Government Bill
143—1
The Government has the goal of reducing daily smoking rates to less than 5% across all population groups by 2025 (the Smokefree 2025 goal). While smoking rates have declined overall, Māori, Pacific people, and those living in the most deprived areas of New Zealand continue to have disproportionately higher smoking rates, and experience greater health inequities from smoking.
The Smokefree Aotearoa 2025 Action Plan sets out several measures that focus less on influencing consumer behaviour and more on changing the smoking environment. Legislative change is required to achieve the Smokefree 2025 goal and address the gaps remaining in New Zealand’s comprehensive regulation of tobacco products.
This Bill amends the Smokefree Environments and Regulated Products Act 1990 and the Customs and Excise Act 2018 as follows:
Reducing retail availability: new provisions restrict the sale of smoked tobacco products to retailers approved by the Director-General of Health, set out the application process and criteria to be an approved retailer, and provide for the Director-General of Health to set a maximum number of retail premises allowed in a certain area. The intent of these provisions is to significantly limit the number of retailers able to sell smoked tobacco products:
Amending the age limits for sale of smoked tobacco products: new provisions allow for the introduction of a smokefree generation policy by prohibiting the sale of smoked tobacco products to anyone born on or after 1 January 2009. The intent of the policy is to prevent young people, and successive generations, from ever taking up smoking:
Reducing the appeal and addictiveness of smoked tobacco products: new provisions require that only smoked tobacco products that meet requirements for constituents will be able to be manufactured, imported, or offered for sale or supply, and provide that it will be an offence for any smoked tobacco product to contain constituents exceeding any limits prescribed in, or prohibited by, regulations. A specific provision provides for a regulation-making power to set limits on the quantity of nicotine levels and other constituents of smoked tobacco products. The intent of these provisions is to increase the number of people who successfully stop smoking, and support tamariki/young people to remain smokefree, by making smoked tobacco products less appealing and addictive.
These legislative changes are mutually reinforcing, and together are expected to deliver the substantial changes needed to achieve the Smokefree 2025 goal and improve health outcomes for all New Zealanders.
This Bill is an omnibus Bill introduced in accordance with Standing Order 267(1)(a). That Standing Order provides that an omnibus Bill to amend more than 1 Act may be introduced if the amendments deal with an interrelated topic that can be regarded as implementing a single broad policy. The single broad policy implemented by the amendments in this Bill is to achieve the Smokefree 2025 goal.
The Ministry of Health is required to prepare a disclosure statement to assist with the scrutiny of this Bill. The disclosure statement provides access to information about the policy development of the Bill and identifies any significant or unusual legislative features of the Bill.
A copy of the statement can be found at http://legislation.govt.nz/disclosure.aspx?type=bill&subtype=government&year=2022&no=143
The Ministry of Health produced a regulatory impact statement on 3 November 2021 to help inform the main policy decisions taken by the Government relating to the contents of this Bill.
A copy of this regulatory impact statement can be found at—
https://www.health.govt.nz/about-ministry/information-releases/regulatory-impact-statements/regulatory-impact-statement-smokefree-aotearoa-2025-action-plan#:~:text=This%20Regulatory%20Impact%20Statement%20has,for%20the%20tobacco%20control%20portfolio
https://treasury.govt.nz/publications/informationreleases/ris
Clause 1 is the Title clause.
Clause 2 is the commencement clause. Clauses 18, 19(1) and (3), 20 to 24, 39(1) and (2), and 48 come into force on 1 January 2027. The rest of the Bill comes into force on the day after the date on which it receives the Royal assent.
Clause 3 provides that the principal Act amended is the Smokefree Environments and Regulated Products Act 1990.
Clause 4 amends section 2 of the principal Act, which defines terms used in the Act.
Clause 5 amends section 3A of the principal Act, which provides the purposes of the Act. The description of the purposes of the Act has been simplified into 3 parts, addressing the purposes of regulation of smoked tobacco products, the purposes of regulation of notifiable products, and the requirement to give effect to New Zealand’s obligations and commitments under international law. The purposes now include the matters dealt with in this Bill.
Clause 6 inserts new sections 3AA and 3AB into the principal Act. New section 3AA provides an outline of the principal Act, as amended by this Bill. New section 3AB describes how the principal Act, as amended by this Bill, provides for the Crown’s intention to give effect to the principles of te Tiriti o Waitangi/the Treaty of Waitangi.
Clause 7 repeals section 4.
Clause 8 amends section 6 to remove duplication of the requirement to provide a dedicated vaping room in certain workplaces.
Clause 9 amends section 14 to provide that section 5 does not apply to a person who vapes in any approved vaping premises of a specialist vape retailer or to the specialist vape retailer who allows the person to vape in those premises.
Clause 10 repeals section 14A.
Clause 11 amends section 16 to correct a cross-reference.
Clause 12 repeals section 20B.
Clause 13 inserts new Part 1B into the principal Act. New Part 1B sets out in 1 place the requirements for entry into both the smoked tobacco and vaping products retail markets. The requirements include provision for the Director-General of Health (the Director-General) to set the maximum numbers of approved smoked tobacco retailers in defined areas (new section 20M), and obligations on general vape retailers and distributors of smoked tobacco products to notify the Director-General that they are selling or distributing products (new sections 20R and 20S).
Clauses 14 and 15 repeal sections 21 and 22.
Clause 16 amends section 25 to provide separate signage exceptions for specialist vaping retailers and retailers of other regulated products from the prohibition on advertising of regulated products.
Clause 17 amends section 33 to limit the permitted exception in that section for a specialist vape retailer to supply free or reduced charge vaping products from their approved vaping premises or approved Internet site.
Clauses 18 to 24 make amendments to the principal Act to provide for the prohibition of the sale or supply of smoked tobacco products to persons born on or after 1 January 2009. The prohibition of the sale or supply of other regulated products to persons under the age of 18 years remains.
Clause 25 replaces section 47. New section 47 now relates to vending machines placed in a public place as defined in the Summary Offences Act 1981 and limits the use of vending machines to those requiring a person to be close to the machine to activate it.
Clauses 26 to 30 amend Part 3 of the principal Act to remove provisions that regulate the constituents of regulated products. These provisions are now found in new Part 3A and new sections 69A and 69B.
