CDSCO Registration for Lip & Cheek Tint Import in India

Multi-use lip-and-cheek tints, liquid stains and gel tints colour both lips and cheeks, 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 used on the lips, they are treated with the same strictness as a lip colour — the stain dyes and pigments must be India-permitted and the heavy-metal limits apply.

📋 Is CDSCO Registration Mandatory for Lip & Cheek Tint?

Yes. Lip-and-cheek tints are Fourth Schedule colour / lip preparations and need CDSCO registration before import. The certificate covers the declared shades.

The application is filed by the overseas manufacturer or, in practice, its Authorised Indian Agent.

📘 The Indian Standard in Detail

No single product-specific Indian Standard applies to a multi-use tint, so it is assessed against the country-of-origin standard plus the Cosmetics Rules, 2020 (a predominantly-lip tint aligns with IS 9875 in substance), with the CoA drawn against the manufacturer's finished-product specification.

Every stain dye and pigment is declared by Colour Index (CI) number and mapped to IS 4707 (Part 1) and the Tenth Schedule, and heavy metals on the colourants are checked strictly (arsenic ≤ 2 ppm, lead ≤ 20 ppm, other heavy metals ≤ 100 ppm total) because a lip-and-cheek tint is worn on the lips and partly ingested. Each shade is a chargeable variant.

🗂️ The Core Document Set — Required for Every Application

Whatever the product, Form COS-1 carries the same core dossier. Getting this base right is what decides whether the file clears in one pass or comes back as a query letter; the product-specific documents in the next section sit on top of it.

• Covering letter — states the purpose (fresh registration, endorsement of a product, site or pack size, or re-registration), references any earlier certificate and points to the correlation charts.
• Authorisation from the manufacturer (First Schedule) — names the manufacturer, every manufacturing premises, the Authorised Indian Agent and each product, variant and pack size; signed jointly on every page, then notarised and apostilled (Hague states) or embassy-attested.
• Part-I of the Second Schedule — company and product particulars, chemical information and the nine statutory undertakings, completed afresh for each COS-1.
• Ingredient list with percentages — INCI nomenclature, percentage of each ingredient, signed by a competent person; must exclude anything listed in Annex A of IS 4707 (Part 2).
• Inner and outer labels — legible originals for the product and every variant, compliant with Chapter VI.
• Specification and method of testing — the finished-product specification and test method, signed and stamped.
• Finished-product Certificate of Analysis — a batch CoA against the applicable Ninth Schedule Indian Standard, or against country-of-origin standards where no Indian Standard exists.
• Manufacturing licence / marketing authorisation — an authenticated copy from the country-of-origin regulator, or a manufacturer's undertaking where no such regime exists.
• Free Sale Certificate (FSC) — original, from the National Regulatory Authority of the country of origin; if issued by a chamber of commerce, apostilled or embassy-attested, and the product list signed and stamped.
• Non-animal-testing declaration — that the products have not been tested on animals after 12 November 2014.
• Heavy-metal and hexachlorophene declaration — a test report for Pb, As, Hg and other heavy metals plus microbiological results, or a manufacturer's undertaking of compliance.
• GMP / ISO 22716 certificate — evidence of cosmetic Good Manufacturing Practice at the overseas site.
• Correlation chart — maps each product serial number in COS-1 against the FSC and the Authorisation; missing or inconsistent charts are among the most common causes of query letters.
• Bharatkosh fee receipt — acknowledgement of the fee paid under head of account 0210041040000-00-1.
• Duly signed Form COS-1 — original, with every detail matching the Authorisation and Second Schedule Part-I exactly.

➕ Extra Documents for Lip & Cheek Tint

On top of the core dossier above, a lip-and-cheek tint application needs:

• Colourant declaration listing every stain dye and pigment by CI number, mapped to IS 4707 (Part 1) and the Tenth Schedule.
• Heavy-metals report on the colourants (As ≤ 2 ppm, Pb ≤ 20 ppm, other heavy metals ≤ 100 ppm total).
• Certificate of Analysis against the country-of-origin specification.
• Shade-wise composition sheet — each shade is a separate variant at USD 50.
• Declaration that no lead or arsenic compounds have been used for colouring.
• Microbiological report.

⚗️ Composition & Safety Limits

Regardless of category, the finished cosmetic must respect the composition limits in the Cosmetics Rules, 2020. CDSCO checks these against the heavy-metal report or the manufacturer's undertaking:

• Arsenic (in permitted colours) — not more than 2 ppm, as arsenic trioxide.
• Lead (in permitted colours) — not more than 20 ppm, as lead.
• Other heavy metals (in permitted colours) — not more than 100 ppm as the total of the respective metals.
• Mercury — up to 70 ppm (0.007%) as a preservative in eye-area products only; unintentional mercury not to exceed 1 ppm in all other products.
• Hexachlorophene — prohibited, except in soaps up to 1% w/w with the prescribed caution.
• Lead and arsenic compounds as colourants — prohibited outright.
• Dyes, colours and pigments — only those specified in IS 4707 (Part 1) / IS 4707 (Part 2) and the Tenth Schedule.

Stain dyes and pigments must be on IS 4707 (Part 1); heavy-metal limits read strictly because the tint is a lip product. A stain dye permitted abroad but not on the Indian list is the usual failure.

