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Abstract The present opinion is the follow‐up of the conclusions and recommendations of the Scientific Opinion on the re‐evaluation of silicon dioxide (E 551) as a food additive relevant to the safety assessment for all age groups. In addition, the risk assessment of silicon dioxide (E 551) for its use in food for infants below 16 weeks of age is performed. Based on the newly available information on the characterisation of the SAS used as E 551 and following the principles of the 2021 EFSA Guidance on Particle‐TR, the conventional safety assessment has been complemented with nano‐specific considerations. Given the uncertainties resulting from the limitations of the database and in the absence of genotoxicity concern, the Panel considered that it is not appropriate to derive an acceptable daily intake (ADI) but applied the margin of exposure (MOE) approach for the risk assessment. The Panel concluded that the MOE should be at least 36 for not raising a safety concern. The calculated MOEs considering the dietary exposure estimates for all population groups using the refined non‐brand loyal scenario, estimated at the time of the 2018 re‐evaluation, were all above 36. The Panel concluded that E 551 does not raise a safety concern in all population groups at the reported uses and use levels. The use of E 551 in food for infants below 16 weeks of age in FC 13.1.1 and FC 13.1.5.1 does not raise a safety concern at the current exposure levels. The Panel also concluded that the technical data provided support an amendment of the specifications for E 551 laid down in Commission Regulation (EU) No 231/2012. The paucity of toxicological studies with proper dispersion protocol (with the exception of the genotoxicity studies) creates uncertainty in the present assessment of the potential toxicological effects related to the exposure to E 551 nanosize aggregates.

Abstract The present opinion deals with the re‐evaluation of shellac (E 904) when used as a food additive and with the new application on the extension of use of shellac (E 904) in dietary foods for special medical purposes. The Panel derived an acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day for wax‐free shellac (E 904) produced by physical decolouring, based on a NOAEL of 400 mg/kg bw per day and applying an uncertainty factor of 100. The Panel concluded that the ADI of 4 mg/kg bw per day should be considered temporary for wax‐free shellac (E 904) produced by chemical bleaching, while new data are generated on the identity and levels of the organochlorine impurities in E 904. This ADI is not applicable for wax‐containing shellac as a food additive. For several age groups, the ADI was exceeded at the 95th percentile in the non‐brand‐loyal exposure assessment scenario and maximum level exposure assessment scenario. Considering the low exceedance and the fact that both the exposure estimation and the toxicological evaluation of shellac were conservative, the panel concluded that the calculated exceedance of the ADI does not indicate a safety concern. The Panel recommended to the European Commission separating specifications for E 904 depending on the manufacturing process, chemical bleaching and physical decolouring, because they result in different impurities; revising the definition of the food additive to include a description of each manufacturing process; deleting information on wax‐containing shellac from the EU specifications; revising the acid value for wax‐free shellac produced by chemical bleaching; lowering the maximum limit for lead; to consider introducing limits for other toxic elements potentially present in shellac; including a maximum limit for chloroform and total inorganic chloride in the EU specification for shellac produced by chemical bleaching.

Abstract Guar gum (E 412) was re‐evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow‐up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of guar gum (E 412) for its uses as food additive in food for infants below 16 weeks of age belonging to food categories 13.1.1 (Infant formulae) and 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants). In addition, the FAF Panel was requested to address the issues already identified during the re‐evaluation of the food additive when used in food for the general population. The process involved the publication of a call for data to allow the interested business operators to provide the requested information to complete the risk assessment. In the response to EFSA requests, one IBO stated that E 412 is not used in food categories 13.1.1 and 13.1.5.1, but it is present in products under food category 13.1.5.2. The Panel concluded that the submitted data are not sufficient to support the safe use of guar gum (E 412) in food for infants (below and above 16 weeks of age) and young children under FC 13.1.1, 13.1.5.1 and 13.1.5.2. Additionally, the Panel concluded that the technical data provided by the IBO support further amendments of the specifications for E 412 laid down in Commission Regulation (EU) No 231/2012.

Abstract Quillaia extract (E 999) was re‐evaluated in 2019 by the EFSA Panel on Food Additives and Flavourings (FAF). EFSA derived an acceptable daily intake (ADI) of 3 mg saponins/kg bw per day for E 999. Following a European Commission call for data to submit data to fill the data gaps, the present follow‐up opinion assesses data provided by interested business operators (IBOs) to support an amendment of the EU specifications for E 999. Additionally, this opinion deals with the assessment of the proposed extension of use for E 999 in food supplements supplied in a solid and liquid form, excluding food supplements for infants and young children and, as a carrier in botanical nutrients. The Panel concluded that the proposed extension of use, if authorised, could result in an exceedance of the ADI at the maximum of the ranges of the mean for children, adolescents and the elderly, and for all populations at the 95th percentile. An additional proposed extension of use for E 999 to be used as a carrier for glazing agents on entire fresh fruits and vegetables has been received. Since no information on the proposed use levels of E 999 on a saponins content basis has been provided by this applicant, the Panel was not able to evaluate the safety of this extension of use. Considering the technical data submitted, the Panel recommended some modifications of the existing EU specifications for E 999, mainly to lower the limits for lead, mercury and arsenic and to include a maximum limit for cadmium and for calcium oxalate. The Panel also recommended that the limits would be expressed on a saponins basis. The Panel proposed to revise the definition of E 999 to better describe the composition in a qualitative way.

Abstract This opinion addresses the re‐evaluation of erythritol (E 968) as food additive and an application for its exemption from the laxative warning label requirement as established under Regulation (EU) No 1169/2011. Erythritol is a polyol obtained by fermentation with Moniliella pollinis BC or Moniliella megachiliensis KW3‐6, followed by purifications and drying. Erythritol is readily and dose‐dependently absorbed in humans and can be metabolised to erythronate to a small extent. Erythritol is then excreted unchanged in the urine. It does not raise concerns regarding genotoxicity. The dataset evaluated consisted of human interventional studies. The Panel considered that erythritol has the potential to cause diarrhoea in humans, which was considered adverse because its potential association with electrolyte and water imbalance. The lower bound of the range of no observed adverse effect levels (NOAELs) for diarrhoea of 0.5 g/kg body weight (bw) was identified as reference point. The Panel considered appropriate to set a numerical acceptable daily intake (ADI) at the level of the reference point. An ADI of 0.5 g/kg bw per day was considered by the Panel to be protective for the immediate laxative effect as well as potential chronic effects, secondary to diarrhoea. The highest mean and 95th percentile chronic exposure was in children (742 mg/kg bw per day) and adolescents (1532 mg/kg bw per day). Acute exposure was maximally 3531 mg/kg bw per meal for children at the 99th percentile. Overall, the Panel considered both dietary exposure assessments an overestimation. The Panel concluded that the exposure estimates for both acute and chronic dietary exposure to erythritol (E 968) were above the ADI, indicating that individuals with high intake may be at risk of experiencing adverse effects after single and repeated exposure. Concerning the new application, the Panel concluded that the available data do not support the proposal for exemption.

