{ "table_version": "v1.3", "generated": "2026-08-14", "published_at": "https://sito.kids/additives", "methodology": "https://sito.kids/score", "corrections": "berkay@sitonutri.com", "attribution": "Compiled by Sito (Invictus Logic LLC). Every classification is derived from the cited sources: EFSA (CC BY 4.0, attributed), FDA and 21 CFR (US public domain), IARC monographs and OEHHA Proposition 65 listings (cited by volume and listing date), named EU and US legal instruments, WHO/FAO JECFA evaluations and national food-agency advisories, and peer-reviewed literature. Please cite https://sito.kids/additives.", "class_criteria": { "high": "IARC Group 1 or 2A with a dietary exposure route; or EFSA has withdrawn or negated a safety conclusion; or EFSA’s own exposure assessment finds a child age group exceeding the ADI at mean intake; or the substance is banned or formally being phased out for food use by the EU, by the US FDA, or under a US state law.", "mid": "IARC Group 2B; or an EFSA re-evaluation that flagged genotoxicity data gaps, found safety could not be assessed on the available data, or cut the ADI citing child exposure; or an EU harmonised classification of the substance as a reproductive or developmental hazard; or an EU withdrawal of one authorised food use while others remain; or an OEHHA/Proposition 65 listing; or membership of the Southampton-six colourants.", "low": "A credible adverse or precautionary signal that stops short of every Moderate and High criterion: peer-reviewed adverse findings not yet reflected in regulatory status, an exposure exceedance confined to high-percentile or single-event estimates, or a precautionary regulatory step short of those criteria — a reduced ADI, a data limitation noted without an adverse conclusion, a narrowed or conditioned authorisation, or a child-focused assessment or school-food law that covers the additive as part of a class.", "none": "Clean current EFSA and FDA status. These rows exist so that an unfamiliar additive is never treated as a bad one: a missing row costs a product nothing, and a clean row says so with citations." }, "class_deductions": { "high": { "label": "High risk", "points_removed": 30 }, "mid": { "label": "Moderate risk", "points_removed": 15 }, "low": { "label": "Low risk", "points_removed": 6 }, "none": { "label": "No risk identified", "points_removed": 0 } }, "child_flag_meaning": "Set only where EFSA’s own exposure assessment shows toddlers or children exceeding or approaching the ADI, or where a regulator used explicitly child-specific language. For a child under 6 a flagged additive moves one class up. No row in the \"none\" class is flagged.", "omitted_fields": { "note": "Internal review notes. Written for us, not for a reader; not published on the page or in this file." }, "counts": { "additives": 253, "citations": 596, "mean_citations_per_additive": 2.36, "child_flagged": 76, "by_class": { "low": 35, "none": 137, "mid": 32, "high": 49 }, "by_citation_source": { "EFSA": 307, "state_law": 86, "OEHHA": 14, "FDA": 126, "peer_reviewed": 32, "IARC": 18, "agency_review": 5, "OFF": 8 } }, "additives": [ { "e_number": "E100", "name": "Curcumin", "off_tag": "en:e100", "category": "colour", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e100", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2010.1679", "finding": "ADI 3 mg/kg bw/day (NOAEL 250-320 mg/kg bw/day, F2 body-weight gain, UF 100); at maximum use levels, intake for 1-10-year-old children at the mean and high level can be above the ADI in some European countries." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2014.3876", "finding": "Refined exposure: mean estimates for toddlers and children below the ADI; high-level estimates at the level of the ADI for both groups, with exceedance in one survey each." } ] }, { "e_number": "E101", "name": "Riboflavin", "off_tag": "en:e101", "category": "colour", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e101", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2013.3357", "finding": "Riboflavin (E101(i)) and riboflavin-5'-phosphate sodium (E101(ii)) are unlikely to be of safety concern at the reported uses and use levels." } ] }, { "e_number": "E102", "name": "Tartrazine (Yellow 5)", "off_tag": "en:e102", "category": "colour", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e102", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2009.1331", "finding": "ADI of 7.5 mg/kg bw/day retained; tartrazine can elicit intolerance reactions in a small fraction of the exposed population and sensitive individuals may react at dose levels within the ADI; McCann 2007 (Southampton) reviewed." }, { "source": "state_law", "ref": "EU: Regulation (EC) No 1333/2008, Annex V", "finding": "Mandatory 'may have an adverse effect on activity and attention in children' warning since July 2010." }, { "source": "OEHHA", "ref": "OEHHA (2021) synthetic food dyes / children neurobehavioral assessment", "finding": "Yellow 5 among the 7 dyes assessed as able to cause or exacerbate neurobehavioral problems in some children." }, { "source": "state_law", "ref": "US-CA: AB 2316 (California School Food Safety Act, signed 2024) ; US-WV: HB 2354 school-food provisions in force 2025-08-01", "finding": "Banned from California public-school food from 2027-12-31; WV school-food ban already in force (WV's statewide 2028 ban preliminarily enjoined 2025-12-23)." } ] }, { "e_number": "E104", "name": "Quinoline Yellow", "off_tag": "en:e104", "category": "colour", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e104", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2009.1329", "finding": "ADI reduced from 10 to 0.5 mg/kg bw/day; at maximum usage levels refined intake estimates were generally well above the new ADI for both children and adults." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4070", "finding": "After the 2013 reduction of maximum permitted levels, mean and high-level exposure estimates were below the ADI for all population groups in all three scenarios." }, { "source": "state_law", "ref": "EU: Regulation (EC) No 1333/2008, Annex V", "finding": "Mandatory child activity/attention warning label." } ] }, { "e_number": "E110", "name": "Sunset Yellow FCF (Yellow 6)", "off_tag": "en:e110", "category": "colour", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e110", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2009.1330", "finding": "ADI reduced from 2.5 to a temporary 1.0 mg/kg bw/day (rat testes effects, extra uncertainty factor of 2.5), against a background of concern about children's exposure." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2014.3765", "finding": "Temporary ADI reconsidered; new ADI of 4 mg/kg bw/day established (NOAEL 375 mg/kg bw/day, UF 100), aligning with JECFA." }, { "source": "state_law", "ref": "EU: Regulation (EC) No 1333/2008, Annex V", "finding": "Mandatory child activity/attention warning label." }, { "source": "OEHHA", "ref": "OEHHA (2021) synthetic food dyes / children neurobehavioral assessment", "finding": "Yellow 6 among the 7 dyes assessed as able to cause or exacerbate neurobehavioral problems in some children." } ] }, { "e_number": "E120", "name": "Cochineal / carmine", "off_tag": "en:e120", "category": "colour", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e120", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4288", "finding": "ADI confirmed at 5 mg carmine/kg bw/day, equivalent to 2.5 mg carminic acid/kg bw/day; no reason found to revise the 1983 SCF ADI." }, { "source": "FDA", "ref": "21 CFR 73.100; Federal Register 2009-03-11 (E9-5286), confirmation of effective date", "finding": "FDA requires cochineal extract and carmine to be declared by their common name on all food labels, in response to reports of severe allergic reactions including anaphylaxis." } ] }, { "e_number": "E122", "name": "Azorubine / carmoisine", "off_tag": "en:e122", "category": "colour", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e122", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2009.1332", "finding": "ADI held at 4 mg/kg bw/day; at the 95th percentile, intake estimates for 1-10-year-old children could be above the ADI under both MPL and reported-use scenarios." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4072", "finding": "Refined exposure: the ADI was not exceeded for any population group at either the mean or the high level." }, { "source": "state_law", "ref": "EU: Regulation (EC) No 1333/2008, Annex V", "finding": "Mandatory 'may have an adverse effect on activity and attention in children' warning." } ] }, { "e_number": "E123", "name": "Amaranth", "off_tag": "en:e123", "category": "colour", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e123", "citations": [ { "source": "FDA", "ref": "FDA Color Additive Status List - FD&C Red No. 2 (amaranth), terminated for US food use in 1976", "finding": "Amaranth has been banned as a food colour in the United States since 1976; it is not a certified colour additive for US food." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2010.1649", "finding": "ADI lowered to 0.15 mg/kg bw/day (from SCF 0-0.8 and JECFA 0-0.5); the Panel concluded amaranth is neither genotoxic nor carcinogenic." } ] }, { "e_number": "E124", "name": "Ponceau 4R", "off_tag": "en:e124", "category": "colour", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e124", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2009.1328", "finding": "ADI reduced from 4 to 0.7 mg/kg bw/day (NOAEL 70 mg/kg bw/day, mouse glomerulonephrosis); at maximum use levels, intakes for 1-10-year-old children at the MEAN and high percentiles are generally above the ADI even in refined estimates." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4073", "finding": "After 24 MPLs were withdrawn and 29 reduced, no exposure estimate exceeded the ADI of 0.7 mg/kg bw/day in any population group." }, { "source": "state_law", "ref": "EU: Regulation (EC) No 1333/2008, Annex V", "finding": "Mandatory child activity/attention warning label." } ] }, { "e_number": "E127", "name": "Erythrosine (Red 3)", "off_tag": "en:e127", "category": "colour", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e127", "citations": [ { "source": "FDA", "ref": "Federal Register 2025-00830 (2025-01-16); fda.gov/industry/color-additives/fdc-red-no-3", "finding": "FDA revoked the colour additive listing for FD&C Red No. 3 in food and ingested drugs on 2025-01-15 under the Delaney Clause; food reformulation deadline 2027-01-15 (drugs 2028-01-18)." }, { "source": "state_law", "ref": "US-CA: AB 418, California Food Safety Act (2023), codified at Health and Safety Code §109025; leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=109025.&lawCode=HSC", "finding": "California Health and Safety Code §109025, added by AB 418 (Stats. 2023, ch. 328): from 2027-01-01 no person or entity may 'manufacture, sell, deliver, distribute, hold, or offer for sale, in commerce a food product for human consumption' containing red dye 3 (CAS 16423-68-0) — listed alongside brominated vegetable oil, potassium bromate and propylparaben." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2011.1854", "finding": "ADI retained at 0.1 mg/kg bw/day - among the lowest for any food colour; thyroid tumorigenic effects in rats judged secondary to effects on thyroid function rather than genotoxic." }, { "source": "OEHHA", "ref": "OEHHA (2021) synthetic food dyes / children neurobehavioral assessment", "finding": "Red 3 among the 7 dyes assessed as able to cause or exacerbate neurobehavioral problems in some children." } ] }, { "e_number": "E128", "name": "Red 2G", "off_tag": "en:e128", "category": "colour", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e128", "citations": [ { "source": "EFSA", "ref": "EFSA AFC Panel, Opinion on the food colour Red 2G (E 128), EFSA Journal (2007), efsa.europa.eu/en/efsajournal/pub/515", "finding": "Red 2G is readily converted in the body to aniline, and a genotoxic and carcinogenic risk from that metabolite could not be excluded." }, { "source": "state_law", "ref": "EU: Commission Regulation (EC) No 884/2007 - emergency measures suspending use of E 128 as a food colour (July 2007)", "finding": "Following the EFSA opinion of 5 July 2007, Member States unanimously approved suspension of E 128 on 20 July 2007 and it was removed from the EU permitted colours list." } ] }, { "e_number": "E129", "name": "Allura Red AC (Red 40)", "off_tag": "en:e129", "category": "colour", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e129", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2009.1327", "finding": "ADI held at 7 mg/kg bw/day; at the high level, intake estimates for 1-10-year-old children can be above the ADI under both MPL and reported-use scenarios." }, { "source": "state_law", "ref": "EU: Regulation (EC) No 1333/2008, Annex V", "finding": "Foods containing E129 must carry 'may have an adverse effect on activity and attention in children' - child-specific regulatory language." }, { "source": "OEHHA", "ref": "OEHHA (2021), Health Effects Assessment: Potential Neurobehavioral Effects of Synthetic Food Dyes in Children", "finding": "Red 40 among 7 dyes that can cause or exacerbate neurobehavioral problems in some children; current federal intake levels may not sufficiently protect children." }, { "source": "peer_reviewed", "ref": "Kwon et al., Nature Communications 2022, s41467-022-35309-y", "finding": "Chronic dietary-level Allura Red AC promotes susceptibility to experimental colitis via intestinal serotonin in mice." } ] }, { "e_number": "E131", "name": "Patent Blue V", "off_tag": "en:e131", "category": "colour", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e131", "citations": [ { "source": "EFSA", "ref": "EFSA ANS Panel, Scientific Opinion on the re-evaluation of Patent Blue V (E 131) as a food additive, EFSA Journal 2013", "finding": "ADI reduced from 15 to 5 mg/kg bw/day on the basis of adverse haematological effects after chronic intake of high doses." } ] }, { "e_number": "E132", "name": "Indigotine (Blue 2)", "off_tag": "en:e132", "category": "colour", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e132", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2023.8103", "finding": "ADI of 5 mg/kg bw/day confirmed; a newly performed in vivo micronucleus study means indigo carmine does not raise concern for genotoxicity; no safety concern at reported use levels." }, { "source": "OEHHA", "ref": "OEHHA (2021) synthetic food dyes / children neurobehavioral assessment", "finding": "Blue 2 among the 7 dyes assessed as able to cause or exacerbate neurobehavioral problems in some children." }, { "source": "state_law", "ref": "US-CA: AB 2316 ; US-WV: HB 2354 (school provisions in force 2025-08-01)", "finding": "Blue 2 banned from California public-school food from 2027-12-31 and already barred from WV school food." }, { "source": "FDA", "ref": "FDA, Tracking Food Industry Pledges to Remove Petroleum Based Food Dyes", "finding": "Blue 2 is in the voluntary industry phase-out FDA targets by end of 2027; it remains legally authorised." } ] }, { "e_number": "E133", "name": "Brilliant Blue FCF (Blue 1)", "off_tag": "en:e133", "category": "colour", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e133", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2010.1853", "finding": "ADI reduced from 10 to 6 mg/kg bw/day; Tier-2 intake estimates above the ADI at the 95th percentile for children (Tier-3 refined estimates below the ADI)." }, { "source": "OEHHA", "ref": "OEHHA (2021) synthetic food dyes / children neurobehavioral assessment", "finding": "Blue 1 among the 7 dyes assessed as able to cause or exacerbate neurobehavioral problems in some children." }, { "source": "state_law", "ref": "US-CA: AB 2316 ; US-WV: HB 2354 (school provisions in force 2025-08-01)", "finding": "Blue 1 banned from California public-school food from 2027-12-31 and already barred from WV school food." }, { "source": "FDA", "ref": "FDA, Tracking Food Industry Pledges to Remove Petroleum Based Food Dyes (fda.gov)", "finding": "Blue 1 is in the voluntary industry phase-out FDA targets by end of 2027; it remains legally authorised in the meantime." } ] }, { "e_number": "E140", "name": "Chlorophylls and chlorophyllins (generic node)", "off_tag": "en:e140", "category": "colour", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e140", "citations": [ { "source": "EFSA", "ref": "European Commission, 'Call for scientific and technical data on the permitted food additives E 140(i) chlorophylls, E 140(ii) chlorophyllins, E 141(i) copper complexes of chlorophylls and E 141(ii) copper complexes of chlorophyllins', published 7 April 2017 (food.ec.europa.eu)", "finding": "Establishes that the single E 140 authorisation covers two separately specified additives with separate EFSA opinions and opposite outcomes: 'in Annex II to Regulation (EC) No 1333/2008, chlorophylls and chlorophyllins are authorised with the same E number, E 140. However, according to Commission Regulation (EU) No 231/2012, separate specifications are defined for chlorophylls (E 140(i)) and chlorophyllins (E 140(ii)). The Panel decided to re-evaluate these two food additives separately, given their different physico-chemical properties.'" }, { "source": "FDA", "ref": "21 CFR 73.125 (Sodium copper chlorophyllin) — Part 73, Subpart A \"Foods\"; verified against the current eCFR structure", "finding": "The only chlorophyll-derived colour additive listed for US food use is sodium copper chlorophyllin (the E 141(ii) copper complex, a separate E number from E 140); plain chlorophylls have no corresponding US food colour listing. Relevant to how a US label is read, not to the class assigned here." } ] }, { "e_number": "E140i", "name": "Chlorophylls", "off_tag": "en:e140i", "category": "colour", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e140i", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4089 (EFSA Journal 2015;13(5):4089 — Scientific Opinion on the re-evaluation of chlorophylls (E 140(i)) as food additives)", "finding": "The available database for chlorophylls was inadequate for risk assessment and did not allow an ADI to be established; however, 'chlorophylls are natural dietary constituents, which are present at relatively high concentrations in a number of foods' and 'the exposure resulting from the use of chlorophylls (E 140(i)) as food additives is lower than the exposure to chlorophylls from the regular diet. Therefore, the Panel concluded that, at the reported use levels, chlorophylls (E 140(i)) are not of safety concern as regards their current use as food additives.'" }, { "source": "EFSA", "ref": "European Commission, 'Call for scientific and technical data on the permitted food additives E 140(i) chlorophylls, E 140(ii) chlorophyllins, E 141(i) copper complexes of chlorophylls and E 141(ii) copper complexes of chlorophyllins', published 7 April 2017 (food.ec.europa.eu)", "finding": "Official EU restatement of the same conclusion, plus the outstanding specification recommendations: the definition and identity of E 140(i) should be updated to describe components other than chlorophylls and possible residual solvents, and the maximum limits for arsenic, lead, mercury and cadmium impurities should be revised." } ] }, { "e_number": "E140ii", "name": "Chlorophyllins", "off_tag": "en:e140ii", "category": "colour", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e140ii", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4085 (EFSA Journal 2015;13(5):4085 — Scientific Opinion on re-evaluation of chlorophyllins (E 140(ii)) as food additives)", "finding": "There are no data regarding the absorption, distribution, metabolism and excretion (ADME) and toxicity of chlorophyllins (E 140(ii)); read-across for toxicity data from chlorophylls could not be supported; 'considering the absence of relevant ADME and toxicity data, and because chlorophyllins (E 140(ii)) are neither natural constituents of the regular human diet nor metabolites of chlorophylls in humans, the Panel concluded that it was not possible to assess the safety of chlorophyllins (E 140(ii)) as food additives.'" }, { "source": "EFSA", "ref": "European Commission, 'Call for scientific and technical data on the permitted food additives E 140(i) chlorophylls, E 140(ii) chlorophyllins, E 141(i) copper complexes of chlorophylls and E 141(ii) copper complexes of chlorophyllins', published 7 April 2017 (food.ec.europa.eu)", "finding": "Official EU restatement of the EFSA conclusions, and the source of the E 140(i)/E 140(ii) split: 'The Panel noted that in Annex II to Regulation (EC) No 1333/2008, chlorophylls and chlorophyllins are authorised with the same E number, E 140. However, according to Commission Regulation (EU) No 231/2012, separate specifications are defined for chlorophylls (E 140(i)) and chlorophyllins (E 140(ii)).' Also records that the material used in many studies identified as 'chlorophyllins' was quite often, if not always, a copper complex of chlorophyllins (E 141(ii))." }, { "source": "EFSA", "ref": "EFSA FAF Working Group on Re-evaluation and Follow-up, meeting minutes (efsa.europa.eu, wg-food-additives-re-evaluation-follow-up); EC call for scientific and technical data on E 140(i), E 140(ii), E 141(i), E 141(ii), submission deadline 25 November 2025", "finding": "Recorded for completeness, not as part of the basis for this classification: the follow-up re-evaluation EFSA-Q-2024-00456 is in progress with the data call closed 2025-11-25 and WG meetings scheduled through March 2026. No adopted or published opinion exists as of 2026-08, so the 2015 'not possible to assess the safety' conclusion remains EFSA's current position." } ] }, { "e_number": "E141", "name": "Copper complexes of chlorophylls and chlorophyllins", "off_tag": "en:e141", "category": "colour", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e141", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4151", "finding": "Reliable data on ADME, genotoxicity, chronic toxicity, carcinogenicity and reproductive/developmental toxicity are lacking for E141(i) and E141(ii); safety of use cannot be assessed and the existing ADI should be withdrawn." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4151", "finding": "Specifications should be updated to identify the non-chlorophyll components of E141(i), which may represent up to 90% of the extract." } ] }, { "e_number": "E142", "name": "Green S", "off_tag": "en:e142", "category": "colour", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e142", "citations": [ { "source": "EFSA", "ref": "EFSA ANS Panel, Scientific Opinion on the re-evaluation of Green S (E 142) as a food additive, EFSA Journal 2010", "finding": "Data on ADME, subchronic, reproductive, developmental and long-term toxicity and carcinogenicity give no reason to revise the SCF's ADI of 5 mg/kg bw/day." } ] }, { "e_number": "E143", "name": "Fast Green FCF (Green 3)", "off_tag": "en:e143", "category": "colour", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e143", "citations": [ { "source": "OEHHA", "ref": "OEHHA (2021) 'Health Effects Assessment: Potential Neurobehavioral Effects of Synthetic Food Dyes in Children'; peer-reviewed synthesis Miller et al., Environmental Health 2022", "finding": "Green 3 is one of the seven dyes assessed as able to cause or exacerbate neurobehavioural problems in some children. The assessment is not a Proposition 65 listing, so it does not meet our Moderate-risk criterion — and the authors concede the class conclusion rides on azo-dye data: of 25 challenge trials, six tested tartrazine alone and the rest tested azo-dominated mixtures, with 'no suitable studies of green or blue dyes' found for the animal neurotoxicity comparison." }, { "source": "state_law", "ref": "US-CA: AB 2316 (California School Food Safety Act) ; US-WV: HB 2354 (school provisions in force 2025-08-01)", "finding": "Green 3 is named in both school-food statutes — barred from California public-school food from 2027-12-31 and already barred from WV school food. This child-specific regulatory language is the basis for higher-concern-for-young-children flag, exactly as on E 132 and E 133." }, { "source": "FDA", "ref": "FDA, 'Tracking Food Industry Pledges to Remove Petroleum Based Food Dyes' (fda.gov); FD&C Green No. 3 listed at 21 CFR 74.203", "finding": "Green 3 is in the VOLUNTARY industry phase-out FDA targets by the end of 2027 and remains legally authorised as a certified colour additive in the meantime. Voluntary policy, not a toxicological finding and not a ban — so it does not change the class, the same treatment this table gives Red 40." }, { "source": "IARC", "ref": "IARC Monographs Vol. 16 (Fast Green FCF); IARC classification list", "finding": "Fast Green FCF is IARC Group 3 — not classifiable as to its carcinogenicity to humans. Group 3 meets neither the High-risk criterion (Group 1 or 2A) nor the Moderate-risk criterion (Group 2B)." }, { "source": "agency_review", "ref": "JECFA evaluations — Fast Green FCF (WHO/FAO JECFA database)", "finding": "ADI 0-25 mg/kg bw/day. No exceedance has been reported for any population group, and no EFSA opinion exists because Green 3 is not authorised in the EU — which under this table's E 927a precedent is non-authorisation, not a ban." } ] }, { "e_number": "E150", "name": "Caramel (generic node)", "off_tag": "en:e150", "category": "colour", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "low", "permalink": "https://sito.kids/additives#e150", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2011.2004", "finding": "Group ADI 300 mg/kg bw/day for E 150a-d; E 150c given a lower individual ADI of 100 mg/kg bw/day because of possible immune effects of its constituent THI. SUPERSEDED IN PART: this opinion's finding that combined MEAN intake for children exceeds the group ADI at maximum reported use levels is superseded by the 2012 refined assessment below (refined combined means 12-105 mg/kg bw/day, all below the 300 group ADI). The 2011 mean exceedance is therefore not a current finding: EFSA itself has refined away the evidence behind it, and it supports no High-risk basis." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2012.3030", "finding": "Refined exposure assessment. E 150c: toddlers (and adults) may still exceed the INDIVIDUAL ADI of 100 mg/kg bw/day at the upper end of 95th-percentile exposure — the sole basis for this row's higher-concern-for-young-children flag. E 150d: NO exceedance — toddler 95th-percentile exposure reaches at most 136 mg/kg bw/day against the group ADI of 300. 'The combined exposure estimates of the four caramel colours do not exceed the group ADI for any population group.'" }, { "source": "OEHHA", "ref": "OEHHA Prop 65, 4-methylimidazole (listed 2011), NSRL 29 ug/day", "finding": "4-MEI in ammonia/sulphite-ammonia caramels is Prop 65 listed." } ] }, { "e_number": "E150a", "name": "Plain caramel", "off_tag": "en:e150a", "category": "colour", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e150a", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2012.3030", "finding": "Refined exposure assessment: no population group - including toddlers and children - exceeded the ADI for E150a at mean or 95th-percentile intake." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2011.2004", "finding": "E150a falls under the group ADI of 300 mg/kg bw/day; the lower 100 mg/kg specific ADI and the THI concern were assigned to E150c only." } ] }, { "e_number": "E150b", "name": "Caustic sulphite caramel", "off_tag": "en:e150b", "category": "colour", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e150b", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2011.2004 (Scientific Opinion on the re-evaluation of caramel colours E 150a,b,c,d), as quoted and tabulated in 10.2903/j.efsa.2012.3030 Table 1", "finding": "Group ADI of 300 mg/kg bw/day for the four caramel colours, with an individual ADI of 100 mg/kg bw/day for E 150c only, due to the immunotoxicity of THI 'found in E 150c only'. E 150b was below the group ADI in every cell of the exceedance table — children mean, children high level, adults mean, adults high level: 'from 22 to 110 mg/kg bw/day for adults respectively at the mean and high level and between 9 to 35 mg/kg bw/day at the mean and 18 to 117 mg/kg bw/day at high level for children'." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2012.3030 (EFSA Journal 2012;10(12):3030), Refined exposure assessment for caramel colours (E 150a, c, d)", "finding": "'Given that the anticipated exposure to caramel colour E 150b was below the group ADI of 300 mg/kg bw/day established by the ANS Panel in 2011, the present statement does not include a refined dietary exposure for caramel colour E 150b.' E 150b was excluded from the refined assessment because it was the one class that did not exceed. The opinion also records that the minor constituents of caramel colours (4-MEI, THI and sulphur dioxide) 'did not give rise to public health concern' at the levels assessed." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex), Annex II Part B 'List of all additives' and Annex III", "finding": "E 150b is present in the Union list (Annex II Part B) as one of the four authorised caramel classes." }, { "source": "FDA", "ref": "21 CFR §73.85 (Caramel, colour additive exempt from certification); 21 CFR §182.1235 (caramel, GRAS, non-colour use)", "finding": "US law does not distinguish the four EU caramel classes: §73.85 is a single listing whose identity paragraph permits sulfate and sulfite caramelisation aids, so E 150b, E 150c and E 150d all fall inside it. 