The present opinion deals with the re-evaluation of propane-1,2-diol alginate (E 405) when used as a food additive. The Panel noted that absorption, distribution, metabolism and excretion (ADME) data on propane-1,2-diol alginate gave evidence for the hydrolysis of this additive into propane-1,2-diol and alginic acid. These two compounds have been recently re-evaluated for their safety of use as food additives (EFSA ANS Panel, 2017, 2018). Consequently, the Panel considered in this opinion the major toxicokinetic and toxicological data of these two hydrolytic derivatives. No adverse effects were reported in subacute and subchronic dietary studies with propane-1,2-diol alginate. The available data did not indicate a genotoxic concern for propane-1,2-diol alginate (E 405) when used as a food additive. Propane-1,2-diol alginate, alginic acid and propane-1,2-diol were not of concern with respect to carcinogenicity. The Panel considered that any adverse effect of propane-1,2-diol alginate would be due to propane-1,2-diol. Therefore, the acceptable daily intake (ADI) of the food additive E 405 is determined by the amount of free propane-1,2-diol and the propane-1,2-diol released from the food additive after hydrolysis. According to the EU specification, the concentration of free and bound propane-1,2-diol amounts to a maximum of 45% on a weight basis. On the worst-case assumption that 100% of propane-1,2-diol would be systemically available and considering the ADI for propane-1,2-diol of 25 mg/kg body weight (bw) per day, the Panel allocated an ADI of 55 mg/kg bw per day for propane-1,2-diol alginate. The Panel concluded that exposure estimates did not exceed the ADI in any of the population groups from the use of propane-1,2-diol alginate (E 405) as a food additive. Therefore, the Panel concluded that there is no safety concern at the authorised use levels.
Exposure of infants and children to lead: working document for the 30th Meeting of the Joint FAO/WHO Expert Committee on Food Additives held in Rome, 2-11 June 1986 , Exposure of infants and children to lead: working document for the 30th Meeting of the Joint FAO/WHO... , مرکز فناوری اطلاعات و اطلاع رسانی کشاورزی
EFSA is re-evaluating the safety of food additives already permitted in the Union before 20 January 2009 and issuing scientific opinions on their safety in line with Regulation (EC) No 1333/2008.Acacia gum (E 414) was re-evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS).As follow-up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of acacia gum (E 414) as carry-over in food for infants below 16 weeks of age belonging to food categories 13.1.1(Infant formulae) and 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) and to address the issues already identified during the re-evaluation of the food additive when used in food for the general population.The process involved the publication of a call for data to allow the interested parties to provide the requested information to complete the risk assessment.Based on the analytical data submitted in response to this call, the Panel recommended to lower the limits in the specifications for toxic elements and identified the need for further specifications for aluminium, microbiological criteria and protein residues.The Panel noted that information was not provided for oxidising enzymes and recommended that oxidases and peroxidases should be inactivated during the manufacturing process.The interested parties did not submit toxicological, clinical and post-marketing surveillance data specific for the assessment of the safety of acacia gum (E 414) in infants below 16 weeks of age.However, taking the highest doses tested without adverse effects from the subchronic studies available from the previous re-evaluation and comparing them with the estimated exposure in infants, the margins of safety were large indicating that there is no reason for health concern.
Copper pipes in the water distribution system are widely used all over the world. Corrosion of the pipes causes elevated copper levels in the drinking water. The corrosion depends on the water composition and the stagnation time of the water in the pipes. Low pH is a main factor determining the release of copper, and high alkalinity is also an important contributing factor, especially at a low pH. This is in contrast to corrosion of iron pipes, which is prevented by increasing the alkalinity. Copper in drinking water may contribute significantly to the dietary intake of copper, and sometimes drinking water is the major source. However, it is difficult to calculate the intake of copper from drinking water, as the concentrations can vary one or two orders of magnitude, depending on the flushing habits. Gastrointestinal effects (e.g., nausea, vomiting, diarrhea, and abdominal pains) have been reported after exposure to high concentrations of copper in drinking water. Owing to lack of data, the tolerated level of copper in water can not be firmly established, but guideline values of 1-2 mg/L have been recommended. A higher sensitivity in newborns to elevated copper exposure has been suggested. Release of copper from the pipes will also result in elevated copper concentrations in waste-water sludge and may limit the use of sludge for agricultural purposes. The critical concentration at which copper must be considered from ecotoxicological aspects depend on the biota and exposure conditions at the actual site. Major effects due to elevated copper concentrations in the environment includes decreased growth of plants, disturbed reproduction in several species of invertebrates, and copper poisoning in livestock and fish. Aquatic organisms, especially certain species of crustaceans, have the highest sensitivity to copper toxicity. Effects on fish can be significant already at levels below 0.01 mg/L. The consequences of the extensive and widespread environmental pollution of copper from the intentional use of copper as piping material need to be investigated and thoroughly evaluated.Key words: copper, drinking water, plumbing, health effects, toxicity, sewage sludge.
