Labeling plays a crucial role in the cosmetic industry, not only providing essential information to consumers but also ensuring compliance with regulatory standards. The labeling of cosmetics is governed by the CDSCO’s Cosmetic Rules 2020, which outline specific labeling requirements for cosmetics in India to be followed by manufacturers and importers in India.
The Legal Metrology Rules, 2011, enacted under section 52(2) of The Legal Metrology Act, 2009, establish general packaging regulations for packaged commodities. However, for cosmetics, the primary laws governing them are the Cosmetic Rules 2020 enacted under the Drugs and Cosmetic Act. Additionally, supplementary labeling guidelines are outlined under relevant Bureau of Indian Standards (BIS) requirements applicable for given cosmetic category as listed in Schedule IX of Cosmetic Rules 2020. BIS serves as India's national standards authority, responsible for formulating, recognizing, or promoting Indian Standards.
CDSCO labeling requirements for cosmetics in India under Cosmetic Rules 2020
The Cosmetic Rules 2020 mandate certain information to be displayed on the label of cosmetics. Labels must be in English or Hindi or both, ensuring that all information is clear and easily readable. The font size and style should be legible, allowing consumers to understand the content without difficulty. Labels should be securely affixed to the packaging, ensuring they remain intact throughout the product's lifecycle. The presentation of labels should be aesthetically pleasing and informative, enhancing the overall appeal of the product while conveying essential information to consumers. Additionally, labels must include warnings and precautions, such as "For external use only" or "Avoid contact with eyes," as necessary for product safety.
The rules state that it's prohibited to modify, erase, or damage any markings or labels made by the manufacturer on cosmetic containers, labels, or wrappers. However, exceptions are made for alterations made under the direction or permission of the Central Licensing Authority. Additionally, cosmetics are not allowed to make false or misleading claims that could deceive consumers about their purpose or effectiveness.
Labeling information to be included on inner and outer labels for cosmetics in India under Cosmetic Rules 2020
The Cosmetic Rules 2020 outline specific labeling requirements that must be included on either the outer or inner labels, or both, as stipulated. Both inner and outer labels are crucial for regulatory compliance and consumer safety, as they provide essential information about the product and its ingredients, usage instructions, and potential hazards.
The outer label is the one visible to consumers when the product is displayed on shelves or purchased. It typically contains essential information that consumers need to know before buying the product. The outer label is designed to attract attention and provide consumers with vital information about the product.
The inner label of a product refers to the label attached to the immediate packaging or container of the product, typically concealed from view when the product is on display or in use. The inner label is designed to provide essential information to consumers and regulatory authorities while ensuring that the product remains protected and intact until it is ready for use. The inner label is usually found underneath the outer label and is not immediately visible to consumers.
In case the cosmetic product has only one label, all the information shall be included in the very same label.
CDSCO labeling requirements for imported osmetics in India under Cosmetic Rules 2020
For imported cosmetics, additional requirements apply. The import registration certificate number must be mentioned on the label of unit pack ("RC" or "RC No" or "Reg. Cert. No) along with the name and address of the importer.
CDSCO labeling requirements for cosmetics in India manufactured for export under Cosmetic Rules 2020
If the cosmetic is intended for export, its packaging must adhere to the specific regulations of the destination country. However, certain essential details must be prominently displayed on the innermost pack and any outer covering. These include:
Name of the cosmetic
Unique batch number, lot number, or serial number (Lot No. / Batch No.)
Expiry date (if applicable)
Name and address of the manufacturer, along with the actual manufacturing premises
License number (Licence No." or "Lie. No.)
Internationally recognized symbols as required
In cases where the consignee requests that the manufacturer's name and address not be displayed, the packaging or containers should feature an approved code number designated by the state Licensing Authority.
CDSCO special labeling provisions for certain cosmetics under Cosmetic Rules 2020
Certain cosmetics, such as hair dyes containing specific dyes are subject to special labeling provisions. Hair dyes containing certain ingredients must carry cautionary legends warning users of potential skin irritation.
"Caution.—This product contains ingredients which may cause skin irritation in certain cases and so a preliminary test according to the accompanying directions should first be made. This product should not be used for dyeing the eyelashes or eyebrows; as such a use may cause blindness."
Each package shall also contain instructions in English and local languages on the following lines for carrying out the test:
"This preparation may cause serious inflammation of the skin in some cases and so a preliminary test should always be carried out to determine whether or not special sensitivity exists. To make the test, cleanse a small area of skin behind the ear or upon the inner surface of the forearm, using either soap and water or alcohol. Apply a small quantity of the hair dye as prepared for use to the area and allow it to dry. After twenty-four hours, wash the area gently with soap and water. If no irritation or inflammation is apparent, it may be assumed that no hypersensitivity to the dye exists. The test should, however, be carried out before each and every application.
This preparation should on no account be used for dyeing eyebrows or eyelashes as severe inflammation of the eye or even blindness may result."
Special provisions for toothpaste containing fluoride include limiting the fluoride content to not exceed 1000 ppm, with the fluoride content specified in ppm on both the tube and carton packaging. Additionally, the expiry date must be clearly indicated on both the tube and carton packaging.
Compliance with labeling regulations under the Cosmetic Rules 2020 is vital for manufacturers and importers operating in the Indian cosmetic market. By adhering to these requirements, businesses can demonstrate their commitment to consumer safety, transparency, and regulatory compliance. Moreover, accurate and informative labeling enhances consumer trust and confidence in cosmetics, fostering long-term success and market competitiveness.
Ready to streamline your compliance process and ensure your cosmetics meet all regulatory standards in India? Contact Artixio today for expert guidance and tailored solutions. Let us help you navigate the complexities of regulatory requirements and labeling guidelines so you can focus on growing your business with confidence. Reach out to us now to get started!
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