Documents
The Krakow Declaration on Iodine
Tasks and responsibilities for prevention programs targeting Iodine Deficiency Disorders. Joint Declaration Iodine deficiency disorders (IDD) represent a global health threat to individuals and societies. The adverse effects of iodine deficiency are diverse and impose a significant burden on public healthcare systems. Although this fact is well established, IDD prevention programs receive surprisingly little attention from policy makers, opinion leaders and the public. European epidemiologists, endocrinologists and nutritionists investigating IDD under the umbrella of the Horizon2020 research and innovation action EUthyroid (Project ID: 634453, http://euthyroid.eu/) are increasingly concerned about the deteriorating commitment of policymakers to address public health strategies against IDD in the European populations. Background With very few exceptions such as Iceland, Europe is an iodine-deficient continent. Adults living in iodine deficient regions carry a high risk of goiter, thyroid nodules and hyperthyroidism. Subclinical hyperthyroidism, as a common and frequently undiagnosed IDD, is tightly associated with an increased risk of mortality and coronary heart disease. Moreover, iodine deficiency during pregnancy and breast- feeding is widespread in Europe and adversely affects the development of the child. Even mild or moderate iodine deficiency of the mother affects the synthesis of thyroid hormones and may impair brain development, neurocognitive function and reduces offspring IQ. During pregnancy, women have a sharply increased need for iodine, which is frequently not covered by food sources and iodine supplements. Due to a lack of valid data, we are uncertain about the scale of the problem but estimates suggest that up to 50% of newborns in Europe are exposed to iodine deficiency. Iodine deficiency can readily and inexpensively be prevented by iodine fortification, usually by provision of iodized salt. More specifically, iodized salt should replace non-iodized salt in nearly all food production, at least in areas where fortification would not increase risk of excessive iodine intake. This approach will not increase total salt intake, which is in line with current dietary recommendations. However, challenges in implementation remain, particularly in Europe due to fragmentation and a diversity of approaches. The EUthyroid consortium has been collecting experience on national IDD prevention programs. The Krakow Declaration on Iodine aims to define the most important tasks for optimal IDD prevention when programs have been introduced and to point out the responsibilities for the different tasks. Ensuring a Euthyroid Europe We, the signatories of the Krakow Declaration on Iodine call on policymakers, public health officials, scientists and the public to join forces to ensure that existing strategies to prevent IDD are implemented across Europe to reach and secure a sufficient iodine status across Europe. In particular we call for: •Methods of IDD Prevention: Regulators and policymakers should harmonize obligatory Universal Salt Iodization to ensure free trade of fortified foodstuffs in Europe. Similarly, iodized animal feed requires regulatory approval to ensure free trade within the EU. •Control of IDD Prevention: National governments and public health authorities have to perform harmonized monitoring and evaluation of fortification programs at regular intervals to ensure optimal iodine supply to the population. •Support for IDD Prevention: Scientists, together with public-health care workers, patient organizations, industry and the public, should support measures necessary to ensure that IDD prevention programs are sustainable, as appropriate within a rapidly changing environment and further social awareness of the issue. Methods of IDD Prevention Universal Salt Iodization Universal salt iodization is the preferred strategy of IDD prevention and is recommended by WHO, UNICEF and the Iodine Global Network (IGN) as the most cost-effective method. The promotion of universal iodization of salt is not antagonistic to policies aimed at limiting salt uptake to reduce hypertension as a risk factor for cardiovascular disease. Limiting daily salt uptake to less than 5 grams and ensuring iodine sufficiency with fortified salt can be pursued in synergy to ensure optimal implementation and promotion of good health. -Responsibility for regulation and execution: Governments and public health authorities -Responsibility for production and quality control: The food industry Obligatory Principle Although grade-A scientific evidence is missing, obligatory prevention programs by universal salt iodization are preferred over voluntary