Study Day Research Articles

AR Dancee: An Augmented Reality-Based Mobile Persuasive Intervention for Promoting Physical Activity Through Dancing

The importance of physical activity (PA) for overall health and well-being cannot be overstated, especially in today’s fast-paced and sedentary society. Engaging in enjoyable activities like dancing can significantly enhance PA levels and positively affect one’s mood. Advances in technology have the potential to increase individuals’ engagement in more physical activities. This work explores the effectiveness of augmented reality-driven persuasive intervention in enhancing users’ physical activity and mood. To achieve our goal, we developed AR Dancee, a mobile-driven intervention combining Augmented Reality, Machine Learning, and persuasive technology to encourage adults to increase their PA through dancing, ultimately improving their mood. A 15-day user study with 104 participants showed that the intervention effectively increased PA levels, with equal effectiveness across genders and a stronger impact on younger adults. The results also show that the intervention improved participants’ mood while reducing anxiety levels, demonstrating its potential for stress management. Overall, the contribution of this work to the HCI fields is threefold: (1) the design and development of an AR-driven persuasive mobile app, (2) providing design recommendations, and (3) pinpointing limitations and providing suggestions for future work.

It's complicated: The good and bad of ambivalence in romantic relationships.

People often feel mixed and conflicting feelings (i.e., ambivalence) toward their romantic partner. So far, research has primarily shown that ambivalence is linked to negative outcomes in relationships, but is this always true? Building off the affect, behavior, cognition model of ambivalence, the present work tests the idea that, when ambivalent, individuals can experience both positive and negative cognitive and behavioral responses toward their partner. This idea was tested in three different studies with people in romantic relationships: a cross-sectional international study (n = 665), a 10-day daily diary study (n = 171), and a 12-day daily diary study with two follow-ups (n = 176 couples and nine individuals). Across studies, when people experienced greater subjective ambivalence (i.e., explicitly reported feeling mixed and conflicted) toward their partner, they spent more time thinking about the difficulties they faced in their relationship but also about ways in which they can make it better and, in turn, engaged in both constructive (e.g., wanting to spend more time with the partner) and destructive (e.g., ignoring or criticizing the partner) behaviors toward their partner. Ambivalence was also associated with greater fluctuations in both constructive and destructive behaviors daily and over time. This work advances the current knowledge about ambivalence in romantic relationships and further demonstrates that individuals can experience both positive and negative cognitions and behaviors toward a partner when ambivalent. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Why your help is unhelpful: A multistage mediation model exploring mechanisms linking unhelpful workplace social support to work engagement.

Recent occupational health research has begun exploring unhelpful workplace social support (UWSS). UWSS refers to actions taken by a colleague that the recipient believes are intended to be helpful but are perceived as ineffective. For example, a colleague may provide help that is not wanted or do something incorrectly while providing aid. Despite the perceived good intentions of UWSS providers, empirical research suggests that UWSS is a potent workplace demand negatively associated with occupational well-being. The mechanisms that link UWSS and reduced occupational well-being, however, have yet to receive empirical examination. We integrate the job demands-resources model, conservation of resources theory, and basic needs theory to construct a multistage model linking UWSS to reduced work engagement via the frustration of basic psychological needs and the consequent experiencing of negative emotions. We test this model across two studies-a three-wave weekly study (NLevel 1 = 960, NLevel 2 = 320) and a 5-day daily diary study (NLevel 1 = 1,680, NLevel 2 = 336)-and find several significant direct and indirect effects. Across both studies (though at different levels of analysis), partial support was linked to reduced work engagement via the frustration of both the need for competence and relatedness and the experiencing of negative affect, while in Study 2, a daily link between undependable support and work engagement through relatedness frustration and the experiencing of negative affect was found. Implications for research and practice are discussed, and future research directions are offered. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Reducing discrepancies between actual and ideal affect across adulthood: the roles of activity flow conduciveness, pleasantness, and familiarity