Clause 31 inserts new Part 3A into the principal Act. New Part 3A sets out approval requirements for smoked tobacco products, limits on the constituents of smoked tobacco products, and testing requirements for smoked tobacco products. New section 57H requires the Minister of Health to recommend the making of regulations within 21 months of the commencement of this Bill prescribing limits on the quantities of nicotine in smoked tobacco products and a method of determining whether those limits have been exceeded.
Clauses 32 and 33 repeal sections 58 and 59.
Clause 34 amends section 65 to apply requirements relating to flavour only to vaping products and smokeless tobacco products.
Clause 35 inserts new sections 69A and 69B, which set out testing requirements for notifiable products.
Clause 36 repeals section 76.
Clause 37 amends section 77 to provide for the protection of the confidentiality of all information entered on the database established under that section.
Clause 38 repeals section 79.
Clause 39 amends section 81 to provide regulation-making powers required to implement other provisions inserted by this Bill into the principal Act.
Clause 40 inserts new sections 82A and 82B to provide regulation-making powers to support the regulation of the sale and distribution of smoked tobacco products and other requirements relating to smoked tobacco products.
Clause 41 amends section 83 to provide for regulations that specify the constituents of a smoked tobacco product that must be listed on packaging.
Clause 42 amends section 84 to provide for regulations that prescribe standards and requirement for testing under new sections 69A and 69B, and for regulations that declare a regulated product to be a notifiable product for the purposes of the principal Act.
Clause 43 amends section 85 to provide a regulation-making power for the setting of fees in relation to new services provided under this Bill.
Clause 44 amends section 86 to provide a regulation-making power for the setting of levies in relation to new functions, powers, and duties of the Director-General under this Bill.
Clause 45 amends the subpart 2 heading in Part 5.
Clause 46 inserts a new cross-heading.
Clause 47 amends the definition of infringement fee and infringement offence in section 87 to include new infringement offences for provisions introduced by this Bill.
Clause 48 inserts a new cross-heading and new section 90A, which deals with employer liability for the actions of employees in specified new sections.
Clause 49 amends section 94 to provide for the change from a prohibited age for sale or supply of smoked tobacco products to the smokefree generation prohibition.
Clause 50 amends section 100 to update the reporting requirements in line with the changes made under this Bill.
Clause 51 inserts new section 101, which sets out the record-keeping requirements for a manufacturer, importer, exporter, distributor, or retailer of regulated products.
Clause 52 inserts new subparts 5 and 6 into Part 5 of the principal Act. New subpart 5 contains provisions dealing with appeals against decisions of the Director-General in respect of approvals of smoked tobacco products or notifications of notifiable products. New subpart 6 provides for agreements between the Director-General and the chief executive of a government agency for access to information in a database for the purpose of assisting the chief executive to administer and enforce the principal Act and the Customs and Excise Act 2018.
Clause 53 inserts into Schedule 1 of the principal Act transitional, savings, and related provisions, which have effect according to their terms. The provisions are set out in the Schedule of this Bill.
Clauses 54 to 56 amend section 95A and Schedule 3A of the Customs and Excise Act 2018. The amendments align the provisions of the Customs and Excise Act 2018 with the amendments made under Part 1.
Clauses 57 to 64 amend the Smokefree Environments and Regulated Products Regulations 2021 to align the regulations with the amendments made under Part 1.
Hon Dr Ayesha Verrall
The Parliament of New Zealand enacts as follows:
This Act is the Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Act 2022.
(1)
Sections 18, 19(1) and (3), 20 to 24, 39(1) and (2), and 48 come into force on 1 January 2027.
(2)
The rest of this Act comes into force on the day after the date on which it receives the Royal assent.
This Act amends the Smokefree Environments and Regulated Products Act 1990.
In section 2(1), insert in their appropriate alphabetical order:
approved smoked tobacco retailer means a person who is approved by the Director-General as an approved smoked tobacco retailer under section 20H
constituent means any thing that makes up, is present in, or is emitted from a regulated product
database means the database established under section 77
entity includes—
a body corporate:
a corporation sole:
in the case of a trust that has—
only 1 trustee, the trustee acting in that capacity as trustee:
more than 1 trustee, the trustees acting jointly in their capacity as trustees:
an unincorporated body (including a partnership)
flavour, in relation to a notifiable product, means a clearly noticeable smell or taste—
resulting from an additive or a combination of additives; and
that is noticeable before or during use of the product
general vape retailer means a retailer of vaping products, other than a specialist vape retailer
iwi-Māori partnership board has the same meaning as in section 4 of the Pae Ora (Healthy Futures) Act 2022
Māori Health Authority means the health entity established under section 17 of the Pae Ora (Healthy Futures) Act 2022
notifiable product means—
a vaping product; or
a smokeless tobacco product; or
a herbal smoking product; or
any other regulated product (other than a smoked tobacco product) declared by regulations to be a notifiable product
notifier means the manufacturer or importer of a notifiable product
product safety requirements means safety requirements prescribed in regulations for a notifiable product
prohibited flavour means a flavour or a class of flavour listed in Part 2 of Schedule 2
prohibited substance means a substance declared under section 70 to be unsafe for use in a notifiable product
responsible person, in relation to an entity, means—
a director, partner, or trustee of the entity; or
if the entity does not have directors, partners, or trustees, a person who acts in relation to the entity in the same or a similar way as a director, partner, or trustee would were the entity a company, partnership, or trust
smoked tobacco product means a tobacco product that is intended to be used in a way that involves ignition or the combustion process
In section 2(1), definition of automatic vending machine, delete “self-service”.
“self-service”
(3)
In section 2(1), repeal the definition of harmful constituent.
(4)
In section 2(1), definition of specialist vape retailer, replace “section 14A” with “section 20P”.
“section 14A”
“section 20P”
Replace section 3A(1) and (2) with:
The purposes of this Act are—
to provide for the regulation of smoked tobacco products—
to prevent the harmful effect of other people’s smoking on the health of others, and especially on young people and children; and
to significantly reduce the retail availability of smoked tobacco products; and
to prevent young people, and successive generations, from ever taking up smoking; and
to reduce the appeal and addictiveness of smoked tobacco products; and
to restrict all forms of advertising and promotion; and
to reduce disparities in smoking rates and smoking-related illnesses between New Zealand population groups, and in particular between Māori and other groups; and
to provide for the regulation of notifiable products in a way that seeks to minimise harm; and
to give effect to certain obligations and commitments that New Zealand has as a party to the WHO Framework Convention on Tobacco Control, done at Geneva on 21 May 2003.
