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India Consults on Draft Standard for Tooth Whitening and Bleaching Products


On May 6, 2022, the Bureau of Indian Standards (BIS) issued a draft standard for tooth whitening and bleaching products (hereinafter referred to as the Standard). The deadline for comments is July 5, 2022.

The Standard prescribed requirements and test methods for external tooth whitening and bleaching products which are intended for use directly on the outer surfaces of teeth by professional application.

In addition, cautions shall be marked on the packaging of tooth bleaching products that

  • not to be used on a person under 18 years of age, and

  • to be sold only to dental practitioners.

The requirements are listed in the table below.

Table 1 Requirements for External Tooth Whitening/ Bleach Products

Sl, 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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