Scientific Committee For Food Research Articles

Natural occurrence of deoxynivalenol, nivalenol and deoxynivalenol-3-glucoside in cereal-derived products from Egypt

The occurrence of deoxynivalenol, nivalenol and deoxynivalenol-3-glucoside in 104 corn and wheat flour samples available on the Egyptian market was investigated using ultra-performance liquid chromatography with a photodiode array detector (UPLC-PDA). Of all samples, 70.2% were contaminated with deoxynivalenol at levels varying between < LOQ and 853 μg/kg. Nivalenol and deoxynivalenol-3-glucoside were detected in only 54.8% (range < LOQ–462 μg/kg) and 32.7% (range < LOQ–257 μg/kg) of the samples, respectively. The occurrence of the target mycotoxins was more frequent in corn flour samples, compared to wheat flour ones (p < 0.05). A total of 46.6% (34/73) of all deoxynivalenol-positive samples contained glucoside conjugate form (deoxynivalenol-3-glucoside) at contamination levels that reached 8.0–33.3% of the parent deoxynivalenol. To the best of our knowledge, this is the first report of deoxynivalenol-3-glucoside in cereal-derived products from Egypt. Dietary risk assessment was also conducted by evaluating the probable daily intakes, which were within the tolerable daily intakes proposed by the Scientific Committee for Food (SCF) of the European Union for legislated mycotoxins (0.7 and 1.0 μg/kg body weight/day for NIV and DON, respectively). However, from the food safety's point of view, the co-occurrence of mycotoxins across a high number of the analyzed samples (64/104) would increase the toxicological hazard due to synergistic effects of possible combined exposure. Still, the need for continuous surveillance of these mycotoxins throughout the cereal production chain is important to control and minimize their potential health hazards, particularly those attributed to DON intake by the consumers.

Characterization and analysis of nitrate content of vegetable ferns (Pleocnemia irregularis (C. Presl) Holttum) from Dramaga District, Bogor

Pleocnemia irregularis (C. Presl) Holttum or vegetable fern is common in partial shade in lowland forest and on the edge of forested hills, especially on slopes. The edible part of this plant is its fiddlehead that serves as a vegetable. This study aimed to characterize this vegetable fern phenotype, as well as analyze the nitrate content of its leaves. The research was conducted at the Arboretum of Faculty of Forestry, Bogor Agricultural University (Arboretum 1), Dramaga Research Forest of Bogor Research Centre, and Forest Conservation (CIFOR 1 and CIFOR 2). The result showed that there were no differences in the qualitative characteristics of the fern obtained from the three locations. Based on quantitative characteristics, the vegetable fern at CIFOR 2 is the smallest. Average NO3- (mg.100 g-1) from fiddlehead extraction is below the nitrate acceptable daily intake value based on human weight, recommended by European Commission’s Scientific Committee for Food, therefore, consuming vegetable fern with an average daily consumption of 100 grams Day-1 is considered safe.

Re-evaluation of sodium aluminium silicate (E554) and potassium aluminium silicate (E555) as food additives.

The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re‐evaluating the safety of Sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) as food additives. The Scientific Committee for Food (SCF) assigned these food additives together with other aluminium‐containing food additives a provisional tolerable weekly intake (PTWI) of 7 mg aluminium/kg body weight (bw). In 2008, EFSA established a tolerable weekly intake (TWI) of 1 mg aluminium/kg bw per week. Sodium aluminium silicate was shown in rats to be absorbed to a limited extent at 0.12 ± 0.011%. The Panel considered that potassium aluminium silicate would be absorbed and become systemically available similarly to sodium aluminium silicate. No information on the physicochemical characterisation of sodium aluminium silicate and potassium aluminium silicate when used as food additives has been submitted and only very limited toxicological data were available for sodium aluminium silicate. Exposure to E 554 was calculated based on the reported use levels in food supplements. Exposure to aluminium from this use of E 554 was calculated to exceed the TWI for aluminium. Based on the data provided by interested business operators, the Panel considered that E 555 is not being used as a carrier, but as an inseparable component of ‘potassium aluminium silicate‐based pearlescent pigments’. The Panel calculated the regulatory maximum exposure to E 555 as a carrier for titanium dioxide (E 171) and iron oxides and hydroxides (E 172). Exposure to aluminium from this single use at the maximum permitted level could theoretically far exceed the TWI. Considering that only very limited toxicological data and insufficient information on the physicochemical characterisation of both food additives were available, the Panel concluded that the safety of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) could not be assessed.

