Cosmetics - Regulatory Aspects

Definition of cosmetic products as per Indian regulation. Indian regulatory requirements for labeling of cosmetics .Regulatory provisions relating to import of cosmetics ,Misbranded and spurious cosmetics. Regulatory provisions relating to manufacture of cosmetics – Conditions for obtaining license, prohibition of manufacture and sale of certain cosmetics, loan license, offences and penalties.

1. COSMETICS –REGULATORY I SILAMBARASAN M PHARM(PHARMACEUTICS) MTPG& RIHS

2. CONTENTS DEFINITIONS REGULATORY PROVISION RELATED TO IMPORT OF COSMETICS REGULATORY PROVISION RELATED TO MANUFACTURE OF COSMETICS REGULATORY PROVISION RELATED TO LABELLING OF COSMETICS OFFENCES AND PENALTIES

3. DEFINITION OF COSMETICS AS PER INDIAN REGULATION According to D & C Act 1940 and the rule in 1945, “Cosmetic is define as the means any article intend to be rubbed, poured, sprinkled or sprayed on , or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic”.

4. MISBRANDED COSMETICS If it contain a color which is not prescribed . If it not labelled in the prescribed manner. If the label or container bears any statement which is false or misleading in any particular.

5. SPURIOUS COSMETICS If it is imported under a name which belongs to another cosmetics . If the label or container bears the name of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist; I f it purports to be the product of a manufacturer of whom it is not truly a product .

6. REGULATORY PROVISION RELATED TO IMPORT OF COSMETICS Import of certain cosmetic is prohibited under D&C Act rules Sec 10 of the act and rules 129F, 134A,135,135A of D & C rules 1945,they are Any cosmetic which is not of standard quality . Any misbranded or spurious cosmetic . Any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended. Any cosmetic the import of which is prohibited by rule . Any cosmetic containing hexachlorophene . Any cosmetic in which lead and arsenic compound has been used for coloring purpose. Any cosmetic which contains mercury compound .

7. 1)APPLICATION FOR REGISTRATION CERTIFICATION OF COSMETICS Application (FORM 42)+ Fees of US $250 (Equivalent to Indian money) Submitted to office of licensing authority appointed by central Govt Application contain all information and signed behalf of manufacturer Single application is enough for import of cosmetics from same manufacturer

8. 2)GRANT FOR REGISTRATION CERTIFICATE Registration Certificate should be issued within 6 months from date of receipt of application. Beyond 6 months ,Licensing authority can issue registration certificate with additional 3 months by recording reason for delay. Registration issued in the FORM 43 . It is valid for 3 years from date of issue. If registration certificate is not given at stipulated time ,applicant appeal for central Govt. If original certificate damaged or lost ,a duplicate copy can get from licensing authority by paying a fees of US $100 .

9. 3)CANCELLATION OF REGISTRATION CERTIFICATE If the manufacturer of cosmetics fails to comply with any of the condition of registration certificate ,they can cancel registration certificate. Incase of any issue ,applicant can appeal to central Govt within 30 days.

10. 4)STANDARD FOR IMPORTED COSMETICS 29 cosmetics are place under “ Schedule S” 1. Skin powder 11. Cologne 21. Baby toilet soap 2. Skin powder for infants 12. Nail polish 22. Transparent toilet soap 3. Tooth powder 13. After shave lotions 23.Shaving Soap 4. tooth paste 14. Pomades &brilliantines 24. Lip salve 5. Skin creams 15. Depilatories, chemical 25. Powder hair dye 6. Hair oils 16. Shaving creams 26. Bindi 7. Shampoos, soap based 17. Cosmetic pencils 27. Kumkum powder 8. Shampoos, synthetic detergent based 18. Lipsticks 28. Henna powder 9. hair creams 19. Toilet soap 29.Bathing bars 10. Oxidation hair dyes , liquid 20. Liquid toilet soap

11. 5)SOME PROHIBITED COSMETICS Misbranded Cosmetics Spurious Cosmetics Rule 134 of D&C Act stipulates that no cosmetic shall be imported which contains a coal tar color other than the one prescribed in schedule ’Q’. Coal tar color used in cosmetics shall not contain more than: 2ppm of arsenic calculated as arsenic trioxide, 20ppm of lead calculated as lead, 100ppm of heavy metals other than lead calculated as the total of the respective metals.

12. REGULATORY PROVISION RELATED TO MANUFACTURE OF COSMETICS CONDITIONS FOR OBTAINING LICENSE: A license is required for the manufacture of cosmetic for sale/distribution . This license is issued by the state regulatory authorities (State Food and drugs administration). Application is required to made in Form no 31 . The application should accompanied by a fee of Rs.2500 and inspection fee of Rs.1000 additional fee will be deposited, if no of items in any category not exceeds ten.

13. Cont, The application is accompanied with following documents. 1. Layout plan of the factory premises 2. A list of equipment and machinery to be installed. 3. A document showing the constitution of the firm . 4. A document showing the possession of applicant on the proposed premises for factory e.g. rent receipt . Apart from the following documents state drug control departments also required some affidavits or some other relevant information . Before granting the license (which is issued in form no 32) the factory premises is inspected by the officer of the state regulatory agency .

