What Should Brands Know About CDSCO Compliance for Foundation Makeup?

There has been growth in the foundation makeup market beyond the traditional beauty product market. With varying consumer preferences, different types of foundation products such as lightweight skin tints, full-coverage foundations, serum-based foundations, and long-wear foundations have been introduced.

Bringing foundation products to the Indian market goes beyond creating the right shades, textures, and packages. It includes consideration of the appropriate safety, quality, and regulatory requirements for cosmetic products, as well as the requirements for the manufacture of cosmetics.

While doing business in India, brand owners need to understand CDSCO certification for foundation to be able to manufacture, import, or market foundations in India. Regulatory compliance for cosmetics is required to ensure that cosmetic products are of the prescribed standard and to legally introduce them in the Indian market.

Is CDSCO certification the same for all foundations? What kind of documents should brands prepare? Is the process the same for Indian and foreign brands? Knowledge about the Indian Cosmetic Regulatory Framework, registrations, documents, procedures, time taken, and other important aspects of the CDSCO Certification is required.

Why is CDSCO Compliance Important for Foundation Makeup?

Foundation is a cosmetic product applied on the face to even out skin tone and conceal imperfections. According to Section 3(aaa) of the Drugs and Cosmetics Act, 1940, products that are intended to alter or change appearance or add to one’s attractiveness or beauty fall under the definition of cosmetics.

Therefore, foundation makeup is under the purview of the Indian cosmetic regulatory framework.

Cosmetics are regulated differently depending on whether they are imported or produced locally in India. Import of cosmetics is regulated by the Central Drugs Standard Control Organisation (CDSCO), while manufacture of cosmetics is regulated by the concerned State Drugs Standard Control Organisation (SDSCO) in the state where the cosmetics are manufactured.

Before foundation products can be launched in the Indian market, the brand needs to identify the correct route for regulation in India.

Essential Compliance Requirements for Foundation Brands

Before a brand applies for CDSCO Certification, the following requirements need to be determined.

• Product formulation
• Product safety
• Manufacturing compliance
• Shade and variant identification
• Labelling and packaging
• Product claims

How Can Brands Get CDSCO Registration for Foundation Makeup?

The regulatory process for Foundation makeup differs based on whether it is manufactured in India or imported from a different country.

Step 1: Register on the CDSCO SUGAM Portal

The applicant has to first register on the CDSCO SUGAM portal by entering details of the applicant, Indian Authorised Agent, foreign manufacturer, and the manufacturing premises. It is important to provide correct information to identify the parties involved in the import registration process.

Step 2: Create and File the Application

After registration, the applicant has to create and file the import registration application as per the Cosmetics Rules, 2020. The application should include the categories of products, intended use, details of formulations, brand name, various types and pack sizes of the foundation makeup products.

Step 3: Upload the Required Supporting Documents

The applicant has to upload the required technical and regulatory documents in support of the application. The documents may include product formulation, test reports, labels, manufacturer’s authorization, Free Sale Certificate, manufacturing license, and other supporting documents.

Step 4: Pay the Applicable Government Fees

The registration fees charged by the government must be paid as per the Third Schedule of the Cosmetics Rules, 2020. Apart from the prescribed fees, additional costs may be incurred due to testing, document authentication, or professional consultancy services, based on the product and applicant requirements.

Step 5: CDSCO Application Review

CDSCO reviews the applications and the information provided regarding product formulation and manufacture, supporting documents, and proposed product labeling. 

During review, if CDSCO identifies any discrepancies or is not able to conclude/validate the information provided by the applicant, it will raise queries. It is the applicant’s responsibility to provide clarification/additional information for CDSCO to conclude its review.

Step 6: Import Registration

After successful review of the application, the Central Licensing Authority issues the Cosmetic Import Registration Certificate in Form COS-2. This certificate allows the foundation make-up products to be imported into India, subject to the requirements of the Cosmetics Act, 1940 and Rules.

