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Last Updated on June 12, 2021 by The Health Master
FAQs on – Cosmetics Rules 2020
1 Q. From which date Cosmetic Rules 2020 shall come into force ?
Ans: Cosmetic Rules 2020 have been modified vide notification No. G.S,R. 763 (E) Dated 15-12-2020 and the same have come into force from the date of its notification i.e. 15-12-2020.
To download the notification No. G.S,R. 763 (E) Dated 15-12-2020, click here
2 Q. What is the status of existing cosmetic manufacturing license issued on form 32?
Ans: As per Rule 72 (Savings) the existing license shall be deemed to be valid for all purposes, still its expiry or for the period of 18 months from the date of these rules are notified, whichever is later.
3 Q. What is the revised license fee under Cosmetic Rules 2020?
Ans: Fee is given in 3rd Schedule of the New Cosmetic Rules 2020.
– Fee for the grant of license is Rs. 10,000/- (Free: ten items of each category)
– Retention fee Rs. 10,000/-
– Item fee: Rs. 500/- per item
– Late Fee per month Rs. 2% of the license fee.
– Fee for additional category Rs. 10,000/-
– Fee for duplicate license Rs. 500/-
– Fee for the approval of testing laboratory Rs. 1,000/-
4 Q. Is inspection required for the grant of cosmetic license?
Ans. As per Cosmetic Rules 2020, no inspection is required before granting the license, but State Licensing Authority (SLA) may verify the documents and fee submitted by the firm as per rule 23 of the Cosmetic Rules 2020.
5 Q. On which form, cosmetic license is granted as per Cosmetic Rules 2020?
Ans. From Cos-8.
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6 Q. What are the new procedure for getting new cosmetic license as per Cosmetic Rules 2020?
Ans. Procedure given in Rule 23 as under:Firm has to apply new cosmetic manufacturing license through online portal on form Cos-5.
– The required fee is mentioned in 3rd schedule of Cosmetics Rules 2020.
– List of documents to be submitted as per 2nd schedule part-2 Cosmetics Rules 2020.
– SLA will issue the license on form Cos-8. If the application was not incomplete then SLA may reject the file and inform the applicant within 45 days.
– After obtaining license, firm has to upload the license on website of CDSCO within 30 days.
– SLA within 30 days of grant of license will inspect the premises and verify the information as given by the firm in self-certificate in form Cos-7.
7 Q. For how much time manufacturing record is to be retained?
Ans. Manufacturing record to be retained for a period of 3 years from the date of expiry of the product.
8 Q. For how much time the testing record is to be retained?
Ans. The test record is to be retained for a period of 3 years from the date of manufacturing.
9 Q. Is there any change in qualification of Technical Staff in Cosmetics Rules 2020?
Ans. No. It will be same as previous.
10 Q. Within how much time the firm has to obtain license due to change in constitution ?
Ans. Within Six months
11 Q. Within how much time the firm has to obtain license due to change in Name of the firm ?
Ans. Within Two months.
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12 Q. What are the Forms under Cosmetic Rules 2020?
Ans. List of such forms is as under:
|1||Application to obtain cosmetics manufacturing license||Cos-5|
|2||Self- certificate compliance for GMP||Cos-7|
|3||Cosmetics Manufacturing license||Cos-8|
|4||Form for sampling||Cos-10|
|7||Memorandum to Govt. Analyst||Cos-17|
|9||Govt. Analyst Test Report||Cos-19|
|10||Application for grant of testing of cosmetics||Cos-22|
|11||License for testing laboratory for cosmetics||Cos-23|
13 Q. What are the different categories and area required to manufacture cosmetics under Cosmetic Rules 2020?
Ans: Details of categories and area required to manufacture cosmetics under Cosmetic Rules 2020 is as under.
|Category||Cosmetics||Area in Sq.Mtrs|
|B||Skin Powder for infants||15|
|C||Creams, Lotions, Shampoo, Shaving Creams, Hair Oils. Emulsions, Pastes, Cleansing Milk, Pomade||25|
|D||Nail Polish and Nail Lacquers||15|
|E||Lipsticks and Lipgloss||15|
|F||Depilatories used for eyes||10|
|G||Eyebrows, Eyelashes Eyeliners||10|
|I||Alcoholic Fragrance Solutions||15|
|K||Tooth powders general and toothpastes etc.||15|
14 Q. Is definition of New cosmetic has been introduced in Cosmetic Rule 2020?
Ans. Yes, definition of New cosmetic has been given in Rule-3(f) of Cosmetics Rules 2020.
Also read | FAQs – on Cosmetics (Series-1)
15 Q. Which are new schedules introduced in Cosmetics Rules 2020 ?
Ans. Following schedules are introduced:
|1||First Schedule||Authorisation from manufacturer|
|2||Second Schedule Part-I||Information and undertaking required to be furnished by the manufacturer or his authorised importer or distributor or agent with the application form for import registration certificate.|
|3||Second Schedule Part-II||Information and undertaking required to be furnished by the manufacturer with the application form for grant of manufacturing licence or loan licence|
|4||Third Schedule||Fee payable for licence, permission and registration certificate.|
|5||Fourth Schedule||List of categories of cosmetics for import|
|6||Fifth Schedule||Fee for test or analysis by the Central cosmetics laboratories or by the state laboratories|
|7||Sixth Schedule||Undertaking for the import of cosmetics to be submitted by the importer with application form for Import Registration Number|
|8||Seventh Schedule||Good manufacturing practices and requirements of premises, plants and equipment for manufacture of cosmetics|
|9||Eighth Schedule||Manufacturing and raw material records|
|10||Ninth Schedule||Standards for cosmetics (BIS)|
|11||Tenth Schedule Part-I||List of colourants allowed for use in cosmetic products as given under IS: 4707 (Part 1) of BIS|
|12||Tenth Schedule Part-II||List of colours permitted to be used in soaps|
|13||Eleventh Schedule||Good laboratory practices and requirements of premises and equipment|
|14||Twelfth Schedule||Extent and conditions of exemption of various class of cosmetics|
|15||Thirteenth Schedule||Word “Cosmetics” is omitted from Drugs and Cosmetics Rules 1945|