Abstract Glycerol esters of wood rosin (GEWR) (E 445) were re‐evaluated in 2018. On the toxicity database and given the absence of reproductive and developmental toxicity data, the acceptable daily intake (ADI) of 12.5 mg/kg body weight (bw) per day for GEWR (E 445) established by the Scientific Committee on Food (SCF) in 1994 was considered temporary. The conclusions of the assessment were restricted to GEWR derived from Pinus palustris and Pinus elliottii and with a chemical composition in compliance with GEWR used in the toxicological testing. Following a European Commission call for data to submit data to fill the data gaps, the present follow‐up opinion assesses data provided by interested business operators (IBOs). Considering the technical data submitted by IBOs, the EFSA Panel on Food Additives and Flavourings (FAF Panel) recommended some modifications of the existing EU specifications for E 445, mainly a revision of the definition of the food additive and lowering the limits for toxic elements. Considering the available toxicological database evaluated during the re‐evaluation of E 445 by the ANS Panel in 2018, and the toxicological studies submitted by the IBOs, the Panel established an ADI of 10 mg/kg bw per day based on the no observed adverse effect level (NOAEL) of 976 mg/kg bw per day from the newly available dietary reproduction/developmental toxicity screening study in rats and applying an uncertainty factor of 100. Since GEWR from P. palustris and P. elliottii were tested in the toxicity studies considered to establish the ADI and in the absence of detailed information on the chemical composition (major constituents) in GEWR generated from other Pinus species, thus not allowing read across, the ADI is restricted to the GEWR (E 445) manufactured from P. palustris and P. elliottii. The Panel concluded that there was no safety concern for the use of GEWR (E 445), at either the maximum permitted levels or at the reported uses and use levels.

Abstract Calcium carbonate (E 170) was re‐evaluated in 2011 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow‐up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of calcium carbonate (E 170) for its uses as a food additive in food for infants below 16 weeks of age belonging to food category 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) and as carry over in line with Annex III, Part 5 Section B to Regulation (EC) No 1333/2008. In addition, the FAF Panel was requested to address the issues already identified during the re‐evaluation of the food additive when used in food for the general population. The process involved the publication of a call for data to allow the interested business operators (IBOs) to provide the requested information to complete the risk assessment. The Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for calcium carbonate and that, in principle, there are no safety concern with respect to the exposure to calcium carbonate per se at the currently reported uses and use levels in all age groups of the population, including infants below 16 weeks of age. With respect to the calcium intake resulting from the use of E 170 in food for the general population and infants

Abstract Indigo carmine (E 312) was re‐evaluated in 2014 by the EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). The ANS Panel confirmed the acceptable daily intake (ADI) of 5 mg/kg body weight (bw) per day for indigo carmine allocated by JECFA (1975). The ANS Panel indicated that the ADI was applicable to a material with a purity of 93% pure colouring and manufactured using processes resulting in comparable residuals as material used in the Borzelleca et al. studies (1985, 1986) and Borzelleca and Hogan (1985) which were the basis for deriving the ADI. The ANS Panel considered that any extension of the ADI to indigo carmine of lower purity and/or manufactured using a different process would require new data to address the adverse effects on the testes observed in the Dixit and Goyal (2013) study. Following a European Commission call for data to submit data to fill the data gaps, an IBO submitted technical and toxicological data. Considering the technical data, the EFSA Panel on Food Additives and Flavourings (FAF Panel) recommended some modifications of the existing EU specifications for E 132, mainly to lower the limits for toxic elements. Considering the toxicological data, an IBO has submitted a 56‐day dietary study to address the adverse effects on testes using a material with 88% purity. The results of this study submitted did not confirm the severe adverse effects observed in the Dixit and Goyal study. Considering all the available information, the Panel confirmed the ADI of 5 mg/kg bw per day for indigo carmine (E 132) disodium salts, meeting the proposed revisions of the specifications (85% minimum for the colouring matter). The Panel concluded that there is no safety concern for the use of indigo carmine (E 132) disodium salts at the reported use levels and submitted analytical data.

Abstract Xanthan gum (E 415) was re‐evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food. As a follow‐up to that assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of xanthan gum (E 415) for its uses as a food additive in food for infants below 16 weeks of age belonging to food category (FC) 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants). In addition, the FAF Panel was requested to address the issues already identified during the re‐evaluation of the food additive when used in food for the general population. The process involved the publication of a call for data to allow the interested business operators to provide the requested information to complete the risk assessment. The Panel concluded that the technical data provided by the interested business operators support an amendment of the specifications for E 415 laid down in Commission Regulation (EU) No 231/2012. Due to the low validity of the available clinical studies, the Panel concluded that a reference point could not be derived from them but the results of the available studies on neonatal piglets could serve to derive a reference point. The Panel calculated the margin of exposure for infants below 16 weeks of age consuming food for special medical purposes (FC 13.1.5.1) for the highest xanthan gum exposure and concluded that there are no safety concerns for the use of xanthan gum (E 415) as a food additive in FC 13.1.5.1.

Abstract Sucrose esters of fatty acids (E 473) was re‐evaluated in 2004 by the former EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC Panel). In addition, the former EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) issued scientific opinions on the safety of sucrose esters of fatty acids (E 473) in 2010, 2012 and 2018. As a follow‐up to these assessments, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of sucrose esters of fatty acids (E 473) for its uses as food additive in food for infants below 16 weeks of age. In addition, the FAF Panel was requested to address the issues already identified by the EFSA AFC and ANS Panels when used in food for the general population. The process involved the publication of calls for data to allow the interested business operators to provide the requested information to complete the risk assessment. The Panel concluded that the technical data provided by the interested business operators support an amendment of the specifications for sucrose esters of fatty acids (E 473) laid down in Commission Regulation (EU) No 231/2012. According to the available information, E 473 is not used in food categories (FCs) 13.1.1 and 13.1.5.1, including all types of food for infants below 16 weeks of age, and in FC 13.1.5.2. As a consequence, an assessment of the safety for the uses of E 473 as food additive in these FCs and age group was not performed. When the updated exposure estimates considering the provided use levels for some food categories are taken into account 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.

Abstract Locust bean gum (E 410) was re‐evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow‐up to that assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of locust bean gum (E 410) for its uses as a food additive in food for infants below 16 weeks of age belonging to food category 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants). In addition, the FAF Panel was requested to address the issues already identified during the re‐evaluation of the food additive when used in food for the general population, including the safety assessment for FC 13.1.5.1 and 13.1.5.2 (Dietary foods for babies and young children for special medical purposes as defined in directive 1999/21/EC). The process involved the publication of a call for data. Based on the received data, the Panel concluded that the technical data provided by the interested business operators support an amendment of the specifications for locust bean gum (E 410) laid down in Commission Regulation (EU) No 231/2012. The Panel identified a reference point of 1,400 mg/kg bw per day based on reduced blood zinc levels in a piglet study. It applied the margin of exposure (MoE) for the safety assessment of locust bean gum (E 410) when used as a food additive in FC 13.1.5.1 and 13.1.5.2. The Panel concluded that a MoE above 1 would not raise a safety concern. A MoE above 1 was obtained for some of the scenarios and exposure levels for infants. For toddlers (consumers only of food for special medical purposes), the MoE was above 1 for all exposure levels.

