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The Panel on Food Additives and Flavourings added to food (FAF) provided a scientific opinion re‐evaluating the safety of hydrogenated poly‐1‐decene (E 907) when used as a food additive. Hydrogenated poly‐1‐decene (E 907) is authorised as a food additive in the EU in accordance with Annex II to Regulation (EC) No 1333/2008. Hydrogenated poly‐1‐decene is of low acute toxicity and does not raise concern for genotoxicity. Toxicity and carcinogenicity, as well as reproductive and developmental toxicological studies, were not available; therefore, the Panel based the derivation of the acceptable daily intake (ADI) on the no observed adverse effect level (NOAEL) identified in the subchronic study in rats and established an ADI of 20 mg/kg bw per day. Dietary exposure to hydrogenated poly‐1‐decene (E 907) from its use as a food additive was calculated based on regulatory maximum level exposure assessment scenario. Mean exposure to hydrogenated poly‐1‐decene (E 907) from its use as a food additive ranged from no exposure in infants to 2.35 mg/kg bw per day in toddlers. The high exposure to hydrogenated poly‐1‐decene (E 907) ranged from 0 mg/kg bw per day in infants and adults to 6.69 mg/kg bw per day in toddlers. The exposure estimates in the regulatory maximum level exposure assessment scenario did not exceed the ADI of 20 mg/kg bw per day for all population groups. The Panel concluded that the exposure to hydrogenated poly‐1‐decene (E 907) does not raise a safety concern when used at the maximum permitted levels. [ABSTRACT FROM AUTHOR]

Abstract: 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The Scientific Committee ( SC) reconfirms that the benchmark dose ( BMD) approach is a scientifically more advanced method compared to the NOAEL approach for deriving a Reference Point ( RP). Most of the modifications made to the SC guidance of 2009 concern the section providing guidance on how to apply the BMD approach. Model averaging is recommended as the preferred method for calculating the BMD confidence interval, while acknowledging that the respective tools are still under development and may not be easily accessible to all. Therefore, selecting or rejecting models is still considered as a suboptimal alternative. The set of default models to be used for BMD analysis has been reviewed, and the Akaike information criterion ( AIC) has been introduced instead of the log-likelihood to characterise the goodness of fit of different mathematical models to a dose-response data set. A flowchart has also been inserted in this update to guide the reader step-by-step when performing a BMD analysis, as well as a chapter on the distributional part of dose-response models and a template for reporting a BMD analysis in a complete and transparent manner. Finally, it is recommended to always report the BMD confidence interval rather than the value of the BMD. The lower bound ( BMDL) is needed as a potential RP, and the upper bound ( BMDU) is needed for establishing the BMDU/ BMDL per ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re-evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 SC guidance was used, in particular when the exposure is clearly smaller (e.g. more than one order of magnitude) than the health-based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the expected wide application of the BMD approach. [ABSTRACT FROM AUTHOR]

The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re‐evaluating the safety of benzyl alcohol (E 1519) when used as a food additive. The Panel considered that adequate exposure and toxicity data were available. Benzyl alcohol (E 1519) is authorised as a food additive in the EU in accordance with Annex III to Regulation (EC) No 1333/2008. The Panel considered benzyl alcohol of low acute toxicity with no concern with respect to genotoxicity and carcinogenicity and established an acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day based on a no observable adverse effect level (NOAEL) of 400 mg/kg bw per day from the carcinogenicity study in rats. The mean and high exposure estimates in the refined exposure scenarios were maximally 0.27 and 0.81 mg/kg bw per day in toddlers, respectively. The exposure estimates to benzyl alcohol (E 1519) were below the ADI of 4 mg/kg bw per day in all population groups. The Panel noted that also the exposure in the regulatory maximum level exposure assessment scenario is below the ADI in all population groups. The Panel concluded that the exposure to benzyl alcohol (E 1519) does not raise a safety concern at the reported uses and use levels. [ABSTRACT FROM AUTHOR]

