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Nanotechnology has been considered to have high potential for food packaging applications very early on. The ability to provide additional consumer benefits through the improvement of key properties of packaging materials and the creation of new functionalities means that the increased use of nanomaterials and nanotechnologies is highly likely. It has however up to now failed to reach the widespread use that was initially expected, mainly because of remaining uncertainties on the safety of these materials during the various stages of their life-cycle, which limit legal and consumer acceptance. This paper aims at presenting the latest developments in the field of nanotechnologies for food packaging applications, describing the legal framework linked to their usage and attempts to clarify the current knowledge of the safety of these materials both for the consumer and the environment. It is shown that particulate migration into foodstuff is absent in many applications, which drastically reduces the potential risk during the use phase of packaging materials, i.e. the exposure of the consumer to nanoparticles. Other release routes are also evaluated, showing that, although safe in normal use conditions, prudence should still be used, especially with regard to release after disposal of the materials. Copyright © 2016 The Authors Packaging Technology and Science Published by John Wiley & Sons Ltd

Many natural chemicals in food are in the nanometer size range, and the selective uptake of nutrients with nanoscale dimensions by the gastrointestinal (GI) tract is a normal physiological process. Novel engineered nanomaterials (NMs) can bring various benefits to food, e.g., enhancing nutrition. Assessing potential risks requires an understanding of the stability of these entities in the GI lumen, and an understanding of whether or not they can be absorbed and thus become systemically available. Data are emerging on the mammalian in vivo absorption of engineered NMs composed of chemicals with a range of properties, including metal, mineral, biochemical macromolecules, and lipid-based entities. In vitro and in silico fluid incubation data has also provided some evidence of changes in particle stability, aggregation, and surface properties following interaction with luminal factors present in the GI tract. The variables include physical forces, osmotic concentration, pH, digestive enzymes, other food, and endogenous biochemicals, and commensal microbes. Further research is required to fill remaining data gaps on the effects of these parameters on NM integrity, physicochemical properties, and GI absorption. Knowledge of the most influential luminal parameters will be essential when developing models of the GI tract to quantify the percent absorption of food-relevant engineered NMs for risk assessment.

With large amounts of nanotoxicology studies delivering contradicting results and a complex, moving regulatory framework, potential risks surrounding nanotechnology appear complex and confusing. Many researchers and workers in different sectors are dealing with nanomaterials on a day-to-day basis, and have a requirement to define their assessment/management needs. This paper describes an industry-tailored strategy for risk assessment of nanomaterials and nano-enabled products, which builds on recent research outcomes. The approach focuses on the creation of a risk profile for a given nanomaterial (e.g., determine which materials and/or process operation pose greater risk, where these risks occur in the lifecycle, and the impact of these risks on society), using state-of-the-art safety assessment approaches/tools (ECETOC TRA, Stoffenmanager Nano and ISO/TS 12901-2:2014). The developed nanosafety strategy takes into account cross-sectoral industrial needs and includes (i) Information Gathering: Identification of nanomaterials and hazards by a demand-driven questionnaire and on-site company visits in the context of human and ecosystem exposures, considering all companies/parties/downstream users involved along the value chain; (ii) Hazard Assessment: Collection of all relevant and available information on the intrinsic properties of the substance (e.g., peerreviewed (eco)toxicological data, material safety data sheets), as well as identification of actual recommendations and benchmark limits for the different nano-objects in the scope of this projects; (iii) Exposure Assessment: Definition of industry-specific and application-specific exposure scenarios taking into account operational conditions and risk management measures; (iv) Risk Characterisation: Classification of the risk potential by making use of exposure estimation models (i.e., comparing estimated exposure levels with threshold levels); (v) Refined Risk Characterisation and Exposure Monitoring: Selection of individual exposure scenarios for exposure monitoring following the OECD Harmonized Tiered Approach to refine risk assessment; (vi) Risk Mitigation Strategies: Development of risk mitigation actions focusing on risk prevention. This work was supported by ongoing projects that received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no 646155 (INSPIRED), grant agreement no 646296 (Hi-Response) and grant agreement no 691095 (NANOGENTOOLS).

This article is one of a series of 4 that report on a task of the NanoRelease Food Additive project of the Intl. Life Science Inst. Center for Risk Science Innovation and Application to identify, evaluate, and develop methods that are needed to confidently detect, characterize, and quantify intentionally produced engineered nanomaterials (ENMs) released from food along the alimentary tract. This particular article focuses on the problem of detecting ENMs that become released into food indirectly from food contact materials. In this review, an in-depth analysis of the release literature is presented and relevant release mechanisms are discussed. The literature review includes discussion of articles related to the release phenomenon in general, as experimental methods to detect ENMs migrating from plastic materials into other (nonfood) complex matrices were determined to be relevant to the focus problem of food safety. From the survey of the literature, several “control points” were identified where characterization data on ENMs and materials may be most valuable. The article concludes with a summary of findings and a discussion of potential knowledge gaps and targets for method development in this area.

