Re-evaluation of shellac (E 904) as a food additive and a new application on the extension of use of shellac (E 904) in dietary foods for special medical purposes.

The present opinion deals with the re-evaluation of shellac (E 904) when used as a food additive and with the new application on the extension of use of shellac (E 904) in dietary foods for special medical purposes. The Panel derived an acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day for wax-free shellac (E 904) produced by physical decolouring, based on a NOAEL of 400 mg/kg bw per day and applying an uncertainty factor of 100. The Panel concluded that the ADI of 4 mg/kg bw per day should be considered temporary for wax-free shellac (E 904) produced by chemical bleaching, while new data are generated on the identity and levels of the organochlorine impurities in E 904.

Time trends of PCDDs, PCDFs, DL-PCBs, and NDL-PCBs in Italian women from biomonitoring studies.

A number of biomonitoring investigations were carried out in Italy between 2000 and 2018 by the Unit of Human Exposure to Environmental Chemicals of the Italian National Institute of Health (Rome). The investigations were characterized by different features (case-control or cross-sectional studies, participants from impacted or no impacted areas, etc), but despite the differences, it was possible to study the time trends of Σ(PCDDs), Σ(PCDFs), Σ(DL-PCBs), and Σ(NDL-PCBs) (analytical and TEQ cumulative concentrations, as appropriate). All the chemicals considered showed clear rates of a time-dependent concentration decrease, data having previously been adjusted for the sampled Region and subject age.

Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources (Revision 1).

[Table: see text] This guidance describes the scientific data required to allow an evaluation of the safety of new substances that are proposed for use as sources of nutrients in food supplements, foods for the general population or foods for specific groups and an assessment 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.

Re-evaluation of polydextrose (E 1200) as a food additive.

This opinion deals with the re-evaluation of polydextrose (E 1200) when used as a food additive. The Panel followed the conceptual framework for the risk assessment of certain additives and considered that: adequate exposure estimates were available; the margin of safety (MOS)/margin of exposure (MOE) for arsenic was between 0.5-14 and 8.

Re-evaluation of name of hydrogenated poly-1-decene (E 907) as food additive.

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.

Re-evaluation of polyvinylpyrrolidone (E 1201) and polyvinylpolypyrrolidone (E 1202) as food additives and extension of use of polyvinylpyrrolidone (E 1201).

The present opinion deals with the re-evaluation of polyvinylpyrrolidone (E 1201, PVP) and polyvinylpolypyrrolidone (E 1202, PVPP) when used as food additives. One request for extension of use of PVP (E 1201) in foods for special medical purposes was also considered in this assessment. The Panel followed the conceptual framework under Commission Regulation (EU) No 257/2010 and considered that: the exposure assessment was based on the reported use and use levels (one food category out of the two food categories in which PVP and PVPP are authorised); the 95th percentile of exposure to PVP and PVPP of maximally 23.

Re-evaluation of hydrochloric acid (E 507), potassium chloride (E 508), calcium chloride (E 509) and magnesium chloride (E 511) as food additives.

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 , 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.

Re-evaluation of benzyl alcohol (E 1519) as food additive.

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.

Re-evaluation of sulphuric acid and its sodium, potassium, calcium and ammonium salts (E 513, 514 (i), 514 (ii), 515 (i), 515 (ii), 516 and 517) as food additive.

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.

Perfuorooctane Sulfonate (PFOS), Perfluorooctanoic Acid (PFOA), Brominated Dioxins (PBDDs) and Furans (PBDFs) in Wild and Farmed Organisms at Different Trophic Levels in the Mediterranean Sea.

The present study shows the results of perfuorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA), brominated dioxins (PBDDs) and furans (PBDFs) measured in several marine fish and seafood of commercial interest at different trophic levels of the food chain. The aims were to investigate the level of the contamination in Mediterranean aquatic wildlife, and in farmed fish, to assess human exposure associated to fishery products consumption. Samples of wild fish were collected during three different sampling campaigns in different Food and Agriculture Organization (FAO) 37 areas of the Mediterranean Sea.

Re-evaluation of aluminium sulphates (E 520-523) and sodium aluminium phosphate (E 541) as food additives.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provided a scientific opinion re-evaluating the safety of aluminium sulphates (E 520-523) and sodium aluminium phosphate, acidic (E 541) as food additives. The Panel considered that adequate exposure and toxicity data were available. Aluminium sulphates (E 520-523) and sodium aluminium phosphate, acidic (E 541) are permitted as food additives in only a few specific products and the exposure is probably near zero.

Re-evaluation of sodium ferrocyanide (E 535), potassium ferrocyanide (E 536) and calcium ferrocyanide (E 538) as food additives.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provided a scientific opinion re-evaluating the safety of sodium ferrocyanide (E 535), potassium ferrocyanide (E 536), and evaluating the safety of calcium ferrocyanide (E 538) as food additives. The Panel considered that adequate exposure and toxicity data were available. Ferrocyanides (E 535-538) are solely authorised in two food categories as salt substitutes.

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.

Re-evaluation of stannous chloride (E 512) as food additive.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of stannous chloride and stannous chloride dihydrate (E 512) as food additives. The Panel considered that adequate exposure and toxicity data were available. Stannous chloride is only permitted as food additives in one food category and no reply on the actual use level of stannous chloride (E 512) as a food additive and on its concentration in food was provided by any interested party.

