EFSA Journal最新文献

This report by the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring and surveillance activities carried out in 2024 in 27 Member States (MSs), the United Kingdom (Northern Ireland) and eight non-MSs, according to the Zoonoses Directive 2003/99/EC. Key statistics on zoonoses and zoonotic agents in humans, food, animals and feed are provided and interpreted historically. In 2024, the first and second most reported zoonoses in humans were campylobacteriosis and salmonellosis, respectively, followed by Shiga toxin-producing Escherichia coli (STEC) infections. Listeriosis was the fourth and most severe zoonotic disease, with the highest percentage of hospitalisations and the highest case fatality rate. The number of cases reported in the last 5 years showed a significant increasing trend in campylobacteriosis, salmonellosis, listeriosis and STEC infections. Fourteen MSs and the United Kingdom (Northern Ireland) met all targets for reducing Salmonella prevalence in poultry populations for the relevant serovars. Salmonella samples from various animal carcases, and samples for Campylobacter quantification in broiler carcases, were more frequently positive when carried out by the competent authorities than with food business operators' own checks. Twenty-seven MSs and the United Kingdom (Northern Ireland) reported more food-borne outbreaks, cases and hospitalisations in 2024 than in 2023, although the number of deaths decreased. Salmonella in 'eggs and egg products' was the agent/food pair of most concern. Salmonella was also the causative agent associated with the majority of multi-country outbreaks reported in the EU in 2024. Foods of non-animal origin, and in particular 'vegetables and other products thereof', caused the largest number of deaths in strong-evidence outbreaks. This report also provides updates on brucellosis, echinococcosis, trichinellosis, tuberculosis due to Mycobacterium bovis, rabies as well as other zoonotic bacteria, viruses and parasites in food and animals.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of FlorEquilibre® Chien when used as a zootechnical additive (functional group: gut flora stabilisers) for dogs. The product under assessment is based on viable cells of Lactobacillus acidophilus CNCM I-3231, Ligilactobacillus salivarius CNCM I-3233, Lactiplantibacillus plantarum CNCM I-3232, Lacticaseibacillus rhamnosus CNCM I-4427 and Bifidobacterium animalis subsp. lactis CNCM I-3993. L. acidophilus CNCM I-3231, L. salivarius CNCM I-3233, L. plantarum CNCM I-3232 and L. rhamnosus CNCM I-4427 are considered by EFSA to be suitable for the qualified presumption of safety approach. The identity of these strains was established, and no acquired antimicrobial resistance genes were detected. Therefore, the FEEDAP Panel concluded that the use of these four strains is presumed safe for the target species and the environment. However, the Panel notes that the use of B. animalis subsp. lactis CNCM I-3993 represents a safety concern for the target species, the users and the environment because the strain harbours an acquired antimicrobial resistance gene. The Panel concluded that the additive is eye irritant, and a skin and respiratory sensitiser. Exposure via any route is considered a risk. Based on the data provided, the Panel is not in the position to conclude on the efficacy of the additive for dogs.

Following the submission of dossier GMFF-2023-21251 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the drought tolerant genetically modified maize MON 87460, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize MON 87460 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2023-21251 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 87460.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of a feed additive consisting of zeolites (≥ 50%) as a technological feed additive for poultry for fattening or reared for laying/reproduction. In 2024, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of the same additive. The Panel concluded that the use of the additive containing zeolites (≥ 50%) in animal nutrition is safe for the consumers and for the environment, and efficacious as an anticaking agent in feed for all animal species. The additive was not considered skin irritant. No conclusion could be reached on the eye irritancy and the respiratory and dermal sensitisation. Due to the dusting potential and its crystalline silica content, the additive was considered a risk by inhalation. In the current assessment, analytical data provided suggests that the inclusion of zeolites (≥ 50%) in poultry feed may interfere with the determination of aflatoxin B1. Regarding the target species, no conclusion could be drawn for poultry for fattening or reared for laying/reproduction. Based on the tolerance studies in chickens for fattening evaluated in the current assessment, the Panel concluded that the inclusion of zeolites (≥ 50%) at 12,500 mg/kg complete feed is safe for chickens for fattening or reared for laying/reproduction. No conclusion could be established on other poultry for fattening or reared for laying/reproduction.

