New cosmetics in India are those with ingredients that haven’t been recognized or used before. To sell them, manufacturers must share information about the product and its safety with the authorities. Only after this review can the product be launched.
In this blog, we will discuss about the regulations and registration process of cosmetic products in India and how businesses can ensure compliance while fostering innovation.
What Is Considered a “New Cosmetic” in India?
Under the Cosmetic Rules, 2020, a new cosmetic is defined as:
- A product containing an ingredient that has never been used anywhere in the world, or
- An ingredient that is not recognized for cosmetic use in any national or international standard or scientific literature.
- In simple terms, if an ingredient is novel or lacks established safety data, the product automatically falls under the “new cosmetic” category.
Working on a product with a novel ingredient? We help brands prepare the right documents and submit new-cosmetic applications in India without unnecessary delays.
How CDSCO Regulates New Cosmetics in India?
India follows different pathways for domestic and imported cosmetics, but when it comes to new cosmetics, the approval process is the same for both. The Indian Authorized Agent or the domestic manufacturer must obtain prior permission from CDSCO before proceeding with the application for either an Import Registration Certificate or a Manufacturing License.
Before applying for an Import Registration Certificate, or a Manufacturing License, the applicant (Indian Authorized Agent or manufacturer) must obtain prior approval from the Central Licensing Authority (CLA).
- For regular cosmetics made in India, licenses are issued by the State Licensing Authority.
- For new cosmetics, approval is granted only at the Central level.
- No State Licensing Authority can issue a manufacturing license without this prior CLA permission.
Relevant Forms
- Form COS-3 – Required before applying for a manufacturing license for a new cosmetic.
- Form COS-12 – Application submitted to obtain permission for a new cosmetic.
- Form COS-03 – Permission granted by the CLA after reviewing safety and quality data.
Also Read: Cosmetics Registration in India for Importation
Documents to be submitted for New Cosmetic Registration with CDSCO –
Checklist for grant of permission for New Cosmetics in Form COS-12 under the provisions of Cosmetics Rules 2020
- Covering Letter – Clearly state the purpose, include page numbers, and add an index.
- Particulars of New Cosmetics:
o Name of the cosmetics
o Category of cosmetic/intended use
o Composition of product.
o Test Protocol/Test method of the raw materials and finished product.
o Specification of the raw materials and finished product along with Certificate of Analysis.
- Assessment of the safety for human health of the finished product, its ingredients, their chemical structure and level of exposure.
- Existing data on undesirable effects on human health resulting from use of the cosmetic product.
- Supporting data for the claimed benefits of cosmetic product should be made available to justify the nature of its effect.
- Specimen copy of the product label and carton.
o Package insert and Promotional literature etc.
- Whether the preparation of the proposed cosmetic is approved and marketed in other major countries if yes details of the same
- Any other data generated on safety, effectiveness and quality parameters.
- Other documents
o Undertaking that the cosmetic products to be imported in to the country have not been tested on animals as per the Cosmetics Rules, 2020.
o Undertaking from the manufacturer stating compliance of all raw materials or pigments used, heavy metals and hexachlorophene contents in products with Bureau of Indian Standards and the Cosmetics Rules, 2020.
o Any other (if any)
o Details of IEC and GSTIN of the firm (enclose copy of documents)
- Fee Bharatkosh e-receipt and challan 11. Application (Form COS – 12)
The manufacturer is required to adhere to the methods of test or analysis specified in IS 4011:2018, titled “Methods of Test for Safety Evaluation of Cosmetics,” published by the Bureau of Indian Standards. These methods should be followed as amended from time to time to ensure the safety evaluation of new cosmetics.
CDSCO Fee for Permission of New Cosmetics
CDSCO Fees for obtaining Permission for New Cosmetic Registration with CDSCO
CDSCO Fee for grant of permission for new cosmetics – $500
- This fee applies whether the product is intended for import or domestic manufacture.
- Conditions for Granting Permission
- Once CDSCO approves a new cosmetic, the product must:
- Conform to the specifications submitted and approved
- Display the product name clearly in indelible ink
- Include any mandatory special instructions on the label
- Avoid adding new claims without obtaining prior approval from CLA
Any special instructions permitted must be included on the cosmetic product label, and claims beyond those permitted require prior approval from the Central Licensing Authority.
When applying for import (Chapter III) or manufacturing license (Chapter IV), applicants must submit a copy of Form COS-3 as mandatory prior permission.
Also Read: CDSCO Registration of Multiple Product Variations of Cosmetics in India
As India’s cosmetics market continues to flourish, navigating the regulatory landscape is paramount for manufacturers seeking to introduce new products. By understanding and adhering to regulatory requirements, businesses can ensure product safety, build consumer trust, and unlock growth opportunities in this dynamic industry.
If you’re unsure whether your formulation qualifies as a new cosmetic, feel free to share the details.
We can take a look and guide you on the next steps with CDSCO. Contact us at info@artixio.com