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CDSCO Certification for Makeup Remover

UMSPCS - CDSCO Certification for Makeup Remover

CDSCO Certification for Makeup Remover

Looking to CDSCO register makeup remover products in India? UMSPCS helps businesses with registration, documentation, compliance, and regulatory approval for cosmetics.

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CDSCO Certification for Make-up Remover Products in India - Process, Documents, Cost & Timeline

Make-up remover seems to be just another cleansing product; however, before its introduction into the Indian market, many issues related to the ingredients of such a product, the purpose of its use, labeling, safety, manufacturing, and others should be solved.

But whatever the product in question - micellar water, cleansing balm, cleansing oil, make-up remover wipes, bi-phase remover, or any other product used for removing make-up from the skin - none of these considerations will matter to us in our particular case. The only important consideration for us will be the classification of the product according to the Indian laws.

According to the Drugs and Cosmetics Act, 1940, the term cosmetics means "articles which are applied, rubbed, poured, sprinkled, sprayed, inserted, inhaled, or otherwise introduced into or upon the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance." As per CDSCO, all imported cosmetics shall be registered, and the manufacture of cosmetics in India shall be licensed.

In this regard, CDSCO certification for make-up remover products is an essential part of the activities of all business companies involved in the production of make-up removers in India, including imported cosmetics.

UMSPCS may help manufacturers, importers, brand owners, and business organizations to receive the required CDSCO approval for cosmetics.

What Is CDSCO Certification for Make-up Remover Products?

CDSCO Certification for Make-up Remover Products is the most commonly used terminology in business parlance to refer to the regulatory approvals or registrations required for cosmetics.

Nevertheless, the regulatory path to follow would depend on whether the make-up remover is:

  • Imported in India
  • Manufactured in India
  • A new cosmetic that requires permission
  • Marketing the cosmetic as per a particular formulation or variant or brand name

In case of importation of make-up removers, the Cosmetics Rules, 2020 provide for the registration of the cosmetic product and the manufacturing establishment with the Central Licensing Authority. The application is made through Form COS-1 and the certificate of import registration is issued in Form COS-2.

In case of manufacture of cosmetics in India, manufacture would be regulated by a licence from the concerned State Licensing Authority. In the Cosmetics Rules, 2020, the licence for manufacture of cosmetics for sale or distribution would be issued in Form COS-8, whereas the loan licence would be issued in Form COS-9.

Thus, before filing for CDSCO approval for make-up removers, businesses should first determine the right regulatory path to follow.

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Which Make-up Remover Products May Come Under This Compliance?

Its specific classification will depend upon the formulation, claims, intended use, presentation, and ingredients. Some of the possible products which may need regulatory review include:

  • Micellar water make-up remover
  • Cleansing water
  • Liquid make-up remover
  • Bi-phase make-up remover
  • Cleansing oil
  • Cleansing balm
  • Cream make-up remover
  • Gel make-up remover
  • Eye make-up remover
  • Lip make-up remover
  • Waterproof make-up remover
  • Make-up remover wipes
  • Cleansing pads having a make-up remover formulation
  • Cosmetic-specific cleansing/removing products

It should be kept in mind that a product’s name is not enough to classify it as needing regulation or not. The above-mentioned factors need to be considered while classifying it.

Why Is Regulatory Classification the First Step?

One of the most ignored parts in the process of CDSCO certification in India is the identification of the exact regulatory category of the product.

A makeup remover could have:

  • Surfactants
  • Solvents
  • Oils
  • Emollients
  • Humectants
  • Preservatives
  • Fragrances
  • Botanicals
  • Colorants
  • Skin-conditioning agents
  • Other functional cosmetic ingredients

Thus, the product needs to be reviewed for its compliance with the relevant rules before submitting the documents and application.

CDSCO says that cosmetics need to conform to the specifications and standards laid down in the Cosmetics Rules, 2020. In cases where the cosmetic is not governed by the provisions in the Ninth Schedule, the rules also lay down standards and specifications, including the standards and specifications that are applicable in the country of origin as per the rules.

Applicable Tests for Make-up Remover Products

There is no one-size-fits-all “makeup remover test.” The test requirements will vary from one product to another, depending on its formulation, ingredients, nature of product, relevant standards, and regulatory assessment.

Depending on the nature of the product, the tests can include:

  • Microbial Tests
  • Heavy Metal Tests
  • Physical and Chemical Tests
  • Preservative Ingredient Tests
  • Safety Test
  • Specific Product Test

In the case of imported cosmetics, CDSCO's official list of documents contains the specifications and testing methods, including heavy metals wherever applicable.

Eligibility Requirements for CDSCO Approval

Before approaching CDSCO for registration of makeup remover products, companies must ensure that they have all the relevant information handy.

