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Abstract Surveillance data published since 2010, although limited, showed that there is no evidence of zoonotic parasite infection in market quality Atlantic salmon, marine rainbow trout, gilthead seabream, turbot, meagre, Atlantic halibut, common carp and European catfish. No studies were found for greater amberjack, brown trout, African catfish, European eel and pikeperch. Anisakis pegreffii, A. simplex (s. s.) and Cryptocotyle lingua were found in European seabass, Atlantic bluefin tuna and/or cod, and Pseudamphistomum truncatum and Paracoenogonimus ovatus in tench, produced in open offshore cages or flow‐through ponds or tanks. It is almost certain that fish produced in closed recirculating aquaculture systems (RAS) or flow‐through facilities with filtered water intake and exclusively fed heat‐treated feed are free of zoonotic parasites. Since the last EFSA opinion, the UV‐press and artificial digestion methods have been developed into ISO standards to detect parasites in fish, while new UV‐scanning, optical, molecular and OMICs technologies and methodologies have been developed for the detection, visualisation, isolation and/or identification of zoonotic parasites in fish. Freezing and heating continue to be the most efficient methods to kill parasites in fishery products. High‐pressure processing may be suitable for some specific products. Pulsed electric field is a promising technology although further development is needed. Ultrasound treatments were not effective. Traditional dry salting of anchovies successfully inactivated Anisakis. Studies on other traditional processes – air‐drying and double salting (brine salting plus dry salting) – suggest that anisakids are successfully inactivated, but more data covering these and other parasites in more fish species and products is required to determine if these processes are always effective. Marinade combinations with anchovies have not effectively inactivated anisakids. Natural products, essential oils and plant extracts, may kill parasites but safety and organoleptic data are lacking. Advanced processing techniques for intelligent gutting and trimming are being developed to remove parasites from fish.

Abstract Between October 2021 and September 2022 Europe has suffered the most devastating highly pathogenic avian influenza (HPAI) epidemic with a total of 2,520 outbreaks in poultry, 227 outbreaks in captive birds, and 3,867 HPAI virus detections in wild birds. The unprecedent geographical extent (37 European countries affected) resulted in 50 million birds culled in affected establishments. In the current reporting period, between 10 September and 2 December 2022, 1,163 HPAI virus detections were reported in 27 European countries in poultry (398), captive (151) and wild birds (613). A decrease in HPAI virus detections in colony‐breeding seabirds species and an increase in the number of detections in waterfowl has been observed. The continuous circulation of the virus in the wild reservoir has led to the frequent introduction of the virus into poultry populations. It is suspected that waterfowl might be more involved than seabirds in the incursion of HPAI virus into poultry establishments. In the coming months, the increasing infection pressure on poultry establishments might increase the risk of incursions in poultry, with potential further spread, primarily in areas with high poultry densities. The viruses detected since September 2022 (clade 2.3.4.4b) belong to eleven genotypes, three of which have circulated in Europe during the summer months, while eight represent new genotypes. HPAI viruses were also detected in wild and farmed mammal species in Europe and North America, showing genetic markers of adaptation to replication in mammals. Since the last report, two A(H5N1) detections in humans in Spain, one A(H5N1), one A(H5N6) and one A(H9N2) human infection in China as well as one A(H5) infection without NA‐type result in Vietnam were reported, respectively. The risk of infection is assessed as low for the general population in the EU/EEA, and low to medium for occupationally exposed people.

Abstract The 2021–2022 highly pathogenic avian influenza (HPAI) epidemic season is the largest HPAI epidemic so far observed in Europe, with a total of 2,467 outbreaks in poultry, 47.7 million birds culled in the affected establishments, 187 outbreaks in captive birds, and 3,573 HPAI virus detections in wild birds with an unprecedent geographical extent reaching from Svalbard islands to South Portugal and Ukraine, affecting 37 European countries. Between 11 June and 9 September 2022, 788 HPAI virus detections were reported in 16 European countries in poultry (56), captive (22) and wild birds (710). Several colony‐breeding seabird species exhibited widespread and massive mortality from HPAI A(H5N1) virus along the northwest coast of Europe. This resulted in an unprecedentedly high level of HPAI virus detections in wild birds between June and August 2022 and represents an ongoing risk of infection for domestic birds. HPAI outbreaks were still observed in poultry from June to September with five‐fold more infected premises than observed during the same period in 2021 and mostly distributed along the Atlantic coast. Response options to this new epidemiological situation include the definition and rapid implementation of suitable and sustainable HPAI mitigation strategies such as appropriate biosecurity measures and surveillance strategies for early detection in the different poultry production systems. The viruses currently circulating in Europe belong to clade 2.3.4.4b with seven genotypes, three of which identified for the first time during this time period, being detected during summer. HPAI A(H5) viruses were also detected in wild mammal species in Europe and North America and showed genetic markers of adaptation to replication in mammals. Since the last report, two A(H5N6), two A(H9N2) and one A(H10N3) human infections were reported in China. The risk of infection is assessed as low for the general population in the EU/EEA, and low to medium for occupationally exposed people.

