Safety and efficacy of copper chelates of lysine and glutamic acid as a feed additive for all animal species

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper chelates of lysine and glutamic acid (Copper-LG) as a nutritional feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that, owing to safety considerations, Copper-LG should not be used in water for drinking. Copper-LG is safe for chickens for fattening; this conclusion can be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total copper in feed are not exceeded. No increases in the copper content of animal tissues/products are expected from the use of Copper-LG in animal nutrition. There is no indication that the toxicity of Copper-LG is essentially different from that of inorganic divalent copper. The use of Copper-LG in animal nutrition is of no concern for consumer safety provided that the maximum authorised total copper in feed is respected. Owing to the copper and nickel content of Copper-LG, the handling of the additive, poses a risk to users by inhalation. The additive is considered as a skin and respiratory sensitiser; it is corrosive to the eye while it is non-irritant to skin. The additive is intended to be a substitute for other authorised copper additives and will not further increase the environmental burden of copper; therefore, the FEEDAP Panel considers that the use of the additive in animal nutrition would not pose an additional risk for the environment. Copper-LG is a bioavailable source of copper, comparable to the standard inorganic copper source, and therefore, the additive is efficacious in meeting the birds copper requirements; this conclusion can be extrapolated to all animal species/categories. The FEEDAP Panel posed a recommendation concerning the description of the additive

Risk perception of arsenic exposure from rice intake in a UK population

In the UK, consumption of rice and rice-based products is on the rise but, notwithstanding public expressed concerns about such products as an exposure route for arsenic (e.g. BBC News report, 2017“Should I worry about arsenic in my rice?”) there are few, if any published data on public perceptions of risks associated with exposure to arsenic in rice. We therefore aimed to determine the risk perception of arsenic exposure from rice intake and factors that are associated with arsenic knowledge and whether or not this knowledge had an influence on rice consumption and cooking practices. A questionnaire, targeting participation of rice-eating ethnic minorities in Greater Manchester, UK, was administered to 184 participants. A multivariate generalized linear model was used to determine the factors associated with rice consumption behaviour, cooking practices, and risk perception. We show for the first time that the general population did not associate arsenic, which they perceive as toxic to health, with rice consumption. More than half of the participants knew about arsenic as a hazardous substance but less than ten percent knew that rice consumption could be an important route of arsenic exposure. Knowledge of arsenic was significantly lower in Asian/Asian British:Pakistanis (Pakistani) (OR: 0.006; 95% CI:0.00-0.03) and Asian/Asian British:Bangladeshis (Bangladeshi) (OR: 0.064; 95% CI:0.01-0.25) compared to White:English/Welsh/Scottish/Northern Irish/British (White British). Moreover, Bangladeshis consumed three times more rice (OR: 2.92; 95% CI:1.73-4.93) compared to White British. Overall higher rice consumption was not associated with higher knowledge of the nutritional value of rice. Rinsing rice before cooking, an effective arsenic removal technique, was practised by 93% of the participants, however the most popular cooking method was the use of adequate water (rice to water ratio of 1:2) but not excess water (rice to water ratio of > 1:4), the latter being more effective in removing arsenic. Better education, higher weekly expenditure on food and prior knowledge of arsenic hazard were all significant factors positively influencing a change in behaviour to reduce arsenic exposure from rice intake

Safety and efficacy of l-lysine monohydrochloride and concentrated liquid l-lysine (base) produced by fermentation using Corynebacterium glutamicum strain KCCM 10227 for all animal species

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l-lysine monohydrochloride and concentrated liquid l-lysine (base) produced using Corynebacterium glutamicum KCCM 10227 when used as nutritional additives in feed and water for drinking for all animal species. The active substance is l-lysine. l-lysine HCl and concentrated liquid l-lysine (base) produced by the strain C. glutamicum KCCM 10227 do not represent a risk for the target species, the consumer and the environment. l-lysine HCl produced by C. glutamicum KCCM 10227 is hazardous by inhalation, it is not irritant to skin but mildly irritant to eyes and it is not a skin sensitiser. Concentrated liquid l-lysine (base) produced by C. glutamicum KCCM 10227 is hazardous by inhalation, not irritant to skin and eyes and it is not a skin sensitiser. l-lysine HCl and concentrated liquid l-lysine (base) are considered as efficacious sources of the essential amino acid l-lysine for non-ruminant animal species. For the supplemental l-lysine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen

Safety of apple fruit cell culture biomass as a novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of an apple fruit cell culture biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and intended as an ingredient for food supplements in adults. The cells have been sourced from the callus grown on a piece of apple placed on a solid medium under sterile conditions. The de-differentiated apple cells are then cultivated in liquid medium. The medium contains sucrose, vitamins, minerals, trace elements and the two synthetic plant hormone analogues, benzylaminopurine (< 0.1 mg/kg) and 2,4-dichlorophenoxyacetic acid (< 0.25 mg/kg). These plant hormones are regulated under the EU pesticide legislation and their residue levels in the NF are in compliance with the EU maximum residue levels. The main components of the NF are carbohydrates (including sugars and non-digestible carbohydrates), ash, proteins and smaller amounts of fatty acids and organic acids. Except for the amount of total fat and the organic acids (succinic and l-malic acid), the quantities of the compositional parameters of the NF and apple have little in common. The Panel considers that a provided subchronic toxicity study was not needed to establish the safety of this NF, when taking into account the source of the NF, i.e. apples, the production process, the low intended use level and the composition of the NF, despite the noted differences to apple. The Panel considers that the NF contains proteins, which were not detected in apple and which may be allergenic. The Panel concludes that the NF, an apple fruit cell culture biomass, is safe under the proposed conditions of use

Safety of whey basic protein isolate for extended uses in foods for special medical purposes and food supplements for infants pursuant to Regulation (EU) 2015/2283

In 2018, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that whey basic protein isolate obtained by ion exchange chromatography from skimmed cow's milk is safe for human consumption under the proposed conditions of use as infant and follow on formula, meal replacement beverages, foods for special medical purposes and food supplements. Following a request from the European Commission, the EFSA NDA Panel was asked to deliver a scientific opinion on whey basic protein isolate for extended uses in foods for special medical purposes and food supplements for infants as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The applicant seeks to extend the conditions of use to infant (powder 30 mg/100 g and reconstituted 3.9 mg/100 mL) and follow on formulae (powdered 30 mg/100 g and reconstituted 4.2 mg/100 mL) as foods for special medical purposes as well as in food supplements for infants (25 mg/day). The Panel considers that the proposed extended uses would not increase the potential intake of the NF compared to that assessed in its 2018 opinion. The Panel concludes that whey basic protein isolate is safe at the extended uses and use levels

Safety of chromium-enriched biomass of Yarrowia lipolytica as a novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on chromium-enriched biomass of Yarrowia lipolytica as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat-killed chromium-enriched biomass of Y. lipolytica. This yeast species is widespread in nature, can be found in the environment and in foods, and was attributed the qualified presumption of safety (QPS) status for production purposes in 2018, including food and feed products based on biomass of the yeast. The production process, fermentation in the presence of chromium chloride, includes a heat-killing step of the yeast, resulting in the absence of viable Y. lipolytica in the NF. The maximum total chromium content of the NF is 23 μg Cr/g, with the chromium present as Cr(III). The applicant proposed to use the NF as a food supplement. The target population proposed by the applicant is the general population from 3 years of age onwards, with maximum proposed use levels of 2 g/day for children from 3 to 9 years of age and 4 g/day thereafter. At the proposed use levels of the NF, the combined intake of chromium provided by the NF, in addition to a background diet high in chromium, would result in total chromium intakes well below the tolerable daily intake (TDI) for chromium(III) for all target population groups. The Panel concludes that the NF, chromium-enriched biomass of Y. lipolytica, is safe under the proposed conditions of use

