In India, the majority of cosmetic registrations comprise more than one shade, fragrance, flavour, or pack size. The difficulty lies in deciding which are acceptable variations by the CDSCO and then properly specifying them during registration.
As per Cosmetics Rules, 2020, imported cosmetics and their variants, pack size and manufacturing locations should be registered prior to entering into the country into India. One of the most frequent causes of the queries and registration delays on the part of CDSCO is variant classification errors or discrepancies in documentation.
In this blog, read about how to register multiple cosmetics variations in India and everything about their registration process and regulations.
CDSCO Regulations for Cosmetic Variants in India
CDSCO has the regulatory authority for the importation of cosmetics as regulated under the Drugs and Cosmetics Act, 1940, and Cosmetics Rules, 2020. All cosmetics and variants of cosmetics, pack sizes, are obligatory to register with the government of India prior to import.
The application for registration shall be in accordance with the product composition, label information, free sale certificate, manufacturing site details, and authorisation documents submitted to CDSCO. Any mismatch will lead to deficiencies as a result of the review.
What are Cosmetic Product Variations under CDSCO?
CDSCO considers cosmetic variants to be the following differences in products:
- Shade variations in cosmetics: for example, touch and tone variation among nail polish shades, among lipsticks, among foundations, among blush colours.
- Fragrance Variations in Cosmetics: Different fragrances available in the same fragrance line.
- Flavour Variations in Cosmetics: e.g., different flavours of lip care cosmetics.
- Pack Size Variations in Cosmetics: When pack sizes vary, they must be declared and won’t be considered variants.
- Product Variants with Same Base Formula: Similar products’ formula, but different colour, shade, perfume, flavour, or other variations.
Form COS-1 to declare pack sizes, variants, and manufacturing sites shall be accompanied by appropriate labels, Free Sale Certificates, and authorisation documents.
When Can Multiple Cosmetic Variants be Registered Under One Application?
Where multiple shades, colours, fragrance(s), or flavour (s) of the same product are submitted in a single application and accompanied by the necessary product variant documentation for registration, then they may be listed together under a single product registration.
All variants should be listed in the following manner across:
- Form COS-1
- Authorization from Manufacturer
- Free Sale Certificate
- Product Labels
- Second Schedule Documentation
Additional variation charges are pursuant to the order of individual declared variations. Site Fees apply to multiple manufacturing locations.
CDSCO Registration Process for Multiple Cosmetic Variants in India
Applications are submitted online through the CDSCO SUGAM portal in Form COS-1.
The process typically includes:
- Identifying the cosmetic category.
- Listing all variants, pack sizes, and manufacturing sites.
- Preparing supporting documents.
- Submit the application and fees.
- Responding to CDSCO queries, if any.
- Obtaining Form COS-2 after approval.
For products with multiple shades or variants, consistency across Form COS-1, labels, authorisation documents, and Free Sale Certificates is critical.
Documents Required for Cosmetic Variant Registration in India
CDSCO generally requires:
- Form COS-1
- Authorization from Manufacturer
- Part I of the Second Schedule
- Free Sale Certificate covering all variants
- Product labels and pack inserts
- Ingredient composition
- Key product requirements and lab testing procedures
- A manufacturing licence or regulatory approval from the country of origin
- Non-animal testing declaration
- Heavy metal and hexachlorophene compliance declaration
- Bharatkosh fee receipt
The details for the variant name, pack sizes, and manufacturing site should be consistent throughout all records submitted.
CDSCO Guidelines for Shade, Fragrance & Pack Size Variants
Before import into India, cosmetic products must be registered along with their declared variants and pack sizes.
Key CDSCO requirements include:
- Different shades, colours, fragrances, and flavours are treated as variants.
- Separate variant fees apply for each variant.
- Different pack sizes are not treated as variants but must still be declared.
- Changes in variants, pack sizes, manufacturing sites, labels, or documentation must be reported to CDSCO.
Pack size and variant details should remain consistent across Form COS-1, labels, authorisation documents, and Free Sale Certificates.
Labelling Requirements for Multiple Cosmetic Variants in India
Labels should match the details submitted during registration and generally include:
- Product name
- Variant name (where applicable)
- Manufacturer name and address
- Country of origin
- Batch/Lot number
- Expiry or use-before date
- Net content
- Registration Certificate Number (RC No.)
- Importer name and address
- Ingredient declaration (where applicable)
- Warnings or directions for use (if required)
For imported cosmetics, India-specific details such as importer information and RC number may be added at bonded warehouses before release into the market.
Timeline for CDSCO Cosmetic Variant Registration
CDSCO’s targeted internal timeline for cosmetic registration is 90 working days.
However, timelines often depend on:
- Number of variants
- Number of manufacturing sites
- Completeness of documents
- CDSCO deficiency queries
If CDSCO raises queries, the review timeline is calculated from the date the response is submitted.
Cost of Registering Multiple Cosmetic Variants in India
For CDSCO registration for cosmetic variants in India, the applicable fees depend on whether the products are being imported into India or manufactured domestically.
| Registration Activity | Government Fee |
| Import Registration Certificate – Each Cosmetic Category | USD 1,000 |
| Additional Cosmetic Category (Import Registration) | USD 1,000 |
| Each Cosmetic Variant (Import Registration) | USD 50 |
| Each Manufacturing Site (Import Registration) | USD 500 |
| Permission for New Cosmetic | USD 500 |
| Manufacturing Licence (Form COS-8) – Up to 10 items in one category | INR 10,000 |
| Additional Item under Form COS-8 | INR 500 per item |
| Additional Cosmetic Category under Form COS-8 | INR 10,000 |
| Loan Licence (Form COS-9) – Up to 10 items in one category | INR 10,000 |
| Additional Item under Form COS-9 | INR 500 per item |
For import registration, shades, colours, fragrances, and flavours are treated as variants and attract a USD 50 fee per variant. Different pack sizes do not attract variant fees but must still be declared in the registration application and Registration Certificate.
Conclusion
The management of multiple cosmetic variants is, for the most part, basic documentation. The major problem associated with registering is caused by the mismatch of variant names, pack size, manufacturing site, label, and Free Sale Certificate through the Application.
Coordinating cosmetic variant registration with regulatory professionals, such as Artixio, will help ease the approval process and make it more efficient for manufacturers and importers. For help with cosmetics import registration, addition of variants, or regulatory registration in India, reach out to Artixio at info@artixio.com.
FAQs
1.Do cosmetic sizes vary for consideration under CDSCO?
No, different pack sizes are not counted as variants. However, they need to be declared as separate instances of the application and Registration Certificate during the registration process.
2. Should there be a separate Free Sale Certificate for all cosmetic variations?
Yes. The Free Sale Certificates for all the declared variants have to be submitted to CDSCO.
3. During registration, how are cosmetic shades treated?
Each unique colour or shade will be considered as a variant and have its own variant fee.
4. When do cosmetics need to be registered by CDSCO?
The processing time for CDSCO is 90 working days. Real timelines for approval, having to do with documents and query resolution.
