TPD2 and PMTA Regulatory Services

E-cigarettes, E-cig Over White BackgroundTPD2 and PMTA regulatory compliance

In 2014, the European Commission added ENDS into the Tobacco Products Directive 2014/14/EU (TPD) under their own Article (Article 20).

https://ec.europa.eu/health//sites/health/files/tobacco/docs/dir_201440_en.pdf

This article details the requirements which must be met with respect to manufacture, importation and retail of ENDS within the European Union. This law came into effect on 20th May 2016 and applies to all products on the market.

The following analytes are listed in the European Data Dictionary with their amounts present to be determined. These are deemed to be the analytes of interest for TPD2 submission.

Analyte
Acetaldehyde
Acetyl Propionyl
Acrolein
Aluminium
Arsenic
Benzene
1,3-Butadiene
Cadmium
Chromium
Copper
Crotonaldehyde
Diacetyl

Analyte
Diethylene Glycol
Ethylene Glycol
Formaldehyde
Iron
Isoprene
Lead
Mercury
Nickel
Nicotine
Tin
Toluene

Also in May 2016, the United States Food and Drug Administration released a draft guidance document for Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (PMTA).

https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM499352.pdf

As with TPD this document details the requirements which must be met with respect to manufacture, importation and retail of ENDS within the United States. A full PMTA submission can take up to 12-18 months, with a current deadline of August 2022 for existing ENDS. A deadline of November 2019, however, has been put in place for HPHCs (Harmful and Potentially Harmful Constituents) to be submitted. The recommended list duplicates many of those listed in the European Data Dictionary.

Analyte
Acetaldehyde
Acetyl Propionyl
Acrolein
Acrylonitrile
4-Aminobiphenyl
1-Aminonaphthalene
2-Aminonaphthalene
Ammonia
Anabasine
Benzene Benzo[a]pyrene
1,3-Butadiene
Cadmium
Chromium
Crotonaldehyde

Analyte
Diacetyl
Diethylene Glycol
Ethylene Glycol
Formaldehyde
Glycerol
Isoprene
Lead
Menthol
Nickel
Nicotine (incl. total & unprotonated)
NNK
NNN
Propylene Glycol
Toluene
Other constituents, as appropriate

Hall Analytical have developed and validated methods for all of the TPD2 and PMTA recommended analytes.

With a view towards “other constituents, as appropriate”, we have added extra analytes that we deem may be of toxicological concern. See Suite of Tests.

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In the interest of our clients product security we are keen to retain our independence however if required we work in partnership with Independent leading Toxicology and Regulatory consultants and can offer a full TPD Notification solution if required.

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