Measuring Emissions as Part of a Regulatory Regime. Prof. Riccardo Polosa Professor of Internal Medicine and Convenor CEN TC437/WG4

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1 Measuring Emissions as Part of a Regulatory Regime Prof. Riccardo Polosa Professor of Internal Medicine and Convenor CEN TC437/WG4

2 . (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;

3 Annex notification requirements Emissions: it is required that the methods for testing be described, but there is no information on which emissions they want data.

4 Room for interpretation.

5 Room for interpretation.

6 Room for interpretation.

7 CEN/TC 437 Setting quality and safety standards CEN/TC 437 E-cigarettes and e-liquids agrees to launch a 3 month ballot for the creation of: WG 4 "Requirements and test methods for emissions" to work on: Testing conditions, equipment and environment Reference products Measurements/quantification/qualification of emissions Consistent delivery of nicotine

8 CEN/TC 437/WG 4 Requirements and test methods for emissions Workplan priorities: CEN/TC 437 E-cigarettes and e-liquids agrees to launch a 3 month ballot for the creation of: WG 4 "Requirements and test methods for emissions" to work on: Testing conditions, equipment and environment (e.g. puffing parameters, aerosol generation and collection, laboratory environmental conditions) Liaison with ISO/TC 126/SC 3/WG 2 CORESTA CRM 81 AFNOR XP D Testing conditions, equipment and environment Reference products Measurements/quantification/qualification of emissions Consistent delivery of nicotine

9 CEN/TC 437/WG 4 Requirements and test methods for emissions Workplan priorities: Reference products CEN/TC 437 E-cigarettes and e-liquids agrees to launch a 3 month ballot for the creation of: WG 4 "Requirements and test methods for emissions" to work on: Testing conditions, equipment and environment Reference products Measurements/quantification/qualification of emissions Reference liquid (e.g. ingredients characteristics, storage conditions) BSI/PAS 54115:2015 AFNOR XP D AEMSA e-liquid manufacturing standards Specific reference liquids for analytical methods validation Reference device (e.g. technical parameters, design) BSI/PAS 54115:2015 AFNOR XP D US document Consistent delivery of nicotine

10 CEN/TC 437/WG 4 Requirements and test methods for emissions CEN/TC 437 E-cigarettes and e-liquids agrees to launch a 3 month ballot for the creation of: WG 4 "Requirements and test methods for emissions" to work on: Testing conditions, equipment and environment Reference products Measurements/quantification/qualification of emissions Consistent delivery of nicotine Workplan priorities: Measurements/quantification/q ualification of emissions Constituent to be measured in the emissions: Nicotine Carbonyls Metals TPD draft data dictionary for e-cig MHRA document BSI/PAS 54115:2015 AFNOR XP D FDA guidance

11 CEN/TC 437/WG 4 Requirements and test methods for emissions CEN/TC 437 E-cigarettes and e-liquids agrees to launch a 3 month ballot for the creation of: WG 4 "Requirements and test methods for emissions" to work on: Testing conditions, equipment and environment Reference products Measurements/quantification/qualification of emissions Consistent delivery of nicotine Workplan priorities: Measurements/quantification/q ualification of emissions Analytical methods for constituents to be measured in the emissions: availability of analytical methods applicability of analytical methods ICH Guidance Q2 British Pharmacopoeia (BP) European Pharmacopoeia (Ph Eur) US Pharmacopeia-National Formulary Japonese Pharmacopoeia (JP) development or modification of test methods, if required expression of the results validation

12 CEN/TC 437/WG 4 Requirements and test methods for emissions Workplan priorities: CEN/TC 437 E-cigarettes and e-liquids agrees to launch a 3 month ballot for the creation of: WG 4 "Requirements and test methods for emissions" to work on: Testing conditions, equipment and environment Reference products Measurements/quantification/qualification of emissions Consistent delivery of nicotine Consistent delivery of nicotine (e.g. parameters and definitions) CHMP guidance: Pharmaceutical quality of inhalation and nasal products ICH Guidance Q2 (R1): Validation of analytical procedures: text and methodology EU pharmacopoeia - Ph Eur monograph (Uniformity of Dosage Units) AFNOR XP D

13 CEN/TC 437/WG 4 Requirements and test methods for emissions Challenges & Concerns Need for substantial coordination Growing complexity (likely WI proliferation) Loss of human resources (increasing no-show) Can we meet the deadline?

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