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BIS Draft Standard for Tooth Whitening and Bleaching Products

2022-06-07 BIS Government

BIS Packaging Test methods

A draft standard was issued by the Bureau of Indian Standards (BIS) on May 6, 2022, for tooth whitening and bleaching products. The authorities invite comments till July 5, 2022. 

The standard prescribes requirements and test methods for external tooth whitening and bleaching products, especially for direct, professional use on the outer surfaces of the teeth. Under the regulation of this draft, caution marks are required on the packaging of tooth bleaching products applicable not to be used on a person under the age of 18 and to be sold only to dental practitioners.

For other requirements, please refer to the table below.

 

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 169131,1-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

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