Special Issue Item
Scientific opinions of Scientific/Scientific Panel
Opinion of the Scientific Committee/Scientific Panel
Statement of the Scientific Committee/Scientific Panel
Guidance of the Scientific Committee/Scientific Panel
Statement of EFSA
Guidance of EFSA
Conclusion on pesticides
Reasoned opinion on pesticide
Scientific report of EFSA
Animal health & welfare
Evidence Management (DATA)
Assessment and methodological support
The EFSA Journal is an open-access, online scientific journal that publishes the scientific outputs of the European Food Safety Authority. EFSA’s various output types are devoted to the field of risk assessment in relation to food and feed and include nutrition, animal health and welfare, plant health and plant protection.
Issue: 12 (December) 2014
- Statement of EFSA
- Guidance of EFSA
- Conclusions on Pesticides
- Reasoned Opinions
- Scientific Reports of EFSA
Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel
This scientific opinion is the outcome of a scoping exercise aimed to identify the main welfare consequences and associated risk factors for sheep across, and within, categories of management systems and production types. The exercise included the construction of a risk (conceptual) model, a literature review and an expert knowledge elicitation, involving an online survey and a technical hearing, in order to rank the welfare consequences on the basis of the amount of suffering and prevalence. Sheep farmed for wool, meat and milk production were the target population, focusing on ewes and lambs. Based on the degree of human contact, use of housing, nature of pasture management and provision of supplementary feeding, sheep management systems were characterised as: shepherding, intensive, semi-intensive, semi-extensive, extensive, very extensive and mixed. The conceptual model proposed seventeen welfare consequences. In ewes, the importance of the welfare consequences was rated differently in different management systems; however, across all systems, the most important welfare consequences were: thermal stress, lameness and mastitis. Prolonged hunger was rated to be more frequent in extensive and very extensive management systems, and mastitis in ewes reared for milk production. For lambs, there were few differences among management systems with thermal stress, pain due to management procedures, gastro-enteric disorders and neonatal disorders rated as main welfare consequences. Respiratory disorders were more frequent in intensive management systems. The technical hearing of experts facilitated consensus on the major risk factors for ewes and lambs. Animal-based measures exist for most welfare consequences in ewes and lambs, but many require further validation. The identified currently available validated ABMs for assessing the main welfare consequences in ewes are: body condition score, locomotion score, udder consistency and somatic cell count in milk; and in lambs: shivering, evidence of painful husbandry procedures and dag score (score of breech soiling).
Bulb and stem vegetables as well as carrots may be minimally processed to obtain ready-to-eat products, and these steps include selection, washing, cleaning, cutting, packaging and storage. Risk factors for the contamination of bulb and stem vegetables as well as carrots with Salmonella, Yersinia, Shigella and Norovirus were considered in the context of the whole food chain. Available estimates of their occurrence in these vegetables were evaluated together with mitigation options relating to prevention of contamination and the relevance of microbiological criteria. Emphasis is given to vegetable types associated with public health risks, i.e. carrots, onion and garlic. It was concluded that each farm environment represents a unique combination of risk factors that can influence the occurrence and persistence of pathogens in the primary production of these vegetables. Appropriate implementation of food safety management systems including Good Agricultural Practices (GAP), Good Hygiene Practices (GHP) and Good Manufacturing Practices (GMP) should be the primary objectives of producers of bulb and stem vegetables as well as carrots. Considering the limited evidence for both the occurrence and public health risks from contamination of Salmonella, Shigella, Yersinia and Norovirus in the primary production and minimal processing of bulb and stem vegetables and carrots, no conclusions can be made on the impact of the establishment of microbiological Hygiene Criteria, Process Hygiene Criteria or Food Safety Criteria on public health. There is a lack of data on the occurrence and levels of Escherichia coli in bulb and stem vegetables as well as carrots. Thus, the effectiveness of E. coli criteria to verify compliance to GAP, GHP, GMP and food safety management systems (including HACCP) in the production and minimal processing of bulb and stem vegetables as well as carrots cannot be assessed.
The European Commission requested the EFSA Panel on Plant Health to perform a pest categorisation of Atropellis spp., the fungal pathogens responsible for causing cankers in several Pinus species. The pathogens are listed in Annex IIAI of Directive 2000/29/EC. The pathogens have been identified as A. apiculata, A. pinicola, A. piniphila and A. tingens. Detection, identification and differentiation of Atropellis species is based on their morphological and cultural characteristics. A. apiculata is present in North Carolina and Virginia (USA), and A. pinicola, A. piniphila and A. tingens are present in Canada and the USA. Atropellis spp. are not known to occur in the EU Member States so far. Several Pinus species have been reported to be hosts of Atropellis spp., with some of them being present in the EU Member States. However, the susceptibility to infection with these pathogens of pine species native to Europe and Eurasia, such as Pinus brutia, P. cembra, P. mugo, P. peuce, P. pinaster and P. sibiricais not yet known. There are no obvious eco-climatic factors limiting the potential establishment and spread of the pathogens in the risk assessment area. The pathogens can spread over short distances by ascospores that are dispersed primarily by wind and secondarily by rain. Spread of Atropellis spp. over long distances may occur by means of movement of infected host plants for planting (especially asymptomatic), cut branches, and wood or isolated bark. Control methods used against Atropellis spp. include cultural practices and sanitary measures. No chemical control measures, resistant host genotypes or biological control measures exist. Potential consequences of the damage caused by Atropellis spp. include malformation of the trees resulting in lower wood quality or tree marketability.
