In India, cosmetic registration of face wash and cleaners is a compliance process under the Drugs and Cosmetics Act of 1940. Any organization that wants to manufacture, import, or sell face creams must get approval from the CDSCO. It includes ingredient validation, quality checks, and labeling compliance with legal requirements.
Learning about the cosmetic/skincare certification procedure for face cream is mandatory to enter the Indian market. In this article, you will learn about Cosmetic Registration for Face washes and Cleansers, including compliance factors, the registration process, and document requirements.
Why Is Cosmetic Registration Important for Face Washes and Cleansers?
Certification for cosmetics such as face wash and cleansers is a crucial step as it ensures consumer safety, product quality, and regulatory compliance for cosmetics. It is regulated by the Drugs and Cosmetics Act of 1940 and the Rules of 2020 to prevent substandard products from being marketed. Below is the detailed information about why cosmetic registration for Face Washes and Cleansers is essential:
1. Ensures Consumer Safety
Registering cosmetics, including face wash and cleansers, is necessary as it ensures consumer safety from contaminated products. Unregistered cosmetic items may contain harmful chemicals that can lead to skin irritation, infections, or long-term health complications.
Registration involves safety testing and compliance with Bureau of Indian Standards (BIS) standards, making face washes and cleansers safe for daily use.
2. Prevents Sale of Below-Standard or Toxic Products
Cosmetic registration for face washes and cleansers ensures that quality and tested products are put on the market only. Products must pass Good Manufacturing Practices (GMP), stability testing, and heavy metal and microbiological safety levels before approval. This prevents fake, misbranded, or toxic cosmetics from being sold.
3. Creates Brand Trust and Consumer Confidence
Registered cosmetics have formal approval from the Central Drugs Standard Control Organization (CDSCO). It provides the consumer with the assurance that the product has standard quality and is safe. This enhances brand image, increases consumer confidence, and allows brands to compete in the market.
4. Compulsory for Legal Compliance and Market Entry
The Indian cosmetics market is strictly regulated, and cleansers and face washes cannot be retailed unless they are properly registered. Violation of CDSCO regulations may result in:
- Product recalls
- Legal penalties and fines
- Prohibition on manufacturing or import business
For Indian manufacturers and global brands, registration is necessary to enter and trade in the Indian cosmetics market legally.
5. Facilitates Export and International Trade
For Indian exporters of face washes and cleansers, CDSCO registration is usually necessary to comply with international regulatory requirements. Most nations accept India’s cosmetic regulatory system, so registered products can be exported and accepted internationally with ease.
6. Harmonizes Labeling and Ingredient Disclosure
Cosmetics registration for face washes and cleansers are subject to strict labeling rules under the Legal Metrology (Packaged Commodities) Rules, 2011, including:
- Ingredient declaration in INCI format
- Manufacturing and expiry dates
- Batch number and net content
- Details of manufacturer/importer
- Warnings for sensitive skin or allergens use
This provides ingredient openness, so customers can make the right choice and steer clear of possible skin reactions.
Licensing and Registration Requirements for Face Washes and Cleansers
To manufacture, sell, or import face washes and cleansers, businesses must secure the following approvals:
Manufacturing and Product Registration
- Cosmetic Manufacturing License (Form COS-8): For manufacturing face washes in India, granted by the State Licensing Authority under the Cosmetic Rules 2020.
- Cosmetic Product Registration (Form COS-2): Required for making a new face wash available in the market, issued by the Central Drugs Standard Control Organization (CDSCO) upon submission of product formulation and safety test information.
Import Registration for Cleansers and Face Washes
- If they are importing face washes, companies need to procure an Import Registration Certificate from CDSCO under the Drugs and Cosmetics Act.
Key Compliance Factors for Face Wash and Cleanser Registration
Facial wash and cleanser cosmetic registration in India requires fulfillment of regulatory requirements under the Drugs and Cosmetics Act of 1940. The regulatory approval process is governed by the CDSCO so that products sold in the market are safe and lawful. The below are the primary compliance factors for which manufacturers and importers are required to adhere to:
1. Regulatory Approval from CDSCO
Before launching a face wash or cleanser in India, businesses must obtain a:
- Registration Certificate (Form COS-1) for imported cosmetics.
- Manufacturing License (Form COS-8) for domestically produced cosmetics.
These approvals ensure that the product complies with Indian cosmetic regulations and is safe for consumer use.
2. Compliance with Ingredient Safety Standards
All cleansers and face washes should have allowable ingredients according to:
- Bureau of Indian Standards (BIS) specifications (IS 4707: Part 2).
- The Indian Standard for Cleansing Products for the Skin (IS 11601:1986).
- Schedule S of the Drugs and Cosmetics Rules, 1945, contains a list of permitted and restricted ingredients.
Limited ingredients like sulfates, parabens, and synthetic fragrances are required to meet set limits in order to avoid skin irritation or allergic reactions.
3. Stability and Safety Testing
To ensure product efficacy and shelf-life, face washes and cleansers must undergo:
- Stability testing to confirm that the formulation remains safe and effective under different storage conditions.
- Microbiological testing to check for harmful bacteria, yeast, or mold.
