cosmetics - regulatory : Regulatory provisions related to cosmetics

REGULATORY PROVISIONS RELATED TO COSMETICS , REGULATORY PROVISIONS RELATING TO IMPORT OF COSMETICS , Application for registration certification for import cosmetics , Grant of registration certificate , Standards for imported cosmetics , REGULATORY PROVISIONS RELATING TO MANUFACTURE OF COSMETICS , REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF COSMETICS , LOAN LICENCE

1. REGULATORY PROVISIONS RELATED TO COSMETICS Presented by P.Pavazhaviji M.Pharm I Year (II Sem ) Dept. of Pharmaceutics MTPG & RIHS Puducherry

2. CONTENTS : Cosmetics definition Regulatory provisions relating to import of cosmetics Application for registration certification for import cosmetics Grant of registration certificate Standards for imported cosmetics Misbranded cosmetics Spurious cosmetics Regulatory provisions relating to manufacture of cosmetics Requirements of factory premises for manufacturing of cosmetics Particulars to be shown in the manufacturing records Loan licence

3. COSMETICS DEFINITION According to D & C Act 1940 : Any article intended to be rubbed, poured sprinkled or sprayed on or introduced into or applied to any part of the human body for cleansing, beautifying, promoting attractiveness & altering appearance and includes any articles intended for use as a component of cosmetics .

4. Import of certain cosmetics is prohibited under 10 of the act and rules 129F.134A,135,135A of the drugs &cosmetics rules , 1945 These 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 or arsenic compound has been used for coloring purpose Any cosmetic which contains mercury compound REGULATORY PROVISIONS RELATING TO IMPORT OF COSMETICS :-

5. Application for registration certification for import cosmetics An application in form 42 prescribed under the drugs & cosmetics rules along with a fee of US $ 250 or equivalent in Indian currency is required to be submitted in the office of licensing authority appointed by the central government i.e. office of the drugs controller general (India)

6. Grant of registration certificate If the application is complete in all respect , and the information specified in schedule D III is in order , the licensing authority will issue registration certificate within six month of receipt of application . Beyond six months , the licensing authority can issue registration certificate with additional three months by recording reasons in writing for the delay The registration certificate is issued in form 43 prescribed under the drugs & cosmetics rules .

7. If the registration certificate is not issued within stipulated time , the applicant can make an appeal to central government. This registration certificate remains valid for three years from the date of issue , if it is not suspended or cancelled . If an application is made within six months before the expiry of the certificate, it will remain valid till orders are passed on the application . If the original registration certificate is defaced , damaged or lost , a duplicate copy can be obtained from the licensing authority by paying a fee of US $100 or its equivalent amount in Indian currency

8. In eighties, the standards framed by Indian standards institution were adopted for certain cosmetics 28 cosmetics have been placed under schedule ‘S’ ( standards for cosmetics ) to the rules and are required to comply with Indian standards and these are : Skin powder Skin powder for infants Powder hair dye Tooth powder tooth paste Bindi (liquid) Skin creams Hair oils Kumkum powder Shampoos, soap based Shampoos, synthetic detergent based hair creams Oxidation hair dyes, liquid Henna powder Standards for imported cosmetics

9. Cologne Nail polish Aftershave lotions Pomades & brilliantine Depilatories, chemical Shaving creams Cosmetic pencils Lipsticks Toilet soap Liquid toilet soap Baby toilet soap Transparent toilet soap Shaving soap Lip salve

10. A cosmetic shall be deemed to be misbranded when- If it contains a color which is not prescribed or If it is not labeled in the prescribed manner or If the label or container bears any statement which is false or misleading in any particular MISBRANDED COSMETICS:

11. SPURIOUS COSMETICS : A cosmetic shall be deemed to be spurious when- If it is imported under a name which belongs to another cosmetic or If it purports to be the product of a manufacturer of whom it is not truly a product . 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

12. Rule 134 of Drugs and cosmetics 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 : 2 ppm of arsenic calculated as arsenic trioxide 20 ppm of lead calculated as lead, 100 ppm of heavy metals other than lead calculated as the total of the respective metals. Restriction

13. REGULATORY PROVISIONS RELATING TO MANUFACTURE OF COSMETICS : A licence is required under the drugs & cosmetics rules for manufacture of cosmetics for sale /distribution. This licence is issued by the state regulatory authorities HOW TO OBTAIN LICENCE ; The application should be accompanied by the following documents : (form 31 ) Lay out plan of the factory premises A list of equipment and machinery installed A document about the constitution of the firm A document showing possession of the applicant on the proposed premises for factory

14. The factory premises are inspected by the officer of the state regulatory agency. The officer finds out whether : The applicant has provided adequate space for manufacturing operations, 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 & finished form of cosmetics

15. REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF COSMETICS :- I. GENERAL REQUIREMENTS : A. LOCATION AND SURROUNDINGS :- The factory shall be located in a sanitary place and hygienic conditions shall be maintained in the premises. Well ventilated and clean .

