The current use and evolving landscape of nutraceuticals.

The nutraceutical market is currently a high-impact multi-billion-dollar industry, and it is anticipated to grow rapidly over the next decade. Nutraceuticals comprise diverse food-derived product categories that have become widespread due to increased consumer awareness of potential health benefits and the need for improved wellness. This targeted review is designed to identify the current global trends, market opportunities, and regulations that drive the nutraceutical industry. Safety and efficacy concerns are also explored with a view to highlighting areas that necessitate further research and oversight. Key drivers of the nutraceutical market include aging populations, consumer awareness, consumer lifestyle, increasing cost of healthcare, and marketing channels. Although some nutraceuticals hold promising preventive and therapeutic opportunities, there is a lack of a universal definition and regulatory framework among countries. Moreover, there is a lack of adequate evidence for their efficacy, safety, and effectiveness, which was even further highlighted during the ongoing coronavirus pandemic. Future prospective epidemiological studies can delineate the health impact of nutraceuticals and help set the scientific basis and rationale foundation for clinical trials, reducing the time and cost of trials themselves. Together, an understanding of the key drivers of the nutraceutical market alongside a consistent and well-defined regulatory framework will provide further opportunities for growth, expansion, and segmentation of nutraceuticals applications.

[Novel food sources: from GMO to the broadening of Russia's bioresource base].

The modern strategy of humanity food providing is aimed at finding the exit from the food crisis in the shortest possible time, by the end of XXI century food and feed production should increase by at least 70%. These tasks solution implies not only the use of science-oriented technologies, but also the expansion of the food base by means of novel food sources, which don't have a history of safe use. In the Russian Federation the formation of novel food's safety assessment approaches is regulated at the state level and is the most important requirement for the possibility of usage. Russian experience of the second half of the XX century in the area of novel food sources' biomedical research unites two stages. The first of them dates back to the middle of the 1960s', when the Soviet scientists, in particular, the workforce of the Institute of Nutrition of the USSR Academy of Medical Sciences, under the leadership of Academician A.A. Pokrovskii, have developed the evaluation approaches of the biological value and safety of microbial synthesized protein. The second stage of the safety assessment research development was the work with the genetically modified organisms of plant origin (GMO), that begun in the middle of the 1990s'. Since the moment of formation in 1995-1996, 9 methodical guidelines that regulate methods of safety assessment and control over GMO have been developed. Comprehensively formed by 2020, safety assessment system has been used in the framework of 27 GMO lines state registration that passed a whole cycle of medical and biological research and were allowed for use in nutrition of the population of the Eurasian Economic Union. Within the framework of these research a considerable amount of factual material has been accumulated, a regulatory and methodological basis has been built, and a substantial background for further fundamental and applied scientific research in the field of development and safety assessment of novel food has been created.

[Microbiological safety of food: development of normative and methodical base].

The main results and prospects of fundamental and applied hygienic research of the laboratory of biosafety and nutrimicrobiome analysis of the Federal Research Centre of Nutrition, Biotechnology and Food Safety (hereinafter - the Institute of Nutrition) in the direction of developing a regulatory and methodological framework for assessing the microbiological safety of food are reviewed. The formation of microbiological regulation as a scientific analytical and administrative managerial process in the former USSR and the Russian Federation is considered in the context of historical data, including personal contribution of the scientists of the Institute of Nutrition and other specialists. The basic principles of regulation are emphasized: the scientific validity of the established criteria and requirements, the feasibility, technological attainability, differentiation according to the degree of danger to the health of consumers, preventive nature. The resource of the national normative and methodological base in the field of microbiological food safety at the turn of the century is characterized, the features of the introduction of the microbiological risk assessment (MRA) methodology in the substantiation of Russian norms and measures for the prevention of food infections are described. The information is given on the developed guidance documents on MRA and on the examples of norms adopted on its basis. The article covers the issues of reglamentation the requirements for food safety and reducing the spread of new pathogens Stx-Escherichia coli, Listeria monocytogenes, Enterobacter sakazakii, Campylobacter spp. in the food chain based on risk-oriented approaches. The necessity of taking specific measures for the prevention of cross-contamination in the poultry processing industry is substantiated, taking into account the evidence of the high adaptability of C. jejuni isolated from domestic raw poultry. In the sanitarian-mycological aspect, the monitoring perspective of mould fungi, taking into account their chemotypes, in cereals and non-grain plant products is shown to predict the risk of mycotoxin accumulation and take timely measures. The need to assess the impact on the population, taking into account the characteristics of consumption in the country, as well as the development of criteria for indirect risk of residues are argued for regulation of the antibiotics in food. In light of the challenges in the field of agro- and food technologies to public health at the present stage, contributing to the acceleration of microbial evolution and the emergence of new risks in food, the priority tasks of improving the regulatory and methodological base for assessing microbiological safety have been identified, with an emphasis on the introduction into the process of substantiating the norms of innovative OMICs-technologies based on the achievements of genomics, transcriptomics, proteomics, metabolomics, bioinformatics.

