Compliance requirements for e-cigarettes in Jordan

Background:

The Electronic atomizer industry adopted the 2019 Principles for the first time in 2019 (" Basis for Tobacco and NicotineIncluding Electronic Products, of 2019 Issued by the Jordan Food and Drug Administration based on the Council of Min4569 of May 8, 2019,  and Article 7(l) of Jordan Food and Drug Administration Law No. 41 of 2008 "), rules of this standard, labeling, advertising, and health warnings. Rthe Display, Sale, and Storage of Electronic Vaping Products, Rthe display, sale, and storage of electronic vaping Products, Electronic liquid Products, and Electronically Heated Toba restrictions on advertising, product display, and retail. Trade in tobacco and nicotine electronic atomizer products, electronic liquid products and electronic heated tobacco products is subject to a sales license obtained through JDJDFA. The Jordan Food and Drug Administration, the regulatory body.

Scope of application:

1. Electronic atomizers and vapors with or without nicotine, and containers designed for refilling;

2. Electronic heating does not burn tobacco products (processed or unprocessed tobacco)

3. Other similar products included in the above concepts

Requirements of fume oil:

1. The concentration of free nicotine in the nicotine oil should not exceed 20mg/mL;

2. The concentration of free nicotine salt in the nicotine oil should not exceed 25mg/mL;

3. The volume of smoke bomb or disposable smoke oil shall not exceed 2ml;

4. The volume of bottled tobacco oil should not exceed 10ml;

5. Nicotine and solvents used in tobacco oil must be of high purity conforming to pharmaceutical grade and in accordance with the requirements of European Pharmacopoeia; Heated or unheated form, except for nicotine

Poses a risk to health;

6. The microbial limits of nicotine used in tobacco oil shall not exceed the European Pharmacopoeia regulations for non-sterile inhaled products;

7. Flavorings and additives used must conform to food grade standards or are permitted by Jordan Standard 94 and Amendments for use in inhaling devices

8. Food grade glycerin, 1-2 propylene glycol, 1-3 butanediol and triethylene glycol (purity of at least 99.5%) may be added to the tobacco oil, which must be pharmaceutical grade and meet requirements.

9. Any material other than nicotine in the liquid when heated or unheated, and when used in accordance with the appropriate instructions at certain concentration levels

10. Study on the stability of product shelf life marked on product packaging.

11. The following substances shall not be contained in the fume oil and its emissions:

a. Vitamins or other additives give the impression that the product is beneficial to health or reduces health risks;

b. Caffeine, taurine or other additives and stimulants related to stimulating performance and vitality;

c. Colorant;

d. Carcinogenic, mutagenic, or toxic substances produced in non-combustion or combustion forms

e. Substances listed as prohibited by law for sale, such as narcotics, hallucinogens, sedatives or stimulants;

f. Long-chain preservatives of ethylene glycol, diethylene glycol, formaldehyde, acetaldehyde, acrolein, acetone, acetyl propionyl and diacetyl, p-hydroxybenzoate;

g. Respiratory allergens

h. Heavy metals such as lead, cadmium, mercury, chromium, nickel, iron, arsenic and tin;

i. Microbiological limits shall not exceed the European Pharmacopoeia requirements for non-sterile inhaled products.

j. Any substance which has been shown to be hazardous to health or which the Committee considers to be prohibited in the product

Basic requirements for electronic equipment and components

1. Electronic atomizer containers must be food grade and cannot be easily broken, damaged or crushed

2. It must be ensured that the smoke oil in the atomizer cannot leak into the mouth when smoking

3. Other components of the product, such as paper and packaging, shall not contain fragrances that alter odor, taste or emission density, and shall not contain tobacco or nicotine

4. Electronic atomizers and refilling containers must be child-proof and tampered with to avoid safety risks to children; Prevent breakage and leakage, and have refills without leakage

5. US FDA CFR 21 certificate and CE certification

Packing requirements:

1. Product name and commodity name;

2. The number of products in each package;

3. The composition and concentration of the product and the concentration of nicotine (must be clearly stated on the package)

4. Shelf life or packaging date of the product (stability study, if any)

5. Production lot number

6. Product composition

7. Country of origin, manufacturer or packer

8. The phrase "Sold in Jordan"

9. Nicotine health warnings (must be in Arabic, English may also be added) covering 30% of the main display area, in English at the bottom of the front and in English at the bottom of the back

(Contains nicotine. Nicotine causes severe addictions, increased heart rate and high blood pressure. Nicotine ipregnant and nursing women and people suffering from asthma)

10. Health warnings are printed on the packaging and any outer packaging and are fully visible; It cannot be erased or removed, including partially or completely hidden or completely covered by signatures, security features, wrapping paper, or otherwise;

11. Warning words (Arabic and English) and ICONS shall not be sold to people under 19 years old. The size of ICONS shall not be less than 1cm*1cm;

(It is prohibited to sell and consume this product by individuals under the age of 19, and it is not recommendedsmokers.)

