Glyceria maxima as new test species for the EU risk assessment for herbicides: a microcosm study

Aromatic amines (anilines and related derivates) are an important class of environmental pollutants that can be released to the aquatic environment as industrial effluents or as breakdown products of pesticides and dyes. The toxicities of aniline, 2-chloroaniline, 3-chloroaniline, 4-chloroaniline and 3,5-dichloroaniline towards a multitrophic test battery comprised of bacteria Aliivibrio fischeri (formerly Vibrio fischeri), a ciliated protozoan Tetrahymena thermophila and two crustaceans (Daphnia magna and Thamnocephalus platyurus) were investigated. Under the applied test conditions, the toxicities of the anilines notably varied among the test species. The bacteria and protozoa were much less sensitive towards the anilines than the crustaceans: EC50 values 13-403 mg L-1 versus 0.13-15.2 mg L-1. No general tendency between toxicity and the chemical structure of the anilines (the degree of chloro-substitution and the position of the chloro-substituents) was found in the case of all the tested aquatic species. The replacement of the artificial test medium (ATM) by the river water remarkably decreased the toxicity of anilines to crustaceans but not to protozoa. This research is part of the EU 6th Framework Integrated Project OSIRIS, in which ecotoxicogenomic studies of anilines (e.g., for Daphnia magna) will also be performed that may help to clarify the mechanisms of toxicity of different anilines.

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National Food Safety Systems in the European Union: A Comparative Survey

International Journal of Food Studies ◽

10.7455/ijfs.v2i1.136 ◽

2013 ◽

Vol 2 (1) ◽

Author(s):

Andreas Hadjigeorgiou ◽

Elpidoforos S. Soteriades ◽

Anastasios Philalithis ◽

Anna Psaroulaki ◽

Yiannis Tselentis ◽

...

Keyword(s):

Risk Assessment ◽

European Union ◽

Food Safety ◽

The European Union ◽

Member States ◽

Eu Member States ◽

Comparative Survey ◽

Safety Systems ◽

Central Level ◽

The Eu

This paper is a comparative survey of the National Food Safety Systems (NFSS) of the European Union (EU) Member-States (MS) and the Central EU level. The main organizational structures of the NFSS, their legal frameworks, their responsibilities, their experiences, and challenges relating to food safety are discussed. Growing concerns about food safety have led the EU itself, its MS and non-EU countries, which are EU trade-partners, to review and modify their food safety systems. Our study suggests that the EU and 22 out of 27 Member States (MS) have reorganized their NFSS by establishing a single food safety authority or a similar organization on the national or central level. In addition, the study analyzes different approaches towards the establishment of such agencies. Areas where marked differences in approaches were seen included the division of responsibilities for risk assessment (RA), risk management (RM), and risk communication (RC). We found that in 12 Member States, all three areas of activity (RA, RM, and RC) are kept together, whereas in 10 Member States, risk management is functionally or institutionally separate from risk assessment and risk communication. No single ideal model for others to follow for the organization of a food safety authority was observed; however, revised NFSS, either in EU member states or at the EU central level, may be more effective from the previous arrangements, because they provide central supervision, give priority to food control programs, and maintain comprehensive risk analysis as part of their activities.

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Workers with Cardiac AIMD Exposed to EMF: Methods and Case Studies for Risk Analysis in the Framework of the European Regulations

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18189709 ◽

2021 ◽

Vol 18 (18) ◽

pp. 9709

Author(s):

Eugenio Mattei ◽

Federica Censi ◽

Giovanni Calcagnini ◽

Rosaria Falsaperla

Keyword(s):

Risk Assessment ◽

Case Studies ◽

Medical Devices ◽

Risk Group ◽

Health And Safety ◽

Implantable Defibrillator ◽

Safety Regulation ◽

Implantable Medical Devices ◽

European Regulations ◽

The Eu

Workers with cardiac active implantable medical devices (AIMD), such as a pacemaker (PM) or an implantable defibrillator (ICD), are considered by the occupational health and safety regulation framework as a particularly sensitive risk group that must be protected against the dangers caused by the interference of electromagnetic field (EMF). In this paper, we first describe the general methodology that shall be followed for the risk assessment of employees with a cardiac AIMD exposed to EMF, according to the EU regulation, and in particular to the EN 50527-2-1:2016 and 50527-2-2:2018 standards. Then, three case studies related to specific EMF sources are presented, to better describe how the initial analysis of the risk assessment can be performed in practice, and to understand if a further specific risk assessment analysis is required or not.

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An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register

F1000Research ◽

10.12688/f1000research.12198.1 ◽

2017 ◽

Vol 6 ◽

pp. 1447 ◽

Cited By ~ 5

Author(s):

Robert Carroll ◽

Sreeram V. Ramagopalan ◽

Javier Cid-Ruzafa ◽

Dimitra Lambrelli ◽

Laura McDonald

Keyword(s):

Risk Assessment ◽

Chart Review ◽

Drug Utilisation ◽

Data Capture ◽

Primary Data ◽

European Medicines Agency ◽

Therapeutic Area ◽

The European Union ◽

Study Designs ◽

The Eu

Background: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS) requested by the European Medicines Agency which were recorded on the European Union (EU) PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Methods: We undertook a cross-sectional descriptive analysis of all studies registered on the EU PAS Register as of 18th October 2016. Results: We identified a total of 314 studies on the EU PAS Register, including 81 (26%) finalised, 160 (51%) ongoing and 73 (23%) planned. Of those studies identified, 205 (65%) included risk assessment in their scope, 133 (42%) included drug utilisation and 94 (30%) included effectiveness evaluation. Just over half of the studies (175; 56%) used primary data capture, 135 (43%) used secondary data and 4 (1%) used a hybrid design combining both approaches. Risk assessment and effectiveness studies were more likely to use primary data capture (60% and 85% respectively as compared to 39% and 14% respectively for secondary). The converse was true for drug utilisation studies where 59% were secondary vs. 39% for primary. For type 2 diabetes mellitus, database studies were more commonly used (80% vs 3% chart review, 3% hybrid and 13% primary data capture study designs) whereas for studies in oncology, primary data capture were more likely to be used (85% vs 4% chart review, and 11% database study designs). Conclusions: Results of this analysis show that study objectives and therapeutic area influence PAS design in terms of type of data capture used.

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