After section 3A, insert:
Part 1 prohibits smoking and vaping in workplaces, certain public enclosed areas, registered schools, and early childhood education and care centres.
Part 1A prohibits smoking and vaping in vehicles carrying children.
Part 1B regulates entry into the smoked tobacco and vaping products markets.
Part 2 regulates and controls the advertising, promotion, sale, and distribution of regulated products.
(5)
Part 3 regulates the packaging and labelling of regulated products.
(6)
Part 3A provides for—
the approval of smoked tobacco products; and
the regulation of constituents of smoked tobacco products.
(7)
Part 4 regulates the safety of notifiable products.
(8)
Part 5—
empowers the making of secondary legislation; and
contains provisions relating to—
the enforcement of this Act; and
reporting requirements relating to regulated products; and
appeals against product approval and notification decisions.
(9)
This section is intended as a guide only.
In order to provide for the Crown’s intention to give effect to the principles of te Tiriti o Waitangi/the Treaty of Waitangi, this Act—
requires the Director-General, before determining an application process for the approval of smoked tobacco retailers, to consult—
the Māori Health Authority; and
each iwi-Māori partnership board; and
any iwi or other Māori who the Director-General considers have an interest in the application process; and
requires the Director-General, before determining the maximum number of approved smoked tobacco retailers and the area to which that number applies, to consult—
any iwi-Māori partnership board for all or part of the proposed area; and
any iwi whose rohe includes all or part of the proposed area; and
any other Māori who the Director-General considers will be affected; and
requires the Director-General to—
have systems in place for the purposes of carrying out the consultation referred to in paragraphs (a) and (b); and
consult the Māori Health Authority before determining the iwi or other Māori to consult; and
requires the Minister, before preparing regulations in relation to the sale and distribution of smoked tobacco products, to consider the risks and benefits to Māori of regulating a constituent (including both users and non-users of smoked tobacco products).
Repeal section 4.
In section 6(1)(a), delete “or vaping” in each place.
“or vaping”
In section 14(1), replace “This Part” with “Section 5”.
“This Part”
“Section 5”
Repeal section 14A.
In section 16(3), replace “section 14” with “section 91”.
“section 14”
“section 91”
Repeal section 20B.
After section 20F, insert:
A person must not sell or offer for sale at retail a smoked tobacco product unless the person is an approved smoked tobacco retailer.
A person who, without reasonable excuse, contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding $400,000.
A person may apply to the Director-General, in accordance with the application process determined under section 20L, to be an approved smoked tobacco retailer in relation to—
specified retail premises; and
if applicable, specified Internet sites directly connected to the specified retail premises.
A person who, without reasonable excuse, provides false or misleading information in an application for approval to be an approved smoked tobacco retailer commits an offence and is liable on conviction to a fine not exceeding $10,000.
The Director-General must not give a person approval to be an approved smoked tobacco retailer unless satisfied that,—
for an individual, the applicant is—
a fit and proper person; and
a New Zealand resident; and
for an entity,—
each responsible person is a fit and proper person; and
the applicant is—
carrying on business in New Zealand; or
incorporated or registered under New Zealand law; and
any retail premises in which the products are or will be sold are—
a fixed permanent structure; and
appropriate premises from which to operate a stand-alone business; and
the applicant’s security, training, sales, delivery, and other business systems meet any requirements in regulations; and
any other requirements in regulations have been met.
When considering a matter in subsection (1)(a)(i) or (b)(i), the Director-General must have regard to any criteria or requirements specified in regulations.
It is a condition of an approval that the criteria in subsection (1)(a) to (e) continue to be complied with.
The Director-General may, in accordance with regulations, impose any other conditions on an approval, or on a class of approval, including the expiry date of the approval.
An approval expires on the date specified in the approval unless it is earlier cancelled.
The Director-General may suspend an approval granted under section 20I for 1 month if the Director-General has reasonable grounds to believe that—
any condition of the approval is not being complied with; or
an applicable requirement under this Act or regulations is not being complied with.
Before suspending an approval, the Director-General must give the holder of the approval a reasonable opportunity to be heard.
The Director-General may extend the period of suspension—
for a further month:
more than once.
The Director-General must tell the holder of the approval in writing of the suspension and give reasons.
Before the period of suspension ends, the Director-General must—
decide whether to cancel or reinstate the approval; and
tell the holder of the approval in writing of the decision and give reasons.
A cancellation or reinstatement takes effect immediately after the end of the period of suspension.
A person whose approval is suspended must not sell a smoked tobacco product during the period of suspension.
A person who knowingly or recklessly contravenes subsection (7) commits an offence and is liable on conviction to a fine not exceeding $400,000.
The Director-General may cancel an approval without any prior suspension if the Director-General is satisfied that 1 or more of the following are not being complied with:
a condition of the approval:
a requirement in this Act or regulations.
Before cancelling an approval without prior suspension, the Director-General must give the holder of the approval a reasonable opportunity to be heard.
The Director-General must tell the holder of the approval in writing of the cancellation and give reasons.
The Director-General must determine an application process for the approval of smoked tobacco retailers that—
ensures that any maximum number of approved smoked tobacco retailers declared for the relevant area under section 20M is not exceeded; and
meets any requirements set out in regulations.
Before determining the application process, the Director-General—
may consult any person whom the Director-General considers appropriate; and
must consult Māori in accordance with section 20N.
The Director-General must set out the application process in writing and publish it on an Internet site maintained by, or on behalf of, the Ministry of Health.
The Director-General must, by written notice, declare the maximum number of approved smoked tobacco retailers permitted in 1 or more areas described in the notice (which may include all of New Zealand).
The maximum number may be a single current maximum or a series of reducing maximum numbers over time.
Before determining the maximum number and the area to which that number applies, the Director-General—
In determining the maximum number and the area to which that number applies, the Director-General must take into account—
the population size in the area and the estimated number of people in the area who smoke; and
the geographic nature of the area, including the estimated average travel time required to purchase smoked tobacco products; and
the views of those consulted under subsection (3).
A notice under this section is secondary legislation (see Part 3 of the Legislation Act 2019 for publication requirements).
For the purposes of section 20L(2), the Director-General must consult—
any iwi or other Māori who the Director-General considers have an interest in the application process.
