CDSCO has laid down stringent guidelines for cosmetics products entering the Indian market to ensure consumer safety. Additionally, it has formulated guidelines for cosmetics product labels. In India, cosmetics product labels are governed by the Drugs & Cosmetics Act of 1940 and the Cosmetics Rules, 2020. Hence, for accessing the Indian cosmetics market, you have to comply with the Indian cosmetics labelling guidelines. Moreover, cosmetics product labels or regulatory artworks have to be submitted to CDSCO as part of regulatory submission for licensing.
Importance of regulatory compliant cosmetics label
We have highlighted the need to comply with CDSCO cosmetics labelling guidelines.
- Transparency in product claims
- Regulatory compliance
- Consumer safety
- Prevents consumer exploitation with misleading claims
- Market access
Cosmetics labelling guidelines: Mandatory declarations on cosmetic labels
The Indian cosmetics labelling guidelines has mandated certain declarations to be mentioned on cosmetics labels for both domestically manufactured and imported products. We have a prepared a detailed checklist to help you navigate the Indian cosmetics labelling requirements.
| Description | Outer Label of the Product | Inner Label of the Product | To be done from Country of Origin | Guidelines |
| Brand name along with product name | Yes | Yes | Requirement as per rule 34 sub rule A | |
| Declaration of Net Contents or Pack size such as 50 ml or 100 gm etc | Yes | Yes | The outer label of the cosmetics is required to mention the net contents expressed in terms of weight for solids, fluid measure for liquids, fluid measure or weight for semi-solids, combined with numerical count if the content is sub-divided. However, this statement need not appear in case of a package of perfume, toilet water or the like. Additionally, this guideline does not apply for products with the net content not exceeding 60 ml or any package of solid or semi-solid cosmetic the net content of which does not exceed 30 grams. | |
| Name and address of Legal Manufacturer | Yes | Yes | ||
| Name and address of Actual Manufacturer or Manufacturing Country | Yes | Yes | As per Chapter VI, Rule 34 and Sub Rule 1b of New Cosmetics Rules December 2020, the name of the manufacturer and complete address of the premises of the manufacturer where the cosmetic has been manufactured should be mentioned. If the product has not been manufactured in a factory owned by the manufacturer, the name and address of the actual manufacturer or the name of the country where it has actually been manufactured as: Made in …….. (name of country)” should be mentioned on the label. However, if the cosmetic is contained in a very small size container as 30 gm or less if the cosmetics are in solid or semi-solid state and 60 ml or less if the cosmetics is in liquid state, where the address of the manufacturer cannot be mentioned, the name of the manufacturer and his principal place of manufacture shall be provided along with pin code. | |
| List of Ingredients | Yes | Yes | In all cases, the list of ingredients, present in concentration of more than one percent shall be listed in the descending order of weight or volume at the time they are added, followed by those in concentration of less than or equal to one percent, in any order, and preceded by “INGREDIENTS”. However, this statement need not appear for packs of less than or equal to 60 ml of liquid and 30 gm of solid and semi-solids. | |
| Caution if any and Instructions for use | This should be mentioned on the label in the country of origin. | In case of cosmetics; where a hazard exists, every inner label shall clearly indicate (a) adequate directions for safe use, (b) any warning, caution or special direction required to be observed by the consumer, (c) a statement indicating the names and quantities of ingredients that are hazardous or poisonous. | ||
| Batch No to be prefixed by “B” | Yes | Yes | A distinctive batch number i.e., the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the letter ―B‖ or the words ―Batch No.‖ or ―B. No.‖ or ―Batch‖ or ―Lot No.‖ or ―Lot‖ shall be mentioned on the inner or outer labels: Exceptions: This clause shall not apply to any cosmetic containing 10 grams or less, if the cosmetic is in solid or semi-solid state and 25 millilitres or less, if the cosmetic is in a liquid state. Furthermore, in case of soaps, instead of the batch number, the month and year of manufacture of soap shall be provided on the label. | |
| Manufactured on | Yes | Yes | ||
| Use before or Date of expiry | Yes | Yes | As per Chapter VI, Rule 34 and Sub Rule 1C of New Cosmetics Rules December 2020, Use before or date of expiry (month and year) or use by or expiry date or expiry XX months from manufactured or date of manufacturing or expiry date has to be mentioned on inner and outer labels. | |
| Name and address of Registered Indian importer/Responsible Person/License Holder | Yes | Yes | Name and address of the importer has to be mentioned on the outer and inner packs. | |
| Registration certificate number [will be received post approval grant by CDSCO] | Yes | Yes | In case of imported cosmetics to be marketed in India, import registration certificate number shall be mentioned on the label of unit pack preceded by letter ― RC or ―RC No or ―Reg. Cert. No along with name and address of the importer. | |
| Customer care number and email address of Indian importer | Yes | Yes | ||
| Month and year of Import [mm/yy] | Yes | Yes | ||
| MRP, inclusive of taxes | Yes | Yes | ||
| Manufacturing licence number | Yes | Yes | Yes | In case of imported products, if such provision is not mandatory in country of origin, such cosmetics may be imported without mentioning manufacturing license number, subject to fulfilment of other import regulations. |
| Package of cosmetic with only One Label | In case the cosmetics package has only one label, such label shall contain all the information required to be shown on both the inner and the outer labels, under these rules. |
Indian cosmetics labelling requirements
We have presented the cosmetics label rules.
