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: 6 (June) 2015
Scientific Opinions: Opinions of the Scientific Committee/Scientific Panel
Copper complexes of chlorophylls (Cu-chlorophylls) (E 141(i)) and copper complexes of chlorophyllins (Cu-chlorophyllins) (E 141(ii)) are prepared from sources that could not be regarded as edible plant material or food (grass, lucerne, nettle) for humans. Considering their manufacturing process, these compounds cannot be regarded as natural compounds. The Panel noted that very few studies have been conducted using Cu-chlorophylls, which hampered assessment of their safety. In contrast to (non-copper) chlorophylls and chlorophyllins, the available data showed that some components of Cu-chlorophyllins can be absorbed and distributed systematically. Given the differences in purity, chemical properties, stability and manufacturing process, the Panel considered that it was not possible to use Cu-chlorophyllins (E 141(ii)) data for read-across for Cu-chlorophylls (E 141(i)). The available data were considered inadequate by the Panel to evaluate the genotoxic potential of Cu-chlorophyllins. The Panel considered that, given the discrepancies and uncertainties in the available data concerning the carcinogenic potential of Cu-chlorophyllins, further and adequate evaluation of the possible carcinogenicity of Cu-chlorophyllins was needed. Finally, the Panel concluded that reliable data on absorption, distribution, metabolism and excretion (ADME), genotoxicity, (chronic) toxicity, carcinogenicity, and reproductive and developmental toxicity of Cu-chlorophylls (E 141(i)) and Cu-chlorophyllins (E 141(ii)) were lacking. Therefore, their safety of use as food additives cannot be assessed and the current Acceptable Daily Intake (ADI) should be withdrawn. In addition, the Panel considered that the specifications should be updated to include information on the non-chlorophyll components of E 141(i), which may represent up to 90 % of the extract, together with the precise identification of the various compounds that are present in the food additives E 141(i) and E 141(ii).
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating sorbic acid (E 200), potassium sorbate (E 202) and calcium sorbate (E 203) when used as food additives. Sorbic acid is absorbed and mainly excreted as expired carbon dioxide. The Panel noted that there was no evidence of genotoxic activity for sorbic acid or potassium sorbate. Sub-acute, sub-chronic and chronic toxicity studies did not show any adverse effects at concentrations up to 9 200 mg/kg body weight (bw)/day in rats. Given the lack of genotoxicity data on calcium sorbate and the available positive genotoxicity data on sodium sorbate, the Panel concluded that calcium sorbate should be excluded from the group ADI. The Panel concluded that the present dataset on reproductive and developmental toxicity gives a reason to revise the group ADI of 25 mg/kg bw/day set by the Scientific Committee on Food in 1996. The Panel considered that the no observed adverse effect level of 300 mg sorbic acid/kg bw/day from the two-generation reproductive toxicity study in rats can be used to allocate a temporary group ADI for sorbic acid and its potassium salt. By applying an uncertainty factor of 100, the Panel established a new temporary group ADI expressed as 3 mg sorbic acid/kg bw/day for sorbic acid and its potassium salt. The Panel noted that the most realistic approach using reported use levels and analytical data in the non-brand-loyal scenario did not exceed the temporary group ADI in any population group at the mean or in adolescents, adults and the elderly at the high level, except in the toddler and children population groups in one country.
Following a request from the European Commission, EFSA carried out an exposure assessment of steviol glycosides (E 960) arising from their use as a food additive, taking into account the proposed extension of uses. In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of steviol glycosides (E 960) and established an Acceptable Daily Intake (ADI) of 4 mg/kg body weight (bw) per day. Conservative estimates of exposure, in both adults and children, suggested that it is likely that the ADI would be exceeded at the maximum proposed use level. In 2011, EFSA carried out a revised exposure assessment of steviol glycosides based on revised proposed uses and concluded that, even if the estimates were reduced, the high-level dietary exposure in children may still exceed the ADI. A request for extension of use in hot beverages has already been evaluated by EFSA in 2014. The current revised exposure estimates are based on the currently authorised uses, the EFSA Comprehensive European Food Consumption Database and the proposed extension of use for tea beverages and instant coffee and instant cappuccino products up to 29 mg/L of steviol equivalents, rather than 10 mg/L, as assessed in the previous 2014 EFSA opinion. The Panel noted that, overall, the mean exposure estimates remain below the ADI of 4 mg/kg bw per day for all population groups, with the exception of toddlers (in one country) at the upper range of the high-level exposure estimates (95th percentile: 4.3 mg/kg bw per day), which remains above the ADI. The Panel concluded that dietary exposure to steviol glycosides (E 960) is similar to the exposure estimated in 2014 and therefore does not change the outcome of the safety assessment.
