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 assessment was based on solubility tests on four batches of the additive, not on studies in people or animals.
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. This matches the definition of 'practically insoluble or insoluble'.
Missing concentration data
No measurements were provided for how solubility changes across different concentrations of sodium hydroxide solution. Published information shows that solubility depends on that concentration.
Manufacturing unchanged
The authors noted that the proposed change was not due to a modification in how microcrystalline cellulose is made.
Specifications gap
The current EU specifications 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 change in the solubility specification would not give rise to a safety concern.
- They recommended that the concentration of sodium hydroxide solution to be used for the solubility test should be indicated in the EU specifications.
How it was done
The European Commission asked EFSA to assess a proposed amendment to the specifications for microcrystalline cellulose (E 460(i)), changing its solubility description from 'slightly soluble in sodium hydroxide' to 'practically insoluble or insoluble in sodium hydroxide solution'.
The authors reviewed the applicant's solubility tests on four batches of microcrystalline cellulose, using a sodium hydroxide solution concentration of 50 g/L as specified in the European Pharmacopoeia. They also checked whether the change was due to a modification in the manufacturing process.
What it can’t tell you
- This assessment looked only at the solubility description and did not include new studies in people or animals.
- It cannot show whether the additive itself has any health effects, because that was not the focus of this opinion.
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
- Full text
- Licence
- CC BY-ND. Words in quotation marks are the authors’; the rest is our summary.
- 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