Procedural by-law amendment

For the registration of companies producing and importing electronic liquids

 

Preamble:

This by-law is regarding the procedures taken according to ministerial decree no.516/2021 regarding the registration of importing/ producing companies for electronic liquid individually as well as electronic cigarettes including electronic liquid according to ES no. 8205-1/2018 

 

Documents required from the applicant for the registration:

1. The application for registration (electronic liquid, whether in a single form or electronic cigarettes containing an electronic liquid) shall be submitted in the name of the chairman  of the Egyptian General organization  for Standardization and Quality, including:

• Name of the item "e-liquid / electronic cigarettes" and the type
• the name of the flavor added in the case of addition
• the percentage of nicotine,
• the number of units inside the package (size),
• The manufacturer / producer and the country of origin via the concerned person or his legal representative by the validity of a bank signature, accompanied by a receipt of payment to open the file.

2. A valid commercial record  that includes e-liquid and electronic cigarettes

3. In the case of local production, an industrial record  that includes the production of electronic liquid and/or electronic cigarettes

4. The approval  of the producing  company to register the product for the importing company of the Authority is authenticated  by the chambers of commerce of the country of origin

5. Statement of the composition and ingredients  of the e-liquid approved by the manufacturer

6. Valid operating license of the producing company and authenticated by the chamber of commerce of the country of origin.

7. A list of the provided flavors and the percentage of nicotine for the required product to be registered in Arabic, and English, if any.  A commitment to provide samples for each item to be registered for analysis after the acceptance of the file.

8. Test Report of the final product to be registered, issued by one of the certified labs containing the lists of analyses stipulated according to ES No. 8205-1/2018.

9. Material safety data sheets (MSDS) for the final product.

10. Certification from the supplier with grade of nicotine, propylene glycol and glycerin purity.

11. Provide written pledge from the producing company that the components of the e-liquid and food grade packaging containers are safe to use and that the final product conforms to the production specifications and is safe to use.

12. Submitting pledge from the producing company that the components of the e-liquid are free from carcinogenic substances that are prohibited to be used and conform to Egyptian Standard No.: 8205-1/ 2018

13. A copy of the certificates of management and quality systems (GMP / ISO 9001 / ........) applied at the factory premises

14. Copies of data cards  of the product to be registered for each flavor conforming to the item of packaging and data to Egyptian standard no: 8205-1/2018

15.  An acknowledgment by the applicant of his commitment to the validity of the submitted documents, accompanied by the validity of a bank signature.

16. Provide packages of the final product for analysis.

17. In the case that the registration requirements are met, the importing/manufacturer company will be registered in the list of companies importing/producing e-liquid at EOS, and a registration notice will be delivered to it.

18. The companies registered in the list are registered on the website of the Egyptian Organization for Standardization and Quality, with continuous updating of that list with respect to completion, suspension, deletion, addition or modification.

19. In the case that the registration requirements are not met, the applicant shall be notified that he did not fulfill the requirements via an official letter containing the unfulfilled items and giving one month period at most to fulfill the requirements , otherwise his/her registration will be canceled and the amount of the payment receipt will not be refunded.

20. An original copy (the submitted file) and 8 hard copies + an electronic copy.

21. In the case of changing one of the components of a previously registered item (flavor - nicotine) or the nature of (electronic liquid or electronic cigarettes containing electronic liquid), the importing company must submit an application to add new flavors attached with the registration number of the previously registered product, with payment of the flavors’ registration fees, as well as analysis fees.

22. To achieve Clause (21), papers and documents are submitted in accordance with the above-mentioned items (1-16), and once the addition is accepted in the light of examining the documents, the importing company will be granted a valid registration notice until the expiration date of the registration notice that was previously issued to the same company.

23. In the case that a request to change any of the data of a previously registered product (producer / manufacturer - country of origin - trademark) is required to open a new file with a commitment to pay all fees (fees for opening a file, registering flavors and analyzing samples).

24. It is prohibited to write down phrases, pictures or drawings on the packaging that give a wrong impression and understanding to the consumer

25. The registration notice shall be valid for one year from the date of its issuance, and a period of two months shall be given to companies to submit a request to renew the registration notices, otherwise they shall be removed from the companies’ registration lists.

26. Fees for replacing damaged items and fees for amending the notification regarding the size amount to 250 pounds per notification, provided that the company is committed to providing the previously granted notifications.

 

Fees for registration:

• 20000 pound is the application value for the main brand
• 3000 pound for each specific product (flavor+ nicotine)
• 500 pound for letter in English in case of request
• 500  pound for a replacement registry certificate

Fees for tests

To be paid for tests conducted by EOS   

Application for registering the importing /producing companies for electronic liquid