Abstract The 2021–2022 highly pathogenic avian influenza (HPAI) epidemic season is the largest epidemic so far observed in Europe, with a total of 2,398 outbreaks in poultry, 46 million birds culled in the affected establishments, 168 detections in captive birds, and 2,733 HPAI events in wild birds in 36 European countries. Between 16 March and 10 June 2022, 1,182 HPAI virus detections were reported in 28 EU/EEA countries and United Kingdom in poultry (750), and in wild (410) and captive birds (22). During this reporting period, 86% of the poultry outbreaks were secondary due to between‐farm spread of HPAI virus. France accounted for 68% of the overall poultry outbreaks, Hungary for 24% and all other affected countries for less than 2% each. Most detections in wild birds were reported by Germany (158), followed by the Netherlands (98) and the United Kingdom (48). The observed persistence of HPAI (H5) virus in wild birds since the 2020–2021 epidemic wave indicates that it may have become endemic in wild bird populations in Europe, implying that the health risk from HPAI A(H5) for poultry, humans, and wildlife in Europe remains present year‐round, with the highest risk in the autumn and winter months. Response options to this new epidemiological situation include the definition and the rapid implementation of suitable and sustainable HPAI mitigation strategies such as appropriate biosecurity measures and surveillance strategies for early detection measures in the different poultry production systems. Medium to long‐term strategies for reducing poultry density in high‐risk areas should also be considered. The results of the genetic analysis indicate that the viruses currently circulating in Europe belong to clade 2.3.4.4b. HPAI A(H5) viruses were also detected in wild mammal species in Canada, USA and Japan, and showed genetic markers of adaptation to replication in mammals. Since the last report, four A(H5N6), two A(H9N2) and two A(H3N8) human infections were reported in China and one A(H5N1) in USA. The risk of infection is assessed as low for the general population in the EU/EEA, and low to medium for occupationally exposed people.

Abstract Between 9 December 2021 and 15 March 2022, 2,653 highly pathogenic avian influenza (HPAI) virus detections were reported in 33 EU/EEA countries and the UK in poultry (1,030), in wild (1,489) and in captive birds (133). The outbreaks in poultry were mainly reported by France (609), where two spatiotemporal clusters have been identified since October 2021, followed by Italy (131), Hungary (73) and Poland (53); those reporting countries accounted together for 12.8 of the 17.5 million birds that were culled in the HPAI affected poultry establishments in this reporting period. The majority of the detections in wild birds were reported by Germany (767), the Netherlands (293), the UK (118) and Denmark (74). HPAI A(H5) was detected in a wide range of host species in wild birds, indicating an increasing and changing risk for virus incursion into poultry farms. The observed persistence and continuous circulation of HPAI viruses in migratory and resident wild birds will continue to pose a risk for the poultry industry in Europe for the coming months. This requires the definition and the rapid implementation of suitable and sustainable HPAI mitigation strategies such as appropriate biosecurity measures, surveillance plans and early detection measures in the different poultry production systems. The results of the genetic analysis indicate that the viruses currently circulating in Europe belong to clade 2.3.4.4b. Some of these viruses were also detected in wild mammal species in the Netherlands, Slovenia, Finland and Ireland showing genetic markers of adaptation to replication in mammals. Since the last report, the UK reported one human infection with A(H5N1), China 17 human infections with A(H5N6), and China and Cambodia 15 infections with A(H9N2) virus. The risk of infection for the general population in the EU/EEA is assessed as low, and for occupationally exposed people, low to medium.

Abstract Following a request from five European Nordic countries, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was tasked to provide scientific advice on a tolerable upper intake level (UL) or a safe level of intake for dietary (total/added/free) sugars based on available data on chronic metabolic diseases, pregnancy‐related endpoints and dental caries. Specific sugar types (fructose) and sources of sugars were also addressed. The intake of dietary sugars is a well‐established hazard in relation to dental caries in humans. Based on a systematic review of the literature, prospective cohort studies do not support a positive relationship between the intake of dietary sugars, in isocaloric exchange with other macronutrients, and any of the chronic metabolic diseases or pregnancy‐related endpoints assessed. Based on randomised control trials on surrogate disease endpoints, there is evidence for a positive and causal relationship between the intake of added/free sugars and risk of some chronic metabolic diseases: The level of certainty is moderate for obesity and dyslipidaemia (> 50–75% probability), low for non‐alcoholic fatty liver disease and type 2 diabetes (> 15–50% probability) and very low for hypertension (0–15% probability). Health effects of added vs. free sugars could not be compared. A level of sugars intake at which the risk of dental caries/chronic metabolic diseases is not increased could not be identified over the range of observed intakes, and thus, a UL or a safe level of intake could not be set. Based on available data and related uncertainties, the intake of added and free sugars should be as low as possible in the context of a nutritionally adequate diet. Decreasing the intake of added and free sugars would decrease the intake of total sugars to a similar extent. This opinion can assist EU Member States in setting national goals/recommendations.

Abstract The 2020–2021 avian influenza epidemic with a total of 3,777 reported highly pathogenic avian influenza (HPAI) detections and approximately 22,900,000 affected poultry birds in 31 European Countries appears to be one of the largest HPAI epidemics that has ever occurred in Europe. Between 15 May and 15 September 2021, 162 HPAI virus detections were reported in 17 EU/EEA countries and the UK in poultry (51), in wild (91) and captive birds (20). The detections in poultry were mainly reported by Kosovo (20), Poland (17) and Albania (6). HPAI virus was detected during the summer months in resident wild bird populations mainly in northern Europe. The data presented in this report indicates that HPAI virus is still circulating in domestic and wild bird populations in some European countries and that the epidemic is not over yet. Based on these observations, it appears that the persistence of HPAI A(H5) in Europe continues to pose a risk of further virus incursions in domestic bird populations. Furthermore, during summer, HPAI viruses were detected in poultry and several wild bird species in areas in Russia that are linked to key migration areas of wild waterbirds; this is of concern due to the possible introduction and spread of novel virus strains via wild birds migrating to the EU countries during the autumn from the eastern breeding to the overwintering sites. Nineteen different virus genotypes have been identified so far in Europe and Central Asia since July 2020, confirming a high propensity for this virus to undergo reassortment events. Since the last report, 15 human infections due to A(H5N6) HPAI and five human cases due to A(H9N2) low pathogenic avian influenza (LPAI) virus have been reported from China. Some of these cases were caused by a virus with an HA gene closely related to the A(H5) viruses circulating in Europe. The viruses characterised to date retain a preference for avian‐type receptors; however, the reports of transmission events of A(H5) viruses to mammals and humans in Russia, as well as the recent A(H5N6) human cases in China may indicate a continuous risk of these viruses adapting to mammals. The risk of infection for the general population in the EU/EEA is assessed as very low, and for occupationally exposed people low, with large uncertainty due to the high diversity of circulating viruses in the bird populations.