ABSTRACT Previous findings demonstrate that people often do not feel how they want to feel, supporting the distinction between “actual affect” and “ideal affect.” But are there certain activities that reduce the discrepancy between actual and ideal affect? Based on flow theory and socioemotional selectivity theory, we examined whether the discrepancy between people’s actual and ideal positive affect would be smaller during activities that were more conducive to flow (a state of intense absorption and concentration), pleasant, and familiar. In Study 1, U.S. participants aged 17–79 (N = 393) reported their ideal affect and how they felt during activities with varying degrees of challenges and skills. For both low-arousal positive affect (LAP) and high-arousal positive affect (HAP), participants reported smaller actual-ideal affect discrepancies during flow-conducive activities (when skills matched challenges). Study 2 was a 14-day experience sampling study, in which Hong Kong participants aged 18–83 (N individual = 109) reported their momentary actual and ideal affect, and how pleasant and familiar their activities were (N experience = 3,815). Greater activity familiarity was associated with smaller discrepancies in actual-ideal LAP, while greater activity pleasantness was associated with smaller discrepancies in actual-ideal HAP. These findings provide insights on the activities that help people achieve their ideal affect more easily.

Selective and low transfer of pyrrolizidine alkaloids from Jacobaea vulgaris Gaertn. into muscle and liver of dairy cattle, goat and sheep

1,2-unsaturated pyrrolizidine alkaloids and their N-oxides (PA/PANO) are plant toxins that are produced by several hundreds of plant species. Due to the pronounced liver toxicity and carcinogenicity of certain PAs, their presence in food and feed has raised concern. However, since PA-producing weeds cannot generally be prevented on grassland and Senecio species often occur in high densities, the transfer of PAs into muscle and liver of dairy cattle, goat and sheep was determined. In 28-day feeding studies extracts of tansy ragwort (Jacobaea vulgaris Gaertn.) were administered orally in three dose levels per animal species. Of the administered Senecio PAs only jacobine, jaconine and jacoline could be detected in relevant quantities by LC-MS/MS in the muscle and liver tissues of the three animal species. The calculated transfer parameters show a low transfer of total PAs into muscle (transfer factors: 0.0004–0.0009) and liver (transfer factors: 0.0008–0.0030), which is lower than reported for other typical contaminants and residues in the literature. This selective transfer can be explained by the rumen passage, during which the other Senecio PAs are largely and rapidly transformed to fully saturated metabolites. These ruminal metabolites were not detected in muscle and liver. No evidence of bioaccumulation of PAs in muscle and liver was observed.

Clinical efficacy of a parasiticide formulation containing eprinomectin, esafoxolaner and praziquantel (NexGard® Combo) in the treatment of natural feline aelurostrongylosis and troglostrongylosis

The metastrongyloids Aelurostrongylus abstrusus and Troglostrongylus brevior are primary causes of feline clinical respiratory disease. The present field trial evaluated the clinical efficacy of a spot-on formulation containing eprinomectin, esafoxolaner and praziquantel (NexGard® Combo) administered per label recommendations to cats affected with aelurostrongylosis and/or troglostrongylosis. Overall, 36 naturally infected cats were randomly assigned to Group 1 (G1) or Group 2 (G2) of 18 cats each. The two groups included 6 cats with A. abstrusus, T. brevior and mixed infection, each. All cats completed the study. Cats in G1 were treated on study Days (SDs) 0 and 28±2. Cats in G2 served as negative control until SD 56±2 and were then treated on SD 56±2 and 84±2. On SD 0/-7, 28±2 and SD 56±2 all cats were subjected to parasitological (quali-quantitative Baermann) and clinical examinations (physical exams and thoracic X-rays). Hematology and biochemistry analyses were performed on SD 0/-7 and SD 56±2. On SD 84±2 quali-quantitative Baermann, clinical examination and thorax radiography were performed on all G2 cats and on two G1 cats that still had radiographic alterations on SD 56±2. On SD 112±2 all G2 cats were subjected to parasitological and clinical evaluations and one cat from G1 that still had radiographic signs at SD 84±2 was clinically and radiographically evaluated. Efficacy criteria were the reduction of larval shedding in faeces and the clinical response in terms of pathological and radiographic scores after treatment compared to the baseline. An efficacy of 100 % based on LPG reduction was recorded after one (20/24 cats) or two (all 24 cats) treatments in cats with single infection by A. abstrusus or T. brevior. For cats with mixed infections, larval shedding was stopped after one (11/12 cats) or two (all 12 cats) treatments. Statistically significant clinical and radiographic improvement was evident in all study cats after 2 treatments. The present data show that two monthly treatments with NexGard® Combo stopped larval shedding and led to a significant clinical recovery and a complete resolution of radiographic abnormalities in cats infected with A. abstrusus and/or T. brevior.

