Browsing by Author "Frutos Fernandez, Maria Jose"
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- 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.
- Follow‐up of the re‐evaluation of silver (E 174) as a food additive (EFSA‐Q‐2023‐00169)Publication . EFSA Panel on Food Additives and Flavourings (FAF); Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Castle, Laurence; Fallico, Biagio; FitzGerald, Reginald; Frutos Fernandez, Maria Jose; Grasl‐Kraupp, Bettina; Gundert‐Remy, Ursula; Gürtler, Rainer; Kurek, Marcin Andrzej; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Oomen, Agnes; Corsini, Emanuela; Wright, Matthew; Furst, Peter; Gaffet, Eric; Loeschner, Katrin; Mast, Jan; Undas, Anna; Mech, Agnieszka; Rincon, Ana Maria; Ruggeri, Laura; Smeraldi, CamillaSilver (E 174) is a food colour that was re‐evaluated by the EFSA ANS Panel (2016). The ANS Panel concluded that the information available then, was insufficient to assess the safety of silver as food additive. The major issues included limited characterisation of silver E 174 (e.g. quantity of nanoparticles) and release of ionic silver. Following a European Commission call for further data to fill the data gap, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of silver (E 174). One interested business operator (IBO) submitted limited data on particle size distribution and morphology, two genotoxicity studies and one subchronic study. The Panel concluded that the technical data submitted on physicochemical characterisation of all types of silver used as food additive E 174 were not adequate. As a result, the Panel was unable to propose changes to the EU specifications of E174 on particle size and morphology. As the additional information requested was not provided, the assessment was based solely on the submitted data. Nonetheless, given the data provided and silver insolubility in water, the Panel concluded that E174 requires risk assessment at the nanoscale following the EFSA Guidance on Risk assessment of nanomaterials to be applied in the food and feed chain, to complement the conventional risk assessment. The Panel considered that the genotoxicity data and sub‐chronic toxicity data were inadequate. Consequently, the Panel could not conclude on the safety of the food additive silver E 174.
- Re‐evaluation of oxygen (E 948) and hydrogen (E 949) as food additivesPublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; 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; Rasinger, Josef Daniel; Smeraldi, Camilla; Di Ciano, Samuele; Dino, Borana; Mazzoli, Elena; Rincon, Ana MariaThe Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of oxygen (E 948) and hydrogen (E 949) as food additives. Their currently permitted use in food in the European Union (EU) is in all food categories, including in foods for infants and young children at quantum satis (QS). They can also be used in food additive preparations, food enzymes and nutrients also at QS. No interested business operators (IBOs) provided information in response to the call for data published by EFSA to support their re‐evaluation. The original evaluation by the EU in 1990 indicated their use as packaging gases, and in the case of oxygen (E 948), also as propellant. The Panel considered the two gases to be of low toxicological concern when used as food additives and their dietary exposure very low. The Panel concluded that the use of oxygen (E 948) and hydrogen (E 949) as food additives does not raise a safety concern. The Panel made some recommendations for amending existing EU specifications for both oxygen (E 948) and hydrogen (E 949).
- Re‐evaluation of pullulan (E 1204) as a food additive and new application for its extension of usePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Frutos Fernandez, Maria Jose; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; Fitzgerald, Reginald; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Barat Baviera, José Manuel; Degen, Gisela; Gott, David; Leblanc, Jean-Charles; Moldeus, Peter; Waalkens-Berendsen, Ine; Wölfle, Detlef; Aguilera Entrena, Jaime; Gagliardi, Gabriele; Mech, Agnieszka; Medrano-Padial, Concepción; Lunardi, Simone; Rincon, Ana Maria; Smeraldi, Camilla; Tard, Alexandra; Ruggeri, LauraThe present opinion deals with the re‐evaluation of pullulan (E 1204) when used as a food additive and with the new application on the extension of use to several food categories. Pullulan (E 1204) is obtained by fermentation of a food‐grade hydrolysed starch with non‐genetically modified Aureobasidium pullulans ■■■■■. Based on the available information, the Panel considered that the manufacturing process of pullulan (E 1204) using this microorganism does not raise a safety concern. The Panel confirmed that pullulan (E 1204) is of no concern for genotoxicity. In vitro, pullulan (E 1204) is broken down by salivary and pancreatic amylase and intestinal iso‐amylase and it is further metabolised to short chain fatty acids in the colon by fermentation. Human adult volunteer studies suggested that effects of pullulan (E 1204) are similar to the effects of other poorly digestible carbohydrate polymers including modified celluloses and that mild undesirable gastrointestinal symptoms (i.e. abdominal fullness, flatulence, bloating and cramping) may occur at doses of 10 g pullulan per day and greater. The Panel compared the dose of 10 g pullulan per day with the dietary exposure estimates to pullulan (E 1204) in its currently permitted uses and considering the proposed changes to the currently permitted uses. The Panel concluded that there is no need for a numerical ADI for pullulan (E 1204) and there is no safety concern for the currently reported uses and use levels. Additionally, the Panel concluded that the exposure estimates considering the proposed changes to the currently permitted uses and use levels of pullulan (E 1204) are of no safety concern. The estimates for dietary exposure to pullulan (E 1204) indicate that individuals with a high level of exposure, principally coming from food supplements, may experience mild gastrointestinal symptoms at the currently reported uses and use levels.
