Guidelines of Labels of Cosmetic Products as per Drugs & Cosmetics ACT 1940 and the Cosmetic Rules 2020

The labels or regulatory artworks of the products are required to be submitted to CDSCO as part of documents for processing of application for grant of approval.

Under the Drugs & Cosmetics Act, strict and clear guidelines are laid out for overseas brands and importers to follow on the product packaging. 

Regulatory is Evolving and so does the Regulator himself.Since 2013 when the regulation came into Place the Department has been notifying Various Amendments and inclusions in Documentary processes such as Non animal Declarations, Heavy metal, Microbeads Declaration and many more. Similar to such Changes CDSCO has been on its toes to avoid False or Misleading Claims.

Declaration and many more. Similar to such Changes CDSCO has been on its toes to avoid False or Misleading Claims.

For cosmetic products, strict enforcement of compliance to various provisions of labelling is rountily being done during the processing of regulatory dossiers before grant of approval, at Indian Customs during the customs clearance procedures and in the online – offline marketplaces by the CDSCO enforcement teams.

Therefore, it is critically important to have an understanding of how the labels should be as per various Indian Regulations.

Checklist of Labels: 

Description	Outer Label	Inner Label	To be done from Country of Origin	Comments
Brand name along with product name	✓	✓		Rule 34 sub rule A
Declaration of Net Contents or Pack size such as 50ml or 100gm etc	✓	✓		The outer label of the cosmetics shall carry a declaration of 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: Provided that this statement need not appear in case of a package of perfume, toilet water or the like, the net content of which does not exceed 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	✓	✓
Name and address of Actual Manufacturer or Manufacturing Country	✓	✓		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. 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 there on the label. Provided that if the cosmetic is contained in a very small size container as 30gm 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 given, the name of the manufacturer and his principal place of manufacture shall be given along with pin code.
List of Ingredients	✓	✓		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 the words INGREDIENTS. Provided that 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 to use			✓	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”	✓	✓		A distinctive batch number, that is to say, 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 carry on the inner or outer labels: Exceptions: Provided that 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: Provided further that in the case of soaps, instead of the batch number, the month and year of manufacture of soap shall be given on the label.
Manufactured on	✓	✓
Use before or Date of expiry	✓	✓		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.
Name and address of Registered Indian importer/Responsible Person/License Holder	✓	✓		In the 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.
Registration certificate number[will be received post approval granted by CDSCO]	✓	✓		In the 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	✓	✓
Month and year of Import[mm/yy]	✓	✓
MRP, inclusive of taxes	✓	✓
Manufacturing licence number	✓	✓	✓	Provided that in case of imported products, if such provision is not mandatory in country of origin, such cosmetics may be allowed without mentioning manufacturing license number, subject to fulfilment of other import regulations.
Package of cosmetic with only One Label				Where a package of a cosmetic 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.

NOTES

1. 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.
   
2. 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. Provided further that in 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.
   
3. 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.
   
   Provided that where 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.
   
4. 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.
   
5. 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.
   
6. 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.”
   
7. 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.
   
8. 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”.

LABEL CLAIMS – DIFFERENTIATING BETWEEN A COSMETIC OR A DRUG CLAIM?

Cosmetic products cannot make therapeutic or medical claims; such as claims for modifying a physiological process or to treat or prevent a disease. These claims can only be made by medicines which must be Registered under the Drugs Division of CDSCO Product Labels must not mention words such as Treatment as it may attract definition of Drugs Many SPF products mention the word Drug Facts on the product labels, which must also be avoided. Since drug facts may attract definition of a Drug

NKG Insight

– There has been no Information issued in Public Domain on the Objected or restricted words for claims Cosmetics. Labels containing phrases that may appear to attract the definition of the drug Such as Cellular Renewal, Acne, Antiseptic, Antibacterial or Treatment if any Disease or Disorder, Drugs Facts on SunScreen or any other types of Products are not approved by CDSCO. These Claims must be removed from the Product labels for Approval of Application.

– Stickering of labels containing the registration certificate number of the brand and the name and address of the registration certificate holder may be allowed to be carried out after import at a suitable declared place approved by the Licensing Authority on an application made to the Licensing Authority.

– In Addition to the above, Cosmetic products are Packaged Commodities, therefore they are also regulated under the Legal Metrology (PACKAGED COMMODITIES) Rules 2011. Various aspects of India specific labelling & mandatory declarations need to be followed on the product labels before the products are placed on the Indian Markets.Cosmetic Products have to follow the mandatory declarations on label requirements as per both the Drugs & Cosmetics Act as well as the Legal Metrology (PACKAGED COMMODITIES) Rules 2011. 

At NKG We Screen label and Validate the labels so that all such Requirements can be met.

NKG has designed bespoke labeling compliance services. Years of experience and deepen understanding of the framework of the law helps NKG experts to suggest exhaustive pointers which can be used to make correct India Specific labels. Incorrect labeling can lead to compliance issues thereby posing a risk to the business of a brand as well as the image of a company. 

NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by-Step “ process that puts a lot of method in between the madness.