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

Draft for internal testing Scientific Committee guidance on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments.

EFSA requested its Scientific Committee to prepare a guidance document on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments. The guidance document provides an introduction to epidemiological studies and illustrates the typical biases of the different epidemiological study designs. It describes key epidemiological concepts relevant for evidence appraisal. Regarding study reliability, measures of association, exposure assessment, statistical inferences, systematic error and effect modification are explained. Regarding study relevance, the guidance describes the concept of external validity. The principles of appraising epidemiological studies are illustrated, and an overview of Risk of Bias (RoB) tools is given. A decision tree is developed to assist in the selection of the appropriate Risk of Bias tool, depending on study question, population and design. The customisation of the study appraisal process is explained, detailing the use of RoB tools and assessing the risk of bias in the body of evidence. Several examples of appraising experimental and observational studies using a Risk of Bias tool are annexed to the document to illustrate the application of the approach. This document constitutes a draft that will be applied in EFSA's assessments during a 1-year pilot phase and be revised and complemented as necessary. Before finalisation of the document, a public consultation will be launched

Update of the risk assessment of hexabromocyclododecanes (HBCDDs) in food

Panel members: Margherita Bignami, Laurent Bodin, James Kevin Chipman, Jesus del Mazo, BettinaGrasl-Kraupp, Christer Hogstrand, Laurentius (Ron) Hoogenboom, Jean-Charles Leblanc, Carlo StefanoNebbia, Elsa Nielsen, Evangelia Ntzani, Annette Petersen, Salomon Sand, Dieter Schrenk, TanjaSchwerdtle, Christiane Vleminckx and Heather Wallace Requestor: European Commission Question number: EFSA‐Q‐2018‐00433 Acknowledgements: The Panel wishes to thank the hearing experts: Cathy Fernandes and Henri Schroeder, and EFSA staff members: Kelly Niermans and Federico Cruciani, for the support provided to this scientific output. The Panel wishes to acknowledge all European competent institutions and Member State bodies that provided consumption and occurrence data for this scientific output. Data: All annexes on occurrence and exposure data, as well as the protocol used to produce this Scientific opinion, cross‐referenced in the text, are available on the EFSA Knowledge Junction at: https://doi.org/10.5281/zenodo.4475651Peer reviewedPublisher PD

Assessing the health status of managed honeybee colonies (HEALTHY-B): a toolbox to facilitate harmonised data collection

Tools are provided to assess the health status of managed honeybee colonies by facilitating further harmonisation of data collection and reporting, design of field surveys across the European Union (EU) and analysis of data on bee health. The toolbox is based on characteristics of a healthy managed honeybee colony: an adequate size, demographic structure and behaviour; an adequate production of bee products (both in relation to the annual life cycle of the colony and the geographical location); and provision of pollination services. The attributes ‘queen presence and performance’, ‘demography of the colony’, ‘in-hive products’ and ‘disease, infection and infestation’ could be directly measured in field conditions across the EU, whereas ‘behaviour and physiology’ is mainly assessed through experimental studies. Analysing the resource providing unit, in particular land cover/use, of a honeybee colony is very important when assessing its health status, but tools are currently lacking that could be used at apiary level in field surveys across the EU. Data on ‘beekeeping management practices’ and ‘environmental drivers’ can be collected via questionnaires and available databases, respectively. The capacity to provide pollination services is regarded as an indication of a healthy colony, but it is assessed only in relation to the provision of honey because technical limitations hamper the assessment of pollination as regulating service (e.g. to pollinate wild plants) in field surveys across the EU. Integrating multiple attributes of honeybee health, for instance, via a Health Status Index, is required to support a holistic assessment. Examples are provided on how the toolbox could be used by different stakeholders. Continued interaction between the Member State organisations, the EU Reference Laboratory and EFSA is required to further validate methods and facilitate the efficient use of precise and accurate bee health data that are collected by many initiatives throughout the EU

Guidance on aneugenicity assessment

The EFSA Scientific Committee was asked to provide guidance on the most appropriate in vivo tests to follow up on positive in vitro results for aneugenicity, and on the approach to risk assessment for substances that are aneugenic but not clastogenic nor causing gene mutations. The Scientific Committee confirmed that the preferred approach is to perform an in vivo mammalian erythrocyte micronucleus test with a relevant route of administration. If this is positive, it demonstrates that the substance is aneugenic in vivo. A negative result with evidence that the bone marrow is exposed to the test substance supports a conclusion that aneugenic activity is not expressed in vivo. If there is no evidence of exposure to the bone marrow, a negative result is viewed as inconclusive and further studies are required. The liver micronucleus assay, even though not yet fully validated, can provide supporting information for substances that are aneugenic following metabolic activation. The gastrointestinal micronucleus test, conversely, to be further developed, may help to assess aneugenic potential at the initial site of contact for substances that are aneugenic in vitro without metabolic activation. Based on the evidence in relation to mechanisms of aneugenicity, the Scientific Committee concluded that, in principle, health-based guidance values can be established for substances that are aneugenic but not clastogenic nor causing gene mutations, provided that a comprehensive toxicological database is available. For situations in which the toxicological database is not sufficient to establish health-based guidance values, some approaches to risk assessment are proposed. The Scientific Committee recommends further development of the gastrointestinal micronucleus test, and research to improve the understanding of aneugenicity to support risk assessment

