Food Trade for Specific Health Use FOSHU through Patents in LATAM: Relevant Aspects in International Law / Comercio de Alimentos para Uso Específico de Salud FOSHU a través de Patentes en LATAM: Aspectos Relevantes en el Derecho Internacional

Introduction: This article addresses the legal regulations for Foods for Specified Health Uses (FOSHU) in the main trade associations of Latin America (LATAM), based on the Codex Alimentarius system. Objective: The objective is to determine regulatory progress in the trade of FOSHU products. Material and methods: This study includes a review of the literature emanating from the databases from 2018 to 2022, according to the framework of three general food marketing regulations: food safety claims; inspection regulations, and food manufacturing and labeling. Results: The results reveal the absence of a specific legislation for FOSHU foods, as these are only mentioned in the area of nutrition. Conclusions: The legal framework in the trade of these products is based on jus cogens. Registration of industrial patents in the main member countries of LATAM trade associations can be facilitated through the Patent Prosecution Highway (PPH)(AU)

Introducción: El artículo aborda las regulaciones jurídicas en Alimentos para Uso Específico de Salud "FOSHU" en las principales asociaciones comerciales de América Latina (LATAM), basados en el sistema Codex Alimentarius. Objetivo: Determinar el avance regulatorio en la comercialización de productos FOSHU. Materiales y métodos: Se revisa la literatura emanada de las bases de datos desde el año 2018 al 2022, según el marco de tres regulaciones generales de comercialización de alimentos: las declaraciones de seguridad alimentaria; las regulaciones de inspecciones, las de manufacturas de alimentos y etiquetado. Resultados: Los resultados revelaron la ausencia de una legislación específica para alimentos FOSHU, siendo solo mencionados en el área de la nutrición. Conclusiones: El revestimiento jurídico en la comercialización de estos productos; se cimienta en el ius cogens. Las inscripciones de patentes industriales en los principales países miembros de las asociaciones comerciales en LATAM pueden facilitarse por la vía del Patent Prosecution Highway (PPH)(AU)

A review of polyols - biotechnological production, food applications, regulation, labeling and health effects.

Food research is constantly searching for new ways to replace sugar. This is due to the negative connotations of sugar consumption on health which has driven consumer demand for healthier products and is reflected on a national level by the taxation of sugary beverages. Sugar alcohols, a class of polyols, are present in varying levels in many fruits and vegetables and are also added to foods as low calorific sweeteners. The most commonly used polyols in food include sorbitol, mannitol, xylitol, erythritol, maltitol, lactitol and isomalt. Of these, microorganisms can produce sorbitol, mannitol, xylitol and erythritol either naturally or through genetic engineering. Production of polyols by microbes has been the focus of a lot of research for its potential as an alternative to current industrial scale production by chemical synthesis but can also be used for in situ production of natural sweeteners in fermented products using microbes approved for use in foods. This review on the generation of these natural sweetening compounds by microorganisms examines the current understanding and methods of microbial production of polyols that are applicable in the food industry. The review also considers the health benefits and effects of polyol usage and discusses regulations which are applicable to polyol use.

Science-based regulatory approach for safe nutraceuticals.

Food safety is a very complex issue. The food that reaches the plate from the farm is exposed to many hazards in processing methods and each of those steps is likely to contribute, indirectly or directly, to contaminants and pathogens that ultimately make the food unsafe. Consumers would always wish for 100% product safety; even regulators want to ensure 100% safety of the product and protect consumers. Every country has its own food safety regulations, but the application of food safety management in the plant and prescription of standards with a clear network of organising the risk analysis in the chain is lacking. However, with the wide array of new health products - nutraceuticals, nutritional supplements, functional foods, dietary supplements, foods for special medical purposes and foods for special dietary uses - safety draws the attention consumers to a much greater extent. Foods may contain herb/plant or animal extracts that perhaps were not previously ingredients, making health claims a very challenging and difficult task for manufacturers and regulators in the food industry. This Mini-Review attempts to address this issue from a science-based viewpoint. © 2018 Society of Chemical Industry.

Responsible decision-making for plant research and breeding innovations in the European Union.

Plant research and breeding has made substantial technical progress over the past few decades, indicating a potential for tremendous societal impact. Due to this potential, the development of policies and legislation on plant breeding and the technical progress should preferably involve all relevant stakeholders. However, we argue here that there is a substantial imbalance in the European Union (EU) regarding the influence of the various stakeholder groups on policy makers. We use evidence from three examples in order to show that the role of science is overlooked: 1) important delays in the decision process concerning the authorization of genetically modified (GM) maize events, 2) the significance attributed to non-scientific reasons in new legislation concerning the prohibition of GM events in EU member states, and 3) failure of the European Commission to deliver legal guidance to new plant breeding techniques despite sufficient scientific evidence and advisory reports. We attribute this imbalance to misinformation and misinterpretation of public perceptions and a disproportionate attention to single outlier reports, and we present ideas on how to establish a better stakeholder balance within this field.

