time point

On August 9, 2021, New Zealand issued regulations "Smokefree Environments and Regulated Products Regulations 2021" (SERPA=The Smokefree Environments and Regulated Products Amendment Act);

On August 11, 2021, manufacturers and importers can start registering their products with the “Vaping Regulatory Authority”;

On February 11, 2022, unregistered products will be banned from being sold in New Zealand.

 

cost

NZD 50 per product (excluding tax);

Different volumes or nicotine concentrations of the same product can be registered together for a single fee;

If the components of e-cigarette products are also sold separately, each component should be registered, and the kit should be registered at the same time, and the kit can apply for fee reduction because the components have already been paid.

Note: Products containing e-liquid need to register the device and e-liquid as components respectively, and also need to register products containing e-liquid, namely kits.

 

who will register

Importers or manufacturers in New Zealand;

Overseas manufacturers will not be allowed to register products through the HARP system, and provide the required information to importers in New Zealand to register products;

If an overseas manufacturer has multiple importers in New Zealand, each importer needs to register the product before it can be legally sold.

 

Validity period of registration

12 months;

Registration must be renewed every 12 months or it will expire;

If the product changes significantly, it must be registered as a new product, and the registration of existing products must be cancelled.

 

Information required for registration

Electronic cigarette equipment

1.product brand

2.Product name/flavor

3.UPC (if any)

4.Components (such as atomizers, coils, etc.)

5.Quantity (the quantity of each component sold with the device)
 

suit

1.product brand

2.Product name/flavor

3.UPC (if any)

4.Components (such as atomizers, coils, etc.)

5.Quantity (the quantity of each component sold with the device)
 

E-liquid (containing free nicotine or nicotine salts)

1.product brand

2.Product name/flavor

3.UPC (if any)

4.PG/VG ratio

5.Nicotine concentration

6.volume

7.product ingredients
 

a.CAS number

b.Ingredient name

c.Content (weight or volume per ml)
 

registration cycle

10-15 working days

 

Registered product announcement URL

https://www.health.govt.nz/our-work/regulation-health-and-disability-system/regulation-vaping-and-smokeless-tobacco-products/vaping-information-all-industry/product-notification- applications

 

other

From 11 November 2020, manufacturers and importers of e-cigarette products must report to the New Zealand Pharmacovigilance Centre (https://nzphvc.otago.ac.nz/report-vaping/) as soon as they become aware of adverse reactions to their products. Electronic Cigarette Regulatory Authority report.

Manufacturers and importers (as well as specialist e-cigarette retailers) must keep sales records and provide annual reports to e-cigarette regulators. Reports and returns for the previous calendar year should be submitted to the Authority by 31 January each year.

From November 11, 2020, advertising is prohibited.

From November 11, 2020, sponsorship (organizations or events, etc.) is prohibited.

From November 11, 2020, free/discounted/bundled distribution or supply is prohibited.

From May 11, 2021, the use of colorants (colorants refers to additives that change the color of e-liquids) will be banned.

From August 11, 2021, flavorings are prohibited (non-specialist vape retailers are not allowed to sell e-cigarettes other than tobacco, mint, and menthol)

 

related requirements

Testing requirements

Analysis of harmful substances in e-liquid components

number	category	substance	Substance	CAS NO	Limit	equipment
1	Acetyls	diacetyl	Diacetyl (or 2,3-butane dione)	431-03-8	22mg/L	GC-MS
2		2,3-pentanedione	Pentane 2,3-dione (or acetylpropionyl)	600-14-6	22mg/L	GC-MS
3	Aldehydes	formaldehyde	Formaldehyde	50-00-0	22mg/L	LC-DAD/MSMS
4		Acrolein	Acrolein	107-02-8	22mg/L	LC-DAD/MSMS
5		Acetaldehyde	Acetaldehyde	75-07-0	200mg/L	LC-DAD
6	Alcohols	Ethylene Glycol	Ethylene glycol	107-21-1	1,000mg/L	GC-FID/GC-MS
7		Diethylene glycol	Diethylene glycol	111-46-6	1,000mg/L	GC-FID/GC-MS
8	Metal	Al	Aluminium	7429-90-5	12mg/L	ICP-MS
9		Sb	Antimony	7440-36-0	4mg/L	ICP-MS
10		As	Arsenic	7440-38-2	0.4mg/L	ICP-MS
11		Cd	Cadmium	7440-43-9	0.6mg/L	ICP-MS
12		Cr	Chromium	7440-47-3	0.6mg/L	ICP-MS
13		Fe	Iron	7439-89-6	12mg/L	ICP-MS
14		Pb	Lead	7439-92-1	1mg/L	ICP-MS
15		Hg	Mercury	7439-97-6	0.2mg/L	ICP-MS
16		Ni	Nickel	7440-02-0	1mg/L	ICP-MS
17		Sn	Tin	7440-31-5	12mg/L	ICP-MS
18	Nitrosamines*	NNN	N-nitrosonornicotine	80508-23-2	50ug/L	LC-MSMS
19		NAT	N-nitrosoanatabine	71267-22-6		LC-MSMS
20		NAB	N-nitrosoanabasine	1133-64-8		LC-MSMS
21		NNK	4-methyl-N-nitrosamino-1-(3- pyridyl)-1-butanone	64091-91-4		LC-MSMS

