Re‐evaluation of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) as food additives
2020; Wiley; Volume: 18; Issue: 6 Linguagem: Inglês
10.2903/j.efsa.2020.6152
ISSN1831-4732
AutoresMaged Younes, Gabriele Aquilina, Laurence Castle, Karl‐Heinz Engel, Paul Fowler, María José Frutos Fernández, Peter Fürst, Rainer Gürtler, Ursula Gundert‐Remy, Trine Husøy, Melania Manco, Wim Mennes, Sabina Passamonti, Romina Shah, D.H. Waalkens-Berendsen, Detlef Wölfle, Matthew Wright, Polly Boon, Paul Tobback, Ana María Rincón, Alexandra Tard, Peter Moldéus,
Tópico(s)Heavy Metal Exposure and Toxicity
ResumoEFSA JournalVolume 18, Issue 6 e06152 Scientific OpinionOpen Access 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), Corresponding Author fip@efsa.europa.eu Correspondence: fip@efsa.europa.euSearch for more papers by this authorMaged Younes, Search for more papers by this authorGabriele Aquilina, Search for more papers by this authorLaurence Castle, Search for more papers by this authorKarl-Heinz Engel, Search for more papers by this authorPaul Fowler, Search for more papers by this authorMaria Jose Frutos Fernandez, Search for more papers by this authorPeter Fürst, Search for more papers by this authorRainer Gürtler, Search for more papers by this authorUrsula Gundert-Remy, Search for more papers by this authorTrine Husøy, Search for more papers by this authorMelania Manco, Search for more papers by this authorWim Mennes, Search for more papers by this authorSabina Passamonti, Search for more papers by this authorRomina Shah, Search for more papers by this authorDina Hendrika Waalkens-Berendsen, Search for more papers by this authorDetlef Wölfle, Search for more papers by this authorMatthew Wright, Search for more papers by this authorPolly Boon, Search for more papers by this authorPaul Tobback, Search for more papers by this authorAna Maria Rincon, Search for more papers by this authorAlexandra Tard, Search for more papers by this authorPeter Moldeus, Search for more papers by this author EFSA Panel on Food Additives and Flavourings (FAF), Corresponding Author fip@efsa.europa.eu Correspondence: fip@efsa.europa.euSearch for more papers by this authorMaged Younes, Search for more papers by this authorGabriele Aquilina, Search for more papers by this authorLaurence Castle, Search for more papers by this authorKarl-Heinz Engel, Search for more papers by this authorPaul Fowler, Search for more papers by this authorMaria Jose Frutos Fernandez, Search for more papers by this authorPeter Fürst, Search for more papers by this authorRainer Gürtler, Search for more papers by this authorUrsula Gundert-Remy, Search for more papers by this authorTrine Husøy, Search for more papers by this authorMelania Manco, Search for more papers by this authorWim Mennes, Search for more papers by this authorSabina Passamonti, Search for more papers by this authorRomina Shah, Search for more papers by this authorDina Hendrika Waalkens-Berendsen, Search for more papers by this authorDetlef Wölfle, Search for more papers by this authorMatthew Wright, Search for more papers by this authorPolly Boon, Search for more papers by this authorPaul Tobback, Search for more papers by this authorAna Maria Rincon, Search for more papers by this authorAlexandra Tard, Search for more papers by this authorPeter Moldeus, Search for more papers by this author First published: 10 June 2020 https://doi.org/10.2903/j.efsa.2020.6152 Requestor: European Commission Question numbers: EFSA-Q-2016-00409; EFSA-Q-2016-00410 Panel members: 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, Peter Moldeus, Romina Shah, Ine Waalkens-Berendsen, Detlef Wölfle, Matthew Wright and Maged Younes. Acknowledgements: The Panel wishes to thank Claude Lambré, 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. Adopted: 12 May 2020 Amended: 7 Jul 2020 AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinked InRedditWechat 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. Summary Following a request from the European Commission, the Panel on Food Additives and Flavourings (FAF) was asked to deliver a scientific opinion on the re-evaluation of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) as food additives. Sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) are authorised food additives in the European Union (EU) according to Annex II and III of Regulation (EC) No 1333/2008 and specifications have been defined in Commission Regulation (EU) No 231/2012. In 1990, 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, the EFSA Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials (AFC Panel) established a tolerable weekly intake (TWI) of 1 mg aluminium/kg bw per week for dietary aluminium from all sources. No information on the physicochemical characterisation of sodium aluminium silicate and potassium aluminium silicate when used as food additives E 554 and E 555, respectively, has been submitted. 