For salt with potassium or sodium iodate, the simplified designation "iodised salt" is sufficient from a health perspective Joint statement by the BfRshort forGerman Federal Institute for Risk Assessment and MRIshort forMax Rubner Institute

Regulation (EU) No 1169/2011 on the provision of food information to consumers (Food Information Regulation) stipulates that ingredients must be listed in accordance with Article 18(2) of the Food Information Regulation with their specific designation, where applicable in accordance with the provisions of Article 17 and Annex VI.

If iodised table salt is added to a foodstuff, it is considered a compound ingredient under the Food Information Regulation, as it is produced from an iodine compound and a sodium or potassium compound. The individual components must therefore be indicated in accordance with Article 18(4) in conjunction with Annex VII Part E of the Food Information Regulation, for example "iodised salt (salt, potassium iodate)". Until the Food Information Regulation came into force, however, the indication "iodised salt" was sufficient.

In this opinion, the BfRshort forGerman Federal Institute for Risk Assessment and the MRIshort forMax Rubner Institute examined the question of whether there are population groups for whom knowledge of the specific iodine compound is important for health reasons.

The BfRshort forGerman Federal Institute for Risk Assessment and the MRIshort forMax Rubner Institute conclude that, from a risk assessment perspective, simplified labelling with the sole indication "iodised salt" or "iodised table salt" does not lead to gaps in knowledge that would be relevant for health reasons, even in sensitive population groups.

In the case of iodised table salt – enriched with potassium or sodium iodate in accordance with legal requirements – the intake of the accompanying counterion (K⁺, Nashort forsodium⁺) is so low with normal salt consumption that it is insignificant compared to the intake of potassium or sodium from a normal diet.

If the corresponding iodide compounds, i.e. potassium and sodium iodide, are also approved in future, the BfRshort forGerman Federal Institute for Risk Assessment and the MRIshort forMax Rubner Institute do not believe that there are any particular population groups for whom it would be relevant for health reasons to know whether they are consuming iodine from table salt in the form of iodate or iodide compounds, as the small amounts of iodate consumed via salt are almost exclusively available to the body as iodide.

Since 1981, only iodates (sodium and potassium iodate) have been approved for the production of iodised table salt in the Federal Republic of Germany. In other countries, sodium or potassium iodide are also used (WHO, 2004), a step currently under discussion in Germany (BfRshort forGerman Federal Institute for Risk Assessment, 2022).

The question of whether it is relevant for health reasons whether iodine from salt is absorbed in the form of iodide or iodate compounds was already investigated and answered in 2022 in a External Link:joint statement by the BfR and MRI (BfRshort forGerman Federal Institute for Risk Assessment, 2022).

The BfRshort forGerman Federal Institute for Risk Assessment and the MRIshort forMax Rubner Institute concluded that there are no nutritional, technological or toxicological data that speak against the use of iodides or iodates as food salt additives.

Iodate ingested through food is reduced to iodide in the body, making it more bioavailable. The small amounts of iodate ingested through salt are therefore almost exclusively available to the body as iodide. From the point of view of the BfRshort forGerman Federal Institute for Risk Assessment and the MRIshort forMax Rubner Institute, there are therefore no specific population groups for whom it would be relevant for health reasons to know whether they are consuming iodine from table salt in the form of iodate or iodide compounds, as the small amounts of iodate consumed via salt are almost exclusively available to the body as iodide.

The extracellular potassium concentration in the human organism is strictly homeostatically regulated, with excess potassium being excreted via the kidneys (Domke, 2004; EFSAshort forEuropean Food Safety Authority, 2016). In healthy people (without medically or drug-induced potassium excretion disorders), no negative health effects have been reported to date in connection with potassium intake through normal food (EFSAshort forEuropean Food Safety Authority, 2005; EFSAshort forEuropean Food Safety Authority Panel on Dietetic Products and Allergies, 2010, 2011a, b). However, there are certain population groups in which the homeostatic regulation of potassium is disturbed or restricted for other reasons. They are sensitive to excessive potassium intake and therefore have an increased risk of developing hyperkalaemia (potassium concentration in serum >5 millimoles (mmol) per litre (L)). These include, in particular, patients with renal insufficiency (CKD), heart failure, diabetes mellitus, adrenal insufficiency, but also infants, people aged 85 and over, people taking medication that affects potassium balance, and people who engage in extremely strenuous physical activity (EFSAshort forEuropean Food Safety Authority, 2005; Desai, 2009). The pathophysiological mechanisms of hyperkalaemia are described in the literature (Hunter and Bailey, 2019).