For the purposes of section 20M(3), the Director-General must consult—
any iwi-Māori partnership board for all or part of a proposed area; and
any iwi whose rohe includes all or part of a proposed area; and
any other Māori who the Director-General considers will be affected.
The Director-General must consult the Māori Health Authority before determining whom to consult for the purposes of subsections (1)(c) and (2)(c) and (d).
The Director-General must have systems in place for the purposes of—
carrying out the consultation under subsections (1) and (2); and
enabling that consultation to inform the Director-General’s decisions under sections 20L(1) and 20M(1).
The Director-General must ensure, when granting a person approval to be an approved smoked tobacco retailer, that any maximum number of approved smoked tobacco retailers declared for the relevant area under section 20M is not exceeded.
A person who sells vaping products from retail premises may apply to the Director-General for approval to be a specialist vape retailer in relation to specified retail premises and, if applicable, specified Internet sites.
The Director-General must not give a person approval to be a specialist vape retailer unless satisfied that—
the retail premises in which the vaping products are or will be sold are—
at least—
70% of the total sales from the retail premises are or will be from the sale of vaping products; or
60% of the total sales from the retail premises are or will be from the sale of vaping products and the Director-General is satisfied that the lower threshold is appropriate in the circumstances; and
any requirements in regulations have been met.
In determining whether the lower threshold is appropriate in the circumstances, the Director-General must, in accordance with regulations (if any), have regard to—
the geographic location of the retail premises; and
the population in relation to which the retailer carries out their business; and
any criteria prescribed in regulations.
In making an assessment under subsection (2)(b), the Director-General may take into account the total sales from the retail premises for the previous 12 months (if any) and any other information that the Director-General considers relevant.
A person who, without reasonable excuse, provides false or misleading information in an application for approval to be a specialist vape retailer commits an offence and is liable on conviction to a fine not exceeding $10,000.
It is a condition of an approval granted under section 20P that—
the criteria in section 20P(2)(a) to (c) and the requirements in section 14(2) continue to be complied with; and
the sales threshold be maintained or, if it was not attained when approval was given, that it be maintained on and from a date specified in the approval.
The Director-General may, in accordance with regulations, impose any other conditions on the approval.
The Director-General may suspend an approval if the Director-General has reasonable grounds to believe that any condition of the approval is not being complied with.
The Director-General may cancel an approval if the Director-General is satisfied that any condition of the approval is not being complied with.
In this section, sales threshold means at least 70% or, if section 20P(2)(b)(ii) applies, 60% of total sales from the retail premises are from the sale of vaping products.
A general vape retailer who sells vaping products in New Zealand must notify the Director-General that they are selling the products.
A notification must be made on the database in accordance with requirements in regulations.
A general vape retailer who, without reasonable excuse, fails to notify the Director-General that they are selling a vaping product commits an offence and is liable to a fine not exceeding $5,000.
A distributor of smoked tobacco products in New Zealand must notify the Director-General that they are distributing the products.
A distributor of smoked tobacco products in New Zealand who, without reasonable excuse, fails to notify the Director-General that they are distributing a smoked tobacco product commits an offence and is liable to a fine not exceeding $5,000.
Repeal section 21.
Repeal section 22.
Replace section 25(1)(c) with:
display the retailer’s name or trade name at the outside of the retailer’s place of business or on their Internet site so long as the name is not and does not include a reserved name.
Repeal section 25(2).
After section 25(5), insert:
In this section, reserved name means,—
in respect of a name displayed on the outside of a specialist vape retailer’s approved vaping premises or on their approved Internet site, a name that includes—
any word or expression signifying that a regulated product other than a vaping product is available for purchase in that place; or
the trade mark of a regulated product, other than a trade mark registered by the specialist vape retailer relating to—
a vaping product manufactured by the specialist vape retailer; or
the specialist vape retailer’s retail vaping business; or
the company name of a manufacturer or an importer of regulated products, unless it is also the company name of the specialist vape retailer; and
in respect of a name that is displayed on the outside of the place of business or the approved Internet site of any other retailer of regulated products, a name that includes—
any word or expression signifying that a regulated product is available for purchase in that place; or
the trade mark of a regulated product; or
the company name of a manufacturer or an importer of regulated products.
Replace section 33(4) with:
Subsection (2) does not apply to the supply of vaping products by a specialist vape retailer from their approved vaping premises or approved Internet site.
In Part 2, in the subpart 7 heading, delete “to people under 18 years”.
“to people under 18 years”
In the heading to section 40, replace “regulated product” with “notifiable product”.
“regulated product”
“notifiable product”
In section 40(1)(a) and (b), replace “regulated product” with “notifiable product”.
After section 40(4), insert:
(4A)
A person charged with contravening subsection (1)(a) does not satisfy the requirements of subsection (3)(a) and (b) if the person relies solely on a statement (given orally or in written form) from the person to whom the product was sold that indicated that the person was of or over the age of 18 years.
Repeal section 40(7) and (8).
After section 40, insert:
A person—
must not sell a smoked tobacco product to a person born on or after 1 January 2009; or
having sold a smoked tobacco product to a person of any age, must not deliver it, or arrange for it to be delivered, to a person born on or after 1 January 2009.
A person who knowingly or recklessly contravenes subsection (1)(a) or (b) commits an offence and is liable on conviction to a fine not exceeding $150,000.
A person must not, in a public place,—
supply a smoked tobacco product to a person born on or after 1 January 2009; or
supply a smoked tobacco product to a person with the intention that it be supplied (directly or indirectly) to a person born on or after 1 January 2009.
A person who knowingly or recklessly contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding $50,000.
In this section, public place has the same meaning as in section 2(1) of the Summary Offences Act 1981.
In the heading to section 41, replace “regulated product” with “notifiable product”.
In section 41(1)(a) and (b), replace “regulated product” with “notifiable product”.
Replace section 43 with:
This section applies if regulations made under section 81(1)(17) requiring point-of-sale prohibition information or warnings are in force.
A person to whom those regulations apply who offers a notifiable product for sale by retail must display clearly at each point of sale, at the outside of or inside the person’s place of business, a notice for the public that—
does no more than communicate information or warnings to the effect that the sale of notifiable products to people who are younger than 18 years is prohibited; and
complies with any requirements of those regulations.
