scispace - formally typeset
Search or ask a question
Author

Frederique Istace

Bio: Frederique Istace is an academic researcher from European Food Safety Authority. The author has contributed to research in topics: Risk assessment & Medicine. The author has an hindex of 11, co-authored 100 publications receiving 766 citations.

Papers published on a yearly basis

Papers
More filters
Journal ArticleDOI
TL;DR: The exclusion of filamentous fungi and enterococci from the QPS evaluations was reconsidered but monitoring will be maintained and the status will be re‐evaluated in the next QPS Opinion update.
Abstract: EFSA is requested to assess the safety of a broad range of biological agents in the context of notification for market authorisation as sources of food and feed additives, food enzymes and plant protection products. The qualified presumption of safety (QPS) assessment was developed to provide a harmonised generic pre-assessment to support safety risk assessments performed by EFSA's scientific Panels. The safety of unambiguously defined biological agents (at the highest taxonomic unit appropriate for the purpose for which an application is intended), and the completeness of the body of knowledge are assessed. Identified safety concerns for a taxonomic unit are, where possible and reasonable in number, reflected as ‘qualifications’ in connection with a recommendation for a QPS status. The list of QPS recommended biological agents was reviewed and updated in the current opinion and therefore becomes the valid list. The 2016 update reviews previously assessed microorganisms including bacteria, yeasts and viruses used for plant protection purposes following an Extensive Literature Search strategy. The taxonomic units related to the new notifications received since the 2013 QPS opinion, were periodically evaluated for a QPS status and the results published as Statements of the BIOHAZ Panel. Carnobacterium divergens, Lactobacillus diolivorans, Microbacterium imperiale, Pasteuria nishizawae, Pediococcus parvulus, Bacillus flexus, Bacillus smithii, Xanthomonas campestris and Candida cylindracea were recommended for the QPS list. All taxonomic units previously recommended for the 2013 QPS list had their status reconfirmed as well their qualifications with the exception of Pasteuria nishizawae for which the qualification was removed. The exclusion of filamentous fungi and enterococci from the QPS evaluations was reconsidered but monitoring will be maintained and the status will be re-evaluated in the next QPS Opinion update. Evaluation of bacteriophages should remain as a case-by-case procedure and should not be considered for QPS status.

329 citations

Journal ArticleDOI
TL;DR: The scientific basis of the glyphosate health assessment conducted within the European Union (EU) renewal process is presented, and the differences in the carcinogenicity assessment with IARC are explained.
Abstract: Glyphosate is the most widely used herbicide worldwide. It is a broad spectrum herbicide and its agricultural uses increased considerably after the development of glyphosate-resistant genetically modified (GM) varieties. Since glyphosate was introduced in 1974, all regulatory assessments have established that glyphosate has low hazard potential to mammals, however, the International Agency for Research on Cancer (IARC) concluded in March 2015 that it is probably carcinogenic. The IARC conclusion was not confirmed by the EU assessment or the recent joint WHO/FAO evaluation, both using additional evidence. Glyphosate is not the first topic of disagreement between IARC and regulatory evaluations, but has received greater attention. This review presents the scientific basis of the glyphosate health assessment conducted within the European Union (EU) renewal process, and explains the differences in the carcinogenicity assessment with IARC. Use of different data sets, particularly on long-term toxicity/carcinogenicity in rodents, could partially explain the divergent views; but methodological differences in the evaluation of the available evidence have been identified. The EU assessment did not identify a carcinogenicity hazard, revised the toxicological profile proposing new toxicological reference values, and conducted a risk assessment for some representatives uses. Two complementary exposure assessments, human-biomonitoring and food-residues-monitoring, suggests that actual exposure levels are below these reference values and do not represent a public concern.

251 citations

Journal ArticleDOI
TL;DR: In this paper , the EFSA Panel on Plant Protection Products and their Residue (PPR) developed a guidance document on Pesticide Exposure Assessment for workers, operators, residents and bystanders.
Abstract: Abstract This guidance is designed to assist risk assessors and applicants when quantifying potential non‐dietary, systemic exposures as part of regulatory risk assessment for plant protection products (PPPs). It is based on the Scientific Opinion on ‘Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and Bystanders’ developed by the EFSA Panel on Plant Protection Products and their Residue (PPR) in 2010. Highlighting some inconsistencies between the approaches adopted by regulatory authorities, the PPR Panel proposed a number of changes to the practices in use (i.e. use of deterministic methods for individual PPPs; need to perform an acute risk assessment for PPPs that are acutely toxic; use of appropriate percentile for acute or longer term risk assessments). In the first version of the guidance, issued in 2014, several scenarios for outdoor uses were included, with an annexed calculator, as well as recommendations for further research. The guidance has been updated in 2021 with the inclusion of additional scenarios and revision of default values, on the basis of the evaluation of additional evidence. To support users in performing the assessment of exposure and risk, an online calculator, reflecting the guidance content, has been further developed.

