Iron hydroxide adipate tartrate: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Food supplements as defined in Directive 2002/46/EC for the adult population: ≤ 100 mg/day (≤ 30 mg Fe/day)
• Food supplements as defined in Directive 2002/46/EC for children and adolescents under 18 years of age, excluding children under 4 years of age: ≤ 50 mg/day (≤ 14 mg Fe/day)

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘iron hydroxide adipate tartrate (nano)’. The labelling of food supplements containing iron hydroxide adipate tartrate shall bear a statement that they should not be consumed by children and adolescents under the age of 18/children under 4 years of age (*) (*) Depending on the age group the food supplement is intended for.

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description/Definition:

Iron hydroxide adipate tartrate (IHAT) is an odourless, engineered nanomaterial in powder form that is insoluble in water and is manufactured by a chemical synthesis involving a series of steps involving acid-base reaction, precipitation, filtration, and drying.

The food supplements containing the novel food are manufactured in capsular form. Excess adipate, tartrate and sodium chloride are used at levels resulting from the production process to help stabilise IHAT and ensure the authorised particle size distribution. If other forms of food supplements (e.g. tablets, pastilles, sachets of powders, gummies, syrups, etc.) are used in combination with adipate, tartrate and sodium chloride or in combination with other substances, or if other substances are used in the capsular form food supplements containing the novel food, it must be ensured that the authorised IHAT particle size distribution is maintained.

Common name

Iron oxo-hydroxide adipate tartrate

Other names

Iron hydroxide adipate tartrate, Iron oxyhydroxide adipate tartrate

Trade name

IHAT

CAS number

2460638-28-0

Molecular formula

(calculated)

FeOm(OH)n(H2O)x(C4H6O6)y(C6H10O4)z

where: m and n are undefined as per accepted practice for ferric iron oxohydroxides (*1)

x = 0,28-0,88

y = 0,78-1,50

z = 0,04-0,19

Tartaric (C4H6O6) and adipic (C6H10O4) acid are represented in their protonated form.

Molecular weight

Average molecular weight: 35 803,4 Da (lower-upper bound: 27 670,5 -45 319,4 Da)

Characteristics/Composition:

Physical/chemical

Iron (% dry matter): 24,0-36,0

Adipate: (% dry matter): 1,5-4,5

Tartrate: (% dry matter): 28,0-40,0

Water content (%): 10,0-21,0

Sodium (% dry matter): 9,0-11,0

Chloride (% dry matter): 2,6-4,2

Phase distribution

Soluble (%): 2,0-4,0

Nano (%): 92,0-98,0

Micro (%): 0,0-3,0

Primary particle size

Median diameter (20): 1,5-2,3 nm

Mean diameter (20): 1,8-2,8 nm

Dv(10) (21): 1,5-2,5 nm

Dv(50) (21): 2,5-3,5 nm

Dv(90) (21): 5,0-6,0 nm

Heavy metals

Arsenic: < 0,80 mg/kg

Nickel: < 50,0 mg/kg

Residual solvents

Ethanol: < 500 mg/kg

Microbiological criteria

Total aerobic microbial count: < 10 CFU/g

Total yeast and mould count: < 10 CFU/g

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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