Learn more: PMC Disclaimer | PMC Copyright Notice
Setting of import tolerance for pyraclostrobin in papayas
Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in papayas imported from Brazil. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for papayas. Adequate analytical methods for enforcement are available to control the residues of pyraclostrobin on the commodity under consideration at or above the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of pyraclostrobin on papayas imported from Brazil according to the reported agricultural practices is unlikely to present a risk to consumer health.
Summary
In accordance with Article 6 of Regulation (EC) No 396/2005, BASF SE submitted an application to the competent national authority in Germany (rapporteur Member State, EMS) to set an import tolerance for the active substance pyraclostrobin in papayas.
The application, alongside the dossier containing the supporting data in IUCLID format, was submitted through the EFSA Central Submission System on 13 July 2021. The appointed EMS Germany assessed the dossier and declared its admissibility on 24 March 2022. Subsequently, following the implementation of the EFSA's confidentiality decision, the non‐confidential version of the dossier was published by the European Food Safety Authority (EFSA), and a public consultation launched on the dossier. The consultation aimed to consult stakeholders and the public on the scientific data, studies, and other information part of, or supporting, the submitted application, in order to identify whether other relevant scientific data or studies are available. The consultation run from 18 October 2022 to 8 November 2022. No additional data nor comments were submitted in the framework of the consultation.
At the end of the commenting period, the EMS proceeded drafting the evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 7 February 2023. The EMS proposed to establish maximum residue level (MRL) for papayas imported from Brazil at the level of 0.6 mg/kg. The MRL in place for pyraclostrobin on papayas in Brazil is 0.5 mg/kg.
EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified points which needed further clarification, which were requested from the EMS. On 3 March 2023, the applicant provided the requested information in an updated IUCLID dossier. The additional information was duly considered by the EMS who submitted a revised evaluation report to EFSA on 27 March 2023, which replaced the previously submitted evaluation report.
Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the data evaluated under previous MRL assessments, and the additional data provided by the EMS in the framework of this application, the following conclusions are derived.
The metabolism of pyraclostrobin following foliar application was investigated in crops belonging to the groups of root vegetables (potatoes), fruits (grapes) and cereals (wheat, paddy rice). Studies investigating the effect of processing on the nature of pyraclostrobin (hydrolysis studies) demonstrated that the active substance is stable. As the proposed use of pyraclostrobin is on imported and permanent crops, investigations of residues in rotational crops are not required. Based on the metabolic pattern identified in metabolism studies, hydrolysis studies, the general residue definitions for plant products were proposed as pyraclostrobin for enforcement and risk assessment. These residue definitions are applicable to primary crops, rotational crops, and processed products. EFSA concluded that for the crops assessed in this application, metabolism of pyraclostrobin in primary crops and the possible degradation in processed products has been sufficiently addressed and that the previously derived residue definitions are applicable.
Sufficiently validated analytical methods based on liquid chromatography with tandem mass spectrometry (LC–MS/MS) are available to quantify residues in papayas according to the enforcement residue definition. The methods enable the quantification of residues at or above 0.01 mg/kg in the crops assessed (limit of quantification – LOQ). According to the EMS, extraction efficiency of the analytical enforcement method has been sufficiently demonstrated according to the guidance SANTE/2017/10632 in the context of the renewal assessment report (Germany, 2001), and remains relevant for this application. EFSA would recommend that data on extraction efficiency for all types of matrices are further considered and confirmed in the framework of the ongoing peer review for the renewal of the active substance.
The available residue trials are sufficient to derive an MRL proposal for papayas. A risk management decision is required on whether to set the MRL at the level established in Brazil (0.5 mg/kg) or as calculated applying the OECD methodology (0.6 mg/kg).
Specific studies investigating the magnitude of pyraclostrobin residues in processed commodities were not submitted and are not required, considering the low individual contribution of the processed products prepared from the crop under consideration to the overall dietary consumer exposure. Residues of pyraclostrobin in commodities of animal origin were not assessed since the crop under consideration in this MRL application is normally not fed to livestock.
The toxicological profile of pyraclostrobin was assessed in the framework of the EU pesticides peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.03 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.03 mg/kg bw.
The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). The acute exposure calculation performed on the crop under consideration did not identify acute consumer intake concerns related to the notified use of pyraclostrobin on papayas in Brazil (maximum 35.3% of the ARfD). For the calculation of the chronic exposure, EFSA used the median residue values (STMR) as derived from the residue trials submitted and the STMRs available from previously issued EFSA opinions. The existing MRL was used for table grapes and for the products of animal origin. No long‐term consumer intake concerns were identified for any of the European diets incorporated in EFSA PRIMo. The estimated long‐term dietary intake accounted for a maximum of 32% of the ADI (NL toddler diet). The contribution of residues expected in papayas to the overall long‐term exposure was low and accounted for a maximum of 0.002% of ADI (SE general diet).
EFSA concluded that the use of pyraclostrobin on papayas authorised in Brazil assessed in this MRL application will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health.
The EU peer review of the active substance in accordance with Regulation (EC) No 1107/2009 is ongoing and therefore the conclusions reported in this reasoned opinion might need to be reconsidered in the light of the outcome of the peer review.
EFSA proposes to amend the existing MRL as reported in the summary table below.
Full details of all end points and the consumer risk assessment can be found in Appendices B–D.