In 2016, the German Nutrition Society (DGE) updated the reference values for potassium (DGE, 2016), basing its calculations on the prevention of high blood pressure and stroke. The estimated values for infants aged 0 to under 4 months are 400 milligrams (mgshort formilligram) per day and 600 mgshort formilligram per day for those aged 4 to under 12 months. For children and adolescents, the estimated values are derived from the values for adults. For 1 to under 4-year-olds, the estimated value is 1,100 mgshort formilligram per day, rising to 3,600 mgshort formilligram per day for 13 to under 15-year-olds. From 15 years of age onwards, as well as for adults and pregnant women, the estimated value is 4,000 mgshort formilligram per day. For breastfeeding women, the estimated value for an adequate potassium intake is 4,400 mgshort formilligram per day.

Potassium levels vary greatly between foods. Potassium-rich foods include raw bananas, which have a potassium concentration of 367 mgshort formilligram per 100 grams (g), and raw tomatoes, which have a potassium concentration of 235 mgshort formilligram per 100 g (Federal Food Code (BLS) 3.02). Foods low in potassium include cooked pasta (egg-free pasta) with a potassium concentration of 48 mgshort formilligram per 100 g and cooked bread dumplings with a potassium concentration of 36 mgshort formilligram per 100 g. Since potassium is water-soluble, cooked pasta has a significantly lower potassium concentration than raw pasta (200 mgshort formilligram potassium per 100 g) (Batista et al.short foret alii (lat. "and others"), 2021).

As part of a low-potassium diet for renal insufficiency, it is recommended that people consume no more than 2,000 to 2,500 mgshort formilligram of potassium per day and, to achieve this, specifically choose foods with a low to medium potassium concentration (Fulda, 2021; Hauner, 2010).

The current legal minimum and maximum amount of iodine in table salt is 15 to 25 mgshort formilligram iodine per kilogram (kgshort forkilogram) of salt, i.e. an average of 20 mgshort formilligram iodine per kgshort forkilogram of salt. Based on the molecular formula of KIO_{3 ,}iodine accounts for 59 % and potassium for 18 % of the molecular weight. For an iodine concentration of 20 mgshort formilligram per kgshort forkilogram of table salt, approximately 34 mgshort formilligram of KIO₃ must therefore be added. According to a biomarker-based data analysis of the representative German Health Interview and Examination Survey for Adults (DEGS1) at the Robert Koch Institute (RKI), men consume 10 g of salt and women 8.4 g of salt per day (Remer and Thamm, 2015). Based on a salt consumption of 10 g per day, iodised salt enriched with KIO₃ would provide 61 micrograms (μg) (0.061 mgshort formilligram) of potassium per day.

The potassium intake from KIO₃-enriched iodised salt is more than 1,500 times lower than the potassium intake from a serving of cooked pasta (200 g), which can be considered low in potassium, based on a daily salt intake of 10 g.

From the perspective of the BfRshort forGerman Federal Institute for Risk Assessment and the MRIshort forMax Rubner Institute, there are therefore no specific population groups for whom it would be relevant for health reasons to know whether they are consuming iodine from table salt in the form of a potassium compound. Potassium intake from table salt enriched with KIO₃ is so negligible compared to potassium intake from other foods, including low-potassium foods, that it is irrelevant even in a recommended low-potassium diet.

High sodium or salt intake is associated with high blood pressure (Gupta et al.short foret alii (lat. "and others"), 2023; Mills et al.short foret alii (lat. "and others"), 2020), and reducing sodium intake can lower blood pressure in people with hypertension (Filippini et al.short foret alii (lat. "and others"), 2021).

The American Heart Association recommends consuming no more than 2,300 mgshort formilligram of sodium per day, with no more than 1,500 mgshort formilligram per day being optimal, especially for people with high blood pressure (External Link: https://www.heart.org/en/health-topics/high-blood-pressure/changes-you-can-make-to-manage-high-blood-pressure/shaking-the-salt-habit-to-lower-high-blood-pressure ).