Genetically modified cotton GHB614 × T304-40 × GHB119 × COT102 was developed by crossing to combine four single events: GHB614, T304-40, GHB119 and COT102. The four-event-stack cotton expresses 2mEPSPS, Cry1Ab, Cry2Ae, Vip3Aa19 and PAT/bar to confer herbicide tolerance and insect resistance. Furthermore, event COT102 expresses the antimicrobial APH4 protein used during its molecular development. The GMO Panel previously assessed the four single cotton events and did not identify safety concerns. Since then, no new data on the single cotton events were identified that would require 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 does not indicate interactions which would give rise to new food and feed safety and nutritional concerns. The GMO Panel concludes that the four-event stack cotton, as described in this application, is as safe as its non-GM comparator and non-GM cotton varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of release of processed cotton GHB614 × T304-40 × GHB119 × COT102 or accidental spillage of viable GM cotton seeds 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 cotton GHB614 × T304-40 × GHB119 × COT102. The GMO Panel concludes that four-event stack cotton is as safe as its non-GM comparator and the tested non-GM cotton varieties with respect to potential effects on human and animal health and the environment.

Genetically modified maize DP202216 × NK603 × DAS 40278-9 was developed by crossing to combine three single events: DP202216, NK603 and DAS-40278-9. The three-event stack maize expresses PAT, CP4 EPSPS, CP4 EPSPS L124P, AAD-1 and the maize endogenous protein with altered expression (EPAE) ZMM28 to confer herbicide tolerance and to provide the potential for yield enhancement (PYE) under field conditions. The GMO Panel previously assessed the three single maize events and one of the sub-combinations and did not identify safety concerns. No new data on the single maize events or the assessed sub-combination 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 maize events and of the newly expressed proteins and the EPAE in the three-event stack maize does not give rise to food and feed safety or nutritional concerns. The GMO Panel concludes that three-event stack maize, as described in this application, is as safe as the non-GM comparator and non-GM reference varieties tested and no post-market monitoring of food/feed is considered necessary. In the case of the release of processed maize DP202216 × NK603 × DAS 40278-9 or accidental spillage of viable GM maize grains, into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in two of the maize sub-combinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed sub-combination and the three-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP202216 × NK603 × DAS 40278-9. The GMO Panel concludes that this three-event stack maize and its sub-combinations are as safe as its non-GM comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.

Genetically modified cotton T304-40 × GHB119 × COT102 was developed by crossing to combine three single events: T304-40, GHB119 and COT102. The three-event stack cotton expresses Cry1Ab, Cry2Ae, Vip3Aa19 and PAT/bar to confer herbicide tolerance and insect resistance. Furthermore, event COT102 expresses the antimicrobial APH4 protein used during its molecular development. The GMO Panel previously assessed the three single cotton events and did not identify safety concerns. Since then, no new data on the single cotton events were identified that would require 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 does not indicate interactions which would give rise to new food and feed safety and nutritional concerns. The GMO Panel concludes that three-event stack cotton, as described in this application, is as safe as its non-GM comparator and non-GM cotton varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of release of processed cotton T304-40 × GHB119 × COT102 or accidental spillage of viable GM cotton seeds, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton T304-40 × GHB119 × COT102. The GMO Panel concludes that three-event stack cotton is as safe as its non-GM comparator and the tested non-GM cotton varieties with respect to potential effects on human and animal health and the environment.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of the Novel Food (NF) ‘algal meal from Haematococcus (H.) pluvialis containing astaxanthin (ATX)’ pursuant to Regulation (EU) 2015/2283. The NF is produced by homogenising, crushing and spray-drying of the biomass of cultivated H. pluvialis and contains approximately 5% w/w ATX. It has been marketed in food supplements (FS) since the 90s. With the present dossier, the applicant seeks authorisation as a NF for its use in dairy analogues, including beverage whiteners and fruit juices as defined by Directive 2001/112/EC. The NF has been already assessed by the Panel in 2014. The applicant performed an intake assessment for ATX, which covered combined exposure from the background diet with the consumption of fish and crustacea plus intakes of the NF from the intended new uses. In such a scenario, the exposure for all population groups is below or at the acceptable daily intake (ADI) of 0.2 mg/kg bw per day. When adding also potential intake of ATX from FS, for children of 3 years of age and older and adolescents, the combined exposure from all three sources exceeds the ADI. For adults, the combined estimated intake is at the level of the ADI. The Panel concludes that the NF is safe at the intended new uses (dairy analogues, including beverage whiteners and fruit juices), provided that FS containing ATX are not consumed on the same day by children and adolescents.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on egg membrane collagen peptides as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is derived from farmed chicken eggs. It is produced by enzymatic hydrolysis, and it contains 15%–30% collagen peptides. The production process is sufficiently described and does not raise safety concerns. The applicant proposed to market the NF for use in food supplements for adults, excluding pregnant and lactating women, at a maximum daily dose of 500 mg. Taking into account the nature of the NF, the compositional data and information on the production process, the Panel considers that no toxicological studies are required for the NF. The Panel concludes that the NF, egg membrane collagen peptides, is safe under the proposed conditions of use.