This article is one of a series of 4 that report on a task of the NanoRelease Food Additive (NRFA) project of the International. Life Science Institute Center for Risk Science Innovation and Application. The project aims are to identify, evaluate, and develop methods that are needed to confidently detect, characterize, and quantify intentionally produced engineered nanomaterials (ENMs) released from food along the alimentary tract. This particular article offers an overview of the NRFA project, describing the project scope and goals, as well as the strategy by which the task group sought to achieve these goals. A condensed description of the general challenge of detecting ENMs in foods and a brief review of available and emerging methods for ENM detection is provided here, paying particular attention to the kind of information that might be desired from an analysis and the strengths and weaknesses of the various approaches that might be used to attain this information. The article concludes with an executive summary of the task group's broad findings related to the 3 topic areas, which are covered in more detail in 3 subsequent articles in this series. The end result is a thorough evaluation of the state of ENM measurement science specifically as it applies to oral uptake of ENMs from human dietary sources.

This article is one of a series of 4 that report on a task of the NanoRelease Food Additive project of the International Life Science Institute Center for Risk Science Innovation and Application to identify, evaluate, and develop methods that are needed to confidently detect, characterize, and quantify intentionally produced engineered nanomaterials (ENMs) released from food along the alimentary tract. This particular article focuses on the problem of detecting and characterizing ENMs in the various compartments of the alimentary tract after they have been ingested from dietary sources. An in depth analysis of the literature related to oral toxicity of ENMs is presented, paying particular attention to analytical methodology and sample preparation. The review includes a discussion of model systems that can be used to study oral uptake of ENMs in the absence of human toxicological data or other live-animal studies. The strengths and weaknesses of various analytical and sample preparation techniques are discussed. The article concludes with a summary of findings and a discussion of potential knowledge gaps and targets for method development in this area.

This article is one of a series of 4 that reports on a task of the NanoRelease Food Additive project of the International Life Science Institute Center for Risk Science Innovation and Application to identify, evaluate, and develop methods that are needed to confidently detect, characterize, and quantify intentionally produced engineered nanomaterials (ENMs) released from food along the alimentary tract. This particular article focuses on the problem of detecting ENMs in food, paying special attention to matrix interferences and how to deal with them. In this review, an in-depth analysis of the literature related to detection of ENMs in complex matrices is presented. The literature review includes discussions of sampling methods, such as centrifugation and ENM extraction. Available analytical methods, as well as emerging methods, are also presented. The article concludes with a summary of findings and an overview of potential knowledge gaps and targets for method development in this area.

Food authorities should base their decisions on both risk assessment and benefit assessment in relation to foods, food constituents or nutrients when risk–benefit assessment can be carried out. Benefit assessment should mirror the well-established steps of risk assessment. However, methods for their comparison, weighing risks against benefits, have as yet to be developed. The general framework currently available in risk–benefit health assessment of food is described and illustrated with two examples: food fortification with vitamins and minerals, and the consumption of vegetables in relation to their nitrate content.

Cloning via somatic cell nucleus transfer (SCNT) is a potential way for using validated genomes in farm animal breeding and to save endangered breeds or species. Although this technique is relatively inefficient and costly, it is envisaged to use it as an assisted reproduction technique. Despite numerous problems observed in the perinatal period, after some time clones appear normal although they may have kept some epigenetic modifications. Meat and milk from cattle and meat from pig clones and their offspring are substantially equivalent to conventional animals with no observed toxicity or allergenicity. Due to limited data, monitoring of clones and their offspring is recommended to detect whether there are unexpected long-term effects of cloning.

Immunotherapy with specific antibodies is an alternative to antibiotics for the prevention of infections in humans and animals. We have used orally administered immunoglobulin Y (IgY) preparations, purified from eggs of hens immunized with Pseudomonas aeruginosa bacteria, to prevent pulmonary P. aeruginosa infections in a group of patients with cystic fibrosis (CF). Respiratory infections are major problems for CF patients because of the thick mucus in the airways, and chronic P. aeruginosa lung infections occur in virtually all CF patients and cause morbidity and mortality. The IgY-treated group had only 2.5 P. aeruginosa-positive sputum cultures per 100 months, and none of the IgY-treated patients became chronically colonized with P. aeruginosa. In the control group, 13.7 of the cultures per 100 months were positive for P. aeruginosa, and 24% of patients became chronically colonized with P. aeruginosa. The first enrolled patient in this study has now been treated continuously for more than 10 years. During the first 8 years she only had four P. aeruginosa-positive cultures. After 8 years she became chronically infected, but still after 10 years the bacteria have not turned mucoid. No negative side effects of IgY treatment have been noted during these 10 years. To our knowledge this is the longest treatment with specific yolk antibodies for therapeutic purposes.