Growing the Business of Whole Grain in the Australian Market: A 6-Year Impact Assessment.

The Australia New Zealand Food Standards Code does not regulate on-pack claims describing the amount of whole grain in foods. In July 2013, The Grains & Legumes Nutrition CouncilTM (GLNC) established a voluntary Code of Practice for Whole Grain Ingredient Content Claims (the Code) providing guidance for whole grain claims, with cut-off values and suggested wording ≥8 g, ≥16 g, and ≥24 g per manufacturer serve (contains; high and very high in whole grain), based on a 48 g whole grain daily target intake. The aim of this impact assessment was to report the uptake of the Code by manufacturers, changes in numbers of whole grain products, and claims on-pack since 2013, including compliance. The impact assessment was undertaken in August 2019, comparing current registered manufacturers ("users") and their products to the total number of products in the market deemed eligible for registration through GLNC product audits since 2013. Reporting included breakfast cereals, bread products, crispbreads, crackers, rice/corn cakes, rice, pasta, noodles, couscous, other grains (e.g., quinoa, buckwheat, freekeh), and grain-based muesli bars. As of 30 June 2019, there were 33 registered users and 531 registered products in Australia and New Zealand representing 43% of the eligible manufacturers and 65% of the eligible whole grain foods. Three-quarters (78% and 74%) of the eligible breakfast cereals and bread products were registered with the Code in 2019, followed by 62% of grain-based muesli bars. Only 39% of crispbread, crackers, rice/corn cakes, and rice, pasta, noodles, couscous, and other grains were registered. From 2013 there has been a 71% increase in the number of whole grain foods making claims, demonstrating strong uptake by industry, with clearer, more consistent, and compliant on-pack communication regarding whole grain content.

A New Age of Evolution: Protecting the Consumer's Moral and Legal Right to Know through the Clear and Transparent Labeling of All Genetically Modified Foods.

The United States government, until recently, did not require the labeling of genetically modified organisms (GMOs). On July 29, 2016, President Barack Obama signed into law the National Bioengineered Food Disclosure Standard (NBFDS). This law directs the United States Department of Agriculture (USDA) to create regulations that require manufacturers to disclose certain bioengineered products on food labels. On December 20, 2018, the USDA released the final regulations for the NBFDS, which requires food manufactures, importers, and certain retailers to ensure bioengineered foods are appropriately disclosed. The final regulations include provisions that will leave the majority of GMO derived foods unlabeled. The final regulations also restrict approximately 100 million Americans from accessing GMO information by allowing QR codes to replace clear and transparent labeling, an issue that will be discussed in further detail later in this Note. This Note explores why you, as a consumer, may want to know whether your food contains GM products, and furthermore, why you as a consumer have a moral and legal right to know.

Time for Change: Stepping Up the FDA's Regulation of Dietary Supplements to Promote Consumer Safety and Awareness.

People are often looking for that quick fix when it comes to their health. With dietary supplements so readily available on the market, the public assume that they have been through rigorous testing. Dietary supplements are not tested as much as consumers believe. The Food and Drug Administration (FDA) does not initiate the same type of testing and analysis for supplements as it does for food, drink and medication. Given that people are now choosing supplemental meal replacements and the like, as opposed to whole foods, regulations drastically need to be stepped up in an effort to emphasise public safety. An authoritative body needs to stop manufacturers from taking advantage of an already vulnerable marketplace. I suggest a new form of regulation that takes the pressure away from the FDA and into the hands of someone who wholly focuses on the supplement market. Dietary supplements have revolutionised the "health" world; however, the only way that the market can keep growing is through enacting more stringent rules and regulations--at the same time allowing consumers to maintain their autonomy and freedom when purchasing.

