1. The Ministry of Health proposes to make regulations under section 84 of the Smokefree Environments and Regulated Products Act 1990 (the Smokefree Environments and Regulated Products Regulations 2021 – “Regulations”), which will set the product safety requirements for vaping products, including quality standards for vaping substance ingredients.

2. It is proposed that the Regulations incorporate by reference the quality standards set in the United States Pharmacopoeia and the European Pharmacopoeia monograph (“Proposed Material”) for the quality of the following substances:

1. Nicotine [Ph Eur 1452]
2. Propylene glycol [Ph Eur 0430]
3. Vegetable glycerol [Ph Eur 0497]
4. Acids used in the manufacture of nicotine salts (e.g. benzoic acid [Ph Eur 0066])
5. Alcohol (ethanol) [Ph Eur 1317], and
6. Purified water [Ph Eur 0008].

3. The material incorporated by reference can be inspected free of charge by appointment during normal working hours (8.00am–4.00pm, Monday to Friday) at the Ministry of Health, 133 Molesworth Street, Thorndon, Wellington.

4. To arrange an appointment between Thursday 8 July and Thursday 22 July 2021, please email vaping@health.govt.nz.

5. Under copyright law, we are not able to display a copy online or distribute electronic copies of the United States Pharmacopoeia or the European Pharmacopoeia.

6. The USP42-NF37 edition of the United States Pharmacopoeia can be purchased at: https://www.uspnf.com/purchase-usp-nf.

7. The 10th edition of the European Pharmacopoeia can be purchased at: https://store.edqm.eu.

8. If you have any comment on the proposal to incorporate the Proposed Material by reference, please email vaping@health.govt.nz by Thursday 22 July 2021.

Dated at Wellington this 7th day of July 2021.

Dr ASHLEY BLOOMFIELD, Director-General of Health.