Abstract Sodium carboxy methyl cellulose (E 466) was re‐evaluated in 2018 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow‐up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of E 466 for its uses as a food additive in food for infants below 16 weeks of age belonging to food categories (FC) 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) in line with Regulation (EC) No 1333/2008. In addition, the FAF Panel was requested to address the issues already identified during the re‐evaluation of the food additive when used in food for the general population, including the safety assessment for FC 13.1.5.1 and 13.1.5.2 (Dietary foods for babies and young children for special medical purposes as defined in directive 1999/21/EC). The process involved the publication of a call for data. Based on the received data, the Panel concluded that the technical data provided by the interested business operator support an amendment of the specifications for sodium carboxy methyl cellulose (E 466) laid down in Commission Regulation (EU) No 231/2012. The interested business operators declared that E 466 is not used in food for infants below 16 weeks of age and in FC 13.1.5.1. Due to the lack of data, an assessment has not been performed for this FC and age group. The interested business operators did not provide biological and toxicological data to support the uses of E 466 in FC 13.1.5.2. Due to the almost unchanged database compared to the situation before the call for data, the FAF Panel confirmed the previous EFSA ANS Panel conclusion according to which the available data did not allow for an adequate assessment of the safety of use of sodium carboxy methyl cellulose (E 466) in infants and young children consuming foods belonging to the FC 13.1.5.2. ©2022 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Abstract The present opinion deals with the re‐evaluation of neohesperidine dihydrochalcone (E 959) when used as a food additive. It is obtained by catalytic hydrogenation of a flavanone – neohesperidine – which is naturally occurring and thus isolated by alcohol extraction in bitter oranges (Citrus aurantium). Based on in vivo data in rat, neohesperidine dihydrochalcone is likely to be absorbed, also in humans, and to become systemically available. It does not raise a concern regarding genotoxicity. The toxicity data set consisted of studies on subchronic and prenatal developmental toxicity. No human studies were available. The data set was considered sufficient to derive a new acceptable daily intake (ADI). Based on the weight of evidence (WoE) analysis, the Panel considered unlikely that neohesperidine dihydrochalcone would lead to adverse effects on health in animals in the dose ranges tested. The Panel also considered that a carcinogenicity study was not warranted and that the lack of human data did not affect the overall confidence in the body of evidence. The Panel derived an ADI of 20 mg/kg bodyweight (bw) per day based on a no observed adverse effect level (NOAEL) of 4,000 mg/kg bw per day from a 13‐week study in rat, applying the standard default factors of 100 for inter‐ and intraspecies differences and of 2 for extrapolation from subchronic to chronic exposure. For the refined brand‐loyal exposure assessment scenario, considered to be the most appropriate for the risk assessment, the exposure estimates at the mean ranged from

Abstract The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of buffered vinegar as a new food additive. Buffered vinegar is a liquid or dried product prepared by adding sodium/potassium hydroxides (E 524 to E 525) and sodium/potassium carbonates (E 500 to E 501) to vinegar, compliant with European Standard EN 13188:2000 and exclusively obtained from an agricultural source origin (except wood/cellulose). The primary constituents of buffered vinegar are acetic acid and its salts. No biological or toxicological data obtained with the proposed food additive were submitted by the applicant as part of the dossier as, following oral ingestion, buffered vinegar dissociates into the acetic anion a natural constituent of the diet, and of the human body for which extensive data on their biological effects exist and for which EFSA in 2013 has previously concluded that the establishment of an acceptable daily intake (ADI) is not considered necessary. At the proposed maximum/typical use levels, the mean exposure to buffered vinegar from its use as a food additive expressed as acetic acid equivalents ranged from 8.9 mg/kg body weight (bw) per day in infants to 280.3 mg/kg bw per day in children. The 95th percentile of exposure to buffered vinegar ranged from 27.9 mg/kg bw per day in infants to 1,078 mg/kg bw per day in toddlers. The Panel concluded that there is no safety concern for the use of buffered vinegar as a food additive at the proposed maximum/typical use levels. The Panel could not conclude on the safety for the proposed uses at quantum satis as Group I food additive since the resulting exposure could not be estimated.

Abstract Glycerol (E 422) was re‐evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow‐up to that assessment, in this opinion, the Panel on Food Additives and Flavourings (FAF) addresses the data gaps identified to support an amendment of the EU specifications for E 422 in Commission Regulation (EU) No 231/2012. The Panel performed a risk assessment of undesirable impurities present in E 422. The Panel concluded that the maximum limits in the EU specifications for the four toxic elements (arsenic, lead, mercury and cadmium) should be lowered based on actual levels in the commercial food additive E 422. The Panel recommended setting a numerical limit value for acrolein in the specifications for E 422. The potential exposure to free 3‐monochloropropanediol at the maximum limit of 0.1 mg/kg, as laid out in the specifications for E 422, does not give rise to a health concern. The Panel recommended to consider modifying the definition of E 422 in Commission Regulation (EU) No 231/2012 indicating that E 422 is obtained only from vegetable oils and fats and undergoes purification processes that involve distillation, and other clean up steps to obtain refined glycerol. Overall, the Panel concluded that the technical data provided support an amendment of the specifications for glycerol (E 422).

Abstract Polyglycerol polyricinoleate (PGPR, E 476) was re‐evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow‐up to this assessment, in this opinion, the Panel on Food Additives and Flavouring (FAF) addresses the data gaps identified to support an amendment of the EU specifications for E 476. Additionally, this opinion deals with the assessment of the proposed extension of use for E 476 in edible ices and a revision of the maximum permitted level in emulsified sauces. The Panel concluded that the proposed extension of use, if authorised, would not give rise to a safety concern. Additionally, the Panel performed a risk assessment of undesirable impurities potentially present in E 476. The Panel concluded that the maximum limits in the EU specifications for the four toxic elements (arsenic, lead, mercury, cadmium) should be lowered based on actual levels in the commercial food additive E 476. The Panel also concluded that maximum limits for glycidyl esters and 3‐monochloropropanediol should be included in the EU specifications for E 476. Alternatively, the Panel recommends an amendment of the definition of E 476 to include a requirement that the fats and oils used in the manufacturing of E 476 comply with the respective EU legislation regarding suitability for human consumption. Further, the Panel recommends a modification of the definition of E 476 indicating that polyglycerol used for the manufacturing of E 476 should be produced from glycerol meeting the specifications for E 422 (Commission Regulation (EU) No 231/2012). In this case, respective specification limits for epichlorohydrin, acrolein and butanetriol would not be needed for E 476. Finally, the Panel concluded that the proposed method based on the determination of ricinoleic acid is suitable for the determination of E 476 content in food.

Abstract Polyglycerol esters of fatty acids (PEFA, E 475) was re‐evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow‐up to this assessment, in this opinion, the Panel on Food Additives and Flavouring (FAF) addresses the data gaps identified to support an amendment of the EU specifications for E 475. The Panel performed a risk assessment of undesirable impurities and constituents potentially present in E 475. The Panel concluded that the maximum limits in the EU specifications for the 4 toxic elements (arsenic, lead, mercury and cadmium) should be lowered based on actual levels in the commercial food additive E 475. The Panel also concluded that maximum limits for erucic acid, 3‐monochloropropanediol and glycidyl esters should be included in the EU specifications for E 475. Alternatively, the Panel recommends an amendment of the definition of E 475 to include a requirement that the fats and oils used in the manufacturing of E 475 comply with the respective EU legislation regarding suitability for human consumption. Further, the Panel concluded that there is no need for setting a specification limit for the content of trans‐fatty acids in E 475 as a limit is established in the Regulation (EU) No 2019/649, i.e. 2 g of trans‐fat per 100 g fat in food for the final consumer. Finally, the Panel recommends a modification of the definition of E 475 indicating that polyglycerol used for the manufacturing of E 475 should be produced from glycerol meeting the specifications for E 422 (Commission Regulation (EU) No 231/2012). In this case, respective specification limits for epichlorohydrin, acrolein and butanetriol would not be needed for E 475.

Abstract The EFSA Panel on Food Additive and Flavourings (FAF) assessed the safety of glucosylated steviol glycosides proposed for use as a new food additive in different food categories. Glucosylated steviol glycosides consist of a mixture of glucosylated steviol glycosides, containing 1–20 additional glucose units bound to the parent steviol glycosides. Glucosylated steviol glycosides consist of not less than 95% (on dry, dextrin‐free, basis) of total steviol glycosides, comprised of glucosylated and parent steviol glycosides. Glucosylated steviol glycosides are produced via enzymatic bioconversion using cyclomaltodextrin glucanotransferase (CGTase) (EC 2.4.1.19), derived from a non‐genetically modified strain of Anoxybacillus caldiproteolyticus, that catalyses the transfer of glucose from starch to steviol glycosides mixtures isolated from the dried leaves of Stevia Rebaudiana. The Panel considered that the metabolism of glucosylated steviol glycosides is sufficiently similar to the already authorised steviol glycosides, and thus, the toxicological data previously assessed by the ANS Panel for steviol glycosides (E 960) were considered to support their safety as food additive. The existing acceptable daily intake (ADI) for steviol glycosides (E 960) of 4 mg/kg body weight (bw) per day expressed as steviol can also be applied to glucosylated steviol glycosides. The Panel concluded that there is no safety concern for the use of glucosylated steviol glycosides as a new food additive at the proposed use and use levels. The Panel recommended some modifications to the specifications proposed by the applicant for glucosylated steviol glycosides with respect to the assay, the definition of the proposed new food additive and the proposed maximum limits for arsenic.

