The Health and Safety Executive (HSE) has approved the herbicidal active substance Bixlozone for use in Great Britain (GB). This approval marks a significant step in the regulation of plant protection products, which are governed under assimilated Regulation No 1107/2009.
Applicant and Substance Details
FMC Corporation, operating as FMC Chemical sprl, submitted the application for Bixlozone, a new active substance designed to control a variety of broadleaf and grass weeds in crops such as cereals, oilseed rape, and maize.
Regulatory Process and Conclusion
The HSE undertook a thorough assessment of Bixlozone against the approval criteria set out in assimilated Regulation No 1107/2009. The evaluation process included the preparation of a draft assessment report (DAR), which was subsequently reviewed by the UK Expert Committee on Pesticides (ECP) in a series of meetings between July and December 2022. Following public consultation on the DAR from March to May 2023, HSE incorporated additional data and feedback, culminating in a 'Conclusion of the Authority' document.
The conclusion, now published on HSE's website, indicates that Bixlozone meets the necessary approval criteria. The assessment demonstrated that Bixlozone is not classified as a mutagen, carcinogen, or toxic to reproduction and does not possess endocrine-disrupting properties.
Safety and Environmental Impact
HSE's extensive evaluation of Bixlozone included a thorough review of its safety profile and potential environmental impact:
- Human Health Hazard:
- Absorption, Distribution, and Excretion: Bixlozone is rapidly absorbed from the gastrointestinal tract, with no evidence of accumulation in organs or tissues. It is extensively metabolized and primarily excreted via urine.
- Acute Toxicity: Studies indicate that Bixlozone is not acutely toxic by oral, dermal, or inhalation routes. It is neither a skin nor an eye irritant, nor a skin sensitizer.
- Repeated-Dose Toxicity: The target organs identified in toxicity studies were the liver and kidney. The most relevant No-Observed-Adverse-Effect Level (NOAEL) was 29 mg/kg bw/day.
- Genotoxicity and Carcinogenicity: Bixlozone is not genotoxic or carcinogenic. The lowest relevant NOAEL for carcinogenicity was 167 mg/kg bw/day.
- Reproductive and Developmental Toxicity: No effects on fertility, reproductive performance, or specific developmental effects were observed up to doses causing generalized toxicity.
- Environmental Fate and Behaviour:
- Persistence and Bioaccumulation: Bixlozone is not classified as a persistent organic pollutant (POP), a persistent, bioaccumulative, and toxic (PBT) substance, or a very persistent and very bioaccumulative (vPvB) substance.
- Ecotoxicology: The substance has no unacceptable effects on non-target species or the environment, including air, soil, and water.
- Residues:
- The residues of Bixlozone have no harmful effects on human health or groundwater. Suitable methods are available to measure residues in food, feed, soil, water, and air.
Government Decision
HSE referred its conclusion and the intended decision to GB governments, in accordance with the Agency Agreements. The GB governments have approved Bixlozone as a candidate for substitution, allowing its inclusion in plant protection products within GB. This decision is based on the comprehensive evaluation that demonstrated Bixlozone's compliance with the criteria for approval.
Listing and Authorisation
Following this decision, Bixlozone is now listed in the GB Pesticides Approvals Register. Plant protection products containing Bixlozone can be authorised for use in GB, adhering to the requirements of assimilated Regulation No 1107/2009.
Further Information
Detailed technical information about Bixlozone, including its identity and reference values, is available in the published HSE conclusion. This includes comprehensive data on the substance's efficacy, safety, and environmental impact.
The approval of Bixlozone represents a significant development in the regulation of herbicidal substances in GB, promising enhanced control of weed populations in key agricultural crops while maintaining stringent safety and environmental standards.
