Compliance requirements under the Cosmetic Rules:

1. Form COS-2: Registration Certificate for Import of Cosmetics in India (Rule 12(1), 14(2))

An application for registration of a cosmetic product intended to be imported into India shall be made through the online portal of the Central Government in Form COS-1 either by the manufacturer himself or by his authorised agent or the importer in India or by the subsidiary in India authorised by the manufacturer.

2. Form COS-3: Prior Permission for Import or Manufacture of New Cosmetic (Rule 32(1))

Application for prior permission of import or manufacture a new cosmetic shall be applied to the Central Licensing Authority in Form COS-12 along with requisite fee and the data on safety and effectiveness of cosmetic.

3. Fresh Application in case of Change in Constitution (Rule 15(1))

In case of change in constitution of a registration holder or overseas manufacturer, an application for fresh registration shall be made in Form COS-1 within a period of 180 days from the date of such change in constitution.

4. Intimation of change in labelling or composition or testing of products registered for Imports (Rule 15(2))

In case of any change in respect of labelling or composition or testing of registered product or its specifications, the Central Licensing Authority shall be informed by the manufacturer or by the authorised agent or the importer or the subsidiary in India authorised by the manufacturer within fifteen days along with an undertaking that products comply with standards laid down by the Bureau of Indian Standards as referred in the Ninth Schedule.

5. Application for amendment of name or address of registration holder (Rule 15(3))

In case of change in name or address of a registration holder or overseas manufacturer, an application for amendment shall be made in the online portal of the Central Government for prior approval from the Central Licensing Authority for the said changes in registration certificate within a period of sixty days from the date of such change.

6. Appeal to Central Government on suspension or cancellation of Registration Certificate (Rule 16)

A person aggrieved by the order for suspension or cancellation of registration certificate may appeal to the Central Government within 30 days of receipt of the order.

7. Form COS-4: Import Registration Number for already registered Cosmetic (Rule 17)

A cosmetic manufactured in a foreign site and already registered for import may be imported by making an application in Form COS-4. The registration number shall be in Form COS-4A, which remains valid for 3 years from the date of its issue.

8. Prohibition of import of certain Cosmetic (Rule 18)

Prohibition of import of certain Cosmetic:

• • Prohibited in the country of origin
  • “Use before / Use by” date if later than 6 months from the date of import
  • Contains Hexachlorophene
  • Tested on animals after the 12th day of November 2014

9. Form COS-8: License to Manufacture Cosmetics (Rule 23)

Any person who intends to manufacture cosmetics shall make an application for grant of a licence or loan licence to manufacture for sale or for distribution to the State Licensing Authority.

10. Manufacture of cosmetics under competent staff (Rule 26(a))

Manufacture of cosmetics shall be conducted under the direction and personal supervision of competent technical staff consisting of at least one person who is a whole-time employee and who possesses any one of the prescribed qualifications.

11. Testing of Cosmetics Manufactured (Rule 26(c))

The manufacturer shall provide adequate arrangements for testing the cosmetics manufactured and raw materials used for manufacture in such cosmetics.

12. Maintain records of each Batch Manufactured (Rule 26(f))

The licensee shall keep records of the details of each batch of cosmetic manufactured by him and of the raw materials used therein as per particulars specified in the Eighth Schedule. Such records shall be retained for a period of three years after the date of expiry of the batch.

13. Testing of each Batch of Raw Material and Finished Goods (Rule 26(h))

The licensee shall test each batch or lot of the raw materials used for manufacturing the cosmetics and also each batch of the final product. They shall maintain records or registers showing the particulars in respect of such tests. The records or registers shall be retained for a period of three years from the date of manufacture.

14. Form COS-11: Inspection Book (Rule 26(k))

The licensee shall maintain an Inspection Book in Form COS-11 to enable an Inspector to record his impression and the defects noticed.

15. Intimation of change in labelling or composition or testing of products registered for Manufacture (Rule: Rule 26(k)(2))

The manufacturer shall inform the Licensing Authority within thirty days, in writing, in the event of change in labelling or composition or testing, or specification or in documentation of any of the cosmetic pertaining to this license, along with an undertaking that the products comply with standards laid down by the Bureau of Indian Standards as referred in the Ninth Schedule.

16. Ensure license of actual manufacturer in case of sale or distribution of cosmetics (Rule 33)

Subject to the other provisions of the Act and these rules, no person shall sell or distribute any cosmetic unless the cosmetic, if of Indian origin, is manufactured by a licensed manufacturer and labelled and packed in accordance with these rules.

17. Ensure labelling compliances as per Rules (Rule 34)

The licensee shall ensure compliance with all required labelling requirements as specified in the rules.

18. Ensure compliance with Standards of Cosmetics (Rule 39)

The licensee shall ensure compliance with Standards of Cosmetics laid down in Rule 39.