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

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; EFSA Panel on Food Additives and Flavourings (FAF)

doi:10.2903/j.efsa.2020.6152

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

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 RinconAlexandra Tard, Peter Moldeus, EFSA Panel on Food Additives and Flavourings (FAF)

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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 ± 0.011considered 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.

Original language	English
Pages	e06152
Number of pages	27
Volume	18
No.	6
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2020.6152
Publication status	Published - Jun 2020

Bibliographical note

Acknowledgements: The Panel wishes to thank Claude Lambre, Jan Mast and Galvin Eyong for the support provided to this scientific output. The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.

Keywords

sodium aluminium silicate
E 554
potassium aluminium silicate
E 555
pearlescent pigments

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© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. https://creativecommons.org/licenses/by-nd/4.0/
Final published version, 2.71 MBLicence: CC BY-ND

Cite this

Younes, M., Aquilina, G., Castle, L., Engel, K.-H., Fowler, P., Frutos Fernandez, M. J., Fürst, P., Gürtler, R., Gundert-Remy, U., Husøy, T., Manco, M., Mennes, W., Passamonti, S., Shah, R., Waalkens-Berendsen, D. H., Wölfle, D., Wright, M., Boon, P., Tobback, P., ... EFSA Panel on Food Additives and Flavourings (FAF) (2020). Re-evaluation of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) as food additives. EFSA Journal, 18(6), e06152. https://doi.org/10.2903/j.efsa.2020.6152

Younes, M, Aquilina, G, Castle, L, Engel, K-H, Fowler, P, Frutos Fernandez, MJ, Fürst, P, Gürtler, R, Gundert-Remy, U, Husøy, T, Manco, M, Mennes, W, Passamonti, S, Shah, R, Waalkens-Berendsen, DH, Wölfle, D, Wright, M, Boon, P, Tobback, P, Rincon, AM, Tard, A, Moldeus, P & EFSA Panel on Food Additives and Flavourings (FAF) 2020, 'Re-evaluation of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) as food additives' EFSA Journal, vol. 18, no. 6, pp. e06152. https://doi.org/10.2903/j.efsa.2020.6152

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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 ± 0.011considered 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 {\textquoteleft}potassium aluminium silicate-based pearlescent pigments{\textquoteright}. 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.",

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author = "Maged Younes and Gabriele Aquilina and Laurence Castle and Karl-Heinz Engel and Paul Fowler and {Frutos Fernandez}, {Maria Jose} and Peter F{\"u}rst and Rainer G{\"u}rtler and Ursula Gundert-Remy and Trine Hus{\o}y and Melania Manco and Wim Mennes and Sabina Passamonti and Romina Shah and Waalkens-Berendsen, {Dina Hendrika} and Detlef W{\"o}lfle and Matthew Wright and Polly Boon and Paul Tobback and Rincon, {Ana Maria} and Alexandra Tard and Peter Moldeus and {EFSA Panel on Food Additives and Flavourings (FAF)}",

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AU - Younes, Maged

AU - Aquilina, Gabriele

AU - Castle, Laurence

AU - Engel, Karl-Heinz

AU - Fowler, Paul

AU - Frutos Fernandez, Maria Jose

AU - Fürst, Peter

AU - Gürtler, Rainer

AU - Gundert-Remy, Ursula

AU - Husøy, Trine

AU - Manco, Melania

AU - Mennes, Wim

AU - Passamonti, Sabina

AU - Shah, Romina

AU - Waalkens-Berendsen, Dina Hendrika

AU - Wölfle, Detlef

AU - Wright, Matthew

AU - Boon, Polly

AU - Tobback, Paul

AU - Rincon, Ana Maria

AU - Tard, Alexandra

AU - Moldeus, Peter

AU - EFSA Panel on Food Additives and Flavourings (FAF)

N1 - Acknowledgements: The Panel wishes to thank Claude Lambre, Jan Mast and Galvin Eyong for the support provided to this scientific output. The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.

PY - 2020/6

Y1 - 2020/6

N2 - 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 ± 0.011considered 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.

AB - 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 ± 0.011considered 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.

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KW - potassium aluminium silicate

KW - E 555

KW - pearlescent pigments

U2 - 10.2903/j.efsa.2020.6152

DO - 10.2903/j.efsa.2020.6152

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