For imported cosmetics, the applicant could be any one of the following:

  • The foreign manufacturer
  • An authorised representative in India
  • An importer in India
  • A subsidiary in India authorised by the manufacturer

The latest guidance from CDSCO clearly mentions that applications for import registration could be made by the manufacturer or authorised representative in India via the SUGAM portal.

The manufacturing facility and cosmetic product information must be consistent throughout the application.

CDSCO Registration Process for Make-up Remover Products

Step 1: Product Classification & Regulatory Assessment

An initial assessment is conducted to determine the proper category of cosmetic for the given make-up remover and the CDSCO requirements for it, depending on its formula, intended purpose, claims, mode of application, packaging, and labeling.
  • Ingredients and formulation review of the product
  • Purpose and use assessment
  • Product claims evaluation
  • Mode of application assessment
  • Packaging and labeling review

    • Step 2: Document Collection and Verification

    Documents relating to the product, manufacturer, and regulation are all collected and verified for completeness, accuracy, and consistency before moving ahead with the process of filing.
  • Free Sale Certificate for imported goods
  • Manufacturing License
  • Formula of the product along with INCI names
  • Labels and labeling artwork
  • Pack sizes and packaging details
  • Safety and Stability Information
  • Manufacturer Information
  • Authorization Documents

    • Step 3: Appointment of Authorized Indian Agent

    In case of overseas manufacturers, an Authorised Indian Agent (AIA) is appointed as the representative of the manufacturer with respect to CDSCO.
  • Support in application filing
  • Communication with CDSCO
  • Addressing regulatory queries
  • Providing additional information
  • Regulatory compliance coordination

    • Step 4: Application Dossier Preparation

    Following verification of the documents, an application dossier is compiled, which contains necessary information related to the products, formulation, manufacturing process, packaging, and regulations needed for the CDSCO application.
  • Product category and variants
  • Brand and product information
  • Information on manufacturing plant
  • Product formulation
  • Packaging information
  • Labels and proposed artwork
  • Regulatory documents

    • Step 5: Online Application Submission

    The application, along with the required documentation and government fees, is submitted through the online system of the CDSCO, making sure that all the information is accurate.
  • Preparation of online application
  • Upload of the required documents
  • Submission of product information
  • Payment of government fee
  • Submission of application

    • Step 6: CDSCO Application Review

    The CDSCO reviews the application and other documents submitted to determine the compliance of the product with all the necessary cosmetic regulations.
  • Product classification review
  • Ingredients compliance
  • Manufacturing information
  • Label review
  • Safety information
  • Verification of supporting documents

    • Step 7: Addressing Regulatory Queries

    Where there are any questions or deficiencies highlighted by CDSCO during the evaluation of the application, the necessary replies, clarifications, or additional documents will be provided within the specified period.
  • Submission of additional documents
  • Clarification on the formulation of the make-up remover
  • Revised labeling, wherever needed
  • Product Information
  • Regulatory declarations and clarifications

    • Step 8: Registration and Approval

    Following completion of the review of the application in accordance with the applicable regulatory requirements, CDSCO registration of the application will be issued as per the applicable regulatory process.
  • Conclusion of regulatory review
  • Compliance with the applicable requirements
  • Issuance of relevant registration/approval
  • Import Registration Certificate for relevant imported cosmetic

    • Step 9: Post-Registration Compliance

    In order to maintain compliance of the make-up remover following obtaining the requisite registration/approval, businesses need to comply with the applicable regulatory requirements.
  • Continuing compliance with product labeling requirements
  • Maintenance of manufacture and quality control records
  • Maintenance of import documents
  • Management of regulatory changes
  • Updating of product information
  • Modification handling

    • Documents Required for Make-up Remover Registration

    Documentation may differ depending on the nature of the product and route of regulation. For cosmetic imports, the list of documents recommended by CDSCO is as follows:

    • 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

    In case of foreign manufacturers, manufacturer authorization becomes particularly significant. The recommendation of CDSCO for authenticity requires consistency in the manufacturer's name and address, Indian authorized agent, product, and manufacturing facility with the application.

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    What About New Make-up Remover Products?

    All cosmetic products do not always follow the same method of application. If the cosmetic product is regarded as "new cosmetic" according to the relevant legislation, additional permits may become necessary.

    Form COS-12 is used for applying for permission for new cosmetics in order to obtain either the import registration certificate or manufacturing license. The information includes:

    • Name of the cosmetic product
    • Classification/purpose
    • Formula
    • Specifications for testing raw materials and finished product
    • Safety assessment
    • Known information on undesirable effects
    • Data in support of the benefit claims
    • Draft label and carton
    • Marketing status in other countries
    • Others

    Consequently, companies must not expect all new make-up removers to fit into a routine registration procedure.

