E-cigarette compliance requirements in Saudi Arabia

Background:

In 2021, Saudi Arabia fully implemented the regulation on electronic atomizers. The control of electronic smoking systems (including electronic atomizers) in Saudi Arabia is divided into two parts: electronic equipment and electronic liquid: Electronic devices are regulated by the SASO(03-04-19-172) Technical Regulation (TR), Electronic Devices Used in Electronic Smoking Systems, published by the Saudi Standards, Metrology and Quality Organization (SASO) in its Government Gazette on 1 November 2019. Tobacco oil is regulated by a technical regulation (TR), "Tobacco Oil and Heated Tobacco for Use in Electronic Smoking Systems", adopted by the Ministry of Food and Drug of Saudi Arabia (SFDA) on 20 July 2020 by resolution 11/7-18-1440.

Part 1 Electronic atomizer equipment

Scope of application:

Electronic atomizer and heating does not burn smoke

Age limit:

The sale, use and distribution of steam products to - persons under 18 years of age are prohibited.

Electronic atomizer equipment requirements:

Packing requirements:

•     Suppliers shall comply with the requirements of the non-smoking system.

•     Suppliers are prohibited from presenting products as healthy alternatives to smoking.

Label requirements for electronic equipment:

1. All information used in the technical label shall be correct and scientifically proven;

2. Data/labels should be easy to understand and written in Arabic and/or English;

3. The data/labels shall not contain any advertising or propaganda that contradicts Saudi Arabia and/or the World Health Organization regulations;

4. The requirements of the competent authorities and laws relating to the regulation and trading of electronic smoking devices shall be complied with;

5. Labels on electronic smoking devices should include the following data:

Factory mark and country of origin;

Components and quantities of electronic smoking devices;

According to the requirements of the SFDA, devices containing nicotine should have warnings related to the safety and potential risks of children, to ensure the safety of children and avoid leakage of nicotine liquid;

Technical characteristics of electronic smoking devices (suction devices).

6. According to the requirements of SFDA, mandatory label data should be added if the equipment contains lampblack, including the warning mark of lampblack;

7. Adequate markers should be placed to ensure traceability (QR codes).

The instructions are required to include the following information:

Components of electronic smoking devices;

Technical characteristics of electronic smoking devices (suction devices)

Instructions for use and storage, including mechanisms for opening and refilling the product;

Assembly and use;

A warning about the potential risks of such equipment.

Electronic smoking devices require a COC Certificate of Product Compliance and a SASO IECEE Certificate of Recognition

SASO IECEE Recognition Certificate (SASO IECEE Recognition Certificate, Saudi Standards, Quality and Measurement Authority implements IECEE Recognition Certificate (SASO IECEE Recognition Certificate, SIRC) for some products.

Within the scope of products imported in Saudi Arabia need to provide the CB test report and the CB test certificate application SASO IECEE recognized certificate, registered platform of https://jeem1.saso.gov.sa/ will need to provide the following materials:

Test report

CB certificate

Country variance test report (if available)

Product photo and size (with product label)

Sample (if required)

Manufacturer's Statement of Conformity (download from registration platform)

Importer's Declaration of Conformity (Download from Registration platform)

Saudi commercial registration Permit

Product description (in Arabic/in both Arabic and English)

Importer business license (industrial license)

HS number

Certificate of compliance COC

SASO has developed an electronic registration system for product compliance. SABER. All products imported to Saudi Arabia are required to be registered on SABER to obtain a product compliance certificate. Saber - Your Gateway to the Saudi Market (saber.sa)

1. Product Conformity Certificate PCOC: registration based on valid certificates (GC mark Certification certificate, SQM license, IECEE recognized certificate, etc.) and test report

2. Shipping Compliance Certificate SCOC: After obtaining PCOC, registration is conducted based on the shipping invoice before shipment

Procedure of product registration on SABER platform:

First, Saudi importers must register accounts with the SABER system.

Stage 1 Application for Product Certificate of Conformity, namely PCOC, PC for short:

Fill in the product information on SABER and select the certification agency for evaluation and review;

Pay for PC;

Certification body approved, issued PC certificate, valid for 1 year.

Shipment Certificate of Conformity, SCOC, SC:

Fill in the shipping information on SABER (based on invoice and packing list information), and the certification authority will review and approve;

Pay SC fees;

The SC certificate is downloaded from the system. The SC certificate is valid only for this batch of exported goods.

Part 2: Tobacco oil

Substances that may not be contained in tobacco oil:

1. Vitamins and any other additives that may give the impression that the product is beneficial to health or reduces the risk to health;

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

3. Additives with emission coloring characteristics;

4. Additives that have or may affect CMR properties (carcinogenic, mutagenic or reproductive toxicity);

5. Psychotropic drugs, narcotic drugs, hallucinogens and stimulants.

Other requirements for fume oil:

Packaging: Containers should be airtight, child-proof, shatterproof, watertight and waterproof when used or refilled;

Only fruit, tobacco, menthol or their combinations are allowed. Other flavors such as cocoa, vanilla, coffee, tea, flavorings and candy are prohibited.

The raw materials for producing tobacco oil should be high purity raw materials;

The content of nicotine in the liquid is not more than 20mg/mL;

The capacity of a single bomb shall not exceed 2mL;

The maximum capacity of the liquid storage bottle shall not exceed 30mL;

The content of ethylene glycol and diethylene glycol in tobacco oil shall not exceed 0.1%.

The microbial limit specified in the table below shall not be detected in the e-cigarette oil;

The residual heavy metal limit specified in the table below shall not be detected in the fume oil.

Illustrative information and health warnings:

1. The information on the label shall not contain the following contents:

1.1 Any indication or suggestion that the product is less harmful than other tobacco products or is intended to reduce the harmful effects of smoke, or has refreshing, refreshing, healing, rejuvenating, natural or organic properties, or has other health or lifestyle benefits.

1.2 Any advertising or promotional offers

2. The outer package shall contain health warnings that meet the following standards:

2.1 The text shall be black, in black body, on a white background, in large font, covering the entire area reserved for it and being prominently visible on both sides (back and front), surrounded by a 1mm wide black border

2.2 The text should cover at least 30% of the entire (including boundary) surface indicated in 2.1 above.

2.3 The contents of the warning statement are as follows:

2.3.1 For nicotine containing nicotine, it shall be stated: “ This product damages your health and contains addictive nicotine. ”

2.3.2 For nicotine free vapors, it shall be stated: “ This product is harmful to your health and is not recommended. .

3. The outer package shall contain the following information:

3.1 Arabic and/or English: Brand name (trademark), variation or flavour (if applicable).

3.2 Production date (month/year).

3.3 Country of origin.

3.4 Name of manufacturer and/or importer.

3.5 Nicotine concentration (in mg/mL), if applicable.

According to SFDA 5005.2020, it is recommended that the following items be tested for tobacco oil:

Heavy metal content

microorganism

Fume density

Nicotine content

Ethylene glycol and diethylene glycol content

Vitamin, caffeine, taurine content

Documents required for customs clearance

Copy of manufacturing company's invoice approved by the Chamber of Commerce in the country of origin. The invoice shall include the following:

Invoice number and date.

Product type.

The lot number and production date of the product.

Quantity, basic unit and package size.

Name, nationality and address of the manufacturing company.

A copy of the transport policy.

Copy of customs declaration form.