Evidence map›Paper›PMID 32874328›Full record

ArticleEFSA journal. European Food Safety Authority2020

Re-evaluation of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) as food additives.

EFSA Panel on Food Additives and Flavourings (FAF), Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Ursula Gundert-Remy and 13 more

Open access · diamondAbstract read
In one paragraph

Article in EFSA journal. European Food Safety Authority, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.3field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 16 citations in OpenAlex.

  1. Review
  2. Article
  3. Innovative In Vitro Strategy for Assessing Aluminum Bioavailability in Oral Care Cosmetics.International journal of environmental research and public health · 2022
    Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

EFSA Panel on Food Additives and Flavourings (FAF)
Maged Younes
Gabriele Aquilina
Laurence Castle
Karl-Heinz Engel
Paul Fowler
Maria Jose Frutos Fernandez
Peter Fürst
Rainer Gürtler
Ursula Gundert-Remy
Trine Husøy
Melania Manco
Wim Mennes
Sabina Passamonti
Romina Shah
Dina Hendrika Waalkens-Berendsen
Detlef Wölfle
Matthew Wright
Polly Boon
Paul Tobback
Ana Maria Rincon
Alexandra Tard
Peter Moldeus

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of Sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) as food additives. The Scientific Committee for Food (SCF) assigned these food additives together with other aluminium-containing food additives a provisional tolerable weekly intake (PTWI) of 7 mg aluminium/kg body weight (bw). In 2008, EFSA established a tolerable weekly intake (TWI) of 1 mg aluminium/kg bw per week. Sodium aluminium silicate was shown in rats to be absorbed to a limited extent at 0.12 ± 0.011%. The Panel considered that potassium aluminium silicate would be absorbed and become systemically available similarly to sodium aluminium silicate. No information on the physicochemical characterisation of sodium aluminium silicate and potassium aluminium silicate when used as food additives has been submitted and only very limited toxicological data were available for sodium aluminium silicate. Exposure to E 554 was calculated based on the reported use levels in food supplements. Exposure to aluminium from this use of E 554 was calculated to exceed the TWI for aluminium. Based on the data provided by interested business operators, the Panel considered that E 555 is not being used as a carrier, but as an inseparable component of 'potassium aluminium silicate-based pearlescent pigments'. The Panel calculated the regulatory maximum exposure to E 555 as a carrier for titanium dioxide (E 171) and iron oxides and hydroxides (E 172). Exposure to aluminium from this single use at the maximum permitted level could theoretically far exceed the TWI. Considering that only very limited toxicological data and insufficient information on the physicochemical characterisation of both food additives were available, the Panel concluded that the safety of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) could not be assessed.

Indexed as

E 554E 555pearlescent pigmentspotassium aluminium silicatesodium aluminium silicate

Identifiers

PMID32874328
PMCPMC7448050
OpenAlexW3035320421

What OpenQuestion holds

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LicenceCC BY-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.