BIS Specifications and Analytical Cosmetics BIS Specifications and Analytical Methods for Shampoo

1. Dr. KUMARA SW A MY SA MA NTHUL A
A S S O C I A T E P R O F E S S O R
F a c u l t y o f P h a r m a c e u t i c a l S c i e n c e
A S S A M D O W N T O W N U N I V E R S I T Y
BIS specification and analytical
methods for shampoo, skincream and
toothpaste

2. BUREAU OF INDIAN STANDARDS (BIS)
 BIS is the National Standards Body of India Functioning Under Ministry Of
Consumer Affairs, Food and Public Distribution and leaders in all matters
concerning standardization, certification & quality.
 Why are Cosmetics regulated?
 To ensure that the cosmetics sold in India are safe, effective and conform to
state quality standards.
 Indian Standards Institution (ISI) in 1947
 Bureau of Indian Standards (BIS) Act 1986
 Bureau of Indian Standards 1 April 1987
 It sets the standard of quality for consumer goods and industrial goods.
 Cosmetic products in India are regulated under the D & C act 1940 and rules
1945 and labelling declaration by BIS.
 BIS sets standards for cosmetics for the products which are under Schedule S
of Drugs and Cosmetics rules 1945.

3. Cosmetics Regulation in India
 The Central Drugs Standard Control Organisation (CDSCO) is India's national
regulatory body for cosmetics, pharmaceuticals and medical devices.
 Cosmetic Legislation is driven through Drugs and Cosmetics Act, and the
legislative body is CDSCO headed by Drugs controller general of India.

4. Objectives of BIS specifications
 The primary goal is the harmonious growth of the processes of
standardisation, marking, and quality certification.
 Providing new thrust to standardization and quality control.
 Evolving the national strategy for according recognition to standards and
integrating them with growth and development of industrial production
and exports.
 Product specification, method of test, codes of practices, terminologies,
basic standards (17000 standards).

5. Main activities of BIS specifications
Standards Formulation
Certification
⚫ Laboratory Management Inter
national Activities
⚫ Training Services. Others
 Product
 Hallmarking of Gold Jewelry
 Quality Management System
 Environmental Management
Systems
 Occupational Health and Safety
Management System
 Hazard Analysis and Critical Control
Points
 Imported Products FMCS (Foreign
Manufacturer Certification Scheme)
 Information Services
 Consumer Affairs & Standards
 Promotion Sale of Standards

6. Indian Standards on Cosmetics
 30 Indian Standards on finished cosmetics are listed in Schedule 'S' of the
Drugs and Cosmetics Act 1940 and Rules, 1945 as per which the cosmetics in
their finished form (manufactured or imported) need to conform to these
Specifications.

7. List of Indian Standards referred in Schedule S
of the Drugs and Cosmetics Rules, 1945
 1. Skin powders (IS 3959)
 2. Skin powders for infants (IS 5339)
 3. Tooth Powder (IS 5383)
 4. Tooth paste (IS 6356)
 5. Skin Creams (IS 6608)
 6. Hair Oils (IS 7123)
 7. Shampoo, Soap-based (IS 7669)
 8. Shampoo, Synthetic-Detergent based (IS 7884)
 9. Hair Creams (IS 7679)
 10. Oxidation hair dyes, Liquid (IS 8481)
 11. Cologne (IS 8482)
 12. Nail polish (IS 9245)
 13. After shave lotion (IS 9255)
 14. Pomades and Brilliantines (IS 9339)-
 15.-Depilatorier chemicals (IS -5030)
 16.Shaving creams (IS 9740)
 17.Cosmetic Pencils (IS 9832)
 18. Lipstick (IS 9875)
 19. Lipsalve (IS 10284)
 20.Powder hair dyes (IS 10350)
 21.Bindi (Liquid) (IS 10998)
 22. Kumkum powder (IS 10999)
 23.Henna powder (IS 11142)
 24.Sindoor (IS 14649)
 25.Liquid foundation make-up (IS 14318)
 26.Cold Wax-Hair remover (IS 15152)
 27. Face pack (IS 15153)
 28. Kajal (IS 15154)
 29.Oxidation Hair Dyes (Emulsion type) (IS 15205)
 30.Cream Bleach (IS 15608)