'Caramel may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice.' A US label reading only 'caramel color' therefore cannot be resolved to a class from the ingredient panel." } ] }, { "e_number": "E150c", "name": "Ammonia caramel", "off_tag": "en:e150c", "category": "colour", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e150c", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2011.2004", "finding": "Group ADI 300 mg/kg bw/day for E150a-d, but a lower individual ADI of 100 mg/kg bw/day for E150c because of possible immune effects of its constituent THI. SUPERSEDED IN PART: the clause that combined mean intake for children exceeded the group ADI at maximum reported use levels is superseded by the 2012 refined assessment (refined combined means 12-105 mg/kg bw/day, all below 300). The individual-ADI half stands and is what this row's class and higher-concern-for-young-children flag rest on." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2012.3030", "finding": "Refined exposure: toddlers exceed the E150c ADI of 100 mg/kg bw/day at the upper end of the 95th percentile. This is the age-group-specific basis for this row's higher-concern-for-young-children flag, and — via E 150c's dominance of resolved caramel occurrences — for the en:e150 parent's higher-concern-for-young-children flag too." }, { "source": "OEHHA", "ref": "OEHHA Prop 65, 4-methylimidazole (listed as carcinogen 2011); NSRL 29 ug/day (oehha.ca.gov/sites/default/files/media/100711_4MEIfindings.pdf)", "finding": "4-MEI, formed during manufacture of ammonia caramels, is a Prop 65 listed carcinogen with a No Significant Risk Level of 29 ug/day." } ] }, { "e_number": "E150d", "name": "Sulphite ammonia caramel", "off_tag": "en:e150d", "category": "colour", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e150d", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2012.3030", "finding": "Refined exposure assessment. NO E 150d EXCEEDANCE: toddler 95th-percentile exposure reaches at most 136 mg/kg bw/day against the group ADI of 300 mg/kg bw/day, and 'the combined exposure estimates of the four caramel colours do not exceed the group ADI for any population group'. Only E 150c may exceed, and only against its lower individual ADI of 100 mg/kg bw/day. The absence of any E 150d exceedance is the basis on which this row carries no child flag." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2011.2004", "finding": "SUPERSEDED — recorded for provenance, not load-bearing. The 2011 opinion reported that combined dietary exposure to all caramel colours exceeds the group ADI of 300 mg/kg bw/day at the 95th/97.5th percentile and by combined MEAN intake for children. The 2012 refined assessment (cited above) supersedes it: refined combined means are 12-105 mg/kg bw/day, all below 300, and no population group exceeds the group ADI. The 2011 exceedance is not a current finding and does not support a High-risk basis for this row." }, { "source": "OEHHA", "ref": "OEHHA Prop 65, 4-methylimidazole (listed 2011), NSRL 29 ug/day", "finding": "4-MEI, present in ammonia and sulphite-ammonia caramels, is a Prop 65 listed carcinogen; EU specifications cap 4-MEI at 250 ppm for class IV caramel." } ] }, { "e_number": "E151", "name": "Brilliant Black BN", "off_tag": "en:e151", "category": "colour", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e151", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2010.1540", "finding": "The Panel confirmed the existing ADI of 5 mg/kg bw/day established by the SCF in 1984." } ] }, { "e_number": "E153", "name": "Vegetable carbon", "off_tag": "en:e153", "category": "colour", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e153", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2012.2592", "finding": "Toxicological database on vegetable carbon is sparse; no ADI could be derived; data gaps identified on impurities and particle characterisation." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2026.9855", "finding": "2026 opinion: still no ADI; benzo[a]pyrene and PAH4 margins of exposure all above 10,000 (no concern), but E153 contains a fraction of small particles including nanoparticles and the submitted characterisation was inadequate - the 2012 assessment should be complemented with nanoscale considerations." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2026.9855", "finding": "Toddlers showed the highest exposure estimates across surveys: mean 2.5-29.5 mg/kg bw/day, 95th percentile 11.7-64.3 mg/kg bw/day." } ] }, { "e_number": "E155", "name": "Brown HT", "off_tag": "en:e155", "category": "colour", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e155", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2010.1536", "finding": "ADI halved to 1.5 mg/kg bw/day from a long-term mouse carcinogenicity/toxicity study; dietary exposure of adults and 1-10-year-old children at the high level may exceed it at the upper end of the range." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2014.3719", "finding": "Refined exposure: under the first two scenarios the 95th-percentile estimate exceeded the ADI for all age groups except the elderly; under reported use levels only, mean and high estimates were below the ADI for all groups." } ] }, { "e_number": "E160", "name": "Carotenoids (generic node)", "off_tag": "en:e160", "category": "colour", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "low", "permalink": "https://sito.kids/additives#e160", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2012.2593", "finding": "Mixed carotenes and beta-carotene (E160a), the dominant resolution of a bare carotenoid declaration, are not of safety concern as food colours at the levels considered." } ] }, { "e_number": "E160a", "name": "Carotenes", "off_tag": "en:e160a", "category": "colour", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e160a", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2012.2593", "finding": "No numerical ADI needed; use as a food colour is not of safety concern provided combined additive + supplement intake stays near amounts obtained from normal consumption of foods where carotenes occur naturally (5-10 mg/day) and below 15 mg/day." } ] }, { "e_number": "E160b", "name": "Annatto", "off_tag": "en:e160b", "category": "colour", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e160b", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4544", "finding": "ADIs derived: 6 mg bixin/kg bw/day and 0.3 mg norbixin/kg bw/day." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4966 (EFSA Journal 2017;15(8):4966)", "finding": "Norbixin dietary exposure exceeds the ADI at the high level (95th percentile) for toddlers and children; bixin below the ADI for all groups." } ] }, { "e_number": "E160c", "name": "Paprika extract", "off_tag": "en:e160c", "category": "colour", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e160c", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4320", "finding": "ADI established at 1.7 mg carotenoids/kg bw/day (24 mg paprika extract/kg bw/day); refined exposure estimates below the ADI in all scenarios; no genotoxic, reproductive or carcinogenic effects at doses well above estimated intakes." } ] }, { "e_number": "E160e", "name": "Beta-apo-8'-carotenal (C30)", "off_tag": "en:e160e", "category": "colour", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e160e", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2012.2499", "finding": "Re-evaluation set an ADI of 0.05 mg/kg bw/day; Tier-2 exposure for children (mean 0.5-3.4, P95 1.2-7.2 mg/kg bw/day) was far above it." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2014.3492", "finding": "ADI reconsidered upward to 0.3 mg/kg bw/day (NOAEL 30 mg/kg bw/day, 13-week rat study, UF 100); high-level toddler exposure of up to 0.45 mg/kg bw/day still exceeds it." } ] }, { "e_number": "E161b", "name": "Lutein", "off_tag": "en:e161b", "category": "colour", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e161b", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2010.1678", "finding": "ADI 1 mg/kg bw/day; Tier-3 intake estimates at then-current use levels were above the ADI at the upper end of the range." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2012.2589", "finding": "Revised exposure after corrected industry data: children's mean intake below the ADI, but the ADI exceeded at the 95th/97.5th percentile in the Netherlands and the UK." } ] }, { "e_number": "E162", "name": "Beetroot red", "off_tag": "en:e162", "category": "colour", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e162", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4318", "finding": "The available database was inadequate to establish a numerical ADI for beetroot red; no restriction or adverse safety conclusion followed and the additive remains authorised." } ] }, { "e_number": "E163", "name": "Anthocyanins", "off_tag": "en:e163", "category": "colour", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e163", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2013.3145", "finding": "Available toxicological database inadequate to establish a numerical ADI, but exposures from current uses and use levels of aqueous grape-skin extract and blackcurrant extracts are unlikely to be of safety concern; additive exposure is comparable to dietary anthocyanin intake." } ] }, { "e_number": "E170", "name": "Calcium carbonates", "off_tag": "en:e170", "category": "colour", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e170", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2023.8106", "finding": "No need for a numerical ADI; no safety concern with respect to exposure to calcium carbonate per se at reported uses and use levels in all age groups, including infants below 16 weeks; the unavoidable presence of aluminium in E170 flagged as the one issue to address." } ] }, { "e_number": "E171", "name": "Titanium dioxide", "off_tag": "en:e171", "category": "colour", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e171", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2021.6585", "finding": "'E171 can no longer be considered as safe when used as a food additive'; a concern for genotoxicity of TiO2 particles cannot be ruled out; an ADI cannot be established." }, { "source": "state_law", "ref": "EU: Commission Regulation (EU) 2022/63 (adopted 2022-01-14)", "finding": "Authorisation to use titanium dioxide as a food additive withdrawn across the EU." }, { "source": "IARC", "ref": "IARC Monographs Vol. 93 (2010), titanium dioxide", "finding": "Group 2B (possibly carcinogenic to humans) - scoped to airborne, unbound particles of respirable size, i.e. the inhalation route, not dietary exposure." }, { "source": "OEHHA", "ref": "OEHHA Prop 65, titanium dioxide (airborne, unbound particles of respirable size), listed 2011; NSRLs effective 2025-10-01", "finding": "Prop 65 listing covers only the airborne respirable form; it does not reach titanium dioxide bound in food." } ] }, { "e_number": "E172", "name": "Iron oxides and hydroxides", "off_tag": "en:e172", "category": "colour", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e172", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4317 (EFSA Journal 2015;13(12):4317 — Scientific Opinion on the re-evaluation of iron oxides and hydroxides (E 172) as food additives)", "finding": "'Red and black iron oxide, both in nano- and micro-form, were positive in in vitro genotoxicity assays in mammalian cells. Due to the limitations of the database, and considering the impossibility to read-across between iron oxides with different redox state, the Panel considered that the genotoxicity of iron oxides cannot be evaluated based on the available data.' 'The Panel concluded that an adequate assessment of the safety of E 172 could not be carried out because a sufficient biological and toxicological database was not available.'" }, { "source": "EFSA", "ref": "European Commission, 'Call for scientific and technical data on the permitted food additives iron oxides and hydroxides (E 172)', published 5 December 2016 (food.ec.europa.eu, fs_food-improvement-agents_reeval_call_20161205_e172_data.pdf)", "finding": "Official EU restatement of the EFSA conclusions verbatim. Records that 'In 1980, an acceptable daily intake (ADI) of 0-0.5 mg/kg bw/day was established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA)', that the Panel recommended particle size and particle size distribution be included in the specifications 'because of the potential importance of nanoparticles in toxicokinetics and toxicological effects', and that refined exposure ranged 'from 0.03 mg/kg bw/day for infants to 3.7 mg/kg bw/day for toddlers at the mean and from 0.1 mg/kg bw/day for infants to 9.5 mg/kg bw/day for toddlers at the 95th percentile for the non-brand-loyal scenario'." }, { "source": "FDA", "ref": "21 CFR 73.200 (Synthetic iron oxide) — Part 73 \"Listing of Color Additives Exempt from Certification\", Subpart A \"Foods\"; verified against the current eCFR structure", "finding": "Synthetic iron oxide is a US colour additive exempt from certification listed for human food use, so E 172 appears in products commonly sold in the US; the section carries its own identity and specification requirements for the human-food grade." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex ELI: reg/2008/1333)", "finding": "E 172 iron oxides and hydroxides authorised in the EU, including at quantum satis in some categories and as a contrast enhancer for marking citrus fruit and melons; authorisation continues while the data gaps identified in 2015 are addressed." } ] }, { "e_number": "E173", "name": "Aluminium", "off_tag": "en:e173", "category": "colour", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e173", "citations": [ { "source": "EFSA", "ref": "EFSA AFC Panel (2008), Safety of aluminium from dietary intake - TWI 1 mg Al/kg bw/week", "finding": "Tolerable weekly intake set at 1 mg aluminium/kg bw/week; a significant proportion of the European population exceeds it, and the TWI can be exhausted or slightly exceeded for children." }, { "source": "state_law", "ref": "EU: Commission Regulation (EU) No 380/2012 (CELEX 32012R0380)", "finding": "Conditions of use and use levels for aluminium-containing food additives amended and reduced specifically to ensure the EFSA TWI is not exceeded by European consumers." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2023.8106", "finding": "EFSA continues to treat dietary aluminium load as an open concern - the unavoidable aluminium content of calcium carbonate (E170) was flagged as needing to be addressed." } ] }, { "e_number": "E200", "name": "Sorbic acid", "off_tag": "en:e200", "category": "preservative", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e200", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2019.5625", "finding": "Group ADI 11 mg sorbic acid/kg bw/day for sorbic acid and potassium sorbate; no genotoxicity; refined toddler/children exposure well below the ADI." }, { "source": "FDA", "ref": "21 CFR §182.3089 (sorbic acid, GRAS)", "finding": "GRAS in the US as a chemical preservative." }, { "source": "OFF", "ref": "Open Food Facts additives taxonomy node en:e200", "finding": "Stale — superseded by the 2019 follow-up opinion." } ] }, { "e_number": "E202", "name": "Potassium sorbate", "off_tag": "en:e202", "category": "preservative", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e202", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2019.5625 (EFSA Journal 2019;17(3):e05625)", "finding": "Group ADI raised to 11 mg sorbic acid/kg bw/day for E200/E202 after the EOGRTS; no evidence of genotoxic activity; refined non-brand-loyal exposure for toddlers/children 1.7 mg/kg bw/day mean and 3.7 mg/kg bw/day at P95 — both well below the ADI." }, { "source": "FDA", "ref": "21 CFR §182.3640 (potassium sorbate, GRAS)", "finding": "GRAS in the US as a chemical preservative." }, { "source": "OFF", "ref": "Open Food Facts additives taxonomy node en:e202", "finding": "The OFF entry is stale: it still encodes the temporary ADI of 2015, which the 2019 re-evaluation above replaced. It is recorded as a cross-check; the classification rests on the EFSA and FDA citations." } ] }, { "e_number": "E210", "name": "Benzoic acid", "off_tag": "en:e210", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e210", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4433", "finding": "ADI 5 mg/kg bw/day derived from a NOAEL of 500 mg/kg bw/day; group ADI exceeded for toddlers and children (flavoured drinks; and non-brand-loyal scenario once carry-over is counted)." }, { "source": "peer_reviewed", "ref": "Bateman et al., Arch Dis Child 2004; doi:10.1136/adc.2003.031435", "finding": "Benzoate preservative (with colourings) increased hyperactive behaviour in a general-population sample of 3-year-olds." }, { "source": "FDA", "ref": "21 CFR §184.1021 (benzoic acid, GRAS)", "finding": "GRAS in the US as a chemical preservative." } ] }, { "e_number": "E211", "name": "Sodium benzoate", "off_tag": "en:e211", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e211", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4433 (EFSA Journal 2016;14(3):4433)", "finding": "Group ADI 5 mg/kg bw/day (as benzoic acid). 'the group ADI was exceeded in the brand-loyal scenario in particular for toddlers and children consuming on a regular basis flavoured drinks'; with carry-over the ADI is also exceeded 'in toddlers and children for the non-brand-loyal scenario'." }, { "source": "peer_reviewed", "ref": "McCann et al., Lancet 2007; doi:10.1016/S0140-6736(07)61306-3", "finding": "Randomised, double-blind, placebo-controlled crossover: mixes of artificial colours PLUS sodium benzoate increased hyperactive behaviour in 3-year-olds and 8/9-year-olds in the general population." }, { "source": "peer_reviewed", "ref": "Bateman et al., Arch Dis Child 2004; doi:10.1136/adc.2003.031435", "finding": "Double-blind placebo-controlled challenge with artificial colourings + 45 mg/day sodium benzoate in 3-year-olds: significantly greater increases in hyperactive behaviour on active vs placebo by parental report." }, { "source": "FDA", "ref": "21 CFR §184.1733 (sodium benzoate, GRAS)", "finding": "GRAS in the US as a chemical preservative; no US restriction or phase-out." } ] }, { "e_number": "E212", "name": "Potassium benzoate", "off_tag": "en:e212", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e212", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4433", "finding": "E212 is covered by the 5 mg/kg bw/day group ADI; exceedance identified specifically for toddlers and children." }, { "source": "peer_reviewed", "ref": "McCann et al., Lancet 2007; doi:10.1016/S0140-6736(07)61306-3", "finding": "Benzoate-containing challenge mixes increased hyperactivity in 3-year-olds and 8/9-year-olds (mixture effect, not benzoate-specific)." }, { "source": "OFF", "ref": "Open Food Facts additives taxonomy node en:e212", "finding": "Cross-check only: OFF flags the same high overexposure risk with children/toddlers/infants among the exceeding groups." } ] }, { "e_number": "E213", "name": "Calcium benzoate", "off_tag": "en:e213", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e213", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4433", "finding": "Read-across to calcium benzoate accepted; same 5 mg/kg bw/day group ADI and the same toddler/children exceedance conclusion." }, { "source": "peer_reviewed", "ref": "Bateman et al., Arch Dis Child 2004; doi:10.1136/adc.2003.031435", "finding": "Benzoate preservative + colourings challenge increased hyperactive behaviour in 3-year-olds." } ] }, { "e_number": "E214", "name": "Ethyl p-hydroxybenzoate (ethylparaben)", "off_tag": "en:e214", "category": "preservative", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e214", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2004.83", "finding": "E214 covered by the 0–10 mg/kg bw group ADI for methyl and ethyl p-hydroxybenzoates; the sex-hormone/reproductive concern that removed propylparaben did not apply to ethylparaben." }, { "source": "peer_reviewed", "ref": "The controversies of parabens – an overview nowadays, Acta Pharm 2020; doi:10.2478/acph-2021-0001", "finding": "Class-level endocrine-activity signals not reflected in regulatory status." }, { "source": "FDA", "ref": "eCFR search of 21 CFR — no GRAS/food-additive section for ethylparaben (methylparaben is §184.1490)", "finding": "No US food authorisation located for ethylparaben." } ] }, { "e_number": "E215", "name": "Sodium ethyl p-hydroxybenzoate", "off_tag": "en:e215", "category": "preservative", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e215", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2004.83", "finding": "Group ADI 0–10 mg/kg bw explicitly covers the sodium salts of methyl and ethyl p-hydroxybenzoates." }, { "source": "peer_reviewed", "ref": "The controversies of parabens – an overview nowadays, Acta Pharm 2020; doi:10.2478/acph-2021-0001", "finding": "Paraben-class endocrine literature not reflected in regulatory status." } ] }, { "e_number": "E216", "name": "Propyl p-hydroxybenzoate (propylparaben)", "off_tag": "en:e216", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e216", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2004.83 (AFC Panel opinion on para hydroxybenzoates E214–E219)", "finding": "Propyl paraben excluded from the 0–10 mg/kg bw group ADI granted to methyl and ethyl p-hydroxybenzoates because, unlike them, it affected sex hormones and the male reproductive organs in juvenile rats, and no clear NOAEL could be identified — the finding that led directly to the withdrawal of E 216 and E 217." }, { "source": "state_law", "ref": "EU: Directive 2006/52/EC of 5 July 2006 (OJ 26.7.2006), recital (6) and Annex I point (3)(a)(i); status re-checked against Regulation (EC) No 1333/2008, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex), Annex II Part B 'List of all additives' and Annex III", "finding": "Recital (6): 'EFSA considered that propyl paraben should not be included in this group ADI because propyl paraben, contrary to methyl and ethyl paraben, had effects on sex hormones and the male reproductive organs in juvenile rats.' Annex I(3)(a)(i): 'the rows for \"E 216 Propyl p-hydroxybenzoate\" and \"E 217 Sodium propyl p-hydroxybenzoate\" are deleted'. Neither 'E 216' nor 'E 217' appears anywhere in the current consolidated Union list, confirming the withdrawal is still in force." }, { "source": "state_law", "ref": "US-CA: AB 418, California Food Safety Act (2023), codified at Health and Safety Code §109025; US-WV: HB 2354 (signed 2025-03-24)", "finding": "California Health and Safety Code §109025, added by AB 418 (Stats. 2023, ch. 328), bans propylparaben (CAS 94-13-3) in food products manufactured, sold, delivered, distributed, held or offered for sale in California from 2027-01-01, alongside Red 3, potassium bromate and BVO. WV HB 2354 deems food containing propylparaben (with BHA and seven dyes) adulterated: school nutrition programmes from 2025-08-01 (in force, not enjoined), all food from 2028-01-01 (preliminarily enjoined Dec 2025)." }, { "source": "FDA", "ref": "21 CFR §184.1670 (propylparaben, GRAS)", "finding": "GRAS in the US: 'The ingredient is used as an antimicrobial agent as defined in §170.3(o)(2) of this chapter' and 'current good manufacturing practice results in a maximum level of 0.1 percent in food.' Still lawful on the US shelf — no federal restriction." } ] }, { "e_number": "E217", "name": "Sodium propyl p-hydroxybenzoate", "off_tag": "en:e217", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e217", "citations": [ { "source": "state_law", "ref": "EU: Directive 2006/52/EC of 5 July 2006 (OJ 26.7.2006), Annex I point (3)(a)(i); status re-checked against Regulation (EC) No 1333/2008, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex), Annex II Part B 'List of all additives' and Annex III", "finding": "'the rows for \"E 216 Propyl p-hydroxybenzoate\" and \"E 217 Sodium propyl p‐hydroxybenzoate\" are deleted' — E 217 is deleted by name and number, not by read-across. 'E 217' appears nowhere in the current consolidated Union list." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2004.83 (AFC Panel opinion on para hydroxybenzoates E214–E219)", "finding": "The propyl esters were excluded from the methyl/ethyl group ADI on the juvenile-rat sex-hormone and male-reproductive-organ findings with no clear NOAEL; the opinion's scope covers the p-hydroxybenzoates E 214–E 219 including their sodium salts." }, { "source": "state_law", "ref": "US-CA: AB 418, California Food Safety Act (2023), codified at Health and Safety Code §109025; US-WV: HB 2354 (signed 2025-03-24)", "finding": "Both statutes ban 'propylparaben' — CA from all food sold in the state from 2027-01-01, WV via the adulteration route (schools in force 2025-08-01; statewide 2028-01-01 preliminarily enjoined Dec 2025). It is not established whether the statutory text extends to the sodium salt; the classification follows the parent acid." } ] }, { "e_number": "E218", "name": "Methyl p-hydroxybenzoate (methylparaben)", "off_tag": "en:e218", "category": "preservative", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e218", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2004.83 (AFC Panel opinion on para hydroxybenzoates E214–E219)", "finding": "Full group ADI of 0–10 mg/kg bw for the sum of methyl and ethyl p-hydroxybenzoates and their sodium salts (NOAELs 1000 mg/kg bw/day). Propyl paraben excluded from the group ADI because, unlike methyl and ethyl paraben, it affected sex hormones and male reproductive organs in juvenile rats and no clear NOAEL existed — leading to the withdrawal of E216/E217." }, { "source": "peer_reviewed", "ref": "The controversies of parabens – an overview nowadays, Acta Pharm 2020; doi:10.2478/acph-2021-0001", "finding": "Reviews the endocrine-activity and biomonitoring literature for the paraben class that is not reflected in current EU/US regulatory status for methyl/ethyl parabens." }, { "source": "FDA", "ref": "21 CFR §184.1490 (methylparaben, GRAS)", "finding": "GRAS in the US as a chemical preservative; no US restriction." } ] }, { "e_number": "E219", "name": "Sodium methyl p-hydroxybenzoate", "off_tag": "en:e219", "category": "preservative", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e219", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2004.83", "finding": "Group ADI 0–10 mg/kg bw covers methyl and ethyl p-hydroxybenzoic acid esters 'and their sodium salts', which includes E219." }, { "source": "peer_reviewed", "ref": "The controversies of parabens – an overview nowadays, Acta Pharm 2020; doi:10.2478/acph-2021-0001", "finding": "Paraben-class endocrine-activity literature not reflected in regulatory status." } ] }, { "e_number": "E220", "name": "Sulphur dioxide", "off_tag": "en:e220", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e220", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4438 (EFSA Journal 2016;14(4):4438)", "finding": "Temporary group ADI 0.7 mg SO2 eq/kg bw/day (temporary because of uncertainties/limitations in the database); 'exposure estimates to sulfur dioxide and sulfites were higher than the group ADI ... for all population groups'." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2022.7594 (EFSA Journal 2022;20(11):7594)", "finding": "Follow-up: 'The existing ADI was withdrawn because adequate toxicity data were not available.' EFSA switched to a margin-of-exposure approach and concluded the MOEs 'raise some safety concerns for high consumers of foodstuffs that contain sulfites'; no new industry data had been generated." }, { "source": "FDA", "ref": "FDA ORA Laboratory Manual Vol. IV §10 (fda.gov/media/73584/download)", "finding": "US: sulfiting agents prohibited on fresh fruits and vegetables intended to be sold or served raw (except potatoes) effective 1986-08-08 after reports of allergic-type reactions; presence above 10 ppm must be declared (rule published 1986-07-09, effective 1987-01-09)." }, { "source": "IARC", "ref": "IARC classification list — Sulfur dioxide, Group 3 (Vol. 54, 1992)", "finding": "Not classifiable as to carcinogenicity — the sulfite case rests on exposure/ADI withdrawal and asthma sensitivity, not cancer." } ] }, { "e_number": "E221", "name": "Sodium sulphite", "off_tag": "en:e221", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e221", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4438", "finding": "Read-across across all sulfite sources; exposure above the temporary group ADI of 0.7 mg SO2 eq/kg bw/day for all population groups, toddlers and children included." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2022.7594", "finding": "Temporary group ADI withdrawn for lack of adequate toxicity data; MOEs raise safety concerns for high consumers." }, { "source": "FDA", "ref": "21 CFR §182.3798 (sodium sulfite, GRAS) with the 1986 raw-produce prohibition and >10 ppm declaration rule", "finding": "GRAS in the US as a preservative, but restricted from raw fruit/vegetable use and subject to mandatory sulfite declaration." } ] }, { "e_number": "E222", "name": "Sodium bisulphite", "off_tag": "en:e222", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e222", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4438", "finding": "Exposure exceeded the temporary group ADI for all population groups including toddlers and children." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2022.7594", "finding": "ADI withdrawn (inadequate toxicity data); MOE approach flags concern for high consumers." }, { "source": "FDA", "ref": "21 CFR §182.3739 (sodium bisulfite, GRAS); FDA 1986 prohibition on sulfites for raw fruits and vegetables", "finding": "GRAS with the raw-produce prohibition and the 10 ppm declaration threshold." } ] }, { "e_number": "E223", "name": "Sodium metabisulphite", "off_tag": "en:e223", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e223", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4438", "finding": "Temporary group ADI 0.7 mg SO2 eq/kg bw/day; exposure estimates higher than the group ADI for all population groups." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2022.7594", "finding": "Existing ADI withdrawn because adequate toxicity data were not available; MOEs raise safety concerns for high consumers of sulfite-containing foods." }, { "source": "FDA", "ref": "21 CFR §182.3766 (sodium metabisulfite, GRAS); 21 CFR §101.100(a)(3) incidental-additive threshold", "finding": "GRAS in the US, but sulfites >10 ppm must be declared and cannot be used on raw fruits/vegetables." } ] }, { "e_number": "E224", "name": "Potassium metabisulphite", "off_tag": "en:e224", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e224", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4438", "finding": "Within the joint re-evaluation; exposure above the temporary group ADI for all population groups including toddlers and children." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2022.7594", "finding": "Temporary group ADI withdrawn; safety concerns for high consumers via MOE." }, { "source": "FDA", "ref": "21 CFR §182.3637 (potassium metabisulfite, GRAS)", "finding": "GRAS in the US subject to the sulfite declaration rule and the raw-produce prohibition." } ] }, { "e_number": "E226", "name": "Calcium sulphite", "off_tag": "en:e226", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e226", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4438 (EFSA Journal 2016;14(4):4438)", "finding": "Named in the joint re-evaluation of sulfur dioxide and sulfites E 220–E 228; temporary group ADI 0.7 mg SO2 eq/kg bw/day, and 'exposure estimates to sulfur dioxide and sulfites were higher than the group ADI ... for all population groups', toddlers and children included." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2022.7594 (EFSA Journal 2022;20(11):7594)", "finding": "'The existing ADI was withdrawn because adequate toxicity data were not available.' EFSA moved to a margin-of-exposure approach and concluded the MOEs 'raise some safety concerns for high consumers of foodstuffs that contain sulfites'." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex), Annex II Part B 'List of all additives' and Annex III", "finding": "E 226 is present in the Union list (Annex II Part B): it remains an authorised EU sulphite — a direct substitute manufacturers can switch to for E 220–E 224, classified consistently with that family." }, { "source": "FDA", "ref": "21 CFR Part 182 Subpart D enumerated in full (the six US GRAS sulfiting agents are §182.3616, §182.3637, §182.3739, §182.3766, §182.3798, §182.3862); FDA Substances Added to Food inventory", "finding": "No US food authorisation located for calcium sulfite: it is absent from the GRAS chemical-preservative sections and returns no records in the Substances Added to Food inventory. This is a verified absence of authorisation, not a prohibition — no US rule bans the substance; none authorises it." } ] }, { "e_number": "E227", "name": "Calcium bisulphite", "off_tag": "en:e227", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e227", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4438 (EFSA Journal 2016;14(4):4438)", "finding": "Within the joint E 220–E 228 re-evaluation; read-across on SO2-equivalents across all sulfite sources, with exposure above the temporary group ADI of 0.7 mg SO2 eq/kg bw/day for all population groups including toddlers and children." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2022.7594 (EFSA Journal 2022;20(11):7594)", "finding": "Temporary group ADI withdrawn for lack of adequate toxicity data; MOEs raise safety concerns for high consumers of sulfite-containing foods." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex), Annex II Part B 'List of all additives' and Annex III", "finding": "E 227 is present in the Union list (Annex II Part B) and remains an authorised EU sulphite." }, { "source": "FDA", "ref": "21 CFR Part 182 Subpart D enumerated in full; FDA Substances Added to Food inventory", "finding": "No US food authorisation located for calcium bisulfite — absent from the six GRAS sulfiting-agent sections and returning no records in the Substances Added to Food inventory." } ] }, { "e_number": "E228", "name": "Potassium bisulphite", "off_tag": "en:e228", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e228", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4438", "finding": "Named in the joint E220–E228 re-evaluation; exposure above the temporary group ADI for all population groups." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2022.7594", "finding": "ADI withdrawn for lack of adequate toxicity data." }, { "source": "FDA", "ref": "21 CFR §182.3616 (potassium bisulfite, GRAS)", "finding": "GRAS in the US with the sulfite declaration and raw-produce restrictions." } ] }, { "e_number": "E235", "name": "Natamycin", "off_tag": "en:e235", "category": "preservative", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e235", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2009.1412 (EFSA Journal 2009;7(12):1412)", "finding": "No ADI derivable due to database limitations, but 'the highest potential exposure to natamycin was below 0.1 mg/kg bw/day for children at the 97.5th percentile', judged to provide an adequate margin of safety versus JECFA's 0.3 mg/kg bw/day ADI; surface treatment of semi-hard/semi-soft cheese rind and sausage casings not of safety concern; 'no concern for the induction of antimicrobial resistance'." }, { "source": "FDA", "ref": "21 CFR §172.155 (natamycin/pimaricin)", "finding": "Permitted in the US for specified uses (cheese surface treatment)." } ] }, { "e_number": "E239", "name": "Hexamethylene tetramine", "off_tag": "en:e239", "category": "preservative", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e239", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2014.3696 (EFSA Journal 2014;12(6):3696)", "finding": "'Due to the limitations in the database the Panel could not identify a critical study and therefore to derive an ADI.' Child exposure to formaldehyde from HMT could reach 87 µg/kg bw/day under a conservative assumption; the Panel nonetheless concluded the Provolone-only use at 25 mg/kg is not of safety concern, and that any extension of use would need new toxicity data." }, { "source": "IARC", "ref": "IARC classification list — Formaldehyde, CAS 50-00-0, Group 1", "finding": "The breakdown product is Group 1, but on inhalation evidence; there is no IARC classification of hexamethylene tetramine itself and no dietary-route Group 1 finding." }, { "source": "FDA", "ref": "eCFR search of 21 CFR — no listing for hexamethylenetetramine/hexamethylene tetramine as a food additive", "finding": "Not permitted in US food." } ] }, { "e_number": "E249", "name": "Potassium nitrite", "off_tag": "en:e249", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e249", "citations": [ { "source": "IARC", "ref": "IARC Monographs Vol. 94 (2010) — ingested nitrite under conditions resulting in endogenous nitrosation, Group 2A", "finding": "Group 2A with a dietary exposure route." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4786 (title: 'Re-evaluation of potassium nitrite (E 249) and sodium nitrite (E 250) as food additives')", "finding": "ADI 0.07 mg nitrite ion/kg bw/day; additive-use exposure exceeded the ADI only in children at the highest percentile; all-source exposure exceeds the ADI at the mean for infants, toddlers and children." }, { "source": "FDA", "ref": "21 CFR §181.34 (sodium nitrite and potassium nitrite)", "finding": "Prior-sanctioned for use in curing; still permitted in the US." } ] }, { "e_number": "E250", "name": "Sodium nitrite", "off_tag": "en:e250", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e250", "citations": [ { "source": "IARC", "ref": "IARC Monographs Vol. 94 (2010) — 'Ingested nitrate or nitrite under conditions that result in endogenous nitrosation', Group 2A", "finding": "Group 2A (probably carcinogenic) explicitly for the ingested/dietary route, confirmed in the IARC classification list (List_of_Classifications, entry 'Nitrate or nitrite (ingested) ... 2A / 94 / 2010')." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4786 (EFSA Journal 2017;15(6):4786)", "finding": "ADI 0.07 mg nitrite ion/kg bw/day (BMD approach, methaemoglobin). Exposure from additive use 'did not exceed this ADI for the general population, except for a slight exceedance in children at the highest percentile', and represented approximately 17% of overall dietary exposure; counting all dietary sources the ADI is exceeded for infants, toddlers and children at the mean." }, { "source": "IARC", "ref": "IARC Monographs Vol. 114 (2018) — processed meat, Group 1", "finding": "Consumption of processed meat (the food category nitrite is used to cure) is Group 1 — context for the product vehicle, not a classification of the additive itself." }, { "source": "FDA", "ref": "21 CFR §172.175 (sodium nitrite); §181.34 (prior-sanctioned nitrite in curing)", "finding": "Remains a permitted curing agent in the US with use limits; no US ban or phase-out." } ] }, { "e_number": "E251", "name": "Sodium nitrate", "off_tag": "en:e251", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e251", "citations": [ { "source": "IARC", "ref": "IARC Monographs Vol. 94 (2010) — 'Nitrate or nitrite (ingested) under conditions that result in endogenous nitrosation', Group 2A", "finding": "The 2A classification names ingested nitrate, not only nitrite." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4787 (EFSA Journal 2017;15(6):4787)", "finding": "ADI 3.7 mg nitrate/kg bw/day. Exposure from additive use was <5% of overall nitrate exposure and did not exceed the ADI; 'if all sources of exposure to dietary nitrate are considered ... the ADI would be exceeded for all age groups at the mean and the highest exposure'." }, { "source": "OFF", "ref": "Open Food Facts additives taxonomy node en:e251", "finding": "OFF encodes children and toddlers as the mean-exceedance groups for nitrate — consistent with the EFSA all-sources table. Recorded as a cross-check of that taxonomy against the EFSA opinion; the classification rests on the EFSA and IARC citations, not on this entry." }, { "source": "FDA", "ref": "21 CFR §172.170 (sodium nitrate); §181.33", "finding": "Permitted in the US in curing with limits." } ] }, { "e_number": "E252", "name": "Potassium nitrate", "off_tag": "en:e252", "category": "preservative", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e252", "citations": [ { "source": "IARC", "ref": "IARC Monographs Vol. 94 (2010), Group 2A — ingested nitrate under nitrosating conditions", "finding": "Group 2A with a dietary route." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4787", "finding": "ADI 3.7 mg nitrate/kg bw/day; additive use alone does not exceed it; all dietary sources exceed the ADI for all age groups at the mean, with children/toddlers the flagged groups." }, { "source": "FDA", "ref": "21 CFR §172.160 (potassium nitrate)", "finding": "Permitted in the US in specified cured products." } ] }, { "e_number": "E260", "name": "Acetic acid", "off_tag": "en:e260", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e260", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory — acetic acid", "finding": "GRAS direct food substance (pH control, flavouring)." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 260 authorised as a Group I additive at quantum satis in the EU." } ] }, { "e_number": "E261", "name": "Potassium acetate", "off_tag": "en:e261", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e261", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory — potassium acetate", "finding": "GRAS direct food substance (pH control, preservative)." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 261 authorised as a Group I additive at quantum satis in the EU." } ] }, { "e_number": "E262", "name": "Sodium acetates", "off_tag": "en:e262", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e262", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory — sodium acetate / sodium diacetate", "finding": "GRAS direct food substances (pH control, sequestrant, antimicrobial)." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 262 authorised in the EU as a Group I additive at quantum satis." } ] }, { "e_number": "E270", "name": "Lactic acid", "off_tag": "en:e270", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e270", "citations": [ { "source": "state_law", "ref": "Commission Directive 2006/125/EC on processed cereal-based foods and baby foods for infants and young children (EUR-Lex CELEX:32006L0125); Regulation (EC) No 1333/2008 Annex II", "finding": "E 270 authorised at quantum satis generally, but only the L(+) form may be used in foods for infants and young children." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — lactic acid", "finding": "GRAS direct food substance; US labelling does not distinguish the isomer." } ] }, { "e_number": "E280", "name": "Propionic acid", "off_tag": "en:e280", "category": "preservative", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e280", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2014.3779", "finding": "NOAEL 0.3% / LOAEL 1% propionic acid in the diet (90-day dog study, reversible site-of-contact effect); no ADI allocated; concentrations in food at maximum permitted levels are a factor of three below the effect concentration — no safety concern." }, { "source": "peer_reviewed", "ref": "Tirosh et al., Sci Transl Med 2019; doi:10.1126/scitranslmed.aav0120", "finding": "Propionate raises glucagon and FABP4 and impairs insulin action in mice and humans." }, { "source": "FDA", "ref": "21 CFR §184.1081 (propionic acid, GRAS)", "finding": "GRAS in the US." } ] }, { "e_number": "E281", "name": "Sodium propionate", "off_tag": "en:e281", "category": "preservative", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e281", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2014.3779", "finding": "Covered by the joint E280–E283 re-evaluation; no ADI allocated but no safety concern at authorised uses; no genotoxicity/carcinogenicity concern." }, { "source": "peer_reviewed", "ref": "Tirosh et al., Sci Transl Med 2019; doi:10.1126/scitranslmed.aav0120", "finding": "Propionate impairs insulin action in mice and humans (randomised double-blind human arm)." }, { "source": "FDA", "ref": "21 CFR §184.1784 (sodium propionate, GRAS)", "finding": "GRAS in the US as an antimycotic." } ] }, { "e_number": "E282", "name": "Calcium propionate", "off_tag": "en:e282", "category": "preservative", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e282", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2014.3779 (EFSA Journal 2014;12(7):3779)", "finding": "'the present database did not allow allocation of an ADI'; no concern for genotoxicity or carcinogenicity; forestomach hyperplasia judged irrelevant to humans; concluded no safety concern at authorised uses and use levels." }, { "source": "peer_reviewed", "ref": "Tirosh et al., Sci Transl Med 2019; doi:10.1126/scitranslmed.aav0120", "finding": "Propionate increases glucagon and FABP4 production and impairs insulin action in mice and in a randomised double-blind human trial — an adverse metabolic signal not reflected in regulatory status." }, { "source": "FDA", "ref": "21 CFR §184.1221 (calcium propionate, GRAS)", "finding": "GRAS in the US; standard mould inhibitor in bread (see also §136.110)." } ] }, { "e_number": "E284", "name": "Boric acid", "off_tag": "en:e284", "category": "preservative", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e284", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2013.3407 (EFSA Journal 2013;11(10):3407)", "finding": "Group ADI 0.16 mg boron/kg bw/day established (NOAEL 9.6 mg boron/kg bw/day from a rat developmental study, uncertainty factor 60); male reproductive system adversely affected in rats, mice and dogs; boric acid and sodium tetraborate do not raise concern for genotoxicity. Exposure from the additive use at the highest mean: children 0.04 mg boron/kg bw/day. At the 95th percentile for consumers only: children 0.56 vs adolescents 0.37, adults 0.13, elderly 0.15 — children highest, 3.5x the ADI, the basis of the child flag. The Panel concluded regular exceedance of the ADI is unlikely given the caviar-only authorisation." }, { "source": "state_law", "ref": "Commission Regulation (EC) No 790/2009 (1st ATP to CLP Regulation (EC) No 1272/2008), index 005-007-00-2 (boric acid) and 005-011-00-4 (disodium tetraborate); Commission Delegated Regulation (EU) 2021/849", "finding": "Boric acid and disodium tetraborate carry the EU harmonised classification Repr. 1B, H360FD ('may damage fertility; may damage the unborn child'). Regulation (EU) 2021/849 deleted the boron-specific concentration limits, so the generic 0.3% limit for Repr. 1B applies since 2022-12-17. A hazard classification of the substance, not a food rule — CLP labelling does not apply to food sold to the final consumer — but it is the named regulatory reflection of the developmental hazard that keeps this row at mid rather than low. The same substances have been on the REACH Candidate List as SVHCs since 2010-06-18." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II, food category 09.3 (fish roe): E 284 boric acid, maximum 4 000 mg/kg (expressed as boric acid), only sturgeons' eggs (caviar)", "finding": "The single EU-authorised food use, in force: preservative in sturgeon caviar at up to 4,000 mg/kg expressed as boric acid. An authorisation, not a ban." }, { "source": "FDA", "ref": "eCFR search of 21 CFR — boric acid appears only in indirect/food-contact sections (§176.180, §178.2010, §178.3130, §175.105); no direct food-additive or GRAS listing", "finding": "Not permitted as a direct food preservative in the US." }, { "source": "OFF", "ref": "Open Food Facts additives taxonomy node en:e284", "finding": "Cross-check: OFF maps E284 to the same 2013 EFSA re-evaluation; it records no exposure-exceedance flags, so this row's higher-concern-for-young-children flag comes from the EFSA table directly, not from OFF." } ] }, { "e_number": "E285", "name": "Sodium tetraborate (borax)", "off_tag": "en:e285", "category": "preservative", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e285", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2013.3407", "finding": "Boron is the toxicologically active species; group ADI 0.16 mg boron/kg bw/day; children's P95 exposure from additive use 0.56 mg boron/kg bw/day, the highest of any population group; authorised in the EU only as a preservative for sturgeon eggs (caviar)." }, { "source": "FDA", "ref": "eCFR search of 21 CFR — no direct food-additive/GRAS listing for borax or sodium tetraborate (food-contact sections only)", "finding": "Not an approved food preservative in the US." }, { "source": "OFF", "ref": "Open Food Facts additives taxonomy node en:e285", "finding": "Mapped to the same EFSA 2013 re-evaluation; no OFF exposure-exceedance flags — the child figure comes from the EFSA opinion." } ] }, { "e_number": "E290", "name": "Carbon dioxide", "off_tag": "en:e290", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e290", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory — carbon dioxide", "finding": "GRAS direct food substance (propellant, carbonating agent, packaging gas)." } ] }, { "e_number": "E296", "name": "Malic acid", "off_tag": "en:e296", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e296", "citations": [ { "source": "state_law", "ref": "Commission Directive 2006/125/EC (processed cereal-based foods and baby foods); Regulation (EC) No 1333/2008 Annex II", "finding": "E 296 authorised generally; only the L(+) form permitted in infant and young-child foods." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — malic acid", "finding": "GRAS direct food substance (flavour enhancer, pH control)." } ] }, { "e_number": "E297", "name": "Fumaric acid", "off_tag": "en:e297", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e297", "citations": [ { "source": "EFSA", "ref": "EFSA call for data (July 2024) — background document for the re-evaluation of fumaric acid (E 297) and succinic acid (E 363)", "finding": "Both additives entered the re-evaluation programme in 2024; no safety conclusion published as of Aug 2026." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — fumaric acid", "finding": "Permitted US food additive / GRAS use as an acidulant; no restriction tied to children." } ] }, { "e_number": "E300", "name": "Ascorbic acid", "off_tag": "en:e300", "category": "antioxidant", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e300", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4087 (EFSA Journal 2015;13(5):4087)", "finding": "No genotoxicity, no chronic toxicity or carcinogenicity even at high doses, no adverse developmental effects; 'no safety concern ... and there is no need for a numerical ADI for ascorbic acid and its salts'." }, { "source": "FDA", "ref": "21 CFR §182.3013 (ascorbic acid, GRAS as a chemical preservative); §182.8013 (nutrient)", "finding": "GRAS in the US both as a preservative and as a nutrient." } ] }, { "e_number": "E301", "name": "Sodium ascorbate", "off_tag": "en:e301", "category": "antioxidant", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e301", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4087", "finding": "E301 assessed jointly with E300/E302: no safety concern at reported uses and use levels; no numerical ADI needed." }, { "source": "FDA", "ref": "21 CFR §182.3731 (sodium ascorbate, GRAS)", "finding": "GRAS in the US as a chemical preservative." } ] }, { "e_number": "E304", "name": "Fatty acid esters of ascorbic acid", "off_tag": "en:e304", "category": "antioxidant", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e304", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4289 (EFSA Journal 2015;13(11):4289)", "finding": "Near-complete pre-systemic hydrolysis to ascorbic acid + palmitic/stearic acid; toxicity extrapolated from ascorbic acid; data too limited for an ADI but 'no safety concern for the use of ascorbyl palmitate (E 304(i)) and ascorbyl stearate (E 304(ii)) ... at the reported uses and use levels'." }, { "source": "FDA", "ref": "21 CFR §182.3149 (ascorbyl palmitate, GRAS)", "finding": "GRAS in the US as a chemical preservative." } ] }, { "e_number": "E306", "name": "Tocopherol-rich extract", "off_tag": "en:e306", "category": "antioxidant", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e306", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4247 (EFSA Journal 2015;13(9):4247)", "finding": "No genotoxicity or carcinogenicity concern; data too limited for an ADI; ULs not exceeded in any population group except children in one survey from one country; 'tocopherols (E 306–E 309) are not of safety concern at the levels used in food'." }, { "source": "FDA", "ref": "21 CFR §182.3890 (tocopherols, GRAS)", "finding": "GRAS in the US as a chemical preservative." } ] }, { "e_number": "E307", "name": "Alpha-tocopherol", "off_tag": "en:e307", "category": "antioxidant", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e307", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4247", "finding": "α-tocopherol 'for the reported uses and use levels as a food additive, is not considered to be of safety concern'; critical effect (prolonged coagulation time) at a NOAEL of 125 mg/kg bw/day, far above additive exposure." }, { "source": "FDA", "ref": "21 CFR §184.1890 (α-tocopherols, GRAS)", "finding": "GRAS in the US." } ] }, { "e_number": "E310", "name": "Propyl gallate", "off_tag": "en:e310", "category": "antioxidant", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e310", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2014.3642 (EFSA Journal 2014;12(4):3642)", "finding": "ADI 0.5 mg/kg bw/day from a 90-day rat NOAEL of 135 mg/kg with UF 300 'for extrapolation from a subchronic to chronic data and due to the limitations in the reproductive toxicity database'; the old gallate group ADI withdrawn; 'the high level of exposure exceeded the ADI in adults and the elderly', though the Panel concluded current uses are not of safety concern." }, { "source": "state_law", "ref": "Commission Regulation (EU) 2018/1481", "finding": "Confirms the gallate group ADI is no longer valid while E310 itself remains authorised in the EU (only E311 and E312 were deleted)." }, { "source": "FDA", "ref": "21 CFR §184.1660 (propyl gallate, GRAS)", "finding": "GRAS in the US as a chemical preservative/antioxidant." } ] }, { "e_number": "E311", "name": "Octyl gallate", "off_tag": "en:e311", "category": "antioxidant", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e311", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4248 ('Scientific Opinion on the re-evaluation of octyl gallate (E 311) as a food additive')", "finding": "Metabolism data insufficient to justify read-across from propyl gallate; database too limited to establish an ADI or apply a margin-of-safety approach — safety could not be confirmed." }, { "source": "state_law", "ref": "Commission Regulation (EU) 2018/1481 (CELEX 32018R1481)", "finding": "E 311 (and E 312) deleted from the Union list of authorised food additives; recital 9 records that after the 2017 call for data no business operator committed to providing the requested toxicological data; foods lawfully placed on the market could be sold only until 2019-04-25." }, { "source": "FDA", "ref": "eCFR search of 21 CFR — no direct food-additive or GRAS listing for octyl gallate", "finding": "No US food-additive authorisation located; not a US-market ingredient." } ] }, { "e_number": "E312", "name": "Dodecyl gallate", "off_tag": "en:e312", "category": "antioxidant", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e312", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4086", "finding": "'the available database was too limited to either establish an ADI or serve as a basis for a margin of safety approach'; no NOAEL identifiable; could not reach a conclusion on carcinogenic potential." }, { "source": "state_law", "ref": "Commission Regulation (EU) 2018/1481", "finding": "E 312 deleted from the EU Union list of authorised food additives (recital 7 cites the lack of adequate toxicological data); sell-through ended 2019-04-25." }, { "source": "FDA", "ref": "eCFR search of 21 CFR — no direct food-additive or GRAS listing for dodecyl gallate", "finding": "No US food authorisation located." } ] }, { "e_number": "E315", "name": "Erythorbic acid", "off_tag": "en:e315", "category": "antioxidant", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e315", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4360 (EFSA Journal 2016;14(1):4360)", "finding": "ADI of 6 mg/kg bw/day confirmed (NOAEL 650 mg/kg bw/day); no genotoxicity or carcinogenicity concern; 'the ADI is not exceeded by any population group' — no safety concern at permitted/reported use levels." }, { "source": "FDA", "ref": "21 CFR §182.3041 (erythorbic acid, GRAS)", "finding": "GRAS in the US as a chemical preservative." } ] }, { "e_number": "E316", "name": "Sodium erythorbate", "off_tag": "en:e316", "category": "antioxidant", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e316", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4360", "finding": "Combined exposure to erythorbic acid and sodium erythorbate assessed; ADI 6 mg/kg bw/day not exceeded by any population group; no safety concern; OFF records efsa_evaluation_overexposure_risk = en:no." } ] }, { "e_number": "E319", "name": "Tertiary-butylhydroquinone (TBHQ)", "off_tag": "en:e319", "category": "antioxidant", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e319", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4363 (EFSA Journal 2016;14(1):4363)", "finding": "ADI 0.7 mg/kg bw (JECFA 1998, confirmed by EFSA 2004). 'using the maximum permitted levels, exposure estimates exceed the ADI ... at the high level for toddlers and children, however, in the refined exposure scenarios, the ADI was not exceeded in any of the population groups.' The 2004 opinion had also flagged that infant-formula use could push infants over the ADI." }, { "source": "peer_reviewed", "ref": "Alarming impact of the excessive use of tert-butylhydroquinone in food products: a narrative review, Toxicol Rep 2022; doi:10.1016/j.toxrep.2022.04.027", "finding": "Reviews immunomodulatory and endocrine signals for TBHQ (Nrf2 activation, altered T-cell responses) that are not reflected in current regulatory status." }, { "source": "FDA", "ref": "21 CFR §172.185 (TBHQ)", "finding": "Permitted in the US, limited to 0.02% of the oil/fat content of the food." } ] }, { "e_number": "E320", "name": "Butylated hydroxyanisole (BHA)", "off_tag": "en:e320", "category": "antioxidant", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e320", "citations": [ { "source": "IARC", "ref": "IARC classification list — Butylated hydroxyanisole (BHA), CAS 25013-16-5, Group 2B (Vol. 40, Suppl. 7, 1987)", "finding": "Possibly carcinogenic to humans, from oral rodent forestomach studies — dietary route." }, { "source": "OEHHA", "ref": "Proposition 65 list — butylated hydroxyanisole, CAS 25013-16-5, listed 1990-01-01 (cancer)", "finding": "Listed under Prop 65 as known to the State of California to cause cancer since 1990-01-01." }, { "source": "state_law", "ref": "West Virginia HB 2354 (signed 2025-03-24); TX SB 25, 89th Leg. (2025)", "finding": "WV prohibits BHA in food sold in the state — school nutrition programs from 2025-08-01 (in force), all food from 2028-01-01 (preliminarily enjoined Dec 2025). TX SB 25 names BHA among 44 ingredients triggering a warning label from 2027-01-01 (enforcement enjoined 2026-02-11)." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2011.2392 and 10.2903/j.efsa.2012.2759", "finding": "ADI raised to 1.0 mg/kg bw/day (forestomach hyperplasia judged not relevant to humans; NOAEL 100 mg/kg from rat-pup growth/mortality/behaviour); additive-only exposure below the ADI, but combined food + food-contact-material exposure 'does exceed the ADI for most population groups'." } ] }, { "e_number": "E321", "name": "Butylated hydroxytoluene (BHT)", "off_tag": "en:e321", "category": "antioxidant", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e321", "citations": [ { "source": "FDA", "ref": "FDA news release 'FDA finalizes food chemical safety post-market assessment program, launches reassessment of BHT and ADA' (program finalized 2026-05-12)", "finding": "FDA finalised its post-market chemical assessment programme on 2026-05-12 and selected butylated hydroxytoluene as one of the first two chemicals to reassess (with azodicarbonamide, E 927a). Not a ban, a phase-out or a safety finding, and it does not change this classification: BHT is currently under FDA post-market reassessment, so its US status is under active review rather than settled; this citation records that review." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2012.2588 (EFSA Journal 2012;10(3):2588)", "finding": "ADI 0.25 mg/kg bw/day (NOAEL 25 mg/kg, UF 100); not of concern for genotoxicity. 'For exposure of children to BHT from its use as food additive ... it is also unlikely that this ADI is exceeded at the mean, but is exceeded for some European countries (Finland, The Netherlands) at the 95th percentile', while adults are unlikely to exceed it at mean or P95." }, { "source": "IARC", "ref": "IARC classification list — Butylated hydroxytoluene (BHT), CAS 128-37-0, Group 3 (Vol. 40, Suppl. 7, 1987)", "finding": "Not classifiable as to carcinogenicity to humans." }, { "source": "peer_reviewed", "ref": "Liu & Mabury, Environ Int 2019; doi:10.1016/j.envint.2019.04.028; and Koch et al., Int J Hyg Environ Health 2020; doi:10.1016/j.ijheh.2020.113541", "finding": "Human biomonitoring detects BHT and its metabolites in urine at population scale, confirming widespread internal exposure alongside dietary intake." }, { "source": "state_law", "ref": "TX SB 25, 89th Texas Legislature (2025)", "finding": "BHT is among the 44 ingredients that would trigger a warning label from 2027-01-01; enforcement preliminarily enjoined 2026-02-11 (First Amendment). Not a ban." } ] }, { "e_number": "E322", "name": "Lecithins", "off_tag": "en:e322", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e322", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4742", "finding": "Re-evaluation of lecithins (E 322): no need for a numerical ADI; no safety concern for the general population from more than 1 year of age at the refined exposure assessment for reported uses." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2020.6266", "finding": "Follow-up opinion covering E 322 in foods for infants below 16 weeks of age; no adverse finding carried back to general-population uses." } ] }, { "e_number": "E325", "name": "Sodium lactate", "off_tag": "en:e325", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e325", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory — sodium lactate", "finding": "GRAS direct food substance (humectant, pH control, flavour agent)." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 325 authorised as a Group I additive at quantum satis in the EU." } ] }, { "e_number": "E326", "name": "Potassium lactate", "off_tag": "en:e326", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e326", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory — potassium lactate", "finding": "GRAS direct food substance (flavour agent, pH control, humectant)." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 326 authorised in the EU as a Group I additive at quantum satis." } ] }, { "e_number": "E327", "name": "Calcium lactate", "off_tag": "en:e327", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e327", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory — calcium lactate", "finding": "GRAS direct food substance (firming agent, nutrient supplement)." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 327 authorised as a Group I additive at quantum satis in the EU." } ] }, { "e_number": "E330", "name": "Citric acid", "off_tag": "en:e330", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e330", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2016;14(11):4599 — Safety of trimagnesium dicitrate anhydrous as a food additive", "finding": "Panel notes citrate's established role as a citric-acid-cycle intermediate and confirms JECFA's (1974) 'ADI not specified' for citric acid and citrates." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II (EU Union list), EUR-Lex ELI: reg/2008/1333", "finding": "E 330 authorised in the EU as a Group I additive at quantum satis across most food categories; no restriction tied to children." } ] }, { "e_number": "E331", "name": "Sodium citrates", "off_tag": "en:e331", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e331", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2016;14(11):4599 — Safety of trimagnesium dicitrate anhydrous as a food additive", "finding": "Confirms JECFA's 'ADI not specified' for citric acid and its salts; citrate is a normal metabolic intermediate." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — sodium citrate", "finding": "Listed as a GRAS direct food substance (buffer, sequestrant, emulsifier salt)." } ] }, { "e_number": "E332", "name": "Potassium citrates", "off_tag": "en:e332", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e332", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4599 (EFSA Journal 2016;14(11):4599 — Safety of trimagnesium dicitrate anhydrous as a food additive)", "finding": "Confirms JECFA's 'ADI not specified' for citric acid and its salts and notes citrate's established role as a citric-acid-cycle intermediate. Same source as the E 330, E 331 and E 333 rows." }, { "source": "FDA", "ref": "21 CFR 184.1625 (Potassium citrate) — Part 184 \"Direct Food Substances Affirmed as Generally Recognized as Safe\"; verified against the current eCFR structure", "finding": "Potassium citrate is affirmed GRAS as a direct human food substance." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex ELI: reg/2008/1333)", "finding": "E 332 potassium citrates authorised in the EU as a Group I additive at quantum satis; no restriction tied to children." } ] }, { "e_number": "E333", "name": "Calcium citrates", "off_tag": "en:e333", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e333", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2016;14(11):4599 — Safety of trimagnesium dicitrate anhydrous as a food additive", "finding": "Confirms JECFA's 'ADI not specified' for citric acid and citrate salts; citrate is a normal metabolic intermediate." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — calcium citrate", "finding": "GRAS direct food substance (buffer, firming agent, nutrient supplement)." } ] }, { "e_number": "E334", "name": "L(+)-tartaric acid", "off_tag": "en:e334", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e334", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2020;18(3):6030 — doi:10.2903/j.efsa.2020.6030, Re-evaluation of L(+)-tartaric acid (E 334), sodium/potassium/calcium tartrates (E 335–337, E 354)", "finding": "Group ADI of 240 mg/kg bw/day as tartaric acid; no genotoxic potential, no nephrotoxicity for the L(+) form; no safety concern at reported uses across infant, toddler, child, adolescent, adult and elderly groups." } ] }, { "e_number": "E336", "name": "Potassium tartrates", "off_tag": "en:e336", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e336", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2020;18(3):6030 — doi:10.2903/j.efsa.2020.6030", "finding": "Group ADI 240 mg/kg bw/day as tartaric acid for E 334–337 and E 354; no safety concern at reported uses and use levels for any population group." } ] }, { "e_number": "E338", "name": "Phosphoric acid", "off_tag": "en:e338", "category": "acidity", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e338", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2019;17(6):5674 — doi:10.2903/j.efsa.2019.5674", "finding": "Group ADI 40 mg/kg bw/day as phosphorus; mean dietary exposure may exceed the ADI for infants, toddlers and children." }, { "source": "EFSA", "ref": "EFSA news release 190612, 12 June 2019", "finding": "ADI excludes people with moderate-to-severe reduced kidney function; supplement users aged 3+ may exceed it at levels associated with kidney risk." }, { "source": "peer_reviewed", "ref": "Tucker KL et al., Am J Clin Nutr 2006;84(4):936–942 — Colas, but not other carbonated beverages, are associated with low bone mineral density in older women (Framingham Osteoporosis Study)", "finding": "Cola intake (a phosphoric-acid source) associated with lower hip BMD; non-cola carbonated drinks showed no association. Observational, adult cohort — supporting context only, not a basis for the class." } ] }, { "e_number": "E339", "name": "Sodium phosphates", "off_tag": "en:e339", "category": "acidity", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e339", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2019;17(6):5674 — doi:10.2903/j.efsa.2019.5674", "finding": "Group ADI 40 mg P/kg bw/day; mean exposure may exceed the ADI in infants, toddlers and children." }, { "source": "EFSA", "ref": "EFSA news release 190612, 12 June 2019", "finding": "EFSA recommends numerical maximum levels; ADI excludes reduced-kidney-function populations." } ] }, { "e_number": "E340", "name": "Potassium phosphates", "off_tag": "en:e340", "category": "acidity", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e340", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2019;17(6):5674 — doi:10.2903/j.efsa.2019.5674", "finding": "Group ADI 40 mg P/kg bw/day; exposure may exceed the ADI for infants, toddlers and children at mean consumption." }, { "source": "EFSA", "ref": "EFSA news release 190612, 12 June 2019", "finding": "EFSA recommends numerical maximum permitted levels; ADI does not apply to reduced kidney function." } ] }, { "e_number": "E341", "name": "Calcium phosphates", "off_tag": "en:e341", "category": "acidity", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e341", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2019;17(6):5674 — doi:10.2903/j.efsa.2019.5674", "finding": "Group ADI 40 mg/kg bw/day as phosphorus; exposure may exceed the ADI for infants, toddlers and children at mean consumption." }, { "source": "EFSA", "ref": "EFSA news release 190612, 12 June 2019", "finding": "EFSA recommends maximum permitted levels for phosphates and excludes people with reduced kidney function from the ADI." } ] }, { "e_number": "E343", "name": "Magnesium phosphates", "off_tag": "en:e343", "category": "acidity", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e343", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2019;17(6):5674 — doi:10.2903/j.efsa.2019.5674", "finding": "Group ADI 40 mg P/kg bw/day covering E 338–341, E 343 and E 450–452; mean exposure may exceed the ADI in infants, toddlers and children." }, { "source": "EFSA", "ref": "EFSA news release 190612, 12 June 2019", "finding": "EFSA recommends numerical maximum levels; the ADI does not apply to people with reduced kidney function." } ] }, { "e_number": "E350", "name": "Sodium malates", "off_tag": "en:e350", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e350", "citations": [ { "source": "EFSA", "ref": "EFSA FIP Unit, 'Call for data for the re-evaluation of malic acid and malates (E 296; E 350-352) as food additives' (efsa.europa.eu/sites/default/files/2024-07/call-for-data-malic-acid-malates_0.pdf)", "finding": "'Malic acid, sodium malate, potassium malate, and calcium malate, (E 296; E 350 (i), E 351, E 352(i)) have previously been evaluated by the Scientific Committee for Food (SCF) in 1991 when a group ADI (Acceptable Daily Intake) \"not specified\" was established.' JECFA (1980) likewise confirmed the group ADI 'not specified' first established at its 13th meeting in 1969. 'Malate occurs in all living organisms as an intermediate in the citric acid cycle. It occurs in relatively high amounts in many fruits and vegetables.'" }, { "source": "EFSA", "ref": "EFSA info session '(Re-)Evaluating Food Additives', Day 2, 20 March 2024 — 'Ongoing and upcoming calls for data' (efsa.europa.eu/sites/default/files/2024-03/12-re-evaluations-food-additives-ongoing-and-upcoming-calls-for-data.pdf)", "finding": "Lists 'Malic acid and malates (E 296; E 350-352)' among recently launched calls for data, with exposure data published 5 March 2024 and a deadline of 31 August 2024 — i.e. the EFSA re-evaluation opinion is still outstanding as of this table's date." }, { "source": "FDA", "ref": "21 CFR 184.1069 (Malic acid) — Part 184 \"Direct Food Substances Affirmed as Generally Recognized as Safe\"; verified against the current eCFR structure", "finding": "Malic acid is affirmed GRAS as a direct human food substance. Its sodium salt has no separate Part 184 listing; the GRAS status the US shelf relies on is the acid one." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex ELI: reg/2008/1333)", "finding": "E 350 sodium malates authorised in the EU at quantum satis across the Group I categories." } ] }, { "e_number": "E355", "name": "Adipic acid", "off_tag": "en:e355", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e355", "citations": [ { "source": "agency_review", "ref": "JECFA evaluations — adipic acid (WHO/FAO JECFA database, chemical 194; ADI established at the 9th meeting, 1965)", "finding": "ADI of 0–5 mg/kg bw established; JECFA notes hazard-assessment procedures have evolved since and additional data may now be available." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 355 permitted in the EU only in fillings for bakery products, dessert mixes and drink powders, with individual maximum levels per use." } ] }, { "e_number": "E363", "name": "Succinic acid", "off_tag": "en:e363", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e363", "citations": [ { "source": "agency_review", "ref": "JECFA evaluation — succinic acid (ADI 'not specified')", "finding": "Natural constituent of plants and animals; tolerated at high dietary concentrations; does not represent a hazard at food-additive levels because of its normal metabolic role." }, { "source": "EFSA", "ref": "EFSA call for data (July 2024) — background document, re-evaluation of fumaric acid (E 297) and succinic acid (E 363)", "finding": "Re-evaluation opened in 2024; no safety conclusion published as of Aug 2026." } ] }, { "e_number": "E385", "name": "Calcium disodium EDTA", "off_tag": "en:e385", "category": "antioxidant", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "low", "permalink": "https://sito.kids/additives#e385", "citations": [ { "source": "EFSA", "ref": "EFSA call for data for the re-evaluation of Calcium disodium EDTA (E 385) as a food additive (efsa.europa.eu/en/call/call-data-re-evaluation-calcium-disodium-edta-e-385-food-additive), data deadline 2024-12-31", "finding": "E385 has not yet been re-evaluated by EFSA under the Reg (EC) 1333/2008 programme; it remains authorised on the legacy SCF/JECFA ADI of 2.5 mg/kg bw/day while the re-evaluation is pending. No adverse regulatory finding has been published as of this table version." }, { "source": "FDA", "ref": "21 CFR §172.120 (calcium disodium EDTA)", "finding": "Permitted in the US in specified foods with numeric use limits; no US restriction or phase-out." } ] }, { "e_number": "E392", "name": "Extracts of rosemary", "off_tag": "en:e392", "category": "antioxidant", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e392", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2018.5373 (EFSA Journal 2018 — Refined exposure assessment of extracts of rosemary (E 392))", "finding": "Against JECFA's temporary ADI of 0–0.3 mg/kg bw (as carnosic acid + carnosol), the highest refined mean exposure was 0.09 mg/kg bw/day in children (3–9 y) and the highest P95 0.20 mg/kg bw/day in children; the Panel considered these very likely to overestimate real exposure, and margins of safety improved on the 2015 assessment." } ] }, { "e_number": "E401", "name": "Sodium alginate", "off_tag": "en:e401", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e401", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.5049 (PMC7010146)", "finding": "Re-evaluation of alginic acid and its sodium, potassium, ammonium and calcium salts (E 400-E 404): no need for a numerical ADI; no safety concern at the level of the refined exposure assessment for reported uses; exposure of infants and young children should stay below therapeutic dosages at which side effects could occur." } ] }, { "e_number": "E405", "name": "Propane-1,2-diol alginate", "off_tag": "en:e405", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e405", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2018.5371 (PMC7009538)", "finding": "Re-evaluation of propane-1,2-diol alginate (E 405): ADI of 55 mg/kg bw per day allocated, taking account of the 25 mg/kg bw per day ADI for propane-1,2-diol; exposure estimates did not exceed the ADI in any of the population groups." } ] }, { "e_number": "E406", "name": "Agar", "off_tag": "en:e406", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e406", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4645", "finding": "Re-evaluation of agar (E 406): no need for a numerical ADI and no safety concern for the general population at the refined exposure assessment for the reported uses of agar as a food additive." } ] }, { "e_number": "E407", "name": "Carrageenan", "off_tag": "en:e407", "category": "thickener", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e407", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2018.5238", "finding": "Re-evaluation of carrageenan (E 407) and processed Eucheuma seaweed (E 407a): the existing group ADI of 75 mg/kg bw per day was made TEMPORARY because of uncertainties in chemistry, exposure and toxicology, with the database to be improved within 5 years." }, { "source": "EFSA", "ref": "PMC7009739 (full text of 10.2903/j.efsa.2018.5238)", "finding": "Verbatim: 'in the refined brand-loyal exposure assessment scenario the exposure estimates exceeded, in some cases by up to approximately 10-fold, the temporary existing ADI at the high level (95th percentile) for all population groups and at the mean for all population groups except for infants and the elderly' - refined brand-loyal exposure up to 758.6 mg/kg bw per day for toddlers (12-35 months)." }, { "source": "EFSA", "ref": "PMC7009739 (same opinion, infant section)", "finding": "Panel: 'it remains inadvisable to use carrageenan in infant formulae that are fed from birth, including those in the category of foods for special medical purposes'; unresolved question of absorption by the immature gut of very young infants." }, { "source": "IARC", "ref": "IARC Monographs Vol. 31 (1983); Supplement 7 (1987) - carrageenan", "finding": "Degraded carrageenan classified Group 2B (possibly carcinogenic to humans; colorectal tumours induced in rats); native/undegraded carrageenan classified Group 3 (not classifiable)." } ] }, { "e_number": "E410", "name": "Locust bean gum", "off_tag": "en:e410", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e410", "citations": [ { "source": "EFSA", "ref": "PMC7010100 (Re-evaluation of locust bean gum (E 410) as a food additive, EFSA 2017)", "finding": "No need for a numerical ADI for locust bean gum (E 410) and no safety concern for the general population at the refined exposure assessment for its reported uses." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2023.7775 (PMC9909383)", "finding": "Re-evaluation of E 410 in foods for infants below 16 weeks of age and follow-up for all population groups." } ] }, { "e_number": "E412", "name": "Guar gum", "off_tag": "en:e412", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e412", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4669 (PMC7010168)", "finding": "Re-evaluation of guar gum (E 412): ADI 'not specified' retained in effect; no need for a numerical ADI and no safety concern for the general population at reported uses and use levels." } ] }, { "e_number": "E413", "name": "Tragacanth", "off_tag": "en:e413", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e413", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4789", "finding": "Re-evaluation of tragacanth (E 413): no safety concern for the general population at the refined exposure assessment of tragacanth as a food additive at the reported uses and use levels." } ] }, { "e_number": "E414", "name": "Acacia gum", "off_tag": "en:e414", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e414", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4741 (PMC7010027)", "finding": "Re-evaluation of acacia gum (E 414): no need for a numerical ADI; no safety concern for the general population at the refined exposure assessment (JECFA had allocated ADI 'not specified')." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2019.5922 (PMC7008789)", "finding": "Opinion on E 414 in foods for infants below 16 weeks of age and follow-up for all population groups; general-population conclusion unchanged." } ] }, { "e_number": "E415", "name": "Xanthan gum", "off_tag": "en:e415", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e415", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4909", "finding": "Re-evaluation of xanthan gum (E 415): no need for a numerical ADI; no safety concern for the general population at the refined exposure assessment for reported uses." }, { "source": "peer_reviewed", "ref": "PMID 22575248 (Beal J et al., J Pediatr 2012) and PMID 22289705 (Woods CW et al. 2012)", "finding": "Case series of late-onset necrotising enterocolitis in (predominantly premature) infants following use of a xanthan-gum-containing thickening agent; the reports underpinned FDA's 2011 warning against SimplyThick in premature infants." } ] }, { "e_number": "E417", "name": "Tara gum", "off_tag": "en:e417", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e417", "citations": [ { "source": "EFSA", "ref": "PMC7009841 - Re-evaluation of tara gum (E 417) as a food additive", "finding": "SCF and JECFA both allocated ADI 'not specified'; EFSA concluded there is no need for a numerical ADI for tara gum (E 417) and no safety concern for the general population at the reported uses and use levels." }, { "source": "FDA", "ref": "FDA constituent update, 'FDA Update on the Post-market Assessment of Tara Flour'; FDA post-market not-GRAS determination list entry 'taraflour'", "finding": "FDA determined there are insufficient data and no history of safe use to consider tara FLOUR GRAS, and no food additive regulation authorises it - making it an unapproved food additive. This determination concerns tara flour, not tara gum (E 417)." } ] }, { "e_number": "E418", "name": "Gellan gum", "off_tag": "en:e418", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e418", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2018.5296 (PMC7009714)", "finding": "Re-evaluation of gellan gum (E 418): no need for a numerical ADI; no safety concern at the refined exposure assessment for the reported uses and use levels." } ] }, { "e_number": "E420", "name": "Sorbitol", "off_tag": "en:e420", "category": "sweetener", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e420", "citations": [ { "source": "EFSA", "ref": "EFSA Call for data on genotoxicity data on sorbitol (E 420 i), published 2023-06-26, deadline 2024-01-03 (efsa.europa.eu/en/call/call-data-genotoxicity-data-sorbitol-e-420-i)", "finding": "EFSA identified a genotoxicity data gap for sorbitol — the lack of a fully reliable in vitro micronucleus test to current OECD guidance — and requested new data to complete the safety assessment; the re-evaluation opinion has not been published." }, { "source": "FDA", "ref": "21 CFR 184.1835 (govinfo CFR-2024-title21-vol3-sec184-1835)", "finding": "Sorbitol is affirmed GRAS in the US with use limits by food category (e.g. 99% hard candy, 12% other foods) and a mandatory label statement 'Excess consumption may have a laxative effect' where foreseeable daily intake exceeds 50 g." }, { "source": "EFSA", "ref": "Europe PMC query of EFSA Journal for re-evaluation opinions on E 420/421/953/965/967 (executed 2026-08-10)", "finding": "No EFSA re-evaluation opinion exists for sorbitol as of this date — erythritol (E 968) is the only polyol whose re-evaluation is complete; sorbitol's EU status still rests on the pre-2009 SCF acceptance with no numerical ADI." } ] }, { "e_number": "E421", "name": "Mannitol", "off_tag": "en:e421", "category": "sweetener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e421", "citations": [ { "source": "FDA", "ref": "21 CFR 180.25 (govinfo CFR-2024-title21-vol3-sec180-25)", "finding": "Mannitol is permitted 'on an interim basis pending additional study' with per-category limits (98% pressed mints, 31% chewing gum, <2.5% other foods) and a mandatory 'Excess consumption may have a laxative effect' statement where foreseeable daily intake reaches 20 g — a lower laxative trigger than sorbitol's 50 g." }, { "source": "EFSA", "ref": "EFSA Call for data on genotoxicity data on sweeteners (2021-06-30) and Europe PMC EFSA Journal query (2026-08-10)", "finding": "E 421 is not named in EFSA's 2021 genotoxicity data-gap call, and no re-evaluation opinion for mannitol has been published; its EU status remains the pre-2009 SCF acceptance with no numerical ADI." } ] }, { "e_number": "E422", "name": "Glycerol", "off_tag": "en:e422", "category": "other", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e422", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2026;24(?):10057 — doi:10.2903/j.efsa.2026.10057, Safety of acute exposure to the food additive glycerol (E 422) from beverages", "finding": "ARfD of 125 mg glycerol/kg bw per single consumption event derived; acute exposure from a slush ice drink (250 mL for children) exceeds the ARfD in all population groups; max single-event volume 82.7 mL for toddlers 1–2 y; EFSA recommends numerical maximum levels in beverages." }, { "source": "EFSA", "ref": "EFSA Journal 2017;15(3):4720 — Re-evaluation of glycerol (E 422) as a food additive", "finding": "Chronic re-evaluation found no safety concern at reported uses and use levels; no numerical ADI needed." }, { "source": "agency_review", "ref": "Food Safety Authority of Ireland / national advisories on slush ice drinks containing glycerol (updated advice: not for children aged 10 and under)", "finding": "National regulators advise against slush ice drinks for young children following clinical cases of glycerol intoxication." } ] }, { "e_number": "E425", "name": "Konjac", "off_tag": "en:e425", "category": "thickener", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e425", "citations": [ { "source": "state_law", "ref": "Commission Directive 2003/52/EC (CELEX 32003L0052) - EU legal instrument", "finding": "Permanently withdrew the authorisation of E 425 konjac in jelly confectionery including jelly mini-cups by amending Annex IV to Directive 95/2/EC; recital 2 states the products 'have been found to be dangerous as they have caused the death of several children and elderly persons in third countries through choking'. Member States to comply by 17 January 2004." }, { "source": "state_law", "ref": "Commission Decision 2002/247/EC (CELEX 32002D0247); European Commission press release IP/02/435", "finding": "Preceding EU emergency measure suspending the placing on the market and import of jelly confectionery containing E 425 konjac, on choking-risk grounds; parallel bans were adopted in the US, Canada and Australia." } ] }, { "e_number": "E426", "name": "Soybean hemicellulose", "off_tag": "en:e426", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e426", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4721 (PMC7010024)", "finding": "Re-evaluation of soybean hemicellulose (E 426): not evaluated by JECFA and no ADI specified; the Panel concluded it is very unlikely that there is a safety concern from the current use of E 426 as a food additive and that there is no need for a numerical ADI. Authorised in the EU under Annex II to Regulation (EC) No 1333/2008." } ] }, { "e_number": "E428", "name": "Gelatine", "off_tag": "en:e428", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e428", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory - 'Gelatin'", "finding": "Gelatin is listed as a permitted GRAS food substance in the US with no restriction or adverse post-market action; no ADI has been considered necessary by EFSA or JECFA." } ] }, { "e_number": "E431", "name": "Polyoxyethylene (40) stearate", "off_tag": "en:e431", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "low", "permalink": "https://sito.kids/additives#e431", "citations": [ { "source": "state_law", "ref": "UK FSA Regulated Products Register, entry e-431 (data.food.gov.uk) - regulatory register", "finding": "Polyoxyethylene (40) stearate (E 431) is listed as 'Authorised' as a food additive in England, Scotland and Wales under assimilated Regulation (EC) No 1333/2008 Annex II, with specifications under assimilated Regulation (EU) No 231/2012; status last changed 31 December 2020." } ] }, { "e_number": "E432", "name": "Polysorbate 20", "off_tag": "en:e432", "category": "emulsifier", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e432", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4152", "finding": "Re-evaluation of polysorbates E 432 (polyoxyethylene sorbitan monolaurate) through E 436: group ADI 25 mg/kg bw per day; refined non-brand-loyal exposure did not exceed the ADI, but toddlers at the highest level reached 24.5 mg/kg bw per day - 'very close to the ADI'; more data needed because three food categories had no reported uses and other dietary sources could not be considered." }, { "source": "peer_reviewed", "ref": "PMID 25731162 - Chassaing B et al., Nature 2015;519:92-96", "finding": "Polysorbate-80, the group congener tested, induced low-grade inflammation, metabolic syndrome and colitis in mice at low dietary concentrations, with mucus thinning and bacterial encroachment." } ] }, { "e_number": "E433", "name": "Polysorbate 80", "off_tag": "en:e433", "category": "emulsifier", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e433", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4152", "finding": "Group ADI 25 mg/kg bw per day for polysorbates E 432-E 436; refined non-brand-loyal exposure did not exceed the ADI in any group, but toddlers at the highest level reached 24.5 mg/kg bw per day - 'very close to the ADI'." }, { "source": "peer_reviewed", "ref": "PMID 25731162 - Chassaing B et al., Nature 2015;519:92-96", "finding": "Polysorbate-80 at relatively low concentrations induced low-grade intestinal inflammation and metabolic syndrome in wild-type mice and promoted robust colitis in colitis-prone mice; reduced mucus thickness and bacterial encroachment on the epithelium." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4152 (data-gap conclusion)", "finding": "Missing reported-use data for three food categories and unaccounted non-additive dietary sources mean the refined polysorbate exposure estimate understates true intake." } ] }, { "e_number": "E434", "name": "Polysorbate 40", "off_tag": "en:e434", "category": "emulsifier", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e434", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4152", "finding": "Re-evaluation of polysorbates E 432 (polyoxyethylene sorbitan monolaurate) through E 436: group ADI 25 mg/kg bw per day retained; in the refined non-brand-loyal scenario exposure did not exceed the ADI for any age group, but 'the estimated exposure of toddlers at the highest level in a non-brand loyal scenario remains very close to the ADI (24.5 mg/kg bw/day)'." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4152 (data-gap conclusion)", "finding": "The Panel noted no reported uses were obtained for three food categories and that other dietary sources of polysorbates could not be considered, so more data are needed to reduce uncertainty in the refined exposure assessment." }, { "source": "peer_reviewed", "ref": "PMID 25731162 - Chassaing B et al., Nature 2015;519:92-96", "finding": "Polysorbate-80, the group congener tested, induced low-grade inflammation, metabolic syndrome and colitis in mice at low dietary concentrations, with mucus thinning and bacterial encroachment." }, { "source": "FDA", "ref": "21 CFR Part 172 Subpart I enumerated (polysorbate 60 §172.836, polysorbate 65 §172.838, polysorbate 80 §172.840); FDA Inventory of Food Contact Substances (21 CFR 175.105, 178.3400)", "finding": "No direct US food authorisation located for polysorbate 40 (CAS 9005-66-7); it is absent from the Substances Added to Food inventory and appears only as an indirect/food-contact substance." } ] }, { "e_number": "E435", "name": "Polysorbate 60", "off_tag": "en:e435", "category": "emulsifier", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e435", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4152", "finding": "Re-evaluation of polysorbates E 432-E 436: group ADI of 25 mg/kg bw per day (from JECFA) retained; in the refined non-brand-loyal scenario exposure did not exceed the ADI for any age group at mean or high level, but 'the estimated exposure of toddlers at the highest level in a non-brand loyal scenario remains very close to the ADI (24.5 mg/kg bw/day)'." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4152 (data-gap conclusion)", "finding": "Panel noted no reported uses were obtained for three food categories and that other dietary sources of polysorbate exposure could not be considered, so more data are needed to reduce uncertainty in the refined exposure assessment." }, { "source": "peer_reviewed", "ref": "PMID 25731162 - Chassaing B et al., Nature 2015;519:92-96", "finding": "Polysorbate-80 (same E 432-E 436 group) and CMC at low concentrations induced low-grade inflammation, obesity/metabolic syndrome in wild-type mice and robust colitis in colitis-prone mice, with reduced mucus thickness and increased bacterial encroachment." } ] }, { "e_number": "E436", "name": "Polysorbate 65", "off_tag": "en:e436", "category": "emulsifier", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e436", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4152", "finding": "Re-evaluation of polysorbates E 432–E 436 (E 436 = polyoxyethylene sorbitan tristearate): group ADI of 25 mg/kg bw per day from JECFA retained; refined non-brand-loyal exposure did not exceed the ADI for any age group at mean or high level, but 'the estimated exposure of toddlers at the highest level in a non-brand loyal scenario remains very close to the ADI (24.5 mg/kg bw/day)'." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2015.4152 (data-gap conclusion)", "finding": "No reported uses were obtained for three food categories and other dietary sources of polysorbate exposure could not be considered; more data are needed to reduce uncertainty in the refined exposure assessment." }, { "source": "peer_reviewed", "ref": "PMID 25731162 - Chassaing B et al., Nature 2015;519:92-96", "finding": "Polysorbate-80 (same E 432–E 436 group) and CMC at low concentrations induced low-grade inflammation and metabolic syndrome in wild-type mice and robust colitis in colitis-prone mice, with reduced mucus thickness and increased bacterial encroachment." }, { "source": "FDA", "ref": "21 CFR §172.838 (polysorbate 65)", "finding": "Permitted as an emulsifier in ice cream, frozen custard, ice milk, fruit sherbet and non-standardised frozen desserts (≤0.1% alone or with polysorbate 80); cakes and cake mixes; whipped edible oil topping; edible vegetable fat-water emulsions used as milk/cream substitutes in beverage coffee; and cake icings and fillings." } ] }, { "e_number": "E440", "name": "Pectins", "off_tag": "en:e440", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e440", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4866", "finding": "Re-evaluation of pectin (E 440i) and amidated pectin (E 440ii): no safety concern for the general population; no need for a numerical ADI (SCF had allocated ADI 'not specified')." }, { "source": "EFSA", "ref": "PMC7845505 (opinion on E 440i/ii in foods for infants below 16 weeks of age)", "finding": "Infant-specific follow-up opinion; does not alter the general-population conclusion." } ] }, { "e_number": "E442", "name": "Ammonium phosphatides", "off_tag": "en:e442", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e442", "citations": [ { "source": "EFSA", "ref": "EFSA Journal, Re-evaluation of ammonium phosphatides (E 442) as a food additive (2016), efsa.europa.eu/en/efsajournal/pub/4597", "finding": "No reason to revise the existing ADI of 30 mg/kg bw per day; low acute oral toxicity and no adverse effects in a 90-day rat study; no concern for genotoxicity; 'the ADI is not exceeded in any population group', so use at permitted/reported levels is not of safety concern." } ] }, { "e_number": "E443", "name": "Brominated vegetable oil (BVO)", "off_tag": "en:e443", "category": "emulsifier", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e443", "citations": [ { "source": "FDA", "ref": "89 FR 55040, 'Revocation of Authorization for Use of Brominated Vegetable Oil in Food', FR doc 2024-14300 (published 3 July 2024)", "finding": "FDA revoked the food additive regulation authorising BVO to stabilise flavouring oils in fruit-flavoured beverages; effective 2 August 2024, compliance date one year later. FDA concluded the intended use of BVO in food 'is no longer considered safe' after FDA/NIH studies found the potential for adverse health effects in humans." }, { "source": "FDA", "ref": "FDA constituent update, 'FDA Revokes Regulation Allowing the Use of Brominated Vegetable Oil (BVO) in Food'", "finding": "Agency announcement confirming the revocation, its rationale and the reformulation window given to industry." }, { "source": "state_law", "ref": "California AB 418 (California Food Safety Act, 2023), adding Chapter 17 (commencing with §109025) to Part 3, Division 104, Health & Safety Code", "finding": "Prohibits manufacture, sale, delivery, distribution or holding for sale of food containing brominated vegetable oil (with Red 3, potassium bromate and propylparaben) in California from 1 January 2027; civil penalties up to $5,000 first violation / $10,000 subsequent." } ] }, { "e_number": "E444", "name": "Sucrose acetate isobutyrate", "off_tag": "en:e444", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e444", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2016.4489", "finding": "Re-evaluation of sucrose acetate isobutyrate (E 444): ADI revised from 10 to 20 mg/kg bw per day (UF 100); in both exposure scenarios the estimates were below the ADI." } ] }, { "e_number": "E445", "name": "Glycerol esters of wood rosin", "off_tag": "en:e445", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e445", "citations": [ { "source": "EFSA", "ref": "PMC10355140 - Follow-up of the re-evaluation of glycerol esters of wood rosins (E 445)", "finding": "ADI of 10 mg/kg bw per day established (NOAEL 976 mg/kg bw per day, UF 100); toddler exposure 1.07 mg/kg bw per day mean and 4.06 at P95, children 0.09-1.01 mean and 0.46-3.24 at P95; 'no safety concern for the use of GEWR (E 445), at either the maximum permitted levels or at the reported uses and use levels'." } ] }, { "e_number": "E450", "name": "Diphosphates", "off_tag": "en:e450", "category": "acidity", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e450", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2019;17(6):5674 — doi:10.2903/j.efsa.2019.5674, Re-evaluation of phosphoric acid–phosphates, di-, tri- and polyphosphates (E 338–341, E 343, E 450–452)", "finding": "Group ADI of 40 mg/kg bw per day expressed as phosphorus; dietary exposure may exceed the ADI for infants, toddlers and children at MEAN consumption, and for adolescents with high phosphate diets." }, { "source": "EFSA", "ref": "EFSA news release 190612 — 'EFSA issues new advice on phosphates', 12 June 2019", "finding": "ADI does not apply to people with moderate-to-severe reduced kidney function; EFSA recommends numerical maximum levels replace quantum satis in supplements for ages 3+." } ] }, { "e_number": "E451", "name": "Triphosphates", "off_tag": "en:e451", "category": "acidity", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e451", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2019;17(6):5674 — doi:10.2903/j.efsa.2019.5674", "finding": "Group ADI 40 mg P/kg bw/day; mean exposure may exceed the ADI in infants, toddlers and children." }, { "source": "EFSA", "ref": "EFSA news release 190612, 12 June 2019", "finding": "EFSA advises numerical maximum levels and flags reduced-kidney-function populations as outside the ADI." } ] }, { "e_number": "E452", "name": "Polyphosphates", "off_tag": "en:e452", "category": "acidity", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e452", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2019;17(6):5674 — doi:10.2903/j.efsa.2019.5674", "finding": "Group ADI 40 mg/kg bw/day as phosphorus; mean-consumption exposure may exceed the ADI for infants, toddlers and children." }, { "source": "EFSA", "ref": "EFSA news release 190612, 12 June 2019", "finding": "High (P95) exposure ranged from 331 mg P/day in infants to 2,728 mg P/day in adults; ADI excludes those with reduced kidney function." } ] }, { "e_number": "E460", "name": "Cellulose", "off_tag": "en:e460", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e460", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2018.5047 (PMC7009359)", "finding": "Re-evaluation of celluloses including microcrystalline cellulose E 460(i) and powdered cellulose E 460(ii): no need for a numerical ADI; no safety concern at reported uses; do not raise concern for genotoxicity." } ] }, { "e_number": "E461", "name": "Methyl cellulose", "off_tag": "en:e461", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e461", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2018.5047 (PMC7009359)", "finding": "Re-evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468, E 469: no need for a numerical ADI; no safety concern at reported uses and use levels; no concern for genotoxicity." } ] }, { "e_number": "E464", "name": "Hydroxypropyl methyl cellulose", "off_tag": "en:e464", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e464", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2018.5047 (PMC7009359)", "finding": "Re-evaluation of celluloses including hydroxypropyl methyl cellulose (E 464): no need for a numerical ADI; no safety concern at the reported uses and use levels for the general population; no concern for genotoxicity." } ] }, { "e_number": "E466", "name": "Sodium carboxymethyl cellulose (CMC)", "off_tag": "en:e466", "category": "thickener", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e466", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2018.5047 (PMC7009359)", "finding": "Re-evaluation of celluloses E 460(i)/(ii), E 461-E 466, E 468, E 469: no need for a numerical ADI, no safety concern at reported uses for the general population, no genotoxicity concern." }, { "source": "EFSA", "ref": "PMC9732683 (2022 opinion on E 466 in foods for infants below 16 weeks and follow-up)", "finding": "Available data still did not allow an adequate assessment of E 466 in foods for special medical purposes for infants and young children (FC 13.1.5.2); toddler exposure in that category up to 911 mg/kg bw per day at the mean; microbiota effects flagged as requiring further investigation over longer exposure periods." }, { "source": "peer_reviewed", "ref": "PMID 34774538 - Chassaing B et al., Gastroenterology 2022;162(3):743-756", "finding": "Double-blind randomised controlled-feeding trial (15 g/day CMC, 11 days, healthy adults): reduced gut microbiota diversity, reduced faecal short-chain fatty acids and free amino acids, increased postprandial abdominal discomfort, and microbiota encroachment into the normally sterile inner mucus layer in 2 of 7 CMC subjects." }, { "source": "peer_reviewed", "ref": "PMID 25731162 - Chassaing B et al., Nature 2015;519:92-96", "finding": "CMC and polysorbate-80 at relatively low concentrations induced low-grade intestinal inflammation and metabolic syndrome in wild-type mice and robust colitis in colitis-prone mice, with reduced mucus thickness and bacterial encroachment." } ] }, { "e_number": "E470a", "name": "Sodium, potassium and calcium salts of fatty acids", "off_tag": "en:e470a", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e470a", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2018.5180 (EFSA Journal 2018;16(3):5180, PMC7009523 — Re-evaluation of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) as food additives)", "finding": "'The Panel concluded that there was no need for a numerical ADI and that the food additives sodium, potassium, calcium and magnesium salts of fatty acids (E 470a and E 470b) were of no safety concern at the reported uses and use levels.' The salts are expected to dissociate in the gastrointestinal tract to fatty acid carboxylates and their corresponding cations; no concern for mutagenicity was found for the tested members. In 1991 the SCF had established a group ADI 'not specified' for the fatty acids (myristic, stearic, palmitic and oleic) and their salts." }, { "source": "FDA", "ref": "21 CFR 172.860 (Fatty acids) and 21 CFR 184.1090 (Stearic acid) — verified against the current eCFR structure", "finding": "The constituent fatty acids are permitted/affirmed GRAS in the US, and no US body treats the sodium, potassium or calcium salts as a concern." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex ELI: reg/2008/1333)", "finding": "E 470a authorised in the EU as a Group I additive at quantum satis." } ] }, { "e_number": "E470b", "name": "Magnesium salts of fatty acids", "off_tag": "en:e470b", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e470b", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2018.5180 (EFSA Journal 2018;16(3):5180, PMC7009523 — Re-evaluation of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) as food additives)", "finding": "'The Panel concluded that there was no need for a numerical ADI and that the food additives sodium, potassium, calcium and magnesium salts of fatty acids (E 470a and E 470b) were of no safety concern at the reported uses and use levels.' No concern for mutagenicity of magnesium stearate; the salts dissociate in the gut to fatty acid carboxylates and their corresponding cations." }, { "source": "FDA", "ref": "21 CFR 184.1440 (Magnesium stearate) — Part 184 \"Direct Food Substances Affirmed as Generally Recognized as Safe\"; verified against the current eCFR structure", "finding": "Magnesium stearate, the principal E 470b species, is affirmed GRAS as a direct human food substance in the US." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex ELI: reg/2008/1333)", "finding": "E 470b authorised in the EU as a Group I additive at quantum satis." } ] }, { "e_number": "E471", "name": "Mono- and diglycerides of fatty acids", "off_tag": "en:e471", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e471", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.5045 (PMC7010209)", "finding": "Re-evaluation of mono- and di-glycerides of fatty acids (E 471): no need for a numerical ADI; no safety concern at reported uses and use levels; no carcinogenic potential reported. Panel recommended a specification limit for trans fatty acids." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2021.6885 (PMC8573540)", "finding": "Follow-up opinion on E 471 in foods for infants below 16 weeks of age and follow-up for all population groups; no adverse general-population conclusion." } ] }, { "e_number": "E472", "name": "Esters of mono- and diglycerides of fatty acids (generic node)", "off_tag": "en:e472", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e472", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2020.6032 (EFSA Journal 2020;18(3):6032, PMC7448088 — Re-evaluation of acetic, lactic, citric, tartaric, mono- and diacetyltartaric and mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E 472a-f) as food additives)", "finding": "One opinion covers the whole family: 'there is no need for a numerical ADI for E 472a,b,c'; an ADI of 600 mg/kg bw per day (as tartaric acid) for E 472e and E 472f; 'considering the exposure estimates, there is no safety concern at their reported uses and use levels for E 472a-f'; and E 472a-f are not of concern with regard to genotoxicity." } ] }, { "e_number": "E472a", "name": "Acetic acid esters of mono- and diglycerides of fatty acids (ACETEM)", "off_tag": "en:e472a", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e472a", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2020.6032 (EFSA Journal 2020;18(3):6032, PMC7448088 — Re-evaluation of E 472a-f as food additives)", "finding": "'there is no need for a numerical ADI for E 472a,b,c'; 'considering the exposure estimates, there is no safety concern at their reported uses and use levels for E 472a-f'; E 472a-f are not of concern with regard to genotoxicity." }, { "source": "FDA", "ref": "21 CFR 172.828 (Acetylated monoglycerides) — Part 172 \"Food Additives Permitted for Direct Addition to Food for Human Consumption\"; verified against the current eCFR structure", "finding": "The corresponding US listing; acetylated monoglycerides are permitted for direct addition to food in the US." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex ELI: reg/2008/1333)", "finding": "E 472a authorised in the EU at quantum satis across the Group I categories." } ] }, { "e_number": "E472b", "name": "Lactic acid esters of mono- and diglycerides of fatty acids", "off_tag": "en:e472b", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e472b", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2020.6032 (PMC7448088)", "finding": "Re-evaluation of E 472a-f: 'there is no need for a numerical ADI for E 472a,b,c'; no safety concern at reported uses and use levels; E 472a-f not of concern with regard to genotoxicity." } ] }, { "e_number": "E472c", "name": "Citric acid esters of mono- and diglycerides of fatty acids (CITREM)", "off_tag": "en:e472c", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e472c", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2020.6032 (EFSA Journal 2020;18(3):6032, PMC7448088 — Re-evaluation of E 472a-f as food additives)", "finding": "'there is no need for a numerical ADI for E 472a,b,c'; 'considering the exposure estimates, there is no safety concern at their reported uses and use levels for E 472a-f'; E 472a-f are not of concern with regard to genotoxicity." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2025.9202 (EFSA Journal 2025;23(1):9202 — Re-evaluation of citric acid esters of mono- and diglycerides of fatty acids (E 472c) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation)", "finding": "'Regarding the safety of the use of E 472c in food for infants below 16 weeks of age, the Panel concluded that there is no safety concern from its use at the reported use levels and at the maximum permitted levels in food for infants below 16 weeks of age (FCs 13.1.1 and 13.1.5.1).' The Panel also concluded that the technical data provided support an amendment of the EU specifications for E 472c." }, { "source": "FDA", "ref": "21 CFR 172.832 (Monoglyceride citrate) — Part 172 \"Food Additives Permitted for Direct Addition to Food for Human Consumption\"; verified against the current eCFR structure", "finding": "The corresponding US listing for the citric acid ester of monoglycerides; permitted for direct addition to food in the US." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex ELI: reg/2008/1333)", "finding": "E 472c authorised in the EU at quantum satis across the Group I categories." } ] }, { "e_number": "E472e", "name": "DATEM (mono- and diacetyltartaric acid esters of mono- and diglycerides of fatty acids)", "off_tag": "en:e472e", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e472e", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2020.6032 (PMC7448088)", "finding": "Re-evaluation of E 472a-f: ADI of 600 mg/kg bw per day (as tartaric acid) for E 472e and E 472f; 'considering the exposure estimates, there is no safety concern at their reported uses and use levels for E 472a-f'; E 472a-f are not of concern with regard to genotoxicity." } ] }, { "e_number": "E473", "name": "Sucrose esters of fatty acids", "off_tag": "en:e473", "category": "emulsifier", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e473", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2018.5087 (EFSA Journal 2018;16(1):5087 — Refined exposure assessment of sucrose esters of fatty acids (E 473) from its use as a food additive)", "finding": "'The Panel noted that the current exposure estimates to sucrose esters of fatty acids (E 473) exceeded the ADI of 40 mg/kg bw per day for many population groups; especially toddlers and children.' Brand-loyal refined estimates reached 54 mg/kg bw/day at the mean and 124 mg/kg bw/day at the 95th percentile in toddlers (12-35 months); the non-brand-loyal toddler mean was 42.7 mg/kg bw/day, i.e. above the ADI in the less conservative scenario as well. 'The main contributing food categories according to the refined estimated exposure scenario, in both the brand-loyal and non-brand-loyal scenarios were fine bakery wares for all population groups and also flavoured drinks, only dairy-based and almond drinks, for children and adolescents.'" }, { "source": "EFSA", "ref": "10.2903/j.efsa.2023.7961 (EFSA Journal 2023;21(4):7961 — Re-evaluation of sucrose esters of fatty acids (E 473) as a food additive in foods for infants below 16 weeks of age and follow-up of its previous evaluations)", "finding": "The 2023 follow-up leaves the group ADI at 40 mg/kg bw/day and restates the exceedance: 'the estimates of exposure to sucrose esters of fatty acids (E 473) exceeded the group acceptable daily intake (ADI) of 40 mg/kg body weight (bw) per day for many population groups'. The Panel also concluded that the technical data provided support an amendment of the specifications for E 473." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2004.106 (EFSA Journal 2004;2(11):106 — Opinion of the AFC Panel on Sucrose esters of fatty acids E 473 and sucroglycerides E 474)", "finding": "The origin of the group ADI of 40 mg/kg bw per day that the later exposure assessments measure against; it is a GROUP ADI shared by E 473 and E 474, which is why the two cannot be scored differently on the exposure basis." }, { "source": "FDA", "ref": "21 CFR 172.859 (Sucrose fatty acid esters) — Part 172 \"Food Additives Permitted for Direct Addition to Food for Human Consumption\"; verified against the current eCFR text", "finding": "Sucrose fatty acid esters are permitted for direct addition to US food under prescribed conditions of use, so E 473 is live on the US shelf; the US listing carries no child-specific restriction and no US body has acted on the EFSA exceedance." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II, consolidated text 02008R1333 — EN — 09.11.2025 (incorporating Commission Regulation (EU) 2025/2058; EUR-Lex ELI: reg/2008/1333)", "finding": "E 473 remains authorised in the EU, listed jointly with E 474 as \"E 473-474: Sucrose esters of fatty acids, Sucroglycerides\" with numerical maximum levels by food category — the joint listing being further evidence that E 473 and E 474 must be classed together. Verified against the 09.11.2025 consolidation: the joint E 473-474 entry survives Commission Regulation (EU) 2025/2058 unchanged and E 474 is not delisted." } ] }, { "e_number": "E474", "name": "Sucroglycerides", "off_tag": "en:e474", "category": "emulsifier", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e474", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2004.106 (EFSA Journal 2004;2(11):106 — Opinion of the AFC Panel on Sucrose esters of fatty acids (E 473) and sucroglycerides (E 474))", "finding": "The origin of the GROUP ADI of 40 mg/kg bw per day shared by E 473 and E 474 — the single fact on which this row's class rests. Because the ADI is a group ADI, the two members cannot be scored differently on the exposure basis." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2018.5087 (EFSA Journal 2018;16(1):5087 — Refined exposure assessment of sucrose esters of fatty acids (E 473) from its use as a food additive)", "finding": "'The Panel noted that the current exposure estimates to sucrose esters of fatty acids (E 473) exceeded the ADI of 40 mg/kg bw per day for many population groups; especially toddlers and children.' Note the basis: the assessment measures E 473's uses, not E 474's. It is cited here because the ADI it measures against is the group ADI shared with E 474, not because sucroglycerides were measured." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2023.7961 (EFSA Journal 2023;21(4):7961 — Re-evaluation of sucrose esters of fatty acids (E 473) as a food additive in foods for infants below 16 weeks of age and follow-up of its previous evaluations)", "finding": "The FAF Panel MAINTAINED the group ADI at 40 mg/kg bw/day and restated the exceedance with updated use levels, and calls it 'the group acceptable daily intake (ADI) of sucrose esters of fatty acids (E 473) and sucroglycerides (E 474) established by the EFSA AFC Panel in 2004'. The same opinion records that E 474 was labelled on only 6 Mintel products between 2018 and 2023 — i.e. E 474's own market use is negligible, which is why this row's confidence is medium." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II, consolidated text 02008R1333 — EN — 09.11.2025 (incorporating Commission Regulation (EU) 2025/2058; EUR-Lex ELI: reg/2008/1333)", "finding": "E 474 remains authorised in the EU and is listed JOINTLY with E 473 as \"E 473-474: Sucrose esters of fatty acids, Sucroglycerides\" with combined numerical maximum levels by food category. Verified against the 09.11.2025 consolidation: Commission Regulation (EU) 2025/2058 (the only post-2023 Annex II action touching E 473-474) is housekeeping aligning categories with Reg 609/2013 — it does not delist E 474 and does not restrict the fine-bakery-wares category that drives the exceedance." } ] }, { "e_number": "E475", "name": "Polyglycerol esters of fatty acids", "off_tag": "en:e475", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e475", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.5089 (PMC7010213)", "finding": "Re-evaluation of polyglycerol esters of fatty acids (E 475): not of safety concern at reported uses and use levels, no need for a numerical ADI; highest exposure in children 2.6 (mean) and 6.4 (P95) mg/kg bw per day in the non-brand-loyal scenario versus the previous 25 mg/kg bw per day ADI." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2022.7308 (PMC9109700)", "finding": "Follow-up of the re-evaluation of E 475; conclusion maintained." } ] }, { "e_number": "E476", "name": "Polyglycerol polyricinoleate (PGPR)", "off_tag": "en:e476", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e476", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4743 (PMC7010163)", "finding": "Re-evaluation of polyglycerol polyricinoleate (E 476): ADI revised upward from 7.5 to 25 mg/kg bw per day (NOAEL 2,500 mg/kg bw per day); not of concern for genotoxicity or carcinogenicity; exposure estimates did not exceed the ADI." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2022.7294 (PMC9066526)", "finding": "Follow-up of the re-evaluation of PGPR (E 476); position maintained." } ] }, { "e_number": "E477", "name": "Propane-1,2-diol esters of fatty acids (propylene glycol esters)", "off_tag": "en:e477", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e477", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2018.5497 (EFSA Journal 2018;16(12):5497, PMC7009423 — Re-evaluation of propane-1,2-diol esters of fatty acids (E 477) as a food additive)", "finding": "'The Panel confirmed the previously established ADI for propane-1,2-diol esters of fatty acids (E 477) of 25 mg/kg bw per day expressed as propane 1,2 diol', corresponding to 80 mg/kg bw/day for E 477. 