Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data

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doi:10.2903/j.efsa.2012.2579

Cited by 559 publications

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“…0.52 mg/kg bw per day) and a default bodyweight of 70 kg for an adult (EFSA Scientific Committee, 2012), the combined taxifolin intake from fortified foods (36 mg) and from food supplements (100 mg), is estimated at 136 mg/day.…”

Section: Combined Intake From Fortified Foods and Food Supplementsmentioning

confidence: 99%

Statement on the safety of taxifolin‐rich extract from Dahurian Larch (Larix gmelinii)

Products¹,

Turck²,

Bresson³

et al. 2017

EFS2

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Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out a supplementary safety assessment for taxifolin by considering also those population groups which were originally excluded at the request of the applicant (i.e. infants, young children and children up to 9 years) for the food categories set out in the application, and by taking into the extension of use of taxifolin from yogurt to a wider range of dairy products. In 2016, the EFSA NDA Panel adopted the Scientific Opinion on the safety of taxifolin-rich extract from Dahurian Larch (Larix gmelinii) as a novel food ingredient in non-alcoholic beverages, yogurts, chocolate confectionery and food supplements pursuant to Regulation (EC) No 258/97. In order to address the present mandate, an intake assessment was carried out by taking into account all population groups (including now also children below 9 years of age) and by considering the food intended categories for which the applicant provided maximum use levels of taxifolin. Intakes were estimated for all age groups of the general population. The highest 95th percentile intakes per kg bw per day among all population groups are 0.94 and 1.54 mg, respectively, derived for toddlers. Noting that the no-observed-adverse effect level (NOAEL) of the subchronic study was 1,500 mg/kg body weight (bw), the resulting margin of exposure (MOE) would be almost 1,000. For adults weighing 70 kg, the MOE to the combined intake from fortified foods and food supplements would be about 772. For adolescents, taking into account a default mean body weight of 61 kg, the MOE to the combined intake (including 100 mg from food supplements) would be about 627. The Panel considers that these MOEs are sufficient. The Panel concludes that the NF food, taxifolin-rich extract from Dahurian Larch, is safe under the proposed conditions of use. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. SummaryFollowing a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out a supplementary safety assessment for taxifolin by considering also those population groups which were originally excluded at the request of the applicant (i.e. infants, young children and children up to 9 years) for the food categories set out in the application, and by taking into the extension of use of taxifolin from yogurt to a wider range of dairy products.On 13 December 2016, the EFSA NDA Panel adopted the Scientific Opinion on the safety of taxifolin-rich extract from Dahurian Larch (Larix gmelinii) as a novel food ingredient in non-alcoholic beverages, yogurts, chocolate confectionery and food supplements pursuant to ...

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Section: Combined Intake From Fortified Foods and Food Supplementsmentioning

confidence: 99%

Statement on the safety of taxifolin‐rich extract from Dahurian Larch (Larix gmelinii)

Products¹,

Turck²,

Bresson³

et al. 2017

EFS2

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“…The SCF and the EFSA CEF Panel considered the dose of 10 000 mg/kg diet (500 mg/kg bw/day) as the NOAEL for the three 90-day studies. The Panel agreed with the use of 10 000 mg/kg diet for calculating the NOAEL, but, given the values proposed by the EFSA Scientific Committee in its guidance document on default factors (EFSA Scientific Committee, 2012), the Panel calculated the NOAEL to be 800 mg/kg bw/day.…”

Section: Short-term and Subchronic Toxicitymentioning

confidence: 99%

Scientific Opinion on the re‐evaluation of oxidised polyethylene wax (E 914) as a food additive