A person to whom those regulations apply who offers a smoked tobacco product for sale by retail must display clearly, at each point of sale at the outside of or inside the person’s place of business, a notice for the public that—
does no more than communicate information or warnings to the effect that the sale of smoked tobacco products to a person born on or after 1 January 2009 is prohibited; and
A person who, without reasonable excuse, contravenes subsection (2) or (3) commits an offence and is liable to a fine not exceeding $2,000.
Replace section 44 with:
This section applies if regulations made under section 81(1)(18) are in force requiring prohibition information or warnings to be visible on a person’s Internet site when people access it.
A person to whom those regulations apply who offers regulated products for sale must comply with those regulations.
The health warning information or warnings that are required to be visible must,—
for the sale of notifiable products, do no more than communicate information or warnings to the effect that the sale of those products to people who are younger than 18 years is prohibited; and
for the sale of smoked tobacco products, do no more than communicate information or warnings to the effect that the sale of those products to a person born on or after 1 January 2009 is prohibited; and
comply with any requirements of those regulations.
A person who, without reasonable excuse, contravenes subsection (2) commits an offence and is liable to a fine not exceeding $2,000.
In the heading to section 45, replace “regulated product” with “notifiable product”.
In section 45(2)(a)(i) and (ii), (b)(i) and (ii), and (c)(i) and (ii), replace “regulated products” with “notifiable products”.
“regulated products”
“notifiable products”
Replace section 47 with:
A person must not—
permit an automatic vending machine that dispenses or is capable of dispensing regulated products to be located in a public place; or
permit a regulated product to be sold by way of an automatic vending machine in a public place.
Subsection (1) does not apply to an automatic vending machine if—
no individual sale can occur unless the machine is activated by the person who would otherwise be in breach of that subsection (or an employee or agent of that person); and
the device used to activate the machine is permanently located—
in a place from which any person using it can see the person to whom the sale is to be made; and
close to the machine.
For the purposes of this Act, a person who activates an automatic vending machine so that the sale of a regulated product to another person occurs is a party to that sale.
A person who, without reasonable excuse, contravenes subsection (1)(a) or (b) commits an offence and is liable to a fine not exceeding $2,000.
Replace the Part 3 heading with:
Repeal section 49.
Replace section 52(1)(b) with:
for a smoked tobacco product, the constituents required by regulations to be listed, and their respective quantities, that are present in the product’s emissions:
In section 52(2)(b)(i) and (iii), delete “harmful”.
“harmful”
In section 54(3), replace “oral nicotine product” with “regulated product suitable for chewing or for any other oral use”.
“oral nicotine product”
“regulated product suitable for chewing or for any other oral use”
Repeal subpart 2 of Part 3.
After Part 3, insert:
A person must not sell, offer for sale, manufacture, import, or supply a smoked tobacco product unless the product has been approved by the Director-General.
A person who knowingly or recklessly contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding $600,000.
A person may apply to the Director-General for approval of a smoked tobacco product intended for sale, manufacture, import, or supply in New Zealand in accordance with any requirements in regulations.
The Director-General must not grant approval of a smoked tobacco product for sale, manufacture, import, or supply unless satisfied that—
the product has been tested in accordance with regulations; and
the product does not contain a constituent—
prohibited by regulations; or
in a quantity that exceeds any limits in regulations; and
any other criteria in regulations have been met.
However, the Director-General may grant a specified smoked tobacco product that does not meet 1 or more of the requirements listed in subsection (2) temporary approval for sale, manufacture, import, or supply in New Zealand if the specified product is not a cigarette, and the Director-General is satisfied—
that—
no similar compliant product can be sourced; and
the sale and supply of the specified product will not result in a significant increase in the appeal and addictiveness of smoked tobacco products; and
any other criteria specified in regulations are met; or
that the specified product will not be offered for sale or supply in New Zealand.
A temporary approval granted under subsection (3)—
is subject to review by the Director-General in accordance with any requirements in regulations; and
may be revoked following a review under paragraph (a); and
expires on the date that is 12 months after the date on which it is granted unless earlier revoked.
It is a condition of any approval granted under subsection (2) that—
the product continues to meet the requirements in subsection (2); and
there is no significant change to the product.
In this section, significant change means any of the following changes (as applicable):
a change that produces different results in any testing of the product required by this Act or regulations made under this Act:
any other change to the product that is specified in regulations.
The Director-General may, in accordance with regulations, impose any other conditions on an approval or a temporary approval.
A person who, without reasonable excuse, provides false or misleading information in an application for approval or temporary approval under this section commits an offence and is liable on conviction to a fine not exceeding $50,000.
The Director-General may suspend an approval or a temporary approval granted under section 57B for 1 month if the Director-General has reasonable grounds to believe that—
Before suspending an approval or a temporary approval, the Director-General must give the holder of the approval or temporary approval a reasonable opportunity to be heard.
The Director-General must tell the holder of the approval or temporary approval in writing of the suspension and give reasons.
decide whether to cancel or reinstate the approval or temporary approval; and
tell the holder of the approval or temporary approval in writing of the decision and give reasons.
A person must not sell, offer for sale, manufacture, import, or supply a smoked tobacco product whose approval is suspended during the period of suspension.
The Director-General may cancel an approval or a temporary approval without any prior suspension if the Director-General is satisfied that—
Before cancelling an approval or a temporary approval without prior suspension, the Director-General must give the holder of the approval or temporary approval a reasonable opportunity to be heard.
The Director-General must tell the holder of the approval or temporary approval in writing of the cancellation and give reasons.
A person must not sell, offer for sale, manufacture, import, or supply a smoked tobacco product that contains, or generates in its emissions, a constituent that is—
in a quantity that exceeds any limits in regulations, as determined in accordance with any prescribed tests.
A person who knowingly or recklessly contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding $400,000.
In this section, manufacture does not include the making of 1 or more smoked tobacco products by a person for their personal use if the total annual mass of manufactured product is less than 5 kilograms.
This section applies to a smoked tobacco product specified in regulations as a product to which this section applies.
Every manufacturer and every importer of a smoked tobacco product must conduct a test to ensure that the constituents of the product, and their respective quantities, comply with any limits or prohibitions prescribed in regulations.
The tests must be conducted each year by 31 December in accordance with any requirements in regulations.
A manufacturer or an importer who, without reasonable excuse, fails to comply with subsection (2) or (3) commits an offence and is liable on conviction to a fine not exceeding $10,000.
