Browsing by Author "Lindtner, Oliver"
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- Re‐evaluation of acesulfame K (E 950) as 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; 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; Barmaz, Stefania; Wright, Matthew; Civitella, Consuelo; Le Gall, Pauline; Mazzoli, Elena; Rasinger, Josef Daniel; Rincon, Ana; Tard, Alexandra; Lodi, FedericaThe present opinion deals with the re‐evaluation of acesulfame K (E 950) as a food additive. Acesulfame K (E 950) is the chemically manufactured compound 6‐methyl‐1,2,3‐oxathiazin‐4(3H)‐one‐2,2‐dioxide potassium salt. It is authorised for use in the European Union (EU) in accordance with Regulation (EC) No 1333/2008. The assessment involved a comprehensive review of existing authorisations, evaluations and new scientific data. Acesulfame K (E 950) was found to be stable under various conditions; at pH lower than 3 with increasing temperatures, it is degraded to a certain amount. Based on the available data, no safety concerns arise for genotoxicity of acesulfame K (E 950) and its degradation products. For the potential impurities, based on in silico data, a concern for genotoxicity was identified for 5‐chloro‐acesulfame; a maximum limit of 0.1 mg/kg, or alternatively, a request for appropriate genotoxicity data was recommended. Based on the synthesis of systematically appraised evidence of human and animal studies, the Panel concluded that there are no new studies suitable for identification of a reference point (RP) on adverse effects. Consequently, the Panel established an acceptable daily intake (ADI) of 15 mg/kg body weight (bw) per day based on the highest dose tested without adverse effects in a chronic toxicity and carcinogenicity study in rats; a study considered of moderate risk of bias and one of two key studies from the previous evaluations by the Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). This revised ADI replaces the ADI of 9 mg/kg bw per day established by the SCF. The Panel noted that the highest estimate of exposure to acesulfame K (E 950) was generally below the ADI in all population groups. The Panel recommended the European Commission to consider the revision of the EU specifications of acesulfame K (E 950).
- Re‐evaluation of neotame (E 961) as 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; Batke, Monika; Bruzell, Ellen; Chipman, James; Crebelli, Riccardo; Fortes, Cristina; Fürst, Peter; Gaffet, Eric; Karlien, Cheyns; Halldorsson, Thorhallur; Leblanc, Jean‐Charles; Lindtner, Oliver; Loeschner, Katrin; Mast, Jan; Mirat, Manuela; Mortensen, Alicja; Undas, Anna; Wright, Matthew; Barmaz, Stefania; Civitella, Consuelo; Abrahantes, Jose Cortiñas; Le Gall, Pauline; Mazzoli, Elena; Mech, Agnieszka; Rasinger, Josef Daniel; Rincon, Ana; Riolo, Francesca; Smeraldi, Camilla; Tard, Alexandra; Zakidou, Panagiota; Lodi, FedericaThe present opinion deals with the re‐evaluation of neotame (E 961) as a food additive. Neotame is the chemically manufactured compound N‐[N‐(3,3‐dimethylbutyl)‐l‐α‐aspartyl]‐l‐phenylalanine 1‐methyl ester. The main impurity of neotame (E 961) is also a degradation product (de‐esterified form), N‐[N‐(3,3‐dimethylbutyl)‐l‐α‐aspartyl]‐l‐phenylalanine (NC‐00751) and the primary metabolite. No new data were received following the call for biological and toxicological data. A summary of the toxicological studies available in the EFSA opinion of 2007 is presented and studies gathered from the literature are summarised. Neotame is rapidly absorbed and pre‐systemically metabolised, systemic intact neotame is likely to be excreted in the urine with its metabolites. The potential aneugenic effects at the site of contact are not expected to occur; overall, there is no concern for genotoxicity of neotame (E 961) at the maximum permitted levels or reported use levels. A review of the other endpoints from the already available toxicological database did not indicate an adverse effect for neotame at the highest doses tested. The Panel established an acceptable daily intake (ADI) of 10 mg/kg bw per day for neotame based on the no observed adverse effect level (NOAEL) of 1000 mg/kg bw per day from a 52‐week chronic and 104‐week carcinogenicity studies in rats. This ADI replaces the ADI of 2 mg/kg bw per day established by EFSA in 2007. The resulting exposure to methanol and its metabolite formaldehyde from the use of neotame at the ADI of 10 mg/kg bw per day does not raise a concern. The dietary exposure estimates of neotame (E 961) for the different population groups of all exposure scenarios did not exceed the ADI. The Panel concluded that there is no safety concern for neotame (E 961) at the currently permitted and reported uses and use levels. The Panel recommended the European Commission to consider revising the EU specifications of neotame (E 961).