Abstract The present opinion deals with the re‐evaluation of thaumatin (E 957) when used as a food additive. Thaumatin is a natural plant protein, consisting of thaumatin I and thaumatin II proteins together with minor amounts of plant constituents, obtained by acidic aqueous extraction of the arils of the fruit of Thaumatococcus daniellii plant. The Panel followed the conceptual framework for the risk assessment of certain food additives and considered that thaumatin is a digestible protein; adequate exposure estimates were available; there was no concern with respect to the genotoxicity; no conclusion on oral allergenicity could be drawn from the available human data; no adverse effects were observed in sub‐chronic toxicity studies in rats and dogs at the highest dose tested of up 5,200 and 1,476 mg/kg bodyweight (bw) per day, respectively, and in a prenatal developmental toxicity study up to 2,000 mg/kg bw per day; moderate confidence in the body of evidence supported the absence of association between exposure to thaumatin and adverse health outcomes. Therefore, the Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for thaumatin (E 957) and, based on a margin of safety (MOS) of 5,417, considered to be an underestimate and derived using the highest 95th percentile (P95) exposure of 0.48 mg/kg bw per day in consumers only, there is no safety concern for thaumatin (E 957) at the regulatory maximum level exposure assessment scenario, which was considered the most appropriate. The Panel recommended that European Commission considers introducing in the EU specifications for thaumatin (E 957) a new specification limit for the minimum combined content of thaumatin I and II proteins in E 957, a specification limit for yeast, mould counts and Salmonella spp and lowering the existing maximum limit for arsenic along with the inclusion of maximum limits for mercury and cadmium.

Abstract Mono‐ and diglycerides of fatty acids (E 471) was re‐evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow‐up to this assessment, the Panel on Food Additives and Flavouring was requested to assess mono‐ and diglycerides of fatty acids (E 471) for its use as food additive in food for infants below 16 weeks of age belonging to food categories 13.1.1 (Infant formulae) and 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants). In addition, the FAF Panel was requested to address the issues already identified during the re‐evaluation of the food additive in 2017 when used in food for the general population. The Panel considered that there is no indication of adverse effects from the available animal studies at the highest dose tested and from the post marketing data. A comparison was made between the daily exposure to the sum of mono‐ and di‐acylglycerols from breast milk and that resulting from the use of E 471 in the infant formula. The Panel noted that the resulting exposures are in the same order of magnitude. Overall, the Panel concluded that there is no reason for a safety concern when E 471 used as food additive in FC 13.1.1 and 13.1.5.1 and according to the Annex III to Regulation (EC) No 1333/2008. The risk assessment for toxic elements and impurities clearly indicated the need to lower the current maximum limits for arsenic, lead, cadmium and mercury and to include limits for glycidyl esters, 3‐monochloropropane diol and erucic acid in the EU specifications of E 471.

Abstract The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of crosslinked polyacrylic acid polymers (carbomer) proposed for use as food additive in solid and liquid food supplements. Carbomer is formed from the monomer, acrylic acid, which is polymerised and crosslinked with allyl pentaerythritol (APE). The polymers are synthesised in ethyl acetate using ■■■■■ as free‐radical polymerisation initiator. In vivo data showed no evidence for systemic availability or biotransformation of carbomer. Carbomer does not raise a concern regarding genotoxicity. Considering the available data set, the Panel derived an acceptable daily intake (ADI) of 190 mg/kg body weight (bw) per day based on a no observed adverse effect level (NOAEL) of 1,500 mg/kg bw per day from a sub‐chronic 13‐week study in rat, applying a compound specific uncertainty factor (UF) of 8. At the proposed maximum use levels, the exposure estimates ranged at the mean from 1.1 to 90.2 mg/kg bw per day and at the p95 from 12.5 to 237.4 mg/kg bw per day. At the proposed typical use level, the exposure estimates ranged at the mean from 0.7 to 60.2 mg/kg bw per day and at the p95 from 10.3 to 159.5 mg/kg bw per day. The Panel noted that the maximum proposed use levels would result in exposure estimates close to or above the ADI. The Panel also noted that level of exposure to carbomer from its proposed use is likely to be an overestimation. Taking a conservative approach, the Panel considered that exposure to carbomer would not give rise to a safety concern if the proposed maximum use level for solid food supplements is lowered to the typical use level reported by the applicant.

Abstract The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of long‐chain glycolipids from Dacryopinax spathularia (also called AM‐1) as a food additive. AM‐1 is a purified mixture of long‐chain glycolipid congeners obtained by fermentation of the edible non‐genetically modified fungus Dacryopinax spathularia. AM‐1 glycolipids have very low oral bioavailability and overall available toxicology data do not demonstrate any adverse effects of the proposed food additive. Considering the available data set the Panel established an ADI of 10 mg/kg bw per day based on a range of NOAELs between 1,000 and 1,423 mg/kg bw per day (the highest doses tested), from the reproductive and a prenatal developmental toxicity studies in rats and 90‐day studies in rat and dog. At the proposed maximum use levels, the exposure estimates ranged at the mean from 0.01 to 1.07 mg/kg bw per day and at the p95 from 0 to 3.1 mg/kg mg/kg bw per day. At the proposed typical use levels, the exposure estimates ranged at the mean from < 0.01 mg/kg bw per day to 0.23 mg/kg bw per day and at the p95 from 0 to 0.64 mg/kg bw per day. The Panel noted that the highest estimate of exposure of 3.1 mg/kg bw per day (in toddlers) is within the established ADI of 10 mg/kg bw per day and concluded that the exposure to long‐chain glycolipids from Dacryopinax spathularia does not raise a safety concern at the uses and use levels proposed by the applicant.

Abstract Pectin (E 440i) and amidated pectin (E 440ii) were re‐evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow‐up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of pectins (E 440i,ii) for their uses as food additives in food for infants below 16 weeks of age. In addition, the FAF Panel was requested to address the issues already identified during the re‐evaluation of the same food additive. The process involved the publication of a call for data to allow the interested business operators to provide the requested information to complete the risk assessment. Based on the information submitted in response to the call for data, the FAF Panel considered it feasible to amend the current specifications, in particular for the toxic elements arsenic, lead, cadmium, mercury and for sulfur dioxide and to introduce new specifications for aluminium and microbiological criteria. Studies on neonatal piglets, clinical studies and post‐marketing data were made available during the call for data. Due to the low internal validity of the clinical studies, the Panel concluded that a reference point could not be derived from them, but the results of the adequate piglet study could serve to derive a reference point. When calculating the margin of safety for pectins exposure, this was below 1 for some scenarios. At the maximum permitted levels (MPLs), an internal methanol dose would be produced that could lead to adverse health effects in infants below 16 weeks of age. The FAF Panel recommended a reduction of the MPL of pectin (E 440i) and amidated pectin (E 440ii) in food categories 13.1.5.1 and 13.1.5.2, in order to reduce the exposure to both the additives themselves and to methanol.