Review and priority setting for substances that are listed without a specific migration limit in Table1 of Annex 1 of Regulation 10/2011 on plastic materials and articles intended to come into contact with food.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) was requested by the European Commission to review the substances for which a Specific Migration Limit (SML) is not assigned in Regulation (EU) No 10/2011. These substances had been covered by the Generic SML of 60 mg/kg food, but with Regulation (EU) 2016/1416 it was removed, necessitating their re‐examination. EFSA was requested to identify those substances requiring an SML to ensure the authorisation is sufficiently protective to health, grouping them in high, medium and low priority to serve as the basis for future re‐evaluations of individual substances. The CEP Panel established a stepwise procedure. This took into account existing hazard assessments for each substance on carcinogenicity/mutagenicity/reprotoxicity (CMR), bioaccumulation and endocrine disruptor (ED) properties along with the use of in silico generated predictions on genotoxicity. Molecular weights and boiling points were considered with regard to their effect on potential consumer exposure. This prioritisation procedure was applied to a total of 451 substances, from which 78 substances were eliminated at the outset, as they had previously been evaluated by EFSA as food contact substances. For 89 substances, the Panel concluded that a migration limit should not be needed. These are in the lists 0 and 1 of the Scientific Committee for Food (SCF), defined as substances for which an Acceptable Daily Intake (ADI) does not need to be established, along with substances that are controlled by existing restrictions and/or generic limits. Of the remaining 284 substances, 179 were placed into the low priority group, 102 were placed into the medium priority group and 3 were placed into the high priority group, i.e. salicylic acid (FCM No 121), styrene (FCM No 193) and lauric acid, vinyl ester (FCM No 436).

Re-evaluation of l(+)-tartaric acid (E334), sodium tartrates (E335), potassium tartrates (E336), potassium sodium tartrate (E337) and calcium tartrate (E354) as food additives.

The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on tartaric acid‐tartrates (E 334‐337, 354) when used as food additives. The Scientific Committee for Food (SCF) in 1990 established an acceptable daily intake (ADI) of 30 mg/kg body weight (bw) per day, for l(+)‐tartaric acid and its potassium and sodium salts. The metabolism of l(+)‐tartaric acid and its potassium sodium salt was shown to be species dependent, with a greater absorption in rats than in humans. No toxic effects, including nephrotoxicity, were observed in toxicological studies in which the l(+)‐form was tested. There was no indication for a genotoxic potential of tartaric acid and its sodium and potassium salts. In a chronic study in rats, no indication for carcinogenicity of monosodium l(+)‐tartrate was reported at the highest dose tested (3,100 mg/kg bw per day). The available studies for maternal or developmental toxicity did not report any relevant effects; no studies for reproductive toxicity were available; however, no effects on reproductive organs were observed in the chronic toxicity study. The Panel concluded that the data on systemic availability were robust enough to derive a chemical‐specific uncertainty factor instead of the usual default uncertainty factor of 100. A total uncertainty factor of 10 was derived by applying a total interspecies uncertainty factor of 1 instead of 10, based on data showing lower internal exposure in humans compared to rats. The Panel established a group ADI for l(+)‐tartaric acid‐tartrates (E 334‐337 and E 354) of 240 mg/kg bw per day, expressed as tartaric acid, by applying the total uncertainty factor of 10 to the reference point of 3,100 mg sodium tartrate/kg bw per day, approximately to 2,440 mg tartaric acid/kg bw per day. The exposure estimates for the different population groups for the refined non‐brand‐loyal exposure scenario did not exceed the group ADI of 240 mg/kg bw per day, expressed as tartaric acid. Some recommendations were made by the Panel.

