BH xxxx :2020  
 
 
 لائحةفنية بحرينية  
منتجات النيكوتين الالكترونية (نظائر منتجات التبغ 
التقليدية) 
 
BAHRAINI TECHNICAL REGULATION  
Electronic Nicotine Products (Equivalents of 
Traditional Tobacco Products ) 
 
 
 
 
 
 
 
 
 
ICS: 65.160  
English Language – اللغة الإنجليزية                      Edition 1 – ...../...../2020 – الطبعة 1  
  
 
 
© 2018 Ministry of Industry Commerce & Tourism, Kingdom of Bahrain.  
© 2018جميع الحقوق محفوظة لوزارة الصناعة والتجارة والسياحة     
   
   
 
  
 
 
هذه الوثيقة محمية بالقانون  
COPYRIGHT PROTECTED DOCUMENT  
منشورة في مملكة البحرين  © BTMD 20 20 Published in Kingdom of Bahrain  
 
جميع الحقوق محفوظة لوزارة الصناعة والتجارةوالسياحة في مملكة البحرين . 
ما لم يتم النص على خلاف ذلك، لا يجوز إعادة نشر أو استغلال أي جزء من هذه الوثيقة بأي شكل من 
الأشكال، أو بأية وسيلة إلكترونية أو مادية أخرى، بما في ذلك التصوير أو النشر على الإنترنت أو 
الإنترانت، دون إذن كتابي مسبق من إدارة الفحص والمقاييس بوزارة الصناعة والتجارة والسياحة، وإلا  
سيتم اتخاذ كافة الإجراءات القانونية.    
All rights reserved to Ministry of Industry Commerce & Tourism, Kingdom of Bahrain.  
Therefore and unless otherwise specified, no part of this publications may be reproduced or 
utilized (including  reproduction in whole or in part), in any form or by any means, electronic 
or mechanical, including photocopying, scanning, etc., without prior written permission. The 
Ministry reserves the right to take legal action in case of violation.  
   
Requests shou ld be addressed to:  
Ministry of Industry Commerce & Tourism  
Testing & Metrology Directorate  
Harbour Gate 3rd floor  
Bahrain Financial Harbour, Manama – Sea front  
P.O. Box 60667 - Manama - Kingdom of Bahrain  ينبغي توجيه الطلب إلى 
 
وزارة الصناعة والتجارة والسياحة 
إدارة الفحص والمقاييس 
بوابة المرفأ المالي – الدور الثالث 
مرفأ البحرين المالي، المنامة – الواجهة البحرية. 
ص.ب.: 60667 المنامة- مملكة البحرين 
 
هاتف: 17574 909 Tel: 
فاكس: 17530730  Fax: 
بريد إلكتروني: bsmd@moic.gov.bh   E-Mail: 
موقع ويب: www.moic.gov.bh   Website:  
 
 
 
 
 
  
تقديم وطني  
اعتمدت وزارة الصناعة والتجارة والسياحة (اللائحة الفنية الوطنية) رقم (  )، والخاصة بـ 
(منتجات النيكوتين الالكترونية (نظائر منتجات التبغ التقليدية) ). 
 
تاريخ الاعتماد وطنيا  
تاريخ النشر بالجريدة الرسمية  
تاريخ التطبيق  
*(خاص باللوائح  الفنية فقط)  
 
 
National Foreword  
Ministry of Industry, Commerce and Tourism has adopted the National Technical Regulation 
No. (   ), and  titled ( Electronic Nicotine Products (Equivalents of Traditional Tobacco 
Products) ). 
 