14. Cont, During inspection the officer finds out weather: The applicant has provided adequate space for manufacturing , quality control and storage of raw materials, packaging materials and finished products . The applicant has provided adequate Equipment and machinery for manufacture of cosmetics which he intends to manufacture . The applicant has provided adequate testing facilities for raw materials and finished form of cosmetics. The applicant has whole time services of a person who has either of the qualifications, -Diploma in pharmacy , - registered pharmacist , - intermediate in science with chemistry as one of the subjects.

15. Cont, Schedule M (II) of Drug and Cosmetic rule 1945 Deals with Requirements for the factory premises for manufacture of cosmetics. It covers : I. General requirements: Location and Surroundings . Buildings. Water supply. Disposal of water. Health clothing and sanitary requirements of the staff Medical devices Working benches for the operation of cosmetics

16. Cont, II. Requirements of Plant and Equipment's: The following equipment's, area, and other requirements are recommended for manufacturing of A. POWDER : (face powder, cake make-up, compacts, face packs, rouges etc .) Powder mixer of suitable type provided with a dust collector Perfume and color blender. Ball mill or suitable grinder. Filling and Sealing equipment Weighing and measuring device Storage tanks. An area of 15 square meters is recommended.

17. II. Requirements of Plant and Equipment's: B. CREAMS, LOTIONS, SHAMPOOS, HAIR OILS: Mixing and storage tanks of suitable materials. Suitable agitator. Heating kettle steam gas or electrically heated. Filling and Sealing equipment weighing and measuring devices. An area of 25 square meters is recommended

18. II. Requirements of Plant and Equipment's: C. LIPSTICKS : Vertical mixer. Mixing vessel. Triple roller mill/ball mill. Weighing and measuring devices. An area of 15 square meters is recommended

19. II. Requirements of Plant and Equipment's: D. HAIR DYES: Stainless steel tanks. Mixer. Filing and sealing unit. Weighing and measuring devices Gloves, masks. An area of 15 square meter is recommended.

20. II. Requirements of Plant and Equipment's: E. AREOSOL: Air compressor. Mixing tanks Filtering. Filling and cramping equipment. Liquid filing unit Leak test equipment. f. fire extinguisher g. An area of 15 square meters recommended

21. B) Conditions of License a) Manufacturer shall have to continue to provide and maintain the premises, equipment and staff as at the time of grant of license. b) Manufacturer should test each batch of raw material before its use in the manufacture of cosmetic. c) Manufacturer should have to test each batch of finished cosmetics. d) Manufacturer should have to maintain records of raw materials , manufacturer of each batch of cosmetic and their testing.

22. MANUFACTURING RECORDS P articulars to be shown in the manufacturing records : (schedule ‘U’) Serial number. Name of the product. Batch size. Batch number. Name of all ingredients and quantities used. Actual production and packaging particulars indicating the size and quantity of finished packing. Signature of the expert staff responsible for the manufacture.

23. PROHIBITION OF MANUFACTURE /SALE OF CERTAIN COSMETICS Any cosmetic this is not of Standard Quality or is misbranded or spurious . A cosmetic containing ingredient which render it injurious or harmful or unsafe to use . A cosmetic whose import is prohibited by rule . Any cosmetic accept toilet soap containing hexachlorophene . Any cosmetic in which lead or arsenic compound used for coloring purpose . Any cosmetic which contains mercury compounds . Any cosmetics containing colour other than prescribed ones. TOOTH PASTE/TOOTH POWDER containing tobacco . Misbranded cosmetics Spurious cosmetics

24. LOAN LICENCES A person not having his own manufacturing facilities can get cosmetics manufactured from licensed cosmetic manufacturer under license system. Application for loan license in prescribed form ( Form-31-A ) along with a fee Rs.3500 (at present it may be revised) together with other requisite documents should be submitted to the State Regulatory Authorities. The Licensing Authority of the state, after examining that the licensed manufacturer has spare capacity and has agrees to manufacture cosmetics for applicant, will grant loan license.

25. REGULATORY REQUIREMENT FOR LABELING OF COSMETICS ON BOTH THE INNER & OUTER LABELS:- a) Name of the cosmetic . b) Name of the manufacturer and complete address of the premises of the manufacturer where the cosmetic has been manufactured C) Use before(Month And Year)

26. REGULATORY REQUIREMENT FOR LABELING OF COSMETICS ON THE OUTER LABEL a) A declaration of the net contents expressed in terms of weight for solids / semi solids, fluid measure for liquids . b) The names of ingredients in the order of percentage of content .

27. REGULATORY REQUIREMENT FOR LABELING OF COSMETICS ON THE INNER LABEL a) Where a hazard exists, adequate directions for safe use, warning, caution or special direction required to be observed by the consumer, statement of the names and quantities of the ingredients that are hazardous or poisonous. b) The names of ingredients in the order of percentage of content. - Batch number preceded by the letter “B” - Manufacturing license number preceded by the letter “ M”

28. OFFENCES AND PENALTIES

29. REFERENCES Sharma P.P; Cosmetic formulation manufacturing and quality control; 3rd Edition; Nirali Prakashan ; chapter-1; P.13-33 https://cdsco.gov.in/opencms/opencms/en/Home/

30. “If u think compliance is expensive –try non compliance ”