Re-evaluation of acetic acid, lactic acid, citric acid, tartaric acid, mono- and diacetyltartaric acid, mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids (E472a-f) as food additives.

The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re‐evaluating the safety of acetic acid, lactic acid, citric acid, tartaric acid, mono‐ and diacetyltartaric acids, mixed acetic and tartaric acid esters of mono‐ and diglycerides of fatty acids (E 472a‐f) as food additives. All substances had been previously evaluated by the Scientific Committee for Food (SCF) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Hydrolysis of E472a,b,c,e was demonstrated in various experimental systems, although the available data on absorption, distribution, metabolism, excretion (ADME) were limited. The Panel assumed that E472a‐f are extensively hydrolysed in the GI tract and/or (pre‐)systemically after absorption into their individual hydrolysis products which are all normal dietary constituents and are metabolised or excreted intact. No adverse effects relevant for humans have been identified from the toxicological database available for E472a‐f. The Panel considered that there is no need for a numerical acceptable daily intake (ADI) for E 472a,b,c. The Panel also considered that only l(+)‐tartaric acid has to be used in the manufacturing process of E472d,e,f. The Panel established ADIs for E 472d,e,f based on the group ADI of 240 mg/kg body weight (bw) per day, expressed as tartaric acid, for l(+)‐tartaric acid‐tartrates (E334‐337, 354) and considering the total amount of l(+)‐tartaric acid in each food additive. Exposure estimates were calculated for all food additives individually, except for E 472e and f, using maximum level, refined exposure and food supplements consumers only scenarios. Considering the exposure estimates, there is no safety concern at their reported uses and use levels. In addition, exposure to tartaric acid released from the use of E 472d,e,f was calculated. The Panel also proposed a number of recommendations.

Re-evaluation of Quillaia extract (E999) as a food additive and safety of the proposed extension of use.

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established in its latest evaluation a group ADI of 0–1 mg/kg bw per day, expressed as quillaia saponins, for Quillaia extract for Type 1 and Type 2. The Panel considered it likely that intact Quillaia extract saponins are absorbed to a low extent, are hydrolysed in the gastrointestinal (GI) tract and that the aglycone is absorbed only to a limited extent. The Panel considered that the genotoxicity data available did not indicate a concern for genotoxicity. Taking into account the available toxicological database, various no observed adverse effect levels (NOAELs) relevant for the derivation of an ADI were identified. The Panel considered that the 2‐year study in rats was the most robust and that the NOAEL of 1,500 mg Quillaia extract/kg bw per day could be used to derive the ADI for E 999. Considering that the adverse effects reported were due to the presence of saponins in the extract, that saponins were present in Quillaia extract Type 1 (around 20%) and using an uncertainty factor of 100, the Panel derived a ADI of 3 mg saponins/kg bw per day for E 999. None of the exposure estimates for the different population groups of the refined brand‐loyal scenario exceeded the ADI of 3 mg saponins/kg bw per day. The proposed extension of use also would not result in an exceedance of this ADI for the refined scenario. The Panel proposed some recommendations for the European Commission to consider, in particular revising the EU specifications for E 999 in order to differentiate the extracts of Quillaia according to the saponins content and to include other parameters to better characterise the food additive.

Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources.

Whenever new substances are proposed for use as sources of nutrients in food supplements, foods for the general population or foods for specific groups, EFSA is requested by the European Commission to perform an assessment of their safety and of the bioavailability of the nutrient from the proposed source. This guidance describes the scientific data required to allow an evaluation of the safety of the source within the established framework for risk assessment of food additives and novel food ingredients and the bioavailability of the nutrient from this source. This document is arranged in five main sections: one on technical data aimed at characterising the proposed source and at identifying potential hazards resulting from its manufacture and stability in food; one on existing authorisations and evaluation, providing an overview of previous assessments on the proposed source and their conclusions; one on proposed uses and exposure assessment section, allowing an estimate of the dietary exposure to the source and the nutrient based on the proposed uses and use levels; one on toxicological data, describing approaches which can be used to identify (in conjunction with data on manufacture and composition) and to characterise hazards of the source and any relevant breakdown products; the final section on bioavailability focuses on determining the extent to which the nutrient from the proposed source is available for use by the body in comparison with one or more forms of the same nutrient that are already permitted for use on the positive lists. This guidance document should replace the previous guidance issued by the Scientific Committee for Food and published in 2001.

