Re-evaluation of dimethyl polysiloxane (E 900) as a food additive.

The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of dimethyl polysiloxane (E 900) as a food additive. E 900 was evaluated by the Scientific Committee on Food (SCF) in 1990 and agreed with the Acceptable Daily Intake (ADI) of 1.5 mg/kg body weight (bw) per day previously established by Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. Dimethyl polysiloxane was only absorbed to a very limited extent from the gastrointestinal tract following oral administration and the vast majority was excreted unchanged in the faeces. Corneal opacities and other effects on cornea were observed in studies in rats. These effects are considered to be caused by direct contact with the test substance in the feed and/or with the test substance in the faeces and not due to systemic exposure. The Panel considered that oral exposure of dimethyl polysiloxane did not result in any systemic adverse effects in any species and dose tested and there is no concern with respect to genotoxicity of dimethyl polysiloxane (E 900). From a 26-month toxicity study in rats, a No Observed Adverse Effect Level (NOAEL) of 1,742 and 2,055 mg dimethyl polysiloxane/kg bw per day for female and male, respectively, was identified. Using the NOAEL 1,742 mg/kg bw per day, the Panel established an ADI of 17 mg/kg bw per day for E 900 by applying an uncertainty factor of 100. Accordingly, the ADI for dimethyl polysiloxane (E 900) of 1.5 mg/kg bw per day, established by SCF in 1990, is withdrawn. The exposure estimates for the different population groups of all exposure scenarios did not exceed the ADI of 17 mg/kg bw per day for E 900. The Panel concluded that there is not a safety concern at the reported uses and use levels for dimethyl polysiloxane (E 900). The Panel also proposed a number of recommendations for the EU specifications to be amended.

Re-evaluation of l(+)-tartaric acid (E 334), sodium tartrates (E 335), potassium tartrates (E 336), potassium sodium tartrate (E 337) and calcium tartrate (E 354) as food additives.

The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on tartaric acid-tartrates (E 334-337, 354) when used as food additives. The Scientific Committee for Food (SCF) in 1990 established an acceptable daily intake (ADI) of 30 mg/kg body weight (bw) per day, for l(+)-tartaric acid and its potassium and sodium salts. The metabolism of l(+)-tartaric acid and its potassium sodium salt was shown to be species dependent, with a greater absorption in rats than in humans. No toxic effects, including nephrotoxicity, were observed in toxicological studies in which the l(+)-form was tested. There was no indication for a genotoxic potential of tartaric acid and its sodium and potassium salts. In a chronic study in rats, no indication for carcinogenicity of monosodium l(+)-tartrate was reported at the highest dose tested (3,100 mg/kg bw per day). The available studies for maternal or developmental toxicity did not report any relevant effects; no studies for reproductive toxicity were available; however, no effects on reproductive organs were observed in the chronic toxicity study. The Panel concluded that the data on systemic availability were robust enough to derive a chemical-specific uncertainty factor instead of the usual default uncertainty factor of 100. A total uncertainty factor of 10 was derived by applying a total interspecies uncertainty factor of 1 instead of 10, based on data showing lower internal exposure in humans compared to rats. The Panel established a group ADI for l(+)-tartaric acid-tartrates (E 334-337 and E 354) of 240 mg/kg bw per day, expressed as tartaric acid, by applying the total uncertainty factor of 10 to the reference point of 3,100 mg sodium tartrate/kg bw per day, approximately to 2,440 mg tartaric acid/kg bw per day. The exposure estimates for the different population groups for the refined non-brand-loyal exposure scenario did not exceed the group ADI of 240 mg/kg bw per day, expressed as tartaric acid. Some recommendations were made by the Panel.

Re-evaluation of metatartaric acid (E 353) as a food additive.

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.

Re-evaluation of acetic acid, lactic acid, citric acid, tartaric acid, mono- and diacetyltartaric acid, mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E 472a-f) as food additives.

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.

Re-evaluation of stearyl tartrate (E 483) as a food additive.

