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The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non-genetically modified Bacillus amyloliquefaciens strain HPN 131 by ENMEX SA de CV. The production strain qualifies for the qualified presumption of safety (QPS) approach to safety assessment. The food enzyme under assessment is intended to be used in seven food manufacturing processes: processing of cereals and other grains for the production of baked products, brewed products and distilled alcohol; processing of dairy products for the production of modified milk proteins; processing of meat and fish products for the production of protein hydrolysates; processing of plant- and fungal-derived products for the production of protein hydrolysates; processing of yeasts and yeast products. Since residual amounts of total organic solids (TOS) are not carried over to distilled alcohol, a dietary exposure was estimated only for the remaining six food manufacturing processes. Exposure was estimated to be up to 8.302 mg TOS/kg body weight (bw) per day in European populations. As the production strain qualifies for the QPS status and no issue of concern arose from the production process of the food enzyme, the Panel considered that no toxicological studies other than the assessment of allergenicity were necessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no matches were found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded (except for distilled alcohol production), but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. © 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the non-genetically modified yeast Limtongozyma cylindracea strain MS-5-OF by Meito Sangyo Co., Ltd. The food enzyme is free from viable cells of the production organism. It is intended to be used in five food manufacturing processes: brewing processes, baking processes, milk processing for cheese production, production of free fatty acids by hydrolysis and production of flavouring preparations from dairy products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.033 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2,084 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure of at least 2,017. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

The food enzyme lysozyme (peptidoglycan N-acetylmuramoylhydrolase; EC 3.2.1.17) is produced with hens' eggs and submitted by DSM Food Specialties BV. It is intended to be used in brewing processes, milk processing for cheese production as well as wine and vinegar production. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 4.9 mg TOS/kg body weight per day. This exposure is lower than the intake of the corresponding fraction from eggs, for all population groups. Egg lysozyme is a known food allergen. The Panel considered that, under the intended conditions of use, the residual amounts of lysozyme in treated beers, cheese and cheese products as well as wine and wine vinegar may trigger adverse allergenic reactions in susceptible individuals. Based on the data provided, the origin of the food enzyme and an exposure to the food enzyme comparable to the intake from eggs, the Panel concluded that the food enzyme lysozyme does not give rise to safety concerns under the intended conditions of use, except for the known adverse allergic reactions that occur in susceptible individuals.

This document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 17.3 of Regulation (EC) No 1332/2008, for the authorisation of food enzymes. It specifically covers the characterisation of microorganisms used as production organisms.

The food enzyme l-ascorbate: oxygen oxidoreductase (EC 1.10.3.3) is extracted from fruit peels of Cucurbita pepo L. and Cucurbita moschata Duchesne by Nagase (Europa) GmbH. This enzyme is intended to be used in baking and cereal-based processes. Based on maximum use levels recommended for the respective food processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 5.950 mg TOS/kg body weight per day in European populations. This exposure is in the same order of magnitude for infants and toddlers; but for children, adolescents, adults and the elderly it is one order of magnitude higher than the exposure to the fraction of the fruit peels comparable to the food enzyme–TOS. The Panel, while recognising the order of magnitude of difference in the exposure estimates, considers that any realistic exposure derived from the use of the food enzyme would be considerably lower and likely to be within the range of exposure through a typical diet. The Panel agreed that the requirements for exclusion of toxicological data were met. Amino acid sequence similarity to known allergens was searched and no match was found. The Panel considered that the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but are not expected to exceed the likelihood of the allergic reactions following consumption of pumpkin or zucchini per se, which is low. Based on the data provided and the origin of the food enzyme from edible parts of C. pepo L. and C. moschata Duchesne, the Panel considers that the food enzyme l-ascorbate oxidase does not raise safety concerns under the intended conditions of use.