programs for better control, higher effectiveness and lower costs. -Responsibility for decisions: Governments and public health authorities -Responsibility for providing evidence: Scientists Dosage of Iodine Fortification The optimal dosage of iodine for fortifying salt needs to be based on up-to-date results of monitoring and evaluation studies. -Responsibility for decisions: Governments and public health authorities -Responsibility for providing valid findings: Scientists Transnational Harmonization Within a globalized economy with extensive trade of food stuffs across borders, harmonization of national IDD prevention programs is an important priority within the EU to support free movement of goods. Currently the EU constitutes a fragmented market with different national regulations pertaining to carriers of iodine (potassium iodide or iodate) and methods of IDD prevention (mandatory or voluntary programs). This encourages the food industry to provide non-iodized products to avoid trade barriers. With the exception of Iceland, all salt marketed or used in the EU member and candidate member states for alimentary purposes should be fortified by a universally set minimum amount of iodine. Adopting an agreed upon universal minimum concentration of salt iodine will allow the safe and effective improvement in the consumption of iodine throughout the EU. Individual member states would be allowed to regulate salt iodine content depending on the severity of iodine deficiency in their geographical regions, provided that the locally required salt iodine content is equal to or is higher than universally set minimum amount of iodine. -Responsibility for decisions: National and EU trade and public health authorities Control of the IDD Prevention Program Monitoring Iodine Status IDD programs are embedded within a rapidly changing environment of eating habits, food products and regulatory frameworks. The iodine status of populations can be affected by many factors including changing food patterns, level of iodized salt in foods, differing effectiveness of information campaigns or law amendments. There is a requirement for regular monitoring studies that have to be representative of the target population and must provide valid results. -Responsibility for initiating and funding the monitoring: Governments and public health authorities -Responsibility for providing valid findings: Scientists Evaluation Monitoring cannot replace the evaluation of IDD prevention programs that are based on observing primary outcomes of the prevention strategy including any trend in incident thyroid diseases and related treatments. Adequate data sources have to be provided for analyses of effectiveness and the monitoring of potential harms. -Responsibility for regulation and funding: Governments and public health authorities -Responsibility for providing adequate data: Public registries, health insurance companies, hospitals, pharmacies etc. -Responsibility for providing valid findings: Scientists Standardization and Harmonization Scientists have to be aware of potential bias in their studies. Monitoring and outcome studies must be standardized to ensure valid data for evidence-based policy decisions. Data should be harmonized as far as possible to enhance the trans-national comparability between different IDD prevention programs and to identify benchmark countries. -Responsibility: Scientists, data provider for outcome studies Measures Accompanying the IDD Prevention Program Advisory Boards Structures are needed to support governments and public health authorities in accepting responsibility and fulfilling their tasks. Advisory boards should comprise major stakeholders in the field of IDD prevention including thyroidologists, epidemiologists, health economists, pediatricians, gynecologists, nutritionists, communication scientists, patient organizations, representatives of industry and consumer groups. -Responsibility for initiating and funding: Governments, public health authorities Information Campaigns IDD prevention programs, especially those that are voluntary, must be accompanied by public-information campaigns. -Responsibility for initiating and conducting: Governments, public health authorities -Responsibility for advising governments and public health authorities and providing facts and information: Scientists, nutritionists, medical practitioners, patient organizations and industry Support us: We, the signatories of the Krakow Declaration on Iodine ask for support from all stakeholders across Europe and beyond to pool resources and expertise to ensure that our future generations will be able to realize their full potential without any limitation resulting from exposure to iodine deficiency.