Abstract This opinion deals with the re‐evaluation of polydextrose (E 1200) when used as a food additive. The Panel followed the conceptual framework for the risk assessment of certain additives and considered that: adequate exposure estimates were available; the margin of safety (MOS)/margin of exposure (MOE) for arsenic was between 0.5‐14 and 8.5 for lead; the exhaustions of the tolerable weekly intake (TWI) for cadmium would be 165%, 10% for mercury, whereas the exhaustion of the tolerable daily intake (TDI) for nickel would be 9%; the absorption is limited and part of polydextrose is fermented in the large intestine into short‐chain fatty acids (SCFA); adequate toxicity data were available; there is no concern with respect to genotoxicity; no adverse effects were reported in subchronic studies in rats, dogs or monkeys nor in chronic or carcinogenicity studies in mice and rats at the highest doses tested of up 12,500 mg/kg body weight (bw) per day and 15,000 mg/kg bw per day, respectively; the nephrocalcinosis in dogs given high doses of polydextrose was considered to be a treatment‐related but a secondary effect related to diarrhoea, and hence not relevant for the risk assessment; no adverse effects were reported in reproductive or developmental toxicity studies in rats administered up to 10,000 mg polydextrose/kg bw per day, or in a developmental toxicity study in rabbits up to 1,818 mg/kg bw per day (the highest dose tested). Therefore, the Panel concluded that there is no need for numerical acceptable daily intake (ADI) for polydextrose (E 1200), and that there is no safety concern for the reported uses and use levels of polydextrose as a food additive. The Panel recommended that European Commission considers to lower the maximum limit for lead and to introduce limits for arsenic, cadmium and mercury in the EU specifications for polydextrose (E 1200), and to verify that polydextrose‐N as a food additive (E 1200) is no longer marketed in the EU.

Abstract Lecithins (E 322) were re‐evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As follow‐up to that assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of lecithins (E 322) for uses as food additive in food for infants below 16 weeks of age belonging to food categories 13.1.1 and 13.1.5.1 and as carry over in line with Annex III to Regulation (EC) No 1333/2008. In addition, the FAF Panel was requested to address the issues identified during the re‐evaluation of the food additive (E 322). The process involved the publication of a call for data to allow the interested business operators to provide the requested information to complete the risk assessment. Based on the information submitted in response to the call for data, the FAF Panel considered it feasible to amend the EU specifications, in particular for the toxic elements arsenic, lead, mercury and introduce new specifications for cadmium and microbiological criteria. The safety issue identified by the ANS Panel in 2017 concerned potential neurodevelopmental effects. For the reason that choline is a precursor of the neurotransmitter acetylcholine, the Panel considered it appropriate to address the safety of lecithins (E 322) as food additive in infant formula used in infants below the age of 16 weeks by comparing the concentration of choline in human milk with that in the formula. The Panel concluded that the intake of lecithins (E 322) as a food additive in infant formula belonging to FC 13.1.1 or in food for special medical purposes belonging to FC 13.1.5.1 does not raise safety concerns up to the maximum permitted level (MPL) of lecithins (E 322).

Abstract As a follow‐up to the re‐evaluation of starch sodium octenyl succinate (SSOS; E 1450), the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of SSOS (E 1450) when used in food for infants below 16 weeks of age for food categories 13.1.5.1 and 13.1.1 and to address the data gaps identified during the re‐evaluation of the SSOS (E 1450). The process involved the publication of a call for data. The Panel considered it feasible to amend the specifications based on the analytical evidence submitted. In the call for data, clinical trials were submitted to support the safe use in this age group. In addition, the report of a postnatal piglet study was provided. Due to the low internal validity of the clinical studies, the Panel concluded that a reference point could not be derived from them. The Panel noted that the uncertainty surrounding the results of the piglet study precludes deriving a reference point from this study. On the other hand, both data sources did not clearly indicate an adverse effect due to SSOS (E 1450). Given the available data, the Panel concluded that at use levels of SSOS in food for infants below 16 weeks within the range reported in the clinical studies (up to 2,725 mg/kg body weight (bw) per day), there is no indication for safety concern and reiterated the conclusion of the Panel on Food Additives and Nutrient Sources added to Food (ANS) that there was no need for a numerical acceptable daily intake (ADI). When extrapolating this conclusion to the safety assessment of the food additive when used in food categories (FCs) 13.1.5.1 and 13.1.5.2 in food for infants above 16 weeks of age and young children, the Panel considered that there is no indication for safety concern also for these uses within the range reported in the clinical studies.

Abstract Ascorbyl palmitate (E 304(i)) was re‐evaluated in 2015 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow‐up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of ascorbyl palmitate (E 304(i)) for its uses as food additive in food for infants below 16 weeks of age belonging to food categories 13.1.1 (Infant formulae) and 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) and as carry over in line with Annex III, Part 5 Section B to Regulation (EC) No 1333/2008. In addition, the FAF Panel was requested to address the issues already identified during the re‐evaluation of the food additive when used in food for the general population. The process involved the publication of a call for data to allow the interested business operators to provide the requested information to complete the risk assessment. On the basis of the data submitted by interested business operators and the considerations from the Panel, a revision of the existing EU specifications for ascorbyl palmitate (E 304 (i)) has been recommended. Based on in vitro data, the FAF Panel assumed that ascorbyl palmitate fully hydrolyses pre‐systemically to ascorbic acid and palmitate. The Panel concluded that the intake of both metabolites, at the MPLs for ascorbyl palmitate as a food additive in infant formula belonging to FC 13.1.1 or in food for special medical purposes belonging to FC 13.1.5.1, does not raise health concerns.

Abstract The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of the proposed amendment of the specifications for steviol glycosides (E 960) as a food additive, in particular to expand the list of steviol glycosides to 60 steviol glycosides identified in the leaves of Stevia Rebaudiana Bertoni. With the existing specifications, the food additive must be comprised of not less than 95% of the 11 named steviol glycosides. The proposed change is to include all 60 steviol glycosides in the same limit value of 95% and this would allow the presence of up to 5% of impurities. FAF Panel considered that all steviol glycosides share the same metabolic fate, and therefore, the safety of 60 identified steviol glycosides can be based on read‐across from toxicological data previously evaluated by EFSA and the acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day will apply to all those steviol glycosides. However, according to the proposed change in specifications, there remains a small but not insignificant fraction of the additive that would be undefined and therefore cannot be evaluated by the Panel. The Panel concluded that the inclusion of the 60 steviol glycosides in the proposed specifications for steviol glycoside (E960) would not be of safety concern. However, the Panel cannot conclude on the safety of the proposed amendment to the specifications of steviol glycosides (E 960) as food additive if the purity assay value of not less than 95% for the total content of steviol glycosides is maintained.

Abstract The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re‐evaluating the safety of metatartaric acid (E 353) when used as a food additive. Metatartaric acid (E 353) had been previously evaluated by the Scientific Committee on Food (SCF) and Joint FAO/WHO Expert Committee on Food Additives (JECFA). Based on the presumption that metatartaric acid is fully hydrolysed pre‐systemically to l(+)‐tartaric acid, the Panel concluded that metatartaric acid (E 353) should be included in the group acceptable daily intake (ADI) of 240 mg/kg body weight (bw) per day, expressed as tartaric acid, for l(+)‐tartaric acid‐tartrates (E 334–337, 354) which was established by the EFSA FAF Panel in 2020. Exposure estimates were calculated for metatartaric acid (E 353) using a maximum level and refined exposure assessment scenario. The Panel also concluded that there is no safety concern for the use of metatartaric acid (E 353) at the reported use and use level. The Panel made a number of recommendations.

