Document oeJdwqR8K3xMXLnRVX1n1LkZr

Comments on the Annex XV report proposing a restriction of PFAS - September 2023 Comments regarding the time unlimited derogation for active substances in plant protection products Summary In this document, Generations Futures provides data on the use of PFAS being active substances in phytopharmaceutical products (PPP) in France. We found that 30 PFAS are currently authorised as active substance in PPP in France. The volume sold of these 30 PFAS were 2297 tonnes in 2021. This accounted for 3.7% of the whole sales of pesticide active substances authorised in France. Thus, the estimation of the amount of PFAS used in PPP in UE of 5479 t/y indicated in the Annex XV report (Table A.65) may be underestimated. Among these 30 PFAS authorised in PPP in France, 9 (30%) are classified CMR and 7 (23%) are considered as substances candidate for substitution. Of the 9 PFAS substances in PPP most sold in France, 5 are candidates for substitution and 4 are classified as CMR. The restriction proposal currently provides for a time unlimited derogation for active substances in plant protection products, because they are regulated by a specific approval system under regulation 1107/2009. It is said that "Extensive environmental risk assessments are already conducted under the PPP-regulation". We disagree with this approach and are convinced that the REACh restriction is the best instrument to address these very problematic substances for the following reasons: 1. Spreading of plant protection products is an obvious direct source of contamination of the environment and is responsible for a widespread contamination. All environmental compartments are contaminated by these persistent active substances and their metabolites. We show in the document that many substances have persistent metabolites that have the potential for leaching into the groundwaters above the legal limit for drinking waters of 0,1 g/L. 2. The current regulation 1107/2009 is not adequately controlling the authorisation and the risks of PFAS active substances. We show that the risks associated with PFAS active substances in PPP are not addressed by regulation 1107/2009 to a level at least similar to the one afforded by a restriction for the following reasons: a) Regulation 1107/2009 does not regulate the manufacture of pesticides in Europe. It only regulates the authorisation for use in the EU. Many substances that have been forbidden in Europe are still manufactured in UE and then exported outside the UE, such as fipronil for instance. However, we know that the manufacture phase of PFAS is responsible for an important contamination of the environment through atmospheric emissions and water effluent as documented in the Annex XV report. The manufacture of "PFAS pesticides" is no exception and is also responsible for environmental contamination.1 The only way to restrict the manufacturing of these substances is therefore through a REACH restriction. 1 Generations Futures will have soon field data to illustrate the contamination of the environment due to the manufacture of PFAS pesticides active substances. Unfortunately, we do not have these data on time to submit them to the public consultation but we hope we will have the opportunity to submit these data to ECHA after the end of the consultation. Comments on the Annex XV report proposing a restriction of PFAS - September 2023 b) Persistency is not an exclusion criteria in Regulation 1107/2009 which means that persistent or very persistent substances or substances not considered as persistent but that have very persistent metabolites (e.g. flufenacet) may still be approved for 10 years and their approbation can be renewed. c) The substance by substance approach under Regulation 1107/2009, ignoring the cocktail effect, fundamentally conflicts with the environmental and health protection objective pursued by the Annex XV report. d) Serious shortcomings in the assessment and authorization process are highlighted following an analysis of the dossiers of the 10 PFAS pesticide active substance most widely used in France - Authorisations of these substances are granted or prolonged for many years even when critical areas of concern (i.e. no safe use has been demonstrated) have been identified by EFSA or the Rapporteur Member State (RMS). We show that the European Commission is going against EFSA's scientific advice by authorizing substances for which critical areas of concern have been identified (ex: lambda-cyhalothrin, flurochloridone) - Authorisations of these substances are granted or prolonged for many years even if many issues in the risk assessment have not been finalised. This is the case for all substances we have studied. We show that the European Commission authorised or prolonged the authorisations of substances without requesting additional data even though EFSA has identified such data as necessary to finalise the assessment (ex: flutianil, mefentrifluconazole, fluopicolide). - Diflufenican was considered as a PBT substance by the RMS, yet its authorisation has been prolonged for 5 years. - Flurochloridone was classified by ECHA as reprotoxic category 1B in 2018, yet its authorisation has been prolonged for 5 years - 6/10 substances have metabolites with potential for leaching to groundwaters above 0,1 g/L. It has therefore been demonstrated that the instruments in place with Regulation 1107/2009 do not afford the same level of environmental and health protection as an EU wide restriction. 