2015

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The EFSA ANS Panel delivered a scientific opinion re-evaluating the safety of oxidised polyethylene wax (OPEW) (E 914) as a food additive. E 914 is authorised at quantum satis only for the surface treatment of some fruits. The Scientific Committee on Food (SCF) evaluated the use of OPEW as a food additive but could not allocate an ADI and as an additive in food contact materials. The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated OPEW as a food contact material and established a TDI of 1 mg/kg bw/day. The ANS Panel considered that OPEW-an oxidised form of long-chain acids, alcohols and esters with a low epoxide and peroxide content-is stable in food matrices. Various 90-day studies in rats and a 90-day study in dogs reported no evidence of accumulation. In one rat study, at the highest dose, statistically significant increases in serum glucose and serum alkaline phosphatase and fatty livers were observed without other abnormalities. The lowest no observed adverse effect level (NOAEL) was considered 800 mg/kg bw/day. OPEW is not genotoxic. Owing to the lack of chronic toxicity and carcinogenicity studies, the limitations of the reprotoxicity study and the unavailability of the key 90-day study, the Panel considered that the overall toxicity database was insufficient to derive an ADI. Mean intake estimates of OPEW ranged from 0.001-0.03 mg/kg bw/day and high intake estimates ranged from 0.03-0.18 mg/kg bw/day across all population groups. Considering the NOAEL of 800 mg/kg bw/day, the calculated margin of safety (MoS) at the highest intake level of 0.18 mg/kg bw/day was 4 400. The Panel concluded that the exposure estimates of E 914 from its use at the maximum reported use level resulted in a sufficient MoS and that, despite the limitations in the database, E 914 is of no safety concern at the maximum reported use level in its currently authorised use. SUMMARYFollowing a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on oxidised polyethylene wax (E 914) when used as a food additive.The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that has become available since then and the data available following an EFSA call for data. The Panel noted that not all original studies on which previous evaluations were based were available to the Panel.Oxidised polyethylene wax (E 914) is a food additive authorised in the European Union (EU) only for the surface treatment of citrus fruit, melon, papaya, mango, avocado and pineapple. For most of these fruits, the peel is not consumed. Based on the available data on subchronic toxicity and taking into account the fact that longterm/carcinogenicity data were missing, the CEF Panel established a tolerable daily intake (TDI) of 1 mg/kg body weight (bw). The Panel noted that, in the EC specifications (Commission Regulation (EU) No 231/2012), oxidised po...

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“…(default adult body weight according to EFSA SC, 2012). This resulted in a value for exposure to chloramphenicol of 12 ng/kg b.w.…”

Section: Dietary Exposure From Enzyme-based Food Supplementsmentioning

confidence: 99%

Scientific Opinion on Chloramphenicol in food and feed

2014

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Chloramphenicol is an antibiotic not authorised for use in food-producing animals in the European Union (EU). However, being produced by soil bacteria, it may occur in plants. The European Commission asked EFSA for a scientific opinion on the risks to human and animal health related to the presence of chloramphenicol in food and feed and whether a reference point for action (RPA) of 0.3 µg/kg is adequate to protect public and animal health. Data on occurrence of chloramphenicol in food extracted from the national residue monitoring plan results and from the Rapid Alert System for Food and Feed (RASFF) were too limited to carry out a reliable human dietary exposure assessment. Instead, human dietary exposure was calculated for a scenario in which chloramphenicol is present at 0.3 µg/kg in all foods of animal origin, foods containing enzyme preparations and foods which may be contaminated naturally. The mean chronic dietary exposure for this worst-case scenario would range from 11 to 17 and 2.2 to 4.0 ng/kg b.w. per day for toddlers and adults, respectively. The potential dietary exposure of livestock to chloramphenicol was estimated to be below 1 µg/kg b.w. per day. Chloramphenicol is implicated in the generation of aplastic anaemia in humans and causes reproductive/hepatotoxic effects in animals. Margins of exposure for these effects were calculated at 2.4 × 10 5 or greater and the CONTAM Panel concluded that it is unlikely that exposure to food contaminated with chloramphenicol at or below 0.3 µg/kg is a health concern for aplastic anaemia or reproductive/hepatotoxic effects. Chloramphenicol exhibits genotoxicity but, owing to the lack of data, the risk of carcinogenicity cannot be assessed. The SUMMARYChloramphenicol is a broad-spectrum antibiotic effective against Gram-positive and Gram-negative bacteria and, in the past, has been widely used to treat infections in both humans and animals. Chloramphenicol is not authorised for use in food-producing animals in the European Union (EU) but may be used in human medicine and in treatments for non-food-producing animals. Apart from its potential occurrence as a residue in food from illicit treatment of food-producing animals, chloramphenicol has also been used in feed and food enzyme products and may occur naturally in plants from its production by the soil bacterium Streptomyces venezuelae.The EFSA Scientific Opinion entitled "Guidance on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non-allowed pharmacologically active substances present in food of animal origin" identified an approach for establishing RPAs for various categories of non-allowed pharmacologically active substances. However, the opinion also identified certain categories of non-allowed pharmacologically active substances that are considered to be outside the scope of the procedure, including substances causing blood dyscrasias (aplastic anaemia) such as chloramphenicol. As chloramphenicol is excluded fro...

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Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data

Cited by 559 publications

References 18 publications

Statement on the safety of taxifolin‐rich extract from Dahurian Larch (Larix gmelinii)

Statement on the safety of taxifolin‐rich extract from Dahurian Larch (Larix gmelinii)

Scientific Opinion on the re‐evaluation of oxidised polyethylene wax (E 914) as a food additive

Scientific Opinion on Chloramphenicol in food and feed

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