Abstract The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re‐evaluating the safety of acetic acid, lactic acid, citric acid, tartaric acid, mono‐ and diacetyltartaric acids, mixed acetic and tartaric acid esters of mono‐ and diglycerides of fatty acids (E 472a‐f) as food additives. All substances had been previously evaluated by the Scientific Committee for Food (SCF) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Hydrolysis of E472a,b,c,e was demonstrated in various experimental systems, although the available data on absorption, distribution, metabolism, excretion (ADME) were limited. The Panel assumed that E472a‐f are extensively hydrolysed in the GI tract and/or (pre‐)systemically after absorption into their individual hydrolysis products which are all normal dietary constituents and are metabolised or excreted intact. No adverse effects relevant for humans have been identified from the toxicological database available for E472a‐f. The Panel considered that there is no need for a numerical acceptable daily intake (ADI) for E 472a,b,c. The Panel also considered that only l(+)‐tartaric acid has to be used in the manufacturing process of E472d,e,f. The Panel established ADIs for E 472d,e,f based on the group ADI of 240 mg/kg body weight (bw) per day, expressed as tartaric acid, for l(+)‐tartaric acid‐tartrates (E334‐337, 354) and considering the total amount of l(+)‐tartaric acid in each food additive. Exposure estimates were calculated for all food additives individually, except for E 472e and f, using maximum level, refined exposure and food supplements consumers only scenarios. Considering the exposure estimates, there is no safety concern at their reported uses and use levels. In addition, exposure to tartaric acid released from the use of E 472d,e,f was calculated. The Panel also proposed a number of recommendations.

Abstract The Panel on Food Additives and Flavourings added to food (FAF) provided a scientific opinion re‐evaluating the safety of hydrogenated poly‐1‐decene (E 907) when used as a food additive. Hydrogenated poly‐1‐decene (E 907) is authorised as a food additive in the EU in accordance with Annex II to Regulation (EC) No 1333/2008. Hydrogenated poly‐1‐decene is of low acute toxicity and does not raise concern for genotoxicity. Toxicity and carcinogenicity, as well as reproductive and developmental toxicological studies, were not available; therefore, the Panel based the derivation of the acceptable daily intake (ADI) on the no observed adverse effect level (NOAEL) identified in the subchronic study in rats and established an ADI of 20 mg/kg bw per day. Dietary exposure to hydrogenated poly‐1‐decene (E 907) from its use as a food additive was calculated based on regulatory maximum level exposure assessment scenario. Mean exposure to hydrogenated poly‐1‐decene (E 907) from its use as a food additive ranged from no exposure in infants to 2.35 mg/kg bw per day in toddlers. The high exposure to hydrogenated poly‐1‐decene (E 907) ranged from 0 mg/kg bw per day in infants and adults to 6.69 mg/kg bw per day in toddlers. The exposure estimates in the regulatory maximum level exposure assessment scenario did not exceed the ADI of 20 mg/kg bw per day for all population groups. The Panel concluded that the exposure to hydrogenated poly‐1‐decene (E 907) does not raise a safety concern when used at the maximum permitted levels.

Abstract The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of oat lecithin for use as a new food additive in the proposed food category (FC05.1) ‘cocoa and chocolate products’. Oat lecithin is an oil, containing polar lipids (≥ 35% w/w) and non‐polar lipids (55–65% w/w),obtained by ethanol extraction and subsequent fractionation (water/ethanol) from oat suitable for food consumption. This lecithin does not meet the specification parameter for the authorised food additive lecithins (E 322) of ‘not less than 60% of substances insoluble in acetone’ which represents the polar lipid content (phospholipids and glycolipids). Oat lecithin is expected to undergo hydrolysis in the gastrointestinal tract and this hydrolysis resembles that of other edible vegetable oils. Oat lecithin did not induce gene mutations or structural chromosomal aberrations in the absence or presence of metabolic activation. No treatment‐related adverse effects were observed with oat lecithin in 28‐day studies in rats and dogs at the highest dose tested. The toxicological database for oat lecithin was limited. Considering the composition of oat lecithin (similar components in different ratio) and the fact that it undergoes the same biotransformation, resulting in similar metabolites as those from lecithins (E 322) re‐evaluated by the EFSA Panel on Food Additives and Nutrient Sources added to Food (EFSA ANS) in 2017, the Panel considered the possibility to use the read‐across approach from toxicological data on lecithins (E 322). Based on the toxicological data provided for oat lecithin along with read across from lecithins (E322) to oat lecithin no additional toxicological data were required. Therefore, the Panel considered that the previous conclusion for lecithins (E322) equally applies to oat lecithin to be used as food additive. Mean exposure ranged from

Abstract EFSA is re‐evaluating the safety of food additives already permitted in the Union before 20 January 2009 and issuing scientific opinions on their safety in line with Regulation (EC) No 1333/2008. Acacia gum (E 414) was re‐evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As follow‐up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of acacia gum (E 414) as carry‐over in food for infants below 16 weeks of age belonging to food categories 13.1.1 (Infant formulae) and 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) and to address the issues already identified during the re‐evaluation of the food additive when used in food for the general population. The process involved the publication of a call for data to allow the interested parties to provide the requested information to complete the risk assessment. Based on the analytical data submitted in response to this call, the Panel recommended to lower the limits in the specifications for toxic elements and identified the need for further specifications for aluminium, microbiological criteria and protein residues. The Panel noted that information was not provided for oxidising enzymes and recommended that oxidases and peroxidases should be inactivated during the manufacturing process. The interested parties did not submit toxicological, clinical and post‐marketing surveillance data specific for the assessment of the safety of acacia gum (E 414) in infants below 16 weeks of age. However, taking the highest doses tested without adverse effects from the subchronic studies available from the previous re‐evaluation and comparing them with the estimated exposure in infants, the margins of safety were large indicating that there is no reason for health concern.

Abstract The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re‐evaluating the safety of sulphuric acid (E 513) and its sodium (E 514), potassium (E 515), calcium (E 516) and ammonium (E 517) salts when used as a food additive. The Panel considered that adequate exposure and toxicity data were available. Sulphuric acid and its sodium, potassium, calcium and ammonium salts (E 513, E 514, E 515, E 516, E 517) are authorised food additives in the EU, in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008. In the refined estimated exposure non brand‐loyal scenario, mean exposure ranged from 0.4 mg sulphate/kg body weight (bw) per day in infants to 35 mg sulphate/kg bw per day in toddlers. The high percentile of exposure ranged from 3 mg sulphate/kg bw per day in adolescents to 68 mg sulphate/kg bw per day in toddlers. The Panel considered sulphates of low acute toxicity and there is no concern with respect to genotoxicity and carcinogenicity. The Panel noted that the exposure to sulphates at mean and 95th percentile in the non brand‐loyal scenario as well as in the other scenarios, is far below the 300 mg/kg a dose that induced laxative effect in humans. Based on the toxicological database available, the Panel concluded that the exposure to sulphuric acid (E 513), sodium sulphate (E 514), potassium sulphates (E 515), calcium sulphate (E 516) and ammonium sulphate (E 517) does not raise a safety concern at the reported uses and use levels and there is no need for a numerical acceptable daily intake (ADI).

Abstract The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re‐evaluating the safety of benzyl alcohol (E 1519) when used as a food additive. The Panel considered that adequate exposure and toxicity data were available. Benzyl alcohol (E 1519) is authorised as a food additive in the EU in accordance with Annex III to Regulation (EC) No 1333/2008. The Panel considered benzyl alcohol of low acute toxicity with no concern with respect to genotoxicity and carcinogenicity and established an acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day based on a no observable adverse effect level (NOAEL) of 400 mg/kg bw per day from the carcinogenicity study in rats. The mean and high exposure estimates in the refined exposure scenarios were maximally 0.27 and 0.81 mg/kg bw per day in toddlers, respectively. The exposure estimates to benzyl alcohol (E 1519) were below the ADI of 4 mg/kg bw per day in all population groups. The Panel noted that also the exposure in the regulatory maximum level exposure assessment scenario is below the ADI in all population groups. The Panel concluded that the exposure to benzyl alcohol (E 1519) does not raise a safety concern at the reported uses and use levels.

