Guidance on the assessment of the safety of feed additives for the target species
Efsa Panel on Additives,Guido Rychen,Gabriele Aquilina,Giovanna Azimonti,Vasileios Bampidis,Maria de Lourdes Bastos,Georges Bories,Andrew Chesson,Pier Sandro Cocconcelli,Gerhard Flachowsky,Jürgen Gropp,Boris Kolar,Maryline Kouba,Marta López-Alonso,Secundino López Puente,Alberto Mantovani,Baltasar Mayo,Fernando Ramos,Maria Saarela,Roberto Edoardo Villa,Robert John Wallace,Pieter Wester,Montserrat Anguita,Jaume Galobart,Matteo Lorenzo Innocenti,Laura Martino +25 more
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TLDR
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.read more
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Guidance on the characterisation of microorganisms used as feed additives or as production organisms
Efsa Panel on Additives,Guido Rychen,Gabriele Aquilina,Giovanna Azimonti,Vasileios Bampidis,Maria de Lourdes Bastos,Georges Bories,Andrew Chesson,Pier Sandro Cocconcelli,Gerhard Flachowsky,Jürgen Gropp,Boris Kolar,Maryline Kouba,Marta López-Alonso,Secundino López Puente,Alberto Mantovani,Baltasar Mayo,Fernando Ramos,Maria Saarela,Roberto Edoardo Villa,Robert John Wallace,Pieter Wester,Boet Glandorf,Lieve Herman,Sirpa Kärenlampi,Jaime Aguilera,Montserrat Anguita,Rosella Brozzi,Jaume Galobart +28 more
TL;DR: 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.
Journal ArticleDOI
Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals
Simon J. More,Vasileios Bampidis,Diane Benford,Susanne Hougaard Bennekou,Claude Bragard,Thorhallur I. Halldorsson,Antonio F Hernandez-Jerez,Konstantinos Koutsoumanis,Hanspeter Naegeli,Josef Rudolf Schlatter,Vittorio Silano,Søren Saxmose Nielsen,Dieter Schrenk,Dominique Turck,Maged Younes,Emilio Benfenati,Laurence Castle,Nina Cedergreen,Anthony Hardy,Ryszard Laskowski,Jean-Charles Leblanc,Andreas Kortenkamp,Ad M.J. Ragas,Leo Posthuma,Claus Svendsen,Roland Solecki,Emanuela Testai,Bruno Dujardin,George E.N. Kass,Paola Manini,Maryam Zare Jeddi,Jean Lou Cm Dorne,Christer Hogstrand +32 more
TL;DR: This Guidance document describes harmonised risk assessment methodologies for combined exposure to multiple chemicals for all relevant areas within EFSA's remit, i.e. human health, animal health and ecological areas.
Journal ArticleDOI
Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment.
Simon J. More,Vasileios Bampidis,Diane Benford,Claude Bragard,Thorhallur I. Halldorsson,Antonio F Hernandez-Jerez,Susanne Hougaard Bennekou,Kostas Koutsoumanis,Kyriaki Machera,Hanspeter Naegeli,Søren Saxmose Nielsen,Josef Rudolf Schlatter,Dieter Schrenk,Vittorio Silano,Dominique Turck,Maged Younes,Ursula Gundert-Remy,George E.N. Kass,Juliane Kleiner,Anna Maria Rossi,Rositsa Serafimova,Linda Reilly,Heather M. Wallace +22 more
TL;DR: The TTC approach should not be used for substances for which EU food/feed legislation requires the submission of toxicity data or when sufficient data are available for a risk assessment or if the substance under consideration falls into one of the exclusion categories.
Journal ArticleDOI
Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health.
Simon J. More,Vasileios Bampidis,Diane Benford,Claude Bragard,Thorhallur I. Halldorsson,Antonio F Hernandez-Jerez,Susanne Hougaard Bennekou,Kostas Koutsoumanis,Claude Lambré,Kyriaki Machera,Hanspeter Naegeli,Søren Saxmose Nielsen,Josef Rudolf Schlatter,Dieter Schrenk,Vittorio Silano,Dominique Turck,Maged Younes,Jacqueline Castenmiller,Qasim Chaudhry,Francesco Cubadda,Roland Franz,David Michael Gott,Jan Mast,Alicja Mortensen,Agnes G. Oomen,Stefan Weigel,Eric Barthélémy,Ana Rincón,Jose Tarazona,Reinhilde Schoonjans +29 more
TL;DR: The EFSA has updated the guidance on nano risk assessment (SC Guidance on Nano-RA), which has taken account of relevant scientific studies that provide insights to physico-chemical properties, exposure assessment and hazard characterisation of nanomaterials and areas of applicability as discussed by the authors.
Journal ArticleDOI
Metabolism and pharmacokinetics of pharmaceuticals in cats (Felix sylvestris catus) and implications for the risk assessment of feed additives and contaminants.
TL;DR: This paper aims to assess the scientific basis and validity of the UF for inter-species differences in kinetics and the extra UF applied for cats through a comparison of kinetic parameters between rats and cats for 30 substrates of phase I and phase II metabolism.
References
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Book
Generalized Linear Models
Peter McCullagh,John A. Nelder +1 more
TL;DR: In this paper, a generalization of the analysis of variance is given for these models using log- likelihoods, illustrated by examples relating to four distributions; the Normal, Binomial (probit analysis, etc.), Poisson (contingency tables), and gamma (variance components).
Journal ArticleDOI
Generalized Linear Models
TL;DR: This is the rst book on generalized linear models written by authors not mostly associated with the biological sciences, and it is thoroughly enjoyable to read.
Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA 1 Opinion of the Scientific Committee
Sue Barlow,Andrew Chesson,John Dan Collins,Erik Dybing,Albert Flynn,Claudia Fruijtier,Anthony Hardy,Ada Knaap,Jan Schans,Vittorio Silano,Staffan Skerfving +10 more
TL;DR: In this article, a system was proposed for a pre-market safety assessment of selected groups of microorganisms leading to a "Qualified Presumption of Safety (QPS)", which is based on four pillars (establishing identity, body of knowledge, possible pathogenicity and end use).
Journal ArticleDOI
Scientific Opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA
Antonia Ricci,Ana Allende,Declan Bolton,Marianne Chemaly,Robert Davies,Rosina Girones,Lieve Herman,Konstantinos Koutsoumanis,Roland Lindqvist,Birgit Nørrung,Lucy J. Robertson,Giuseppe Ru,Moez Sanaa,Marion Simmons,Panagiotis N. Skandamis,Emma Snary,Niko Speybroeck,Benno H. ter Kuile,John Threlfall,Helene Wahlström,Pier Sandro Cocconcelli,Günter Klein,Miguel Prieto Maradona,Amparo Querol,Luísa Peixe,Juan E. Suárez,Ingvar Sundh,Just M. Vlak,Margarita Aguilera-Gómez,Fulvio Barizzone,Rosella Brozzi,Sandra Correia,Leng Heng,Frederique Istace,Christopher Lythgo,Pablo Salvador Fernández Escámez +35 more
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.
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