- 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).
- Towards a Harmonised Total Diet Study Approach: a guidance document:joint guidance of EFSA, FAO and WHOPublication . Peltonen, Kimmo; Charrondiere, Ruth; Georgescu, Ioana Madalina; Kambek, Liis; Lombardi-Boccia, Ginevra; Lindtner, Oliver; Marcos Suarez, Victoria; Oliveira, Luísa; Ruprich, Jirí; Shavila, Joseph; Sirot, Veronique; Verger, PhilippeA Total Diet Study (TDS) can be a complementary approach to traditional monitoring and surveillance programs, which instead of focusing on compliance is designed to provide a solid basis for calculating population dietary exposure and assessing potential impact on public health. A TDS includes the selection of foods based on food consumption data to represent a large portion of a typical diet, their preparation to food as consumed and the subsequent pooling of related foods before analysis. There is already a wealth of international TDS data available, but to better enable comparisons it is important that methods are harmonised to the extent possible. The Working Group of experts provides a definition of the TDS approach highlighting its inherent value; it gives guidance for a harmonised methodology starting from the TDS planning to the collection of analytical results, exposure assessment calculation and communication of TDS results; and it proposes a general approach to facilitate the use of TDS information at international level. A TDS can be used for screening purposes or as a more refined exposure assessment tool. It provides background concentration and exposure levels of chemical substances in a range of representative foods prepared for consumption, while monitoring and surveillance programs can better capture highly contaminated individual food items. Their complementarities would allow the identification of the relative importance of individual sources of chemical substances from the whole diet. In conclusion, a TDS is considered to be a good complement to existing food monitoring or surveillance programs to estimate population dietary exposure to beneficial and harmful chemical substances across the entire diet. Harmonising the TDS methodology will enhance the value of these programs by improving the comparability at international level.
- Validation of a picture book to be used in a pan-European dietary surveyPublication . Vilela, Sofia; Lopes, Carla; Guiomar, Sofia; Severo, Milton; Rangelova, Lalka; Petrova, Stefka; Horváth, Zuszsanna; Cseh, Júlia; Schweter, Antje; Lindtner, Oliver; Ambrus, Árpád; Torres, DuarteObjective: To validate a picture book for estimation of food portion sizes using two approaches: (i) ‘perception’ of food portions by comparison with a series of food photos; and (ii) ‘conceptualization and memory’, using the same photos to estimate the amount of served food one hour after self-served food portions. Design: Each partner developed a country-specific picture book based on the so-called EPIC-Soft picture book. Representative and common photo series were chosen achieving approximately 25 % of the original picture book (n 23). Three portions from each photo series were randomly selected. Setting: The study was performed within the Pilot study in the view of a Pan-European dietary survey – Adolescents, adults and elderly (PILOT-PANEU) project. Subjects: A sample of adolescents and adults was recruited in five countries: Bulgaria (n 103), Finland (n 34), Germany (n 69), Hungary (n 62) and Portugal (n 77). Results: Among the portions of the corresponding photo series and depending on the type of food, from 18 % (cheese) to 96 % (ratatouille) of participants chose the correct portions. In the perception study, agreement between the portions shown and reported was substantial (intraclass correlation coefficient (ICC)=0·805) and the mean difference was very low. In the memory study, agreement between the served and reported portions was lower than in the perception study (ICC=0·536). Agreement also seemed to decrease as the appearance of food on the plate differed from food in the picture. Conclusions: Overall, the picture series selected can be applied in future intake surveys to quantify foods similar to those depicted in the pictures.