Risk assessmentindependent cross-checkabstract checked I-UPF-121 standard review

EU safety review of cellulose additives (including CMC)

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.

Overview

EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) et al.. EFSA J 2018 · PMID 32625652 · DOI 10.2903/j.efsa.2018.5047

EFSA found no safety concern for cellulose additives such as carboxymethylcellulose at the levels used in food.

Does the study support the specific claim? No · Methodological quality: high

Study explained simply

What did the researchers want to find out?: To re-evaluate cellulose food additives.
How was the study done?: Regulatory risk assessment.
How many people, animals or samples were studied?: Not applicable.
What was actually found?: No toxicity concerns at reported uses.
How large was the observed effect?: Not applicable.
What do the results mean in everyday life?: Authorities consider CMC safe at current levels.
What are the study's limitations?: Mainly animal toxicology; microbiome data not decisive.
What does it say about Elawady's specific claim?: Contradicts C-UPF-06.
Do the results apply to Germany and Europe?: EU.
What can explicitly not be concluded from this study?: Cannot exclude subtle gut effects.

Authors: EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) et al.
Journal: EFSA J
Year: 2018
Identifier: PMID 32625652 DOI 10.2903/j.efsa.2018.5047 · PMC7009359
Verification: verified – PubMed efetch 2026-10-26; Crossref works API 2026-10-26
Retracted: no
Corrections: none
Extent checked: abstract only
Conflicts of interest and funding: EFSA panel opinion (declarations of interest managed by EFSA; not reviewed here)

Are unmodified and modified celluloses (including sodium carboxymethylcellulose E 466) safe at reported uses?

Study design: Risk assessment – EFSA scientific opinion (re-evaluation of celluloses E 460-E 469 as food additives)
Population: General population (exposure assessment)
Country: EU
Period: 2018
Sample size: Not applicable
Inclusion and exclusion criteria: Toxicological and exposure data

Results: Celluloses not absorbed and excreted intact; can be fermented by gut flora. Low acute toxicity; no genotoxic concern; no adverse effects in subchronic studies up to 10% of diet; chronic NOAELs up to 9,000 mg/kg bw/day; no carcinogenicity; no reproductive/developmental effects above 1,000 mg/kg bw. 95th percentile exposure up to 506 mg/kg bw/day. No numerical ADI needed; no safety concern at reported uses and use levels.
Absolute risks: Not applicable
Authors' conclusion: No need for a numerical ADI; no safety concern at reported uses and use levels for celluloses including E 466.

Did not weigh microbiome/mucus findings from Chassaing 2015 as adverse endpoints (not stated in abstract)
Animal toxicology endpoints

Not applicable.

The responsible EU regulator found no safety concern for CMC at reported uses; contrasts with the claim.

Microbiome-based concerns (A-UPF-15, A-UPF-16).

Directly applicable (EU).

Regulatory reassurance; does not settle microbiome questions.

Multidimensional assessment
Multidimensional assessment
Authenticity of the source	verified
Methodological quality	high
Risk of bias	not assessable
Precision of results	not applicable
Directness	indirect
Reproducibility	replicated
Consistency with the overall evidence	mixed
Regional transferability	high
Adequacy of the interpretation (by the archive)	not applicable

Whether future re-evaluations consider microbiome data.