🏷️ Lip & Cheek Tint Label Requirements

In addition to the general Chapter VI requirements, lip-and-cheek tint labels are checked for these product-specific points:

• Shade name and number on the unit pack.
• Registration Certificate number preceded by “RC” or “Reg. Cert. No.”.
• Directions for use on lips and cheeks.
• Net content by fluid measure or weight.

⚖️ A Lip Product First — Colour and Heavy Metals

A lip-and-cheek tint raises no drug question; it is judged as a lip colour, which is the stricter of its two uses. The recurring failures are a stain dye not on IS 4707 (Part 1) and heavy-metal exceedances on the colourants, because the tint is worn on the lips and ingested in small amounts. Shade reconciliation across the three documents is the other check.

Map every stain dye and pigment to the Indian list, keep heavy metals within limits, and declare each shade as a variant.

🛠️ Step-by-Step Registration Process

1. Classify the productConfirm the article meets the definition of a cosmetic under Section 3(aaa) and is not a drug, then map it to the correct Fourth Schedule category — this drives both the fee and the certificate scope.
2. Appoint the Authorised Indian AgentExecute the authorisation in the First Schedule format, signed jointly by manufacturer and agent on every page, then notarised and apostilled (Hague states) or attested by the Indian Embassy.
3. Assemble the technical dossierIngredient list with percentages, specification and method of testing, finished-product test reports, inner and outer labels, GMP / ISO 22716 evidence and the Free Sale Certificate.
4. Align the label to Chapter VIIndian labelling is one of the top rejection reasons. India-specific content may be stickered onto the unit pack at a bonded warehouse before clearance.
5. Pay the fee on BharatkoshCompute the category, site and variant fees, pay online under head 0210041040000-00-1 and retain the acknowledgement receipt for upload.
6. File Form COS-1 on SUGAMUpload the full checklist, including the correlation chart that ties each product serial number in COS-1 to the Free Sale Certificate and the authorisation.
7. Respond to CDSCO queriesQueries typically concern apostille defects, Free Sale Certificate scope mismatch, ingredient limits and label non-compliance. Reply within the stipulated period, as each query restarts the effective clock.
8. Receive Form COS-2Print the Registration Certificate number on every unit pack, alongside the holder's name and address, before the goods are cleared for sale.

💰 Government Fees

CDSCO cosmetic registration is priced under the Third Schedule and paid category by category, not as a single flat licence. The headline components are:

Fees are paid online through the Bharatkosh gateway under head of account 0210041040000-00-1, and the acknowledgement receipt is uploaded with the application. A duplicate certificate is USD 200, permission for a novel ingredient not previously used in India is USD 500, and inspection of an overseas manufacturing site, if ordered, is a further USD 5,000.

⏱️ Timeline & Validity at a Glance

A complete, well-drafted application is typically cleared in about four to six months. The single biggest lever on that timeline is the quality of the first filing: every query CDSCO raises effectively restarts the clock, so a dossier that pre-empts the common objections is worth far more than one filed quickly and corrected later. The certificate is valid for five years and should be re-registered before expiry — an application filed after lapse is treated as a fresh registration, and a retention fee keeps the certificate alive across the term.

⚠️ Where Lip & Cheek Tint Applications Get Queried

Most lip-and-cheek tint queries reduce to colour and heavy metals:

• A stain dye / pigment with a CI number not on IS 4707 (Part 1).
• Heavy-metals exceedance on the colourants for a lip product.
• Shade lists that do not reconcile across the three documents.
• Shades under-declared for the USD 50 variant fee.

🔗 Related Approvals Alongside CDSCO

CDSCO registration rarely travels alone. Depending on the product and the importer, plan for these adjacent approvals in parallel, because any one of them can hold a consignment at the port even when the CDSCO certificate is in order:

• Importer-Exporter Code (DGFT) — mandatory for any importer of record, obtained before the first consignment.
• LMPC registration (Legal Metrology) — importers of pre-packaged commodities register under the Legal Metrology (Packaged Commodities) Rules, 2011 and carry MRP, net quantity, importer details, country of origin, consumer-care details and date of import on the pack.
• Wholesale licence (Form 20B / 21B) — where the Indian agent also distributes drugs alongside cosmetics.
• Drug import licence (Form 10) — where the product contains a pharmacologically active ingredient or makes a therapeutic claim, it is a drug, not a cosmetic, and this route replaces COS-1.

✅ Post-Approval Obligations

The certificate is the start of an ongoing compliance duty, not the end of it. After grant, the registration holder must:

• Print the Registration Certificate number on every unit pack, with the name and address of the certificate holder.
• Report any change in labelling, composition, testing or specification within 30 days, with an undertaking of continued compliance with the Ninth Schedule standards.
• Report any market withdrawal, regulatory restriction, cancellation of authorisation or not-of-standard-quality finding in any country where the product is sold, and stop dispatch and marketing immediately.
• Allow the Licensing Authority to draw samples for testing and to inspect the overseas manufacturing premises.
• Track BIS standard revisions — a new or amended Indian Standard becomes mandatory six months after publication.
• Diarise re-registration well before the five-year expiry.

❓ Frequently Asked Questions