EFSA Supporting Publications最新文献

This Mock assessment is a part of the Framework Partnership Agreement between ANSES and EFSA with the help of RIVM to investigate the feasibility of a tiered approach proposed by EFSA for prospective acute cumulative risk assessment (CRA). Three tiers address successively a need for prospective CRA (Tier 0), the safety of the MRL (Tier I) and the safety of the intended GAP (Tier II). ANSES tested this approach with an application for change of MRL for the active substance tefluthrin (with acute effects on functional alterations of the motor division) on carrot based on a new intended use. For each tier, the Margin of Exposure (MOE) was calculated for 9 populations with MCRA software using input data provided by EFSA. At P99.9 of exposure, all the adjusted MOET at Tier I and Tier II of all populations were below the threshold of 100. Different settings were tested (IESTI equation, consumption data, adjustment for uncertainties, cycle of monitoring data…). With respect to Tier I, the trigger value of 1000 for the MOE_{Tier 0} is pragmatic. In the vast majority of cases, when the MOE_{Tier 0} is above 1000, the MOET_{Tier I} would be above 100. With respect to Tier II, a MOE_{Tier 0} higher than 1000 ensures a MOET_{Tier II} above 100. Tier I could be considered a good first estimate for a prospective CRA with conservative parameters for the foreground. Two routes were tested to account for uncertainties. One was not possible. The second resulted in a new median multiplicative factor (MF)_{exposure*toxicology} of 2.82 that differs significantly from the value of 5.13 found in the retrospective assessment. Despite the simplifications envisaged, the uncertainty analysis seems difficult to be implemented on a routine basis and it might be useful to define criteria to identify cases where an uncertainty analysis is really needed.

There is currently no comprehensive feed consumption database using a harmonised feed classification system. This means there is a lack of accurate information on the individual amount of feed consumed daily by farmed and companion animals. Such a database would support exposure assessments of feed. This report provides a complete overview of the main feed databases, their structure, and how feed materials are classified. It highlights their limits and potential and reports any differences from FoodEx2. A proposal for future updates of FoodEx2 and the development of a comprehensive feed consumption model database is provided. The proposed model database is based on three information areas represented by three Excel sheets. These represent Animal, Feed, and Consumption, allowing the determination of animal dietary exposure. A proof of concept of the developed model database was carried out by performing two case studies focused on genetically modified feed and feed contaminants. For genetically modified feed, a reduced animal dietary exposure was obtained compared to estimations reported in the scientific opinions and obtained using Excel calculators proposed by EFSA. For the contaminants in feed, differences were limited, resulting in slightly higher or lower exposure values. Weaknesses and possible mitigations are also addressed, and recommendations are made for a comprehensive feed consumption database. These include recommendations establishing an EU classification system in which the main features and items reported in the European Catalogue of Feed Materials are harmonised with FoodEx2. It is also recommended that real-life animal consumption data are collected by the feed industry, animal nutritionists, breeders, and farmers, along with the collaboration of stakeholders.

This Mock assessment is a part of the Framework Partnership Agreement between ANSES and EFSA with the help of RIVM to investigate the feasibility of a tiered approach proposed by EFSA for prospective chronic cumulative risk assessment (CRA). Three tiers address successively (i) a need for prospective CRA (Tier 0) using a deterministic approach to estimate the foreground exposure based on IEDI equation, (ii) a first estimation of prospective CRA (Tier I) using a probabilistic approach to estimate the background exposure at P99.9 and a deterministic approach to estimate the foreground exposure at mean or P97.5 consumption and (iii) a second estimation of prospective CRA (Tier II) using a probabilistic approach to estimate the background and foreground exposure at P99.9. ANSES tested this approach with an MRL application for the active substance fenamidone (with chronic effects on the thyroid) on lettuce, based on a new intended use currently under assessment at national level. For each Tier, the Margin of Exposure (MOE) was calculated for 9 populations with MCRA software using input data provided by EFSA and settings according to EFSA protocol. Different combinations of settings were tested as part of sensitivity analyses (consumption data, adjustment for additional uncertainties, cycle of monitoring data, etc.) and were used as the basis for discussion of different open points (trigger value in Tier 0, use frequency for the focal combination in tier II, ad hoc uncertainty analysis to account for additional uncertainties, etc.) to be addressed before prospective CRA could be implemented as a routine exercise. Finally, based on these discussions, recommendations were made to consolidate the approach for chronic prospective CRA.