 National adoption date  
 Official gazette publication date  
 Implementation date  
* (For Technical Regulation)  
 
  
 
  
Electronic Nicotine Products  
(Equivalents of Traditional Tobacco Products)  
 
1. Scope  
 
This Bahraini Technical Regulation  is concerned with the requirements of electronic nicotine 
products which are designed in the form of traditional tobacco products such as (cigarettes, cigar, 
pipe, cigarillo or hookah), which includes the following products:  
• Electronic vape products which  do not contain tobacco (and may or may not contain nicotine) 
and their refill packages, e.g. e -liquid containers.  
• Heated tobacco products that contain tobacco (processed or unprocessed) which is heated by 
an electronic device (without combustion).  
It also  specifies the requirements for importing, manufacturing, packing, displaying and trading, and 
weights and descriptive data on their labels but does not include any products that are consumed 
through lighting and smoking with combustion or any products tha t contain nicotine such as nicotine 
patches and tobacco products which  are consumed orally.  
 
2. Supplementary References  
 
2.1 GSO ISO 9001: Quality Management Systems – Requirements.  
2.2 GSO IEC 60335 -1: Household and Electrical appliances – Safety – Part One: General 
Requirements.  
2.3 GSO ISO 8317:  Child -Resistant Packaging – Requirements and Testing Procedures for Re -
Closable Packages.  
2.4 IEC 62133 -1: Secondary cells and batteries containing alkaline  
electrolytes or other Non -acidic electrolytes - Safety requirements  for enclosed, portable 
secondary cells and batteries made of them, for use in portable applications - Part 1: Nickel 
systems.  
2.5 IEC 62133 -2: Secondary cells and batteries containing alkalis or other non -acidic electrolytes - 
Safety requirements for enclosed  secondary cell lithium cells, and batteries made of them, for use 
in portable applications - Part 2: Lithium systems.  
2.6 GSO IEC 60086 -4: Primary dry batteries - Part 4: Safety of lithium batteries.  
2.7 GSO IEC 60335 -2-29: Household electrical appliances and sim ilar safety - Part 29 -2: Special 
requirements for battery chargers.  
2.8 GSO 2500 : Additives permitted to be used in food.  
2.9 GSO 707: Flavorings permitted to be used in food products.  
2.10 GSO 9: Labeling  of Prepackaged Food Stuffs.  
2.11 European Pharmacopoeia for Non -Sterile Inhalation Products.  
2.12 European Pharmacopoeia – Study (Monograph) of Nicotine.  
2.13 European Pharmacopoeia – Study (Monograph) of Purified Water.  
2.14 European Pharmacopoeia – Study (Monograph) of Propylene Glycol.  
2.15 European Pharmacopoeia – Study (Monograph) of Gl ycerol.  
2.16 GSO IEC 61558 -1: Safety of power transformers, power supplies, reactors and similar products 
- Part 1: General requirements and tests.  
 
 
  
3. Definitions  
 
3.1 Tobacco : 
Leaves and other natural processed or unprocessed parts of tobacco plants, including expanded 
and reconstituted tobacco.  
 
3.2 Nicotine : 
Nicotinic alkaloids.  
 
3.3 Ingredient : 
Tobacco, any additive, as well as any other substance or element present in a finished tobacco 
product or related product, including paper, filter, ink, capsules and adhesives.  
 
3.4 Flavoring : 
Additive to add smell and/or taste.  
 
3.5 Characterizing Flavors : 
Means a clearly noticeable smell or taste other than one of tobacco, resulting from an additive or 
a combination of additives, including, but not limited to, f ruit, spice, herbs, alcohol, candy, 
menthol or vanilla, which is noticeable before or during the consumption of the tobacco product.  
 
3.6 Electronic Vape Products : 
Electronic devices and its accessories which operate through batteries and  can be used to heat the 
e-liquid to be vaporized, inhaled and exhaled by mouth as a smoke simulation, and they are free 
of tobacco.  
A typical electronic cigarette consists of: the b attery that is used to heat the solution tank 
containing the so -called "electronic liquid" that may be in a disposable cartridge or a tank that can 
be refilled from external cartridges.  
 
3.7 Electronic Liquid : 
A liquid formula (or gel) in the Electronic Vape P roducts or in a replaceable cartridge (which 
may or may not contain nicotine) and some other additives such as distilled water, solvents, 
vegetable glycerin and propylene glycol.  
 
