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Over the past years benefit – risk analysis (BRA) in relation to foods and food ingredients has gained much attention; in Europe and worldwide. BRA relating to food microbiology is however a relatively new field of research. Microbiological risk assessment is well defined but assessment of microbial benefits and the weighing of benefits and risk has not been systematically addressed. In this paper the state of the art in benefit – risk analysis in food microbiology is presented, with a brief overview of microbiological food safety practices.

The quality and safety of foods is commonly best preserved by delaying the growth of spoilage bacteria and contamination by bacterial pathogens. However, microorganisms in food can be both harmful and beneficial. Many microorganisms are integral to various food production processes eg the production of beer, wine and various dairy products. Moreover, the use of some microorganisms in the production of fermented foods are often claimed to have beneficial effects on food nutrition and consumer health. Furthermore, food safety interventions leading to reduced public exposure to foodborne pathogens can be regarded as benefits. The BRA approach integrates an independent assessment of both risks and benefits and weighs the two using a common currency.

Recently, a number of initiatives have been launched in the field of food and nutrition to address the formulation of the benefit – risk assessment approach. BRA has recently been advocated by EFSA for the public health management of food and food ingredients; as beneficial and adverse chemicals can often be found within the same foods and even the same ingredients. These recent developments in the scoping of BRA could be very relevant for food microbiological issues. BRA could become a valuable methodology to support evaluations and decision making regarding microbiological food safety and public health, supplementing other presently available policy making and administrative tools for microbiological food safety management.

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Benefit – risk assessment in medicine has been a valuable tool in the regulation of medicines since the 1960s. Benefit risk assessment takes place in multiple stages during a medicine's life-cycle and can be conducted in a variety of ways, using methods ranging from qualitative to quantitative. Each benefit – risk assessment method is subject to its own specific strengths and limitations. Despite its widespread and long-time use, benefit – risk assessment in medicine is subject to debate and suffers from a number of limitations and is currently still under development.

This state of the art review paper will discuss the various aspects and approaches to benefit – risk assessment in medicine in a chronological pathway. The review will discuss all types of benefit – risk assessment a medicinal product will undergo during its lifecycle, from Phase I clinical trials to post-marketing surveillance and health technology assessment for inclusion in public formularies. The benefit – risk profile of a drug is dynamic and differs for different indications and patient groups. At the end of this review we conclude benefit – risk analysis in medicine is a developed practice that is subject to continuous improvement and modernization. Improvement not only in methodology, but also in cooperation between organizations can improve benefit – risk assessment.

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Benefit risk assessment in food and nutrition is relatively new. It weighs the beneficial and adverse effects that a food (component) may have, in order to facilitate more informed management decisions regarding public health issues. It is rooted in the recognition that good food and nutrition can improve health and that some risk may be acceptable if benefit is expected to outweigh it. This paper presents an overview of current concepts and practices in benefit – risk analysis for food and nutrition. It aims to facilitate scientists and policy makers in performing, interpreting and evaluating benefit – risk assessments.

Historically, the assessments of risks and benefits have been separate processes. Risk assessment is mainly addressed by toxicology, as demanded by regulation. It traditionally assumes that a maximum safe dose can be determined from experimental studies (usually in animals) and that applying appropriate uncertainty factors then defines the 'safe' intake for human populations. There is a minor role for other research traditions in risk assessment, such as epidemiology, which quantifies associations between determinants and health effects in humans. These effects can be both adverse and beneficial. Benefit assessment is newly developing in regulatory terms, but has been the subject of research for a long time within nutrition and epidemiology. The exact scope is yet to be defined. Reductions in risk can be termed benefits, but also states rising above 'the average health' are explored as benefits. In nutrition, current interest is in 'optimal' intake; from a population perspective, but also from a more individualized perspective.

In current approaches to combine benefit and risk assessment, benefit assessment mirrors the traditional risk assessment paradigm of hazard identification, hazard characterization, exposure assessment and risk characterization. Benefit-risk comparison can be qualitative and quantitative. In a quantitative comparison, benefits and risks are expressed in a common currency, for which the input may be deterministic or (increasingly more) probabilistic. A tiered approach is advocated, as this allows for transparency, an early stop in the analysis and interim interaction with the decision-maker. A general problem in the disciplines underlying benefit – risk assessment is that good dose – response data, ie at relevant intake levels and suitable for the target population, are scarce.

It is concluded that, provided it is clearly explained, benefit – risk assessment is a valuable approach to systematically show current knowledge and its gaps and to transparently provide the best possible science-based answer to complicated questions with a large potential impact on public health.

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Risk-taking is normal in everyday life if there are associated (perceived) benefits. Benefit-Risk Analysis (BRA) compares the risk of a situation to its related benefits and addresses the acceptability of the risk. Over the past years BRA in relation to food and food ingredients has gained attention. Food, and even the same food ingredient, may confer both beneficial and adverse effects. Measures directed at food safety may lead to suboptimal or insufficient levels of ingredients from a benefit perspective. In BRA, benefits and risks of food (ingredients) are assessed in one go and may conditionally be expressed into one currency. This allows the comparison of adverse and beneficial effects to be qualitative and quantitative. A BRA should help policy-makers to make more informed and balanced benefit-risk management decisions. Not allowing food benefits to occur in order to guarantee food safety is a risk management decision much the same as accepting some risk in order to achieve more benefits. BRA in food and nutrition is making progress, but difficulties remain. The field may benefit from looking across its borders to learn from other research areas. The BEPRARIBEAN project (Best Practices for Risk-Benefit Analysis: experience from out of food into food; http://en.opasnet.org/w/Bepraribean) aims to do so, by working together with Medicines, Food Microbiology, Environmental Health, Economics & Marketing-Finance and Consumer Perception. All perspectives are reviewed and subsequently integrated to identify opportunities for further development of BRA for food and food ingredients. Interesting issues that emerge are the varying degrees of risk that are deemed acceptable within the areas and the trend towards more open and participatory BRA processes. A set of 6 'state of the art' papers covering the above areas and a paper integrating the separate (re) views are published in this volume.

