EFSA Journal最新文献

The food additive vegetable carbon (E 153) was re-evaluated by the EFSA ANS Panel in 2012. During that re-evaluation, data gaps were identified, in particular with respect to impurities and particle characterisation. Following a European Commission call for data to address these gaps, one interested business operator (IBO) submitted analytical data on toxic elements, polycyclic aromatic hydrocarbons (PAHs) and particle size distribution of commercial samples of E 153. The present opinion deals with the assessment of the data provided by the IBO in response to the European Commission call. Based on the analytical data provided, the Panel concluded that the information on toxic elements supports a revision of the current EU specification limits for arsenic, cadmium, mercury and lead, and the introduction of a limit for aluminium. Regarding PAHs, the Panel assessed the risks associated with benzo[a]pyrene and PAH4 under several scenarios and concluded that the resulting margins of exposure (MOE) were above the level of concern but recommended lowering the current limit for benzo[a]pyrene and introducing a limit for PAH4 in the EU specifications for E 153. For what concerns the data on particle size distribution and morphology, the Panel considered that, due to methodological limitations, these data did not allow a full characterisation of the materials used as a food additive and did not adequately support an amendment of the specifications in relation to particle properties. Nevertheless, the Panel concluded that a fraction of small particles, including nanoparticles, is present in vegetable carbon (E 153) and noted that the substance is insoluble in water. Therefore, in line with the EFSA Guidance on Particles-TR, the Panel concluded that the risk assessment of E 153 performed by the EFSA ANS Panel in 2012 should be complemented with nanoscale considerations.

The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety assessment of the proposed use of pectin rich extract derived from Coffea arabica L. as a food additive. The proposed food additive consists of 70%–85% dietary fibres (of which the major part is pectin), 4%–6.5% proteins and substances of potential concern including caffeine, chlorogenic acid, ■■■■■, caffeic acid, ■■■■■, trigonelline. The Panel integrated all available information including existing EFSA evaluations on pectins, coffee fruit pulp, and conducted a new quantitative structure–activity relationship (QSAR) analysis for the substances of potential concern. Studies from literature confirmed that the pectins are not absorbed intact but extensively fermented by intestinal microbiota. No adverse effects were reported in two 90-day toxicity studies in rats up to 7.8 g/kg body weight (bw) per day and in one human study on sugar beet pectin at 0.2 g/kg bw per day for 4 weeks. The calculated MOE for ■■■■■ indicated that there is a low concern from a public health point of view. The Panel considered that the exposure to caffeine, caffeic acid, ■■■■■, chlorogenic acid, ■■■■■ and trigonelline from use of the proposed food additive would contribute only to a minimal increase over existing dietary exposure and is not of safety concern. Considering the composition of the proposed food additive, the absence of genotoxic concern of its components and lack of adverse effects of the major component (i.e. pectins), the Panel considered that there was no need for a numerical acceptable daily intake. The Panel concluded that the use of pectin-rich extract derived from Coffea arabica as a new food additive does not raise a safety concern at the proposed use and use levels.

Based on the need for a scientific basis for existing requirements in EU legislation on freezing of meat or for its possible amendment, the opinion compares microbial growth of relevant pathogenic, spoilage and indicator microorganisms within five scenarios of chilling, storage and defrosting of bovine, ovine and porcine meat, using predictive microbiology models that considered various conditions of temperature and, where possible, pH and a_w. Results obtained were compared to a reference scenario: storing meat at 7°C, aerobically, until 15 days post-slaughter. Storage of meat for 6 weeks, vacuum-packed immediately after stabilisation or 15 days post-slaughter, resulted in more growth of at least some of the bacteria assessed compared to the reference scenario, both at 3°C (certainty level 66%–90%) and at 7°C (certainty level 95%–99%). Predictions allowed estimating time at which equivalent microbial growth (i.e. ≤ 0.5 log₁₀ difference) to the reference scenario is reached (‘equivalence time’), assuming different initial contamination levels of relevant spoilage bacteria. When storing meat at 7°C, vacuum-packed immediately after stabilisation, equivalence time was determined by Salmonella and reached in 5–6 days of post-slaughter storage (certainty level 66%–90%). When storing meat at 3°C, equivalence time was determined by spoilage lactic acid bacteria and reached in 29–30 days post-slaughter (certainty level 66%–90%). However, when initial contamination with spoilage bacteria was high (e.g. 5 log₁₀ CFU/cm²), predicted spoilage levels of 7 log₁₀ CFU/cm² were reached after 15–16 days. When considering also expected growth during post-defrosting storage at 4°C for 7 days, equivalence times were of 5–6 days (unchanged) and 13–16 days, respectively, though meat would have to be frozen immediately after stabilisation when initial contamination with spoilage bacteria is high. Predicted levels of indicator microorganisms for verification are provided for different assumed initial contamination levels, representing examples to be further adjusted based on actual measurements in practical settings.

Genetically modified soybean GMB151 × DAS-44406-6 was developed by crossing to combine two single events: GMB151 and DAS-44406-6. The two-event stack soybean expresses the Cry14Ab-1, HPPD-4, PAT, AAD-12 and 2mEPSPS proteins to confer herbicide tolerance and resistance to plant parasitic nematodes. The GMO Panel previously assessed the two single soybean events and did not identify safety concerns. No new data on the single soybean events were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the two-event stack soybean does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that two-event stack soybean, as described in this application, is as safe as the comparator and non-GM reference soybean varieties tested and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of GM two-event stack soybean material into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean GMB151 × DAS-44406-6. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that two-event stack soybean is as safe as its comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.

