Safety assessment of hydroxypropyl methylcellulose as a food ingredient.

Hydroxypropyl methyl cellulose (HPMC; CAS No. 9004-65-3) is an odorless and tasteless, white to slightly off-white, fibrous or granular, free-flowing powder that is a synthetic modification of the natural polymer, cellulose. It is used in the food industry as a multipurpose food ingredient. HPMC is approved by FDA as both a direct and an indirect food additive, and is approved for use as a food additive by the EU. The JECFA has evaluated the food uses of HPMC and established an acceptable daily intake (ADI) of 'not specified' for such uses. Based on the no-observed-adverse-effect level (NOAEL) of 5000 mg/kg body weight/day from a 90-day feeding study in rats, a tolerable intake for ingestion of HPMC by humans of 5 mg/kg body weight/day is posited and, as such, is more than 100-fold greater than the estimated current consumption of 0.047 mg/kg body weight/day.