European Food Safety Authority Guidelines Research Articles

EFSA Guidelines on the environmental risk assessment of genetically modified animals in the EU: the process and risk assessment considerations

The scientific Panel of the European Food Safety Authority (EFSA) on genetically modified organisms (GMOs) developed guidelines for the environmental risk assessment of genetically modified (GM) animals that provide specific recommendations for GM fish, GM insects, GM mammals and GM birds. The guidelines advocate that the environmental risk assessment of GM animals is conducted on a case-by-case basis, in a scientifically sound and transparent manner, and follows common methodology for the identification, gathering and interpretation of the data. Besides specific considerations, the guidelines provide generic advice on the choice of comparators, the use of non-GM surrogates, the assessment of long-term effects, uncertainty analysis, modelling requirements and statistical principles. Three dedicated Working Groups of the EFSA GMO Panel were involved in the elaboration of the environmental risk assessment guidelines, which underwent a public consultation before finalisation. Relevant comments received from risk assessment bodies of EU Member States, the scientific community, stakeholders and the public were considered by the Working Groups. The Working Groups also took into account the external scientific reports on GM fish, GM insects, GM mammals and GM birds commissioned by EFSA. These reports provided background information by mapping relevant fields of expertise and identifying essential elements to be considered when performing an environmental risk assessment of GM animals.

Focal species of birds in European crops for higher tier pesticide risk assessment

Focal species have been defined by the European Food Safety Authority (EFSA) as real species that represent others in a crop resulting from their potential higher level of exposure to pesticides. As such they are the most appropriate species for refining estimates of exposure further, through, for example, radio tracking and dietary studies. Plant protection product manufacturers collectively commissioned many studies in Europe, according to the EFSA guidelines, to identify focal species in different crops that may be used in risk assessments for spray applications of pesticides. Using frequency of occurrence in crops and risk-based criteria for exposure, all studies have been reviewed to identify if possible at least 1 focal species per feeding guild, per crop in the new registration zones for southern and central Europe. Some focal species repeatedly appeared across a wide range of arable or tree crops but not both, demonstrating broad adaptation to these 2 different crop structures. Many have widespread distributions, for example, 15 of the focal species have a distribution covering all agricultural regions of Europe (northern, central, and southern zones). Three species, corn bunting, serin, and tree sparrow, are restricted to the central and southern zones, whereas another 4 species, Sardinian and fan-tailed warbler, and crested and short-toed lark, are essentially restricted to the southern zone. The authors consider the focal species identified as suitable for risk assessment in Europe at the zonal level and for further refinement of exposure through studies, such as radio tracking or diet analysis, if necessary.

Is PET bottle-to-bottle recycling safe? Evaluation of post-consumer recycling processes according to the EFSA guidelines

For almost 15 years now in Europe, used plastic bottles made of polyethylene terephthalate (PET) have been recycled in such a way that the recyclate can be used for new PET bottles. Several recycling plants have been established all over Europe. Since May 2008 the European Recycling Regulation 282/2008 has been in force. According to this regulation, every recycling process must be individually approved by the European Food Safety Authority (EFSA). For this evaluation process, EFSA has developed a conservative evaluation concept in order to protect consumers. The evaluation is partly based on mathematical calculation of the migration. The current migration model overestimates the migration. EFSA acknowledges that the migration model overestimates by at least a factor of 5. This applies for small molecules such as toluene. However, higher molecular weight contaminants such as benzophenone are even more overestimated. The reason for this overestimation is that the currently used migration model is based on a fixed activation energy of diffusion. Conversely, the curve of the maximum bottle wall concentration calculated using the current migration model increases much too gradually with the molecular weight. New developments in migration modelling consider more precisely the activation energies of diffusion. Consequently, using the new, more realistic diffusion coefficients influences significantly the EFSA evaluation criteria.

