background:
In 2021, Saudi Arabia will fully implement the regulations on the control of electronic atomizers. The country's control of electronic smoking systems (including electronic atomizers) products is divided into two parts: electronic equipment and electronic liquids: electronic equipment is produced by Saudi Arabia. SASO (03-04-19-172) Technical Regulation (TR) - Electronic Equipment for Use in Electronic Smoking Systems, published by the Standards, Metrology and Quality Organization (SASO) in its Official Gazette on 1 November 2019 " to be regulated; and e-liquid is a technical regulation (TR) passed by the Ministry of Food under the Saudi Food and Drug Administration (SFDA) on July 20, 2020 by Resolution 11/7-18-1440--" E-liquid and heated tobacco for use in electronic smoking systems.
Part 1 Electronic Atomizer Equipment
Scope of application:
Electronic atomizers and heat-not-burn cigarettes
age limit:
The sale, use and distribution of vapor products to persons under the age of 18 is prohibited.
Electronic atomizer equipment requirements:
|
serial number |
standard encdoing |
standard name |
|
1 |
IEC 62133-2 |
Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and portable sealed secondary batteries for use in portable equipment - Part 2 Lithium systems |
|
2 |
IEC 60335-1 |
Household and similar electrical appliances - Safety - Part 1: Basic requirements |
|
3 |
IEC 62321/IEC 63000 |
Determination of Certain Substances in Electrical and Electronic Products/Technical Document for Assessment of Hazardous Substances in Electrical and Electronic Products |
|
4 |
CISPR 14-2 |
Electromagnetic Compatibility - Requirements for Household Appliances, Power Tools and Similar Equipment - Part 2: Immunity - Product Family Standard |
|
5 |
CISPR 14-1 |
Electromagnetic Compatibility - Requirements for Household Appliances, Power Tools and Similar Electrical Appliances - Part 1: Emissions - Product Family Standard |
Packaging Requirements:
• Suppliers shall comply with the requirements of the no smoking system.
• Prohibit suppliers from presenting products as healthy alternatives to smoking.
Labeling requirements for electronic equipment:
1. All information used in technical labels should be correct and scientifically proven;
2. Data/labels should be easy to understand and written in Arabic and/or English;
3. Data/labels must not contain any advertisements or promotions that contradict Saudi and/or WHO regulations;
4. Comply with the requirements of competent authorities and laws related to the regulation and trade of electronic smoking devices;
5. Labels for electronic smoking devices should include the following data:
-
Factory trademark and country of origin;
-
The components and quantities of electronic smoking devices;
-
According to the requirements of the SFDA, devices containing e-liquid should have warnings related to child safety and potential risks to ensure child safety and avoid nicotine liquid leakage;
-
Technical characteristics of electronic smoking devices (smoking devices).
6. According to SFDA requirements, if the device contains e-juice, mandatory labeling data should be added, including warning signs of e-juice;
7. Sufficient marking should be placed to ensure traceability (QR code).
The instruction manual requires the following information:
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Components of electronic smoking devices;
-
Technical characteristics of electronic smoking devices (smoking devices);
-
Instructions for use and storage, including mechanisms for opening and refilling the product;
-
assembly and use;
-
Warning about the potential risks of such equipment.
Electronic smoking equipment needs to obtain COC product conformity certificate and SASO IECEE accreditation certificate
SASO IECEE Recognition Certificate (SIRC) The Saudi Bureau of Standards, Quality and Metrology implements IECEE accreditation requirements (SASO IECEE Recognition Certificate, SIRC) for some products.
Products imported into Saudi Arabia need to provide CB test report and CB test certificate to apply for SASO IECEE accreditation certificate. The registration platform is https://jeem1.saso.gov.sa/ The following materials are required:
-
testing report
-
CB certificate
-
National Difference Test Report (if any)
-
Product photos and dimensions (with product label)
-
sample (if needed)
-
Manufacturer's Declaration of Conformity (Registration Platform Download)
-
Importer's Declaration of Conformity (download from the registration platform)
-
Saudi business registration license
-
Product Instructions (Arabic / Both Arabic and English)
-
Importer business license (industrial license)
-
HS number
Certificate of Conformity—COC
SASO has developed an electronic registration system for product conformity - SABER. All products imported into Saudi Arabia need to be registered on SABER to obtain a product conformity certificate. Saber - Your Gateway to the Saudi Market (saber.sa)
1. Product Conformity Certificate PCOC: Registration based on valid certificates (GC Mark Certificate, SQM License, IECEE Accreditation Certificate, etc.) and test report
2. Shipping Compliance Certificate SCOC: After obtaining PCOC, register based on the shipping invoice before shipping
SABER platform product registration steps:
First, Saudi importers must register an account on the SABER system.
