The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 3.2 of FGE.19 in the ...Flavouring Group Evaluation 215, Revision 1 (FGE.215Rev1). In FGE.215, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the concern for genotoxicity could not be ruled out and requested in vivo data for the two representative substances 4-phenylbut-3-en-2-one FL-no: 07.024 and 1-(4-methoxyphenyl)pent-1-en-3-one FL-no: 07.030. The Flavour Industry has provided additional genotoxicity studies for both representative substances FL-no: 07.024 and FL-no: 07.030. Based on these new data, the Panel concluded that the concern for genotoxicity is ruled out for the representative substance FL-no: 07.024 and for the structurally related substances 4-phenylbut-3-en-2-ol FL-no: 02.066 and 3-methyl-4-phenylbut-3-en-2-one FL-no: 07.027 which can accordingly be evaluated through the Procedure in FGE.69. For the representative substance 1-(4-methoxyphenyl)pent-1-en-3-one FL-no: 07.030, the Panel concluded that FL-no: 07.030 is aneugenic in vitro. For such substances, there is currently no agreed follow-up strategy to finalise their safety assessment. The Panel is aware that the EFSA Scientific Committee is going to address this issue and a statement clarifying the assessment of in vitro aneugenic substances is under preparation. The Panel concluded therefore that, for the time being, the representative substance 1-(4-methoxyphenyl)pent-1-en-3-one FL-no: 07.030 and the structurally related substances vanillylidene acetone FL-no: 07.046 and 1-(4-methoxyphenyl)-4-methylpent-1-en-3-one FL-no: 07.049 cannot be evaluated through the Procedure. The Panel further concluded that 4-(2,3,6-trimethylphenyl)but-3-en-2-one FL-no: 07.206 is to be considered as a stand-alone substance due to the presence of the methyl groups, therefore, in vitro genotoxicity data were requested for FL-no: 07.206. Industry communicated that the evaluation of FLno: 07.206 is not supported any longer, therefore additional data were not submitted. (C) 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
The EFSA Panelon Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision ...3 (FGE.208Rev3). In FGE.208Rev1, the Panelon Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p-mentha-1,8-dien-7-al FL-no: 05.117, which was found to be genotoxic invivo. The Panelconcluded that there was a potential safety concern for the nine substances in this FGE that were all represented by FL-no: 05.177. Consequently, substance FL-no: 05.117, as well as four substances (FL-no: 05.121, 09.272, 09.899 and 09.900), no longer supported by industry were deleted from the Union List. In FGE.208Rev2, the Panelassessed genotoxicity studies submitted on five flavouring substances FL-no: 02.060, 02.091, 05.106, 09.278 and 09.302 and concluded that the concern for genotoxicity could be ruled out for these substances, except from myrtenal FL-no: 05.106 for which the available data were considered equivocal. Thus, industry provided additional genotoxicity studies (a bacterial reverse mutation assay and a combined invivo bone marrow erythrocytes micronucleus test and Comet assay in liver and duodenum) for this substance which were evaluated in the present opinion, FGE.208Rev3. Based on these new data, the Panelconcluded that the concern for genotoxicity could be ruled out for myrtenal FL-no: 05.106. Subsequently, this substance can be evaluated through the Procedure.
The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of gellan gum (E 418) as a food additive. Following the conceptual ...framework for the risk assessment of certain food additives re‐evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that adequate exposure and toxicity data were available. Based on the reported use levels, a refined exposure of up to 72.4 mg/kg body weight (bw) per day in toddlers at the 95th percentile was estimated. Gellan gum is unlikely to be absorbed intact and would not be fermented by human intestinal microbiota. There is no concern with respect to carcinogenicity and genotoxicity. No adverse effects were reported in chronic studies at the highest doses tested in mice and rats (3,627 and 1,460 mg gellan gum/kg bw per day, respectively). Repeated oral intake up to 200 mg/kg bw per day for 3 weeks had no adverse effects in humans. The Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for gellan gum (E 418), and that there is no safety concern at the refined exposure assessment for the reported uses and use levels of gellan gum (E 418) as a food additive. The Panel recommended to better define the specifications of gellan gum including the absence of viable cells of the microbial source and the presence of polyhydroxybutyrate (PHB), protein and residual bacterial enzymatic activities.
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 on the re‐evaluation of pectin ...(E 440i) and amidated pectin (E 440ii) as food additives. An acceptable daily intake (ADI) ‘not specified’ was allocated by the Scientific Committee for Food (SCF) for E 440i and E 440ii. Pectin and amidated pectin would not be absorbed intact, but extensively fermented by intestinal microbiota in animals and humans; products formed from pectins in the gastrointestinal tract are similar to manufactured pectin‐derived acidic oligosaccharides (pAOS). There is no indication of genotoxicity for pectin and amidated pectin, although the available data were limited. No adverse effects were reported in a chronic toxicity study in rats at levels up to 5,000 mg pectin/kg bw per day, the highest dose tested. No treatment‐related effects were observed in a dietary one‐generation reproductive toxicity study with pAOS in rats at up to 6,200 mg/kg body weight (bw) per day, the highest dose tested. The Panel did not consider E 440i and E 440ii as having allergenic potential. A dose of 36 g/day (equivalent to 515 mg/kg bw per day) for 6 weeks in humans was without adverse effects. Exposure to pectins from their use as food additives ranged up to 442 mg/kg bw per day for toddlers at the 95th percentile (brand‐loyal scenario). The Panel concluded that there is no safety concern for the use of pectin (E 440i) and amidated pectin (E 440ii) as food additives for the general population and that there is no need for a numerical ADI.