Re-evaluation of pectin (E440i) and amidated pectin (E440ii) as food additives.

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient sources added to Food (ANS) was asked to deliver a scientific opinion on the re‐evaluation of pectin (E 440i) and amidated pectin (E 440ii) as food additives. An acceptable daily intake (ADI) ‘not specified’ was allocated by the Scientific Committee for Food (SCF) for E 440i and E 440ii. Pectin and amidated pectin would not be absorbed intact, but extensively fermented by intestinal microbiota in animals and humans; products formed from pectins in the gastrointestinal tract are similar to manufactured pectin‐derived acidic oligosaccharides (pAOS). There is no indication of genotoxicity for pectin and amidated pectin, although the available data were limited. No adverse effects were reported in a chronic toxicity study in rats at levels up to 5,000 mg pectin/kg bw per day, the highest dose tested. No treatment‐related effects were observed in a dietary one‐generation reproductive toxicity study with pAOS in rats at up to 6,200 mg/kg body weight (bw) per day, the highest dose tested. The Panel did not consider E 440i and E 440ii as having allergenic potential. A dose of 36 g/day (equivalent to 515 mg/kg bw per day) for 6 weeks in humans was without adverse effects. Exposure to pectins from their use as food additives ranged up to 442 mg/kg bw per day for toddlers at the 95th percentile (brand‐loyal scenario). The Panel concluded that there is no safety concern for the use of pectin (E 440i) and amidated pectin (E 440ii) as food additives for the general population and that there is no need for a numerical ADI.

Re‐evaluation of tragacanth (E 413) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of tragacanth (E 413) as a food additive. In the EU, tragacanth (E 413) has been evaluated by the Scientific Committee for Food (SCF, 1989) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA, 1987), who both allocated an acceptable daily intake (ADI) ‘not specified’ for this gum. Following the conceptual framework for the risk assessment of certain food additives, re‐evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that adequate exposure and toxicity data were available. Tragacanth (E 413) is unlikely to be absorbed intact and is partially fermented by intestinal microbiota. No adverse effects were reported in carcinogenicity studies at the highest dose tested and there is no concern with respect to the genotoxicity. Oral daily intake of a large amount of tragacanth up to 9,900 mg tragacanth/person per day (approximately equivalent 141 mg tragacanth/kg body weight (bw) per day) for up to 21 days was well tolerated in humans. The Panel concluded that there is no need for a numerical ADI for tragacanth (E 413) and that there is no safety concern for the general population at the refined exposure assessment of tragacanth (E 413) as a food additive at the reported uses and use levels.

Dietary reference values for vitamin K.

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) derives dietary reference values (DRVs) for vitamin K. In this Opinion, the Panel considers vitamin K to comprise both phylloquinone and menaquinones. The Panel considers that none of the biomarkers of vitamin K intake or status is suitable by itself to derive DRVs for vitamin K. Several health outcomes possibly associated with vitamin K intake were also considered but data could not be used to establish DRVs. The Panel considers that average requirements and population reference intakes for vitamin K cannot be derived for adults, infants and children, and therefore sets adequate intakes (AIs). The Panel considers that available evidence on occurrence, absorption, function and content in the body or organs of menaquinones is insufficient, and, therefore, sets AIs for phylloquinone only. Having assessed additional evidence available since 1993 in particular related to biomarkers, intake data and the factorial approach, which all are associated with considerable uncertainties, the Panel maintains the reference value proposed by the Scientific Committee for Food (SCF) in 1993. An AI of 1 μg phylloquinone/kg body weight per day is set for all age and sex population groups. Considering the respective reference body weights, AIs for phylloquinone are set at 70 μg/day for all adults including pregnant and lactating women, at 10 μg/day for infants aged 7–11 months, and between 12 μg/day for children aged 1–3 years and 65 μg/day for children aged 15–17 years.

