Overview of Cosmetic Import Registration Certificate
The cosmetic industry of India is growing at a rapid pace because of the rise in demand for cosmetics and personal care products. Most of these products are not manufactured in India which requires Indians to import such products. In order to ensure that such imported cosmetic products are safe and effective for the Indian residents, the government has made it necessary for every cosmetic importer to obtain a CDSCO Import Registration Certificate from the Ministry of Health and Family Welfare. A cosmetic Import Registration Certificate is a certificate issued under Rule 13 of the Cosmetics Rules, 2020 by the Central Licensing Authority for the registration of cosmetics for their import and use in India.
What is the meaning of Cosmetic?
Cosmetic refers to any article that is intended to be rubbed, introduced, poured, sprayed or sprinkled on or otherwise applied to human body or any part of that for the purpose of beautifying, cleansing, altering the appearance of, promoting attractiveness and any article that is intended to be used as a component of cosmetic.
Who can apply for CDSCO Cosmetic Import Registration?
Under the Drugs & Cosmetics Act, 1940, the following applicants are eligible to apply for CDSCO Cosmetic Import Registration in India:
- Authorised Agent of Manufacturer: In case the manufacturer has authorised an agent on its behalf to import cosmetics.
- Authorised subsidiary of the Manufacturer: For any foreign cosmetic manufacturer, the authorised Indian subsidiary firm can apply on its behalf for the CDSCO Cosmetic Import Registration.
- Manufacturer: The manufacturer itself can apply for the grant of CDSCO Cosmetic Import Registration in India.
- Any Other Importer: Any other importer in India willing to import cosmetics in India from a foreign manufacturer can apply for CDSCO Cosmetic Import Registration.
Documents required for CDSCO Cosmetic Import Registration
An online application is supposed to be made either by the manufacturer itself or by its authorised agent or authorised subsidiary in India or by any other importer in India. The following documents are required to obtain CDSCO Cosmetic Import Registration certificate:
The purpose must be clearly mentioned along with the information of earlier issued Import Registration Certificate (if any) and product or product category (whether registered or not).
Authorisation from the manufacturer:
An authorisation has to be made from the manufacturer’s end to accompany an application for issuance of import registration certificate.
- The authorisation should be executed & authenticated either in India before a First Class Magistrate or attested by the Indian Embassy of the said country or in the country of origin before such an equivalent authority or Apostilled from Hague convention member countries.
- The name and address of manufacturer and its manufacturing premises as per Form COS-1.
- The name and full address of the authorised Indian Agent as per Form COS-1.
- The name of the Cosmetic product, its variants along with name and complete address of manufacturing premises of the product to be registered.
- A duly conjointly signed, stamped, and dated with name & designation of the signatory by both authorised Indian agent & the manufacturer.
- Part-1 Of Second Schedule: Information& undertaking has to be provided by the manufacturer or his authorised distributor or agent or any other importer with the application form for Import Registration Certificate. The format should be properly filled for each application in Form COS-1.
List Of Composition Or Ingredients:
- The cosmetic name and ingredients’ name in the nomenclature of standard reference along with the percentage contained in the cosmetic signed by the authorised person along with the stamp from the manufacturer.
- No cosmetic can be manufactured or imported which contains pigments, colours and dyes other than the ones specified by the BIS and included in the 10th
- The allowed synthetic organic colours and natural organic colours used in the Cosmetic shall not contain more than:
- 20 parts/million of lead calculated as lead;
- 2 parts/million of Arsenic calculated as Arsenic Trioxide;
- 100 parts/million of Heavy Metals other than lead are calculated as the total of the respective metals.
- Raw material stated in ANNEX A of the IS: 4707 Part 2, as amended from time to time, shall not be added to the cosmetic product.
- No cosmetic containing Hexachlorophene shall be manufactured. In the case of soaps, Hexachlorophene can be used in concentrations not exceeding 1% weight by weight with a cautionary note be shown & shall appear in a conspicuous manner on the wrapper of a package of each soap.
- Cosmetics manufactured or imported into the country should contain mercury in the following proportions:
- For the cosmetics aimed for use only in the area of the eye, the level of mercury should not exceed 70 parts per million (0,007 per cent) of mercury, calculated as the metal, as a preservative;
- In other finished cosmetic products, unplanned mercury should not exceed one part/million (1 ppm).
- The use of arsenic and lead compounds for the purpose of colouring cosmetics is prohibited.