Soberania alimentar na interseção entre bioética e direitos humanos: uma revisão integrativa da literatura / Soberanía alimentaria en la intersección entre bioética y derechos humanos: una revisión integrada de literatura / Food sovereignty in the intersection between bioethics and human rights: an integrative review of literatura / Sobirania alimentària en la intersecció entre bioètica i drets humans: una revisió integrada de literatura

O conceito de soberania alimentar pauta-se na tentativa de contrariar o sistema de produção alimentar, comandado pelas grandes empresas, que retiram o direito dos povos de decidirem sobre sua alimentação. Realizou-se uma revisão integrativa da literatura com pergunta norteadora orientada pela bioética, através da Declaração Universal sobre Bioética e Direitos Humanos. Para busca, utilizaram-se os descritores «soberania» e «alimentar», tendo como resultado 21 artigos para leitura integral. Compilou-se em três categorias: [I] Aspectos do meio-ambiente, [II] Direitos Humanos e [III] Aspectos político-econômicos. A análise demonstrou que a concentração de terras, de meios de produção, e capital, têm trazido consequências para a saúde e iniquidades das populações, sem atentar-se com a sustentabilidade e a sobrevivência do próprio planeta

El concepto de soberanía alimentaria se basa en intentar contrarrestar el sistema de producción de alimentos desarrollado por grandes empresas que anula la autonomía de las personas para decidir sobre su consumo alimentario. A través de la Declaración Universal sobre Bioética y Derechos Humanos, se realizó una revisión integral de la literatura existente guiada por una preguntada orientada dentro del campo de la bioética. La búsqueda en la base de datos se hizo con los descriptores «soberanía» y «comida», y como resultado aparecieron 21 artículos de lectura completa. Éstos se compilaron en tres categorías: [I] Aspectos vinculados al medio ambiente, [II] Derechos Humanos y [III] Aspectos político-económicos. El análisis ha demostrado que la tenencia de la tierra en pocas manos, los medios de producción y el capital han traído graves consecuencias para la población y para su salud, sin tener en cuenta la sostenibilidad y la supervivencia del planeta

El concepte de sobirania alimentària es basa en intentar contrarestar el sistema de producció d'aliments desenvolupats per grans empreses que anul·la l'autonomia de les persones per a decidir sobre el seu consum alimentari. A través de la Declaració Universal sobre Bioètica i Drets Humans, es va realitzar una revisió integral de la literatura existent guiada per una preguntada orientada dins del camp de la bioètica. La recerca dins la base de dades es va fer amb els descriptors «sobirania» i «menjar», i com a resultat varen aparèixer 21 articles de lectura completa. Aquests es van recopilar en tres categories: [I] Aspectes lligats al medi ambient, [II] Drets Humans i [III] Aspectes polític-econòmics. L'anàlisi ha demostrat que la tinència de la terra en poques mans, els mitjans de producció i el capital han generat grans conseqüències per a la població i per a la seva salut, sense tenir en compte la sostenibilitat i la supervivència del planeta

The concept of food sovereignty is based on the attempt to counteract the food production's system, led by large companies, which withdraw the autonomy of people to decide on their food actions. An integrative review of literature was conducted with a guiding question oriented by bioethics, through the Universal Declaration on Bioethics and Human Rights. The search on the database was made with the descriptors «sovereignty» and «food», resulting in 21 articles for full reading. They were compiled in three categories: [I] Aspects of the environment, [II] Human Rights and [III] Political-economic aspects. The analysis has shown that the concentrations of land, means of production, and capital, have brought consequences for the iniquities of populations and their health, without regard to the sustainability and survival of the planet

Por qué todavía no comemos insectos: marco legal en la Unión Europea / Why we still do not eat insects: legal framework in the European Union / Per què encara no mengem insectes: marc legal en la Unió Europea

