No MRLs: the granulovirus Betabaculovirus phoperculellae and elemental iron entered in Annex IV to Regulation 396/2005 instead of the default 0.01 mg/kg, rape seed oil stays there permanently
Commission Regulation (EU) 2025/2473, published on 8 December 2025, enters in Annex IV to Regulation (EC) No 396/2005 (substances for which no MRLs are required) two low-risk active substances: Betabaculovirus phoperculellae — a granulovirus controlling Phthorimaea operculella larvae — and elemental iron (a molluscicide). Until now the default value of 0.01 mg/kg under Article 18(1)(b) applied to them. Rape seed oil, included in Annex IV temporarily, stays there without the footnote on temporary inclusion.
- For residue monitoring laboratories this means that there is no MRL against which results for these three substances are compared. For iron, EFSA stated explicitly that methods for residues in plants, food of animal origin and the environment are not required, because no residue definitions for monitoring were proposed.
- Virus (EFSA conclusion e8976, rapporteur Member State the Netherlands): representative product TUTAVIR — a suspension of isolate PhopGV V65 containing 2 × 10¹³–1 × 10¹⁴ occlusion bodies (OB) per litre, determined by bioassay; of the five Annex IV criteria EFSA considered criterion III met — no known hazardous properties. Contaminants of the product include Bacillus cereus — a calculation showed it will not exceed the threshold of 10⁵ CFU/g on crops.
- Iron (EFSA conclusion e9056, rapporteur Member State Austria): representative bait Final Bite® with 10 g/kg total iron. The minimum purity of 989 g/kg corresponds to total iron because the batches were analysed with a non-specific method — EFSA set a data gap: no determinations of elemental iron with a specific method in at least five batches. Relevant impurities: arsenic ≤ 0.003 g/kg, mercury ≤ 0.001 g/kg, lead ≤ 0.01 g/kg. Criterion IV is met — natural exposure of plants via soil is higher than from the use as a plant protection product.
- Rape seed oil (EFSA conclusion e7305 of 2022): a mixture of triglycerides from seeds of Brassica napus and B. rapa containing less than 5 % erucic acid; the representative product NEU 1160 I contains 883 g/L of oil; uses as an acaricide and insecticide; two Annex IV criteria are met. According to recital 4 of the act, exposure from its use as a plant protection product will not be higher than exposure via food.