BIS Standards for Hair Dye and Skin Creams in India

The Bureau of Indian Standards (BIS) plays a crucial role in ensuring the quality, safety, and effectiveness of cosmetic products in India. Among the wide range of cosmetic formulations, hair dyes and skin creams are among the most widely used – and therefore, highly regulated. This article explains the BIS standards for hair dye and skin creams in India, the requirements for compliance, and why adhering to these standards is essential for both manufacturers and consumers.

What are BIS Standards for Cosmetics in India?

The Bureau of Indian Standards (BIS) issues specific Indian Standards (IS) under the Drugs and Cosmetics Rules, 1945, to regulate cosmetic products’ quality, purity, and labeling.

These standards help ensure:

• Consumer safety, by limiting harmful chemicals.
• Product consistency, in terms of formulation and stability.
• Transparency, through mandatory labeling requirements.

All cosmetics, including hair dyes and skin creams, must comply with the respective BIS standards before being marketed or imported into India.

BIS Standards for Hair Dye in India

Hair dyes are cosmetic products used to color or tint hair, either permanently or temporarily. Since they involve chemical interaction with hair and scalp, BIS ensures they are safe and free from harmful substances.

• 1. Relevant BIS Standard:
• IS 8481:2021 – Hair Dye, Powder Type (Chemical Composition and Safety Requirements)
• IS 4707 (Part 1 & 2):2017 – Classification of Cosmetic Raw Materials and List of Raw Materials Generally Not Recognized as Safe

Key Provisions Under BIS Standards for Hair Dyes

Parameter	Requirement as per BIS (IS 8481:2021
Composition	Must be free from heavy metals like lead, arsenic, and mercury.
Colorants	Only approved colorants listed under IS 4707 (Part 2) can be used.
Safety Testing	Must pass skin sensitivity tests and toxicity assessments before marketing.
Labelling Requirements	Must display: product name, ingredients, directions for use, manufacturer/importer details, batch number, MRP, and warning for skin allergy test.
Prohibited Ingredient	Substances like paraphenylenediamine (PPD) are restricted to permissible limits (not exceeding 2% after dilution).
Packaging	Should be safe, tamper-proof, and must not react with the product.

BIS Standards for Skin Creams in India

Skin creams, such as moisturising creams, fairness creams, and anti-ageing creams, are applied directly to the skin, which makes their safety and purity highly critical.

1. Relevant BIS Standard:

• IS 6608:2020 – Skin Creams (Specification)
• IS 4707 (Part 1 & 2):2017 – Cosmetic Raw Material Classification and Safety List

Key Provisions Under BIS Standards for Skin Creams

Parameter	Requirement as per BIS (IS 6608:2020)
Microbial Limit	Must be between 4.5 to 8.5, suitable for normal skin balance.
pH Value	Should be free from harmful microorganisms such as E. coli and Pseudomonas aeruginosa.
Heavy Metals	Lead ≤ 20 ppm, Arsenic ≤ 2 ppm, Mercury ≤ 1 ppm.
Ingredient Approval	Only substances approved under IS 4707 (Part 2) should be used.
Performance Test	The cream should provide the intended function (moisturizing, fairness, etc.) without irritation.
Labeling	Must include product name, manufacturer/importer details, ingredients, batch number, expiry date, and direction for use.
Preservatives and Fragrance	Should comply with limits prescribed under BIS guidelines.

Important Points for Manufacturers:

• Each batch of cream must undergo microbial and stability testing.
• The ingredient list must match the INCI (International Nomenclature of Cosmetic Ingredients) name system.
• All imported creams must also meet these BIS standards before sale or marketing in India.

Why BIS Compliance is Important for Hair Dyes and Skin Creams?

Complying with BIS standards ensures both legal safety and consumer trust. Non-compliance can lead to product bans, recalls, or penalties under the Drugs and Cosmetics Act.

Benefits of BIS Compliance	Description
Consumer Safety	Prevents use of harmful or banned chemicals.
Quality Assurance	Ensures consistent performance and product stability.
Legal Protection	Avoids penalties and suspension under the Drugs and Cosmetics Act.
Market Access	Enables product sale in India’s regulated cosmetic market.
Brand Reputation	Builds trust among consumers and regulators.

Testing and Certification Requirements

Before sale or import, cosmetic products must be:

• Tested in BIS-recognized laboratories.
• Certified for safety and compliance with the relevant Indian Standards.
• Registered with CDSCO, as per the Cosmetic Rules, 2020.

Testing parameters include:

• Heavy metal detection
• Microbial contamination
• pH and viscosity testing
• Safety and irritation studies

Difference Between BIS and CDSCO Role in Cosmetics

Aspect	BIS	CDSCO
Purpose	Defines product standards and safety specifications.	Regulates cosmetic registration and import approval.
Function	Sets Indian Standards for quality, purity, and labeling.	Ensures compliance before marketing or import.
Example Standard	IS 8481 (Hair Dye), IS 6608 (Skin Cream).	Cosmetic Registration under Form COS-3.
Outcome	Ensures product meets Indian standards.	Grants legal permission to market/import.

Conclusion

The BIS standards for hair dye and skin creams in India act as a strong foundation for ensuring safe, high-quality, and trustworthy cosmetic products in the Indian market.

By adhering to standards such as IS 8481 (for hair dyes) and IS 6608 (for skin creams), companies demonstrate their commitment to consumer health and regulatory compliance.

Whether domestic or imported, no cosmetic product can legally enter the Indian market without meeting BIS specifications and obtaining CDSCO approval.

How ELT Corporate Can Help?

ELT Corporate is the best regulatory consultancy in India for cosmetics and personal care compliance. We assist cosmetic brands with:

• BIS certification and testing support for all product categories.
• CDSCO cosmetic registration (Form COS-1/COS-3).
• Technical documentation and ingredient assessment.
• Lab coordination and safety report preparation.
• End-to-end compliance management for both domestic and imported cosmetics.
• Renewal and product modification filings.
• Regulatory advisory and training for cosmetic manufacturers and importers.

With our expertise, brands can ensure 100% regulatory compliance with BIS and CDSCO – avoiding penalties, delays, and rejections.