The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re‐evaluating the safety of sulphuric acid (E 513) and its sodium (E 514), potassium (E 515), calcium (E 516) and ammonium (E 517) salts when used as a food additive. The Panel considered that adequate exposure and toxicity data were available. Sulphuric acid and its sodium, potassium, calcium and ammonium salts (E 513, E 514, E 515, E 516, E 517) are authorised food additives in the EU, in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008. In the refined estimated exposure non brand‐loyal scenario, mean exposure ranged from 0.4 mg sulphate/kg body weight (bw) per day in infants to 35 mg sulphate/kg bw per day in toddlers. The high percentile of exposure ranged from 3 mg sulphate/kg bw per day in adolescents to 68 mg sulphate/kg bw per day in toddlers. The Panel considered sulphates of low acute toxicity and there is no concern with respect to genotoxicity and carcinogenicity. The Panel noted that the exposure to sulphates at mean and 95th percentile in the non brand‐loyal scenario as well as in the other scenarios, is far below the 300 mg/kg a dose that induced laxative effect in humans. Based on the toxicological database available, the Panel concluded that the exposure to sulphuric acid (E 513), sodium sulphate (E 514), potassium sulphates (E 515), calcium sulphate (E 516) and ammonium sulphate (E 517) does not raise a safety concern at the reported uses and use levels and there is no need for a numerical acceptable daily intake (ADI). [ABSTRACT FROM AUTHOR]

The Panel on Food Additives and Flavourings added to Food (FAF) provided a scientific opinion re‐evaluating the safety of chlorides (E 507–509, E 511) as food additives. Chlorides are authorised food additives in the EU in accordance with Annex II and III to Regulation (EC) No 1333/2008. In the non‐ brand‐loyal scenario, mean exposure to chlorides (E 507–509, E 511) as food additives ranged from 2 mg/kg body weight (bw) per day in the elderly to 42 mg/kg bw per day in toddlers. The 95th percentile of exposure ranged from 5 mg/kg bw per day in the elderly to 71 mg/kg bw per day in toddlers. Chloride is an essential nutrient and after absorption is distributed to organs and tissues. The Panel considered chlorides to be of low acute oral toxicity and there is no concern with respect to genotoxicity and carcinogenicity. No effects were reported in developmental toxicity studies in rats following administration of magnesium chloride hexahydrate at 800 mg/kg bw per day. Some animal studies suggested a role of chloride in increasing blood pressure but based on the toxicological database available the Panel considered human data more appropriate to identify a level of chloride intake which does not raise a safety concern. The Panel identified a human dose of 40 mg chloride/kg bw per day as a reference value for the assessment. Mean levels of exposure in all age groups were below or at this reference value, which indicates no safety concern. In some age groups (toddlers, children and adolescents), the 95th percentile exposure estimates were slightly above this reference value. The Panel concluded that the exposure to chloride from hydrochloric acid and its potassium, calcium and magnesium salts (E 507, E 508, E 509 and E 511) does not raise a safety concern at the reported use and use levels. [ABSTRACT FROM AUTHOR]

The Scientific Committee confirms that the Threshold of Toxicological Concern (TTC) is a pragmatic screening and prioritisation tool for use in food safety assessment. This Guidance provides clear step‐by‐step instructions for use of the TTC approach. The inclusion and exclusion criteria are defined and the use of the TTC decision tree is explained. The approach can be used when the chemical structure of the substance is known, there are limited chemical‐specific toxicity data and the exposure can be estimated. The TTC approach should not be used for substances for which EU food/feed legislation requires the submission of toxicity data or when sufficient data are available for a risk assessment or if the substance under consideration falls into one of the exclusion categories. For substances that have the potential to be DNA‐reactive mutagens and/or carcinogens based on the weight of evidence, the relevant TTC value is 0.0025 μg/kg body weight (bw) per day. For organophosphates or carbamates, the relevant TTC value is 0.3 μg/kg bw per day. All other substances are grouped according to the Cramer classification. The TTC values for Cramer Classes I, II and III are 30 μg/kg bw per day, 9 μg/kg bw per day and 1.5 μg/kg bw per day, respectively. For substances with exposures below the TTC values, the probability that they would cause adverse health effects is low. If the estimated exposure to a substance is higher than the relevant TTC value, a non‐TTC approach is required to reach a conclusion on potential adverse health effects. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2019.EN-1661/full [ABSTRACT FROM AUTHOR]