Nitrofurans are antimicrobial agents not authorised for use in food-producing animals in the European Union. Nitrofurans are rapidly metabolised, occurring in animal tissues as protein-bound metabolites. The European Commission requested EFSA to provide a scientific opinion on the risks to human health related to the presence of nitrofurans in food and whether a reference point for action (RPA) of 1.0 µg/kg for the marker metabolites is adequate to protect public health. Data on occurrence of nitrofuran marker metabolites in food were extracted from the national residue monitoring plan results and from the Rapid Alert System for Food and Feed (RASFF). The CONTAM Panel concluded that these data were too limited to carry out a reliable human dietary exposure assessment. Instead, human dietary exposure was calculated for a scenario in which a single nitrofuran marker metabolite is present at 1.0 µg/kg in foods of animal origin, excluding milk and dairy products. The mean chronic dietary exposure for this worst-case scenario would range from 3.3 to 8.0 and 1.9 to 4.3 ng/kg b.w. per day for toddlers and adults, respectively. Nitrofurans and their marker metabolites, generally, are genotoxic and carcinogenic and, also, have non-neoplastic effects in animals. Margins of exposure (MOEs) were calculated at 2.0 × 105 or greater for carcinogenicity and at 2.5 × 103 or greater for non-neoplastic effects. The CONTAM Panel concluded that it is unlikely that exposure to food contaminated with nitrofuran marker metabolites at or below 1.0 µg/kg is a health concern. A scenario in which foods are considered to be contaminated with semicarbazide, from use of carrageenan as a food additive, at 1 µg/kg was used to assess whether it is appropriate to apply the RPA to foods of non-animal origin; MOEs of greater than 104 calculated for non-neoplastic effects do not indicate a health concern.
The European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the risks for human health related to the presence of tetrahydrocannabinol (THC) in milk and other food of animal origin. THC, more precisely delta-9-tetrahydrocannabinol (Δ9-THC) is derived from the hemp plant Cannabis sativa. In fresh plant material, up to 90 % of total Δ9-THC is present as the non-psychoactive precursor Δ9-THC acid. Since few data on Δ9-THC levels in foods of animal origin were available, the Panel on Contaminants in the Food Chain (CONTAM Panel) estimated acute human dietary exposure to Δ9-THC combining different scenarios for the presence of Δ9-THC in hemp seed-derived feed materials. Acute exposure to Δ9-THC from the consumption of milk and dairy products ranged between 0.001 and 0.03 µg/kg body weight (b.w.) per day in adults, and 0.006 and 0.13 µg/kg b.w. per day in toddlers. From human data, the CONTAM Panel concluded that 2.5 mg Δ9-THC/day, corresponding to 0.036 mg Δ9-THC/kg b.w. per day, represents the lowest observed adverse effect level. By applying an overall uncertainty factor of 30, an acute reference dose (ARfD) of 1 μg Δ9-THC/kg b.w. was derived. The exposure estimates are at most 3 % and 13 % the ARfD, in adults and toddlers, respectively. The CONTAM Panel concluded that exposure to Δ9-THC via consumption of milk and dairy products, resulting from the use of hemp seed-derived feed materials at the reported concentrations, is unlikely to pose a health concern. A risk assessment resulting from the use of whole hemp plant-derived feed materials is currently not feasible due to a lack of occurrence data. The CONTAM Panel could also not conclude on the possible risks to public health from exposure to Δ9-THC via consumption of animal tissues and eggs, due to a lack of data on the potential transfer and fate of Δ9-THC.