3. Alternatives to the use of synthetic pesticide exist. agronomical, mechanical, physical and biological methods can be used in replacement of the use of pesticide without creating resistance. According to INRAE2, "pesticide-free farming would be possible thanks to: crop and landscape diversification, the development of biocontrol, the choice of suitable crops and varieties, prevention and anticipation of disease, crop pests and weeds, the use of digital technology and agricultural equipment". Pesticide use therefore can't be considered as essential In conclusion, the time unlimited derogation is not acceptable. Generations Futures asks for including these substances in the scope of the restriction. 2 https://www.inrae.fr/actualites/agriculture-europeenne-pesticides-2050 Comments on the Annex XV report proposing a restriction of PFAS - September 2023 1/ Data on sales volume of PFAS pesticides in France Dossier submitters identified 48 PFAS used as active substances in PPP. We found that among this list of 48 substances, 30 PFAS are authorised in France as active substance in PPP (ref: https://ephy.anses.fr/). Sales volume for the years 2020 and 2021 (last year for which data is available) are indicated in the following table. These data come from the national database on sales of phytopharmaceutical products BNVD: https://ventes-produits-phytopharmaceutiques.eaufrance.fr/ In 2021, a total of 2297 tonnes of "PFAS pesticides" were sold in France. This accounted for 3.7% of the whole sales of pesticide active substances authorised in France. CAS Number 958647-10-4 400882-07-7 142459-58-3 83164-33-4 658066-35-4 1417782-03-6 141517-21-7 91465-08-6 61213-25-0 239110-15-7 79622-59-6 102851-06-9 79538-32-2 141112-29-0 158062-67-0 142469-14-5 112281-77-3 137641-05-5 79241-46-6 (83066-88-0) 66332-96-5 335104-84-2 180409-60-3 126535-15-7 1003318-67-9 422556-08-9 94125-34-5 104040-78-0 113614-08-7 219714-96-2 183675-82-3 Total Name Pesticide flutianil cyflumetofene flufenacet diflufenican fluopyram mfentrifluconazole trifloxystrobine lambda cyhalothrine flurochloridone fluopicolide fluazinam tau-fluvalinate tefluthrine isoxaflutole flonicamid tritosulfuron tetraconazole picolinafen Fongicide Acaricide Herbicide Herbicide Fongicide Fongicide Fongicide Insecticide Herbicide Fongicide Fongicide Insecticide Insecticide Herbicide Insecticide Herbicide Fongicide Herbicide fluazifop P butyl Herbicide flutolanil tembotrione cyflufenamid triflusulfuron-methyle oxathiapiprolin pyroxsulame prosulfuron flazasulfuron beflubutamid penoxsulame penthiopyrad Fongicide Herbicide Fongicide Herbicide Fongicide Herbicide Herbicide Herbicide Herbicide Herbicide Fongicide Sales in France in 2020 (kg) Sales in France in 2021 (kg) no data available no data available 673 849 499 397 141 873 58 979 90 312 80 021 102 794 59 493 54 356 49 423 51 309 46 384 64 710 29 566 28 795 21 974 no data available no data available 803 808 560 875 137 242 110 059 94 198 79 732 70 298 61 303 60 677 47 674 46 171 40 028 34 882 27 856 25 845 19 224 14 519 15 197 12 876 10 618 8 881 7 484 6 187 8 562 3 824 5 154 2 802 1 117 2135 tonnes 11 334 9 754 8 618 7 162 6 227 5 968 5 577 4 278 2 630 689 21 2297 tonnes Comments on the Annex XV report proposing a restriction of PFAS - September 2023 2/ Data regarding the classification as CMR and candidate for the substitution Among the 30 PFAS pesticides authorised in France, 9 (30%) are classified CMR: 8 are classified CMR category 2 and one is classified reprotoxic, category 1B CAS Number 400882-07-7 141517-21-7 61213-25-0 239110-15-7 79622-59-6 141112-29-0 79241-46-6 (83066-88-0) 335104-84-2 126535-15-7 Name cyflumetofene trifloxystrobine flurochloridone fluopicolide fluazinam isoxaflutole fluazifop P butyl tembotrione triflusulfuron-methyle Classification CMR H351 H362 H360fd H361d H361d H361d H361d H361d H351 Among the 30 PFAS pesticides authorised in France, 7 (23%) are considered as substance candidate for the substitution. CAS Number 142459-58-3 83164-33-4 91465-08-6 61213-25-0 239110-15-7 335104-84-2 94125-34-5 Name flufenacet diflufenican lambda cyhalothrine flurochloridone fluopicolide tembotrione prosulfuron Reason two PBT criteria two PBT criteria low ADI / ARfD / AOEL, two PBT criteria toxic for reproduction 1A / 1B two PBT criteria low ADI / ARfD / AOEL two PBT criteria Comments on the Annex XV report proposing a restriction of PFAS - September 2023 3/ Assessment of the authorisation dossier for 10 substances We have studied in detail the authorisation dossiers for 10 PFAS pesticides: we have selected the 9 most widely sold substances in France and flutianil, whose marketing authorisation is recent (2019). To carry out this assessment, we studied, for each substance, the Renewal Assessment Reports (RAR), the EFSA peer reviews and the review reports from the European Commission. In particular, we looked at data on the substance's persistency and the risk of leaching into groundwater. We also looked at whether EFSA had identified any "critical areas of concern" or "issues that could not be finalised", and if so, how these identified problems were considered by the Commission. Here are the definition of the terms "critical area of concern" and "issue that could not be finalised" according to EFSA. According to these definitions, when critical are of concern or issue that could not be finalised are identified, the substance does not meet the criteria approval, or it is not possible to know if approval criteria are met. Critical area of concern: "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 the Regulation 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. 