The food supplement market has expanded rapidly in recent years, driven by demand for health, wellness, and healthy ageing; yet, the integrity of associated Health Claims (HC) remains uncertain. In the European Union (EU), food supplements are regulated under Directive 2002/46/EC, while HC use is governed by Regulation (EC) No. 1924/2006 (NHCR), which requires scientific substantiation evaluated by the European Food Safety Authority and subsequent authorisation by the European Commission/Member States. Despite this framework, concerns persist regarding unauthorised or non-compliant HC. This study examined the prevalence and compliance of HC on food supplement labels in the Republic of Ireland, comparing products sold in-store and online. A total of 192 food supplements were randomly selected across multiple categories, with HC compliance assessed against the EU Register of Nutrition and Health Claims and mandatory labelling requirements. In total, 2604 HC were identified, with multivitamins and botanicals as the most common categories reviewed. Although most HC referred to vitamins D and C and focused on immune function, only 80.7% of in-store claims and 75.6% of online claims were authorised, and only around one-third used the prescribed wording. Compliance was notably lower for botanicals, reflecting regulatory ambiguities around their use. These findings highlight persistent challenges in enforcing the NHCR, particularly for online sales and botanicals, and underscore the need for greater regulatory clarity and consumer protection.

Aims: The genotoxic safety of the extract Zembrin® of the medicinal plant S. tortuosum was evaluated. Sceletium tortuosum (L.) N.E.Br. (S. tortuosum) is a succulent plant found in South Africa. Whereas the number of toxicological evaluations of Zembrin® is limited, the purpose of this paper is to report on the genotoxic safety of Zembrin® by describing Zembrin®’s effects in a set of three genotoxicity tests according to OECD guidelines and under Good Laboratory Practice. Study Design: Genotoxic safety was evaluated performing three standard genotoxicity tests according to OECD guidelines 471, 487 and 474. Place and Duration of Study: Assays were performed at Toxi-Coop Zrt., Arácsi út 97 and Ady E. utca 12, 8230 Balatonfüred, Hungary in 2023. Methodology: Assays were run in compliance with internationally accepted guidelines included the bacterial reverse mutation assay (OECD 471), the in vitro mammalian cell micronucleus test (OECD 487) and the in vivo mouse micronucleus test (OECD 474). Results: Zembrin® extract, in concentrations varying from 16 up to 5000 µg/plate, did not change the mutation rates of the various Salmonella strains and the E. coli strain tested without and with metabolic activation in an in vitro OECD 471 mutation assay. Zembrin® extract did also not show an increased frequency of micronuclei without and with metabolic activation in an in vitro OECD 487 assay using L5178Y tk+/- cells. However, a dose dependent increase was found at the two higher concentrations (2500 and 5000 μg/mL) in the absence of metabolic activation. Since results were not clearly negative in the initial in vitro genotoxicity test, as per existing EFSA Guidance a confirmatory in vivo test was conducted. In an in vivo OECD 474 test in which the test substance was administered intravenously, frequency of micronucleated polychromatic erythrocytes was not increased. Conclusion: Therefore, based on the outcome of the three genotoxicity tests, it can be concluded that Zembrin® is not of genotoxic concern.

Nutrients serve physiological functions in a dose-dependent manner and that needs to be recognized in risk assessment. An example of the consequences of not properly considering this can be seen in a recent assessment by the European Food Safety Authority (EFSA). EFSA concluded in 2022 that the intake of added and free sugars should be “as low as possible in the context of a nutritionally adequate diet”. That conclusion of EFSA is based on the effects on two surrogate endpoints for an adverse effect found in randomized controlled trials with high sugars intake levels: fasting glucose and fasting triglycerides. The lowest intake levels in these trials were around 10 energy% and at this intake level there were no adverse effects on the two outcomes. This indicates that the adverse effects of sugars have an observable threshold value for these two endpoints. The most appropriate interpretation from the vast amount of data is that currently no definitive conclusion can be drawn on the tolerable upper intake level for dietary sugars. Therefore, EFSA's own guidance would lead to the conclusion that the available data do not allow the setting of an upper limit for added sugars and hence, that more robust data are required to identify the threshold value for intake of sugars.