The Panel on Plant Health undertook a pest categorisation for the scale insect Aonidiella citrina for the European Union. A. citrina is a distinct species, but examination with a microscope is required to distinguish it from A. aurantii, which is also a citrus pest originating from Asia, but is much more widespread in southern Europe and far more damaging than A. citrina. A. citrina was first found in Europe in 1994 but has been recorded only in Italy, France and Greece. It is primarily a citrus pest, but has been found in association with a variety of other plant genera. Southern areas of the EU, where citrus plants are cultivated, are potentially suitable for outdoor establishment of A. citrina. The pest has not been recorded in protected cultivation. No serious impacts of A. citrina have been recorded in Europe, and an integrated pest management programme, combining chemical and biological controls, is considered to be effective. A. citrina is an insect listed in Annex IIAI of Council Directive 2000/29/EC in relation to its main hosts: Citrus, Fortunella and Poncirus plants. These hosts are also regulated in Annex III and Annex V and are explicitly mentioned in Council Directive 2008/90/EC.
The European Commission requested the EFSA Panel on Plant Health to perform a pest categorisation of Verticillium dahliae Kleb., the fungal pathogen responsible for many Verticillium wilt diseases. V. dahliae is a single taxonomic entity, and sensitive and reliable methods exist for its detection and identification. V. dahliae is a highly polyphagous pathogen, affecting, overall, 400 cultivated and non-cultivated plant species. It is a host-adapted rather than a host-specific pathogen and has the ability to continuously widen its host range and develop races/pathotypes that can overcome host resistance or be more virulent on known hosts and host cultivars. V. dahliae is a vascular pathogen that causes wilt and plant death, thus impairing the growth and shortening the lifespan of its hosts. The pathogen is currently present in most parts of the risk assessment area, where yield reductions up to 50 % or more have been reported on some high value crops, including cotton, olive, potato, strawberry and ornamentals. There are no obvious eco-climatic factors limiting its potential establishment and spread in the non-infested part of the risk assessment area, where hosts are present.Once established, the pathogen can spread by both natural and human-assisted means. Movement of infected host plants for planting, especially asymptomatic plants, and seeds can introduce the pathogen (and its highly virulent races/pathotypes) into new areas. Application of integrated management strategies combined with disease risk assessment (assessment of the available soil-borne inoculum, determination of races/pathotypes present in the site, field cropping history) may reduce the impacts of Verticillium wilt in the risk assessment area, but it cannot eliminate the pathogen. V. dahliae is listed in Annex IIAII of Directive 2000/29/EC and, despite its wide host range, it is regulated only on Humulus lupulus (hop), for which the pathogen is considered of minor importance compared to V. nonalfalfae.
The European Commission requested the EFSA Panel on Plant Health to perform a pest categorisation of Verticillium albo-atrum Reinke and Berthold, the causal agent of Verticillium wilts. V. albo-atrum causes wilt and plant death, impairing the growth and shortening the lifespan of its hosts. V. albo-atrum was recently split into three species, V. albo-atrum sensu stricto, V. alfalfae and V. nonalfalfae, for which reliable detection and identification methods exist. V. albo-atrum sensu lato is present in most parts of the EU. The new taxonomic status of the pathogen, and the confusion that existed in the past between V. albo-atrum sensu lato and V. dahliae, cause uncertainty on its distribution worldwide and in the EU. Based on recent studies, the presence of each of the new species (V. albo-atrum sensu stricto, V. alfalfae, V. nonalfalfae) has so far been confirmed in a relatively small part of the EU. The pathogen has a wide host range. In the EU, it affects many cultivated and non-cultivated plant species, including some very important crops (alfalfa, cotton, hop, potato and tomato). However, the so far known host range of each of the above-mentioned new species is more restricted than that of V. albo-atrum sensu lato. There are no obvious ecoclimatic factors limiting the potential establishment and spread of the pathogen in the non-infested part of the EU where hosts are present. Once established, the pathogen can spread by natural and human-assisted means. Movement of infected host plants for planting, especially asymptomatic plants, can introduce the pathogen into new areas. Integrated management strategies may reduce impacts of V. albo-atrum sensu lato in the EU, but they do not eliminate the pathogen. V. albo-atrum sensu lato is listed in Annex IIAII of Directive 2000/29/EC. Despite its wide host range, it is regulated only on Humulus lupulus.