Abstract The 2020‐2021 epidemic with a total of 3,555 reported HPAI detections and around 22,400,000 affected poultry birds in 28 European Countries appears to be one of the largest and most devastating HPAI epidemics ever occurred in Europe. Between 24 February and 14 May 2021, 1,672 highly pathogenic avian influenza (HPAI) virus detections were reported in 24 EU/EEA countries and the UK in poultry (n=580), and in wild (n=1,051) and captive birds (n=41). The majority of the detections in poultry were reported by Poland that accounted for 297 outbreaks occurring in a densely populated poultry area over a short period of time, followed by Germany with 168 outbreaks. Germany accounted for 603 detections in wild birds, followed by Denmark and Poland with 167 and 56 detections, respectively. A second peak of HPAI‐associated wild bird mortality was observed from February to April 2021 in north‐west Europe. The observed longer persistence of HPAI in wild birds compared to previous years may result in a continuation of the risk for juveniles of wild birds and mammals, as well as for virus entry into poultry farms. Therefore, enhanced awareness among farmers to continue applying stringent biosecurity measures and to monitor and report increases in daily mortality and drops in production parameters, are recommended. Sixteen different genotypes were identified to date in Europe and Russia, suggesting a high propensity of these viruses to reassort. The viruses characterized to date retain a preference for avian‐type receptors; however, transmission events to mammals and the identification of sporadic mutations of mammal adaptation, indicate ongoing evolution processes and possible increased ability of viruses within this clade to further adapt and transmit to mammals including humans. Since the last report, two human infections due to A(H5N6) HPAI were reported from China and Laos and 10 human cases due to A(H9N2) low pathogenic avian influenza (LPAI) virus identified in China and Cambodia. The risk of infection for the general population in the EU/EEA is assessed as very low and for occupationally exposed people low. People exposed during avian influenza outbreaks should adhere to protection measures, strictly wear personal protective equipment and get tested immediately when developing respiratory symptoms or conjunctivitis within 10 days after exposure.

Abstract The European Commission requested EFSA to assess if different thermal processes achieve a 5 log10 reduction in Enterococcus faecalis or Salmonella Senftenberg (775W) and (if relevant) a 3 log10 reduction in thermoresistant viruses (e.g. Parvovirus) as well as if different chemical processes achieve a 3 log10 reduction of eggs of Ascaris sp., in eight groups of Category 2 and 3 derived products and animal by‐products (ABP). These included (1) ash derived from incineration, co‐incineration and combustion; (2) glycerine derived from the production of biodiesel and renewable fuels; (3) other materials derived from the production of biodiesel and renewable fuels; (4) hides and skins; (5) wool and hair; (6) feathers and down; (7) pig bristles; and (8) horns, horn products, hooves and hoof products. Data on the presence of viral hazards and on thermal and chemical inactivation of the targeted indicator microorganisms and biological hazards under relevant processing conditions were extracted via extensive literature searches. The evidence was assessed via expert knowledge elicitation. The certainty that the required log10 reductions in the most resistant indicator microorganisms or biological hazards will be achieved for each of the eight groups of materials mentioned above by the thermal and/or chemical processes was (1) 99–100% for the two processes assessed; (2) 98–100% in Category 2 ABP, at least 90–99% in Category 3 ABP; (3) 90–99% in Category 2 ABP; at least 66–90% in Category 3 ABP; (4) 10–66% and 33–66%; (5) 1–33% and 10–50%; (6) 66–90%; (7) 33–66% and 50–95%; (8) 66–95%, respectively. Data generation on the occurrence and reduction of biological hazards by thermal and/or chemical methods in these materials and on the characterisation of the usage pathways of ABP as organic fertilisers/soil improvers is recommended.

Abstract Between 16 September and 8 December 2021, 867 highly pathogenic avian influenza (HPAI) virus detections were reported in 27 EU/EEA countries and the UK in poultry (316), in wild (523) and in captive birds (28). The detections in poultry were mainly reported by Italy (167) followed by Hungary and Poland (35 each). Tha majority of the detections in wild birds were reported by Germany (280), Netherlands (65) and United Kingdom (53). The observed persistence and continuous circulation of HPAI viruses in migratory and resident wild birds will continue to pose a risk for the poultry industry in Europe for the coming months. The frequent occurrence of HPAI A(H5) incursions in commercial farms (including poultry production types considered at low avian influenza risk) raises concern about the capacity of the applied biosecurity measures to prevent virus introduction. Short‐term preparedness and medium‐ and long‐term prevention strategies, including revising and reinforcing biosecurity measures, reduction of the density of commercial poultry farms and possible appropriate vaccination strategies, should be implemented. The results of the genetic analysis indicate that the viruses characterised during this reporting period belong to clade 2.3.4.4b. Some of the characterized HPAI A(H5N1) viruses detected in Sweden, Germany, Poland and United Kingdom are related to the viruses which have been circulating in Europe since October 2020; in North, Central, South and East Europe novel reassortant A(H5N1) virus has been introduced starting from October 2021. HPAI A(H5N1) was also detected in wild mammal species in Sweden, Estonia and Finland; some of these strains characterised so far present an adaptive marker that is associated with increased virulence and replication in mammals. Since the last report, 13 human infections due to HPAI A(H5N6) and two human cases due to LPAI A(H9N2) virus have been reported from China. Some of these A(H5N6) cases were caused by a reassortant virus of clade 2.3.4.4b, which possessed an HA gene closely related to the A(H5) viruses circulating in Europe. The risk of infection for the general population in the EU/EEA is assessed as low, and for occupationally exposed people, low to medium, with large uncertainty due to the high diversity of circulating viruses in the bird populations.