Los insectos son considerados un alimento inusual en Europa, cuando no lo son para otras regiones del mundo. Este consumo inexistente es debido a la aversión cultural hacia ellos y a la falta de legislación comunitaria que los contemple. Para esclarecer la situación de la comercialización de grillos fritos enteros, se presentan dos situaciones distintas en un caso práctico: la venta en octubre de 2017 y enero de 2025. En la primera situación, los grillos no podrán comercializarse por el vacío legal de la legislación comunitaria y española, mientras que, en el año 2025, serán considerados nuevos alimentos y por lo tanto sí podrán comercializarse. Aun así, son necesarias normativas complementarias para abordar su calidad y seguridad alimentaria

Insects are considered unusual food in Europe whereas in other regions of the world are very common. Its consumption is non-existent due mainly to the cultural aversion towards them and the lack of regulations. To clarify what the legal status of insects is, two different situations in selling fried crickets are presented inside a case study: selling in October 2017 and in January 2025. Analysing the first situation it turns out that its merchandising is non-viable due to the legal vacuum in the European and Spanish regulations, whereas in 2025, fried crickets will be considered as a novel food. Despite all, more efforts are needed in order to create other regulations that focus into the expected quality and food safety

Els insectes es consideren un aliment inusual a Europa, però no en altres regions del món. Aquest consum inexistent es produeix a causa de l'aversió cultural cap a ells i a la falta d'una legislació comunitària que ho contempli. Per esclarir la situació de la comercialització de grills fregits enters, s'exposen dues situacions diferents en un mateix cas pràctic: la venda d’aquests insectes l'octubre de 2017 i el gener de 2025. En la primera situació, els grills no poden comercialitzar-se a causa del buit legal existent en la legislació comunitària i en l’espanyola, mentre que l'any 2025 seran considerats com aliments nous que podran comercialitzar-se. Així i tot, calen normatives complementàries que facin referència a la seva qualitat i seguretat alimentària

Rebooting the generally recognized as safe (GRAS) approach for food additive safety in the US.

The US Food and Drug Administration (FDA) has premarket review authority over food additives, but a food manufacturer may, according to the legislation, intentionally add a substance to human food or animal food without their premarket review or approval if the substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use. Generally recognized as safe (GRAS) implies that the current scientific community agrees on the adequacy of how data is generated. This system has come under public pressure because of doubts as to its efficiency and the FDA's recent GRAS rule is part of the response. The FDA guidance for testing food additives, known as the "Redbook", is about two decades old. Work toward a new "Redbook" is on the way, but the US Grocery Manufacturer Association (GMA) also has initiated the development of an independent standard on how to perform GRAS determinations. This review of the current guidance shows a very rigorous system for higher concern levels, but also many waiving options. Opportunities and challenges for safety evaluations of food additives are discussed. Where scientific progress has allowed improving existing and adapting new methods, these should be adopted to improve product safety and animal welfare. The continuous adaptation of such improved methods is therefore needed. Especially, there are opportunities to embrace developments within the toxicity testing for the 21st century movement and evidence-based toxicology approaches. Also, the growing understanding of the limitations of traditional tests needs to be considered.

The legislative framework for salt iodization in Asia and the Pacific and its impact on programme implementation.

OBJECTIVE: Fortification of food-grade (edible) salt with iodine is recommended as a safe, cost-effective and sustainable strategy for the prevention of iodine-deficiency disorders. The present paper examines the legislative framework for salt iodization in Asian countries. DESIGN: We reviewed salt iodization legislation in thirty-six countries in Asia and the Pacific. We obtained copies of existing and draft legislation for salt iodization from UNICEF country offices and the WHO's Global Database of Implementation of Nutrition Actions. We compiled legislation details by country and report on commonalities and gaps using a standardized form. The association between type of legislation and availability of iodized salt in households was assessed. RESULTS: We identified twenty-one countries with existing salt iodization legislation, of which eighteen were mandatory. A further nine countries have draft legislation. The majority of countries with draft and existing legislation used a mandatory standard or technical regulation for iodized salt under their Food Act/Law. The remainder have developed a 'stand-alone' Law/Act. Available national surveys indicate that the proportion of households consuming adequately iodized salt was lowest in countries with no, draft or voluntary legislation, and highest in those where the legislation was based on mandatory regulations under Food Acts/Laws. CONCLUSIONS: Legislation for salt iodization, particularly mandatory legislation under the national food law, facilitates universal salt iodization. However, additional important factors for implementation of salt iodization and maintenance of achievements include the salt industry's structure and capacity to adequately fortify, and official commitment and capacity to enforce national legislation.

