Smokefree Environments and Regulated Products Amendment Regulations 2023
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Version as at 6 March 2024
Smokefree Environments and Regulated Products Amendment Regulations 2023
(SL 2023/201)
Cindy Kiro, Governor-General
Order in Council
At Wellington this 21st day of August 2023
Present:
Her Excellency the Governor-General in Council
Note
The Parliamentary Counsel Office has made editorial and format changes to this version using the powers under subpart 2 of Part 3 of the Legislation Act 2019.
Note 4 at the end of this version provides a list of the amendments included in it.
These regulations are administered by the Ministry of Health.
These regulations are made under sections 81, 82A, 82B, 84, and 85 of the Smokefree Environments and Regulated Products Act 1990—
(a)
on the advice and with the consent of the Executive Council; and
(b)
in relation to new subparts 2A and 2B of Part 3 of the principal regulations (as inserted by regulation 6) and new subpart 4 of Part 3 of the principal regulations (as inserted by regulation 8), on the recommendation of the Minister of Health, having considered the matters set out in section 82B(2) of that Act.
Contents
Regulations
1 Title
These regulations are the Smokefree Environments and Regulated Products Amendment Regulations 2023.
2 Commencement
(1)
Except as provided in subclause (2), these regulations come into force on 21 September 2023.
(2)
[Revoked]Regulation 2(2): revoked, on 6 March 2024, by section 43 of the Smokefree Environments and Regulated Products Amendment Act 2024 (2024 No 6).
3 Principal regulations
These regulations amend the Smokefree Environments and Regulated Products Regulations 2021.
4 Regulation 3 amended (Interpretation)
In regulation 3, insert in their appropriate alphabetical order:
Act means the Smokefree Environments and Regulated Products Act 1990
activate, in relation to a vaping device, means to turn on the vaping device so that it can be used to vape
areas of community interest means kōhanga reo, early childhood education and care centres, registered schools listed on the Ministry of Education’s Internet site, and marae listed on the Ministry of Māori Development—Te Puni Kōkiri Internet site
battery, in relation to a vaping device, includes 1 or more batteries or battery packs used at the same time to power a vaping device
child safety mechanism means, in relation to a vaping device, a mechanism or combination of mechanisms that—
(a)
requires at least 2 simultaneous or 5 sequential operations before the vaping device is activated; and
(b)
automatically deactivates the device within a period of no more than 10 minutes after vaping has stopped
deactivate means, in relation to a vaping device, to turn off a vaping device so that it cannot be used to vape
IEC means the International Electrotechnical Commission
ISO means the International Organization for Standardization
NZBN means New Zealand Business Number
refilling, in relation to a vaping device, means adding a vaping substance or heated tobacco product to a device so that it can be vaped, whether adding it directly or by using a pod, cartridge, or similar storage container
removable battery means a battery that can be inspected, removed, and replaced, without damaging the battery or the device, by a person using no more than a screwdriver
reusable vaping device means a vaping device other than a single-use vaping device
single-use vaping device means a vaping device that is pre-filled with a vaping substance or heated tobacco product and that is not designed to be refilled once used
5 Regulation 32 replaced (Smell of tobacco)
Replace regulation 32 with:
32 Smell of tobacco
A tobacco product may smell only of manufactured tobacco or menthol.
6 New subparts 2A to 2D of Part 3 inserted
After regulation 61, insert:
Subpart 2A—Limits on constituents of smoked tobacco products
61A Limits on constituents of smoked tobacco products
(1)
A smoked tobacco product must not contain any synthetic or naturally occurring chemical or ingredient that is structurally analogous or has functional similarity to nicotine or synthetic nicotine.
(2)
Nicotine, or any other addictive substance or substances (including psychoactive substances) that could maintain an addiction, must not be present in any constituent of an individual smoked tobacco product, other than tobacco leaf or filler.
Subpart 2B—Product safety requirements for smoked tobacco products
61B Product safety requirements for smoked tobacco products
It is a product safety requirement for a smoked tobacco product that there are systems in place that enable the following activities in relation to the product:
(a)
investigating and resolving any complaints about the product; and
(b)
recalling the product from sale, supply, or distribution; and
(c)
informing the Ministry of Health of any recall of the product, the extent to which the product is recalled, and the outcome of the recall.