Phase 1 Apply for Product Certificate of Conformity, PCOC, referred to as PC:
• Fill in the product information on SABER and select the certification body to evaluate the audit;
• Pay for PC;
• The certification body has passed the review and issued a PC certificate, which is valid for 1 year.
Stage 2 Shipment Certificate of Conformity, namely SCOC, SC for short:
• Fill in the shipping information (based on the invoice and packing list information) on SABER, and the certification body will review and approve it;
• Pay SC fees;
• The system downloads the SC certificate, which is only valid for this batch of exported goods.
Substances that should not be contained in e-liquid:
1. Vitamins and any other additives that may give the impression that the product has health benefits or reduces health risks;
2. Caffeine, taurine or other additives or stimulants related to energy and vitality;
3. Additives with emission coloring properties;
4. Additives that have or may affect CMR properties (carcinogenic, mutagenic or reproductive toxicity);
5. Psychotropic drugs, narcotics, hallucinogens and stimulants, etc.
Other requirements for e-liquid:
1. Packaging: When used or refilled, the container should be airtight, childproof, shatterproof, watertight and waterproof;
2. E-liquids are only allowed to have fruit, tobacco, menthol or their mixed flavors, and other flavors such as cocoa, vanilla, coffee, tea, condiments and candies are prohibited;
3. The raw materials for producing e-liquid should be high-purity raw materials;
4. The content of nicotine in e-liquid should not exceed 20mg/mL;
5. The capacity of a single cartridge does not exceed 2mL;
6. The maximum capacity of the e-liquid storage bottle shall not exceed 30mL;
7. The content of ethylene glycol and diethylene glycol in e-liquid shall not exceed 0.1%;
8. The limit of microorganisms specified in the table below shall not be detected in the e-liquid;
|
Microbial testing |
limit value |
|
Total number of aerobic microorganisms |
102 CFU/mL 或 CFU/g |
|
Total yeast and mold |
101 CFU/mL 或 CFU/g |
|
Staphylococcus aureus |
not checked out |
|
Pseudomonas aeruginosa |
not checked out |
|
Bile-resistant Gram-negative bacteria (1g or 1mL) |
not checked out |
-
No excess heavy metal residue limits specified in the table below shall be detected in the e-liquid.
|
heavy metal |
Limit value (μg/g) |
|
cadmium |
0.2 |
|
lead |
0.5 |
|
arsenic |
0.2 |
|
HG |
0.1 |
|
chromium |
0.3 |
|
nickel |
0.5 |
|
tin |
6 |
|
copper |
3 |
Prescriptive information and health warnings:
1. The information on the label must not contain the following:
1.1 Any indication that the product is less harmful than other tobacco products or designed to reduce the harmful effects of smoke, or has refreshing, refreshing, healing, rejuvenating, natural or organic properties, or has other health or lifestyle benefits or Suggest.
1.2 Any advertising or promotional offers
2. The outer packaging should contain health warnings that meet the following standards:
2.1 Text shall be black, bold, white background, large font, cover the entire area reserved for it, and be prominently visible on both sides (back and front) and be surrounded by a 1mm wide black border
2.2 The text shall cover at least 30% of the entire (including boundary) surface indicated in 2.1 above.
2.3 The warning statement reads as follows:
2.3.1 For nicotine-containing e-liquids, it should state: "This product is harmful to your health and contains addictive nicotine."
2.3.2 For nicotine-free e-liquid, it should be stated: "This product is harmful to your health and is not recommended for use".
3. The outer packaging should contain the following information:
3.1 Arabic and/or English: brand name (trademark), variant or flavour (if applicable).
3.2 Date of manufacture (month/year).
3.3 Country of Origin.
3.4 Name of manufacturer and/or importer.
3.5 Nicotine concentration (if applicable) in mg/mL.
According to SFDA 5005.2020, e-liquid is recommended to test the following items:
1. Heavy metal content
2. Microorganisms
3. E-liquid density
4. Nicotine Content
5. Ethylene glycol and diethylene glycol content
6. Vitamin, caffeine, taurine content
Documents required for customs clearance
1. A copy of the manufacturing company's invoice recognized by the Chamber of Commerce in the country of origin. Invoices should include the following:
• Invoice number and date.
• product type.
• Lot number and date of manufacture of the product.
• Quantity, base unit and package size.
• The name, nationality and address of the manufacturing company.
2. A copy of the Shipping Policy.
3. Copy of customs declaration