3.8 External Cartridges (Single Container) : 
Any package used for refilling elect ronic nicotine products, whether in the form of rolls, tanks, 
small containers, capsules containing granules or other forms, and whether disposable or can be 
used for refilling each time.  
 
3.9 Heated Tobacco electronic device : 
An electronic device used to heat tobacco products that is activated by electronic heating or by 
other means to be used in the consumption of heated tobacco products through the mouth.  
 
3.10 Heated tobacco products:  
A product consisting of tobacco and non -tobacco materials exclusively inte nded for use with or 
without a nicotine -containing aerosol without the combustion of tobacco.  
 
 
 
 
  
3.11 Toxicity : 
The harmful effects that the product may have on the human organism, including the effects that 
occur over time, whether through consumption or repeated or continuous exposure to the effects 
of the product.  
 
3.12 Package (pack) : 
The unit package of the product (with its accessories) sold to the consumer as a complete product 
unit, including the carton (the container of the unit package).  
 
3.13 Label : 
Any label, tag, mark, picture, or any other descriptive data written, printed, stamped, affixed, 
engraved or embossed on the package in a non -removable manner.  
 
3.14 Descriptive Data:  
Any writing, pictures or graphics on the label related to the produc t's characteristics, properties, 
nature or consumption, or one of its ingredients or any other properties.  
 
3.15 Main Display Area : 
The front and back panels of the package. If this is not easily identifiable, the largest area is 
considered the front panel and the second largest area is considered the back panel.  
 
 
3.16 Health Warning : 
The warning about the harmful effects of the product on human health or other undesirable 
consequences of its consumption, including written warnings, attached health warnings, general  
warnings and information messages.  
 
3.17 External Packaging : 
Any container in which the products or related products containing a unit package,  or a set of unit 
packages are placed.  
Transparent wrapping is not considered part of the outer packaging.  
 
3.18 Production code (Batch Number) : 
A code for a quantity of the product that was produced under the same conditions during a specific 
period of time, usually for a  specific product line and production unit.  
 
4. Requirements  
 
4.1 General requirements  
4.1.1 The manufacturing facilities must meet the requirements of the standard mentioned in item (2.1).  
4.1.2 The devices (electronic and electrical) must meet the requirements of the standard mentioned in 
item (2.2) (or the equivalent) that is relevant to the safety o f electrical equipment and devices, 
including the falling test, contact temperature and the electromagnetic compatibility (EMC) test.  
4.1.3 Batteries, accumulators, secondary cells and chargers must meet the requirements of the 
applicable standards mentioned in items (2. 4), (2. 5), (2. 6) and (2. 7). 
4.1.4 The product and/or cartridges must meet the requirements of child protection set forth in item 
(2.3), so that they do not pose any potential health risks to children. It is necessary to ensure that 
these products are protected and resistant to harm caused by children, including the affixation of 
 