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The collapse of marine fisheries worldwide has forced recognition of the fact that sustainable fisheries management cannot be achieved without a reasonable understanding of stock structure. Fisheries focusing on species that exhibit seasonal migrations between spawning and feeding grounds should consider the composition of feeding aggregations of presumed mixed origin. Using nine microsatellites and the Pan I locus, we assess the contribution of two previously described major spawning components of Icelandic cod Gadus morhua (southwest and northeast) to two large feeding and two large juvenile aggregations of presumed mixed origin and situated in the northwest and northeast of Iceland. The Bayesian approaches (STRUCTURE and BAYES) revealed that, with the exception of the juvenile samples collected in 2002 and 2003 in the northeast, most of the individuals originated from the southwest. These results confirmed that the Icelandic cod exhibit a complex biological pattern involving spawning site fidelity and migration to and from feeding aggregations. The sustainable management of the Icelandic cod is likely to be compromised if its complex dynamics is not properly integrated into fisheries management plans.

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The stock structure of the Atlantic wolffish was investigated at Icelandic fishing grounds, using 16 microsatellite loci. Despite the potential of the Atlantic wolffish to exhibit genetic structure (lack of eggs / larval dispersal and adults are sedentary), none of the genetic tests applied in this study detected significant genetic differentiation among the contemporary samples as well as among the contemporary and archived samples . The results of this study therefore suggested a lack of genetic structure among the populations of Atlantic wolffish in Icelandic waters and temporal stability over a period of ∼10 years. These results are discussed in terms of biological characteristics of Atlantic wolffish, recent isolation of populations, and their application to sustainable fisheries management issues.

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Fish protein solutions were extracted from cod (Gadusmorhua) trim using the pH-shift process. Fresh and frozen stability of cod protein solutions (CPS) [at 3% protein, pH 7.9, and different levels of salt, with / without cryoprotectants (sucrose, sorbitol and polyphosphate)] stored for different times and temperatures were studied. The results indicated that the fresh CPS was spoiled microbiologically after 3 days of storage at + 2 ° C. Viscosity (Brabander Unit) decreased in samples containing 3% and 5% salt and increased in samples containing 10 and 15% salt after 2 days of storage at + 2 ° C. Viscosity of fresh samples containing 10% and 15% salt decreased with storage time. The expressible moisture and whiteness of fresh samples were not influenced by the storage time. Adding cryoprotectants to CPS containing 1.2, 3, 5 and 15% salt increased the water holding capacity (WHC) and decreased the expressible moisture. It also increased viscosity (BU) in samples containing 3 and 5% salt significantly after 14 weeks of storage at -24 ° C. The cryoprotectants had no significant effect on improving the whiteness of the samples. The storage time also increased the expressible moistureand decreased WHC in frozen samples. The most stable frozen samples were those with 5% salt and cryoprotectants followed by the samples with 3% salt and cryoprotectants.

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Phosphate blend can be used in salted cod processing to improve yields, water holding capacity and appearance of the final product. However, added phosphates are gradually degraded during processing and storage, leading to changes in functional properties of phosphates. The objective of the study was to monitor the quantitative and qualitative changes in added phosphates in cod during salting, storage and rehydration using ion chromatography (IC) and spectrophotometric analysis. The phosphates diffused into the fish muscle during brining but the phosphate content (mg P₂O₅/ g sample) decreased again as liquid drained away from the muscle in the following dry salting step. Changes during six months storage of the dry salted products were minor. Further losses were observed during rehydration where the phosphates were washed out to levels lower than in the raw material.

The advantage of the IC method was the ability to separate and determine different soluble phosphate species in the fish muscle. The IC results showed that pyrophosphate (P₂O₇) and triphosphate (P₃O₁₀) were partly degraded into orthophosphate (PO₄) during the storage period. Lower values were obtained for the total phosphate content by IC than with the spectrophotometric method, which explained by difference is sample preparation.

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A dietary study was undertaken to test the effect of different protein and lipid levels in feed for turbot, Scophthalmus maximus (Rafinesque, 1810) in the grow-out phase (initial size 580 g). The experimental diets were formulated to contain 35 (LP), 42.5 (MP) and 50 (HP) % crude protein (CP), protein with a subsequent level of 15 (LL) and 25 (HL) % crude lipid (CL) for each protein level. Final weights and specific growth rates were significantly affected by the dietary treatments. Fish fed the low protein low lipid (LP / LL) diet displayed lower final mean weight compared to fish fed the high protein (HP / LL and HP / HL) diets. The overall SGR was higher in the HP / LL group compared to both low protein groups and the MP / LL group. The calculated feed conversion efficiency (FCE) demonstrated that turbot are able to utilize high lipid feed efficiently and that lipids are essential when fish are fed diets with reduced amounts of protein. No clear relationship was found between CP content in feed and CP in fillet. CL in fillet were, however, affected by dietary CL, where fish fed the LP / HL and MP / HL diets had elevated levels of CL in fillet. The diets did not affect the texture properties of the fillet, whereas some differences were found regarding water holding capacity (WHC) and muscle pH in fillet. The present findings suggest that CP can be reduced by approximately 10% compared to current level in commercial feed without negative effects on growth. This will make production of a more cost efficient and less expensive feed for large turbot (> 500 g) possible.

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