Code (a) | Commodity | Existing EU MRL (mg/kg) | Proposed EU MRL (mg/kg) | Comment/justification |
---|---|---|---|---|
Enforcement residue definition: Pyraclostrobin (F) | ||||
0163040 | Papayas | 0.07 |
0.5 or 0.6 Further risk management considerations required |
The submitted data are sufficient to derive an import tolerance (Brazilian GAP). Based on the residue trials on papayas submitted an MRL of 0.6 mg/kg is derived with the OECD calculator. The MRL set in Brazil for papayas is lower, 0.5 mg/kg. In the residue trials on papayas, the highest residue level was 0.25 mg/kg, which is half the Brazilian MRL. Risk management decision is required on whether to set the MRL at the level established in Brazil (0.5 mg/kg) or as calculated applying the OECD methodology (0.6 mg/kg). Risk for consumers is unlikely. |
MRL: maximum residue level; GAP: Good Agricultural Practice.
Assessment
The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in papayas. The detailed description of the use of pyraclostrobin authorised in Brazil in papayas, which is the basis for the import tolerance application, is reported in Appendix A.
Pyraclostrobin is the ISO common name for methyl 2‐[1‐(4‐chlorophenyl)‐1H‐pyrazol‐3‐yloxymethyl]‐N‐methoxycarbanilate (IUPAC). The chemical structures of the active substance and its main metabolite are reported in Appendix E.
Pyraclostrobin was evaluated in the framework of Directive 91/414/EEC 1 with Germany designated as rapporteur Member State (RMS) for the representative uses as a foliar application on grapes. The draft assessment report (DAR) prepared by the RMS was not peer reviewed by EFSA. Therefore, no EFSA conclusion is available. Pyraclostrobin was approved 2 for the use as fungicide on 1 June 2004. In 2009, the approval for pyraclostrobin was extended to be used as a plant growth regulator. 3 The process of renewal of the first approval is currently ongoing.
The EU MRLs for pyraclostrobin are established in Annex II of Regulation (EC) No 396/2005 4 . The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2011b) and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA has issued several reasoned opinions on the modification of MRLs for pyraclostrobin (EFSA, 2011a, 2012a, 2013, 2014a,b, 2016, 2017, 2018a,c,d, 2019a). Furthermore, the evaluation of the MRL review confirmatory data on pyraclostrobin was performed in 2018 (EFSA 2018b). The proposals from these reasoned opinions have been considered in recent MRL regulations. 5 In addition, certain Codex maximum residue limits (CXLs) from pyraclostrobin have been taken over in the EU MRL legislation taking into account EFSA recommendations (EFSA, 2011, 2019b, 2021).
In accordance Article 6 of Regulation (EC) No 396/2005 and following the provisions set by the ‘Transparency Regulation’ (EU) 2019/1381 6 , the applicant BASF SE submitted on 13 July 2021 an application to the competent national authority in Germany, alongside the dossier containing the supporting data using the IUCLID format.
The appointed EMS Germany assessed the dossier and declared its admissibility on 24 March 2022. Subsequently, following the implementation of the EFSA's confidentiality decision, the non‐confidential version of the dossier was published by EFSA, and a public consultation launched on the dossier. The consultation aimed to consult stakeholders and the public on the scientific data, studies, and other information part of, or supporting, the submitted application, in order to identify whether other relevant scientific data or studies are available. The consultation run from 18 October 2022 to 8 November 2022. No additional data nor comments were submitted in the framework of the consultation.
At the end of the commenting period, the EMS proceeded drafting the evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 7 February 2023. The EMS proposed to increase the MRL for papayas to the level of 0.6 mg/kg. The MRL in place for pyraclostrobin on papayas in Brazil is 0.5 mg/kg.
EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified points which needed further clarification, which were requested from the EMS. On 3 March 2023, the applicant provided the requested information in an updated IUCLID dossier. The additional information was duly considered by the EMS who submitted a revised evaluation report to EFSA on 27 March 2023, which replaced the previously submitted evaluation report.
EFSA based its assessment on the evaluation report submitted by the EMS (Germany, 2023), the DAR (and its addendum) (Germany, 2001, 2003) prepared under Council Directive 91/414/EEC, the Commission review report on pyraclostrobin (European Commission, 2004), as well as the conclusions from previous EFSA opinions on pyraclostrobin (EFSA, 2011a, 2012a, 2013, 2014a,b, 2016, 2017, 2018a,b,c), including the review of the existing MRLs for pyraclostrobin under Article 12 of Regulation (EC) No 396/2005 (EFSA, 2011b), the assessment of confirmatory data following the MRL review for pyraclostrobin (EFSA, 2018b) as well as, EFSA outputs on the Scientific support for preparing an EU position for the 44th, 51st and 52nd Sessions of the CCPR (EFSA, 2012b, 2019b, 2021).
For this application, the data requirements established in Regulation (EU) No 544/2011 7 and the guidance documents applicable at the date of submission of the IUCLID application are applicable (European Commission, 1997a,b,c,d,e,f,g, 2010, 2017, 2020, 2021; OECD, 2011). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/2011 8 .
As the EU pesticides peer review of the active substance in accordance with Regulation (EC) No 1107/2009 is not yet finalised, the conclusions reported in this reasoned opinion may need to be reconsidered in the light of the outcome of the peer review.
A selected list of end points of the studies assessed by EFSA in the framework of this MRL application including the end points of relevant studies assessed previously, is presented in Appendix B.
