Report from the BfR expert hearing on practicability of hormonal measurements: recommendations for experimental design of toxicological studies with integrated hormonal end points

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Coverage of endangered species in environmental risk assessments at EFSA

The EFSA performs environmental risk assessment (ERA) for single potential stressors such as plantprotection products, genetically modified organisms and feed additives, and for invasive alien speciesthat are harmful to plant health. This ERA focusses primarily on the use or spread of such potentialstressors in an agricultural context, but also considers the impact on the wider environment. It isimportant to realise that the above potential stressors in most cases contribute a minor proportion ofthe total integrated pressure that ecosystems experience. The World Wildlife Fund listed the relativeattribution of threats contributing to the declines in animal populations as follows: 37% fromexploitation (fishing, hunting, etc.), 31% habitat degradation and change, 13% from habitat loss, 7%from climate change, and only 5% from invasive species, 4% from pollution and 2% from disease. Inthis scientific opinion, the Scientific Committee gathered scientific knowledge on the extent of coverageof endangered species in current ERA schemes that fall under the remit of EFSA. The legal basis andthe relevant ecological and biological features used to classify a species as endangered areinvestigated. The characteristics that determine vulnerability of endangered species are reviewed.Whether endangered species are more at risk from exposure to potential stressors than other non-target species is discussed, but specific protection goals for endangered species are not given. Due toa lack of effect and exposure data for the vast majority of endangered species, the reliability of usingdata from other species is a key issue for their ERA. This issue and other uncertainties are discussedwhen reviewing the coverage of endangered species in current ERA schemes. Potential tools, such aspopulation and landscape modelling and trait-based approaches, for extending the coverage ofendangered species in current ERA schemes, are explored and reported

Scientific principles for the identification of endocrine-disrupting chemicals: a consensus statement

Endocrine disruption is a specific form of toxicity, where natural and/or anthropogenic chemicals, known as "endocrine disruptors" (EDs), trigger adverse health effects by disrupting the endogenous hormone system. There is need to harmonize guidance on the regulation of EDs, but this has been hampered by what appeared as a lack of consensus among scientists. This publication provides summary information about a consensus reached by a group of world-leading scientists that can serve as the basis for the development of ED criteria in relevant EU legislation. Twenty-three international scientists from different disciplines discussed principles and open questions on ED identification as outlined in a draft consensus paper at an expert meeting hosted by the German Federal Institute for Risk Assessment (BfR) in Berlin, Germany on 11-12 April 2016. Participants reached a consensus regarding scientific principles for the identification of EDs. The paper discusses the consensus reached on background, definition of an ED and related concepts, sources of uncertainty, scientific principles important for ED identification, and research needs. It highlights the difficulty in retrospectively reconstructing ED exposure, insufficient range of validated test systems for EDs, and some issues impacting on the evaluation of the risk from EDs, such as non-monotonic dose-response and thresholds, modes of action, and exposure assessment. This report provides the consensus statement on EDs agreed among all participating scientists. The meeting facilitated a productive debate and reduced a number of differences in views. It is expected that the consensus reached will serve as an important basis for the development of regulatory ED criteria

Antimikrobielle Produkte im Haushalt – eine Betrachtung zu Auswirkungen auf Gesundheit und Umwelt sowie zum Nutzen für den Anwender

