Although a makeup remover might appear to be a straightforward skincare product, such as micellar water, a cleansing balm, cleansing oil, wipes, or a liquid remover, its regulatory status becomes significant when it is intended for use on the human body for cleansing or beautifying.
When businesses plan to manufacture, import, market, or sell makeup removers in India, their first question is: does a makeup remover need CDSCO certification?
The answer depends on how the product is classified as well as whether it is produced in India or imported there. The Cosmetics Rules of 2020 and the Drugs and Cosmetics Act of 1940 state that products that qualify as cosmetics must be regulated. The CDSCO mentions that cosmetics should be registered if they are imported into India; however, if they are manufactured in India, then a license should be obtained from the respective State Licensing Authority.
The blog provides information regarding the CDSCO certification for makeup removers, including the relevant rules, the documents required, the procedure, the validity period, the labelling requirements, the challenges involved, and the way in which UMSPCS can assist businesses during the compliance process.
Is remover for makeup classified as a cosmetic in India?
The legal definition is where we begin; according to section 3(aaa) of the Drugs and Cosmetics Act of 1940, a cosmetic is described as any article which is applied on the human being for the purposes of cleansing, beautifying, increasing attractiveness, or modifying appearance.
A conventional makeup remover that is meant to cleanse the face or remove cosmetic products will usually be covered by the cosmetic regulatory framework if the formulation and intended use conform to this definition.
Examples can include:
- Micellar water
- Makeup-removing lotion
- Cleansing oil
- Cleansing balm
- Makeup-removing gel
- Makeup-removing cream
- Cosmetic cleansing wipes
- Eye makeup remover
- Waterproof makeup remover
The classification of a product should, on a case-by-case basis, be considered taking into account its formulation, intended use, claims, ingredients, and method of application.
Does the Need for Makeup Removers to Have CDSCO Certification Exist?
For Imported Makeup Removers
So, if a product comes within the definition of a cosmetic, then it must be registered before it is imported into India.
According to CDSCO, cosmetics imported into India are subject to a registration system provided for under the Drugs and Cosmetics Act, 1940, and the Cosmetics Rules, 2020, and the product is registered together with the relevant pack size, variants, and manufacturing premises.
The online submission of the import registration application is made through the CDSCO system, usually using Form COS-1, together with the necessary documents and the relevant fee; when it has been approved, the Import Registration Certificate is issued in the form of COS-2.
For Makeup Removers Manufactured in India
The route involving regulation is different. The production of domestic cosmetics is controlled by the State Licensing Authority through inspections and the awarding of licences. According to the Cosmetics Rules, 2020, a licence to manufacture cosmetics is given in Form COS-8, and a loan licence is issued in Form COS-9.
Hence, it is wrong for businesses to assume that every makeup remover needs the same kind of CDSCO certificate; the appropriate approval varies according to the product and on whether it is imported or produced in India.
Documents Required for CDSCO Certification for Makeup Removers
A typical application may require documentation such as:
- Covering letter
- Application form
- Authorization letter
- Free sale certificate
- License to manufacture from the country of origin
- Product formula and ingredients used
- Specifications of the product
- Labeling and artwork copy
- Packaging size & variants
- Certificate of analysis
- Safety data, if any
- Undertaking and declaration
- Manufacturer information
- Information about manufacturer’s manufacturing facility
- Information about importer
- Information about brand owner
When it comes to imported cosmetics, the guidance issued by CDSCO states that the application must be accompanied by the required documents and submitted via the online regulatory system.
CDSCO Certification for Makeup Removers: Step-by-Step Process
Step 1: Product Classification & Assessment
To determine the relevant CDSCO requirements, evaluate the formulation, intended use, claims, packaging, and labelling of the makeup remover.
- Formula and ingredients
- Intended use and claims
- Packaging and labelling
Step 2: Document Collection & Verification
Gather and check all the product, manufacturer, and regulatory documents that are required.
- Manufacturing Licence
- Product formula
- Free Sale Certificate, if applicable
- Labels and artwork
- Safety information
- Manufacturer and authorization documents
Step 3: Appointment of Authorised Indian Agent
Foreign manufacturers should appoint an Authorised Indian Agent to co-ordinate with the CDSCO.
- Application support
- CDSCO communication
- Query handling
Step 4: Application Dossier Preparation
Put together the product, formulation, manufacturing, packaging, and regulatory information that is required.
- Product details
- Formulation
- Manufacturer details
- Labels and packaging
- Supporting documents
Step 5: Online Application Submission
Send the application together with the documents via the relevant CDSCO online system along with the required fee.
Step 6: CDSCO Review
The CDSCO examines the application to see if it complies with the relevant cosmetic requirements.