The evaluation report submitted by the EMS (Germany, 2023) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available as background documents to this reasoned opinion. 9
1. Residues in plants
1.1. Nature of residues and methods of analysis in plants
1.1.1. Nature of residues in primary crops
The metabolism of pyraclostrobin in primary crops belonging to the group of fruit crops (grapes), root crops (potatoes) and cereals (wheat) has been assessed in the framework of Directive 91/414/EEC and reassessed by EFSA during the MRL review (Germany, 2001; EFSA, 2011b). An additional study on paddy rice was assessed in a reasoned opinion issued after the MRL review (EFSA, 2018c). The metabolic pathway was found to be similar in all crop groups investigated. After foliar application, the predominant compound of the total residues in the crops investigated was the parent pyraclostrobin; the desmethoxy metabolite (500 M07) occurred in small amounts compared to the parent pyraclostrobin (Germany, 2001; EFSA, 2011b).
Since the crops under consideration belong to the fruit crop group, EFSA concluded that the metabolic behaviour in primary crops is sufficiently addressed, and further studies are not required.
1.1.2. Nature of residues in rotational crops
As the use of pyraclostrobin under assessment is on permanent, imported crops, investigations of residues in rotational crops are not required. However, metabolism studies in rotational crops are available and are reported in Appendix B for completeness.
1.1.3. Nature of residues in processed commodities
Standard hydrolysis studies simulating processing conditions representative of pasteurisation, boiling and sterilisation were assessed in the framework of Directive 91/414/EEC and reassessed by EFSA during the MRL review (Germany, 2001; EFSA, 2011b). From these studies, it was concluded that processing by pasteurisation, baking/brewing/boiling and sterilisation is not expected to have a significant impact on the composition of residues in matrices of plant origin.
1.1.4. Analytical methods for enforcement purposes in plant commodities
An analytical method using liquid chromatography with tandem mass spectrometry (LC–MS/MS) and its independent laboratory validation (ILV) were sufficiently validated at a limit of quantification (LOQ) of 0.02 mg/kg for the determination of pyraclostrobin in high oil content, high water content, high acid content and dry commodities. For confirmatory purposes, a second MS/MS transition was validated. In addition, the multi‐residue quick, easy, cheap, effective, rugged, and safe (QuEChERS) method in combination with high‐performance chromatography with tandem mass spectrometry (HPLC–MS/MS) is reported for the routine analysis of pyraclostrobin in high water content, acidic content, and dry commodities with an LOQ of 0.01 mg/kg (EFSA, 2011b). A validated analytical method, including its ILV, for enforcement of pyraclostrobin in coffee beans is also available (EFSA, 2018c).
EFSA concluded that pyraclostrobin can be enforced in food of plant origin by LC–MS/MS with an LOQ of at least 0.02 mg/kg in in crops belonging to the group of high‐water content commodities, to which papayas belong (EFSA, 2011b, 2018b). The analytical multi‐residue QuEChERS method for routine monitoring achieves a lower LOQ of 0.01 mg/kg. According to the EMS, extraction efficiency of the LC–MS/MS analytical enforcement method 421/0 has been sufficiently demonstrated according to the guidance SANTE/2017/10632 in the context of the renewal assessment report (Germany, 2001). It remains relevant for this application.
EFSA would recommend that data on extraction efficiency for all types of matrices are further considered and confirmed in the framework of the ongoing peer review for the renewal of the active substance.
1.1.5. Storage stability of residues in plants
The storage stability of pyraclostrobin in high water, high acid, high oil content and dry commodities was assessed in the framework of the of Directive 91/414/EEC and reassessed during the MRL review (Germany, 2001; EFSA, 2011b). In the high‐water content matrices, to which group the crop under assessment belongs, pyraclostrobin residues were stable for at least 18 months when stored at −10°C.
1.1.6. Proposed residue definitions
Based on the metabolic pattern identified in metabolism studies, the results of hydrolysis studies, the following residue definitions were proposed during the MRL review (EFSA, 2011b):
- residue definition for risk assessment: pyraclostrobin
- residue definition for enforcement: pyraclostrobin
The same residue definitions are applicable to rotational crops and processed products (EFSA, 2011b). The residue definition for enforcement set in Regulation (EC) No 396/2005 is identical with the above‐mentioned residue definition.
For the use assessed in this application, EFSA concluded that these residue definitions are appropriate and no further information is required.
1.2. Magnitude of residues in plants
1.2.1. Magnitude of residues in primary crops
In support of the MRL application, the applicant submitted Good Agricultural Practice (GAP)‐compliant residue trials performed in Brazil on papayas (six trials). The trials were performed over two seasons in Brazil and half of them were designed as decline trials. The samples were analysed for the parent compound in accordance with the residue definition for enforcement and risk assessment and for the metabolite 500 M07. In all the trials, residues of pyraclostrobin were measured in the whole fruit. Residue decline data show that residues of pyraclostrobin and its metabolite (500 M07) decline in papaya fruits with increasing PHIs. According to the EMS, the methods used were sufficiently validated and fit for purpose (Germany, 2023). EFSA notes that the solvent system used for the analytical method (L0076/09) to assess the residue trials is comparable with the one used for the enforcement method (421/0), therefore extraction efficiency is considered sufficiently proven according to the guidance SANTE/2017/10632 for the crop under assessment. The samples of these residue trials were stored for a maximum storage interval of 166 days prior to analyses under conditions for which the integrity of the samples has been demonstrated for pyraclostrobin.
The number of trials is sufficient to derive an MRL proposal in support of the reported Brazilian use of pyraclostrobin on papayas.
1.2.2. Magnitude of residues in rotational crops
As the use of pyraclostrobin assessed in this application is on permanent and imported crops, investigations on the magnitude of residues in rotational crops are not required.
1.2.3. Magnitude of residues in processed commodities
No studies were submitted in the context of this MRL application are not available and are not necessary because the theoretical maximum daily intake (TMDI) for the individual crops under assessment is expected to be less than 10% of the acceptable daily intake (ADI).
Papayas are fruits with inedible peel, however information of the distribution of residues between peel and pulp was not investigated in the residue trials submitted.
1.2.4. Proposed MRLs
The available data are considered sufficient to derive an MRL proposal as well as risk assessment values for the commodity under evaluation (see Appendix B.4). The MRL proposal derived using the OECD calculator and the results of the submitted residue trials is of 0.6 mg/kg, which is higher than the MRL set in Brazil for papayas (0.5 mg/kg). In the residue trials on papayas, the highest residue level was 0.25 mg/kg, which is equal to half the Brazilian MRL. According to the applicant, the MRL value was originally established in Brazil by extrapolation from residue trials on mangos (Germany, 2023). Extrapolation from mangos to papayas is not foreseen at the EU level (European Commission, 2020). In Section B.3, EFSA assessed whether residues on papayas resulting from the use reported to be authorised in Brazil are likely to pose a consumer health risk.
2. Residues in livestock
Not relevant as papayas are not used for feed purposes. Hence, investigations on residues in livestock are not further considered in the framework of the current evaluation.
3. Consumer risk assessment
EFSA performed a dietary risk assessment using revision 3.1 of the EFSA PRIMo (EFSA, 2018e, 2019c). This exposure assessment model contains food consumption data for different sub‐groups of the EU population and allows the acute and chronic exposure assessment to be performed in accordance with the internationally agreed methodology for pesticide residues (FAO, 2016).
The toxicological reference values for pyraclostrobin used in the risk assessment (i.e. ADI and ARfD values) were derived in the framework of the EU pesticide peer review (European Commission, 2004).
Short‐term (acute) dietary risk assessment
The short‐term exposure assessment for papayas was performed in accordance with the internationally agreed methodology for pesticide residues (FAO, 2016). The calculation was based on the highest residue (HR) level expected in the raw agricultural commodity derived from supervised field trials. The input value can be found in Appendix D.1.
The short‐term exposure did not exceed the ARfD (exposure accounted for 35.3% of the ARfD for NL children diet, see Appendix B.3).
Long‐term (chronic) dietary risk assessment
In the framework of the MRL review a comprehensive long‐term exposure assessment was performed, taking into account the existing uses at EU level, existing import tolerances and the acceptable CXLs (EFSA, 2011b). EFSA updated these calculations several times after the MRL review. The chronic risk assessments were updated again by including the STMR value derived for papayas. For the remaining commodities covered by the MRL regulation, the STMR derived in the framework of the MRL review and the STMR values derived in EFSA opinions issued after the MRL review were selected as input values (EFSA, 2011a, 2012a, 2013, 2014a,b, 2016, 2017, 2018a,c,d, 2019a). For table grapes, the existing MRL was used as the related STMR could not be retrieved. Available peeling factors were also considered to refine the calculations in certain products with inedible peel. The commodities of animal origin are all set at the LOQ, and, as worst scenario exposure, the conversion factor of 4 derived for liver, of 1 for tissues of swine and ruminants in the framework of the MRL review and of 6.8 for milks derived during a previous EFSA reasoned opinion (EFSA, 2018a) were used to take into consideration the metabolites included in the residue definition for risk assessment of products of animal origin. The STMR for the Codex MRLs (CXLs) implemented in the EU MRL regulation were also included in the calculation (FAO, 2011, 2019, 2021). The complete list of input values used in the exposure calculations is presented Appendix D.1.
The estimated long‐term dietary intake was in the range up to 32% of the ADI. The contribution of residues expected in the commodity assessed in this application to the overall long‐term exposure is low and presented in more detail in Appendix B.3.
EFSA concluded that the long‐term intake of residues of pyraclostrobin resulting from the existing and the use in papayas under assessment is unlikely to present a risk to consumer health.
For further details on the exposure calculations, a screenshot of the Report sheet of the PRIMo is presented in Appendix C.
4. Conclusion and recommendations
The data submitted in support of this MRL application were found to be sufficient to derive an MRL proposal for papayas. A risk management decision is required on whether to set the MRL at the level established in Brazil (0.5 mg/kg) or as calculated applying the OECD methodology (0.6 mg/kg). In the residue trials on papayas submitted, the highest residue level was 0.25 mg/kg, which is half the Brazilian MRL.
EFSA concluded that the use of pyraclostrobin on papayas authorised in Brazil will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health.
The EU peer review of the active substance in accordance with Regulation (EC) No 1107/2009 is ongoing and therefore the conclusions reported in this reasoned opinion might need to be reconsidered in the light of the outcome of the peer review.
The MRL recommendations are summarised in Appendix B.4.
Abbreviations
- a.s.
