Regulatory declarations usually do not receive the same importance as cosmetic product claims and design, but they are essential nonetheless and may invite liability if they are found to be missing from a product package.
The above statement may apply to cosmetics sold all around the word, but is especially true for cosmetics products sold in India because the Indian cosmetics regulator (the State Licensing Authority i.e. SLA for domestically manufactured cosmetics, and the Central Drugs Standards Control Organization i.e. CDSCO for imported cosmetics) does not approve labels at the time of granting marketing authorization (even though it is mandatory to submit a copy of the label at the time of application). It is up to the importers and manufactures of cosmetics products to ensure that mandatory declarations laid down under the Cosmetics Rules, 2020 (“Cosmetics Rules”) and other laws appear on the product’s label.
Omitting any of the compulsory declarations would render the product ‘misbranded’ under the Drugs and Cosmetics Act, 1940 and may have consequences for the manufacturer or importer, ranging from suspension or cancelation of manufacturing license or import registration to criminal prosecution. It may even have consequences for the whole sellers and retailers, as misbranded products are bound to be confiscated without compensation.
In this article, we have described mandatory labelling requirements for sale of cosmetics in India.
Understanding inner label and outer label
Typically, a cosmetic product would have labels on the container (“inner label”), an outer wrapper or box (“outer label”), and sometimes a leaflet containing instructions or additional information.
The Cosmetics Rules not only prescribe the declarations but also stipulate the label on which those declarations should appear.
As per the Cosmetics Rules the following declarations must appear on the label or labels specified. If the product has only a single label, all declarations must appear on that label.
Mandatory declarations for cosmetics manufactured in India under Cosmetics Rules, 2020
Inner and Outer labels
The following information needs to appear on label on the container as well as any external packaging.
- Name of the cosmetic
- Name of legal manufacturer
- Complete address of the premises where the cosmetic has been manufactured
- Use before date/date of expiry.
- 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”
Inner or Outer labels
The following information needs to appear on either the inner or outer label.
- Distinctive batch/lot code* [preceded by “Batch No.”, “B. No”, “Batch”, “Lot No.” or “Lot”]
- Manufacturing License Number* [preceded by “M”, “M.L. No.”, or “Mfg. Lic. No.”]
It is advisable to include the license number and batch code on the both outer and inner label, as most regulatory authorities check the external label for compliance, but most consumers discard the secondary package upon unboxing.
Only on Outer label:
The following information only needs to appear on the outer label:
- Net contents (weight for solids, fluid measure for liquids, and either for semi-solids)*
- Number of items, if more than one
Only on Inner Label(s):
If there are any hazards linked to a cosmetic, the following should appear:
- Adequate directions for use
- Any warning, caution or special directions
- Names and quantities of ingredients that are hazardous or poisonous
If not, only the declarations that need to appear on both the inner and outer label must be mentioned on the container.
Mandatory declarations for cosmetics imported into India under Cosmetics Rules, 2020
The Cosmetics Rules stipulate the labelling requirements for all products that are sold in the Indian market, which includes imported cosmetics. All the information that must appear on the domestically produced cosmetics must also appear on imported cosmetics (except to the extent mentioned below). In addition, details of the importer must also be mentioned, so that consumers and the regulators have access to a domestic entity in relation to the imported products. Note that the modifications to the labelling may be effected at a customs bonded warehouse i.e. before clearing Indian customs before after importing into India.
The following additional declarations must appear:
- Import registration certificate number [preceded by “RC”, “RC No.”, “Reg. Cert. No.”]
- Name of importer
- Address of importer
- If the importer does not wisht to declare the manufacturing site, –then a declaration of country of manufacture as would suffice [“Made in (Country)”].
- If the cosmetic is imported from a country that does not require that the manufacturing license number be mentioned, manufacturing license number need not be mentioned.
Exemptions for small-size cosmetic packages under Cosmetics Rules, 2020:
Small containers of cosmetics are subject to certain relaxations.
- Address of manufacturer may be shortened to only principal place of manufacture and the pin code where the cosmetic’s container is less than or equal to 60 ml of liquid and 30g of solids and semi-solids.
- Batch code need not be mentioned on any cosmetic that are up to 10 grams if in the solid or semi-solid state or 25 ml if in the liquid state.
- The declaration of net contents 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
- The list of ingredients need not appear for cosmetics that are less than or equal to 60 ml of liquid and 30g of solids and semi-solids.
These relaxations have likely been granted to ensure that the vital declarations are still present and readable, while avoiding unnecessary packaging and inserts.
Requirements for Hair Dyes containing dyes, colours and pigments under Cosmetics Rules, 2020:
Hair dyes must contain additional declarations due to their strong chemical composition, and the likelihood of reactions occurring.
The following statements must appear on both the inner and outer labels in English and in local languages:
- “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.”
- “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.”
Cosmetics that are subject to any Bureau of Indian Standards (BIS):
The Ninth Schedule to the Cosmetics Rules specifies the BIS Standards that are applicable to a total of 37 categories of cosmetics including skin powders, skin creams, hair oils, shampoos, soaps, lipsticks, foundations, etc. Further, if any new BIS standards are introduced for cosmetics, those would become mandatory after six months from the date of publication.
If any of the standards specify labelling requirements, they must mandatorily be complied with. This requirement applies to both domestically manufactured and imported cosmetics.
Animal Testing Declaration
While most products do include a statement or symbol to signify that the cosmetic product was not tested on animals, the Cosmetics Rules do not require that the declaration be made since animal testing has been outrightly banned for cosmetic products. Should the brand choose to include the declaration, however, care should be taken that they do not use any of the symbols associated with certifications such as the PETA’s ‘Beauty without Bunnies’ or the Cruelty-Free International’s ‘Leaping Bunny’ unless the certification has actually been obtained.
Mandatory declarations for cosmetics imported or manufactured into India under Legal Metrology (Packaged Commodities) Rules, 2011
In addition to the Cosmetics Rules, the label must also contain the declarations required under the Legal Metrology (Packaged Commodities) Rules, 2011 (“Packaged Commodity Rules”).
The additional declarations that would be required are:
- Generic name of the product
- Maximum retail price
- Contact details for customer care
- Date of import, if applicable
Alteration of Mandatory Declaration on Cosmetics Product Labels:
Caution should be taken while finalising the labels for a cosmetic product, since making any modifications to the label once the product leaves the manufacturing factory premise (in case of manufactured cosmetics) or the Indian customs (in case of imported cosmetics), would require prior approval from the office of Drugs Controller General of India (India), who heads the CDSCO, and, if the modification relates to a mandatory declaration under the Packaged Commodity Rules, the authority thereunder as well.