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. An issue is also listed as a critical area of concern if, in the light of current scientific and technical knowledge using guidance documents available at the time of application, the active substance is not expected to meet the approval criteria provided for in Article 4 of the Regulation." Issue that could not be finalised: "An issue is listed as `could not be finalised' if there is not enough information available to perform an assessment, even at the lowest tier level, for the representative uses in line with the uniform principles in accordance with Article 29(6) of the Regulation and as set out in Commission Regulation (EU)No 546/20113 and if the issue is of such importance that it could, when finalised, become a concern (which would also be listed as a critical area of concern if it is of relevance to all representative uses). An issue is also listed as `could not be finalised' if the available information is considered insufficient to conclude on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of the Regulation". We identified Serious shortcomings in the assessment and authorisation process for the 10 PFAS pesticide we have studied (see below the details for each substance) An overview of the issues found in the dossiers are summarised in the following table. Comments on the Annex XV report proposing a restriction of PFAS - September 2023 Overview of the main issues of the 10 substances for which we have analysed the authorisation dossier: Substance flutianil flufenacet Candidate for substitution ? No Yes Classification CLP H400/H410 H400/H410 H373 H317 H302 Persistency(1) ? Persistent Metabolite OC 56635: Very persistent Metabolite TFA : Very persistent Risk of contamination of groundwater above 0.1g/L? Yes (Metabolites OC 56635 and 53276) Yes (Metabolites FOE Oxalate, FOE Sulfonic acid, FOE Methylsulfon, FOE 5043 Trifluoroethanesulfonic acid, Trifuloroacetic acid - TFA) (TFA > 0.75 g/L for all uses) Critical area of concern identified by EFSA? No No EFSA peer review available Issue that could not be finalised identified by EFSA? Yes No EFSA peer review available diflufenican Yes H400/H410 Very persistent fluopyram No mfentrifluconazole No H411 H400/H410 H317 Very persistent Very persistent trifloxystrobin No H400/H410 H362 Not persistent lambda Yes cyhalothrine flurochloridone Yes fluopicolide Yes H400/H410 H301, H312, H330 H400/H410 H360fd H317, H302 H361d Not persistent Not persistent Very persistent fluazinam No H400/H410 H361d H318, H317, H332 (1)According to REACh Annex XIII criteria Metabolite HYPA : persistent Yes (Metabolite AE B107137) No No Yes (Metabolites CGA 321113, NOA 413161 NOA 413163) No No recent ESFA peer review available RMS estimates diflufenican is PBT No No Yes Yes No recent EFSA peer review available. Issue that could not be finalised identified by the RMS in the RAR Yes Yes Yes Yes Yes (Metabolite R42819) Yes (Metabolite M15) No Yes Yes Yes No recent EFSA peer review available. Criteria area of concern identified by the RMS in the RAR Yes No recent EFSA peer review available. Issue that could not be finalised identified by the RMS in the RAR Flutianil: Comments on the Annex XV report proposing a restriction of PFAS - September 2023 Issues that could not be finalised identified by EFSA: 1/ The assessment of the potential endocrine disrupting properties of flutianil for non-target organisms other than wild mammals according to point 3.8.2 of Annex II to Regulation (EC)No 1107/2009, as amended by Commission Regulation (EU) 2018/605, could not be finalised (EFSA, 2022) 2/ The consumer risk assessment is not finalised with regard to residues of the highly persistent soil metabolite OC 56635. Preliminary data suggest a preferential uptake of significant proportions of OC 56635 from the soil into the crops (relevant for residues) (EFSA, 2018) 3/ The consumer risk assessment is not finalised with regard to residues of metabolite OC56635 for the use on grapevines and OC 53276 for the use on grapevines and ornamentals, in situations where groundwater is used as drinking water. Therefore, the relevance assessment of these metabolites for groundwater in accordance with European Commission (2003) guidance was not finalised (relevant for environmental fate and behaviour) (EFSA, 2018) 4/ The consumer risk assessment is not finalised with regard to the unknown nature of residues that might be present in drinking water, consequent to water treatment following abstraction of surface and groundwater water that might contain metabolites OC 56635, AP5A and OC53276 (relevant for environmental fate and behaviour) (EFSA, 2018) Other issues: As the metabolites of flutianil have the potential to leach towards groundwater in concentrations above 0.1 g/L, a consumer risk assessment has been performed by EFSA. An ADI of 0.02 g/kg b.w was derived for the metabolite OC 53276 based on a Toxicological Threshold of Concern (TTC) approach. Estimated intakes by adults are below 0.02g/kg bw per day but are above for toddlers and infants alone due to the consumption of drinking water. EFSA concluded that "the consumer risk assessment cannot be finalised without toxicological reference values for OC 53276. This leads to the concern that the groundwater relevance assessment for OC 53276 cannot be