- active substance
- ADI
- acceptable daily intake
- AR
- applied radioactivity
- ARfD
- acute reference dose
- BBCH
- growth stages of mono‐ and dicotyledonous plants
- bw
- body weight
- CCPR
- Codex Committee on Pesticide Residues
- CF
- conversion factor for enforcement to risk assessment residue definition
- CXL
- Codex maximum residue limit
- DAR
- draft assessment report
- DAT
- days after treatment
- FAO
- Food and Agriculture Organization of the United Nations
- GAP
- Good Agricultural Practice
- HPLC–MS/MS
- high‐performance liquid chromatography with tandem mass spectrometry
- HR
- highest residue
- IEDI
- international estimated daily intake
- IESTI
- international estimated short‐term intake
- ILV
- independent laboratory validation
- InChiKey
- International Chemical Identifier Key
- ISO
- International Organization for Standardization
- IUPAC
- International Union of Pure and Applied Chemistry
- JMPR
- Joint FAO/WHO Meeting on Pesticide Residues
- LC–MS/MS
- liquid chromatography with tandem mass spectrometry
- LOQ
- limit of quantification
- MRL
- maximum residue level
- MS
- Member States
- NEU
- northern Europe
- OECD
- Organisation for Economic Co‐operation and Development
- PF
- processing factor
- PHI
- preharvest interval
- PRIMo
- (EFSA) Pesticide Residues Intake Model
- RA
- risk assessment
- RAC
- raw agricultural commodity
- RD
- residue definition
- RMS
- rapporteur Member State
- SC
- suspension concentrate
- SEU
- southern Europe
- SMILES
- simplified molecular‐input line‐entry system
- STMR
- supervised trials median residue
- TMDI
- theoretical maximum daily intake
- WHO
- World Health Organization
Appendix A – Summary of intended notified GAP triggering the amendment of existing EU MRLs
1.
Crop and/or situation | NEU, SEU, MS or country | F G or I (a) | Pests or Group of pests controlled | Preparation | Application | Application rate per treatment | PHI (days) (d) | Remarks | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Type (b) | Conc. a.s. (g/L) | Method kind | Range of growth stages and season (c) | Number min–max | Interval between application (days) min–max | g a.s./hL min–max | Water (L/ha) min–max | Rate min–max | Unit | ||||||
Papayas | BR | F | Anthracnose, powdery mildew | SC | 333 | Foliar treatment ‐ broadcast spraying on foliage | Initiate applications at onset of 1st symptoms or preventively | 1–4 | 7–14 | 0.004–0.027 | 500–1,000 | 42–133 | g a.i./ha | 7 | Max annual rate: 533 g a.i./ha |
MRL: maximum residue level; GAP: Good Agricultural Practice; NEU: northern European Union; SEU: southern European Union; MS: Member State; BR: Brazil; a.s.: active substance; SC: Suspension concentrate.
Appendix B – List of end points
B.1. Residues in plants
B.1.1. Nature of residues and analytical methods for enforcement purposes in plant commodities
B.1.1.1. Metabolism studies, analytical methods and residue definitions in plants
Primary crops (available studies) | Crop groups | Crops | Applications | Sampling (DAT) | Comment/Source |
---|---|---|---|---|---|
Fruit crops | Grapes | Foliar: 6 × 130 to 480 g a.s./ha, from BBCH 53–55 to 81 | 40 | Radiolabelled active substance: [tolyl‐U‐14C]‐pyraclostrobin and [chlorophenyl‐U‐14C]‐pyraclostrobin (EFSA, 2011b) | |
Root crops | Potatoes | Foliar: 6 × 300 to 400 g a.s./ha, from BBCH 31 to maturity | 7 | ||
Cereals/grass | Wheat | Foliar: 2 × 300 g a.s./ha, from BBCH 32 to 61 |
0, 31, 41, 63/65 (forage), 74/76 (hay) and 103/104 (grain, straw) | ||
Paddy rice | Foliar: 3 × 130 g a.s./ha, from BBCH 39 to 69 | –1 (forage) and 57 (straw, grain) | Radiolabelled active substance: [tolyl‐U‐14C]‐pyraclostrobin and [chlorophenyl‐U‐14C]‐pyraclostrobin (FAO, 2018) | ||
Rotational crops (available studies) | Crop groups | Crops | Application | PBI (DAT) | Comment/Source |
Root/tuber crops | Radishes | Bare soil, 1 × 900 g a.s./ha | 30, 120, 365 | Radiolabelled active substance: [tolyl‐U‐14C]‐pyraclostrobin and [chlorophenyl‐U‐14C]‐pyraclostrobin (EFSA, 2011b) | |
Leafy crops | Lettuces | ||||
Cereal (small grain) | Wheat | ||||
Other | |||||
Processed commodities (hydrolysis study) | Conditions | Stable? | Comment/Source | ||
Pasteurisation (20 min, 90°C, pH 4) | Yes | EFSA (2011b) | |||
Baking, brewing and boiling (60 min, 100°C, pH 5) | Yes | EFSA (2011b) | |||
Sterilisation (20 min, 120°C, pH 6) | Yes | EFSA (2011b) | |||
Other processing conditions |
B.1.1.2. Stability of residues in plants
Plant products (available studies) | Category | Commodity | T (°C) | Stability period | Compounds covered | Comment/Source | |
---|---|---|---|---|---|---|---|
Value | Unit | ||||||
High water content | Tomatoes | < −10 | 18 | Months | Pyraclostrobin/500 M07 | Germany (2001) | |
High water content | Sugar beet tops | ||||||
High oil content | Peanut nutmeat | ||||||
Dry/High starch | Wheat grain | ||||||
High acid content | Grape juice | ||||||
Others | Wheat straw |
B.1.2. Magnitude of residues in plants
B.1.2.1. Summary of residues data from the supervised residue trials
Commodity | Region (a) | Residue levels observed in the supervised residue trials (mg/kg) | Comments/Source | Calculated MRL (mg/kg) | HR (b) (mg/kg) | STMR (c) (mg/kg) | CF (d) |
---|---|---|---|---|---|---|---|
Papayas | BR | 3 × < 0.01, 0.06, 0.24, 0.25 |
Residue trials on papayas compliant with reported Brazilian GAP. 500 M07: 3 × < 0.01, 0.06, 0.02, 0.05 mg 500 M07/kg | 0.6 | 0.25 | 0.035 | N/A |
MRL: maximum residue level; GAP: Good Agricultural Practice; Mo: monitoring; RA: risk assessment; N/A: not applicable.