Background: The front -of -pack label Nutri-Score is currently proposed as the system of choice in seven EU countries. However, there is still much scientific debate about the validation and efficacy of Nutri-Score and there is much discussion about author affiliation and study outcome. Methods: To address these issues, we conducted a complete PubMed search on Nutri-Score which resulted in n = 180 results and selected all papers that address the relevance of the evidence for the validation of Nutri-Score (n = 104). Results: Our main observations are that the large majority of studies that support the Nutri-Score are carried out by the developers of Nutri-Score. In contrast, the majority (61%) of studies that are carried out independently from the developers of Nutri-Score showed unfavourable results. A second observation is that even though the theoretical effect of Nutri-Score is validated on a multi -nutrient algorithm (FSA-NPS), there is no real -life evidence of any beneficial effects of Nutri-Score on this algorithm in a complete supermarket range. In conclusion, there is insufficient scientific evidence to support the use of Nutri-Score as an effective public health tool. Discussion: Overall, the available evidence is limited and biased, and more research is needed to substantiate or disprove the effectiveness of Nutri-Score.

BackgroundThe front-of-pack label Nutri-Score is currently proposed as the system of choice in seven EU countries. However, there is still much scientific debate about the validation and efficacy of Nutri-Score and there is much discussion about author affiliation and study outcome.MethodsRecently we published our paper: Nutri-Score and publication bias: A complete literature review of the substantiation of the effectiveness of the front-of-pack logo Nutri-Score Peters & Verhagen, PharmaNutrition 27C (2024) 100380. This paper received a commentary paper by the developers of Nutri-Score: M. Touvier et al. 2024 “Rebuttal to the paper published by S. Peters and H. Verhagen”. We herewith provide an invited commentary to that rebuttal paper, which further supports the observed publication bias.ResultsIn this response to the rebuttal, we primarily respond on the scientific issues raised in the rebuttal and explain more about our alleged conflict of interest and our motivation to write the paper. Moreover, we basically thank the authors of the rebuttal paper for, perhaps ironically but essentially, confirming our analysis: there is a publication bias versus affiliation.DiscussionOverall, the available evidence is clearly limited and biased, and more research is needed to substantiate or disprove the effectiveness of Nutri-Score.

In the EU and Great Britain (GB), all health claims (HCs) on food must be authorised before use and should comply with Regulation 1924/2006. In GB, all HCs, authorised or not, are listed in the Great Britain Nutrition and Health Claims Register. This study reviews the prevalence and compliance of HCs on prepacked foods sold within three GB supermarkets and via their grocery shopping websites. In June 2023, food labels and online product information of 440 products were evaluated across three food categories—dairy and dairy alternatives; fruit juices, fruit juice drinks and fruit smoothies; and teas and infusions. In store, 26.3% of products carried an HC and 28.3% online. The prevalence of HCs was higher when compared with data from 2016. Overall compliance was high, in store (94.3%) and online (90.0%), with no statistically significant difference in overall HC compliance between in store and online products (p = 0.724). The HC violations observed in the present study were due to non-compliant wording of HCs or use of non-authorised HCs. This study demonstrates changes in the HC landscape and the need for continued monitoring of the prevalence and compliance of HCs as consumer trends alter.

Background and objectives: The front-of-pack label Nutri-Score has met a lot of scientific opposition [...]

The reverberations of the Ukraine-Russia conflict have been keenly felt in 2022 as the impacts of Russia's invasion of Ukraine quickly cascaded across the globe, significantly exacerbating existing pressures on global systems. The vulnerabilities of the global food system have been particularly laid bare with significant disruptions to food and fertiliser supply chains instigating profound shocks on global food supply - disproportionately affecting poorer and vulnerable populations of the Global South. The immediate concerns and potential solutions to the global impacts of the Ukraine-Russia conflict were recently discussed by a panel of industry, academic and civil society experts convened by the European branch of the International Life Sciences Institute, all of whom are authors of this manuscript. The key concerns: the reduced affordability of food - focussing on those most vulnerable to its effects; the socio-political implications of reduced food security; food safety; and nutrition security are all discussed in this Point de Vue. The authors voice the need for improved resilience to future shocks and stress on the food system.