finalised." The commission said in its review report "However, the exceedance of the ADI is only by a factor 2.4 (toddlers) and 3.6 (infant) and the threshold of 0.02 g/kg bw per day used for risk assessment of groundwater metabolites is actually much more severe than the non-genotoxicity trigger of 1.5 g/kg b.w./d recommended for dietary risk assessment of metabolites. Therefore, the groundwater risk assessment can be considered sufficiently conservative". No additional data has been asked by the Commission to refine the assessment. This is not what has recommended EFSA, who concluded that the consumer assessment cannot be finalised and who identified as data gap: a "Repeated-dose toxicity of metabolite OC 53276 relevant to consumer exposure (relevant for all representative uses evaluated)". Flutianil was approved for the first time in 2019 even though: - a potential risk for toddlers and infant due to the consumption of drinking water was identified by EFSA and a refinement of the assessment was not possible. No additional data has been requested by the Commission even though a data gap has clearly been identified by EFSA - the consumer risk assessment was not finalised - the endocrine disruption assessment for non-target organisms other than wild mammals was not finalised References: *EFSA Peer Review, 2014 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2014.3805 Comments on the Annex XV report proposing a restriction of PFAS - September 2023 *Statement on the impact of the harmonised classification on the conclusion on the peer review of the pesticide risk assessment of the active substance flutianil, 2018 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5383 *Peer review in light of confirmatory data on the endocrine disruption assessment, 2022 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2022.7455 * Review report, 2019 https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/start/screen/active-substances/details/1059 Flufenacet: Initially approved from 2004 to 2013, the authorisation has been prolonged 8 times for almost 10 years (until 31/10/2023) without any EFSA peer review being published. However, flufenacet is a candidate for substitution and according to the RAR, there is a concern regarding the contamination of groundwater by flufenacet metabolites (TFA is predicted into groundwater at levels above 0,75 g/L for all representatives uses in all FOCUS scenarios and above 10 g/L in some scenarios for all uses) References: *Renewal Assessment Report, 2017 https://www.efsa.europa.eu/en/consultations/call/170920 Diflufenican: Initially approved from 2009 to 2018, the authorisation has been prolonged for 5 years (until 31/12/2023) The only EFSA peer review available is from 2008. DIflufenican is a candidate for substitution because it fulfils the criteria P and T of the PBT assessment. According to the RAR of 2018 (Vol 1, p.203), Diflufenican also fulfils the B criteria: "The active substance fulfils the bioaccumulation criterion as the bio concentration factor for aquatic species is > 2000 (Fish, 5 % lipid normalised BCFgeomean = 2064). RMS explains p. 146: "With regard to setting the appropriate BCF value for consideration of the PBT criteria this value would exceed the trigger value (BCF > 2000) and establish the substance as `bioaccumulative' according to Reg. (EC) 1107/2009 (the substance is also considered to meet the `persistence' and `toxicity' criteria). However, according to guidance on identifying substances according to the PBT criteria it is recommended to establish a geometric mean BCF value (BCFgeomean) when multiple studies are available for the same taxonomic group of organisms. The guidance does not specify how to address the case where multiple endpoints are available from the same study, due to testing multiple concentrations, as is the case for both of the available studies. Unless it can be confirmed that the BCF estimates are not concentration dependent the RMS proposes that the BCFgeomean should be based on the worst-case value available from each of the valid studies (BCFs = 1650 and 2583 from the treatments at 3 g a.s./L). The resulting geometric mean BCFgeomean = 2064; this value also exceeds the PBT criteria (BCF > 2000) and therefore the active substance would meet all three criteria to be defined as a PBT substance. It is noted that: 1) If concentration dependence does not apply the BCFgeomean could be established from a mean derived from the whole data set (e.g. BCFgeomean = 1971) and the PBT criteria would not be met. Comments on the Annex XV report proposing a restriction of PFAS - September 2023 2) The Applicant(s) have questioned the suitability of the study (2008). However, based on the currently available information the RMS does not consider any change to the interpretation of the study is required. More information may be provided during the commenting period. Given the uncertainty an expert discussion is recommended with regard to the BCF estimate for consideration of the PBT criteria. The BCF estimate proposed by the RMS, in relation to consideration of the PBT criteria, is BCFgeomean = 2064. If concentration dependence does not apply the BCFgeomean could be established from a mean derived from the whole data set (e.g. BCFgeomean = 1971) and the PBT criteria would not be met. Given the uncertainty an expert discussion is recommended with regard to the BCF estimate for consideration of the PBT criteria. The BCF estimate proposed by the RMS, in