Chemical name: Phosphorothioic acid, O,O-dimethyl O-[3-methyl-4-(methylthio)phenyl] ester Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Severely Restricted Use or uses prohibited by the final regulatory action: All applications of plant protection products containing fenthion, except the essential uses listed below. Pesticide use or uses that remain allowed: Authorisations for essential uses may be maintained until 30 June 2007 by the EC Member States indicated, provided that they: (a) ensure that such plant protection products remaining on the market are relabeled in order to match the restricted use conditions; (b) impose all appropriate risk mitigation measures to reduce any possible risks in order to ensure the protection of human and animal health and the environment; and (c) ensure that alternative products or methods for such uses are being seriously sought, in particular, by means of action plans. For all non-essential uses, for which existing authorisations had to be withdrawn by 11 August 2004, the EC Member States may grant a period of grace for disposal, storage, placing on the market and use of existing stocks that must expire no later than 11 August 2005. For essential uses that can continue to be authorised until 30 June 2007, the grace period for disposal, etc of existing stocks is 6 months (i.e., up to 31 December 2007). List of essential uses that may continue to be authorised Member States Use Spain Bait application in citrus and peaches Greece Bait application in olives Italy Bait application in olives Portugal Bait application in citrus and olives Cyprus* Bait application in citrus and olives * As provided for in Commission Regulation 1335/2005 amending Decision 2004/140/EC. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: Fenthion is not included in the list of authorised active ingredients in Annex I to Directive 91/414/EEC. The authorisations for plant protection products containing fenthion had to be withdrawn by 11 August 2004. From 17 February 2004 no authorisations for plant protection products containing fenthion could be granted or renewed. For certain essential uses for specific Member States listed in the Annex to Commission Decision 2004/140/EC a prolonged period of withdrawal may be allowed until 30 June 2007 under specific conditions (see point 2.5.2). The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: The final regulatory action was taken in order to protect the environment. However, fenthion is considered harmful owing to its acute oral toxicity value LD50 in rats being within the range 343-556 mg/kg bw. Results of the evaluation indicated a high risk to operators when applying fenthion. Based on an assessment using the German operator exposure model, this risk can be reduced to an acceptable level if personal protective equipment is worn during mixing/loading and application of the substance for the representative uses that were evaluated. However, it should be noted that missing or inappropriate personal protective equipment in violation of the product label and uses other than those evaluated might pose considerably higher risks to operators. Expected effect of the final regulatory action in relation to human health: Reduction of risk from plant protection products. Summary of known hazards and risks to the environment: The risk evaluation carried out by the Member States identified a high risk to birds by application of fenthion in orchards (citrus, olives, cherries, peaches). These concerns were confirmed by the Scientific Committee on Plants, which concluded that risks to birds from the proposed uses of fenthion are very uncertain. Therefore, the risks to birds could not be excluded and consequently no acceptable use of fenthion was identified. The risks to other relevant species (mammals, non-target arthropods, earthworms, aquatic organisms) were considered acceptable for the proposed uses, i.e. spot application of bait formulation in olives and citrus. However, it should be noted that fenthion is highly toxic to bees and risk mitigation measures were considered indispensable. It should also be noted that uses other than those evaluated might pose considerably higher risks to the environment. Expected effect of the final regulatory action in relation to the environment: Reduction of risks to the environment. Date of entry into force of the final regulatory action: 11/08/2004 |