Re-evaluation of acacia gum (E414) as a food additive.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of acacia gum (E 414) as a food additive. In the EU, acacia gum has not been formally evaluated by the Scientific Committee for Food (SCF), and therefore, no ADI has been allocated. However, it was accepted for use in weaning food (SCF, 1991). In 1999, the SCF considered ‘that the use of acacia gum/gum arabic in coatings for nutrient preparations containing trace elements is acceptable provided carry‐over levels in infant formulae, follow‐on formulae or FSMP do not exceed 10 mg/kg’. Acacia gum was evaluated by JECFA in 1982 and 1990 and the specifications were amended in 1998. Based on the lack of adverse effects in the available toxicity studies, an ADI ‘not specified’ was allocated. Following the conceptual framework for the risk assessment of certain food additives re‐evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that adequate exposure and toxicity data were available. Acacia gum is unlikely to be absorbed intact and is slightly fermented by intestinal microbiota. No adverse effects were reported in subchronic and carcinogenicity studies at the highest dose tested and there is no concern with respect to the genotoxicity. Oral daily intake of a large amount of acacia gum up to 30,000 mg acacia gum/person per day (approximately equivalent 430 mg acacia gum/kg bw per day) for up to 18 days was well tolerated in adults but some individuals experienced flatulence which was considered by the Panel as undesirable but not adverse effect. The Panel concluded that there is no need for a numerical ADI for acacia gum (E 414), and there is no safety concern for the general population at the refined exposure assessment of acacia gum (E 414) as a food additive.

Re-evaluation of polyglycerol polyricinoleate (E476) as a food additive.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of polyglycerol polyricinoleate (PGPR, E 476) used as a food additive. In 1978, the Scientific Committee for Food (SCF) established an acceptable daily intake (ADI) of 7.5 mg/kg body weight (bw) per day for PGPR. PGPR is hydrolysed in the gut resulting in the liberation of free polyglycerols, polyricinoleic acid and ricinoleic acid. Di‐ and triglycerol are absorbed and excreted unchanged in the urine; long‐chain polyglycerols show lower absorption and are mainly excreted unchanged in faeces. Acute oral toxicity of PGPR is low, and short‐term and subchronic studies indicate PGPR is tolerated at high doses without adverse effects. PGPR (E 476) is not of concern with regard to genotoxicity or carcinogenicity. The single reproductive toxicity study with PGPR was limited and was not an appropriate study for deriving a health‐based guidance value. Human studies with PGPR demonstrated that there is no indication of significant adverse effect. The Panel considered a 2‐year combined chronic toxicity/carcinogenicity study for determining a reference point and derived a no observed adverse effect level (NOAEL) for PGPR (E 476) of 2,500 mg/kg bw per day, the only dose tested. Therefore, the Panel concluded that the present data set give reason to revise the ADI of 7.5 mg/kg bw per day allocated by SCF to 25 mg/kg bw per day. Exposure estimates did not exceed the ADI of 25 mg/kg bw per day and a proposed extension of use would not result in an exposure exceeding this ADI. The Panel recommended modification of the EU specifications for PGPR (E 476).