- Re‐evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additivesPublication . Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; 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; Batke, Monika; Bruzell, Ellen; Chipman, James; Cheyns, Karlien; Crebelli, Riccardo; Fortes, Cristina; Fürst, Peter; Halldorsson, Thorhallur; LeBlanc, Jean‐Charles; Mirat, Manuela; Lindtner, Oliver; Mortensen, Alicja; Ntzani, Evangelia; Shah, Romina; Wallace, Heather; Wright, Matthew; Barmaz, Stefania; Civitella, Consuelo; Georgelova, Petra; Lodi, Federica; Mazzoli, Elena; Rasinger, Josef; Maria Rincon, Ana; Tard, Alexandra; Zakidou, Panagiota; Younes, Maged; EFSA Panel on Food Additives and Flavourings (FAF)This opinion deals with the re-evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additives. Saccharin is the chemically manufactured compound 1,2-benzisothiazol-3(2H)-one-1,1-dioxide. Along with its sodium (Na), potassium (K) and calcium (Ca) salts, they are authorised as sweeteners (E 954). E 954 can be produced by two manufacturing methods i.e. Remsen-Fahlberg and Maumee. No analytical data on potential impurities were provided for products manufactured with the Maumee process; therefore, the Panel could only evaluate saccharins (E 954) manufactured with the Remsen-Fahlberg process. The Panel concluded that the newly available studies do not raise a concern for genotoxicity of E 954 and the saccharins impurities associated with the Remsen-Fahlberg manufacturing process. For the potential impurities associated with the Maumee process, a concern for genotoxicity was identified. The data set evaluated consisted of animals and human studies. The Panel considered appropriate to set a numerical acceptable daily intake (ADI) and considered the decrease in body weight in animal studies as the relevant endpoint for the derivation of a reference point. An ADI of 9 mg/kg body weight (bw) per day, expressed as free imide, was derived for saccharins (E 954). This ADI replaces the ADI of 5 mg /kg bw per day (expressed as sodium saccharin, corresponding to 3.8 mg /kg bw per day saccharin as free imide) established by the Scientific Committee on Food. The Panel considered the refined brand-loyal exposure assessment scenario the most appropriate exposure scenario for the risk assessment. The Panel noted that the P95 exposure estimates for chronic exposure to saccharins (E 954) were below the ADI. The Panel recommended the European Commission to consider the revision of the EU specifications of saccharin and its sodium, potassium and calcium salts (E 954).
- Safety evaluation of d‐α‐tocopheryl polyethylene glycol‐1000 succinate (Vitamin E TPGS) as a food additivePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; 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; Barat Baviera, José Manuel; Degen, Gisela; Gott, David; Leblanc, Jean‐Charles; Moldeus, Peter; Waalkens‐Berendsen, Ine; Wölfle, Detlef; Consuelo, Civitella; Mech, Agnieszka; Medrano‐Padial, Concepción; Rincon, Ana Maria; Smeraldi, Camilla; Tard, Alexandra; Ruggeri, LauraThe EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of d‐α‐tocopheryl polyethylene glycol‐1000 succinate (Vitamin E TPGS) as a new food additive to be used in several food categories as emulsifier. In 2007, the EFSA AFC Panel assessed TPGS as a source of tocopherol intended to be used in foods for particular nutritional uses. The Panel considered the AFC Panel assessment relevant for the present new food additive. Compositional data showed that the proposed food additive is composed of Vitamin E TPGS monoesters (< 82% w/w of the whole preparation) and diesters (<20% w/w of the whole preparation). Data on the hydrolysis of Vitamin E TPGS showed that the ester bond between d‐α‐tocopherol and succinic acid is stable under the tested conditions, as no increase in free d‐α‐tocopherol was observed. Vitamin E TPGS is poorly absorbed and does not represent a source of Vitamin E in the healthy population. Vitamin E TPGS does not raise a concern with respect to genotoxicity and no adverse effects on reproductive and developmental parameters were observed up to 1000 mg TPGS/kg bw per day, the highest dose tested and identified as a reference point. Due to the limitations in the available data (e.g. in reporting), the Panel decided to use an MOE approach instead of deriving an ADI. The Panel considered the calculated MOEs sufficient. Based on the available data, the Panel concluded that the use of Vitamin E TPGS as a new food additive does not raise a safety concern at the proposed use and use levels.
- Scientific opinion on the extension of uses of quillaia extract (E 999) as a food additivePublication . Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; 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; Barat Baviera, José Manuel; Leblanc, Jean-Charles; Tard, Alexandra; Vermeiren, Sam; Zakidou, Panagiota; Ruggeri, Laura; EFSA Panel on Food Additives and Flavourings (FAF)The EFSA Panel on Food Additives and Flavourings (FAF Panel) evaluated the safety of the extension of uses of quillaia extract (E 999) as a food additive in food supplements supplied in a solid or liquid form, excluding food supplements for infants and young children. Quillaia extract (E 999) was re-evaluated in 2019 by the EFSA FAF Panel, which derived an acceptable daily intake (ADI) of 3 mg saponins/kg bw per day for E 999, while in 2024 a follow-up of the re-evaluation was published by the FAF Panel, recommending some modifications of the existing EU specifications for quillaia extract (E 999). Currently, quillaia extract (E 999) is authorised in two food categories (FCs) i.e. FC 4.1.4 'Flavoured drinks' and FC 14.2.3 'Cider and perry' (excluding ). A 'food supplements consumers only' scenario was calculated for this opinion considering the proposed extension of uses, together with the current authorised uses at both the maximum permitted level (MPLs) and the typical reported use levels of quillaia extract (E 999) at the time of the 2019 re-evaluation. The Panel concluded that the exposure estimates using the typical reported use levels for the currently authorised food categories and considering the proposed extension of uses for E 999 in FC 17.1 'Food supplements supplied in a solid form, excluding food supplement for infants and young children' and FC 17.2 'Food supplements supplied in a liquid form, excluding food supplement for infants and young children', if authorised, would not result in an exceedance of the ADI in any population group.