- Product classification
- Ingredients
- Labelling
- Safety and documents
Step 7: Regulatory Query Resolution
Answer the CDSCO’s questions by giving clarifications, submitting revised documents, or supplying further information.
Step 8: Registration & Approval
Once the review has been successfully completed, the relevant registration or approval is issued, including the Import Registration Certificate for cosmetics that are eligible for import.
Step 9: Post-Registration Compliance
Continue to comply with the relevant requirements.
- Labelling compliance
- Record maintenance
- Regulatory updates
- Product modifications
How Long Does it Take to Obtain Approval from the CDSCO?
There is no fixed timeline for the approval of makeup removers by CDSCO, as this will depend on the product and the way it is applied. The total timeline may be influenced by:
- Completeness of documents
- Product testing requirements
- Foreign document verification
- Manufacturing location
- CDSCO queries
- Response time
- Regulatory review
| Stage | Estimated Timeline |
| Product evaluation | 2–5 working days |
| Documentation preparation | 5–10 working days |
| Product testing, if applicable | Depends on product |
| CDSCO application review | Subject to regulatory authority |
| Overall completion | Depends on project complexity |
Common Compliance Challenges for Makeup Remover Businesses
Businesses often encounter difficulties with:
- Incorrect product classification
- Incomplete ingredient information
- Mismatch between product labels and submitted documents
- Missing manufacturer documentation
- Incorrect or incomplete authorization documents
- Product variants not properly identified
- Non-compliant claims
- Inadequate supporting safety information
- Queries raised during CDSCO scrutiny
- Changes in formulation, manufacturing site, or packaging after registration
The growing significance of precise regulatory documentation is also shown by the recent public notices issued by CDSCO regarding the cancellation and surrender of cosmetic registrations.
How UMSPCS Helps With CDSCO Certification for Makeup Removers
We at UMSPCS, having gained more than 6 years of experience in the industry and with knowledge of over 600 product compliance requirements, provide businesses with end-to-end regulatory compliance for cosmetics and other regulated products.
We help with the evaluation of the product, the preparation of documentation, coordinating the testing, submitting the application, answering any regulatory questions, and ensuring continued compliance.
Our support for CDSCO Certification for Makeup Removers can include:
- Product classification assessment
- Regulatory pathway identification
- Ingredient and formulation documentation review
- Applicable standard identification
- Document checklist preparation
- Label and packaging compliance review
- Application preparation
- CDSCO/SUGAM filing support
- Query and deficiency response assistance
- Import registration documentation
- Post-registration compliance support
Conclusion
In accordance with India’s definition of cosmetics, any makeup remover being used is subject to the cosmetic regulations in the country, while imported preparations must be registered with the CDSCO before entering India. However, if a makeup remover is manufactured locally, it is regulated in accordance with the licensing regime of the relevant state licensing authority.
There is no single answer that can be given as to which route a company would like to comply with, as it would depend on various factors like formulation, claims about the product, intended purpose, country of manufacture, and nature of regulation.
In conclusion, before using a product in India, companies are advised to analyze the product classification, documentation of the product, standards, labels, and registration or licensing requirements.
Thinking of launching or importing a makeup remover into India?
Connect with UMSPCS if you need help with product classification, submitting the CDSCO application, and ensuring cosmetic regulatory compliance together with the documentation.
Read more also: How to Get BIS ISI Certification for Cement in India
FAQs
- Is it necessary for a makeup remover to have CDSCO certification in India?
If the makeup remover is classified as a cosmetic, then the relevant cosmetic regulatory requirements will apply; imported cosmetics must be registered before they are imported, whereas those manufactured domestically operate under the State Licensing Authority system.
- Is it necessary to have registration with the CDSCO for makeup removers that are imported?
Yes, cosmetics that are imported into India must have their registration carried out under the Cosmetics Rules, 2020, together with details regarding the product and the place of manufacture.
- Do you have any information regarding the approval process of the CDSCO for cosmetics?
Getting the approval involves a number of activities such as the classification of the product, finalizing the paperwork, filling in the forms on the web platform, and paying the required fees.
- What documents are necessary for the application process with the CDSCO?
Documents that may be required in this case include information on the composition of the product, data about the producer of the product, product specifications, the labels, registrations, authorizations, and certificates necessary for a successful application.
- Do makeup remover labels need CDSCO registration details?
Cosmetics that are imported into India must have printed on them the registration certificate number and the details of the certificate holder of the importer as specified in the Cosmetics Rules.
- Does a new makeup remover require extra approval?
It may be necessary to obtain prior approval under the relevant provisions before importing or manufacturing the product if it is classified as a new cosmetic; for this purpose, the Cosmetics Rules set out a particular procedure which involves the use of Form COS-12 and Form COS-3.
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