16. B. BUILDINGS :- The buildings used for the factory shall be constructed so as to permit production under hygienic conditions and not to permit entry of insects, rodents , lies etc. The walls of the room in which manufacturing operations are carried out, shall be up to a height of six feet from the floor, water proof and capable of being kept clean. The flooring shall be smooth, even and washable and shall be such as not to permit retention or accumulation of dust . C. WATER SUPPLY : The water used in manufacture shall be of potable quality

17. D . DISPOSAL OF WATER : Suitable arrangements shall be made for disposal of waste water E. HEALTH, CLOTHING & SANITARY REQUIREMENTS OF THE STAFF: All workers shall be free from contagious or infectious diseases . They shall be provided with clean uniforms and gloves wherever required. washing facilities shall be provided.

18. II. REQUIREMENTS OF PLANT AND EQUIPMENT: A . POWDERS :- ( face powder, cake make-up, compacts, face packs, rouges etc.) EQUIPMENT: 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 devices. Storage tanks. An area of 15 square meters is recommended. The section is to be provided with adequate exhaust fans.

19. B. CREAMS, LOTIONS, SHAMPOOS, HAIR OILS : EQUIPMENT: Mixing and storage tanks of suitable materials. Suitable agitator. Heating kettle- steam, gas or electrically heated. Colloidal mill or homogenizer (wherever necessary ) Triple roller mill (wherever necessary ) Filling and sealing equipment, weighing and measuring devices An area of 25 square meters is recommended

20. C. NAIL POLISHES AND NAIL LACQUERS : 1.EQUIPMENT : A suitable mixer. Storage tanks. Filling machine – hand operated or power driven Weighing and measuring devices. An area of 15 square meters is recommended . The section shall be provided with flame proof exhaust syste m 2.PREMISES : It shall be situated in an industrial area . It shall be separate from other cosmetic manufacturing areas Floors , walls, and doors shall be fire proof. 3 . STORAGE; All explosive solvents and ingredients shall be stored in metal cupboards or in a separated enclosed area 4 . MANUFACTURE: workers shall be asked to wear shoes in the section.

21. D. LIPSTICKS : EQUIPMENT: Vertical mixer Mixing vessel Triple roller mill/ball mill Weighing and measuring devices An area of 15 square meters is recommended

22. E. DEPILATORIES : EQUIPMENT : Mixing tanks Mixers Triple roller mill or homogenizer Filling and sealing equipment Weighing & measuring devices Moulds An area of 10 square meters us recommended

23. F. PREPARATION USED FOR EYE : EYEBROWS ,EYELASHES, EYELINERS ETC. EQUIPMENT : mixing tanks A suitable Homogeniser Filling and sealing equipment Weighing and measuring devices An area of 10 square meters is recommended

24. 2) KAJAL AND SURMA : EQUIPMENT : base sterilser Powder sterilser Stainless steel sieves Filling and sealing arrangements Weighing and measuring devices Homogenizer Pestle and mortar An area of 10 square meters with a separate area of 5 square meters for base sterilization is recommended

25. G . AEROSOL : EQUIPMENT : Air compressor Mixing tanks Suitable propellant filling and crimping equipments Liquid filing unit Leak test equipment

26. H. ALCOHOLIC FRAGRANCE SOLUTION : EQUIPMENT : mixing tanks with stirrer Filtering equipment Filling unit Weighing and measuring devices Masks , gloves and goggles An area of 15 square meters with proper exhaust is recommended

27. HAIR DYES: EQUIPMENT : Stainless steel tanks. Mixer Filling unit Weighing and measuring devices Gloves, masks and goggles an area of 15 square meters with proper exhaust is recommended

28. J . TOOTH POWDER : EQUIPMENT : Weighing and measuring devices. Dry mixer (powder blender) Stainless steel sieves Powder filling and sealing equipment An area of 15 square meters is recommended

29. k . TOOTH PASTES: EQUIPMENT: Weighing and measuring devices Kettle-steam, gas or electrically heated Planetory mixer Tube filling equipment Crimping machine 15 square meters area is recommended

30. Kettles/pans for saponification Boiler or any other suitable heating arrangement Suitable stirring arrangement Storage tanks or trays Drier Amalgamator/chipping machine Mixer triple roller mill Granulator Plodder Cutter Pressing , stamping and embossing machine Weighing and measuring A minimum area of 100 square meters is recommended for the small scale manufacture of toilet soaps L . TOILET SOAPS EQUIPMENT :

31. 1 . Serial number 2 . Name of the product 3 . Batch size 4 . Batch number 5 . Name of all ingredients and quantities used . 6 . Actual production and packaging particulars indicating the size and quantity of finished packings. Signature of the expert staff responsible for the manufacture. PARTICULARS TO BE SHOWN IN THE MANUFACTURING RECORDS (schedule ‘U’):

32. A person not having his own manufacturing facilities can get cosmetics manufactured from a licensed cosmetic manufacturer under loan licence system. Application for loan l icence in prescribed form (form 31-A) along with a fee of Rs 3500 together with other requisite documents should be submitted to the state regulatory authorities. LOAN LICENCE

33. Bibliography Cosmetics formulation manufacturing & Quality control by P.P. Sharma page no:13 TO 33 http://www.vediclifesciences.com/pdfs/New Regulations in Cosmetics.pdf http ://en.wikipedia.org/wiki/Cosmetics REFERENCES