Cleansing creams and milks, cleansing tissues, makeup-remover wipes and dedicated lip & eye removers are the gentle end of the cleansing shelf, and every one needs CDSCO registration under the Cosmetics Rules, 2020 before import. Registration is product-level and tied to the specific formulation and factory.
None of these formats has a dedicated Indian Standard, so the file rests on the country-of-origin specification — with a pre-soaked wipe adding a substrate and a preservation dimension that a bottle does not.
📌 Under Rule 12(1) of the Cosmetics Rules, 2020, no Cleansing Cream, Milk & Wipes 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 Cleansing Cream, Milk & Wipes?
Yes. A cleansing cream, milk, tissue or remover wipe is a Fourth Schedule cosmetic and needs CDSCO registration before the first consignment. The absence of an Indian Standard changes the evidence base to the country-of-origin standard plus the Cosmetics Rules, not the duty to register.
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 to a cleansing cream, milk, tissue or wipe, so the product is assessed against the country-of-origin standard plus the Cosmetics Rules, 2020. The Certificate of Analysis is drawn against the manufacturer's finished-product specification — pH, appearance, preservative content and microbiological limits.
A pre-soaked makeup-remover wipe or cleansing tissue is assessed on the lotion it carries, not the fabric, but the preservative system matters more because a wet wipe is a higher microbiological risk; the microbiological report and preservative-efficacy data are read closely. A lip & eye remover marketed for the eye area inherits the eye-area caution.
🗂️ 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 Cleansing Cream, Milk & Wipes
On top of the core dossier above, a cleansing-cream or wipe application needs:
- Certificate of Analysis against the country-of-origin finished-product specification — pH, appearance, preservative content and microbiological limits.
- Country-of-origin standard and specification, since no Ninth Schedule Indian Standard applies.
- Preservative-system declaration and preservative-efficacy (challenge) data — critical for pre-soaked wipes and tissues.
- Microbiological limits report.
- For lip & eye removers: an ophthalmological safety / eye-irritation assessment.
- Substrate information for wipes and tissues (the impregnating lotion is the registered cosmetic).
⚗️ 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 preservative system is the composition control that matters most for this group, because pre-soaked wipes and tissues are prone to microbiological growth. Declare each preservative and its concentration, and hold preservative-efficacy data for the wet formats.
🏷️ Cleansing Cream, Milk & Wipes Label Requirements
In addition to the general Chapter VI requirements, cleansing-cream and wipe labels are checked for these product-specific points:
- Directions for use, including any rinse-off or wipe-off instruction.
- Full ingredient list preceded by “INGREDIENTS” — not required for packs of 60 ml/30 g or less.
- Net content — fluid measure for creams/milks, count and net weight for wipes/tissues.
- Any eye-area caution for a lip & eye remover.
⚖️ Preservation and the Eye-Area Remover
Cleansing creams, milks and wipes are firmly cosmetic; the classification question rarely arises. The two watch-points are practical rather than legal: the higher preservation risk of a wet wipe, and the eye-area status of a lip & eye remover, which inherits the eye-area caution and any colour restriction if it is tinted.
Keep the preservative-efficacy data in the file for the wet formats and treat the impregnating lotion — not the fabric — as the registered cosmetic.
🛠️ 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 Cleansing Cream, Milk & Wipes Applications Get Queried
Most cleansing-cream and wipe queries are preservation- and documentation-driven:
- Missing preservative-efficacy data for a pre-soaked wipe or tissue.
- A CoA with no country-of-origin specification behind it.
- Eye-irritation data missing for a lip & eye remover.
- Formats and pack counts 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
Is CDSCO registration mandatory for imported cleansing wipes and cleansing milk?
Yes. They are Fourth Schedule cosmetics 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 a cleansing cream or wipe?
No. There is no product-specific Ninth Schedule standard, so the product is assessed against the country-of-origin specification plus the Cosmetics Rules.
Is the wipe fabric or the lotion registered?
The impregnating lotion is the registered cosmetic; the substrate is described in the file. Because a wet wipe is a higher microbiological risk, preservative-efficacy data is read closely.
Do lip and eye removers have extra requirements?
Yes — a remover marketed for the eye area inherits the eye-area caution and, if tinted, the eye-area colour rules, and an eye-irritation assessment strengthens the file.
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.
Cleansing Cream, Milk & Wipes Import Registration, Handled End to End
Global Approbation manages the complete CDSCO cosmetic registration for imported cleansing cream, milk & wipes — 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