The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of stearyl tartrate (E 483) as a food additive. The previously evaluated toxicological studies were not available, in addition to no genotoxicity data being available. Thus, adequate toxicity data on stearyl tartrate were not available for its re-evaluation. In addition, adequate data demonstrating the complete hydrolysis of stearyl tartrate (E 483) in the gastrointestinal tract and/or presystemically, that could allow read-across from data on its constituents, were lacking. Therefore, the safety of the use of stearyl tartrate as a food additive could not be assessed and the acceptable intake established by the Scientific Committee on Food (SCF) in 1978 could not be confirmed. Exposure to stearyl tartrate (E 483) was calculated using the maximum level exposure assessment scenario as neither use levels nor analytical data were available. Mean exposure to stearyl tartrate (E 483) as a food additive ranged from 0.1 mg/kg body weight (bw) per day in infants to 82.5 mg/kg bw per day in toddlers. The 95th percentile of exposure ranged from 0 mg/kg bw per day in adults to 192.7 mg/kg bw per day in toddlers. The Panel also noted that information from the Mintel's GNPD indicates that only two products have been labelled with stearyl tartrate (E 483) since 1996. Some recommendations were proposed by the Panel.

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

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

Re-evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use.

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.

Safety of orthosilicic acid-vanillin complex (OSA-VC) as a novel food ingredient to be used in food supplements as a source of silicon and bioavailability of silicon from the source.

The present scientific opinion deals with the safety of orthosilicic acid-vanillin complex (OSA-VC) as a novel food ingredient for use as a source of silicon (Si) in food supplements and with the bioavailability of Si from this source. OSA-VC is stable in liquid solution at low pH values. OSA from OSA-VC was available as revealed by the increase in plasma Si concentrations after oral ingestion in human volunteers. The toxicological data provided in support of the current application were not in accordance with the Tier 1 requirement of the 'Guidance for submission for food additive evaluations'; however, this was considered justified by the Panel given that OSA-VC at pH 6.8 dissociates into orthosilicic acid and vanillin. The daily consumption of OSA-VC at the dose recommended by the applicant would provide a supplemental intake of Si of approximately 10-18 mg Si/day which would result in an estimated total intake of roughly 30-70 mg Si/day. The maximum vanillin intake resulting from the consumption of OSA-VC would be less than 5% of the acceptable daily intake (ADI) value for vanillin of 10 mg/kg body weight (bw) per day established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2002. The Panel concluded that there would be no safety concern with the proposed use and use level of OSA-VC as a novel food ingredient intended to be used as a source of Si in food supplements for the adult population. The Panel concluded that OSA, measured as Si, is bioavailable following ingestion of OSA-VC and appears similar to values reported in the literature for other established sources of OSA.

Safety of low-substituted hydroxypropyl cellulose (L-HPC) to be used as a food additive in food supplements in tablet form.

Low-substituted hydroxypropyl cellulose (L-HPC) is a low-substituted poly(hydroxypropyl) ether of cellulose. L-HPC is proposed for use as a food additive in food supplements in solid form (tablet), with a maximum use level of 20,000 mg/kg and a typical use level of 10,000 mg/kg. Exposure estimates to L-HPC from its proposed use were calculated for both typical and maximum use levels. Due to the close chemical relationship between L-HPC and other celluloses recently re-evaluated by EFSA, the Panel decided to read-across the biological data already evaluated in the context of the re-evaluation programme. The Panel concluded that there was no safety concern from the proposed use and use levels of L-HPC.

Re-evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives.

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating the safety of microcrystalline cellulose (E 460(i)), powdered cellulose (E 460(ii)), methyl cellulose (E 461), ethyl cellulose (E 462), hydroxypropyl cellulose (E 463), hydroxypropyl methyl cellulose (E 464), ethyl methyl cellulose (E 465), sodium carboxy methyl cellulose (E 466), enzymatically hydrolysed carboxy methyl cellulose (E 469) and cross-linked carboxy methyl cellulose (E 468) as food additives. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Scientific Committee on Food (SCF) established an acceptable daily intake (ADI) 'not specified' for unmodified and modified celluloses. Celluloses are not absorbed and are excreted intact in the faeces; in addition, microcrystalline cellulose, powdered and modified celluloses could be fermented by the intestinal flora in animals and humans. Specific toxicity data were not always available for all the celluloses evaluated in the present opinion and for all endpoints. Given their structural, physicochemical and biological similarities, the Panel considered it possible to read-across between all the celluloses. The acute toxicity of celluloses was low and there was no genotoxic concern. Short-term and subchronic dietary toxicity studies performed with E 460(i), E 461, E 462, E 463, E 464, E 466 and E 469 at levels up to 10% did not indicate specific treatment related adverse effects. In chronic toxicity studies performed with E 460(i), E 461, E 463, E 464, E 465 and E 466, the no observed adverse effect level (NOAEL) values reported ranged up to 9,000 mg/kg body weight (bw) per day. No carcinogenic properties were detected for microcrystalline cellulose and modified celluloses. Adverse effects on reproductive performance or developmental effects were not observed with celluloses at doses greater than 1,000 mg/kg bw by gavage (often the highest dose tested). The combined exposure to celluloses (E 460-466, E 468 and E 469) at 95th percentile of the refined (brand-loyal) exposure assessment for the general population was up to 506 mg/kg bw per day. The Panel concluded that there was no need for a numerical ADI and that there would be no safety concern at the reported uses and use levels for the unmodified and modified celluloses (E 460(i); E 460(ii); E 461-466; E 468 and E 469). The Panel considered an indicative total exposure of around 660-900 mg/kg bw per day for microcrystalline, powdered and modified celluloses.