Cancer patients treated with chemotherapy often become neutropenic, which predisposes for oral and systemic C. albicans infections. The purpose of this feasibility study was to find out if gargling with anti-C. albicans immunoglobulin Y from egg yolk can prevent oral candidiasis in children, treated for acute lymphatic leukemia. Four patients gargled with the antibodies once a day during the induction phase of chemotherapy. None of four patients treated with IgY got any C. albicans infection. In the non-treated control and in a historic group, seven of thirteen patients had suspected C. albicans infection. This study indicates that anti-C. albicans IgY may prevent oral candidiasis in immunocompromized children.

Respiratory infection is the major cause of morbidity and mortality in cystic fibrosis (CF) patients. Chronic Pseudomonas aeruginosa (PA) infections ultimately occur in virtually all patients. It is impossible to eradicate PA when a patient has been chronically colonized. Immunotherapy with specific egg-yolk antibodies (IgY) may be an alternative to antibiotics for the prevention of PA infections. We wanted to determine if treatment with specific IgY can prolong the period between the first and the second PA colonization? And long-term, can the treatment diminish the number of positive PA cultures and postpone the onset of chronic colonization? CF patients gargled daily with an IgY-antibody preparation, purified from eggs of hens immunized with PA bacteria. They were compared to a group of patients who did not gargle with the preparation. Both groups had their first colonization with PA eradicated by antibiotics. The basic treatment was essentially the same in both groups. In the initial study, the period between the first and second colonization with PA was significantly prolonged for the treated vs. the control group (Kaplan-Meier P = 0.015, Breslow test). In the prolonged study, the treated group had only 2.5 sputum cultures positive for PA per 100 months of observation, and none of these patients became chronically colonized with PA. No adverse events were reported. In the control group, 13.7 cultures per 100 months of observation were positive for PA, and 5 (24%) patients became chronically colonized with PA. This feasibility study shows that antipseudomonal IgY has the potential to effectively prevent PA colonization without any severe adverse effects. A phase III study should be initiated.

Laying hens are very efficient producers of antibodies and provide an interesting alternative for large-scale production of specific antibodies. These antibodies also have biochemical advantages over mammalian antibodies (e.g. rabbit antibodies) that can be used to improve immunoassays where antibodies are used. The concentration of IgY in egg yolk is an important production parameter. The purpose of this study was to investigate the genetic variation of IgY levels in egg yolk. We have compared IgY concentrations in egg yolks from two lines, selected for egg production traits at the Swedish University for Agricultural Sciences (Single Comb White Leghorn and Rhode Island Red) and a cross between the two lines (SLU-1392). Single Comb White Leghorns have the highest mean concentration of yolk IgY, 2.21 mg ml−1 compared to SLU-1392 1.95 mg ml−1 and Rhode Island Red 1.68 mg ml−1. The cross thus had an intermediate IgY concentration in relation two the two other lines. There were great differences between indiv...

This article is one of a series of 4 that reports on a task of the NanoRelease Food Additive project of the International Life Science Institute Center for Risk Science Innovation and Application to identify, evaluate, and develop methods that are needed to confidently detect, characterize, and quantify intentionally produced engineered nanomaterials (ENMs) released from food along the alimentary tract. This particular article focuses on the problem of detecting ENMs in food, paying special attention to matrix interferences and how to deal with them. In this review, an in-depth analysis of the literature related to detection of ENMs in complex matrices is presented. The literature review includes discussions of sampling methods, such as centrifugation and ENM extraction. Available analytical methods, as well as emerging methods, are also presented. The article concludes with a summary of findings and an overview of potential knowledge gaps and targets for method development in this area.

This article is one of a series of 4 that report on a task of the NanoRelease Food Additive project of the International Life Science Institute Center for Risk Science Innovation and Application to identify, evaluate, and develop methods that are needed to confidently detect, characterize, and quantify intentionally produced engineered nanomaterials (ENMs) released from food along the alimentary tract. This particular article focuses on the problem of detecting and characterizing ENMs in the various compartments of the alimentary tract after they have been ingested from dietary sources. An in depth analysis of the literature related to oral toxicity of ENMs is presented, paying particular attention to analytical methodology and sample preparation. The review includes a discussion of model systems that can be used to study oral uptake of ENMs in the absence of human toxicological data or other live-animal studies. The strengths and weaknesses of various analytical and sample preparation techniques are discussed. The article concludes with a summary of findings and a discussion of potential knowledge gaps and targets for method development in this area.

