A call for action on the development and implementation of new methodologies for safety assessment of chemical-based products in the EU – A short communication

The formulation of next-generation probiotics requires competent preclinical studies to show their efficacy and safety status. This study aims to confirm the safety of the prolonged oral use of Bacteroides uniformis CECT 7771, a strain that protected against metabolic disorders and obesity in preclinical trials, in a sub-chronic 90 day trial in animals. The safety assessment was conducted in male and female Wistar rats (n = 50) administered increasing doses (108 CFU/day, 109 CFU/day, or 1010 CFU/day) of B. uniformis CECT 7771, 1010 CFU/day of B. longum ATCC 15707T, which complies with the qualifying presumption of safety (QPS) status of the EU, or vehicle (placebo), as the control. Pancreatic, liver, and kidney functions and cytokine concentrations were analyzed. Bacterial translocation to peripheral tissues was evaluated, and colon integrity was investigated histologically. No adverse metabolic or tissue integrity alterations were associated with treatments; however, alanine aminotransferase levels and the ratio of anti-inflammatory to pro-inflammatory cytokines in serum indicated a potentially beneficial role of B. uniformis CECT 7771 at specific doses. Additionally, the microbial community structure was modified by the interventions, and potentially beneficial gut bacteria were increased. The results indicated that the oral consumption of B. uniformis CECT 7771 during a sub-chronic 90 day study in rats did not raise safety concerns.

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Practical Fire Safety Assessment of Steel-beam Floors Made According to the Old Technologies – an Exemplary Case Study. Influence of the Initial Assumptions on the Final Results of Analyses

Periodica Polytechnica Civil Engineering ◽

10.3311/ppci.9662 ◽

2017 ◽

Author(s):

Pawel Artur Krol

Keyword(s):

Fire Resistance ◽

Structural Design ◽

Safety Assessment ◽

Steel Beam ◽

Practical Applications ◽

Standard Fire ◽

The Subject ◽

Technical Features ◽

The Eu

The purpose of this article is to present procedures and methodsfor assessing fire resistance of steel-beam floors with thejoists hidden within the thickness of the slab. These technologiesare currently experiencing their renaissance, both in contemporarilydesigned buildings and the existing ones, subjectedto comprehensive redevelopment, refurbishment or modernization.Due to their simplicity and ease of execution, these floorsare just perfect as technology ideal for repairs or alterations ofbuildings under use or in the case of need of complete replacementof existing floors with new ones. These arguments justifythe need to raise the subject of proper safety assessment of thesefloors in relation to the regulations and requirements of lawsapplicable in the EU and pursuant to provisions of the latestcodes for structural design. A significant part of the study consistsof a suggestive computational example, which is a sort ofguide, in which the author, by making detailed step-by-step calculationsproduces a finished pattern of procedure, intended formultiple use. The suggested method of procedure can be successfullyused in the assessment of the fire resistance of floorstructures with similar technical features. The computationalexample presented in the study shows that contrary to a popularbelief, the use of standard fire model does not always leadto conservative estimates. In the article summary, the authorformulates a number of practical applications and conclusions.

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Safety assessment of seafood with respect to chemical pollutants in European Seas

Oceanological and Hydrobiological Studies ◽

10.2478/s13545-013-0063-1 ◽

2013 ◽

Vol 42 (1) ◽

Cited By ~ 2

Author(s):

Piotr Szefer

Keyword(s):

Health Risks ◽

Safety Assessment ◽

Human Consumption ◽

Inorganic Pollutants ◽

The Baltic Sea ◽

Potential Health ◽

Chemical Pollutants ◽

The Baltic ◽

The Eu ◽

European Seas

AbstractThis mini-review discusses the occurrence of chemical pollutants in edible biota from European seas, including the Baltic Sea ecosystem. The bioaccumulation of organic and inorganic pollutants in marine fish and edible molluscs and crustaceans is briefly approached within the context of European Union (EU) food quality standards. The health risks associated with the human consumption of seafood have been assessed mainly by the European Food Safety Authority (EFSA), an independent European agency funded by the EU. The potential health risks arising from the consumption of “frutti di mare” are examined from the standpoint of estimated Provisional Tolerable Weekly Intakes (PTWIs) for toxic pollutants.