B.1.2.2. Residues in rotational crops
B.1.2.3. Processing factors
No processing studies were submitted in the framework of the present MRL application.
B.2. Residues in livestock
Not relevant as papayas are not used for feed purposes.
B.3. Consumer risk assessment
B.4. Recommended MRLs
Code (a) | Commodity | Existing EU MRL (mg/kg) | Proposed EU MRL (mg/kg) | Comment/justification |
---|---|---|---|---|
Enforcement residue definition: Pyraclostrobin (F) | ||||
0163040 | Papayas | 0.07 |
0.5 or 0.6 Further risk management considerations required |
The submitted data are sufficient to derive an import tolerance (Brazilian GAP). Based on the residue trials on papayas submitted an MRL of 0.6 mg/kg is derived with the OECD calculator. The MRL set in Brazil for papayas is lower, 0.5 mg/kg. In the residue trials on papayas, the highest residue level was 0.25 mg/kg, which is half the Brazilian MRL. Risk management decision is required on whether to set the MRL at the level established in Brazil (0.5 mg/kg) or as calculated applying the OECD methodology (0.6 mg/kg). Risk for consumers is unlikely. |
MRL: maximum residue level; NEU: northern Europe; SEU: southern Europe; GAP: Good Agricultural Practice.
Appendix C – Pesticide Residue Intake Model (PRIMo)
1.
Appendix D – Input values for the exposure calculations
D.1. Consumer risk assessment
Commodity | Existing/proposed MRL (mg/kg) | Source | Chronic risk assessment | Acute risk assessment | ||
---|---|---|---|---|---|---|
Input value (a) (mg/kg) (d) | Comment (b) | Input value (a) (mg/kg) (d) | Comment (b) | |||
Risk assessment residue definition: Pyraclostrobin | ||||||
Grapefruits | 2 | EFSA (2018d) | 0.054 | STMR‐RAC*PeF | 0.13 | HR‐RAC*PeF |
Oranges | 2 | EFSA (2018d) | 0.0756 | STMR‐RAC*PeF | 0.182 | HR‐RAC*PeF |
Lemons | 2 | EFSA (2018d) | 0.054 | STMR‐RAC*PeF | 0.13 | HR‐RAC*PeF |
Limes | 2 | EFSA (2018d) | 0.054 | STMR‐RAC*PeF | 0.13 | HR‐RAC*PeF |
Mandarins | 2 | EFSA (2018d) | 0.0689 | STMR‐RAC*PeF | 0.156 | HR‐RAC*PeF |
Other citrus fruit | 2 | EFSA (2018d) | 0.0054 | STMR‐RAC*PeF | ||
Almonds | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Brazil nuts | 0.02 |
EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Cashew nuts | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Chestnuts | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Coconuts | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Hazelnuts/cobnuts | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Macadamia | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Pecans | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Pine nut kernels | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Pistachios | 1 | EFSA (2011b) | 0.22 | STMR‐RAC | 0.45 | HR‐RAC |
Walnuts | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Other tree nuts | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | ||
Apples | 0.5 | EFSA (2011b) | 0.14 | STMR‐RAC | 0.29 | HR‐RAC |
Pears | 0.5 | EFSA (2011b) | 0.14 | STMR‐RAC | 0.29 | HR‐RAC |
Quinces | 0.5 | EFSA (2011b) | 0.14 | STMR‐RAC | 0.29 | HR‐RAC |
Medlar | 0.5 | EFSA (2011b) | 0.14 | STMR‐RAC | 0.29 | HR‐RAC |
Loquats/Japanese medlars | 0.5 | EFSA (2011b) | 0.14 | STMR‐RAC | 0.29 | HR‐RAC |
Other pome fruit | 0.5 | EFSA (2011b) | 0.14 | STMR‐RAC | ||
Apricots | 1 | EFSA (2011b) | 0.43 | STMR‐RAC | 0.63 | HR‐RAC |
Cherries (sweet) | 3 | FAO (2011) | 0.51 | STMR‐RAC | 1.57 | HR‐RAC |
Peaches | 0.3 | FAO (2011) | 0.065 | STMR‐RAC | 0.13 | HR‐RAC |
