Chemical name: Methanimidamide, N'-(2,4-dimethylphenyl)-N-[[(2,4-dimethylphenyl)imino]methyl]-N-methyl- 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 the applications as plant protection products, 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 relabelled in order to match the restricted use and 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 For all non-essential uses, for which existing authorisations had to be withdrawn by 12 August 2004, the EC Member States may grant a period of grace for disposal, storage, placing on the market and use of existing stocks that must expire no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 12 August 2005. For essential uses that can continue to be authorised until 30 June 2007, the grace period for disposal etc of the existing stocks is 6 months (i.e. up until 31 December 2007). List of essential uses that may continue to be authorised Member States Use Greece Cotton The Netherlands Tree nursery Strawberry (only propagating material) Pear trees after harvest United Kingdom Pear trees after harvest Portugal Pear trees after harvest 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 amitraz. Amitraz 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 The authorisations for plant protection products containing amitraz had to be withdrawn by 12 August 2004. From 17 February 2004 no authorisations for plant protection products containing amitraz could be granted or renewed. For certain essential uses for specific Member States listed in the Annex to Commission Decision 2004/141/EC a prolonged period of withdrawal until 30 June 2007 may be allowed (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: Final regulatory action was taken to protect consumers from the potential neurological effects of acute exposure to amitraz. It had not been demonstrated for the proposed uses that consumers might not be exposed to amitraz exceeding the Acute Reference Dose, i.e. the estimate of the amount of the substance that can be ingested over a short period of time without appreciable health risk to the consumer. A probabilistic risk assessment was prepared by the notifier. However it had to be taken into consideration that agreed criteria for the interpretation of such a probabilistic risk assessment are not yet established. It was concluded that it would not be appropriate, in view of the possible risks, to delay a decision further until such criteria are agreed. Expected effect of the final regulatory action in relation to human health: Reduction of risk to consumers from plant protection products. Summary of known hazards and risks to the environment: During the evaluation of the risks to the environment some concerns were identified with regards to non-targets organisms, in particular birds and mammals eating treated insects. The final decision on the non-inclusion in Annex I of Directive 91/414/EEC, however, was not based on such concerns. Expected effect of the final regulatory action in relation to the environment: Reduction of risk from plant protection uses. Date of entry into force of the final regulatory action: 12/08/2004 |