Safety evaluation of Bifidobacterium animalis subsp. lactis BLa80 under in vitro, and in vivo conditions

Bifidobacterium animalis subsp. lactis BLa80 is a new probiotic strain with extensive applications in food products both domestically and internationally. Given the rising consumption of this probiotic, its safety assessment is increasingly crucial in the food industry. This study evaluates the safety of strain BLa80 using a combination of in vitro and in vivo assays along with genomic analysis. Methods included exposing the strain to artificial gastric and intestinal fluids, as well as a medium containing bile salts, to stimulate human digestive conditions. The strain showed high tolerance to gastric fluid at pH of 2.5 and to 0.3 % bile salts. It maintained a 99.92 % survival rate in intestinal fluid. Additional tests assessed hemolytic activity, antibiotic susceptibility (revealing sensitivity to 7 antibiotics), and biogenic amine production using HPLC-ELSD, confirming the absence of histamine, and other harmful amines. Bile salt hydrolase activity was demonstrated qualitatively, and metabolic byproducts were quantitatively analyzed using a D-/l-lactic acid assay kit, showing that BLa80 produces 1.48 mg/mL of l-lactic acid and no harmful d-lactic acid. Genomic analysis confirmed the absence of virulence or pathogenicity genes, and a 90-day oral toxicity study in rats confirmed no toxic effects at various doses. Overall, these findings support the safety classification of the strain BLa80.

Development of a measuring app for systemic sclerosis-related digital ulceration (SALVE: Scleroderma App for Lesion VErification).

To test the hypothesis that photographs (in addition to self-reported data) can be collected daily by patients with systemic sclerosis (SSc) using a smartphone app designed specifically for digital lesions, and could provide an objective outcome measure for use in clinical trials. An app was developed to collect images and patient reported outcome measures (PROMS) including Pain score and the Hand Disability in Systemic Sclerosis-Digital Ulcers (HDISS-DU) questionnaire. Participants photographed their lesion(s) each day for 30 days and uploaded images to a secure repository. Lesions were analysed both manually and automatically, using a machine learning approach. 25 patients with SSc-related digital lesions consented of whom 19 completed the 30-day study, with evaluable data from 27 lesions. Mean (standard deviation [SD]) baseline Pain score was 5.7 (2.4) and HDISS-DU 2.2 (0.9), indicating high lesion and disease-related morbidity. 506 images were used in the analysis (mean number of used images per lesion 18.7, SD 8.3). Mean (SD) manual and automated lesion areas at day 1 were 11.6 (16.0) and 13.9 (16.7) mm2 respectively. Manual area decreased by 0.08mm2 per day (2.4mm2 over 30 days) and automated area by 0.1mm2 (3.0mm2 over 30 days). Average gradients of manual and automated measurements over 30 days correlated strongly (r = 0.81). Manual measurements were on average 40% lower than automated, with wide limits of agreement. Even patients with significant hand disability were able to use the app. Automated measurement of finger lesions could be valuable as an outcome measure in clinical trials.

Frequency and mental health consequences of microaggressions experienced in the day-to-day lives of transgender and gender diverse people

Introduction Increasingly, it is apparent that in order to understand mental health and well-being, it is necessary to examine the ebb and flow of experiences and emotions across people’s day-to-day lives. For transgender and gender diverse (TGD) people, daily life is sometimes punctured by experiences of minority stress (e.g. in the form of microaggressions). Method The current daily diary study investigated the frequency and types of microaggressions experienced by TGD people as well as their concurrent and prospective associations with mental health and well-being. Daily surveys measuring microaggressions, gender dysphoria, depressive and anxious symptoms, and self-esteem over the last 24 h were completed by TGD participants (N = 39) across 10 consecutive days (total of 351 diary entries). Results Seventy-four percent of participants experienced some form of microaggression within the 10-day study period, reporting an average of 1 microaggression approximately every other day. Microaggressions were associated with greater feelings of gender dysphoria, depressive and anxious symptoms, and lower self-esteem at the between-person level, while evidence for within-person effects was mixed (with some evidence for significant associations with gender dysphoria and self-esteem for specific microaggression domains). No evidence for prospective associations between microaggressions and mental health were found in the current study. Discussion Given the frequency of experiences of microaggressions in TGD people’s daily lives, particularly misuse of pronouns, it is critical that healthcare providers are aware of potential effects on mental health and well-being.