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 85 biological agents were notified to EFSA between October 2014 and March 2015. From those, 35 biological agents already had a QPS status and were not further evaluated, and 45 were also not included as they are filamentous fungi or enterococci, biological groups which have been excluded from the QPS activities since 2014. Two notifications referred to two taxonomic units which were evaluated for the QPS status, one of which was recommended for the QPS list: Xanthomonas campestris, only for the production of xanthan gum, while the other, Bacillus circulans, was not due to insufficient body of knowledge on a safe history of use in foods and feeds. Three notifications belonging to the genus Streptomyces were not evaluated for the QPS status, because the genus was recently considered not suitable for the QPS approach.
Following a request from the European Commission, in this scientific opinion the EFSA Panel on Plant Health evaluates the risk of entry into the European Union of harmful organisms associated with soil or growing medium attached to plants for planting, as commodities, and as contaminants on imported consignments. The Panel compared several definitions of soil and growing media and used, in this opinion, the current definition for growing media of the International Plant Protection Convention. In Council Directive 2000/29/EC, no specific definition of soil and growing media is provided but growing media are described in two different ways. From the soil and growing media and/or components thereof identified through extensive literature searches, the Panel distinguished eight groups of soil and growing media and assessed the probability of association of these groups with harmful organisms. A total of 207 scientific publications were reviewed by the Panel in order to identify and rate the effectiveness of options that could reduce the risk of entry of pests posed by the import of soil and growing media. A detailed description and evaluation of the requirements for soil and growing media laid down in current EU legislation on plant health and in a few other regions of the world is provided. The Panel found that the ‘prohibition of import’ is the only phytosanitary measure with a very high effectiveness and a low uncertainty. The effectiveness of the phytosanitary measures ‘pest free production site and preparation of consignment’ is rated as moderate to high with an uncertainty rated as medium to high. Although several phytosanitary measures in these categories of risk reduction options could be highly effective, EU legislation does not provide clear formulation and guidance on their implementation.
Following a request from the European Commission, the risks to human health related to the presence of chlorate in food were assessed by the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel). The presence of chlorate in food can arise from the use of chlorinated water for food processing and the disinfection of food-processing equipment. Inhibition of iodine uptake in humans was identified as the critical effect for chronic exposure to chlorate. A tolerable daily intake (TDI) of 3 µg chlorate/kg body weight (b.w.) was set by read-across from a TDI of 0.3 µg/kg b.w. derived for this effect for perchlorate, multiplied by a factor of 10 to account for the lower potency of chlorate. Formation of methaemoglobin was identified as the critical acute effect of chlorate. An acute reference dose (ARfD) of 36 µg chlorate/kg b.w. was derived from a no-observed-effect-level for chlorate in a controlled clinical study. Chronic exposure of adolescent and adult age classes did not exceed the TDI. However, at the 95th percentile the TDI was exceeded in all surveys in ‘Infants’ and ‘Toddlers’ and in some surveys in ‘Other children’. Chronic exposures are of concern in particular in younger age groups with mild or moderate iodine deficiency. Mean and 95th percentile acute exposures were below the ARfD for all age groups indicating no concern. Based on the current practices in food industry, application of a hypothetical maximum residue limit (MRL) of 0.7 mg/kg for all foodstuffs and drinking water would only minimally reduce acute/chronic exposures and related risks. Assuming chlorate concentrations of 0.7 mg/kg for all foods and drinking water consumed in a day, acute exposures would increase by up to about 5-fold and the ARfD be exceeded at mean estimates in ‘Infants’ and ‘Toddlers’ and at 95th percentile also in ‘Other children’and ‘Adults’.