Abstract The European Commission requested EFSA assess antimicrobial‐resistant bacteria responsible for animal transmissible diseases, with a view to listing such pathogens for European Union action. This Scientific Opinion addresses the ad hoc method developed: (i) to give a global state of play as regards resistant animal pathogens that cause transmissible animal diseases, (ii) to identify the most relevant bacteria in the EU and (iii) to summarise their actual or potential animal health impact, and to perform their assessment for being listed and categorised according to the criteria of Articles 7, 5, 9 and 8 within the Animal Health Law (AHL) framework. An extensive literature review is carried out to give the global state of play of selected resistant bacteria that constitute a threat to animal health (i). An expert judgement procedure, based on the outcome of the literature review, is applied to identify which among those bacteria subjected to the literature review are the ‘most relevant’ in the European Union (ii). Their animal health impact in the European Union and their assessment for being listed and categorised according to the AHL framework will follow the ‘ad hoc method for the assessment on listing and categorisation of animal diseases within the framework of the Animal Health Law’ that EFSA has developed in the past (iii). The assessment of (i) and (ii) is addressed in distinct scientific opinions that are published separately by animal species of interest (dogs and cats, horses, pigs, poultry, cattle, small ruminants, rabbits and aquatic animal species). The assessment of (iii) is addressed in distinct scientific opinions and published separately by the animal pathogen.

Between 8 December 2020 and 23 February 2021, 1,022 highly pathogenic avian influenza (HPAI) virus detectionswere reported in 25 EU/EEA countries and the UK in poultry (n=592), wild (n=421) and captive birds (n=9).The majority of the detections were reported by Francethat accounted for 442 outbreaks in poultry,mostly located inthe Landes regionandaffecting the foie gras production industry,and six wild bird detections; Germany,who reported 207 detections in wild birds and 50 poultry outbreaks; Denmark,with 63 detections in wild birds and one poultry outbreak; and Poland,with 37 poultry outbreaks and 24 wild bird detections. Due to the continued presence of HPAI A(H5) viruses in wild birds and the environment,there is still a risk of avian influenza incursions with the potential further spread between establishments, primarily in areas with high poultry densities. As the currently circulating HPAI A(H5N8) virus cancause high mortality also in affected duck farms, mortality eventscan be seen as a good indicator of virus presence. However,also subclinical virusspread in this type of poultry production system have been reported.To improve early detection of infection in poultry within the surveillance zone, the clinical inspection of duck establishments should be complemented by encouraging farmers to collect dead birds to be pooled and tested weekly (bucket sampling).Six different genotypes were identified to date in Europe and Russia, suggesting a high propensity of these viruses to undergo multiple reassortment events. To date, no evidence of fixation of known mutations previously described as associated to zoonotic potential has been observed in HPAI viruses currently circulanting in Europe based on the available sequences.Seven cases due to A(H5N8) HPAI virus have been reported from Russia, all were poultry workerswith mild or no symptoms. Five human cases due to A(H5N6) HPAI and 10 cases due to A(H9N2) LPAI viruseshave been reported from China. The risk for the general population as well as travel‐related imported human cases is assessed as very lowand the risk forpeople occupationally exposedpeople as low.Any human infections with avian influenza viruses are notifiablewithin 24 hoursthrough the Early Warning and Response System (EWRS) and the International Health Regulations (IHR) notification system.

Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the renewal of the authorisation of additives for use in animal nutrition. Draft Endorsed by the FEEDAP Panel 14 November 2019 Submitted for public consultation 29 November 2019 End of public consultation 26 January 2020 Adoption by the FEEDAP Panel 19 November 2020 Implementation date 27 March 2021

Between 16 May and 15 August 2020, seven highly pathogenic avian influenza (HPAI) A(H5N8) virus outbreaks were reported in Europe in poultry, with one outbreak reported in Bulgaria(n=1) andsix in Hungary (n=6) and one low pathogenic avian influenza (LPAI) A(H5N3) virus outbreak was reported in poultry in Italy. All six outbreaks detected in Hungary were secondary outbreaks and seem to be the tail end of the HPAI A(H5N8) epidemic that wasobserved in poultry over the winter and spring in central Europe from December 2019 (n=334).Genetic analysis of the HPAI A(H5N8) viruses isolated during this reporting period from Bulgaria and Hungary did not identify any major changes compared tothe viruses collected in the respective countries during the first months of 2020. This suggests a persistence of the virus in the two countries rather than new introductions via infectedwild birds. HPAI A(H5N8) virus has been detected in poultry and wild birds in western Russia within the reporting period, and as of the middle of September also in Kazakhstan. The presence of HPAI virus in western Russiaand in north Kazakhstan,spatially associated with autumnmigration routes of wild waterbirds, is of concern due to the possible spread of the virus via wild birds migrating to the EU.It is highly recommended thatMember States take appropriate measures to promptly detect suspected cases of HPAI, including increasing biosecurity measures. According to past experiences (2005‐2006 and 2016‐2017 epidemic waves), the northern and eastern European areas might be at higher risk of virus introduction in the coming autumn‐winter seasonand should be the key regions where prompt response measures to early detect the virusshould be set up. One human case due to A(H9N2) avian influenza virus infection was reported during the reporting period.

Between 16 February and 15 May 2020, 290highly pathogenic avian influenza (HPAI) A(H5) virus outbreakswere reported in Europe in poultry (n=287), captive birds (n=2) and wild birds (n=1)in Bulgaria, Czechia,Germany,Hungary andPolandand two low pathogenic avian influenza (LPAI) A(H7N1) virus outbreaks were reported in poultry in Italy. 258 of 287 poultry outbreaks detected in Europe were secondary outbreaks, suggesting that in the large majoryty of cases the spread of the virus was not due to wild birds.Allthe HPAI outbreaks were A(H5N8) apart from three,which were reported as A(H5N2) from Bulgaria. Genetic analysis of the HPAI A(H5N8) viruses isolated from the eastern and central European countries indicates that this is a reassortant between HPAI A(H5N8) viruses from Africa and LPAI viruses from Eurasia. Two distict subtypes were identified in Bulgaria, a novel reassortant A(H5N2) and A(H5N8) that is persisting in the country since 2016. There could be several reasons why only very few HPAI cases were detected in wild birds in this 2019‐2020 epidemic season and a better knowledge of wild bird movements and virus‐host interaction (e.g. susceptibility of the hosts to this virus) could help to understand the reasons for poor detection of HPAI infected wild birds. In comparison with the last reporting period, a decreasing number of HPAI A(H5)‐affected countries and outbreaks were reported from outside Europe. However, there is considerable uncertainty regarding the current epidemiological situation in many countries out of Europe. Four human cases due to A(H9N2) virus infection were reported during the reporting period from China.