Changes in Consumer Attitudes toward Broad-Based and Environment-Specific Sodium Policies-SummerStyles 2012 and 2015.

We examined temporal changes in consumer attitudes toward broad-based actions and environment-specific policies to limit sodium in restaurants, manufactured foods, and school and workplace cafeterias from the 2012 and 2015 SummerStyle surveys. We used two online, national research panel surveys to conduct a cross-sectional analysis of 7845 U.S. adults. Measures included self-reported agreement with broad-based actions and environment-specific policies to limit sodium in restaurants, manufactured foods, school cafeterias, workplace cafeterias, and quick-serve restaurants. Wald Chi-square tests were used to examine the difference between the two survey years and multivariate logistic regression was used to obtain odds ratios. Agreement with broad-based actions to limit sodium in restaurants (45.9% agreed in 2015) and manufactured foods (56.5% agreed in 2015) did not change between 2012 and 2015. From 2012 to 2015, there was a significant increase in respondents that supported environment-specific policies to lower sodium in school cafeterias (80.0% to 84.9%; p < 0.0001), workplace cafeterias (71.2% to 76.6%; p < 0.0001), and quick-serve restaurants (70.8% to 76.7%; p < 0.0001). Results suggest substantial agreement and support for actions to limit sodium in commercially-processed and prepared foods since 2012, with most consumers ready for actions to lower sodium in foods served in schools, workplaces, and quick-serve restaurants.

[Food supplements : Legal requirements, borderline issues and other aspects]. / Nahrungsergänzungsmittel : Rechtliche Grundlagen, Abgrenzung zu Arzneimitteln, sonstige Fragestellungen.

Food supplements are classified as foods. They are concentrated sources of vitamins and minerals or other substances with a nutritional or physiological effect. Their purpose is to supplement the normal diet. Food supplements have to comply with the applicable legal provisions of the food law. In order to ensure the health protection of consumers, food supplements that will be put on the market must be safe. For food supplements, regulations exist at the EU level as well as at the national level. Specific requirements are regulated in the Ordinance on Food Supplements, with which the European Directive on Food Supplements was transposed into German law. The European and German legal provisions applicable to food supplements are outlined. Important aspects regarding the delimitation between food supplements and medicinal products are addressed. These borderline issues are of special importance to food supplements which are marketed in dose forms such as capsules, tablets etc., the typical forms of medicinal products. Problems resulting from the lack of harmonized rules are described. The European harmonization of the rules is still incomplete for substances with a nutritional or physiological effect other than vitamins and minerals for use in food supplements. The setting of maximum amounts of vitamins and minerals present in food supplements as envisaged in the Directive on Food Supplements has not yet been implemented.

Food and feed chemical contaminants in the European Union: Regulatory, scientific, and technical issues concerning chemical contaminants occurrence, risk assessment, and risk management in the European Union.

A priority of the European Union is the control of risks possibly associated with chemical contaminants in food and undesirable substances in feed. Following an initial chapter describing the main contaminants detected in food and undesirable substances in feed in the EU, their main sources and the factors which affect their occurrence, the present review focuses on the "continous call for data" procedure that is a very effective system in place at EFSA to make possible the exposure assessment of specific contaminants and undesirable substances. Risk assessment of contaminants in food atances in feed is carried currently in the European Union by the CONTAM Panel of EFSA according to well defined methodologies and in collaboration with competent international organizations and with Member States.

Reviewing the Nutrition and Health Claims Regulation (EC) No. 1924/2006: What do we know about its challenges and potential impact on innovation?