- Heavy metal testing (lead, mercury, arsenic, and cadmium) to ensure levels remain within permissible limits.
Products that fail these tests cannot be registered or sold in India.
4. Good Manufacturing Practices (GMP) Compliance
All manufacturers must follow Good Manufacturing Practices (GMP) as per Schedule M-II of the Drugs and Cosmetics Rules. This includes:
- Hygienic production environments to avoid contamination.
- Proper documentation of raw materials and batch production.
- Quality control throughout the manufacturing process.
For imported cosmetics, manufacturers must provide a Good Manufacturing Certificate (GMP) from their country of origin.
5. Labeling and Packaging Compliance
Face washes and cleansers must meet Legal Metrology (Packaged Commodities) Rules, 2011, and BIS standards for cosmetic labeling. Mandatory labeling elements include:
- Product name and intended use.
- Complete ingredient list (INCI format).
- Manufacturing date and expiry date.
- Batch number and net quantity.
- Storage instructions.
- Warnings (e.g., for sensitive skin or allergens).
- Name and address of the manufacturer/importer.
- Registration number issued by CDSCO.
- โFor external use onlyโ warning.
Non-compliance with cosmetic labeling standards can lead to product rejection or penalties.
6. Free Sale Certificate for Imported Products
Foreign manufacturers must submit a Free Sale Certificate (FSC) from the regulatory authority. This certifies that the face wash or cleanser is legally sold in the country of origin and meets international safety standards.
7. Testing and Certification Requirementsโน
All face washes and cleansers must be tested in CDSCO-approved laboratories for:
- pH balance to ensure skin compatibility.
- Irritancy and dermatological safety tests.
- Absence of prohibited substances (e.g., steroids, hydroquinone, or harmful preservatives).
Test reports must be submitted along with the face wash registration application to prove product safety and compliance.
8. Import Regulations and Market Authorization
For imported face washes and cleansers, companies must:
- Appoint an Authorized Indian Representative (AIR) to manage registration and compliance.
- Ensure that import packaging and labeling meet Indian standards before sale.
- Submit a Notarized Power of Attorney (PoA) authorizing the Indian entity to act on behalf of the foreign manufacturer.
Failure to comply with import regulations can lead to shipment rejections or legal penalties
9. Compliance with Ethical and Advertising Guidelines
Face wash and cleanser brands must adhere to:
- Schedule J of the Drugs and Cosmetics Rules, prohibits misleading claims.
- The Advertising Standards Council of India (ASCI) guidelines, ensure that product claims are scientifically backed and not deceptive.
Misleading advertisements can result in legal action, product recalls, and brand reputation damage.
10. Renewal and Post-Market Surveillance
Cosmetic registrations are valid for five years, after which they must be renewed with updated safety and compliance reports.
Moreover, post-market surveillance ensures that registered face washes and cleansers continue to meet safety standards. Any adverse reactions or consumer complaints must be reported to CDSCO.
Process for Cosmetic Registration For Facewashes And Cleansers in India
There are a few steps involved in the process of face wash registration, such as:
- Create an account on the SUGAM Portal, the official CDSCO website.
- Fill out the application form COS-2 for product registration.
- Upload required documents, including ingredient lists and safety test reports.
- Apply and pay the applicable fees as per the product category.
- Await CDSCO review and approval before marketing the product.
- Once approved, the product can be legally sold in India.
Documents Required for Face Wash and Cleanser Registration
To obtain cosmetic registration for face washes and cleansers, the following documents required for cosmetic certification must be submitted:
- Application Form (COS-2): Completed with accurate product details.
- Cover Letter: Explanation of the product and its compliance.
- Free Sale Certificate: Required for imported products.
- Ingredient List: Including percentage compositions of each ingredient.
- Good Manufacturing Practice (GMP) Certificate: Proof of adherence to quality standards.
- Safety Test Reports: Clinical test results demonstrating product safety.
- Power of Attorney: If an authorized agent is applying on behalf of the manufacturer.
How Can ELT Corporate Pvt. Ltd. Help You With Face Washes And Cleansers Registration?
Navigating cosmetic registration for face washes and cleansers can be complex. ELT Corporate Pvt. Ltd. simplifies the process and ensures full compliance with Indian regulations.
Our services include:
- Assistance with product licensing and registration
- Guidance on BIS compliance and safety testing
- Support for import registration and documentation
For expert assistance, contact ELT Corporate Pvt. Ltd. today. +91 85859 19582
Do Face Washes And Cleansers Need FDA Approval In India?
No, In India, cosmetics fall under the regulation of CDSCO, not the FDA. However, adherence to the Drugs and Cosmetics Act is compulsory.
Is It Legal To Sell Face Wash Without Registration?
No, selling an unregistered cosmetic in India is against the law and may lead to fines or recalls.
What Are The BIS Standards For Face Washes?
BIS standards for face washes ensure safety, quality, and proper labeling under IS 4707-1:2005, covering ingredients, preservatives, and microbial safety.
How Long Does It Take To Register Cosmetics In India?
The registration process generally takes three to six months, depending on regulatory approvals and the complexity of the product.
Can Imported Face Washes Be Marketed In India?
Yes, but a cosmetic import registration certificate from CDSCO is required before marketing the product in India.