New Authorization of Use of Iron Hydroxide Adipate Tartrate in Food Supplements
The evolution of European regulations in the field of food supplements has recently introduced significant changes regarding the use of Iron Hydroxide Adipate Tartrate. On January 17, 2024, the European Commission published Regulation (EU) 2024/248, which amends Annex II of Directive 2002/46/EC of the European Parliament and of the Council. These changes allow the inclusion of Iron Hydroxide Adipate Tartrate in the list of permitted ingredients for the production of food supplements.
The use of Iron Hydroxide Adipate Tartrate was authorized in September 2022 as a new food ingredient, according to Implementing Regulation (EU) 2022/13731. However, the recent Regulation (EU) 2024/248 establishes binding conditions for the use of this substance in products intended for human consumption.
Iron Hydroxide Adipate Tartrate, an engineered material at the nanometric level, has been designated exclusively for use in food supplements. Directives regarding the conditions of use and technical specifications related to this compound were not directly included in Directive 2002/46/EC. For detailed information on use and technical specifications, refer to Implementing Regulation (EU) 2022/1373 or the Union List of Novel Foods (reg.). (EU) 2017/24702).
The conditions of use established for Iron Hydroxide Adipate Tartrate include maximum daily dosages for different age groups. For the adult population, the maximum allowed dose is 100 mg/day, corresponding to 30 mg of iron per day. The maximum amount of iron allowed per day for children and adolescents aged 4 to 18 is 50 mg. This corresponds to 14 mg of iron per day.
It is important to note that the labeling of food products containing Iron Hydroxide Adipate Tartrate must include the designation “iron hydroxide adipate tartrate (nano)” to indicate its nanometric nature.
Furthermore, based on the concentration of Iron Hydroxide Adipate Tartrate present in the product and the age group for which the food supplement is intended, the label must provide clear indications regarding consumption, discouraging use by children and adolescents under 18 years of age or 4 years old, depending on the specific concentration of the compound.
It should be emphasized that the authorization for placing Iron Hydroxide Adipate Tartrate on the market is tied to the first applicant, who has the exclusive right to market and distribute this ingredient. This implies that only the first applicant has the right to market and distribute Iron Hydroxide Adipate Tartrate.
In conclusion, the addition of Iron Hydroxide Adipate Tartrate as an authorized ingredient in food supplements represents an important regulatory evolution. However, it is crucial for manufacturers and consumers to fully understand the implications of these regulatory changes and adhere scrupulously to the directives established to ensure the safety and compliance of products intended for human consumption.
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