Species which may act as vectors or reservoirs of diseases covered by the Animal Health Law: Listed pathogens of molluscs.

Vector or reservoir species of five mollusc diseases listed in the Animal Health Law were identified, based on evidence generated through an extensive literature review, to support a possible updating of Regulation (EU) 2018/1882. Mollusc species on or in which Mikrocytos mackini, Perkinsus marinus, Bonamia exitiosa, Bonamia ostreae and Marteilia refringens were detected, in the field or during experiments, were classified as reservoir species with different levels of certainty depending on the diagnostic tests used. Where experimental evidence indicated transmission of the pathogen from a studied species to another known susceptible species, this studied species was classified as a vector species. Although the quantification of the risk of spread of the pathogens by the vectors or reservoir species was not part of the terms of reference, such risks do exist for the vector species, since transmission from infected vector species to susceptible species was proven. Where evidence for transmission from infected molluscs was not found, these were defined as reservoir. Nonetheless, the risk of the spread of the pathogens from infected reservoir species cannot be excluded. Evidence identifying conditions that may prevent transmission by vectors or reservoir mollusc species during transport was collected from scientific literature. It was concluded that it is very likely to almost certain (90-100%) that M. mackini, P. marinus, B. exitiosa B. ostreae and M. refringens will remain infective at any possible transport condition. Therefore, vector or reservoir species that may have been exposed to these pathogens in an affected area in the wild or at aquaculture establishments or through contaminated water supply can possibly transmit these pathogens. For transmission of M. refringens, the presence of an intermediate host, a copepod, is necessary.

Species which may act as vectors or reservoirs of diseases covered by the Animal Health Law: Listed pathogens of crustaceans.

Vector or reservoir species of three diseases of crustaceans listed in the Animal Health Law were identified based on evidence generated through an extensive literature review, to support a possible updating of Regulation (EU) 2018/1882. Crustacean species on or in which Taura syndrome virus (TSV), Yellow head virus (YHV) or White spot syndrome virus (WSSV) were identified, in the field or during experiments, were classified as reservoir species with different levels of certainty depending on the diagnostic tests used. Where experimental evidence indicated transmission of the pathogen from a studied species to another known susceptible species, the studied species was classified as vector species. Although the quantification of the risk of spread of the pathogens by the vectors or reservoir species was not part of the terms of reference, such risks do exist for the vector species, since transmission from infected vector species to susceptible species was proven. Where evidence for transmission from infected crustaceans was not found, these were defined as reservoirs. Nonetheless, the risk of the spread of the pathogens from infected reservoir species cannot be excluded. Evidence identifying conditions that may prevent transmission by vectors during transport was collected from scientific literature. It was concluded that it is very likely to almost certain (90-100%) that WSSV, TSV and YHV will remain infective at any possible transport condition. Therefore, vector or reservoir species that may have been exposed to these pathogens in an affected area in the wild or aquaculture establishments or by water supply can possibly transmit WSSV, TSV and YHV.

Species which may act as vectors or reservoirs of diseases covered by the Animal Health Law: Listed pathogens of fish.

Vector or reservoir species of five fish diseases listed in the Animal Health Law were identified, based on evidence generated through an extensive literature review (ELR), to support a possible updating of Regulation (EU) 2018/1882. Fish species on or in which highly polymorphic region-deleted infectious salmon anaemia virus (HPR∆ ISAV), Koi herpes virus (KHV), epizootic haematopoietic necrosis virus (EHNV), infectious haematopoietic necrosis virus (IHNV) or viral haemorrhagic septicaemia virus (VHSV) were detected, in the field or during experiments, were classified as reservoir species with different levels of certainty depending on the diagnostic tests used. Where experimental evidence indicated transmission of the pathogen from a studied species to another known susceptible species, the studied species was classified as a vector species. Although the quantification of the risk of spread of the pathogens by the vectors or reservoir species was not part of the terms or reference, such risks do exist for the vector species, since transmission from infected vector species to susceptible species was proven. Where evidence for transmission from infected fish was not found, these were defined as reservoirs. Nonetheless, the risk of the spread of the pathogens from infected reservoir species cannot be excluded. Evidence identifying conditions that may prevent transmission by vectors or reservoir fish species during transport was collected from scientific literature. For VHSV, IHNV or HPR∆ ISAV, it was concluded that under transport conditions at temperatures below 25°C, it is likely (66-90%) they will remain infective. Therefore, vector or reservoir species that may have been exposed to these pathogens in an affected area in the wild, aquaculture establishments or through water supply can possibly transmit VHSV, IHNV or HPR∆ ISAV into a non-affected area when transported at a temperature below 25°C. The conclusion was the same for EHN and KHV; however, they are likely to remain infective under all transport temperatures.

Update of environmental risk assessment conclusions and risk management recommendations of EFSA (2016) on EU teosinte.

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.

Avian influenza overview December 2021 - March 2022.

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.

Tolerable upper intake level for dietary sugars.

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.

Application of evidence-based methods to construct mechanism-driven chemical assessment frameworks.

The workshop titled "Application of evidence-based methods to construct mechanism-driven chemical assessment frameworks" was co-organized by the Evidence-based Toxicology Collaboration and the European Food Safety Authority (EFSA) and hosted by EFSA at its headquarters in Parma, Italy on October 2 and 3, 2019. The goal was to explore integration of systematic review with mechanistic evidence evaluation. Participants were invited to work on concrete products to advance the exploration of how evidence-based approaches can support the development and application of adverse outcome pathways (AOP) in chemical risk assessment. The workshop discussions were centered around three related themes: 1) assessing certainty in AOPs, 2) literature-based AOP development, and 3) integrating certainty in AOPs and non-animal evidence into decision frameworks. Several challenges, mostly related to methodology, were identified and largely determined the workshop recommendations. The workshop recommendations included the comparison and potential alignment of processes used to develop AOP and systematic review methodology, including the translation of vocabulary of evidence-based methods to AOP and vice versa, the development and improvement of evidence mapping and text mining methods and tools, as well as a call for a fundamental change in chemical risk and uncertainty assessment methodology if to be conducted based on AOPs and new approach methodologies (NAM). The usefulness of evidence-based approaches for mechanism-based chemical risk assessments was stressed, particularly the potential contribution of the rigor and transparency inherent to such approaches in building stakeholders' trust for implementation of NAM evidence and AOPs into chemical risk assessment.

Avian influenza overview May - September 2021.

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.

Inactivation of indicator microorganisms and biological hazards by standard and/or alternative processing methods in Category 2 and 3 animal by-products and derived products to be used as organic fertilisers and/or soil improvers.

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.

In vivo and in vitro random mutagenesis techniques in plants.

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.

Avian influenza overview December 2020 - February 2021.

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.

Guidance on the renewal of the authorisation of feed additives.

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. [Table: see text].

Avian influenza overview September - December 2021.

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.

Avian influenza overview May - August 2020.

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.

Effectiveness of in planta control measures for Xylella fastidiosa.

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.

Avian influenza overview February- August 2019.

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.

Avian influenza overview August - November 2018.

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.

Avian influenza overview February - May 2018.

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.

Avian influenza overview May - August 2018.

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.

Low atmospheric pressure system for stunning broiler chickens.

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.