Abstract The present opinion deals with the assessment of the data provided by interested business operators in support of an amendment of the EU specifications for titanium dioxide (E 171) with respect to the inclusion of additional parameters related to its particle size distribution. Titanium dioxide which is used as a food additive E 171 in food undergoes no surface treatment and is not coated. It consists of anatase or rutile generally containing small amounts of the other phase (rutile or anatase,

Abstract The Panel on Food Additives and Flavourings added to Food (FAF) provided a scientific opinion re‐evaluating the safety of chlorides (E 507–509, E 511) as food additives. Chlorides are authorised food additives in the EU in accordance with Annex II and III to Regulation (EC) No 1333/2008. In the non‐ brand‐loyal scenario, mean exposure to chlorides (E 507–509, E 511) as food additives ranged from 2 mg/kg body weight (bw) per day in the elderly to 42 mg/kg bw per day in toddlers. The 95th percentile of exposure ranged from 5 mg/kg bw per day in the elderly to 71 mg/kg bw per day in toddlers. 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 there is no concern with respect to genotoxicity and carcinogenicity. No effects were reported in developmental toxicity studies in rats following administration of magnesium chloride hexahydrate at 800 mg/kg bw per day. Some animal studies suggested a role of chloride in increasing blood pressure but based on the toxicological database available the Panel considered human data more appropriate to identify a level of chloride intake which does not raise a safety concern. 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.

Abstract The Panel on Food Additives and Flavourings added to Food (FAF) provided a scientific opinion re‐evaluating the safety of phosphates (E 338–341, E 343, E 450–452) as food additives. The Panel considered that adequate exposure and toxicity data were available. Phosphates are authorised food additives in the EU in accordance with Annex II and III to Regulation (EC) No 1333/2008. Exposure to phosphates from the whole diet was estimated using mainly analytical data. The values ranged from 251 mg P/person per day in infants to 1,625 mg P/person per day for adults, and the high exposure (95th percentile) from 331 mg P/person per day in infants to 2,728 mg P/person per day for adults. Phosphate is essential for all living organisms, is absorbed at 80–90% as free orthophosphate excreted via the kidney. The Panel considered phosphates to be of low acute oral toxicity and there is no concern with respect to genotoxicity and carcinogenicity. No effects were reported in developmental toxicity studies. The Panel derived a group acceptable daily intake (ADI) for phosphates expressed as phosphorus of 40 mg/kg body weight (bw) per day and concluded that this ADI is protective for the human population. The Panel noted that in the estimated exposure scenario based on analytical data exposure estimates exceeded the proposed ADI for infants, toddlers and other children at the mean level, and for infants, toddlers, children and adolescents at the 95th percentile. The Panel also noted that phosphates exposure by food supplements exceeds the proposed ADI. The Panel concluded that the available data did not give rise to safety concerns in infants below 16 weeks of age consuming formula and food for medical purposes.

Abstract The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl lauroyl arginate (E 243) is an already authorised food additive in the EU for use in heat‐treated meat products only, with some exceptions. The safety of ethyl lauroyl arginate (E 243) as a food additive has been evaluated in 2007 by EFSA and an acceptable daily intake (ADI) of 0.5 mg/kg body weight (bw) was set. The present assessment is based on a new interpretation of the available data elaborated by the applicant and on exposure estimates calculated by the Panel for both the current and the proposed changes to the authorised uses of this food additive. The Panel considered the new information provided, including the re‐examination of some of the results from the toxicological studies included in the original application dossier submitted for the initial evaluation of ethyl lauroyl arginate (E 243) in 2007. The Panel concluded that it does not contain new scientific evidence. The concerns and uncertainties expressed in the previous scientific opinions of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Foods (AFC) and Panel on Food additives and Nutrient Sources added to Food (ANS) remain to be addressed and there is no justification for changing the current ADI. Based on the above, the Panel concluded that the current ADI of 0.5 mg/kg bw would be reached in toddlers and children at the 95th percentile already for exposure estimates calculated using the currently permitted maximum level (ML) for ethyl lauroyl arginate (E 243). At the proposed new uses and use levels, the ADI would be exceeded at mean level of consumption in all age groups.

Abstract The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established in its latest evaluation a group ADI of 0–1 mg/kg bw per day, expressed as quillaia saponins, for Quillaia extract for Type 1 and Type 2. The Panel considered it likely that intact Quillaia extract saponins are absorbed to a low extent, are hydrolysed in the gastrointestinal (GI) tract and that the aglycone is absorbed only to a limited extent. The Panel considered that the genotoxicity data available did not indicate a concern for genotoxicity. Taking into account the available toxicological database, various no observed adverse effect levels (NOAELs) relevant for the derivation of an ADI were identified. The Panel considered that the 2‐year study in rats was the most robust and that the NOAEL of 1,500 mg Quillaia extract/kg bw per day could be used to derive the ADI for E 999. Considering that the adverse effects reported were due to the presence of saponins in the extract, that saponins were present in Quillaia extract Type 1 (around 20%) and using an uncertainty factor of 100, the Panel derived a ADI of 3 mg saponins/kg bw per day for E 999. None of the exposure estimates for the different population groups of the refined brand‐loyal scenario exceeded the ADI of 3 mg saponins/kg bw per day. The proposed extension of use also would not result in an exceedance of this ADI for the refined scenario. The Panel proposed some recommendations for the European Commission to consider, in particular revising the EU specifications for E 999 in order to differentiate the extracts of Quillaia according to the saponins content and to include other parameters to better characterise the food additive.

Abstract The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐term studies in rats and dogs at the highest doses tested. The Panel considered that E 477 did not raise a concern for genotoxicity. No chronic toxicity, carcinogenicity, reproductive and developmental toxicity studies with propane‐1,2‐diol esters of fatty acids were available to the Panel. The Panel considered that any potential adverse effect of propane‐1,2‐diol ester of fatty acids would be due to propane‐1,2‐diol, previously re‐evaluated as a food additive and for which an ADI of 25 mg/kg bw per day was established. Considering the overall metabolic and toxicity database, 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. This corresponds to an ADI for E 477 of 80 mg/kg bw per day, based on the concentration of free and bound propane‐1,2‐diol amounting to a maximum of 31% as laid down in the EU specification. The Panel concluded that there would not be a safety concern at the reported use levels for E 477 because exposure estimates from the refined non‐brand loyal scenario did not exceed the ADI for E 477 in any of the population groups. However, the Panel aims to explore the feasibility of establishing a group ADI for those food additives that result in an exposure to propane‐1,2‐diol, such as E 477, E 1520 and E 405. Additionally, the Panel will also consider performing a combined exposure assessment to propane‐1,2‐diol resulting from the use of these food additives. The Panel also recommended some modifications of the EU specifications for E 477.

Abstract The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was no reliable information regarding the absorption, distribution, metabolism, excretion (ADME) for TOSOM. No adverse effects have been detected in a limited subchronic toxicity study in pigs. The Panel identified a no observed adverse effect level (NOAEL) of 5,400, the highest dose tested, from a chronic and carcinogenicity study in rats. No genotoxicity data were available. No reliable studies for reproductive or developmental toxicity were available. From the chronic and carcinogenicity study, no lesions in reproductive organs were described and the lack of carcinogenic effect alleviated the concern for genotoxicity at the first site of contact. The Panel concluded that the available toxicological data were insufficient to support the current ADI, in particular, due to the lack of ADME data and absence of developmental toxicity studies TOSOM (E 479b) is only authorised in one food category and only one reported use level that equals the maximum permitted level was submitted. The estimated high (P95) exposure reached an upper value of 10.1 mg/kg bw per day for toddlers. When comparing the highest estimated exposure of 10 mg/kg bw per day in toddlers with the NOAEL of 5,400 mg/kg bw per day (the highest dose tested), the margin of safety (MoS) would be 540. Therefore, the Panel considered the use of TOSOM (E 479b) to be of no safety concern, in particular when considering the limited current use of this food additive. The Panel also recommended some modifications of the EU specifications for E 479b.