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.
EFSA JournalVolume 16, Issue 6 e05294 Scientific OpinionOpen Access Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)Search for more papers by this authorMaged Younes, Maged YounesSearch for more papers by this authorPeter Aggett, Peter AggettSearch for more papers by this authorFernando Aguilar, Fernando AguilarSearch for more papers by this authorRiccardo Crebelli, Riccardo CrebelliSearch for more papers by this authorBirgit Dusemund, Birgit DusemundSearch for more papers by this authorMetka Filipicč, Metka FilipicčSearch for more papers by this authorMaria Jose Frutos, Maria Jose FrutosSearch for more papers by this authorPierre Galtier, Pierre GaltierSearch for more papers by this authorUrsula Gundert-Remy, Ursula Gundert-RemySearch for more papers by this authorGunter Georg Kuhnle, Gunter Georg KuhnleSearch for more papers by this authorClaude Lambré, Claude LambréSearch for more papers by this authorJean-Charles Leblanc, Jean-Charles LeblancSearch for more papers by this authorInger Therese Lillegaard, Inger Therese LillegaardSearch for more papers by this authorPeter Moldeus, Peter MoldeusSearch for more papers by this authorAlicja Mortensen, Alicja MortensenSearch for more papers by this authorAgneta Oskarsson, Agneta OskarssonSearch for more papers by this authorIvan Stankovic, Ivan StankovicSearch for more papers by this authorIne Waalkens-Berendsen, Ine Waalkens-BerendsenSearch for more papers by this authorRudolf Antonius Woutersen, Rudolf Antonius WoutersenSearch for more papers by this authorMatthew Wright, Matthew WrightSearch for more papers by this authorAlessandro Di Domenico, Alessandro Di DomenicoSearch for more papers by this authorSusan Fairweather-Tait, Susan Fairweather-TaitSearch for more papers by this authorHarry McArdle, Harry McArdleSearch for more papers by this authorCamilla Smeraldi, Camilla SmeraldiSearch for more papers by this authorDavid Gott, David GottSearch for more papers by this author EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)Search for more papers by this authorMaged Younes, Maged YounesSearch for more papers by this authorPeter Aggett, Peter AggettSearch for more papers by this authorFernando Aguilar, Fernando AguilarSearch for more papers by this authorRiccardo Crebelli, Riccardo CrebelliSearch for more papers by this authorBirgit Dusemund, Birgit DusemundSearch for more papers by this authorMetka Filipicč, Metka FilipicčSearch for more papers by this authorMaria Jose Frutos, Maria Jose FrutosSearch for more papers by this authorPierre Galtier, Pierre GaltierSearch for more papers by this authorUrsula Gundert-Remy, Ursula Gundert-RemySearch for more papers by this authorGunter Georg Kuhnle, Gunter Georg KuhnleSearch for more papers by this authorClaude Lambré, Claude LambréSearch for more papers by this authorJean-Charles Leblanc, Jean-Charles LeblancSearch for more papers by this authorInger Therese Lillegaard, Inger Therese LillegaardSearch for more papers by this authorPeter Moldeus, Peter MoldeusSearch for more papers by this authorAlicja Mortensen, Alicja MortensenSearch for more papers by this authorAgneta Oskarsson, Agneta OskarssonSearch for more papers by this authorIvan Stankovic, Ivan StankovicSearch for more papers by this authorIne Waalkens-Berendsen, Ine Waalkens-BerendsenSearch for more papers by this authorRudolf Antonius Woutersen, Rudolf Antonius WoutersenSearch for more papers by this authorMatthew Wright, Matthew WrightSearch for more papers by this authorAlessandro Di Domenico, Alessandro Di DomenicoSearch for more papers by this authorSusan Fairweather-Tait, Susan Fairweather-TaitSearch for more papers by this authorHarry McArdle, Harry McArdleSearch for more papers by this authorCamilla Smeraldi, Camilla SmeraldiSearch for more papers by this authorDavid Gott, David GottSearch for more papers by this author First published: 26 June 2018 https://doi.org/10.2903/j.efsa.2018.5294Citations: 16 Correspondence:fip@efsa.europa.eu Requestor: Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) Question number: EFSA-Q-2016-00150 Panel members: Peter Aggett, Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Metka Filipicč, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Gunter Georg Kuhnle, Claude Lambré, Jean-Charles Leblanc, Inger Therese Lillegaard, Peter Moldeus, Alicja Mortensen, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes. Acknowledgements: The Panel wishes to thank EFSA staff members: Agnes De Sesmaisons-Lecarre and Andrea Germini and the NDA Panel for the support provided to this scientific output. Adopted: 16 May 2018 This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2018.EN-1439/full This guidance document is applicable for applications submitted until 26 March 2021
