Rule 34 of the Cosmetics Rules, 2020 governs every mandatory declaration on a cosmetics label in India. Non-compliant labelling is the most common COS-1 rejection trigger.
Cosmetics labelling in India is governed by Chapter VI of the Cosmetics Rules, 2020, issued under the Drugs and Cosmetics Act, 1940. Rule 34 establishes the mandatory declaration framework for every cosmetic product sold in India — imported or domestically manufactured. Supplementary obligations arise under the Legal Metrology (Packaged Commodities) Rules, 2011, and Bureau of Indian Standards specifications under the Ninth Schedule, principally IS 4707.
Non-compliant labelling is the single most common reason for COS-1 rejection at CDSCO. A label submitted during import registration is not a formality — it is a compliance document reviewed against Rule 34, the Second Schedule, and applicable BIS standards before registration is granted. Foreign manufacturers and their Indian importers bear joint responsibility for every declaration that appears, or fails to appear, on that label.
Rule 34 applies to both inner and outer labels of every cosmetic sold in India. The following declarations are mandatory:
The product name as it will appear in commerce.
Full address of the manufacturing facility. Where the product is not manufactured at a facility owned by the brand, the label must state the name of the actual manufacturer or the country of manufacture in the format: Made in [country name].
Month and year only, in uncoded form. The Rules do not permit expiry coding — the date must be consumer-readable.
Preceded by "B", "Batch No.", "B. No.", "Batch", "Lot No.", or "Lot". Exemptions apply for liquids in packs of 25 ml or less and solids or semi-solids in packs of 10 g or less.
Preceded by "M", "M.L. No", or "Mfg. Lic. No.". For imported cosmetics, this declaration is exempt where it is not a mandatory requirement in the country of origin.
Declared on the outer label by weight, fluid measure, or numerical count. Exempt for perfumes in packs of 60 ml or less and solids or semi-solids in packs of 30 g or less.
Mandatory where any hazard exists. Specific categories — including products containing hexachlorophene or hair dyes — carry additional warning text requirements that must appear in a conspicuous manner.
Ingredients in descending order of concentration by weight or volume for those present at concentrations above 1 percent; ingredients below 1 percent may be listed alphabetically. The list must be preceded by the word INGREDIENTS — no abbreviation or variation is permitted. Pack-size exemptions apply: the ingredient list is not required for liquids in packs of 60 ml or less and solids or semi-solids in packs of 30 g or less under Rule 34(7).
For imported cosmetics, two additional mandatory declarations apply:
Preceded by "RC", "RC No", or "Reg. Cert. No". This is the COS-1 or COS-2 number issued by CDSCO following successful import registration.
The registration certificate holder responsible for marketing the product.
Rule 34(9) permits these India-specific declarations to be added by stickering onto unit packs at customs bonded warehouses before final import clearance. This provision exists precisely because foreign manufacturers cannot pre-print an RC number that does not yet exist at the time of manufacturing. The sticker must be permanent, legible, and fully compliant — a temporary label or a label that obscures other mandatory declarations will be rejected at customs.
Rule 34(3)(e) requires ingredients to be declared by common name or chemical name in the prescribed order. CDSCO's own checklists for COS-1 applications interpret this requirement as INCI nomenclature in practice — submissions using trade names or proprietary ingredient identifiers are routinely flagged.
A formal proposal to mandate INCI names by rule amendment was reviewed by the Drugs Consultative Committee in 2024 and rejected, primarily on grounds of label space constraints. The regulatory position therefore remains: INCI is the operative standard applied during CDSCO review, but the Cosmetics Rules 2020 do not yet codify this by explicit rule number. Use INCI names on every label submitted for COS-1 registration. Deviation from INCI will draw a deficiency notice.
There is no exemption from ingredient naming based on the number of ingredients in a formulation. The only exemptions are pack-size based, as set out under Rule 34(7).
The Ninth Schedule to the Cosmetics Rules, 2020 requires cosmetics in specified categories to comply with the labelling requirements set out in the relevant Indian Standard. IS 4707 is the primary standard:
Classifies colourants permitted for use in cosmetics. Dyes and pigments used in skin creams, lipsticks, and eye preparations must comply with the permitted colourant list in Part 1. A label that names a colourant not included in the IS 4707 Part 1 permitted list — or that uses a colourant in a category where it is not permitted — will not pass CDSCO ingredient review.
Covers raw materials and adjuncts excluding colours, including the GNRA (generally not regarded as adverse) list, restricted substances with concentration limits, permitted preservatives, and UV filters. BIS notified amendments to Parts 1 and 2 in 2025, updating the permitted and restricted ingredient lists.
