European Food Safety Authority EFSA

Parma, Italy

European Food Safety Authority EFSA

Parma, Italy
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Franceschi N.,European Food Safety Authority EFSA | Paraskevopoulos K.,European Food Safety Authority EFSA | Waigmann E.,European Food Safety Authority EFSA | Ramon M.,European Food Safety Authority EFSA
Trends in Biotechnology | Year: 2017

In the EU novel proteins used in food or feed are assessed for their potential toxic effects in humans and livestock animals. The discovery of clear molecular features linked to the toxicity of a protein may be an important step towards the use of predictive protein toxicity in risk assessment. © 2017 Elsevier Ltd.


Minkkinen P.,Lappeenranta University of Technology | Minkkinen P.,University of Aalborg | Esbensen K.H.,Geological Survey of Denmark | Paoletti C.,European Food Safety Authority EFSA
TrAC - Trends in Analytical Chemistry | Year: 2012

Official testing and sampling of large kernel lots for impurities [e.g., genetically modified organisms (GMOs)] is regulated by normative documents and international standards of economic, trade and societal importance.In Part I, we reviewed current official guides and standards for sampling large contaminated kernel lots and the basic concepts of the Theory of Sampling (TOS) for chemical analysis. Here, we re-interpret the data collected in a recent field study (KeLDA) from a stringent TOS perspective, focusing on representative process sampling and variographic analysis in order to characterize the heterogeneities of large kernel lots and to estimate both Total Sampling Error (TSE) and Total Analytical Error (TAE). This is used as a basis for developing a general approach for optimization of kernel sampling protocols that are " fit for purpose" i.e. robust to heterogeneity and sufficiently accurate also to detect critically low levels of concentration.We demonstrate that both TSE and TAE are significantly large for GMO quantitation, but that TSE still can be up two orders of magnitude larger than TAE, depending on heterogeneity, sampling mode and GMO concentration, signifying that efforts to reduce uncertainties should focus on sampling plans and not on further refinements of analytical precision.For GMO testing based on the current labeling threshold (0.9%) in European Union regulations, we show that 42 is the absolute minimum number of increments needed for reliable characterization of all lots with a heterogeneity comparable to the most severely heterogeneous KeLDA lots (Lot #1).We demonstrate that the TOS is a comprehensive tool for reliable estimation of the effects of alternative sampling procedures and schemes, especially when using 1-D process variography, with which to optimize both sampling accuracy and precision. We show how it is always possible to estimate TSE from one simple variographic experiment based solely on the simple process-sampling requirements of TOS. This approach is universal and can be carried to very many other (static or dynamic) sampling scenarios and materials (e.g., impurities, contaminants and trace concentrations). The present variographic approach is crucial for meaningful definition of " appropriate sampling plans" (i.e. sampling plans minimizing TSE as function of the specific heterogeneity of any given lot). © 2012 Elsevier Ltd.


Esbensen K.H.,Geological Survey of Denmark | Esbensen K.H.,University of Aalborg | Paoletti C.,European Food Safety Authority EFSA | Minkkinen P.,University of Aalborg | Minkkinen P.,Lappeenranta University of Technology
TrAC - Trends in Analytical Chemistry | Year: 2012

Official testing and sampling of large kernel lots for impurities [e.g., genetically-modified organisms (GMOs)] is regulated by normative documents and international standards of economic, trade and societal importance. The focus nearly always includes only analytical issues - omitting, with very few exceptions, proper accounting for sampling errors. With total sampling errors for irregularly distributed contaminants and impurities typically 10-100 times larger than analytical errors, this issue is critical for procedures based on general notions of effective material uniformity. When the focus includes sampling, most guidelines recommend sampling plans based on the assumption that kernel-lot impurities, if present, are randomly distributed. The only exceptions are EC Rec. 787/2004 and prCEN/TS 1568 (2006), which suggest sampling strategies suitable for more heterogeneous situations.A recent field project, KeLDA, documented highly significant heterogeneity in 13 out of 15 randomly chosen soybean kernel shiploads arriving in Europe intended for the feed market. The KeLDA study argued strongly that only sampling guidelines taking this into account can be viewed as authoritative for kernel-lot testing. The Theory of Sampling (TOS) is the only fully comprehensive, scientifically documented approach for representative sampling of all types of heterogeneous lots and materials (trace constituents, contaminants), and, in this context, GMO-contaminated lots constitute no special type.In this three-part series, we re-interpret KeLDA data from a proper TOS perspective. Part I introduces the fundamental principles for process sampling, resolves terminology differences between TOS and ISO usages and defines variographic analysis in the full detail necessary for parts II and III. © 2012 Elsevier Ltd.