Labels of Proposed Products:
Readable original label for the proposed cosmetic products along with their variants (if any) as per Chapter VI Of The Cosmetics Rules, 2020 should comprise of the following:
- Cosmetics’ name;
- Manufacturer’s name and manufacturer's premises complete address where the cosmetic has been manufactured. In case the product has not been manufactured in the factory owned by the manufacturer, the name & address of the actual manufacturer or the country name where it has actually been manufactured as “Made in ... (country’s name)” should be mentioned on the label;
- Date of expiry or use by or use before or expiry of...(XX) months from manufactured date or date of manufacturing or expiry date should also be mentioned;
- The distinctive Lot Number or Batch Number;
- Manufacturing License Number, the number that is preceded by the letter M or M.L. No or Mfg. Lic. No. should be carried on the outer or inner labels;
- A declaration about the net contents stated in terms of weight for solids, fluid measure for liquids, fluid measure/weight for semi-solids, combined with numerical count if the content is sub-divided;
- In case of cosmetics, where hazard exists; every inner label must clearly mention adequate directions for caution, safe use or any special direction required to be followed by the customer while using it;
- In case of imported cosmetics intended to be marketed in India, the CDSCO Cosmetic Import Registration number shall be mentioned on the unit pack label preceded by the letter “RC” or “RC No” or “Reg. Cert. No.”, along with the address & name of the importer;
- In case a cosmetic package has only one label, such label should contain all the mandatory details required to be displayed on both the inner and outer labels as per the prescribed rules;
- In all cases, the ingredients list, present in a concentration of more than 1%, must be listed in the descending order of volumes or weight at the time when they are added. Those ingredients in concentration of equal or less than 1% can be mentioned in any order and should be preceded by the word "INGREDIENTS”;
- The Cosmetic should be in compliance with all the labelling requirements specified in the relevant Indian standards set by BIS for the cosmetics notified under the 9th Schedule;
- No Cosmetic will be imported unless it has been packed & labelled in conformity with the applicable rules. Additionally, the label of imported cosmetics must bear the Registration Certificate Number of the product along with the name and address of the owner of the Cosmetic Import Registration certificate for marketing such product in India.
Specification & Testing Methods for testing of cosmetics:
The cosmetic has to comply with the prescribed specifications under the applicable schedule of the Cosmetics Rules 2020 or any other prescribed standards of safety and quality. All the specification and testing methods have to be signed and stamped by the competent person of the company.
Pack Insert (If Any).
Authenticated copy of the manufacturing registration or license or marketing authorisation with respect to the applied products issued by the Regulatory Authority of the country of origin and in case no such provision exists in that country, an undertaking of the same from the manufacturer.
Free Sale Certificate:
This certificate is issued by the appropriate National Regulatory Authority or other appropriate organisations from the country of the principal manufacturer or actual manufacturer from the country of origin or from such associations duly authenticated by the Indian Embassy of the country of origin of the applied product. List of products of Free Sale Certificate should be stamped and signed by the appropriate authority. A Free Sale Certificate should contain the statement that in which nation the applied product is freely sold.
Declaration of Non-Animal Testing:
Along with the application form, an undertaking has to be given by the manufacturer that the imported product has not been tested on animals.
Declaration for Heavy Metal & Hexachlorophene:
Result of a test report stating that Pb, Hg, As and other heavy metals and microbial test or an undertaking from the manufacturer that all the pigments/raw materials, heavy materials and hexachlorophene contents used in the manufacture of the applied products is in compliance with the parameters specified in the Cosmetics Rules, 2020.
Application COS-I Form.
Note: All the documents must be drafted in the English language.
Procedure for CDSCO Cosmetic Import Registration in India
Following is the four-step procedure to obtain your CDSCO Cosmetic Import Registration in India:
Step 1: Determination of Cosmetics Classification:
The first step begins with checking the Gazette Notification of the CDSCO in order to find out the classification and regulatory status of the cosmetic.
Step 2: Appointment of an Indian Agent:
The next step is to appoint an authorised agent to liaise with the government department in obtaining the Cosmetic Import Registration certificate. For such purposes, agent is granted a power of attorney to make it easier for the agent to take approvals and further manage registration and import in India. It must be noted that apart from an authorised agent, the manufacturer itself or through its subsidiary can apply for the cosmetic import registration.
Step 3: Fill out the Application Form for CDSCO Cosmetic Import Registration:
Once the agent has been appointed, the registration form COS-1 is required to be submitted online along with the relevant documents and prescribed fees to the Drug Controller General of India (DGCI) after logging on to the website of CDSCO.
Step 4: Issuance of CDSCO Cosmetic Import Registration Certificate:
On successful submission of the application form along with the documents and prescribed fee, the DGCI may send a query via an inquiry letter to the manufacturer or the authorised representative of the importer. If the DGCI is satisfied with the application, it may issue a Cosmetic Import Registration Certificate in the form COS-2.