Re-evaluation of silicon dioxide (E 551) as a food additive.

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of silicon dioxide (E 551) when used as a food additive. The forms of synthetic amorphous silica (SAS) used as E 551 include fumed silica and hydrated silica (precipitated silica, silica gel and hydrous silica). The Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) 'not specified' for silicon dioxide and silicates. SAS materials used in the available biological and toxicological studies were different in their physicochemical properties; their characteristics were not always described in sufficient detail. Silicon dioxide appears to be poorly absorbed. However, silicon-containing material (in some cases presumed to be silicon dioxide) was found in some tissues. Despite the limitations in the subchronic, reproductive and developmental toxicological studies, including studies with nano silicon dioxide, there was no indication of adverse effects. E 551 does not raise a concern with respect to genotoxicity. In the absence of a long-term study with nano silicon dioxide, the Panel could not extrapolate the results from the available chronic study with a material, which does not cover the full-size range of the nanoparticles that could be present in the food additive E 551, to a material complying with the current specifications for E 551. These specifications do not exclude the presence of nanoparticles. The highest exposure estimates were at least one order of magnitude lower than the no observed adverse effect levels (NOAELs) identified (the highest doses tested). The Panel concluded that the EU specifications are insufficient to adequately characterise the food additive E 551. Clear characterisation of particle size distribution is required. Based on the available database, there was no indication for toxicity of E 551 at the reported uses and use levels. Because of the limitations in the available database, the Panel was unable to confirm the current ADI 'not specified'. The Panel recommended some modifications of the EU specifications for E 551.

Re-evaluation of oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (E 479b) as a food additive.

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.

Re-evaluation of propane-1,2-diol esters of fatty acids (E 477) as a food additive.

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.

Safety in use of glucosylated steviol glycosides as a food additive in different food categories.

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety of glucosylated steviol glycosides proposed for use as a new food additive in different food categories. According to the applicant, glucosylated steviol glycosides preparations consist of not less than 95% (on anhydrous basis) total steviol glycosides, made up of glucosylated steviol glycosides of different molecular weights as well as any remaining steviol glycosides. The applicant proposed that glucosylated steviol glycosides and parent steviol glycosides undergo a common metabolic process in pathway following ingestion and suggested that data from steviol glycosides can be used for read-across to glucosylated steviol glycosides. The limited evidence provided in the application dossier did not demonstrate the complete hydrolysis of the glucosylated steviol glycosides. No toxicological studies on glucosylated steviol glycoside preparations under evaluation have been provided for its assessment. The Panel concluded that the submitted data are insufficient to assess the safety of the glucosylated steviol glycoside preparations to be used as a new food additive.

Re-evaluation of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) as food additives.

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) when used as food additives. 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) and their salts. The sodium, potassium, calcium and magnesium salts of fatty acids are expected to dissociate in the gastrointestinal tract to fatty acid carboxylates and their corresponding cations. There were no data on subchronic toxicity, chronic toxicity, reproductive and developmental toxicity of the salts of fatty acids. There was no concern for mutagenicity of calcium caprylate, potassium oleate and magnesium stearate. From a carcinogenicity study with sodium oleate, a no observed adverse effect level (NOAEL) could not be identified but the substance was considered not to present a carcinogenic potential. Palmitic- and stearic acid which are the main fatty acids in E 470a and E 470b were already considered of no safety concern in the re-evaluation of the food additive E 570. The fatty acid moieties of E 470a and E 470b contributed maximally for 5% to the overall intake of saturated fatty acids from all dietary sources. Overall, 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.

Safety of the proposed amendment of the specifications of the food additive steviol glycosides (E 960).