The European Commission requested EFSA’s Panel on Plant Health to perform the pest categorisation for Xylophilus ampelinus, which is the causal agent of bacterial necrosis of grapevine. X. ampelinus is a single taxonomic entity and grapevine is the only known host. X. ampelinus is regulated in the EU; it is listed in Annex II, Part A, Section II of the Directive 2000/29/EC. Reliable detection and identification tests are available. X. ampelinus is present on grapevine in 5 out of the 21 grapevine-producing EU countries.Nevertheless, it should be stressed that disease occurrence is sporadic in areas where X. ampelinus is present and depends on cultivar susceptibility and environmental conditions. The survival of X. ampelinus is unlikely to be affected by ecoclimatic conditions. In areas where X. ampelinus is present, the direct and indirect impacts can be high: yield reduction, death of grapevine plants and specific disease management procedures (use of healthy plant for planting, cumbersome management of infected vineyards). X. ampelinus is transmitted locally by rain, wind, overhead sprinkler irrigation and human activity within vineyards, and by plants for planting material over long distances, especially as infected planting material is, most of the time, asymptomatic. Control measures include the destruction of the infected plants and the application of copper compounds.
The Panel on Plant Health performed a pest categorisation of potato stolbur mycoplasma, recently renamed Candidatus Phytoplasma solani (CPs), for the European Union (EU) territory. CPs is a well-defined species of the genus Candidatus Phytoplasma, for which molecular detection assays are available. It is a regulated harmful organism in the EU, and is listed as potato stolbur mycoplasma in Annex II, Part A, Section II of Council Directive 2000/29/EC. Although CPs can infect a wide range of host plants, this listing concerns only Solanaceae plants for planting. CPs is transmitted by grafting and vegetative propagation of infected hosts, and by several insect vector species including Hyalesthes obsoletus, Reptalus panzeri, Pentastiridius leporinus and possibly others. The geographical distributions and population densities of these vectors govern the spread of CPs. CPs can infect a wide range of host plants and has been reported in 14 EU Member States (MSs). CPs can cause yield losses in potato and other solanaceous crops, in grapevine, strawberry, maize and lavender. Because host plants, wild or cultivated, are widely distributed throughout the EU, the distribution of vector populations is the main determinant of CPs establishment and spread; therefore, CPs has the potential to establish and spread in unaffected parts of the EU with the extension of the distribution range of its vectors. There are high annual fluctuations in the impact of CPs, and this is mostly affected by the prevalence of plant reservoirs for CPs and by the size of local vector populations, which cannot easily be controlled. There are uncertainties regarding the precise distribution of CPs and its vectors, the evolution of vector distribution, the long-term impact of emerging CPs genotypes and the extent of impact on the various susceptible crops grown in the EU.
Genetically modified (GM) carnation IFD-25958-3 was developed to express anthocyanins in the petals conferring a mauve colour to the flowers. The GM carnation is intended to be imported in the European Union as cut flower for ornamental use only. Based on the molecular characterisation data, the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) confirms the stability of the newly introduced trait and the absence of disruption of known endogenous genes. Since anthocyanins are common pigments in many food plants, it is not expected that accidental intake of petals of carnation IFD-25958-3 would contribute substantially to the overall intake of anthocyanins from foods. Considering the ornamental use of cut flowers, and the limited exposure scenarios expected, the EFSA GMO Panel identified no reasons for any food safety concerns relating to carnation IFD-25958-3. The EFSA GMO Panel is also of the opinion that accidental release of GM carnations into the environment would not give rise to environmental safety concerns. The EFSA GMO Panel agrees with the methodology, including reporting intervals, proposed for post-market environmental monitoring. In response to the European Commission, the EFSA GMO Panel concludes that, in the light of the ornamental use of carnation IFD-25958-3 cut flowers, there is no scientific reason to consider that the placing on the market of the GM carnation will cause any adverse effects on human health or the environment.
The Panel on Plant Health performed a pest categorisation of European isolates of Citrus tristeza virus (CTV) for the European Union (EU) territory. European CTV isolates are listed in Annexes IIAII and IIB of Directive 2000/29/EC. CTV is a well-defined and easily diagnosed Closterovirus species transmitted by the vegetative multiplication of infected hosts and through the activity of aphid vectors. Toxoptera citricida is the most efficient vector but Aphis gossypii is the most important in Europe. European isolates of CTV have been reported in seven of the eight EU Member States (MSs) with significant citrus production. The natural host range of CTV is restricted to citrus species and to a few, related genera, such as Fortunella and Poncirus. CTV is unlikely to be affected by ecoclimatic conditions in regions where its host plants are grown and has the potential to establish in southern regions of the EU territory. The majority of European CTV isolates cause severe decline symptoms (tristeza disease) in several citrus species, in particular sweet orange and mandarin grafted on susceptible sour orange or lemon rootstocks, which are commonly used in many EU MSs with the exception of Spain and, to a lesser extent, France. Symptoms of the severe stem pitting disease (SP) have not been reported by any EU MSs, despite the identification of isolates closely related to non-European isolates that cause SP in other regions of the world. The observed impact of CTV is on citrus industries still heavily reliant on susceptible rootstocks. Replacing those with CTV-tolerant rootstocks, as was done in Spain, virtually eliminates the impact of CTV in the absence of SP. Comprehensive certification systems can also reduce CTV spread and impact. The most critical area of uncertainty concerns the potential ability of some European isolates to cause SP in sweet orange.