Abstract The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol (E 1520) when used as a food additive. In 1996, the Scientific Committee on Food (SCF) established an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day for propane‐1,2‐diol. Propane‐1,2‐diol is readily absorbed from the gastrointestinal and is expected to be widely distributed to organs and tissues. The major route of metabolism is oxidation to lactic acid and pyruvic acid. At high concentrations, free propane‐1,2‐diol is excreted in the urine. No treatment‐related effects were observed in subchronic toxicity studies. The available data did not raise concern with respect to genotoxicity. Haematological changes suggestive of an increased red blood cell destruction with a compensatory increased rate of haematopoiesis were observed at the highest dose level (5,000 mg/kg bw per day) in a 2‐year study in dogs. No adverse effects were reported in a 2‐year chronic study in rats with propane‐1,2‐diol (up to 2,500 mg/kg bw per day). The SCF used this study to derive the ADI. No adverse effects were observed in the available reproductive and developmental toxicity studies. Propane‐1,2‐diol (E 1520) is authorised according to Annex III in some food additives, food flavourings, enzymes and nutrients and it is then carried over to the final food. Dietary exposure to E 1520 was assessed based on the use levels and analytical data. The Panel considered that for the food categories for which information was available, the exposure was likely to be overestimated. Considering the toxicity database, the Panel concluded that there was no reason to revise the current ADI of 25 mg/kg bw per day. The Panel also concluded that the mean and the high exposure levels (P95) of the brand‐loyal refined exposure scenario did not exceed the ADI in any of the population groups from the use of propane‐1,2‐diol (E 1520) at the reported use levels and analytical results.

Abstract The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives. The Scientific Committee on Food (SCF) allocated an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day for E 491, E 492 and E 495 singly or in combination; and a separate group ADI for E 493 and E 494 singly or in combination of 5 mg/kg bw per day calculated as sorbitan monolaurate in 1974. The Panel noted that after oral administration sorbitan monostearate can be either hydrolysed to its fatty acid moiety and the corresponding anhydrides of sorbitol and excreted via urine or exhaled as CO2 or excreted intact in the faeces. The Panel considered that sorbitan esters did not raise concern for genotoxicity. Based on the no observed adverse effect level (NOAEL) of 2,600 mg sorbitan monostearate/kg bw per day, taking into account the ratio between the molecular weight of sorbitan monostearate (430.62 g/mol) and sorbitan (164.16 g/mol), and applying an uncertainty factor of 100, the Panel derived a group ADI of 10 mg/kg bw per day expressed as sorbitan for sorbitan esters (E 491–495) singly or in combination. This group ADI of 10 mg sorbitan/kg bw per day is equivalent to 26 mg sorbitan monostearate/kg bw per day. The Panel concluded that the exposure at the mean and the 95th percentile level, using non‐brand‐loyal scenario, did not exceed the ADI in any of the population groups. The Panel on the request for an amendment of specifications regarding the removal of ‘congealing range’ concluded that it could be eventually replaced by another identification parameter such as melting point.

Abstract The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of fatty acids (E 570) when used as a food additive. The food additive includes caprylic‐ (C8), capric‐ (C10), lauric‐ (C12), myristic‐ (C14), palmitic‐ (C16), stearic‐ (C18) and oleic acid (C18:1), present alone or in combination. In 1991, the Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) ‘not specified’ for the fatty acids (myristic, stearic, palmitic and oleic acid). The fatty acids (E 570) are absorbed in the same way as the free fatty acids from the regular diet. They show low acute toxicity. The available studies on subchronic toxicity were limited but there was no evidence for toxic effects at doses up to 10% in the diet (equivalent to 9,000 mg lauric acid/kg body weight (bw) per day). The Panel considered that the fatty acids (E 570) did not raise a concern for genotoxicity. Data on chronic toxicity, reproductive toxicity and developmental toxicity were too limited to reach a conclusion on these endpoints. The Panel noted that the contribution of fatty acids (E 570) represented on average only 1% of the overall exposure to saturated fatty acids from all dietary sources (food additive and regular diet). Based on the approach described in the conceptual framework for the risk assessment of certain food additives re‐evaluated under Commission Regulation (EU) No 257/2010 and taking into account the considerations mentioned above, the Panel concluded that the food additive fatty acids (E 570) was of no safety concern at the reported uses and use levels.

Abstract The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of polyglycerol polyricinoleate (PGPR, E 476) used as a food additive. In 1978, the Scientific Committee for Food (SCF) established an acceptable daily intake (ADI) of 7.5 mg/kg body weight (bw) per day for PGPR. PGPR is hydrolysed in the gut resulting in the liberation of free polyglycerols, polyricinoleic acid and ricinoleic acid. Di‐ and triglycerol are absorbed and excreted unchanged in the urine; long‐chain polyglycerols show lower absorption and are mainly excreted unchanged in faeces. Acute oral toxicity of PGPR is low, and short‐term and subchronic studies indicate PGPR is tolerated at high doses without adverse effects. PGPR (E 476) is not of concern with regard to genotoxicity or carcinogenicity. The single reproductive toxicity study with PGPR was limited and was not an appropriate study for deriving a health‐based guidance value. Human studies with PGPR demonstrated that there is no indication of significant adverse effect. The Panel considered a 2‐year combined chronic toxicity/carcinogenicity study for determining a reference point and derived a no observed adverse effect level (NOAEL) for PGPR (E 476) of 2,500 mg/kg bw per day, the only dose tested. Therefore, the Panel concluded that the present data set give reason to revise the ADI of 7.5 mg/kg bw per day allocated by SCF to 25 mg/kg bw per day. Exposure estimates did not exceed the ADI of 25 mg/kg bw per day and a proposed extension of use would not result in an exposure exceeding this ADI. The Panel recommended modification of the EU specifications for PGPR (E 476).

Abstract The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of β‐cyclodextrin (E 459) as a food additive. β‐Cyclodextrin is a non‐reducing cyclic oligosaccharide consisting of seven α‐1,4‐linked d‐glucopyranosyl units. The Scientific Committee on Food (SCF) allocated an acceptable daily intake (ADI) of 5 mg/kg body weight (bw) per day to β‐cyclodextrin (E 459) in 1996. β‐Cyclodextrin is poorly absorbed following oral administration in animals and humans. It is hydrolysed to maltose and glucose by the gut microflora and endogenous amylases in the colon; consequently, β‐cyclodextrin levels in tissues and serum are low (

Abstract The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of ammonium phosphatides (E 442) as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) allocated an acceptable daily intake (ADI) of 30 mg/kg body weight (bw) per day in 1978 and 1974, respectively. The Panel noted that after oral administration of E 442 ([32P]YN), a proportion of the radioactivity passed through the gastrointestinal tract and was excreted via faeces and also a quantity of radioactivity was absorbed rapidly after dosing as indicated by its presence in the skeletal tissue and liver. Acute oral toxicity of ammonium phosphatides is low and no adverse effects were observed in a 90‐day rats study. The Panel considered that ammonium phosphatides did not raise concern for genotoxicity. The Panel identified no observed adverse effect levels (NOAELs) of 8,500 and 3,000 mg/kg bw per day, the highest doses tested, from dietary chronic and carcinogenicity studies with ammonium phosphatides in mice and rats, respectively. No effects on reproduction and development were observed in a dietary two‐generation reproductive toxicity study at the only dose tested of 3,000 mg/kg bw per day, and in addition, no maternal or developmental effects were recognised in a dietary prenatal developmental toxicity study up to a dose of 4,774 mg/kg bw per day. Based on the available toxicological database, the Panel concluded that there is no reason to revise the current ADI for ammonium phosphatides of 30 mg/kg bw per day. Considering that the ADI is not exceeded in any population group, the Panel also concluded that the use of ammonium phosphatides (E 442) as a food additive, at the permitted or reported use and use levels, would not be of safety concern.