Gutter oil: an overview of Chinese food safety issues and policies.

Food safety has become a focus of attention worldwide. In China, one of the top concerns in food safety is gutter oil, known as 'swill-cooked oil'. This Commentary summarizes the key incidents disclosed to the public by the media, and the policies regarding gutter oil at national, regional, and provincial or city levels. Several challenges the country still faces in tackling this issue are identified, including a lack of evaluation of the implementation and effect of the policies, a lack of effective technology to detect and recycle gutter oil, and the overlooking of the hazardous effect of gutter oil on health. This commentary suggests that strengthening policy implementation and evaluation, improving measurement and recycling technologies, and launching public health campaigns would help eliminate gutter oil from dining tables.

Policies for healthy and sustainable edible oil consumption: a stakeholder analysis for Thailand.

OBJECTIVE: Palm oil is a cheap and versatile edible oil in widespread use as a food ingredient that has been linked to negative health and environmental outcomes. The current study aimed to understand the prospects for future health-focused policy development to limit food use of palm oil and promote a greater diversity of oils in Thailand's food system. DESIGN: Eighteen semi-structured interviews were conducted with a range of stakeholders. The interviews probed views on the economic, health and environmental dimensions of the issue, the prospects for health-focused policy development and the policy development process. Transcripts were analysed using a health policy analytical framework. SETTING: Thailand. SUBJECTS: Stakeholders from a range of ministries, regulatory agencies, the private sector, non-governmental organizations and academia. RESULTS: There are several impediments to the emergence of strong regulation, including the primacy of economic considerations in setting policy, doubt and misperception about health implications and a complex regulatory environment with little space for health-related considerations. At the same time, some sections of the food industry producing food for domestic consumption are substituting palm with other oils on the basis of consumer health perceptions. CONCLUSIONS: Strong regulation to curb the growth of palm oil is unlikely to emerge soon. However, a long-term strategy can be envisaged that relies on greater policy support for other indigenous oils, strategic rebalancing towards the use of palm oil for biofuels and oleochemicals, and harnessing Thailand's food technology capabilities to promote substitution in food production in favour of oils with healthier fatty acid composition.

[Methodological approaches to the creation of healthy food].

The substantiation of necessity of creation of healthy food products and their classification. Formulated methodological approaches to the creation of healthy food: enriched, functional and specialized purpose.

COMPANION ANIMALS SYMPOSIUM: Rendered ingredients significantly influence sustainability, quality, and safety of pet food.

The rendering industry collects and safely processes approximately 25 million t of animal byproducts each year in the United States. Rendering plants process a variety of raw materials from food animal production, principally offal from slaughterhouses, but include whole animals that die on farms or in transit and other materials such as bone, feathers, and blood. By recycling these byproducts into various protein, fat, and mineral products, including meat and bone meal, hydrolyzed feather meal, blood meal, and various types of animal fats and greases, the sustainability of food animal production is greatly enhanced. The rendering industry is conscious of its role in the prevention of disease and microbiological control and providing safe feed ingredients for livestock, poultry, aquaculture, and pets. The processing of otherwise low-value OM from the livestock production and meat processing industries through rendering drastically reduces the amount of waste. If not rendered, biological materials would be deposited in landfills, burned, buried, or inappropriately dumped with large amounts of carbon dioxide, ammonia, and other compounds polluting air and water. The majority of rendered protein products are used as animal feed. Rendered products are especially valuable to the livestock and pet food industries because of their high protein content, digestible AA levels (especially lysine), mineral availability (especially calcium and phosphorous), and relatively low cost in relation to their nutrient value. The use of these reclaimed and recycled materials in pet food is a much more sustainable model than using human food for pets.

Food traceability systems in China: The current status of and future perspectives on food supply chain databases, legal support, and technological research and support for food safety regulation.

Over the past few decades, the field of food security has witnessed numerous problems and incidents that have garnered public attention. Given this serious situation, the food traceability system (FTS) has become part of the expanding food safety continuum to reduce the risk of food safety problems. This article reviews a great deal of the related literature and results from previous studies of FTS to corroborate this contention. This article describes the development and benefits of FTS in developed countries like the United States of America (USA), Japan, and some European countries. Problems with existing FTS in China are noted, including a lack of a complete database, inadequate laws and regulations, and lagging technological research into FTS. This article puts forward several suggestions for the future, including improvement of information websites, clarification of regulatory responsibilities, and promotion of technological research.