relation to consideration of the PBT criteria, is BCFgeomean = 2064" Approval of diflufenican expired in 2018 but was prolonged for 5 years even though - It is a candidate for substitution (P and T criteria met) - The RMS estimates in 2018 that diflufenican is a PBT substance because the B criteria is also met. An expert discussion has been recommended to state if BCF = 2064 or 1971! References: *Renewal Assessment Report, 2018: https://www.efsa.europa.eu/fr/consultations/call/181009 Fluopyram: Issue that could not be finalised identified by EFSA: *The assessment of the potential endocrine disruptor effects in birds and fish could not be finalised (EFSA, 2013) *No data were provided to address the potential for causing endocrine disrupting effects in non-target vertebrates other than mammals. (EFSA, 2018) Other issues: A high long-term risk to insectivorous birds was identified by EFSA in its peer review in 2013 for the uses on strawberries and tomato. These uses were however authorised for 5 years, from 2014 to 2019, pending confirmatory data are submitted to refine the assessment for birds. Theses 2 uses were finally withdrawal in 2019 only, because "The confirmatory data provided for addressing the risk to insectivorous birds were not sufficient to resolve the high risk previously identified to birds for the uses in strawberries and tomatoes." (EFSA, 2018) Fluopyram was approved for the first time in 2014 even though the assessment of the potential endocrine disruptor effects in birds and fish could not be finalised. This assessment still can't be finalised after submission of confirmatory data. Field uses of Fluopyram on strawberries and tomato were authorised for 5 years from 2014 to 2019 even though a high long-term risk to insectivorous birds was identified by EFSA for these uses. References: *EFSA peer review, 2013 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2013.3052 *Outcome of the consultation on confirmatory data used in risk assessment for fluopyram, 2018 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2018.EN-1359 Comments on the Annex XV report proposing a restriction of PFAS - September 2023 *Review reports 2013, 2019 https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/start/screen/active-substances/details/723 Mefentrifluconazole: Issue that could not be finalised identified by EFSA: *The consumer risk assessment is not finalised with regard to the unknown nature of residues that might be present in drinking water, consequent to water treatment following abstraction of surface water that might contain mefentrifluconazole and its metabolites (EFSA, 2018) *No final conclusion could be drawn with regard to endocrine disruption in fish (EFSA, 2018) Other issue: EFSA could not finalised the ED assessment for fish and identified this issue as an "issue that could not be finalised". EFSA explained in its peer review that: "a fish full life cycle test (FFLC) and a test according to OECD TG 234 were submitted in order to address potential endocrine effects on fish. In the FFLC, effects on reproduction and growth were observed at the highest tested concentration of 45.5g a.s./L. However, the available FFLC lacks important ED-related parameters such as vitellogenin levels, and oestrogen level in females. The available test according to OECD TG 234 does not cover the reproductive life stages of fish. Considering the results of in vitro data (positive for aromatase inhibition) further information, e.g. a test according to OECD 229, should be provided in order to draw a firm conclusion the endocrine potential of mefentrifluconazole in fish " EFSA therefore clearly identified as data gap that "Further information on endocrine disruption in fish, e.g. a test according to OECD 229, should be provided" However, the Commission authorised the substance without asking for complementary data, and therefore without following the EFSA's scientific advice: "The EFSA Conclusion indicates that mefentrifluconazole shows a weak inhibition of aromatase activity in vitro which did not translate into any relevant adverse effects in vivo, and that overall it is unlikely to have endocrine disrupting properties regarding estrogen, androgen, thyroid and steroidogenesis modalities for humans. For fish, mefentrifluconazole was tested in the fish sexual development test (FSDT, OECD 234) which addresses effects on steroidogenesis (especially aromatase inhibition), including vitellogenin levels and did not show major concerns. Overall, the issues raised by EFSA concerning the reproductive life stages of fish are addressed by the fish life cycle toxicity test (FLCTT OPPTS 850.1500) and by the additional fish early life stage toxicity test (OECD TG 210) which do not highlight any relevant adverse effects. Hence, further screening assays such as the fish short term reproductive assay (OECD TG 229) as suggested by EFSA, appear to be unnecessary". Mefentrifluconazole was approved for the first time in 2019 even though: - the consumer risk assessment was not finalised - No final conclusion could be drawn with regard to endocrine disruption in fish. The Commission authorised the substance without requesting any additional data, going against EFSA's opinion, which considered that further information (e.g. a test according to OECD 229) was necessary in order to draw a final conclusion regarding endocrine disruption in fish. References: *EFSA peer review, 2018: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5379 Comments on