Commission Implementing Regulation (EU) 2025/1530 of 30 July 2025 authorising the placing on the market of potassium magnesium trichloride hexahydrate as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2025/1530
• Articles: 5

Article 1

1.   Potassium magnesium trichloride hexahydrate is authorised to be placed on the market within the Union.

Potassium magnesium trichloride hexahydrate 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 BK Giulini GmbH, member of ICL Group  ( 8 ) , is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 20 August 2025, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific studies and data protected pursuant to Article 3 or with the agreement of BK Giulini GmbH, member of ICL Group.

Article 3

The scientific studies and 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 five years from the date of entry into force of this Regulation without the agreement of BK Giulini GmbH, member of ICL Group.

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 in alphabetical order:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

‘ Potassium magnesium trichloride hexahydrate

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘potassium magnesium mineral salt’.

2.

Where the addition of the novel food to a final product result in an amount of potassium and/or magnesium that is considered significant in accordance with Point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011, the nutrition declaration shall contain the amount of potassium and/or magnesium.

Authorised on 20 August 2025.

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

Applicant: BK Giulini, GmbH, member of ICL Group, Am Hafen 2, 68526 Ladenburg, Germany.

During the period of data protection, the novel food potassium magnesium trichloride hexahydrate is authorised for placing on the market within the Union only by BK Giulini GmbH, member of ICL Group, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of BK Giulini GmbH, member of ICL Group.

End date of the data protection: 20 August 2030’

Raw cured (or seasoned) meat

1 050  mg/100  g

Cooked cured (or seasoned) meat

700  mg/100  g

Cereal-based dishes

600  mg/100  g

Preserved or partly preserved sausages

1 050  mg/100  g

(2)

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

Authorised Novel Food

Specifications

‘ Potassium magnesium trichloride hexahydrate

Description / Definition:

The novel food is a mineral salt, which mainly consists of potassium magnesium trichloride hexahydrate. It is a white, off-white crystalline, fine granular, slightly hygroscopic product with a characteristic saline taste. It is produced by a multi-step crystallisation process of seawater from the Dead Sea by solar evaporation.

Synonym:

Potassium magnesium chloride hydrate, carnallite.

Identity:

Positive by X-ray diffraction

Characteristics:

Melting point (range): 149,6 – 160,2 °C

Solubility:

—

pH 1,94: 4,13 and 6,80: freely soluble

—

pH 8,06: slightly soluble

—

Insoluble parts: ≤ 0,3 % (w/w)

Water at 180 °C (water of crystallisation plus moisture): 32 %–40 %

Main constituents:

Chloride: 40 % – 42 % (w/w)

Potassium: 11,0 % – 13,6 % (w/w)

Magnesium: 7,9 % – 8,9 % (w/w)

Calcium: ≤ 0,2 % (w/w)

Sodium: ≤ 2,75 % (w/w)

Heavy metals:

Arsenic < 0,1 mg/kg

Cadmium < 0,1 mg/kg

Mercury < 0,05 mg/kg

Lead < 0,1 mg/kg

Trace elements:

Bromide: ≤ 0,40 % (w/w)

Strontium: ≤ 25 mg/kg

Manganese: ≤ 3,0 mg/kg

Iron: ≤ 4,0 mg/kg

Copper: ≤ 0,5 mg/kg

Boron: ≤ 10 mg/kg

Aluminium: ≤ 1,0 mg/kg

Total phosphorous: ≤ 5 mg/kg

Sulfate: < 500 mg/kg

Nitrite: < 10 mg/kg

Nitrate: < 400 mg/kg

Chlorate: < 0,2 mg/kg

Bromate: < 1 mg/kg

Fluoride: ≤ 5 mg/kg

Iodine: < 0,1 mg/kg

Microbiological parameters:

Total plate count: < 100 CFU/g

E. coli : not detected in 1 g

Salmonella : not detected in 25 g

Salt-tolerant microorganisms: < 100 CFU/g

Sum parameters:

Total organic carbon: < 0,10 % (w/w)

CFU: colony forming units’