[Probiotics as functional food products: manufacture and approaches to evaluating of the effectiveness].

This review concerns the issues of foodfortifications and the creation of functional foods (FF) and food supplements based on probiotics and covers an issue of approaches to the regulation of probiotic food products in various countries. The status of functional foods, optimizing GIT functions, as a separate category of FF is emphasized. Considering the strain-specificity effect of probiotics, the minimum criteria used for probiotics in food products are: 1) the need to identify a probiotics at genus, species, and strain levels, using the high-resolution techniques, 2) the viability and the presence of a sufficient amount of the probiotic in product at the end of shelf life, 3) the proof of functional characteristics inherent to probiotic strains, in the controlled experiments. The recommended by FA O/WHO three-stage evaluation procedure offunctional efficiency of FF includes: Phase I--safety assessment in in vitro and in vivo experiments, Phase II--Evaluation in the Double-Blind, Randomized, Placebo-Controlled trial (DBRPC) and Phase III--Post-approval monitoring. It is noted that along with the ability to obtain statistically significant results of the evaluation, there are practical difficulties of conducting DBRPC (duration, costs, difficulties in selection of target biomarkers and populations). The promising approach for assessing the functional efficacy of FF is the concept of nutrigenomics. It examines the link between the human diet and the characteristics of his genome to determine the influence of food on the expression of genes and, ultimately, to human health. Nutrigenomic approaches are promising to assess the impact of probiotics in healthy people. The focusing on the nutrigenomic response of intestinal microbial community and its individual populations (in this regard the lactobacilli can be very informative) was proposed.

Reformulating partially hydrogenated vegetable oils to maximise health gains in India: is it feasible and will it meet consumer demand?

BACKGROUND: The consumption of partially hydrogenated vegetable oils (PHVOs) high in trans fat is associated with an increased risk of cardiovascular disease and other non-communicable diseases. In response to high intakes of PHVOs, the Indian government has proposed regulation to set limits on the amount of trans fat permissible in PHVOs. Global recommendations are to replace PHVOs with polyunsaturated fatty acids (PUFAs) in order to optimise health benefits; however, little is known about the practicalities of implementation in low-income settings. The aim of this study was to examine the technical and economic feasibility of reducing trans fat in PHVOs and reformulating it using healthier fats. METHODS: Thirteen semi-structured interviews were conducted with manufacturers and technical experts of PHVOs in India. Data were open-coded and organised according to key themes. RESULTS: Interviewees indicated that reformulating PHVOs was both economically and technically feasible provided that trans fat regulation takes account of the food technology challenges associated with product reformulation. However, there will be challenges in maintaining the physical properties that consumers prefer while reducing the trans fat in PHVOs. The availability of input oils was not seen to be a problem because of the low cost and high availability of imported palm oil, which was the input oil of choice for industry. Most interviewees were not concerned about the potential increase in saturated fat associated with increased use of palm oil and were not planning to use PUFAs in product reformulation. Interviewees indicated that many smaller manufacturers would not have sufficient capacity to reformulate products to reduce trans fat. CONCLUSIONS: Reformulating PHVOs to reduce trans fat in India is feasible; however, a collision course exists where the public health goal to replace PHVOs with PUFA are opposed to the goals of industry to produce a cheap alternative product that meets consumer preferences. Ensuring that product reformulation is done in a way that maximises health benefits will require shifts in knowledge and subsequent demand of products, decreased reliance on palm oil, investment in research and development and increased capacity for smaller manufacturers.

Food product tracing technology capabilities and interoperability.

