The labeling requirements for cosmetics in India are based on the Drugs and Cosmetics Act and Rules (last revised in 1940) & Cosmetics Rules (2020). The CDSCO is the authority that enforces the labeling regulations for consumer safety. The importance of labeling regulations is to protect consumers from hazardous cosmetics, track products and movement, and enforce a standard. This section of the guide addresses the principal labeling requirements for cosmetics, which will cover: main requirements, exemptions, and compliance with labeling regulations.
Introduction To Cosmetic Labeling Regulations
Manufacturing & distribution of cosmetics in India are controlled under the Drugs and Cosmetics Act, 1940, & Rule 2020. These regulations include the proper labeling of products to allow the consumer to use the product in a safe manner. In other words, every business related to cosmetic manufacturing or packaging must comply with labeling requirements, or there will be consequences.
Mandatory Labeling Information As Per Labeling Requirements For Cosmetics
The Cosmetics Rules, 2020, identify certain labeling and branding elements that are specific and comprehensive enough to enable product transparency, consumer safety, and regulatory compliance. All cosmetic products, whether manufactured in India or imported into India, must comply with label elements (required on the product’s inner pack and outer pack).
Inner and Outer Labeling Requirements For Cosmetics
The Drugs and Cosmetics Rule, 2020 mandates the labeling of cosmetic products on both inner (primary) packaging and outer (secondary) packaging, primarily for product transparency, safe use by consumers, and regulatory adherence.
Labeling Element | Inner Label (Primary Packaging) | Outer Label (Secondary Packaging) |
---|---|---|
Product Name | Must be mentioned | Must be mentioned |
Manufacturer’s Name & Address | Required (short form allowed for small packages) | Required in full |
Batch or Lot Number | Required (not mandatory for packs ≤10g or 25ml) | Mandatory |
Net Contents (Weight/Volume) | Must be indicated in metric units | Must be indicated in metric units |
Manufacturing Date | Required | Required |
Expiry Date / Best Before Date | Required | Required |
Directions for Use | Required if special usage instructions are needed | Required |
Cautionary Statements / Warnings | Required if the product includes hazardous or allergenic content | Required |
Ingredient List | Not required for packs ≤30g or 60ml | Mandatory (preferably in INCI format) |
Manufacturing License Number | Not mandatory | Mandatory |
Country of Origin (if imported) | Required | Required |
Specific Requirements For Hazardous Products
As per cosmetic labeling requirements, hazardous products need to show additional safety information beyond the regular labeling. These are:
Labeling Element | Requirement |
---|---|
Warning or Caution Statement | A clear and prominent warning label (e.g., “Caution: Contains hazardous ingredients. Follow instructions strictly.”) |
Usage Directions | Precise instructions to ensure safe and correct application |
First Aid Information | Emergency action steps in case of accidental ingestion or exposure (if applicable) |
Patch Test Advisory | For products like hair dyes: “A patch test is advised before each application.” |
Restricted Ingredient Declaration | Any ingredient that falls under a restricted or controlled list must be mentioned |
Storage Instructions | Details on how to store the product safely (e.g., “Keep away from heat or flame”) |
‘For External Use Only’ Statement | Required if the product is not intended for internal use |
Exemptions Permitted For Small Packages Under Cosmetic Labeling Rules
The labeling requirement for cosmetics is found in the Drugs and Cosmetics Rule, 2020, and small packages are given certain exemptions, such as,
- Batch No../Lot number. Small packages that contain a net quantity of 10-25 grams don’t have to show a batch number or lot number.
- Ingredients: Products that contain a net quantity of 30 grams or 60ml or below don’t have to show a full ingredient list on the container. This was done to avoid looking cluttered, yet still provide necessary safety information.
Language And Presentation Standards For Labeling
All mandatory information on any pack of cosmetics, according to the labeling requirements for cosmetics as part of the Drugs and Cosmetics Rules, 2020, will have to be done in English. Brands may also use Hindi or their respective language, but English is a requirement for regulatory support. It is important to remember that the label must be:
- Clear and easy to read.
- Printed in a good-sized font (that is not too small or too fancy).
- In a contrasting color to the background and easily visible (black text on a white background).
Important onboarding information, including the product name, expiration date, usage instructions, and warnings, should be easy to find and understand. Any safety warnings should be bold and highly visible as you want your consumers to see, especially when a product dye, such as hair dye, bleaching ingredient, etc, can irritate someone.
Compliance And Enforcement Of Labeling Requirements For Cosmetics
The compliance with cosmetic labeling is important for consumer safety and fairness among competitors. Understanding that regulatory authorities, including the Central Drugs Standard Control Organization (CDSCO) and drug controllers at the modified provincial/state level, do keep watch on the labels of the cosmetics they regulate to ensure all legal standards are being met. The manufacturers and importers must do the following things as mentioned:
- Abide by all labeling requirements.
- Keep records of labels current and complete, including details regarding batches and ingredients.
- Ensure that the label representations are truthful and not misleading.
How an ELT Corporate Can Help with Labeling Requirements For Cosmetics?
An ELT Corporate Pvt. Ltd. provides tools and platforms that automate the Extract, Load, and Transform process. This allows cosmetic manufacturers and distributors to organize large amounts of product data quickly and remain compliant with cosmetic labeling requirements.
What Is Required To Be Labeled For Cosmetics In India?
According to the Drugs and Cosmetics Rules, 2020, the label of the cosmetic products contains the product name, name and address of the manufacturer, net contents, batch number, expiry date, directions for use, list of ingredients, and cautions or warnings where applicable.
Are Small-Sized Cosmetic Products Exempt From Any Labeling Rules?
Yes, products in 10g or 25 mL or less are not required to display a batch number. Products in 30g or 60ml or less may not be required to show the ingredient list, but must still display critical safety and usage information.
Is English Mandatory On Cosmetic Labels?
Yes, the required labeling information has to be in English. You can also have Hindi and/or regional languages, but they need to be in addition to, and not instead of, English.
What Happens If A Cosmetic Product Fails Labeling Requirements?
Failure to meet the labeling requirements for cosmetics may lead to fines or a product recall. For major mistakes, the license can also be suspended or canceled.