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. Only developmental toxicity studies with sodium aluminium silicate in mice, rats, hamsters and rabbits were available. No treatment-related maternal and developmental effects were observed. The reporting of the prenatal developmental studies was limited to allow the use of these data for hazard assessment. Only use levels for sodium aluminium silicate (E 554) in food supplement (FC 17) were available. The exposure to E 554 based on the reported use levels could be up to 2.9 mg/kg bw per day at the mean level and 3.9 mg/kg bw per day at the high intake level (P95), both in children. In this assessment, it was assumed that all food supplements consumed contained sodium aluminium silicate (E 554) at the highest reported use level. Based on the maximum amount of Al2O3 in sodium aluminium silicate (E 554) as stated in the EU specifications, E 554 contains up to 7.8% aluminium. Thus, the maximum exposure to aluminium from the use of E 554 could be up to 1.58 mg/kg bw per week at the mean and up to 2.13 mg/kg bw per week at the P95 for children. This alone would exceed the TWI of 1 mg/kg bw per week for dietary aluminium from all sources established by the European Food Safety Authority (EFSA). 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'. According to the Mintel Global New Products Database (GNPD), E 555 was labelled on 151 products, of which 146 were also labelled with iron oxide and hydroxides (E 172) or titanium dioxide (E 171). Based on the current authorisation for E 555 as a carrier for titanium dioxide (E 171) and iron oxides and hydroxides (E 172), where it can constitute '90% relative to the pigment' (Annex III of Regulation 1333/2008), the Panel calculated the theoretical regulatory maximum exposure to E 555 from this authorised use. Considering that potassium aluminium silicate (E 555) contains 20.4% aluminium (based on the molecular mass), the maximum exposure to aluminium from potassium aluminium silicate (E 555) as carrier for E 171 could be up to 388 mg/kg bw per week and the maximum exposure to aluminium from potassium aluminium silicate (E 555) as carrier for E 172 could be up to 297 mg/kg bw per week. The Panel noted that this single use at the maximum permitted level could theoretically far exceed the TWI for dietary aluminium from all sources established by EFSA. 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. The Panel recommended that data in line with the current Guidance document on evaluation of food additives is required for E 554 and E 555 to perform the risk assessment of these food additives and evaluate the potential exceedance of the TWI for aluminium resulting from their use as food additives. According to the interested business operators, potassium aluminium silicate is only used for the manufacturing of 'potassium aluminium silicate-based pearlescent pigments' and the components – potassium aluminium silicate, titanium dioxide or iron oxides - are bound to each other by strong physical forces and cannot be separated from each other by standard methods. The interested business operators stated that 'without mica, a pearlescent effect is absent. The colour of the pearlescent effect could not be achieved without titanium dioxide or iron oxide'. The description of the technological role of mica in 'potassium aluminium silicate-based pearlescent pigments' does not meet the definition of 'carrier' according to Regulation (EC) No 1333/2008. The Panel therefore considered that 'potassium aluminium silicate-based pearlescent pigments' is a new entity, not listed in the Regulation (EC) No 1333/2008 and not previously evaluated in the EU. Therefore, the Panel concluded that potassium aluminium silicate in 'potassium aluminium silicate-based pearlescent pigments' does not meet the definition of a carrier according to Regulation (EC) 1333/2008 and 'potassium aluminium silicate-based pearlescent pigments' are not listed in Regulation (EC) 1333/2008. Consequently, 'potassium aluminium silicate-based pearlescent pigments' should be evaluated as a new food additive. 1 Introduction The present opinion deals with the re-evaluation of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) when used as food additives. 1.1 Background and Terms of Reference as provided by the European Commission 1.1.1 Background Regulation (EC) No 1333/200811 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. OJ L 354, 31.12.2008, p. 16–33. of the European Parliament and of the Council on food additives requires that food additives are subject to a safety evaluation by the European Food Safety Authority (EFSA) before they are permitted for use in the European Union. In addition, it is foreseen that food additives must be kept under continuous observation and must be re-evaluated by EFSA. For this purpose, a programme for the re-evaluation of food additives that were already permitted in the European Union before 20 January 2009 has been set up under Regulation (EU) No 257/201022 Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. OJ L 80, 26.3.2010, p. 19–27.. This Regulation also foresees that food additives are re-evaluated whenever necessary in light of changing conditions of use and