Exploration-Exploitation and Suicidal Behavior in Borderline Personality Disorder and Depression

Clinical theory and behavioral studies suggest that people experiencing suicidal crisis are often unable to find constructive solutions or incorporate useful information into their decisions, resulting in premature convergence on suicide and neglect of better alternatives. However, prior studies of suicidal behavior have not formally examined how individuals resolve the tradeoffs between exploiting familiar options and exploring potentially superior alternatives. To investigate exploration and exploitation in suicidal behavior from the formal perspective of reinforcement learning. Two case-control behavioral studies of exploration-exploitation of a large 1-dimensional continuous space and a 21-day prospective ambulatory study of suicidal ideation were conducted between April 2016 and March 2022. Participants were recruited from inpatient psychiatric units, outpatient clinics, and the community in Pittsburgh, Pennsylvania, and underwent laboratory and ambulatory assessments. Adults diagnosed with borderline personality disorder (BPD) and midlife and late-life major depressive disorder (MDD) were included, with each sample including demographically equated groups with a history of high-lethality suicide attempts, low-lethality suicide attempts, individuals with BPD or MDD but no suicide attempts, and control individuals without psychiatric disorders. The MDD sample also included a subgroup with serious suicidal ideation. Behavioral (model-free and model-derived) indices of exploration and exploitation, suicide attempt lethality (Beck Lethality Scale), and prospectively assessed suicidal ideation. The BPD group included 171 adults (mean [SD] age, 30.55 [9.13] years; 135 [79%] female). The MDD group included 143 adults (mean [SD] age, 62.03 [6.82] years; 81 [57%] female). Across the BPD (χ23 = 50.68; P < .001) and MDD (χ24 = 36.34; P < .001) samples, individuals with high-lethality suicide attempts discovered fewer options than other groups as they were unable to shift away from unrewarded options. In contrast, those with low-lethality attempts were prone to excessive behavioral shifts after rewarded and unrewarded actions. No differences were seen in strategic early exploration or in exploitation. Among 84 participants with BPD in the ambulatory study, 56 reported suicidal ideation. Underexploration also predicted incident suicidal ideation (χ21 = 30.16; P < .001), validating the case-control results prospectively. The findings were robust to confounds, including medication exposure, affective state, and behavioral heterogeneity. The findings suggest that narrow exploration and inability to abandon inferior options are associated with serious suicidal behavior and chronic suicidal thoughts. By contrast, individuals in this study who engaged in low-lethality suicidal behavior displayed a low threshold for taking potentially disadvantageous actions.

The safety and effectiveness of naldemedine for opioid-induced constipation in patients with advanced cancer in real-world palliative care settings: a multicenter prospective observational study.

In this study, we aimed to evaluate the safety and effectiveness of naldemedine for treating opioid-induced constipation (OIC) in patients with advanced cancer, who are receiving palliative care, and particularly explored its early effects. Palliative care teams and inpatient palliative care units across 14 institutions in Japan were included in this multicenter, prospective, observational study. Patients who were newly prescribed a daily oral dose of 0.2mg naldemedine were enrolled. The spontaneous bowel movement (SBM) within 24h after the first dose of naldemedine was considered the primary outcome, whereas, the secondary outcomes included weekly changes in SBM frequency and adverse events. A total of 204 patients were enrolled and 184 completed the 7-day study. The average age of the participants (103 males, 101 females) was 63 ± 14years. The primary cancer was detected in the lungs (23.5%), gastrointestinal tract (13.7%), and urological organs (9.3%). A considerable proportion of patients (34.8%) had ECOG performance status of 3-4. Most patients were undergoing active cancer treatment, however, 40.7% of the patients were receiving the best supportive care. Within 24h of the first naldemedine dose, 146 patients (71.6%, 95% CI: 65.4-77.8%) experienced SBMs. The weekly SBM counts increased in 62.7% of the participants. The major adverse events included diarrhea and abdominal pain, detected in 17.6% and 5.4% of the patients, respectively. However, no serious adverse events were observed. Conclusively, naldemedine is effective and safe for OIC treatments in real-world palliative care settings. UMIN000031381, registered 20/02/2018.

Assessing the interplay between off-target promiscuity, cytotoxicity, and tolerability in rodents to improve the safety profile of novel anti-malarial plasmepsin X inhibitors.

