Bahrain e-cigarette compliance requirements

Background:

November 11, 2021, BH 2:2021 BAHRAINI TECHNICAL REGULATION Electronic Nicotine Prodof Traditional Tobacco Products), The effective date of the standard is May 12, 2022. UAE regulation for EleProducts (UAE.S 5030: UAE Regulation for Eleproducts (UAE.S 5030: Electronic Nicotine Products -- Equivalents of Traditional Tobacco Products), the explicit technical requirements for electronic atomizer. It also stipulates that before electronic atomizers can be put on the market in Bahrain, they must first obtain approval from a regulatory body, currently Bahrain Health.

Scope of application:

1. Electronic atomizers and vapors that contain or do not contain nicotine;

2. Heating does not burn smoke;

Burning products (such as tobacco, herbs, etc.), nicotine patches, and smoke in the mouth do not apply to this standard.

Requirements:

1. Nicotine concentration should not exceed 20mg/mL;

2. The volume of e-cigarette liquid should not exceed 10mL;

3. The volume of bottled tobacco oil should not exceed 50mL;

4. Nicotine and solvents used in e-vape must be of high purity in accordance with pharmaceutical grade specifications and comply with the requirements of the European Pharmacopoeia;

5. The microbial limits of nicotine used in e-vape should not exceed the European Pharmacopoeia regulations for non-sterile inhaled products;

6. Ingredients other than nicotine should not pose a risk to human health;

7. The additives used must meet food grade standards;

8. E-vapers can contain food-grade glycerin, 1-2 propylene glycol, 1-3 butanediol, and triethylene glycol (purity of at least 99.5%).

Forbidden ingredients of tobacco oil:

1. Vitamins or other additives give the impression that the product is beneficial to health or reduces health risks;

2. Caffeine, taurine or other additives and stimulants related to stimulating performance and vitality;

3. Colorant;

4. Substances with carcinogenic, mutagenic or reproductive toxic (CMR) properties, either in unused form or after use in e-cigarettes;

5. Substances classified as substances prohibited by law, such as narcotics, hallucinogens, sedatives, etc.;

6. Glycol and diethylene glycol, formaldehyde, acetaldehyde, acrolein, crotonal, acetone, levulyl and diacetyl, pentane-3, 2-diketone and related ketones, p-hydroxybenzene agents;

7. Acrylonitrile, benzene, 3, 1-polydiene, isoprene, toluene, 4-amino-biphenyl, 1-amino-naphthalene, 2-amino-naphthalene, ammonia, cinnamon compounds;

8. Residues of respiratory allergens and heavy metals (lead, cadmium, mercury, chromium, nickel, iron, arsenic and tin);

9. Tobacco's polypolar hydrocarbons, carbon monoxide and nitrosamines (e.g. NNK and NNN);

10. Mineral oils, vegetable oils and fats such as olive oil.

Requirements for e-cigarette equipment:

1. GSO IEC 60335-1: Household Appliances - Safety - Part 1: General requirements;

2. GSO ISO 8317, Safe Packaging for Children - Requirements and test procedures for resealable Packaging;

3. IEC 62133-1: Secondary batteries and battery packs containing alkaline electrolytes or other non-acidic electrolytes -- enclosed portable secondary electricity for portable applications

Full requirements - Part 1: Nickel systems;

4. IEC 62133-2: Secondary batteries and batteries containing alkali metals or other non-acidic electrolytes -- Safety of enclosed secondary batteries lithium batteries and batteries made from them

Type applications -- Part 2: Lithium systems;

5. GSO IEC 60086-4: Primary dry batteries - Part 4: Safety of lithium batteries;

6. GSO IEC 60335-2-29: Safety of household appliances and similar - Part 29-2: Particular requirements for battery chargers.

Packing requirements:

1. Product name and commodity name;

2. The number of products in each package;

3. Shelf life of the product;

4. Production lot number;

5. Ingredients (flavor name must be next to product name);

6. Country of origin;

7. Only available in Bahrain (English and Arabic). (For sale in the Kingdom of Bahrain) (an ل ب ح ر ی ن م م ل ك ة ف ي ل ل ب ی ع

8. Nicotine health warnings (in English and Arabic), in English under the front and Arabic under the back, covering at least 50 per cent of each side;

9. Warning words (English and Arabic) and ICONS shall not be sold to people under the age of 18. The size of ICONS shall not be less than 1cm*1cm;

10. The following warnings (in English and Arabic) should also be added to products containing tobacco oil;

1. The package shall not contain the following elements:

a. Printing vouchers, discounts, two-in-one or free distribution offers;

b. Elements that give a false impression of their characteristics, health or therapeutic effects, hazards or emissions;

c. Names, symbols, images or phrases that may be contrary to public order;

d. Descriptions and statements such as low tar/nicotine, no tar/nicotine, light, mild, moderate, natural, organic, no additives, no fragrances;

e. Mention social status, elegance, femininity, masculinity, or weight loss.

2. In addition, the following restrictions apply to packaging and labeling:

a. Packaging shall not be similar to food or cosmetics;

b. Nothing can be written on the cellophane wrapper outside.

c. If allergic ingredients are used, this should be stated on the label.

Instructions (in English or Arabic) :

1. Instructions for use and storage of the product, including indicating that the use of the product is not recommended for young people and non-smokers;

2. The conditions for not using the product and the warnings mentioned in the labelling requirements and any special warnings for certain groups of consumers;

3. Product use and storage instructions;

Addiction and toxicity; 4.

5. Potential hazards.

Information required to obtain approval from the Ministry of Health:

General information:

1. Valid business license of the importer (which shall include the business scope of tobacco);

2. ISO9001 certificate of the factory (the factory needs to provide both soot and equipment);

3. Packaging pictures and warning words of products shall meet the standard requirements;

4. ISO17025 certificate of laboratory;

5. Statement of compliance with standard requirements issued by the factory;

6. The manufacturer provides a statement that the product complies with the requirements of GSO ISO8317.

Fume oil data:

1. Smoke oil test report: nicotine, caffeine, ethylene glycol, diethylene glycol, formaldehyde, acetone, heavy metals (lead, cadmium, mercury, chromium, nickel, iron, arsenic, tin);

2. The tobacco oil factory shall provide a statement that it does not add the prohibited substances in the standard;

3. The tobacco oil factory provides the shelf life statement;

4. The composition and content of tobacco oil in descending order, including the use of each component;

5. Release test report and data.

Equipment information:

1. GSO IEC 60335-1 Test Report;

2. GSO IEC 62133-2 Test Report;

3. EMC test report;

4. Instruction manuals in Arabic and English.