Background:
On November 11, 2021, Bahrain issued the electronic cigarette standard "BH 2:2021 Bahraini technical regulation electronic cigarette products (equivalents of traditional tobacco products)", and the effective date of the standard is May 12, 2022. The standard is prepared with reference to UAE standard "UAE regulation for electronic nicotine products (uae.s 5030: electronic nicotine products – assets of traditional tobaccos)" and puts forward clear technical requirements for electronic cigarettes to enter Bahrain market. At the same time, it is stipulated that before e-cigarettes enter the Bahrain market, they must first obtain the approval of the regulatory authority. The current regulatory authority is the Ministry of health of Bahrain.
Scope of application：
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Electronic cigarettes and cigarette oils with or without nicotine;
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Heating incombustible smoke;
Burning products (such as tobacco, herbal medicine, etc.), nicotine patches, cigarette in mouth, etc. are not applicable to this standard.
requirement:
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Nicotine concentration shall not exceed 20mg/ml;
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The volume of electronic cigarette oil shall not exceed 10ml;
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The volume of bottled tobacco oil shall not exceed 50ml;
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Nicotine and solvent used in electronic cigarette oil must be of high purity in accordance with pharmaceutical grade specifications and meet the requirements of European Pharmacopoeia;
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The microbial limit of nicotine used in electronic cigarette oil shall not exceed the provisions of European Pharmacopoeia on non sterile inhalation products;
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Ingredients other than nicotine shall not pose a risk to human health;
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The additives used must comply with food grade standards;
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Electronic cigarette oil can contain food grade glycerol, 1-2 propylene glycol, 1-3 butanediol and triethylene glycol (purity of at least 99.5%).
Prohibited ingredients for bituminous oil:
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Vitamins or other additives give people the impression that the product is beneficial to health or reduces health risks;
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Caffeine, taurine or other additives and stimulants related to stimulating performance and vitality;
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Colorants;
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Substances with carcinogenic, mutagenic or reproductive toxicity (CMR) characteristics, whether in unused form or after use in e-cigarettes;
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Substances listed as prohibited substances by law, such as narcotics, hallucinogens, sedatives, etc;
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Long chain preservatives of ethylene glycol and diethylene glycol, formaldehyde, acetaldehyde, acrolein, crotonaldehyde, acetone, acetylpropionyl and diacetyl, pentane-3,2-dione and related ketones, and p-hydroxybenzoate;
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Acrylonitrile, benzene, 3,1-polydiene, isoprene, toluene, 4-aminobiphenyl, 1-amino-naphthalene, 2-amino-naphthalene, ammonia and cinnamon compounds;
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Respiratory allergens and heavy metal residues (lead, cadmium, mercury, chromium, nickel, iron, arsenic and tin);
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Multipolar hydrocarbons, carbon monoxide and nitrosamines of tobacco (e.g. NNK and NNN);
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Mineral oils, vegetable oils and fats, such as olive oil.
Requirements for electronic cigarette equipment:
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GSO IEC 60335-1：Household appliances - Safety - Part 1: General requirements;
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GSO ISO 8317：Child safety packaging - Requirements and test procedures for resealable packaging;
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IEC 62133-1：Secondary batteries and battery packs containing alkaline or other non acid electrolytes - Safety requirements for closed portable secondary batteries and battery packs for portable applications - Part 1: nickel systems;
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IEC 62133-2：Secondary batteries and batteries containing alkali metals or other non acid electrolytes - Safety requirements for closed secondary lithium batteries and batteries made thereof for portable applications - Part 2: lithium systems;
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GSO IEC 60086-4：Primary dry batteries - Part 4: safety of lithium batteries;
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GSO IEC 60335-2-29：Household electrical appliances and similar safety - Part 29-2: Particular requirements for battery chargers.
Packaging requirements:
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Product name and trade name
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Quantity of products in each package
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Shelf life of the product
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batch number
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Ingredients (the taste name must be next to the product name)
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Country of origin
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Sales in Bahrain only (English and Arabic)
(For sale in the Kingdom of Bahrain) (????? ?? ????? ???????)
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Nicotine health warnings (English and Arabic), English below the front and Arabic below the back, occupying at least 50% of the area of each face
9.It is prohibited to sell warning words (English and Arabic) and icons to people under 18 years old. The size of the icon shall not be less than 1cm*1cm;
10.The following warning words (English and Arabic) shall be added to the products containing smoke oil;
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The following elements must not be included on the package：
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Printed vouchers, discounts, two in one or free distribution；
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Elements that give a false impression of their characteristics, health or therapeutic effects, hazards or emissions；
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Names, symbols, images or phrases that may violate public order；
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Description and declaration, e.g. low tar / nicotine, no tar / nicotine, light, mild, moderate, natural, organic, additive free, fragrance free；
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Mention social status, elegance, femininity, masculinity or weight loss。
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In addition, the following restrictions apply to packaging and labeling：
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Packaging must not be similar to food or cosmetics；
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Nothing can be written on the cellophane wrapping outside；
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If an allergic ingredient is used, it should be noted on the label。
Instruction requirements (English or Arabic)：
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Instructions for the use and storage of the product, including a statement that it is not recommended for young people and non-smokers；
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The warnings mentioned in the conditions of not using the product and the labeling requirements, as well as any special warnings for certain consumer groups；
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Product use and storage instructions；
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Addiction and toxicity；
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Potential hazards。
Information required to obtain approval from the Ministry of health：
General information：
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Valid business license of the importer (including the business scope of tobacco)；
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ISO9001 certificate of the factory (both the smoke oil and equipment factories need to provide it)；
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The packaging pictures and warnings of the product shall meet the standard requirements；
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ISO17025 certificate of laboratory；
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Statement of conformity with the standard issued by the factory；
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The manufacturer provides a statement that the product complies with the requirements of GSO iso8317。
Bituminous oil data：
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Smoke oil test report: nicotine, caffeine, ethylene glycol, diethylene glycol, formaldehyde, acetone, heavy metals (lead, cadmium, mercury, chromium, nickel, iron, arsenic, tin)；
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Statement of no addition of substances prohibited in the standard provided by the tobacco and oil factory；
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Declaration of shelf life provided by the tobacco oil factory；
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Composition and content of tobacco oil in descending order, including the use of each component substance；
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Release test report and data。
Equipment data：
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GSO IEC 60335-1Test report；
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GSO IEC 62133-2Test report；
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EMCTest report；
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Instructions in Arabic and English。
