Gibberellins (GA4/GA7) renewed as a low-risk substance until 31 December 2040: ≥ 890 g/kg, fumonisins B1 + B2 ≤ 200 μg/kg in the technical material; EFSA: ADI and ARfD 0.33 mg/kg bw, no method for fumonisins in the formulation
Commission Implementing Regulation (EU) 2025/2272, published on 13 November 2025, renews the approval of gibberellins (GA4/GA7 mixture) as a low-risk active substance for the period from 1 January 2026 to 31 December 2040 and moves them from Part A to Part D of the Annex to Regulation (EU) No 540/2011. The Polish title of the act speaks of “approval” (“zatwierdzenia”), the English one of “renewing the approval”; Article 1 of both versions speaks of renewal.
- Specification (Annex I): CAS No GA4 468-44-0, GA7 510-75-8, GA4/GA7 mixture 8030-53-3, CIPAC No 904; purity ≥ 890 g/kg; relevant impurities — fumonisins B1 and B2, their sum must not exceed 200 μg/kg in the technical material. Recital 14: the previous restriction to use as a plant growth regulator is not maintained. Regulation (EU) 2025/787, which extended the approval to 31 October 2026, lists gibberellic acid and gibberellins as separate substances — gibberellic acid (GA3) was renewed by a separate Regulation (EU) 2025/2313.
- Course of the assessment: rapporteur Member State Slovenia, co-rapporteur Slovakia; draft report 26 April 2019; on 13 July 2020 EFSA requested information on endocrine-disrupting properties under the criteria of Regulation (EU) 2018/605; updated draft in April 2023; EFSA conclusions on 16 October 2024. In Polish recitals 4 and 16 the substance name has two typos (“gibeleriny”, “gibeleryn”).
- Data from the EFSA conclusions (e9066): the purity of 890 g/kg is the sum of GA4 and GA7, the specification was unified for three applicants; the 200 μg/kg limit for fumonisins was accepted because intake of gibberellins at the ADI keeps fumonisin intake below the group TDI of 1.0 μg/kg bw per day. ADI 0.33 mg/kg bw per day and ARfD 0.33 mg/kg bw (LOAEL 100 mg/kg bw from the rabbit developmental study, factor 100 plus an additional 3 for using a LOAEL); AOEL 0.09 mg/kg bw per day. In the previous 2012 conclusions an ARfD was considered not justified.
- Methods (e9066): GA4 and GA7 in the technical material and the formulation — HPLC-UV; relevant impurities in the technical material — methods available, in the formulation — data gap; GA4/GA7 in soil — LC-MS/MS with an LOQ of 0.01 mg/kg per analyte, in drinking and surface water — LC-MS/MS with LOQs of 0.1 and 10 μg/L. In residue trials on pome fruit results were below the LOQ of 0.05 mg/kg, but hydroxylated metabolites (GA1, GA2, GA8, GA34), their glucosides and epoxy metabolites were not analysed — for this reason the consumer risk assessment was not finalised. Representative use: plant growth regulator on apple and pear.