EFSA News

The European Food Safety Authority (EFSA) is the agency of the European Union (EU) that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain. EFSA was established in February 2002, is based in Parma, Italy and had a budget for 2008 of €65.9 million.

The work of EFSA covers all matters with a direct or indirect impact on food and feed safety, including animal health and welfare, plant protection and plant health and nutrition. EFSA supports the European Commission, the European Parliament and EU member states in taking effective and timely risk management decisions that ensure the protection of the healthof European consumers and the safety of the food and feed chain. EFSA also communicates to the public in an open and transparent way on all matters within its remit.

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Published on: Fri, 21 Apr 2017 +0200

EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of flupyrsulfuron-methyl as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with Member States in order to collect and validate the data submitted by the applicant. The current scientific report summarises the outcome of the evaluation of eight different uses (crops) in seven Member States. The evaluation demonstrated that in general a wide range of alternative herbicide active substances to flupyrsulfuron-methyl are available for chemical weed control; however, for some uses, no sufficient chemical alternatives are available. The evaluation included an assessment of non-chemical alternatives for the presented uses. A wide range of non-chemical methods are available; however, often these methods do not have the same efficacy as chemical methods or have economic limitations. A combination of both chemical and non-chemical methods seems often possible.


© European Food Safety Authority, 2015

Evaluation of data concerning the necessity of flupyrsulfuron-methyl as a herbicide to control a serious danger to plant health which cannot be contained by other available means, including non-chemical methods


Published on: Thu, 20 Apr 2017 +0200

Tetrodotoxin (TTX) and its analogues are produced by marine bacteria and have been detected in marine bivalves and gastropods from European waters. The European Commission asked EFSA for a scientific opinion on the risks to public health related to the presence of TTX and TTX analogues in marine bivalves and gastropods. The Panel on Contaminants in the Food Chain reviewed the available literature but did not find support for the minimum lethal dose for humans of 2 mg, mentioned in various reviews. Some human case reports describe serious effects at a dose of 0.2 mg, corresponding to 4 μg/kg body weight (bw). However, the uncertainties on the actual exposure in the studies preclude their use for derivation of an acute reference dose (ARfD). Instead, a group ARfD of 0.25 μg/kg bw, applying to TTX and its analogues, was derived based on a TTX dose of 25 μg/kg bw at which no apathy was observed in an acute oral study with mice, applying a standard uncertainty factor of 100. Estimated relative potencies for analogues are lower than that of TTX but are associated with a high degree of uncertainty. Based on the occurrence data submitted to EFSA and reported consumption days only, average and P95 exposures of 0.00–0.09 and 0.00–0.03 μg/kg bw, respectively, were calculated. Using a large portion size of 400 g bivalves and P95 occurrence levels of TTX, with exception of oysters, the exposure was below the group ARfD in all consumer groups. A concentration below 44 μg TTX equivalents/kg shellfish meat, based on a large portion size of 400 g, was considered not to result in adverse effects in humans. Liquid chromatography with tandem mass spectroscopy (LC–MS/MS) methods are the most suitable for identification and quantification of TTX and its analogues, with LOQs between 0.1 and 25 μg/kg.


© European Food Safety Authority, 2015

Risks for public health related to the presence of tetrodotoxin (TTX) and TTX analogues in marine bivalves and gastropods


Published on: Thu, 20 Apr 2017 +0200

An epidemiological analysis of the temporal and spatial patterns of LSD epidemics and of the risk factors for LSD spread in south-eastern Europe was performed, based on the data collected from affected and at risk countries. Since 2015, the extent of the LSD epidemics in south-eastern Europe was over 7,600 LSD outbreaks with 12,800 affected animals, with most outbreaks occurring between May and August. Most LSD spread occurs over a relatively small distance, approximately between 10 and 20 km, and the speed of propagation was estimated to be mostly up 2 km/day, in agreement with the vector-borne pattern of LSD. Proximity to affected farms, warm temperatures and related vector abundance were among the main risk factors for LSD spread. Within a few months’ at least 90% of the animal population had been vaccinated with live homologous vaccine against LSD in south-eastern Europe. Where almost total vaccination coverage was achieved, no further outbreaks were reported. The vaccination effectiveness in Albania was estimated to be around 70% at farm level and 77% at animal level. Possible adverse effects to live homologous vaccine, including fever, decreased milk production and oedema at injection site were reported in Croatia (a LSD-free country) mostly within 2 weeks after vaccination, in 0.09% of the vaccinated animals. Unique farm identifiers should be always used across all databases, so to allow further analysis especially on improving the mathematical models for more robust estimates of transmission parameters applicable to the region, and for better estimation of vaccination effectiveness. All suspected clinical cases in vaccinated animals should be confirmed by differentiating field virus from vaccine strain. Trapping surveys for estimation of vector abundance can be carried out by targeting some sentinel farms, to be followed up during the whole LSD season, while long-term studies can give more accurate information about species composition and seasonality of potential LSD vectors.


© European Food Safety Authority, 2015

Lumpy skin disease: I. Data collection and analysis


Published on: Wed, 19 Apr 2017 +0200

EFSA was requested by the European Commission to produce a report on the susceptibility of olive varieties to the Apulian strain of Xylella fastidiosa (subsp. pauca strain CoDiRO, ST53). A systematic literature search identified 21 references providing results of primary research studies on olive plants infected (naturally or artificially) by ST53. From experimental infectivity studies and from surveys in olive orchards, converging lines of evidence indicate tolerance of the Leccino variety to ST53 infections, although no long-term observations on yield are available yet. While the variety Leccino can become infected with the pathogen, it develops milder symptoms compared to those observed on susceptible varieties (e.g. Cellina di Nardò, Ogliarola salentina). Also, the size of the X. fastidiosa bacterial populations measured in Leccino-infected plants is lower compared to susceptible olive varieties. Preliminary results show that tolerance or resistance traits can also be found in other olive varieties. New research is now in place in the EU to study the level of susceptibility of many olive varieties to ST53 infections, therefore more relevant results will become available in the coming years.


© European Food Safety Authority, 2015

Susceptibility of Olea europaea L. varieties to Xylella fastidiosa subsp. pauca ST53: systematic literature search up to 24 March 2017


Published on: Wed, 19 Apr 2017 +0200

The EFSA Panel on Contaminants in the Food Chain (CONTAM) reviewed new studies on nivalenol since the previous opinion on nivalenol published in 2013, but as no new relevant data were identified the tolerable daily intake (TDI) for nivalenol (NIV) of 1.2 μg/kg body weight (bw) established on bases of immuno- and haematotoxicity in rats was retained. An acute reference dose (ARfD) of 14 μg/kg bw was established based on acute emetic events in mink. The only phase I metabolite of NIV identified is de-epoxy-nivalenol (DE-NIV) and the only phase II metabolite is nivalenol-3-glucoside (NIV3Glc). DE-NIV is devoid of toxic activity and was thus not further considered. NIV3Glc can occur in cereals amounting up to about 50% of NIV. There are no toxicity data on NIV3Glc, but as it can be assumed that it is hydrolysed to NIV in the intestinal tract it should be included in a group TDI and in a group ARfD with NIV. The uncertainty associated with the present assessment is considered as high and it would rather overestimate than underestimate any risk.


© European Food Safety Authority, 2015

Appropriateness to set a group health based guidance value for nivalenol and its modified forms