12. The following warnings (in Arabic and English) should also be added to products containing tobacco oil.

(This product may pose a health hazard when inhaled, swallowed or get in contact with the skin)

13. The information must be clear and legible. The color of the text must be different or different from the background color and must not overlap

14. The outer cellophane wrapping paper shall not contain any statement, name, image, mark, correspondence or information.

15. Consumption of electronically heated tobacco and nicotine products should not be encouraged by creating false impressions of their characteristics or health effects or risks or their releases

a. Printing vouchers, discounts or free distribution of offers or any other similar offer likely to give consumers the impression of economic benefit;

b. Claims that they have vital, active, therapeutic, restorative, natural or organic properties

c. Claims that they have other health or lifestyle benefits

[d] Claim they are like food

e. claims that they are less harmful to the environment

f. The phrase "do little harm/do little harm" appears

g. No indication of taste, smell or other additives (other than flavorings)

16. No names, symbols, markings, pictures or declarative commands shall be used that are contrary to the public interest.

17. Do not use description cards or data to describe or provide packaging features of the products and their accessories, names, forms or symbols, or any internally or externally unapproved suggestive slogans that give a false, misleading or promotional impression.

18. Each product package must contain an instruction booklet, printed in Arabic and English, containing the following information:

a. Instructions for use and storage of the product, including instructions that the product is not recommended for use by non-smokers under 19 years of age;

b. Taboos and warnings for certain consumer groups;

c. Addiction and toxicity;

d. Potential harm.

Registration requirements for electronic atomizing equipment

1. Letter from the importer requesting registration, including the name of the commodity to be registered, type, manufacturer and country of origin.

2. Valid business registration Certificate issued by the Ministry of Industry and Trade must include import/tobacco trade rights.

3. Valid business license of the importer

4. Valid authentication certificate

4.1 US FDA CFR 21 Certificate.

4.2. A CE certificate issued by an EU national authority shall meet the following requirements:

ROHS Directive (2011/65/EU) : Restriction of electrical and electronic equipment using certain hazardous substances.

LVD (2014/35/EU) : Low voltage instruction

EMC: electromagnetic compatibility instruction

5. Product catalog or label file containing product instruction description, including opening and closing mechanism, refills, storage methods, safety instructions, etc

6. Equipment Specifications or Safety Data Certificate (SDS, MSDS, or PSDS) including components, uses, contraindications, warnings...... Etc.

7. Toxicity studies of burned and unburned components and emissions

8. Pictures of the outer and inner packaging of the product.

9. Instructions (if any).

10. Safety test report issued by JFDA approved scientific institution or laboratory - drop test, leak test, interface temperature test, electromagnetic efficiency

11. Declaration that the manufacturer and importer take full responsibility for the safety and quality of the product when used under normal and foreseeable usage after it has been placed on the market.

12. There must be a bar code on the outer package of the equipment.

13. Equipment and its accessories must have serial numbers.

14. If any changes are made to previously reviewed and approved material, the application must be resubmitted for re-review and approval.

Registration requirements for tobacco oil (flavors registered separately) :

1. Letter from the importer requesting registration, including the name of the commodity to be registered, type, manufacturer and country of origin.

2. A valid business register of importers issued by the Ministry of Industry and Trade, including the purpose of importing/trading electronic atomizers.

3. The original certificate of Free Sale in the country of origin issued by the relevant official agency, showing:

Name and trademark of the product to be approved.

The name of the manufacturing and/or packaging company.

Producers are licensed to produce tobacco oil and subject to health monitoring.

The product conforms to the production specification.

4. GMP or evidence of compliance with internationally recognized manufacturing quality management systems.

5. Ingredient Certificate issued by the manufacturer, showing in descending order by weight all ingredients in the product, including the percentage of nicotine and the percentage of purity.

6. Certificate of analysis issued by the manufacturer showing the percentage of nicotine according to allowable limits.

7. Certificate from the manufacturer stating that the container is food grade and safe for filling with soot.

8. Toxicological studies of product components and their emissions.

9. Product sample.

10. Copy of data card (outer package and instruction manual).

11. Electronic copies of the above documents

12. If any changes are made to previously reviewed and approved material, the application must be resubmitted for re-review and approval.

Test requirements:

Soot oil

1. Toxicological analysis report

2. Release test report and data;

3. Composition analysis of tobacco oil includes nicotine content;

equipment

4. IEC 60335-1 Test report;

5. IEC 62321 Test report;

6. EMC test report;

7. FDA food contact material testing.