New cosmetics in India are those with novel ingredients that haven’t been used anywhere in the world before and aren’t found anywhere in national or international literature. Differing from an ordinary cosmetic, a new cosmetic requires prior permission from the Central Licensing Authority (CLA). The applicant should get it before proceeding with the applicable import-registration or manufacturing-license process. They must also submit safety and effectiveness data for the product.
This guide explains the regulatory requirements, prior-permission process, documentation, and fees that apply to new cosmetics in India.
What Is Considered a “New Cosmetic” in India?
Under the Cosmetic Rules, 2020, a new cosmetic is defined as the following:
- 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.
Any ingredient if novel or lacking established data will make the product fall automatically under the “new cosmetic” category.
Working on a product with a novel ingredient? Explore Artixio’s cosmetics regulatory services in India for support with CDSCO requirements and market entry.
How Does CDSCO Regulate New Cosmetics in India?
India follows different pathways for domestic and imported cosmetics. However, for new cosmetics, both pathways require prior permission from the Central Licensing Authority.
Under Rule 32 of the Cosmetics Rules, 2020:
- An applicant that wants to import or manufacture a new cosmetic applies to the Central Licensing Authority in Form COS-12. They should have the requisite fee and safety/effectiveness data.
- If the Central Licensing Authority is satisfied that the cosmetic will be safe and effective, it may issue prior permission in Form COS-3.
- The applicant must then submit the COS-3 prior permission with the applicable application for import under Chapter III or manufacture under Chapter IV.
This means that Form COS-3 is not itself the import registration certificate or manufacturing license. It is the prior permission for the new cosmetic that must accompany the subsequent regulatory application.
Also Read: Cosmetics Registration in India for Importation
Prior Permission Process for Import or Manufacture of New Cosmetics
The following sequence can help get prior permission for import or manufacturing of new cosmetics:
Step 1: Determine Whether the Product Is a New Cosmetic
Review your product’s formulation against the legal definition of a new cosmetic. Check for novel ingredients as defined under the Cosmetics Rules, 2020.
Step 2: Keep Safety and Effectiveness Data Ready
The applicant must provide data on the safety and effectiveness of the cosmetic with the Form COS-12 application.
Step 3: Submit Form COS-12
Apply to the Central Licensing Authority in Form COS-12, together with the requisite fee and supporting information. CDSCO’s official checklist provides the documentation expected for this application.
Step 4: Obtain Prior Permission in Form COS-3
If the Central Licensing Authority is satisfied that the new cosmetic will be safe and effective for use in India, it may issue prior permission in Form COS-3. It is subject to the conditions specified in the permission.
Step 5: Apply for Import Registration or Manufacturing License
The COS-3 permission must then accompany the applicable application. Imported new cosmetics require import registration under Chapter III. New cosmetics manufactured in India will follow the manufacturing license under Chapter IV.
Documents for New Cosmetic Registration with CDSCO
CDSCO’s official Online Application Checklist for grant of permission for New Cosmetics in Form COS-12 specifies the information and documents to be submitted.
1. Covering Letter – Clearly state the purpose, include page numbers, and add an index.
2. Particulars of New Cosmetics:
- Name of the cosmetics
- Category of cosmetic/intended use
- Composition of product.
- Test Protocol/Test method of the raw materials and finished product.
- Specification of the raw materials and finished product along with Certificate of Analysis
3. Assessment of the safety for human health of the finished product, its ingredients, their chemical structure, and level of exposure.
4. Existing data on undesirable effects on human health resulting from use of the cosmetic product.
5. Supporting data for the claimed benefits of cosmetic products should be made available to justify the nature of their effect.
6. Specimen copy of the product label and carton, including package insert and promotional literature, etc.
7. Whether the preparation of the proposed cosmetic is approved and marketed in other major countries. If yes, details of the same
8. Any other data generated on safety, effectiveness, and quality parameters.
9. Other documents:
- Undertaking that the cosmetic products to be imported into the country have not been tested on animals as per the Cosmetics Rules, 2020.
- An 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.