This report evaluates the thyroid-related effects of various active substances and metabolites, categorizing them into Cumulative Assessment Groups (CAGs) based on indicators of hypothyroidism and C-cell effects. 21 active substances and six metabolites were scrutinized resulting in 18 substances and three metabolites for hypothyroidism (CAG-TCF) and two substances for C-cell hypertrophy, hyperplasia, and neoplasia (CAG-TCP). Detailed NOAEL and LOAEL values were derived for each substance, highlighting differences between current findings and previous assessments. The analysis reveals uncertainties due to variations in data quality and study durations. Overall, the report provides a comprehensive hazard characterization of substances affecting thyroid function, contributing to cumulative risk assessment update for effects on the thyroid.

In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission has requested the European Food Safety Authority (EFSA) to organise a stakeholder consultation on the reasoned opinions for the following active substances, non-approved for use as plant protection products in the European Union: azocyclotin, bifenthrin, chlorfenapyr, cyhexatin, diazinon, dicofol, endosulfan, fenarimol, fenpropathrin and profenofos. This technical report presents the outcome of the consultation, an appraisal of the data received and a conclusion on whether a reconsideration of the previous assessments will be needed based on the additional data collected.

Plenty of new approach methodologies (NAMs) for risk assessment have been developed but only some are included in OECD Test Guidelines (TGs) for regulatory implementation. Nevertheless, NAMs are increasingly applied, e.g. for nanomaterial (NM) risk assessments. The EFSA Guidance on NM risk assessment suggests that NAM-derived data concerning degradation/dissolution (in relevant biofluids), intestinal uptake/crossing, genotoxicity, cytotoxicity, oxidative stress, (pro-)inflammatory potential and barrier integrity, for many of which no OECD TGs exist, have to be evaluated first. Consequently, NM risk assessments involve data from non-guideline studies, requiring time-consuming and challenging case-by-case evaluations. Establishing an OECD TG is a formal process aiming for international use according to the Mutual Acceptance of Data (MAD). However, not every promising NAM can be prioritised for OECD TGs. A qualification, based on an expert opinion, may enable an efficient use of adequate NAMs for a specific context-of-use. Furthermore, it supports the optimisation of promising NAMs for regulatory applications. Existing qualification systems operate in the context of e.g., drug development tools (FDA) and research and development into pharmaceuticals (EMA). The NAMS4NANO consortium was tasked to propose a generic framework for a qualification system for chemical risk assessment in the food and feed sector to speed up the regulatory use of NAMs. Here we describe our proposal including the process and evaluation criteria. A detailed test method description, preferably as standard operating procedures (SOPs), describing the set-up of the NAM including its application and evaluation phase is crucial. Furthermore, the scientific validity, i.e. its reliability and relevance for the context-of-use, needs to be demonstrated, for which we suggest a less rigorous process compared to OECD TGs. We propose to initially establish a qualification system for NM risk assessment, aligned with the EFSA framework. This document is an interim version to stipulate a broader discussion among experts and stakeholders.

New Approach Methodologies (NAMs), broadly understood to include in silico, in chemico, in vitro and ex vivo methods, show great potential in advancing risk assessment albeit their regulatory implementation is lagging. The EFSA Guidance on risk assessment of nanomaterials (EFSA Guidance on Nano-RA) suggests nano-specific risk assessment is best achieved through Integrated Approaches to Testing and Assessment (IATAs) with NAMs as the first choice to generate new information. Integrating NAMs in risk assessment promises several advantages such as a better human focus, more detailed insights into molecular mechanisms and a higher efficacy. However, applying NAMs to NMs also poses considerable challenges such as issues related to dispersion stability, dosimetry, agglomeration, dissolution, transformations or assay interferences. Significant efforts are being undertaken by standardisation organisations and research projects to establish various NAMs for NMs. Here a thorough review is provided covering NAMs that will be potentially useful for risk assessment of NMs in the food and feed sector. It follows the structure of the EFSA Guidance on Nano-RA and expands it, where needed, to support decision-making in selection of NAMs for NM risk assessment. The review begins with an overview on nano-specific NAM-frameworks, followed by a description of individual NAMs including those relevant to NM physicochemical characterisation, exposure and hazard assessment covering toxicodynamics and toxicokinetics. The focus is on NAMs concerning NM degradation/dissolution, genotoxicity, cytotoxicity, oxidative stress, (pro-)inflammation, and barrier integrity as those are important endpoints for initial screening according to the EFSA framework. As a result, in total 267 individual nano-relevant NAMs, mostly “not validated” (with a few notable exceptions), were included in this review. Validation notwithstanding, NAMs could already prove relevant and reliable for risk assessment of NMs, especially in integrated approaches.