the Annex XV report proposing a restriction of PFAS - September 2023 *Review report, 2019 and 2021 https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/start/screen/active-substances/details/1332 Trifloxystrobin: Critical area of concern identified by EFSA: * Trifloxystrobin is proposed by the pesticide peer review to be classified as toxic for reproduction category 2, in accordance with the provisions of Regulation (EC) No 1272/2008 and toxic effects on the endocrine organs have been observed in the available data; therefore the conditions of the interim provisions of Annex II, Point 3.6.5 of Regulation (EC)No 1107/2009 concerning human health for the consideration of endocrine disrupting properties may be met (see Section2). However, following a scientific assessment trifloxystrobin is considered unlikely to be an endocrine disruptor in mammals. (EFSA, 2018) * CGA 321113, NOA 413161 and NOA 413163 are considered relevant metabolites in groundwater according to SANCO/221/2000 guidance since it cannot be excluded that they will share the potential of trifloxystrobin for reproductive toxicity. The available ground water exposure assessment indicated that 80th percentile annual average recharge concentrations moving below the top 1 m soil layer for these three metabolites would be above the parametric drinking water limit of 0.1lg/L (that applies to groundwater relevant metabolites) in geoclimatic situations that are represented by all nine FOCUS ground water scenarios considering all the representative uses (EFSA, 2018) Issue that could not be finalised identified by EFSA: *The consumer risk assessment from the consumption of drinking water could not be finalised, while satisfactory information was not available to address the effect of water treatment processes on the nature of the residues that might be present in surface water or groundwater, when surface water or groundwater are abstracted for drinking water and the consumer risk assessment has to be regarded as provisional pending upon the toxicological assessment of CGA 357262, CGA 357261, CGA 331409 and CGA 321113 that have been included in the residue definition for risk assessment for plants with CGA 321113 also having been included in residue definition for risk assessment for animal commodities Other issue: Classification for reproduction in category 2 is a key issue for the authorisation of trifloxystrobin. Indeed, if the classification is confirmed, the metabolites of trifloxystrobin have to be considered as relevant. The substance can't be authorised if these metabolites are considered as relevant because they are predicted in groundwater at levels above the drinking water limit of 0.1 g/L for all uses. EFSA peer review proposed to classify trifloxystrobin as toxic for reproduction category 2 in 2018. During the public consultation on the harmonised classification of trifloxystrobin, 2 Members States (France and Germany) agree with EFSA and propose to classify trifloxystrobin as toxic for reproduction category 2. However, ECHA did not follow EFSA's opinion and did not classify trifloxystrobin as reprotoxic, which allowed the substance to be authorised. To conclude to the no classification, ECHA relied on confidential data provided by Bayer during the public consultation phase. Trifloxystrobin was approved in 2018 for the second time for 15 years even though - The consumer risk assessment was not finalised - EFSA and 2 Member States (France and Germany) were of opinion to classifiy trifloxystrobin as reprotoxic of category 2, which would have led to a ban of the substance due to contamination of groundwater above the legal limit by relevant metabolites. However, ECHA did not classify (and the metabolites are thus considered non relevant) on the basis of confidential data provided by Bayer during the public consultation phase. Comments on the Annex XV report proposing a restriction of PFAS - September 2023 References: *EFSA peer review, 2017: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4989 *Review report, 2018: https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/start/screen/active-substances/details/176 *Response to comments document (RCOM) to the Opinion proposing harmonised classification, 2019 https://echa.europa.eu/documents/10162/2953f945-4621-bb1a-5911-037182cc8263 Lambda-cyhalothrin Critical areas of concern identified by EFSA in 2014: *It could not be fully demonstrated that the batches used in the toxicological and ecotoxicological studies are compliant to the proposed technical specification, as it appears that some impurities have not been tested (or not at an appropriate level) in the toxicological studies. *A high acute and chronic risk to aquatic organisms was indicated for all representative uses, even when, where available, the risk assessment was performed using exposure estimates which assumed the maximum permissible risk mitigation according to the FOCUS Landscape and Mitigation Guidance Document (FOCUS, 2007) Issues that could not be finalised identified by EFSA in 2014: *An endocrine-mediated mode of action could not be ruled out regarding the brain morphological changes observed in the developmental neurotoxicity study (and possible sperm effects, which have to be clarified in the first place) and the potential for endocrine disrupting effects could not be finalised (see Sections 2 and 5). *The consumer risk assessment could not be finalised as the proposed residue definition for risk assessment remains provisional