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Bahrain Electronic Cigarette Detection
The Bahrain Ministry of Health officially published technical regulation BH 2.2021 “Electronic Nicotine Products (equivalent to traditional tobacco products)” on November 11, 2021, which came into force on May 12, 2022. BH 2.2021 was created with reference to UAE. S 5030:2018, therefore the technical requirements for E-cigarette products in Bahrain are essentially the same as those in the UAE.
Products Containing E-liquid
- The ingredients for producing e-liquid must be pharmaceutical grade high-purity;
- The nicotine content in the e-liquid shall not exceed 20 mg/mL;
- Prohibit the addition of vitamins, caffeine, taurine, colorants, CMR substances, psychotropic substances, stimulants, ethylene glycol, diethylene glycol, formaldehyde, acetaldehyde, acrolein, crotonaldehyde, acetone, 2,3-butanedione, 2,3-pentanedione, benzene, toluene, acrylonitrile, 1,3-butadiene, isoprene, 4-aminobiphenyl, 1-naphthylamine, 2-naphthylamine, ammonia, cinnamon compounds, respiratory allergens, lead, cadmium, mercury, chromium, nickel, iron, arsenic, tin Tobacco specific nitrosamines, long chain preservatives of p-hydroxybenzoate, plant oils, mineral oils, fats, etc.
E-cigarette Device
- The capacity of the integrated liquid storage container or cartridge for E-cigarette Device shall not exceed 10mL, and the capacity of the E-liquid refill container shall not exceed 50mL.
- Products that meet the standard range should meet the technical requirements specified in the corresponding standards, as shown in the table below:
No. | Test Standard | Title |
1 | UAE.S / IEC 60335-1 | Household and similar electrical appliance - Safety - Part 1: General requirements |
2 | GSO IEC 60086-4 | Primary batteries - Part 4: Safety of lithium batteries |
3 | IEC 62133-1 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems |
4 | IEC 62133-2 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems |
5 | GSO IEC 60335-2-29 | Household and similar electrical appliance - Safety - Part 2-29: particular requirements for battery chargers |
6 | GSO ISO 8317 | Child-resistant packaging - Requirements and testing procedure for reclosable packages |
Core content of BH 2.2021 regulation
The BH 2.2021 regulation aims to regulate the production, import, sale, and use of electronic cigarette products, ensuring their safety and compliance. Its main contents include:
1. Scope of application
Electronic cigarette devices (such as electronic cigarette hosts, atomizers, etc.).
Electronic cigarette liquid (with or without nicotine).
Electronic cigarette cartridges and heated tobacco products.
2. Technical requirements
Smoke composition restrictions:
The nicotine concentration shall not exceed 20mg/mL.
The capacity of the smoke liquid shall not exceed 10mL, and the capacity of the smoke cartridge shall not exceed 2mL.
Prohibit the use of certain additives (such as vitamins, caffeine, etc.).
Equipment safety requirements:
Electronic cigarette devices should comply with electrical and mechanical safety requirements.
The device should have a function to prevent children from opening it.
Labeling and packaging requirements:
The packaging should be labeled with the following information:
Product Name and Specifications
Manufacturer name and address
Nicotine content (if applicable)
Health warnings (such as' containing nicotine, addictive ')
Production date and shelf life
The packaging should have anti child opening function.
Restriction of harmful substances:
Harmful substances (such as formaldehyde, acetaldehyde, etc.) in smoke and emissions shall not exceed the prescribed limits.
3. Testing and certification requirements
Electronic cigarette products must be tested by accredited laboratories in Bahrain to ensure compliance with the technical requirements of BH 2.2021.
The testing items include:
Nicotine content detection
Hazardous substance detection
Electrical safety testing
Mechanical safety testing
The product needs to obtain an approval certificate from the Bahrain Ministry of Health before entering the market.
4. Pre listing notice
Electronic cigarette products need to submit a pre-market notice to the Bahrain Ministry of Health before entering the Bahrain market.
The announcement includes:
Product information (name, model, specifications, etc.)
Composition Table of Smoke Liquid
Test report (such as nicotine content, harmful substance detection, etc.)
Label and packaging samples
Comparison between BH 2.2021 and UAE. S 5030:2018
As BH 2.2021 refers to the UAE standard UAE. S 5030:2018, the technical requirements of both are basically the same, mainly including:
Nicotine concentration limit: none should exceed 20mg/mL.
Smoke liquid and cartridge capacity limit: Smoke liquid shall not exceed 10mL, and cartridge shall not exceed 2mL.
Harmful substance restrictions: The limits for harmful substances such as formaldehyde and acetaldehyde are the same.
Labeling and packaging requirements: Both require health warnings and nicotine content to be labeled, and have anti child opening function.
Market Access Process for Electronic Cigarettes in Bahrain
Product testing
Conduct testing in a laboratory recognized by Bahrain to ensure compliance with the technical requirements of BH 2.2021.
Prepare technical documents:
Including product specifications, smoke liquid composition table, test reports, etc.
Submit pre listing notice:
Submit a pre-market notice and relevant documents to the Bahrain Ministry of Health.
Obtain approval certificate:
After passing the review, obtain the approval certificate from the Bahrain Ministry of Health.
Customs clearance and listing:
Upon completion of customs clearance procedures with the approval certificate, the product can be sold in the Bahrain market.
Your company's Bahrain market access service
Your company can provide the following services to help customers smoothly enter the Bahrain market:
Regulatory Consultation:
Provide a detailed interpretation and compliance guidance for the BH 2.2021 regulation.
Test support:
Assist clients in completing testing at accredited laboratories in Bahrain.
Technical document preparation:
Assist clients in preparing the technical documents required for pre-market announcements.
Notice submission:
Assist clients in submitting pre-market notifications to the Bahrain Ministry of Health.
Continuous support:
Provide regulatory updates and certification maintenance services.
summary
The release and implementation of Bahrain's electronic cigarette technology regulation BH 2.2021 marks a trend towards stricter regulation of electronic cigarette products in Bahrain. By meeting the technical requirements of BH 2.2021, companies can ensure the smooth entry of their products into the Bahrain market and achieve compliant operations. Your company's professional services can help clients efficiently complete testing, document preparation, and notification submission, assisting in their global business development.
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