Between 16 November 2019 and 15 February 2020, 36 highly pathogenic avian influenza (HPAI) A(H5N8) virus outbreakswere reported in Europe in poultry (n=34), captive birds (n=1) and wild birds (n=2), in Poland, Hungary, Slovakia, Romania, Germany, Czechiaand Ukraine,one HPAI outbreakcaused by a simultaneous infection with A(H5N2) and A(H5N8) was reported in poultry in Bulgaria, andtwo low pathogenic avian influenza (LPAI) A(H5) virus outbreaks were reported in poultryin the United Kingdom and in Denmark. Genomic characterisation of the HPAI A(H5N8) viruses suggests that they are reassortants of HPAI A(H5N8) viruses from Africa and LPAI viruses from Eurasia. It is likely that this reassortment occurred in wild migratory birds in Asia during the summer and then spread to eastern Europe with the autumnmigration. This is the first time that wild bird migration from Africa to Eurasia has been implicated in the long‐distance spread of HPAI viruses to the EU. Given the late incursion of HPAI A(H5N8) virus into the EU in this winter season (first outbreak reported on 30 December 2019), its overall restriction to eastern Europe, and the approaching spring migration, the risk of the virus spreadingfurther in the west via wild birds is decreasing for the coming months. Genetic analysis of the HPAI A(H5N2) and A(H5N8) viruses detected in the Bulgarian outbreak reveals that these virusesare both related to the 2018‐19 Bulgarian HPAI A(H5N8) viruses and not to the HPAI A(H5N8) viruses currently circulating in Europe.An increasing number of HPAI A(H5N1), A(H5N2), A(H5N5) and A(H5N6) virus outbreaks in poultry in Asia were reported during the time period for this report compared with the previous reporting period. Single outbreaks of HPAI A(H5N8) virus were notified by Saudi Arabia and South Africa. Furthermore, in contrast to the last report, HPAI virus‐positive wild birds were reported from Israel and one of the key migration areas in northern China.Two human cases due to A(H9N2) virus infection were reported during the reporting period.

Between 16 February and 15 August 2019, five HPAI A(H5N8) outbreaks at poultry establishments in Bulgaria, two low pathogenic avian influenza (LPAI) A(H5N1) outbreaks in poultry in Denmark and one in captive birds in Germany, one LPAI A(H7N3) outbreak in poultry in Italy and one LPAI A(H7N7) outbreak in poultry in Denmark were reported in Europe. Genetic characterisation reveals that viruses from Denmark cluster with viruses previously identified in wild birds and poultry in Europe; while the Italian isolate clusters with LPAI viruses circulating in wild birds in Central Asia. No avian influenza outbreaks in wild birds were notified in Europe in the relevant period for this report. A decreased number of outbreaks in poultry and wild birds in Asia, Africa and the Middle East was reported during the time period for this report, particularly during the last three months. Furthermore, only six affected wild birds were reported in the relevant time period of this report. Currently there is no evidence of a new HPAI virus incursion from Asia into Europe. However, passive surveillance systems may not be sensitive for early detection if the prevalence or case fatality in wild birds is very low. Therefore, it is important to encourage and maintain passive surveillance in Europe encouraging a search for carcasses of wild bird species that are in the revised list of target species in order to detect any incursion of HPAI virus early and initiate warning. No human infections due to HPAI viruses ‐ detected in wild birds and poultry outbreaks in Europe ‐ have been reported during the last years and the risk of zoonotic transmission to the general public in Europe is considered very low.

Abstract This opinion updates the information included in the previous EFSA Scientific Opinion concerning the in planta control measures for Xylella fastidiosa, with a systematic review and critical analysis of the potential treatment solutions that have been published against this pest so far. The output of this opinion focuses on the application of chemical or biological treatments on living plants. In vitro studies, hot water treatments, use of resistant varieties and vector control are excluded from the review. The use of antibiotics is not considered due to the risk of antimicrobial resistance development. The use of weakly virulent or avirulent strains of X. fastidiosa is covered in this review, although this organism is an EU quarantine plant pest and its introduction in the EU territory is banned. Experiments were recently conducted to assess the effect of application of zinc, copper, and citric acid biocomplex, of N‐acetylcysteine, and of ‘diffusible signal factor’ (and of its homologs). Their results showed that these control measures were sometimes able to reduce symptoms caused by X. fastidiosa. Recent experiments also showed that several species of endophytic microorganisms, some bacteriophages and inoculation of weakly virulent/avirulent strains of X. fastidiosa could offer some protection against the Pierce's disease. However, based on the reviewed results, the Panel concludes that, although several published experiments show some effects in reducing symptoms development, the tested control measures are not able to completely eliminate X. fastidiosa from diseased plants. The Panel confirms as previously stated that there is currently no control measure available to eliminate the bacteria from a diseased plant in open field conditions.

