Recently, the Bureau of Indian Standards (BIS) released a draft standard on ultramarine blue for use as a colourant in plastics for toys and food contact materials (FCMs). The earlier standard IS 9833:2018 which was already released in 2018, lists colorants that can be safely used in FCMs. However, due to the high toxicity risks associated with ultramarine blue when used in FCMs and children's toys, a new standard is required to strictly limit its lead and sulfur content to mitigate health risks.
The draft standard specifies the restricted substances in ultramarine blue and their maximum threshold limits as follows:
| Restricted Substances | Maximum Threshold Limit (% by weight) |
| Volatile matter | 1.0 |
| Matter soluble in water | 1.0 |
| Oil absorption | 30-40 |
| Alkalinity as Na2CO3 | 0.1 |
| Free Sulphur | 0.02 |
| Lead as Pb | 0.002 |
| Chloride as NaCl | 0.4 |
| Sulphates as Na2SO4 | 0.6 |
In addition, the draft emphasizes the importance of complying with Good Manufacturing Practices (GMP). It stipulates that the colorant should not leach or migrate from the product into food during tests conducted according to the standard IS 9845, nor should it show indications of instability or degradation during the manufacturing process.
Products containing ultramarine blue should be labeled with the material name, manufacturer's name, trademark (if available), net weight, and lot/batch number. Products that meet the standard requirements may apply for a BIS license and use the standard mark on the product.
The draft is currently open for public comment until August 23, 2024.
