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.
The application is filed by the overseas manufacturer or, in practice, its Authorised Indian Agent.
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
Every Form COS-1 application needs the core document set — covering letter; First Schedule authorisation; Second Schedule Part-I; ingredient list with percentages; inner and outer labels; specification and method of testing; finished-product Certificate of Analysis; country-of-origin manufacturing licence or marketing authorisation; original Free Sale Certificate; non-animal-testing declaration; heavy-metal and hexachlorophene declaration; GMP / ISO 22716 certificate; correlation chart; Bharatkosh receipt; and the signed Form COS-1. On top of this base, Eyeshadow & Eye Palettes needs:
- 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
- Classify the product. Confirm it meets the definition of a cosmetic under Section 3(aaa) and map it to the eye preparations category under the Fourth Schedule — this drives the fee and the certificate scope.
- Appoint the Authorised Indian Agent. Execute the First Schedule authorisation, signed jointly by manufacturer and agent, then notarised and apostilled (Hague states) or embassy-attested.
- Assemble the technical dossier. Ingredient list with INCI names and percentages, the finished-product CoA against the applicable standard, inner and outer labels, GMP / ISO 22716 evidence and the Free Sale Certificate.
- Align the label to Chapter VI. Indian labelling is a top rejection reason; India-specific content may be stickered onto the unit pack at a bonded warehouse before clearance.
- Pay the fee on Bharatkosh. Compute category + site + variant fees, pay online under head 0210041040000-00-1 and retain the acknowledgement receipt.
- File Form COS-1 on SUGAM. Upload the full checklist, including the correlation chart that ties each product serial number in COS-1 to the Free Sale Certificate and the authorisation.
- Respond to CDSCO queries. Reply within the stipulated period — each query effectively restarts the clock, so a clean first filing is the biggest lever on timeline.
- Receive Form COS-2. Print the Registration Certificate number on every unit pack, with the holder’s name and address, before the goods are cleared for sale.
Fees and Timeline
Government fees are paid online via Bharatkosh under head 0210041040000-00-1: USD 1,000 for the eye preparations category, USD 500 per manufacturing site and USD 50 per variant (shade, fragrance or formulation). A duplicate certificate is USD 200, permission for a novel ingredient is USD 500, and inspection of an overseas manufacturing site, if ordered, 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.
Typical approval time is four to six months from acceptance of a complete application, and each CDSCO query effectively restarts the clock. The Registration Certificate is valid for five years from the date of issue and must be re-registered before it lapses.
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 — mandatory for any importer of record 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) — where a therapeutic claim or a pharmacologically active ingredient makes the product a drug rather than 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.
How long does registration take and how long is it valid?
Around four to six months for a complete application; the certificate is valid for five years and must be re-registered before expiry.
Do we need an Authorised Indian Agent?
In practice yes — the agent files on the First Schedule format and carries statutory liability for the product in India.
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 9289587478, or email admin@pcnindiaglobal.com, to get your import registration underway.
