Commission Implementing Regulation (EU) 2022/1373 of 5 August 2022 authorising the placing on the market of iron hydroxide adipate tartrate as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/1373
• Articles: 5

Article 1

1.   Iron hydroxide adipate tartrate is authorised to be placed on the market within the Union.

Iron hydroxide adipate tartrate shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

2.   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Only the company ‘Nemysis Limited’  ( 10 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 28 August 2022, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of ‘Nemysis Limited’.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of ‘Nemysis Limited’.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data Protection

‘ Iron hydroxide adipate tartrate

Specified food category

Maximum levels

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.

Authorised on 28.8.2022. This inclusion is based on proprietary scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Nemysis Limited, Suite 4.01 Ormond Building 31-36 Ormond Quay Upper Arran Quay Dublin 7, D07 F6DC, Dublin, Ireland. During the period of data protection, the novel food iron hydroxide adipate tartrate is authorised for placing on the market within the Union only by Nemysis Limited, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Nemysis Limited.

End date of the data protection: 28.8.2027.’

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)

(2)

in Table 2 (Specifications), the following entry is inserted:

Authorised novel food

Specification

‘ Iron hydroxide adipate tartrate

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)

FeO m (OH) n (H 2 O) x (C 4 H 6 O 6 ) y (C 6 H 10 O 4 ) 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 (C 4 H 6 O 6 ) and adipic (C 6 H 10 O 4 ) 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  ( 1 ) : 1,5-2,3 nm

Mean diameter  ( 1 ) : 1,8-2,8 nm

Dv(10)  ( 2 ) : 1,5-2,5 nm

Dv(50)  ( 2 ) : 2,5-3,5 nm

Dv(90)  ( 2 ) : 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

( *1 )   Cornell RM and Schwertmann U, 2003. The Iron Oxides: Structure, Properties, Reactions, Occurrences and Uses. 2nd Edition. Wiley. https://doi.org/10.1002/3527602097

( 1 )   Number-based (by Transmission Electron Microscopy (TEM)).

( 2 )   Volume-based (hydrodynamic diameter by Dynamic Light Scattering (DLS)); CFU: Colony Forming Units.’