Position Paper on Endocrine Disruptors and Active Substances
The case of iodine Introduction: Iodine and iodate are vital for nutrition and human health, playing a crucial role in thyroid hormone synthesis and the functioning of the thyroid gland. Moreover, both iodine and iodate are utilised in various forms for different purposes, ranging from addressing iodine deficiency disorders to serving as potent disinfectants and biocides. Iodine is an essential trace element that naturally occurs in the human body and that is crucial for the synthesis of thyroid hormones, which are responsible for regulating the body's metabolism and promoting proper growth and development, particularly in infants and young children. It is widely used to support the human hormonal system and constitutes an essential dietary trace element for ensuring population health. More specifically, as recognised by the European Food Safety Agency’s (EFSA) favourable opinion on health claims related to iodine, it contributes to normal cognitive and neurological function (ID 273), normal energy-yielding metabolism (ID 402) as well as normal thyroid function and production of thyroid hormones (ID 1237) . This is further underlined by EFSA’s scientific advice on nutrition and health claims from 19 April 2022, which stresses the importance of iodine in the development of neurological and cognitive functions, normal thyroid function, as well as the prevention of iodine deficiency disorders. Moreover, povidone-iodine (PVP-I) is commonly used in the healthcare sector, due to the its broad-spectrum antimicrobial properties and its high effectiveness against bacteria, fungi, and viruses, including SARS-CoV-2 (COVID-19). Iodate, on the other hand, occurs when iodine bonds with oxygen and is the most common form of iodine in nature. When iodate is ingested, it is reduced to iodide in the gastrointestinal tract before being transported to the thyroid gland where it is converted into iodine, which is then used to produce thyroid hormones . Due to its crucial role in ensuring population health, the World Health Organisation (WHO) recommends the fortification of food with iodate. Moreover, iodate is added to food (i.e. salt) as per Regulation (EC) 1333/2008 on food additives, as a way to fight iodine deficiency disorders. It is further prescribed to pregnant and breast-feeding women as food supplement to secure proper iodine intake for both the mother as well as the foetus and contribute to the latter’s cognitive and physical development. Policy background In the European Union (EU), biocides are regulated by the EU Biocidal Products Regulation (BPR) which governs the approval, placing on the market, and use of products containing biocidal active substances. In February 2020, building on COM(2018) 743 concerning a comprehensive EU framework on endocrine disruptors, the European Commission (EC) triggered the early review of the approval of biocidal active substances. Subsequently, on 17 May 2021, the European Chemicals Agency (ECHA) received the mandate on the review of the approval of biocidal substances, which assigned the Swedish Chemicals Agency (KEMI) as a rapporteur to develop and deliver ECHA’s opinion to the EC. In September 2022, KEMI’s working group on the environment and human health identified iodine and povidone-iodine (PVP-I) as endocrine disruptors, given their potentially adverse effect on thyroid function - an assessment that was later confirmed by ECHA and the EC. Endocrine effect versus endocrine disruptor The classification of iodine and PVP-I as an endocrine disruptor represents a drastic shift compared to a previous 2013 assessment report commissioned by ECHA, which clearly distinguishes between an active substance having an endocrine effect or being an endocrine disruptor. Specifically, the report states that: •“…both iodine deficiency as well as excess iodine can impair thyroid homeostasis/thyroid hormone levels. This is to be considered as an endocrine effect. However, it would not be justified to conclude from this that iodine should be considered to be an endocrine disruptor.” (p.32) •“Consequently, the concept of endocrine disruption is not meaningful for essential elements such as iodine since it neglects that they are needed for maintaining hormone homeostasis.” (p.33) The 2022 opinion , on the other hand, utilises a different methodology which no longer accounts for this critical distinction. Moreover, the methodology did not assess the actual risks posed by using iodine in biocides, but only evaluated the substances’ inherent properties without accounting for the dosage, exposure, and application. Whereas endocrine effects encompass intended action on the hormonal system to correct a certain malfunction or deficiency, endocrine disruptors interfere with the proper functioning of the endocrine system. Clearly distinguishing between endocrine effect and endocrine disruption based on the specific dosage, exposure, and application of iodine is crucial, as it avoids extreme simplifications and misconceptions about iodine. It is crucial to note that any current authorisation of iodine-based biocidal products already considers an upper limit of iodine intake which accounts for endocrine properties and represents a conservative basis for the risk assessment. Classifying iodine as an endocrine disruptor therefore provides no additional safety, but rather fuels misperceptions by end users of iodine-based biocides such as patients, healthcare professionals, farmers, and livestock owners. Implications Considering that the EC endorses ECHA’s assessment of iodine being considered as an endocrine disruptor, it no longer qualifies for Union Authorisation, in line with Article 5(1) of the BPR. After discussions between EU Member States and ECHA, the European Commission has opted for a compromise approach whereby existing Union Authorisation will remain valid until August 2025 before having to be renewed on a case-by-case basis at national level. All requests for the authorisation of new biocidal products have to be individually assessed by the competent authorities at national level. The revocation of the Union Authorisation will have severe consequences for users of iodine-based