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EFSA Strategy 2027 outlines the need for fit-for-purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the ?Draft framework for protocol development for EFSA's scientific assessments? published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and sub-questions is proposed: the ?APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross-cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub-questions, including uncertainty analysis. Five possible approaches to answering individual (sub-)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi-formal or formal expert knowledge elicitation processes; using mathematical/statistical models; and ? not covered in this g

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

EFSA Strategy 2027 outlines the need for fit-for-purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the 'Draft framework for protocol development for EFSA's scientific assessments' published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and sub-questions is proposed: the 'APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross-cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub-questions, including uncertainty analysis. Five possible approaches to answering individual (sub-)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi-formal or formal expert knowledge elicitation processes; using mathematical/statistical models; and - not covered in this g

The need for reliable, sensitive (developmental) neurotoxicity testing of chemicals has steadily increased. Given the limited capacities for routine testing according to accepted regulatory guidelines, there is potential risk to human health and the environment. Most toxicity studies are based on mammalian test systems, which have been questioned for low sensitivity, limited relevance for humans, and animal welfare considerations. This increased the need for alternative models, one of which is the zebrafish (Danio rerio) embryo. This study assessed selected neonicotinoids at sub-lethal concentrations for their effects on embryonic development and behavior. The fish embryo acute toxicity test (OECD TG 236) determined the lowest observable effective concentrations, which were used as the highest test concentrations in subsequent behavioral assays. In the FET test, no severe compound-induced sublethal effects were seen at < 100 µM. In the coiling assay, exposure to ≥ 1.25 µM nicotine (positive control) affected both the burst duration and burst count per minute, whereas ≥ 50 µM thiacloprid affected the mean burst duration. Exposure to ≥ 50 µM acetamiprid and imidacloprid induced significant alterations in both mean burst duration and burst count per minute. In the swimming assay, 100 µM acetamiprid induced alterations in the frequency and extent of movements, whilst nicotine exposure only induced non-significant changes. All behavioral changes could be correlated to findings in mammalian studies. Given the quest for alternative test methods of (developmental) neurotoxicity, zebrafish embryo behavior testing could be integrated into a future tiered testing scheme.

EFSA's aim by 2030, is that the Agency and its partners will be equipped for the routine implementation of human health risk assessment to multiple chemicals, across EFSA's domains of activity. To facilitate this effort, a roadmap for action has been developed by mapping the methods, data and tools that are currently available for mixture risk assessment and identifying current scientific gaps including challenges and blockers. The results shows that extensive methods, data and tools are available for dietary mixture risk assessment for pesticides, but that several scientific gaps still exist for the non-dietary mixture exposure to pesticides. For food additives and for certain contaminants, the regulatory readiness for mixture risk assessment was also found to be fairly high compared to food contact materials and cross-silo mixture risk assessment. The scientific gaps identified were prioritised according to their impact on the implementation of mixture risk assessment and, as a result, ten multi-annual project proposals were defined to address these scientific gaps on the short-term, mid-term and long-term. The roadmap also proposes and prioritises a number of working areas in the regulatory domains of pesticides, food contact materials, contaminants, food additives, as well as in the overarching domain of chemicals. Besides the scientific proposals, recommendations to improve stakeholder engagement and communication on mixture risk assessment was investigated. These included, among others, creating an online catalogue of tools, methods and data for mixture risk assessment, as well as the organisation of regular webinars/workshop to promote exchange of information between stakeholders and making more efficient use of national communication hubs for food safety in communicating with the general public.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af en prøve af en færdigret indeholdende nudler med restindhold af ethylenoxid (sum) på 0,26 mg/kg, krydderipulver med restindhold af ethylenoxid (sum) på 0,16 mg/kg og tørre grøntsager med restindhold af ethylenoxid (sum) på 12,0 mg/kg.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af en prøve indeholdende nudler med restindhold af ethylenoxid (sum) på 0,08 mg/kg og grønsagsmix med restindhold af ethylenoxid (sum) på 1,1 mg/kg.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,046 mg/kg af bifenthrin i en prøve af hvidløgsblade. MRL er 0,01* mg/kg.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,21 mg/kg af chlorpyrifos, 0,61 mg/kg af tau-fluvalinat og 0,14 mg/kg af deltamethrin i en prøve af kvæder. MRL er 0,01* mg/kg for chlorpyrifos, 0,3 mg/kg for tau-fluvalinat og 0,1 mg/kg fordeltamethrin.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 2,14 mg/kg af carbendazim og 5,03 mg/kg af metalaxyl i en prøve af basilikum. MRL er 0,1* mg/kg for carbendazim og 3 mg/kg for metalayl.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et batch byggræs med restindhold af ethylenoxid (sum) på henholdsvis 786 mg/kg og 1090 mg/kg. Det pågældende batch er anvendt i kosttilskud, der også ønskes en risikovurdering af.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af is med indhold af to emulgatorer, guargum og johannesbrødkernemel med et restindhold af ethylenoxid (sum) på henholdsvis 0,28 mg/kg og 3,0 mg/kg.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et kosttilskud med restindhold af ethylenoxid (sum) på 416 mg/kg.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,011 mg/kg af propiconazol, 0,106 mg/kg af thiamethoxam og 0,116 mg/kg af tricyclazol i en prøve af ris. MRL er 0,01* mg/kg for alle stoffer.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,074 mg/kg af thiamethoxam og 0,055 mg/kg af tricyclazol i en prøve af ris. MRL er 0,01* mg/kg for begge stoffer.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,778 mg/kg af carbendazim i en prøve af chilipeber. MRL er 0,01* mg/kg.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af ris protein indhold af ethylenoxid (sum) på højst 38,4 mg/kg.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,011 mg/kg af carbendazim, 0,016 mg/kg af hexaconazol, 0,013 mg/kg af propiconazol, 0,049 mg/kg af thiamethoxam og 0,14 mg/kg af tricyclazol i en prøve af ris. MRL er 0,01* mg/kg for alle stoffer.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,011 mg/kg af carbendazim i en prøve af ris. MRL er 0,01* mg/kg.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af to prøver af lakridspulver, begge med restindhold af matrine på 0,52 mg/kg.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af marcipanæg med indhold af lakridspulver med restindhold af matrine på 0,020 mg/kg.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af en prøve af emulgator med et restindhold af ethylenoxid (sum) på 0,5 mg/kg. Emulgatoren er anvendt i is, som der også ønskes en risikovurdering af.

