Chemical name: Phosphoramidothioic acid, acetyl-, O,S-dimethyl ester 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. Pesticide use or uses that remain allowed: EC 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 2003/219/EC (i.e. until 24/09/2004). 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 acephate. Acephate is not included as an authorised active ingredient in Annex I to Directive 91/414/EEC. The authorisations for plant protection products containing acephate had to be withdrawn within a period of 6 months from the date of adoption of the Commission Decision 2003/219/EC. From that date, no authorisations for plant protection products containing acephate could 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: Final regulatory action was taken to protect consumers exposed to potential residues resulting from the use of these plant protection products. Maximum Residue Limits were proposed for the intended uses within the European Community (ppm): apples/pears: 3; artichoke: 0.2; bean: 3; cauliflower/broccoli: 2, leeks: 1.Having regard to the defined ARfD, under the proposed conditions of use, the safety of consumers potentially exposed to acephate was not satisfactorily demonstrated. There were also concerns about operators applying plant protection products containing acephate.Exposure scenarios were performed for the proposed uses within the European Community in order to ensure the estimated exposure would not exceed the acceptable operator exposure level (AOEL). An acceptable exposure to acephate formulations was obtained only with the German model, when Personal Protective Equipment (PPE), i.e. gloves, hat, mask and standard protective garment, is worn, while the safety limit is exceeded, even if PPE is worn, when the exposure estimates are performed with the UK POEM model.However no further evaluation was performed as it was already demonstrated that the use of acephate was not safe for consumers, which was sufficient grounds to take the final regulatory action.
Expected effect of the final regulatory action in relation to human health: Complete reduction of risk from plant protection uses. Summary of known hazards and risks to the environment: Final regulatory action was taken to protect non-target organisms. Concerns were identified with regards to non-target organisms, in particular non-target arthropods, birds and mammals, as well as aquatic organisms. ·Birds and mammals: The risk evaluation was performed using an application rate of 1.2 kg a.s./ha. The acute risk was unacceptable for birds eating small insects/seed and herbivorous mammals. A long-term risk was also identified for birds eating small insects/seed and birds eating leaves as well as for herbivorous mammals, with toxicity/exposure ratio well below the trigger value set by the European community. ·Aquatic species: The risk evaluation was performed using an application rate of 1.0 kg a.s./ha. The risk was found acceptable for aquatic species using a scenario with 20% drift and a buffer zone of 5 m from the water body. An unacceptable risk was identified for invertebrates (daphnia, brown shrimp) when an aerial application of acephate formulation is performed (100 % drift).·Honeybees: no risk was identified for bees at applications rates up to 1.2 kg a.s./ha.
Other arthropods: Application rates ranging from 1 to 3 kg a.s./ha produced 98 - 100 % mortality (laboratory test) in Typhlodromus pyri, Orius insidiosus, Aphidius rhodalopsi, Poecilus cupreus and Coccinella septenpuncta. This risk was not acceptable. ·Earthworms: no risk was identified for earthworms at applications rates up to 1.0 kg a.s./ha.
Soil micro-organisms: no effect of 75% SP formulation tested two times at 2.5 kg/ha at 10 intervals. Expected effect of the final regulatory action in relation to the environment: Complete reduction of risk from plant protection uses. Date of entry into force of the final regulatory action: 24/09/2003 Authorisations for plant protection products containing acephate had to be withdrawn within a period of six months from the date of adoption of the final regulatory action. |