Re-evaluation of guar gum (E412) as a food additive.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of guar gum (E 412) as a food additive. In the EU, guar gum was evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1970, 1974 and 1975, who allocated an acceptable daily intake (ADI) ‘not specified’. Guar gum has been also evaluated by the Scientific Committee for Food (SCF) in 1977 who endorsed the ADI ‘not specified’ allocated by JECFA. Following the conceptual framework for the risk assessment of certain food additives re‐evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that adequate exposure and toxicity data were available. Guar gum is practically undigested, not absorbed intact, but significantly fermented by enteric bacteria in humans. No adverse effects were reported in subchronic and carcinogenicity studies at the highest dose tested; no concern with respect to the genotoxicity. Oral intake of guar gum was well tolerated in adults. The Panel concluded that there is no need for a numerical ADI for guar gum (E 412), and there is no safety concern for the general population at the refined exposure assessment of guar gum (E 412) as a food additive. The Panel considered that for uses of guar gum in foods intended for infants and young children the occurrence of abdominal discomfort should be monitored and if this effect is observed doses should be identified as a basis for further risk assessment. The Panel considered that no adequate specific studies addressing the safety of use of guar gum (E 412) in food categories 13.1.5.1 and 13.1.5.2 were available. Therefore, the Panel concluded that the available data do not allow an adequate assessment of the safety of guar gum (E 412) in infants and young children consuming these foods for special medical purposes.

Re-evaluation of locust bean gum (E410) as a food additive.

Following a request from European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of locust bean gum (E 410) as a food additive. Locust bean gum (E 410) is an authorised food additive in the EU. Locust bean gum (E 410) as specified in the Commission Regulation (EU) No 231/2012 is derived from the ground endosperm of the seeds of the strains of carob tree, Ceratonia siliqua (L.) Taub. (Family Leguminosae). An acceptable daily intake (ADI) ‘not specified’ was allocated by the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (JECFA) in 1981. Although not evaluated by the Scientific Committee for Food (SCF), it was accepted by the SCF in 1991 for use in weaning food, and in 1994, in infant formulae for special medical purposes. Locust bean gum is practically undigested, not absorbed intact, but significantly fermented by enteric bacteria in humans. No adverse effects were reported in 90‐day toxicity and carcinogenicity studies in rodents at the highest doses tested and there was no concern with respect to the genotoxicity and to reproductive and developmental toxicity of locust bean gum (E 410). The Panel concluded that there is no need for a numerical ADI for locust bean gum (E 410), and that there is no safety concern for the general population at the refined exposure assessment for its reported uses as a food additive. However, infants and young children consuming foods for special medical purposes may show a higher susceptibility to gastrointestinal effects of locust bean gum due to their underlying medical condition. The Panel concluded that the available data do not allow an adequate assessment of the safety of locust bean gum (E 410) in these foods for infants and young children.

Re‐evaluation of karaya gum (E 416) as a food additive

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient sources added to Food (ANS) was asked to deliver a scientific opinion on the re-evaluation of karaya gum (E 416) as a food additive. Karaya gum (E 416) is an authorised food additive in the EU. Karaya gum (E 416) as specified in the Commission Regulation (EU) No 231/2012 is derived from the exudates from the stems and branches of strains of Sterculia urens Roxburgh and other species of Sterculia (family Sterculiaceae) or from Cochlospermum gossypium A.P. De Candolle or other species of Cochlospermum (family Bixaceae). An acceptable daily intake (ADI) ‘not specified’ was allocated by the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (JECFA), whereas the Scientific Committee for Food (SCF) allocated an ADI of 12.5 mg/kg body weight (bw) per day. Karaya gum is practically undigested and not degraded by intestinal microflora and it is most probably not or only negligibly absorbed unchanged in humans. There is no concern with respect to the genotoxicity of karaya gum from Sterculia spp. Karaya gum (E 416) from Sterculia spp. did not induce toxic effects in animals at dose levels up to 1,250 mg/kg bw per day, the highest dose tested. Karaya gum from Sterculia spp. was well tolerated in humans at dose about 100 mg/kg bw per day for 4 weeks. The Panel concluded that there is no safety concern at the refined exposure assessment for the use of karaya gum as a food additive and that there is no need for a numerical ADI for karaya gum. The Panel further concluded that exposure to karaya gum by the use of this food additive should not exceed 7,000 mg/person per day in adults, the level at which some experienced abdominal discomfort.

