Insufficient data prevent a conclusion on the additive's safety for marine sediment use in sea cages. Though the additive lacks skin-irritating properties, it exhibits a pronounced eye-irritating quality. Subsequent to the discovery of nickel, the additive is recognized as a respiratory and skin sensitizer. The product's ability to produce the desired effect could not be ascertained by the Panel.

Following the European Commission's request, EFSA provided a scientific assessment of Streptococcus salivarius DSM 13084/ATCC BAA 1024's safety and efficacy as a functional group acidity regulator, a technological additive, in dog and cat feed. For dogs and cats, the additive is intended for use in liquid feed at a minimum concentration of 1.1011 CFU/l or kg. The FEEDAP Panel's assessment of the additive's safety for the target species was hampered by the absence of sufficient data. Although the additive was identified as a respiratory sensitizer, it demonstrated no skin-irritating effects. The study yielded no conclusions about the additive's potential to be an eye irritant or a skin sensitizer. No environmental risk assessment is needed for the inclusion of this additive in animal feed for pets. The Panel determined that the proposed conditions of use for the additive make it potentially effective in dog and cat feed.

Amano Enzyme Inc. utilizes the non-genetically modified Cellulosimicrobium funkei strain AE-TN in the manufacturing process for 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. The use of the food enzyme is targeted towards the baking industry and yeast processing. European populations' estimated daily dietary exposure to the food enzyme total organic solids (TOS) was projected to be a maximum of 175 milligrams per kilogram of body weight. There were no safety concerns emanating from the genotoxicity tests. The assessment of systemic toxicity relied on a 90-day repeated oral dose toxicity study performed in rats. PIK-III clinical trial The maximum tested dose, 1788 mg TOS per kilogram of body weight daily, yielded no observed adverse effects according to the Panel. Comparing this to estimated dietary intake, a margin of exposure of at least 1022 was evident. A thorough investigation of the amino acid sequence of the food enzyme, in relation to the known allergen database, resulted in no matches found. The Panel considered the risk of allergic reactions through dietary exposure under intended use, and concluded that it is possible, though the probability is low. PIK-III clinical trial The Panel's analysis revealed that the food enzyme cannot be considered safe, given the presence of living cells from the production strain within it.

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 enzyme derived from the food, is completely clear of any active cells of the production strain. Six food manufacturing processes—baking, starch processing for glucose syrup and starch hydrolysate production, fruit and vegetable juice production, other fruit and vegetable processing, brewing, and distilled alcohol production—all intend its use. Distillation and purification steps in glucose syrup production, used to remove residual total organic solids (TOS), resulted in dietary exposure not being calculated for these two food processing techniques. In the remaining four food processes, the maximum daily dietary exposure to food enzyme-total organic solids was projected to be 1238 mg TOS per kilogram of body weight. No safety concerns emerged from the genotoxicity test results. Rats were administered repeated oral doses for 90 days to ascertain systemic toxicity, as determined by a toxicity study. Based on the highest dose tested, 1735 mg TOS per kg body weight per day, the Panel established a no-observed-adverse-effect level. This, when considered alongside estimated dietary intake, demonstrates a margin of exposure exceeding 1401. In the process of identifying similar amino acid sequences between the food enzyme and known allergens, a single match with a respiratory allergen was found. The Panel determined that, within the proposed operational parameters, the chance of allergic reactions triggered by food consumption is unlikely, though not impossible. The Panel's findings, based on the supplied data, indicate that this food enzyme does not present safety problems under the planned conditions of application.

By employing the non-genetically modified Geobacillus thermodenitrificans strain TRBE14, Nagase (Europa) GmbH created 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 production strain's eligibility for the qualified presumption of safety (QPS) approach has been validated. The intended use of the food enzyme spans cereal-based processes, baking procedures, as well as meat and fish processing operations. European populations' intake of the food enzyme-total organic solids (TOS) through their diet was projected at a daily maximum of 0.29 milligrams per kilogram of body weight. Due to the Qualified Production Site (QPS) designation of the production strain and the type of manufacturing process in use, toxicological studies were deemed not required. In assessing the similarity of the food enzyme's amino acid sequence to known allergens, no matches were found. The Panel's findings highlighted the inclusion of lysozyme, a well-established allergen, within the food enzyme. For this reason, allergenicity cannot be eliminated as a factor. The Panel's evaluation of the presented data revealed that this food enzyme is safe for use under the conditions intended.

In response to a request from the European Commission, the EFSA Panel on Plant Health undertook a risk assessment of Citripestis sagittiferella (Lepidoptera: Pyralidae), the citrus pulp borer, a pest restricted to Citrus species and originating from Southeast Asia. The citrus fruit pathway was the subject of the entry risk assessment. Considering two scenarios, scenario A0 (current practice) and A2 (additional post-harvest cold treatment) , analysis was performed. The median frequency of founder populations in the EU citrus-growing area, as determined by the entry model's output under scenario A0, is estimated to be slightly less than ten per year. The 90% uncertainty interval for this estimation includes the range from roughly one event every 180 years to a maximum of 1300 events annually. PIK-III clinical trial Scenario A2 demonstrates a substantially lower order of magnitude in both the risk of entry and the simulated founder populations when 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. Simulated numbers of existing populations show only a slight decrease compared to those of the founding populations. Despite the paucity of data concerning the pest's thermal biology, the impact of establishment probability on the number of established populations remains relatively minor, thus not a major source of uncertainty. Studies estimate a median lag exceeding one year between the start of an event and its general diffusion, with 90% confidence this lag falling between two months and 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. The extent to which environmental factors might restrain population growth, combined with the lack of data on the spread rate at its point of origin, constitute critical sources of uncertainty affecting the overall propagation rate. In the European Union's citrus-growing areas, approximately 10% of harvested citrus fruits are estimated to be affected by C. sagittiferella, with a range of about 2% to 25% (90% confidence interval). The impact assessment's predictions are influenced by the susceptibility of diverse citrus species and their corresponding cultivars.

AB Enzymes GmbH produces the food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) using the genetically modified Aspergillus oryzae strain AR-962. Safety was not compromised by the genetic modifications. The food enzyme lacked viable cells and DNA from the production 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. Due to the removal of residual total organic solids through repeated washing or distillation, dietary ingestion of food enzyme total organic solids (TOS) from the production of flavouring extracts and coffee demucilation was judged to be unnecessary. For the remaining three food processes, the estimated maximum daily dietary exposure to the food enzyme-TOS in European populations was 0.647 milligrams per kilogram of body weight. Genotoxicity tests indicated no reason for safety concern. Using a 90-day repeated-dose oral toxicity study in rats, the researchers assessed the systemic toxicity. A no-observed-adverse-effect level of 1000 mg TOS per kilogram body weight daily was established by the Panel, representing the highest dose examined. This, when compared to the estimated dietary intake, revealed a margin of safety of at least 1546. In the quest to find similarities in amino acid sequence to known allergens, two matches were identified, linking them to pollen allergens. The Panel found that, in the intended operational context, a risk of allergic reactions from dietary exposure, notably in people sensitive to pollen allergens, is a potential concern that persists. The Panel's review of the data confirmed that this food enzyme does not evoke safety concerns under the intended use.