biocides (e.g. patients, healthcare professionals, farmers, and livestock owners), as well as for producers, processors, retailers, as the products’ placing on the market would only be possible if authorised by the competent national authorities on a case-by-case basis. As iodine-based biocides play a crucial role in surface disinfection, pre-operative skin preparation, or impregnated dressings, the revocation of the Union Authorisation could affect existing infection control practices and adversely affect patient safety. In addition, it could negatively affect the population’s iodine status, as iodine-based biocides used in the livestock sector (e.g. teat dips) play a crucial role in the fortification of milk. Finally, the decision to consider iodine as an endocrine disruptor poses the risk of setting precedence for other sectors, potentially affecting the placing on the market of, and public perception of, iodine-containing products such as x-ray contrast media, cosmetics, colorants, or dyes. The same applies to fortified food, feed, or crops, posing a risk of negatively impacting public perception about the benefits of iodine in food fortification. This is particularly concerning, given the high prevalence of iodine deficiency and implications on public health across Europe, as stressed by the Krakow Declaration on iodine . Lastly, the early review of the BPR is closely monitored outside of the EU, for instance in the United States and Asia Pacific Region, risking a similar classification of iodine and the same implications for healthcare professionals, the patient community, as well as the biocides value chain, in these regions. Derogation criteria Article 5(2) of the BPR lists several derogation criteria that allow for the authorisation of substances that have been labelled as an endocrine disruptor. Specifically, the BPR states that the authorization of a substance with endocrine-disrupting properties may be justified if: 1.“The risk to humans, animals or the environment from exposure to the active substance in a biocidal product, under realistic worst-case conditions of use, is negligible.” Human health Any authorisation of iodine-based biocidal products already accounts for a conservative upper limit intake as part of the risk assessment. This risk assessment is specifically intended to avoid any negative effects on human health and, given that iodine-based biocides been used for decades without any reports of adverse effects to human health, appears to be highly effective. Moreover, ECHA’s very own 2013 risk assessment of iodine clearly states that: •“Iodine is not harmful via oral exposure.” (p.17) •“Because of the low absorption through skin, acute dermal toxicity in man is very unlikely and cases of death due to single application or exposure via dermal route are virtually unknown.” (p.17) •“…iodine is not regarded as a skin sensitizer.” (p.18) •“Several expert groups which have evaluated the available data base have concluded that iodine is not considered to be a mutagen in vivo.” (p.19) •With respect to carcinogenetic properties, “No clear dose-response relationship is evident.” (p.19) The same applies to ECHA’s 2018 risk assessment of betadine solution , stating that: •“No physico-chemical hazard was identified...” (p.4) •“If the professional users follow the instructions about the safe application of the product it is unlikely that the intended uses cause any unacceptable acute or chronic risk to professional users or to the patients.” (p.4) Animal health Primary applications of iodine-based biocides in this context are composed of disinfection of animals’ teats or udders, as well as an antiseptic agent for a wide range of wounds. Povidone-iodine is often the first choice for the treatment of wounds due to its broad antimicrobial spectrum, lack of resistance, efficacy against biofilms, good tolerability, and its effect on excessive inflammation. As such, iodine-based biocides do not pose a risk to animals but are, in fact, critical to safeguarding their health. Moreover, ECHA’s 2018 risk assessment of iodine teat dip products states that “the biocidal product family has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects.“ (p.13) Environment With respect to environmental risks poses by iodine-based biocides, ECHA’s 2018 risk assessment of betadine solution, states that “…the intended uses of the product do not pose unacceptable risk to the environment.” (p.4). Moreover, ECHA’s 2018 risk assessment of iodine teat dip products clearly states that “the biocidal product family has no unacceptable effects itself, or as a result of its residues, on the environment...” (p.13) In light of the presented evidence, iodine-based biocides pose a negligible risk to humans, animals, and the environment. 2.“It is shown by evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment.” Human health Iodine-based biocides are widely used in the healthcare sector, due to iodine’s broad-spectrum antimicrobial properties and its high effectiveness against bacteria, fungi, and viruses. PVP-I formulations in particular are crucial in a healthcare setting for limiting the impact and spread of infectious diseases with potent antiviral, antibacterial, and antifungal effects. In addition, PVP-I has been shown to be highly effective against SARS-CoV-2 (COVID-19), both with respect to reducing the viral load in patients , as well as protecting healthcare professionals. Moreover, the broad antimicrobial spectrum of PVP-I, its efficacy against biofilms, good tolerability and its effect on excessive inflammation position it extraordinarily well for wound healing. Due to its rapid, potent, broad-spectrum antimicrobial properties, and favorable risk/benefit profile, PVP-I is expected to remain a highly effective treatment for acute and chronic wounds in the foreseeable future. Animal health Iodine-based teat dips are widely used by the livestock industry to prevent mastitis, an inflammation of the mammary gland in the udder, typically caused by bacterial infection. Iodine-based teat dips are used after milking to kill bacteria on the teat’s surface, preventing the bacteria from entering the teat canal and causing mastitis. By preventing mastitis and other infections, iodine-based teat dips contribute animal health, as well as the safety and quality of the milk supply. In addition, they increase the iodine content of milk, thereby contributing to the population’s iodine status. Moreover, the same antimicrobial and wound healing properties mentioned in the context of human health also apply to animals and iodine-based biocides remain widely utilized for the treatment of animal wounds, both by veterinarians, as well as the livestock sector. In conclusion, iodine-based biocides are essential to controlling serious dangers to both human and animal health by limiting the impact and spread of infectious diseases, as well as its excellent properties for wound healing. 