The Drugs & Cosmetics Act provide the guidelines for labelling cosmetics. Certain mandatory declarations have to be mentioned on the labels of the cosmetics products to be sold in India. Furthermore, specific requirements for outer and inner labels of the cosmetics products are also in place. Enforcement of cosmetics labelling guidelines is done during the processing of regulatory dossiers before the cosmetics registration license grant. Thus, Indian cosmetics labelling guideline compliance is required to market your product in online and offline Indian marketplaces. In this blog, we will focus on the Indian cosmetics labelling guidelines. Additionally, we will mention some labelling exemptions and guidelines specific for imported cosmetics. Furthermore, we will present some FAQs on guidelines for labelling cosmetics under Cosmetics Rules, 2020.

Guidelines for labelling cosmetics under Cosmetics Rules, 2020

The Drugs & Cosmetics Act has laid down stringent guidelines for labelling cosmetic products to be placed in the Indian market. Recently, the Ministry of Health and Family Welfare, Government of India, has published the Cosmetics Rules, 2020. These rules provide guidelines for labelling cosmetics intended to enter the Indian cosmetics market. Thus, strict and clear guidelines are in place for cosmetics product labelling and packaging. The labels or regulatory artworks of the cosmetics are a part of the necessary supporting documents to be submitted to CDSCO for grant of license and registration. Additionally, in case of imported cosmetics, compliance with cosmetics labelling guidelines is mandatory for Indian customs clearance. Hence, it is vital to understand the Indian cosmetics labelling guidelines to sell your cosmetics products in India.

Indian cosmetics labelling guidelines for outer and inner labels

Cosmetic products usually have an inner label (container label), outer label (outer wrapper or box), and in some cases a leaflet with instructions. The Cosmetics Rules, 2020, provide the mandatory label declarations. Additionally, the guidelines also mention on which label (outer/inner) these declarations should appear. We have provided an overview of the label specific declarations as per Indian cosmetics labelling guidelines.

Inner and outer label declarations:

• Cosmetic’s name
• Legal manufacturer
• Expiry date or use before date
• Cosmetic manufacturing facility address
• List of components having a concentration of more than 1% has to be listed in the descending order of volume or weight at the time they were added. Then, this list has to followed by components having a concentration of less than/equal to 1 %, in any order. Furthermore, this list has to be preceded by the word “INGREDIENTS”.

Declarations for inner cosmetic labels only

If the cosmetic product may be associated with any potential hazard, the following declaration should be mentioned in the inner cosmetic labels only:

• Directions for use
• Warning, caution, or special directions
• Names and quantities of ingredients that maybe potentially poisonous or hazardous

Declarations for outer cosmetic labels only

• In case more than one product is packaged, number of productsshould be mentioned
• Net contents, weight for solids, fluid measure for liquids, and either one for semi-solids should be mentioned.

Declarations to be mentioned in either outer label or inner labels

• Manufacturing license number (mentioned as M.L.No. or Mfg. Lic. No.)
• Distinctive lot/batch code (mentioned as Lot No. /Lot, Batch No. /B. No.)

Indian cosmetics labelling guidelines under Cosmetics Rules, 2020, have provided some exemptions for small-sized cosmetics

1. Batch code need not be mentioned for cosmetics that are up to 10 grams for semi-solid or solid products or 25 ml for liquid products.
2. For cosmetics that are less than or equal to 60 ml in case of liquid or 20 grams in case of semi-solid or solid, the ingredients list need not be mentioned.
3. For cosmetics that are less than or equal to 60 ml in case of liquid or 30 grams in case of semi-solid or solid, the manufacturer’s address may be shortened to only the principal place of manufacture and the pin code.
4. For perfumes and similar cosmetics that are less than or equal to 60 ml in case of liquid or 30 grams in case of semi-solid or solid, the net contents need not be declared.

Indian cosmetics labelling guidelines specifically for imported cosmetics

The Indian cosmetics labelling guidelines have outlined certain mandatory declarations for cosmetic products to be imported into India. All details that need to be declared for domestically manufactured cosmetics have to be mentioned on the imported cosmetic labels. Additionally, importer information needs to be provided. The Cosmetics Rules, 2020, have clearly stated the guidelines for imported cosmetics label declaration. The following additional declarations have to be made on imported cosmetic labels:

• Importer’s name
• Importer’s complete address
• Import registration certificate number (“RC”, “RC No.”, and “Reg. Cert. No.”)
• In case the importer does not wish to declare the manufacturing premises, then a declaration of country of manufacture would suffice. For example, the label should mention “Made in [Country]”.
• Certain countries do not require the manufacturing license number to be mentioned on their cosmetic’s label. Then, in such cases, the manufacturing license number need not be mentioned on the label.

Vital points to remember when labelling cosmetics to be sold in India

• Information on the label, such as the manufacturer’s name, net weight of the product, and components, should match the official documents of the cosmetics.
• The cosmetic labels should comply with all the labelling guidelines mentioned in the New Cosmetics Rules 2020.
• If the label does not comply with the Indian cosmetics labelling guidelines mentioned in the New Cosmetics Rules 2020, then the regulatory body may reject the cosmetics registration application.

FAQs on Indian cosmetics labelling guidelines

Does the ingredient list on the cosmetic label and composition sheet need to match for cosmetics product registration?

Yes, the ingredient list on the cosmetic label and composition sheet need to match for cosmetics product registration.  Additionally, information on the cosmetic’s label, such as the manufacturer’s name, net weight of the product, and components, should match the official documents of the cosmetic.

Can drug claims, such as phrases that fall within the definition of drugs, be mentioned on cosmetics labels?

No, drug claims and phrases that fall within the definition of drugs cannot be mentioned on labels of cosmetic products. Section 3 of Drugs and Cosmetics Act, 1940, has defined Cosmetic and Drug as different entities. Products having drug claims do not fall under the definition of cosmetics provided by the Act. Hence, products having drug claims cannot be registered as cosmetics. Thus, cosmetics labels for products to be sold in India should not have drug claims.

Will original labels be required at the time of application for cosmetics registration?

Original labels are usually required at the time of application for cosmetics registration. However, a copy of the original label presenting all the details as per Part XV of Drugs and Cosmetics Rules, 1945, may be submitted.

Pharmadocx Consultants: Your trusted regulatory support

Indian cosmetics labelling guidelines can be confusing and difficult to comprehend. All cosmetics to be sold in India have to be properly labelled as per regulatory guidelines. We at Pharmadocx Consultants have extensive knowledge of the regulatory guidelines for labelling cosmetics to be sold in India. Moreover, our team of experts, with over 27 years of experience, have helped set up more than 100 cosmetics factories. We have served more than 200 clients in the cosmetics industry. Thus, we will leverage our expertise in this field to help you overcome all regulatory obstacles. Furthermore, our team of experts will be more than happy to help you with any queries on guidelines for labelling cosmetics. Drop an email at [email protected] or call/Whatsapp on 9996859227, to let us help you.