Genetically modified (GM) carnation IFD-26407-2 was developed to express anthocyanins in the petals conferring a mauve colour to the flowers. The GM carnation is intended to be imported in the European Union as cut flower for ornamental use only. Based on the molecular characterisation data, the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) confirms the stability of the newly introduced trait and the absence of disruption of known endogenous genes. Since anthocyanins are common pigments in many food plants, it is not expected that accidental intake of petals of carnation IFD-26407-2 would contribute substantially to the overall intake of anthocyanins from foods. Considering the ornamental use of cut flowers, and the limited exposure scenarios expected, the EFSA GMO Panel identified no reasons for any food safety concerns relating to carnation IFD-26407-2. The EFSA GMO Panel is also of the opinion that accidental release of GM carnations into the environment would not give rise to environmental safety concerns. The EFSA GMO Panel agrees with the methodology, including reporting intervals, proposed for post-market environmental monitoring. In response to the European Commission, the EFSA GMO Panel concludes that, in the light of the ornamental use of carnation IFD-26407-2 cut flowers, there is no scientific reason to consider that the placing on the market of the GM carnation will cause any adverse effects on human health or the environment.
Following a request from the European Commission, the risks to human and animal health related to modified forms of the Fusarium toxins zearalenone, nivalenol, T-2 and HT-2 toxins and fumonisins were evaluated. Modified (often called “masked”) mycotoxins are metabolites of the parent mycotoxin formed in the plant or fungus, e.g. by conjugation with polar compounds. Fumonisins, which are difficult to extract from the plant matrix, are also termed modified mycotoxins. The CONTAM Panel considered it appropriate to assess human exposure to modified forms of the various toxins in addition to the parent compounds, because many modified forms are hydrolysed into the parent compounds or released from the matrix during digestion. For modified forms of zearalenone, nivalenol, T-2 and HT-2 toxins and fumonisins, 100 %, 30 %, 10 % and 60 % were added, respectively based on reports on the relative contribution of modified forms. The same factors were used for animal exposure from feed. In the absence of specific toxicity data, toxicity equal to the parent compounds was assumed for modified mycotoxins. Risk characterization was done by comparing exposure scenarios with reference doses of the parent compounds. In humans, all lower bound (LB) and upper bound (UB) mean and 95th percentile exposures to the sum of modified and parent toxins were below the respective provisional maximum tolerable daily intakes (PMTDIs) and tolerable daily intakes (TDIs), with two exceptions: for zearalenone and modified zearalenone the UB 95th percentile exposure was up to 2.2-fold the TDI. For fumonisins and modified fumonisins the exposure of toddlers and other children exceeded the PMTDI at both the LB and the UB estimates, which could be of concern. For farm animal species and pets the exposure to the sum of modified and parent toxins was in general not of concern. The risk in fish could not be addressed. The CONTAM Panel identified several uncertainties and data gaps for modified mycotoxins.
The European Commission requested the EFSA Panel on Plant Health to perform the pest categorisation for Erwinia amylovora, which is the causal agent of fire blight. E. amylovora is a plant pathogenic bacterium regulated by the Directive 2000/29/EC (Annexes II-A-II). E. amylovora is a single taxonomic entity. This organism can be accurately identified, based on a range of discriminative methods. Detection methods are available for symptomatic and asymptomatic plant material. E. amylovora ispresent in all EU Member States except Estonia, Finland and Malta, where host plants are not widely distributed or are rare. The host plants (mainly pear and apple) are cultivated throughout Europe where environmental conditions are conducive to disease development. Although no recent data are available on losses caused by E. amylovora in the EU, fire blight is considered to be the most destructive disease on pear and apple owing to the loss of trees. The analysis of past disease outbreaks previously reported in the EU highlights their considerable potential to have a severe impact on commercial horticulture, especially on apple, pear and quince, as well as on ornamentals and on nursery trade. The disease causes a range of symptoms on the aerial parts of plants, including the fruits, and E. amylovora often kills the trees and causes destructive outbreaks. Contaminated rootstocks, cuttings and grafted trees for transplanting, beehive transportation, rain and wind, are responsible for medium- and long-distance dissemination of the pathogen. Existing control is mainly based on prevention and exclusion. The use of chemical or biological products can prevent infection, and sanitation methods applied to infected plants can control the disease to a certain extent. No curative chemical control agents are available that eradicate E. amylovora in infected orchards.
The European Commission requested EFSA’s Panel on Plant Health to perform the pest categorisation for Clavibacter michiganensis subsp. insidiosus. The identity of the bacterium responsible for the bacterial wilt of lucerne is clearly defined. C. michiganensis subsp. insidiosus is present in only a few MSs in the EU and it is listed in the Annex IIAII of the Directive 2000/29/CE. Only sporadic disease outbreaks occur, and not in countries where lucerne production is of importance. The pathogen causes yield and quality loss only if susceptible cultivars are grown and conditions are favourable for disease expression. The pathogen is not reported in the main lucerne-producing MSs. There are no indications that in last decade the pathogen has a high impact on lucerne production in the EU, possibly because of the use of bacterial wilt-resistant varieties. C. michiganensis subsp. insidiosus is seed-borne and probably seed-transmitted, although with some uncertainty. The main pathway for long-distance dispersal of this pathogen is very likely via seeds, while machines and contaminated hay may also potentially play some role in the dissemination of the pathogen. The pathogen can be easily detected and identified on the basis of various microbiological and molecular tests and disease symptoms, including leaf mottling, reduction in plant height, and “witches’ broom” syndrome. Effective management strategies are available and include the use of resistant cultivars and, probably, the use of pathogen-free seeds. Finally, the Panel concluded that severe consequences, in terms of yield and quality losses, are expected for lucerne only if bacterial wilt-susceptible varieties are grown and if weather conditions are conducive to the disease.
