ha-1, pyriproxyfen 10% EC @ 100 g a.i. All other components of the residue were below 10% TRR. Based on the regulatory studies submitted for pyriproxyfen together with the publications from the literature review where a link of pyriproxyfen to microcephaly was reported, the experts agreed that there was no indication of a link between the active substance and the finding of microcephaly. In addition, a key supporting document to this conclusion is the peer review report (EFSA, By continuing to browse this site, you agree to its use of cookies as described in our, I have read and accept the Wiley Online Library Terms and Conditions of Use, Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009, Opinion on a request from EFSA related to the default Q10 value used to describe the temperature effect on transformation rates of pesticides in soil, Guidance on Risk Assessment for Birds and Mammals on request from EFSA, Submission of scientific peer‐reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009, EFSA Guidance Document on the risk assessment of plant protection products on bees (, EFSA Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil, Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products, Peer review report to the conclusion regarding the peer review of the pesticide risk assessment of the active substance pyriproxyfen, Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge‐of‐field surface waters, Residues: guidance for generating and reporting methods of analysis in support of pre‐registration data requirements for Annex II (Part A, Section 4) and Annex III (Part A, Section 5) of Directive 91/414, Technical material and preparations: guidance for generating and reporting methods of analysis in support of pre‐ and post‐registration data requirements for Annex II (Part A, Section 4) and Annex III (Part A, Section 5) of Directive 91/414, Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC, Guidance Document on Aquatic Ecotoxicology Under Council Directive 91/414/EEC, Guidance Document on Assessment of the Relevance of Metabolites in Groundwater of Substances Regulated under Council Directive 91/414/EEC, Guidance Document on residue analytical methods, Review report for the active substance pyriproxyfen, Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs, Guidance document on the assessment of the equivalence of technical materials of substances regulated under Regulation (EC) No 1107/2009, Assessing potential for movement of active substances and their metabolites to ground water in the EU. The main data regarding the identity of pyriproxyfen and its physical and chemical properties are given in Appendix A. No experimental data were provided for the comparative in vitro metabolism with other species, including human cell systems (data gap and issue that could not be finalised). However, except for the chronic risk assessment to aquatic invertebrates for metabolite PYPAC, this data gap did not result in an assessment not finalised for parent pyriproxyfen (soil compartment) and metabolites DPH‐Pyr (aquatic environment), 4’‐OH‐Pyr and PYPAC due to the margins of safety between hazard endpoints and PEC indicated in the available environmental risk assessments. Short‐term dietary and reproduction toxicity data on birds with pyriproxyfen were reported. Pyriproxyfen is an insect growth regulator (IGR). In soil laboratory incubations under aerobic conditions in the dark, pyriproxyfen exhibited low to moderate persistence, forming the major (> 10% applied radioactivity (AR)) metabolite PYPAC (max. The necessary surface water and sediment exposure assessments (PEC calculations) were carried out for pyriproxyfen and metabolites 4’‐OH‐Pyr, PYPAC and DPH‐Pyr using the FOCUS (2001) step 1 and step 2 approach (version 3.2 of the Steps 1‐2 in FOCUS calculator). 8.9% AR) exceeded 5% AR in at least two consecutive sampling dates in the degradation experiments; therefore, it was included in the present assessment. Appropriate endpoints to assess sub‐lethal effects were not available and the available higher tier effect studies were not considered to be reliable (data gap).1313 A list of the relevant end points for the active substance and the formulation and the proposed MRLs is provided in Appendix A. An MRL application has been submitted to modify the current EU MRL on citrus fruit. Agrotechnica is an integrated company that provides complete service of manufacturing, formulation and packing of Crop Protection Products, with a marketing position in the Greek Crop Protection Industry the last 50 years. Therefore, for those processes in which microbial metabolism is involved, some degree of enantioselective transformation in the environment cannot be