The environmental impact on health is an inevitable by-product of human activity. Environmental health sciences is a multidisciplinary field addressing complex issues on how people are exposed to hazardous chemicals that can potentially affect adversely the health of present and future generations. Exposure sciences and environmental epidemiology are becoming increasingly data-driven and their efficiency and effectiveness can significantly improve by implementing the FAIR (findable, accessible, interoperable, reusable) principles for scientific data management and stewardship. This will enable data integration, interoperability and (re)use while also facilitating the use of new and powerful analytical tools such as artificial intelligence and machine learning in the benefit of public health policy, and research, development and innovation (RDI). Early research planning is critical to ensuring data is FAIR at the outset. This entails a well-informed and planned strategy concerning the identification of appropriate data and metadata to be gathered, along with established procedures for their collection, documentation, and management. Furthermore, suitable approaches must be implemented to evaluate and ensure the quality of the data. Therefore, the 'Europe Regional Chapter of the International Society of Exposure Science' (ISES Europe) human biomonitoring working group (ISES Europe HBM WG) proposes the development of a FAIR Environment and health registry (FAIREHR) (hereafter FAIREHR). FAIR Environment and health registry offers preregistration of studies on exposure sciences and environmental epidemiology using HBM (as a starting point) across all areas of environmental and occupational health globally. The registry is proposed to receive a dedicated web-based interface, to be electronically searchable and to be available to all relevant data providers, users and stakeholders. Planned Human biomonitoring studies would ideally be registered before formal recruitment of study participants. The resulting FAIREHR would contain public records of metadata such as study design, data management, an audit trail of major changes to planned methods, details of when the study will be completed, and links to resulting publications and data repositories when provided by the authors. The FAIREHR would function as an integrated platform designed to cater to the needs of scientists, companies, publishers, and policymakers by providing user-friendly features. The implementation of FAIREHR is expected to yield significant benefits in terms of enabling more effective utilization of human biomonitoring (HBM) data.

A meeting on “Dietary supplements, 'functional' and 'super' foods: Science, regulations and roles in the diet” was held at the Royal Society of Medicine in London on 29 November 2022. Eight invited speakers drawn from academic, public health, clinical and commercial backgrounds addressed different aspects of the topic from scientific, legislative and commercial perspectives. This document provides an informal summary of the individual presentations and discussions with the audience.

SummaryThe reverberations of the Ukraine–Russia conflict have been keenly felt in 2022 as the impacts of Russia's invasion of Ukraine quickly cascaded across the globe, significantly exacerbating existing pressures on global systems. The vulnerabilities of the global food system have been particularly laid bare with significant disruptions to food and fertiliser supply chains instigating profound shocks on global food supply – disproportionately affecting poorer and vulnerable populations of the Global South. The immediate concerns and potential solutions to the global impacts of the Ukraine–Russia conflict were recently discussed by a panel of industry, academic and civil society experts convened by the European branch of the International Life Sciences Institute, all of whom are authors of this manuscript. The key concerns: the reduced affordability of food – focussing on those most vulnerable to its effects; the socio‐political implications of reduced food security; food safety; and nutrition security are all discussed in this Point de Vue. The authors voice the need for improved resilience to future shocks and stress on the food system.

In this narrative review, the scientific evidence in support of the front-of-pack label (FOPL) Nutri-Score system is evaluated along with the reasoning for scientific substantiation of health claims in the EU. A health claim could be phrased as 'Nutri-Score as an FOPL system results in an increased purchase of healthier foods by consumers'. Peer-reviewed scientific literature as found in Pubmed under search terms "NutriScore" and "Nutri-Score" that investigate the effects of the Nutri-Score on food purchases were evaluated. In total, eight papers were identified. Only three studies were conducted in real-life settings, and five were on online purchases. In the EU, health claims are evaluated by the European Food Safety Authority (EFSA). Considering the three basic questions that EFSA uses to evaluate scientific substantiation of health claims, it appears that the (i) food/constituent (the Nutri-Score system) is sufficiently defined/characterised, and (ii) the evidence is sufficient to appraise the system as 'beneficial to human health'. However, the scientific evidence for a (iii) cause-and-effect relationship is contradictory and limited. In conclusion, based on the EFSA approach for substantiation of health claims, there is insufficient evidence to support a health claim based on the Nutri-Score system, since a cause-and-effect relationship could not be established.

Fish and other seafood are important sources of nutrients, but they are also sources of chemical contaminants that may cause adverse health effects. This article aimed to identify existing risk-benefit assessments (RBA) of fish, shellfish, and other seafood, compare methodologies, discuss differences and commonalities in findings, and identify limitations and ways forward for future studies. We conducted a scoping review of the scientific literature of studies in all languages published from 2000 through April 2019. We identified 106 RBA of fish and other seafood across Europe, Asia, North America, Africa, and at the global level. Studies were heterogeneous in terms of types of fish and other seafood considered, beneficial and adverse compounds assessed, and overall methodology. Collected data showed that a diet consisting of a variety of lean and fatty fish and other seafood is recommended for the overall population and that women of childbearing age and children should limit the consumption of fish and other seafood types that have a high likelihood of contamination. Our review emphasizes the need for evidence-based, up-to-date, and harmonized approaches in RBA in general.

