Safety of iron hydroxide adipate tartrate as a novel food pursuant to Regulation (EU) 2015/2283 and as a source of iron in the context of Directive 2002/46/EC.

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 iron hydroxide adipate tartrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and as a source of iron in the context of Directive 2002/46/EC. The NF is intended to be used in food supplements up to a maximum dose of 100 mg per day, corresponding to a maximum daily intake of iron of 36 mg. The target population proposed by the applicant is the general population above 3 years of age. The NF which is the subject of the application is an engineered nanomaterial having primary particles, of almost spherical morphology, with a diameter typically smaller than 5 nm. The studies provided for absorption, distribution, metabolism and excretion (ADME) and bioavailability indicate that iron, once taken up into the epithelial cells of the gut, is subject to the same mechanisms of regulation and absorption as that of other forms of iron. Further studies provided in the context of the toxicological assessment indicate that the NF does not lead to iron bioaccumulation in tissues and organs at the doses tested. The Panel notes that the NF contains nickel at concentrations that may increase the risk of flare-up reactions in nickel-sensitised young individuals up to 10 years of age. In the 90-day toxicity study, findings related to haematology, clinical biochemistry and organ weights were observed and the Panel defined a no observed adverse effect level (NOAEL) of 231 mg/kg body weight (bw) per day, that is, the mid-dose used in the study. The Panel considers that the NF is a source from which iron is bioavailable and it is safe under the proposed conditions of use.

Scientific opinion on the safety of selenite triglycerides as a source of selenium added for nutritional purposes to food supplements.

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 selenite triglycerides as a novel food (NF) pursuant to Regulation (EU) 2015/2283, their safety when added for nutritional purposes to food supplements as a source of selenium and the bioavailability of selenium from this source, in the context of Directive 2002/46/EC. The proposed NF is the first lipophilic organic form of selenium so far described in the literature. It is composed by a mixture of individual Se-containing lipids which do not occur in nature. The Panel considers that the information provided on the composition of the NF does not allow a complete characterisation of the product. From the data provided to characterise the absorption, distribution, metabolism and excretion of the NF, it cannot be established in which chemical form Se is systemically available and if it can enter the functional Se body pool to fulfil Se physiological functions. The Panel considers that, since it is not demonstrated that the NF is converted to a known form of Se following ingestion and absorption, the NF is to be treated as a xenobiotic with unknown properties in the body. From a subchronic toxicity study in rats, the Panel derives a lowest observed adverse effect level (LOAEL) for general toxicity of 2 mg Se/kg body weight (bw) per day based on findings indicating liver as a target organ, as it has been shown for other studies on dietary Se. The Panel concludes that the NF is absorbed and provides Se, but in an unknown form of which the bioavailability has not been determined. The Panel also concludes that the safety of the NF under the intended conditions of use cannot be established.

Calcium l-methylfolate as a source of folate added for nutritional purposes to infant and follow-on formula, baby food and processed cereal-based food.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the extension of use of calcium l-methylfolate to be used as a source of folate added for nutritional purposes to infant and follow-on formula, baby food and processed cereal-based food pursuant to Regulation (EU) 609/2013. In 2004, EFSA assessed the use of calcium l-methylfolate as a source of folate in foods for particular nutritional uses, food supplements and foods intended for the general population. The new alternative synthetic step proposed to produce the nutrient source, using platinum as a catalyst, did not raise any safety concern and the production process was found to consistently yield a product in line with the proposed specifications. Based on the studies assessed in the previous evaluation, it was concluded that calcium l-methylfolate is non-genotoxic and that subchronic and embryotoxicity/teratogenicity studies in rats did not reveal any adverse effects up to the highest doses tested. The Panel considered that no additional toxicological studies are required on the nutrient source. The intervention study in healthy infants provided by the applicant did not indicate differences in growth and tolerance parameters in infants who consumed either an infant formula supplemented with calcium l-methylfolate or with folic acid, and did not raise concerns regarding safety or tolerability of the infant formula with the proposed nutrient source. The study also provided further supporting evidence for the bioavailability of calcium l-methylfolate. The Panel considers that calcium l-methylfolate is a source from which folate is bioavailable and concludes that calcium l-methylfolate is safe under the proposed uses and use levels for infants and young children.

Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Allergens (NDA) was asked to deliver an opinion on nicotinamide riboside chloride as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in food supplements as a source of niacin, and the bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. The NF, a synthetic form of nicotinamide riboside, is proposed to be used in food supplements for the healthy adult population at levels up to 300 mg/day. The production process, composition, specifications, batch-to-batch variability and stability of the NF do not raise safety concerns. Animal and human data indicate that the NF contributes to the nicotinamide body pool. There are no concerns regarding genotoxicity. Human studies do not raise safety concerns. The proposed maximum use level corresponds to an amount of nicotinamide, which is sixfold lower than the tolerable upper intake level (UL) set for adults, excluding pregnant and lactating women. The margin of exposure (MoE) of 70 derived from repeated dose toxicity studies with rats and dogs is considered sufficient for the adult population, excluding pregnant and lactating women. Regarding these two population groups, the MoE of 76 derived from a developmental toxicity study in rats is considered insufficient in the absence of data which could justify accepting a MoE lower than 100. The Panel concludes that the NF is safe under the proposed conditions of use for the healthy adult population, excluding pregnant and lactating women, and that an intake of the NF up to 230 mg/day is safe for pregnant and lactating women. The Panel also concludes that the NF is a source from which nicotinamide, a form of niacin, is bioavailable.

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements.

The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12-15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300-540 mg/day magnesium. The data provided demonstrate that the production process results in batches of MgCM that comply with the product specifications and that the product is stable throughout its proposed shelf life. The human studies provided demonstrate that magnesium from MgCM is bioavailable. However, the extent of its bioavailability per se or compared to other magnesium sources cannot be established due to the lack of an appropriate magnesium source as a comparator in the studies provided or relevant kinetic data for magnesium. One publication provided in the dossier reported that supplementation with MgCM decreases calcium absorption, but this finding was not supported by publications on different magnesium salts and therefore the Panel could not draw conclusions from this finding. The Panel concludes that MgCM is a source from which magnesium is bioavailable, but the extent of its bioavailability cannot be established. The Panel notes that at the proposed maximum use levels of MgCM, the existing tolerable upper intake level for magnesium in nutritional supplements, water, or added to food and beverages (250 mg/day) is exceeded.

Kinetic and affinity analyses of hybridization reactions between peptide nucleic acid probes and DNA targets using surface plasmon field-enhanced fluorescence spectroscopy.

Peptide nucleic acid (PNA), a polyamide DNA mimic, has inspired the development of a variety of hybridization-based methods for the detection, quantification, purification, and characterization of nucleic acids owing to the stability of the PNA/DNA duplex. In this work, PNA probes complementary to a specific sequence of Roundup Ready soybean were immobilized onto a sensor surface via a self-assembled matrix employing streptavidin/biotin binding. The specific hybridization of PNA and DNA has been monitored by applying the chromophore-labeled DNA target oligonucleotides to the PNA modified Au sensor surface in real time using surface plasmon field-enhanced fluorescence spectroscopy. The authors demonstrate three kinds of experiments called global, titration, and kinetic analyses for the determination of rate constants for the association (k(on)) and dissociation processes (k(off)), and the affinity constant (K(A)) of the PNA/DNA duplex formation by fitting the data to a simple Langmuir model. Discrimination of a single base mismatched DNA (15mer) target on a 15mer PNA probe was documented, with a difference of the affinity constant of two orders of magnitude. Finally, the affinity constant for the hybridization of a long polymerase chain reaction product (169mer) obtained by amplification of DNA extracted from genetically modified soybean reference material has been determined by a kinetic-titration analysis. The results show the influence of a Coulomb barrier at high target surface coverage even for the hybridization to PNA at low ionic strength.