excluded. The RMS provided its initial evaluation of the dossier on pyriproxyfen in the RAR, which was received by EFSA on 14 December 2017 (Netherlands, 2017). Since single residue fraction did not exceed 0.01 mg eq/kg in the rotational crops planted at 30‐day PBI, it is not expected that residues > 0.01 mg eq/kg for 4’‐OH‐PYR and PYPAC would be observed in rotational crops planted at longer PBIs. MRLs are not required for products of animal origin. Pyriproxyfen exhibited a low acute toxicity when administered orally, dermally or by inhalation in rats or mice. The experts concluded that pyriproxyfen was unlikely to be teratogenic.66 Pyriproxyfen can be considered as hydrolytically stable under conditions representative of pasteurisation, baking/brewing/boiling and sterilisation. @ 250 ml, Fenpropathrin 30% EC 100 g.a.i @ 340 ml were applied against sucking pests of chilli i.e. However, since the crop types which are included in the category of ornamentals is not defined, EFSA did not consider that the available risk assessments would cover the risk, when it is assessed with the EFSA guidance document (EFSA, 2013) from the outdoor use on ornamentals (data gap).1212 Regulation (EC) No 1107/2009 of 21 October 2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. In the area of residues, the consumer dietary risk assessment cannot be finalised in view of the identified data gaps. The proposed specification for pyriproxyfen is based on batch data from industrial plant production. the reports of the scientific consultation with Member State experts (where relevant); the comments received on the assessment of the additional information (where relevant); the comments received on the draft EFSA conclusion. However, the consumer risk assessment cannot be finalised in view of the identified data gaps. UNIVERSAL PYRIPROXYFEN 100 EC SAFETY DATA SHEET Page 2 of 5 . According to point 3.6.5 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605, it can be concluded that pyriproxyfen is not an endocrine disruptor.77 Both AOEL and AAOEL have been derived with the application of an UF of 100 and a correction for an oral absorption value of 40%. Missing information identified as being required by the regulatory framework is listed. Reliable field DegT50 values were derived for pyriproxyfen following normalisation to FOCUS reference conditions (20° C and pF2 soil moisture) following the EFSA (2014a) DegT50 guidance. The rates of dissipation and degradation in the environmental matrices investigated were estimated using FOCUS (2006) kinetics guidance. Mineralisation of these radiolabels accounted for 11–52% AR at the end of the study. It does not allow the hatching of eggs. Low risk to algae was concluded for all the representative uses at FOCUS Step 1‐3. Overall, the risk was considered as low. A high acute risk was indicated using FOCUS Step 1‐3, for the representative uses in citrus and for the majority of the FOCUS Step 3 scenarios (8 out of 10) in pome fruit (early) and in pome fruit (late) for 2 out of 10 FOCUS scenarios at Step 3 (R2/R3). Differences in the metabolism of pyriproxyfen in the different animal species and in humans could not be excluded based on the available data (issue that could not be finalised). The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. (m/v %) Classification EC 1272/2008 Pyriproxyfen TC 95 % wate. As the intended use on citrus fruit was the same as the representative use, the use in this MRL application does not trigger a revision of the calculated livestock dietary burden and the consumer dietary risk assessment. This regulates for the European Food Safety Authority (EFSA) the procedure for organising the consultation of Member States, the applicant(s) and the public on the initial evaluation provided by the rapporteur Member State (RMS) and/or co‐rapporteur Member State (co‐RMS) in the renewal assessment report (RAR), and the organisation of an expert consultation where appropriate. It is available in powder, dust, spray, emulsifier and smoke forms. The other impurities were concluded as not toxicologically relevant, based on available data including quantitative structure–activity relationship (QSAR) analyses and read‐across considerations. uuid:be017223-4de7-46f0-9ee5-8dff51f0a689 Eggs, Nymphs and Adults. Refer to experts’ consultation 2.5 in the Report of Pesticides Peer Review Experts’ Meeting 190 (EFSA, 2019). The data available on environmental fate and behaviour were sufficient to carry out the required environmental exposure assessments at the EU level for the representative uses, with the notable exception that the consumer risk assessment from the consumption of drinking water could not be finalised for all the representative uses