'The exposure estimates from the refined non-brand loyal scenario did not exceed the ADI of E 477 in any of the population groups.' The Panel considered that E 477 'did not raise a concern for genotoxicity', and that there would be no safety concern at the reported use levels." }, { "source": "FDA", "ref": "21 CFR 172.856 (Propylene glycol mono- and diesters of fats and fatty acids) — Part 172 \"Food Additives Permitted for Direct Addition to Food for Human Consumption\"; verified against the current eCFR structure", "finding": "The corresponding US listing; permitted for direct addition to food in the US." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex ELI: reg/2008/1333)", "finding": "E 477 authorised in the EU with numerical maximum levels by food category (e.g. 5 000 mg/kg in some categories, 1 000 mg/kg for beverage whiteners) rather than quantum satis." } ] }, { "e_number": "E481", "name": "Sodium stearoyl-2-lactylate", "off_tag": "en:e481", "category": "emulsifier", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e481", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2013.3144", "finding": "Re-evaluation of sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482): ADI of 22 mg/kg bw per day established for E 481/E 482 singly or in combination, from a 1-year rat NOAEL of 2,200 mg/kg bw per day with an uncertainty factor of 100." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2013.3144 (exposure conclusion)", "finding": "Verbatim: exposure 'is below the ADI of 22 mg/kg bw/day for all the adult population including the elderly, but exceeds the ADI for other groups of the population at mean level and for all groups of the population at high level' - i.e. children exceed at the mean, with combined SSL+CSL exposure of 28-81 mg/kg bw/day for children at the mean. Main sources: flavoured fermented milk products, bread and rolls, fine bakery wares." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2013.3125", "finding": "Companion EFSA statement on the exposure assessment of SSL/CSL (including the extension of authorisation), reporting high-level toddler and child intake estimates well above the 22 mg/kg bw per day ADI." } ] }, { "e_number": "E482", "name": "Calcium stearoyl-2-lactylate", "off_tag": "en:e482", "category": "emulsifier", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e482", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2013.3144", "finding": "Re-evaluation of sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482): ADI of 22 mg/kg bw per day established for E 481/E 482 singly or in combination, from a 1-year rat NOAEL of 2,200 mg/kg bw per day with an uncertainty factor of 100. One opinion, one ADI, both additives — the fact this row's class rests on." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2013.3144 (exposure conclusion)", "finding": "Verbatim: exposure 'is below the ADI of 22 mg/kg bw/day for all the adult population including the elderly, but exceeds the ADI for other groups of the population at mean level and for all groups of the population at high level' — i.e. children exceed at the mean. The figure behind it is a COMBINED SSL+CSL exposure of 28-81 mg/kg bw/day for children at the mean; it is not an E 482-only estimate. Main sources: flavoured fermented milk products, bread and rolls, fine bakery wares." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2013.3125", "finding": "Companion EFSA statement on the exposure assessment of SSL/CSL (including the extension of authorisation), reporting high-level toddler and child intake estimates well above the 22 mg/kg bw per day ADI." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II, consolidated text 02008R1333 — EN — 09.11.2025 (incorporating Commission Regulation (EU) 2025/2058; EUR-Lex ELI: reg/2008/1333)", "finding": "E 482 calcium stearoyl-2-lactylate is authorised in the EU under Annex II alongside E 481, with maximum levels by food category — the sibling authorisation that makes E 482 a direct substitute manufacturers can switch to for E 481, and the reason the two are classified consistently as a family." } ] }, { "e_number": "E491", "name": "Sorbitan monostearate", "off_tag": "en:e491", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e491", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4788 (PMC7010202)", "finding": "Re-evaluation of sorbitan esters E 491-E 495: group ADI of 10 mg/kg bw per day expressed as sorbitan; under the refined non-brand-loyal scenario 'the mean and the 95th percentile level did not exceed the ADI in any of the population groups'; no safety concern at reported use levels." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4788 (maximum-level scenario tables)", "finding": "Under the regulatory maximum-level scenario, toddler exposure was 26.1-88.9 mg/kg bw per day at the mean and 80.1-211.2 at P95, and children 21.4-78.4 mean / 54-183.4 P95 - above the group ADI, but EFSA judged this scenario not the relevant one." } ] }, { "e_number": "E492", "name": "Sorbitan tristearate", "off_tag": "en:e492", "category": "emulsifier", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e492", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4788 (PMC7010202)", "finding": "Re-evaluation of sorbitan esters E 491-E 495 (including sorbitan tristearate E 492): group ADI 10 mg/kg bw per day as sorbitan; refined non-brand-loyal exposure did not exceed the ADI at mean or P95 in any population group; no safety concern at reported levels and use patterns." } ] }, { "e_number": "E500", "name": "Sodium carbonates", "off_tag": "en:e500", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e500", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory — sodium carbonate / sodium bicarbonate (hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=FoodSubstances)", "finding": "Listed as GRAS direct food substances (multipurpose, no limitation other than cGMP)." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II, EUR-Lex ELI: reg/2008/1333", "finding": "E 500 authorised in the EU as a Group I additive at quantum satis." } ] }, { "e_number": "E501", "name": "Potassium carbonates", "off_tag": "en:e501", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e501", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory — potassium carbonate / potassium bicarbonate", "finding": "GRAS direct food substances (alkali, leavening)." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 501 authorised in the EU as a Group I additive at quantum satis." } ] }, { "e_number": "E502", "name": "Carbonates (generic node)", "off_tag": "en:e502", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "low", "permalink": "https://sito.kids/additives#e502", "citations": [ { "source": "OFF", "ref": "Open Food Facts additives taxonomy node en:e502 (1,878 products world / 185 US)", "finding": "Node exists in the OFF additives taxonomy without a corresponding entry in the EU Union list of food additives; behaves as a generic parent for the carbonate family." } ] }, { "e_number": "E503", "name": "Ammonium carbonates", "off_tag": "en:e503", "category": "acidity", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e503", "citations": [ { "source": "state_law", "ref": "Commission Regulation (EU) 2017/2158 Annex I Part III (acrylamide mitigation measures, fine bakery wares), EUR-Lex CELEX:32017R2158", "finding": "Binding mitigation measure: 'FBOs shall consider reducing or replacing fully or partially ammonium bicarbonate with alternative raising agents such as (a) sodium bicarbonate and acidulants, or (b) sodium bicarbonate and disodium diphosphates with organic acids or potassium variants thereof.'" }, { "source": "peer_reviewed", "ref": "Foods 2022;11(15):2343 — doi:10.3390/foods11152343, Mitigation of acrylamide content in biscuits through combined physical and chemical strategies", "finding": "Partial replacement of ammonium bicarbonate with sodium bicarbonate plus baking-profile changes cut acrylamide in biscuits by 87.2% versus reference." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — ammonium bicarbonate / ammonium carbonate", "finding": "GRAS direct food substances (leavening agents); no US restriction." } ] }, { "e_number": "E508", "name": "Potassium chloride", "off_tag": "en:e508", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e508", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2019.5751 (EFSA Journal 2019;17(7):5751 — Re-evaluation of hydrochloric acid (E 507), potassium chloride (E 508), calcium chloride (E 509) and magnesium chloride (E 511) as food additives)", "finding": "'The Panel identified a human dose of 40 mg chloride/kg bw per day as a reference value for the assessment. Mean levels of exposure in all age groups were below or at this reference value, which indicates no safety concern. In some age groups (toddlers, children and adolescents), the 95th percentile exposure estimates were slightly above this reference value. The Panel concluded that the exposure to chloride from hydrochloric acid and its potassium, calcium and magnesium salts (E 507, E 508, E 509 and E 511) does not raise a safety concern at the reported use and use levels.' In the non-brand-loyal scenario mean exposure ranged from 2 mg/kg bw/day in the elderly to 42 mg/kg bw/day in toddlers; the 95th percentile from 5 to 71 mg/kg bw/day in toddlers." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2019.5751 (EFSA Journal 2019;17(7):5751)", "finding": "Same opinion: 'Chloride is an essential nutrient and after absorption is distributed to organs and tissues'; the Panel considered chlorides to be of low acute oral toxicity and found no concern with respect to genotoxicity and carcinogenicity. The pre-existing ADI was 'not specified' (SCF 1991; JECFA 1965)." }, { "source": "FDA", "ref": "21 CFR 184.1622 (Potassium chloride) — Part 184 \"Direct Food Substances Affirmed as Generally Recognized as Safe\"; verified against the current eCFR text", "finding": "Potassium chloride is affirmed GRAS as a direct human food substance with no limitation other than current good manufacturing practice, and 'may be used in infant formula' in accordance with the Act — the strongest US signal available that this is not a child-risk additive." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex ELI: reg/2008/1333)", "finding": "E 508 potassium chloride authorised in the EU at quantum satis." } ] }, { "e_number": "E509", "name": "Calcium chloride", "off_tag": "en:e509", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e509", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory — calcium chloride", "finding": "GRAS direct food substance (firming agent, nutrient supplement, pH control)." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 509 authorised as a Group I additive at quantum satis in the EU." } ] }, { "e_number": "E510", "name": "Ammonium chloride", "off_tag": "en:e510", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e510", "citations": [ { "source": "state_law", "ref": "Regulation (EC) No 1333/2008, Article 3(2)(a)(vii), consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex ELI: reg/2008/1333)", "finding": "Article 3's definition of 'food additive' is followed by an exclusion list: 'The following are not considered to be food additives: ... (vii) ammonium chloride'. A search of the full consolidated text returns no E 510 entry in Annex II or Annex III, consistent with that exclusion." }, { "source": "FDA", "ref": "21 CFR 184.1138 (Ammonium chloride) — Part 184 \"Direct Food Substances Affirmed as Generally Recognized as Safe\"; verified against the current eCFR structure", "finding": "Ammonium chloride is affirmed GRAS as a direct human food substance in the US, so products bearing it are legitimately on the US shelf." } ] }, { "e_number": "E514", "name": "Sodium sulphates", "off_tag": "en:e514", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e514", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2019;17(8):5868 — doi:10.2903/j.efsa.2019.5868, Re-evaluation of sulphuric acid and its sodium, potassium, calcium and ammonium salts (E 513–517)", "finding": "No need for a numerical ADI; no safety concern at reported uses and use levels; toddler exposure (mean 35, P95 68 mg sulphate/kg bw/day) far below the ~300 mg/kg laxative threshold." } ] }, { "e_number": "E516", "name": "Calcium sulphate", "off_tag": "en:e516", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e516", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2019;17(8):5868 — doi:10.2903/j.efsa.2019.5868, Re-evaluation of sulphuric acid and its sodium, potassium, calcium and ammonium salts (E 513–517)", "finding": "No need for a numerical ADI; no safety concern at reported uses; toddler mean 35 and P95 68 mg sulphate/kg bw/day, far below the 300 mg/kg dose associated with laxation." } ] }, { "e_number": "E517", "name": "Ammonium sulphate", "off_tag": "en:e517", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e517", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2019;17(8):5868 — doi:10.2903/j.efsa.2019.5868, Re-evaluation of sulphuric acid and its salts (E 513–517)", "finding": "No need for a numerical ADI; exposure does not raise a safety concern at reported uses; low acute toxicity, no genotoxicity or carcinogenicity concern." } ] }, { "e_number": "E520", "name": "Aluminium sulphate", "off_tag": "en:e520", "category": "acidity", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e520", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2018;16(7):5372 — doi:10.2903/j.efsa.2018.5372", "finding": "Aluminium sulphates E 520–523 of no safety concern at current EU authorised uses, which are niche; no genotoxicity or carcinogenicity concern; toddler/child P95 aluminium estimates up to 0.88 mg/kg bw/day judged highly uncertain." }, { "source": "state_law", "ref": "Commission Regulation (EU) No 380/2012, EUR-Lex CELEX:32012R0380", "finding": "Restricted aluminium-containing additives for consumer protection on the basis that EFSA's 1 mg Al/kg bw/week TWI 'is generally exceeded for high consumers, especially children'." }, { "source": "EFSA", "ref": "EFSA Journal 2008;6(7):754 — Safety of aluminium from dietary intake", "finding": "TWI 1 mg Al/kg bw/week; exceeded by a significant part of the EU population, children in particular." } ] }, { "e_number": "E521", "name": "Aluminium sodium sulphate", "off_tag": "en:e521", "category": "acidity", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e521", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2018;16(7):5372 — doi:10.2903/j.efsa.2018.5372, Re-evaluation of aluminium sulphates (E 520–523) and sodium aluminium phosphate (E 541)", "finding": "No safety concern at current EU authorised uses (near-zero exposure); no genotoxicity/carcinogenicity concern; P95 aluminium exposure up to 0.88 mg/kg bw/day in toddlers and children flagged as highly uncertain." }, { "source": "state_law", "ref": "Commission Regulation (EU) No 380/2012, EUR-Lex CELEX:32012R0380", "finding": "Aluminium additive levels cut across the board for consumer protection; recitals rely on EFSA's TWI of 1 mg Al/kg bw/week being 'generally exceeded for high consumers, especially children'." }, { "source": "EFSA", "ref": "EFSA Journal 2008;6(7):754 — Safety of aluminium from dietary intake (AFC Panel, 22 May 2008)", "finding": "TWI of 1 mg aluminium/kg bw per week established; dietary exposure exceeds it for a significant part of the European population, with children the group of concern." } ] }, { "e_number": "E522", "name": "Aluminium potassium sulphate", "off_tag": "en:e522", "category": "acidity", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e522", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2018;16(7):5372 — doi:10.2903/j.efsa.2018.5372, Re-evaluation of aluminium sulphates (E 520–523) and sodium aluminium phosphate (E 541)", "finding": "Aluminium sulphates E 520–523 of no safety concern at current EU authorised uses, which are niche; no genotoxicity or carcinogenicity concern; toddler/child P95 aluminium estimates up to 0.88 mg/kg bw/day judged highly uncertain." }, { "source": "state_law", "ref": "Commission Regulation (EU) No 380/2012, EUR-Lex CELEX:32012R0380", "finding": "Restricted aluminium-containing additives for consumer protection on the basis that EFSA's 1 mg Al/kg bw/week TWI 'is generally exceeded for high consumers, especially children'." }, { "source": "EFSA", "ref": "EFSA Journal 2008;6(7):754 — Safety of aluminium from dietary intake", "finding": "TWI 1 mg Al/kg bw/week; exceeded by a significant part of the EU population, children in particular." }, { "source": "FDA", "ref": "21 CFR §182.1129 (aluminum potassium sulfate, GRAS)", "finding": "'This substance is generally recognized as safe when used in accordance with good manufacturing practice.' CAS 7784-24-9; FDA technical effects firming agent, fumigant, pH control agent." } ] }, { "e_number": "E523", "name": "Aluminium ammonium sulphate", "off_tag": "en:e523", "category": "acidity", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e523", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2018;16(7):5372 — doi:10.2903/j.efsa.2018.5372, Re-evaluation of aluminium sulphates (E 520–523) and sodium aluminium phosphate (E 541)", "finding": "Aluminium sulphates E 520–523 of no safety concern at current EU authorised uses (niche exposure); no genotoxicity or carcinogenicity concern; P95 aluminium exposure up to 0.88 mg/kg bw/day in toddlers and children flagged as highly uncertain." }, { "source": "state_law", "ref": "Commission Regulation (EU) No 380/2012, EUR-Lex CELEX:32012R0380", "finding": "Aluminium additive levels cut across the board for consumer protection; the recitals rely on EFSA's TWI of 1 mg Al/kg bw/week being 'generally exceeded for high consumers, especially children'." }, { "source": "EFSA", "ref": "EFSA Journal 2008;6(7):754 — Safety of aluminium from dietary intake", "finding": "TWI of 1 mg aluminium/kg bw per week; dietary exposure exceeds it for a significant part of the European population, with children the group of concern." }, { "source": "FDA", "ref": "21 CFR §182.1127 (aluminum ammonium sulfate, GRAS)", "finding": "'This substance is generally recognized as safe when used in accordance with good manufacturing practice.' CAS 7784-26-1; FDA technical effects leavening agent, pH control agent, processing aid, surface-finishing agent." } ] }, { "e_number": "E524", "name": "Sodium hydroxide", "off_tag": "en:e524", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e524", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory — sodium hydroxide", "finding": "GRAS direct food substance (pH control agent, processing aid)." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 524 authorised as an acidity regulator in the EU." } ] }, { "e_number": "E535", "name": "Sodium ferrocyanide", "off_tag": "en:e535", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e535", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2018;16(7):5374 — doi:10.2903/j.efsa.2018.5374, Re-evaluation of sodium ferrocyanide (E 535), potassium ferrocyanide (E 536) and calcium ferrocyanide (E 538)", "finding": "Group ADI of 0.03 mg/kg bw/day as ferrocyanide ion; maximum-permitted-level exposure up to 0.009 and refined exposure ~0.003 mg/kg bw/day in children and adolescents; 'of no safety concern in these current authorised use and use levels'." } ] }, { "e_number": "E536", "name": "Potassium ferrocyanide", "off_tag": "en:e536", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e536", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2018;16(7):5374 — doi:10.2903/j.efsa.2018.5374", "finding": "Group ADI 0.03 mg ferrocyanide ion/kg bw/day; refined exposure ~0.003 mg/kg bw/day in children and adolescents; no safety concern at authorised uses (salt and salt substitutes only)." } ] }, { "e_number": "E538", "name": "Calcium ferrocyanide", "off_tag": "en:e538", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e538", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2018;16(7):5374 — doi:10.2903/j.efsa.2018.5374", "finding": "Group ADI 0.03 mg ferrocyanide ion/kg bw/day for E 535–538; exposure in children up to 0.009 (MPL) and ~0.003 (refined) mg/kg bw/day; no safety concern at authorised uses." } ] }, { "e_number": "E541", "name": "Sodium aluminium phosphate", "off_tag": "en:e541", "category": "acidity", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e541", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2018;16(7):5372 — doi:10.2903/j.efsa.2018.5372, Re-evaluation of aluminium sulphates (E 520–523) and sodium aluminium phosphate (E 541)", "finding": "No safety concern at current EU authorised uses (near-zero exposure); P95 aluminium exposure up to 0.88 mg/kg bw/day in toddlers and children was judged highly uncertain because the niche products are not captured in EU consumption surveys." }, { "source": "state_law", "ref": "Commission Regulation (EU) No 380/2012 (conditions of use for aluminium-containing food additives), EUR-Lex CELEX:32012R0380", "finding": "Restricted all aluminium additives for consumer protection and de-authorised E 556/E 558/E 559; recitals rest on EFSA's 1 mg/kg bw/week TWI being 'generally exceeded for high consumers, especially children'. E 541 as a raising agent survives only for one sponge-cake type at 0.4 g/kg." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — sodium aluminum phosphate", "finding": "Permitted in the US as a leavening acid and processed-cheese emulsifier with no aluminium-specific intake limit." } ] }, { "e_number": "E551", "name": "Silicon dioxide", "off_tag": "en:e551", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e551", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2024;22(10):8880 — doi:10.2903/j.efsa.2024.8880, Re-evaluation of silicon dioxide (E 551) for infants below 16 weeks and follow-up for all population groups", "finding": "'E 551 does not raise a safety concern in any population group, including infants under 16 weeks'; no ADI derived (MOE approach used) in the absence of a genotoxicity concern; EFSA recommends tighter specification limits for lead, mercury, arsenic and a new limit for aluminium." }, { "source": "EFSA", "ref": "EFSA Journal 2018;16(1):5088 — doi:10.2903/j.efsa.2018.5088, Re-evaluation of silicon dioxide (E 551)", "finding": "No concern for genotoxicity, including studies with nano-sized silicon dioxide; SCF group 'ADI not specified' noted." } ] }, { "e_number": "E552", "name": "Calcium silicate", "off_tag": "en:e552", "category": "other", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e552", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2018;16(8):5375 — doi:10.2903/j.efsa.2018.5375, Re-evaluation of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b)", "finding": "'The safety of calcium silicate (E 552), magnesium silicate, magnesium trisilicate and talc when used as food additives cannot be assessed'; the 1991 group ADI is obsolete; reliable subchronic, chronic, carcinogenicity and reproductive data are lacking; silicon accumulation in kidney and liver reported in rats; no genotoxicity or developmental-toxicity indication." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — calcium silicate", "finding": "Permitted US anticaking agent; no US restriction and no FDA re-review flagged." } ] }, { "e_number": "E553", "name": "Magnesium silicates / talc (family node, carries E553b)", "off_tag": "en:e553", "category": "other", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e553", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2018;16(8):5375 — doi:10.2903/j.efsa.2018.5375", "finding": "The safety of magnesium silicate (E 553a) and talc (E 553b) as food additives cannot be assessed; the 1991 group ADI is obsolete; no oral chronic-toxicity or carcinogenicity data for talc are available; the available data did not raise a concern with respect to genotoxicity of talc used as a food additive; specifications require asbestos-free material. The same data-gap finding shape that carries E 552 and E 141 at this class." }, { "source": "IARC", "ref": "IARC Monographs Volume 136 (meeting 11–18 June 2024; results announced 5 July 2024) — Talc and Acrylonitrile; Stayner et al., Lancet Oncol 2024, 10.1016/S1470-2045(24)00384-X", "finding": "Talc reclassified from Group 2B to Group 2A, probably carcinogenic to humans. The evidence streams: limited human evidence for ovarian cancer, from perineal body-powder use and occupational (pulp and paper) cohorts; sufficient evidence in experimental animals, from a rat inhalation study; strong mechanistic evidence. No dietary evidence stream was part of the evaluation, so the finding does not establish a dietary exposure route. Applies to talc not containing asbestos." }, { "source": "EFSA", "ref": "EFSA call for data on talc (E 553b), EFSA-Q-2021-00560 — efsa.europa.eu/en/call/call-data-talc-e-553b (data submission deadline 2027-07-31); amended European Commission mandate of July 2026", "finding": "EFSA's follow-up risk assessment of talc is ongoing, with a talc-first opinion mandated. The mandate states that oral-route carcinogenicity would need to be addressed if absorption of talc particles cannot be excluded — the EU treats dietary carcinogenicity as an open question, not a finding — and the food authorisation remains in force while the assessment runs." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — talc; magnesium silicate; FDA expert panel on talc, 2025-05-20 (fda.gov/patients/fda-expert-panels/fda-expert-panel-talc-05202025)", "finding": "Both remain permitted US anticaking agents. FDA's May 2025 expert panel unanimously recommended removing talc from food and drugs, but no rulemaking has followed as of August 2026, so the US regulatory status is unchanged." } ] }, { "e_number": "E554", "name": "Sodium aluminium silicate", "off_tag": "en:e554", "category": "other", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e554", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2020;18(6):6152 — doi:10.2903/j.efsa.2020.6152, Re-evaluation of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555)", "finding": "Aluminium exposure from E 554 up to 1.58 mg/kg bw per week (mean) and 2.13 (P95) in children, exceeding the TWI at both mean and high intake; the safety of E 554 could not be assessed due to insufficient toxicological data and physicochemical characterisation." }, { "source": "EFSA", "ref": "EFSA Journal 2008;6(7):754 — Safety of aluminium from dietary intake", "finding": "TWI of 1 mg aluminium/kg bw per week; dietary exposure exceeds the TWI in a significant part of the European population, children in particular." }, { "source": "state_law", "ref": "Commission Regulation (EU) No 380/2012, EUR-Lex CELEX:32012R0380", "finding": "Cut permitted levels for aluminium additives including E 554 for consumer protection, citing exceedance of the TWI by high consumers, especially children." } ] }, { "e_number": "E555", "name": "Potassium aluminium silicate", "off_tag": "en:e555", "category": "other", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e555", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2020;18(6):6152 — doi:10.2903/j.efsa.2020.6152, Re-evaluation of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) as food additives", "finding": "'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.' For E 555 specifically the Panel considered it 'is not being used as a carrier, but as an inseparable component of potassium aluminium silicate-based pearlescent pigments', and calculated a theoretical regulatory maximum exposure as carrier for E 171 and E 172 that 'could theoretically far exceed the TWI' — no age-group-specific exposure estimate was produced for E 555." }, { "source": "EFSA", "ref": "EFSA Journal 2008;6(7):754 — Safety of aluminium from dietary intake", "finding": "TWI of 1 mg aluminium/kg bw per week; dietary exposure exceeds the TWI in a significant part of the European population, children in particular." }, { "source": "state_law", "ref": "Commission Regulation (EU) No 380/2012, EUR-Lex CELEX:32012R0380", "finding": "Cut permitted levels for aluminium-containing additives for consumer protection, citing EFSA's finding that the aluminium TWI 'is generally exceeded for high consumers, especially children'." }, { "source": "FDA", "ref": "21 CFR Part 182 Subpart C enumerated in full (six anticaking sections, none of them potassium aluminum silicate); 21 CFR §73.350 (mica-based pearlescent pigments), incorporating the identity spec at §73.1496(a)(1)", "finding": "No US anticaking authorisation located for potassium aluminum silicate. It appears in US food law only as the mica substrate of a titanium-dioxide-coated pearlescent colour additive permitted under §73.350 at ≤1.25% in cereals, confections and frostings, gelatin desserts, candies, supplement tablets and chewing gum." } ] }, { "e_number": "E570", "name": "Fatty acids", "off_tag": "en:e570", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e570", "citations": [ { "source": "EFSA", "ref": "EFSA re-evaluation of fatty acids (E 570) and of sodium/potassium/calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) — EFSA Journal 2018;16(3):5180, doi:10.2903/j.efsa.2018.5180", "finding": "No safety concern at the reported uses and use levels." } ] }, { "e_number": "E572", "name": "Magnesium stearate", "off_tag": "en:e572", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e572", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2018;16(3):5180 — doi:10.2903/j.efsa.2018.5180, Re-evaluation of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b)", "finding": "Magnesium salts of fatty acids are of no safety concern at reported uses and use levels." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — magnesium stearate", "finding": "GRAS direct food substance (anticaking agent, lubricant, release agent)." } ] }, { "e_number": "E575", "name": "Glucono-delta-lactone", "off_tag": "en:e575", "category": "acidity", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e575", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory — glucono delta-lactone", "finding": "GRAS direct food substance (curing/pickling agent, leavening agent, pH control)." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 575 authorised as a Group I additive at quantum satis in the EU." } ] }, { "e_number": "E579", "name": "Iron gluconate", "off_tag": "en:e579", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e579", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory — ferrous gluconate", "finding": "Listed for US food use as a colour additive for ripe olives and as a nutrient/dietary supplement iron source." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 579 authorised in the EU as a colour stabiliser for olives darkened by oxidation." } ] }, { "e_number": "E620", "name": "Glutamic acid", "off_tag": "en:e620", "category": "flavour_enhancer", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e620", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2017;15(7):4910, doi:10.2903/j.efsa.2017.4910 (PMC7009848)", "finding": "Group ADI of 30 mg/kg bw/day expressed as glutamic acid for E 620–625 — i.e. E 620 is the substance the group ADI is expressed in terms of — derived from a NOAEL of 3,200 mg MSG/kg bw/day in a neurodevelopmental toxicity study with a default 100-fold uncertainty factor." }, { "source": "EFSA", "ref": "EFSA Journal 2017;15(7):4910, exposure assessment section (PMC7009848)", "finding": "In the refined non-brand-loyal scenario the MEAN exposure in toddlers and children exceeded the group ADI and the dose associated with the MSG symptom complex (>42.9 mg/kg bw/day); at the 95th percentile, exposure in infants, toddlers and children exceeded doses associated with adverse effects in humans." }, { "source": "FDA", "ref": "21 CFR §182.1045 (glutamic acid, GRAS); cross-cited at 21 CFR §172.320 (amino acids)", "finding": "'This substance is generally recognized as safe when used as a salt substitute in accordance with good manufacturing practice.' Separately permitted under §172.320 as a nutrient to improve protein quality. US regulatory status is clean — the child concern is the EU exposure assessment, not a US restriction." } ] }, { "e_number": "E621", "name": "Monosodium glutamate", "off_tag": "en:e621", "category": "flavour_enhancer", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e621", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2017;15(7):4910, doi:10.2903/j.efsa.2017.4910 (PMC7009848)", "finding": "Group ADI of 30 mg/kg bw/day expressed as glutamic acid for E 620-625, derived from a NOAEL of 3,200 mg MSG/kg bw/day in a neurodevelopmental toxicity study with a default 100-fold uncertainty factor — the first numerical ADI ever set for glutamates." }, { "source": "EFSA", "ref": "EFSA Journal 2017;15(7):4910, exposure assessment section (PMC7009848)", "finding": "In the refined non-brand-loyal scenario the MEAN exposure in toddlers and children exceeded the dose associated with the MSG symptom complex (>42.9 mg/kg bw/day), i.e. well above the 30 mg/kg bw/day ADI; at the 95th percentile, exposure in infants, toddlers and children exceeded doses associated with adverse effects in humans (MSG symptom complex 42.9, headache 85.8, blood-pressure increase 150 mg/kg bw/day)." }, { "source": "FDA", "ref": "FDA, Questions and Answers on Monosodium glutamate (MSG), fda.gov/food/food-additives-petitions/questions-and-answers-monosodium-glutamate-msg", "finding": "FDA considers added MSG generally recognized as safe (GRAS) and requires it to be declared as 'monosodium glutamate' on the ingredient panel; US regulatory status is therefore clean — the child concern is EU exposure-based, not US-regulatory." } ] }, { "e_number": "E622", "name": "Monopotassium glutamate", "off_tag": "en:e622", "category": "flavour_enhancer", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e622", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2017;15(7):4910, doi:10.2903/j.efsa.2017.4910 (PMC7009848)", "finding": "Group ADI of 30 mg/kg bw/day expressed as glutamic acid covers E 620-625 including monopotassium glutamate, derived from a NOAEL of 3,200 mg MSG/kg bw/day with a 100-fold uncertainty factor." }, { "source": "EFSA", "ref": "EFSA Journal 2017;15(7):4910, exposure assessment (PMC7009848)", "finding": "Mean exposure in toddlers and children exceeded the group ADI (and the MSG symptom complex dose of 42.9 mg/kg bw/day); at P95, infants, toddlers and children exceeded doses associated with adverse effects in humans." } ] }, { "e_number": "E623", "name": "Calcium diglutamate", "off_tag": "en:e623", "category": "flavour_enhancer", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e623", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2017;15(7):4910, doi:10.2903/j.efsa.2017.4910 (PMC7009848)", "finding": "Group ADI of 30 mg/kg bw/day expressed as glutamic acid applies to E 620-625 including calcium diglutamate." }, { "source": "EFSA", "ref": "EFSA Journal 2017;15(7):4910, exposure assessment (PMC7009848)", "finding": "Mean glutamate exposure in toddlers and children exceeded the group ADI and the MSG symptom complex dose; P95 exposure in infants, toddlers and children exceeded doses associated with adverse effects in humans." } ] }, { "e_number": "E624", "name": "Monoammonium glutamate", "off_tag": "en:e624", "category": "flavour_enhancer", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e624", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2017;15(7):4910, doi:10.2903/j.efsa.2017.4910 (PMC7009848)", "finding": "Group ADI of 30 mg/kg bw/day expressed as glutamic acid applies jointly to E 620-625, including monoammonium glutamate." }, { "source": "EFSA", "ref": "EFSA Journal 2017;15(7):4910, exposure assessment (PMC7009848)", "finding": "Mean exposure to the glutamate group in toddlers and children exceeded both the group ADI and the dose associated with MSG symptom complex (>42.9 mg/kg bw/day) in the refined non-brand-loyal scenario; P95 exposure in infants, toddlers and children exceeded doses associated with adverse effects in humans." } ] }, { "e_number": "E625", "name": "Magnesium diglutamate", "off_tag": "en:e625", "category": "flavour_enhancer", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e625", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2017;15(7):4910, doi:10.2903/j.efsa.2017.4910 (PMC7009848)", "finding": "Group ADI of 30 mg/kg bw/day expressed as glutamic acid applies to E 620-625 including magnesium diglutamate." }, { "source": "EFSA", "ref": "EFSA Journal 2017;15(7):4910, exposure assessment (PMC7009848)", "finding": "Mean glutamate exposure in toddlers and children exceeded the group ADI and the MSG symptom complex dose; P95 exposure in infants, toddlers and children exceeded doses associated with adverse effects in humans." } ] }, { "e_number": "E626", "name": "Guanylic acid", "off_tag": "en:e626", "category": "flavour_enhancer", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e626", "citations": [ { "source": "FDA", "ref": "21 CFR 172.530 (disodium guanylate, govinfo CFR-2024-title21-vol3)", "finding": "The guanylate family holds an affirmative US authorisation as a flavour enhancer at levels not exceeding what is reasonably required for the intended effect." }, { "source": "EFSA", "ref": "EFSA Call for data for the re-evaluation of ribonucleotides (E 626-635), 2023-06-28", "finding": "E 626 is the lead substance of the open ribonucleotide re-evaluation; no opinion, ADI or age-group exposure assessment exists yet." } ] }, { "e_number": "E627", "name": "Disodium guanylate", "off_tag": "en:e627", "category": "flavour_enhancer", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e627", "citations": [ { "source": "FDA", "ref": "21 CFR 172.530 (govinfo CFR-2024-title21-vol3-sec172-530)", "finding": "Disodium guanylate may be safely used as a flavour enhancer in food at a level not in excess of that reasonably required to produce the intended effect." }, { "source": "EFSA", "ref": "EFSA Call for data for the re-evaluation of ribonucleotides (E 626-635), 2023-06-28", "finding": "E 627 is inside the open ribonucleotide re-evaluation; no EFSA opinion, ADI or age-group exposure assessment exists yet." } ] }, { "e_number": "E628", "name": "Dipotassium guanylate", "off_tag": "en:e628", "category": "flavour_enhancer", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e628", "citations": [ { "source": "FDA", "ref": "21 CFR 172.530 (disodium guanylate, govinfo CFR-2024-title21-vol3)", "finding": "Guanylate salts are authorised US flavour enhancers; no separate hazard classification exists for the dipotassium form." }, { "source": "EFSA", "ref": "EFSA Call for data for the re-evaluation of ribonucleotides (E 626-635), 2023-06-28", "finding": "E 628 sits inside the open ribonucleotide re-evaluation; no EFSA opinion, ADI or exposure assessment yet." } ] }, { "e_number": "E629", "name": "Calcium guanylate", "off_tag": "en:e629", "category": "flavour_enhancer", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e629", "citations": [ { "source": "FDA", "ref": "21 CFR 172.530 (disodium guanylate, govinfo CFR-2024-title21-vol3)", "finding": "Guanylate salts hold an affirmative US authorisation as flavour enhancers; no separate hazard classification exists for the calcium form." }, { "source": "EFSA", "ref": "EFSA Call for data for the re-evaluation of ribonucleotides (E 626-635), 2023-06-28", "finding": "E 629 sits inside the open ribonucleotide re-evaluation; no EFSA opinion, ADI or exposure assessment yet." } ] }, { "e_number": "E630", "name": "Inosinic acid", "off_tag": "en:e630", "category": "flavour_enhancer", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e630", "citations": [ { "source": "FDA", "ref": "21 CFR 172.535 (disodium inosinate, govinfo CFR-2024-title21-vol3)", "finding": "The inosinate family holds an affirmative US food additive authorisation as a flavouring adjuvant, with no restriction relevant to children." }, { "source": "EFSA", "ref": "EFSA Call for data for the re-evaluation of ribonucleotides (E 626-635), 2023-06-28", "finding": "E 630 is inside the ribonucleotide group re-evaluation, which has produced no opinion, ADI or age-group exposure assessment as of 2026-08." } ] }, { "e_number": "E631", "name": "Disodium inosinate", "off_tag": "en:e631", "category": "flavour_enhancer", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e631", "citations": [ { "source": "FDA", "ref": "21 CFR 172.535 (govinfo CFR-2024-title21-vol3-sec172-535)", "finding": "Disodium inosinate may be safely used as a flavouring adjuvant in food, subject to a soluble-barium limit of 150 ppm — an affirmative US food additive authorisation with no restriction relevant to children." }, { "source": "EFSA", "ref": "EFSA Call for data for the re-evaluation of ribonucleotides (E 626-635) as food additives, launched 2023-06-28 (efsa.europa.eu/en/call/call-data-re-evaluation-ribonucleotides-e-626-635-food-additives)", "finding": "Re-evaluation of the ribonucleotide group under Reg. (EU) 257/2010 is under way and proceeded to opinion drafting with data gaps; no opinion published as of 2026-08, so there is no EFSA ADI, exposure assessment or child-specific finding to cite." } ] }, { "e_number": "E632", "name": "Dipotassium inosinate", "off_tag": "en:e632", "category": "flavour_enhancer", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e632", "citations": [ { "source": "FDA", "ref": "21 CFR 172.535 (disodium inosinate, govinfo CFR-2024-title21-vol3)", "finding": "Inosinate salts are authorised US flavouring adjuvants with no child-relevant restriction; no separate hazard classification exists for the dipotassium form." }, { "source": "EFSA", "ref": "EFSA Call for data for the re-evaluation of ribonucleotides (E 626-635), 2023-06-28", "finding": "E 632 sits inside the open ribonucleotide re-evaluation; no EFSA opinion or age-group exposure assessment has been published." } ] }, { "e_number": "E633", "name": "Calcium inosinate", "off_tag": "en:e633", "category": "flavour_enhancer", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e633", "citations": [ { "source": "FDA", "ref": "21 CFR 172.535 (disodium inosinate, govinfo CFR-2024-title21-vol3)", "finding": "Inosinate salts hold an affirmative US authorisation as flavouring adjuvants; no separate hazard classification exists for the calcium form." }, { "source": "EFSA", "ref": "EFSA Call for data for the re-evaluation of ribonucleotides (E 626-635), 2023-06-28", "finding": "E 633 sits inside the open ribonucleotide re-evaluation; no EFSA opinion, ADI or age-group exposure assessment has been published." } ] }, { "e_number": "E634", "name": "Calcium 5'-ribonucleotides", "off_tag": "en:e634", "category": "flavour_enhancer", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e634", "citations": [ { "source": "FDA", "ref": "21 CFR 172.530 and 21 CFR 172.535 (govinfo CFR-2024-title21-vol3)", "finding": "Both constituent ribonucleotide families hold affirmative US food additive authorisations as flavour enhancers/adjuvants with no child-relevant restriction." }, { "source": "EFSA", "ref": "EFSA Call for data for the re-evaluation of ribonucleotides (E 626-635), 2023-06-28", "finding": "E 634 sits inside the open ribonucleotide re-evaluation; no EFSA opinion, ADI or age-group exposure assessment has been published." } ] }, { "e_number": "E635", "name": "Disodium 5'-ribonucleotides", "off_tag": "en:e635", "category": "flavour_enhancer", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e635", "citations": [ { "source": "FDA", "ref": "21 CFR 172.530 and 21 CFR 172.535 (govinfo, CFR-2024-title21-vol3)", "finding": "Both constituent salts (disodium guanylate, disodium inosinate) hold affirmative US food additive authorisations as flavour enhancers/adjuvants with no child-relevant restriction." }, { "source": "EFSA", "ref": "EFSA Call for data for the re-evaluation of ribonucleotides (E 626-635), 2023-06-28", "finding": "E 635 sits inside the ribonucleotide group re-evaluation, which is under way with acknowledged data gaps and has produced no opinion, ADI or age-group exposure assessment." } ] }, { "e_number": "E640", "name": "Glycine and its sodium salt", "off_tag": "en:e640", "category": "flavour_enhancer", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e640", "citations": [ { "source": "FDA", "ref": "21 CFR 170.50 (govinfo CFR-2024-title21-vol3-sec170-50)", "finding": "FDA no longer regards glycine and its salts as generally recognized as safe for use in human food; by 1971-05-08 manufacturers had to reformulate to eliminate added glycine or operate under an authorising food additive regulation supported by toxicity data (GRAS status for animal feed was unaffected)." }, { "source": "FDA", "ref": "21 CFR 172.812 (govinfo CFR-2024-title21-vol3-sec172-812)", "finding": "The only authorised human-food uses of glycine are as a masking agent for saccharin's bitter aftertaste in beverages and beverage bases (not to exceed 0.2% in the finished beverage) and as a stabiliser in mono- and diglycerides (not to exceed 0.02%)." }, { "source": "EFSA", "ref": "Europe PMC search of EFSA Journal for a glycine (E 640) re-evaluation (executed 2026-08-10)", "finding": "No EFSA re-evaluation opinion for glycine and its sodium salt could be located; claims of a 2013 EFSA glycine opinion appear only on low-quality aggregator sites and are not cited here." } ] }, { "e_number": "E650", "name": "Zinc acetate", "off_tag": "en:e650", "category": "flavour_enhancer", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "low", "permalink": "https://sito.kids/additives#e650", "citations": [ { "source": "EFSA", "ref": "Scientific Committee on Food (EFSA predecessor), 'Opinion on Zinc Acetate as a flavour enhancer in chewing gum', food.ec.europa.eu sci-com_scf_out06", "finding": "Use of zinc acetate as a flavour enhancer in chewing gum was considered acceptable at up to approximately 1 mg zinc acetate dihydrate (about 0.30 mg zinc) per 1,000 mg of chewing gum centre; EU authorisation under Reg. (EC) 1333/2008 is restricted to chewing gum and no EFSA re-evaluation opinion could be located." } ] }, { "e_number": "E900", "name": "Dimethylpolysiloxane and methylphenylpolysiloxane", "off_tag": "en:e900", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e900", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2020;18(5):6107 — doi:10.2903/j.efsa.2020.6107, Re-evaluation of dimethyl polysiloxane (E 900)", "finding": "SCF's 1990 ADI of 1.5 mg/kg bw/day withdrawn and replaced by an ADI of 17 mg/kg bw/day (NOAEL 1,742 mg/kg bw/day, UF 100); no safety concern at reported uses and use levels." } ] }, { "e_number": "E901", "name": "White and yellow beeswax", "off_tag": "en:e901", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e901", "citations": [ { "source": "EFSA", "ref": "EFSA Journal (2007) 615, 1–28 — Beeswax (E 901) as a glazing agent and as carrier for flavours (AFC Panel)", "finding": "No safety concern from use of beeswax as a glazing agent and flavour carrier at the proposed uses and use levels." } ] }, { "e_number": "E903", "name": "Carnauba wax", "off_tag": "en:e903", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e903", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2012;10(10):2880 — doi:10.2903/j.efsa.2012.2880, Re-evaluation of carnauba wax (E 903)", "finding": "No ADI set (long-term data lacking); subchronic and reproductive/developmental studies showed no adverse effects; exposure gives sufficient margins of safety, so authorised uses are not of safety concern." } ] }, { "e_number": "E904", "name": "Shellac", "off_tag": "en:e904", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e904", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2024;22(8):8897 — doi:10.2903/j.efsa.2024.8897, Re-evaluation of shellac (E 904)", "finding": "ADI of 4 mg/kg bw/day derived (NOAEL 400 mg/kg bw/day, UF 100); temporary for chemically bleached shellac pending organochlorine impurity data; P95 exceedance in several age groups under conservative scenarios judged not to indicate a safety concern." } ] }, { "e_number": "E905", "name": "Synthetic wax", "off_tag": "en:e905", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e905", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2013;11(4):3146 — doi:10.2903/j.efsa.2013.3146, Re-evaluation of microcrystalline wax (E 905)", "finding": "No concern for genotoxicity; no ADI established for lack of long-term studies; conservative quantum satis exposure gives a sufficient margin of safety versus the high-viscosity mineral oil NOAEL, so authorised uses are not of safety concern." } ] }, { "e_number": "E912", "name": "Montanic acid esters", "off_tag": "en:e912", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "low", "permalink": "https://sito.kids/additives#e912", "citations": [ { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 912 authorised in the EU only for the surface treatment of specified fruits; no general food use." } ] }, { "e_number": "E914", "name": "Oxidised polyethylene wax", "off_tag": "en:e914", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "low", "permalink": "https://sito.kids/additives#e914", "citations": [ { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 914 authorised in the EU only as a surface-treatment/glazing agent on the skin of listed fruits; no general food use." } ] }, { "e_number": "E920", "name": "L-cysteine", "off_tag": "en:e920", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e920", "citations": [ { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II", "finding": "E 920 L-cysteine authorised in the EU as a flour treatment agent." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — L-cysteine / L-cysteine monohydrochloride", "finding": "GRAS direct food substance (dough strengthener, nutrient)." } ] }, { "e_number": "E924a", "name": "Potassium bromate", "off_tag": "en:e924a", "category": "other", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e924a", "citations": [ { "source": "IARC", "ref": "IARC Monographs Vol. 73 (1999) — potassium bromate", "finding": "Group 2B, possibly carcinogenic to humans, on sufficient evidence of renal tumours in experimental animals." }, { "source": "state_law", "ref": "California AB 418, the California Food Safety Act (signed 7 Oct 2023), Health & Safety Code", "finding": "Prohibits the manufacture, sale or distribution of any food containing potassium bromate in California from 1 January 2027 (with Red 3, BVO and propylparaben)." }, { "source": "OEHHA", "ref": "Proposition 65 list of chemicals (OEHHA, list current to 31 July 2026) — potassium bromate/bromate, listed as causing cancer 1 January 1990", "finding": "Listed carcinogen under California Proposition 65." }, { "source": "FDA", "ref": "21 CFR part 137 (Cereal flours and related products) — bromated flour; FDA post-market chemical review table (2024)", "finding": "Still federally permitted as an optional flour treatment in the US; FDA lists potassium bromate in 'review of information' status since March 2024." } ] }, { "e_number": "E926", "name": "Chlorine dioxide", "off_tag": "en:e926", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e926", "citations": [ { "source": "FDA", "ref": "21 CFR 137.105 (eCFR) — Flour, optional bleaching ingredients", "finding": "Chlorine dioxide permitted as an optional bleaching ingredient in US flour." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex), Annex II Part B 'List of all additives' and Annex III", "finding": "Checked against the consolidated primary text: 'E 926' occurs nowhere in the Union list — neither in Annex II Part B (the enumeration of all authorised additives) nor in Annex III. Under Article 4 the Union list is a positive list, so chlorine dioxide has no authorised food use in the EU. Absence from the list is non-authorisation, not a ban or a withdrawal." } ] }, { "e_number": "E927", "name": "Azodicarbonamide and carbamide (generic node)", "off_tag": "en:e927", "category": "other", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "low", "permalink": "https://sito.kids/additives#e927", "citations": [ { "source": "FDA", "ref": "21 CFR 172.806 and 21 CFR 137.105 (eCFR)", "finding": "Azodicarbonamide (E 927a) is permitted in the US as an ageing/bleaching ingredient in cereal flour and as a dough conditioner at up to 45 ppm — the use behind the overwhelming majority of the bare en:e927 tags in this corpus, which is why the parent follows E 927a." }, { "source": "state_law", "ref": "Commission Regulation (EU) No 1129/2011 (Annex II Part B of Regulation (EC) No 1333/2008); Commission Directive 2004/1/EC", "finding": "The two children sit on opposite sides of EU law: E 927b carbamide is authorised (chewing gum with no added sugar), while E 927a azodicarbonamide has no authorised EU food use and was separately prohibited by name in food-contact plastics from 2005-08-02. The split is real, which is why this node needs an explicit default rather than a family verdict." }, { "source": "state_law", "ref": "US-TX: S.B. 314 (2025); US-LA: S.B. 14 / Act 463 (2025)", "finding": "Both school-meal statutes name azodicarbonamide — the sub-form a bare en:e927 tag overwhelmingly resolves to — so the parent carries the same child flag as en:e927a; see that row for the full citation." } ] }, { "e_number": "E927a", "name": "Azodicarbonamide", "off_tag": "en:e927a", "category": "other", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "medium", "permalink": "https://sito.kids/additives#e927a", "citations": [ { "source": "peer_reviewed", "ref": "Canas BJ et al., Food Additives and Contaminants 1997;14(1) (PMID 9059587); Dennis MJ et al., Food Additives and Contaminants 1997;14(1) (PMID 9059588)", "finding": "At the US-permitted 45 mg/kg flour treatment level, azodicarbonamide led to significant increases in ethyl carbamate concentrations in both bread and toast, on the order of 1–3 µg/kg. Ethyl carbamate is IARC Group 2A. This is the strongest primary signal behind the low class: a dietary formation route at the permitted use level with no concluded regulatory assessment." }, { "source": "peer_reviewed", "ref": "Becalski A et al., J Agric Food Chem 2004, 10.1021/jf0495385; Noonan GO et al., J Agric Food Chem 2005, 10.1021/jf050480j (PMID 15941299); Noonan GO et al., J Agric Food Chem 2008 (PMID 18303820)", "finding": "Semicarbazide forms in ADA-treated flour only on baking, via a biurea intermediate; free semicarbazide was measured at 10–1,200 µg/kg (mean ~260 µg/kg) in commercial US breads. Context rather than the basis of the class: both EFSA (2005) and FDA (2016) have since assessed dietary semicarbazide and found no concern." }, { "source": "EFSA", "ref": "EFSA AFC Panel statement on semicarbazide, 1 July 2005 (efsa.europa.eu/en/press/news/afc050701)", "finding": "New in-vivo data showed a lack of genotoxic activity; the Panel judged carcinogenicity 'not of concern for human health' at reported semicarbazide levels, while reconfirming infant food as the most important exposure source via packaging gaskets — a route Commission Directive 2004/1/EC closed from August 2005." }, { "source": "FDA", "ref": "21 CFR 172.806 and 21 CFR 137.105 (eCFR); FDA, 'Azodicarbonamide (ADA) — Questions and Answers' (fda.gov), including the 2016 semicarbazide exposure assessment presented at the ACS 251st National Meeting", "finding": "Azodicarbonamide is permitted in the US as an ageing/bleaching ingredient in cereal flour and as a dough conditioner at up to 45 ppm. FDA's 2016 exposure assessment of semicarbazide from bread — covering the general population and children aged 2–5, the group expected to have the highest exposure per body weight — recommended no dietary change and reaffirmed ADA as safe at the permitted level." }, { "source": "FDA", "ref": "FDA Request for Information: Azodicarbonamide (ADA), 91 FR 27060, docket FDA-2026-N-4126 (published 2026-05-13; comment period closed 2026-07-13); FDA news release 'FDA finalizes food chemical safety post-market assessment program, launches reassessment of BHT and ADA' (2026-05-12)", "finding": "FDA selected azodicarbonamide as one of the first two chemicals in its post-market reassessment programme, and the Request for Information explicitly seeks data on residual levels of ADA's decomposition products, including semicarbazide and ethyl carbamate. Not a ban, a phase-out or a safety finding — but the US status is under active review rather than settled, which is why this row sits at low rather than none." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annex II (EU Union list of food additives); Commission Directive 2004/1/EC (ADC prohibited as a blowing agent in food-contact plastics from 2 Aug 2005)", "finding": "Azodicarbonamide has no entry in the EU list of permitted food additives — non-authorisation, not a ban — and its food-contact use was separately prohibited in 2005. Neither is a withdrawal of an authorised food use, so no high trigger fires." }, { "source": "state_law", "ref": "US-TX: S.B. 314 (89R, signed 2025-05-27; free and reduced-price school-meal contracts from 2026-09-01); US-LA: S.B. 14 / Act 463 (signed June 2025; school food from the 2028–29 school year)", "finding": "Both statutes name azodicarbonamide among the ingredients barred from school meals. Child-specific regulatory language — the basis for higher-concern-for-young-children flag, exactly as on E 132, E 133 and E 143. School statutes are not Red-3-class food bans, so they do not raise the class." } ] }, { "e_number": "E927b", "name": "Carbamide (urea)", "off_tag": "en:e927b", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e927b", "citations": [ { "source": "state_law", "ref": "Commission Regulation (EU) No 1129/2011 (establishing Annex II Part B to Regulation (EC) No 1333/2008); Commission Regulation (EU) No 231/2012, specifications for E 927b CARBAMIDE", "finding": "VERIFIED in the primary text: 'E 927b Carbamide' is listed in Annex II Part B among additives other than colours and sweeteners — the Union positive list — and Reg 231/2012 gives it full identity and purity specifications (synonym urea, assay not less than 99.0%). The permitted use is chewing gum with no added sugar at a maximum of 30,000 mg/kg; the Part B listing was quoted directly, while the 30,000 mg/kg level is corroborated by secondary additive databases and by JECFA's 3% figure rather than quoted from the truncated consolidated Part E text." }, { "source": "agency_review", "ref": "JECFA evaluations — urea/carbamide (WHO/FAO JECFA database, chemical 2177; 41st meeting, 1993)", "finding": "'Use at levels of up to 3% in chewing-gum not of toxicological concern.' This is a positive assessment at the same level the EU permits — the classification rests on an affirmative clean finding, not on an absence of evidence." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2023.8112 (EFSA 2023 peer review of the pesticide risk assessment for urea) and 10.2903/j.efsa.2011.2071 (EFSA NDA Panel 2011, carbamide chewing gum and plaque acid neutralisation, claim ID 1153)", "finding": "Supportive, not load-bearing. The 2023 pesticide peer review notes urea's historical safe use as food additive E 927b; the 2011 NDA opinion assessed a positive health claim for carbamide chewing gum without raising a safety concern. No EFSA re-evaluation of E 927b as a food additive has been published as of 2026-08." } ] }, { "e_number": "E930", "name": "Calcium peroxide", "off_tag": "en:e930", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e930", "citations": [ { "source": "FDA", "ref": "FDA Substances Added to Food inventory — calcium peroxide (hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=FoodSubstances&id=CALCIUMPEROXIDE)", "finding": "Listed for US food use as a dough conditioner / flour bleaching and maturing agent." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008, consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex), Annex II Part B 'List of all additives' and Annex III", "finding": "Checked against the consolidated primary text: 'E 930' occurs nowhere in the Union list — neither in Annex II Part B (the enumeration of all authorised additives) nor in Annex III. Under Article 4 the Union list is a positive list, so calcium peroxide has no authorised food use in the EU. Absence from the list is non-authorisation, not a ban or a withdrawal." } ] }, { "e_number": "E943a", "name": "Butane", "off_tag": "en:e943a", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e943a", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2025;23(1):9203 — doi:10.2903/j.efsa.2025.9203", "finding": "Butane, isobutane and propane are of low toxicological concern when used as food additives, with very low dietary exposure; 1,3-butadiene capped at ≤0.1% v/v in EU specifications." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 as amended by Commission Regulation (EU) 2017/874", "finding": "Authorised as a propellant in vegetable oil pan spray (professional use only), water-based emulsion spray, and colour preparations at ≤1 mg/kg in food." } ] }, { "e_number": "E944", "name": "Propane", "off_tag": "en:e944", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e944", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2025;23(1):9203 — doi:10.2903/j.efsa.2025.9203, Re-evaluation of butane (E 943a), isobutane (E 943b) and propane (E 944)", "finding": "The three gases are of low toxicological concern as food additives with very low dietary exposure; EU specifications already limit 1,3-butadiene to ≤0.1% v/v; uncertainty remains about impurities not covered by current specifications." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008 Annexes II/III as amended by Commission Regulation (EU) 2017/874", "finding": "Permitted only as propellants in vegetable oil pan spray (professional use) and water-based emulsion spray at quantum satis, plus colour preparations at ≤1 mg/kg residue in food." } ] }, { "e_number": "E950", "name": "Acesulfame K", "off_tag": "en:e950", "category": "sweetener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e950", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2025;23(4):9317, doi:10.2903/j.efsa.2025.9317 (PMC12041894), published 2025-04-30", "finding": "Re-evaluation established a new ADI of 15 mg/kg bw/day (NOAEL 1,500 mg/kg bw/day, UF 100), replacing the SCF's 9 mg/kg bw/day; concluded it is unlikely that acesulfame K intake is associated with cancer, glucose/insulin disturbance, cardiovascular risk or organ toxicity, and that neither the sweetener nor its degradation products raise genotoxicity concerns even at low pH and elevated temperature." }, { "source": "EFSA", "ref": "EFSA Call for data on genotoxicity data on sweeteners, 2021-06-30 (efsa.europa.eu/en/call/call-data-genotoxicity-data-sweeteners)", "finding": "E 950 had been listed as needing basic-battery genotoxicity testing (bacterial reverse mutation + in vitro micronucleus) — a gap that the completed 2025 re-evaluation closed." }, { "source": "FDA", "ref": "FDA, High-Intensity Sweeteners (fda.gov/food/food-additives-petitions/high-intensity-sweeteners)", "finding": "Acesulfame potassium is one of six high-intensity sweeteners approved by FDA as a food additive, with an ADI established at pre-market review." } ] }, { "e_number": "E951", "name": "Aspartame", "off_tag": "en:e951", "category": "sweetener", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e951", "citations": [ { "source": "IARC", "ref": "IARC Monographs Volume 134 (2023), aspartame; monographs.iarc.who.int/news-events/iarc-monographs-evaluation-of-the-carcinogenicity-of-aspartame-methyleugenol-and-isoeugenol/", "finding": "A Working Group of 25 experts (Lyon, 6-13 June 2023) classified aspartame as Group 2B, possibly carcinogenic to humans, on limited evidence for an association with hepatocellular carcinoma in humans." }, { "source": "EFSA", "ref": "EFSA Journal 2013;11(12):3496, doi:10.2903/j.efsa.2013.3496", "finding": "Full re-evaluation confirmed the ADI of 40 mg/kg bw/day and concluded aspartame was not of safety concern at current exposure estimates or at the ADI; intakes up to the ADI would not raise plasma phenylalanine above clinical guideline levels in normal subjects or PKU heterozygotes." }, { "source": "FDA", "ref": "FDA, High-Intensity Sweeteners / Aspartame and Other Sweeteners in Food (fda.gov/food/food-additives-petitions/high-intensity-sweeteners)", "finding": "Aspartame remains an approved US food additive; FDA states it has no safety concerns at approved conditions of use, while people with phenylketonuria should avoid or restrict it." } ] }, { "e_number": "E952", "name": "Cyclamic acid and its Na and Ca salts", "off_tag": "en:e952", "category": "sweetener", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e952", "citations": [ { "source": "FDA", "ref": "21 CFR 189.135 (govinfo CFR-2024-title21-vol3-sec189-135); order at 34 FR 17063, 1969-10-21", "finding": "Food containing any added or detectable level of cyclamate is deemed adulterated in the US; the prohibition covers cyclohexane sulfamic acid and its calcium, sodium, magnesium and potassium salts." }, { "source": "EFSA", "ref": "EFSA Call for data on genotoxicity data on sweeteners, 2021-06-30 (efsa.europa.eu/en/call/call-data-genotoxicity-data-sweeteners)", "finding": "Cyclamates (E 952 i, ii, iii) are named as requiring in vivo follow-up because of POSITIVE in vitro genotoxicity results, plus testing of metabolites — an open, unresolved genotoxicity question, with no re-evaluation opinion published." }, { "source": "EFSA", "ref": "European Commission amended proposal COM(2003) 277 final amending Directive 94/35/EC on sweeteners (EUR-Lex CELEX 52003PC0277)", "finding": "Following the SCF opinion revising the cyclamate ADI (7 mg/kg bw/day, driven by cyclohexylamine toxicity), the Commission proposed cutting maximum permitted levels in soft drinks because 'there are indications that the ADI could be exceeded', soft drinks being a dominant intake route; levels were ultimately reduced to 250 mg/l." } ] }, { "e_number": "E953", "name": "Isomalt", "off_tag": "en:e953", "category": "sweetener", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e953", "citations": [ { "source": "EFSA", "ref": "EFSA Call for data on genotoxicity data on sweeteners, 2021-06-30 (efsa.europa.eu/en/call/call-data-genotoxicity-data-sweeteners)", "finding": "Isomalt (E 953) is named among the sweeteners for which additional genotoxicity information was identified as needed — basic battery: bacterial reverse mutation (OECD TG 471) and in vitro micronucleus (OECD TG 487)." }, { "source": "EFSA", "ref": "Europe PMC query of EFSA Journal for polyol re-evaluation opinions (executed 2026-08-10)", "finding": "No EFSA re-evaluation opinion for isomalt exists; erythritol (E 968) remains the only completed polyol re-evaluation, so isomalt's EU status is still the pre-2009 SCF acceptance with no numerical ADI." } ] }, { "e_number": "E954", "name": "Saccharin and its salts", "off_tag": "en:e954", "category": "sweetener", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e954", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2024;22(11):9044, doi:10.2903/j.efsa.2024.9044 (PMC11565076), published Nov 2024", "finding": "New ADI of 9 mg/kg bw/day as free imide (replacing the SCF's 5 mg/kg bw/day as sodium saccharin); P95 chronic exposure in the refined brand-loyal scenario was below the ADI; no genotoxicity concern for E 954 or its Remsen-Fahlberg-process impurities, BUT a concern for genotoxicity was identified for potential impurities associated with the Maumee process." }, { "source": "IARC", "ref": "IARC Monographs Volume 73 (1999), 'Saccharin and its salts' (inchem.org/documents/iarc/vol73/73-19.html; IARC List of Classifications)", "finding": "Saccharin and its salts were reclassified as Group 3, not classifiable as to carcinogenicity to humans, with inadequate evidence in experimental animals for the acid form — the rat bladder mechanism depends on rat-specific urine chemistry." }, { "source": "OEHHA", "ref": "OEHHA notice, 'Saccharin Delisted Effective April 6, 2001 as Known to the State to Cause Cancer' (oehha.ca.gov/proposition-65/crnr/saccharin-delisted-effective-april-6-2001-known-state-cause-cancer)", "finding": "Saccharin (CAS 81-07-2), listed under Prop 65 since 1989, was delisted effective 2001-04-06 following the IARC Group 3 reclassification and NTP's removal of saccharin from its 'reasonably anticipated' list in 2000." } ] }, { "e_number": "E955", "name": "Sucralose", "off_tag": "en:e955", "category": "sweetener", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e955", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2026;24(2):9854, doi:10.2903/j.efsa.2026.9854 (PMC12911467), adopted 2025-12-10", "finding": "Re-evaluation concluded there is no need to revise the ADI of 15 mg/kg bw/day; exposure at currently authorised uses did not exceed the ADI in any population group (toddlers and children below ADI); no safety concern for genotoxicity of sucralose or its impurities, incl. sucralose-6-acetate at the 0.5% specification limit." }, { "source": "EFSA", "ref": "EFSA Journal 2026;24(2):9854 (same opinion), extension-of-use part", "finding": "The Panel could not conclude on the safety of the proposed extension into fine bakery wares because of uncertainty over transfer of chlorine from sucralose to organic molecules under prolonged high temperature (>120 C) — the single unresolved hazard question, relevant to baked and fried foods." }, { "source": "peer_reviewed", "ref": "Schiffman et al. 2023, J Toxicol Environ Health B 26(6), doi:10.1080/10937404.2023.2213903", "finding": "Sucralose-6-acetate (a manufacturing impurity and gut metabolite) was genotoxic in MultiFlow and in vitro micronucleus assays with a clastogenic mode of action; commercial sucralose samples contained up to 0.67% sucralose-6-acetate." }, { "source": "EFSA", "ref": "EFSA Call for data on genotoxicity data on sweeteners, published 2021-06-30 (efsa.europa.eu/en/call/call-data-genotoxicity-data-sweeteners)", "finding": "E 955 was named among sweeteners with identified genotoxicity data gaps (in vivo follow-up of positive in vitro results, plus testing of degradation products) — gaps subsequently addressed by the 2026 opinion for authorised uses only." } ] }, { "e_number": "E960", "name": "Steviol glycosides", "off_tag": "en:e960", "category": "sweetener", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e960", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2024;22(11):9045, doi:10.2903/j.efsa.2024.9045 (PMC11533382)", "finding": "The Panel found insufficient justification to raise the steviol ADI of 4 mg/kg bw/day and concluded that the proposed extension of use and higher maximum permitted levels would result in an INCREASED exceedance of the ADI for TODDLERS at the 95th percentile." }, { "source": "EFSA", "ref": "EFSA ANS Panel, revised exposure assessment of steviol glycosides (E 960), EFSA Journal 2014;12(5):3639 (efsa.europa.eu/en/efsajournal/pub/3639); ADI of 4 mg/kg bw/day set in 2010", "finding": "High-level (95th percentile) exposure exceeded the ADI for toddlers and children in four dietary surveys, with toddler high-consumer estimates around 4.3 mg/kg bw/day against the 4 mg/kg bw/day ADI — the age-group basis for higher-concern-for-young-children flag." }, { "source": "FDA", "ref": "FDA GRAS Notice Inventory (high-purity steviol glycoside notices, e.g. GRN 000619, GRN 000745) and Import Alert 45-06", "finding": "US status splits: high-purity steviol glycosides (>=95%) are covered by GRAS notices FDA has not objected to, while stevia leaf and crude extracts are not GRAS and are subject to import alert — the US status depends on which form the ingredient list names." } ] }, { "e_number": "E961", "name": "Neotame", "off_tag": "en:e961", "category": "sweetener", "risk_class": "low", "risk_class_label": "Low risk", "points_removed": 6, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e961", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2025;23(7):9480, doi:10.2903/j.efsa.2025.9480 (PMC12231243)", "finding": "Re-evaluation set an ADI of 10 mg/kg bw/day (NOAEL 1,000 mg/kg bw/day from combined chronic/carcinogenicity rat studies, UF 100), found no concern for genotoxicity at permitted levels, and reported toddler exposure at most 0.16 mg/kg bw/day at P95 and children at most 0.01 mg/kg bw/day — far below the ADI; no safety concern at permitted uses." }, { "source": "peer_reviewed", "ref": "Shil A, Ladeira Faria LM, Walker CA, Chichger H. 2024, Front Nutr 11:1366409, doi:10.3389/fnut.2024.1366409 (PMID 38721028)", "finding": "At physiologically relevant concentrations neotame caused intestinal epithelial (Caco-2) apoptosis via T1R3 signalling and induced pathogenic changes in model gut bacteria (E. coli, E. faecalis) including breakdown of the epithelial barrier — in vitro only, not reflected in any regulatory status." }, { "source": "FDA", "ref": "FDA, High-Intensity Sweeteners (fda.gov/food/food-additives-petitions/high-intensity-sweeteners)", "finding": "Neotame is one of six high-intensity sweeteners approved by FDA as a food additive, with an ADI set at pre-market review." } ] }, { "e_number": "E962", "name": "Salt of aspartame-acesulfame", "off_tag": "en:e962", "category": "sweetener", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e962", "citations": [ { "source": "IARC", "ref": "IARC Monographs Volume 134 (2023), aspartame — applied to the aspartame moiety of E 962", "finding": "Aspartame is classified Group 2B, possibly carcinogenic to humans; E 962 dissociates to aspartame and acesulfame K, so the 2B hazard travels with the aspartame moiety." }, { "source": "EFSA", "ref": "EFSA Call for data on genotoxicity data on sweeteners, 2021-06-30 (efsa.europa.eu/en/call/call-data-genotoxicity-data-sweeteners)", "finding": "Salt of aspartame-acesulfame (E 962) is one of the nine sweeteners named as having identified genotoxicity information needs; no re-evaluation opinion for E 962 has been published (Europe PMC EFSA Journal check, 2026-08-10)." }, { "source": "EFSA", "ref": "EFSA Journal 2025;23(4):9317 (acesulfame K) and EFSA Journal 2013;11(12):3496 (aspartame)", "finding": "Both constituent moieties have current ADIs with no exposure exceedance reported in any age group (ace-K 15 mg/kg bw/day, 2025; aspartame 40 mg/kg bw/day, 2013), so the deduction rests on the IARC hazard classification, not on intake." } ] }, { "e_number": "E965", "name": "Maltitol", "off_tag": "en:e965", "category": "sweetener", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e965", "citations": [ { "source": "EFSA", "ref": "EFSA Call for data on genotoxicity data on maltitol (E 965 i), published 2023-01-24, deadline 2023-07-24 (efsa.europa.eu/en/call/call-data-genotoxicity-data-maltitol-e-965-i)", "finding": "After a full assessment of the reliability and relevance of available genotoxicity studies, EFSA stated that 'the need for additional genotoxicity data of maltitols (E 965 i,ii) has been identified', citing the lack of a fully reliable in vitro micronucleus test." }, { "source": "EFSA", "ref": "Europe PMC query of EFSA Journal re-evaluation opinions for E 420/421/953/965/967 (executed 2026-08-10)", "finding": "No completed EFSA re-evaluation opinion exists for maltitols; EU status rests on the pre-2009 SCF acceptance with no numerical ADI, plus the Reg. (EU) 1169/2011 laxative warning for foods with more than 10% added polyols." } ] }, { "e_number": "E967", "name": "Xylitol", "off_tag": "en:e967", "category": "sweetener", "risk_class": "mid", "risk_class_label": "Moderate risk", "points_removed": 15, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e967", "citations": [ { "source": "EFSA", "ref": "EFSA Call for data on genotoxicity data on sweeteners, 2021-06-30 (efsa.europa.eu/en/call/call-data-genotoxicity-data-sweeteners)", "finding": "E 967 is named among sweeteners for which additional information relevant to the genotoxicity assessment was identified as needed, specifically the basic battery (bacterial reverse mutation OECD TG 471 and in vitro micronucleus OECD TG 487); no re-evaluation opinion has followed." }, { "source": "peer_reviewed", "ref": "Witkowski et al. 2024, European Heart Journal, 'Xylitol is prothrombotic and associated with cardiovascular risk' (PMID 38842092)", "finding": "Elevated plasma xylitol was associated with increased 3-year risk of heart attack, stroke or death; ingestion of 30 g xylitol produced comparable plasma elevations and acute enhancement of platelet aggregation in healthy volunteers." }, { "source": "FDA", "ref": "21 CFR 172.395 (govinfo CFR-2024-title21-vol3-sec172-395)", "finding": "Xylitol may be safely used in foods for special dietary uses at no more than the amount required to produce the intended effect — a narrower US authorisation than a general-purpose sweetener approval." } ] }, { "e_number": "E968", "name": "Erythritol", "off_tag": "en:e968", "category": "sweetener", "risk_class": "high", "risk_class_label": "High risk", "points_removed": 30, "child_flag": true, "confidence": "high", "permalink": "https://sito.kids/additives#e968", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2023;21(12):8430, doi:10.2903/j.efsa.2023.8430 (PMC10731997), published 2023-12-20; plus EFSA plain-language summary", "finding": "First-ever numerical ADI of 0.5 g/kg bw/day set from a NOAEL for diarrhoea; erythritol is not genotoxic; EFSA states that in all population groups both acute and chronic exposure sits above the new ADI, and that the highest mean and 95th-percentile chronic exposure was in children (742 mg/kg bw/day) and adolescents (1,532 mg/kg bw/day) respectively — i.e. children were the most exposed group at the mean, a MEAN exceedance in a child age group." }, { "source": "peer_reviewed", "ref": "Witkowski et al. 2023, Nature Medicine, doi:10.1038/s41591-023-02223-9", "finding": "Plasma erythritol was associated with roughly doubled 3-year risk of major adverse cardiovascular events in at-risk cohorts, with mechanistic support from enhanced platelet reactivity and thrombosis after ingestion — a signal not reflected in current EFSA/FDA status (adult-cardiac, not paediatric)." }, { "source": "peer_reviewed", "ref": "Witkowski et al. 2024, Arterioscler Thromb Vasc Biol, doi:10.1161/ATVBAHA.124.321019 (PMID 39114916)", "finding": "Ingestion of erythritol, but not glucose, enhanced platelet reactivity and thrombosis potential in healthy volunteers — the interventional follow-up to the 2023 cohort finding." } ] }, { "e_number": "E969", "name": "Advantame", "off_tag": "en:e969", "category": "sweetener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e969", "citations": [ { "source": "EFSA", "ref": "EFSA ANS Panel, 'Scientific Opinion on the safety of advantame for the proposed uses as a food additive', EFSA Journal 2013", "finding": "ADI of 5 mg/kg bw/day derived from a NOAEL of 500 mg/kg bw/day for maternal toxicity in a rabbit prenatal developmental toxicity study with a 100-fold uncertainty factor; the Panel concluded advantame and its metabolites pose no safety concern at proposed uses and use levels." }, { "source": "FDA", "ref": "21 CFR 172.803 (govinfo CFR-2024-title21-vol3-sec172-803)", "finding": "Advantame is authorised as a sweetening agent and flavour enhancer in food generally, except in meat and poultry, subject to good manufacturing practice." } ] }, { "e_number": "E999", "name": "Quillaia extract", "off_tag": "en:e999", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e999", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2019;17(3):5622 — doi:10.2903/j.efsa.2019.5622, Re-evaluation of quillaia extract (E 999) and safety of the proposed extension of use", "finding": "ADI of 3 mg saponins/kg bw/day (NOAEL 1,500 mg extract/kg bw/day, UF 100); no population group exceeded the ADI — toddler mean 0.3 and P95 1.0 mg/kg bw/day in the refined brand-loyal scenario." }, { "source": "EFSA", "ref": "EFSA Journal 2024;22(2):8563 — doi:10.2903/j.efsa.2024.8563, Follow-up of the re-evaluation of quillaia extract (E 999)", "finding": "Follow-up opinion addressing the 2019 recommendations and proposed extensions of use." } ] }, { "e_number": "E1100", "name": "Alpha-amylase", "off_tag": "en:e1100", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e1100", "citations": [ { "source": "state_law", "ref": "Regulation (EC) No 1332/2008 on food enzymes; European Commission 'EU rules — Enzymes' (food.ec.europa.eu)", "finding": "Food enzymes are regulated separately from additives; the additive authorisations for enzymes under Directive 95/2/EC are repealed on adoption of the Union list of food enzymes." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — alpha-amylase enzyme preparations", "finding": "Listed as GRAS enzyme preparations for use in baking and starch processing." } ] }, { "e_number": "E1101", "name": "Proteases (papain, bromelain, ficin)", "off_tag": "en:e1101", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e1101", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2026.9837 (EFSA Journal 2026;24(1):9837 — Safety evaluation of the food enzyme papain from the latex of Carica papaya L.)", "finding": "'the Panel concluded that there is no concern for genotoxicity of the food enzyme papain'; 'the food enzyme papain extracted from the latex of the unripe C. papaya L. does not give rise to safety concerns under the intended conditions of use'; and 'a risk of allergic reactions upon dietary exposure to this food enzyme, particularly for papaya, ananas, kiwi, soy, fig and pollen allergic individuals, cannot be excluded'." }, { "source": "state_law", "ref": "Regulation (EC) No 1333/2008, Article 34 (Transitional provisions), consolidated text 02008R1333 — EN — 16.12.2024 — 059.001 (EUR-Lex ELI: reg/2008/1333)", "finding": "Food enzymes are governed by Regulation (EC) No 1332/2008, not the additives Regulation: 'the authorisations for E 1103 Invertase and E 1105 Lysozyme laid down in Directive 95/2/EC shall be repealed with effect from the date of application of the Community list on food enzymes in accordance with Article 17 of Regulation (EC) No 1332/2008'. A search of the full consolidated text returns no E 1101 entry in Annex II or Annex III — absence by jurisdiction, not by refusal." }, { "source": "FDA", "ref": "21 CFR 184.1585 (Papain) — Part 184 \"Direct Food Substances Affirmed as Generally Recognized as Safe\"; verified against the current eCFR structure", "finding": "Papain (CAS Reg. No. 9001-73-4), the proteolytic enzyme from Carica papaya, is affirmed GRAS as a direct human food ingredient for use as an enzyme, processing aid and texturizer." } ] }, { "e_number": "E1103", "name": "Invertase", "off_tag": "en:e1103", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e1103", "citations": [ { "source": "state_law", "ref": "Regulation (EC) No 1332/2008 on food enzymes (EUR-Lex CELEX:32008R1332)", "finding": "The additive authorisations for E 1103 invertase and E 1105 lysozyme under Directive 95/2/EC are repealed with effect from application of the Union list of food enzymes." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — invertase (invertine)", "finding": "Listed as a GRAS enzyme preparation." } ] }, { "e_number": "E1104", "name": "Lipase", "off_tag": "en:e1104", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e1104", "citations": [ { "source": "state_law", "ref": "Regulation (EC) No 1332/2008 on food enzymes; European Commission 'EU rules — Enzymes' (food.ec.europa.eu)", "finding": "Food enzymes fall under the enzymes regulation, not the additives Union list; legacy additive authorisations for enzymes are repealed." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — lipase enzyme preparations", "finding": "Listed as GRAS enzyme preparations for food use." } ] }, { "e_number": "E1105", "name": "Lysozyme", "off_tag": "en:e1105", "category": "preservative", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e1105", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2023.7918 (Safety evaluation of the food enzyme lysozyme from hens' eggs); see also 10.2903/j.efsa.2025.9726", "finding": "Dietary exposure lower than the corresponding intake from eggs for all population groups; 'the food enzyme lysozyme does not give rise to safety concerns under the intended conditions of use, except for the known adverse allergic reactions that occur in susceptible individuals' — residual lysozyme in treated beers, cheese and wine may trigger allergenic reactions." } ] }, { "e_number": "E1200", "name": "Polydextrose", "off_tag": "en:e1200", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e1200", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2021;19(1):6363 — doi:10.2903/j.efsa.2021.6363, Re-evaluation of polydextrose (E 1200)", "finding": "No concern for genotoxicity; no adverse effects in subchronic studies in rats, dogs or monkeys, nor in chronic/carcinogenicity studies in mice and rats at the highest doses tested." } ] }, { "e_number": "E1400", "name": "Dextrin", "off_tag": "en:e1400", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e1400", "citations": [ { "source": "FDA", "ref": "21 CFR 184.1277 (Dextrin)", "finding": "Dextrin is affirmed as generally recognized as safe (GRAS) as a direct human food ingredient, used as a formulation aid, processing aid, stabilizer and thickener, and surface-finishing agent under cGMP conditions." } ] }, { "e_number": "E14xx", "name": "Modified starch (generic node)", "off_tag": "en:e14xx", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e14xx", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4911 (PMC7009865)", "finding": "Re-evaluation of modified starches E 1404, 1410, 1412, 1413, 1414, 1420, 1422, 1440, 1442, 1450, 1451, 1452: previous ADI 'not specified' upheld, no need for a numerical ADI, no safety concern at reported uses and use levels for the general population; modified starches are hydrolysed by intestinal enzymes and fermented by the microbiota rather than absorbed intact." }, { "source": "EFSA", "ref": "10.2903/j.efsa.2020.5874", "finding": "Follow-up on starch sodium octenyl succinate (E 1450) in foods for infants below 16 weeks: available data did not allow an adequate safety assessment at authorised maximum use levels in infant formula (gastrointestinal symptoms reported)." }, { "source": "OFF", "ref": "Open Food Facts additives taxonomy node en:e14xx (live taxonomy, 683 nodes, verified 2026-08-10)", "finding": "OFF names this node 'E14XX - Modified Starch'; there is no 'en:e1499' node in the taxonomy, confirming that 'e14xx' is the correct E-number for this entry." } ] }, { "e_number": "E1422", "name": "Acetylated distarch adipate", "off_tag": "en:e1422", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e1422", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4911 (PMC7009865)", "finding": "Re-evaluation of modified starches including acetylated distarch adipate (E 1422): ADI 'not specified' upheld, no need for a numerical ADI, no safety concern at the reported uses and use levels for the general population." } ] }, { "e_number": "E1442", "name": "Hydroxypropyl distarch phosphate", "off_tag": "en:e1442", "category": "thickener", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e1442", "citations": [ { "source": "EFSA", "ref": "10.2903/j.efsa.2017.4911 (PMC7009865)", "finding": "Re-evaluation of modified starches including hydroxypropyl distarch phosphate (E 1442): no need for a numerical ADI; no safety concern for the general population at reported uses and use levels; phosphate-containing members assessed by read-across within the group with no separate concern raised." } ] }, { "e_number": "E1510", "name": "Ethanol", "off_tag": "en:e1510", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "low", "permalink": "https://sito.kids/additives#e1510", "citations": [ { "source": "IARC", "ref": "IARC Monographs Vol. 100E (2012) — Personal habits and indoor combustions: alcoholic beverages", "finding": "'Alcoholic beverages' and 'ethanol in alcoholic beverages' are classified Group 1 (carcinogenic to humans). The evaluation addresses beverage-level consumption, not trace carrier solvent." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — ethyl alcohol", "finding": "Listed for US food use as a solvent/carrier; no additive-level restriction identified." } ] }, { "e_number": "E1519", "name": "Benzyl alcohol", "off_tag": "en:e1519", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "high", "permalink": "https://sito.kids/additives#e1519", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2019;17(10):5876 — doi:10.2903/j.efsa.2019.5876, Re-evaluation of benzyl alcohol (E 1519)", "finding": "ADI of 4 mg/kg bw/day established; low acute toxicity, no genotoxicity or carcinogenicity concern; refined exposure maximally 0.27 (mean) and 0.81 (P95) mg/kg bw/day in toddlers, below the ADI in all population groups." } ] }, { "e_number": "E1520", "name": "Propylene glycol", "off_tag": "en:e1520", "category": "other", "risk_class": "none", "risk_class_label": "No risk identified", "points_removed": 0, "child_flag": false, "confidence": "medium", "permalink": "https://sito.kids/additives#e1520", "citations": [ { "source": "EFSA", "ref": "EFSA Journal 2018;16(4):5235 — doi:10.2903/j.efsa.2018.5235, Re-evaluation of propane-1,2-diol (E 1520)", "finding": "No reason to revise the ADI of 25 mg/kg bw/day; mean and P95 refined brand-loyal exposure did not exceed the ADI in any population group." }, { "source": "FDA", "ref": "FDA Substances Added to Food inventory — propylene glycol", "finding": "GRAS direct food substance (humectant, solvent, carrier)." } ] } ] }