Browsing by Author "Bastos, Maria"
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- Flavouring group evaluation 418 (FGE. 418): 3‐[3‐(2‐isopropyl‐5‐methyl‐cyclohexyl)‐ureido]‐butyric acid ethyl esterPublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos-Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Benigni, Romualdo; Chipman, Kevin; Cordelli, Eugenia; Degen, Gisela; Engel, Karl-Heinz; Fowler, Paul; Carfí, Maria; Gagliardi, Gabriele; Mech, Agnieszka; Multari, Salvatore; Martino, CarlaThe EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of 3‐[3‐(2‐isopropyl‐5‐methyl‐cyclohexyl)‐ureido]‐butyric acid ethyl ester [FL‐no: 16.136] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. The substance has not been reported to occur naturally and it is chemically synthesised. The information provided on the manufacturing process, the composition and the stability of [FL‐no: 16.136] was considered sufficient. The chronic dietary exposure to [FL‐no: 16.136] estimated using the added portions exposure technique (APET) is calculated to be 860 μg/person per day for a 60‐kg adult and 540 μg/person per day for a 15‐kg 3‐year‐old child. [FL‐no: 16.136] did not show genotoxic effects in bacterial mutagenicity and mammalian cell micronucleus assays in vitro. No ADME studies on [FL‐no: 16.136] were provided. In a prenatal developmental toxicity study, no maternal or fetal toxicity was observed in rats dosed up to 1000 mg/kg body weight (bw) per day. In a 90‐day toxicity study in rats, no adverse effects were observed. In this study, the Panel considered that the NOAEL is 777 and 923 mg/kg bw per day (the highest dose tested) for male and female rats, respectively. Considering the lowest NOAEL of 777 mg/kg bw per day, as a reference point, adequate margins of exposure of 55 × 103 and 21 × 103 were calculated for adults and children, respectively, when considering the chronic APET dietary exposure estimates. The Panel concluded that the use of 3‐[3‐(2‐isopropyl‐5‐methylcyclohexyl)‐ureido]‐butyric acid ethyl ester [FL‐no: 16.136] as a flavouring substance under the proposed conditions of use does not raise a safety concern at the dietary exposure estimates calculated using the APET approach.
- Flavouring group evaluation 420 (FGE.420): Hesperetin dihydrochalconePublication . Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Degen, Gisela; Engel, Karl-Heinz; Fowler, Paul; Carfí, Maria; Civitella, Consuelo; Dino, Borana; Gagliardi, Gabriele; Mech, Agnieszka; Zakidou, Panagiota; Martino, Carla; EFSA Panel on Food Additives and Flavourings (FAF)The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of hesperetin dihydrochalcone [FL-no: 16.137] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. The substance is structurally related to the group of flavonoids evaluated in FGE.32 and is the aglycone of neohesperidine dihydrochalcone. Based on the data provided for [FL-no: 16.137], the Panel considered that a read-across between hesperetin dihydrochalcone and the substances in FGE.32 is not needed. Nevertheless, the flavonoids evaluated in FGE.32 were considered in a cumulative exposure assessment. The information provided on the manufacturing process, the composition and the stability of [FL-no: 16.137] was considered sufficient. The Panel concluded that there is no concern with respect to genotoxicity. No absorption, distribution, metabolism and excretion (ADME) studies on [FL-no: 16.137] were provided, but studies investigating the ADME of neohesperidine dihydrochalcone were submitted. The Panel noted that [FL-no: 16.137] has the same fate in the organism, as that of neohesperidine dihydrochalcone and considered that [FL-no: 16.137] can be anticipated to be metabolised to innocuous products only. In a prenatal developmental toxicity study, no maternal or foetal toxicity was observed. In a 90-day toxicity study, indications were obtained that the substance affects thyroid hormone levels at all doses tested (100-1000 mg/kg bw per day). Since these changes were not accompanied by apical findings indicative of hypothyroidism, the Panel considered these hormonal effects as not adverse. Using 1000 mg/kg bodyweight (bw) per day as reference point, adequate margins of exposure were calculated for adults and children, when considering the chronic added portions exposure technique (APET) dietary exposure estimates. Cumulative chronic exposure estimates to [FL-no: 16.137] and the four structurally related substances evaluated in FGE.32 do not raise a safety concern. The use of [FL-no: 16.137] as food flavouring, under the proposed conditions of use, does not raise a safety concern.