Subpart 2C—Product information
61C Information that manufacturer and importer must provide with application for approval for sale, import, or manufacture of smoked tobacco product
(1)
Except as provided in subclauses (2) and (3) (which relate to applications for temporary approval), a manufacturer or an importer must provide the following with its application for approval for sale, import, or manufacture of a smoked tobacco product:
(a)
a description of the product type, brand, variant, and unique product code; and
(b)
a summary of test results for nicotine content and any other constituents of at least 3 batches of the full-scale manufactured product; and
(c)
a full list of ingredients, including any additives; and
(d)
an appendix containing a record that includes full test reports for at least 3 batches of the full-scale manufactured product, information on the testing methodology used, product and packaging images, and any relevant documentation.
(2)
A manufacturer or an importer must provide the following with its application for temporary approval for import of a smoked tobacco product for the purposes of research or testing, or both:
(a)
a description of the product type, brand, variant, and unique product code (if available); and
(b)
a description of, and statement of the purpose of, the proposed research or testing, or both, including an explanation for requiring the import of a non-compliant product; and
(c)
the volume of the product proposed to be imported or manufactured for research or testing, or both, including an explanation of how that relates to the research or testing; and
(d)
evidence that the product meets the requirements of section 57C(3)(b) of the Act.
(3)
A manufacturer or an importer must provide the following with its application for temporary approval for sale, import, or manufacture of a niche smoked tobacco product:
(a)
a description of the product type, brand, variant, and unique product code; and
(b)
evidence that the product meets the requirements of section 57C(3)(a) of the Act.
Subpart 2D—Product notification
61D Notification requirements for distributor of smoked tobacco products
A distributor of smoked tobacco products must provide the following information when making a notification (including a renewal of a notification) as required by section 20S of the Act:
(a)
its contact details (including name, business name, company number, NZBN, address, phone numbers, and email addresses); and
(b)
a declaration that it meets the requirements of the Act and that the details provided are correct.
7 Regulation 63 revoked (Conduct of tests of manufactured cigarettes)
[Revoked]Regulation 7: revoked, on 6 March 2024, by section 44 of the Smokefree Environments and Regulated Products Amendment Act 2024 (2024 No 6).
8 New subpart 4 of Part 3 inserted
After regulation 63, insert:
Subpart 4—Analytical testing methods to determine nicotine levels in smoked tobacco products
63A Smoked tobacco products for sale or import to be tested
A manufacturer or an importer of a smoked tobacco product must ensure that the analytical testing methods set out in regulation 63B are used to determine nicotine levels in the smoked tobacco product.
63B Analytical testing methods
Tests for nicotine levels in a smoked tobacco product must—
(a)
be carried out in a laboratory that is accredited to the most recent version of ISO/IEC 17025 and for which the test is included in the scope of accreditation for that laboratory; and
(b)
be independent from the manufacturer or importer of the smoked tobacco product; and
(c)
be carried out—
(i)
using an appropriate chromatography-based analytical test that uses a gas chromatographic method that is demonstrated as suitable to test the nicotine content of the product and any constituents; and
(ii)
using appropriate instrumentation for the method selected, and in appropriate laboratory conditions; and
(iii)
using a method that has been shown to be appropriately validated for assessment and measurement of nicotine content at the accredited laboratory, including for accuracy, precision, specificity, limits of detection, quantification of results, and range.
63C Review of details of test methodology
(1)
A manufacturer or an importer of smoked tobacco products must submit full details of its proposed test methodology to the Director-General for review.
(2)
The submission must include evidence of the proposed test methodology’s validity and the accreditation of the laboratory where the testing was carried out.
63D Testing methods and compliance
(1)
A testing methodology must be designed to ensure that each smoked tobacco product will comply with these regulations and the Act.
(2)
When developing a test methodology, a manufacturer of smoked tobacco products must test a representative range of samples and account for any variance.
9 Regulation 66 amended (Prohibited features of smokeless tobacco package)
After regulation 66(1)(c), insert:
(ca)
depicts a cartoon or toy; or
10 New subpart 1A of Part 5 inserted
After regulation 69, insert:
Subpart 1A—Flavour description
69A Flavour description
(1)
A variant name on a vaping product must describe the actual flavour of the vaping product using only 1 or 2 flavour names listed in Schedule 4A.