Within drug development, high off-target promiscuity as well as potent cytotoxicity, are associated with a high attrition rate. We investigated the safety profile of novel plasmepsin X (PMX) inhibitors for the treatment of malaria. In our screening cascade, a total of 249 PMX compounds were profiled in a panel of in vitro secondary pharmacology assays containing 44 targets (SafetyScreen44 panel) and in a cytotoxicity assay in HepG2 cells using ATP as an endpoint. Six of the lead compounds were subsequently tested in a 7-d rat toxicology study, and/or in a cardiovascular study in guinea pigs. Overall, compounds with high cytotoxicity in HepG2 cells correlated with high promiscuity (off-target hit rate >20%) in the SafetyScreen44 panel and were associated with poor tolerability in vivo (decedents, morbidity, adverse clinical signs, or severe cardiovascular effects). Some side effects observed in rats or guinea pigs could putatively be linked with hits in the secondary pharmacological profiling, such as the M1 or M2 muscarinic acetylcholine receptor, opioid µ and/or κ receptors or hERG/CaV1.2/Na+ channels, which were common to >50% the compounds tested in vivo. In summary, compounds showing high cytotoxicity and high promiscuity are likely to be poorly tolerated in vivo. However, such associations do not necessarily imply a causal relationship. Identifying the targets that cause these undesirable effects is key for early safety risk assessment. A tiered approach, based on a set of in vitro assays, helps selecting the compounds with highest likelihood of success to proceed to in vivo toxicology studies.

Carvacrol protects rats against bleomycin-induced lung oxidative stress, inflammation, and fibrosis.

The main objective of this study was to investigate the potential efficacy of carvacrol (CAR) in mitigating bleomycin (BLM)-induced pulmonary fibrosis (PF). Sixty-six male Wistar rats were assigned into two main groups of 7 and 21 days. They were divided into the subgroups of control, BLM, CAR 80 (only for the 21-day group), and CAR treatment groups. The CAR treatment groups received CAR (20, 40, and 80 mg/kg, orally) for 7 or 21 days after an instillation of BLM (5 mg/kg, intratracheally). Results indicated that BLM significantly increased total cell count in bronchoalveolar lavage fluid and the percentages of neutrophils and lymphocytes, and reduced the percentage of macrophages. CAR dose-dependently decreased total cell count and the percentage of neutrophils and lymphocytes. CAR significantly reduced thiobarbituric acid reactive substances and hydroxyproline levels and elevated the total thiol level and catalase, superoxide dismutase, and glutathione peroxidase activities in BLM-exposed rats. Furthermore, CAR decreased the transforming growth factor-β1, connective transforming growth factor, and tumor necrosis factor-α on days 7 and 21. BLM increased interferon-γ on day 7 but decreased its level on day 21. However, CAR reversed interferon-γ levels on days 7 and 21. Based on histopathological findings, BLM induced inflammation on days 7 and 21, but for induction of fibrosis, 21-day study showed more fibrotic injuries than the 7-day group. CAR showed the improvement of fibrotic injuries. The effect of CAR against BLM-induced pulmonary fibrosis is possibly due to its antioxidant, anti-inflammatory, and antifibrotic activity.

Dual-earner couples' sharing of work-related experiences: Effects on relational and personal well-being.

Personal growth and self-expressive goals have become increasingly important in modern marriages. In dual-earner couples, sharing work-related experiences with the partner can be particularly important in promoting mutual support for each other's personal growth. The current study examined dual-earner couples' sharing of work-related experiences and how it influenced both partners' relationship satisfaction and personal well-being. A total of 102 heterosexual dual-earner couples were recruited from communities in Hong Kong. They completed a pretest survey, a 14-day daily diary study, and a follow-up survey 1year later. The Actor-Partner Interdependence Model was adopted to analyze the dyadic effects of sharing positive and negative work-related experiences on relationship satisfaction and personal well-being on the same day and 1year later. In general, the sharing of both positive and negative work-related experiences had beneficial effects on the outcomes. Specifically, wives' sharing had more immediate effects on both partners' relational and personal well-being, whereas husbands' sharing had more long-term effects on the partner's personal well-being. The findings highlight the importance of work-related sharing in dual-earner couples. Practical implications are discussed.

