#32026R0747Commission Implementing Regulation (EU) 2026/747 approving the active substance bixlozone and amending Regulation (EU) No 540/2011
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This regulation formally approves bixlozone as an active substance for use in plant protection products across the EU. It sets a minimum purity of 960 g/kg and limits the impurity TBAB to a maximum of 2 g/kg. Approval is valid for 10 years from 21 April 2026 until 21 April 2036. The approval is conditional on the submission of confirmatory data by 21 April 2028 regarding technical specification, impurity relevance, metabolite toxicity, natural occurrence, livestock relevance, and drinking water treatment effects. Member States must pay special attention to consumer risk from succeeding crops, protection of aquatic organisms, non-target plants, and unacceptable co-formulants.
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Key Changes
- Approves bixlozone with minimum purity ≥ 960 g/kg and maximum TBAB impurity of 2 g/kg
- Approval period: 21 April 2026 to 21 April 2036 (10 years)
- Requires submission of 5 specific confirmatory information packages by 21 April 2028
+ 3 more changes with Pro
Obligations
What this law requires
Applicant must submit confirmatory information regarding the technical specification of bixlozone as manufactured based on commercial scale production, the relevance of impurities, and compliance of toxicity batches with confirmed technical specification by 21 April 2028
Applicant must submit confirmatory information on natural occurrence of 2,2-dimethyl-3-OH-propionic acid and dimethylmalonic acid by 21 April 2028
Applicant must submit data on genotoxic and general toxicity potential of specified metabolites (dimethylmalonic acid, 2,2-dimethyl-3-OH-propionic acid, F9600-dimethyl-malonamide, F9600-hydroxy-isobutyramide, and F9600-3-OH-propanamide) by 21 April 2028
Applicant must submit confirmatory information on relevance of livestock metabolites (dimethylmalonic acid, F9600-dimethyl-malonamide, and F9600-3-OH-propanamide) by 21 April 2028
Bixlozone active substance must maintain minimum purity of 960 g/kg and impurity TBAB shall not exceed 2 g/kg in technical material