Pre-submission label audit against Rule 34, IS 4707, and CDSCO non-compliance requirements. Every defect identified before your application reaches the portal.
A non-compliant label is the single most common reason a COS-1 application triggers a stop-clock notice. Under Rule 34 of the Cosmetics Rules, 2020, every cosmetic product — imported or domestically manufactured — must carry a defined set of declarations on its inner and outer labels before it can be submitted for CDSCO registration. Labels that reach the CDSCO portal without a pre-submission audit routinely return with objections on ingredient declarations, manufacturer address mismatches, expiry date formatting, or claims that attract drug classification under Rule 36. Each objection cycle adds 3–6 weeks to a 60-day processing window that does not restart at zero — it compounds.
Our Label Review Service audits your artwork against the full compliance framework before your application reaches CDSCO. We identify every defect, specify the corrective action with the applicable rule reference, and confirm the revised label is submission-ready.
CDSCO's label review is not a formality. Every field on your artwork is cross-referenced against the application form, the Free Sale Certificate, and the regulatory framework below.
Both your inner label (the container) and outer label (the carton or box) must carry:
Product name
Name and complete address of the manufacturer, including manufacturing premises location
Where manufacturing is outsourced: the actual manufacturer's name and address, or "Made in [Country Name]"
For containers of 30g or less (solids) or 60ml or less (liquids): manufacturer name with principal place of manufacture and PIN code
Batch number
Manufacturing licence number
Use Before date or date of expiry in Month–Year format
The outer label exclusively must carry the declaration of net contents — expressed as weight for solids, fluid measure for liquids, or either for semi-solids, combined with numerical count where the product is sub-divided.
The inner label exclusively must carry adequate directions for safe use where hazards exist, all warnings and cautions, and a statement specifying the names and quantities of any hazardous or poisonous ingredients.
For imported cosmetics: the name and address of the registered Indian importer, responsible person, or licence holder is additionally required on the label.
If your product has only a single label — no separate inner and outer — that label must contain every element from both categories without exception.
Ingredients must be listed in descending order of concentration for all ingredients present at 1% or above, followed by ingredients at or below 1% in any order, preceded by the heading "INGREDIENTS". Nomenclature must follow INCI convention throughout.
Under IS 4707 (Part 2):2017, fragrance and perfume components are subject to additional disclosure thresholds: individual fragrance substances must be declared in the ingredient list when concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products.
All colour ingredients must be drawn exclusively from the permitted lists in IS 4707 Part 1 or IS 4707 Part 2. No ingredient may appear on the prohibited substances list at Annexure A of IS 4707 (Part 1 and 2).
Rule 36 prohibits any label from conveying an idea that is false or misleading to the user. CDSCO's non-compliance list extends this to any phrase that attracts drug classification: claims referencing treatment of disease or disorder, structural or functional effects on the human body, "Drug Facts" panels, and phrases such as "Dermatologist recommended" used in a therapeutic context. Products bearing such claims fall outside the statutory definition of a cosmetic and cannot be registered under the Cosmetics Rules, 2020. A claims review is not optional — it is the first filter.
Net content declarations must use metric units. MRP must be declared on the outer label in the format prescribed under the Legal Metrology (Packaged Commodities) Rules, 2011. Non-metric unit declarations and absent or incorrectly formatted MRP are among the most frequent objection triggers at the customs stage, independent of CDSCO's review.
The Cosmetics (Amendment) Rules, 2025 clarified that "Use Before" refers to the first day of the marked month, while "date of expiry" indicates the final day of the month. Labels prepared before this amendment that do not reflect this distinction require revision before submission.
These are the defect categories that generate stop-clock notices and objection cycles in active COS-1 and COS-2 applications.
The manufacturer name and address on your label must match the Power of Attorney, the Letter of Authorization, and Form COS-1 exactly — character for character. Any divergence triggers an objection requiring re-authentication of the POA or re-amendment of the application. This is the longest-resolving category: 40–50 days across multiple objection cycles.
Missing INCI names, incorrect ordering, absent fragrance thresholds under IS 4707 Part 2, and failure to demarcate the ≥1% and ≤1% thresholds correctly. Typical resolution: 10–20 days per cycle.
Dates not presented in Month–Year format, or labels that do not reflect the 2025 amendment's clarification on "Use Before" versus "date of expiry". Resolution: 10–15 days per resubmission cycle.
CDSCO requires a clear mapping between each product variant and pack size on your label artwork and the corresponding entry on the Free Sale Certificate issued by the source country. Where this matrix is absent or ambiguous, CDSCO demands a correlation table — 15–20 days to resolve.
Labels with phrases referencing treatment, disease, structural or functional body effects, or "Dermatologist recommended" in a therapeutic context. Applications bearing these claims are returned; the product cannot proceed to registration without full claims revision.
Missing MRP, MRP in non-metric format, or net content expressed in non-standard units.
Absent from inner labels or inconsistent with declarations in Form COS-1.
Labels that do not conform to the BIS specifications referenced in the Ninth Schedule of the Cosmetics Rules, 2020, including use of non-permitted colour ingredients or fragrances below the IS 4707 Part 2 disclosure threshold.
Incorrect unit conversions, failure to specify whether the measure is weight or volume, or omission of item count where the product is sub-divided.
A COS-1 application with label defects that triggers a first-round objection and single correction cycle adds a minimum of 3–6 weeks to processing. Applications that cycle through multiple objection rounds extend total approval time from the standard 60-day window to 9–12 months.
1. Document Submission — Submit your label artwork (inner and outer, all variants and pack sizes), ingredient list with percentage data, draft application form, and any existing Free Sale Certificates. For COS-1 applications: also submit the draft Power of Attorney and Letter of Authorization.
2. Rule 34 Structural Audit — We check every mandatory field against Rule 34 requirements for inner and outer labels. Each field is verified for presence, format, and consistency with your application form and POA documentation.
3. Ingredient and IS 4707 Review — We verify INCI nomenclature for every listed ingredient, ordering against the ≥1% and ≤1% thresholds, fragrance disclosure against IS 4707 Part 2 thresholds, and colour ingredients against the IS 4707 Part 1 and Part 2 permitted lists.
4. Claims Screening Under Rule 36 — Every claim on the label — front panel, back panel, and any pack insert — is screened against CDSCO's non-compliance list and Rule 36. Claims that attract drug classification are flagged with the specific phrase and the applicable regulatory basis for revision.
5. Legal Metrology Check — Net content declarations, MRP format, and unit notation are verified against the Legal Metrology (Packaged Commodities) Rules, 2011.
6. POA–Form–Label Consistency Matrix — Manufacturer name, address, and authorised signatory details are cross-referenced across all submitted documents to confirm exact consistency before submission.
7. Written Audit Report — We deliver a written report listing every defect, the applicable rule or standard, the required corrective action, and — where applicable — the exact revised text.
8. Post-Revision Confirmation — Once you return the revised artwork, we confirm each correction against the audit report before the label is submitted with your application.
Service | Scope | Turnaround
Single product label review | Inner + outer label, one variant | 3 working days
Multi-variant review | Up to 10 SKUs, same brand | 5 working days
Portfolio review | 11–50 SKUs (COS-1 cap per application) | 8–10 working days
Claims screening only | Rule 36 + CDSCO non-compliance list | 2 working days
Post-objection label correction | Response to CDSCO stop-clock notice | 3–5 working days
Fee schedules are provided on enquiry. All reviews include the written audit report and one post-revision confirmation round.
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 →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.
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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