Japan Flavour and Fragrance Materials Association’s (JFFMA) safety assessment of food-flavouring substances uniquely used in Japan that belong to the class of aliphatic primary alcohols,aldehydes, carboxylic acids,acetals and esters containing additional oxygenated functional groups

ABSTRACT

We performed a safety evaluation using the procedure devised by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the following four flavouring substances that belong to the class of ‘aliphatic primary alcohols, aldehydes, carboxylic acids, acetals, and esters containing additional oxygenated functional groups’ and are uniquely used in Japan: butyl butyrylacetate, ethyl 2-hydroxy-4-methylpentanoate, 3-hydroxyhexanoic acid and methyl hydroxyacetate. Although no genotoxicity study data were found in the published literature, none of the four substances had chemical structural alerts predicting genotoxicity. All four substances were categorised as class I by using Cramer’s classification. The estimated daily intake of each of the four substances was determined to be 0.007–2.9 μg/person/day by using the maximised survey-derived intake method and based on the annual production data in Japan in 2001, 2005 and 2010, and was determined to be 0.250–600.0 μg/person/day by using the single-portion exposure technique and based on average-use levels in standard portion sizes of flavoured foods. Both of these estimated daily intake ranges were below the threshold of toxicological concern for class I substances, which is 1800 μg/person/day. Although no information from in vitro and in vivo toxicity studies for the four substances was available, these substances were judged to raise no safety concerns at the current levels of intake.     

JECFA对食品添加剂的安全性评价

食品添加剂的安全性问题是食品工业普遍关注并亟待解决的问题,JECFA是国际食品添加剂与污染物安全评价的权威机构。介绍了JECFA对食品添加剂的安全性评价概况及评价结果。总结了近几年JECFA对几种食品添加剂的评价结果,主要介绍了各种物质的ADI值,并对各种物质的功能类别做了说明。     

Occurrence and estimation of aflatoxin M1 exposure in milk in Serbia

The occurrence of AFM1 was investigated in 150 cow's, 10 goat's, 5 donkey's, 10 breasts milk and 1 infant formula samples. Analyses were done using Enzyme Linked Immunosorbent Assay (ELISA) method. AFM1 was detected in 98.7% of analyzed cow's milk samples in concentrations ranged from 0.01 to 1.2 μg/kg. Further, even 129 (86.0%) cow's milk samples contained AFM1 in concentration greater than maximum residue levels (MRL) of 0.05 μg/kg defined by European Union (EU) Regulation. Analysis of other types of milk showed that AFM1 was detected in 80.0% goat's, 60.0% donkey's and 60.0% of breasts milk samples.Although Serbian Regulation for MRL of AFM1 in milk has been changed and harmonized with EU Regulation in 2011, occurrence of AFM1 in milk in Serbia during 2013 resulted in Regulation changes, and MRL were changed from 0.05 to 0.5 μg/kg.On the basis of the obtained concentrations of the AFM1 in cow's milk, collected information about average milk intake and mean body weight (bw) for different age's categories, mean ingestion of AFM1 in ng/kg per bw per day were estimated. Obtained results showed that all age's categories, especially children, are exposed with high risk related to presence of AFM1 in milk.There are only a few published data about occurrence of AFM1 in milk in Serbia and none about intake assessment for AFM1.     

The Japan Flavour and Fragrance Materials Association’s (JFFMA) safety assessment of acetal food flavouring substances uniquely used in Japan

Using the procedure devised by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), we performed safety evaluations on five acetal flavouring substances uniquely used in Japan: acetaldehyde 2,3-butanediol acetal, acetoin dimethyl acetal, hexanal dibutyl acetal, hexanal glyceryl acetal and 4-methyl-2-pentanone propyleneglycol acetal. As no genotoxicity study data were available in the literature, all five substances had no chemical structural alerts predicting genotoxicity. Using Cramer’s classification, acetoin dimethyl acetal and hexanal dibutyl acetal were categorised as class I, and acetaldehyde 2,3-butanediol acetal, hexanal glyceryl acetal and 4-methyl-2-pentanone propyleneglycol acetal as class III. The estimated daily intakes for all five substances were within the range of 1.45–6.53 µg/person/day using the method of maximised survey-derived intake based on the annual production data in Japan from 2001, 2005, 2008 and 2010, and 156–720 µg/person/day using the single-portion exposure technique (SPET), based on the average use levels in standard portion sizes of flavoured foods. The daily intakes of the two class I substances were below the threshold of toxicological concern (TTC) – 1800 μg/person/day. The daily intakes of the three class III substances exceeded the TTC (90 μg/person/day). Two of these, acetaldehyde 2,3-butanediol acetal and hexanal glyceryl acetal, were expected to be metabolised into endogenous products after ingestion. For 4-methyl-2-pentanone propyleneglycol acetal, one of its metabolites was not expected to be metabolised into endogenous products. However, its daily intake level, based on the estimated intake calculated by the SPET method, was about 1/15 000th of the no observed effect level. It was thus concluded that all five substances raised no safety concerns when used for flavouring foods at the currently estimated intake levels. While no information on in vitro and in vivo toxicity for all five substances was available, their metabolites were judged as raising no safety concerns at the current levels of intake.     