(2)
The package of a vaping product must describe the actual flavour of the vaping product using only 1 or 2 flavour names listed in Schedule 4A.
11 Regulation 70 amended (Prohibited features of vaping product)
After regulation 70(1)(b), insert:
(ba)
depicts a cartoon or toy; or
12 New regulation 76A inserted (Notification requirements for general retailer of notifiable products)
After regulation 76, insert:
76A Notification requirements for general retailer of notifiable products
A general retailer of notifiable products must provide the following information when making a notification (including a renewal of a notification) as required by section 20R of the Act:
(a)
its contact details (including name, business name, company number, NZBN, address, phone numbers, and email addresses); and
(b)
a declaration that it meets the requirements of the Act and that the details provided are correct.
13 New Parts 6A and 6B inserted
After regulation 80, insert:
Part 6A Requirements for approval as smoked tobacco retailer
Subpart 1—Fit and proper person
80A Criteria for fit and proper person
(1)
In determining whether an applicant for approval as a smoked tobacco retailer is a fit and proper person, the Director-General must be satisfied that—
(a)
the applicant is over the age of 18 years; and
(b)
the applicant has not had a conviction in the previous 7 years for any of the following offences:
(i)
an offence under the Act:
(ii)
an offence under Part 6 of the Customs and Excise Act 2018:
(iii)
an offence under the Sale and Supply of Alcohol Act 2012:
(iv)
a crime involving dishonesty (as defined in section 2(1) of the Crimes Act 1961).
(2)
The Director-General may also have regard to any other matters the Director-General thinks relevant, including, but not limited to, any evidence of previous non-compliance with the Act.
(3)
Before deciding that an applicant is a fit and proper person, the Director-General must consult the chief executive of the Ministry of Justice to ascertain whether the applicant has a relevant conviction for an offence under subclause (1)(b).
(4)
This regulation applies to—
(a)
an applicant who is an individual; and
(b)
in the case of an application by an entity, each responsible person.
Subpart 2—Security measures
80B Retail premises security measures
An applicant for approval as a smoked tobacco retailer must demonstrate that the retail premises specified in the application (the specified retail premises) have, or will have, the following security measures in place:
(a)
an alarm system suitable for the specified retail premises; and
(b)
security cameras with recording facilities suitable for the specified retail premises; and
(c)
secure product storage suitable for the specified retail premises; and
(d)
external protection to protect the premises from theft suitable for the specified retail premises; and
(e)
a fog cannon system suitable for the specified retail premises.
Subpart 3—Business systems
80C Business system requirements
(1)
An applicant for approval as a smoked tobacco retailer must demonstrate the following:
Training requirements
(a)
that every person (whether paid, unpaid, or contracted) working at the specified retail premises is, or will be, given appropriate training to understand and carry out the retailer’s obligations under the Act:
(b)
that training includes a component about preventing sales to minors and to persons born on or after 1 January 2009:
(c)
that appropriate records of training, including effectiveness of training, will be kept:
Sales: general
(d)
that accurate records of all smoked tobacco products will be kept:
(e)
that records will include the type, brand, quantity, and price of the products sold:
(f)
that systems will be in place to prevent sales to minors or to persons born on or after 1 January 2009:
Delivery
(g)
that systems will be in place to ensure that smoked tobacco products are not delivered to minors or to persons born on or after 1 January 2009.
(2)
In the case of an application for approval as a smoked tobacco retailer for a specified Internet site, the applicant must demonstrate systems are in place to ensure that—
(a)
the criteria in section 20I(1)(d) of the Act (relating to the operation of an Internet site and the identified geographic area and population that a smoked tobacco retailer may sell within) will be met; and
(b)
smoked tobacco products will not be delivered to minors or to persons born on or after 1 January 2009.
Subpart 4—Additional assessment criteria for application process
80D Additional assessment criteria for application process
(1)
When determining an application, the Director-General must consider the following matters:
(a)
the proximity of the retail premises to 1 or more areas of community interest:
(b)
the type of business the applicant operates:
(c)
any security measures in place in addition to those required by regulation 80B:
(d)
any business systems in place in addition to those required by regulation 80C:
(e)
whether the requirements in regulations 80B and 80C are met, or will be met, when section 20G of the Act comes into force.