3.“Not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance.” As previously highlighted, iodine-based biocides play a crucial role for healthcare professionals and patients by limiting the impact and spread of infectious diseases, including COVID-19, as well as being highly effective in the treatment of acute and chronic wounds. Moreover, iodine-based biocides are a staple product in the livestock sector and are widely used to prevent infectious diseases such as mastitis in cows, thereby enhancing the safety and quality of the milk supply, as well as supporting the population’s iodine intake via the fortification of milk. Considering the essential role of iodine-based biocides in both human and animal health, its safety, as well as the fact that it does not pose unacceptable risks to human health, animal health, as well as the environment, not approving iodine as an active substance would indeed have a disproportionate negative impact on society.
WHO-IGN Report
Executive Summary This report reviews the iodine status in the 53 Member States of the WHO European Region, and Kosovo, as well as current scientific knowledge on the consequences of mild iodine deficiency, dietary sources of iodine and the present effectiveness of iodine deficiency prevention measures. It also explores the economic impact of iodine deficiency in the current WHO European Region context. The use of iodized salt as a vehicle for preventing iodine deficiency is a highly successful global public health intervention and has been implemented in most countries of the Region with remarkable impact. A century ago, large parts of the population of the Region were affected by endemic iodine deficiency due to severely iodine deficient diets. As a result of salt iodization, iodine deficiency disorders such as endemic goitre, clinical hypothyroidism and severe congenital iodine deficiency disorder (previously referred to as cretinism), once historically widespread, are now controlled. However, iodine deficiency, especially mild deficiency, is still a widespread problem in the European Region, with consequences extending beyond potential effects on brain development early in life, to increased risk for goitre, thyroid nodules and hyperthyroidism in adults and the elderly, with a major impact on population health and the economy. Iodine status in school-age children is adequate in 26 of the 27 WHO European Region Member States, and Kosovo, with data on urinary iodine concentration (n=28), largely due to salt iodization and dietary iodine from milk and dairy products. Salt iodization is implemented in 43 of 53 Member States, and Kosovo3 (n=54). Iodization is mandatory in 29 Member States, and Kosovo, (n=30) and voluntary in 13. Progress towards optimal iodine nutrition in some Member States is deteriorating, especially in those with voluntary salt iodization, and iodine intake needs improvement to prevent iodine deficiency and ensure optimal iodine nutrition in all population groups. Iodization of salt remains the main strategy to ensure adequate iodine intake in the WHO European Region. A key finding is that milk and dairy products are also important sources of iodine in many western and central European countries, especially for children. Yet consumption of milk and dairy products is declining among adolescents and adults, heightening their risk of iodine deficiency. Iodine status in adults and pregnant women is less than optimal in several countries with voluntary or no salt iodization. Foods produced or cooked outside the home, such as bread, processed meats or ready-to- eat meals, are now the main sources of salt in many countries of the WHO European Region (70–80% of total); yet, recent market surveys found that a low proportion of salt in processed food products (e.g. 9% in Germany and 34% in Switzerland) was iodized. In countries with voluntary or no iodization, commonly consumed foods are often produced with non-iodized salt. The shift towards plant-based dairy alternatives, particularly among women, is concerning from an iodine nutrition perspective, especially in countries relying on milk as a source of iodine, as most dairy alternatives do not contain iodine. Overall, lifestyle choices and dietary trends, including more frequent use of processed foods and the switch to plant-based diets and dairy alternatives, are contributing to a persistent, and in some countries an increased, proportion with insufficient iodine intakes. Routine iodine status surveillance using nationally representative population-based studies is lacking in most countries and in many the most recent data is more than 10 years old. Data frequently comes from universities, medical experts and research centres, often with little support, or recognition, from health authorities. Poor knowledge about the consequences of iodine deficiency among the public, health authorities, health professionals and food producers is a barrier to improving iodine intake. There is little understanding that advice to reduce salt intake for health reasons is compatible with use of iodized salt. Since the publication of the last WHO report on iodine deficiency in the WHO European Region 15 years ago, much new data has become available, including information about vulnerable population groups. The present report uniquely combines information sourced not only from scientific health and nutrition publications and public health reports, but also from animal husbandry science and reporting and the food industry.