for processed commodities and considering the uncertainties due to the identified data gaps. *A complete route of degradation of lambda-cyhalothrin in the aquatic compartment could not be finalised as satisfactory information to address the levels of metabolites formed from the phenoxy-14C labelled lambdacyhalothrin when applied at doses below the water solubility is not available. Consequently, the risk to aquatic organisms from any additional pertinent metabolites could not be finalised. Other issues: *34 other data gaps were identified by EFSA in the authorisation dossier *The Commission did not follow the EFSA opinion regarding the high risk to aquatic organisms: While EFSA considered as critical area of concern the high risk for aquatic organisms identified for all representative uses, the Commission said that "Using a weight of evidence approach [...], the risk to the aquatic compartment is considered acceptable." * Lambda cyhalothrin is a neurotoxic with brain morphological changes observed in the developmental neurotoxicity study. The acceptable operator exposure level (AOEL) is very low (0,63 g/kg/bw) and the bystander risk assessment is acceptable only if bystanders remain at a minimal distance of 10 m from the spray application. This a risk management measure not applicable in practice because bystanders are not aware of the nature and the moment of the treatment. Lambda-cyhalothrin was approved for the second time in 2016 for 7 years and the approval was prolonged of 1 year until 31/03/2024 even though: Comments on the Annex XV report proposing a restriction of PFAS - September 2023 - It is a candidate for substitution because it is bioaccumulative and toxic and because ADI and AOEL values are very low; - Lambda cyhalothrin is a neurotic with a risk identified for bystanders if they remain between 3 to 10 meters from the spray application; - 2 critical areas of concern were identified by EFSA in 2014, including a high risk for aquatic organisms for all representative uses. However, the commission considered that the risk is acceptable thus going against the EFSA opinion, which clearly concludes that there is a high risk; - the ED assessment for non target organisms was not finalised; - The consumer risk assessment was not finalised; - The risk assessment for aquatic organisms of metabolites of lambda-cyhalothrin was not finalised; - Many data gaps (34) were identified; References: EFSA peer review, 2014: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2014.3677 Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for lambdacyhalothrin in light of confirmatory data, 2020 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2020.EN-1883 Review reports, 2016 and 2020: https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/start/screen/active-substances/details/259 Flurochloridone Critical areas of concern identified by EFSA in 2010: *A high risk to algae was identified for the representative uses based on the available data (EFSA Peer review, 2010) *It has not been demonstrated that the test material used in the ecotoxicity studies is representative of the technical specification (Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance flurochloridone, 2013). The Commission said in the review report of 2015 that according to the outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment of confirmatory data for the active substance flurochloridone : "the specification of the technical material, as commercially manufactured, is equivalent to that of the test material used in the ecotoxicity dossiers". However, no discussion regarding this issue is present in this outcome! The Commission therefore did not follow the conclusions of EFSA regarding this issue. Issue that could not be finalised identified by EFSA: *Based on the data available it was not possible to address the potential risk to birds and fish from FLC acting as endocrine disruptor Other issue: *In 2018, flurochloridone was classified by ECHA as reprotoxic category 1B, which is an exclusion criteria according to article 4 of Regulation 1107/2009. However, the authorisation of flurochloridone was prolonged 3 times (in 2021, 2022 and 2023) until 15/03/2026, for a total of 5 years of prolongation. Flurochloridone was approved for the first time in 2011 even though: Comments on the Annex XV report proposing a restriction of PFAS - September 2023 - A high risk for algae for all representative uses was identified and considered as a critical area of concern by EFSA in 2010 - It has not been demonstrated that the test material used in the ecotoxicity studies is representative of the technical specification. This has been identified as a critical area of concern after the submission of confirmatory data in 2013. The Commission did not follow the opinion of EFSA on this issue Approval of flurochloridone was prolonged 3 times (in 2021, 2022 and 2023) until 15/03/2026, for a total of 5 years of prolongation even though flurochloridone was classified by ECHA as reprotoxic category 1B in 2018. References: *EFSA peer review, 2010 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2010.1869 *Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance flurochloridone, 2013 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2013.3116 *Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment of confirmatory data for the active substance flurochloridone, 2014 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2014.EN-642 *Review reports, 2011 