new scientific information. For efficiency and practical purposes, the re-evaluation should, as far as possible, be conducted for groups of food additives according to the main functional class to which they belong. The order of priorities for the re-evaluation of the currently approved food additives should be set on the basis of the following criteria: the period of time since the last evaluation of a food additive by the Scientific Committee on Food (SCF) or EFSA, the availability of new scientific evidence, the extent of use of a food additive in food and the human exposure to a food additive taking also into account the outcome of the Report from the Commission on Dietary Food Additive Intake in the EU33 COM(2001) 542 final. of 2001. The report "Food additives in Europe 2000"44 Food Additives in Europe 2000, Status of safety assessments of food additives presently permitted in the EU, Nordic Council of Ministers, TemaNord 2002, 560. submitted by the Nordic Council of Ministers to the Commission, provides additional information for the prioritisation of additives for re-evaluation. As colours were among the first additives to be evaluated, these food additives should be re-evaluated with a highest priority. In 2003, the Commission already requested EFSA to start a systematic re-evaluation of authorised food additives. However, as a result of adoption of Regulation (EU) 257/2010 the 2003 Terms of References are replaced by those below. 1.1.2 Terms of Reference The Commission asks the European Food Safety Authority to re-evaluate the safety of food additives already permitted in the Union before 2009 and to issue scientific opinions on these additives, taking especially into account the priorities, procedures and deadlines that are enshrined in the Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with the Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. 1.2 Information on existing authorisations and evaluations Sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) are authorised food additives in the EU according to Annex II and III of Regulation (EC) No 1333/2008 and specifications have been defined in Commission Regulation (EU) No 231/201255 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) no 1333/2008 of the European Parliament and of the Council. OJ L 83, 22.3.2012, p 1.. In 1990, the Scientific Committee for Food (SCF) considered sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555), together with other aluminium-containing food additives, as 'accepted additives' and indicated that the provisional tolerable weekly intake (PTWI) of 7 mg aluminium/kg body weight (bw) from all intake sources previously established by JECFA, should be considered when setting conditions of use for these food additives (SCF, 1991). In 2008, the EFSA Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials (AFC Panel) prepared a scientific opinion on the safety of aluminium from dietary intake. In view of the potential for accumulation of aluminium through dietary exposure, the Panel considered it more appropriate to establish a tolerable weekly intake (TWI) for aluminium rather than a tolerable daily intake (TDI). The Panel established a TWI of 1 mg aluminium/kg bw per week (EFSA, 2008). In 2011, a statement on the evaluation of a new study related to the bioavailability of aluminium in food was published by EFSA (2011). EFSA concluded that this study did not provide any additional information on the bioavailability of aluminium from aluminium-containing compounds that would modify the conclusions reached in 2008 by the AFC Panel. Therefore, the previous safety evaluation of aluminium-based food additives authorised in the European Union was not reconsidered. In 2011, JECFA evaluated aluminium-containing food additives (including sodium aluminium silicate and potassium aluminium silicate-based pearlescent pigments) and established a PTWI of 2 mg/kg bw for aluminium from all aluminium compounds in food including food additives based on a no-observed adverse effect level (NOAEL) of 30 mg/kg bw per day from a neurodevelopmental study (Poirier et al., 2011 as referred to by JECFA, 2012) and applying a safety factor of 100 (JECFA, 2012). In 2017, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER, 2017) published an opinion on the tolerable intake of aluminium with regards to adapting the migration limits for aluminium in toys. The SCHEER used the same study of Poirier et al. (2011) and established a TDI of 0.3 mg aluminium/kg bw per day. 2 Data and methodologies 2.1 Data The Panel on Food Additives and Flavourings (FAF) was not provided with a newly submitted dossier. EFSA launched public calls for data66 Call for food additives usage level and/or concentration data in food and beverages intended for human consumption (batch 5). Published 24 may 2016. Available online: http://www.efsa.europa.eu/en/data/call/160524 ,77 Call for scientific data on sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) authorised food additives in the EU. Published: 7 November 2018. Available online