Health claims potentially represent an opportunity for firms to engage in product differentiation and thereby induce investment into R&D and innovation in the food sector. The Nutrition and Health Claims Regulation (EC) No. 1924/2006 (NHCR) aims at protecting and promoting innovation as one of its objectives. However, existing studies indicate that this regulation may create several challenges for innovation in the food sector. To this end, we review the challenges related to the NHCR (Article 13.1) and its impact on innovation. Extant literature suggests that companies face challenges related to changing list of ingredients, missing transparency, wording of claims, limited financial resources, limited R&D resources, switching product categories and abandoning the functional foods sector. Moreover, current studies imply that so far the NHCR (in specific Article 13.1) does not seem to encourage innovation in the EU food sector.

Exploring the Nutrition and Health Claims Regulation (EC) No. 1924/2006: What is the impact on innovation in the EU food sector?

Literature suggests that despite its positive aim of promoting innovation, the Nutrition and Health Claims Regulation (EC) No. 1924/2006 (NHCR) may bring along several compliance challenges, which might affect innovation in the EU food sector. This study investigates the challenges faced by companies to comply with the NHCR (specifically Article 13.1) and their impact on innovation. To this end, we conducted an online survey with 105 companies involved in the EU food sector. Results indicate that companies perceive wording of claims, missing transparency and limited financial resources as major challenges to comply with the NHCR (Article 13.1). Companies reported not to have increased their R&D expenditure or innovation activities after the NHCR (Article 13.1) was implemented. Thus, this study highlights specific compliance challenges related to the NHCR (Article 13.1) and indicates that currently, the regulation does not seem to have fostered innovation in the EU food sector.

Environmental impact of non-certified versus certified (ASC) intensive Pangasius aquaculture in Vietnam, a comparison based on a statistically supported LCA.

Pangasius production in Vietnam is widely known as a success story in aquaculture, the fastest growing global food system because of its tremendous expansion by volume, value and the number of international markets to which Pangasius has been exported in recent years. While certification schemes are becoming significant features of international fish trade and marketing, an increasing number of Pangasius producers have followed at least one of the certification schemes recognised by international markets to incorporate environmental and social sustainability practices in aquaculture, typically the Pangasius Aquaculture Dialogue (PAD) scheme certified by the Aquaculture Stewardship Council (ASC). An assessment of the environmental benefit of applying certification schemes on Pangasius production, however, is still needed. This article compared the environmental impact of ASC-certified versus non-ASC certified intensive Pangasius aquaculture, using a statistically supported LCA. We focused on both resource-related (water, land and total resources) and emissions-related (global warming, acidification, freshwater and marine eutrophication) categories. The ASC certification scheme was shown to be a good approach for determining adequate environmental sustainability, especially concerning emissions-related categories, in Pangasius production. However, the non-ASC certified farms, due to the large spread, the impact (e.g., water resources and freshwater eutrophication) was possibly lower for a certain farm. However, this result was not generally prominent. Further improvements in intensive Pangasius production to inspire certification schemes are proposed, e.g., making the implementation of certification schemes more affordable, well-oriented and facilitated; reducing consumed feed amounts and of the incorporated share in fishmeal, especially domestic fishmeal, etc. However, their implementation should be vetted with key stakeholders to assess their feasibility.

FEMA expert panel review of p-mentha-1,8-dien-7-al genotoxicity testing results.

p-Mentha-1,8-dien-7-al is a naturally occurring cyclic alpha,beta-unsaturated aldehyde that is used as a flavoring substance throughout the world. Due to the chemical structure and the potential DNA reactivity of the alpha,beta-unsaturated carbonyl moiety, a battery of genotoxicity assays was requested by the European Food Safety Authority. Previous genotoxicity studies on the substance gave mixed results, but both positive and negative results were hampered by not always being performed to any standard guideline. The new test battery data indicated some evidence of mutagenicity in vitro, but an in vivo comet/micronucleus combination assay performed in rats was concluded by the study directors to not result in any biologically relevant positive responses. However, EFSA concluded that the in vivo assay gave evidence that p-mentha-1,8-dien-7-al was of potential genotoxic concern. The Expert Panel of the Flavor and Extract Manufacturers Association (FEMA) has reviewed the newly available data and considered its interpretation relative to standard guidelines such as that established by the Organization for Economic Cooperation and Development, and has concluded that the results in the comet/micronucleus combination assay are consistent with the interpretation by the study directors; namely, that p-mentha-1,8-dien-7-al does not appear to have any in vivo genotoxic potential.