Regulatory aspects in cometics

1. Regulatory Aspects In Cosmetics

2. Cosmetics
• As per the Drug and cosmetic act 1940, “cosmetic” means any article
intended to be rubbed, poured, sprinkled or sprayed on, or
introduced into, or otherwise applicated to, the human body or any
part thereof for cleansing, beautifying, promoting attractiveness, or
altering the appearance, and includes any article .
Included in this definition are products such as skin creams, lotions, perfumes, lipsticks, fingernail
polishes, eye and facial make-up preparations, shampoos, permanent waves, hair colors, toothpastes,
deodorants, and any material intended for use as a component of a cosmetic product. Soap products
consisting primarily of an alkali salt of fatty acid and making no label claim other than cleansing of the
human body are not considered cosmetics under the law.

3. Labeling Requirements For Imported Cosmetics
• Since 2001, the government of India has made it mandatory for packaged goods and
cosmetics that are imported into the country to be correctly labeled as per regulations.
All labels on packaged goods must have :
1. Name and address of the importer
2. Generic or common name of the commodity
packed
3. Net quantity in terms of a standard unit of
weights and measures
4. Month and year of packing in which the
commodity is manufactured or packed or
imported.
5. Maximum retail sales price (MRP) of the
packaged commodity at which the commodity
will be sold to the end consumer
The MRP includes :
taxes,
freight transport charges,
commission payable to dealers,
all charges towards advertising, delivery, packing,
and forwarding.
For cosmetic products specific information has to be
clearly mentioned on both the inner and outer labels:
1. Name of the cosmetic.
2. Name of the manufacturer and complete address of
the premises of the manufacturer where the cosmetic
has been manufactured
3. The names of ingredients in the order of percentage
of content.

4. On the inner label:
1. Warning words about where a hazard exists,
2. Adequate directions for safe use which includes
a warning, caution or special direction that the
consumer must observe when using the
product.
3. A mention must be made of the names and
quantities of the ingredients that are hazardous
or poisonous.
4. The names of ingredients in the order of
percentage of content.
5. The batch number preceded by the letter “B”.
6. In the case of soaps instead of a batch number,
the month and year of manufacture of the soap
shall be mentioned on the label.
7. Manufacturing license number preceded by the
letter “M.
On the outer label:
1. A declaration of the net contents expressed in
terms of weight for solids/ semi-solids, fluid
measure for liquids.
2. The names of ingredients in the order of
percentage of the content.

5. Regulatory Provisions on Import of Cosmetics in India
• Chapter III of Drug and Cosmetic Act deals with import of Drug and Cosmetic. Now import
of certain cosmetic is prohibited under section 10 of the Act and rules 134A, 135, 135A of
Drug and Cosmetic Rules 1945
1. Any cosmetic this is not of Standard Quality.
2. Any cosmetic this is misbranded or spurious.
3. A cosmetic containing ingredient which render
it injurious or harmful or unsafe to use.
4. A cosmetic whose import is prohibited by rule.
5. Any cosmetic containing hexachlorophene.
6. Any cosmetic in which lead or arsenic
compound used for coloring purpose.
7. Any cosmetic which contains mercury
compounds.
Cosmetic can be imported in India only
through following ports as per the rule 43A.
1. Firozpur Cantonment and Amritsar
Railway Stations.
2. Chennai, Kolkata, Mumbai, Cochin, Nhava
Sheva and Kandla by Sea route.
3. Ahmedabad, Chennai, Delhi, Hyderabad,
Kolkata, and Mumbai by Air.
4. Raxaul by Road/Railway lines connecting
in India.

6. 28 Cosmetic which are Placed under Schedule S to the
rule which are imported in India only after compliance
with the Indian standards.
1. Skin Powder.
2. Skin Powder for infants.
3. Tooth powders.
4. Toothpastes.
5. Skin Creams.
6. Hair oils.
7. Shampoos soap based.
8. Shampoos synthetic detergent based.
9. Hair creams Oxidation hair dyes, liquid.
11. Cologne.
12. Nail Polish.
13. Aftershave Lotion.
14. Pomades and Brilliantine’s.
15. Depilatories.
16. Shaving Creams
17. Cosmetic Pencils.
18. Lipstick.
19. Toilet soap.
20. Liquid Toilet soap.
21. Baby Toilet soap.
22. Transparent toilet soap
23. Shaving soap.
24. Lipslave.
25. Powder Hair dye.
26. Bindi.
27. Kumkum Powder.
28. Henna Powder.

7. Misbranded Cosmetic & Spurious cosmetic:
Misbranded Cosmetic: - A cosmetic is deemed to be misbranded if:
A. If it contains a color which is not prescribed; or
B. If it is not labeled in the prescribed manner; or
C. If the label or container bears any statement which is false or misleading in any
particular.
Spurious cosmetic: - A cosmetic is deemed to be spurious if:
A. If it is imported under a name which belong to another cosmetic; or
B. if the label or containers bears the made of an individual or a company
purporting to be the manufacturer of the cosmetic which individual or company is
fictitious or does not exist; or
C. if it purports to be the product of a manufacturer of whom it is not truly a
product.

