Dichlorprop-P is one of the 52 substances of the second stage of the review programme covered by Commission Regulation (EC) No 451/20001, as amended by Commission Regulation (EC) No 1490/20022. This Regulation requires the European Food Safety Authority (EFSA) to organise a peer review of the initial evaluation, i. e. the draft assessment report (DAR), provided by the designated rapporteur Member State and to provide within one year a conclusion on the risk assessment to the EUCommission. Denmark being the designated rapporteur Member State submitted the DAR on dichlorprop-P in accordance with the provisions of Article 8(1) of the amended Regulation (EC) No 451/2000, which was received by the EFSA on 5 November 2003. Following a quality check on the DAR, the peer review was initiated on 13 February 2004 by dispatching the DAR for consultation of the Member States and the notifier, the dichlorprop-P Task Force which originally consisted of BASF AG, Aventis Crop Science (now Bayer Crop Science) and A H Marks Co. Ltd. On 20 February 2004, the Task Force membership changed. BASF and Bayer CropScience effectively divested their Task Force positions to Nufarm bv. Subsequently, the comments received on the DAR were examined by the rapporteur Member State and the need for additional data was agreed in an evaluation meeting in July 2004. Remaining issues as well as further data made available by the notifier upon request were evaluated in a series of scientific meetings with Member State experts in January-March 2005. A final discussion of the outcome of the consultation of experts took place with representatives from the Member States on 30 September 2005 leading to the conclusions as laid down in this report. The conclusion was reached on the basis of the evaluation of the representative uses as herbicide as proposed by the applicant which comprises broadcast spraying to control grass and broad-leaved weeds in cereals, grassland and grass seed crops at an application rate of 1.5 kg dichlorprop-P per hectare. Dichlorprop-P can be used only as herbicide. The representative formulated product for the evaluation was "DP-P K 600" ("Optica DP"), a soluble concentrate (SL), registered under different trade names in Europe. In the formulation the active substance is present as the potassium salt variant. Adequate methods are available to monitor all compounds given in the respective residue definitions. Whether or not sufficient enforcement methods are available to monitor food of plant and animal origin depends on the final residue definition. The reason is that none of the submitted method is enantio selective. The residues are determined as a sum parameter of both, the R-and the S-isomer. This means that for the determination of dichlorprop-P no specific enforcement method would be available. The methodologies used are GC with MS detection and HPLC with UV detection. None of them is enantio selective. A multi-residue method like the Dutch MM1 or the German S19 is not applicable to due the nature of the residues. Sufficient analytical method as well as methods and data relating to physical, chemical and technical properties are available to ensure that quality control measurements of the plant protection product are possible. Dichlorprop-P is extensively and rapidly absorbed after oral administration in rats (>88% based on urinary and faecal excretion). It is of moderate oral toxicity and low dermal toxicity as well as after inhalatory exposure. Dichlorprop-P was found to be non-irritant to the skin of rabbits but it is a severe eye irritant. Therefore, classification with Xi; R41 (Risk of serious damage to eyes) and R22 (Harmful if swallowed) is justified. It is not a skin sensitiser. Dichlorprop-P is of no genotoxic concern and does not show any carcinogenic potential. Furthermore, it does not induce reproduction toxic or neurotoxic effects. The acceptable daily intake (ADI) is 0.06 mg/kg bw/day, the acceptable operator exposure level (AOEL) is 0.35 mg/kg bw/day, and the acute reference dose (ARfD) is 0.5 mg/kg bw/day, all with a safety factor of 100 applied. The exposure estimates for workers and bystanders is below the AOEL. The metabolism of dichlorprop-P has been studied in cereals. In straw unchanged dichlorprop-P accounted for the majority of total radioactivity at maturity, whereas no further work on identification or characterisation of grain residue was performed due to low extractable residue levels. Two major metabolites were found in straw. One of them, metabolite 11 was not identified in the study and therefore its toxicological relevance could not be addressed. Further data on the identity of that metabolite were required (data gap). The residue definition for risk assessment was agreed by the experts' meeting for residues as sum of dichlorprop-P, its salts and conjugates expressed as dichlorprop-P. Based on information of potential conversion of dichloprop-P residues to the S-isomer, which