Joint Statement - A collective call to action on tackling iodine deficiency in Europe
Iodine is essential for human health, playing a crucial role in thyroid function, metabolism, cognitive development, and growth. Adequate iodine intake is particularly vital for pregnant women, infants, children, and adolescents. Yet, despite well-documented health risks—including impaired brain development, impaired growth, goitre, and thyroid disorders—iodine deficiency remains largely overlooked by policymakers and the public. The first EUthyroid project (2016–2018) revealed alarming findings: up to 50% of newborns in Europe are at risk of iodine deficiency and do not reach their full cognitive potential due to insufficient iodine intake. This represents a major but preventable public health issue. Despite these risks, most European countries lack dedicated policies to prevent iodine deficiency disorders, and no harmonised framework exists across the European Union (EU). Recognising the urgency of this issue, 65 organisations—including patient groups, healthcare professionals, scientists, and industry representatives—endorsed the Krakow Declaration on Iodine, calling for decisive political action. However, progress has been slow, and iodine deficiency remains widespread across Europe. In 2023, EUthyroid2 was launched to build on the first EUthyroid initiative, aiming to improve iodine knowledge and intake, particularly among children, adolescents, and young women. The WHO-IGN 2024 report later confirmed that changes in diet and lifestyle are threatening a re-emergence of the problem in parts of Europe, with pregnant women being especially vulnerable. To address this, the Iodine Coalition Europe (ICE) was established in 2025 as a multi-stakeholder partnership bringing together iodine nutrition experts, representatives from the salt, food, and iodine industries, experts in research and endocrinology, and organisations with global reach to promote the use of iodised salt in processed foods and advance iodine nutrition initiatives. While salt iodisation is a safe, effective, and affordable solution, several obstacles hinder the wider use of iodised salt in Europe. A call for coordinated action Food fortification—adding iodine to ingredients and/or foods—has proven to be an effective strategy for combating iodine deficiency. However, inconsistent national policies across the EU are undermining these efforts. To ensure that all European citizens have adequate iodine intake, a harmonised approach is needed. As Members of the European Parliament, we call for urgent action from the European Commission and national governments to: •Recognise the essential role of iodine in human nutrition and health. •Recognise iodine deficiency as a public health priority in Europe. •Review national policies on salt iodisation to remove intra-community trade barriers and provide legal certainty for commercial operators •Simplify labelling to encourage the use of iodised salt in food production. •Provide a uniform interpretation of the EU Fortification Regulation to ensure harmonized enforcement among Member States. •Ensure that the current EU conversation on setting maximum levels for vitamins and minerals does not introduce new barriers to salt iodisation. •Monitor dietary iodine intake at the national level across Europe Stronger EU-wide regulations and monitoring mechanisms are essential to protect public health and ensure that future generations do not suffer the consequences of preventable iodine deficiency. We kindly ask the Members of the European Parliament to actively engage in this important public health issue and support policies that promote the health and well-being of European citizens. The time to act is now.
_jpg.avif)