since information on the effect of water treatment processes on the nature of residues of both the active substance and its identified metabolites potentially present in surface, when surface water is abstracted for drinking water was insufficient. In accordance with Article 1 of Regulation (EU) No 844/2012, the rapporteur Member State (RMS), the Netherlands, and co‐rapporteur Member State (co‐RMS), Spain, received an application from Sumitomo Chemical Agro Europe for the renewal of approval of the active substance pyriproxyfen. In a 28‐day inhalation study with rats, the NOAEL was 86.8 mg/kg bw per day based on salivation, reduced body weight gain, increased lactate dehydrogenase (LDH) and changes in organ weights (liver, spleen and lung). U.S. EPA, Pesticides, Label, -, 6/13/2011 In a 21‐day dermal study with rats, no local or systemic effects were observed up to the highest dose tested. On the basis of the comments received, the applicant's response to the comments and the RMS's evaluation thereof, it was concluded that additional information should be requested from the applicant, and that EFSA should conduct an expert consultation in the areas of mammalian toxicology, environmental fate and behaviour and ecotoxicology. Any queries (other than missing content) should be directed to the corresponding author for the article. EYES: Causes temporary irritation, tearing and blurred vision. A risk assessment for the sediment compartment (using FOCUS PECsed values) was not available although it is triggered,1111 OJ L 155, 11.6.2011, p. 127–175. Using the triple pack approach (combination of in vitro and in vivo results with pyriproxyfen 100 g/L EC, following the EFSA PPR Panel, 2012), the dermal absorption values were 3% for the concentrate and 4% for the dilution. This has led to the identification of a data gap (see Section 7) and results in the consumer risk assessment not being finalised (see Section 9). for indigenous manufacture Quinalphos-5% granules Spinetoram 11.7% SC w/w Spinosad 2.5 % SC Enter your email address below and we will send you your username, If the address matches an existing account you will receive an email with instructions to retrieve your username. Pyriproxyfen residues can be monitored in food and feed of plant origin by the QuEChERS method using high‐performance liquid chromatography with tandem mass spectrometry (HPLC–MS/MS) with a limit of quantification (LOQ) of 0.01 mg/kg in the four major crop groups and black tea. A final consultation on the conclusions arising from the peer review of the risk assessment and on the proposed MRLs took place with Member States via a written procedure in April–May 2019. The necessary groundwater exposure assessments were appropriately carried out using FOCUS (European Commission, 2014a) scenarios and the models PEARL 4.4.4, PELMO 5.5.3 and MACRO 5.5.48.8 The potential for groundwater exposure from the representative uses by pyriproxyfen and its metabolites 4’‐OH‐Pyr and PYPAC above the parametric drinking water limit of 0.1 μg/L was concluded to be low in geoclimatic situations that are represented by all the relevant FOCUS groundwater scenarios. The situation when pyriproxyfen is used in open‐protected structures in tomato is covered by the available risk assessment for the outdoor use on tomato. For the rat studies (28‐day, 90‐day and 6‐month), the lowest no observed adverse effect level (NOAEL) was 23.5 mg/kg body weight (bw) per day. Pyriproxyfen was discussed in the Pesticide Peer Review meeting 190 in February 2019. Refer to experts’ consultation 2.3 in the Report of Pesticides Peer Review Experts’ Meeting 190 (EFSA, 2019). The field data endpoints were combined with laboratory values to derive modelling endpoints. It is primarily used to fight pests in a number of crops. For the renewal, the agreed ADI is 0.05 mg/kg bw per day based on the 78‐week mouse study and applying an increased UF of 300 for using a LOAEL instead of a NOAEL. Batch adsorption/desorption studies indicated that pyriproxyfen is expected to be immobile in soil. MRLs were assessed in citrus fruits. Pyriproxyfen was discussed at the Pesticides Peer Review TC 201 in January 2019. In accordance with Article 13 of the Regulation, unless formally informed by the European Commission that a conclusion is not necessary, EFSA is required to adopt a conclusion on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 within 5 months from the end of the period provided for the submission of written comments, subject to an extension of up to 8 months where additional information is required to be submitted by the applicant(s) in accordance with Article 13(3). The carcinogenic NOAEL is 107.3 mg/kg bw per day based on liver haemangiosarcoma. In addition, a bird reproduction test and a fish early life stage test were also available. An issue is also listed as a critical area of concern if the assessment at a higher tier level could not be finalised due to lack of information, and if the assessment performed at the lower tier level does not permit the conclusion that, for at least one of the representative uses, it may be expected that a plant protection product containing the active substance will not have any harmful effect on human or animal health or on groundwater, or any unacceptable influence on the environment. In addition to the acute data, appropriate chronic data were available for adult honeybees and larvae with the active substance. The risk to honeybees from the field use in ornamentals and the risk from sublethal effects for all field uses could not be concluded upon. Pyriproxyfen is an isomeric mixture, only produced as a racemate. Refer to experts’ consultation 2.4 in the Report of Pesticides Peer Review Experts’ Meeting 190 (EFSA, 2019). It should be noted that there are CIPAC methods for determination of the active substance in the technical material (CIPAC 715/TC/M/‐) and in the formulation (CIPAC 715/EC/M/‐). Appendix A can be found in the online version of this output (‘Supporting information’ section): https://doi.org/10.2903/j.efsa.2019.5732, 4‐phenoxyphenyl (RS)‐2‐(2‐pyridyloxy)propyl ether, CC(OC1=NC=CC=C1)COC2=CC=C(OC3=CC=CC=C3)C=C2, 4‐(4‐{2‐[(pyridin‐2‐yl)oxy]propoxy}phenoxy)phenyl β‐D‐glucopyranosiduronic acid, O[C@H]1[C@@H]([C@@H](C(O)=O)O[C@H]([C@@H]1O)OC2=CC=C(OC3=CC=C(OCC(OC4=NC=CC=C4)C)C=C3)C=C2)O, 4‐(4‐(2‐(pyridin‐2‐yloxy)propoxy)phenoxy)phenol, CC(OC1=NC=CC=C1)COC2=CC=C(OC3=CC=C(O)C=C3)C=C2, 4‐(4‐(2‐(pyridin‐2‐yloxy)propoxy)phenoxy)phenyl hydrogen sulfate, CC(OC1=NC=CC=C1)COC2=CC=C(OC3=CC=C(OS(O)(=O)=O)C=C3)C=C2, European Food Safety Authority, Refer to experts’ consultation 2.4 in the Report of Pesticides Peer Review Experts’ Meeting 190 (EFSA, 2019). Cyper10-Cypermethrin 10% ECCypermethrin is a synthetic pyrethroid used as an insecticide in large-scale commercial agricultural applications as well as in consumer products for domestic purposes. In a confined rotational crop metabolism study (0.9N), radish, lettuce and wheat were planted at 30‐day plant‐back intervals (PBIs). Based on GAP‐specific residue data on citrus, the risk was refined and a low long‐term risk to frugivorous mammal was finally concluded for the uses in citrus. High acute risk to aquatic invertebrates and to algae was also indicated for walk‐in tunnels. No particular conditions are proposed for the MRL applications. Pyriproxyfen was shown to be stable under frozen conditions for up to 12 months in tomatoes (high water content matrices), 4 months in oranges (high acid content matrices) and 13 months in cotton seed (high oil content matrices). The representative formulated product for the evaluation was ‘Pyriproxyfen 100 g/L EC’, an emulsifiable concentrate (EC) containing 100 g/L pyriproxyfen. For the acceptable operator exposure level (AOEL), the original value of 0.04 mg/kg bw per day has been confirmed, based on the 1‐year dog study. In addition, several specific ED studies in vitro and in vivo demonstrated negative results or indirect effects mediated by liver enzyme induction or secondary to decreased body weight. For high‐technology greenhouse uses the aquatic exposure does not cover the sediment compartment since the GEM assessment does not provide sediment PEC values, which could be particularly relevant for strongly adsorbed substances such as pyriproxyfen. Polythene bags (30 cm × 60 cm) over pyriproxyfen 5% + fenpropathrin 15% EC @ 50 and 100 with a cotton swab containing 80% chloroform were tied g a.i. Parma, Italy. The PECsw values at FOCUS Step 4 were less than the ETO‐RAC for all the outdoor representative uses, whereas high risk was concluded for the soil‐less greenhouse use in ornamentals and walk‐in tunnels (open). Extended summary and recommendations, Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues, Rome, Italy, 20–29 September 2004, 383 pp, Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues, Geneva, Switzerland, 18–27 September 2007, 164 pp, Renewal Assessment Report (RAR) on the active substance pyriproxyfen prepared by the rapporteur Member State the Netherlands, in the framework of Commission Implementing Regulation (EU) No 844/2012, December 2017, Revised Renewal Assessment Report (RAR) on the active substance pyriproxyfen prepared by the rapporteur Member State the Netherlands, in the framework of Commission Implementing Regulation (EU) No 844/2012, Guidance document on overview of residue chemistry studies, OECD MRL calculator: spreadsheet for single