https://www.efsa.europa.eu/en/consultations/call/181107 to collect information from interested business operators. The Panel based its assessment on information submitted to EFSA following the public calls for data, information from previous evaluations and additional available literature up to April 2020. Attempts were made at retrieving relevant original study reports on which previous evaluations or reviews were based; however, these were not always available to the Panel. Food consumption data used to estimate the dietary exposure to sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) were derived from the EFSA Comprehensive European Food Consumption Database (Comprehensive Database88 Available online: http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm ). The Mintel Global New Products Database (GNPD) was used to verify the use of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) in food and beverage products and food supplements within the EU market. The Mintel GNPD is an online database that contains the compulsory ingredient information present on the label of numerous products. 2.2 Methodologies This opinion was formulated following the principles described in the EFSA Guidance on transparency concerning scientific aspects of risk assessment (EFSA Scientific Committee, 2009) and following the relevant existing Guidance from the EFSA Scientific Committee. The FAF Panel assessed the safety of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) as food additives in line with the principles laid down in Regulation (EU) 257/2010 and in the guidance document 'Guidance on submission for food additive evaluations' by the Scientific Committee on Food (SCF, 2001). When in animal studies, the test substance was administered in the feed or in drinking water, but doses were not explicitly reported by the authors as mg/kg bw per day based on actual feed or water consumption, the daily intake is calculated by the Panel using the relevant default values. In case of rodents, the values as indicated in the EFSA Scientific Committee Guidance document (EFSA Scientific Committee, 2012) are applied. In the case of other animal species, the default values used by JECFA (2000) are applied. In these cases, the dose was expressed as 'equivalent to mg/kg bw per day'. If a concentration in feed or drinking water was reported and the dose in mg/kg bw per day was calculated based on these reported concentrations and on reported consumption data for feed or drinking water, the dose was expressed as 'equal to mg/kg bw per day'. Dietary exposure to sodium aluminium silicate (E 554) from its use as a food additive was estimated combining food consumption data available within the EFSA Comprehensive European Food Consumption Database with the reported use level (see Section 3.3.3). Dietary exposure to potassium aluminium silicate (E 555) was calculated based on the provisions of Regulation (EC) No 1333/2008 (Section 3.3.4). 3 Assessment 3.1 Technical data 3.1.1 Identity of the substance Sodium aluminium silicate (E 554) In Commission Regulation (EU) No 231/2012, sodium aluminium silicate (E 554) is defined by the chemical name and the content of SiO2 (66–88%) and Al2O3 (5–15%). Sodium aluminium silicate with a CAS No of 1344-00-9 is registered in REACH as 'silicic acid, aluminium sodium salt', but its Registrant did not express an interest in its use as a food additive (Documentation provided to EFSA No 4). Potassium aluminium silicate (E 555) According to Commission Regulation (EU) No 231/2012, the definition is 'natural mica consists of mainly potassium aluminium silicate (muscovite)'. Mica is a synonym for potassium aluminium silicate. The assay is defined as not less than 98% potassium aluminium silicate. The chemical formula given is KAl2[AlSi3O10](OH)2. Interested business operators have not provided data on potassium aluminium silicate (E 555). According to them, potassium aluminium silicate is only used for the manufacturing process of a group of 'pearl pigments' (Documentation provided to EFSA No 2 and 3) (see Section 4). 3.1.2 Specifications The specifications for sodium aluminium silicate (E 554) according to Commission Regulation (EU) No 231/2012 and JECFA (2017) are listed in Table 1. Table 1. Specifications for sodium aluminium silicate (E 554) according to Commission Regulation (EU) No 231/2012 and JECFA (2017) Commission Regulation (EU) No 231/2012 JECFA (2017) Synonyms Sodium silicoaluminate; sodium aluminosilicate; aluminium sodium silicate Sodium silicoaluminate; sodium aluminosilicate; aluminium sodium silicate; silicic acid, aluminium sodium salt; INS No 554 Definition Sodium aluminium silicate is a series of amorphous hydrated sodium aluminium silicates with varying proportions of Na2O, Al2O3 and SiO2. It is manufactured by reacting aluminium sulfate and sodium silicate followed by precipitation Chemical name Sodium aluminium silicate Aluminium sodium silicate CAS No 1344-00-9 Chemical formula xSiO2.yAl2O3.zNa2O3 Assay Content on the anhydrous basis: – as SiO2 not less than 66% and not more than 88% – as