Residue analyses and exposure assessment of the Irish population to nitrofuran metabolites from different food commodities in 2009–2010

peer-reviewedAn exposure assessment to nitrofuran residues was performed for three human populations (adults, teenagers and children), based on residue analyses of foods of animal origin (liver, honey, eggs and aquaculture) covering the 2-year period 2009– 2010. The occurrence of nitrofuran metabolites in food on the Irish market was determined for the selected period using the data from Ireland’s National Food Residue Database (NFRD) and from results obtained from the analysis of retail samples (aquaculture and honey). Laboratory analyses of residues were performed by methods validated in accordance with Commission Decision 2002/657/EC regarding performance of the analytical method and interpretation of results. Semicarbazide (SEM) was the contaminant most frequently identified and its content ranged from 0.09 to 1.27 μg kg−1. SEM is currently used as a marker of nitrofuran abuse, but it may also occur from other sources. The presence of nitrofuran metabolite 3-amino-2-oxazolidinone (AOZ) was detected in two aquaculture samples (prawns) at 1.63 and 1.14 μg kg−1, but such a low number of positive cases did not present sufficient data for a full AOZ exposure assessment. Therefore, the evaluation of exposure was focused on SEM-containing food groups only. Exposure assessments were completed using a probabilistic approach that generated 10 iterations. The results of both the upper- and lower-bound exposure assessments demonstrate that SEM exposure for Irish adults, teenagers and children from selected food commodities are well below EFSA-estimated safe levels.This research was funded by the Food for Health Research Initiative (FHRI) administered by the Irish Department of Agriculture, Food and the Marine and the Health Research Board (Contract 07FHRIAFRC5

Harmonising and integrating existing exposure factors systems world-wide: feasibility study report

Eight world-wide available exposure factors systems have been selected including the ExpoFacts database that we manage. They include USA, Canada, Australia, China, Japan and Korea in addition to Germany. They are analysed across their commonalities and differences with ultimate objective to identify the potential for harmonisation, interoperability and integration. The cross-analysis is based on 20 criteria that have been grouped into five categories: project management, design & architecture, data content, data quality and data values types & usage. The selected criteria are mainly extracted from the WHO-IPCS harmonisation project on uncertainty and data quality in exposure assessment and then adapted to better fit the purpose of this analysis. The main conclusions and recommendations have resulted from the comparison and the relative analysis.JRC.I.1-Chemical Assessment and Testin

Detection of banned nitrofuran metabolites in animal plasma samples using UHPLC–MS/MS

peer-reviewedThe use of nitrofurans as veterinary drugs in food-producing animals has been banned in the EU since the 1990s. Monitoring programs in the EU are based on the detection of protein-bound metabolites after slaughter. An UHPLC–MS/MS method was developed and validated for pre slaughter determination of four nitrofuran metabolites (AHD, AOZ, SEM, AMOZ) in animal plasma (bovine, ovine, equine and porcine). This method is proposed as an alternative method for on-farm surveillance. Plasma samples were derivatised with 2-nitrobenzaldehyde and subsequently extracted with organic solvent. Extracts were concentrated and then analysed by UHPLC–MS/MS. The method was validated according to Commission Decision 2002/657/EC. Inter-species recovery for AHD, AOZ, SEM and AMOZ was 72, 74, 57 and 71%, respectively. Decision limits (CC ) were calculated from within laboratory reproducibility experiments to be 0.070, 0.059, 0.071 and 0.054 gkg−1, respectively. In addition, the assay was applied to incurred plasma samples taken from pigs treated with furazolidone

INJURY AND ACCIDENT DATA COLLECTION EFFORTS IN EUROPE IN SUPPORT OF CONSUMER PRODUCT SAFETY POLICY

Background Availability of data on the external causes of injuries/accidents which includes product related information is a prerequisite to guide targeted preventive actions in the area of consumer product safety and to support market surveillance enforcement and policy efforts in the EU. Description of the problem Unlike in the USA, no common injury database with meaningful information to support product safety work is currently in force in the EU. Data on injuries/accidents are collected in an extremely patchy and diverse way across Member States. Yet, the amount of data available at national level in diverse fields (e.g. injury datasets, fire statistics, poison centers) can potentially provide relevant information for market surveillance and product safety policy and enforcement purposes. However, it is frequently not comparable due to lack of harmonized methodology and classification, covers only a limited number of injury types or has a limited territorial coverage. Results/Changes EC (DG JUST and DG JRC) collaborate on injuries/accident data collection for product safety and market surveillance with the aim to: map existing data collection systems on injuries/accidents of relevance for product safety and market surveillance in MS; explore innovative IT tools to improve systems’ interoperability; develop a methodology to organize/filter/extract/use available data trends; identify possible alternatives/solutions with a view to increase the availability of injury/accident data useful for product safety purposes and assessing the related costs. Conclusions European Commission works towards adding EU value to existing national data collections in MS on accident/injuries in support of product safety and market surveillance with traceable policy impact and societal benefits: informing and boosting the effectiveness of product safety policy actions; improving product safety standards; reducing societal burden of injuries and accidents due to unsafe products and related health costs.JRC.F.2-Consumer Products Safet

