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Iron hydroxide adipate tartrate authorized as a novel food

European Union

Aug 10, 2022

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.

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.

 

 

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)

 

 

For further information (in English), click on the Link

 

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