Electronic Cigarettes Product Registration by ESMA in Dubai – UAE

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Dubai Government has made it official to sale Electronics cigarettes in Dubai from 15th April 2019. However, the product needs to be registered with Emirates Authority for Standardization and Metrology (ESMA).

Traders and manufacturers from all over the world have started entering into the market to capture an early entrant share of the business.

The following are the main points that need to be considered to register Electronic cigarette products (Liquid and Heated Cigarettes) with ESMA (Emirates Authority for Standardization and Metrology)

1. 1. Valid trade license
   2. Trademark registration with UAE authorities (recommended through an offshore company registered in UAE as an asset holding)
   3. The manufacturing facilities should meet the requirements of standard (ISO 9001) by submitting QMS Manual
      • Colouring if declared in the list of ingredients
      • Ethylene glycol
      • Diethyl Glycol
      • Formaldehyde
   4. ECAS (Emirates Conformity Assessment Scheme) certificate for product label
   5. Laboratory test report for the following materials as per clause 4.1.11 in UAE. SGSO 5030 from ISO 17025 accredited laboratory which will be valid for one year only (So should not be older than one year)
      • Nicotine concentration
      • Caffeine
      • Taurine
      • Acetone
      • Residues of heavy metals, lead, cadmium, mercury, chromium, nicker, iron, arsenic and tin
      • One flavor/formulation/nicotine strength should have one test report
      • Full test report will be submitted at the time of renewal
   6. Declaration from the manufacturer for not adding the prohibited materials mentioned in clause 4.1.11 in UAE standards
   7. Declaration of compliance with standard GSO ISO 8317 UAE which is resistant packaging for children
   8. Data on doses and nicotine intake when consumed in normal or reasonably expected conditions
   9. Declaration of the validity period on the product label
   10. Risk assessment study from the manufacturer
   11. Distributor ownership (For traders)
   12. List of ingredients in descending order including the following: Percentage of each commercial name of ingredients, their functionality, the emission related to each ingredient, and toxicity including literature data
   13. Electronic declaration of conformity

Following are the main points need to be considered to approve the Labeling of electronic Cigarette products from ESMA

1. 1. 1. Valid trade license
      2. Trademark registration with UAE authorities (recommended through an offshore company registered in UAE as an asset holding)
      3. Product card label and warning label (front and rear face layout of package) as per UAE.S/GSO 5030
      4. Distributor ownership (For traders)
      5. Electronic declaration of conformity

The following are the main points need to be considered to approve electronic nicotine product devices by ESMA

1. 1. 1. Valid trade license
      2. Trademark registration with UAE authorities (recommended through an offshore company registered in UAE as an asset holding)
      3. ECAS certificate for ROHS
      4. IEC CB test reports and certificates as per standard no UAE.S/GSO IEC 60335-1
      5. Plug requirements compliance as per the standard BS 1363, plugs with earth and fuse
      6. Photos of rating label on the product
      7. Distributor ownership
      8. User manual in Arabic and English
      9. Manufacturing process description with flow diagram
      10. Risk/benefit assessment based on the analysis of available scientific data
      11. Manufacturing site certification under ISO 9001
      12. Electronic declaration of conformity

So the application is required for each label, each liquid (without label), and each devise (including label).

Information provided above is for guidelines only and can differ in the Government department as the policies keep changing time to time. The actual valid information can be known at the time of making an inquiry.

We at Flyingcolour always believe in helping our clients in all the possible ways to setup their business in UAE, with respect to the local law. This blog is written by Mr. Raj, Chairman of Flyingcolour Business Setup, Accounting & Tax Services, who holds decades of experience in business consulting and have helped thousands of businesses to establish themselves in Dubai and all over UAE. Feel free to call us today for a quality consultation related to your business setup queries. Please send inquiry to info[at]flyingcolour[dot]com or call +971 4 4542366