Desinfektionsmittel für Oberflächen und Wäsche, auch für den häuslichen Gebrauch, zählen zu den Biozidprodukten und unterliegen damit der Biozid-Gesetzgebung. Gegenwärtig am Markt verfügbare Produkte sind weder behördlich bewertet noch zugelassen, sondern lediglich bei der Bundesanstalt für Arbeitsschutz und Arbeitsmedizin gemeldet, da die Prüfung der enthaltenen Wirkstoffe im Rahmen des europäischen Bewertungsverfahrens bezüglich ihrer toxikologischen und umwelttoxikologischen Eigenschaften sowie hinsichtlich ihrer Wirksamkeit noch nicht abgeschlossen ist. Aufgrund von Übergangsregelungen dürfen diese Biozidprodukte derzeit zulassungsfrei auf dem Markt verbleiben. Folglich werden für die Auslobung der Wirksamkeit von Desinfektionsmitteln, eingeschlossen Produkte für den Haushalt, im Rahmen des Zulassungsverfahrens derzeit noch keine spezifischen Nachweise gefordert. Ebenso liegen bis zur Zulassung Angaben, z. B. auf dem Etikett, zu toxikologisch oder umweltrelevanten Auswirkungen im Ermessen des Herstellers bzw. Vertreibers. Der Nutzen von Desinfektionsmitteln für den Haushalt ist gegenwärtig nicht belegbar. Nicht auszuschließen sind dagegen Risiken für den Anwender, für unbeteiligte Personen, für die Umwelt und bezüglich einer möglichen Resistenzbildung bei unsachgemäßer Anwendung. Diese Risiken werden erst durch die im Zulassungsverfahren angelegten Bewertungsmaßstäbe verringert werden. Liegen keine medizinischen Indikationen für die Anwendung von Desinfektionsmitteln vor, vermeidet man Risiken, indem einfache mechanische Reinigungsverfahren zum Einsatz kommen. Gesundheitliche Risiken durch Mikroorganismen sind in einem regelmäßig gereinigten Haushalt nicht zu befürchten, vorausgesetzt die Grundregeln der Hygiene werden beachtet.Disinfectants for surfaces and clothes, including those for private domestic use, are considered biocidal products and are within the scope of the biocidal products regulatory framework. Due to the ongoing assessment of toxicological and environmental properties as well as of the efficacy of biocidal active substances at EU level, the disinfectants currently available on the market Prohave neither been evaluated nor nationally authorised as biocidal products up to now. They are, however, notified at the Federal Institute for Occupational Safety and Health. Due to transitional provisions these biocidal products can currently be marketed without authorisation. Hence, disinfectants including products for domestic use do not yet require specific evidence for their efficacy claims within the framework of biocidal product authorisation. In addition, until authorisation it is at the discretion of the manufacturer or the distributor to provide information on toxicological or environmental effects on the label. The benefit of the use of disinfectant biocidal products in domestic areas has so far not been proven. On the other hand, it must be assumed that the inappropriate use of non-approved disinfectants in domestic areas might result in risks for operators, bystanders like children and the environment as well as possible resistance development. These risks will be minimised during the evaluation that takes place when these products are authorised. If there is no medical indication for the use of disinfectants, risks for the user, for third persons or the environment can be avoided by using simple mechanical cleaning procedures. Health risks from microorganisms are highly unlikely in households that are regularly cleaned using basic hygiene rules

Guidance on setting of acute reference dose (ARfD) for pesticides

Abstract This paper summarises and extends the work developed over the last decade by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) for acute health risk assessment of agricultural pesticides. The general considerations in setting of acute reference doses (ARfDs) in a step-wise process, as well as specific considerations and guidance regarding selected toxicological endpoints are described in detail. The endpoints selected are based on the practical experience with agricultural pesticides by the JMPR and are not a comprehensive listing of all possible relevant endpoints. Haematotoxicity, immunotoxicity, neurotoxicity, liver and kidney toxicity, endocrine effects as well as developmental effects are taken into account as acute toxic alerts, relevant for the consideration of ARfDs for pesticides. The general biological background and the data available through standard toxicological testing for regulatory purposes, interpretation of the data, conclusions and recommendations for future improvements are described for each relevant endpoint. The paper also considers a single dose study protocol. This type of study is not intended to be included in routine toxicological testing for regulatory purposes, but rather to guide further testing when the current database indicates the necessity for an ARfD but does not allow a reliable derivation of the value

OECD/EFSA workshop on developmental neurotoxicity (DNT) : The use of non-animal test methods for regulatory purposes

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Risk profile related to production and consumption of insects as food and feed

The present opinion has the format of a risk profile and presents potential biological and chemical hazards as well as allergenicity and environmental hazards associated with farmed insects used as food and feed taking into account of the entire chain, from farming to the final product. The opinion also addresses the occurrence of these hazards in non-processed insects, grown on different substrate categories, in comparison to the occurrence of these hazards in other non-processed sources of protein of animal origin. When currently allowed feed materials are used as substrate to feed insects, the possible occurrence of microbiological hazards is expected to be comparable to their occurrence in other non-processed sources of protein of animal origin. The possible occurrence of prions in non-processed insects will depend on whether the substrate includes protein of human or ruminant origin. Data on transfer of chemical contaminants from different substrates to the insects are very limited. Substrates like kitchen waste, human and animal manure are also considered and hazards from insects fed on these substrates need to be specifically assessed. It is concluded that for both biological and chemical hazards, the specific production methods, the substrate used, the stage of harvest, the insect species and developmental stage, as well as the methods for further processing will all have an impact on the occurrence and levels of biological and chemical contaminants in food and feed products derived from insects. Hazards related to the environment are expected to be comparable to other animal production systems. The opinion also identifies the uncertainties (lack of knowledge) related to possible hazards when insects are used as food and feed and notes that there are no systematically collected data on animal and human consumption of insects. Studies on the occurrence of microbial pathogens of vertebrates as well as published data on hazardous chemicals in reared insects are scarce. Further data generation on these issues are highly recommended