No human infections due to highly pathogenic avian influenza (HPAI) A(H5N8) or A(H5N6) viruses ‐ detected in wild birds and poultry outbreaks in Europe ‐ have been reported so far and the risk of zoonotic transmission to the general public in Europe is considered very low. Between 16 November 2018 and 15 February 2019, two HPAI A(H5N8) outbreaks in poultry establishments in Bulgaria, two HPAI A(H5N6) outbreaks in wild birds in Denmark and one low pathogenic avian influenza (LPAI) A(H5N3) in captive birds in the Netherlands were reported in the European Union (EU). Genetic characterisation of the HPAI A(H5N6) viruses reveals that they cluster with the A(H5N6) viruses that have been circulating in Europe since December 2017. The wild bird species involved were birds of prey and were likely infected due to hunting or scavenging infected wild waterfowl. However, HPAI virus was not detected in other wild birds during this period. Outside the EU, two HPAI outbreaks were reported in poultry during the reporting period from western Russia. Sequence information on an HPAI A(H5N6) virus found in a common gull in western Russia in October 2018 suggests that the virus clusters within clade 2.3.4.4c and is closely related to viruses that transmitted zoonotically in China. An increasing number of outbreaks in poultry and wild birds in Asia, Africa and the Middle East was observed during the time period for this report. Currently there is no evidence of a new HPAI virus incursion from Asia into Europe. However, passive surveillance systems may not be sensitive enough if the prevalence or case fatality in wild birds is very low. Nevertheless, it is important to encourage and maintain a certain level of passive surveillance in Europe testing single sick or dead wild birds and birds of prey as they may be sensitive sentinel species for the presence of HPAI virus in the environment. A well‐targeted active surveillance might complement passive surveillance to collect information on HPAI infectious status of apparently healthy wild bird populations.

Between 16 August and 15 November 2018, 14 highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments in Bulgaria and seven HPAI A(H5N6) outbreaks, one in captive birds in Germany and six in wild birds in Denmark and the Netherlands were reported in the European Union (EU). No human infection due to HPAI A(H5N8) and A(H5N6) viruses have been reported in Europe so far. Seroconversion of people exposed during outbreaks in Russia has been reported in one study. Although the risk of zoonotic transmission to the general public in Europe is considered to be very low, appropriate personal protection measures of people exposed will reduce any potential risk. Genetic clustering of the viruses isolated from poultry in Bulgaria suggests three separate introductions in 2016 and a continuing circulation and transmission of these viruses within domestic ducks. Recent data from Bulgaria provides further indication that the sensitivity of passive surveillance of HPAI A(H5N8) in domestic ducks may be significantly compromised. Increased vigilance is needed especially during the periods of cold spells in winter when aggregations of wild birds and their movements towards areas with more favourable weather conditions may be encouraged. Two HPAI outbreaks in poultry were reported during this period from western Russia. Low numbers of HPAI outbreaks were observed in Africa and Asia, no HPAI cases were detected in wild birds in the time period relevant for this report. Although a few HPAI outbreaks were reported in Africa and Asia during the reporting period, the probability of HPAI virus introductions from non‐EU countries via wild birds particularly via the north‐eastern route from Russia is increasing, as the fall migration of wild birds from breeding and moulting sites to the wintering sites continues. Furthermore, the lower temperatures and ultraviolet radiation in winter can facilitate the environmental survival of any potential AI viruses introduced to Europe.

Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date that HPAI A(H5N8) and A(H5N6) viruses circulating in Europe have caused any human infections. The risk of zoonotic transmission to the general public in Europe is considered to be very low. Several HPAI outbreaks in poultry were reported during this period from Russia. The presence of the A(H5N2) and A(H5N8) viruses in parts of Russia connected with fall migration routes of wild birds is of concern for possible introduction and spread with wild birds migrating to the EU. Although few AI outbreaks were observed in Africa, Asia and the Middle East during the reporting period, the probability of AI virus introductions from non‐EU countries via wild birds particularly via the north‐eastern route from Russia is increasing, as the fall migration of wild birds will start in the coming weeks. Further, the lower temperatures in autumn and winter may facilitate the environmental survival of avian influenza viruses potentially introduced to Europe.

Between 16 February and 15 May 2018, three highly pathogenic avian influenza (HPAI) A(H5N6) and 11 HPAI A(H5N8) outbreaks in poultry holdings, one HPAI A(H5N6) and one HPAI A(H5N8) outbreak in captive birds, and 55 HPAI A(H5N6) wild bird events were reported in Europe. There is no evidence to date that HPAI A(H5N6) viruses circulating in Europe are associated with clades infecting humans. Fewer HPAI wild bird cases have been detected than during the same period of previous year. Most of mortality events among wild birds involved single birds and species listed in the revised list of target species for passive surveillance. Raptor species constitute 74% of the HPAI‐infected wild birds found dead. Those raptor species probably became infected by hunting or scavenging HPAI virus‐positive birds, and so raptor cases may predominate later in the course of an HPAI epidemic. Despite the important HPAI virus incursion via wild birds there have been few associated HPAI A(H5N6) outbreaks in poultry. Fifteen low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. The risk of zoonotic transmission to the general public in Europe is considered to be very low. The situation in Africa and the Middle East should be closely monitored with regards to HPAI A(H5N1) and A(H5N8). Uncontrolled spread of the virus and subsequent further genetic evolution in regions geographically connected to Europe may increase uncertainty and the risk for further dissemination of virus. Long‐distance migrating wild birds from southern Africa, e.g. the common tern (Sterna hirundo), may be included in targeted active surveillance schemes at a few priority locations in Europe in order to detect HPAI A(H5)‐infected migrating birds early. However, the risk of HPAI introduction from non‐EU countries via migratory wild birds to Europe is still considered to be much lower for wild birds crossing the southern borders than for those crossing the north‐eastern borders.