The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 15 flavouring substances in the Flavouring Group Evaluation 12, Revision 5, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision is made due to the inclusion of the assessment of three additional candidate substances, beta-isomethylionone [FL-no: 07.041], 4-(2,5,6,6-tetramethyl-1-cyclohexenyl)but-3-en-2-one [FL-no: 07.200] and tr-1-(2,6,6-trimethyl-1-cyclohexen-1-yl)but-2-en-1-one [FL-no: 07.224], compared to FGE.12Rev4. These three substances have been cleared for a genotoxic concern in FGE.213Rev1 and can accordingly be evaluated using the Procedure in the present revision of FGE.12. The 15 substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that all 15 flavouring substances [FL-no: 02.134, 02.186, 02.216, 02.217, 05.157, 05.182, 05.183, 05.198, 07.041, 07.200, 07.224, 08.135, 09.342, 09.670 and 09.829] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI (Maximised Survey-derived Daily Intake) approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for all 15 candidate substances.
This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process SOREPET GR+ (EU register No RECYC074) which is based on Erema basic and Buhler technologies. The input to the process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, mainly bottles, containing no more than 5 % PET from non-food consumer applications. In this process, washed and dried PET flakes are crystallised and heated to the decontamination temperature, the flakes are extruded into pellets, the pellets are crystallised and heated and are solid state polymerised in a continuous reactor. Having examined the challenge test provided, the Panel concluded that the continuous decontamination (step 2), extrusion (step 3), crystallisation (step 4) and the solid state polymerisation (SSP) (step 5) are the critical steps that determine the decontamination efficiency of the process. The operating parameters to control its performance are temperature, pressure and residence time (step 2), temperature (step 3), temperature, pressure, gas flow and residence time (step 4), temperature, pressure, gas flow and residence time, (step 5). Under these conditions, it was demonstrated that the recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the modelled migration of 0.1 μg/kg food. The Panel concluded that recycled PET obtained from the process, intended to be used up to 100 % for manufacture of materials and articles for contact with all type of foodstuffs for long term storage at room temperature, with or without hot fill, is not considered of safety concern.
The EFSA Panel on Plant Health undertook a pest categorisation of the insect Scirtothrips dorsalis for the European Union. Although there are reports that this is a species complex and there are host-specific races, it is generally treated as a distinct taxon. Both morphological and molecular methods are required to confirm identification. Apart from one long-term outbreak in a botanic garden glasshouse in England, it is absent from the EU. Native to southern and eastern Asia, this species has been introduced to tropical and subtropical areas of Africa, Australasia and the Americas in recent years. It is highly polyphagous, with over 225 known hosts, which include many important EU crops. Southern areas of the EU are potentially suitable for outdoor establishment and it could establish in protected cultivation throughout the EU. Based on its phenology, the Panel showed that the climate in southern Europe could allow a similar number of generations to develop as in Japan and South Korea, where significant damage occurs to citrus and other crops outdoors. In protected cultivation, even though control methods used against other thrips species may be effective in keeping populations at low densities, damage can still occur at these densities owing to the transmission of tospoviruses. Despite being highly polyphagous, S. dorsalis is an insect listed in Annex IIAI of Council Directive 2000/29/EC only in relation to Citrus, Fortunella and Poncirus plants. These hosts are also regulated in Annex III and Annex V. They are also explicitly mentioned in Council Directive 2008/90/EC.
The EFSA Panel on Plant Health undertook a pest categorisation of the insect Rhagoletis ribicola for the European Union. This taxonomically distinct species is known to occur only in western states of the USA and Canada, where it feeds on Ribes aureum, R. rubrum and R. uva-crispa. There have been no records of it causing serious damage for over 70 years. Its geographical distribution implies that all parts of the risk assessment area where its hosts occur, i.e. all but lowland southern areas of the EU, would be suitable for establishment. Adults of the Rhagoletis genus have a limited capacity for flight. Furthermore, there are no records of R. ribicola moving via international trade routes. Therefore, spread would be most likely to occur as a result of larvae in fruit or pupae in soil. Should the pest be introduced to the EU, the limited control measures available would be similar to those used for other Rhagoletis species, being primarily based on insecticide sprays, timed to kill adults, combined with cultural methods, e.g. netting and trapping. As a non-European tephritid, R. ribicola is listed in Annex IAI of Council Directive 2000/29/EC, and requirements for Ribes are set out in Annex V of Council Directive 2000/29/EC. In addition, Ribes spp. plant material should be produced in accordance with the requirements laid down in Council Directive 2008/90/EC on the marketing of fruit plants propagating material and fruit plants intended for fruit production.