*CAS NO for nitrosamines reference ISO 19290

1.Consistency analysis of nicotine in smoke (refer to AFNOR XP-D90-300-3)

2.Safety Testing of Equipment 60335

3.Battery Safety Test 62133

4.If it is a product with a ceramic core, it is also necessary to test whether there are small particles in the release

5.If the shelf life is more than 2 years, stability test is also required
 

E-liquid requirements
 

1.Nicotine concentration should not exceed 20mg/mL

2.Nicotine salt concentration should not exceed 50mg/mL

3.The total amount of nicotine in the bottled e-liquid cannot exceed 1800mg

4.Bottled e-juice cannot exceed 120mL

5.Prohibited use of certain substances (refer to the table below)

1. 禁止使用若干物质(参考下表)

number	substance		illustrate
	致癌、致突变、生殖毒性物质（CMRs）	carcinogenic, mutagenic, reprotoxic substances (CMRs)	不完全燃烧状态下有CMR特性的添加剂； 使用过程中，添加剂量增加至大量或可测量的程度，会导致毒性、成瘾或CMR特性	(i)additives that have CMR properties in unburnt form: (ii)additives in quantities that increase, to a significant or measurable degree, the toxic or addictive effect or CMR properties of the product when it is consumed:
	Substances with specific target organ toxicity class 1 (STOT-RE Category 1), with the exception of benzoic acid-nicotine salts.
	呼吸致敏物质；respiratory sensitisers
	放射性物质；radioactive substances
	着色剂；colouring substances
	除尼古丁外的任何药理活性物质	any pharmacologically active substance other than nicotine	药用、精神活性、麻醉、合成代谢或者草药	medicinal, psychoactive, narcotic, anabolic, or herbal
	植物油	vegetable oils:
	矿物油	mineral oils:
	与能量和活力有关的添加剂和兴奋剂化合物	additives and stimulant compounds that are associated with energy and vitality	咖啡因、牛磺酸	caffeine; and taurine:
	葡萄糖醛酸内酯
	乙二醇	ethylene glycol
	二甘醇	diethylene glycol
	聚乙二醇	polyethylene glycol
	食物或膳食补充剂	food or dietary supplements
	维生素或其他添加剂	vitamins or other additives	给人留下有益健康或降低健康风险的印象	create the impression there are health benefits or reduced health risks
	益生菌
	甲醛释放剂	formaldehyde releasers	季铵盐 咪唑烷基脲 重氮氨基脲 2-溴-2-硝基丙烷-1,3-二醇（或2-溴-2-硝基-1,3-丙二醇） 二羟甲基二甲基乙内酰脲 （苄氧基）甲醇（或苯甲氧基甲醇） 2-氯-N-（羟甲基）乙酰胺 六氢-1,3,5-三（羟乙基）-s-三嗪 羟甲基甘氨酸钠	quaternium imidazolidinyl urea diazolidinyl urea 2-bromo-2-nitropropane-1,3-diol (or 2-bromo-2-nitro-1,3-propanediol) dimethyl-dimethyl hydantoin (DMDM hydantoin) (benzyloxy)methanol (or phenylmethoxymethanol) 2-chloro-N-(hydroxymethyl)acetamide hexahydro-1,3,5-tris(hydroxyethyl)-s-triazine sodium hydroxymethylglycinate
	糖和甜味剂	sugars and sweeteners	葡萄糖 白砂糖 果糖 乳糖 麦芽糖 蔗糖 乙酰氨基磺酸钾 阿斯巴甜 糖精酸钠 甜菊糖甙	glucose sucrose fructose lactose maltose saccharose acesulfame potassium aspartame sodium saccharinate stevia
	防腐剂		三氯生 苯氧乙醇 异噻唑啉酮 长链对羟基苯甲酸酯，包括对羟基苯甲酸异丙酯及其盐、对羟基苯甲酸异丁酯、对羟基苯甲酸苯酯、对羟基苯甲酸苄酯和对羟基苯甲酸戊酯	triclosan phenoxyethanol isothiazolinone long-chain parabens, including isopropylparaben and its salts, isobutylparaben, phenylparaben, benzylparaben, and pentylparaben.

1. 原材料要求

number	substance		Require
	尼古丁	nicotine	USP or Ph. Eur. monograph
	丙二醇	propylene glycol	USP or Ph. Eur. monograph
	丙三醇	vegetable glycerol	USP or Ph. Eur. monograph
	苯甲酸	benzoic acid	USP or Ph. Eur. monograph
	乙醇	Ethanol	USP or Ph. Eur. monograph
	纯水	Purified water	USP or Ph. Eur. monograph
	香精	essence	Australia New Zealand Food Standards Code 2002.
	烟弹塑料材料	Smoke bomb plastic material	Australia New Zealand Food Standards Code 2002

Packaging Requirements