Water-related ecosystems' mapping and assessment based on remote sensing techniques and geospatial analysis: The SWOS national service case of the Greek Ramsar sites and their catchments

Water-related ecosystems' mapping and assessment based on remote sensing techniques and geospatial analysis: The SWOS national service case of the Greek Ramsar sites and their catchments. Remote Sensing of Environment 245 (2020) 111795. doi.org/10.1016/j.rse.2020.11179

Novel foods in the European Union: Scientific requirements and challenges of the risk assessment process by the European Food Safety Authority

The European Food Safety Authority (EFSA) has been involved in the risk assessment of novel foods since 2003. The implementation of the current novel food regulation in 2018 rendered EFSA the sole entity of the European Union responsible for such safety evaluations. The risk assessment is based on the data submitted by applicants in line with the scientific requirements described in the respective EFSA guidance document. The present work aims to elaborate on the rationale behind the scientific questions raised during the risk assessment of novel foods, with a focus on complex mixtures and whole foods. Novel foods received by EFSA in 2003–2019 were screened and clustered by nature and complexity. The requests for additional or supplementary information raised by EFSA during all risk assessments were analyzed for identifying reoccurring issues. In brief, it is shown that applications concern mainly novel foods derived from plants, microorganisms, fungi, algae, and animals. A plethora of requests relates to the production process, the compositional characterization of the novel food, and the evaluation of the product's toxicological profile. Recurring issues related to specific novel food categories were noted. The heterogeneous nature and the variable complexity of novel foods emphasize the challenge to tailor aspects of the evaluation approach to the characteristics of each individual product. Importantly, the scientific requirements for novel food applications set by EFSA are interrelated, and only a rigorous and cross-cutting approach adopted by the applicants when preparing the respective application dossiers can lead to scientifically sound dossiers. This is the first time that an in-depth analysis of the experience gained by EFSA in the risk assessment of novel foods and of the reasoning behind the most frequent scientific requests by EFSA to applicants is made

Safety of 1-methylnicotinamide chloride (1-MNA) as a novel food pursuant to Regulation (EC) No258/97

Following a request from the European Commission, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 1-methylnicotinamide chloride (1-MNA) as a novel food (NF) ingredient submitted pursuant to Regulation (EC) No258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. 1-MNA is a substance present naturally in the human body as a normal downstream product of niacin metabolism. The Panelconsiders that the information provided on the composition, the specification and the batch-to-batch variability of the NF is sufficient. The applicant intends to use 1-MNA in food supplements and proposes a maximum intake of 58mg/day. 1-MNA is not genotoxic. In a subchronic rat study, epithelium degeneration of the non-glandular stomach was observed at all dose levels with increasing frequency. The Panelnotes that the human stomach does not have non-glandular epithelium and considers this finding is toxicologically not relevant for humans. At doses of 500 and 1,000mg/kg body weight (bw), changes of the urine pH, that did not reverse in the recovery period, were reported. As adversity of this finding cannot be ruled out, the Panelselected 250mg/kg bw in this rat study as the reference point. The Margin of Exposure to humans weighing 70kg and consuming 58mg would be about 300. The Panelnotes the upper level for nicotinamide, i.e. 900mg/day for adults. Taking into account that 1-MNA is a main metabolite from nicotinamide, the Panelconsiders that it is unlikely that an intake of 58mg 1-MNA from food supplements would result in adverse health outcomes in humans. The Panelconcludes that the NF, 1-MNA, is safe under the proposed uses and use levels. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority

Safety of frozen and dried formulations from whole yellow mealworm (Tenebrio molitor larva) as a novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on frozen and dried formulations from whole yellow mealworm (Tenebrio molitor larva) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The term yellow mealworm refers to the larval form of the insect species Tenebrio molitor. The NF comprises the frozen and freeze-dried formulations of the yellow mealworm, whole or in the form of powder. The frozen formulation consists mainly of water, crude protein and fat whereas the freeze-dried formulations of crude protein, fat, digestible carbohydrates and fibre (chitin). The Panel notes that the levels of contaminants in the NF depend on the occurrence levels of these substances in the insect feed. The Panel notes furthermore that there are no safety concerns regarding the stability of the NF if the NF complies with the proposed specification limits during its entire shelf-life. The dried formulations of the NF have a high protein content, although the true protein levels in the NF are overestimated when using the nitrogen-to-protein conversion factor of 6.25, due to the presence of non-protein nitrogen from chitin. The applicant proposed to use the NF as whole frozen or whole dried insect, or in the form of powder, added as an ingredient to various food products such as cereal bars, pasta, meat imitates and bakery products. The target population is the general population. The Panel notes that, considering that the NF will not be the sole source of dietary protein, and the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The submitted toxicity studies from the literature did not raise safety concerns. The Panel considers that the consumption of the NF may induce primary sensitisation and allergic reactions to yellow mealworm proteins and may cause allergic reactions in subjects with allergy to crustaceans and dust mites. Additionally, allergens from the feed may end up in the NF. The Panel concludes that the NF is safe under the proposed uses and use levels

Safety of frozen and freeze-dried formulations of the lesser mealworm (Alphitobius diaperinus larva) as a Novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on frozen and dried formulations from whole lesser mealworm (Alphitobius diaperinus larva) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The term lesser mealworm refers to the larval form of the insect species Alphitobius diaperinus. The NF comprises the frozen and freeze-dried formulations of the lesser mealworm as whole or in the form of a paste or powder. Apart from water in the frozen formulations (whole, paste), the main components of the NF are crude protein and fat, besides smaller amounts of digestible carbohydrates and fibre (chitin). The Panel notes that the levels of contaminants in the NF depend on the concentration of such substances in the insect feed. The Panel notes furthermore that the true protein levels in the NF are overestimated when using the nitrogen-to-protein conversion factor of 6.25, due to the presence of non-protein nitrogen from chitin. The applicant proposed to use the NF formulations added as an ingredient to various food products such as cereal bars, pasta, meat imitates and bakery products. The target population is the general population. Additionally, the applicant proposed to use the NF as a food supplement in adults. The Panel notes that, considering that the NF will not be the sole source of dietary protein, and the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The submitted subchronic 90-day toxicity study with the NF as testing material did not raise safety concerns. The Panel considers that the consumption of the NF may induce primary sensitisation and allergic reactions to lesser mealworm proteins and may cause allergic reactions in subjects with allergy to crustaceans and dust mites. Additionally, allergens from the feed may end up in the NF. Allergenicity aside, the Panel concludes that the NF is safe under the proposed uses and use levels

RNA sequencing supports distinct reactive oxygen species-mediated pathways of apoptosis by high and low size mass fractions of Bay leaf (Lauris nobilis) in HT-29 cells

Anti-proliferative and pro-apoptotic effects of Bay leaf (Laurus nobilis) in mammalian cancer and HT-29 adenocarcinoma cells have been previously attributed to effects of polyphenolic and essential oil chemical species. Recently, we demonstrated differentiated growth-regulating effects of high (HFBL) versus low molecular mass (LFBL) aqueous fractions of bay leaf and now confirm by comparative effects on gene expression, that HFBL and LFBL suppress HT-29 growth by distinct mechanisms. Induction of intra-cellular lesions including DNA strand breakage by extra-cellular HFBL, invoked the hypothesis that iron-mediated reactive oxygen species with capacity to penetrate cell membrane, were responsible for HFBL-mediated effects, supported by equivalent effects of HFBL in combination with γ radiation. Activities of HFBL and LFBL were interpreted to reflect differentiated responses to iron-mediated reactive oxygen species (ROS), occurring either outside or inside cells. In the presence of LFBL, apoptotic death was relatively delayed compared with HFBL. ROS production by LFBL mediated p53-dependent apoptosis and recovery was suppressed by promoting G1/S phase arrest and failure of cellular tight junctions. In comparison, intra-cellular anti-oxidant protection exerted by LFBL was absent for extra-cellular HFBL (likely polysaccharide-rich), which potentiated more rapid apoptosis by producing DNA double strand breaks. Differentiated effects on expression of genes regulating ROS defense and chromatic condensation by LFBL versus HFBL, were observed. The results support ferrous iron in cell culture systems and potentially in vivo, can invoke different extra-cellular versus intra-cellular ROS-mediated chemistries, that may be regulated by exogenous, including dietary species