Fødevarestyrelsen har forespurgt DTU Fødevareinstituttet om evt. eksisterende tilgængelig toksikologisk viden på de to ovenstående stoffer matrine og oxymatrine. Stofferne er blevet klassificeret som pesticider i EU med virkning fra 2021, men har ikke været ansøgt eller godkendt hidtil. FVST har efterfølgende sendt relevant information omhandlende ovenstående stoffer indsendt i forbindelse med et EU-møde i 2022, som DTU bl.a. har anvendt til opdatering af notatet. Den nye relevante information består af German Risk Assessment (udført af konsulentfirmaet RDA Scientific Consultant GmbH) samt en NL Risk Assessment (dossier fra firmaet Ruitenberg). BfR (Federal Institute for Risk Assessment) har på opfordring indsendt valide kommentarer på DTU notat/vurdering af 3. maj 2022 samt indsendt yderligere oplysninger herunder information om igangsættelse af de manglende forsøg til afdækning af det genotoksiske potentiale for matrine. BfR forventer at disse forsøg forlægger slut 2022. DTU's vurdering af 3. maj 2022 er revideret på denne baggrund. Ingen originale studierapporter for forsøgene (herunder OECD guideline forsøg) har været tilgængelige for DTU, hvorfor vurderingen alene er baseret på informationen angivet i artiklerne og resume af studier heri. På den baggrund kan DTU ikke verificere compliance med OECD TG og GLP.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,22 mg/kg af chlorpyrifos og 0,093 mg/kg af iprodion i en prøve af grønne rosiner. MRL er 0,01* mg/kg for begge stoffer.

Following a mandate from the European Commission, EFSA has developed a Guidance on Technical Requirements (Guidance on Particle-TR), defining the criteria for assessing the presence of a fraction of small particles, and setting out information requirements for applications in the regulated food and feed product areas (e.g. novel food, food/feed additives, food contact materials and pesticides). These requirements apply to particles requiring specific assessment at the nanoscale in conventional materials that do not meet the definition of engineered nanomaterial as set out in the Novel Food Regulation (EU) 2015/2283. The guidance outlines appraisal criteria grouped in three sections, to confirm whether or not the conventional risk assessment should be complemented with nanospecific considerations. The first group addresses solubility and dissolution rate as key physicochemical properties to assess whether consumers will be exposed to particles. The second group establishes the information requirements for assessing whether the conventional material contains a fraction or consists of small particles, and its characterisation. The third group describes the information to be presented for existing safety studies to demonstrate that the fraction of small particles, including particles at the nanoscale, has been properly evaluated. In addition, in order to guide the appraisal of existing safety studies, recommendations for closing the data gaps while minimising the need for conducting new animal studies are provided. This Guidance on Particle-TR complements the Guidance on risk assessment of nanomaterials to be applied in the food and feed chain, human and animal health updated by the EFSA Scientific Committee as co-published with this Guidance. Applicants are advised to consult both guidance documents before conducting new studies.

