New Zealand vaping requirements

作者:admin 发布时间:2022-05-11 07:12:29点击:295
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
  •  
  1.  
致癌、致突变、生殖毒性物质(CMRs) carcinogenic, mutagenic, reprotoxic substances (CMRs)
  1. 不完全燃烧状态下有CMR特性的添加剂;
  2. 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:
  1.  
Substances with specific target organ toxicity class 1 (STOT-RE Category 1), with the exception of benzoic acid-nicotine salts.
  1.  
呼吸致敏物质;respiratory sensitisers
  1.  
放射性物质;radioactive substances
  1.  
着色剂;colouring substances
  1.  
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
  1.  
植物油 vegetable oils:
  •  
 
  1.  
矿物油 mineral oils:
  •  
 
  1.  
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:
  1.  
葡萄糖醛酸内酯
  •  
  •  
 
  1.  
乙二醇 ethylene glycol
  •  
 
  1.  
二甘醇 diethylene glycol
  •  
 
  1.  
聚乙二醇 polyethylene glycol
  •  
 
  1.  
食物或膳食补充剂 food or dietary supplements
  •  
 
  1.  
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
  1.  
益生菌
  •  
  •  
 
  1.  
甲醛释放剂 formaldehyde releasers
  1. 季铵盐
  2. 咪唑烷基脲
  3. 重氮氨基脲
  4. 2-溴-2-硝基丙烷-1,3-二醇(或2-溴-2-硝基-1,3-丙二醇)
  5. 二羟甲基二甲基乙内酰脲
  6. (苄氧基)甲醇(或苯甲氧基甲醇)
  7. 2-氯-N-(羟甲基)乙酰胺
  8. 六氢-1,3,5-三(羟乙基)-s-三嗪
  9. 羟甲基甘氨酸钠
  1. quaternium
  2. imidazolidinyl urea
  3. diazolidinyl urea
  4. 2-bromo-2-nitropropane-1,3-diol (or 2-bromo-2-nitro-1,3-propanediol)
  5. dimethyl-dimethyl hydantoin (DMDM hydantoin)
  6. (benzyloxy)methanol (or phenylmethoxymethanol)
  7. 2-chloro-N-(hydroxymethyl)acetamide
  8. hexahydro-1,3,5-tris(hydroxyethyl)-s-triazine
  9. sodium hydroxymethylglycinate
  1.  
糖和甜味剂 sugars and sweeteners
  1. 葡萄糖
  2. 白砂糖
  3. 果糖
  4. 乳糖
  5. 麦芽糖
  6. 蔗糖
  7. 乙酰氨基磺酸钾
  8. 阿斯巴甜
  9. 糖精酸钠
  10. 甜菊糖甙
  1. glucose
  2. sucrose
  3. fructose
  4. lactose
  5. maltose
  6. saccharose
  7. acesulfame potassium
  8. aspartame
  9. sodium saccharinate
  10. stevia
  1.  
防腐剂
  1.  
  1. 三氯生
  2. 苯氧乙醇
  3. 异噻唑啉酮
  4. 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
  1. triclosan
  2. phenoxyethanol
  3. isothiazolinone
  4. long-chain parabens, including isopropylparaben and its salts, isobutylparaben, phenylparaben, benzylparaben, and pentylparaben.
  1. 原材料要求
number substance
  •  
Require
  1.  
尼古丁
  • nicotine
USP or Ph. Eur. monograph
  1.  
丙二醇 propylene glycol USP or Ph. Eur. monograph
  1.  
丙三醇 vegetable glycerol USP or Ph. Eur. monograph
  1.  
苯甲酸 benzoic acid USP or Ph. Eur. monograph
  1.  
乙醇
  • Ethanol
USP or Ph. Eur. monograph
  1.  
纯水 Purified water USP or Ph. Eur. monograph
  1.  
香精
  • essence
Australia New Zealand Food Standards Code 2002.
  1.  
烟弹塑料材料
  • Smoke bomb plastic material
Australia New Zealand Food Standards Code 2002

Packaging Requirements
1.Must have the name and contact information of the New Zealand importer or manufacturer, and cannot write the contact information outside New Zealand
2.Need to reflect the name and content of ingredients, including flavoring agents
3.Products that resemble food or cosmetics are prohibited. For example, a product can have a strawberry flavor on the label, but the product cannot look like a strawberry.
4.PG:VG ratio
5.E-cigarettes containing nicotine need to reflect warnings,
 
 a.2 languages, English + Maori, as follows
“This product contains nicotine, which is a highly addictive substance
He nikotīni kei roto i tēnei mea, he matū tino whakawara”.

b.Both the front and back of the package are required. If it is a cylindrical package, it only needs to be reflected once.
c.Centered left and right, top and bottom do not need to be centered
d.Parallel to the name of the product, or to the largest font if none
e.Black on white, font black Helvetica
f.Not less than 32% of the surface area where the warning is located, in the largest possible font size
 
g.Products containing e-liquid must also reflect the following warnings:
“CAUTION: Keep this substance out of reach of children or pets.”:
"Do not swallow this substance. If this substance is taken into the mouth, rinse mouth thoroughly.":
“Contact 0800 POISON (0800 764 766) for advice if this substance is swallowed.”:
“Seek medical advice if you feel unwell after contact with this substance or use of this product.”.
 
h.Electronic Cigarette Prohibition Features
1.It is forbidden to state that it contains additives other than flavoring agents or that it does not contain additives
2.Prohibition of products similar to food or cosmetics
3.Imply that the product is less harmful than other regulated products; has energizing, revitalizing, healing, rejuvenating, natural or organic properties; has other health or lifestyle benefits.
4.The features mentioned in a, b, c above apply to including but not limited to words, symbols, names, trademarks or graphics or other types of signs.

Labels - Products Containing E-liquid
1.Safety instructions for use (including storage, replenishment and disposal):
2.Name and quantity (in milligrams) of ingredients in e-liquid:
3.Volume or weight of e-juice in the container (in milliliters or milligrams, as the case may be):
4.Production batch:
5.Manufacturer's name and contact information: (only for manufacturers or importers in New Zealand)
6.Expiration date (such as M/YY, MM/YY, M/YYYY, or MM/YYYY):
7.Ratio of Propylene Glycol to Vegetable Glycerin (in PG:VG or percentage):
8.For substances containing more than 3% alcohol, label "Contains Alcohol":
9.For e-liquids containing nicotine, the nicotine concentration (mg/mL) needs to be marked:
10.For nicotine-free e-juice, the words "non-nicotine" or "zero nicotine" are required.