Microcrystalline cellulose solubility change and safety
What it found
The authors found that changing the solubility description for microcrystalline cellulose (E 460(i)) would not raise a safety concern.
The tests were done in a lab, not in people.
What they found
Solubility test results
The tests showed that more than 10,000 mL of sodium hydroxide solution was needed to dissolve 1 g of the sample.
Missing measurements
No measurements were provided for solubility across a range of sodium hydroxide concentrations.
Solubility depends on concentration
Published information shows that how well microcrystalline cellulose dissolves depends on the concentration of the sodium hydroxide solution.
Specifications lack concentration
The current EU specifications for microcrystalline cellulose do not state what concentration of sodium hydroxide solution should be used for the solubility test.
What the authors conclude
“the amendment to the specifications as regards the solubility of microcrystalline cellulose (E 460(i)) proposed by the applicant would not give rise to a safety concern”
Also in their conclusions
- They concluded that the proposed amendment to the specifications for microcrystalline cellulose (E 460(i)) would not give rise to a safety concern.
- They recommended that the concentration of sodium hydroxide solution to be used in the solubility test should be indicated in the EU specifications.
How it was done
The European Commission asked the authors to look at a request to change how microcrystalline cellulose is described in the rules, from slightly soluble to practically insoluble or insoluble in sodium hydroxide solution.
The applicant ran solubility tests on four batches of microcrystalline cellulose. They used a sodium hydroxide solution at 50 g/L, as set out in the European Pharmacopeia, because the JECFA testing procedures do not state a concentration.
What it can’t tell you
- We summarised it from the abstract only.
- This paper only looks at how the additive dissolves in a lab test.
- It does not report any studies in people or animals, so it cannot show what happens when microcrystalline cellulose is eaten.
The paper
- Title
- Safety of the proposed amendment of the specifications for microcrystalline cellulose (E 460(i)) as a food additive
- Type
- Scientific opinion of the European Food Safety Authority
- Summarised from
- Abstract only
- Cite
- EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) (2017). Safety of the proposed amendment of the specifications for microcrystalline cellulose (E 460(i)) as a food additive. EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2017.4699Free full textPubMed 32625405DOI
Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error