(2)
Further details of the matters referred to in subclause (1) are set out in the application process published on the Internet site maintained by, or on behalf of, the Ministry.
(3)
Subclause (1)(a) applies only to areas of community interest that exist on the date on which the application process is published.
Part 6B Requirements for approval as specialist vape retailer
80E Requirements for approval as specialist vape retailer
(1)
In determining whether to grant an application for approval as a specialist vape retailer, the Director-General must be satisfied that—
(a)
the applicant understands its obligations under the Act (including in regard to sales to minors); and
(b)
the retail premises are—
(i)
at least 300 metres from the location point of a registered school listed on the Ministry of Education Internet site; and
(ii)
at least 300 metres from a marae listed on the Ministry of Māori Development—Te Puni Kōkiri Internet site.
(2)
Subclause (1) applies only to a registered school or marae that is listed on the relevant Internet site on the date on which an application for approval as a specialist vape retailer is received.
14 Schedule 1 amended
In Schedule 1,—
(a)
insert the Part set out in Schedule 1 of these regulations as the last Part; and
(b)
make all necessary consequential amendments.
15 New Schedule 4A inserted
After Schedule 4, insert the Schedule 4A set out in Schedule 2 of these regulations.
16 Schedule 5 amended
(1)
In Schedule 5, after clause 1, insert:
1A
Clause 1 applies to a single-use vaping device if the device is also the container, except for the requirement in clause 1(a) that a label of vaping substances contains safety of use instructions in relation to refilling.
(2)
In Schedule 5, replace clauses 14 and 15 with:
14
For a vaping substance that contains nicotine only in salt form and is intended for use in a reusable vaping device, the concentration of nicotine must not exceed 28.5 mg/mL.
15
For all other vaping substances, the concentration of nicotine must not exceed 20 mg/mL.
(3)
In Schedule 5, before clause 20, insert:
19A
A vaping device must have—
(a)
a child safety mechanism to prevent the vaping device from being activated or accidentally operated by a child; and
(b)
a removable battery.
(4)
In Schedule 5, after clause 24, insert:
24A
A single-use vaping device must display overall nicotine strength on its product label in mg/mL.
(5)
In Schedule 5, clause 25, delete “However, single-use devices may have the serial or batch number displayed on the package instead of on the device.”
.
17 Schedule 8 amended
In Schedule 8, after the item relating to specialist vape retailer applying for additional retail premises or Internet site to be included in approval, insert:
| Applicant to be an approved smoked tobacco retailer | Assessment fee for each application to be an approved smoked tobacco retailer | On application, per application | 1,475 | |||
| Applicant for approval of a smoked tobacco product | Assessment fee for smoked tobacco product application | On application, per product | 13,450 | |||
| Applicant for temporary approval of a smoked tobacco product that cannot meet product requirements | Assessment fee for smoked tobacco product application | On application, per product | 2,650 | |||
| Smoked tobacco distributors, general vape retailers, and retailers of other notifiable products | Notification fee | When notifying, and every anniversary of that notification | 80 |
Schedule 1 New Part 2 inserted into Schedule 1
Part 2 Transitional provisions relating to Smokefree Environments and Regulated Products Amendment Regulations 2023
6 Interpretation
In this Part,—
amendment regulations means the Smokefree Environments and Regulated Products Amendment Regulations 2023
new product safety requirements means the amendments to Schedule 5 (product safety requirements for vaping products) in regulation 16 of the amendment regulations.
7 Transitional provision relating to regulations 63A to 63D (analytical testing methods)
Regulations 63A to 63D, as inserted by regulation 8 of the amendment regulations, apply to—
(a)
an application for approval of a smoked tobacco product received on and from 21 September 2023; and
(b)
all smoked tobacco products on and from 1 April 2025.
8 Transitional provision relating to regulation 66 (prohibited features of smokeless tobacco package)
Regulation 66, as amended by regulation 9 of the amendment regulations, applies to the sale of a smokeless tobacco product, its packaging, and any insert in the package, by a retailer on and from 21 March 2024.
9 Prohibition on sale of smokeless tobacco packages that do not meet new requirement of regulation 66 (prohibited features of smokeless tobacco package)
Smokeless tobacco products that do not meet the new requirement in regulation 66, as amended by regulation 9 of the amendment regulations, must not be sold on and from 21 March 2024.
