Union Health Ministry publishes draft amendments to the Cosmetics Rules, 2020; public comments invited till 1st July, 2023

The Ministry of Health and Family Welfare has proposed draft amendments (“Draft Amendment”) to the Cosmetics Rules, 2020 and has invited objections and suggestions from the public which may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 437 C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in. till 1st July, 2023.

Key Highlights:

1. The Draft Amendment proposes to add an explanation with a view to clarify the usage of terms “Use Before” or “Date of Expiry” on the label. The first day of the month is proposed to be associated with the month mentioned under “use before” and when date of expiry is used, it shall mean the cosmetic will expire on the last day of the month provided on the label. Further, the term “Controlling Officer” is proposed to be replaced with “Controlling Authority”;

2. The Draft Amendment proposes to allow manufacturers to arrange testing services with a laboratory approved by the State Licensing Authority, as opposed to the Central Licensing Authority;

3. It is proposed that manufacturers shall maintain records of each batch of cosmetics they produce along with details of the raw materials used for a minimum period of either 6 months or 3 years from the batch’s expiration date (whichever is later), as opposed to the existing minimum retention requirement for period of three years after the date of expiry of the batch;

4. Soap manufacturers are proposed to be exempted from the obligation to maintain records and details of each batch of cosmetics produced, as well as the raw materials used. Further, requirment to conduct tests for each batch or lot of raw materials and final products is dispensed with. Additionally, it is proposed that soap manufacturers will be exempted from the requirement of maintaining records and registers displaying information regarding the tests conducted;

5. The labelling requirements for cosmetics intended for export are proposed to be simplified. It is proposed that such cosmetics may only fulfil the requirements of law of the destination country only. It aims to eliminate any additional labelling obligations specified in the Cosmetic Rules 2020, except for the requirement to display an approved code number by the State Licensing Authority in cases where the consignment does not need to be labelled with the manufacturer’s name and address.

Source: Ministry of Health and Family Welfare