- Flavouring Group Evaluation 80, Revision 2 (FGE.80Rev2): Consideration of alicyclic, alicyclic‐fused and aromatic‐fused ring lactones evaluated by the JECFA (61st and 82nd meetings) structurally related to an aromatic lactone evaluated in FGE.27Publication . Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria; Boon, Polly; Fallico, Biagio; Fitzgerald, Reginald; Frutos Fernandez, Maria Jose; Grasl‐Kraupp, Bettina; Gundert‐Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Benigni, Romualdo; Degen, Gisela; Engel, Karl‐Heinz; Fowler, Paul; Nørby, Karin; Svendsen, Camilla; Carfí, Maria; Dino, Borana; Gagliardi, Gabriele; Martino, Carla; Mennes, Wim; EFSA Panel on Food Additives and Flavourings (FAF)The EFSA Panel on Food Additives and Flavourings was requested to evaluate 14 flavouring substances assigned to the Flavouring Group Evaluation 80 (FGE.80), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Thirteen substances have already been considered in FGE.80 and its revision and in FGE.96 [FL‐no: 10.005, 10.024, 10.025, 10.050, 10.061, 10.069, 10.070, 10.072, 10.169, 13.009, 13.012, 13.161 and 16.055]. The remaining flavouring substance 3a,4,5,7a‐tetrahydro‐3,6‐dimethylbenzofuran‐2(3H)‐one [FL‐no: 10.057] has been cleared with respect to genotoxicity in FGE.217Rev3 and it is considered in this revision 2 of FGE.80. The substance [FL‐no: 10.057] was evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, threshold of toxicological concern (TTC) and available data on metabolism and toxicity. The Panel concluded that [FL‐no: 10.057] does not give rise to safety concerns at its levels of dietary intake, when estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. Besides the safety assessment of the flavouring substance, the specifications for the material of commerce have also been considered and the information provided was complete for [FL‐no: 10.057]. However, for the flavouring substance [FL‐no: 10.057] in the present revision and for eight substances evaluated in previous revisions, the ‘modified Theoretical Added Maximum Daily Intakes’ (mTAMDIs) values are above the TTC for their structural class (III). For four substances previously evaluated in FGE.80Rev1 and in FGE.96, use levels are still needed to calculate the mTAMDI estimates. Therefore, in total for 13 flavouring substances, data on uses and use levels should be provided to finalise their safety evaluations. For [FL‐no: 10.050, 10.069 and 13.161], information on the composition of stereoisomeric mixtures is needed.
- Re‐evaluation of argon (E 938) and helium (E 939) as food additivesPublication . EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria; Boon, Polly; Fallico, Biagio; Fitzgerald, Reginald; Frutos Fernandez, Maria Jose; Grasl‐Kraupp, Bettina; Gundert‐Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Multari, Salvatore; Rasinger, Josef Daniel; Rincon, Ana Maria; Vermeiren, Sam; Smeraldi, CamillaThe Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of the two food additives argon (E 938) and helium (E 939). Argon (Ar) and helium (He) are two noble gases, highly stable single atoms. Their chemical inertness is well known. Their physicochemical properties have served as a basis for their previous evaluations by SCF and JECFA, which have considered the use of these food additives safe even in the absence of a toxicological evaluation. No business operator or other interested party provided information in response to the call for data published by EFSA to support the re-evaluation of these two food additives with respect to their identity and specifications, manufacturing process (including the identification and quantification of potential impurities) and how they are applied to food to exert their technological function. One business operator replied to the call for data issued by EFSA reporting use levels of E 938 as a packaging gas in one food category. Based on their physicochemical properties, both gases are considered by the Panel to be of low toxicological concern when used as food additives. No information was available on the potential presence of impurities of toxicological concern resulting from the manufacturing process(es) applied to the production of the food additives E 938 and E 939. The Panel however noted that a minimum purity of 99.0% is required to comply with existing specifications. The Panel concluded that the use of argon (E 938) and helium (E 939) as food additives does not raise a safety concern. The Panel recommended an amendment of the existing EU specifications to introduce the respective CAS numbers.
- Re‐evaluation of butane (E 943a), isobutane (E 943b) and propane (E 944) as food additivesPublication . EFSA Panel on Food Additives and Flavourings; Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria; Boon, Polly; Fallico, Biagio; Fitzgerald, Reginald; Frutos-Fernandez, Maria Jose; Grasl‐Kraupp, Bettina; Gundert‐Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Gagliardi, Gabriele; Multari, Salvatore; Rasinger, Josef Daniel; Rincon, Ana Maria; Smeraldi, CamillaThe Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of butane (E 943a), isobutane (E 943b) and propane (E 944) as food additives. Butane, isobutane and propane are short‐chain (C3–C4) alkanes, which are in gaseous state at room temperature. Their currently permitted use in food is in vegetable oil pan spray (for professional use only) and water‐based emulsion spray as propellants at quantum satis. They can also be used in food colour preparations with a maximum residual limit of 1 mg/kg in food. Two interested business operators (IBOs) provided information in response to the call for data published by EFSA reporting typical and maximum use levels. The toxicological hazards of the three gases via inhalation are known, however this route of exposure is not considered relevant for their safety assessment as food additives. Existing EU specifications for the three food additives already contain limits for the toxic impurity 1,3‐butadiene (1,3‐BD), however due to a lack of information on the manufacturing processes used, uncertainties do remain regarding the potential presence of other impurities not listed in the current EU specifications for food additives. Based on their physicochemical properties, the three gases are considered by the Panel to be of low toxicological concern when used as food additives and their dietary exposure very low. The Panel concluded that the use of butane (E 943a), isobutane (E 943b) and propane (E 944) as food additives at the currently permitted uses and use levels does not raise a safety concern. The Panel made some recommendations for amending existing EU specifications for butane (E 943a), isobutane (E 943b) and propane (E 944).