Laying hens are highly efficient producers of polyclonal antibodies (PAbs). These antibodies are transported to the egg yolk in large quantities from the blood of laying hens. The IgY concentration in the egg yolk is important to protect the newly hatched chick against infections and it is also an important factor for the production of yolk antibodies for commercial purposes. A single egg yolk contains approximately the same amount of IgY as 30 ml of blood. This is a significant loss of antibodies for an animal the size of a hen. We have studied the IgY levels in egg yolk. We found low day to day variability. There was no decrease in IgY levels at the end of the egg laying cycle and there was no correlation between IgY concentration and egg production.

Antibodies derived from egg yolk offer many advantages over mammalian antibodies in several aspects. Chicken antibodies do not activate the human complement system and are sometimes a more suitable choice in designing solid-phase immunometric assays than mammalian antibodies. The material often recommended for immunological assays is serum. A freshly drawn serum sample contains an active complement system, which is inactivated during storage. Mammalian antibodies used in most immunological assays may activate the human complement system. Activated complement components will bind to the antibodies thereby partly block the antibody binding epitopes. We show that an active complement system in undiluted samples reduce the absorbance values by approximately 50 % when using goat antibodies but not when using chicken antibodies. This difference will cause erroneous test results that will vary depending on the handling of the samples. Chicken antibodies can be used to eliminate this interference problem.

Oral administration of specific antibodies is an attractive approach to establish protective immunity against gastrointestinal pathogens in humans and animals. The increasing number of antibiotic-resistant bacteria emphasize the need to find alternatives to antibiotics. Immunotherapy can also be used against pathogens that are difficult to treat with traditional antibiotics. Laying hens are very good producers of specific antibodies. After immunization, the specific antibodies are transported to the egg yolk from which the antibodies then can be purified. A laying hen produces more than 20 g of yolk antibodies (IgY) per year. These antibodies also have biochemical properties that make them attractive for peroral immunotherapy: They neither activate mammalian complement nor interact with mammalian Fc receptors that could mediate inflammatory response in the gastrointestinal tract. Eggs are also normal dietary components and thus there is practically no risk of toxic side effects of IgY. Yolk antibodies have been shown in several studies to prevent bacterial and viral infections.

The chicken immune system has been studied for many years and these studies have contributed substantially to our understanding of the fundamental concepts of immunology and the development of different immunoglobulin classes. It is thus surprising that only a small fraction of the antibodies presently used in laboratories are of avian origin. A laying hen produces more yolk antibodies than a rabbit can produce during the same time period, and the animal care costs are lower for the chicken compared to the rabbit. Chicken antibodies offer many advantages to the traditional mammalian antibodies when used for the detection of mammalian antigen. Due to the evolutionary difference chicken IgY will react with more epitopes on a mammalian antigen, which will give an amplification of the signal. Chicken antibodies can also be used to avoid interference in immunological assays caused by the human complement system, rheumatoid factors, human anti-mouse IgG antibodies (HAMA) or human and bacterial Fc-receptors. The antibodies can be purified in large amounts from egg yolk, making laying hens highly efficient producers of polyclonal antibodies.

Chicken antibodies offer many advantages over the traditional mammalian ones. A laying hen produces large amounts of yolk antibodies and the use of yolk antibodies eliminates the painful procedure of collecting blood from the animal. Thus, the use of chicken antibodies will reduce both the number of animals required to produce antibodies and also animal distress. Chicken antibodies also have several biochemical advantages compared to mammalian antibodies: they often increase the signal and reduce interference in many assays. However, the species chosen for antibody production have usually been mammals. This is probably due to tradition, but also to limited knowledge about the production of chicken antibodies. We studied the immune response in the chicken using small amounts of mammalian antigen, and show that a good immune response can be obtained with 0.1–1.0 μg of bovine serum albumin.

