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

Approval of the active substance

Article 1

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

Amendments to Implementing Regulation (EU) No 540/2011

Article 2

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

Entry into force

Article 3

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

ANNEX ISupplementary provisions

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 IISupplementary provisions

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.’