Insufficient data prevent a conclusion on the additive's safety for marine sediment use in sea cages. The additive is harmless to the skin, but it does prove to be a source of eye irritation. The additive's sensitivity to the respiratory system and skin is directly attributable to its nickel content. The Panel was unable to determine the product's efficacy.

At the behest of the European Commission, EFSA rendered a scientific opinion regarding the safety and effectiveness of Streptococcus salivarius DSM 13084/ATCC BAA 1024, a functional group acidity regulator used as 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. For lack of adequate data, the FEEDAP Panel could not reach a definitive conclusion regarding the additive's safety for the target species. Though the additive was implicated as a respiratory sensitizer, it was deemed non-irritating to the skin. The potential for the additive to be an eye irritant or a skin sensitizer could not be established. The introduction of the additive into pet food does not mandate an environmental risk assessment. Regarding the additive's potential, the Panel found it to be efficacious in dog and cat diets under the stipulated conditions of use.

Amano Enzyme Inc. produces the food enzyme endo-13(4),glucanase (3-(1-3;1-4),d-glucan 3(4)-glucanohydrolase; EC 32.16) through a process that utilizes the non-genetically modified Cellulosimicrobium funkei strain AE-TN. The food enzyme sample demonstrated the presence of viable cells belonging to the production strain, a species previously implicated in human opportunistic infections. Baking processes and the processing of yeast are where the food enzyme is meant to be utilized. In European populations, daily dietary exposure to the food enzyme total organic solids (TOS) was estimated to be as high as 175 mg of TOS per kilogram of body weight. Safety was not compromised by the results of the genotoxicity tests. A 90-day oral toxicity study using repeated doses was conducted on rats to determine systemic toxicity. find more The Panel determined a no-observed-adverse-effect level of 1788 mg TOS/kg body weight daily, the highest dose evaluated. Comparison with predicted dietary intake yielded a margin of exposure exceeding 1022. An investigation into the amino acid sequence similarity of the food enzyme to existing allergens yielded no matches. In the context of the planned use conditions, the Panel identified the risk of allergic reactions from dietary exposure as possible, though the likelihood is low. find more The presence of functioning cells from the manufacturing strain in the food enzyme caused the Panel to deem the food enzyme unsafe.

Shin Nihon Chemical Co., Ltd.'s production of the food enzyme glucan-14-glucosidase (4,d-glucan glucohydrolase; EC 31.23) relies on the non-genetically modified Rhizopus delemar strain CU634-1775. Viable cells of the production strain are entirely excluded from the food enzyme's composition. This product is intended for use in six food manufacturing segments: baking processes, starch processing for glucose syrup and other starch hydrolysate creation, fruit and vegetable juice extraction, other fruit and vegetable processing, brewing processes, and distilled alcohol production. Dietary exposure estimations were not performed for the food processes of distillation and purification, which eliminate residual total organic solids (TOS) during the glucose syrup manufacturing process. The estimated upper limit of dietary intake, for the four remaining food processes, of food enzyme-total organic solids was 1238 mg TOS per kg body weight daily. The genotoxicity tests did not yield any safety alarms. A 90-day oral toxicity study in rats was employed to evaluate systemic toxicity. 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. A single match between the amino acid sequence of the food enzyme and a respiratory allergen was detected during a search for similar sequences among known allergens. The Panel observed that allergic responses arising from food consumption are possible under the designed conditions of use, though their probability is low. 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.

Nagase (Europa) GmbH produced 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) using the non-genetically modified Geobacillus thermodenitrificans strain TRBE14. The production strain is shown to be suitable for classification under the qualified presumption of safety (QPS) system. Cereal-based processes, baking processes, and meat and fish processing are all intended applications for the food enzyme. 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. In assessing the similarity of the food enzyme's amino acid sequence to known allergens, no matches were found. The food enzyme, as noted by the Panel, includes lysozyme, a commonly known allergen. In conclusion, the likelihood of an allergic reaction cannot be discounted. The Panel's assessment of the provided data indicates that this enzyme, under its specified use conditions, does not trigger safety concerns for this food product.

The European Commission prompted the EFSA Panel on Plant Health to perform a risk assessment concerning Citripestis sagittiferella (Lepidoptera: Pyralidae), the citrus pulp borer, a pest limited to citrus species and documented in the Southeast Asian region. The citrus fruit pathway was the primary focus of the entry risk assessment. An evaluation of two scenarios was undertaken: A0 (current practice) and A2 (additional post-harvest cold treatment). Based on the output of the entry model in scenario A0, the estimated median annual count of founder populations within the EU citrus-growing region is slightly below 10, with a 90% uncertainty range encompassing values between one per 180 years and 1300 per year. find more Scenario A0's risk of entry and simulated founder populations are vastly greater than those of scenario A2, differing by orders of magnitude. Among the crucial uncertainties in the entry model are the transfer mechanisms, the efficacy of cold treatment, disaggregation calculation, and sorting protocols. Simulated counts of established populations are only slightly less 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. It is estimated that the median time lag between the establishment and the spread of this phenomenon is slightly more than one year; a 90% confidence interval for this lag is between about two months and thirty-three months. After the initial lag, the estimated median spread rate of citrus fruits, through natural means (like flying) and from orchard to packinghouse, is approximately 100 kilometers annually; this estimate has a 90% uncertainty interval between roughly 40 and 500 kilometers per year. Uncertainty regarding the propagation rate is largely attributable to the degree to which environmental conditions might impede population growth, along with the absence of data on the spread rate at its inception. The median impact of C. sagittiferella on the citrus fruit harvest in the EU citrus-growing regions is projected to be around 10%, with an uncertainty interval of approximately 2% to 25% (90% confidence). The impact assessment's accuracy is contingent upon the variable sensitivities of various citrus species and cultivars.

The genetically modified Aspergillus oryzae strain AR-962, cultivated by AB Enzymes GmbH, is the source of the food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11). Safety was not compromised by the genetic modifications. Viable cells and DNA of the production organism were not present in the food enzyme. The intended use cases for this are in five areas of food manufacturing: juice production from fruits and vegetables, other fruit and vegetable processing, wine and vinegar production, creating plant extracts for flavor, and coffee demucilation. The repeated washing or distillation process assures the removal of residual total organic solids, thereby rendering dietary exposure to the food enzyme total organic solids (TOS) from flavouring extract and coffee demucilation production superfluous. European populations' dietary exposure to the food enzyme-TOS, for the remaining three food processes, was estimated to reach a maximum of 0.647 milligrams of TOS per kilogram of body weight per day. 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. The amino acid sequence was scrutinized for similarities to known allergens, uncovering two matches among pollen allergens. The Panel assessed that, in the envisioned utilization scenario, the chance of allergic reactions from dietary sources, in particular for people sensitised to pollen allergens, cannot be disregarded. Upon examination of the data, the Panel concluded that this food enzyme is not anticipated to create safety issues under the proposed conditions of use.