Al2O3 not less than 5% and not more than 15% – SiO2 not less than 66% and not more than 88% – Al2O3 not less than 5% and not more than 15% – Na2O not less than 5% and not more than 8.5% All values expressed on the dried basis Description Fine white amorphous powder or beads Odourless, fine, white amorphous powder or as beads Identification Solubility Insoluble in water Test for sodium Passes test Passes testaa More information about the test available at JECFA specifications (2017). Test for aluminium Passes test Passes testaa More information about the test available at JECFA specifications (2017). Test for silicate Passes test Passes testaa More information about the test available at JECFA specifications (2017). pH 6.6–11.5 (5% slurry) 6.6–11.5 (5% slurry) Purity Loss on drying Not more than 8% (105°C, 2 h) Not more than 8% (105°C, 2 h)aa More information about the test available at JECFA specifications (2017). Loss on ignition Not less than 5% and not more than 11% on anhydrous basis (1,000°C to constant weight) Not less than 5% and not more than 11% on anhydrous basis (1,000°C to constant weight) Sodium Not less than 5% and not more than 8.5% (as Na2O) on the anhydrous basis Arsenic Not more than 3 mg/kg Not more than 3 mg/kg Lead Not more than 5 mg/kg Not more than 5 mg/kg Mercury Not more than 1 mg/kg Not more than 1 mg/kg a More information about the test available at JECFA specifications (2017). The specifications for potassium aluminium silicate (E 555) according to Commission Regulation (EU) No 231/2012 and JECFA (2014) are listed in Table 2. Table 2. Specifications for potassium aluminium silicate (E 555) according to Commission Regulation (EU) No 231/2012 Commission Regulation (EU) No 231/2012 JECFA (2014) Synonyms Mica Mica, Muscovite, INS No 555 Definition Natural mica consists of mainly potassium aluminium silicate (muscovite) Potassium aluminium silicate is mined from natural sources and then further purified Chemical name Potassium aluminium silicate Potassium aluminium silicate EINECS No 310-127-6 CAS No 12001-26-2 Chemical formula KAl2[AlSi3O10](OH)2 KAl2[AlSi3O10](OH)2 (idealised) Formula weight 398.31 Assay Content not less than 98% Not less than 98% Description Light grey to white crystalline platelets or powder Light grey to white crystalline platelets or powder Identification Solubility Insoluble in water, diluted acids and alkali and organic solvents Practically insoluble or insoluble in water, diluted acids and alkali and organic solvents Test for aluminium and silicon Passes test Purity Loss on drying Not more than 0.5% (105°C, 2 h) Not more than 0.5% (105°C, 2 h) Antimony Not more than 20 mg/kg Not more than 20 mg/kg Zinc Not more than 25 mg/kg Not more than 25 mg/kg Barium Not more than 25 mg/kg Not more than 25 mg/kg Chromium Not more than 100 mg/kg Not more than 100 mg/kg Copper Not more than 50 mg/kg Not more than 25 mg/kg Nickel Not more than 25 mg/kg Not more than 50 mg/kg Cadmium Not more than 1 mg/kg Not more than 2 mg/kg Arsenic Not more than 3 mg/kg Not more than 3 mg/kg Lead Not more than 5 mg/kg Not more than 5 mg/kg Mercury Not more than 1 mg/kg Not more than 1 mg/kg Based on the EU specifications, the Panel noted that impurities of the toxic elements arsenic, lead and mercury are tolerated up to 3, 5 and 1 mg/kg, respectively, for both sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) (Tables 1 and 2). Cadmium is tolerated up to 1 mg/kg for potassium aluminium silicate (E 555) (Table 2). The overall dietary exposure to these contaminants is close to the health-based guidance values or (lower confidence limits of the) benchmark doses (EFSA CONTAM Panel, 2009a,b, 2012a,b,c, 2014a). Moreover, the Panel noted the high limits for chromium, copper and nickel of 100, 50 and 25 mg/kg for potassium aluminium silicate (E 555), respectively, for which there are health-based guidance values established (EFSA CONTAM Panel, 2014b, 2015; ongoing EFSA assessment on copper99 http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2019-00385 ). The presence of all these impurities at these levels could have significant impacts on exposures to all these toxic elements from all dietary sources. The panel also noted that the oxidation state is not mentioned for chromium. The Panel further noted that chromium(VI) has been classified by the International Agency for Research on Cancer (IARC) as being carcinogenic to humans (Group 1) (IARC, 1990). Despite the fact that chromium from geological origin is mostly likely chromium(III), the Panel considered that the levels of chromium(VI) should be as low as possible and at least result in an adequate margin of exposure (EFSA, 2005). The Panel noted that in the EU specifications for E 554, a 'passes test' is requested for sodium, aluminium and silica while the amounts for sodium (as Na2O), silica (SiO2) and aluminium (as Al2O3) are specified. Therefore, these parameters of 'passes test' are redundant and could be deleted. 3.1.3 Manufacturing process No information on the manu
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