The Commission resumed works to define maximum and minimum doses of vitamins and minerals in fortified food and food supplements.
The intake of vitamins and minerals through fortified foods and food supplements, in addition to ordinary foods, is part of consumer habits. This opens the way of a public health matter: if on the one hand it is necessary that the substances supplied are present in appreciable and useful quantities, on the other hand it is important to ensure that the doses from each source do not exceed a threshold beyond which adverse health consequences could occur.
The need to set maximum and minimum quantities of vitamins and minerals in fortified foods and in food supplements had already been foreseen by the two founding texts of the legislation of these two categories: Regulation (EC) 1925/2006 concerning the addition of vitamins, minerals and substances, and Directive (EC) 2002/46 on food supplements, respectively. However, reasons such as the complexity of the subject and the diversity of views among Member States had led the discussions to a dead end. For the time being, each Member State can define these parameters independently (as shown in our comparison between French and Italian food supplement regulations). Regulatory harmonization would represent additional consumer protection and an incentive to trade.
The current situation could change in the near future: in 2021, the European Commission resumed working on setting maximum and minimum doses of micronutrients in fortified foods and food supplements. The year 2022 should see the execution of the necessary preparatory work and impact assessment, and the goal should be attained by the end of the current Commission mandate in 2024. To this end, the DG SANTE has established a dedicated task force, which includes representatives from the Member States. The Commission has also requested EFSA to pronounce itself on the Tolerable Upper Intake Level (ULs) of 8 micronutrients: vitamin A (in the forms of retinol and beta-carotene), vitamins D, E, B6, folic acid/folate, iron, and manganese.
In this context, on January 24, 2022 the EFSA Journal published a Guidance revisiting the methodology to determine the ULs of micronutrients; the text updates the previous publication by the Scientific Committee on Food (which dates back to 2000), taking into account the experience gained, and scientific developments occurred, in the meantime. The Guidance, which has been drafted by consulting international guidelines (WHO, FAO, …), divides the population into two age groups: one between 4/6 months and 3 years old, and one (defined as general population) starting from 3 years of age. The content of the Guidance will be implemented over a one-year pilot phase, after which it will be revised as necessary. After a public consultation, the document will be finalized.
It is important to remember the definition of UL (the maximum chronic daily intake of a nutrient, from all sources, judged to be unlikely to pose a risk of adverse health effects to humans), and to underline that this value represents a threshold not to be exceeded, and that it cannot be understood as a maximum daily intake from a single source or food category.
On the basis of the ULs established by EFSA over its risk assessment, the Commission, which deals with risk management, will be able to set maximum doses of vitamins and minerals in fortified foods and food supplements.
Within this context, the European federation of associations of Health Products Manufacturers (EHPM) developed and proposed to the Commission a model to establish maximum and minimum daily doses of micronutrients in food supplements. Published on December 1, 2021, the EHPM proposal was submitted to DG SANTE later that month. The model was developed by a working group composed of experts and trade associations from several Member States; the work was based on recent scientific surveys, peer-reviewed sources, and risk management models. The paper considers all micronutrients currently allowed in food supplements, and focuses on two population subsets: children between 4 and 10 years of age on the one hand, and “adults”, 10 years and older, on the other (with the exception of the case of retinol, that has also a specific maximum dose for adolescents).
The proposed method, which only applies to those micronutrients for which adverse effects beyond a certain threshold of consumption exist, is simple; for each micronutrient:
Maximum amount = UL – intake observed at the 95° percentile
The value can be adjusted, by rounding the value to obtain “practical” reference doses, and by applying additional qualitative assessments (for those micronutrients with a higher risk). Micronutrients may be accompanied by additional consumer information.
The EHPM proposal also concerns minimum daily amounts, which are suggested as 15% of the nutritional reference value (NRV), with some exceptions.
The calculation proposed by EHPM does not mention the maximum and minimum quantities that could be attributed to fortified foods.
More details on the EHPM proposal are available in our dedicated article.
Germany, which has long been calling for a harmonization of values at the European level, has also provided the Commission with a proposal for a calculation methodology.
At the national level, the federal institute for risk assessment (Bundesinstitut für Risikobewertung, BfR), calculates the maximum levels of each nutrient basing on the UL and the 95th percentile intake, as does the EHPM. However, the value obtained, identified as “residual amount”, is not yet considered as a maximum daily dose for added vitamins and minerals. First, depending on its value, it will be either entirely allocated to the food supplement category, or, if possible, split among food supplements and fortified foods. Then, the maximum amount will be calculated for each of the two food categories by applying further transformations to the “residual amount”, such as by relating it to the average daily energy intake (for fortified foods), or by dividing it by an uncertainty factor usually equal to 2 (for food supplements).
The coming months will reveal whether the Commission will choose to rely on any of the methods we have outlined and, if so, which one will be chosen. We will keep you updated!
Orchidali accompanies you in the formulation of fortified foods and food supplements in line with European regulations.