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety of proposed amendment of the specifications of the food additive steviol glycosides (E 960). The applicant asked to amend the existing EU specifications for steviol glycosides to allow for the inclusion of all steviol glycosides identified in Stevia rebaudiana Bertoni leaves, including both 'major' and 'minor' glycosides, that may comprise the assay value of not less than 95% total steviol glycosides. According to the applicant, all steviol glycosides are subject to microbial metabolism in a similar manner, ultimately generating the common primary metabolite steviol. There are uncertainties on the rate and extent of the metabolism of different steviol glycosides to steviol in the evidence provided and they did not allow the Panel to endorse the applicant's argumentation that all steviol glycosides generate the common metabolite steviol when subjected to microbial metabolism under realistic conditions. The available information was not sufficient to assess the safety of the proposed amendment of the specifications for E 960 and the conclusions on the previous assessments on steviol glycosides cannot be extrapolated to any other mixture of steviol glycosides (containing not less than 95% of any steviol glycosides) extracted from S. rebaudiana Bertoni leaves. Therefore, the Panel concluded that the submitted data were insufficient to assess the safety of proposed amendment of the specifications of the food additive steviol glycosides (E 960).

Safety and bioavailability of silver hydrosol as a source of silver added for nutritional purposes to food supplements.

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety and bioavailability of silver hydrosol as a source of silver added for nutritional purposes to food supplements. Silver hydrosol is a suspension comprised of a mixture of positively charged silver ions and silver metal particles in water. The study report submitted, being a gastric disappearance study performed in six individuals, did not provide information on the systemic absorption of silver as such, and was not able to provide information on the bioavailability of silver from silver hydrosol. If silver from silver hydrosol is systematically available a complete toxicological evaluation is needed for its assessment. The application dossier was limited to an acute toxicity study with silver hydrosol and references to toxicological studies performed with forms of silver (e.g. salts of silver) which were considered neither relevant nor adequate to the risk assessment of silver hydrosol. The Panel concluded that the submitted data are insufficient to characterise the silver hydrosol regarding its nano specific properties and to assess either the bioavailability of silver from the source or the safety of the silver hydrosol as a source of silver added for nutritional purposes to food supplements.

Re-evaluation of propane-1,2-diol (E 1520) as a food additive.

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.

Evaluation of di-calcium malate, used as a novel food ingredient and as a source of calcium in foods for the general population, food supplements, total diet replacement for weight control and food for special medical purposes.

The present scientific opinion deals with the evaluation of the safety of di-calcium malate (DCM) proposed as a novel food ingredient and as a source of calcium for use in foods for the general population, food supplements, total diet replacement for weight control and food for special medical purposes (FSMP), and with the bioavailability of calcium from this source. The structural formula of the proposed complex is based on expert judgement and not supported by any analytical data. On the basis of the available data, the Panel concluded that there was insufficient scientific evidence of a difference between the proposed novel food ingredient named as di-calcium malate (DCM) and calcium malate already authorised as a source of calcium included in Annex II to Directive 2002/46/EC. Accordingly, the Panel was unable to assess the safety of DCM as a novel food ingredient. On the basis of the results provided, the Panel considered that DCM does not completely dissociate into calcium and malic acid. The Panel concluded that when DCM dissociates, calcium would be available following ingestion of DCM and the bioavailability would appear similar to values reported for other sources of calcium already permitted. Furthermore, the Panel concluded that on the basis of the information available it was not possible to calculate the exposure to DCM as a source of calcium to foods for the general population, food supplements, total diet replacement for weight control and FSMP.

Evaluation of di-magnesium malate, used as a novel food ingredient and as a source of magnesium in foods for the general population, food supplements, total diet replacement for weight control and food for special medical purposes.

The present scientific opinion deals with the evaluation of the safety of di-magnesium malate (DMM) proposed as a novel food ingredient and as a source of magnesium for use in foods for the general population, food supplements, total diet replacement for weight control and food for special medical purposes (FSMP), and with the bioavailability of magnesium from this source. Additional information was sought from the applicant during the assessment process. However, despite several requests, the applicant did not provide the additional data. Consequently, the Panel performed this assessment on the basis of the available data and concluded that there was insufficient scientific evidence of a difference between the proposed novel food ingredient named as DMM and magnesium malate already authorised as a source of magnesium included in Annex II to Directive 2002/46/EC. Accordingly, the Panel was unable to assess the safety of DMM as a novel food ingredient. The Panel concluded that based on the data provided it was not possible to assess the dissociation of DMM into magnesium and malic acid. The Panel further concluded that if DMM dissociates, magnesium would be available following ingestion of DMM and the availability would appear similar to values reported for other sources of magnesium already permitted. Finally, the Panel noted that the proposed use levels could result in exposures to magnesium greater than its upper level (UL) (250 mg/day) for food supplements and for food for special medical purposes.