Paraffin oil (CAS 8042-47-5) renewed until 30 June 2041: PAHs ≤ 0.3 mg/kg in the technical material, by 12 May 2027 data from validated methods for PAH4 and PAH8, and in the consumer risk assessment — compliance with the MOAH limits
Commission Implementing Regulation (EU) 2026/870, published on 22 April 2026, renews the approval of paraffin oil (CAS No 8042-47-5, CIPAC No 898, “Paraffinum Perliquidum” according to the European Pharmacopoeia) as an active substance in plant protection products for the period from 1 July 2026 to 30 June 2041. It introduces a limit for polycyclic aromatic hydrocarbons (PAHs) in the technical material and requires confirmatory data.
- Specification (Annex I): white mineral oil (petroleum), purity 1 000 g/kg; PAH contamination must not exceed 0.3 mg/kg in the technical material in accordance with the European Pharmacopoeia. The substance moves from Part A to Part B of the Annex to Regulation (EU) No 540/2011 (entry 180). Recital 12: the previous restriction to use as an insecticide and acaricide is not maintained.
- Confirmatory data by 12 May 2027: the applicant must demonstrate compliance of technical-grade paraffin oil with the 0.3 mg/kg limit for PAH4 (benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene, chrysene) and PAH8 — using validated analytical methods for these PAHs in the technical paraffin oil and in the formulations — and complete the consumer risk assessment in which exposure to PAH residues is estimated with an approach based on the application rate and yield.
- In their overall assessment Member States pay particular attention to the consumer risk, in particular compliance with the maximum levels for the sum of mineral oil aromatic hydrocarbons (MOAH), and to the protection of aquatic organisms, off-field non-target arthropods and bees. The act cites the EFSA conclusions of 1 July 2024 and their updated version of 17 June 2025; the data below come from the 2024 version (e8913), the updated version was not read.
- Data from the EFSA conclusions (e8913, chain lengths C17–C31): PAHs were considered relevant impurities because of their genotoxic and carcinogenic properties; the European Pharmacopoeia 6.0 gives no numerical threshold for PAH content and no batch data demonstrating 0.3 mg/kg were submitted — EFSA set a data gap (batch data and a validated method for PAHs), with which the rapporteur Member State (Greece) disagreed. For the substance itself no consumer risk assessment was needed (low toxicity); for some representative uses a high risk was indicated for aquatic organisms, bees and arthropods, and in the risk assessment for soil organisms a high risk for earthworms (NEU 1130 I EW in fruiting vegetables) and the springtail Folsomia candida (BCP405D/CCL742 in potatoes).