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

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:
1. Skin powder
2. Skin powder for infants
3. Powder hair dye
4. Tooth powder
5. tooth paste
6. Bindi (liquid)
7. Skin creams
8. Hair oils
9. Kumkum powder
10. Shampoos, soap based
11. Shampoos, synthetic detergent based
12. hair creams
13. Oxidation hair dyes, liquid
14. Henna powder
Standards for imported cosmetics

9. 15) Cologne
16) Nail polish
17) Aftershave lotions
18) Pomades & brilliantine
19) Depilatories, chemical
20) Shaving creams
21) Cosmetic pencils
22) Lipsticks
23) Toilet soap
24) Liquid toilet soap
25) Baby toilet soap
26) Transparent toilet soap
27) Shaving soap
28) 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 system
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 :
1) 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. I. 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 licence 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