regulatory provisions related to cosmetics

8/7/2019 REGULATORY PROVISIONS RELATED TO COSMETICS

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REGULATORY PROVISIONS

RELATED TO COSMETICS

SEMINAR BY : B.SHASHIDHAR REDDYREG NO : 016080064

B.Pharm IV yrUNDER THE GUIDENCE OF:

PRASANNA KUMARI . M.pharmASST.PROFESSOR

DEPT:PHARMACEUTICS

ST.PAULS COLLEGE OF PHARMACY


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CONTENTS :

Cosmetics definition

Regulatory provisions relating to import of 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


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COSMETICS DEFINITION

It means 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.

REGULATORY PROVISIONS RELATING TO

IMPORT OF COSMETICS:-

Import of certain cosmetics is prohibited under D&C Act rules

134A,135,135AThese are:

Any cosmetic which is not of standard quality:


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Any misbranded orspurious 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.


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In eighties, the standards framed by Indian standardsinistitution were adopted for certain cosmetics

28 cosmetics have been placed underschedule S ( standardsfor cosmetics ) to the rules and are required to comply withIndian standards and these are:

1. Skin powders 11. Cologne 22.Transparent toilet

2. Skin powders for infants 12. Nail polish soap 3. Toothpowders 13. Aftershave lotion 23. Shaving soap

4. Tooth pastes 14. Pomades 24. Lip salve

5. Skin creams 15.Depilatories 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 18. Lipsticks 28.Henna powder

detergent based 19. Toilet soap

9. Hair creams 20. Liquid toilet soap

10.Oxidation hair dyes, liquid 21. Baby toilet soap


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MISBRANDED COSMETICS:

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:

SPURIOUS COSMETICS:A cosmetic shall be deemed to be spurious when:

If it is imported under a name which belongs to anothercosmetic:

or


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Rule 134 of Drugs and cosmetics act stipulates that nocosmetic shall be imported which contains a coal tar colorother 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 totalof the respective metals.

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.


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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

REGULATORYPROVISIONSRELATINGTO

MANUFACTUREOFCOSMETICS:

HOW TO OBTAINLICENCE ;The application should be accompanied by the following

documents: (form 31)

Lay out plan of the factory premises:

A list ofequipment and machinery installed:

A document about the constitution of the firm :

A document showing possession of the applicant on the

proposed premises for factory


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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


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REQUIREMENTS OFFACTORYPREMISESFOR

MANUFACTUREOF COSMETICS:-

I.GENERALREQUIREMENTS:A. LOCATIONANDSURROUNDINGS:-

The factory shall be located in a sanitary place and hygienicconditions shall be maintained in the premises.

Well ventilated and clean.

B. BUILDINGS:-

The walls of the room in which manufacturing operations arecarried out, shall be up to a height ofsix feet from the floor,water proof and capable of being kept clean.

C. WATERSUPPLY:

The water used in manufacture shall be ofpotable quality


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D.DISPOSAL OF WATER:

Suitable arrangements shall be made for disposal of

waste water

F.HEALTH, CLOTHING& SANITARY

REQUIREMENTS OFTHESTAFF: 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.


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II. REQUIREMENTS OF PLANT AND EQUIPMENT:

A.POWDERS :- (face powder, cake make-up, compacts, face packs, rouges etc.)EQUIPMENT:

a. Powder mixer of suitable type provided with a dust collector.

b. Perfume and color blender.

c. Ball mill or suitable grinder.

d. Filling and sealing equipment

e. Weighing and measuring devices.f. Storage tanks.

g. An area of15 square meters is recommended.

B. CREAMS,LOTIONS,SHAMPOOS,HAIROILS:EQUIPMENT:

a. Mixing and storage tanks of suitable materials.b. Suitable agitator.

c. Heating kettle- steam, gas or electrically heated.

d. Filling and sealing equipment, weighing and measuring devices.


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C. NAILPOLISHESANDNAILLACQUERS:1.EQUIPMENT:

a. A suitable mixer.

b. Storage tanks.

c. Filling machine.

d. Weighing and measuring devices.

2.PREMISES:

a. It shall be situated in an industrial area.b. It shall be separate from other cosmetic manufacturing areas

c. Floors, walls, and doors shall be fire proof.

3.STORAGE;

All explosive solvents and ingredients shall be stored in metal

cupboards.4.MANUFACTURE:

a. workers shall be asked to wearshoes in the section.


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D.Lipsticks :1.EQUIPMENT:

a. Vertical mixerb. Mixing vessel

c. Triple roller mill/ball mill

d. Weighing and measuring devices

e. An area of15 square meters is recommended

E.Hair dyes:

EQUIPMENT:

a. Stainless steel tanks.

b. Mixer

c. Filling unitd. Weighing and measuring devices

e. Gloves, masks.


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F.TOOTHPOWDER:

EQUIPMENT:

a. Weighing and measuring devices.b. Dry mixer (powder blender)

c. Stainless steel sieves

d. Powder filling and sealing equipment

e. An area of15 square meters is recommended

G.TOOTHPASTES:

EQUIPMENT:

a. Weighing and measuring devices

b. Kettle-steam, gas or electrically heated

c. Planetory mixerd. Tube filling equipment

e. Crimping machine

f. 15 square meters area is recommended


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H. AEROSOLS:EQUIPMENT:

a. Air compressor

b. Mixing tanksc. Suitable propellant filling equipments

d. Leak testing equipment

e. Suitable filtration equipment

f. Fire extinguisher

g. 15 square meters area is recomended

I. Eye brows,Eye lashes,Eye liners:

EQUIPMENT:

a. Mixing tanks

b. A suitable mixer

c. Homogenizer

d. Weighing and measuring devices

e. Filling and sealing equipment


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PARTICULARS TO BE SHOWN IN THE

MANUFACTURING RECORDS: (schedule U)

1. Serial number

2. Name of the product

3. Batch size

4. Batch number5. 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 staffresponsible for the

manufacture.


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LOANLICENCE:

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.


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CONCLUSION :

All the cosmetics which are imported and

manufactured must be within the provisions of D&C

Act.


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Bibliography

Cosmetics formulation manufacturing & Quality control by P.P.

Sharma

page no:13 TO 33

http://en.wikipedia.org/wiki/Cosmetics

http://www.vediclifesciences.com/pdfs/New Regulations in Cosmetics.pdf


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ACKNOWLEDGEMENT :

This is an opportunity to express my sincere

thanks to our;

H.O.D

CLASS INCHARGE

STAFF &

CLASSMATES

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