- Any other (if any)
- Details of IEC and GSTIN of the firm (enclose copy of documents)
10. Fee Bharatkosh e-receipt and challan
11. Application (Form COS – 12)
Safety Evaluation Requirements for New Cosmetics
Safety evaluation is a central part of the new-cosmetic permission process. Rule 32 requires the applicant to submit data on safety and effectiveness.
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.
The COS-12 checklist further requires an assessment of the safety of the finished product & its ingredients, chemical structure, and level of exposure. Existing data concerning undesirable effects and other safety, effectiveness, and quality information should also be submitted where applicable.
CDSCO Fee for Permission of New Cosmetics
The Third Schedule of the Cosmetics Rules, 2020, specifies a fee of US$500 for grant of permission for new cosmetics. This is separate from the fees that may apply to the subsequent import registration or manufacturing licence.
For example, the Third Schedule separately specifies fees for import-registration certificates, manufacturing sites and cosmetic variants.
Also Read: CDSCO Registration of Multiple Product Variations of Cosmetics in India
Labelling & Claims for CDSCO New Cosmetics
The prior permission issued in Form COS-3 contains conditions concerning the product’s specifications, labelling, and claims. Under this form, the following applies:
- The cosmetic must conform to the specifications permitted by the Central Licensing Authority.
- The cosmetic name must appear clearly and indelibly.
- Any special instructions permitted by the authority must appear on the label.
- Claims other than those permitted cannot be made on the label without prior approval from the Central Licensing Authority.
More generally, the Cosmetics Rules prohibit the sale or distribution of cosmetics that do not comply with applicable labelling and packing requirements.
Import or Manufacture of New Cosmetics
The regulations for the import or manufacturing of new cosmetics in India are as follows:
For Imported New Cosmetics
For imported cosmetics, the Central Licensing Authority is responsible for the import-registration framework. Cosmetics imported into India must be registered before import, and the registration includes the pack size, variants and manufacturing premises.
For a new cosmetic, the applicant must first obtain the COS-3 prior permission under Rule 32. That permission is then submitted with the applicable import-registration application.
For New Cosmetics Manufactured in India
For domestic manufacture, the manufacturing licence is handled by the State Licensing Authority. However, when the product is a new cosmetic, Rule 23 requires the applicant to obtain prior permission in Form COS-3 from the Central Licensing Authority before the State Licensing Authority can grant the manufacturing licence.
The manufacturing application is made under Chapter IV, using Form COS-5 for a manufacturing licence or Form COS-6 for a loan licence, accompanied by the applicable documentation and fee.
Conclusion
India’s Cosmetics Rules, 2020, establish a specific prior-permission pathway for new cosmetics. An applicant intending to import or manufacture such a product must apply to the Central Licensing Authority in Form COS-12, with the required fee and safety/effectiveness data. If the authority is satisfied with the safety and effectiveness of the product, it may issue prior permission in Form COS-3. That permission must then accompany the applicable import-registration or manufacturing-licence application.
The current CDSCO checklist provides the supporting technical and safety information expected for the COS-12 submission, while the Cosmetics Rules specify the applicable testing, labelling and claim conditions.
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
FAQs
1. What is a new cosmetic under India’s Cosmetics Rules, 2020?
A new cosmetic is a cosmetic containing a novel ingredient that has not been used anywhere in the world or is not recognised for use in cosmetics in any national or international literature.
2. Is prior permission required for a new cosmetic in India?
Yes. An applicant intending to import or manufacture a new cosmetic must apply to the Central Licensing Authority in Form COS-12. If the authority is satisfied with the product’s safety and effectiveness, it may issue prior permission in Form COS-3.
3. Is COS-3 the final registration certificate for a new cosmetic?
No. COS-3 is the prior permission for the new cosmetic. The applicant must subsequently submit the COS-3 permission with the applicable import-registration application or manufacturing-licence application
4. What are the conditions after permission for a new cosmetic?
Once prior permission is granted in Form COS-3, the cosmetic must comply with the specifications and conditions permitted by the Central Licensing Authority.
The COS-3 form specifically requires:
- Compliance with the specifications permitted by the Central Licensing Authority;
- Clear and indelible display of the cosmetic’s name;
- Inclusion of permitted special instructions on the label; and
- Prior approval for claims beyond those permitted in the permission.
