Elemental iron approved as a low-risk active substance until 26 May 2040: ≥ 989 g/kg total iron, arsenic ≤ 0.003, mercury ≤ 0.001 and lead ≤ 0.01 g/kg; EFSA: no specific method for elemental iron, so purity refers to total iron
Commission Implementing Regulation (EU) 2025/845, published on 6 May 2025, approves elemental iron (CAS No 7439-89-6) as a low-risk active substance in plant protection products for the period from 26 May 2025 to 26 May 2040 and adds it to Part D of the Annex to Regulation (EU) No 540/2011 as entry 52. It is based on the EFSA conclusions of 2 October 2024.
- Specification (Annex I): iron ≥ 989 g/kg total iron; impurities of toxicological concern in the technical material — arsenic max. 0.003 g/kg, mercury max. 0.001 g/kg, lead max. 0.01 g/kg; no CIPAC No. Risk mitigation measures are applied in the conditions of use where appropriate. Recital 10: the substance is not a substance of concern and meets the conditions of point 5 of Annex II to Regulation (EC) No 1107/2009.
- Course: the draft assessment report was submitted on 2 July 2021, the updated one on 25 April 2022 after additional information; EFSA conclusions — 2 October 2024; the review report went to the Standing Committee on 4 December 2024 and the draft regulation on 11 March 2025. According to EFSA the rapporteur Member State was Austria and the application was submitted on 28 June 2018 by ADAMA Agriculture B.V.
- Analytics according to EFSA (e9056): the minimum purity of 989 g/kg was proposed on the basis of industrial-scale batches, but since a method non-specific for elemental iron was used, it corresponds to total iron — hence a data gap: elemental iron content in at least five batches determined with a specific method; no specific methods exist for the formulation either. Methods for arsenic, mercury and lead in the technical material and the formulation are available; residue methods for plants, food of animal origin, the environment and body fluids were not required because no residue definitions for monitoring were proposed.
- Other EFSA findings: representative use — molluscicide granules spread in the field and under protection on all edible and non-edible crops, ornamentals and amenity grassland; the toxicological assessment relied mainly on literature, data on iron as a food supplement in humans and data on related compounds (ferric phosphate, ferric pyrophosphate, ferrous sulfate). The identity of one co-formulant in the formulation also remained a data gap.