BIS Draft Standard for Tooth Whitening and Bleaching Products

Serial, No.

Characteristic

Requirement for

Method of Test Ref   to Annex/ IS

Non-
  Fluoridated

Fluoridated

i)

Concentration of active ingredient(s)   for bleaching (equivalent to hydrogen peroxide)，Percent

>0.1 percent

≤6 percent
(more than 0.1% but less than/equal to 6% of Hydrogen Peroxide present or   released)

>0.1 percent

≤6 percent

(more than 0.1% but less than/equal to 6% of Hydrogen Peroxide present or   released)

A

ii)

pH of aqueous suspension

4.7-10

4.7-10

D

iii)

Heavy metals (as lead)¹⁾, parts per million，Max

20

20

IS 16913^1,1-a)

iv)

Arsenic (as As2O3)¹⁾,   parts per million, Max

2

2

F/IS 16913

v)

Mercury，parts   per million, Max

1

1

IS 16913

vi)

Available Fluoride ion，parts per million, Max

50  (Type Test)²⁾

1000

G

vii)

Microbial limit

a)       Total microbial count, CFU/g, Max

100

100

IS 14648

b)       Yeast and mould count, CFU/g, Max

100

100

IS 14648

c)       Escherichia coli， per gram

Absent

Absent

IS 14648

d)       Pseudomonas aeruginosa, per gram

Absent

Absent

IS 14648

e)       Staphylococcus aureus, per gram

Absent

Absent

IS 14648

f)        Candida albicans, per gram

Absent

Absent

IS 14648