The food enzyme aspergillopepsin I (EC 3.4.23.18) is produced with the non-genetically modified Aspergillus niger strain CCTCC M 2023234 by Suntaq International Limited. The food enzyme was free from viable cells of the production organism. The food enzyme is intended to be used in eight food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining seven food manufacturing processes. It was estimated to be up to 6.664 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 300. A search for the homology of the amino acid sequence of the aspergillopepsin I to known allergens was made and matches with two respiratory allergens and one injected allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

The qualified presumption of safety (QPS) process was developed to provide a harmonised safety assessment approach to support EFSA Scientific Panels and Units. The QPS approach assesses the taxonomic identity, body of relevant knowledge and safety of microorganisms intentionally added to the food and feed chain. Safety concerns identified for a taxonomic unit (TU) are, where possible, reflected by ‘qualifications’ that should be assessed at the strain level by EFSA's Scientific Panels. During the period covered by this Statement, no new information warranted changes to the status of previously recommended QPS TUs. The QPS list was updated to verify the correctness of the names and the completeness of synonyms. Of the 47 microorganisms notified to EFSA between April and September 2025 (28 as feed additives, 11 as food enzymes or additives, 6 as novel foods, none as plant protection products and 2 as food contact materials), 43 were not evaluated. These latter included 9 filamentous fungi and 9 Escherichia coli (all excluded from the QPS evaluation), and 25 already present on the QPS list. One of the other four notifications, Heyndrickxia faecalis (previously known as Weizmannia faecalis), had been assessed recently within this 3-years QPS cycle. The remaining 3 were assessed for a possible QPS status. Microchloropsis gaditana, Bacillus thermoamylovorans (both notified for the first time) and an additional TU, Aurantiochytrium acetophilum, not evaluated previously, which was included in response to an internal request. B. thermoamylovorans cannot be granted the QPS status due to the lack of body of knowledge. A. acetophilum cannot be granted the QPS status due to a limited body of knowledge. M. gaditana can be granted the QPS status with the qualification for ‘production purpose only’.

The qualified presumption of safety (QPS) process was developed to provide a harmonised safety assessment approach to support EFSA Scientific Panels and Units. The QPS approach assesses the taxonomic identity, body of relevant knowledge and safety concerns of microorganisms intentionally added to the food and feed chain. Safety concerns identified for a taxonomic unit (TU) are, where possible, reflected by ‘qualifications’ that should be assessed at the strain level by EFSA's Scientific Panels. In total, 340 notifications were received between October 2022 and September 2025, of which, 190 were of microorganisms used for the production of feed additives, 87 for the production of food enzymes, food additives and flavourings, 3 for food contact materials, 22 as Plant Protection Products (PPPs) and 38 for novel foods. Bacteriophages, previously ineligible for the QPS status, are now eligible at the species level. The QPS list has been updated in relation to the most recent taxonomic insights and the qualifications were revised and streamlined. A BIOHAZ Panel Statement on how to interpret the QPS qualification on ‘acquired antimicrobial resistance genes’ was published and revised; the qualification ‘for production purposes only’ was extended to production strains or biomass; the qualification on genetic modified microorganisms (GMMs) was also extended to production strains, biomass or active agents, when the gene of concern is removed. Since 2023, Chlamydomonas reinhardtii, Microchloropsis gaditana, Candida oleophila, Vibrio natriegens and Agrobacterium radiobacter were recommended for QPS status with the qualification for ‘production purposes only’. Clostridium tyrobutyricum also but with the qualification ‘absence of genetic determinants for toxin production’. Lacticaseibacillus huelsenbergensis and Lactobacillus paragasseri (formerly included in Lactobacillus gasseri) were also included. Bacillus sonorensis was also recommended with the qualifications ‘absence of bacitracin production ability’ and ‘absence of toxigenic activity’. Bacillus thuringiensis was not recommended for the QPS list due to safety concerns.

The Panel on Food Additives and Flavourings (FAF) of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No. 1565/2000. The present consideration concerns a group of 19 bicyclic secondary alcohols, ketones and related esters evaluated by JECFA at the 63rd meeting. This revision of FGE.87 is made due to new information on annual production volume, allowing the calculation of maximised survey-derived daily intake (MSDI) for 4,4a,5,6-tetrahydro-7-methylnaphthalen-2(3H)-one [FL-no: 07.136]. In addition, new data on uses and use levels for the substances [FL-no: 07.089, 07.0136, 07.153 and 07.159] have been provided and considered for the estimation of exposure (mTAMDI approach). For [FL-no: 07.136], the Panel agrees with the Procedure as applied by JECFA and with JECFA conclusion: ‘No safety concern at estimated levels of intake as flavouring substance’, when based on the MSDI approach. For the other 18 substances considered in FGE.87Rev3, the same conclusion was already drawn in FGE.87Rev2. For [FL-no: 07.136], the mTAMDI exposure estimate is below the TTC for structural class II substances. Accordingly, no further data are required in the context of the current evaluation programme. For [FL-no: 07.089, 07.153, 07.159], mTAMDI exposure estimates are above the TTC for structural class II substances; therefore, more reliable data on uses and use levels should be provided in order to refine the exposure assessment and to finalise their safety evaluation. For the remaining 15 substances, use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessments and to finalise the evaluation. Information on specifications for the materials of commerce is considered adequate for all 19 substances.