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 | |||
i) | Concentration of active ingredient(s) for bleaching (equivalent to hydrogen peroxide)，Percent | >0.1 percent ≤6 percent | >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 | |