Despite the best efforts of food safety and food defense professionals, contaminated food continues to enter the food supply. It is imperative that contaminated food be removed from the supply chain as quickly as possible to protect public health and stabilize markets. To solve this problem, scores of technology companies purport to have the most effective, economical product tracing system. This study sought to compare and contrast the effectiveness of these systems at analyzing product tracing information to identify the contaminated ingredient and likely source, as well as distribution of the product. It also determined if these systems can work together to better secure the food supply (their interoperability). Institute of Food Technologists (IFT) hypothesized that when technology providers are given a full set of supply-chain data, even for a multi-ingredient product, their systems will generally be able to trace a contaminated product forward and backward through the supply chain. However, when provided with only a portion of supply-chain data, even for a product with a straightforward supply chain, it was expected that interoperability of the systems will be lacking and that there will be difficulty collaborating to identify sources and/or recipients of potentially contaminated product. IFT provided supply-chain data for one complex product to 9 product tracing technology providers, and then compared and contrasted their effectiveness at analyzing product tracing information to identify the contaminated ingredient and likely source, as well as distribution of the product. A vertically integrated foodservice restaurant agreed to work with IFT to secure data from its supply chain for both a multi-ingredient and a simpler product. Potential multi-ingredient products considered included canned tuna, supreme pizza, and beef tacos. IFT ensured that all supply-chain data collected did not include any proprietary information or information that would otherwise identify the supply-chain partner who provided the information prior to sharing this information with product tracing technology providers. The 9 traceability solution providers who agreed to participate in this project have their systems deployed in a wide range of sectors within the food industry including, but not limited to, livestock, dairy, produce, fruits, seafood, meat, and pork; as well as in pharmaceutical, automotive, retail, and other industries. Some have also been implemented across the globe including Canada, China, USA, Norway, and the EU, among others. This broad commercial use ensures that the findings of this work are applicable to a broad spectrum of the food system. Six of the 9 participants successfully completed the data entry phase of this test. To verify successful data entry for these 6, a demo or screenshots of the data set from each system's user interface was requested. Only 4 of the 6 were able to provide us with this evidence for verification. Of the 6 that completed data entry and moved on to the scenarios phase of the test, 5 were able to provide us with the responses to the scenarios. Time metrics were useful for evaluating the scalability and usability of each technology. Scalability was derived from the time it took to enter the nonstandardized data set into the system (ranges from 7 to 11 d). Usability was derived from the time it took to query the scenarios and provide the results (from a few hours to a week). The time was measured in days it took for the participants to respond after we supplied them all the information they would need to successfully execute each test/scenario. Two of the technology solution providers successfully implemented and participated in a proof-of-concept interoperable framework during Year 2 of this study. While not required, they also demonstrated this interoperability capability on the FSMA-mandated food product tracing pilots for the U.S. FDA. This has significant real-world impact since the demonstration of interoperability enables U.S. FDA to obtain evidence on the importance and impact of data-sharing moving forward. Another real-world accomplishment is the modification or upgrade of commercial technology solutions to enhance or implement interoperability. As these systems get deployed by clients in the food industry, interoperability will no longer be an afterthought but will be built into their traceability systems. In turn, industry and regulators will better understand the capabilities of the currently available technologies, and the technology provider community will identify ways in which their systems may be further developed to increase interoperability and utility.

Proceedings of the August 2011 Traceability Research Summit.

IFT's Traceability Improvement Initiative aims to advance work in the area of food product tracing through several means including hosted events where thought leaders exchange knowledge and ideas. In August 2011, the Initiative, in collaboration with GS1 US, convened a group of 50 product tracing stakeholders, as a follow-on to a successful event the month prior. Representatives conducting pilots or implementation studies in produce, seafood, dairy, and other industries discussed the objectives, challenges and learnings. Some of the learnings from on-going initiatives included the sense that better information management provides a return of investment; data often exist but may not necessarily be appropriately linked through the supply chain; and enhanced product tracing enables better accountability and quality control. Challenges identified in enabling traceability throughout the supply chain were the distribution complexity; the need for training, communication, and collaboration; improving the reliability, quality and security of data captured, stored and shared as well as the importance of standards in data and interoperability of technology. Several approaches to overcoming these challenges were discussed. The first approach incrementally improves upon the current "one up/one down" system by requiring electronic records and tracking internal as well as external critical tracking events. The benefits of this approach are its similarity to existing regulatory requirements and low cost of implementation; resulting in a higher probability of adoption. The major disadvantage to this process is the longer response time required during a trace (back or forward). The second approach is similar to a "pedigree" approach where historical information about the food travels with it through the value chain. A major advantage of this approach is the quickest response time during a trace. Some of the disadvantages of this approach are potential for misuse of data, the volume of data required to be maintained at value chain end points, and data privacy concerns. The third approach requires individual nodes within the value chain to maintain electronic records for its own data and make them available for querying during a traceback for outbreak investigation. The major advantage of this approach is the protection of confidential information and the potential for quicker access during a trace. However, the primary disadvantage of this approach is the need for greater computational power and a more complex mechanism to linking the value chain through the data. As next steps, a subgroup will work on clarifying the approach to meeting the goals of traceability, better defining critical tracking events, and articulating the strategy and return on investment from a regulatory and industry perspective. This will result in improved alignment of on-going traceability pilots and initiatives as well as a more actionable guidance document for public review.

