedure

• Health-related complaints procedure

• Recycling

3. Product Stewardship & TPDII


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Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. The notification shall be submitted in electronic form six months before the intended placing on the market. For electronic cigarettes and refill containers alreadyplaced on the market on 20 May 2016, the notification shall be submitted within six months of that date. A new notification shall be submitted for each substantial modification of the product.

The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the followinginformation:

(a) the name and contact details of the manufacturer, a responsible legal or natural person within the Union, and, if applicable, the importer into the Union;

(b) a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof;

(c) toxicological data regarding the product's ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account, inter alia, any addictive effect;

(d) information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions;

(e) a description of the components of the product; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers;

(f) a description of the production process, including whether it involves series production, and a declaration that the production process ensures conformity with the requirements of this Article;

(g) a declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions.

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TPDII Notification requirements for e-cigs (Art.20, 2)


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Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. The notification shall be submitted in electronic form six months before the intended placing on the market. For electronic cigarettes and refill containers alreadyplaced on the market on 20 May 2016, the notification shall be submitted within six months of that date. A new notification shall be submitted for each substantial modification of the product.

The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the followinginformation:

(a) the name and contact details of the manufacturer, a responsible legal or natural person within the Union, and, if applicable, the importer into the Union;

(b) a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof;


(d) information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions;

(e) a description of the components of the product; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers;


(g) a declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions.

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TPDII Notification requirements for e-cigs (Art.20, 2)


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EHS


(a) the name and contact

details of the manufacturer,

a responsible legal or

natural person within the

Union, and, if applicable,

the importer into the Union;

A. Manufacturer details

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EHS


(b) a list of all ingredients

contained in, and

emissions resulting from

the use of, the product, by

brand name and type,

including quantities thereof;

B. Lists of ingredients & emissions

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EHS



C. Toxicological data on ingredients & emissions

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EHS


(d) information on the

nicotine doses and uptake

when consumed under

normal or reasonably

foreseeable conditions;

D. Nicotine dose & uptake

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EHS


(e) a description of the components of the product; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers

E. Components & mechanisms

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EHS



F. Production process

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EHS


(g) a declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions

G. Declaration

4. Summary


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• TPDII and Product Stewardship

approaches speak to ‘what goes in’ and

‘what comes out’ of e-cigs.

• Thus effective stewardship of e-cigs

facilities the product notification process

under TPDII.

Supply chain

Manufacturing / production process

Ingredients

Emissions

Scientific assessment

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Take-home messages


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Product Stewardship of Electronic Cigarettes 101 Stewardship of...Ian Jones, PhD ECig Germany Industry Conference February 2015 Product Stewardship of Electronic Cigarettes 2