Documents Required for Foundation Make-up Compliance

Based on the type of regulatory route taken by the brand, certain documents may be required as part of the CDSCO certification for foundation make-up products, such as:

• Proof of Identity
• Rental Agreement for the business
• Building Plan
• ISO 13485 Certificate (with previous audit report)
• Technical manpower for manufacturing and testing
• Device Master File
• Testing License, if any
• Environmental Compliance
• Analysis reports of 3 consecutive batches
• Translation of documents into English, if done in any other language
• Other documents, if any

Costing Of CDSCO Certification For Foundation

The cost of CDSCO certification for foundation depends on the number of categories, product variations (i.e., different foundation shades), and manufacturing sites in the application.

The prescribed import registration fees as per the Third Schedule of the Cosmetics Rules, 2020, are as follows:

The above fees are only for the prescribed government registration fees. There could be additional costs for product testing, document attestation, translation, and professional fees based on the application requirements. Read more about CDSCO Cosmetic Registration 

Timeline For CDSCO Registration For Foundation Makeup

The time taken for CDSCO certification in India depends on the registration route, completeness of the application, and other regulatory requirements.

• Imported cosmetics: As per Rule 13 of the Cosmetics Rules, 2020, CDSCO is required to either grant or reject the import registration within a period of 6 months. However, according to CDSCO’s published FAQs, the target time for processing a complete application is 90 days.
• Manufacturing cosmetics: As per Rule 23, the State Licensing Authority is required to dispose of the application for a cosmetic manufacturing license within a period of 45 days from the date of its receipt.

That said, the actual time for processing an application varies based on product classification, documentation, testing, regulatory queries, and inspection of the manufacturing facility, if required.

It is advisable for brands to initiate their regulatory compliance process well in advance of their desired launch date.

Challenges Commonly Faced with Foundation Brands

Even established beauty brands can face regulatory challenges during product registration and market entry.

Some challenges include:

• Wrong product classification
• Inadequate formulation information
• Multiple Shade Variants
• Labeling discrepancies
• Foreign manufacturer documents
• Unsubstantiated claims

Addressing the above-mentioned issues can help brands avoid unnecessary delays.

How UMSPCS Helps Brands with CDSCO Compliance

In order to launch Foundation Makeup in India, it is essential to understand the country-specific requirements of regulatory frameworks. The UMSPCS team helps clients understand and fulfill requirements for cosmetic products, Foundation Makeup, and other cosmetics.

Being a compliance service provider with 6+ years of experience in 600+ product compliance requirements spanning multiple industries, UMSPCS has the necessary expertise to offer structured regulatory services to manufacturers and importers of beauty products.

Our services include:

• Understanding the requirements related to cosmetic products.
• Classification of cosmetic products.
• Assessment of compliance of cosmetic products.
• Drafting applications for CDSCO.
• Document Management.
• SUGAM Portals.
• Regulatory Queries.
• Labelling and Packaging requirements.

Conclusion

Foundation Makeup is a commonly available beauty product. However, understanding the Indian Cosmetic regulatory framework and navigating through the requirements pertaining to formulations, manufacturing, and import of beauty products can be challenging.

Prior understanding of CDSCO requirements can help beauty brands address documentation and compliance gaps.

Planning to launch foundation makeup in India?

UMSPCS can assist you with regulatory service support and end-to-end compliance.

Read more also: How Does BIS ISI Certification Shape the Future of Footwear

FAQs

1. Is CDSCO certification mandatory for foundation makeup in India?

Registration of imported foundation makeup is required under the Cosmetics Rules, 2020. Indian manufacturers require the applicable manufacturing license from their respective state licensing authority.

2. Who is the regulating authority for foundation makeup in India?

While cosmetic import is regulated by the Central Licensing Authority, CDSCO, domestic cosmetic manufacturing is regulated by State Licensing Authorities.

3. Are different shades of a foundation required to have a separate registration?

It depends on the product category and the details of the manufacturing process.

4. Can a foreign foundation brand sell its products in India without registration?

No,  Import of cosmetics is allowed only if registration is done prior to import, as per the specific exemptions provided in the rules.

5. Are product testing and disclosing the ingredient details required for foundation registration?

It depends on the product and the type of assessment. The brand needs to retain product specifications and safety information.