Outcome of a public consultation on the Draft Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on Dietary Reference Values for vitamin B6

Outcome of a public consultation on the Draft Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on Dietary Reference Values for vitamin B6

Maternal dietary exposure to dioxins and polychlorinated biphenyls (PCBs) is associated with language delay in 3 year old Norwegian children

BackgroundPrenatal exposure to dioxins and PCBs is potentially harmful to the developing fetus and may increase the risk of delayed or impaired neurodevelopment. Several studies have reported negative associations between prenatal exposure to these compounds and aspects of cognition related to language in early childhood. ObjectivesThe aim was to examine the association between maternal low level dietary exposure to dioxins and PCB during pregnancy and language development in 3year old children in a large group of mother-child pairs participating in the Norwegian Mother and Child Cohort Study (MoBa). MethodsThis study includes 44,092 children of women who were recruited to the Norwegian Mother and Child Cohort Study (MoBa) during the years 2002–2009. Maternal dietary exposure to dioxins and PCBs was estimated based on a validated food frequency questionnaire (FFQ) answered mid-pregnancy and a database of dioxin and PCB concentrations in Norwegian foods. Exposure to dioxins and dioxin-like PCBs (dl-compounds) was expressed in total toxic equivalents (TEQ), and PCB-153 was used as marker for non-dioxin-like PCBs (ndlPCBs). Children's language skills at age 3 were assessed by parental report including a Dale and Bishop grammar rating and questions about communication skills from the Ages and Stages Questionnaire (ASQ). Logistic regression models adjusted for confounders were used to examine the association between maternal dietary exposure to dl-compounds or PCB-153 and language development in children. ResultsThe maternal dietary exposure to dl-compounds and PCB-153 was generally low, and 98% of women had intakes of dl-compounds ≤14pg TEQ/kg bw/week, which is the tolerable weekly intake set by EU's Scientific Committee for Food (SCF). High maternal exposure (>14pg TEQ/kg bw/week of dl-compounds (median 2.6pg/kg bw/day, range 2–16) or >97.5-percentile intake of PCB-153 (median 11ng/kg bw/day, range 5–28) was associated with higher odds of incomplete grammar (in boys and girls, adjusted ORs 1.1 to 1.3) and severe language delay in girls, adjusted ORs 2.8 [95% CI 1.1, 7.1] for PCB-153 and 2.9 [95% CI 1.4, 5.9] for dl-compounds. Furthermore, high exposure to dl-compounds was associated with moderate language delay 1.4 [95% CI 1.0, 2.0] and lower communication score (ASQ), adjusted OR 1.4 [95% CI 1.1, 1.9] in girls. ConclusionsThe main findings of this study were: 1) Girls born to mothers who exceeded the tolerable weekly intake for dl-compounds or had a PCB-153 intake above the 97.5 percentile in early pregnancy may have increased risk of language delay at age 3years. 2) Negative associations with maternal exposure to dl-compounds or PCB-153 were observed for both boys and girls having incomplete grammar, which is a subtle reduction in language skills. This interesting finding should not be considered as deviant at this age.

Occurrence of deoxynivalenol in wheat, Hebei Province, China

Analysis of deoxynivalenol (DON) and its metabolites 3-acetyl and 15-acetyldeoxynivalenol (3-ADON and 15-ADON) in wheat flour samples by liquid chromatography–tandem mass spectrometry (LC/MS/MS) during 2011–2013 was conducted. [13C15]–DON was used as the internal standard to accomplish as accurate as possible quantitation.Of all wheat samples (n=672), 91.5% were positive for DON, at levels ranging from 2.4 to 1130μg/kg, with a median value of 154μg/kg. The DON derivatives (3-Ac-DON, 15-Ac-DON) were far less frequently found and at lower levels than DON. The probable daily intakes (PDI) of DON (0.49 in 2011; 0.86 in 2012; 0.56 in 2013, expressed as μg/kg body weight/day) were all within the PDI of 1.0μg/kg of bw/day for DON set by Scientific Committee for Food (SCF) in 2002. Still, persistent monitoring of DON is important.

Outcome of a public consultation on the Draft Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on Dietary Reference Values for vitamin A

Outcome of a public consultation on the Draft Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on Dietary Reference Values for vitamin A