Labels referencing ingredients must be cross-checked against the current IS 4707 specifications before submission. A mismatch between label declarations and IS 4707 compliance status is a primary basis for COS-1 rejection under Rule 34(8).
Cosmetics sold in India are packaged commodities under the Legal Metrology Act, 2009. The Legal Metrology (Packaged Commodities) Rules, 2011 impose declarations that are separate from, and additional to, the Cosmetics Rules 2020 requirements. Mandatory declarations under the PCR include:
Maximum Retail Price (MRP), inclusive of all taxes
Net quantity in standard units
Name and address of the manufacturer, packer, or importer
Month and year of manufacture or packing (for packs above 30 g or 60 ml)
Customer care details for the person responsible for the product
For imported cosmetics, the importer's Indian address satisfies the manufacturer/packer declaration. MRP must be declared in the format MRP ₹ [amount] (incl. all taxes). Products without a valid MRP declaration will not clear Legal Metrology inspection at ports of entry, irrespective of CDSCO registration status.
Both compliance frameworks must be satisfied simultaneously. A label that passes CDSCO review but fails Legal Metrology will be detained at the port.
Rule 36 states: No cosmetic may purport or claim to purport or convey any idea which is false or misleading to the intending user.
Beyond the prohibition on false claims, the critical compliance risk is drug reclassification. A cosmetic label that makes claims triggering the definition of a drug under Section 3(b) of the Drugs and Cosmetics Act, 1940 converts the product into a drug — which requires a drug manufacturing or import licence, not a cosmetics registration.
Claims that trigger drug classification include:
Any claim to treat, prevent, cure, or mitigate a disease or disorder — acne treatment, anti-dandruff treatment, eczema relief
Claims that affect the structure or function of the human body — stimulates collagen production, regulates sebum secretion
Terms that imply pharmaceutical action — clinically proven to treat, dermatologist-prescribed, Drug Facts
Depigmenting or skin-lightening claims using ingredients such as tranexamic acid, which attracts Rule 36 classification as a drug in depigmenting claims
CDSCO will reject any COS-1 or COS-2 application where the submitted label contains drug claims. The label must be revised and resubmitted; the application clock restarts.
Artwork review at the pre-submission stage is therefore not optional. Every claim on the label — including claims on the secondary packaging, the box, and any accompanying literature — must be assessed against Rule 36 before filing.
CDSCO requires original labels or draft artwork incorporating all Chapter VI mandatory declarations as part of the COS-1 application. The review covers:
Presence and correct format of all Rule 34 declarations
IS 4707 compliance of all listed ingredients
Absence of drug claims under Rule 36
Correct INCI nomenclature
Ingredient list completeness and descending order accuracy
Country of origin and manufacturer address accuracy
Common rejection triggers include: missing importer address, absent or incorrectly formatted expiry date, ingredient names not in INCI format, colourants not listed in IS 4707 Part 1, and claims language that approaches drug territory.
Rule 15(2) requires that any post-registration change to labelling be notified to the Central Licensing Authority within 15 days. Artwork changes — reformulations, pack size changes, claim additions — all trigger this notification obligation.
Activity | Applicable Form / Rule | Timeline
COS-1 label review (as part of import registration) | Form COS-1, Rule 13 | 60 days from complete submission
Post-registration label change notification | Rule 15(2) | Within 15 days of change
Legal Metrology LMPC registration (importer) | LMPC application | 60 days
Endorsement for pack size / variant addition | Rule 15(1) | 30–45 days
Cosmetics labelling compliance requires simultaneous adherence to Rule 34 of the Cosmetics Rules 2020, IS 4707 Parts 1 and 2 under the Ninth Schedule, Rule 36 for claims, and the Legal Metrology (Packaged Commodities) Rules 2011. A label audit before COS-1 submission is not optional — it is the only reliable way to prevent a rejection that restarts the 60-day clock.
Contact Cosmetics Consultants India for a pre-submission label review. We assess every Rule 34 declaration, verify IS 4707 ingredient compliance, and identify Rule 36 exposure before your application reaches CDSCO.
Rule 34 of the Cosmetics Rules, 2020 governs every mandatory label declaration for imported cosmetics in India — from RC number and INCI ingredients list to expiry date format and net contents. Full compliance reference with inner vs. outer label obligations.
Learn more →Pre-submission label audit against Rule 34, IS 4707, and CDSCO non-compliance requirements. Every defect identified before your application reaches the portal.
Learn more →Rule 34(7) of the Cosmetics Rules 2020 mandates descending-order ingredient listing on Indian cosmetics labels. INCI nomenclature is required at the dossier level under Second Schedule Part-I, Clause 3(a). This page covers the full compliance standard: listing order, fragrance declaration thresholds, colour additive identification, pack-size exemptions, and CDSCO rejection triggers.
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