Read-across approaches are considered key in moving away from in vivo animal testing towards addressing data-gaps using new approach methods (NAMs). Ample successful examples are still required to substantiate this strategy. Here we present and discuss the learnings from two OECD IATA endorsed read-across case studies. They involve two classes of pesticides - rotenoids and strobilurins - each having a defined mode-of-action that is assessed for its neurological hazard by means of an AOP-based testing strategy coupled to toxicokinetic simulations of human tissue concentrations. The endpoint in question is potential mitochondrial respiratory chain mediated neurotoxicity, specifically through inhibition of complex I or III. An AOP linking inhibition of mitochondrial respiratory chain complex I to the degeneration of dopaminergic neurons formed the basis for both cases but was deployed in two different regulatory contexts. The two cases also exemplify several different read-across concepts: analogue versus category approach, consolidated versus putative AOP, positive versus negative prediction (i.e., neurotoxicity versus low potential for neurotoxicity), and structural versus biological similarity. We applied a range of NAMs to explore the toxicodynamic properties of the compounds, e.g., in silico docking as well as in vitro assays and readouts - including transcriptomics - in various cell systems, all anchored to the relevant AOPs. Interestingly, although some of the data addressing certain elements of the read-across were associated with high uncertainty, their impact on the overall read-across conclusion remained limited. Coupled to the elaborate regulatory review that the two cases underwent, we propose some generic learnings of AOP-based testing strategies supporting read-across.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af guar gummi med restindhold af ethylenoxid på 0,360 mg/kg.

Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af karrysaucemix med indhold af ethylenoxid på 11,7 mg/kg.

This guidance document provides harmonised and flexible methodologies to apply scientific criteria and prioritisation methods for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals. In the context of EFSA’s risk assessments, the problem formulation step defines the chemicals to be assessed in the terms of reference usually through regulatory criteria often set by risk managers based on legislative requirements. Scientific criteria such as hazard-driven criteria can be used to group these chemicals into assessment groups. In this guidance document, a framework is proposed to apply hazard-driven criteria for grouping of chemicals into assessment groups using mechanistic information on toxicity as the gold standard where available (i.e. common mode of action or adverse outcome pathway) through a structured weight of evidence approach. However, when such mechanistic data are not available, grouping may be performed using a common adverse outcome. Toxicokinetic data can also be useful for grouping, particularly when metabolism information is available for a class of compounds and common toxicologically relevant metabolites are shared. In addition, prioritisation methods provide means to identify low-priority chemicals and reduce the number of chemicals in an assessment group. Prioritisation methods include combined risk-based approaches, risk-based approaches for single chemicals and exposure-driven approaches. Case studies have been provided to illustrate the practical application of hazard-driven criteria and the use of prioritisation methods for grouping of chemicals in assessment groups. Recommendations for future work are discussed.

Next generation risk assessment (NGRA) is an exposure-led, hypothesis-driven approach that has the potential to support animal-free safety decision-making. However, significant effort is needed to develop and test the in vitro and in silico (computational) approaches that underpin NGRA to enable confident application in a regulatory context. A workshop was held in Montreal in 2019 to discuss where effort needs to be focussed and to agree on the steps needed to ensure safety decisions made on cosmetic ingredients are robust and protective. Workshop participants explored whether NGRA for cosmetic ingredients can be protective of human health, and reviewed examples of NGRA for cosmetic ingredients. From the limited examples available, it is clear that NGRA is still in its infancy, and further case studies are needed to determine whether safety decisions are sufficiently protective and not overly conservative. Seven areas were identified to help progress application of NGRA, including further investments in case studies that elaborate on scenarios frequently encountered by industry and regulators, including those where a 'high risk' conclusion would be expected. These will provide confidence that the tools and approaches can reliably discern differing levels of risk. Furthermore, frameworks to guide performance and reporting should be developed.