Abstract Council Regulation (EC) No 1099/2009 on the protection of animals at the time of killing lists in Annex I the stunning interventions currently allowed in the EU, together with the related conditions under which those interventions can be implemented. The regulation allows the Commission to amend Annex I, listing additional stunning interventions, provided they ensure a level of animal welare at least equivalent to that ensured by the one already approved. EFSA was requested to perform such assessment with regard to the implementation of the low atmospheric pressure stunning (LAPS) system on broiler chickens. The ad hoc Working Group (WG) set up by EFSA performed the assessment in three main steps, i.e. checking the data provided against the criteria laid down in the EFSA Guidance (EFSA AHAW Panel, 2013); running an extensive literature search, followed by data extraction and performing a judgemental ranking exercise based on expert opinion. As main outcome, the LAPS intervention was found to be able to provide a level of animal welfare not lower than that provided by at least one of the currently allowed methods. The overall assessment of EFSA is valid ONLY under the technical conditions described in the submission and for broiler chickens, intended for human consumption, weighting less than 4 kg. Deviations from these conditions might have different consequences for animal welfare which were not assessed in this exercise. The LAPS method may, in addition to commercial slaughter, be suitable for depopulation, respecting the technical conditions defined in the present conclusions. The WG considers that a revision of the present version of the EFSA Guidance could be beneficial.

Centro de Trabajo: (1) Documentalista. GuíaSalud – Instituto Aragonés de Ciencias de la Salud (I+CS). (2) Documentalista. Instituto Aragonés de Ciencias de la Salud (I+CS). Fecha del Trabajo: 07/02/2012

Centro de Trabajo: (1) Documentalista. GuíaSalud – Instituto Aragonés de Ciencias de la Salud (I+CS). (2) Documentalista. Instituto Aragonés de Ciencias de la Salud (I+CS). Fecha del Trabajo: 07/02/2012

Centro de Trabajo: (1) Documentalista. GuíaSalud – Instituto Aragonés de Ciencias de la Salud (I+CS). (2) Documentalista. Instituto Aragonés de Ciencias de la Salud (I+CS). Fecha del Trabajo: 16/12/2011

Centro de Trabajo: (1) Documentalista. GuíaSalud – Instituto Aragonés de Ciencias de la Salud (I+CS). (2) Documentalista. Instituto Aragonés de Ciencias de la Salud (I+CS). Fecha del Trabajo: 01/11/2011

Abstract Acetamiprid is a pesticide active substance with insecticidal action whose approval was renewed by Commission Implementing Regulation (EU) 2018/113. In January 2022, the EFSA PPR Panel published a statement following a request from the European Commission to advise on human health or the environment based on new scientific evidence presented by France during the decision‐making phase. In July 2022, by means of a further mandate received from the European Commission, EFSA was requested to provide advice if new information and any other scientific evidence that has become available since the assessment conducted for the renewal in 2018 warrant re‐evaluation of (i) toxicological parameters used for the risk assessment of acetamiprid during the renewal process, including toxicological endpoints; (ii) the residue definition for acetamiprid in products of plant origin; and (iii) the safety of existing maximum residue levels (MRLs). Meanwhile, the applicant of acetamiprid in the EU submitted new toxicology studies regarding the toxicological profile of the metabolite IM‐2‐1. Furthermore, the European Commission was made aware that several recent publications in scientific literature were made available after the literature searches conducted by EFSA. As the new data could affect the advice that EFSA was expected to deliver through the 2022 mandate, EFSA was further requested to consider this information by means of a revised mandate received in September 2023. As regards re‐evaluation of point (i) in this statement, this was addressed by an EFSA Working Group integrating all the available evidence. The results of the weight of evidence indicated that there are major uncertainties in the body of evidence for the developmental neurotoxicity (DNT) properties of acetamiprid and further data are therefore needed to come to a more robust mechanistic understanding to enable appropriate hazard and risk assessment. In view of these uncertainties, the EFSA WG proposed to lower the acceptable daily intake (ADI) and acute reference dose (ARfD) from 0.025 to 0.005 mg/kg body weight (per day). A revised residue definition for risk assessment was proposed for leafy and fruit crops as sum of acetamiprid and N‐desmethyl‐acetamiprid (IM‐2‐1), expressed as acetamiprid. Regarding pulses/oilseeds, root crops and cereals, the new data received did not indicate a need to modify the existing residue definition for risk assessment, which therefore remains as parent acetamiprid. Regarding the residue definition for enforcement, the available data did not indicate a need to modify the existing definition because acetamiprid is still a sufficient marker of the residues in all crop groups. Considering the new health‐based guidance values derived in the present statement, a risk for consumer has been identified for 38 MRLs currently in place in the EU Regulation. Consequently, EFSA recommended to lower the existing MRLs for 38 commodities based on the assessment of fall‐back Good Agricultural Practices received within an ad hoc data call. Some fall‐back MRLs proposals require further risk management considerations.

Abstract Mutations are changes in the genetic material that may be transmitted to subsequent generations. Mutations appear spontaneously in nature and are one of the underlying driving forces of evolution. In plants, in vivo and in vitro random mutagenesis relies on the application of physical and chemical mutagens to increase the frequency of mutations thus accelerating the selection of varieties with important agronomic traits. The European Commission has requested EFSA to provide a more detailed description of in vivo and in vitro random mutagenesis techniques and the types of mutations and mechanisms involved, to be able to conclude on whether in vivo and in vitro random mutagenesis techniques are to be considered different techniques. To address the European Commission request, a literature search was conducted to collect information on the random mutagenesis techniques used in plants both in vivo and in vitro, on the type of mutations generated by such techniques and on the molecular mechanisms underlying formation of those mutations. The GMO Panel concludes that most physical and chemical mutagenesis techniques have been applied both in vivo and in vitro; the mutation process and the repair mechanisms act at cellular level and thus there is no difference between application of the mutagen in vivo or in vitro; and the type of mutations induced by a specific mutagen are expected to be the same, regardless of whether such mutagen is applied in vivo or in vitro. Indeed, the same mutation and the derived trait in a given plant species can be potentially obtained using both in vivo and in vitro random mutagenesis and the resulting mutants would be indistinguishable. Therefore, the GMO Panel concludes that the distinction between plants obtained by in vitro or in vivo approaches is not justified.