Plums | 0.8 | FAO (2011) | 0.09 | STMR‐RAC | 0.4 | HR‐RAC |
Table grapes | 0.3 | Existing MRL | 0.3 | MRL | 0.3 | MRL |
Wine grapes | 2 | EFSA (2011b) | 0.48 | STMR‐RAC | 1.27 | HR‐RAC |
Strawberries | 1.5 | FAO (2011) | 0.2 | STMR‐RAC | 0.75 | HR‐RAC |
Blackberries | 3 | FAO (2011) | 0.87 | STMR‐RAC | 1.32 | HR‐RAC |
Dewberries | 2 | EFSA (2011b) | 0.87 | STMR‐RAC | 1.32 | HR‐RAC |
Raspberries (red and yellow) | 3 |
FAO (2011) | 0.87 | STMR‐RAC | 1.32 | HR‐RAC |
Other cane fruit | 2 | EFSA (2011b) | 0.87 | STMR‐RAC | ||
Blueberries | 4 | FAO (2011) | 0.78 | STMR‐RAC | 2.08 | HR‐RAC |
Cranberries | 3 | EFSA (2011b) | 0.94 | STMR‐RAC | 2.1 | HR‐RAC |
Currants (red, black and white) | 3 | EFSA (2011b) | 0.94 | STMR‐RAC | 2.1 | HR‐RAC |
Gooseberries (green, red and yellow) | 3 | EFSA (2011b) | 0.94 | STMR‐RAC | 2.1 | HR‐RAC |
Rose hips | 3 | EFSA (2011b) | 0.94 | STMR‐RAC | 2.1 | HR‐RAC |
Mulberries (black and white) | 3 | EFSA (2011b) | 0.94 | STMR‐RAC | 2.1 | HR‐RAC |
Azarole/Mediterranean medlar | 3 | EFSA (2011b) | 0.94 | STMR‐RAC | 2.1 | HR‐RAC |
Elderberries | 3 | EFSA (2011b) | 0.94 | STMR‐RAC | 2.1 | HR‐RAC |
Other small fruit & berries | 3 | EFSA (2011b) | 0.94 | STMR‐RAC | ||
Passion fruits/maracujas | 0.2 | FAO (2019) | 0.045 | STMR‐RAC | 0.1 | HR‐RAC |
Avocados | 0.2 | FAO (2019) | 0.053 | STMR‐RAC | 0.104 | HR‐RAC |
Bananas | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Mangoes | 0.6 | FAO (2019) | 0.11 | STMR‐RAC | 0.35 | HR‐RAC |
Papayas | Intended use | 0.035 | STMR‐RAC | 0.25 | HR‐RAC | |
Pineapples | 0.3 | EFSA (2018d) | 0.0135 | STMR‐RAC*PeF | 0.0513 | HR‐RAC*PeF |
Potatoes | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Cassava roots/manioc | 0.02 | FAO (2019) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Sweet potatoes | 0.02 | FAO (2019) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Yams | 0.02 | FAO (2019) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Arrowroots | 0.02 | FAO (2019) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Other tropical root and tuber vegetables | 0.02 | FAO (2019) | 0.02 | STMR‐RAC | ||
Beetroots | 0.5 | EFSA (2011b) | 0.03 | STMR‐RAC | 0.06 | HR‐RAC |
Carrots | 0.5 | EFSA (2011b) | 0.12 | STMR‐RAC | 0.24 | HR‐RAC |
Celeriacs/turnip rooted celeries | 0.5 | EFSA (2017) | 0.16 | STMR‐RAC | 0.23 | HR‐RAC |
Horseradishes | 0.5 |
EFSA (2011b) | 0.08 | STMR‐RAC | 0.18 | HR‐RAC |
Jerusalem artichokes | 0.06 | EFSA (2013) | 0.02 | STMR‐RAC | 0.05 | HR‐RAC |
Parsnips | 0.5 | EFSA (2011b) | 0.08 | STMR‐RAC | 0.18 | HR‐RAC |
Parsley roots/Hamburg roots parsley | 0.5 | EFSA (2011b) | 0.03 | STMR‐RAC | 0.06 | HR‐RAC |
Radishes | 0.5 | EFSA (2011b) | 0.08 | STMR‐RAC | 0.3 | HR‐RAC |
Salsifies | 0.5 | EFSA (2011b) | 0.03 | STMR‐RAC | 0.06 | HR‐RAC |
Swedes/rutabagas | 0.5 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.06 | HR‐RAC |
Turnips | 0.5 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.06 | HR‐RAC |
Garlic | 0.3 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.21 | HR‐RAC |
Onions | 1.5 | FAO (2011) | 0.06 | STMR‐RAC | 0.62 | HR‐RAC |
Shallots | 0.3 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.21 | HR‐RAC |
Spring onions/green onions and Welsh onions | 1.5 | FAO (2011) | 0.42 | STMR‐RAC | 0.6 | HR‐RAC |
Tomatoes | 0.3 | EFSA (2011b) | 0.1 | STMR‐RAC | 0.26 | HR‐RAC |
Sweet peppers/bell peppers | 0.5 | EFSA (2011b) | 0.13 | STMR‐RAC | 0.3 | HR‐RAC |
Aubergines/egg plants | 0.3 | EFSA (2011b) | 0.1 | STMR‐RAC | 0.26 | HR‐RAC |