  
marks for protection from children and protection by appropriate mechanisms for opening and 
closing the packages.  
4.1.5 The product and cartridges must remain conformant to the requirements of this standard 
throughout the shelf life . 
4.1.6 No modification or change in the ingredients or characteristics of the product  and cartridges may 
be made unless the official approval from the responsible entity  is obtained.  
4.1.7 It is not allowed to import, manufacture or launch the product and cartridges in the market unless 
the official approval from the responsible entity  is obtain ed and the following documents are 
submitted:  
4.1.7.1  Reports of the tests of safety of electronic components / falling test / leakage test / contact 
temperatures / electromagnetic efficiency, from scientific entities or laboratories accepted by the 
responsible en tity. 
4.1.7.2  A list of all ingredients and their quantities used in the product in descending order according to 
the weight of each ingredient, indicating the trade name, type and relevant quantities, 
accompanied by a statement specifying the reasons for includin g these ingredients in the products 
concerned, as well as level of emissions arising from the use and any other emissions.  
4.1.7.3  The results of necessary toxicological studies for the product ingredients before and after use and 
its emissions, including when hea ted, issued by scientific entities or laboratories accepted by the 
responsible entity . 
4.1.7.4  Data on nicotine doses and absorption when consumed in normal or reasonably expected 
conditions.  
4.1.7.5  Acknowledgment that the manufacturer and importer assume full responsibi lity for the quality 
and safety of the product when placed in the market and used in normal or expected conditions.  
4.1.7.6  Description for using the product ingredients and cartridges, including, where appropriate, the 
product opening and re -filling mechanism.  
4.1.7.7  Description of the production process, including the sequence of production processes, and 
ensuring that the production process conforms to the requirements of this standard.  
4.1.7.8  Stability studies supporting the product's shelf life as indicated on the product  label , where 
applicable.  
4.1.7.9  Laboratory reports from entities accepted from the responsible entity , including information on 
nicotine concentration in the product and cartridges, the quality and safety of the product, post -
marketing and post -consumption analy ses, and electrical safety and any other similar information 
upon request.  
4.1.8 Risk assessment studies of the consumable part of the products.  
4.1.9 Products and cartridges must meet the safety and quality requirements so that liquids do not break 
or leak during use  and refilling.  
4.1.10  The following materials must not be added in product, cartridges and e -liquids:  
- Vitamins or other additives that give the impression that the product has a health benefit or 
reduces health risks.  
- Caffeine, taurine or other additives and stimulants associated with stimulating performance and 
vitality.  
- Colored additives with emission -coloring properties.  
- Carcinogens or agents of genetic mutations or producing toxins before and after use of the 
products.  
 
  
- Substances classified a s legally -prohibited substances, such as narcotics, hallucinogens, 
tranquilizers, etc.  
- Ethylene glycol and diethylene glycol, formaldehyde, acetaldehyde, acrolein, Crotone aldehyde, 
acetone, acetylpropionyl and diacetyl, pentane -3,2-dione and related keton es, and long chain 
preservatives of paraben.  
- Acrylonitrile, benzene, 3,1 -potadiene, isoprene, toluene.  
- 4 amino -diphenyl, 1 -amino -naphthalene, 2 -amino -naphthalene.  
- Ammonia.  
- Cinnamic compounds.  
- Respiratory allergens.  
- Residues of heavy metals such as lead, ca dmium, mercury, chromium, nickel, iron, arsenic and 
tin. 
- Multipolar hydrocarbons, carbon monoxide, and nitrosamines of tobacco (e.g. NNK and NNN).  
- Mineral oils, vegetable oils and fats such as (olive oil).  
4.1.11  It is allowed to use the materials necessary for t he manufacture of products and cartridges, such 
as sugar to replace the sugar lost during the treatment process, provided that these substances do 
not result in increase of addiction or toxicity.  
4.1.12  Other product components such as filters, paper, parcels, ca psules or any other related 
components shall not contain flavors that modify the smell or taste of the products or the 
emissions' intensity, nor shall they contain tobacco, tobacco extracts or nicotine.  
4.1.13  The packages or their outer packaging shall not conta in printed vouchers, discount offers or a 
reference to free distribution, two -for-one offers or any other similar offers that may suggest 
economic advantages to consumers and thus induce them to purchase the products.  
 