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Release and speciation of14C during the corrosion of activated steel in deep geological repositories for the disposal of radioactive waste

Radiocarbon ◽

10.1017/rdc.2018.138 ◽

2018 ◽

Vol 60 (6) ◽

pp. 1657-1670 ◽

Cited By ~ 2

Author(s):

J Mibus ◽

N Diomidis ◽

E Wieland ◽

S W Swanton

Keyword(s):

Radioactive Waste ◽

Safety Assessment ◽

Nuclear Reactors ◽

Steel Corrosion ◽

Work Package ◽

Carbon 14 ◽

Term Evolution ◽

Safety Assessments ◽

The Eu

ABSTRACTCarbon-14 (radiocarbon,14C) is an important radionuclide in the inventory of radioactive waste in many disposal programs due to its significant dose contributions in safety assessments for geological repositories. Activated steels from nuclear reactors are one of the major sources of14C. Knowledge of14C release from steel wastes and its chemical form (speciation) is limited giving rise to uncertainty regarding the fate of14C and a conservative treatment in assessment calculations. In this work, we summarize and make a synthesis of selected results from Work Package 2 of the EU CAST project aiming to improve understanding of14C release related to steel corrosion under repository-relevant conditions. The outcome of the experiments is discussed in the context of the long-term evolution of a repository and its potential consequences for safety assessment.

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Consumer safety assessment of the EU MRLs established for methidathion

EFSA Journal ◽

10.2903/j.efsa.2010.1639 ◽

2010 ◽

Vol 8 (6) ◽

pp. 1639

Author(s):

Keyword(s):

Safety Assessment ◽

Consumer Safety ◽

The Eu

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Safety assessment of traditional Plaisentif cheese

Italian Journal of Food Safety ◽

10.4081/ijfs.2021.9769 ◽

2022 ◽

Vol 10 (4) ◽

Author(s):

Daniele Pattono ◽

Alessandra Dalmasso ◽

Pier Giorgio Peiretti ◽

Francesco Gai ◽

Maria Teresa Bottero

Keyword(s):

Biogenic Amines ◽

Safety Assessment ◽

Point Of View ◽

Cultural Identities ◽

Traditional Foods ◽

Salmonella Spp ◽

National Cultures ◽

Mountainous Regions ◽

Willingness To Buy ◽

The Eu

Traditional foods are gaining more and more market due to consumers’ increasing willingness to buy products linked to national cultures: among these products, cheese plays an important role. Plaisentif is a traditional Piedmont cheese, only made during violets blooming season. The aim of this work is to evaluate the safety of this cheese, taking into account the EU Regulations. Microbiological hazards as well chemical, biogenic amines and mycotoxins, analysis were investigated. Salmonella spp. and Listeria monocytogenes were never detected in cheeses after ripening. Biogenic amines were present in very low quantities. Ochratoxin A was never detected and patulin was detected in over one cheese during the two years of sampling. This is the first attempt to characterize traditional Plaisentif cheese from a safety point of view. All the information acquired can be held as a necessary basis for reinforcing the culture of traditional products, for economic opportunities in mountainous regions and for safeguarding traditions and cultural identities.

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A multicentre randomised assessment of the DAWN AC computer-assisted oral anticoagulant dosage program

Thrombosis and Haemostasis ◽

10.1160/th08-10-0664 ◽

2009 ◽

Vol 101 (03) ◽

pp. 487-494 ◽

Cited By ~ 35

Author(s):

Michelle Keown ◽

Saied Ibrahim ◽

Gordon Lowe ◽

Marco Moia ◽

Alexander G. Turpie ◽

...

Keyword(s):

Oral Anticoagulation ◽

Oral Anticoagulant ◽

Safety Assessment ◽

Computer Assisted ◽

Clinical Safety ◽

Randomised Study ◽

Clinical Events ◽

Computer Assistance ◽

The Difference ◽

The Eu

SummaryComputer-assisted oral anticoagulant dosage is being increasingly used to meet growing demands for oral anticoagulation. The DAWN AC is one of the most widely used computer-dosage programs. Evidence of its value and that of other computer programs has been based previously only on laboratory evidence of “time in target INR range” (TIR) not on clinical safety in practice. A five-year international randomised clinical study of computer assistance with the DAWN AC program compared with manual dosage in 2,631 patients has been performed at 13 centres with established expertise in oral anticoagulation mainly in the EU. Safety assessment have been based on the comparison of bleeding or thrombotic events with DAWN AC compared with manual dosage in a randomised study. Safety of the DAWN AC program has been demonstrated. Clinical events of bleeding and thrombosis were almost identical with the experienced manual dosage group. Therapeutic control improved with DAWN AC to 66.8% from 63.4% TIR. The program failed to provide a dosage recommendation on only 5.7% of occasions. At a group of experienced centres with a special interest in oral anticoagulation, the DAWN AC computer-dosage program proved as safe clinically as manual dosage by experienced medical staff. With DAWN AC, laboratory control was improved, the difference being highly significant. The results should reassure hospitals and community clinics that the DAWN AC program is safe and facilitate greater and longer provision of warfarin treatment where required.

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