Under the Drugs and Cosmetics Act, 1940, the Ministry of Health and Family Welfare has published the Cosmetics Rules, 2020. This action is intended to bring effective compliance throughout all processes in India’s cosmetic industry. The notification was issued to define and amend the older Drugs and Cosmetics Rules, 1945[1] regulations governing the import, production, labelling, sale, and distribution of cosmetics in India. Section 12 and 33 under the Drugs and Cosmetics Act, 1940 govern the notice (23 of 1940). These guidelines will apply to cosmetics as specified in Section 3 of the Drugs & Cosmetics Act of 1940, clause (aaa) (23 of 1940). The Ministry had earlier released the proposed norms and requested feedback and ideas from the interested parties. Last, the Central Government announced the Cosmetic Rules, 2020. In this article, we have described compulsory labelling Standards for Cosmetics.
Definition of Cosmetics
Cosmetics are designed to be applied to the human body for cleansing, beautification, boosting attractiveness, or altering the appearance without changing the body’s structure or functions. Products including skin creams, lotions, lipsticks, nail polishes, eye and face makeup preparations, shampoos, permanent waves, hair colours, toothpaste, deodorants, and any substance intended for use as a cosmetic product component are all covered by this description. Products like soap that predominantly contain an alkali salt of fatty acid and have no additional label claim to clean the human body are not legally considered cosmetics.
Mandatory Requirements of Labelling Standards for Cosmetics
Regulatory declarations usually don’t receive the same importance as cosmetic item claims & design. Still, they are essential nonetheless and may invite liability in case they are found to be missing from a cosmetic product package. This statement may apply to cosmetics sold all around the sentence but is especially true for cosmetics items sold in India because the Indian cosmetics regulator (State Licensing Authority for domestically manufactured cosmetics and the Central Drugs Standards Control Organisation for imported cosmetics) does not approve labels at the time of granting marketing authorization. It is set up for the manufacturers & importers of cosmetics items to ensure that compulsory declarations laid down under the Cosmetics Rules, 2020 and other laws appear on the products’ labels. Omitting mandatory declarations would render the item ‘misbranded’ under the Drugs & Cosmetics Act, 1940. It may have consequences for the manufacturer or importer, ranging from cancellation or suspension of a manufacturing license or import registration certificate to criminal prosecution. It may even have repercussions for the whole seller & retailer, as misbranded cosmetic items are bound to be confiscated without compensation.
Essential Points of Labelling Standards for Cosmetics
Following are some essential points of Labelling Standards for Cosmetics under Cosmetics Rules 2020:
- Before applying for label compliance, ensure that the label follows the guidelines according to the labelling requirements mentioned in the New Cosmetics Rules 2020.
- The regulatory body can provide a significant update or rejection of the label in case the label on the product doesn’t comply with the New Cosmetics Rules 2020.
- Information on the label, like the manufacturer’s name, net weight of the product, and components, should be verified with the official documents of the cosmetic product.
Understanding Outer & Inner Labelling Standards for Cosmetics
Typically, cosmetic items would have labels on the inner label (container), an outer label (outer wrapper or box), and sometimes a leaflet containing instructions or additional details. The Cosmetics Rules not only mention the declarations but also stipulate the label on that those declarations should appear. The Cosmetics Rules not only prescribe the declaration but also stipulate the label on that those declarations should appear. Following are the mandatory declarations for cosmetics manufactured in India under Cosmetics Rules, 2020:
- Inner & Outer Labels: The following details must appear on the label on the container and any external packaging.
- Name of Cosmetic;
- Name of the legal manufacturer;
- Expiry date or use before date;
- Address of cosmetic manufacturing premises;
- List of components present in a concentration of more than 1% shall be listed in the descending order of volume or weight at the time they are added, followed by those in a concentration of less than/equal to 1 %, in any order, and preceded by the words “INGREDIENTS”.
- Inner or Outer Labels: The following details must appear on either the outer or inner label.
- Distinctive lot/batch code (mentioned as Lot No. /Lot, Batch No. /B. No.)
- Manufacturing License Number (M.L.No. or Mfg. Lic. No.)
- Only on Inner Label: If any hazards are linked to a cosmetic product, the following should appear.
- Any warning, caution or special directions;
- Adequate directions for use;
- Names & quantities of ingredients which are poisonous or hazardous;
- Only on Outer Label: The following details must appear on the only outer label.
- Number of products, in case of more the one;
- Net contents (fluid measure for liquids, weight for solids, and either one semi-solids)
Mandatory Labelling Standards for Cosmetics Imported into India under Cosmetics Rules, 2020
The Cosmetics Rules stipulate the labelling standards for all cosmetics products sold in the Indian market, including imported cosmetics. All the details that need to appear on domestically produced cosmetics need to appear on imported cosmetics. In addition, information about the importer needs to be mentioned so that users and regulators can access a domestic entity concerning the imported cosmetic products. The following are additional Labelling Standards for Cosmetics that need to appear:
- Name of Importer;
- Complete Address of Importer;
- Import Registration Certificate Number (“RC”, “RC No.”, and “Reg. Cert. No.”);
- In case the cosmetics are imported from a country that doesn’t need the manufacturing license number to be mentioned, the manufacturing license number is not required.
- In case of the importer doesn’t wish to declare the manufacturing premises, then a declaration of country of manufacture would suffice (Made in Country).
Exemption for Small-size Cosmetic Packages under Cosmetics Rules, 2020
Small Containers of Cosmetics are subject to specific relaxation:
- Manufacturer address may be shortened to the only principal place of manufacture and the pin code where the cosmetics container is less than/ equal to 60 ml of liquid and 30g of solids & semi-solids.
- The declaration of net contents does not require to appear in case of the package of toilet water, perfume or the like, the net content of that doesn’t more than 60 ml or ant package of semi-solid or solid cosmetic the net content of that doesn’t more than 30 grams.
- Batch code is not required to be mentioned on cosmetics that are up to 1o grams in case of the semi-solid or solid state or 25 ml in case of the liquid state.
- The ingredients list is not required for cosmetics that are less than or equal to 60 ml of liquid or 20 grams of semi-solid or solid.
Conclusion
With the growth in the cosmetic market, it is important to make cosmetic products stand out from competitors. A cosmetics product is also assessed by its users based on its labelling standards for cosmetics. Hence, a label should appear under regulations prescribed by the New Cosmetics Rules, 2020, for fast approval from the authorities.
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