Hypromellose | whatsinit

About

What it is and where it shows up.

Hypromellose (HPMC) is a semi-synthetic, cellulose-derived polymer produced by chemically modifying cellulose with propylene oxide and methyl groups. It is widely used in food as an emulsifier, thickener, stabiliser, and gelling agent in a range of processed foods and food supplements.

Safety summary

The regulatory and scientific consensus.

JECFA, the EU's Scientific Committee on Food (SCF), and EFSA have all established an ADI of 'not specified' for hypromellose, meaning no numerical daily limit is considered necessary at typical use levels. The compound is not absorbed in the human gut and is excreted intact in faeces, though it may be partially fermented by intestinal flora; at very high experimental doses in animals, soft stools and diarrhoea were observed. EFSA noted that a separate risk assessment is warranted for infants under 12 weeks of age, as general population conclusions may not apply to this group.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Approved	Authorised quantum satis under Regulation (EC) No 1333/2008 (Annex II). Re-evaluated in 2018 by EFSA ANS Panel, which concluded no need for a numerical ADI and no safety concern at reported use levels. Specific risk assessment required for infants under 12 weeks of age per EFSA guidance.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Hydroxypropyl Methyl Cellulose (INS 464) is recognised under FSS (Food Products Standards and Food Additives) Regulations 2011 and explicitly permitted in double fortified salt at not more than 2.0% under the Food Safety and Standards (Fortification of Foods) Regulations.source
FDA (Food and Drug Administration) (United States)	Approved	Permitted as a direct food additive for human consumption under 21 CFR 172.874. The US National Research Council recommends 30 g/day as the upper safe level for dietary fibre from modified celluloses as a general guidance figure.source

Who should approach with care

Whose guidance would steer them away.

Infants — EFSA specifically noted that the general population safety conclusion does not automatically apply to infants under 12 weeks of age and that a separate risk assessment is warranted for this group before use in infant formula.

Ibs — HPMC can be fermented by intestinal flora and at high doses produced soft stools and diarrhoea in animal studies, which may exacerbate symptoms in individuals with irritable bowel syndrome.

Ibd — As a fermentable modified cellulose, HPMC may alter gut microbial activity and intestinal transit, which could be a concern for individuals with inflammatory bowel disease who have heightened gut sensitivity.

Research citations

The sources behind this verdict.

1FSSAI. Food Safety and Standards (Fortification of Foods) Regulations — Compendium (2021), 2021. fssai.gov.in
2EFSA. Safety and efficacy of hydroxypropyl methyl cellulose for all animal species, 2020. efsa.europa.eu
3EFSA. Re-evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives, 2018. efsa.europa.eu
4EFSA. Safety of change in specifications for HPMC (E 464), 2015. efsa.europa.eu
5FDA. Pharmacology Review: Hypromellose as direct food additive, 21 CFR 172.874, 2009. accessdata.fda.gov

Independently researched5 citations