Acetone and acetone-free (ethyl-acetate) nail polish removers, in bottles and pre-soaked pads, must be registered with CDSCO under the Cosmetics Rules, 2020 before import. Registration is product-level and tied to the specific formulation, its variants and the factory.
The CDSCO file is straightforward; the real hurdle is that the solvent base is flammable, so the consignment travels as dangerous goods and needs the matching transport and handling paperwork.
📌 Under Rule 12(1) of the Cosmetics Rules, 2020, no Nail Polish Remover may be imported into India unless the product is registered by the Central Licensing Authority. The application is Form COS-1 on the CDSCO SUGAM portal, and the approval is issued as an Import Registration Certificate in Form COS-2 — it must be in place before the first consignment lands.
📋 Is CDSCO Registration Mandatory for Nail Polish Remover?
Yes. Nail polish remover is a Fourth Schedule nail preparation and needs CDSCO registration before import. Flammable solvent removers additionally attract dangerous-goods handling that sits outside CDSCO.
The application is filed by the overseas manufacturer or, in practice, its Authorised Indian Agent.
📘 The Indian Standard in Detail
No Ninth Schedule Indian Standard applies specifically to a remover, 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 — solvent identity and content, appearance, and any added conditioning agents.
The defining document is the Safety Data Sheet: acetone and ethyl acetate are flammable, so the SDS, the flammable-goods transport classification and PESO / dangerous-goods handling are needed alongside the CDSCO registration. A pre-soaked pad is registered on the impregnating liquid, with preservation data.
🗂️ 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 Nail Polish Remover
On top of the core dossier above, a remover application needs:
- Certificate of Analysis against the country-of-origin specification — solvent identity and content, appearance and any conditioning agents.
- Safety Data Sheet — acetone / ethyl-acetate removers are flammable and ship as dangerous goods.
- Solvent declaration (acetone vs ethyl acetate) and any added oils / conditioning agents.
- Country-of-origin standard and specification, since no Ninth Schedule Indian Standard applies.
- For pre-soaked pads: substrate information and preservative-efficacy data.
- Microbiological report where a water phase is present.
⚗️ 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.
The solvent identity and content is the composition control, and it drives the flammability classification. There are no colourants to worry about, but the dangerous-goods profile is the dominant factor.
🏷️ Nail Polish Remover Label Requirements
In addition to the general Chapter VI requirements, remover labels are checked for these product-specific points:
- Flammability warning — keep away from flame, do not smoke while using.
- Keep out of reach of children; avoid contact with eyes.
- Directions for use.
- Net content by fluid measure (bottle) or count (pads).
⚖️ Dangerous Goods, Not Drug Status
Nail polish remover raises no drug question at all. Its entire compliance risk is logistics: the flammable solvent means the consignment is dangerous goods, so a Safety Data Sheet, the correct UN transport classification and PESO / dangerous-goods handling must be in place — a valid CDSCO certificate does not remove that. This is the same trap as nail polish and aerosols: the product clears CDSCO but is held at the port over flammable-goods paperwork.
Prepare the SDS and dangerous-goods documentation in parallel with the CDSCO file.
🛠️ Step-by-Step Registration Process
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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:
Each cosmetic category
USD 1,000 for the grant or retention of the Registration Certificate, per Fourth Schedule category.
Each additional category
USD 1,000 for every further category added to the same application.
Each variant
USD 50 for each shade, fragrance or formulation variant declared.
Each manufacturing site
USD 500 for every overseas manufacturing premises covered.
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 Nail Polish Remover Applications Get Queried
Most remover queries sit at the dangerous-goods boundary:
- Safety Data Sheet or dangerous-goods classification missing at the port even though CDSCO is in order.
- Solvent identity/content undeclared.
- No preservative data for a water-containing pre-soaked pad.
- Variants 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.
- PESO / dangerous goods — flammable acetone / ethyl-acetate removers need transport, storage and handling compliance under the Explosives Rules and the dangerous-goods framework, in addition to the SDS.
✅ 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
Is CDSCO registration mandatory for imported nail polish remover?
Yes. It is a Fourth Schedule nail preparation and cannot be imported until registered under Rule 12(1) of the Cosmetics Rules, 2020, with the certificate issued in Form COS-2.
Is there an Indian Standard for nail polish remover?
No specific Ninth Schedule standard applies, so it is assessed against the country-of-origin specification plus the Cosmetics Rules.
Why do remover shipments get held even after CDSCO approval?
Because the solvent (acetone or ethyl acetate) is flammable, so the consignment is dangerous goods and needs a Safety Data Sheet, the right transport classification and PESO handling — separate from the CDSCO certificate.
Is an acetone-free remover treated differently?
It still uses a flammable solvent (ethyl acetate), so the dangerous-goods handling applies; the solvent identity is declared either way.
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.
Nail Polish Remover Import Registration, Handled End to End
Global Approbation manages the complete CDSCO cosmetic registration for imported nail polish remover — classification, standard mapping, CoA and label review, dossier assembly and query response — so your first consignment clears without avoidable delay.
Talk to Our CDSCO Team Global Market Access