In this section, manufacturer does not include a person who makes 1 or more smoked tobacco products for their personal use if the total annual mass of manufactured product is less than 5 kilograms.
The Director-General may, by notice in writing, require a manufacturer or an importer of a smoked tobacco product to conduct tests of the product.
Any tests required under this section may be in addition to any tests required under section 57F.
The tests must be conducted—
in accordance with regulations (if any); and
at the expense in all respects of the manufacturer or importer.
The manufacturer or importer must, if required by the Director-General in the notice in writing, provide, at their own cost, a sample of the product required to be tested—
to the Director-General; and
in the quantity specified in the notice.
In any year, the Director-General must not require tests to be conducted under this section in respect of more than 1 of the brands of smoked tobacco products sold by a particular manufacturer or importer.
A person commits an offence if the person, without reasonable excuse,—
fails to conduct any tests required under this section; or
fails to conduct those tests in accordance with regulations.
A person who commits an offence under subsection (6) is liable on conviction to a fine not exceeding $10,000.
The Minister must, within 21 months of the commencement of section 31 of the Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Act 2022, recommend that regulations be made prescribing the limits for the quantity of nicotine in any smoked tobacco product, and a method of determining whether those limits have been exceeded.
Repeal section 58.
Repeal section 59.
In section 65(2), replace “notifiable product” with “vaping product or smokeless tobacco product”.
“vaping product or smokeless tobacco product”
In section 65(4), replace “notifiable products” with “vaping products or smokeless tobacco products”.
“vaping products or smokeless tobacco products”
After section 69, insert:
This section applies to a notifiable product specified in regulations as a product to which this section applies.
Every manufacturer and every importer of a notifiable product must conduct either or both of the following tests (as regulations require):
a test for the constituents of each brand of the product sold by the manufacturer or importer, and the respective quantities of those constituents:
a test for the constituents of any emissions.
If regulations require it, each variant of the brand must be tested separately.
The Director-General may, by written notice, require a manufacturer or an importer of a notifiable product to conduct tests of the product.
Any tests required under this section may be in addition to any tests required under section 69A.
in accordance with regulations; and
The manufacturer or importer must, if required by the Director-General in the written notice, provide, at their own cost, a sample of the product required to be tested—
In any year, the Director-General must not require tests to be conducted under this section in respect of more than 1 of the brands of prescribed notifiable products to which section 69A applies that are sold by a particular manufacturer or importer.
However, subsection (5) does not apply to vaping products.
A person who commits an offence under subsection (7) is liable on conviction,—
in the case of a body corporate, to a fine not exceeding $10,000; or
in any other case, to a fine not exceeding $5,000.
Repeal section 76.
In section 77(3)(a), delete “by a notifier”.
“by a notifier”
Repeal section 79.
Replace section 81(1)(17) with:
prescribing, for the purposes of section 43(2)(b) and (3)(b), requirements with which the following notices for the public must comply:
a notice to the effect that the sale of notifiable products to people who are younger than 18 years is prohibited:
a notice to the effect that the sale of smoked tobacco products to a person born on or after 1 January 2009 is prohibited:
In section 81(1)(18), replace “purchase age information” with “purchase prohibition information”.
“purchase age information”
“purchase prohibition information”
Replace section 81(1)(20) and the heading above section 81(1)(20) with:
prescribing requirements for the purposes of section 57B(1):
prescribing criteria that the Director-General must have regard to for the purpose of section 57B(2)(c) or (4):
prescribing criteria that a smoked tobacco product or class of smoked tobacco product must meet for temporary approval by the Director-General under section 57B(3):
prescribing the circumstances in which a temporary approval granted under section 57B(3) may be reviewed or revoked:
After section 81(1)(21), insert:
prescribing standards and requirements for testing for the purpose of section 57B(2)(a):
In the heading above section 81(1)(22), replace “and reports” with “, reports, and records”.
“and reports”
“, reports, and records”
Replace section 81(1)(22)(i) with:
sales-related information that manufacturers, importers, approved smoked tobacco retailers, and specialist vape retailers must provide in the annual return required under that section:
reporting requirements for distributors of smoked tobacco products and general vape retailers:
After section 81(1)(22), insert:
prescribing for the purposes of section 101 the constituents of a regulated product that the manufacturer must record:
In section 81(1)(25), replace “section 14A(4)” with “section 20P(4)”.
“section 14A(4)”
“section 20P(4)”
In section 81(1)(26), replace “section 14A(4)” with “section 20P(4)”.
After section 82, insert:
The Governor-General may, by Order in Council made on the recommendation of the Minister, make regulations prescribing requirements for the purposes of sections 20H and 20I, which may include setting—
a competitive process for applying for approvals; and
criteria for the approval of—
a person as an approved smoked tobacco retailer; and
retail premises to which an application for approval applies; and
fit and proper person criteria; and
requirements for business systems; and
criteria for imposing conditions on approvals or classes of approval.
The Governor-General may, by Order in Council, make regulations for all or any of the following purposes:
prescribing safety standards for smoked tobacco products:
specifying changes to a smoked tobacco product for the purposes of the definition of significant change in section 57B(6):
for the purposes of section 57E(1),—
prohibiting constituents of smoked tobacco products:
prescribing limits for the quantities of constituents in smoked tobacco products or their emissions and a method of determining whether those limits have been exceeded:
prescribing standards and requirements for testing for the purposes of section 57F(3) or 57G(3):
prescribing limits for the quantity of nicotine and a method of determining whether those limits have been exceeded for the purposes of section 57H.
Before preparing regulations under subsection (1)(a), (c), or (e), the Minister must consider—
the risks and benefits to the population (including both users and non-users of smoked tobacco products) of regulating the constituent; and
the risks and benefits to Māori (including both users and non-users of smoked tobacco products) of regulating the constituent; and
whether regulating a constituent of a smoked tobacco product will reduce the use of the product by reducing the appeal or addictiveness of the product, including—
the likelihood that existing users of smoked tobacco products will stop using the product; and
the likelihood that those who do not use smoked tobacco products will start using the product.
After section 83(1)(c)(iii), insert:
the constituents in the emissions of a smoked tobacco product that must be listed:
After section 84(1)(b), insert:
prescribing standards and requirements for testing for the purposes of section 69A(3) or 69B(3):
After section 84(1)(f), insert:
declaring a regulated product to be a notifiable product.