The sympathetic nervous system may be involved in the pathophysiology of insulin resistance and metabolic cardiovascular syndrome in young men. The aim was to study the effects of long-term stress on different features of the metabolic syndrome (MES) in formerly non-obese healthy young males during 5 months of defined conditions.Sixteen healthy male sailors (mean age 36.5 (SD)+/-7 years) participating in a sailing race around the world were recruited for the study. Investigations were done before the start and at stop overs after finishing laps 1, 2 and 4 (1, 2(1/2) and 5 months, respectively). Anthropometric and blood pressure data as well as biochemical data associated with MES were substantiated. Food intake and exercise were chartered and largely controlled. A mean weight loss of 4.5+/-2 kg (P0.005), comprising both fat and lean body mass, was recorded during the first lap. Subsequently after 5 months, a weight gain, mainly consisting of 1.2+/-1.1 kg body fat (P0.05), took place, concomitantly with a protein mass drop of 0.6+/-1.1 kg (P0.05). The body fat gain accumulated on the abdominal region. Elevated blood levels of HbA1c, insulin and the triglycerides/high-density lipoprotein ratio were also observed during the race. Likewise heart rate and systolic blood pressure increased slightly but to a statistically significant extent.Non-obese healthy young men exposed to long-term stress developed abdominal obesity and signs of a metabolic syndrome in embryo, also emphasized by biochemical and blood pressure alterations. It is suggested that long-term and sustained stress activation might be an additional risk factor for the development of MES, even after control of dietary and exercise habits.

There is an increasing prevalence of antibiotic-resistant bacteria, which makes traditional antibiotics less effective. It is thus important to find an alternative to the use of antibiotics. Oral administration of specific antibodies is an attractive approach to establish protective immunity against gastrointestinal pathogens in humans and animals. Immunotherapy can also be used against pathogens that are difficult to treat with traditional antibiotics. Laying hens are good producers of specific antibodies. After immunisation, the specific antibodies are transported to the egg yolk from which the antibodies (IgY) can be purified in large quantities. Eggs are also normal dietary components and thus there is practically no risk of toxic side effects of IgY. Yolk antibodies have been shown in several studies to prevent both bacterial and viral infections. We have treated one patient with yolk antibodies against P. aeruginosa daily for more than eight years, which shows that it is possible to use yolk immunotherapy over long treatment periods.

Respiratory infection is the major cause of morbidity and mortality in cystic fibrosis (CF) patients. Chronic Pseudomonas aeruginosa (PA) infections ultimately occur in virtually all patients. It is impossible to eradicate PA when a patient has been chronically colonized. Immunotherapy with specific egg-yolk antibodies (IgY) may be an alternative to antibiotics for the prevention of PA infections. We wanted to determine if treatment with specific IgY can prolong the period between the first and the second PA colonization? And long-term, can the treatment diminish the number of positive PA cultures and postpone the onset of chronic colonization? CF patients gargled daily with an IgY-antibody preparation, purified from eggs of hens immunized with PA bacteria. They were compared to a group of patients who did not gargle with the preparation. Both groups had their first colonization with PA eradicated by antibiotics. The basic treatment was essentially the same in both groups. In the initial study, the period between the first and second colonization with PA was significantly prolonged for the treated vs. the control group (Kaplan-Meier P = 0.015, Breslow test). In the prolonged study, the treated group had only 2.5 sputum cultures positive for PA per 100 months of observation, and none of these patients became chronically colonized with PA. No adverse events were reported. In the control group, 13.7 cultures per 100 months of observation were positive for PA, and 5 (24%) patients became chronically colonized with PA. This feasibility study shows that antipseudomonal IgY has the potential to effectively prevent PA colonization without any severe adverse effects. A phase III study should be initiated.

The increasing prevalence of antibiotic-resistant bacteria emphasises the need for new treatments that can replace traditional antibiotics. Oral immunotherapy with yolk antibodies from hyperimmunised hens is a new promising treatment strategy, primarily for infections in the mouth and gastrointestinal tract. Several studies show that bacterial and viral infections can be prevented with egg yolk immunoglobulin (IgY) in a dose-dependent manner. Oral treatment could potentially be used against many frequently encountered diseases (e.g. common cold, tonsillitis and caries). GROUP STUDIED: Healthy volunteers.We studied the presence of yolk anti-Pseudomonas aeruginosa antibodies in saliva from healthy volunteers over time after 1 or 2 minutes' mouth rinse, performed in the evening, with an aqueous IgY antibody preparation. The test persons rinsed the mouth with 8.0ml phosphate buffered saline before gargling with the antibody preparation 8 and 24 hours later. Statistical analysis was performed with the Mann-Whitney U test.The antibody titres in the mouth rinses were tested for their specific activity against P. aeruginosa by ELISA.The next morning there were still active antibodies detected in the saliva from 18 of 19 subjects. After 24 hours, active antibodies could be detected in saliva from only a few of the subjects. A 2-minute mouth rinse resulted in higher mean ELISA absorbance values than a 1-minute rinse.