Dose-response study on the transfer of pyrrolizidine alkaloids from a tansy ragwort extract (Jacobaea vulgaris Gaertn.) to bovine milk

Ragworts like tansy ragwort (J. vulgaris Gaertn., syn. Senecio jacobaea L.) contain hepatotoxic and cancerogenic pyrrolizidine alkaloids (PA) and their corresponding pyrrolizidine alkaloid N-oxides (PANO). Due to increasing spread of ragworts (Jacobaea spp.) PA/PANO may pose a health risk to animals and humans consuming contaminated feed and food. Therefore, the aim of the present study was to investigate the transfer of individual PA/PANO originating from a well-defined PA/PANO extract into the milk of dairy cows. For this objective, 16 German Holstein cows were assigned to four treatment groups (n = 4) in a 28-day dose-response study. Administration into the reticulorumen was performed daily by gavage after the morning milking. Three groups received different amounts of the J. vulgaris extract resulting in a PA/PANO exposure of 0.47, 0.95, or 1.91 mg PA/PANO/kg body weight/day, respectively. Furthermore, a control group received molasses to account for the sugar content of the used PA/PANO extract. While the composition of the PA/PANO extract was more diverse, the PA/PANO pattern in milk was dominated by the PA in their free base form. It was shown that mainly PA considered stable in the rumen environment were transferred into the milk. The main compounds in milk were jacoline (74.3 ± 2.4% of the PA/PANO sum), jaconine (11.2 ± 1.3%), and jacobine (7.2 ± 0.6%) with concentrations up to 29.7, 4.65 µg/l, or in the highest exposed group, 3.44 µg/l. There was no dose-dependent effect on the total PA/PANO transfer rate into the milk. The average transfer rate was 0.064 ± 0.005% of the administered content.

Safety evaluation of the food enzyme asparaginase from the genetically modified Aspergillus niger strain ASP.

The food enzyme asparaginase (l-asparagine amidohydrolase; EC 3.5.1.1) is produced with the genetically modified Aspergillus niger strain ASP by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in the prevention of acrylamide formation in foods and in the processing of yeast and yeast products. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.792 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 at the highest dose tested of 1038 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1311. 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 the risk of allergic reactions upon 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.

Safety evaluation of the food enzyme triacylglycerol lipase from the non-genetically modified Penicillium caseifulvum strain AE-LRF.

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non-genetically modified Penicillium caseifulvum strain AE-LRF by Amano Enzyme Inc. The food enzyme was free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.013 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 69 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 5308. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. However, the Panel noted that traces of ■■■■■, used in the manufacture of the triacylglycerol lipase, may be found in the food enzyme. The Panel considered that the risk of allergic reactions upon dietary exposure could not be excluded, particularly in individuals sensitised to fish. 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.

Safety evaluation of the food enzyme β-glucosidase from the non-genetically modified Penicillium guanacastense strain AE-GLY.

The food enzyme β-glucosidase (β-D-glucoside glucohydrolase; EC 3.2.1.21) is produced with the non-genetically modified Penicillium guanacastense strain AE-GLY by Amano Enzyme Inc. The food enzyme is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 4.054 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 943 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 233. 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 the 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.

Safety evaluation of the food enzyme 3-phytase from the non-genetically modified Aspergillus niger strain PHY93-08.

The food enzyme 3-phytase (myo-inositol-hexakisphosphate 3-phosphohydrolase EC 3.1.3.8) is produced with the non-genetically modified Aspergillus niger strain PHY93-08 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production organism. It is intended to be used in nine food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in two of the food manufacturing processes, dietary exposure was calculated only for the remaining seven processes. It was estimated to be up to 0.763 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise safety concerns. 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 2560 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 3355. 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 upon 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.

Safety evaluation of an extension of use of the food enzyme pullulanase from the non-genetically modified Pullulanibacillus naganoensis strain AE-PL.

The food enzyme pullulanase (pullulan 6-α-glucanohydrolase; EC 3.2.1.41) is produced with the non-genetically modified Pullulanibacillus naganoensis strain AE-PL by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in one food manufacturing process. Subsequently, the applicant has requested to extend its use to include seven additional processes and to revise the previous use level. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of eight food manufacturing processes. As the food enzyme-total organic solids (TOS) are not carried into the final foods in two food manufacturing processes, the dietary exposure was estimated only for the remaining six processes. The dietary exposure was calculated to be up to 0.004 mg TOS/kg body weight (bw) per day in European populations. The Panel evaluated the repeated dose 90-day oral toxicity study in rats submitted in the previous application and identified a no observed adverse effect level of 643 mg TOS/kg bw per day, the highest dose tested. When compared with the calculated dietary exposure, this resulted in a margin of exposure of at least 160,750. Based on the data provided for the previous evaluation and the revised margin of exposure in the present evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.