Hexane (called ‘technical hexane’ in this report) is authorised for use as an extraction solvent in the production of foodstuffs and food ingredients under Directive 2009/32/EC. Following a request from the European Commission, EFSA assessed the need for a re-evaluation of its safety, which was addressed by the Scientific Committee on Food (SCF) in 1996. To this end, EFSA focused on the composition of technical hexane, its established and potential toxicological adverse effects and the potential exposure of consumers. Technical hexane is defined in the Directive as ‘a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64°C and 70°C’. Specifications, including the identity and fraction of constituents, are not defined. n-Hexane is reported to be the main constituent. Impurities may be of concern, as they may be transferred to the extracted food, depending on their physicochemical properties and the extraction procedure. An exposure assessment based on regulatory limits showed that the exposure of infants, toddlers and other children may be higher than that considered by the SCF. Regarding genotoxicity, EFSA reiterated the absence of concern. The information provided by the 90-day study in rats considered by the SCF was no longer considered sufficient to adequately conclude on the safety of technical hexane. Moreover, as n-hexane is absorbed in humans, additional toxicity studies exploring more end points may be needed. A scoping literature search showed that recent toxicological information on the safety of technical hexane is available, although its relevance was not appraised during this activity. EFSA concluded that there is a need for a re-evaluation of the safety of the use of technical hexane as an extraction solvent in the production of foodstuffs and food ingredients.

EFSA was asked by the European Commission to provide scientific and technical assistance on the evaluation of human-identical milk oligosaccharides (HiMOs) as novel foods (NFs). In recent years, the number of authorisations of HiMOs as NFs has markedly increased, which may lead to situations of multiple concurrent uses. Since the safety assessment of HiMOs is based on the comparison with the ‘natural’ intake of human milk oligosaccharides (HMOs), i.e. the HMO intake from human milk in exclusively breastfed infants, a scoping literature review was outsourced to update the database of mean concentrations of single and total HMOs in human milk, and relevant HMO intakes were thus updated. It is noted that in infants up to 16 weeks of age exclusively fed with infant formula, when adding all the assessed HiMOs at their highest maximum use levels across production methods, the resulting highest daily intakes of single HiMOs and the sum of HiMOs are within the natural HMO intake range. These intakes were also estimated (DietEx) for the most exposed population groups (i.e., infants and young children) considering the highest maximum use levels in those food categories with the highest contribution to the overall HiMO intake (i.e., infant and follow-on formulae, ready-to-eat meals, yoghurt and cow milk). The resulting highest P95 daily HiMO intakes were unlikely to be higher than the highest mean daily HMO intakes. However, any possible higher intake would not necessarily imply a safety concern since such natural intake estimates represent an upper end of average natural intakes. It can be concluded that currently there are no safety concerns resulting from the authorised or assessed HiMO intakes from their concurrent combined uses. Nonetheless, in consideration of the increased interest in the use of HiMOs as NFs, a simplified but realistic approach for the intake assessment is proposed in the case of new HiMOs or extensions of use of already authorised HiMOs.

The main objectives of EFSA's activities on emerging risks encompass: (i) conducting activities to identify emerging risks; (ii) developing and improving emerging risk identification (ERI) methodologies and approaches; and (iii) communicating identified issues and risks. The outcome of these activities equips EFSA to anticipate forthcoming challenges in the continuously evolving landscape of risk assessment. EFSA networks of knowledge contributing to the emerging risks identification activity include the Emerging Risks Exchange Network (EREN), the Stakeholder Discussion Group on Emerging Risks (StaDG-ER), EFSA's scientific units, the scientific panels, the Scientific Committee and their working groups. The current technical report summarises the activities of all groups involved in the emerging risk identification procedure, the issues identified in the course of 2022, the emerging risk identification methodologies being developed, and the collaborative activities. In total, 13 potential emerging issues were discussed in 2022 and two were concluded to be emerging risks. The potential issues were classified according to the hazard. The year 2022 marks a turn in EFSA's activities on emerging risk identification. To achieve strategic objective no. 2 ‘Ensure preparedness for future risks analysis needs’ of the EFSA Strategy 2027, a new process ‘Environmental scanning and strategic options definition’ has been developed. The process adds to the already existing emerging risks analysis workflow a second workflow that is more forward-looking, to deal with horizon scanning in the areas of food and feed safety, plant health and animal health. Similarly to the emerging risks analysis workflow, the new workflow for horizon scanning strongly relies on partnership to be prepared for future challenges, build resilience, and proactively shape the future in a one-health approach.