10 Transitional provision relating to regulation 69A (flavour description)
Regulation 69A, as inserted by regulation 10 of the amendment regulations, applies to new vaping product notifications on and from 21 October 2023.
11 Prohibition on sale of vaping products that do not meet requirements of regulation 69A (flavour description)
Vaping products that do not meet the new flavour requirements in regulation 69A, as inserted by regulation 10 of the amendment regulations, must not be sold on and from 21 March 2024.
12 Transitional provision relating to regulation 70 (prohibited features of vaping product)
Regulation 70, as amended by regulation 11 of the amendment regulations, applies to the sale of a vaping product, its packaging, and any insert in the package, by a retailer on and from 21 March 2024.
13 Prohibition on sale of vaping products that do not meet new requirement of regulation 70 (prohibited features of vaping product)
Vaping products that do not meet the new requirement in regulation 70, as amended by regulation 11 of the amendment regulations, must not be sold on and from 21 March 2024.
14 Transitional provision relating to Schedule 5 (product safety requirements for vaping products)
Schedule 5, as amended by regulation 16 of the amendment regulations, applies on and from 21 October 2023 to all new product notifications for single-use and resuable vaping devices.
15 Prohibition on sale of vaping products that do not meet new product safety requirements of Schedule 5 (product safety requirements for vaping products)
(1)
Single-use vaping products that do not meet the product safety requirements, as amended by regulation 16 of the amendment regulations, must not be sold on and from 21 December 2023.
(2)
Reusable vaping products that do not meet the product safety requirements, as amended by regulation 16 of the amendment regulations, must not be sold on and from 21 March 2024.
Schedule 2 New Schedule 4A inserted
Schedule 4A Flavour names
r 69A
| Category | Flavour name | |
|---|---|---|
| Tobacco | Tobacco | |
| Mint | Menthol | |
| Mint | ||
| Peppermint | ||
| Spearmint | ||
| Nuts and grains | Almond | |
| Hazelnut | ||
| Nut | ||
| Oat | ||
| Peanut | ||
| Pecan | ||
| Spice | Cinnamon | |
| Clove | ||
| Licorice | ||
| Nutmeg | ||
| Pepper | ||
| Spice | ||
| Coffee/tea | Cappuccino | |
| Coffee | ||
| Espresso | ||
| Latte | ||
| Tea | ||
| Fruit | Apple | |
| Banana | ||
| Berry | ||
| Blackberry | ||
| Blueberry | ||
| Cherry | ||
| Citrus | ||
| Coconut | ||
| Grape | ||
| Guava | ||
| Kiwifruit | ||
| Lemon | ||
| Lime | ||
| Lychee | ||
| Mango | ||
| Orange | ||
| Passionfruit | ||
| Peach | ||
| Pear | ||
| Pineapple | ||
| Plum | ||
| Pomegranate | ||
| Raspberry | ||
| Strawberry | ||
| Tropical | ||
| Watermelon | ||
| Sweet and sour | Caramel | |
| Chocolate | ||
| Cream | ||
| Custard | ||
| Honey | ||
| Sour | ||
| Sweet | ||
| Vanilla | ||
| None | Unflavoured |
Rachel Hayward,
Clerk of the Executive Council.
Date of notification in Gazette: 24 August 2023.
Notes
1 General
This is a consolidation of the Smokefree Environments and Regulated Products Amendment Regulations 2023 that incorporates the amendments made to the legislation so that it shows the law as at its stated date.
2 Legal status
A consolidation is taken to correctly state, as at its stated date, the law enacted or made by the legislation consolidated and by the amendments. This presumption applies unless the contrary is shown.
Section 78 of the Legislation Act 2019 provides that this consolidation, published as an electronic version, is an official version. A printed version of legislation that is produced directly from this official electronic version is also an official version.
3 Editorial and format changes
The Parliamentary Counsel Office makes editorial and format changes to consolidations using the powers under subpart 2 of Part 3 of the Legislation Act 2019. See also PCO editorial conventions for consolidations.
4 Amendments incorporated in this consolidation
Smokefree Environments and Regulated Products Amendment Act 2024 (2024 No 6): Part 2 subpart 3
Versions
Smokefree Environments and Regulated Products Amendment Regulations 2023
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