Encapsulation of new active ingredients.

The organic construct consumed as food comes packaged in units that carry the active components and protect the entrapped active materials until delivered to targeted human organs. The packaging and delivery role is mimicked in the microencapsulation tools used to deliver active ingredients in processed foods. Microencapsulation efficiency is balanced against the need to access the entrapped nutrients in bioavailable forms. Encapsulated ingredients boosted with bioactive nutrients are intended for improved health and well-being and to prevent future health problems. Presently, active ingredients are delivered using new techniques, such as hydrogels, nanoemulsions, and nanoparticles. In the future, nutraceuticals and functional foods may be tailored to individual metabolic needs and tied to each person's genetic makeup. Bioactive ingredients provide health-enhancing nutrients and are protected through encapsulation processes that shield the active ingredients from deleterious environments.

Impact of non-livelihood-based land management on land resources: the case of upland watersheds in Uporoto Mountains, South West Tanzania.

Various land management strategies are used to prevent land degradation and keep land productive. Often land management strategies applied in certain areas focus on the context of the physical environment but are incompatible with the social environment where they are applied. As a result, such strategies are ignored by land users and land degradation becomes difficult to control. This study observes the impacts of land management in the upland watersheds of the Uporoto Mountains in South West Tanzania. In spite of various land management practices used in the area, 38% of the studied area experienced soil fertility loss, 30% gully erosion, 23% soil loss, 6% biodiversity loss and drying up of river sources. Land management methods that were accepted and adopted were those contributing to immediate livelihood needs. These methods did not control land resource degradation, but increased crop output per unit of land and required little labour. Effective methods of controlling land degradation were abandoned or ignored because they did not satisfy immediate livelihood needs. This paper concludes that Integrating poor people's needs would transform non-livelihood-based land management methods to livelihood-based ones. Different ways of transforming these land management methods are presented and discussed.

Alchemy in eden: entrepreneurialism, branding, and food marketing in the United States, 1880­1920.

Through an investigation into the origins of American food marketing, this dissertation reveals how branding­specifically, the centennial brands Quaker Oats, Coca-Cola, and Crisco­came to underpin much of today's market-driven economy. In a manner akin to alchemy, the entrepreneurs behind these three firms recognized the inherent value of an agricultural Eden, then found ways to convert common, low-cost agricultural goods­oats, sugar, and cottonseed oil­into appealing, high-revenue branded food products. In the process, these ventures devised new demand-driven business models that exploited technology and communications advances, enabling them to tap a nascent consumer culture. Their pioneering efforts generated unprecedented profits, laid the foundation for iconic billion-dollar brands, and fundamentally changed how Americans make daily food choices.

Biofuel, dairy production and beef in Brazil: competing claims on land use in São Paulo state.

This paper examines the competing claims on land use resulting from the expansion of biofuel production. Sugarcane for biofuel drives agrarian change in So Paulo state, which has become the major ethanol-producing region in Brazil. We analyse how the expansion of sugarcane-based ethanol in So Paulo state has impacted dairy and beef production. Historical changes in land use, production technologies, and product and land prices are described, as well as how these are linked to changing policies in Brazil. We argue that sugarcane/biofuel expansion should be understood in the context of the dynamics of other agricultural sectors and the long-term national political economy rather than as solely due to recent global demand for biofuel. This argument is based on a meticulous analysis of changes in three important sectors - sugarcane, dairy farming, and beef production - and the mutual interactions between these sectors.

Exploring the resilience of Bt cotton's "pro-poor success story".

Expectations play a powerful role in driving technological change. Expectations are often encapsulated in narratives of technological promise that emphasize potential benefits and downplay potential negative impacts. Genetically modified (GM, transgenic) crops have been framed by expectations that they would be an intrinsically "pro-poor" innovation that would contribute powerfully to international agricultural development. However, expectations typically have to be scaled back in the light of experience. Published reviews of the socio-economic impacts of GM crops among poor, small-scale farmers in the developing world indicate that these effects have been very mixed and contingent on the agronomic, socio-economic and institutional settings where the technology has been applied. These conclusions should modulate expectations about the pro-poor potential of GM crop technology and focus attention on the conditions under which it might deliver substantial and sustainable benefits for poor farmers. However, the idea of GM crop technology as an intrinsically pro-poor developmental success story has been sustained in academic, public and policy arenas. This narrative depends upon an analysis that disembeds the technology from the technical, social and institutional contexts in which it is applied. Agricultural development policy should be based on a more rigorous and dispassionate analysis, rather than optimistic expectations alone.