Replace section 85(1)(a)(iii) with:
by an applicant in relation to an application for approval as a specialist vape retailer under Part 1B; and
by a general vape retailer in respect of vaping products notified under section 20R; and
by a distributor in respect of smoked tobacco products notified under section 20S; and
by an applicant in relation to an application for approval as an approved smoked tobacco retailer under Part 1B; and
by an applicant in relation to an application for approval or temporary approval of a smoked tobacco product under Part 3A; and
Replace section 86(1) and (2) with:
The Governor-General may, by Order in Council made on the recommendation of the Minister, make regulations providing for the levies that must be paid by a retailer, distributor, importer, or manufacturer of—
a notifiable product under Part 4; or
a smoked tobacco product.
Levies may be prescribed on the basis of—
the costs of the Director-General in performing or exercising the Director-General’s functions, powers, and duties under Part 4, where the size of the portion to be met by levies under that Part is determined by the Minister; and
the costs of the Director-General in performing or exercising the Director-General’s functions, powers, and duties under Parts 1B and 3A, to the extent that the costs are not met by fees imposed by regulations made under section 85; and
the costs of collecting the levy money.
Replace section 86(4)(a) with:
specify the class or classes of retailer, distributor, importer, or manufacturer that are required to pay a levy:
Replace section 86(4)(f) with:
provide different levies for different classes of retailer, distributor, importer, or manufacturer:
Replace section 86(5) with:
If a person is in 2 or more classes of retailer, distributor, importer, or manufacturer in respect of which different levies have been prescribed, the person must pay each of those levies (unless the regulations provide otherwise).
In Part 5, in the subpart 2 heading, replace “Infringement offences” with “Offences”.
“Infringement offences”
“Offences”
Before section 87, insert:
In section 87, definition of infringement fee, paragraph (a), replace “43(3)” with “43(4)”.
“43(3)”
“43(4)”
In section 87, definition of infringement fee, paragraph (b), delete “53(4),”.
“53(4),”
In section 87, definition of infringement fee, after paragraph (b), insert:
in relation to an infringement offence against section 20R(2) or 20S(2), $500.
In section 87, definition of infringement offence, replace “sections 34(4),” with “sections 20R(2), 20S(2), 34(4),”.
“sections 34(4),”
“sections 20R(2), 20S(2), 34(4),”
In section 87, definition of infringement offence, replace “43(3)” with “43(4)”.
After section 90, insert:
This section applies to an offence against section 20G(2), 20H(2), 20J(8), 40(2), 40A(2), 40B(2), 43(4), 44(4), 57A(2), 57B(8), 57C(8), 57E(2), 57G(6), or 69B(7).
Anything done by a person (A) as the employee of another person (B) is, for the purposes of an offence, to be treated as done by B as well as by A, whether or not it was done with B’s knowledge or approval.
Anything done by a person (A) as the agent of another person (B) is, for the purposes of an offence, to be treated as done by B as well as by A, unless it is done without B’s express or implied authority, given before or after the action.
Replace section 94(1) with:
An enforcement officer may at any time require information under subsection (2) if the officer believes on reasonable grounds that within the previous 14 days—
notifiable products have been sold to a person younger than 18 years in and from a place where those products are sold; or
smoked tobacco products have been sold to a person born on or after 1 January 2009 in and from a place where those products are sold; or
notifiable products have, after they are sold, been delivered to a person younger than 18 years in and from a place where those products are sold; or
smoked tobacco products have, after they are sold, been delivered to a person born on or after 1 January 2009 in and from a place where those products are sold; or
notifiable products have been delivered to a person younger than 18 years after being sold at that place (where the products were sold) or at another place; or
smoked tobacco products have been delivered to a person born on or after 1 January 2009 after being sold at that place (where the products were sold) or at another place; or
smoked tobacco products have been sold or offered for sale at retail by a person who is not an approved smoked tobacco retailer; or
smoked tobacco products that are not currently approved by the Director-General have been sold or offered for sale at retail.
In the heading to section 100, replace “and specialist vape retailers” with “distributors, approved smoked tobacco retailers, and vape retailers”.
“and specialist vape retailers”
“distributors, approved smoked tobacco retailers, and vape retailers”
In section 100(1)(a)(ii), replace “section 56 or 57” with “section 56, 57, 57F, 57G, 69A, or 69B”.
“section 56 or 57”
“section 56, 57, 57F, 57G, 69A, or 69B”
In section 100(2), after “specialist vape retailer”, insert “and an approved smoked tobacco retailer”.
“specialist vape retailer”
“and an approved smoked tobacco retailer”
After section 100(2), insert:
(2A)
A distributor of smoked tobacco products and a general vape retailer must report to the Director-General on their distribution and retail activities in accordance with regulations.
In section 100(4), replace “subsection (1) or (2)” with “subsection (1), (2), or (2A)”.
“subsection (1) or (2)”
“subsection (1), (2), or (2A)”
After section 100, insert:
This section applies to a manufacturer, importer, exporter, distributor, or retailer of a regulated product.
The person must take reasonable steps to keep accurate records of—
all the regulated products that they manufacture, import, export, buy, sell, or supply; and
for a manufacturer, the constituents required by regulations to be recorded that the manufacturer uses or intends to use in the manufacture of each regulated product.
The person must keep the records for 3 years from the date of each transaction.
An enforcement officer may require a person to provide a copy of the records kept under this section by notice in writing.
The person must provide the enforcement officer with a copy of the records, in the format required in the notice, within 10 working days of receiving the notice.
A person who, without reasonable excuse, fails to comply with subsection (2), (3), or (5) commits an offence and is liable on conviction,—
In Part 5, after section 101 (as inserted by section 51), insert:
If the Director-General decides to suspend or cancel the approval of a smoked tobacco product or a notification of a notifiable product, the following persons may appeal to the appeals committee against the decision:
in the case of an approval of a smoked tobacco product, the holder of the approval:
in the case of a notification of a notifiable product, the notifier.
The holder of the approval or the notifier may lodge the appeal within 60 days after the Director-General’s decision or within any further period that the appeals committee may allow.
The decision being appealed against continues in force unless the appeals committee orders otherwise.
An appeal is by way of rehearing.
On hearing the appeal, the appeals committee may—
confirm, reverse, or modify the decision appealed against:
make any other decision that the Director-General could have made.
