Chemical name: O,S-dimethyl phosphoramidothioate Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: All applications as plant protection products. Not relevant Use or uses that remain allowed: Not relevant Pesticide use or uses that remain allowed: EU Member States may have granted a period of grace for disposal, storage, placing on the market and use of existing stocks, no longer than 18 months from the date of adoption of Commission Decision 2002/479/EC of 20/06/2002 (i.e. until 20/12/2003). The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: It is prohibited to place on the market or use plant protection products containing Fentin Hydroxide. Fentin Hydroxide has not been included as an active ingredient in Annex I to Directive 91/414/EEC. The authorisations for plant protection products containing Fentin Hydroxide had to be withdrawn within a period of 6 months from the date of adoption of Commission Decision 2002/479/EC. From that date, no authorisations for plant protection products containing Fentin Hydroxide can be granted or renewed. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: - Medical data: Some irritant effects reported in manufacturing plant personnel, pesticide operators and bystanders. - Summary: - ADI: 0.0004 mg/kg/bw (based on rat, 2 years, carcinogenicity, safety factor 1000) - Systemic AOEL: 0.0002 mg/kg/bw/d (based on rabbit, maternal effects in developmental toxicity study, safety factor 100, with correction for 21% oral absorption). - ARfD (acute reference dose): 0.001 mg/kg bw/d (based on rabbit, maternal effects in developmental toxicity study, safety factor 100, with correction for 21% oral absorption). - Dermal absorption: 4% per day Areas of concern: 1. Wide spectrum of significant toxic effects of the substance. 2. AOEL exceeded for operators (with full Personal Protective Equipment) during tractor application (boom sprayer) and for bystanders (in worst case situation, at 8 m distance from a boom sprayer). Expected effect of the final regulatory action in relation to human health: Complete risk reduction for plant protection use. Summary of known hazards and risks to the environment: Final regulatory action was taken with regard to the fate and behaviour of the substance in the environment and its possible impact on non-target organisms. Areas of concern: 1. Long-term risk to birds. 2. Acute and chronic risk to aquatic organisms. 3. Risk to non-target arthropods and earthworms. 4. Possible accumulation in non-target species. Expected effect of the final regulatory action in relation to the environment: Complete risk reduction for plant protection uses. Date of entry into force of the final regulatory action: 20/12/2002 (Authorisations for plant protection products containing Fentin Hydroxide have to be withdrawn within a period of 6 months from the date of the final regulatory action). |