Regulatory framework for vape products in The Kingdom of Saudi Arabia
In these emerging markets, a regulatory framework akin to that seen in the European Union has been adopted, some introducing specific technical requirements ahead of those pending from the European Commission in Europe. The Kingdom of Saudi Arabia is one such country where the Saudi Standards, Metrology and Quality Organization (SASO) has issued Technical Regulations for vape products.
The Kingdom of Saudi Arabia has adopted many of the requirements of the Tobacco Products Directive (TPD) such as:
• A limit of 20mg/mL of nicotine in e-liquid
• A maximum capacity of 2mL in a cartridge
• 10mL limit on bottles of e-liquid.
Additionally, the following flavours are prohibited:
• Cocoa
• Vanilla
• Coffee
• Tea
• Spices
• Candy
• Chewing gum
• Cola
• Ethanol
General testing requirements for vape products
Below, you can find a summary of the general testing requirements for vape products (excluding electrical testing):
Toxicants
The testing of toxic compounds found in e-liquid is conducted by extracting a sample of e-liquid from the product before using chromatographic methods to separate them from other constituents before determining their quantity using a specialist detector.
| Compound | Limit |
|---|---|
| Ethylene Glycol | 0.10% |
| Diethylene Glycol | 0.10% |
Metals in e-liquids
The testing of metals found in e-liquid is conducted by extracting a sample of e-liquid from the product before testing it by specialist equipment used for the determination of metals in a sample, typically inductively coupled plasma (ICP).
| Metal | Maximum Limit (ug/g) |
|---|---|
| Cadmium | 0.2 |
| Lead | 0.5 |
| Arsenic | 0.2 |
| Mercury | 0.1 |
| Arsenic | 0.2 |
| Chromium | 0.3 |
| Nickel | 0.5 |
| Tin | 6.0 |
Microbiological Testing
Typically, microbial testing involves taking a sample of the e-liquid and introducing it to a nutrient plate. The plate is then incubated for a number of days and the microbes counted to determine the number of colony forming units (CFU).
| Microbiological testing | Maximum Limit |
|---|---|
| Aerobic Plate Count | 102 CFU/mL |
| Yeast and Mould | 102 CFU/mL |
| S. aureus | Absent |
| P. aeruginosa | Absent |
| Enterobacteriaceae | Absent |
Electrical Safety Testing
Several electrical safety tests are cited by the Kingdoms Technical Regulation including; IEC 60335-1 for Household and similar electrical appliances. Safety – part 1: General requirements, IEC 60950-1 Information Technology Equipment – Safety – Part 1: General Requirements, IEC 60529 Degrees of Protection Provided by Enclosures (IP Code), IEC 61558-1 Safety of Power transformers, power supply units and similar – Part 1: General requirements, CISPR 14-2 Electromagnetic compatibility – Requirements for household appliances, electrical tools and similar apparatus – Part 2: Immunity – Product family standard.
Inter Scientific is uniquely positioned to assist companies looking to enter emerging markets. With a team dedicated to vape product compliance, Inter Scientific is the UK’s only laboratory to conduct all required testing in-house, from chemical analysis through to microbial testing. Our laboratory is accredited to ISO 17025 by the United Kingdom Accreditation Service (UKAS) and by the Medicines Healthcare Products Regulatory Agency (MHRA) to GMP.
Contact us to find out more about the specific requirements for the Kingdom of Saudi Arabia, including regulatory requirements at
info@inter-scientific.com or speak to our team through our website live chat.
Found this insightful? Share it:
