I. Introduction
Endocrine-disrupting chemicals (EDCs) pose a significant threat to public health in the EU, contributing to a substantial burden of disease and disability, with estimated annual healthcare costs reaching €163 billion.Footnote 1 These chemicals interfere with hormonal systems, affecting metabolism,Footnote 2 reproductive health,Footnote 3 and neurodevelopment.Footnote 4 Emerging research also suggests that EDC exposure may influence dietary nutrition and play a role in the increasing prevalence of obesity and related non-communicable diseases (NCDs).Footnote 5 While dietary modifications can help reduce some health risks,Footnote 6 minimising EDC exposure is a crucial disease prevention strategy that requires strong regulatory measures.Footnote 7
Despite existing EU regulations that restrict EDCs in pesticides and biocides, these measures are insufficient to mitigate risks across the entire food supply chain. Many potential EDCs remain unregulated in food production, packaging and processing, leaving gaps in consumer protection. Given the growing recognition of EDC-related health risks, it is crucial to examine how the EU’s food governance framework – specifically its risk regulation mechanisms – can be strengthened to control foodborne EDC exposure and contribute to reducing NCD rates more – effectively.
1. Endocrine-disrupting chemicals in food: links to non-communicable diseases
EDCs are external substances that interfere with the normal functioning of the hormone system in living organisms, potentially leading to harmful effects in the individual, their descendants, or even entire populations.Footnote 8 They are different from endocrine active substances, which can interact or interfere with normal hormonal action but without leading to adverse health effects.Footnote 9 In food products, ECDs can be introduced through contamination or intentional addition during food processing. Contamination occurs across all food categories (e.g., eggs, fresh vegetables, meat, etc.),Footnote 10 and originates from pesticide residuesFootnote 11 or food packaging materials.Footnote 12 Processed foods – especially high-fat items packaged in plastic – are particularly susceptible to EDCs leaching, as many EDCs are lipid-soluble (e.g., phthalates and Bisphenol A (BPA)).Footnote 13 Food processing also contributes to EDC exposure through the intentional addition of artificial additives, dyes and sweeteners used to enhance flavour, colour or preservation.Footnote 14 Major substances of concern include BPA, phthalates, tartrazine, erythrosine and perfluoroalkyl substances (PFAS), all of which have been linked to hormonal disruption and adverse health effects.Footnote 15
Minimising food-borne EDC exposure is vital, given their significant links to NCDs.Footnote 16 Research suggests that beyond diet and calorie intake, EDCs play a crucial but underexplored role in obesity and associated metabolic disorders such as diabetes.Footnote 17 EDCs are also associated with other NCDs, including cardiometabolic disordersFootnote 18 and cancer,Footnote 19 and pose specific risks to vulnerable populations, such as developmental issues in infantsFootnote 20 and infertility in women.Footnote 21 Moreover, some health effects of EDC exposure can be passed down to future generations through epigenetic changes, altering gene expression without modifying the DNA sequence.Footnote 22 All these long-term, transgenerational risks highlight the pressing need for stronger regulatory measures to limit EDC exposure in food and protect both current and future generations.
2. EDC regulation: what has the EU done so far?
The EU is active on the matter and has made progress in regulating EDCs through legislation on plant protection products (the Plant Products Protection Regulation – PPPR),Footnote 23 biocides (the Biocidal Products Regulation – BPR),Footnote 24 and chemicals (Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation – REACH).Footnote 25 The European Commission has evaluated in a 2016 Communication various approaches to establish scientific criteria for identifying EDCs in pesticides and biocides.Footnote 26 It was followed by a more refined 2018 Communication outlining essential steps to address EDCs, including applying a uniform definition across all legislation, screening existing laws and supporting research.Footnote 27 However, a 2019 report requested by the European Parliament found that food additives and food contact materials regulations lag behind in defining EDCs, providing guidance, establishing tests and managing risks.Footnote 28 The European Parliament addressed these concerns in a subsequent 2019 Resolution urging the Commission to take stronger action to regulate EDCs.Footnote 29 The Resolution specifically demanded a comprehensive and effective approach to regulating EDCs by treating them with the same level of concern as carcinogenic, mutagenic and reprotoxic substances; adopting a clear definition of EDCs across all EU legislation; incorporating specific provisions in relevant product regulations; accelerating the development of EDC identification tests; and considering the combined effects of exposure to multiple EDCs.Footnote 30
The EU took several steps to address these challenges, particularly in the food sector. This included continuous work to refine criteria for identifying EDCs in pesticides, biocides, food additives and contaminants, through the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA).Footnote 31 It also included a risk-preventive approach to address EDCs. Horizon Europe, the EU’s research and innovation program, has dedicated funding to study EDCs, their impact on health, and to develop better risk assessment methods.Footnote 32 The initiative aimed to improve risk assessment, management and communication by generating better data and a clearer understanding of the links between EDC exposure and health effects.Footnote 33
The European Green DealFootnote 34 also addressed EDCs under the Farm to Fork StrategyFootnote 35 and the One Substance–One Assessment (OSOA) approach.Footnote 36 The Farm to Fork Strategy aimed to review import tolerances for hazardous substances used in plant protection, including EDCs.Footnote 37 However, this objective was limited in scope, and the policy failed to address EDCs in the EU food supply. The current OSOA framework is more focused on hazardous chemicals such as EDCs, targeting streamlined chemical safety assessments through greater coherence, efficiency and transparency.Footnote 38 It includes proposals to enhance the scientific contributions of competent EU agencies, enhance inter-agency cooperation and establish a centralised data platform for chemicals.Footnote 39 These reforms are designed to improve the efficiency, consistency and scientific integrity of chemical assessments, with particular relevance for substances such as EDCs, which often fall under multiple legal frameworks (e.g., food, cosmetics, medical devices), causing regulatory inconsistencies. Finally, to further increase transparency around EDCs, the EU made available public resources such as the ED ListsFootnote 40 and the REACH Candidate List of substances of very high concernFootnote 41 providing information on identified and evaluated EDCs.
Despite ongoing efforts to regulate EDCs, a major challenge remains: the absence of a comprehensive regulatory system that translates scientific evidence on EDC exposure into consistent rules across the entire food supply chain. Specifically, the lack of a clear and transparent risk regulation framework continues to hinder effective regulation, highlighting the need for a stronger, science-based approach – a concern consistently emphasised in the literature.
3. Risk-based vs hazard-based approaches to EDC regulation in the literature
In current EU regulation, only biocides and pesticides have a legal framework for EDCs, while other food-related sectors across the supply chain – such as food additives and food contact materials – lack clear definitions, mandatory testing and clear approaches to regulation, weakening enforcement.Footnote 42 To broaden and strengthen this regulatory framework, the literature suggests two approaches to regulating EDCs across sectors: a risk-based regulation and hazard-based regulation.
On the one hand, risk-based regulation assesses and manages risks based on the likelihood and severity of harm, considering factors such as exposure level and affected populations.Footnote 43 Some have emphasised the advantages of risk-based approaches for regulating EDCs at both EU and global levels, highlighting the need and current efforts to develop testing and assessment strategies.Footnote 44 Others critiqued the EU for leaning toward a hazard-based approach rather than a risk-based one in its regulation of EDCs, recommending a more rigorous, weight-of-evidence, risk assessment framework that considers exposure, potency and biological plausibility to better inform regulatory decisions.Footnote 45
On the other hand, the hazard-based approach to regulating EDCs bans substances based solely on their intrinsic harmful properties: if a substance can cause harm, it is banned, regardless of exposure levels.Footnote 46 Research supporting this approach recommends focusing on scientific hazard identification, similar to carcinogen classification,Footnote 47 meaning recognising EDCs as a distinct hazard category. Proponents argue that a global shift to hazard-based regulation is needed to prioritise public health.Footnote 48 They strongly reject the risk-based approach, which assumes harm occurs only above certain thresholds, citing evidence that EDCs can cause harm at very low doses and have non-monotonic effects, particularly endangering vulnerable groups such as foetuses and children.Footnote 49 Because thresholds cannot be reliably established for EDCs, hazard-based regulation is seen as scientifically necessary.Footnote 50 Critics of risk-based methods also oppose including potency – a risk concept – in hazard assessment, arguing it introduces economic bias and undermines precautionary principles.Footnote 51 They maintain that hazard identification must remain science-driven and independent of risk considerations to preserve the EU’s precautionary EDC policy framework.Footnote 52 While initially applied to pesticides and biocides, researchers argue industry opposition has delayed broader implementation of the hazard-based approach to regulating EDCs.Footnote 53
Despite the ranging opinions on how to approach EDCs, the literature appears to be more in favour of the hazard-based approach. Additionally, the literature review and the review of recent EU actions on EDC regulation highlight one idea: There is a significant regulatory gap in EU food law, with uneven protection against EDCs across the food supply chain. To address this gap, we critically examine how the EU’s food governance framework regulates EDCs in the food supply chain and propose legal reforms to better protect public health. First, we frame this analysis within food risk governance, examining EDC regulatory challenges, the role of the Science-Policy Interface (SPI) in informing EU legislative developments, and the role of risk analysis in addressing decision-making challenges in EDC regulation (Part II). Next, we review the current EU legal framework on endocrine disruption in the food supply chain, focusing on legislation that directly and indirectly addresses EDCs, and exploring the General Food Law Regulation (GFL)Footnote 54 as a framework for broadening regulation (Part III). Finally, drawing on these findings, we discuss how the EU can enhance its risk governance framework based on three recommendations: leveraging risk analysis, the GFL and a hazard-based approach in sector-specific regulations (Part IV).
II. EU food governance: a risk regulation framework hinging on scientific evidence
In this paper, we understand food governance as the system of rules, organisations and stakeholders that shape how food is produced, distributed and consumed.Footnote 55 This includes the EU food law framework as well as the influence of markets, traditions and non-state actors such as businesses and civil society. A core element of EU food governance is its risk regulation framework, which enables policymakers to assess and manage food-borne hazards in a structured and transparent way. Risk regulation is embedded in the GFL, where risk analysis ensures a science-based approach to food safety and public health protection.Footnote 56
Risk analysis bridges scientific knowledge with regulatory decision-making, ensuring that food safety measures are both evidence-based and proportionate. It consists of three interconnected steps: risk assessment, where EFSA conducts a scientific evaluation of food safety hazards and issues an expert opinionFootnote 57 ; risk management, where the European Commission and European Parliament translate EFSA’s opinions into regulatory measures while also considering other legitimate factors (e.g., political, economic and social concerns)Footnote 58 ; and risk communication, which ensures transparency by disseminating information on risks and regulatory decisions to the public.Footnote 59
The effectiveness of risk analysis depends on the strength of the science-policy interface. As risk analysis underpins EU food risk governance, a well-functioning SPI is essential for translating complex scientific data into actionable policy measures. This is particularly relevant for EDC regulation, which is impacted by multi-dimensional challenges. In this section, we explore these challenges within the EU food governance framework, the actionable role of the SPI in contributing to stronger, evidence-based regulation of EDCs, and how risk analysis can leverage this for stronger EDC regulation.
1. Multi-factorial challenges impacting EDC regulation
Regulating EDCs in EU food law faces numerous challenges. The most significant ones are scientific uncertainty and political-economic factors, both leading to regulatory hurdles. First, the considerable scientific uncertainty in studying EDC effects is due to complex human exposures, imprecise measurements and unpredictable effects.Footnote 60 Establishing safe exposure levels is further complicated by uncertainties surrounding low-dose and mixture effects, and difficulties in proving causality.Footnote 61 Current regulatory efforts often focus on a limited range of endocrine pathways, potentially overlooking other mechanisms of harmFootnote 62 Standard testing often fails to provide enough data to identify EDCs or trigger further investigation, especially for data-poor substances.Footnote 63 Generating additional data is hindered by limitations in testing methods and procedures.Footnote 64 Furthermore, interpreting non-apical endpoints (biological markers that indicate activity but lack clear correlations with population-level adverse effects) and accounting for species sensitivity variations pose significant challenges for scientific risk assessment.Footnote 65 These uncertainties necessitate a more comprehensive approach to EDC regulation, encompassing broader pathways, improved EDC-specific data and integration of this data in risk regulation processes.
Second, regulating EDCs in EU food supply has faced significant political-economic challenges, primarily due to industry lobbying and trade concerns that can hinder regulation.Footnote 66 Major chemical and food packaging companies have actively lobbied EU institutions to weaken or delay restrictions on substances such as BPA and titanium dioxide, arguing that bans would be economically disruptive.Footnote 67 A notable case is the EU’s debate over the criteria for identifying EDCs, where industry pressure caused years of delay, ultimately resulting in a final set of criteria criticised for imposing high burdens of proof and containing loopholes that could hinder effective regulation.Footnote 68 Similarly, France’s unilateral ban on BPA in all food contact materials sparked EU concerns over internal market disruptions, with the European Commission considering legal action against France for undermining trade rules,Footnote 69 before finally banning BPA itself years later.Footnote 70 Efforts to ban PFAS chemicals in food packaging have been met with strong industry lobbying and resistance from Germany, a major chemical producer.Footnote 71 Additionally, global chemical production and trade also raise concerns.Footnote 72 For instance, countries such as Canada and Brazil have lobbied the EU to ensure that EDC limits do not restrict agricultural imports.Footnote 73 This resistance stems from concerns about the potential economic impacts of restricting or banning widely used chemicals, creating tension between economic interests and public health protection.
These scientific and political–economic challenges contribute to regulatory delay. The European Commission was legally required to define criteria for identifying EDCs in pesticides by 2013, but missed the deadline, citing the complexity of the science, and the need for further consultation.Footnote 74 This insistence on complete scientific certainty slowed decision-making at a critical early stage. Meanwhile, intensified lobbying from industry further reinforced regulatory inaction.Footnote 75 In response to this delay, Sweden filed a legal challenge against the Commission in 2014, arguing that the failure to adopt EDC criteria violated EU law.Footnote 76 In 2015, the EU General Court ruled in Sweden’s favour, confirming that the Commission had unlawfully delayed its obligation.Footnote 77 This ruling ultimately forced the Commission to act on defining EDC criteria. However, even when the criteria were adopted in 2017, they reflected years of industry and political influence, applying only to known disruptors with definitive evidence and excluding many suspected EDCs.Footnote 78 Further loopholes allowed certain EDCs to remain approved if exposure was deemed negligible, weakening the regulation’s impact. This is particularly evident in pesticides, where EDC restrictions are applied less stringently than for other hazardous chemicals such as carcinogens and reproductive toxicants.Footnote 79 The result was a decade-long delay in banning harmful substances, with the first actual pesticide bans under the new criteria only occurring in 2023.Footnote 80
These multi-factorial challenges reinforce one another in a self-perpetuating loop, causing significant stagnation in EDC regulation in the food sector. Stalled legal developments contribute to scientific and political uncertainty, which in turn delays regulatory action, preventing meaningful progress. Breaking free from this inertia requires a comprehensive and integrated response that not only strengthens regulatory frameworks but also addresses the underlying gaps in scientific knowledge and risk assessment methodologies. Increased research into EDC exposure and health impacts is essential for developing more effective, evidence-based regulations, reducing the ambiguity that industry and political actors often exploit to delay action. However, science alone is not enough – regulation must evolve to reflect the complexities of EDC exposure, long-term effects and cumulative risks while ensuring harmonised and enforceable legal standards. A science-based approach is key to navigating these challenges, but for it to drive meaningful regulatory progress, scientific evidence must be effectively translated into policy and action. It is here that the science-policy interface plays a pivotal role, bridging the gap between research and regulation to ensure that scientific insights inform effective risk governance rather than becoming another point of contention or delay.
2. Bridging science and policy: the crucial role of the SPI in EDC risk regulation
A fundamental component of food risk governance is science-based decision-making. This approach necessitates collaboration among various stakeholders, including policymakers, scientists, industry representatives and the public, to ensure that policies are informed by the most reliable evidence and are effectively implemented.Footnote 81 Science-based decision-making relies on the science-policy interface – a process that facilitates the communication and application of scientific knowledge to inform policy, helping ensure that independent research is effectively integrated into regulatory frameworks and contributes to more transparent, responsive and evidence-based risk governance.Footnote 82
Overall, the design of SPIs depends on individual country contexts and existing institutional arrangements.Footnote 83 In the EU, the SPI is legally given shape through the comitology procedure, a framework that enables EU Member States to oversee the European Commission’s implementation of EU legislation.Footnote 84 This process involves committees composed of representatives from each Member State, who review and provide input on draft implementing measures proposed by the Commission.Footnote 85 In this decision-making framework, the SPI provides strong scientific evidence on which these decisions are made; its contribution highlights ‘the common trust in science and expertise, not only as a means to facilitate decision-making but also as a source of legitimacy.’Footnote 86 A major initiative supporting this idea is the Commission’s high-level expert group, which emphasises the importance of the SPI in leading to safer food systems.Footnote 87
In the case of EDCs, the SPI plays a particularly crucial role in strengthening regulatory decision-making. It serves as a mechanism to focus on available (and encourage future) scientific data, translating it into concrete policy measures – helping define what should be regulated, to what extent and on what basis.Footnote 88 While comitology is an end-step where decisions are implemented legally, it all begins with the GFL’s risk analysis process.Footnote 89
3. EDC risk analysis: enhancing the influence of scientific assessments in risk management
In this section, we use the SPI as a key mechanism to inform and guide EDC regulation. To do this, we focus on the risk assessment and risk management steps of risk analysis, as they are directly involved in evaluating food-borne risks and informing regulatory decisions. We specifically examine EFSA’s central role in risk assessment and transparency challenges in risk management.
The risk analysis process generally involves EFSA as the EU’s designated risk assessor, operating under mandates issued by the European Commission. EFSA provides independent risk assessments on EDCs in the food chain, which inform EU risk managers responsible for regulatory decisions. However, EFSA’s assessments have at times appeared inconsistent, concluding that no risks exist despite growing concerns from other scientific bodies or public sources. For example, despite early concerns about BPA in food contact materials,Footnote 90 EFSA initially deemed the substance safe.Footnote 91 Only after sustained scientific and public pressureFootnote 92 did it reassess BPA, eventually concluding that it posed serious health risksFootnote 93 and prompting a swift Commission ban.Footnote 94 Similarly, after assessing evidence on glyphosate and repeated calls for a ban,Footnote 95 EFSA did not identify any critical areas of concern that would justify such action.Footnote 96 Industry interests and influence are widely viewed as key factors behind these delays and cautious assessments.Footnote 97 These examples highlight the complex tension between science, regulation and industry interests, where delayed or conflicting assessments can undermine consumer protection and erode trust in regulatory science. More importantly, they suggest a reluctance to issue scientific opinions against the use of certain substances, raising questions about the transparency and independence of EFSA’s assessment processes and the criteria underpinning its conclusions.
While EFSA plays a crucial role in risk assessment, its effectiveness ultimately depends not only on the independence and transparency of its findings, but also on how risk management decisions respond to those findings. Ensuring that science drives regulation requires a transparent, structured risk analysis process that separates scientific evidence from external influences and builds public trust.Footnote 98 Independence and transparency must be present at two key levels: in how scientific evidence is processed and conclusions are drawn, and in how those conclusions inform risk management decisions.
This is reinforced in EU food law through the Transparency Regulation,Footnote 99 which amended the GFL and several secondary food laws to enhance transparency, independence, accountability and sustainability in EFSA’s risk assessment process. The Regulation identifies, as a key objective, a clearer separation between risk assessment, risk management and risk communication to strengthen the independence of scientific advice and limit undue industry influence.Footnote 100 To achieve this, Article 1 of the Regulation introduced a range of procedural reforms. These include requirements for the electronic publication of industry-submitted studies and data used in EFSA assessments; public access to ongoing consultations on authorisation applications; and the obligation for industry to notify EFSA of all commissioned studies. It also empowers EFSA, upon request from the Commission, to commission verification studies and introduces fact-finding missions by Commission experts to assess research standards in both Member States and third countries. In addition, EFSA’s governance was reformed by expanding its Management Board to include representatives from all Member States, thereby increasing their involvement in the development of scientific opinions.
These amendments strengthen EFSA’s transparency and independence and help clarify the division between risk assessment and risk management functions. Nevertheless, it is argued that despite these improvements, risk management remains opaque,Footnote 101 with scientific opinions often being weighed against powerful political or economic factors.Footnote 102 This can lead to inconsistent decisions and weakened health protections when external pressures override scientific evidence and delay regulation, highlighting the need to strengthen transparency at every stage of risk analysis beyond what the Transparency Regulation currently provides.
To address these concerns, it has been proposed to separate scientific assessments from external factors within risk management by introducing an independent “external factors assessment” conducted by a designated authority.Footnote 103 This authority would review and provide non-binding opinions on external considerations – such as political, economic, societal and environmental factors – similar to how EFSA conducts scientific risk assessments. Under this structure, risk management would first evaluate EFSA’s scientific opinion before separately considering the external factors assessment, ensuring a clear distinction between scientific evidence and other influences.Footnote 104 By isolating and documenting all decision-making inputs, this framework strengthens independence, prioritises scientific integrity, enhances transparency and traceability, and ensures a balanced yet not overly politicised approach. In doing so, it leverages the SPI in risk analysis.
A structured and transparent risk analysis process is essential for an effective SPI and strong EDC regulation. However, legislative coherence on EDCs is equally necessary to ensure uniform application across all stages of the food supply chain. Building on these insights, the next section explores how EU food law can strengthen EDC regulation through a harmonised legal framework.
III. EDCs in current EU law: strengthening legislation
In this section, we examine the EU’s legal approach to EDCs as substances that negatively impact human health through food consumption. First, we focus on EU legislation that explicitly addresses EDCs and that impacts the food supply chain.Footnote 105 Second, we review regulations that aim to protect consumers from harmful chemicals in the food supply chain, without explicitly referencing EDCs. Finally, we examine the GFL framework to explore how it can be leveraged to broaden the scope of EDC regulation throughout the entire food supply chain.
1. A direct regulation of EDCs in agriculture and chemical products legislation
The EU currently addresses EDCs as substances with adverse health effects on humans in three regulations: the Plant Protection Products Regulation, the Biocidal Products Regulation and the REACH Regulation.
The Plant Protection Products Regulation establishes the framework for the authorisation and use of plant protection products in the EU, aiming to balance agricultural needs with the protection of human health and the environment.Footnote 106 The regulation is based on the precautionary principle, allowing for restrictive measures if scientific uncertainty or inconclusive evidence suggests potential harm to human health, animal health, or the environment.Footnote 107 The regulation includes specific provisions on endocrine disruption. One of the approval criteria for active substances used in plant protection products is that they must not have endocrine-disrupting properties that may cause adverse effects in humans or non-target organisms.Footnote 108 Additionally, as some low-risk substances are sometimes authorised,Footnote 109 the Regulation considers that an active substance cannot be considered as low risk if it is deemed to be an endocrine disruptor,Footnote 110 thus adopting a hazard-based approach to EDCs.
The Biocidal Products Regulation aims to harmonise the rules governing biocidal products across the EU while ensuring a high level of protection for human health, animal health and the environment.Footnote 111 The regulation follows the precautionary principle, allowing for preventive action even in cases of scientific uncertainty to safeguard public health, particularly for vulnerable groups.Footnote 112 Under the BPR, active substances cannot be approved or authorised for market use if they are identified as endocrine disruptors that may cause “adverse effects in humans.”Footnote 113 This provision ensures that substances with endocrine-disrupting properties are restricted to minimise potential health risks, also adopting a hazard-based approach to EDCs.
To improve the regulatory framework for EDCs, the European Commission conducted an impact assessment to evaluate the effects of different criteria for identifying and regulating EDCs under the PPPR and the BPR, affecting new and ongoing applications.Footnote 114 The assessment recommended adopting the WHO definitionFootnote 115 of EDCs in EU legislation to ensure a scientifically sound basis for regulation.Footnote 116 It also evaluated both risk-based and hazard-based approaches for EDC regulation,Footnote 117 concluding that although a general hazard-based approach for EDCs would be maintained, some exceptions would rely on a risk-based approach assessment if exposure is low.Footnote 118 The introduction of a risk-based approach aimed to enhance regulatory clarity and consistency while balancing scientific, legal and economic considerations.
This initiative resulted in two key regulations: an amendment to the PPPRFootnote 119 and a Delegated Regulation under the BPR.Footnote 120 Both adopt the WHO definition of endocrine disruptors and establish criteria for identifying EDCs based on adverse effects caused by endocrine mechanisms, assessed through a weight-of-evidence approach.Footnote 121 As a result, the same chemical may be banned under one regulation but allowed with restrictions under the other, because the PPPR and BPR have distinct scopes and evaluation criteria. Consequently, EDCs on the list of endocrine disruptorsFootnote 122 are not automatically banned, as exceptions can be made under specific conditions.Footnote 123
The amendments to EU pesticide and biocide regulations have been criticised as a missed opportunity to strengthen protection against EDCs.Footnote 124 Instead of maintaining a strict hazard-based ban on EDCs, the changes introduced risk-based exemptions, allowing approval if exposure is considered negligible.Footnote 125 The amendments also increased the burden of proof for classifying EDCs, making regulation harder.Footnote 126 This shift enables continued used of harmful EDCs such as glyphosateFootnote 127 and chlorpyrifosFootnote 128 in agriculture, despite evidence of irreversible health effects,Footnote 129 and undermines protections against low-dose effects that a hazard-based approach is designed to address.
Finally, the EU also regulates EDCs under the REACH Regulation, a cornerstone of EU chemical management. REACH mandates the registration and safety assessment of chemicals manufactured, marketed, used, or imported in the EU, applying the precautionary principle to minimise risks.Footnote 130 Recognising the adverse health effects of EDCs, REACH includes them among substances requiring authorisation before market placement.Footnote 131 EDCs can be classified as Substances of Very High Concern and added to the Candidate List, which may lead to further restrictions, including bans or usage limitations.Footnote 132 While REACH has a broad scope across multiple sectors, it excludes food ingredients, additives and flavourings,Footnote 133 which fall under the GFL Regulation and related food legislation.Footnote 134
While the PPPR, BPR and REACH Regulation set out specific rules for certain chemicals, they do not comprehensively address risk across the entire food supply chain. First, they focus primarily on the agricultural stage, whereas EDCs can be introduced through production, processing, or packaging. Second, following the shift from a hazard-based approach that immediately restricts identified EDCs, these regulations now allow for limited use under certain conditions, failing to account for potential health risks from EDC mixtures and low-dose exposure in real-world scenarios. Beyond this sector-specific framework, EU food law includes broader provisions aimed at ensuring food safety, and that could include EDCs in their scope.
2. An indirect regulation of EDCs in food legislation
Unlike the targeted and textually explicit regulation of EDCs in pesticides and biocides, there are secondary food laws that rely on general safety principles for hazardous substances. Such provisions can regulate EDCs if they fit within their criteria and can be found in legislation on food contact materials, additives, enzymes, flavourings and contaminants.
The Food Contact Materials RegulationFootnote 135 ensures that materials intended to come into contact with food do not transfer harmful substances at unsafe levels. Similarly, Commission Regulation (EU) No 10/2011Footnote 136 governs plastics used in food packaging, requiring risk assessment and authorisation for monomers and additives.Footnote 137 While both regulations seek to prevent harmful chemical migration into food, they lack targeted safeguards against endocrine-disrupting properties specifically, leaving consumers potentially exposed to EDCs from packaging and processing materials.
The Food Additives Regulation (FAR),Footnote 138 Food Enzymes Regulation (FER),Footnote 139 and Food Flavourings Regulation (FFR),Footnote 140 establish rules for the respective use of food additives, enzymes and flavourings to protect human health, consumer interests and fair-trade practices. While food additives must be proven safe and justified by a technological need, the precautionary principle applies only in a general sense, and testing requirements do not explicitly mandate screening for endocrine-disrupting effects.Footnote 141 Instead, risk assessments for additives, enzymes and flavourings rely on EFSA scientific opinions, which do not require specific data on endocrine activity.Footnote 142 As a result, potential endocrine-disrupting properties of food additives, enzymes or flavourings may go unexamined, highlighting inconsistencies in EU risk assessment across different categories of food-related chemicals.
The new Food Contaminants RegulationFootnote 143 updates and consolidates maximum levels for certain contaminants in foodstuffs to protect public health across the EU.Footnote 144 It sets limits for contaminants such as dioxins, polychlorinated biphenyls and PFAS in various food products.Footnote 145 Although EDCs are not explicitly categorised in the regulation, it still helps to reduce exposure to them by targeting substances with similar harmful effects. If a substance is recognised as harmful due to endocrine-disrupting properties and fits within the listed contaminant categories, it can still be regulated under this framework.
The lack of specific EDC provisions in secondary food law leaves a critical gap, as often food is in contact with materials such as plastics or cans, or is subject to additions or contamination throughout the supply chain. Regulation of EDCs from these sources is slow and lags behind industry changes. While the BPA banFootnote 146 marks a critical milestone, this progress remains limited in scope. Many other substances with potential endocrine-disrupting effects continue to be used in food contact materials and as added food ingredients, while risk assessments and regulation remain pending, highlighting regulatory inertia. For instance, pressure is mounting for the EU to take a group-based approach to banning phthalatesFootnote 147 (similar to BPA and similar substances ban),Footnote 148 which are still used in some food contact materials despite endocrine-disrupting concerns.Footnote 149 Also, butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) are synthetic antioxidants, both authorised in specific food categories with set limits.Footnote 150 EFSA recently raised the acceptable daily intake for BHT, though high-exposure levels in children may still exceed this threshold.Footnote 151 BHA was deemed non-genotoxic in a 2011 EFSA review,Footnote 152 but has not been reassessed for endocrine-disrupting effects, despite emerging concerns.Footnote 153 Both substances are under review for endocrine disruption under REACH and cosmetics legislation, but not in food.Footnote 154 Another example is synthetic food dyes such as Tartrazine (E102), Sunset Yellow (E110) and Erythrosine (E127), which have recently shown endocrine-disrupting potential.Footnote 155 These additives remain authorised in the EU with limits and labelling requirements,Footnote 156 while EFSA maintains their safety at permitted exposure levels despite assessments not addressing endocrine effects.Footnote 157 As evidence grows and questions arise about safe thresholds for such substances, current regulations may not fully reflect the latest scientific understanding from these potential hazards, leading to inconsistent consumer protection.
By contrast to this spotty EDC regulation, current EU food law implements hazard-based elements for certain hazardous substances. For example, Regulation (EC) No 315/93 prohibits placing food on the market if it is injurious to health,Footnote 158 including contamination by carcinogens above acceptable limits. The Food Contaminants Regulation enforces this by setting maximum levels for numerous carcinogenic and toxic substances.Footnote 159 The PPPR uses cut-off criteria to block approval of substances classified as CMRs or endocrine disruptors.Footnote 160 The Food Additives Regulation, Food Enzymes Regulation and Food Flavourings Regulation all require that substances do not pose a safety concern to consumer health at the level of use proposed.Footnote 161 This safety clause excludes substances with carcinogenic or genotoxic properties, as these are considered unsafe at any level. While these laws apply a risk-based framework, the exclusion of non-threshold carcinogens or genotoxins reflects hazard-driven decision-making. In practice, such substances are banned because no safe level of exposure can be demonstrated. Thus, hazard leads to exclusion through risk-based reasoning, making the legal framework functionally equivalent to a hazard-based model in these cases – and also underscoring the importance of strengthening both risk analysis and secondary food law for a comprehensive EDC regulation.
These sector-specific food laws focus on carcinogenicity and other hazardous substances, while potential endocrine effects remain loosely addressed. This is largely due to insufficient evidence and the lack of a legal framework for restricting EDCs in food contact materials and food additives. With the lack of mandatory EDC-specific testing requirements, this raises additional concerns that the current safety limits cannot be properly verified or enforced.Footnote 162 Without systematic testing and clear legal provisions, oversight remains fragmented and inconsistent.
To overcome these limitations, harmonising EU food law is crucial to ensure a consistent legislative approach to EDCs across all stages of the food supply chain. The next section examines the GFL as the structural foundation for food safety and explores how this framework can be leveraged to establish a unified legal approach to regulating EDCs.
3. The GFL’s potential for EDCs regulation
Comprehensively addressing EDCs in all food legislation is essential to minimise health risks across the food supply chain. Within this framework, the GFL Regulation serves as the foundational regulation for protecting human health and consumer interests. It sets out common principles and responsibilities, provides the scientific basis for food safety, and establishes procedures to analyse risk and support decision-making – applicable across all stages of the food chain.Footnote 163 In this section, we argue that the GFL’s core provisions on food-borne health risks can support the development of EDC regulation, focusing on its definitions of risk, hazard and food safety.
The GFL adopts a scientific, risk-based approach by defining risk, hazard and food unsafety and setting principles to prevent them. It defines risk as ‘a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard,’Footnote 164 and hazard as ‘a biological, chemical, or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect.’Footnote 165 These definitions are linked by the concept of “adverse health effects”: a hazard has the potential to cause harm, while risk concerns the probability and severity of that harm.Footnote 166
However, the GFL does not define what qualifies as an adverse health effect. By contrast, Annex II(1) of the PPPR explicitly defines endocrine-related adverse effects, including changes in morphology, physiology, growth, development, reproduction, or lifespan in organisms (including humans) and their descendants. While its direct application to the GFL is uncertain, these effects clearly bring EDCs within the scope of the GFL’s hazard definition. Given EDCs’ potential for harm, and their presence in food, exposure turns this hazard into a risk.
Article 14 GFL reinforces this by prohibiting food that is “unsafe,”Footnote 167 defining it as “injurious to health”Footnote 168 or “unfit for human consumption,”Footnote 169 and explicitly referencing “long-term” and “cumulative toxic effects,” including those on future generations.Footnote 170 While usually applied to acute hazards, this framework also covers chronic chemical risks such as EDCs. The reference to “cumulative toxic effects” shows EU law’s capacity to address long-term harms. Where evidence shows EDCs in food or contact materials pose such risks, they may be deemed “unsafe” under Article 14.
In fact, Article 14 has been proposed as a legal basis to address EDC contamination in the food supply chain and remove products containing persistent toxic substances (e.g. PFAS) from the market.Footnote 171 In the absence of a specific EDC ban, Article 14 allows authorities to restrict or withdraw food products based on scientific evidence or the precautionary principle.Footnote 172 Regulators may invoke this general safety mandate to prohibit products containing EDCs – even if they comply with current limits – when new evidence indicates risk.Footnote 173 This interpretation positions Article 14 as a legal safety net for emerging hazards such as EDCs.
However, while Article 14 is a powerful tool, reliance on it as a catch-all provision has raised concerns. It places responsibility on the food industry to ensure safety and conduct risk assessments. Yet this broad framework can lead to ambiguity and legal uncertainty, especially where definitions of “unsafe food” are applied beyond well-established parameters.Footnote 174 This concern is especially relevant in the regulation of EDCs, where scientific uncertainty and complex risk profiles complicate regulatory clarity. The food industry has often resisted broad EDC regulation,Footnote 175 preferring case-by-case evaluations over blanket bans.Footnote 176 Industry-led risk assessments have been criticised as biased or inconsistent, downplaying risks and undermining transparency.Footnote 177 Others argue that hazard-based bans without detailed assessments may lead to unjustified trade barriers.Footnote 178 Over-reliance on Article 14 can result in ambiguity and inconsistent enforcement,Footnote 179 underlining the need for clearer, hazard-specific regulation.Footnote 180
Therefore, while Article 14 provides a basis for addressing EDCs in food, it should not be the sole regulatory mechanism. Instead, sector-specific, hazard-based tools are needed to improve precision and legal certainty. Strengthening these frameworks would improve food safety across the supply chain. Our view that GFL provisions could support EDC regulation highlights the complexity of integration – one that requires more than textual amendments. The next section explores how regulatory gaps can be addressed through a three-pronged approach, combining risk analysis methodologies and a comprehensive EDC regulation rooted in the GFL and sector-specific, hazard-based legislative amendments.
IV. Discussion: a comprehensive legislative framework to strengthen EDC risk regulation in EU food law
Our research shows that the EU framework for EDCs in the food supply chain is fragmented and inconsistent, lacking a unified regulatory approach. While some laws – such as those governing pesticides and biocides – include specific criteria to identify and restrict EDCs, others – such as food contact materials, food additives and general food safety regulations – lack explicit provisions, creating legal uncertainty and uneven consumer protection.
This regulatory patchwork is further complicated by the influence of several factors in decision-making. Under the GFL Regulation, risk management decisions are shaped not only by scientific evidence but also by other legitimate factors, such as economic and political interests. In theory, this balancing act aims to generate fair decision-making that benefits all parties. However, in practice, it has delayed or weakened regulatory action, as seen when the European Commission was found in breach of EU law for failing to establish timely EDC criteriaFootnote 181 – a delay widely attributed to industry lobbying and political pressure.
These challenges underscore the need for a stronger, more harmonised regulatory framework to ensure comprehensive and consistent EDC oversight across the entire food supply chain. A unified approach – covering agriculture, food production, processing, packaging, distribution and retail – would close regulatory gaps and strengthen consumer protections. Recognising this need, both the European ParliamentFootnote 182 and CommissionFootnote 183 have called for cross-sector, coordinated action to ensure that food safety regulations effectively manage EDC risks throughout the food supply chain.
To address these gaps, we propose three key recommendations: leverage the SPI to reinforce the role of scientific evidence in risk management; leverage the GFL as the legal foundation for comprehensive EDC regulation; and implement these provisions in a harmonised hazard-based approach in sector-specific (secondary) food law.
1. Recommendation 1: leverage the SPI to reinforce science in risk analysis
A key first step toward strengthening EDC regulation is ensuring that scientific evidence remains the primary driver in risk analysis through risk management decisions. To achieve this, we support the recommendation to explicitly divide the risk management step into two separate phases: review of scientific assessment – where EFSA’s independent risk assessment informs regulatory decisions; and review of external factors assessment – where political, economic and societal considerations are reviewed independently.Footnote 184
This recommendation leverages the SPI to ensure that scientific expertise translates effectively into policy without political–economic interests overshadowing public health. It operationalises the “science-policy interface” at two main levels. In the “science” component, EFSA’s role as the EU’s scientific gatekeeper should be expanded and refined to include long-term, cumulative, mixture and intergenerational exposure assessments, particularly given the growing recognition of cocktail effects – where multiple low-dose exposures collectively pose significant health risks. In the “policy” component, two assessments are distinct: EFSA’s scientific risk assessment and a separate evaluation of “other legitimate factors” by an independent external body. This body would assess economic, political and societal considerations and issue a non-binding advisory opinion for risk managers to consider separately from EFSA’s scientific assessment.
The “policy” component of the SPI is a key common denominator to all EDC risk regulation. This two-step risk management structure enhances transparency, reinforces the integrity of EFSA’s scientific role in decision-making, and limits undue “other legitimate factors,” namely political and economic influences, on public health protections. Applying this structured approach where risks are pinpointed across the food supply chain – from primary production to retail – ensures that science remains the central pillar of food safety policy, ultimately strengthening consumer protection and regulatory credibility.
To complement this science-based approach, leveraging key GFL provisions on food safety is essential, as it ensures a consistent and comprehensive regulation across the entire food supply chain – bringing us to our second recommendation.
2. Recommendation 2: leverage the GFL for comprehensive EDC regulation
The GFL Regulation provides a broad, “farm-to-fork” safety framework that can be leveraged to comprehensively regulate EDCs. Its general principles and risk analysis approach apply to all stages of food production, processing and distribution, ensuring that the same fundamental safety standards govern them. In this GFL framework, we support recommendations to address EDCs horizontally across sectorsFootnote 185 : any substance posing a health hazard in food, once recognised and classified through an agreed scientific and policy mechanism, should be assessed and controlled at the appropriate stage of the food chain.