Efficacy and safety testing of mycotoxin-detoxifying agents in broilers following the European Food Safety Authority guidelines

Contamination of feeds with mycotoxins is a worldwide problem and mycotoxin-detoxifying agents are used to decrease their negative effect. The European Food Safety Authority recently stated guidelines and end-points for the efficacy testing of detoxifiers. Our study revealed that plasma concentrations of deoxynivalenol and deepoxy-deoxynivalenol were too low to assess efficacy of 2 commercially available mycotoxin-detoxifying agents against deoxynivalenol after 3 wk of continuous feeding of this mycotoxin at concentrations of 2.44±0.70 mg/kg of feed and 7.54±2.20 mg/kg of feed in broilers. This correlates with the poor absorption of deoxynivalenol in poultry. A safety study with 2 commercially available detoxifying agents and veterinary drugs showed innovative results with regard to the pharmacokinetics of 2 antibiotics after oral dosing in the drinking water. The plasma and kidney tissue concentrations of oxytetracycline were significantly higher in broilers receiving a biotransforming agent in the feed compared with control birds. For amoxicillin, the plasma concentrations were significantly higher for broilers receiving an adsorbing agent in comparison to birds receiving the biotransforming agent, but not to the control group. Mycotoxin-detoxifying agents can thus interact with the oral bioavailability of antibiotics depending on the antibiotic and detoxifying agent, with possible adverse effects on the health of animals and humans.

New bolus models for in vivo efficacy testing of mycotoxin-detoxifying agents in relation to EFSA guidelines, assessed using deoxynivalenol in broiler chickens

In this study, three new models were developed for efficacy testing of mycotoxin-detoxifying agents in relation to recent European guidelines. In the first model, deoxynivalenol was given to broiler chickens as an intra-crop bolus together with a mycotoxin-detoxifying agent in order to study the plasma concentration–time profile of deoxynivalenol. In the second model, the same oral bolus was given, preceded by an oral bolus of mycotoxin-detoxifying agent, to make sure the detoxifying agent was present in the whole intestinal tract when the mycotoxin was administered. In the third model, the mycotoxin-detoxifying agent was mixed in the feed of broiler chickens, and after 1 week's feeding, deoxynivalenol was given as an oral bolus. In order to evaluate the efficacy of these agents, plasma concentration–time profiles were set up and the main toxicokinetic parameters were compared. Two commercially available mycotoxin-detoxifying agents were tested, but they were not able to lower the oral availability of deoxynivalenol. As a positive control, activated carbon was used. We showed that activated carbon significantly reduces the absorption and oral availability of deoxynivalenol in all three models. Therefore, it can be concluded that these models are able to demonstrate the efficacy of mycotoxin-detoxifying agents in relation to European Food Safety Authority guidelines.

Bifidobacterium bifidum MIMBb75 in irritable bowel syndrome: authors’ reply

Sirs, We thank Prof. Quigley for his comment1 on our research regarding Bifidobacterium bifidum MIMBb75 in irritable bowel syndrome (IBS).2 With regard to instruments used, we are not sure which instruments are seen as ‘somewhat novel’ as we based our questionnaires on the current literature and the European Food Safety Authority guidelines. As pointed out in Prof. Quigley′s letter, our findings show parallels to those demonstrated by Whorwell et al. who used the strain Bifidobacterium infantis 35624.3 However, in contrast to that report, our study population was not restricted to female patients. Furthermore, in comparison to Bifidobactereium longum subsp. infantis and other probiotics, we have been able to show – for the first time – a significant improvement of the major IBS symptoms along with a simultaneous improvement in quality of life. Since IBS patients have a somewhat decreased quality of life, this finding seems to be of special interest. As shown in several reviews on probiotics in IBS, Bifidobacterium strains seem to be superior to Lactobacillus strains. However, we think that the properties of a single strain are strongly strain specific,4 and that the properties of one strain do not predict the properties of another, even very similar strain. We clearly agree on the call for longer-term studies of probiotics in IBS. Declaration of personal interests: None. Declaration of funding interests: This study was funded by Naturwohl Pharma GmbH, München, Germany.