Chemical name: Propanal, 2-methyl-2-(methylthio)-, O-[(methylamino)carbonyl]oxime 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 as plant protection products, except the essential uses listed below. Use or uses that remain allowed: No known industrial uses. Not relevant. 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 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; (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 For all non-essential uses, for which existing authorisations had to be withdrawn by 18 September 2003, the EC Member States may grant a period of grace for disposal, storage, placing on the market and use of existing stocks that must expire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 18 September 2004. For essential uses that can be continue to be authorised until 30 June 2007, the grace period for disposal etc of existing stocks is 6 months (i.e. up until 31 December 2007). List of essential uses that may continue to be authorised Member StateUse Belgium Beet Greece Potatoes Tobacco Spain Cotton Citrus (young plantation) Woody nurseries FranceSugar beet Vineyards ItalySugar beet Tobacco Nurseries NetherlandsOrnamentals Sugar beet Potatoes (seed and starch) PortugalCitrus Floriculture Vineyards United KingdomPotatoes Carrots (including parsnips) Onions Ornamentals 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 aldicarb. Aldicarb 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 The authorisations for plant protection products containing aldicarb had to be withdrawn by 18 September 2003. From the date of adoption of Council Decision 2003/199/EC (18 March 2003), no authorisations for plant protection products containing aldicarb could be granted or renewed. Certain essential uses listed in the Aneex to Council Decision 2003/199/EC may remain authorised until 30 June 2007 under specific conditions (see point 2.5.2). The reasons for the final regulatory action were relevant to: Environment Summary of known hazards and risks to human health: The final regulatory action was taken to protect the environment. However aldicarb is very toxic by inhalation and if swallowed, and toxic in contact with skin, and an evaluation of the risk to human health was also undertaken. This evaluation focused on the risk presented by aldicarb to operator and consumer health only for formulations and uses which were intented in the European Community, i.e. soil application/incorporation of granular formulation at application rates ranging from 0.25 to 20 kg aldicarb/ha. For theses conditions of use, the following conclusiones were reached: Consumers: After consideration of a number of toxicological findings and in conjunction with the fact that the potential dietary exposure to aldicarb residues for adults, young children and infants as derived by the probabilistic approach at selected high percentiles of the exposure distribuiton are below th ARfD, it was concluded that based on the available information there is no appreciable health risk for adults, young children and infants. Operator exposure: The first risk assessment performed concluded that the overall application by downward placement and band application might be acceptable but further exposure data were required. Usage of hand held equipment and overall application by broadcast was considered unacceptable. While the available toxicological information supported the setting of a AOEL value of 0.0025 mg/kg bw (based on a NOEL from human volunteer study with an assessment factor of 10), exposure predictions for the various scenarios of use were uncertain, pending the submission of specific field studies conducted under relevant conditions. During the course of the evaluation process, a new study was provided which enabled it to be concluded that for tractor-mounted equipment the measured exposure is well below the AOEL with either a 10% or 100% dermal absorption factor. Due to the particular modes of application of this plant protection product, specific information was needed on exposure for the various techniques of application used. Additional information was submitted to the Repporteur Member State on han held application in Citrus with a study conducted in the field using hand held injectors. The study data combined with a dermal penetration factor of 10% as recommended by the RMS showed an acceptable margin of safety for operators protected in accordance with label recommendations. The use of hand held applications in greehouse was not fully assessed. A further study examined the use of tractor-mounted granule applicators with surface application and subsequent incorporation. Although not tegarded as fully meeting the required standard for a registration study, these data indicated an estimated systemic expusure of 0.007 mg/kg/bw, corresponding to 40% of the AOEL. Therefore it was concluded that further data would be required to support this method of application. Expected effect of the final regulatory action in relation to human health: Reduction of human exposure risk from plant protection uses. Summary of known hazards and risks to the environment: Final regulatory action was taken to protect on non-target organisms, in particular birds and earthworms. Concerns were identified with regard to: Terrestrial vertebrates: The toxicity/estimated exposure ratios were very low on the basis of laboratory studies. Uses lead to an unacceptable risk to small birds. The risk to birds was investigated by means of a probabilistic risk assessment. The effects on national populations would not be expected, although some local impact might occur. Broadcast administration was not acceptable regarding birds and mammals. Incorporation in soil was considered as part of the evaluation, but the actual quantities of granules remaining on the soil, and thus available for small birds, depended strongly on the quality of the application conditions. Thus the risk to small birds through exposure to the granules cannot be totally minimised to an acceptable level. Aquatic species: The toxicity/estimated exposure ratios were very low. Aldicarb is very toxic to aquatic organisms. A broadcast application was unacceptable. Application rates above 2.5 kg aldicarb/ha were unacceptable. Bees and other arthropods species: there was no risk to bees for an application rate up to 3.7 kg as/ha, but higher application rates were not addressed. A high risk for other non-target arthropod species was identified. Earthworms: acute risk was acceptable at 1 kg a.s./ha. For higher application rates, more field data concerning the acute risk of aldicarb on earthworms were requested: A study under agricultural field conditions revealed no significant effects up to 3.36 kg a.s./ha. However, at the time of the regulatory action, the available information from field studies about the effects of aldicarb or its metabolites on earthworms was considered as still insufficient to conclude that the risks were acceptable. The risk to birds and small mammals via ingestion of earthworms as a food source was considered as acceptable. 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: 18/09/2003 Authorisations for plant protection products containing aldicarb had to be withdrawn bu then with the exception of certain essential uses as described in point 2.5.2 subchapter "Forumulation(s) and use or uses that remain allowed" ). |