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Maximum and minimum amounts of vitamins and minerals in food supplements: towards harmonization at the European level?
The Commission resumed works to define maximum and minimum doses of vitamins and minerals in fortified food and food supplements.
The intake of vitamins and minerals through fortified foods and food supplements, in addition to ordinary foods, is part of consumer habits. This opens the way of a public health matter: if on the one hand it is necessary that the substances supplied are present in appreciable and useful quantities, on the other hand it is important to ensure that the doses from each source do not exceed a threshold beyond which adverse health consequences could occur.
The need to set maximum and minimum quantities of vitamins and minerals in fortified foods and in food supplements had already been foreseen by the two founding texts of the legislation of these two categories: Regulation (EC) 1925/2006 concerning the addition of vitamins, minerals and substances, and Directive (EC) 2002/46 on food supplements, respectively. However, reasons such as the complexity of the subject and the diversity of views among Member States had led the discussions to a dead end. For the time being, each Member State can define these parameters independently (as shown in our comparison between French and Italian food supplement regulations). Regulatory harmonization would represent additional consumer protection and an incentive to trade.
The current situation could change in the near future: in 2021, the European Commission resumed working on setting maximum and minimum doses of micronutrients in fortified foods and food supplements. The year 2022 should see the execution of the necessary preparatory work and impact assessment, and the goal should be attained by the end of the current Commission mandate in 2024. To this end, the DG SANTE has established a dedicated task force, which includes representatives from the Member States. The Commission has also requested EFSA to pronounce itself on the Tolerable Upper Intake Level (ULs) of 8 micronutrients: vitamin A (in the forms of retinol and beta-carotene), vitamins D, E, B6, folic acid/folate, iron, and manganese.
In this context, on January 24, 2022 the EFSA Journal published a Guidance revisiting the methodology to determine the ULs of micronutrients; the text updates the previous publication by the Scientific Committee on Food (which dates back to 2000), taking into account the experience gained, and scientific developments occurred, in the meantime. The Guidance, which has been drafted by consulting international guidelines (WHO, FAO, …), divides the population into two age groups: one between 4/6 months and 3 years old, and one (defined as general population) starting from 3 years of age. The content of the Guidance will be implemented over a one-year pilot phase, after which it will be revised as necessary. After a public consultation, the document will be finalized.
It is important to remember the definition of UL (the maximum chronic daily intake of a nutrient, from all sources, judged to be unlikely to pose a risk of adverse health effects to humans), and to underline that this value represents a threshold not to be exceeded, and that it cannot be understood as a maximum daily intake from a single source or food category.
On the basis of the ULs established by EFSA over its risk assessment, the Commission, which deals with risk management, will be able to set maximum doses of vitamins and minerals in fortified foods and food supplements.
Within this context, the European federation of associations of Health Products Manufacturers (EHPM) developed and proposed to the Commission a model to establish maximum and minimum daily doses of micronutrients in food supplements. Published on December 1, 2021, the EHPM proposal was submitted to DG SANTE later that month. The model was developed by a working group composed of experts and trade associations from several Member States; the work was based on recent scientific surveys, peer-reviewed sources, and risk management models. The paper considers all micronutrients currently allowed in food supplements, and focuses on two population subsets: children between 4 and 10 years of age on the one hand, and “adults”, 10 years and older, on the other (with the exception of the case of retinol, that has also a specific maximum dose for adolescents).
The proposed method, which only applies to those micronutrients for which adverse effects beyond a certain threshold of consumption exist, is simple; for each micronutrient:
Maximum amount = UL – intake observed at the 95° percentile
The value can be adjusted, by rounding the value to obtain “practical” reference doses, and by applying additional qualitative assessments (for those micronutrients with a higher risk). Micronutrients may be accompanied by additional consumer information.
The EHPM proposal also concerns minimum daily amounts, which are suggested as 15% of the nutritional reference value (NRV), with some exceptions.
The calculation proposed by EHPM does not mention the maximum and minimum quantities that could be attributed to fortified foods.
More details on the EHPM proposal are available in our dedicated article.
Germany, which has long been calling for a harmonization of values at the European level, has also provided the Commission with a proposal for a calculation methodology.
At the national level, the federal institute for risk assessment (Bundesinstitut für Risikobewertung, BfR), calculates the maximum levels of each nutrient basing on the UL and the 95th percentile intake, as does the EHPM. However, the value obtained, identified as “residual amount”, is not yet considered as a maximum daily dose for added vitamins and minerals. First, depending on its value, it will be either entirely allocated to the food supplement category, or, if possible, split among food supplements and fortified foods. Then, the maximum amount will be calculated for each of the two food categories by applying further transformations to the “residual amount”, such as by relating it to the average daily energy intake (for fortified foods), or by dividing it by an uncertainty factor usually equal to 2 (for food supplements).
The coming months will reveal whether the Commission will choose to rely on any of the methods we have outlined and, if so, which one will be chosen. We will keep you updated!
Orchidali accompanies you in the formulation of fortified foods and food supplements in line with European regulations.