Re-evaluation of the existing health-based guidance values for copper and exposure assessment from all sources

Copper is an essential micronutrient and also a regulated product used in organic and in conventional farming pest management. Both deficiency and excessive exposure to copper can have adverse health effects. In this Scientific Opinion, the EFSA 2021 harmonised approach for establishing health-based guidance values (HBGVs) for substances that are regulated products and also nutrients was used to resolve the divergent existing HBGVs for copper. The tightly regulated homeostasis prevents toxicity manifestation in the short term, but the development of chronic copper toxicity is dependent on copper homeostasis and its tissue retention. Evidence from Wilson disease suggests that hepatic retention is indicative of potential future and possibly sudden onset of copper toxicity under conditions of continuous intake. Hence, emphasis was placed on copper retention as an early marker of potential adverse effects. The relationships between (a) chronic copper exposure and its retention in the body, particularly the liver, and (b) hepatic copper concentrations and evidence of toxicity were examined. The Scientific Committee (SC) concludes that no retention of copper is expected to occur with intake of 5 mg/day and established an Acceptable Daily Intake (ADI) of 0.07 mg/kg bw. A refined dietary exposure assessment was performed, assessing contribution from dietary and non-dietary sources. Background copper levels are a significant source of copper. The contribution of copper from its use as plant protection product (PPP), food and feed additives or fertilisers is negligible. The use of copper in fertilisers or PPPs contributes to copper accumulation in soil. Infant formula and follow-on formula are important contributors to dietary exposure of copper in infants and toddlers. Contribution from non-oral sources is negligible. Dietary exposure to total copper does not exceed the HBGV in adolescents, adults, elderly and the very elderly. Neither hepatic copper retention nor adverse effects are expected to occur from the estimated copper exposure in children due to higher nutrient requirements related to growth

Safety assessment of titanium dioxide (E171) as a food additive

Acknowledgements: The Panel wishes to thank the following for the support provided to this scientific output: Ana Campos Fernandes, Laura Ciccolallo, Esraa Elewa, Galvin Eyong, Christina Kyrkou, Irene Munoz, Giorgia Vianello, the members of the SCER Cross-cutting WG nanotechnologies: Jacqueline Castenmiller, Mohammad Chaudhry, Roland Franz, David Gott, Stefan Weigel and the former member of the SCER Cross-cutting WG Genotoxicity Maciej Stepnik. The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.Peer reviewedPublisher PD

Update of the risk assessment of hexabromocyclododecanes (HBCDDs) in food: Occurrence data in food submitted to EFSA and dietary exposure assessment for humans

Annex A – Protocol for the risk assessments for human health related to the presence of brominated flame retardants (BFRs) in food The Annex is provided as a separate pdf file containing the risk assessment protocol selected by the CONTAM Panel to update the previous risk assessments of brominated flame retardants (BFRs) in food. Annex B: Occurrence data on HBCDDs in food submitted to EFSA and dietary surveys per country and age group available in the EFSA Comprehensive Database, considered in the exposure assessment Table B.1 Number of analytical results excluded from the initial dataset during data cleaning, and justification for exclusion Table B.2 Occurrence values of HBCDDs calculated total (µg/kg) by food category in the final dataset Table B.3 Food categories of FoodEx and mean LB and UB values as used for the exposure assessment Table B.4 Dietary surveys and the number of subjects by country and population class, available for the chronic exposure assessment, in the EFSA Comprehensive European Food Consumption Database Table B.5 Summary statistics on data reported for HBCDDs total, analysed with GC-MS, not considered for the exposure Figure B.1 Frequency distribution of the occurrence values for the food categories of interest at the LB without zeros presented on a log 10 scale Figure B.2 Frequency distribution of the occurrence values for the food categories of interest at the UB presented on a log 10 scale HBCDDs_Raw_Occurrence_Data.CSV contains the raw occurrence dataset on Hexabromocyclododecanes (HBCDDs) contaminant as extracted from EFSA DWH in December 2019 on 2530 food samples presented in the opinion as described in its section 3.2.1. Occurrence data submitted to EFSA. The data is provided in .csv format. This dataset is compliant with EFSA SSD model and contains two additional columns documenting issues identified in the cleaning process (column: issue) and the action taken (column: outcome) to address the issue (e.g. delete record or update values in specific fields). The link to the catalogues of controlled terminologies can be found under "Related identifiers”. Annex D: Chronic dietary exposure to HBCDDs and the contribution of different food groups to the dietary exposure Table D.1 Mean chronic dietary exposure (ng/kg b.w. per day) to HBCDDs for total population across European dietary surveys Table D.2 95th percentile chronic exposures to HBCDDs (ng/kg b.w. per day) for total population for each dietary survey across age classes Table D.3 Relative contribution (%) of food categories to the LB and UB estimates of dietary exposure to HBCDDs across different age classes, dietary surveys and countries Table D.4 Relative contribution of food categories to the LB estimates of dietary exposure to HBCDDs and related figure Table D.5 Relative contribution of food categories to the UB estimates of dietary exposure to HBCDDs and related figure Annex E – Outcome of the Public consultation on the Update of the risk assessment of hexabromocyclododecanes (HBCDDs) in food The Annex is provided as a separate pdf file contain the outcome of the public consultation of the draft scientific Opinion, including the comments received and how they were taken into account when finalising the scientific OpinionPeer reviewe