4.2 Requirements for the Electronic Liquid:  
4.2.1 The electronic liquid shall be manufactured according to the requirements of the standard 
mentioned in item (2.1).  
4.2.2 The components of electronic liquid such as nicotine and solvents shall be of high purity and in 
line with pharmaceutical grade specification and must meet the requirements of the European 
Pharmacopoeia mentioned in items (2.1 1 – 2.15). 
4.2.3 The microbiological  limits of the nicotine used in electronic liquid shall not exceed what is 
specified in the European Pharmacopoeia for Non -Sterile Inhalation Products mentioned in item 
(2. 11). 
4.2.4 The content of nicotine in the electronic liquid shall be less than or equal t o 20 milligrams per 
milliliter.  
4.2.5 The capacity of the integrated electronic liquid tank shall not exceed 10 ml.  
4.2.6 The capacity of the electronic liquid's refill packages shall not exceed 50 ml per package.  
4.2.7 The electronic liquid packages shall not be easily bre akable, damageable or destroyable.  
4.2.8 Electronic liquid packages shall function in such a manner as to ensure that the electronic liquid 
does not leak to the mouth during inhalation.  
4.2.9 The ingredients used in electronic liquids shall not pose a health hazard (e xcept for nicotine and 
other types of tobacco extracts if used), whether in product use conditions or as -is, at the 
concentration used and under the conditions of use for which they are intended.  
4.2.10  Materials prohibited under item (4.1.1 0) shall not be added to the electronic liquid.  
 
  
4.2.11  It is allowed to add the following moisturizing substances:  
glycerol (of food grade and non -petroleum products), 1 -2 propylene glycol, 1 -3 butylene glycol, 
triethylene glycol (with a minimum purity of 99.5%) and they shall be suit able for human 
consumption and in line with pharmaceutical grade specification in conformity with the 
requirements of the European Pharmacopoeia.  
4.2.12  The additives used in the product shall be of the food grade and authorized in accordance with 
the standard me ntioned in item (2.8). 
4.2.13  The substances with the flavored characteristics shall be permitted in accordance with the 
standard mentioned in Item (2.9). 
4.2.14  If hypersensitivity constituents are used, this should be indicated on the label of the product in 
accordanc e with the standard mentioned in item (2.10). 
 
5. Descriptive Data:  
 
5.1 General requirements:  
5.1.1 It is prohibited to use any names, symbols, marks, images or phrases that violate public order.  
5.1.2 The product and its accessories shall not be described or presented with labels, descriptive data, 
names, shapes or symbols that may lead to an erroneous, misleading or promotional impression, 
inside or outside the package, about their characteristics, or that may mislead consumers, and in 
a false or deceptive manner, or that may lead to erroneous impression about their characteristics 
in any way, suggest that they are less harmful than any other type of products, or indicate a 
reduced risk of smoking -related diseases, including, but not limited to: Low or no tar and/or 
nicotine; light, very light, mild, moderate, natural, organic; no additives; no (or very little) flavors; 
or claims about economic advantages compared to traditional cigarettes, or suggestion  of 
therapeutic benefits in terms of weight loss, sex appeal, social status, social life, or qualities such 
as femininity, masculinity or elegance, or improved biological performance, or the size and 
appearance of the products in terms of their resemblance  to food or cosmetics.  
5.1.3 The information shall be clear and easily legible,  and the colors used for writing shall be distinctly 
different from the background colors and not close thereto or overlapping therewith.  
5.1.4 The descriptive data ( in Arabic or English fo r items 5.2.1 to 5.2. 7) shall be placed directly on the 
package and  may be placed on a non -removable sticker.  
5.1.5 No words, names, images, marks, symbols or data may be written on the outer cellophane 
wrapper.  
5.1.6 The health warning on the package directly and any  outer cover of the package, and shall be fully 
visible in front of the consumer on the main display interface, indelible and irremovable, this 
includes that it must not be partially or totally hidden or permanently covered by tax stamps, price 
marks, secu rity features and wrappers, etc.  
 
5.2 The following descriptive data shall be written on the label of the unit package of the 
product and the label of the cartridges:  
5.2.1 Product name and trade name.  
5.2.2 Number of units per package.  
5.2.3 Validity or packing dates for month and year (according to validity studies).  
5.2.4 Production code (batch number)  
5.2.5 Product ingredients (the name or type of flavor used shall be  placed near the product name).  
5.2.6 Country of origin, manufacture or packaging  
5.2.7 The phrase (For sale in the Kingdom of Bahrain)  
   (للبيع في مملكة البحرين  
 
 
  
5.2.8 For products which contain nicotine, the following health warning should be written in both 
Arabic and English on packages (literally):  
 