In 2016, the DGE specified an estimated value for an adequate sodium intake of 1,500 mgshort formilligram per day for adults (DGE, 2016). The estimated values for infants aged 0 to under 4 months are 130 mgshort formilligram per day, and 200 mgshort formilligram per day for those aged 4 to under 12 months. For children aged 1 to under 4, the estimated value is 400 mgshort formilligram per day, rising to 1,400 mgshort formilligram per day for children aged 13 to under 15. From the age of 15 onwards, as well as for adults, pregnant women and breastfeeding women, the estimated value for an adequate intake is 1,500 mgshort formilligram per day.

In 2019, the European Food Safety Authority (EFSAshort forEuropean Food Safety Authority) derived current reference values for sodium (EFSAshort forEuropean Food Safety Authority, 2019). The panel considers 2,000 mgshort formilligram of sodium per day to be a safe and adequate intake for the general adult population in the EU. The same value applies to pregnant and breastfeeding women. For children aged 1 to 3 years, the value is 1,100 mgshort formilligram per day, for children aged 4 to 6 years it is 1,300 mgshort formilligram per day, for children aged 7 to 10 years it is 1,700 mgshort formilligram per day, and for children aged 11 to 17 years it is 2,000 mgshort formilligram per day. For infants aged 7 to 11 months, an adequate intake (AI) of 200 mgshort formilligram per day is recommended.

The DGE recommends a maximum daily intake of 6 g of table salt for adults (DGE, 2016), which corresponds to approximately 2,300 mgshort formilligram of sodium. According to a study by the RKI (DEGS1), the actual consumption of salt is closer to 8.4 g (women) and 10 g (men) per day (Remer and Thamm, 2015).

Based on the molecular formula of NaIO_{3 ,} iodine accounts for 64 % and sodium for 11.6 % of the molecular weight. For an iodine concentration of 20 mgshort formilligram per kgshort forkilogram of table salt, approximately 31 mgshort formilligram of NaIO₃ must therefore be added. The sodium concentration would then be 3.6 mgshort formilligram sodium (from NaIO₃) per kgshort forkilogram of salt. With a salt intake of 6 g, approximately 2,300 mgshort formilligram of sodium would be absorbed from sodium chloride and 0.022 mgshort formilligram (22 μg) from sodium iodate. With an intake of 10 g of salt per day, approximately 3,900 mgshort formilligram of sodium from sodium chloride and 0.036 mgshort formilligram (36 μg) of sodium from NaIO₃ would be consumed. This means that the sodium intake from sodium iodate is more than 100,000 times lower than that from salt (sodium chloride).

From the perspective of the BfRshort forGerman Federal Institute for Risk Assessment and the MRIshort forMax Rubner Institute, there are therefore no specific population groups for whom it would be relevant for health reasons to know whether they are consuming iodine from table salt in the form of a sodium compound. The sodium intake from NaIO₃ in table salt enriched with NaIO₃ is so low compared to the sodium intake from sodium chloride that it is irrelevant even for sensitive population groups, such as people with high blood pressure.

Furthermore, it should be noted that between January 2014 and September 2024 a search of the MINTEL database for salt products to which either potassium iodate or sodium iodate is added identified a total of 66 product names, none of which contained sodium iodate. However, the MINTEL database only includes new product launches, although products with new packaging and relaunches are also taken into account.

3.4.1 ALS decision of the 121st ALS meeting from 25 to 27 September 2023

In its 24 March 2022 judgement in Case C-533/20, the European Court of Justice (ECJ) ruled that Regulation (EU) No 1169/2011 (Food Information Regulation), in particular under consideration of Article 18(2), must be interpreted to mean that, in the case of foodstuffs to which a vitamin has been added, the list of ingredients of that food must include the name of the vitamin but not the name of the vitamin compound used. In the opinion of ALS and ALTS, this ruling is not transferable to the indication of minerals added for nutritional purposes in the list of ingredients (ALS, 2024) and provides the following rationale:

"The compounds listed in Annex II to Regulation (EC) No 1925/2006 are used to fortify foods with minerals. In contrast to vitamin compounds, the name of the compound in minerals always includes the name of the fortified substance, which is listed by name in the nutrition declaration. The indication of the name of the mineral compounds used in the list of ingredients has become established as the "customary name" and is to be regarded as generally accepted. Therefore, the indication of the mineral compound used as an ingredient does not result in less clear and less easily understandable information, but rather in accurate information within the meaning of Article 7(2) of the Food Information Regulation. Unlike the names of vitamins, the indication of an element name does not represent the generic term for a group of compounds, but is the chemical name of an element that has different nutritional properties from the corresponding cation or anion of a mineral compound. The link with the counterion also provides consumers with additional information which, in particularly well-known or advertised contexts, significantly influences consumer decisions and thus, within the meaning of Article 3(1) of the Food Information Regulation, provides consumers with a basis for making an informed choice. ALS and ALTS therefore consider that the compounds listed in Annex II to Regulation (EC) No 1925/2006 correspond to the specific names that must be listed in the list of ingredients in accordance with Article 18(2) of the Food Information Regulation. The mere mention of the enriched nutrients, e.g. in the form of "magnesium", "potassium", etc., in the list of ingredients is not a customary designation that sufficiently characterises the ingredient used. The opinion expressed above regarding the correct designation also applies to mineral compounds used as salt substitutes (e.g. potassium chloride) and to iodised table salt (e.g. potassium iodate).

The BfRshort forGerman Federal Institute for Risk Assessment and the MRIshort forMax Rubner Institute fundamentally concur with the ALS decision. However, further aspects must be taken into account when labelling iodised salt. Even with simplified labelling, the term "iodised salt" would be used. This makes it clear that it is a compound (salt with iodine content), even if the exact iodine compound is not specified. Furthermore, until 2014, the simplified labelling "iodised salt" or "iodised table salt" had been common practice for many years and had thus established itself as a "customary designation". From the point of view of the BfRshort forGerman Federal Institute for Risk Assessment and the MRIshort forMax Rubner Institute, knowledge of the mineral compound used in other products, such as in food supplements, is important because it is generally consumed in larger quantities and therefore represents important additional information for consumers.

In the case of iodised salt, it is likely that knowledge of whether the salt contains iodine is the main factor influencing consumer decisions, particularly because simplified labelling had already been established and accepted for years prior to 2014. It can therefore be assumed that knowledge of the exact iodine compound does not constitute additional information that would significantly influence consumer decisions. This knowledge is also not relevant for health reasons.

ALS (2024). 121. ALS-Sitzung. Journal of Consumer Protection and Food Safety External Link:https://linkspringercom/article/101007/s00003-024-01502-y. 19: 351-362.

Batista RAB, Japur CC, Prestes IV, Fortunato Silva J, Cavanha M, das Graças Pena G (2021). Potassium reduction in food by preparation technique for the dietetic management of patients with chronic kidney disease: a review. J Hum Nutr Diet. 34: 736-746.

BfRshort forGerman Federal Institute for Risk Assessment (2022). External Link:Declining iodine intake in the population: model scenarios to improve iodine intake in children and adolescents. BfRshort forGerman Federal Institute for Risk Assessment Opinion Nr. 026/2022 of 17.Oktober 2022.

BLS. Bundeslebensmittelschlüssel Version 3.02. External Link:https://www.blsdb.de/

Desai AS (2009). Hyperkalemia in patients with heart failure: incidence, prevalence, and management. Curr Heart Fail Rep. 6: 272-280.

DGE (2016). Speisesalzzufuhr in Deutschland, gesundheitliche Folgen und resultierende Handlungsempfehlung. Ernährungs Umschau international. 63: 62-70.

DGE (2016). Referenzwerte Kalium. External Link:https://www.dge.de/wissenschaft/referenzwerte/kalium/

DGE (2016). Referenzwerte für Natrium. External Link:https://www.dge.de/wissenschaft/referenzwerte/natrium/

Domke A. GR, Niemann B., Przyrembel H., Richter K., Schmidt E., Weißenborn A., Wörner B., Ziegenhagen R. (2004). Verwendung von Mineralstoffen in Lebensmitteln - Teil II. BfRshort forGerman Federal Institute for Risk Assessment Wissenschaftsheft. p 1-323

EFSAshort forEuropean Food Safety Authority (2005). External Link:Opinion of the Scientific Panel on Dietetic products, nutrition and allergies [NDA] on a request from the Commission related to the Tolerable Upper Intake Level of Potassium. EFSAshort forEuropean Food Safety Authority Journal. 3: 193.

EFSAshort forEuropean Food Safety Authority Panel on Dietetic Products, Nutrition and Allergies (NDA) (2010). External Link:Scientific Opinion on the substantiation of health claims related to potassium and maintenance of normal muscular and neurological function (ID 320, 386) and maintenance of normal blood pressure (ID 321) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSAshort forEuropean Food Safety Authority Journal. 8: 1469.