Persistence of alphacypermethrin residues in milk of lactating donkeys (Equus asinus) using UHPLC-MS/MS

The aim of this study was to measure the persistence of residues of the pyrethroid insecticide α-cypermethrin (ACYP) in the milk of lactating donkeys following pour-on treatment. Milk was collected from animals (n = 7) before the treatment and at 12, 24, 36, 48, 60, 72 and 84 h post-treatment. The last sampling was taken 7 days post-treatment (168 h). Milk samples were analysed by ultra-high-performance liquid chromatography coupled to tandem mass spectrometry (UHPLC-MS/MS). The analytical method was validated following requirements of Commission Decision 2002/657/EC. All samples showed levels of ACYP below the maximum residue limit (MRL) of 20 μg kg−1 established for bovine milk (Commission Regulation (EU) No. 37/2010). The results demonstrate that there is minimal partitioning of ACYP into milk in lactating donkeys from pour-on treatment

Improving substance information in USEtox®, Part 2: Data for estimating fate and ecosystem exposure factors

The scientific consensus model USEtox® is developed since 2003 under the auspices of the UNEP-SETAC Life Cycle Initiative as a harmonized approach for characterizing (eco-) toxicity in life cycle assessment (LCA) and other comparative assessment frameworks. Using physicochemical substance properties, USEtox® quantifies potential human toxicity and freshwater ecotoxicity impacts by combining environmental fate, exposure and toxicity effects information, considering multimedia fate and multi-pathway exposure processes. The main source to obtain substance properties for USEtox® is the Estimation Program Interface (EPI SuiteTM) from the U.S. Environmental Protection Agency. However, since the development of the original USEtox® substance databases, new chemical regulations have been enforced in Europe such as the REACH and the Plant Protection Products regulations. These regulations require that a chemical risk assessment for humans and the environment is performed before a chemical is placed on the European market. Consequently, new end-points and additional physicochemical property data are now available for thousands of chemical substances. The aim of the present study is to explore to which extent the new available data can be used as input for USEtox® – especially for application in Product Environmental Footprint studies – and to discuss how this would influence the quantification of fate and exposure factors. Initial results show that the choice of data source can greatly influence fate and exposure factors leading to potentially different rankings and relative contributions of substances to overall human toxicity and ecotoxicity impacts. Moreover, it is crucial to discuss the relevance of exposure of sediment species for freshwater ecotoxicity impacts particularly for persistent and bio-accumulating substances.JRC.D.1-Bio-econom

Assessment of the feed additive consisting of thaumatin for all animal species for the renewal of its authorisation (ADISSEO France S.A.S.)

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of authorisation of thaumatin as a sensory additive (flavouring compound) for all animal species. The applicant requested a change in the authorising regulation for the minimum content of nitrogen and protein in the specification of the additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) confirms that the use of thaumatin under the current authorised conditions of use is safe for the target species, the consumers and the environment. This conclusion can be extended to the newly proposed specification. Due to its proteinaceous nature, the additive is considered to be a respiratory sensitiser. Thaumatin is not irritant to the eyes and the skin. In the absence of data, no conclusion on skin sensitisation could be made. The proposed modification of the specification of the additive is not considered to have an impact on the efficacy of thaumatin

Safety and efficacy of a feed additive consisting of manganese(II)‐betaine complex for all animal species (Biochem Zusatzstoffe Handels‐ und Produktionsges. mbH)

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganese(II)‐betaine complex as a nutritional feed additive for all animal species and categories. Based on the tolerance study performed in chickens, the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the maximum proposed level of manganese in feed; this conclusion was extrapolated to all animal species and categories at the corresponding maximum manganese levels in complete feed (100 mg Mn/kg feed for fish and 150 mg Mn/kg feed for all other animal species). The FEEDAP Panel concluded that the use of additive in animal nutrition does not represent a concern for consumer safety or for the environment. The additive is irritant to the eyes, but not irritant to skin. Owing to the presence of nickel the additive is considered to be a dermal and respiratory sensitiser. The Panel concluded that the additive is efficacious as a nutritional additive for all animal species under the proposed conditions of use