    How Long Does CDSCO Approval Take?

    Approval time for a make-up remover by the CDSCO cannot be defined as a definite period for all applications.

    The overall period may depend on the following factors:

    • Completeness of information
    • Testing needs
    • Verification of foreign documents
    • Places of manufacture
    • Regulatory questions
    • Respondent’s time
    • CDSCO review

    Stage

    Estimated Timeline

    Product evaluation

    2 - 5 Working Days

    Documentation preparation

    5 - 10 Working Days

    Product testing (if applicable)

    Depends on product type

    Application review

    Subject to regulatory authority

    Overall completion

    Varies depending on project complexity

    For this reason, firms must not assume that the filing date is also the approval date.

    Common Challenges Businesses Face

    • Incorrect Product Classification
    • Incomplete Manufacturer Documentation
    • Ingredient Percentage Discrepancy
    • Labeling Nonconformity
    • Invalid Claims
    • Lack of Test Data
    • Several Variants

    Imported vs Indian-Manufactured Make-up Removers

    ParticularImported ProductIndian-Manufactured Product
    Regulatory authorityCentral Licensing Authority/CDSCO for import registrationState Licensing Authority for manufacture
    Key routeImport registrationManufacturing licence
    ApplicationForm COS-1 for import registrationApplicable manufacturing licence process
    Certificate/licenceForm COS-2Form COS-8 / COS-9, as applicable
    Manufacturing siteRegistered as applicable for importLicensed premises
    TestingBased on applicable requirementsTesting arrangements as required
    Foreign documentsRequired where applicableGenerally not applicable
    Indian agentRelevant for foreign manufacturers/import routeNot applicable in the same manner

    CDSCO clearly states that imported products are subject to central registration control, whereas domestically manufactured cosmetics are subject to State Licensing Authorities.

    Key Benefits of Obtaining Proper Cosmetic Regulatory Approval

    Proper regulatory compliance could be useful for businesses in:

    • Accessing the Indian cosmetics market legally
    • Reducing regulatory risks
    • Ensuring product compliance
    • Ensuring smooth import/customs clearance procedures
    • Increasing documentation readiness
    • Creating consumer trust
    • Reducing risks of any unnecessary regulatory objections
    • Ensuring consistency between product, label, and technical documentation
    • Enabling future product

    Of great importance is that recently, the CDSCO has once again emphasized vigilance towards the sale of imported cosmetics in the domestic market without a valid Import Registration Certificate.

    Why Choose UMSPCS for CDSCO Certification in India?

    Regulatory Applications are not just about submitting documents, but the quality and consistency of the entire compliance portfolio could have a substantial impact on the success of the application process.

    As a company with experience in helping 600+ products with their compliance requirements and 6+ years of experience, UMSPCS aims at simplifying complicated regulatory processes.

    Our assistance includes guiding CDSCO Certification in India through:

    • Product Regulatory Assessment
    • Document Assistance
    • Ingredient and Labeling Review
    • Testing Coordination
    • Application Preparation
    • SUGAM Filing Assistance
    • Query and Deficiency Assistance

    Conclusion

    To enter the Indian cosmetic industry, it is not enough to just formulate an appealing cosmetic. All aspects such as product classification, ingredients, safety, testing, documentation, labeling, and regulatory processes have to be aligned.

    Irrespective of whether you are an Indian manufacturer, importer, foreign cosmetic company, distributor, or a private label, proper regulation process preparation prior to the product launch may help minimize unnecessary delays and problems.

    In case your plan is to launch a make-up remover product in India, our specialists at UMSPCS will be able to guide you regarding the necessary regulations for that.

    Contact UMSPCS today for professional CDSCO Certification for Make-up Remover Products services, cosmetic registration, documentation, testing, and CDSCO approval in India.

    We also provide the service of CDSCO Certification for Bath & Shower Products.

    Frequently Asked Questions (FAQs)

     

    Registration with the Central Licensing Authority is required for imported cosmetics. Domestic manufacturing is regulated by the State Licensing Authority.

     

    Import registration is done using Form COS-1, while the certificate is issued in Form COS-2.

     

    Documentation may consist of formulation, labels, manufacturing authorization, Free Sale Certificate, manufacturing license, testing data, safety declarations, and fee receipt.

    Registration cost for imported cosmetics consists of USD 1,000 per category, USD 500 per manufacturing plant, and USD 50 per variation, where applicable.

     

    Whether or not the product requires testing depends on product formulation, standards and other regulatory requirements.

     

    Yes, foreign manufacturers may register directly or via an authorised Indian agent, importer or Indian subsidiary, where applicable.

    A product classified as a new cosmetic may require additional permission under the Cosmetics Rules, 2020, using Form COS-12.

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