Human biomonitoring (HBM) is a crucial approach for exposure assessment, as emphasised in the European Commission's Chemicals Strategy for Sustainability (CSS). HBM can help to improve chemical policies in five major key areas: (1) assessing internal and aggregate exposure in different target populations; 2) assessing exposure to chemicals across life stages; (3) assessing combined exposure to multiple chemicals (mixtures); (4) bridging regulatory silos on aggregate exposure; and (5) enhancing the effectiveness of risk management measures. In this strategy paper we propose a vision and a strategy for the use of HBM in chemical regulations and public health policy in Europe and beyond. We outline six strategic objectives and a roadmap to further strengthen HBM approaches and increase their implementation in the regulatory risk assessment of chemicals to enhance our understanding of exposure and health impacts, enabling timely and targeted policy interventions and risk management. These strategic objectives are: 1) further development of sampling strategies and sample preparation; 2) further development of chemical-analytical HBM methods; 3) improving harmonisation throughout the HBM research life cycle; 4) further development of quality control / quality assurance throughout the HBM research life cycle; 5) obtain sustained funding and reinforcement by legislation; and 6) extend target-specific communication with scientists, policymakers, citizens and other stakeholders. HBM approaches are essential in risk assessment to address scientific, regulatory and societal challenges. HBM requires full and strong support from the scientific and regulatory domain to reach its full potential in public and occupational health assessment and in regulatory decision-making.

BackgroundIn this paper, the European chapter of the International Society for Exposure Science (ISES Europe) provides a vision on how dietary exposure sciences can contribute to address the challenges in the field of food safety and nutrition due to changes in food systems by answering the following question: How can we assess timely and accurately changes in dietary exposure to hazardous chemicals (and mixtures thereof) or intake of nutrients due to changes in food production, food consumption and food composition?Scope and approachWe first describe the current role of dietary exposure sciences and the instruments that are being used to assess dietary exposure in food safety and nutrition. This is followed by an analysis of current changes and developments, primarily at the European level, relevant for food safety and nutrition. This results in a list of identified challenges for dietary exposure sciences.Key findings and conclusionsWe thus focus on the timely and accurate assessment of the impact of changes and developments on consumer's and public health, from the perspective of dietary exposure sciences. This includes making better use of chemical analysis, dietary exposure assessment and human biomonitoring, providing increased insight in food composition and nutrients, taking into account the impact of new technologies on human exposure, and making better use of risk-benefit assessment.

Background: Seaweed has a high potential for nourishing the future planet. However, besides being beneficial, it also contains adverse components; this poses the question whether consumption of seaweed foods overall contributes beneficially or detrimentally to human health, and hence if their consumption should be promoted or restricted.Methods: This study evaluated the impact of substituting regular foods with seaweed foods in the diet, both in terms of nutritional quality (via iodine and sodium) and food safety (via arsenic, cadmium, lead, and mercury). Food consumption data from the Netherlands and Portugal (adults aged >18 years) were used, in which 10% of the amounts of pasta, bacon, and lettuce consumed were replaced by seaweed-derived products made from kelp (Saccharina latissima). Using Monte Carlo Risk Assessment software (MCRA), long-term nutrient intake and exposure to contaminants were assessed. The results obtained for the Netherlands and Portugal were compared with data from Japan, a country that has a high natural consumption of seaweed.Results: This low-tier risk-benefit study reveals that an increased seaweed consumption (as assessed by the 10% replacement with seaweed products) has no consequences in terms of intake of sodium and exposure to cadmium, lead, and mercury, and the associated (absence of) adverse health aspects. The alternative scenario almost doubled the mean iodine intake in the Netherlands (to 300 μg/day) and Portugal (to 208 μg/day) and increased the average exposure to arsenic levels in the Netherlands (to 1.02 μg/kg bw/day) and Portugal (to 1.67 μg/kg bw/day).Conclusion: The intake of iodine and exposure to arsenic in the Netherland and Portugal were certainly higher due to the modeled increase of seaweed foods. If seaweed consumption increases close to the 10% substitution, the public health consequences thereof may trigger further research.

