Regulatory statements are usually not given the same importance as cosmetic claims and design, but they are nonetheless essential and may give rise to liability if they are found to be missing from a product’s packaging.
The above statement may apply to cosmetics sold worldwide, but is especially true for cosmetics sold in India because the Indian cosmetics regulator (the National Licensing Authority, i.e. say the SLA for cosmetics made in the country, and the Central Drugs Standards Control Organization, i.e. the CDSCO for imported cosmetics) does not approve the labels at the time of granting authorization to put in the market (although it is mandatory to submit a copy of the label at the time of application). It is the responsibility of importers and manufacturers of cosmetic products to ensure that the mandatory declarations provided for in the Cosmetic Regulations, 2020 (âCosmetic Regulationsâ) and other laws are included on the product label.
Failure to make any of the mandatory declarations would render the product “mislabelled” under the Drugs and Cosmetics Act 1940 and could have consequences for the manufacturer or importer, ranging from suspension or termination to ‘cancellation of manufacturing license or import registration to criminal prosecution. It can even have consequences for all sellers and retailers, as mislabelled products are doomed to be confiscated without compensation.
In this article, we have described the mandatory labeling requirements for the sale of cosmetics in India.
Understanding the inner label and the outer label
Typically, a cosmetic product would have labels on the container (“inner label”), an outer packaging or box (“outer label”), and sometimes a package leaflet containing additional instructions or information.
The Cosmetic Rules not only prescribe the declarations but also specify the label on which these declarations must appear.
In accordance with cosmetic rules, the following statements must appear on the label or specified labels. If the product has only one label, all declarations must appear on that label.
Mandatory declarations for cosmetics made in India according to cosmetic rules, 2020
Interior and exterior labels
The following information must appear on the container label as well as any outer packaging.
- Cosmetic name
- Name of legal manufacturer
- Full address of the premises where the cosmetic was manufactured
- Use before the expiration date / date.
- The list of ingredients, present in a concentration of more than one percent, must be listed in descending order of weight or volume at the time they are added, followed by those in a concentration less than or equal to one percent, in any order, and preceded by the words “INGREDIENTS”
Interior or exterior labels
The following information must appear on the inner or outer label.
- Distinctive lot / lot code * [preceded by âBatch No.â, âB. Noâ, âBatchâ, âLot No.â or âLotâ]
- Manufacturing license number * [preceded by âMâ, âM.L. No.â, or âMfg. Lic. No.â]
It is advisable to include the license number and lot code on the outer and inner label, as most regulatory authorities verify the compliance of the outer label, but most consumers discard the secondary packaging when checking out. unpacking.
Only on Outer label:
The following information should only appear on the outer label:
- Net content (weight for solids, measurement of fluid for liquids and either for semi-solids) *
- Number of articles, if several
Only on interior labels:
If there are dangers associated with a cosmetic, the following must appear:
- Appropriate instruction manual
- Any warnings, cautions or special instructions
- Names and quantities of hazardous or toxic ingredients
Otherwise, only the statements that must appear on both the inner and outer label must be mentioned on the container.
Mandatory Declarations for Cosmetics Imported to India under Cosmetics Rules, 2020
The Cosmetics Rules stipulate the labeling requirements for all products sold in the Indian market, including imported cosmetics. All information that must appear on cosmetics produced in the country must also appear on imported cosmetics (except to the extent mentioned below). In addition, the contact details of the importer should also be mentioned, so that consumers and regulators have access to a national entity regarding imported products. Note that labeling changes can be made in a customs bonded warehouse i.e. before Indian customs clearance prior to import into India.
The following additional declarations must appear:
- Import registration certificate number [preceded by âRCâ, âRC No.â, âReg. Cert. No.â]
- Name of importer
- Importer’s address
- If the importer does not wish to declare the manufacturing site, then a declaration of the country of manufacture would suffice [âMade in (Country)â].
- If the cosmetic is imported from a country which does not require that the manufacturing license number be mentioned, the manufacturing license number does not need to be mentioned.
Small cosmetic packaging exemptions under cosmetic rules, 2020:
Small cosmetic containers are subject to certain relaxations.
- The manufacturer’s address can be shortened to the main place of manufacture only and to the PIN code when the cosmetic container is less than or equal to 60 ml of liquid and 30 g of solids and semi-solids.
- Cosmetics weighing up to 10 grams do not need to be listed on cosmetics weighing up to 10 grams if they are in a solid or semi-solid state or 25ml if they are in a liquid state.
- The declaration of the net content does not have to appear in the case of a packaging of perfume, eau de toilette or similar, the net content of which does not exceed 60 ml or of any solid or semi-solid cosmetic packaging. the net content of which does not exceed 30 grams
- The list of ingredients does not need to appear for cosmetics which are less than or equal to 60 ml of liquid and 30 g of solids and semi-solids.
These relaxations were probably granted to ensure that vital declarations are always present and legible, while avoiding unnecessary packaging and instructions.
Requirements for hair dyes containing dyes, colors and pigments under cosmetic rules, 2020:
Hair dyes should contain additional statements due to their strong chemical composition and the likelihood of reactions.
The following statements must appear on interior and exterior labels in English and local languages:
- âWarning.ï¹ ââThis product contains ingredients which may cause skin irritation in some cases and therefore a preliminary test according to the attached instructions must first be done. This product should not be used to tint eyelashes or eyebrows ; as such use can lead to blindness.
- âThis preparation can cause severe inflammation of the skin in some cases and therefore a preliminary test should always be done to determine whether or not there is particular sensitivity. To do the test, clean a small area of ââskin behind the ear. or on the inner surface of the forearm, using either soap and water or alcohol.Apply a small amount of hair dye as prepared for use on 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 can be assumed that no dye hypersensitivity exists. However, testing should be done beforehand. each application This preparation should not be used to tint eyebrows or eyelashes under any circumstances as severe inflammation of the eye or even blindness may result.
Cosmetics submitted to a Bureau of Indian Standards (BIS):
The ninth annex of the Cosmetics Rules specifies the BIS standards applicable to a total of 37 categories of cosmetic products, including skin powders, skin creams, hair oils, shampoos, soaps, lipsticks , foundations, etc. In addition, if new BIS standards are introduced for cosmetics, these would become mandatory six months after the publication date.
If any of the standards specify labeling requirements, they must be met. This requirement applies to both domestically produced and imported cosmetics.
Animal experimentation declaration
While most products include a statement or symbol to signify that the cosmetic has not been tested on animals, cosmetics rules do not require the statement to be made since animal testing has been done. outright banned for cosmetic products. If the brand chooses to include the statement, however, care should be taken to ensure that it does not use any of the symbols associated with certifications such as “Beauty without Bunnies” by PETA or “Leaping Bunny” by Cruelty-Free International, unless certification has actually been obtained.
Mandatory declarations for cosmetics imported or manufactured in India under the rules of legal metrology (packaged products), 2011
In addition to the cosmetic rules, the label must also contain the declarations required by the rules of legal metrology (packaged products) of 2011 (ârules relating to packaged productsâ).
The additional declarations that would be required are:
- Generic Product Name
- Maximum sale price
- Customer service contact information
- Date of import, if applicable
Modification of the mandatory declaration on the labels of cosmetic products:
Care should be taken when finalizing the labels of a cosmetic product, as any changes to the label after the product leaves the premises of the manufacturing plant (in the case of manufactured cosmetics) or Indian Customs (in the case of imported cosmetics), would require the approval of the Office of the Comptroller General of Medicines of India (India), which heads CDSCO, and, if the change concerns mandatory reporting under the Packaged Products Rules , the resulting authority as well.