Scientific Opinions: Statements of the Scientific Committee/Scientific Panel
EFSA is requested to assess the safety of a broad range of biological agents in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS) assessment was developed to provide a harmonised generic pre-assessment to support safety risk assessments performed by EFSA’s scientific Panels. The safety of unambiguously defined biological agents (at the highest taxonomic unit appropriate for the purpose for which an application is intended), and the completeness of the body of knowledge are assessed. Identified safety concerns for a taxonomic unit are, where possible and reasonable in number, reflected as ‘qualifications’ in connection with a recommendation for a QPS status. A total of 99 biological agents were notified to EFSA between May 2013 and October 2014. From those, 26 biological agents already had a QPS status and were not further evaluated, and 54 were also not included as they are filamentous fungi or enterococci, biological groups which have been excluded from the QPS activities since 2014. The remaining 19 notifications were considered for the assessment of the suitability for the QPS list. These 19 notifications referred to 13 taxonomic units which were evaluated for the QPS status, three of which were recommended for the QPS list: a) Carnobacterium divergens, with the qualification of absence of acquired antibiotic resistance determinants; b) Microbacterium imperiale, only for enzyme production, and c) Candida cylindracea, only for enzyme production.
Statements of EFSA
Following a request of the European Commission, the European Food Safety Authority (EFSA) evaluated the concerns raised by Bulgaria and the accompanying documentation submitted under Article 34 of Regulation (EC) 1829/2003 in support of its request to prohibit the cultivation of the genetically modified maize MON 810 in the European Union. EFSA concludes that neither the arguments put forward by Bulgaria nor the documentation reveal new scientific evidence, in terms of risk to human and animal health or the environment, that would support the adoption of an emergency measure on the cultivation of maize MON 810 under Article 34 of Regulation (EC) 1829/2003. In the absence of new relevant scientific evidence, EFSA concludes that its previous risk assessment conclusions and risk management recommendations on maize MON 810 and those of its GMO Panel remain valid and applicable.
Guidance of EFSA
The availability of detailed, harmonised and high-quality food consumption data for use in dietary exposure assessments is a long-term objective of EFSA. In 2009, the EFSA guidance on “General principles for the collection of national food consumption data in the view of a pan-European dietary survey” was published, and a pan-European food consumption survey, also known as the “EU Menu”, was launched. Based on the 2009 EFSA guidance, two EU Menu feasibility pilot studies and two methodological projects, EFSA has updated the former guidance document to cover the EU Menu methodology and therefore facilitate the collection of more harmonised food consumption data from all European Union Member States by the year 2020. This guidance has been developed by the EFSA Evidence Management Unit (DATA) and the EU Menu Working Group with Advisory Function, and has been endorsed by the EFSA Network on Food Consumption Data. It provides recommendations for the collection of more harmonised food consumption data among the EU Member States for use in dietary exposure assessments of food-borne hazards and nutrient intake estimations under the remit of EFSA’s scientific panels. Food consumption information should be collected for two non-consecutive days. The 24-hour food diary method, followed by a computer-assisted personal or telephone interview (CAPI/CATI), should be used to collect data from infants and children. For all other age groups, the 24-hour dietary recall CAPI/CATI method should be used. The reported foods should be described in accordance with the EFSA FoodEx2 food classification system. A short food propensity questionnaire should be used to collect information on the consumption of some less frequently eaten foods and the consumption frequencies of food supplements. Information on the weight, height and physical activity levels of participants should also be collected in the survey.
Data collection is an important task of EFSA and a fundamental component of many of its risk assessment activities. Transparency and openness regarding the way in which data are collected and analysed are underlying principles of EFSA’s operations. This guidance, for use in conjunction with the Standard Sample Description for Food and Feed version 2.0 guidance document (SSD2), published in October 2013, addresses the transmission mechanisms, file formats, security requirements and message exchange protocols (including validation messages) to be used to facilitate the exchange of data between Member States and EFSA. These two guidance documents, updated since their original publications in January and October 2010, have been enhanced to cover additional data domains and improvements in processes and technology. They are intended to provide a transparent basis to harmonise the collection and transmission of a wide range of measurements in the area of food and feed safety assessment across all data domains for which EFSA collects and analyses data. The documents are intended to ensure the efficient flow of data into the EFSA data warehouse where EU-wide food safety data will be stored and made accessible for appropriate scientific purposes.
Statistical analyses are an essential part of risk assessments. Statistical reporting varies considerably amongst the documents that EFSA receives and produces, which can lead to lack of transparency and reproducibility of results. This guidance aims to improve quality, openness and transparency of EFSA’s work and information/analyses received by EFSA (including dossiers). It is not intended to provide guidance on which statistical methodology should be applied and how statistical analysis should be performed. A template is proposed, that covers in the broadest possible way, the reporting of relevant aspects of a statistical analysis including: objectives, sources of information (data), study design, data quality, analysis methods, results and interpretation. The guidance and template serve to harmonise and standardise transparent statistical reporting to facilitate reproducibility of the analysis, interpretation and use of the statistical results, and independent peer review.
Conclusions on Pesticide Peer Review
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State Austria, for the pesticide active substance haloxyfop-P are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data regarding mammalian toxicology and environmental fate and behaviour. The conclusions were reached on the basis of the evaluation of the representative uses of haloxyfop-P as a herbicide on carrots, fodder legumes (peas and beans), rape seed, soya bean and sugar beet. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Concerns are identified.