data set and spreadsheet for multiple data set, 2 March 2011, Guidance document on regulatory testing and risk assessment procedures for plant protection products with non‐target arthropods, https://echa.europa.eu/guidance-documents/guidance-on-clp, Low risk to aquatic organisms apart from the acute risk to fish, Low risk to aquatic organisms apart from the chronic risk to aquatic invertebrates, List of end points for the active substance and the representative formulation. %PDF-1.6 %���� For the representative uses on protected crops, the necessary surface water exposure assessment was appropriately carried out following the EFSA guidance on emission from protected crops (EFSA, 2014a). Methods of analysis are available for the determination of the active substance and the relevant impurity in the technical material and in the representative formulations and for the determination of the respective impurities in the technical material. Commission Implementing Regulation (EU) No 844/2012 as amended by Commission Implementing Regulation (EU) No 2018/165911 The methods of analyses used in the radiolabelled soil and water studies in the dark were able to distinguish between the enantiomers and there was no significant change in the isomeric ratio over the duration of the studies. For the metabolites 4’‐OH‐Pyr (and conjugate), 2,5‐OH‐PY, POPA and POP sulfate conjugate and PYPA, since none of them can be considered as a major rat metabolite (systemically available), they are not covered by the toxicological studies with pyriproxyfen. Bifenthrin 10% EC Cotton Bollworm White Fly 80 80 800 800 500 500 15 15 Rice Stem borer, leaf folder & Green leaf hopper 50 500 500 21 Bifenthrin 2.5% EC (1) Pre and post construction. Acts as an insect juvenile hormone analogue that inhibits insect maturation processes. It is also used as a prevention for flea control on household pets, for killing indoor and outdoor ants and roaches. An issue is listed as a critical area of concern if there is enough information available to perform an assessment for the representative uses in line with the uniform principles in accordance with Article 29(6) of Regulation (EC) No 1107/2009 and as set out in Commission Regulation (EU) No 546/2011, and if this assessment does not permit the conclusion that, for at least one of the representative uses, it may be expected that a plant protection product containing the active substance will not have any harmful effect on human or animal health or on groundwater, or any unacceptable influence on the environment. EFSA also provided comments. Adequate methods are available for the generation of data required for the risk assessment except for the (old) toxicological studies, for which no information was submitted (data gap). All the metabolites identified at a level > 10% TRR were concluded to be not genotoxic (see Section 2). Metabolite 4’‐OH‐Pyr exhibited low to slight soil mobility, metabolite PYPAC exhibited very high soil mobility and metabolite DPH‐Pyr (a major metabolite in the aquatic compartment) exhibited medium to low soil mobility. Toluene is proposed as a relevant impurity therefore it is proposed that an update of the reference specification would be needed since in the current reference specification no relevant impurities are specified. In liver and kidney, it was extensively degraded into numerous minor metabolites and a significant fraction of radioactive residues being associated with proteins. The risk assessment conducted according to the Guidance Document on Terrestrial Ecotoxicology (European Commission, 2002a) indicated a low acute contact and acute oral risk to honeybees (all representative uses). From the representative uses, the livestock dietary burden calculation triggered investigation of pyriproxyfen residues in ruminants only. Mainly excreted in faeces but also in urine, the compound showed the highest concentrations in the liver, fat, kidney and blood, showing a potential for bioaccumulation. Pyriproxyfen residues in body tissues can be determined by using the monitoring method for residue in food of animal origin. Since the representative uses are not feed items for fish, metabolism and feeding studies are not required. If you do not receive an email within 10 minutes, your email address may not be registered, The following guidance documents were followed in the production of this conclusion: European Commission (2000a,b, 2010a). In laboratory incubations in dark aerobic natural sediment water systems, pyriproxyfen exhibited low persistence, forming the major metabolites 4’‐OH‐Pyr (max. The RMS considered unlikely that a significant change in isomeric composition would occur. 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