The existing data are insufficient to ascertain the safety of the additive in marine sediment when deployed in sea cages. The additive shows no skin-irritating properties, but it certainly proves to be an irritant to the eyes. Because of the detectable nickel content, the additive poses a risk of respiratory and skin sensitization. The Panel was unable to determine the product's efficacy.

EFSA, at the request of the European Commission, offered a scientific opinion on the safety and effectiveness of Streptococcus salivarius DSM 13084/ATCC BAA 1024 as a feed additive, particularly in the role of a functional group acidity regulator, for use in the diet of dogs and cats. A proposed minimum concentration of 1.1011 CFU/l or kg of liquid feed is intended for use with the additive in dog and cat diets. A deficiency in data prevented the FEEDAP Panel from reaching a conclusion regarding the safety of the additive for the target species. While the additive was deemed a respiratory sensitizer, it was not found to irritate the skin. The potential for the additive to be an eye irritant or a skin sensitizer could not be established. The deployment of the additive in animal feed for pets exempts it from environmental risk assessment. Under the proposed parameters of use, the Panel found the additive capable of yielding positive results in canine and feline feed, signifying efficacy potential.

The non-genetically modified Cellulosimicrobium funkei strain AE-TN is employed by Amano Enzyme Inc. to generate the food enzyme endo-13(4),glucanase (3-(1-3;1-4),d-glucan 3(4)-glucanohydrolase; EC 32.16). Live cells from the production strain, a species known to cause opportunistic infections in humans, were found to be present within the food enzyme sample. Baking processes and yeast processing are the intended applications for the food enzyme. The daily dietary intake of the food enzyme total organic solids (TOS) in European populations was estimated to reach a maximum of 175 milligrams per kilogram of body weight. Safety was not compromised by the results of the genotoxicity tests. The assessment of systemic toxicity relied on a 90-day repeated oral dose toxicity study performed in rats. https://www.selleck.co.jp/peptide/adh-1.html The Panel identified 1788 mg TOS/kg body weight per day as the no observed adverse effect level, the highest dose studied. This substantial dose, when compared to estimated dietary exposure, results in a margin of exposure of at least 1022. An investigation into the amino acid sequence similarity of the food enzyme to existing allergens yielded no matches. The Panel's evaluation of the planned conditions of use indicates a theoretical possibility of allergic reactions due to dietary exposure, although the likelihood of occurrence is low. https://www.selleck.co.jp/peptide/adh-1.html Despite various considerations, the Panel concluded that the food enzyme's safety is compromised by the inclusion of viable cells from the manufacturing strain.

Shin Nihon Chemical Co., Ltd. produces the food enzyme glucan-14-glucosidase (4,d-glucan glucohydrolase; EC 31.23) using the non-genetically modified Rhizopus delemar strain CU634-1775. The food enzyme is devoid of live cells from the production strain. This product's purpose is use in six distinct food manufacturing processes: baking, starch processing for glucose syrup and other starch hydrolysates production, fruit and vegetable juice processing, different fruit and vegetable processing techniques, brewing, and the production of distilled alcohol. Since distillation and purification procedures in glucose syrup production eliminate remaining total organic solids (TOS), the calculation of dietary exposure for these two food processing steps could not be accomplished. The remaining four food procedures' maximum estimated dietary exposure to food enzyme-total organic solids was 1238 mg TOS per kilogram body weight daily. The genotoxicity tests did not yield any safety alarms. Systemic toxicity was determined through a 90-day repeated oral dose toxicity study in rats. The Panel's findings point to a no-observed-adverse-effect level of 1735 mg TOS per kg body weight daily. This highest tested dose, when gauged against estimated dietary exposure, suggests a margin of exposure of at least 1401. Investigating the amino acid sequence of the food enzyme for matches to known allergens uncovered a single match among respiratory allergens. The Panel found that, in the specified usage context, the risk of allergic responses from food intake is present, however its likelihood remains low. The Panel, after examining the supplied information, concluded that this food enzyme is not anticipated to cause safety problems under the intended use conditions.