EFSAshort forEuropean Food Safety Authority Panel on Dietetic Products, Nutrition and Allergies (NDA) (2011a). External Link:Scientific Opinion on the substantiation of health claims related to calcium and potassium and maintenance of normal acid-base balance (ID 400, 407) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSAshort forEuropean Food Safety Authority Journal. 9: 2201.

EFSAshort forEuropean Food Safety Authority Panel on Dietetic Products, Nutrition and Allergies (NDA) (2011b). External Link:Scientific Opinion on the substantiation of health claims related to sodium and potassium salts of citric acid and maintenance of normal bone (ID 330) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSAshort forEuropean Food Safety Authority Journal. 9: 2302.

EFSAshort forEuropean Food Safety Authority NDA Panel (EFSAshort forEuropean Food Safety Authority Panel on Dietetic Products, Nutrition and Allergies) (2016).External Link: Scientific opinion on dietary reference values for potassium. EFSAshort forEuropean Food Safety Authority Journal. 14: 4592

EFSAshort forEuropean Food Safety Authority (2019). Dietary reference values for sodium. EFSAshort forEuropean Food Safety Authority J. 17: e05778. External Link:https://pubmed.ncbi.nlm.nih.gov/32626425/

Filippini T, Malavolti M, Whelton PK, Naska A, Orsini N, Vinceti M (2021). Blood Pressure Effects of Sodium Reduction: Dose-Response Meta-Analysis of Experimental Studies. Circulation. 143: 1542-1567.

Fulda H (2021). Informationsblatt zum Thema Kalium bei chronischer Niereninsuffizienz mit Dialysetherapie. External Link:https://www.hs-fulda.de/fileadmin/user_upload/RIGL/MoDiVe/Niereninsuffizienz/Niereninsuffizienz_Kalium_Informationsblatt_MoDiVe.pdf

Gupta DK, Lewis CE, Varady KA, Su YR, Madhur MS, Lackland DT, Reis JP, Wang TJ, Lloyd-Jones DM, Allen NB (2023). Effect of Dietary Sodium on Blood Pressure: A Crossover Trial. JAMA. 330: 2258-2266.

Hauner H (2010). Kaliumarme Ernährung - TU München - Klinik für Ernährungsmedizin. External Link:https://www.mri.tum.de/sites/default/files/seiten/kaliumarme_ernaehrung.pdf

Hunter RW, Bailey MA (2019). Hyperkalemia: pathophysiology, risk factors and consequences. Nephrol Dial Transplant. 34: iii2-iii11.

Mills KT, Stefanescu A, Heshort forhelium J (2020). The global epidemiology of hypertension. Nat Rev Nephrol. 16: 223-237.

Remer T, Thamm M (2015). Abschlussbericht - Ermittlung der täglichen Jod- und Salzzufuhr Erwachsener in Deutschland: Biomarkerbasierte Datenanalyse der repräsentativen DEGS-Studie und methodologische Basislegung für künftige Gesundheitssurveys. Förderkennzeichen: 2813HS013. Berichtszeitraum: September 2013 - Januar 2015. Robert Koch-Institut. External Link:https://service.ble.de.

WHO (2004). Iodine status worldwide - WHO global database on iodine deficiency.
External Link:https://www.who.int/publications/i/item/9241592001

The German Federal Institute for Risk Assessment (BfRshort forGerman Federal Institute for Risk Assessment) is a scientifically independent institution within the portfolio of the German Federal Ministry of Agriculture, Food and Regional Identity (BMLEH). It protects people's health preventively in the fields of public health and veterinary public health. The BfRshort forGerman Federal Institute for Risk Assessment provides advice to the Federal Government as well as the Federal States (‘Laender’) on questions related to food, feed, chemical and product safety. The BfRshort forGerman Federal Institute for Risk Assessment conducts its own resear

The Max Rubner Institute (MRIshort forMax Rubner Institute), Federal Research Institute for Nutrition and Food, focuses its research on consumer health protection in the field of nutrition and food. It advises the Federal Ministry of Agriculture, Food and Regional Identity (BMLEH) in these areas. Important research priorities include the nutritional and health value of food, eating habits, and food safety and quality.