Paoletti C.,European Food Safety Authority EFSA | Esbensen K.H.,Geological Survey of Denmark | Esbensen K.H.,University of Aalborg
Journal of AOAC International | Year: 2015

Material heterogeneity influences the effectiveness of sampling procedures. Most sampling guidelines used for assessment of food and/or feed commodities are based on classical statistical distribution requirements, the normal, binomial, and Poisson distributions - and almost universally rely on the assumption of randomness. However, this is unrealistic. The scientific food and feed community recognizes a strong preponderance of non random distribution within commodity lots, which should be a more realistic prerequisite for definition of effective sampling protocols. Nevertheless, these heterogeneity issues are overlooked as the prime focus is often placed only on financial, time, equipment, and personnel constraints instead of mandating acquisition of documented representative samples under realistic heterogeneity conditions. This study shows how the principles promulgated in the Theory of Sampling (TOS) and practically tested over 60 years provide an effective framework for dealing with the complete set of adverse aspects of both compositional and distributional heterogeneity (material sampling errors), as well as with the errors incurred by the sampling process itself. The results of an empirical European Union study on genetically modified soybean heterogeneity, Kernel Lot Distribution Assessment are summarized, as they have a strong bearing on the issue of proper sampling protocol development. TOS principles apply universally in the food and feed realm and must therefore be considered the only basis for development of valid sampling protocols free from distributional constraints.


Georgiev M.,Royal Veterinary College RVC | Afonso A.,European Food Safety Authority EFSA | Neubauer H.,Friedrich Loeffler Institute | Needham H.,Centers for Disease Control and Prevention | And 7 more authors.
Eurosurveillance | Year: 2013

Q fever is a disease of humans, caused by Coxiella burnetii, and a large range of animals can be infected. This paper presents a review of the epidemiology of Q fever in humans and farm animals between 1982 and 2010, using case studies from four European countries (Bulgaria, France, Germany and the Netherlands). The Netherlands had a large outbreak between 2007 and 2010, and the other countries a history of Q fever and Q fever research. Within all four countries, the serological prevalence of C. burnetii infection and reported incidence of Q fever varies broadly in both farm animals and humans. Proximity to farm animals and contact with infected animals or their birth products have been identified as the most important risk factors for human disease. Intrinsic farm factors, such as production systems and management, influence the number of outbreaks in an area. A number of disease control options have been used in these four countries, including measures to increase diagnostic accuracy and general awareness, and actions to reduce spill-over (of infection from farm animals to humans) and human exposure. This study highlights gaps in knowledge, and future research needs.


Salman M.,Colorado State University | Silano V.,European Food Safety Authority EFSA | Heim D.,Swiss Federal Veterinary Office | Kreysa J.,European Commission - Joint Research Center Ispra
Preventive Veterinary Medicine | Year: 2012

Bovine Spongiform Encephalopathy (BSE) rapidly evolved into an issue of major public concern particularly when, in 1996, evidence was provided that this disease had crossed the species barrier and infected humans in the UK with what has become known as " variant Creutzfeldt Jakob Disease" (vCJD). The aim of this paper is to describe the European Geographical BSE risk assessment (GBR) that was successfully used for assessing the qualitative likelihood that BSE could be present in a country where it was not yet officially recognized. It also discusses how this can lead to risk-based and therefore preventive management of BSE at national and international levels.The basic assumption of the GBR method is that the BSE agent is initially introduced into a country's domestic cattle production system through the importation of contaminated feedstuffs or live cattle. This is referred to as an " external challenge" . The ability of the system to cope with such a challenge is, in turn, referred to as its " stability" : a stable system will not allow the BSE agent to propagate and amplify following its introduction, while an unstable system will.The BSE-status of a country assessed by this system was used by the European Commission as the basis for trade legislation rules for cattle and their products.The GBR was an invaluable tool in evaluating the potential global spread of BSE as it demonstrated how a disease could be transferred through international trade. This was shown to be a critical factor to address in reducing the spread and amplification of BSE throughout the world. Furthermore, GBR resulted in the implementation of additional measures and management activities both to improve surveillance and to prevent transmission within the cattle population. © 2012 Elsevier B.V.