Abstract The European Commission asked EFSA for a scientific opinion on the risks to animal health related to nitrite and nitrate in feed. For nitrate ion, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) identified a BMDL10 of 64 mg nitrate/kg body weight (bw) per day for adult cattle, based on methaemoglobin (MetHb) levels in animal's blood that would not induce clinical signs of hypoxia. The BMDL10 is applicable to all bovines, except for pregnant cows in which reproductive effects were not clearly associated with MetHb formation. Since the data available suggested that ovines and caprines are not more sensitive than bovines, the BMDL10 could also be applied to these species. Highest mean exposure estimates of 53 and 60 mg nitrate/kg bw per day in grass silage‐based diets for beef cattle and fattening goats, respectively, may raise a health concern for ruminants when compared with the BMDL10 of 64 mg nitrate/kg bw per day. The concern may be higher because other forages might contain higher levels of nitrate. Highest mean exposure estimates of 2.0 mg nitrate/kg bw per day in pigs’ feeds indicate a low risk for adverse health effects, when compared with an identified no observed adverse effect level (NOAEL) of 410 mg nitrate/kg bw per day, although the levels of exposure might be underestimated due to the absence of data on certain key ingredients in the diets of this species. Due to the limitations of the data available, the CONTAM Panel could not characterise the health risk in species other than ruminants and pigs from nitrate and in all livestock and companion animals from nitrite. Based on a limited data set, both the transfer of nitrate and nitrite from feed to food products of animal origin and the nitrate‐ and nitrite‐mediated formation of N‐nitrosamines and their transfer into these products are likely to be negligible.

Abstract Following a request from the European Commission, the European Food Safety Authority (EFSA) Plant Health (PLH) Panel analysed a dossier submitted by the Japanese authorities in order to clarify the host status of Citrus junos with regard to Xanthomonas citri pv. citri and Xanthomonas citri pv. aurantifolii, causal agents of citrus bacterial canker, and to indicate whether C. junos fruit could represent a pathway for the introduction of citrus bacterial canker into the European Union. In a previous opinion in the year 2014, the EFSA PLH Panel concluded that commercial fresh citrus fruit is generally pathway and that no commercially important Citrus species or variety can be considered as immune to citrus bacterial canker. In the current assessment, the EFSA PLH Panel analysed the two scientific papers provided by the Japanese authorities, as well as 16 additional papers identified through a systematic literature review. The PLH Panel considered that the conclusions of its previous opinion remain valid and that convergent lines of evidence provide sufficient demonstration that C. junos is a host of X. citri pv. citri and X. citri pv. aurantifolii. Therefore, there is no reason to consider the C. junos fruit differently from other citrus species. Consequently, the assessment of the general citrus fruit pathway from the 2014 opinion still applies. Uncertainties on these conclusions are a result of the scarce scientific evidence published on this subject in addition to the methodological and reporting limitations of the published papers.

Abstract A new fungus, Batrachochytrium salamandrivorans (Bsal), was identified in wild populations of salamanders in the Netherlands and Belgium, and in kept salamander populations in Germany and the United Kingdom. EFSA assessed the potential of Bsal to affect the health of wild and kept salamanders in the EU, the effectiveness and feasibility of a movement ban of traded salamanders, the validity, reliability and robustness of available diagnostic methods for Bsal detection, and possible alternative methods and feasible risk mitigation measures to ensure safe international and EU trade of salamanders and their products. Bsal was isolated and characterised in 2013 from a declining fire salamander (Salamandra salamandra) population in the Netherlands. Based on the available evidence, it is likely that Bsal is a sufficient cause for the death of S. salamandra both in the laboratory and in the wild. Despite small sample sizes, the available experimental evidence indicates that Bsal is associated with disease and death in individuals of 12 European and 3 Asian salamander species, and with high mortality rate outbreaks in kept salamanders. Bsal experimental infection was detected in individuals of at least one species pertaining to the families Salamandridae, Plethodontidae, Hynobiidae and Sirenidae. Movement bans constitute key risk mitigation measures to prevent pathogen spread into naïve areas and populations. The effectiveness of a movement ban is mainly dependent on the import volumes, possibility of Bsal to remain viable outside susceptible/tolerant species, and the capacity to limit illegal movements. Duplex real‐time PCR can be used to detect Bsal DNA, but has not been fully validated. Quarantining salamanders, enacting legislation that requires testing of animals to demonstrate freedom from Bsal, before movement can take place, restricting salamander movements, tracking all traded species, hygienic procedures/biosecurity measures before and during movements, and increasing public awareness are relevant measures for ensuring safe intra‐EU and international trade of salamanders.

Abstract Teosinte, wild maize relatives originating from Mexico and Central America, emerged as a noxious agricultural weed in France and Spain. In 2016, the European Food Safety Authority (EFSA) issued a technical report that assessed the available scientific information on teosinte for its relevance for the environmental risk assessment (ERA) and risk management (RM) of genetically modified (GM) maize MON810, Bt11, 1507 and GA21 for cultivation. It was concluded that the impact of insect resistance and/or herbicide tolerance in GM teosinte hybrid progeny (potentially acquired through hybridisation between GM maize and teosinte) on target and non‐target organisms, the abiotic environment and biogeochemical cycles would be very low under EU conditions. Following a request of the European Commission, EFSA evaluated whether the ERA conclusions and RM recommendations of EFSA (2016) remain applicable, or require revision in light of new scientific evidence on teosinte that has become available since the publication of EFSA (2016). A protocol was developed to clarify the interpretation of the terms of reference of the mandate and make them operational. The assessment relied on evidence retrieved via an extensive literature search and from reports of the Competent Authorities of France and Spain, and on hearing expert testimonies. A limited collection of 18 publications of varying relevance and quality was retrieved and assessed. Based on this evidence, it is concluded that the ERA conclusions and RM recommendations of EFSA (2016) remain applicable, except those pertaining to the use of glyphosate‐based herbicides on maize GA21 which should be considered under Regulation (EC) No 1107/2009. In infested agricultural areas (especially in regions where maize MON810 is widely grown), weed management measures implemented to monitor, control and/or eradicate teosinte must remain in place, as they will contribute to further reduce the low vertical gene flow potential between GM maize and EU teosinte.