Chemical name: Phosphoric acid, 2,2-dichloroethenyl dimethyl ester, Phosphoric acid, 2,2-dichloroethenyl 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 uses of dichlorvos as a plant protection product were prohibited. All applications of dichlorvos as a biocidal product for product-type 18 (insecticides, acaricides and products to control other arthropods) were prohibited. No other uses of dichlorvos as biocidal product are authorised in the European Union. Not relevant. Use or uses that remain allowed: Not relevant. Pesticide use or uses that remain allowed: Not relevant. 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 dichlorvos. Dichlorvos is not included in the list of authorised active substances in Annex I to Directive 91/414/EEC. Authorisations for plant protection products containing dichlorvos had to be withdrawn by 6 December 2007. From 7 June 2007 no authorisations for plant protection products containing dichlorvos can be granted or renewed. It is prohibited to place on the market or use biocidal products containing dichlorvos. Dichlorvos has not been approved for inclusion in Annex I, IA or IB to Directive 98/8/EC for its use in biocidal products of product- type 18. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: Risk evaluation for the use of Dichlorvos as active substance in biocidal products: Risk Characterization for Human Health for carcinogenic effects exerting through the threshold mechanism. Dichlorvos is a volatile active substance and therefore, the inhalation route is the main exposure route in all the considered scenarios. The chronic exposure estimate for bystanders (consumers or workers in the area where the strip is present) has been associated to a potential risk for all the scenarios considered (cupboards, non-occupied room and barns). For the calculation of the risk related to the bystander exposure the AEL approach has been adopted. To this purpose a chronic AEL of 0.0005 mg/m3 has been derived from a NOAEC of 0.05 mg/m3 (2-year inhalation study in rats) taking into account an assessment factor of 1 for interspecies variability, 10 for intraspecies variability and an additional safety factor of 10 due to the nature of the induced effects. In all the scenarios evaluated for chronic exposure the derived exposure estimates are higher than the AEL. AELacute = 0.01 mg/kg bw/d: Overall NOAEL for acute neurotoxicity in rats of 1.0 mg/kg bw, AF 100. AEClong-term = 0.0005 mg/m3: NOAEC of 0.05 mg/m3 from the results from the 2-yr rat study, supported by the 1-yr dog study, and an AF 100. AELlong-term = 2.5 x 10-4 mg/kg bw/d: NOAEC of 0.05 mg/m3 from the results from the 2-yr rat study, supported by the 1-yr dog study, and an AF 100. Inhalation volume: 30 m3/d (1.25 m3/h x 24 h) and Body weight: 60 kg. The following values have been calculated for the humans chronically exposed to Dichlorvos in Pest Strip: - Use scenario: In house (small areas, cupboards, Garbage cans (note that for garbage cans outdoors only the opening and hanging exposures are relevant) Chronic inhalation exposure: 0.022 mg/m3 (0.011 mg/kg bw/d)
- Use scenario: In house (attics / non-occupied rooms) Chronic inhalation exposure: 0.015 mg/m3 (7.5 x 10-3 mg/kg bw/d)
- Use scenario: Barns, Warehouses/storage, Animal buildings Chronic inhalation exposure: 0.0041 mg/m3 (2.1 x 10-3 mg/kg bw/d)
- Use scenario: Barns, Warehouses/storage, Animal buildings (from new values on barn application) Chronic inhalation exposure: 0.0503 mg/m3 (2.5 x 10-2 mg/kg bw/d)
A potential risk has been identified for all the chronic scenarios. Risk Characterization for Human Health for carcinogenic effects exerting through the non-threshold mechanism The T25 dose-descriptor approach (dose defined as the chronic dose rate giving a 25% incidence of cancer in an appropriately designed animal experiment, within the standard lifetime of that species) has highlighted that an unacceptable risk occur from long-term exposures to pest-strip containing Dichlorvos as active substance. The exposure values for consumers and workers are above the DMELs calculated by “Linearized” approach and no safe scenarios can be identified for the relevant intended uses. Summary of known hazards and risks to the environment: Risk evaluation for the use of Dichlorvos as active substance in biocidal products: Dichlorvos has been proved to be very toxic for aquatic organisms. Therefore, it was proposed classifying dichlorvos as R50-53 - Very toxic to aquatic organisms, may cause long term adverse effects in the aquatic environment. Taking into account the uses supported by the applicant, it has been concluded that all the scenarios pose an unacceptable risk for the environment. Because the dichlorvos strip is only used in-house, emissions to the environment will occur indirectly as a result of dry or wet cleaning of indoor receiving materials such as furniture, equipment, clothes, walls and floors. Cleaning will lead to releases either to wastes or to waste water. Therefore, the sewage treatment plants (STP) were considered as one of the main “receiving compartments”. In Europe, estimates of potential exposures from STP are carried out using standard calculation frameworks from a Technical Guidance Document. According to this guidance, the “final” environmental compartments are surface water and sediment, soil and groundwater (via sewage sludge application onto soil) and outdoor air. Two exposure scenarios were evaluated: one where 60% of dichlorvos contained in the strip is released over the strip’s lifetime, and a worst-case scenario where 100 % of dichlorvos is released. Assuming standard insecticide treatment frequencies resulting from a survey in France, and a standard number of private houses and large buildings in each STP catchment, cumulative Predicted Environmental Concentrations (PEC) were calculated from PEC values for releases via waste water from private households and large buildings. The ratios of these PEC to the Predicted No-effect Concentration (PNEC) for surface water, sediment and soil were >> than 1 for both release scenarios. Thus, it was concluded that the use of dichlorvos poses an unacceptable risk for surface water, sediment and soil. Therefore, an inclusion in Annex I of Directive 98/8/EC cannot be recommended for Dichlorvos as an active substance for the use as product-type 18 (Insecticide). Reference: European Union Assessment report Dichlorvos (PT 18) - Finalized in the Standing Committee on Biocidal Products at its meeting on 9th December 2011 in view of its inclusion in Annex I or IA to Directive 98/8/EC. Expected effect of the final regulatory action in relation to the environment: Reduction of risk to the environment from the use of biocidal products containing dichlorvos. Date of entry into force of the final regulatory action: 06/12/2008 |
