On December 15, 2020, Ministry of Health and Family Welfare, Government of India, notified the Cosmetic Rules 2020 with an objective to update the rules related to import, distribution, manufacturing, labelling and sale of cosmetics in India that were earlier set under the Drugs and Cosmetics Rules 1945.

 

For the benefit of the manufacturers, importers and distributors of the cosmetic products, the Cosmetic Rules 2020 requires that all the licenses granted under the Drugs and Cosmetic Rules 1945 prior to commencement of Cosmetics Rules 2020 to remain valid until the date of license expiry or for a period of 18 months from the date of notification of Cosmetics Rules 2020.

 

Introduction of ‘New Cosmetic’

A ‘new cosmetic’ is defined for the first time in the Cosmetic Rules 2020 where a new cosmetic means ‘a cosmetic that contains a novel ingredient that has not been used anywhere in the world or is not recognized for use in cosmetics in any national or international literature’. The new rule requires manufacturers and/or importers to seek approval from Central Licensing Authority before such product is imported or manufactured in India by providing requisite safety and efficacy data related to such products. The manufacturers must comply with ISO 4011:2018 standards for testing the safety of such products.

 

New Forms under the Cosmetic Rules 2020

Form COS-1Application for New RegistrationForm 42
Form COS-2Import registration certificate

valid for 5 years

Form 43

Validity 3 years

Form COS-12Application for import or manufacturing of New Cosmetic 
Form COS-4Application for importing cosmetics from manufacturer who already has Registration Certificate for said products 
Form COS-4ARegistration Certificate for importing cosmetics from manufacturer who already has Registration Certificate for said products, valid for 3 years 

 

Documents Required Under Cosmetic Rules 2020

  • Letter of Authorization from the Manufacturer of cosmetic
  • Part 1 of Second Schedule
  • List of Ingredients in Cosmetic
  • Product Label
  • Certificate of Analysis of Product Specification
  • Free Sales Certificate
  • Manufacturing License or Marketing Authorization from National Regulatory Agency or Free Sale Certificate

In addition, following documents can also be requested:

  • List of countries where market authorization or import permission was granted
  • Heavy metals and hexachlorophene content undertaking issued from manufacturer
  • Undertaking regarding fragrance with IFRA certificate or declaration for no allergens

 

Applicable Registration Fee

ParticularFee
Registration Certificate Grant or Renewal (per cosmetic category)$1000
Registration Certificate Grant or Renewal (per variant of cosmetic)$50
Grant of permission for New Cosmetic$500
Renewal of Registration CertificateSame as New Certificate. 2% retention fee every month to be paid within 180 days.

 

How the Cosmetic Rule 2020 is Different?

OLD COSMETIC RULESNEW COSMETIC RULES
Particulars of manufacturer and details of cosmetics to be imported filled in Schedule D(III)Particulars of manufacturer and details of cosmetics to be imported filled in Second Schedule Part-I
No Fee for Manufacturing Site$500 Fee for Each Manufacturing Site
Concept of new cosmetics was not providedNew Cosmetics Definition Included
Schedule S included Standards for 28 CosmeticsNinth Schedule  includes Standards for 37 Cosmetics

 

The New Rule Prohibits the Following:

  • Manufacture, sale and distrubition of cosmetics prohibited in country of origin
  • The ‘use before or use by date’ is less than 6 months from the date of import
  • Cosmetics containing hexachlorophene
  • Cosmetics that have been tested on animals after November 12, 2014

 

Summary:

It is recommended that importers and manufacturers of cosmetics in India get their existing licenses reviewed or review their planned applications in India for new registrations/renewals to ensure business continuity as well as plan their launch strategy. Lack of any documents or information may impact the supply chain and this the ROI for cosmetic manufacturers and importers.

 

About Artixio:

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