8. BIS requirements of Shampoos

11. Additional requirements for ECO Marks

13. Packing and Marking

14. BIS Specification and Marking

15. Sampling

16. Annexure A: List of Raw Material Used in the formulation
of surfactant based Shampoo
 A-1 DETERGENTS
 a) Sodium or potassium or ethanolamine
salts of lauryl sulphonic acid,
 b) Lauryl ether sulphates,
 c) Sulphated monoglycerides,
 d) Sodium alkyl sulpho-acetate.
 e) Alkyl benzene polyoxyethyl
sulphonales,
 f) Sodium n-lauryl sarcosinate,
 g) Sodium alpha olefin sulphonates, and
 h) Other synthetic detergents.
 A-2 FOAM STABILIZERS
 a) Ethanolamides or
isopropanolamides of fattyacids,
 b) Amine oxides,
 c) Cocobetaines, and
 d) Cocoamidopropyl betaines.

17. Annexure A: List of Raw Material Used in the formulation
of surfactant based Shampoo….

18. Annexure A: List of Raw Material Used in the formulation
of surfactant based Shampoo….

19. Annexure B:

20. Annexure C:

21. Annexure D: BIS requirements of Shampoos
 Characteristics
 The pH of shampoo should be
 The maximum heavy metals (lead)
permitted in shampoos
 The maximum arsenic (As2O3)
permitted in shampoos is
 List of dyes, colours and pigments
permitted to be used in cosmetics is
under
 Non-volatile alcohol soluble matter,
percent by mass, Min
 Foam height for 2% solution, Min
 Requirements
 Between 4.0 to 9.0
 20 ppm
 2 ppm
 Schedule Q of Drug and
Cosmetics Act
 10
 150 mm

22. Annexure E: Ideal Properties of a Shampoo
 Ease of Application
 Rinsing
 Easy Wet Combing
 Manageability
 Luster
 Body
 Fragrance
 Low Level of Irritation
 Well Preserved
 Good Stability
 Economical

23. BIS requirements of Toothpastes
Characteristics Requirements Fluoridated
 Fineness:
 Particles retained on 150
micron IS sieve, percent
by mass,
 Particles retained on 75
micron IS sieve, percent
by mass, Max
 The pH of aqueous
suspension should be
 1.0
 2.5
 5.5 to 10.5
Requirements Non Fluoridated
 10
 2.5
 5.5 to 10.5

24. BIS requirements of Toothpastes
Characteristics Requirements Fluoridated
 The maximum heavy
metals (lead) permitted
 The maximum arsenic
(As2O3) permitted
 Foaming power, ml, Min
 Available fluoride ion, parts
per million, Max
 Microbial counts:
 Total viable counts per
gram, Max
 Gram negative pathogens
per gram, Max
 20 ppm
 2 ppm
 50
 1000
 1000
 Absent
Requirements Non Fluoridated
20 ppm
2 ppm
50
50
1000
Absent

25. BIS requirements of Skin creams
 Characteristics Requirements
 Thermal stability To pass the test
 The pH Between 4.0 to 9.0
 For creams with bees wax and borax pH Between 5.0 to 10.0
 The maximum heavy metals (lead) permitted 20 ppm
 The maximum arsenic (As2O3) permitted 2 ppm
 List of dyes, colours and pigments permitted to be used in cosmetics is under
• Schedule Q of Drug and Cosmetics Act
 Total fatty substance content, percent by mass, Min 5.0
 Total residue percent by mass, Min 10.0
 Microbial counts:
 Total viable counts per gram, Max 1000
 Gram negative pathogens par gram. Max Abs

26. Thank
you