Re-evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 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 re-evaluating the safety of microcrystalline cellulose (E 460(i)), powdered cellulose (E 460(ii)), methyl cellulose (E 461), ethyl cellulose (E 462), hydroxypropyl cellulose (E 463), hydroxypropyl methyl cellulose (E 464), ethyl methyl cellulose (E 465), sodium carboxy methyl cellulose (E 466), enzymatically hydrolysed carboxy methyl cellulose (E 469) and cross-linked carboxy methyl cellulose (E 468) as food additives. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Scientific Committee on Food (SCF) established an acceptable daily intake (ADI) 'not specified' for unmodified and modified celluloses. Celluloses are not absorbed and are excreted intact in the faeces; in addition, microcrystalline cellulose, powdered and modified celluloses could be fermented by the intestinal flora in animals and humans.

Approach followed for the refined exposure assessment as part of the safety assessment of food additives under re-evaluation.

This statement describes the approach followed by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) for performing refined exposure assessment in the framework of the re-evaluation of already permitted food additives. Estimation of exposure is obtained through combination of different type of data originating from different sources: food additive concentration is obtained from information provided to EFSA on use levels and/or information obtained by means of analytical measurements. In recent years, the use of market research data has also been used.

Re-evaluation of oxidised starch (E 1404), monostarch phosphate (E 1410), distarch phosphate (E 1412), phosphated distarch phosphate (E 1413), acetylated distarch phosphate (E 1414), acetylated starch (E 1420), acetylated distarch adipate (E 1422), hydroxypropyl starch (E 1440), hydroxypropyl distarch phosphate (E 1442), starch sodium octenyl succinate (E 1450), acetylated oxidised starch (E 1451) and starch aluminium octenyl succinate (E 1452) 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 12 modified starches (E 1404, E 1410, E 1412, E 1413, E 1414, E 1420, E 1422, E 1440, E 1442, E 1450, E 1451 and E 1452) authorised as food additives in the EU in accordance with Regulation (EC) No 1333/2008 and previously evaluated by JECFA and the SCF. Both committees allocated an acceptable daily intake (ADI) 'not specified'. In humans, modified starches are not absorbed intact but significantly hydrolysed by intestinal enzymes and then fermented by the intestinal microbiota.

Re-evaluation of xanthan gum (E 415) 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 xanthan gum (E 415) as food additive. 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. Based on the reported use levels, a refined exposure of up to 64 mg/kg bw per day in children for the general population, 38 mg/kg bw per day for children consumers only of food supplements at the high level exposure and 115 mg/kg bw per day for infants consuming foods for special medical purposes and special formulae (FSMPs), were estimated.

Re-evaluation of glutamic acid (E 620), sodium glutamate (E 621), potassium glutamate (E 622), calcium glutamate (E 623), ammonium glutamate (E 624) and magnesium glutamate (E 625) as food additives.

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of glutamic acid-glutamates (E 620-625) when used as food additives. Glutamate is absorbed in the intestine and it is presystemically metabolised in the gut wall. No adverse effects were observed in the available short-term, subchronic, chronic, reproductive and developmental studies.

Re-evaluation of pectin (E 440i) and amidated pectin (E 440ii) 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).

Re-evaluation of konjac gum (E 425 i) and konjac glucomannan (E 425 ii) as food additives.

The present opinion deals with the re-evaluation of konjac (E 425), comprising konjac gum (E 425 i) and konjac glucomannan (E 425 ii) when used as food additives. 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 current use of konjac (E 425) was limited in all food categories to maximum permitted level (MPL) of 10 g/kg, and that the calculated indicative refined exposure assessment for all population groups was below 0.1 mg/kg body weight (bw) per day for the general population (mean and high level).

Re-evaluation of tara gum (E 417) 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 tara gum (E 417) as a food additive. Tara gum (E 417) has been evaluated by the EU Scientific Committee for Food (SCF, 1992) 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 for tara gum (E 417).

Re-evaluation of sodium nitrate (E 251) and potassium nitrate (E 252) as food additives.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provided a scientific opinion re-evaluating the safety of sodium nitrate (E 251) and potassium nitrate (E 252) when used as food additives. The current acceptable daily intakes (ADIs) for nitrate of 3.7 mg/kg body weight (bw) per day were established by the SCF (1997) and JECFA (2002).

Re-evaluation of potassium nitrite (E 249) and sodium nitrite (E 250) as food additives.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provided a scientific opinion re-evaluating the safety of potassium nitrite (E 249) and sodium nitrite (E 250) when used as food additives. The ADIs established by the SCF (1997) and by JECFA (2002) for nitrite were 0-0.06 and 0-0.

Safety of the proposed amendment of the specifications for the food additive polyvinyl alcohol-polyethylene glycol-graft-co-polymer (E 1209).

The European Commission asked EFSA to provide a scientific opinion on the request for a modification of the EU specifications for polyvinyl alcohol-polyethylene glycol--co-polymer (PVA-PEG -co-polymer) (E 1209) and its possible impact on the safety. In accordance with Annex II to Regulation (EC) No 1333/2008, PVA-PEG -co-polymer (E 1209) has a single authorisation for use as a food additive in the EU, in the food category food supplements in solid form. According to the current EU specifications, ethylene glycol and diethylene glycol can be present as impurities in other food additives authorised in the EU, namely in polysorbates (E 432-436) and polyethylene glycol (E 1521).