8. Regulatory Provisions for the Manufacturing of Cosmetics
• Issued by : state regulatory authorities (State Food and drugs administration)..
• How to Obtain: Application is to made in form no 31. with fee of Rs.2500 and inspection
fee of Rs. 1000.
Documents required
1. Layout plan of the factory premises
2. list of equipment and machinery to
be installed.
3. document showing the constitution
of the firm.
4. document showing the possession
of applicant on the proposed
premises for factory e.g. rent
receipt.
Inspector inspects
1. adequate space for manufacturing,
2. quality control and storage of raw materials
3. packaging materials and finished products.
4. dequate Equipment and machinery for manufacture
5. testing facilities for raw materials and finished form
6. qualifications of personnel: Diploma in pharmacy,
registered pharmacist, intermediate in science with
chemistry as one of the subjects.

9. Schedule M (II): Requirements for the factory premises.
General requirements:
A. Location and Surroundings.
B. Buildings.
C. Water supply.
D. Disposal of water.
E. Health clothing and sanitary
requirements of the staff
F. Medical devices.
G. Working benches for the
operation of cosmetics.
Equipments
Lipstick and lip-gloss: Equipment's –
a. Vertical mixer.
b. Jacketed kettle.
c. Mixing vessel.
d. Triple roller mill.
e. Moulds with refrigeration facility.
f. Weighing and measuring devices
Hair dyes: Equipments-
a. Stainless steel tanks.
b. Mixer.
c. Filling unit.
d. WEIGHING and measuring devices.
e. Masks, Gloves, goggles
Toothpowders: Equipments-
a. Weighing and measuring devices.
b. Dry mixer.
c. Stainless steel tanks.
d. Powder filling and sealing
equipments.
Tooth Pastes: Equipments-
a. Weighing and measuring devices.
b. Jacketed kettle.
c. Planetary mixer.
d. Stainless steel tanks.
e. Tube filling equipments.
f. Crimping Machine.

10. Conditions for obtaining License:
1. Manufacturer shall have to continue to provide and maintain the
premises, equipment and staff as at the time of grant of license.
2. Manufacturer should test each batch of raw material before its use
in the manufacture of cosmetic.
3. Manufacturer should have to test each batch of finished cosmetics.
4. Manufacturer should have to maintain records of raw materials,
manufacturer of each batch of cosmetic and their testing.

11. Prohibition of manufacture and sale of certain cosmetics
1. Any cosmetic this is not of Standard
Quality.
2. Any cosmetic this is misbranded or
spurious.
3. A cosmetic containing ingredient which
render it injurious or harmful or unsafe to
use.
4. A cosmetic whose import is prohibited by
rule.
5. Any cosmetic containing hexachlorophene.
6. Any cosmetic in which lead or arsenic
compound used for coloring purpose.
7. Any cosmetic which contains mercury
compounds.
Misbranded Cosmetic: -
A. If it contains a color which is not prescribed;
or
B. If it is not labeled in the prescribed manner; or
C. If the label or container bears any statement
which is false or misleading in any particular.
Spurious cosmetic: -
A. If it is imported under a name which belong to
another cosmetic; or
B. if the label or containers bears the made of an
individual or a company purporting to be the
manufacturer of the cosmetic which individual or
company is fictitious or does not exist; or
C. if it purports to be the product of a
manufacturer of whom it is not truly a product.

12. Loan License:
Application for the loan license should be made in
the form (31-A). along with a fee of RS.3500 along
with the prescribe documents the licensing
authority will examining the licensed manufacturer
has spare capacity and has agreed to manufacture
of cosmetic for applicant will grant loan license
Labeling of cosmetics
1. Name of the cosmetic
2. Name of the manufacturer and complete address
On outer label: A declaration of the net contents
expressed in terms of weigh ofr solids, fluid measure for
liquids weight for the semisolids.
On inner label where hazard exists: Adequate directions
for safe use, any warning or caution required to be
observed by the consumer, and statement for the name
and quantities of ingredients that are hazardous
• Special Provisions
Fluoride content in toothpaste should not be more
than 1000 ppm
• Date of expiry should be mention on tube and cartons
• Hair dyes containing coal tar dyes should be well
labeled with cautions

13. Offences and penalties
Offences Penalties
Import of spurious cosmetic or
cosmetic containing any ingredient
which harmful for use.
Imprisonment for term of 3 years
which may extends to 5 years with
fine of five thousand rupees.
Import of cosmetic whose import is
prohibited under section 10-A
Import of cosmetic whose import is
prohibited under section 10-A
Repeated offence of above two. Imprisonment for term of 5 years and
fine which may extend to 10 thousand
rupees.
Sale/manufacture of cosmetic which
is not of standard or misbranded
cosmetic
Imprisonment for term of 3 years
which may extends to 5 years with
fine of five thousand rupees