An alternative method to the HTST treatment (High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or equivalent pasteurisation effect achieving a negative reaction to a phosphatase test), approved for the treatment of bovine colostrum (Category 3 material), was assessed. The purpose of the alternative method, based on a series of filtration steps, is the production of Colostrinov, a product whose main ingredient is bovine colostrum, to be used for foal nutrition. Since the filtration techniques used are known to eliminate particles of the size of bacteria, fungi and protozoa from liquids, it is reasonable to assume that the microfiltration process reduces these contaminants to a level at least equivalent to the treatment required by the legislation. Owing to their small size, viruses are not retained by the mechanical effect of the filters but they may be retained by physico-chemical interactions with the surface of the filter, depending on the surface properties of the viruses and those of the filter, as well as on the properties of the surrounding liquid. From the information provided by the applicant, it cannot be concluded whether or not the microfiltration process reduces the relevant viral contaminants to a level at least equivalent to a single HTST treatment as required by the legislation.
Maize MON 87427 was developed by Agrobacterium tumefaciens-mediated transformation to express the CP4 5-enolpyruvyl-shikimate-3-phosphate synthase (EPSPS) protein, in all tissues except for the male reproductive tissues, conferring tissue-selective tolerance to glyphosate. The molecular characterisation of maize MON 87427 did not give rise to safety issues. Agronomic and phenotypic characteristics as well as compositional data of maize MON 87427 did not raise food/feed and environmental safety concerns. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed CP4 EPSPS protein. The nutritional value of maize MON 87427 is not expected to differ from that of non-genetically modified (GM) maize varieties. There are no indications of an increased likelihood of establishment or spread of feral maize plants. Given its intended use in food and feed, interactions with the biotic and abiotic environment were not considered an issue. Risks associated with an unlikely, but theoretically possible, horizontal gene transfer from maize MON 87427 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the scope of the application for maize MON 87427. In conclusion, the EFSA Panel on Genetically Modified Organisms considers that the information available for maize MON 87427 addresses the scientific comments raised by Member States and that the maize MON 87427, as described in this application, is as safe as its conventional counterpart and non-GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of the application.
Single events MON 87708 and MON 89788 were combined to produce the stack two-event soybean MON 87708 × MON 89788. The EFSA GMO Panel previously assessed the two single events and did not identify safety concerns in the context of their scope. No new data on single soybean events leading to a modification of the original conclusions on their safety were identified. Agronomic and phenotypic characteristics, as well as compositional data of soybean MON 87708 × MON 89788, did not give rise to food/feed and environmental safety concerns. The EFSA GMO Panel considers that there is no reason to expect interactions between the single events that could impact on the food and feed safety and the nutritional properties of soybean MON 87708 × MON 89788. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering the scope of application EFSA-GMO-NL-2012-108, potential interactions with the biotic and abiotic environment were not considered to be a relevant issue. The unlikely but theoretically possible transfer of the recombinant genes from soybean MON 87708 × MON 89788 to environmental bacteria does not give rise to any safety concern. The post-market environmental monitoring plan and reporting intervals are in line with the scope. In conclusion, the EFSA GMO Panel considers that the information available for soybean MON 87708 × MON 89788 addresses the scientific comments raised by Member States and that the soybean MON 87708 × MON 89788, as described in this application, is as safe as its non-GM comparator and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment in the context of its scope.
This opinion reviews information on small-scale dairy cow farming systems in Europe, including the impact of production diseases on welfare of cows, and proposes a methodology for welfare assessment in those systems. To address specific expectations of consumers that food be produced locally or regionally or maintaining acceptable animal welfare conditions, in addition to herd size, criteria to define farms as “non-conventional” were proposed. Several sources were investigated for identifying criteria for the description and categorisation of small-scale farms, including dairy umbrella organisations and literature. In addition to herd size (up to 75 cows), proposed criteria related to small-scale farming comprise the workforce source, input level, indigenous breed use and production type certification. To cover the large diversity of farming systems across Europe, it was proposed that farms meeting at least two of these criteria be considered non-conventional. To adapt the welfare assessment to small-scale farms, the same risk factors and welfare consequences, as measured by corresponding animal-based measures identified in previous opinions for intensive farming systems were considered to be also relevant for small-scale systems. In addition, factors related to resources provided on pasture (e.g. shelter), management of pasture (e.g. mixing herds) and management of the cows (e.g. use of local breeds) were considered more likely to be present in small-scale systems. An on-farm survey was run to collect data for welfare assessment from 124 European farms. The distribution of risk factors and animal-based measures varied across the full range in study farms and showed similar patterns in farms with different grazing systems (from no time to full year on pasture). The animal-based measures identified for intensive farming are well suited for application in small-scale dairy farms. Production disease impact on the individual animal’s welfare state does not depend on herd size or farming system.
This updated scientific opinion on oyster mortality addresses 1) the role of ostreid herpesvirus (OsHV-1) in mortality, 2) evidence for a role of Vibrio aestuarianus in mortality, 3) effectiveness of water treatment in inactivating OsHV-1 and V. aestuarianus and 4) feasibility, availability and effectiveness of the disease prevention and control measures. A new pattern of mass mortality of Pacific oysters (C. gigas) was observed in France and other European countries from 2008 onwards. Similar outbreaks were reported in 2010-11 from Australia and New Zealand. Studies performed since 2010 has provided strong evidence that OsHV-1 µVar is causally linked to increased oyster spat mortality at sea water temperatures above 16 °C. V. aestuarianus subsp. francensis was detected in France in 2001 in moribund oysters; since then this bacterium has been regularly detected during oyster mortality events. Owing to a lack of information, the causal relationship between V. aestuarianus and oyster mortality has not been established. Discharge of untreated seawater from depuration plants remains a potential mode of transmission of diseases affecting bivalves and other marine life. Effective disinfection of seawater effluent from depuration and holding facilities will minimize the risk of transmission of infectious agents. Unrestricted movement of oysters is associated with a high risk of spread of OsHV-1. Wild populations of C. gigas also contribute to spread of OsHV-1. Only a few areas in Europe continue to remain free from OsHV-1. Once infected, an area is not likely to regain freedom from OsHV-1 if a wild population of C. gigas is present. Almost all OsHV-1 strains isolated after 2008 conform to the definition of microvariants. Therefore, it appears unnecessary to maintain a separate definition of microvariants for disease control purposes. The criteria in Directive 2006/88/EC for listing of non-exotic diseases are currently not fulfilled for mortality caused by OsHV-1 microvariants.
EFSA was asked to deliver a scientific opinion on acrylamide (AA) in food. AA has widespread uses as an industrial chemical. It is also formed when certain foods are prepared at temperatures above 120 °C and low moisture, especially in foods containing asparagine and reducing sugars. The CONTAM Panel evaluated 43 419 analytical results from food commodities. AA was found at the highest levels in solid coffee substitutes and coffee, and in potato fried products. Mean and 95th percentile dietary AA exposures across surveys and age groups were estimated at 0.4 to 1.9 µg/kg body weight (b.w.) per day and 0.6 to 3.4 µg/kg b.w. per day, respectively. The main contributor to total dietary exposure was generally the category ‘Potato fried products (except potato crisps and snacks)’. Preferences in home-cooking can have a substantial impact on human dietary AA exposure. Upon oral intake, AA is absorbed from the gastrointestinal tract and distributed to all organs. AA is extensively metabolised, mostly by conjugation with glutathione but also by epoxidation to glycidamide (GA). Formation of GA is considered to represent the route underlying the genotoxicity and carcinogenicity of AA. Neurotoxicity, adverse effects on male reproduction, developmental toxicity and carcinogenicity were identified as possible critical endpoints for AA toxicity from experimental animal studies. The data from human studies were inadequate for dose-response assessment. The CONTAM Panel selected BMDL10 values of 0.43 mg/kg b.w. per day for peripheral neuropathy in rats and of 0.17 mg/kg b.w. per day for neoplastic effects in mice. The Panel concluded that the current levels of dietary exposure to AA are not of concern with respect to non-neoplastic effects. However, although the epidemiological associations have not demonstrated AA to be a human carcinogen, the margins of exposure (MOEs) indicate a concern for neoplastic effects based on animal evidence.
This opinion investigated the use of perches for laying hens in cage and non-cage systems. It is based on various activities reviewing the effects of perch height and design on hen health and welfare. Systematic and extensive literature reviews were conducted to assess the scientific evidence about hen motivation to grasp and seek elevation, and the appropriate height of perches as well as other features (position, material, colour, temperature, shape, width and length). In addition, an expert knowledge elicitation (EKE) exercise was run with technical hearing experts to discuss and prioritise the various design aspects of perches. Overall, the body of literature on perches is limited. Relevant features of perches are often confounded with others. In the literature, the most commonly used animal-based measures to assess perch adequacy are keel bone damages, foot pad lesions and perch use by hens. Overall, hens seek elevation during the day as well as during the night, when they select a site for roosting. Elevated perches allow hens to monitor the environment, to escape from other hens, avoid disturbances and improve thermoregulation. For night-time roosting hens show a preference for perches higher than 60cm compared with lower perches. However, elevated perches can have negative consequences with increased prevalence of keel deformities and fractures. The risk of injury increases when hens have to jump a distance of more than 80cm vertically, horizontally or diagonally to reach or leave a perch, or jump an angle between 45 and 90° (measured at the horizontal plane). Material, shape, length and width of the perch also influence perch preference by hens. The EKE exercise suggests that an adequate perch is elevated, accessible and functional (providing sufficient overview). The opinion concludes that for the design of an adequate perch, different features of perches need to be further investigated and integrated.
Scientific Opinions: Statements of the Scientific Committee/Scientific Panel
The Panel has interpreted the Terms of Reference by carrying out a stepwise evaluation of the BEEHAVE simulation model with a view to assessing its suitability for use in a regulatory context and for risk assessment of multiple stressors at the landscape level. The EFSA opinion on good modelling practice was used to evaluate the model and its documentation systematically. The overall conclusion is that BEEHAVE performs well in modelling honeybee colony dynamics, and the supporting documentation is generally good but does not fully meet the criteria of the good modelling opinion. BEEHAVE is not yet usable in a regulatory context primarily because it needs a pesticide module. BEEHAVE has a Varroa/ virus module, although this seems to underestimate the impact of Varroa/virus on colony survival, and additional stressors (chemical and biological) would need to be added to allow investigation of the effects of interactions of pesticides with multiple stressors. BEEHAVE currently uses a very simple representation of a landscape and this should be extended. There is only one environmental scenario in the present version of BEEHAVE (European central zone—weather scenarios for Germany and the UK) and extension to other European zones would be needed. The supporting data and default parameter values should be further evaluated and justified. The modelling environment used by BEEHAVE (NetLogo) has an excellent user interface but provides limited opportunities for extending the model. The Panel recommends that BEEHAVE should be adopted as the basis for modelling the impact on honeybee colonies of pesticides and other stressors, but that further development should use a standard, object-oriented language rather than NetLogo.
Classical biological control has been successfully used in various continents to manage many invasive alien plants originating from Europe, but this approach is still not widely adopted in Europe, despite its advantages (sustainable, effective, efficacious, good safety record) compared to chemical and manual control of weeds. Following the publication in April 2015 of the EFSA PLH Scientific Opinion on the risk posed to plant health in the EU by the intentional release of the bud-galling wasp Trichilogaster acaciaelongifoliae for the control of the invasive alien plant Acacia longifolia, the EFSA PLH Panel is publishing this statement on the procedure to follow should similar requests be made in future. Ideally what is required for an EFSA Opinion on a risk assessment of a BCA release is: (i) host specificity tests of a plant list agreed in advance by an appropriate body; (ii) a risk assessment for plant health produced using a standardized template for the whole of the EU or at the least for an appropriate bio-climatic area within the EU; and (iii) consideration of benefits. This process could be facilitated by an expert working group that would be available to advise the applicant at regular intervals. The role of EFSA is best suited to providing a peer review of a weed BCA risk assessment for the EU considering that peer review of applications prepared by researchers specialized in a particular BCA is the procedure adopted for BCA risk assessment in the countries that have much experience with using exotic BCAs of weeds. Following the appropriate International Standard for Phytosanitary Measures (ISPM) 3 and European and Mediterranean Plant Protection Organization (EPPO) Phytosanitary Measure (PM) 6/1 standards will help the releasing authority manage the process. Post-release, as per EPPO PM 6/2, all appropriate safety procedures should be put in place.
Scientific Opinions: Guidance of the Scientific Committee/Scientific Panel
This document provides guidance for the agronomic and phenotypic characterisation of geneticallymodified (GM) plants and clarifies the EFSA GMO Panel’s view on how agronomic and phenotypicdata support the risk assessment of GM plants. Specific recommendations are given on (1) theselection of sites and test materials; (2) the quality and design of field trials; (3) the selection ofrelevant agronomic and phenotypic endpoints; and (4) data analysis. The guidance proposes acomprehensive and harmonised approach for the agronomic and phenotypic characterisation of GMplants, which should ensure the best use of agronomic and phenotypic data for the comparativeanalysis of GM plants and derived food and feed products, and for their food and feed andenvironmental risk assessment.
According to Articles 11(6) and 23(6) of Regulation (EC) No 1829/2003 on genetically modified food and feed, the European Food Safety Authority should publish detailed guidance to assist applicants in the preparation and presentation of their applications for the renewal of authorisations of that genetically modified food and feed. This guidance document describes the data requirements for renewal applications, which should contain a copy of the authorisation, post-market monitoring and post-market environmental monitoring reports, systematic search and evaluation of literature, updated bioinformatics and any additional documents or studies performed by or on behalf of the applicant during the authorisation period. The applicant is requested to assess the collected information and conclude whether the previous risk assessment remains valid. The applicant can also propose amending or complementing the original conditions of the authorisation, including the monitoring plan(s).
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 Germany, for the pesticide active substance epoxiconazole are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data regarding residues and ecotoxicology. The conclusions were reached on the basis of the evaluation of the representative uses of epoxiconazole as a fungicide on cereals and sugar beets. 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.
In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium, hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing maximum residue levels (MRLs) for the active substance ametoctradin in sage and basil. In order to accommodate for the intended uses of ametoctradin, Belgium proposed to raise the existing MRLs from the limit of quantification (LOQ) 0.01* mg/kg to 60 mg/kg. Belgium 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 an MRL proposal of 20 mg/kg for the proposed uses on sage and basil. Adequate analytical enforcement methods are available for the enforcement of ametoctradin residues in high water content plant matrices. Based on the risk assessment results, EFSA concludes that the proposed uses of ametoctradin on sage and basil will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.
In accordance with Article 6 of Regulation (EC) No 396/2005, Italy, hereafter referred to as the evaluating Member State (EMS), received an application from Cheminova A/S to set a maximum residue level (MRL) for the active substance fluazinam in tomatoes. In order to accommodate for the intended use of fluazinam, Italy proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.05 mg/kg to 0.3 mg/kg. Italy 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 a MRL proposal of 0.3 mg/kg for the intended use on tomatoes. Adequate analytical enforcement methods are available to control the residues of fluazinam on the commodity under consideration. Based on the risk assessment results, EFSA concludes thatthe proposed use of fluazinam on tomatoes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.
In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), United Kingdom, received an application from Bayer CropScience S.A.S. to modify the existing maximum residue level (MRL) for the active substance fluoxastrobin in shallots. In order to accommodate for the intended use of fluoxastrobin, the United Kingdom proposed to set the MRL at 0.04 mg/kg. According to EFSA the data are sufficient to derive a MRL proposal of 0.04 mg/kg for the intended use on shallots in northern Europe. Adequate analytical enforcement methods are available to control the residues of fluoxastrobin and its Z-isomer in the commodity under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of fluoxastrobin on shallots will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.
In compliance with Article 43 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) received from the European Commission (EC) a mandate to provide its reasoned opinion on the existing maximum residue levels (MRLs) for chlorpyrifos which might lead to consumers intake concerns on the basis of the new toxicological reference values and of the data currently available to EFSA. In order to identify the potential MRLs of concern that require a more detailed assessment, EFSA performed a first unrealistically conservative intake calculation on the basis of the existing EU MRLs for chlorpyrifos. Those potential MRLs of concern were assessed in more detail by EFSA and where the safety of the existing EU MRLs could not be confirmed by the available data, possible measures for risk mitigation were assessed by EFSA.
In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission (EC) requested EFSA to provide a scientific opinion on atrazine in cereals and the appropriateness to maintain the current temporary maximum residue level (MRL) of 0.1 mg/kg considering the import tolerance request from Argentina. Based on the data submitted by Argentina, EFSA concluded that an MRL at the level of 0.05 mg/kg for atrazine in maize is more appropriate than 0.1 mg/kg. Moreover, EFSA recommends setting the MRLs for all cereals at 0.05 mg/kg, a level equivalent to the LOQ for atrazine in plant commodities that can be achieved with analytical methods used for enforcement purposes. The proposed MRLs do not pose a consumer health risk for the European consumers.
Scientific Reports of EFSA
In order to identify the drivers for spillover of Ebola virus from animal to humans, a set of drivers for spillover of infectious diseases was identified from the literature. A subset of scientific studies was used to structure a corpus of relevant arguments. This corpus was used to analyse the driver network and visualise the driver behaviour. The analysis led to the identification of 40 drivers, connected through 142 linkages. The visualisation of the driver network showed that central drivers involved in spillover are ‘Hunting’, ‘Deforestation/forest fragmentation’, and ‘Demographic changes of wildlife’. The most frequent driver links identified were ‘Deforestation/forest fragmentation’ leading to ‘Ecosystem changes’ and ‘Livelihoods resilience’ leading to ‘Hunting’. Different limitations may affect this methodology, such as the limited number of documented Ebola spillover events from which scientific evidence is available, the limited number of published studies which address the issue of drivers for spillover, and the nature of some review studies interpreting evidence from original research papers. The findings reported here should therefore be interpreted as a reflection of the current view of the scientific community on Ebola virus spillover, rather than a comprehensive representation of drivers of spillover. The methodology used in this report demonstrates a more structured and transparent approach to analysing drivers for infectious diseases. This methodology could further be applied to other complex topics that would benefit from visualisations of diverse yet connected factors. One of the main conclusions of this work is that understanding the drivers of Ebola virus spillover in West Africa requires a multi-disciplinary perspective. The need for cooperation across disciplines is not limited to Ebola. Research on the drivers of emergence of infectious diseases at the human/animal interface should take a holistic approach, including multidisciplinary backgrounds and fostering knowledge from different disciplines.
In the context of further developing the excellence of its scientific assessments, enhancing their transparency and openness and in line with the trend in the scientific community, EFSA started the PROMETHEUS project (Promoting Methods for evidence use in scientific assessments) (2014–2016), which aims at further improving EFSA’s methods for “dealing with data and evidence” (i.e. for collecting/extracting, validating/appraising, analysing and integrating data and evidence) and increasing their consistency. The project envisages two scientific reports: the present document, which illustrates the principles and process for evidence use, and a second one, which will contain an analysis of the methods for dealing with evidence applied by the Authority and an impact analysis of the implementation of the PROMETHEUS process in EFSA. Methodological aspects related to the definition of the risk assessment process and domain-specific methodological issues are beyond the scope of PROMETHEUS. On the basis of EFSA core values, the principles for evidence use are: impartiality; excellence in scientific assessments (specifically related to the concept of methodological quality); transparency and openness; and responsiveness. The principles are interdependent and sometimes even in conflict; finding a compromise between them remains a responsibility of the assessors. A series of aspects to consider for promoting each principle is described. The process for dealing with data and evidence in a scientific assessment consists of: 1) Planning upfront a strategy for the assessment; 2) Conducting the assessment in line with the planned strategy and documenting the modifications to it; 3) Verifying the process; 4) Documenting and reporting the process, results and conclusions, and ensuring accessibility of methods and data. The principles and process illustrated apply to scientific assessments performed by generating data ex novo, using already existing data and to all types of scientific assessments irrespective of their objective, scope and authors. The principles also apply when scientific information is obtained by eliciting expert knowledge.