85 citations

Journal ArticleDOI
TL;DR: The peer review provided conclusions on whether exposure of humans to thiacloprid can be considered negligible, taking into account the European Commission's draft guidance on this topic.
Abstract: Abstract The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance thiacloprid are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of thiacloprid as an insecticide on oilseed rape foliar use and maize seed treatment. The peer review also provided conclusions on whether exposure of humans to thiacoprid can be considered negligible, taking into account the European Commission's draft guidance on this topic. Confirmatory data following the review of existing maximum residue levels (MRLs) according to Article 12 of Regulation (EC) No 396/2005 were also assessed in this conclusion. The reliable end points, appropriate for use in regulatory risk assessment are presented. An evaluation of data concerning the necessity of thiacloprid as an insecticide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods is presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

47 citations

Journal ArticleDOI
TL;DR: The conclusions were reached on the basis of the evaluation of the representative uses of copper compounds as a fungicide on grapes, tomatoes and cucurbits, and missing information identified as being required by the regulatory framework was listed.
Abstract: Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, France, and co‐rapporteur Member State, Germany, for the pesticide active substance copper compounds are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of copper compounds as a fungicide on grapes, tomatoes and cucurbits. The reliable end points appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

42 citations


Cited by
More filters
Journal ArticleDOI
TL;DR: This paper provides a review of available information and summarises the current knowledge on the effects of probiotics, prebiotics, and synbiotics on human health, and verified study results proving their efficacy in human nutrition are presented.
Abstract: The human gastrointestinal tract is colonised by a complex ecosystem of microorganisms. Intestinal bacteria are not only commensal, but they also undergo a synbiotic co-evolution along with their host. Beneficial intestinal bacteria have numerous and important functions, e.g., they produce various nutrients for their host, prevent infections caused by intestinal pathogens, and modulate a normal immunological response. Therefore, modification of the intestinal microbiota in order to achieve, restore, and maintain favourable balance in the ecosystem, and the activity of microorganisms present in the gastrointestinal tract is necessary for the improved health condition of the host. The introduction of probiotics, prebiotics, or synbiotics into human diet is favourable for the intestinal microbiota. They may be consumed in the form of raw vegetables and fruit, fermented pickles, or dairy products. Another source may be pharmaceutical formulas and functional food. This paper provides a review of available information and summarises the current knowledge on the effects of probiotics, prebiotics, and synbiotics on human health. The mechanism of beneficial action of those substances is discussed, and verified study results proving their efficacy in human nutrition are presented.

1,247 citations

Journal ArticleDOI
TL;DR: This review discussed classification, mechanisms, benefits and adverse effects of the pesticides on both human beings and the environment, and some remedial measures to mitigate their toxicity.

373 citations

Journal ArticleDOI
TL;DR: The identity, body of knowledge, safety concerns and antimicrobial resistance of valid taxonomic units were assessed and Lactobacillus animalis was a new taxonomic unit recommended to have the QPS status.
Abstract: Qualified presumption of safety (QPS) was developed to provide a generic safety evaluation for biological agents to support EFSA's Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance are assessed. Safety concerns identified for a taxonomic unit (TU) are where possible to be confirmed at strain or product level, reflected by 'qualifications'. No new information was found that would change the previously recommended QPS TUs and their qualifications. The list of microorganisms notified to EFSA was updated with 54 biological agents, received between April and September 2019; 23 already had QPS status, 14 were excluded from the QPS exercise (7 filamentous fungi, 6 Escherichia coli, Sphingomonas paucimobilis which was already evaluated). Seventeen, corresponding to 16 TUs, were evaluated for possible QPS status, fourteen of these for the first time, and Protaminobacter rubrum, evaluated previously, was excluded because it is not a valid species. Eight TUs are recommended for QPS status. Lactobacillus parafarraginis and Zygosaccharomyces rouxii are recommended to be included in the QPS list. Parageobacillus thermoglucosidasius and Paenibacillus illinoisensis can be recommended for the QPS list with the qualification 'for production purposes only' and absence of toxigenic potential. Bacillus velezensis can be recommended for the QPS list with the qualification 'absence of toxigenic potential and the absence of aminoglycoside production ability'. Cupriavidus necator, Aurantiochytrium limacinum and Tetraselmis chuii can be recommended for the QPS list with the qualification 'production purposes only'. Pantoea ananatis is not recommended for the QPS list due to lack of body of knowledge in relation to its pathogenicity potential for plants. Corynebacterium stationis, Hamamotoa singularis, Rhodococcus aetherivorans and Rhodococcus ruber cannot be recommended for the QPS list due to lack of body of knowledge. Kodamaea ohmeri cannot be recommended for the QPS list due to safety concerns.

347 citations

Journal ArticleDOI
TL;DR: Used mainly for maintenance of the equilibrium of the intestinal microbiota of livestock, probiotics, prebiotics and synbiotics turn out to be an effective method in fight against pathogens posing a threat for both animals and consumers.
Abstract: Along with the intensive development of methods of livestock breeding, breeders' expectations are growing concerning feed additives that would guarantee such results as accelerating growth rate, protection of health from pathogenic infections and improvement of other production parameters such as: absorption of feed and quality of meat, milk, eggs. The main reason for their application would be a strive to achieve some beneficial effects comparable to those of antibiotic-based growth stimulators, banned on 01 January 2006. High hopes are being associated with the use of probiotics, prebiotics and synbiotics. Used mainly for maintenance of the equilibrium of the intestinal microbiota of livestock, they turn out to be an effective method in fight against pathogens posing a threat for both animals and consumers. This paper discusses definitions of probiotics, prebiotics and synbiotics. Criteria that have to be met by those kinds of formulas are also presented. The paper offers a list of the most commonly used probiotics and prebiotics and some examples of their combinations in synbiotic formulas used in animal feeding. Examples of available study results on the effect of probiotics, prebiotics and synbiotics on animal health are also summarised.

332 citations

Journal ArticleDOI
TL;DR: This guidance document is intended to assist the applicant in the preparation and the presentation of an application for the authorisation of additives for use in animal nutrition and specifically covers the assessment of the safety for the target species.
Abstract: Draft Endorsed by the FEEDAP Panel 22 March 2017 Submitted for public consultation 6 April 2017 End of public consultation 31 May 2017 Adoption by the FEEDAP Panel 26 September 2017 Entry into force 1 May 2018 Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the safety for the target species.

314 citations