Rape seed oil renewed as a low-risk active substance until 31 October 2040: specification based on fatty acid composition, erucic acid ≤ 2 %, purity according to the European Pharmacopoeia; EFSA received no information on whether the oil is of food grade quality
Commission Implementing Regulation (EU) 2025/1879, published on 17 September 2025, renews the approval of rape seed oil as a low-risk active substance for the period from 1 November 2025 to 31 October 2040 and moves it from Part A to Part D of the Annex to Regulation (EU) No 540/2011. The EFSA conclusions were sent to the Commission on 4 April 2022 and the draft regulation to the Standing Committee on 9 December 2022.
- Specification (Annex I): CAS No 8002-13-9 (rape seed oil) and 93165-31-2 (low erucic acid rape seed oil), no CIPAC No; purity in line with the European Pharmacopoeia 7.0 and the Deutscher Arzneimittel-Codex 1986, 6. Erg. 1994 and Ph. Eur. 5, 2005. The substance is a mixture of fatty acid triglycerides acting mechanically rather than chemically, so 100 % of the technical material is considered the active substance; the specifications are based on the fatty acid composition and certain physical and chemical parameters, and erucic acid contamination should not exceed 2 %.
- Conditions: Member States pay particular attention to the protection of aquatic organisms, honey bees and non-target arthropods and apply risk mitigation where appropriate. The assessment was prepared by the Netherlands (rapporteur) and Finland (co-rapporteur), the draft report was submitted on 24 March 2020; the approval had been extended by Regulation (EU) 2024/2221 to 31 March 2026, but the renewal applies from 1 November 2025.
- Data from the EFSA conclusions (e7305): the oil is obtained from seeds of rape (Brassica napus and Brassica rapa) containing less than 5 % erucic acid; the representative formulation “NEU 1160 I” is an emulsifiable concentrate with 883 g/L of oil; uses — acaricide on pome fruit, berries, vegetables and ornamentals and insecticide against Colorado beetle on potatoes. Erucic acid is a natural constituent of the oil legally permitted up to 20.0 g/kg; according to EFSA the uses do not lead to an exceedance of the TDI for erucic acid. As rape seed oil is a food item, a conventional consumer risk assessment was not considered necessary, but no information was provided on whether the substance is of food grade quality.
- Methods and gaps (e7305): methods for the substance in the technical material and the formulation are available; methods for residues in food, feed, body fluids and tissues or the environment were not required as no residue definitions were set. A data gap was identified: no validated method for determining the rate of chemical degradation of the oil in aerobic soil (the study was nevertheless accepted, noting that the DT50 could have been shorter), and no PECgw calculations for the Châteaudun scenario with FOCUS MACRO. A high risk was indicated for bees, other arthropods and soil macroorganisms other than earthworms for some uses.