Pathogenicity assessment of Shiga toxin‐producing Escherichia coli (STEC) and the public health risk posed by contamination of food with STEC

The provisional molecular approach, proposed by EFSA in 2013, for the pathogenicity assessment of Shiga toxin‐producing Escherichia coli (STEC) has been reviewed. Analysis of the confirmed reported human STEC infections in the EU/EEA (2012–2017) demonstrated that isolates positive for any of the reported Shiga toxin (Stx) subtypes (and encoding stx gene subtypes) may be associated with severe illness (defined as bloody diarrhoea (BD), haemolytic uraemic syndrome (HUS) and/or hospitalisation). Although strains positive for stx2a gene showed the highest rates, strains with all other stx subtypes, or combinations thereof, were also associated with at least one human case with a severe clinical outcome. Serogroup cannot be used as a predictor of clinical outcome and the presence of the intimin gene (eae) is not essential for severe illness. These findings are supported by the published literature, a review of which suggested there was no single or combination of virulence markers associated exclusively with severe illness. Based on available evidence, it was concluded that all STEC strains are pathogenic in humans, capable of causing at least diarrhoea and that all STEC subtypes may be associated with severe illness. Source attribution analysis, based on ‘strong evidence’ outbreak data in the EU/EEA (2012–2017), suggests that ‘bovine meat and products thereof’, ‘milk and dairy products’, ‘tap water including well water’ and ‘vegetables, fruit and products thereof’ are the main sources of STEC infections in the EU/EEA, but a ranking between these categories cannot be made as the data are insufficient. Other food commodities are also potentially associated with STEC infections but rank lower. Data gaps are identified, and are primarily caused by the lack of harmonisation in sampling strategies, sampling methods, detection and characterisation methods, data collation and reporting within the EU.info:eu-repo/semantics/publishedVersio

Guidance on date marking and related food information: part 2 (food information)

A risk‐based approach was used to develop guidance to be followed by food business operators (FBOs) when deciding on food information relating to storage conditions and/or time limits for consumption after opening a food package and thawing of frozen foods. After opening the package, contamination may occur, introducing new pathogens into the food and the intrinsic (e.g. pH and aw), extrinsic (e.g. temperature and gas atmosphere) and implicit (e.g. interactions with competing background microbiota) factors may change, affecting microbiological food safety. Setting a time limit for consumption after opening the package (secondary shelf‐life) is complex in view of the many influencing factors and information gaps. A decision tree (DT) was developed to assist FBOs in deciding whether the time limit for consumption after opening, due to safety reasons, is potentially shorter than the initial ‘best before’ or ‘use by’ date of the product in its unopened package. For products where opening the package leads to a change of the type of pathogenic microorganisms present in the food and/or factors increasing their growth compared to the unopened product, a shorter time limit for consumption after opening would be appropriate. Freezing prevents the growth of pathogens, however, most pathogenic microorganisms may survive frozen storage, recover during thawing and then grow and/or produce toxins in the food, if conditions are favourable. Moreover, additional contamination may occur from hands, contact surfaces or contamination from other foods and utensils. Good practices for thawing should, from a food safety point of view, minimise growth of and contamination by pathogens between the food being thawed and other foods and/or contact surfaces, especially when removing the food from the package during thawing. Best practices for thawing foods are presented to support FBOs.info:eu-repo/semantics/publishedVersio

Canagliflozin and renal outcomes in type 2 diabetes and nephropathy

BACKGROUND Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium–glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes. METHODS In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to <90 ml per minute per 1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], >300 to 5000) and were treated with renin–angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically. RESULTS The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P=0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P<0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001). There were no significant differences in rates of amputation or fracture. CONCLUSIONS In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years

Guidance on date marking and related food information: part 2 (food information)

[EN] A risk-based approach was used to develop guidance to be followed by food business operators (FBOs) when deciding on food information relating to storage conditions and/or time limits for consumption after opening a food package and thawing of frozen foods. After opening the package, contamination may occur, introducing new pathogens into the food and the intrinsic (e.g. pH and aw), extrinsic (e.g. temperature and gas atmosphere) and implicit (e.g. interactions with competing background microbiota) factors may change, affecting microbiological food safety. Setting a time limit for consumption after opening the package (secondary shelf-life) is complex in view of the many influencing factors and information gaps. A decision tree (DT) was developed to assist FBOs in deciding whether the time limit for consumption after opening, due to safety reasons, is potentially shorter than the initial ‘best before’ or ‘use by’ date of the product in its unopened package. For products where opening the package leads to a change of the type of pathogenic microorganisms present in the food and/or factors increasing their growth compared to the unopened product, a shorter time limit for consumption after opening would be appropriate. Freezing prevents the growth of pathogens, however, most pathogenic microorganisms may survive frozen storage, recover during thawing and then grow and/or produce toxins in the food, if conditions are favourable. Moreover, additional contamination may occur from hands, contact surfaces or contamination from other foods and utensils. Good practices for thawing should, from a food safety point of view, minimise growth of and contamination by pathogens between the food being thawed and other foods and/or contact surfaces, especially when removing the food from the package during thawing. Best practices for thawing foods are presented to support FBOsS

Guidance on date marking and related food information : part 2 (food information)

A risk-based approach was used to develop guidance to be followed by food business operators (FBOs) when deciding on food information relating to storage conditions and/or time limits for consumption after opening a food package and thawing of frozen foods. After opening the package, contamination may occur, introducing new pathogens into the food and the intrinsic (e.g. pH and a(w)), extrinsic (e.g. temperature and gas atmosphere) and implicit (e.g. interactions with competing background microbiota) factors may change, affecting microbiological food safety. Setting a time limit for consumption after opening the package (secondary shelf-life) is complex in view of the many influencing factors and information gaps. A decision tree (DT) was developed to assist FBOs in deciding whether the time limit for consumption after opening, due to safety reasons, is potentially shorter than the initial 'best before' or 'use by' date of the product in its unopened package. For products where opening the package leads to a change of the type of pathogenic microorganisms present in the food and/or factors increasing their growth compared to the unopened product, a shorter time limit for consumption after opening would be appropriate. Freezing prevents the growth of pathogens, however, most pathogenic microorganisms may survive frozen storage, recover during thawing and then grow and/or produce toxins in the food, if conditions are favourable. Moreover, additional contamination may occur from hands, contact surfaces or contamination from other foods and utensils. Good practices for thawing should, from a food safety point of view, minimise growth of and contamination by pathogens between the food being thawed and other foods and/or contact surfaces, especially when removing the food from the package during thawing. Best practices for thawing foods are presented to support FBOs. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority