The EFSA ANS Panel provides a scientific opinion re-evaluating the safety of vegetable carbon (E 153). Vegetable carbon has been evaluated previously by the SCF (1977, 1983) and by JECFA (1970, 1977, 1987). Neither Committee established an ADI for vegetable carbon, but the SCF concluded that vegetable carbon could be used in food. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations and additional literature. The Panel considered the available toxicological data too limited to establish an ADI for vegetable carbon. The Panel noted that data on the genotoxicity and carcinogenicity of carbon blacks of hydrocarbon origin has been related to the PAHs content of these substances. However, the Panel noted that the margins of exposure for benzo[a]pyrene exposure from vegetable carbon were considerably higher than those estimated from the dietary benzo[a]pyrene exposure.The Panel concluded that at the reported use levels vegetable carbon (E 153) containing less than 1.0 µg/kg of residual carcinogenic PAHs expressed as benzo[a]pyrene is not of safety concern. This was also based on the long history of safe use as a medicinal substance and the knowledge that vegetable carbon is an inert substance which is essentially not absorbed from the gastrointestinal tract following oral administration. The Panel considered that it may be appropriate to introduce in the specifications for vegetable carbon a requirement for residual carcinogenic PAHs expressed as benzo[a]pyrene using a validated analytical method of appropriate sensitivity (e.g. LOD of 0.1 µg/kg). The estimated dietary exposure of European children to vegetable carbon ranged from 3 to 29.7 mg/kg bw/day at the mean, and from 15.3 to 79.1 mg/kg bw/day at the 95^th/97.5^th percentile. The dietary exposure of UK adults was 3.8 mg/kg bw/day at the mean, and 28.1 mg/kg bw/day for high level (97.5^th percentile) consumers.

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 20 alicyclic ketones and secondary alcohols and related esters evaluated by JECFA (59th meeting) in 2002. This revision is made due to inclusion of seven additional substances cleared for genotoxicity concern compared to the previous version. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by the JECFA for all 20 substances considered in this FGE and agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all 20 substances, the information is adequate.

The Panel on Plant Health has delivered a scientific opinion on the different risks posed by European and non-European populations of the potato cyst nematodes (PCN) Globodera pallida and Globodera rostochiensis to solanaceous plants in the EU and on the effectiveness of current control measures. Although PCN, particularly G. rostochiensis, are widespread in the EU, crop damage is limited because breeders have been able to develop varieties that are resistant to the small number of genotypes that are present. These genotypes represent a minor subset of the gene pool and virulence that is present in South America. As new South American genotypes are very likely to have a similar potential for establishment and spread as existing European genotypes, the potato varieties currently grown in Europe will not be resistant to new virulent genotypes. As resistant varieties take a very long time to develop, the consequences of a new introduction of South American PCN would be major. The Panel therefore concluded that it is very important to maintain the current phytosanitary measures to prevent the entry of South American PCN. However, uncertainties over the effectiveness of the measures in Annex IVAI relating to place of production freedom and soil origin were noted, and the Panel identified additional risk reduction options for certain plants for planting (e.g. bulbs) and additional requirements to confirm the absence of PCN in places of production. The Panel also identified some problems with the existing control measures to reduce the spread of PCN within the EU. A thorough and well-coordinated EU-wide survey using standardized methods would be necessary to evaluate the need to maintain these measures. The monitoring of PCN populations should exploit new diagnostic techniques (e.g. mitochondrial DNA sequences) to ensure that the resistance available is deployed appropriately.

EFSA was asked by the European Commission to deliver a scientific opinion on brominated phenols and their derivatives, other than tetrabromobisphenol A (TBBPA) or its derivatives, in food. Brominated phenols and their derivatives comprise a complex group of brominated flame retardants, used as reactive as well as additive flame retardants in a large range of resins and polyester polymers. A call for data was issued by EFSA in December 2009. No data on brominated phenols or their derivatives were submitted to EFSA. A limited number of occurrence data, covering the food group “Fish and other seafood”, was identified in the literature. Data from European sampling showed that 2,4,6-tribromophenol (2,4,6-TBP) predominates over the other brominated phenols. Toxicity studies are scarce and mostly relates to 2,4,6-TBP. The main targets are liver and kidneys. In a limited repeated dose oral toxicity study a no-observed-adverse-effect level (NOAEL) for 2,4,6-TBP of 100 mg/kg b.w. per day was identified. 2,4,6-TBP was not genotoxic in bacterial tests in vitro, and not in vivo, but induced chromosomal aberrations in mammalian cells in vitro. No long-term toxicity or carcinogenicity studies with 2,4,6-TBP were identified. The CONTAM Panel concluded that due to the limitations and uncertainties in the current database, the establishment of a health based guidance value for 2,4,6-TBP was not appropriate. Therefore, the Panel derived a margin of exposure to assess the level of possible health concern for high consumers of fish, molluscs and crustaceans. The CONTAM Panel concluded that it is unlikely that current dietary exposure to 2,4,6-TBP in the European Union would raise a health concern. Also exposure of infants to 2,4,6-TBP via breast feeding is unlikely to raise a health concern. Due to lack of data a risk assessment of the other brominated phenols or their derivatives is not possible.

The quantitative contribution of turkeys and other major animal-food sources to the burden of human salmonellosis in the European Union was estimated. A ‘Turkey Target Salmonella Attribution Model’ (TT-SAM) based on the microbial-subtyping approach was used. TT-SAM includes data from 25 EU Member States, four animal-food sources of Salmonella and 23 Salmonella serovars. The model employs 2010 EU statutory monitoring data on Salmonella in animal populations (EU baseline survey data for pigs), data on reported cases of human salmonellosis and food availability data. It estimates that 2.6 %, 10.6 %, 17.0 % and 56.8 % of the human salmonellosis cases are attributable to turkeys, broilers, laying hens (eggs) and pigs, respectively. The top-6 serovars of fattening turkeys that contribute most to human cases are S. Enteritidis, S. Kentucky, S. Typhimurium, S. Newport, S. Virchow and S. Saintpaul. Comparing the prevalence of Salmonella in turkey flocks reported in 2010 with a theoretical combined prevalence for S. Enteritidis and S. Typhimurium of 1 % (i.e. the transitional target), a reduction of 0.4 % in the percentage of turkey-associated human salmonellosis cases would be achieved. However, when adjusting the combined prevalence of all serovars to 1 %, an 83.2 % reduction in the percentage of turkey-associated human salmonellosis cases, equivalent to 2.2 % of all human salmonellosis cases, is expected. Uncertainty and data limitations are discussed, including recommendations on how these could be overcome. Vertical transmission of Salmonella as well as hatchery acquired Salmonella contamination originating from breeding stock are very important sources for Salmonella infection in turkeys, and therefore controlling Salmonella in breeding flocks as well as in rearing and fattening flocks is necessary to minimise Salmonella in turkeys at slaughter.

Following the request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the monitoring report for the 2010 growing season of maize MON810 provided by Monsanto Europe S.A. On 7 September 2011, the EFSA GMO Panel already adopted a scientifc opinion on the 2009 monitoring report of maize MON 810. The EFSA GMO Panel followed the same approach as for the assessment of the 2009 monitoring report and assessed, in close collaboration with the EFSA Unit for Scientific Assessment Support, the methodology applied by the applicant for the Case-Specific Monitoring and General Surveillance of maize MON 810 in 2010. Concerning the Case- Specific Monitoring (CSM), the EFSA GMO Panel considered the plan for Insect-Resistant Management mainly based on the “high dose/refuge strategy”, monitoring of target pest resistance and education of farmers. Concerning General Surveillance (GS), the EFSA GMO Panel paid particular attention to the design and analysis of the farmer questionnaires. The EFSA GMO Panel notes similar shortcomings in the methodology for CSM and GS as in the 2009 monitoring report. Hence, the EFSA GMO Panel reiterates the same recommendations for improvement of the methodology for the post-market environmental monitoring of maize MON 810 as in its scientific opinion on the 2009 monitoring report of maize MON 810. However, from the data submitted by the applicant in its 2010 monitoring report, the EFSA GMO Panel does not identify adverse effects on the environment, human and animal health due to maize MON810 cultivation during the 2010 growing season. The outcomes of the 2010 monitoring report do not invalidate the previous EFSA GMO Panel’s scientific opinions on maize MON 810.

This scientific opinion of EFSA deals with the risk assessment of the co-monomer N-(2-aminoethyl)ethanolamine (CAS No 111-41-1, Ref. No 35284 and FCM substance No 262). The CEF Panel concluded that the use of N-(2-aminoethylamino)ethanol in manufacturing of can coatings in direct contact with food does not raise a safety concern for the substance itself if migration does not exceed 0.05 mg/kg food. The Panel, however, noted that many oligomers are formed during the manufacturing process which may migrate into the food. Only limited information was provided on the identities of the oligomers in the fraction below 1000 Da. Further structural and quantitative information is needed for a conclusion to be drawn concerning genotoxicity or other toxicity end points of the oligomeric fraction. The toxicological data needed will depend on the identity and level of migration of the oligomers in the food.

Introduction of FMDV into Thrace by wildlife is less likely than introduction due to movement of domestic animals or animal products. Based on a systematic literature review, currently available data of surveillance in wildlife and the epidemiological model, FMD will not be sustainable in the wildlife population in Thrace although limited spread of FMDV in time and space may occur. There are several potential risk factors associated with both introduction and spread of the FMDV infection in the region. The most important of these are biosecurity, movement of live animals and animal products, swill feeding and access to landfill waste. The absence of significant clinical signs in sheep in particular, and the increased levels of livestock movements associated with particular festivals in this region, give rise to specific concerns. Active surveillance for early detection of FMDV infection in wildlife could be a useful addition to an effective passive surveillance system in domestic animals. The EFSAwbFMD model indicated that when the sampling strategy in wildlife was based on hunting alone, the time needed to detect at least one seropositive animal for an FMDV incursion in January and July would be 39 and 13 weeks after incursion of the virus into the population respectively, whilst, when regular sampling was implemented over the whole year, about one month is needed. The precise pathway for the introduction of FMDV into Bulgaria for the 2010/2011 outbreak and its subsequent spread is not known. One possible explanation based on the genetic relationships between viruses in Bulgaria is a single introduction of virus into the country from Anatolian Turkey but it is also possible that the common ancestor was introduced into Turkish Thrace and quickly moved to Bulgaria either through a single introduction or through several introductions from the same source within a relatively short time span.

SVD is a disease of pigs caused by a virus of the family Picornaviridae. All isolates are classified in a single serotype. The disease has been reported mainly in Italy. Due to the pen disease characteristics of SVD, its negligible mortality, low morbidity and negligible production losses, the significance and the impact of SVD are considered low. The between farm spread of SVD is mainly related to movements of infected animals and/or contaminated trucks, but also to the introduction of contaminated material or persons. When applying SVD estimates of transmission, the modelled spread within farms was limited. The modelled spread of SVD between farms is at least similar to CSF if all transportation procedures of CSF contribute. Under the assumption that between-farm transmission of SVD is as low as between-animal transmission the modelled spread halved. Therefore, the impact of SVD has to be assessed on the level of infected farms and not on the level of the spread within livestock populations. VS is a disease of mainly horses, cattle and pigs caused by a virus of the family Rhabdoviridae. Two distinct immunological groups of VS virus have been recognised. There is seasonal variation in the occurrence of VS. Humans are susceptible to VSV but with limited signs of infection. VSV has been isolated from insects but no natural transmission through these vectors has been observed. VS is limited mainly to the Americas. When VS is introduced to a naïve population, the infection can lead to wide range of clinical signs from mild to severe both in cattle and horses. The mortality of VS is negligible, the morbidity is low, but the production losses in cattle can be higher yet the data are limited. For this reason, the significance and overall impact of VS are difficult to estimate. In comparison to CSFV, the modelled spread of VSV was less predictable due to several susceptible species, assuming insect vectors resulted in a VSV spread worse than CSFV. Depending on the testing system and the VSV prevalence in the subpopulation destined for export and considering that 4000 susceptible animals are imported per year, it likely will take between 14 and 100 years to import an infected animal. It is unlikely that animal products will contribute to between farm spread of SVDV and VSV.

Following a request by the European Commission, EFSA’s Panel on Plant Health was asked to deliver a statement to clarify the current scientific knowledge regarding the identity of the apple snails in the context of the evaluation of the pest risk analysis prepared by the Spanish Ministry of Environment and Rural and Marine Affairs (EFSA Panel on Plant Health (PLH), 2012). The Panel concludes on the risk to plant health posed by Pomacea species in the ‘canaliculata complex’, that out of the around 50 species in the genus of Pomacea, four species P. canaliculata, P. insularum, P. lineata and P. maculata belong to the ‘canaliculata complex’, where P. insularum and P. maculata are recently considered to be synonyms. Current methods of identification imply high uncertainty if risk reduction options are applied at the Pomacea single species level. The Spanish pest risk analysis identifies important plant health risks connected to Pomacea species. The available scientific evidence indicates that other Pomacea species may pose similar risks to plant health as identified for P. insularum.
The Panel clarifies that risk reduction options should not be targeted to single species of the genus Pomacea considering: (i) the dynamical situation in the current study on the systematics of the Ampullariidae species and the genus Pomacea in particular; (ii) the uncertainties and the possible unexpected evolution of the invasive potential of species of Pomacea other than P. insularum and P. canaliculata; (iii) the poor knowledge on the trophic habits of many species of the genus Pomacea, with possible overlaps in the trophic niche (macrophytes); (iv) the high uncertainty on the identification of the different Pomacea species.

In 2011, the EFSA Panel on Plant Health was asked by the European Commission to provide an opinion on a technical file submitted by the US Authorities to support a request to list a new heat treatment (60 °C/60 min) among the EU import requirements for wood of Agrilus planipennis host plants. After a thorough analysis of the documents provided the Panel concluded that, with a low uncertainty, A. planipennis is likely to survive the proposed heat treatment of 60 °C/60 min, and that, to ensure a control level of 99 % the temperature of the heat treatment of 60 min should be higher than 70 °C. Following the publication of this scientific opinion, the US Authorities submitted a new proposal to the European Commission, consisting in a new heat treatment (71.1 °C/60 min). The EFSA Panel on Plant Health was asked to consider whether this new proposal was within the scope of the published opinion and, if not, to clarify its conclusion and indicate what data would be needed to assess the effectiveness of the new treatment. The Panel concluded that the new proposal is not within the scope of the opinion as the data provided by the US Authorities cannot be used to evaluate the effectiveness of the new proposed heat treatment. An accurate assessment of the new proposed heat treatment (71.1 °C/60 min) would require an experiment including several temperatures higher than 70 °C (one corresponding to the proposed treatment). Regarding the data requirements for assessing the effectiveness of the new treatment, the Panel lists the information required in the checklist presented in the Panel’s draft guidance document on methodology for evaluation of the effectiveness of options to reduce the risk of introduction and spread of organisms harmful to plant health in the EU territory, currently under public consultation on EFSA website.

This guidance on the assessment of dermal absorption has been developed to assist notifiers, users of test facilities and Member State authorities on critical aspects related to the setting of dermal absorption values to be used in risk assessments of chemical plant protection products. It is based on the opinion on the science behind the revision of the guidance document on dermal absorption (EFSA, 2011) to which the guidance refers to in many instances. Basic details of experimental design, available elsewhere, have not been addressed but recommendations specific to performing and interpreting dermal absorption studies with plant protection products are given. Issues discussed include a brief description of the skin and its properties affecting dermal absorption. To facilitate use of the guidance, flow charts are included. Guidance is also provided, for example, when there are no data on dermal absorption for the product under evaluation. Elements for a tiered approach are presented including use of default values, data on closely related products, in vitro studies with human skin, data from experimental animals (rats) in vitro and in vivo and the so called “Triple pack” approach. Various elements of study design and reporting, that reduce experimental variation and aid consistent interpretation, are presented. A proposal for reporting data for Draft Assessment Reports and Registration Reports is also provided. The issue of nanoparticles in plant protection products is not addressed. Data from volunteer studies have not been discussed since their use is not allowed in EU for risk assessment of plant protection products.

Following a request from the European Commission, the European Food Safety Authority (EFSA), carried out a revised exposure assessment of ethyl lauroyl arginate (LAE) from its use as a food additive, for children and adults, based on the revised proposed uses presented in the terms of reference. Revised exposure estimates have been calculated with revised proposed use levels and individual food consumption data from the EFSA Comprehensive Database. When considering consumers only, the anticipated dietary exposure to LAE ranges from 0.06 to 0.50 mg/kg bw/day at the mean, and from 0.15 to 0.91 mg/kg bw/day at the 95^th percentile. For high consumers (95^th percentile), all population groups except the elderly, have an exposure above the ADI. The main contributor to the total anticipated dietary exposure to LAE is the category of heat-treated meat products. In 2011 by the SCCS estimated the systemic exposure to LAE resulting from its use in cosmetics around 0.0322 mg/kg bw/d. With the assumptions that oral exposure results in a corresponding systemic exposure to all released metabolites and that following dermal absorption and uptake into the circulation LAE will be rapidly and completely converted to the same metabolites as those generated following oral exposure, a comparison between the dietary exposure and the systemic exposure resulting from cosmetic products was made. This exposure is similar to the lowest range of the mean estimates from diet for the total population. For all populations, the additional exposure resulting from the use of LAE in cosmetics could be considered as minor compared to high level dietary exposure and would not change the status of the different population groups regarding the exceedance of the ADI.

In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, herewith referred as the evaluating Member State (EMS), received an application from Nissan Chemical Europe SARL to set new MRLs for the active substance amisulbrom in tomatoes, aubergines and lettuce. In order to accommodate for the intended uses of amisulbrom, Spain proposed to raise the existing default MRL value of 0.01* mg/kg to 0.4 mg/kg for tomatoes and aubergines, and to 5 mg/kg for lettuce. Spain drafted an evaluation report according to 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 MRL proposals of 0.4 mg/kg for the intended use of amisulbrom on tomatoes and aubergines and of 4 mg/kg for the intended use of amisulbrom on lettuce. Analytical enforcement methods are available to control the residues of amisulbrom in the crops under consideration at the LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concludes that the proposed uses of amisulbrom in tomatoes, aubergines and lettuce in Spain will not result in consumer exposure exceeding the provisional toxicological reference values and therefore are unlikely to pose a consumer health risk. However, since the peer review process is not yet finalised, the conclusions reached in this reasoned opinion should be taken as provisional and might need to be reconsidered in the light of the outcome of the peer review.

In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, herewith referred to as the evaluating Member State (EMS), received an application from the company Dow AgroSciences to modify the existing MRLs for the active substance methoxyfenozide in leafy vegetables and fresh herbs (except vine leaves, water cress and witloof). In order to accommodate for the intended use of methoxyfenozide in the SEU, the EMS proposed to raise the existing MRLs in these crops (except in scarole) from the limit of quantification (LOQ) of 0.02 mg/kg to 4 mg/kg. Spain drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA.

EFSA considers that the submitted supervised residue trials are sufficient to support the proposed residue data extrapolation from lettuce to other crops under consideration and to derive a MRL proposal of 4 mg/kg for the proposed use on lettuce and other salad plants including Brassicaceae, the whole group of spinach and similar leaves and the whole group of herbs. Adequate analytical enforcement methods are available to control the residues of methoxyfenozide in the commodities under consideration.

EFSA concludes that the intended uses on the leafy vegetables under consideration (except on scarole) will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern. EFSA confirms the conclusion of the EMS that the intended use of methoxyfenozide on scarole is not acceptable due to acute consumer intake concerns identified.

A quantitative approach to estimate the likelihood of introduction of an infectious disease agent into a disease-free country through the movement of animals is essential to assess the risk of introduction of such disease agent. This approach was used to establish the likelihood of introduction of vesicular stomatitis virus (VSV) in Europe based on probability theory and a set of assumptions in relation to the shipment size of importation (values ranging from 1 up to 4,000 animals), prevalence scenarios from the exporting country for each of the susceptible species and the characteristics of the testing system in place to detect VSV. Several scenarios were modelled. Considering animals imported to Europe with a testing system sensitivity of 0.98 and a prevalence of 1 out of 4,000 in the population of concern (i.e. belonging to a susceptible species and destined to export) the number of single shipments that are needed in order to have VSV introduced in Europe are 199,951. Taking into account that each year approximately 4,000 animals are imported to Europe, at least 50 years are needed for the introduction of an infected animal. When the prevalence is around 9 out of 10,000 and keeping the sensitivity at 0.98, it takes 54,193 single shipments (at least 14 years) to introduce an infected animal. Similarly, it can also be stated that if the prevalence is 1 out of 4,000 and the sensitivity is 0.99, then around 400,000 animals are to be imported (100 years) to introduce an infected animal in Europe. When the prevalence is around 9/10,000 and the sensitivity is 0.99, then the number of imported animals needed to introduce an infected animal in Europe is 108,385 taking at least 27 years.

Foot-and-mouth disease (FMD) is a viral disease primarily of cloven-hoofed animals that can profoundly affect animal husbandry by evolving into severe epidemics that reduce the productivity of susceptible livestock.. Hunting activities are considered valuable for surveillance in the hunting areas, especially at the forest edges, and are a possible option for surveillance. To assess the performance, in terms of early detection, of different monitoring and sampling schemes in case of an incursion of FMD virus in a disease free wild boar population area a simulation model was developed. The findings from this simulation show that a sampling strategy based on hunting alone needs a long time (13 to 39 weeks) before the first sero-positive animal is detected. On the contrary, a sampling strategy based on regular weekly sampling performs relevantly better (maximum number of weeks needed to detect the first sero-positive animal is 5). The simulation results show that in the investigated sensitivity range (i.e. 85% - 100%), the sensitivity of the surveillance system has almost no impact on the number of weeks needed to detect the first case. On the contrary, the specificity of the testing system must be 100% in order to avoid the reporting of false-positive results.