- Chapter VI, Rule 34, Sub Rule 8: The cosmetic shall comply with labelling requirement, if any, specified in the relevant Indian standard as laid down by the ‘Bureau of Indian Standards‘ for the cosmetics covered under the Ninth Schedule.
- Chapter VI, Rule 34, Sub Rule 9: No cosmetic shall be imported unless it is packed and labelled in conformity with these rules and the label of imported cosmetics shall bear registration certificate number of the product and the name and address of the registration certificate holder for marketing the said product in India. Notably, for cases where the imported cosmetics require India specific labelling, the same shall be allowed to be stickered on the unit pack at the bonded warehouses.
- Chapter VI, Rule 34, Sub Rule 10: In case, the cosmetic is meant for export then the labels on packages or container of cosmetic shall meet the specific requirements of law of the country to which the cosmetic is to be exported, but the following particulars shall appear in a conspicuous manner on the label of the inner most pack of the cosmetic in which the cosmetic is packed and every other outer covering in which the container is packed:
(a) name of the cosmetic;
(b) the distinctive batch number or lot number or serial number preceded by the word ―Lot No. or ―Lot or ―Batch No. or ―B. No. or ―Serial No. or ―B;|
(c) use before or date of expiry, if any;
(d) the name and address of manufacturer and address of actual premises where the cosmetic has been manufactured;
(e) license number preceded by letters ―License No. or Lic. No.
(f) internationally recognized symbols in lieu of text, wherever required.
However, when a cosmetic is required by the consignee to be not labelled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the state Licensing Authority. - Chapter VI, Rule 35: Prohibition against altering inscription on containers, labels or wrappers of cosmetic. No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any cosmetic:
Provided that nothing in this rule shall apply to any alteration, inscription or mark made on the container, label or wrapper of any cosmetic at the instance or direction or with the permission of the Central Licensing Authority. - Chapter VI, Rule 36: Prohibition against false or misleading claims. No cosmetic may purport or claim to purport or convey any idea which is false or misleading to the intending user.
- Chapter VI, Rule 37: Labelling of hair dyes containing dyes, colors and pigments. Hair dyes containing Paraphenylenediamine or other dyes, colors and pigments shall be labelled with the following legend in English and local languages and these shall appear on both the inner and the outer labels:
“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.” - Chapter VI, Rule 38-Special provisions relating to toothpaste containing fluoride.
(a) Fluoride content in toothpaste shall not be more than 1000 ppm and the content of fluoride in terms of ppm shall be mentioned on the tube and carton.
(b) Date of expiry should be mentioned on tube and carton. - Chapter VI, Rule 39: Standards of cosmetics-
Hexachlorophene– No cosmetic containing hexachlorophene shall be manufactured:
Provided that in case of soaps, hexachlorophene may be used in concentrations not exceeding one per cent weight by weight:
Provided further that the following cautionary note shall be printed and shall appear in a conspicuous manner on the wrapper of package of each soap, namely. “Contains hexachlorophene – not to be used on babies”.
Cosmetic product labels cannot make therapeutic or medical claims
As per Indian cosmetics labelling guidelines, cosmetic products cannot make therapeutic or medical claims. It cannot claim the ability to modify a physiological process or to treat or prevent a disease. These claims can only be made by registered medicines. Cosmetics product labels must not mention words, such as Treatment, as it may attract the definition of Drugs. Furthermore, many SPF products mention the word “Drug Facts” on the product labels, which should be avoided.
Indian cosmetics labelling guidelines: Key points to keep in mind
- For imported cosmetics products, stickering of labels containing the registration certificate number of the brand and the name and address of the registration certificate holder may be done after import. This can be done at a suitable place approved by the licensing authority. For this an application has to be made to the licensing authority.
- Phrases that may seem to be in the definition of drugs, namely cellular renewal, acne, antiseptic, antibacterial or treatment of any disease or disorder, drugs facts on sun screens or any other types of products are not approved by CDSCO. These claims have to be removed from the product labels prior to applying for the CDSCO license.
- Cosmetic products are considered packaged commodities. Therefore, they are also regulated under the Legal Metrology (PACKAGED COMMODITIES) Rules 2011. Hence, cosmetic products have to follow the mandatory declarations for label requirements as per both the Drugs & Cosmetics Act as well as the Legal Metrology (PACKAGED COMMODITIES) Rules 2011.
Pharmadocx Consultants: Your trusted cosmetics regulatory ally
Incorrect labelling of cosmetics products can lead to compliance issues. We at Pharmadocx Consultants have extensive knowledge and expertise in Indian cosmetics labelling guidelines. Our team will screen and validate cosmetics labels so that they meet the necessary requirements. To avail our cosmetic label compliance service, drop an email at [email protected] or call/Whatsapp on 9996859227. We understand every product is unique, thereby customise our services per client needs.
