Gibberellic acid (GA3) renewed as a low-risk active substance from 1 January 2026 to 31 December 2040: purity ≥ 850 g/kg and a new limit for the sum of fumonisins B1 + B2 of up to 200 µg/kg in the technical material; EFSA — HPLC-UV for the substance, LC-MS/MS in water with an LOQ of 0.1 µg/L, ADI 0.23 instead of 0.68 mg/kg bw
Commission Implementing Regulation (EU) 2025/2313, published on 18 November 2025, renews the approval of gibberellic acid and moves it to Part D of the list — low-risk active substances. The rapporteur was Slovenia, the co-rapporteur Slovakia, and the EFSA conclusions were sent to the Commission on 16 October 2024. The act lifts the restriction to use as a plant growth regulator only and requires particular attention to the protection of non-target terrestrial plants outside the field. It applies from 1 January 2026.
- Annex: gibberellic acid, CAS No 77-06-5, CIPAC No 307, purity ≥ 850 g/kg; relevant impurities — fumonisins B1 and B2, the sum must not exceed 200 µg/kg in the technical material. According to EFSA this is new in the renewal specification (fumonisins were not listed before), and the 200 µg/kg limit is in line with Regulation (EC) No 1881/2006 and, at intake at the ADI level, results in fumonisin exposure below the group TDI of 1.0 µg/kg bw per day. For one other impurity QSAR alerts were identified and its relevance was not concluded.
- Methods (EFSA): HPLC-UV for the determination of gibberellic acid in the technical material and in the formulation; methods for the relevant impurities exist for the technical material but not for the formulation (data gap). Soil: LC-MS/MS with an LOQ of 0.01 mg/kg, but no monitoring method is needed because the DT90 is below 3 days. Drinking and surface water: LC-MS/MS with an LOQ of 0.1 µg/L. Gaps: methods for air and for body fluids and tissues; a method for food of plant origin depends on the final residue definition, and for food of animal origin none is required because no MRLs are proposed.
- EFSA reference values: ADI 0.23 mg/kg bw per day (previously 0.68), ARfD 0.78 mg/kg bw (previously considered unnecessary), AOEL and AAOEL 0.23 mg/kg bw — all from the offspring LOAEL of 233 mg/kg bw per day in the two-generation rat study (increased incidence of omphalocele), with additional factors of 10 or 3. There were no long-term and carcinogenicity studies — they were waived because the substance has low toxicity, is unlikely to be genotoxic and occurs naturally in the diet. Dermal absorption 2.2 %.
- Representative use: spraying of seedless grapes in southern EU (cluster stretching, berry thinning and berry sizing) with the product ‘Progibb 40 SG’ (400 g/kg). What EFSA did not finalise: the consumer risk assessment (no guideline-compliant plant metabolism studies, also the effect of water treatment), the route of degradation in soil and groundwater exposure to metabolite AS7, and the risk to soil microorganisms and non-target plants. Gibberellic acid does not meet criteria I–III for inclusion in Annex IV to Regulation 396/2005, and criteria IV and V could not be evaluated for lack of data. It is unlikely to meet the criteria for endocrine disruption.