and 2015 https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/start/screen/active-substances/details/733 *RAC Opinion proposing harmonised classification, 2018 https://echa.europa.eu/documents/10162/f186167a-b346-82dc-f237-fc8f580416b2 Fluopicolide Critical area of concern identified by EFSA in 2009: *Fluopicolide has potential for long range transport through the atmosphere when applied by spraying as for the representative uses evaluated. *Potential risk of ground water contamination above the regulatory limit of 0.1 g/L. Ground water assessment of lysimeter metabolite M15 needs to be finalized (found at annual average concentrations of up to 0.095 g/L). In 2014, confirmatory data were submitted by the applicant and assessed by the RMS who concluded that: "The annual average concentration of M15 does not exceed the regulatory endpoint of 0.1 g/l and secondly that it is not a metabolite of toxicological concern. Therefore, the RMS agrees with the Notifier that M15 is a non-relevant metabolite in groundwater and thus no further regulatory testing is required according to EU guidelines". However, in the outcome EFSA disagrees with the RMS conclusions and said that they "would not support this conclusion. If the lysimeter study duration had been longer it is extremely likely that the regulatory endpoint of 0.1 g/L would have been exceeded. No new toxicological information has been provided over and above that which was already available in the EFSA conclusion. With this available information risk managers chose to set a confirmatory data requirement". EFSA also explains "No new information is presented now compared to that which was already reported in the EFSA conclusion. In light of this available information the Commission asked for further data to be provided. Such data have not been provided. In a lysimeter study dosed with the amount of the potato representative use (400g/ha) annual average concentrations in lysimeter leachate were 0.095g/L in the third Comments on the Annex XV report proposing a restriction of PFAS - September 2023 year which was the last year of the experiment, with there being no evidence that if sampling had continued into a fourth year, concentrations in leachate would not have continued to increase. Considering the persistence of fluopicolide as precursor of M15, increasing M15 in year 4 and beyond is the outcome that would be expected, if the lysimeter study had been of a longer duration. The lysimeter study was simply too short to conclude that concentrations of the metabolite M15 will be < 0.1g/L." The commission does not follow the opinion of EFSA in its review report and only recommends that "Member States must pay particular attention to protect groundwater" But, in 2020, RAC classified fluopicolide as reprotoxic category 2. As no toxicological information had been provided on metabolite M15, it has now to be considered as relevant according to SANCO 221/2000. Moreover, as EFSA said, it is expected that concentration of M15 will be above the legal limit for relevant metabolite after the fourth year of application. Fluopicolide can't therefore be authorised according to regulation 1107/2009 and SANCO 221/2000. Approval of fluopicolide expired in 2020 but was prolonged for more than 6 years until 31/08/2026 even though: - It is a candidate for substitution (P and T criteria met) - It has the potential for long range transport through the atmosphere when applied by spraying - Metabolite M15, which has to be considered as relevant since fluopicolide is classified as reprotoxic category 2, is expected in groundwater at concentrations above the legal limit for relevant metabolite, according to EFSA. The Commission did not follow the opinion of EFSA on this issue. References: EFSA Peer review, 2009: https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2009.299r Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment of confirmatory data for the active substance fluopicolide https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2014.EN-626 Review reports, 2010 and 2019 https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/start/screen/active-substances/details/722 RAC Opinion proposing harmonised classification, 2020 https://echa.europa.eu/documents/10162/1c55dfdf-c987-e252-abf6-98c3a28dae0b Fluazinam No recent EFSA peer review is available. In the RAR of 2019, the RMS identified one critical area of concern: "A high long-term risk to mammals was identified for the intended uses in potatoes" RMS also identified 11 issues that could not be finalised including: - A high long-term risk to earthworm-eating mammals was identified - A high long-term risk earthworms was identified for the intended uses in potatoes In conclusion, the RMS considered that Article 4 of Regulation (EC) No 1107/2009 is not complied with fluazinam for at least one of the representative uses. Comments on the Annex XV report proposing a restriction of PFAS - September 2023 Approval of fluazinam expired in 2019 but was prolonged for 5 years until 29/02/2024 even though: - No EFSA peer review is available since 2008 - The RMS identified in 2019 in the RAR a high long-term risk to mammals for all representative uses (this is a critical area of concern) and considered that Article 4 of Regulation (EC) No 1107/2009 is not complied with fluazinam for at least one of the representative uses. References: RAR, 2019: https://www.efsa.europa.eu/fr/consultations/call/public-consultation-active-substance-fluazinam