The appeals committee must not review any decision, or any part of a decision, not appealed against.
A party may appeal to the High Court—
against a determination of the appeals committee on a question of law only; and
in accordance with the rules of court.
The appeals committee established under section 79 of this Act is continued.
The appeals committee may determine appeals against decisions of the Director-General to cancel or suspend an approval of a smoked tobacco product or a product notification.
The appeals committee must consist of 3 members, each appointed by the Minister on any terms and conditions that the Minister thinks fit.
The appeals committee may, subject to any provision of this Act or regulations, regulate its own procedure.
In performing its functions or exercising its powers under this Act, the appeals committee must—
act independently; and
comply with the principles of natural justice.
The purpose of this section is to facilitate access by a government agency to information stored in a database for the purpose of assisting the chief executive of that agency to administer and enforce this Act and the Customs and Excise Act 2018.
The Director-General may, for the purposes of this section, allow the chief executive of the New Zealand Customs Service or any other government agency to access 1 or more databases in accordance with a written agreement entered into by the Director-General and the chief executive.
A written agreement must specify—
the database or databases that may be accessed; and
the particular type or class of information that may be accessed; and
the particular purpose or purposes for which the information is accessed; and
the particular function being, or to be, carried out by the government agency for which the information is required; and
the mechanism by which the information is to be accessed; and
how the information accessed is to be used by the government agency to achieve the particular purpose or purposes; and
the positions or designations of the persons in the government agency who may access the database or databases; and
the records to be kept in relation to each occasion a database is accessed; and
the safeguards that are to be applied for protecting personal information, or commercially sensitive information, that is disclosed; and
the requirements relating to storage and disposal of information obtained by the agency from the database or databases; and
the circumstances (if any) in which the information may be disclosed by the government agency to another agency, and how that disclosure may be made; and
the requirements for reviewing the agreement.
In this section,—
chief executive of a government agency includes the Commissioner of Police
government agency means—
a public service agency (as defined in section 5 of the Public Service Act 2020), other than—
the Ministry of Health; and
the Government Communications Security Bureau; and
the New Zealand Security Intelligence Service; and
Statistics New Zealand:
a Crown agent named in Part 1 of Schedule 1 of the Crown Entities Act 2004:
an independent Crown entity named in Part 3 of Schedule 1 of the Crown Entities Act 2004:
the New Zealand Police:
the New Zealand Defence Force.
Compare: 2018 No 4 s 315
In Schedule 1,—
insert the Part set out in the Schedule of this Act as the last Part; and
make all necessary consequential amendments.
Sections 55 and 56 amend the Customs and Excise Act 2018.
Replace section 95A(2) with:
The prohibition in subsection (1) does not apply to the following goods:
chewing tobacco:
snuff:
snus.
Replace section 95A(3) with:
The prohibition in subsection (1) does not apply if—
the person importing the goods (whether or not the goods are intended for commercial or personal use)—
has a permit granted by the chief executive under Schedule 3A, allowing the goods to be imported; and
complies with any conditions of the permit; and
completes a declaration that they understand and will comply with the approval requirements for smoked tobacco products under the Smokefree Environments and Regulated Products Act 1990; and
for manufactured tobacco, the goods have been approved by the Director-General of Health for sale, supply, or import into New Zealand under the Smokefree Environments and Regulated Products Act 1990.
The prohibition in subsection (1) does not apply if the goods are in the possession or under the control of a person specified in section 30(1)(a), and the goods,—
in the case of cigarettes, do not exceed 250 cigarettes; and
in the case of loose tobacco, cigars, cigarillos, water-pipe tobacco, or other smoked tobacco items, do not exceed 200 grams.
The prohibition in subsection (1) does not apply if the goods—
are not unloaded in New Zealand and are destined for a point outside New Zealand; or
are to be, or are being, transhipped internationally, and are covered by a transhipment request made under section 87(2) and granted by the chief executive.
In Schedule 3A, replace clause 3(2) with:
The chief executive must not grant a permit to import the goods unless the chief executive is satisfied—
that the applicant—
holds a current licence to use an area as a Customs-controlled area for one of the purposes specified in subclause (3); or
intends to use the goods for a legitimate purpose unrelated to the manufacture of tobacco for smoking; or
intends to import manufactured tobacco only, either for commercial resale or personal use; and
has provided the declaration required by section 95A(3)(a)(iii); and
has provided evidence that the goods have been approved by the Director-General of Health for sale, supply, or import in New Zealand under the Smokefree Environments and Regulated Products Act 1990.
Sections 58 to 64 amend the Smokefree Environments and Regulated Products Regulations 2021.
In regulation 56(2)(b), replace “persons under the age of 18” with “persons born on or after 1 January 2009”.
“persons under the age of 18”
“persons born on or after 1 January 2009”
In regulation 57(6), replace “persons under the age of 18” with “persons born on or after 1 January 2009”.
In regulation 58(5), replace “persons under the age of 18” with “persons born on or after 1 January 2009”.
Replace regulation 62 with:
Manufactured cigarettes are specified as a smoked tobacco product to which section 57F of the Act applies.
Manufactured cigarettes that are a herbal smoking product are specified as a notifiable product to which section 69A of the Act applies.
In regulation 63, delete “harmful”.
Revoke regulation 66(1)(d)(ii).
In Schedule 10, form 2, replace “Harmful constituent” with “Constituent”.
“Harmful constituent”
“Constituent”
s 53
In this Part, unless the context otherwise requires,—
amendment Act means the Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Act 2022
commencement date means the date on which section 53 of the amendment Act comes into force.
Section 20R (which relates to the notification requirement of a general vape retailer in respect of notifiable products) does not apply until the date that is 9 months after the commencement date.
Section 20S (which relates to the notification requirement of a distributor in respect of smoked tobacco products) does not apply until the date that is 9 months after the commencement date.
Section 20G (which prohibits the sale of smoked tobacco products other than by an approved smoked tobacco retailer) does not apply until the date that is 18 months after the commencement date.
The following provisions do not apply until the date that is 27 months after the commencement date:
section 57A (which prohibits the sale, manufacture, import, or supply of a smoked tobacco product, unless it is approved):
section 57E (which prohibits the sale, manufacture, import, or supply of a smoked tobacco product that contains a prohibited constituent or a constituent in excess of prescribed limits).