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria, for the pesticide active substance Z-13-hexadecen-11-yn-1-yl acetate are reported. The context of the peer review was that required by Commission Regulation (EC) No 2229/2004 as amended by Commission Regulation (EC) No 1095/2007. The conclusions were reached on the basis of the evaluation of the representative uses of Z-13-hexadecen-11-yn-1-yl acetate as a semiochemical on pine and pine forests. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. All aspects necessary to complete the exposure and risk assessments (except for consumers) could not be finalised. There is no agreed technical specification covered by the toxicological and ecotoxicological assessments.
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State United Kingdom for the pesticide active substance halauxifen-methyl are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of halauxifen-methyl as a herbicide on winter cereals (soft wheat, durum wheat, spelt, barley, rye, triticale) and spring cereals (wheat, barley, durum wheat and rye). The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Hungary for the pesticide active substance flumetralin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of flumetralin as a plant growth regulator on tobacco. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), received an application from Bayer CropScience AG to modify the existing MRLs for the active substance fluopyram in various crops. Germany drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive MRLs for most of the proposed uses, except for peaches, apricots, raspberries and chicory roots for which additional residue data are requested. Adequate analytical enforcement methods are available to control the residues of fluopyram in plant commodities. Based on the risk assessment results, EFSA concludes thatthe proposed use of fluopyram on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore, is unlikely to pose a consumer health risk
According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substances clothianidin and thiamethoxam. In order to assess the occurrence of clothianidin and thiamethoxam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.
According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substances thiophanate-methyl and carbendazim. In order to assess the occurrence of thiophanate-methyl and carbendazimresidues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the import tolerances and European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, all MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.
According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substance tolclofos-methyl. In order to assess the occurrence of tolclofos-methyl residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.
Scientific Reports of EFSA
The Commission requested EFSA to assess three studies concerning the use of rubber slats in pig holdings regarding the statistical differences between the welfare outcomes for sows and gilts when comparing concrete slatted floors and floors with a rubber overlay. The appropriateness of the methods used was assessed with respect to objectives of the studies and minimisation of the risk of bias. Measures and methods of measurements applied in the studies were compared against animal-based and non-animal-based measures recommended in EFSA opinions. The risk factors and needs of different categories of pigs regarding flooring as outlined in EFSA opinions were compared. The validity of studies A and B is questionable because of the way the field experiments were performed and/or reported. Their results must be used with caution because of the risk of bias identified. The power of study B is possibly insufficient to detect any biologically relevant effects. Studies A and B only partially use welfare measures that are relevant for assessing the degree of compliance with the legal minimum requirements. The validity of study C is low because of some fundamental limitations in the methods used to perform the study and/or the way methods are described in the report. It does not provide relevant information regarding the degree of compliance of rubber floor with legal minimum requirements. Therefore, results of study C cannot be used to provide evidence of the effect of rubber floor on welfare of sows. The findings of the three studies cannot be extrapolated to other pig categories. Experimental studies should cover the entire range of legal minimum floor requirements in the outcomes assessment and be done under different thermal scenarios. Variability at different experimental unit levels (i.e. individual animal, pen and farm level) should be adequately addressed in order to provide representative results.
Highly pathogenic avian influenza (HPAI) H5N8 outbreaks in poultry farms have been reported in Asia and Europe since January and November 2014, respectively. The entry of HPAI H5N8 into Europe and its subsequent spread within Europe are two separate events with possibly different transmission vectors. Following epidemiological investigations of infected poultry holdings, there is not yet a clear indication of the source of the virus. There are no known direct bird migration routes from Asia to western Europe. It has been hypothesised that long-distance transmission of HPAI viruses could occur as a result of cross-infection between different birds in north Eurasian breeding areas, but this hypothesis needs further investigation. HPAI H5N8 has been detected in wild bird populations in Germany and the Netherlands. Direct contact between wild birds and farmed birds in the affected holdings was unlikely. It is more plausible that indirect introduction of HPAI H5N8 to poultry holdings via humans, vehicles, equipment, fomites, live animals and/or animal-derived products contaminated with virus (for instance in faeces) of infected birds took place. Investigations in the Netherlands suggest separate introductions into four holdings and one between-farm transmission. Assessing biosecurity procedures is recommended with a focus on segregation, cleaning and disinfection, and improving where necessary. Given the apparent low pathogenicity of HPAI H5N8 for several wild bird species, focused strategic and proportionate enhancement of active and passive surveillance of living and dead wild birds in the high risk areas would improve the understanding of the risk of virus transmission to poultry. It might also facilitate the design of targeted measures to reduce the risk of virus transmission between poultry and wild birds. Timely updated analyses on the evolving situation within the European Union are required, as well as assessment of all transmission routes that might transport HPAI viruses from Asia to Europe.
