India’s Cosmetic Ingredient Regulations

India's cosmetic and personal care market has expanded rapidly in recent years, driven by a large consumer base, rising disposable incomes, and growing awareness of personal grooming. In parallel with this growth, the country's regulatory framework has evolved into a more comprehensive and internationally aligned system. As ingredient compliance affects every stage of a cosmetic product's lifecycle—from formulation design to import registration and market surveillance—a sound understanding of India's ingredient regulations is therefore essential for minimizing compliance risks and facilitating market entry.

Part 1 Regulatory Framework for Cosmetic Ingredients

Unlike jurisdictions where ingredient requirements are consolidated in a single regulation, India adopts a multi-layered regulatory framework. Cosmetic ingredients are governed under the Drugs and Cosmetics Act, 1940 (the "1940 Act"), the Cosmetics Rules, 2020 (the "2020 Rules"), and a series of Indian Standards (IS) issued by the Bureau of Indian Standards (BIS), particularly the IS 4707 series and 37 product-specific standards.

Part 2 Ingredient Compliance Requirements

2.1 IS 4707 Series

The IS 4707 series forms the cornerstone of India's cosmetic ingredient regulation, adopting a dual positive and negative list mechanism to manage ingredient safety. Through successive revisions, the standard has achieved closer alignment with international regulatory norms—particularly the EU Cosmetic Regulation—although differences remain in substance coverage, update frequency, and implementation timelines.

The latest IS 4707 series consists of four parts:

These lists clearly define fully banned substances and conditionally permitted ingredients, with restrictions covering maximum concentration, applicable product categories and mandatory warning labels. Salicylic acid (CAS No. 69-72-7) is a typical restricted ingredient specified in IS 4707 Part 2 Annex B, with tiered concentration limits for different cosmetic products:

• Up to 3% in rinse-off hair products;

• Up to 2% in other products, excluding body lotions, eye shadows, mascaras, eyeliners, lipsticks, and roll-on deodorants;

• Up to 0.5% in body lotions, eye shadows, mascaras, eyeliners, lipsticks, and roll-on deodorants.

2.2 BIS Product-Specific Ingredient Requirements

Ingredient compliance in India extends beyond IS 4707. The Bureau of Indian Standards (BIS) has established product-specific standards that set tailored requirements for individual cosmetic categories, covering ingredient selection, packing and marking rules, physicochemical characteristics, heavy metal and/or microbial limits, sampling, and test methods.

The Ninth Schedule to the 2020 Rules currently designates 37 BIS product standards as mandatory. Cosmetics falling within the covered categories must meet corresponding standard requirements before they can be manufactured or imported into India. Products outside the scope of the Ninth Schedule shall comply with the general provisions of the 2020 Rules, the full IS 4707 series and relevant applicable standards of their origin countries.

Overall, the ingredient provisions in these product-specific standards are largely consistent with the 2020 Rules and IS 4707 series, while imposing additional and more stringent safety obligations in specific scenarios. For example,

• Novel ingredients application requires safety evaluation in accordance with IS 4011: Methods of Test for Safety Evaluation of Cosmetics.

• Raw materials used in skin cream products must pose no harmful effects at their finished-product concentrations and after interacting with other formulation components.

• Toothpaste and tooth powder formulations are restricted to conventionally used raw materials (with examples provided in the annexes to the relevant standards) and prohibited from containing mono- or disaccharides such as glucose, sucrose, as well as other readily fermentable carbohydrates.

2.3 Additional Ingredient Restrictions

Beyond BIS standards, the 2020 Rules introduces supplementary restrictions and prohibitions applicable to specific ingredients and product types.

2.3.1 Supplementary Colorants Permitted for Soaps

In addition to the colorants permitted under IS 4707 Part 1, the Tenth Schedule to the 2020 Rules provides an additional list of six colorants that may be used exclusively in soaps. These include:

• Phthalocyanine Blue (CI 74160)

• Citrus Red No. 2 (CI 12156)

• Aqueous Green Paste (CI 74260)

• Pigment Yellow 3 (CI 11710)

• Pigment Red 5 (CI 12490)

• Pigment Red 7 (CI 12420)

Accordingly, any cosmetics containing dyes, colors or pigments outside the scope of IS 4707 and the Tenth Schedule are prohibited from manufacturing and importation in India.

2.3.2 Substance-Specific Restrictions

The 2020 Rules also imposes additional requirements on certain hazardous or closely regulated substances, including:

• Hexachlorophene: Generally prohibited in cosmetics, except in soaps, where it may be used at concentrations not exceeding 1% (w/w). Products containing hexachlorophene must bear the warning: "Contains Hexachlorophene – not to be used on babies".

• Fluoride: The fluoride content in toothpaste is restricted to a maximum of 1,000 ppm. The fluoride concentration (in ppm) and the expiry date must be clearly declared on both the tube and the outer carton.

• Lead and arsenic compounds: Prohibited for use in coloring cosmetics.

• Heavy Metals: Permitted only within specified impurity limits. Mercury may be used as a preservative in eye-area products at concentrations up to 70 ppm, while all other finished cosmetic products must not exceed 1 ppm. For permitted synthetic organic colors and natural organic colors used in cosmetics, arsenic is limited to 2 ppm (calculated as arsenic trioxide), lead to 20 ppm, and the total content of heavy metals other than lead must not exceed 100 ppm, calculated as the sum of the respective metals.

#Reports

Global High-Concern Ingredient Report Series: Vol. 1 Regulatory Requirements for Heavy Metals in CosmeticsHeavy metals are generally prohibited as intentionally added ingredients in cosmetic products. However, they may be present as trace impurities originating from raw materials, colorants, mineral-based ingredients, or manufacturing processes. Due to the potential health risks associated with long-term exposure, including skin irritation, organ toxicity, and bioaccumulation, regulatory authorities worldwide have established limits for certain heavy metal impurities in cosmetics. Manufacturers are therefore expected to implement appropriate quality control measures and ensure compliance with applicable safety requirements before products are placed on the market.

Part 3 Ingredient Compliance during Import Registration

Ingredient compliance is not limited to product formulation design but runs through the entire import approval process. Complete and compliant ingredient information serves as a core basis for regulatory review and directly determines the approval outcome of cosmetic import registration in India.

3.1 Ingredient Documentation for Import Registration

As part of the import registration process, applicants are required to submit a full ingredient list with standardized INCI names, exact ingredient concentrations, and supporting documents demonstrating compliance with the applicable Indian regulatory requirements described above.

During review, regulators assess whether the formulation contains any prohibited substances, whether applicable BIS product standards have been met, and whether the supporting documentation is complete and consistent. Common compliance issues—such as discrepancies in ingredient nomenclature, incomplete disclosures, or failure to meet standard-specific requirements—may result in registration delays or outright rejection.

3.2 Ingredient Labeling Requirements

Labeling compliance is another statutory requirement intended to ensure product transparency and enable consumers to identify potentially hazardous or non-permitted ingredients.

Cosmetic labels must clearly display the product name, manufacturer information, batch number, manufacturing license number, net content, use-before or expiry date, ingredient list, and any required directions for use or warning statements. Imported cosmetics must additionally mark the import registration certificate number and the importer's name and address. All label content must be true and accurate, with no false or misleading claims.

The ingredient list must be preceded by the term "INGREDIENTS". Ingredients present at concentrations above 1% must be listed in descending order by weight or volume at the time of addition, while those present at 1% or below may appear in any order. This declaration requirement is waived for small packages containing 60 mL or less of liquid products or 30 g or less of solid or semi-solid products.