栀子黄色素的生物学功能及安全性的研究进展

栀子黄是一种在我国和许多周边亚洲国家广泛使用的食品着色剂,并已在中国和一些国家获得批准,成为合法消费a的食品添加剂。目前,中国等国家正在积极推动栀子黄的JECFA认证。JECFA认证的关键点之一是栀子黄安全性。藏花素是一种少有的水溶性类胡萝卜素,是栀子黄的主要成分。本文综述了近年来有关藏花素的生物学、毒理和功能研究的结果,最终得出结论:藏花素对人体无毒副作用。这一结论将有助于栀子黄素的JECFA认证。     

Presence of mycotoxins in animal milk: A review

Mycotoxins can cause toxicity when ingested by humans and animals. Although the rumen is supposed to be a barrier against mycotoxins, some studies demonstrate that carry-over of mycotoxins to milk is possible. Different studies have found mycotoxin levels in animal milk, mainly related to contaminated feed for ruminants. Aflatoxin M1 is the most studied mycotoxin in milk and levels exceeding the EU maximum level for this mycotoxin in this matrix (0.050 μg/kg) have been found. Maximum levels in milk for other mycotoxins have not been established; however ochratoxin A, aflatoxins G1, G2, B1, B2 and M2, fumonisin B1, cyclopiazonic acid, zearalenone and its metabolites and deepoxy-deoxynivalenol have also been found in milk samples. Taking into account that multi-exposure to mycotoxins is the most likely scenario and co-occurrence of mycotoxins could affect their toxicological effects in humans and animals, there is a need to determine the co-occurrence of mycotoxins in milk.     

Health risk associated with dietary co-exposure to high levels of antimony and arsenic in the world's largest antimony mine area

Like arsenic (As), antimony (Sb) is known to be a genotoxic element in vitro and in vivo. Sb is now recognized as a global contaminant and has aroused the global concerns recently. However, knowledge is scarce concerning the transfer of Sb from the environment to humans and the related hazards to human health. In this pilot study, the health risk and main pathway of long-term human exposure to Sb and As for residents around Chinese Xikuangshan (XKS) Sb mine, the world's largest Sb mine, were evaluated by dietary exposure and hair accumulations survey. The concentrations and species of Sb and As in food samples (n = 209) from three main categories and six subcategories, and in hair samples (n = 89) were determined. Residents in the vicinity of XKS had an estimated dietary intake of Sb (554 μg/day) which was 1.5 times higher than the tolerable daily intake (TDI) (Sb, 360 μg/day), whereas their dietary intake of inorganic As (107 μg/day) was slightly lower than the provisional tolerable weekly intake (PTWI) of 15 μg/kg BW/week (equal to 129 μg As/day). Hair Sb and As concentrations (Sb, 15.7 mg/kg, DW; As, 3.99 mg/kg, DW) in XKS residents are both above the normal/toxic level. Rice, vegetables (especially leafy vegetable), drinking water, and meat/poultry were the dominant dietary intake sources of Sb for the residents. In contrast, rice was the uniquely dominant dietary intake source of As. Antimonate (Sb(V)) was the dominant Sb species in vegetables, drinking water and residents' hairs. This study highlighted the difference of exposure characteristics between Sb and As. The preliminary results suggested that dietary exposures to Sb, rather than As, was the dominant health risk to local residents. Nevertheless, the adverse effects of As levels on the health of residents still can not be ignored since the elevated As concentrations in human hair have reached the critical level for health risks. In addition, this pilot study did not consider the possible Sb and As combined effects.