The columns of different length used for studying the relation between HETP and column length are supposed to exhibit identical characteristics per meter. In the laboratory this condition cannot be rigorously fulfilled. The best approximation probably consists in starting the work with a relatively long capillary column followed by running shorter parts obtained by progressive cutting of the original column. Based on this procedure a marked increase of HETP with increasing column length is observed

Trace analysis on capillary columns becomes feasible provided appropriate injection techniques without stream splitting are used. To demonstrate potentialities and limitations of the methods, we investigated practical applications, the conditions of which were as dissimilar as possible. Insecticides in dairy products can be estimated by direct analysis of the raw petrol ether extract, without previous purification by column chromatography. 2-4 µl of extract are injected without splitting on a short inlet capillary fitted in a separate injection bloc. The inlet capillary is then connected to the capillary column mounted in the column oven with electron capture detector. Analysis is started by rapid heating to a constant temperature or by temperature programming resp. Head space analysis is another case in which trace components are important. Whereas several workers reported trapping of head space vapors in capillaries at low temperatures, we emphasize avoiding candensation, e.g. of water vapor, in the capillary. All sampling is done, therefore, near the original temperature of the head space material, i.e. at room temperature. In the case of coqnac aroma analysis in which most of the water and ethanol vapor are vented through the inlet capillary, the influences of most sampling variables—gas volume, length of inlet capillary—are studied. In the analysis of auto exhaust gas, again, bypassing of water is an important detail. In addition to hydrocarbons originating directly from the fuel as investigated by several authors, we found many combustion and conversion products, primarily naphthaline derivatives and phenols

The current practice of pretreating the solid support with free alkali to increase separation efficiency for basic compounds proved to be unsuitable for capillary columns. Instead of this, homogenous organic materials of high base strength are required. We found polyethylene imine (PEI) and polypropylene imine (PPI) to be very efficient as liquid phases of capillary columns for the separation of bases. The preparation of polymers is mentioned. Silanization or acetylation of the free hydroxyl groups of carbowax-type substrate makes them more suitable for use as liquid phases in capillary columns

A very simple procedure for splitless injection on capillary columns is discussed. In contrast to more sophisticated devices recently developed for the same purpose, the method described requires no additional equipment. The advantages of the method which broadens the use of capillary columns are discussed. Steroid analysis serves as an example of the applications

BACKGROUND: Injury to the lateral femoral cutaneous nerve (LFCN) is a risk during the operative anterior approach to the hip joint. Although several anatomical studies have described the proximal course of the nerve in relation to the anterior superior iliac spine (ASIS) and the inguinal ligament, the distal course of the LFCN in the proximal aspect of the thigh has not been sufficiently studied. The aim of this cadaveric study was to examine the branching pattern of the nerve, with special consideration to the anterior approach to the hip joint. METHODS: Twenty-eight cadaveric hemipelves from 18 donors (10 paired and 8 unpaired specimens) were dissected. The LFCN branches were localized proximal to the inguinal ligament and traced distally into the area of the proximal aspect of the thigh. Distribution patterns of the nerve with respect to its relationship to the ASIS and the internervous plane of the anterior approach to the hip joint were recorded. RESULTS: We found 3 different branching patterns of the LFCN: sartorius-type (in 36% of the specimens), characterized by a dominant anterior nerve branch coursing along the lateral border of the sartorius muscle with no, or only a thin, posterior branch; posterior-type (in 32%), characterized by a strong posterior nerve branch; and fan-type (in 32%), characterized by multiple spreading nerve branches of equal thickness. In 50% of the specimens, the LFCN divided into ≥2 branches superior to the inguinal ligament. Sixty-two percent of the LFCN branches entered the proximal aspect of the thigh medial to the ASIS; 27%, above; and 11%, lateral to the ASIS. The LFCN consistently coursed within the deep layer of the subcutaneous fat tissue. CONCLUSIONS: Injury to branches of the LFCN cannot be avoided in approximately one-third of surgical dissections that use the anterior approach to the hip joint. To protect the anterior branch of the LFCN, the skin incision should be as lateral as possible. The posterior branch of the LFCN