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.
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
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
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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 .
Supplementary provisions
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.’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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