Background A scientific framework on exposure science will boost the multiuse of exposure knowledge across EU chemicals-related policies and improve risk assessment, risk management and communication across EU safety, security and sustainability domains. Objective To stimulate public and private actors to align and strengthen the cross-policy adoption of exposure assessment data, methods and tools across EU legislation. Methods By mapping and analysing the EU regulatory landscape making use of exposure information, policy and research challenges and key areas of action are identified and translated into opportunities enhancing policy and scientific efficiency. Results Identified key areas of actions are to develop a common scientific exposure assessment framework, supported by baseline acceptance criteria and a shared knowledge base enhancing exchangeability and acceptability of exposure knowledge within and across EU chemicals-related policies. Furthermore, such framework will improve communication and management across EU chemical safety, security and sustainability policies comprising sourcing, manufacturing and global trade of goods and waste management. In support of building such a common framework and its effective use in policy and industry, exposure science innovation needs to be better embedded along the whole policymaking cycle, and be integrated into companies’ safety and sustainability management systems. This will help to systemically improve regulatory risk management practices. Significance This paper constitutes an important step towards the implementation of the EU Green Deal and its underlying policy strategies, such as the Chemicals Strategy for Sustainability.

Abstract Endorsement date 21 January 2021 Implementation date 27 March 2021 Following the adoption of Regulation (EU) 2015/2283 on Novel Foods, the European Commission requested EFSA to develop a scientific and technical guidance for the preparation and submission of notifications for traditional foods from third countries. This guidance presents a common format for the organisation of the information to be presented by applicant for the preparation of a well‐structured dossier. The safety of a traditional food should be substantiated by reliable data on its composition, its experience of continued use and its proposed conditions of use. Its normal consumption should not be nutritionally disadvantageous. This guidance is also intended to support applicants in providing the type and quality of information EU Member States and EFSA need for the assessments of traditional foods from third countries. The applicant should integrate the information on the composition and the experience of continued use and provide a concise overall consideration on how this substantiates the history of safe use of the traditional food and how this relates to the proposed conditions of use for the EU. Where potential health hazards have been identified on the basis of the composition and/or data from the experience of continued use, they should be discussed. On the basis of the information provided, EFSA will assess the safety related to the consumption of the traditional food under the proposed conditions of use. This guidance was originally adopted by the NDA Panel in 2016. It has been revised in 2020 to inform applicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain.It is applicable to allnotifications and applications submitted as of 27 March 2021. The 2016 version remains applicable to notifications and applications submitted before 27 March 2021.

Abstract This Statement presents a proposal for harmonising the establishment of Health‐Based Guidance Values (HBGVs) for regulated products that are also nutrients. This is a recurrent issue for food additives and pesticides, and may occasionally occur for other regulated products. The Statement describes the specific considerations that should be followed for establishing the HBGVs during the assessment of a regulated product that is also a nutrient. It also addresses the elements to be considered in the intake assessment; and proposes a decision tree for ensuring a harmonised process for the risk characterisation of regulated products that are also nutrients. The Scientific Committee recommends the involvement of the relevant EFSA Panels and units, in order to ensure an integrated and harmonised approach for the hazard and risk characterisation of regulated products that are also nutrients, considering the intake from all relevant sources.

Data generated by the rapidly evolving human biomonitoring (HBM) programmes are providing invaluable opportunities to support and advance regulatory risk assessment and management of chemicals in occupational and environmental health domains. However, heterogeneity across studies, in terms of design, terminology, biomarker nomenclature, and data formats, limits our capacity to compare and integrate data sets retrospectively (reuse). Registration of HBM studies is common for clinical trials; however, the study designs and resulting data collections cannot be traced easily. We argue that an HBM Global Registry Framework (HBM GRF) could be the solution to several of challenges hampering the (re)use of HBM (meta)data. The aim is to develop a global, host-independent HBM registry framework based on the use of harmonised open-access protocol templates from designing, undertaking of an HBM study to the use and possible reuse of the resulting HBM (meta)data. This framework should apply FAIR (Findable, Accessible, Interoperable and Reusable) principles as a core data management strategy to enable the (re)use of HBM (meta)data to its full potential through the data value chain. Moreover, we believe that implementation of FAIR principles is a fundamental enabler for digital transformation within environmental health. The HBM GRF would encompass internationally harmonised and agreed open access templates for HBM study protocols, structured web-based functionalities to deposit, find, and access harmonised protocols of HBM studies. Registration of HBM studies using the HBM GRF is anticipated to increase FAIRness of the resulting (meta)data. It is also considered that harmonisation of existing data sets could be performed retrospectively. As a consequence, data wrangling activities to make data ready for analysis will be minimised. In addition, this framework would enable the HBM (inter)national community to trace new HBM studies already in the planning phase and their results once finalised. The HBM GRF could also serve as a platform enhancing communication between scientists, risk assessors, and risk managers/policy makers. The planned European Partnership for the Assessment of Risk from Chemicals (PARC) work along these lines, based on the experience obtained in previous joint European initiatives. Therefore, PARC could very well bring a first demonstration of first essential functionalities within the development of the HBM GRF.