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.
India's ingredient listing requirement sits at the intersection of two regulatory instruments: Rule 34(7) of the Cosmetics Rules 2020, which governs label format, and the Second Schedule Part-I, Clause 3(a), which governs what CDSCO accepts at registration. Understanding both — and where they diverge — is the difference between a label that clears review and one that triggers a stop-clock notice.
Rule 34(7) of the Cosmetics Rules 2020 states:
"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'."
Rule 34(7) does not use the term "INC" or "INCI." It mandates a list, an order, and a header word. The nomenclature standard — the naming system you must use — is established separately, at the point of registration.
Second Schedule Part-I, Clause 3(a) requires submission of the "Name(s) of ingredients in the nomenclature of standard references." CDSCO's General Non-compliances Observed document names the failure mode explicitly: "Nomenclature of each ingredient (INCI) not submitted" is listed under Section 6 (Product Composition data) as a primary non-compliance that halts review.
The practical consequence: your label ingredient list must use INCI names because your registration dossier must use INCI names, and CDSCO cross-checks the two. A label carrying common names or trade names against a dossier submitted in INCI will not pass scrutiny.
In June 2024, a proposal before the Drugs Consultative Committee to formally mandate INCI names on cosmetic labels — making the label-side requirement explicit in the Rules — was rejected on the grounds of space constraints.
This creates a specific compliance ambiguity. The Rules do not mandate INCI on the physical label. CDSCO mandates INCI in the registration dossier. Industry practice has resolved this by using INCI on labels because the dossier and label must be consistent. The DCC rejection does not relax the dossier requirement; it only means the label-side rule was not amended. For any product registered with CDSCO, INCI on the label remains the practical standard.
Rule 34(7) establishes a two-tier listing structure:
Tier 1 — ingredients above 1% concentration: Listed in descending order of weight or volume as added during manufacture.
Tier 2 — ingredients at or below 1% concentration: Listed in any order, following all Tier 1 ingredients.
The rule includes a pack-size exemption: the ingredient statement need not appear on packs of 60 ml or less (liquids) or 30 g or less (solids and semi-solids). This is a label exemption, not a registration exemption — CDSCO still requires full composition data in the dossier regardless of pack size.
The concentration threshold that matters for ordering is 1% by weight or volume at the point of manufacture, not the finished product concentration after processing. Formulators working with actives that undergo concentration change during processing should note that the reference point is the concentration at the time of addition.
Rule 39(3) prohibits the use of any dye, colour, or pigment not specified in IS 4707 Part 1 or Part 2 and included in the Tenth Schedule of the Cosmetics Rules 2020.
The Tenth Schedule lists permitted colourants by common name, chemical name, and Colour Index number. Phthalocyanine Blue, for example, carries CI Number 74160. The regulatory identification standard for colours is the CI number — this is how CDSCO and BIS catalogue permitted colourants.
For label listing, colours should be identified consistently with how they appear in the Tenth Schedule and in the submitted dossier. Where an ingredient has both an INCI name and a CI number, the CI number is the primary regulatory identifier under Indian law. Labels that list a colour only by trade name or common name, without the CI reference, create a mismatch against the dossier that CDSCO will flag.
The EU approach — listing all fragrance components collectively as "parfum" or "aroma" with individual allergen declarations above threshold — does not apply in India.
CDSCO FAQ Q.62, referencing IS 4707 (Part 2):2017, sets individual declaration thresholds for fragrance substances:
Leave-on products: individual fragrance components must be declared when present above 0.001%
Rinse-off products: individual fragrance components must be declared when present above 0.01%
Components below these thresholds are exempt from individual declaration. Components above these thresholds must be listed individually in the ingredient list, not masked under a collective fragrance term.
For import registrations, this requires the foreign manufacturer to provide full fragrance breakdown — individual INCI names and concentrations — in the dossier so CDSCO can verify against IS 4707 Part 2 restrictions. Formulators using proprietary fragrance blends must request the full composition from their fragrance supplier before submission. A declaration that states only "fragrance blend" or "parfum" will not satisfy the dossier requirement.
The Cosmetics Rules 2020 require the ingredient list on both primary (inner) and secondary (outer) labels. Single-label packs must carry all required particulars on that single label. There is no provision permitting the ingredient list to appear only on the outer pack while the inner pack carries a reduced label — both must be compliant.
The space-constraint exemption in Rule 34(7) applies by pack size (≤60 ml / ≤30 g), not by label position. A 50 ml product in a box with an outer carton is exempt from the ingredient list on both labels. A 100 ml product in the same configuration must carry the ingredient list on both.
CDSCO's General Non-compliances Observed document, under Section 6 (Product Composition data), identifies the following as specific rejection triggers:
Nomenclature failures: Ingredient names submitted in common name, trade name, or chemical IUPAC name instead of INCI. Rule 13(1) authorises the Central Licensing Authority to reject applications where Second Schedule Part-I documents are not in order; Clause 3(a) of that Schedule mandates standard reference nomenclature.
Composition mismatch: Ingredient names or concentrations on the label that do not match the dossier submission. CDSCO cross-references the two documents during review.
Colour identification errors: Colours listed without CI number reference, or colours not present in the Tenth Schedule.
Fragrance non-disclosure: Failure to declare individual fragrance components above the IS 4707 Part 2 thresholds for leave-on or rinse-off products.
Order of listing errors: Ingredients above 1% not arranged in correct descending order. This is verifiable against the formula sheet in the dossier.
Each of these triggers a non-compliance notice. Applications do not progress until the deficiency is resolved; the clock restarts from the point of resubmission.
Both frameworks require descending-order listing above 1%, the "INGREDIENTS" header, and a threshold below which order does not apply. The divergences are material for brands entering India from EU-registered markets:
Nomenclature standard: EU mandates INCI per EC 1223/2009. India mandates INCI at the dossier level via Second Schedule Part-I; the label-side rule (Rule 34(7)) references "list of ingredients" without naming INCI explicitly.
Fragrance: EU permits collective "parfum"/"aroma" listing with allergen carve-outs. India requires individual declaration above product-type thresholds per IS 4707 Part 2.
Colour additives: EU uses INCI names for colour additives. India uses CI numbers per the Tenth Schedule as the primary identifier.
Pack exemption: EU has no equivalent small-pack exemption from ingredient listing. India exempts packs ≤60 ml / ≤30 g under Rule 34(7).
Brands with EU-approved labels cannot assume Indian compliance. A label relying on "parfum" for fragrance disclosure will fail CDSCO review regardless of EU status. A colour listed by INCI name without CI number may create a Tenth Schedule verification problem.
Ingredient listing on Indian cosmetics labels is governed by Rule 34(7) of the Cosmetics Rules 2020 for format and by Second Schedule Part-I, Clause 3(a) for nomenclature. The practical standard — INCI names, CI numbers for colourants, individual fragrance declaration per IS 4707 Part 2 thresholds — must be consistent across the label and the CDSCO dossier. Inconsistency between the two is a primary non-compliance trigger under Rule 13(1).
Cosmetics Consultants India reviews ingredient lists against Rule 34(7), Second Schedule Part-I, IS 4707 Parts 1 and 2, and the Tenth Schedule before CDSCO submission. Contact us to audit your label before filing.
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 →COS-1 is the mandatory import Registration Certificate for all cosmetics from non-SAARC countries under Rule 12(1) of the Cosmetics Rules 2020. We manage the full application — Second Schedule, Letter of Authorization, fee calculation, and SUGAM portal filing.
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