Safety of Cetylated Fatty Acids as a Novel Food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on an application for cetylated fatty acids as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF concerns primarily a mixture of cetylated myristic acid and cetylated oleic acid synthesised from cetyl alcohol, myristic acid and oleic acid, and to a lesser degree, other cetylated fatty acids and other compounds from olive oil. The NF is intended for use in food supplements for the general adult population. The highest dose tested in a subchronic toxicity study in rats, i.e. 4,500 mg/kg per day, was considered to be the no-observed-adverse effect level. By applying the default uncertainty factor of 200 as suggested by the EFSA Scientific Committee (2012), and considering a default body weight of 70 kg for the adult target population, this would result in an intake of 1.6 g per day, which is lower than the maximum intake proposed by the applicant (i.e. 2.1 g per day). The Panel concludes that the NF, cetylated fatty acids, is safe at an intake of 1.6 g per day for the intended target population, i.e. adults

Safety of lacto-N-tetraose (LNT) as a novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on lacto-N-tetraose (LNT) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powdered mixture mainly composed by LNT, but also containing D-lactose and other oligosaccharides such as para-lacto-N-hexaose-2 (para-LNH-2), lacto-N-triose II and a small fraction of other carbohydrates. It is produced by fermentation with a genetically modified strain of Escherichia coli K-12. The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant and follow-on formula, foods for infants and toddlers, foods for special medical purposes and food supplements. The target population is the general population except for food supplements, for which the target population is individuals above 1 year of age. The intake of LNT from the NF at the proposed use levels is unlikely to exceed the intake level of naturally occurring LNT in breastfed infants on a body weight basis. The intake of other carbohydrate-type compounds structurally related to LNT is considered of no safety concern. The Panel concludes that the NF is safe under the proposed conditions of use for the proposed target populations. (c) 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewe

Safety of Schizochytrium sp. oil as a novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of Schizochytrium sp. oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Schizochytrium sp. is a single-cell microalga. The strain WZU477, used by the applicant (Progress Biotech bv), was found to belong to the species Schizochytrium limacinum and was obtained in a marine environment from rotted mangrove forest leaves. The NF, an oil rich in docosahexaenoic acid (DHA), is isolated from the microalgae by mechanical extraction. The applicant proposed to use the NF in infant formulae (IF) and follow-on formulae (FOF). The use level defined by the applicant was derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20–50 mg/100 kcal. The intake of DHA resulting from the use of the NF in IF and FOF is not expected to pose safety concerns. The composition of the NF indicates the absence of marine biotoxins in the NF. Furthermore, Schizochytrium limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Based on the information provided, the microalga is not expected to survive the manufacturing process. Toxicological tests conducted with the NF were not performed. However, based on the available toxicological data on various forms of oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process and the composition of the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use

Safety and efficacy of l-leucine produced by fermentation with Escherichia coli NITE BP-02351 for all animal species

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l-leucine produced by fermentation with Escherichia coli NITE BP-02351 when used as nutritional additive or as feed flavouring compound in feed and water for drinking for all animal species. The product under assessment is l-leucine produced by fermentation with a genetically modified strain of E. coli (NITE BP-02351). The production strain and its recombinant DNA were not detected in the final products. l-Leucine, manufactured by fermentation with E. coli NITE BP-02351, does not give rise to any safety concern to the production strain. The use of l-leucine produced with E. coli NITE BP-02351 is safe for the target species when used to supplement the diet in appropriate amounts. It is safe at the proposed use level of 25 mg/kg when used as flavouring compound for all animal species. The use of l-leucine produced by fermentation with E. coli NITE BP-02351 in animal nutrition raises no safety concerns for consumers of animal products. The additive is not irritating to the skin or eyes and is not a skin sensitiser. There is a risk for persons handling the additive from the exposure to endotoxins by inhalation. The use of l-leucine produced by E. coli NITE BP-02351 as feed additive does not represent a risk to the environment. The additive l-leucine produced by E. coli NITE BP-02351 is regarded as an effective source of the amino acid l-leucine when used as nutritional additive. For the supplemental l-leucine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen. It is also considered efficacious as feed flavouring compound under the proposed conditions of use