To operationalise this legally, certain prerequisite steps are necessary. specifically, a policy document or harmonised guidance at EU level (e.g., Commission Communication or delegated act), would be required to outline the process through which certain chemicals are identified as having endocrine-disrupting properties. This identification (supported by EFSA scientific opinions) would make them hazardous and unsafe under the GFL, requiring regulation at the appropriate stages of the food supply chain.
In practice, leveraging the GFL would mean explicitly incorporating EDC risk assessment and management wherever necessary in the food supply chain to pinpoint and limit hazards – from controlling EDC residues on crops and animal feed to assessing food additives and packaging materials for endocrine effects, and ensuring that distribution and retail practices do not introduce additional risks. This end-to-end coverage would harmonise currently fragmented regulations, ensuring consumer protection at all stages of the food supply chain.
This complements the previous recommendation to strengthen a science-policy interface, and also underscores the need to address EDCs as health hazards and for a comprehensive approach in secondary food law. To complement this GFL framework, we support a sector-specific regulation that extends the EDC framework from pesticide and biocide regulations (which affect food but fall outside of food law) into secondary food legislation. We argue that risk analysis and a predominantly hazard-based approach in secondary legislation are not mutually exclusive, as processing scientific evidence is central to identifying hazards, and necessary for regulatory frameworks such as food lawFootnote 186 – bringing us to our third recommendation.
3. Recommendation 3: introduce a hazard-based approach to EDCs in sector-specific regulations
To strengthen risk regulation and public health protection, we support a hazard-based approach to EDCs in sector-specific legislation.Footnote 187 This approach would ban or restrict a substance if it is harmful (i.e. classified as a ‘hazard’), regardless of factors such as exposure level – meaning that the mere identification of a substance as inherently dangerous is sufficient for regulatory action, even without considering how much of it people are actually exposed to or under what conditions. It ensures stricter regulatory control, reducing tolerance for EDC presence in food and aligning their treatment with other well-established hazardous substances, such as carcinogens, mutagens and reproductive toxins.
The layered legal approach for carcinogens and other high-risk substances shows that the EU already treats them with extreme precaution, offering a precedent for similar treatment of EDCs. Yet, EDCs are not currently addressed under food law in the same way as carcinogens and toxins, leaving a gap in regulatory consistency. To close this gap, the EU should extend this precautionary model to EDCs across the food supply chain through sector-specific regulations. This could include amending the Food Additives Regulation, Food Enzymes Regulation and Food Flavourings Regulation to recognise endocrine-disrupting properties as a ground for exclusion; updating the Food Contaminants Regulation to set legal limits for EDCs that enter food unintentionally (e.g., through environmental pollution or processing); revising the Food Contact Materials Regulation to more explicitly address EDC migration from packaging, processing equipment and storage, with tailored exposure assessments. For instance, these sector-specific regulations could be amended to state that “endocrine-disrupting properties, as identified by agreed scientific criteria, shall be managed with the same level of precaution as carcinogenic, mutagenic, or reprotoxic substances.”
The aim is a coherent, legally binding framework in which once a substance is scientifically identified as an EDC, it is formally treated as a health hazard under food law – just like a carcinogen. This classification would then drive risk management decisions, outweighing considerations such as economic cost or technical feasibility. This would re-align food law with the original principles applied to pesticides and biocides, where once a substance is confirmed as an EDC, approval is denied regardless of its benefits. Such alignment would also reduce the excessive burden of proof currently hindering the regulation of EDCs,Footnote 188 and prevent any EDCs from slipping through the cracks of regulation.
V. Conclusion
The EU stands at a critical juncture in its approach to EDCs in food law. Although some progress has been made, current efforts remain fragmented and slow due to ongoing gaps in the regulatory framework. To address these gaps and the pressing urgency of regulating EDCs, EU legislators can build on what already exists instead of creating entirely new laws. This can be done through three main steps: strengthening a transparent and a science-based risk analysis, leveraging the GFL framework for ensuring food safety, and adopting a hazard-based approach in existing secondary food legislation to explicitly include and regulate EDCs. This suggested approach would ensure a science-based regulation of EDCs, strengthen regulatory consistency and enhance food quality and safety. Mainly, it would reflect the EU’s objective, outlined in the 2019 Resolution, to develop a comprehensive, cross-sector EDC strategy based on scientific evidence and clear legal definitions.Footnote 189
Despite this alignment, a key challenge in advancing EDC regulation is the pressure from global trade dynamics, where less regulation is often favoured to facilitate trade and industry competitiveness.Footnote 190 However, weakened standards come at a long-term cost: the continued exposure to EDCs has been linked to rising rates of NCDs, including obesity,Footnote 191 cardiometabolic disorders,Footnote 192 and cancer.Footnote 193 By strengthening EDC regulations, the EU can help reduce public health burdens associated with NCDs, decreasing healthcare and loss of productivity costs, and improving overall quality of life.Footnote 194 It can also solidify its global leadership in chemical risk regulation, ensuring that European food is not only safe from acute hazards but also free from long-term chemical threats that may disrupt hormonal health across generations.
This approach aligns with the Farm to Fork Strategy’s objective to address hazardous substances, including EDCs, through the review of import tolerances for plant protection products.Footnote 195 It also lays the groundwork for expanding this focus into a more comprehensive and protective framework in the EU’s food supply chain. However, with the Farm to Fork Strategy having become politically stranded and falling short on many of its action points,Footnote 196 the goal of effectively tackling EDCs in EU food policy and legislation remains unmet. Building on the Strategy’s original ambition, the 2019 Resolution, the One Substance–One Assessment approach on streamlining chemical safety across EU legislation,Footnote 197 and our recommendations, now is the moment to revive and fulfil this commitment with renewed political resolve and broader legislative reach. A stronger, more harmonised, regulatory framework for EDCs would lead to safer food production, improved packaging standards, greater consumer awareness, and ultimately, stronger public health protection.
Acknowledgments
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Funding
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Competing interests
The author declares none.
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