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).
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 (< 1%). β‐Cyclodextrin has a low acute oral toxicity. Short‐term and subchronic toxicity studies were available in rats and dogs. In rats, the main reported effect was an adaptive enlargement of the caecum, resulting from consumption of poorly digestible carbohydrates. From a 6‐month study in rats, a no observed adverse effect levels (NOAEL) of 600 mg/kg bw per day was identified and from a 52‐week dogs study, the NOAEL was 466 and 476 mg/kg bw per day in males and females, respectively. The Panel considered that there was no indication for genotoxicity of β‐cyclodextrin. From a chronic toxicity studies in rats, a NOAEL of 654 and 864 mg/kg bw per day in males and females, respectively, was identified. Carcinogenicity studies in mice and rats were available and no evidence for carcinogenicity was found. The Panel concluded that, based on the available toxicological database, there is no reason to revise the current ADI of 5 mg/kg bw per day for β‐cyclodextrin. Based on the available reported use and use levels, the Panel also concluded that the ADI was exceeded in the refined brand‐loyal scenario (considered the most relevant scenario) in all population groups except for infants at the mean and in all population groups at the 95th percentile.
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the refined exposure assessment of polyethylene glycol (E 1521) when used as a food ...additive. Polyethylene glycols were evaluated by several international bodies and the AFC Panel previously adopted scientific opinions on the safety polyethylene glycol (E 1521). In 2006, the Panel concluded that based on all the data, consumption of PEG through use as plasticisers in film‐coating formulations for food supplement tablets and/or capsules at the intended use level are not of safety concern. In 2007, in another opinion of the AFC Panel related to d‐alpha‐tocopheryl polyethylene glycol 1000 succinate (TPGS) in use for food for particular nutritional purposes, the Panel noted that TPGS intakes would correspond to intake to PEG 1000 at levels equivalent to 3.3–8.5 mg/kg body wieght (bw) per day which are within the range of group acceptable daily intakes (ADIs) of the SCF () and JECFA (1980). This assessment could only take into account the use of polyethylene glycol (E 1521) in food supplements and thus the food supplements consumers only scenario was performed. It resulted in exposure estimates of polyethylene glycol (E 1521) up to 3.5 mg/kg bw per day at the mean and up to 6.1 mg/kg bw per day at the high level. The current exposure assessment is based on the methodology used in the re‐evaluation of food additives together with reported use levels received following a call for data in 2017. Considering the uncertainties of the exposure assessment, these estimates very likely overestimated the real exposure to polyethylene glycol (E 1521). The Panel also noted that the highest calculated exposure estimate falls within the range of the group ADI previously established by SCF (5 mg/kg bw per day for PEG 300–4000) and of the one set by JECFA (10 mg/kg bw per day for PEG 200–10000).
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 on the re-evaluation of 12 ...modified starches (E 1404, E 1410, E 1412, E 1413, E 1414, E 1420, E 1422, E 1440, E 1442, E 1450, E 1451 and E 1452) authorised as food additives in the EU in accordance with Regulation (EC) No 1333/2008 and previously evaluated by JECFA and the SCF. Both committees allocated an acceptable daily intake (ADI) ‘not specified’. In humans, modified starches are not absorbed intact but significantly hydrolysed by intestinal enzymes and then fermented by the intestinal microbiota. Using the read-across approach, the Panel considered that adequate data on short- and long-term toxicity and carcinogenicity, and reproductive toxicity are available. Based on in silico analyses, modified starches are considered not to be of genotoxic concern. No treatment-related effects relevant for human risk assessment were observed in rats fed very high levels of modified starches (up to 31,000 mg/kg body weight (bw) per day). Modified starches (e.g. E 1450) were well tolerated in humans up to a single dose of 25,000 mg/person. Following the conceptual framework for the risk assessment of certain food additives, the Panel concluded that there is no safety concern for the use of modified starches as food additives at the reported uses and use levels for the general population and that there is no need for a numerical ADI. The combined exposure to E 1404–E 1451 at the 95th percentile of the refined (brand-loyal) exposure assessment scenario for the general population was up to 3,053 mg/kg bw per day. Exposure to E 1452 for food supplement consumers only at the 95th percentile was up to 22.1 mg/kg bw per day.
Safety of use of oat lecithin as a food additive Younes, Maged; Aquilina, Gabriele; Castle, Laurence ...
EFSA journal,
January 2020, 2020-01-00, 20200101, 2020, 2020-01-01, Letnik:
18, Številka:
1
Journal Article
Recenzirano
Odprti dostop
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 < 0.01 mg/kg bw per day in infants to 7.1 mg/kg bw per day in children. The 95th percentile of exposure ranged from 0 mg/kg bw per day in infants to 22.5 mg/kg bw per day in children. The Panel concluded that there is no need for a numerical ADI and there is no safety concern for oat lecithin to be used as a food additive at the proposed use (FC 05.1) and use levels. The Panel recommended that the European Commission considers including specifications for oat lecithin as a new food additive.
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.
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