15 Cancellation of products under RC/COS-005358, for import of Cosmetics under Cosmetics Rules, 2020 (M/s. Beauty Garage India Pvt ltd) 2026-Mar-12 514 KB

File No.: COS-1 1018/1 6/2025-eoffice Government of lndia Directorate General of Health Services Central Drugs Standard Control Organisation (Cosmetics Division) FDA Bhawan, Kotla Road, New Delhi-1 '10002 Dated:l 2 p,r,i,2026

Subject: Cancellation of products under RC/COS-005358, for import of Cosmetics under

Cosmetics Rules, 2020- Regarding Whereas, the firm M/s. Beauty Garage lndia Private Limited, Plot No. 17, Road No. 9, Marol lndustrial Area MIDC Maharashtra, Maharashtra (lndia) - 400093 had registered cosmetics products for import in lndia vide Registration Certificate no. RC/COS-005358, Endorsement No. 3 dated 25-Apr-2025 valid upto 26-Aug-2029. And whereas, according to the provision of the Rule 39 of the Cosmetics Rules, 2020 read with Serial Number '1 580 of Annex A (List of Substances Which Must Not Form Part of the Composition of Cosmetic Products) of lS 4707 (Part 2): 2025, Formaldehyde (CAS No. 50-00-0) is prohibited to be used as an ingredient in Cosmetics products. And whereas, after scrutiny of the above application submitted by the firm, the Cosmetic product BEAUTY GARAGE 3X KERATIN HAIR STRAIGHTENER was found to contain Formaldehyde in concentration of 9.9780% as per the submitted list of ingredients. And whereas, a show cause notice dated 09.10.2025 was issued by the Licensing Authority to the firm M/s. Beauty Garage lndia Private Limited, for violation of Rule 39 of the Cosmetics Rules, 2020 and clause a (d) of Part l, Second Schedule.

.10.2025 was issued by the Licensing Authority to the firm M/s. Beauty Garage lndia Private Limited, for violation of Rule 39 of the Cosmetics Rules, 2020 and clause a (d) of Part l, Second Schedule. ln response to the said Show Cause notice, RC holder accepted that the said product is containing Formaldehyde. AND THEREFORE, the undersigned being the Licensing Authority empowered under Rule 21(b) of the Drugs and Cosmetics Act, "1940, keeping in view of the violation of Rule 39 of the Cosmetics Rules, 2020 and clause 4 (d) of Part l, Second Schedule, thereby order to cancel the registration of the cosmetic product BEAUTY GARAGE 3X KERATIN HAIR STRAIGHTENER containing Formaldehyde, registered under RC/COS- 005358, Endorsement No. 3 mentioned at serial Nos.7 from the date of issue of this order. PaSe 1of 2

File No.: COS-I 101 8/1 6/2025-eoffice Further, it is also directed that any import made by the RC holder on the basis of RC/COS- 005358 of the product containing Formaldehyde shall not be supplied to the market and in case of already supply of said material, it shall be recalled. Details including reconciliation of quantity of import and disposal of such material shall be submitted to this office (Dr. Drugs ontroller eral (lndia) & ng Raghuvanshi) Central Licensing Authority To, M/s. Beauty Garage lndia Private Limited, Plot No. 17, Road No. 9, Marol lndustrial Area MIDC, Maharashtra (lndia) - 400093 Copy To:

1. All Zonal, Sub-Zonal and Port Offices of CDSCO
2. All State Drugs Controller Page 2 ot 2