Affiliation between supplement D as well as navicular bone nutrient denseness throughout Japan older

Author : Emborg Blanton | Published On : 11 Jun 2025

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 OptiPhos PLUS ® to be used as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening, minor poultry species reared for laying, minor poultry species reared for breeding and ornamental birds. The active substance is 6-phytase produced by a genetically modified strain of Komagataella phaffii. The FEEDAP Panel concludes that the genetic modification of the production strain does not give rise to safety concerns. Based on the tolerance studies provided, the Panel concludes that the additive is safe for the target species under the conditions of use with a wide margin of safety. The additive is not a skin irritant. It is found to be a dermal sensitiser. The FEEDAP Panel cannot conclude on the eye irritation potential of the additive. Owing to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The FEEDAP Panel concludes that the additive has the potential to be efficacious in increasing the phosphorus utilisation in chickens for fattening at the level of 250 FTU/kg feed. These conclusions can be extended to turkeys for fattening and chickens and turkeys reared for laying/breeding and extrapolated to all minor poultry species and other avian species up to the point of lay.In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in Finland to set an import tolerance for the active substance flonicamid in various crops and products of animal origin on the basis of the authorised use of flonicamid in the USA. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for all crops under assessment. Based on the results of the feeding studies and the updated animal burden calculations, no need for new MRL proposals on products of animal origin was identified. Adequate analytical methods for enforcement are available to control the residues of flonicamid in plant and animal matrices. EFSA updated the most recent consumer risk assessment for flonicamid and concluded that the authorised USA uses of flonicamid will not result in acute or chronic consumer exposure exceeding the toxicological reference values and, therefore, is unlikely to pose a risk to consumers' health.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 extension of use of the novel food 'plant sterol esters' when added to vegetable fat spreads and to liquid vegetable fat-based emulsions for cooking and baking purposes pursuant to Regulation (EU) 2015/2283. Member States expressed concerns in relation to plant sterol oxidation products (POP) and consumption by non-target population groups. The median (0.5%) and P90 (2.28%) value of the oxidation rates of plant sterols determined by a wide range of cooking experiments were used together with exposure estimates for plant sterol when added and cooked with vegetable fat spreads and liquids. The no-observed adverse effect level (NOAEL) of a subchronic rat study and an applied default uncertainty factor of 200 served to derive levels (i.e. 0.64 mg POP/kg body weight (bw) per day) considered safe for humans. This safe level of exposure would be exceeded at the P95 by all age groups when considering the P90 oxidation rate and using EFSA's comprehensive food consumption database for assessing the potential exposure. When considering the median oxidation rate, the safe level of 0.64 mg POP/kg bw per day would be exceeded at the highest P95 intake estimates in children below 9 years of age. When considering an intake of the maximum authorised use level of 3 g plant sterols/person per day and oxidation rates of 0.5% and 2.28%, the resulting daily POP intakes per kg bw by an adult weighing 70 kg would be 0.21 and 0.98 mg/kg bw per day, respectively, the latter value exceeding 0.64 mg/kg bw per day. The Panel concludes that the safety of the intended extension of use of plant sterol esters under the proposed conditions of use has not been established.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. TGF-beta inhibitor 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.