From the non-genetically modified Geobacillus thermodenitrificans strain TRBE14, Nagase (Europa) GmbH cultivated the food enzyme 14,glucan branching enzyme ((1-4),d-glucan(1-4),d-glucan 6,d-[(1-4),d-glucano]-transferase; EC 24.118). The qualified presumption of safety (QPS) approach is applicable to the production strain, as shown. The food enzyme is intended for use in the various stages of cereal production, baking, as well as meat and fish processing. Studies estimated that European populations' average daily dietary intake of the food enzyme-total organic solids (TOS) could be as high as 0.29 milligrams per kilogram of body weight. Toxicological studies were not deemed necessary owing to the production strain's QPS status and the specifics of the manufacturing procedure. The amino acid sequence of the food enzyme was scrutinized for any similarities to known allergens, and none were found. The Panel's findings highlighted the inclusion of lysozyme, a well-established allergen, within the food enzyme. Hence, the potential for an allergic response remains. Based on the submitted data, the Panel reached the conclusion that this food enzyme, within the prescribed conditions of use, is safe.

The EFSA Panel on Plant Health, in obedience to the European Commission's request, performed a risk assessment of Citripestis sagittiferella (Lepidoptera: Pyralidae), the citrus pulp borer, an oligophagous pest restricted to citrus plants and reported in Southeast Asia. Risk assessment, focused on the citrus fruit pathway, was performed at the entry point. An evaluation of two scenarios was undertaken: A0 (current practice) and A2 (additional post-harvest cold treatment). In scenario A0, the entry model's output indicates a median annual number of founder populations in the EU citrus-growing region slightly below 10, with a 90% uncertainty interval ranging from roughly one founding event every 180 years to approximately 1300 events per year. https://www.selleck.co.jp/peptide/adh-1.html Scenario A2 exhibits significantly lower risks of entry and simulated founder population numbers compared to scenario A0. The entry model's critical uncertainties stem from transfer mechanisms, the efficiency of cold treatment procedures, the disaggregation coefficient, and the sorting technique. The established population's simulated numbers are just a tad lower than those of the founding populations. Establishment probability, while not a significant determinant of the number of established populations, is not a major source of uncertainty in spite of the dearth of data on the pest's thermal biology. The median time period separating the establishment from the spread is estimated to be slightly greater than one year, with a 90% uncertainty interval from roughly two months to a maximum of thirty-three months. The median dispersal rate of citrus fruit, naturally (by flight) and via transport from groves to processing plants, is anticipated to be roughly 100 kilometers per year after the lag period, with a 90% uncertainty interval spanning from approximately 40 to 500 kilometers annually. Uncertainties regarding the spread rate are rooted in the potential limitations environmental factors may impose on population growth and the deficiency of data concerning the spread rate's origins. According to estimations, the median infestation rate of harvested citrus fruits in the EU's citrus-growing regions by C. sagittiferella is approximately 10%, with a 90% uncertainty interval falling between about 2% and 25%. Variability in the resilience of citrus species and cultivars poses a challenge to the accuracy of the impact assessment.

Employing the genetically modified Aspergillus oryzae strain AR-962, AB Enzymes GmbH manufactures the food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11). The genetic modifications proved to be innocuous regarding safety. The food enzyme sample showed no evidence of viable cells or DNA from the source organism. This is intended for use in the following five food manufacturing processes: fruit and vegetable processing for juice, fruit and vegetable processing for products excluding juice, wine and wine vinegar production, plant extract creation for flavorings, and coffee demucilation. Given that repeated washing or distillation processes eliminate residual total organic solids, dietary exposure to the food enzyme total organic solids (TOS) from the manufacturing process of flavoring extracts and coffee demucilation is deemed unnecessary. In European populations, for the remaining three food processes, the estimated maximum dietary exposure to the food enzyme-TOS was 0.647 mg TOS per kg bw per day. Safety was not compromised, according to the genotoxicity tests' findings. Toxicity from systemic exposure was evaluated using a 90-day repeated-dose oral toxicity study in rats. The Panel's analysis highlighted a no observed adverse effect level of 1000 mg TOS per kilogram body weight per day, the maximum dosage examined. Relative to projected dietary consumption, this translates to a margin of exposure of at least 1546. A study of the amino acid sequence's homology to known allergens uncovered two instances matching pollen allergens. The Panel concluded that, according to the intended application circumstances, the risk of allergic reactions resulting from dietary exposure, particularly among individuals already sensitive to pollen allergens, cannot be ruled out. The data provided led the Panel to the conclusion that this food enzyme is safe under its intended application conditions.