Adlhoch C.,Centers for Disease Control and Prevention | Gossner C.,Centers for Disease Control and Prevention | Gossner C.,Maastricht University | Koch G.,Wageningen University | And 5 more authors.
Eurosurveillance | Year: 2014

Since the beginning of November 2014, nine outbreaks of highly pathogenic avian influenza virus (HPAIV) A(H5N8) in poultry have been detected in four European countries. In this report, similarities and differences between the modes of introduction of HPAIV A(H5N1) and A(H5N8) into Europe are described. Experiences from outbreaks of A(H5N1) in Europe demonstrated that early detection to control HPAIV in poultry has proven pivotal to minimise the risk of zoonotic transmission and prevention of human cases. © 2014 European Centre for Disease Prevention and Control (ECDC). All rights reserved.


Jaspers S.,Hasselt University | Aerts M.,Hasselt University | Verbeke G.,Interuniversity Institute for Biostatistics and statistical Bioinformatics | Beloeil P.-A.,European Food Safety Authority EFSA
Statistics in Medicine | Year: 2014

Antimicrobial resistance has become one of the main public health burdens of the last decades, and monitoring the development and spread of non-wild-type isolates has therefore gained increased interest. Monitoring is performed based on the minimum inhibitory concentration (MIC) values, which are collected through the application of dilution experiments. In order to account for the unobserved population heterogeneity of wild-type and non-wild-type isolates, mixture models are extremely useful. Instead of estimating the entire mixture globally, it was our major aim to provide an estimate for the wild-type first component only. The characteristics of this first component are not expected to change over time, once the wild-type population has been confidently identified for a given antimicrobial. With this purpose, we developed a new method based on the multinomial distribution, and we carry out a simulation study to study the properties of the new estimator. Because the new approach fits within the likelihood framework, we can compare distinct distributional assumptions in order to determine the most suitable distribution for the wild-type population. We determine the optimal parameters based on the AIC criterion, and attention is also paid to the model-averaged approach using the Akaike weights. The latter is thought to be very suitable to derive specific characteristics of the wild-type distribution and to determine limits for the wild-type MIC range. In this way, the new method provides an elegant means to compare distinct distributional assumptions and to quantify the wild-type MIC distribution of specific antibiotic-bacterium combinations. © 2013 John Wiley & Sons, Ltd.


Broglia A.,European Food Safety Authority EFSA | Kapel C.,Copenhagen University
Veterinary Parasitology | Year: 2011

Changing eating habits, population growth and movements, global trade of foodstuff, changes in food production systems, climate change, increased awareness and better diagnostic tools are some of the main drivers affecting the emergence or re-emergence of many foodborne parasitic diseases in recent years. In particular, the increasing demand for exotic and raw food is one of the reasons why reports of foodborne infections, and especially waterborne parasitosis, have increased in the last years. Moreover increasing global demand for protein of animal origin has led to certain farming practices (e.g. aquaculture) increasing in emerging or developing countries, where health monitoring may not be sufficiently implemented. Therefore, high quality epidemiological data are needed which together with biological, economic, social and cultural variables should be taken into account when setting control programs for these increasingly popular production systems in emerging economies. This review focuses on the dietary, social, economic and environmental changes that may cause an increase in human exposure to foodborne parasites. Some examples illustrating these new epidemiological dynamics of transmission foodborne parasitic disease are presented. © 2011 Elsevier B.V.


Martin A.,European Food Safety Authority Efsa
Phytotherapie | Year: 2014

The recommended dietary allowance (RDA) of Vitamin C has been established at the level of 110 mg/day. Some suggest higher amounts for more benefit. In this paper some points are discussed: the basis and the significance of this level, whether it is optimal for health, and how it may be applicable for a population and for a subject. © 2014 Springer-Verlag.

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