Commission Implementing Regulation (EU) 2025/845 of 5 May 2025 approving the active substance elemental iron as a low-risk active substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011

• CELEX: Implementing Regulation (EU) 2025/845
• Articles: 5

Article 1 Approval of the active substance

The active substance elemental iron, as specified in Annex I, is approved, subject to the conditions laid down in that Annex.

Article 2 Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3 Entry into force

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 I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Elemental iron

CAS No: 7439-89-6

CIPAC No: -

Iron

≥ 989 g/kg of total iron

The following impurities are of toxicological concern and shall not exceed the following levels in the technical material:

Arsenic: Max 0,003 g/kg

Mercury: Max 0,001 g/kg

Lead: Max 0,01 g/kg

26.5.2025

26.5.2040

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on elemental iron, and in particular Appendices I and II thereto, shall be taken into account.

Conditions of use shall include risk mitigation measures, where appropriate.

( 1 )   Further details on identity and specification of active substance are provided in the review report.

ANNEX II

ANNEX II

In Part D of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

No

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘52

Elemental iron

CAS No: 7439-89-6

CIPAC No: -

Iron

≥ 989 g/kg of total iron

The following impurities are of toxicological concern and shall not exceed the following levels in the technical material:

Arsenic: Max 0,003 g/kg

Mercury: Max 0,001 g/kg

Lead: Max 0,01 g/kg

26.5.2025

26.5.2040

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on elemental iron, and in particular Appendices I and II thereto, shall be taken into account.

Conditions of use shall include risk mitigation measures, where appropriate.

( 1 )   Further details on identity and specification of active substance are provided in the review report.’