CDSCO Import Registration for Eyeshadow & Eye Palettes in India: Standards, Documents and the Complete Process

CDSCO Import Registration for Eyeshadow & Eye Palettes in India: Standards, Documents and the Complete Process

Pressed eyeshadows, glitter shadows and multi-pan palettes are eye-area colour cosmetics, and each must be registered with CDSCO under the Cosmetics Rules, 2020 before import. Registration is product-level and tied to the specific formulation, its shades and the factory.

Because they are applied to the eye area, eyeshadows face the strictest colour controls in colour cosmetics — and a palette multiplies the variant count.

Is CDSCO Registration Mandatory for Eyeshadow & Eye Palettes?

Yes. Eyeshadow and eye palettes are Fourth Schedule eye preparations and require CDSCO registration before import. Each shade in a palette is declared, and the eye-area colour and mercury rules apply throughout.

Applicable Standard for Eyeshadow & Eye Palettes

No single product-specific Indian Standard applies to eyeshadow, so it is assessed against the country-of-origin standard plus the Cosmetics Rules, 2020, with the CoA drawn against the manufacturer’s finished-product specification. The colour rules, however, are the tightest of any category: colourants must be restricted to those permitted for use in the eye area under IS 4707 (Part 1) — several coal-tar colours permitted elsewhere are not allowed near the eye.

Mercury is permitted only as a preservative in eye-area products and only up to 70 ppm (0.007%), so a mercury declaration is expected, and an ophthalmological safety / eye-irritation assessment strengthens the file. A talc-based pressed shadow also needs the asbestos-free talc declaration, and glitter/effect pigments must carry eye-area-permitted CI numbers.

The Eye-Area Colour List and the Mercury Cap

Eyeshadow raises no drug question, but it faces the strictest safety gate in colour cosmetics. The recurring failures are eye-specific: colourants that are permitted on skin or lips but not on the eye area; mercury above the 70 ppm preservative allowance; and missing eye-irritation data. Glitter and effect pigments are the common trap — they must carry eye-area-permitted CI numbers.

Documents Required for Eyeshadow & Eye Palettes CDSCO Registration

  • Colourant declaration restricted to colours permitted for the eye area under IS 4707 (Part 1) — several coal-tar colours permitted elsewhere are not permitted near the eye.
  • Mercury declaration — permitted only as a preservative in eye-area products, up to 70 ppm (0.007%).
  • Ophthalmological safety / eye-irritation assessment.
  • Certificate of Analysis against the country-of-origin finished-product specification, plus microbiological limits.
  • Asbestos-free talc declaration for talc-based pressed shadows.
  • Shade-wise composition sheet — each shade (including every pan in a palette) is a separate variant at USD 50.

Label Requirements Specific to Eyeshadow & Eye Palettes

  • Directions for safe use and a caution to avoid direct contact with the eye.
  • Shade names, and batch number and expiry on the inner label.
  • Registration Certificate number preceded by “RC” or “Reg. Cert. No.”.
  • Net content by weight.

Step-by-Step: CDSCO Import Registration Process

The CDSCO cosmetic import registration route is the same for every product category, and we explain each step in our complete CDSCO cosmetic registration guide. For eyeshadow & eye palettes, these are the points that need the most attention:

  • Classify the product. First, confirm it meets the definition of a cosmetic under Section 3(aaa). Then map it to the eye preparations category under the Fourth Schedule, because this drives the fee and the certificate scope.

Fees and Timeline

You pay government fees online via Bharatkosh under head 0210041040000-00-1. The fee is USD 1,000 for the eye preparations category, USD 500 per manufacturing site and USD 50 per variant (shade, fragrance or formulation). In addition, a duplicate certificate costs USD 200 and permission for a novel ingredient costs USD 500. Finally, if CDSCO orders an inspection of an overseas site, the fee is USD 5,000. Palettes are the biggest fee driver in makeup: a 12-pan eyeshadow palette from one factory is USD 1,000 (category) + USD 500 (site) + 12 × USD 50 (pans) = USD 2,100 in government fees, since each pan is a declarable shade variant.

Common Mistakes That Trigger a CDSCO Query

  • Colourants not on the eye-area permitted list under IS 4707 (Part 1).
  • Glitter or effect pigments without eye-area-permitted CI numbers.
  • Missing eye-irritation / ophthalmological safety data.
  • Palette pans under-declared as variants at USD 50 each.

Related Approvals to Plan Alongside CDSCO

  • DGFT Importer-Exporter Code — every importer of record needs one before the first consignment.
  • LMPC registration (Legal Metrology) — eyeshadow & eye palettes is a pre-packaged commodity requiring MRP, net quantity, importer details, country of origin and consumer-care details on the pack.
  • Wholesale licence (Form 20B / 21B) — where the Indian agent also distributes drugs alongside cosmetics.
  • Drug import licence (Form 10) — needed if a therapeutic claim or a pharmacologically active ingredient makes the product a drug instead of a cosmetic.

Frequently Asked Questions

Is CDSCO registration mandatory for imported eyeshadow and palettes?

Yes. They are Fourth Schedule eye preparations and cannot be imported until registered under Rule 12(1) of the Cosmetics Rules, 2020, with the certificate issued in Form COS-2.

Which colours can an eyeshadow use?

Only colours permitted for the eye area under IS 4707 (Part 1). Several coal-tar colours permitted elsewhere on the body are not permitted near the eye, and glitter/effect pigments must also be eye-area-permitted.

Is mercury allowed in eyeshadow?

Only as a preservative in eye-area products, and only up to 70 ppm (0.007%). A mercury declaration is expected.

Is each pan in a palette charged separately?

Yes. Each shade, including every pan in a palette, is a variant at USD 50 and must be declared in the authorisation, the Free Sale Certificate and Form COS-1.

Why Choose PCN India Global

  • Claims triage — we confirm upfront whether your eyeshadow & eye palettes is cleanly cosmetic or at risk of drug reclassification.
  • Category mapping — the correct Fourth Schedule category and test scope confirmed for your formulation.
  • Dossier assembly — the full core document set prepared and cross-checked against the CDSCO checklist.
  • Label compliance — a Chapter VI review to correct any non-compliant or therapeutic wording before you print packaging.
  • End-to-end SUGAM filing — application, query response and the Form COS-2 grant managed for you.
  • Adjacent approvals — LMPC, DGFT/IEC and, where relevant, PESO/AYUSH coordinated alongside your CDSCO registration.

PCN India Global manages the complete CDSCO import registration process for eyeshadow & eye palettes — from claims triage and category mapping to dossier assembly, SUGAM filing and the Form COS-2 grant. WhatsApp or call +91 80109 05029, or email bdm@pcnindiaglobal.com, to get your import registration underway.

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