)يحتوي على النيكوتين الذي يسبب شدة الإدمان وزيادة ضربات القلب ورفع ضغط الدم، وضار  صحياً للمرأة الحامل 
والمرضع والأشخاص الذين يعانون من الأمراض الرئوية المزمنة مثل الربو والإنسداد الرئوي( 
 
(Contains nicotine which causes severe addiction, increased heart rate and high blood 
pressure. Nicotine is harmful to the health of pregnant and nursing women, and people 
suffering from chronic pulmonary diseases such as asthma and pulmonary embolism. ) 
 
5.2.9 The health warning shall be in conformity with the following requirements:  
5.2.9.1  The producing companies may increase or decrease and fix a health warning (Provided in clause 
5.2.8) to suit the different sizes of product packaging, provided it covers more than 50% 
(excluding the frame) of the main display area (in English on the lower front) and (in Arabic on 
the lower back) on the outside of the package.  
5.2.9.2  The health warning and its location, form and measurements shall be in accordance with the 
appendix 1 attached to this Standard, and it may not be changed, modified or rephrased in any 
way.  
5.2.10  Add the following sentence in both Arabic and English  on packages, in addition to ( 18+) symbol 
which should not be less than 1 cm x 1 cm:  
 
)يحظر بيع واستهلاك هذا المنتج من قبل الأشخاص دون سن الثامنة عشر، ولا ينصح باستخدامه لغير المدخنين.( 
 
(It is prohibited to sell and consume this product by individuals under the age of 18, 
and it is not recommended for non -smokers ) 
 
 
 
 
 
 
5.2.11  For products which contains electronic liquid the following sentence shall be added on packages 
in both Arabic and English:  
 
)قد يشكل هذا المنتج خطراً على الصحة عند استنشاقه أو بلعه أو تماسه مع الجلد ( 
 
(This product may pose a health hazard when inhaled, swallowed or gets in contact with 
the skin ) 
 
5.2.12  The health warning requirements shall be applied in accordance with appendix 1 and s hall be 
changed in accordance with the requirements of the public interest.  
 
5.3 Each package (full system) of the product shall contain a printed leaflet containing the 
following data printed in Arabic or English:  
5.3.1 Instructions for using and storing the product, including indicating that the product is not 
recommended for use by young people and non -smokers.  
5.3.2 Circumstances where the product must not be used and warnings mentioned in Section 5.2 and 
any special warnings for certain groups of consumers.  
5.3.3 Instructions for product use and storage.  
5.3.4 Addiction and toxicity.  
5.3.5 Potential adverse effects.  
 
 
UNDER  
 
  
Annex -1 : Health Warnings  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
تحذير صحييحتوي على النيكوتين الذي يسبب شدة الإدمان وزيادة ضربات  
القلب ورفع ضغط الدم، وضار صحياً للمرأة الحامل والمرضع والأشخاص الذين 
يعانون من الأمراض الرئوية المزمنة مثل الربو والانسداد الرئوي. 
Health Warning: Contains nicotine which causes severe addiction, 
increased heart rate and high blood pressure. Nicotine is harmful to 
the health of pregnant and nursing women, and people suffering 
from chronic pulmonary diseases such as asthma and pulmonary 
embolism  
يحظر بيع واستهلاك هذا المنتج من قبلالأشخاص دون سن الثامنة  
عشر، ولا ينصح باستخدامه لغير المدخنين 
It is prohibited to sell and consume this product by 
individuals under the age of 18, and it is not recommended 
for non -smokers.  
قد يشكل هذا المنتج خطراً على الصحة عند استنشاقه أو 
بلعه أو تماسك مع الجلد.   
This product may pose a health hazard when 
inhaled, swallowed, or gets in contact with the 
skin.  
UNDER  
 
  
References: 
 
• UAE regulation for Electronic Nicotine Products ( UAE.S 5030: Electronic Nicotine 
Products – Equivalents of Traditional Tobacco Products)