The report summarises the results of the control activities related to pesticide residues in food carried out in 2012 in the EU Member States, Norway and Iceland (hereafter referred to as reporting countries). A total of 78,390 samples of more than 750 food products were analysed for pesticide residues. A substantial number of samples from third countries (6,472 samples) were taken for products subject to increased import controls under Regulation (EC) No 669/2009. In the framework of the EU-coordinated monitoring programme which is aimed at providing statistically representative results for the EU, 10,235 samples of 12 different food commodities were analysed for 205 different pesticides. Overall, 98.3 % of the tested food samples were compliant with the legal limits; 54.9 % of the samples contained no quantifiable residues at all. In general, a higher prevalence of residues exceeding the Maximum Residue Levels (MRLs) was observed for products imported from third countries (7.5 % for imported products versus 1.4 % for products produced in one of the reporting countries). On the basis of the dietary exposure assessment performed for the pesticides covered by the EU-coordinated monitoring programme EFSA concluded that according to the current scientific knowledge, the presence of residues found in food in 2012 was unlikely to have a long-term effect on the health of consumers. In 280 cases of the total of 1,765,663 determinations reported for food products covered by the EU-coordinated programme the residues occurred in concentrations where a potential short-term consumer health outcome could not be excluded if the products were consumed in high quantities.
In response to a request from the European Commission to provide advice on risks related to pets having been in contact with people infected with Ebola virus, EFSA and ECDC have jointly prepared a rapid assessment. The assessment addresses three questions: (i) the probability of a pet being in contact with a human Ebola virus disease case; (ii) the probability of a pet being exposed to Ebola virus; and (iii) the probability of a pet infected or contaminated with Ebola virus being capable of transmitting the virus to an uninfected human. This assessment covers dogs and cats as they are the most common pets in Europe. The situation in Europe is different from the one in Western Africa, the area affected by the current Ebola virus (EBOV) epidemic. In Europe, situations where a pet becomes infected through contact with an infected human are likely to bevery rare. In the event of contact with an infected human, the probability of a pet becoming infected, or to act as a fomite, can range from very low to high. However, this probability is associated with high uncertainty. In addition, there is high uncertainty about viraemia and virus excretion in pets. The probability of human exposure to the virus through contact with exposed pets is difficult to assess and may range from very low to high depending on the specific circumstances. It is recommended that risk be assessed jointly by veterinary and public health authorities using a case-by-case approach. In the absence of information about possible EBOV infection in pets and the potential for onward transmission, full precautionary measures should be taken when handling pets of persons infected with EBOV. Although it should not be considered a priority during outbreaks, sharing any information that could help to improve our understanding of EBOV in pets and other domestic animals is important for national and international stakeholders.
The European Food Safety Authority (EFSA) received a request from the European Commission for a scientific opinion on perchlorate in food, in particular fruits and vegetables. Perchlorate is a contaminant released into the environment from both natural and anthropogenic sources. The use of natural fertilisers and perchlorate contaminated irrigation water may lead to substantial concentrations in leafy vegetables. Water disinfection with chlorinated substances that potentially degrade to perchlorate could be another potential source of contamination. EFSA received analytical results for 4 731 samples submitted by six Member States, mainly for fruits, vegetables, and fruit and vegetable products. The EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) performed estimates of both chronic and ‘short-term’ exposure considering the available dataset, and data from the literature on the levels of perchlorate in fruit juices, alcoholic beverages, milk, infant formulae and breast milk. The CONTAM Panel established a tolerable daily intake of 0.3 µg/kg body weight per day, based on the inhibition of thyroid iodine uptake in healthy adults. Amongst the vulnerable subpopulations, potential acute effects of perchlorate have been suggested for fetuses and infants. The CONTAM Panel noted that a single acute exposure to perchlorate at levels found in food and water is unlikely to cause adverse effects on human health, including the more vulnerable groups of the population, and concluded that the establishment of an acute reference dose for perchlorate is not warranted. Overall, the CONTAM Panel concluded that the chronic dietary exposure to perchlorate is of potential concern, in particular for the high consumers in the younger age groups of the population with mild to moderate iodine deficiency. Furthermore, it is possible that short-term exposure to perchlorate is of concern for breast-fed infants and small children with low iodine intake.Erratum/Corrigendum
Please note that this opinion is under review.
Lenziaren is a polynuclear Fe(III) starch–saccharose complex intended to be used in food for adult cats to reduce phosphate absorption in the gastrointestinal tract in order to prevent chronic kidney disease. The recommended minimum and maximum levels are 0.25 and 1.0 g/cat per day, equivalent to 5 000 and 20 000 mg/kg complete feed, respectively. In a previous opinion, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the minimum effective dose was 1 g/cat per day based on three studies which showed either a significant reduction in serum phosphorus or a reduction in urinary phosphate. Two of these studies showed an effect at 0.25 g/cat per day, while the third one only showed an effect at a level of 1 g/cat per day. The results of a new study submitted in this application showed that overall urine inorganic phosphorus concentrations significantly decreased in cats receiving Lenziaren at 0.25 g/day compared with the control group. Therefore, considering the two previous studies, which showed an effect at 0.25 g/cat per day, and the results of the new study, the FEEDAP Panel considers that Lenziaren has the potential to be efficacious in binding intestinal phosphorus at the minimum recommended dose of 0.25 g/cat per day (equivalent to 5 g/kg complete feed). On balance, the Panel considers that the sex difference seen in the new study is an anomaly, possibly owing, as the applicant suggests, to selective feed intake. However, the Panel notes that sex differences were not explored in the remaining efficacy studies. The Panel still has the reservations expressed in the previous opinion regarding the value of the long-term use of the additive in healthy cats.Erratum/Corrigendum