became available after the experts' meeting the residue definition for consumer risk assessment would need to be reconsidered not only in terms of relevance of metabolite 11. In supervised residue trials the sum of the R-and the S-isomer of dichlorprop was determined, however, it still needs to be clarified whether also conjugates that are part of the residue definition have been analysed in those trials. A livestock metabolism study in lactating goats indicated that residues above LOQ could occur in edible animal matrices, and thus a feeding study on ruminants is required (data gap). Due to the lack of the above stated information and data the consumer risk assessment cannot currently be concluded. However, a provisional assessment of consumer risk with currently proposed MRLs for cereals, which are still pending their confirmation, indicates that consumer exposure is low for all considered consumer groups (significantly less than 10% ADI and ARfD, respectively). Exposure from food of animal origin has not been considered in the assessment. Under aerobic conditions in soil, no degradation products of dichlorprop-P that accounted for more than 10% AR were identified. Non-extractable residues reached a maximum of 33.6% AR and CO2 maximum of 43.4% AR. Under anaerobic conditions in a water/ sediment system no new metabolites were identified. Dichlorprop-P can be considerate as moderate persistent in soil. During the peer review process, experts decided to address a general question to the PPR Scientific Panel on the use of a Q10 value based on measured data in place of the FOCUS default value of 2.2 for temperature correction of DT50 values. However, in this case the Q10 of 5 was accepted. Only initial PECsoil values are used in the ecotoxicological risk assessment. The batch soil adsorption/desorption studies indicate that dichlorprop-P is potentially mobile. Modelling and a lysimeter study for the representative uses evaluated indicated that dichlorprop-P is unlikely to contaminate groundwater when used as recommended. Also monitoring data in 3 different countries in EU (UK, Germany and Denmark) showed that dichlorprop-P occurrence in groundwater as well as in surface fresh water is rare. Dichlorprop-P is expected to be stable to hydrolysis at environmental relevant pH. Photolysis can contribute to the degradation of dichlorprop-P in the environment. 2,4-dichlorophenol was the only identified metabolite (max. 23.6% day 8) in soil. Scientific literature demonstrated that 2,4dichlorophenol is degraded by soil micro-organism in less than 10 days. However, due to its pesticidal activity, the potential groundwater contamination for 2,4-dichlorophenol should be assessed. Dichlorprop-P should be classified as a non ready biodegradable substance. In water/sediment systems dichlorprop-P was degraded to 5.1 and 2.3% AR in the water phase and reached maximum levels of 11.9% AR and 10.3% AR in the sediment. The maximum amounts of sediment residue that was not extracted were up to 25.4% AR and 16.0% AR (day 30). The remaining amount was recovered as volatiles (more than 80% AR two months after application). The amount of dichlorprop-P in the system was 0.1% AR or less at the end of the study. PECsw due to contamination via spray drift were calculated for dichlorprop-P for a 30 cm deep static water body at 1 m distance for the evaluated representative use on spring cereals. PECsed values are not included in the endpoints since they are not relevant for the risk assessment. Concentration of dichlorprop-P in the air compartment and transport through it is not expected to be significant. A high short term risk has been identified for herbivorous birds and a high acute risk for mammals for the use of dichlorprop-P in grass and grass seed crops. Additionally a potential high acute risk to insectivorous bird was identified considering the yellow wagtail as a representative species consuming 100% small insects as a worst case. Further data is thus needed to address the risk to birds and mammals. Additionally, a provisional data requirement was set to address the acute risk for both uses, pending the opinion of the PPR panel concerning the use of dietary short-term endpoint for the acute assessment. The opinion for pirimicarb was adopted in July 20053 and it is proposed by the EFSA that a risk assessment is performed in accordance with the recommendations provided in this opinion. The diatom algae Navicula pelliculosa was the most sensitive of the aquatic species tested with dichlorprop-P. The predicted environmental concentration in surface water was calculated based on spray drift. The TER value for algae indicates a high risk and risk mitigation measures comparable to 5 m buffer zones are required. The risk to bees, non-target arthropods, earthworms and other soil organism is considered low. To protect non-target plants outside the field risk mitigation measures comparable to a 5 m buffer zone is required.