Cucumbers | 0.5 | EFSA (2013) | 0.15 | STMR‐RAC | 0.41 | HR‐RAC |
Gherkins | 0.5 | EFSA (2011b) | 0.17 | STMR‐RAC | 0.27 | HR‐RAC |
Courgettes | 0.5 | EFSA (2011b) | 0.17 | STMR‐RAC | 0.27 | HR‐RAC |
Other cucurbits ‐ edible peel | 0.5 | EFSA (2011b) | 0.17 | STMR‐RAC | ||
Melons | 0.5 | EFSA (2011b) | 0.055 | STMR‐RAC*PeF | 0.145 | HR‐RAC*PeF |
Pumpkins | 0.5 | EFSA (2011b) | 0.055 | STMR‐RAC*PeF | 0.145 | HR‐RAC*PeF |
Watermelons | 0.5 | EFSA (2011b) | 0.055 | STMR‐RAC*PeF | 0.145 | HR‐RAC*PeF |
Other cucurbits ‐ inedible peel | 0.5 | EFSA (2011b) | 0.055 | STMR‐RAC*PeF | ||
Sweet corn | 0.04 | EFSA (2019a) | 0.016 | STMR‐RAC | 0.021 | HR‐RAC |
Broccoli | 0.5 | EFSA (2018d) | 0.05 | STMR‐RAC | 0.19 | HR‐RAC |
Cauliflowers | 0.5 | EFSA (2018d) | 0.05 | STMR‐RAC | 0.19 | HR‐RAC |
Other flowering brassica | 0.5 | EFSA (2018d) | 0.05 | STMR‐RAC | ||
Brussels sprouts | 0.3 | EFSA (2011b) | 0.03 | STMR‐RAC | 0.14 | HR‐RAC |
Head cabbages | 0.4 | EFSA (2018d) | 0.01 | STMR‐RAC | 0.22 | HR‐RAC |
Chinese cabbages/pe‐tsai | 1.5 | EFSA (2012a) | 0.19 | STMR‐RAC | 0.7 | HR‐RAC |
Kales | 1.5 | EFSA (2011b) | 0.19 | STMR‐RAC | 0.61 | HR‐RAC |
Other leafy brassica | 1.5 | EFSA (2012a) | 0.19 | STMR‐RAC | ||
Kohlrabies | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Lamb's lettuce/corn salads | 10 | EFSA (2018d) | 2.31 | STMR‐RAC | 4.16 | HR‐RAC |
Lettuces | 2 | EFSA (2011b) | 0.26 | STMR‐RAC | 0.81 | HR‐RAC |
Escaroles/broad‐leaved endives | 0.4 | EFSA (2011b) | 0.04 | STMR‐RAC | 0.28 | HR‐RAC |
Cress and other sprouts and shoots | 10 | EFSA (2018d) | 2.31 | STMR‐RAC | 4.16 | HR‐RAC |
Land cress | 10 | EFSA (2018d) | 2.5 | STMR‐RAC | 4.16 | HR‐RAC |
Roman rocket/rucola | 10 | EFSA (2018d) | 2.5 | STMR‐RAC | 4.16 | HR‐RAC |
Red mustards | 10 | EFSA (2018d) | 2.5 | STMR‐RAC | 4.16 | HR‐RAC |
Baby leaf crops (including brassica species) | 10 | EFSA (2018d) | 2.5 | STMR‐RAC | 4.16 | HR‐RAC |
Other lettuce and other salad plants | 10 | EFSA (2018d) | 2.5 | STMR‐RAC | ||
Spinaches | 0.6 | FAO (2021) | 0.071 | STMR‐RAC | 0.31 | HR‐RAC |
Chards/beet leaves | 1.5 | EFSA (2016) | 0.26 | STMR‐RAC | 0.81 | HR‐RAC |
Witloofs/Belgian endives | 0.09 | FAO (2019) | 0.03 | STMR‐RAC | 0.04 | HR‐RAC |
Chervil | 2 | EFSA (2011b) | 0.26 | STMR‐RAC | 0.81 | HR‐RAC |
Chives | 2 | EFSA (2011b) | 0.26 | STMR‐RAC | 0.81 | HR‐RAC |
Celery leaves | 2 | EFSA (2011b) | 0.26 | STMR‐RAC | 0.81 | HR‐RAC |
Parsley | 2 | EFSA (2011b) | 0.26 | STMR‐RAC | 0.81 | HR‐RAC |
Sage | 2 | EFSA (2011b) | 0.26 | STMR‐RAC | 0.81 | HR‐RAC |
Rosemary | 2 | EFSA (2011b) | 0.26 | STMR‐RAC | 0.81 | HR‐RAC |
Thyme | 2 | EFSA (2011b) | 0.26 | STMR‐RAC | 0.81 | HR‐RAC |
Basil and edible flowers | 2 | EFSA (2011b) | 0.26 | STMR‐RAC | 0.81 | HR‐RAC |
Laurel/bay leaves | 2 | EFSA (2011b) | 0.26 | STMR‐RAC | 0.81 | HR‐RAC |
Tarragon | 2 | EFSA (2011b) | 0.26 | STMR‐RAC | 0.81 | HR‐RAC |
Other herbs | 2 | EFSA (2011b) | 0.26 | STMR‐RAC | ||
Beans (with pods) | 0.6 | EFSA (2017) | 0.13 | STMR‐RAC | 0.37 | HR‐RAC |
Beans (without pods) | 0.3 | EFSA (2011b) | 0.01 | STMR‐RAC | 0.27 | HR‐RAC |
Peas (with pods) | 0.6 | EFSA (2017) | 0.13 | STMR‐RAC | 0.37 | HR‐RAC |
Peas (without pods) | 0.15 | EFSA (2017) | 0.01 | STMR‐RAC | 0.07 | HR‐RAC |
Asparagus | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | HR‐RAC |
Celeries | 1.5 | FAO (2019) | 0.15 | STMR‐RAC | 0.61 | HR‐RAC |
Florence fennels | 1.5 | EFSA (2017) | 0.4 | STMR‐RAC | 0.61 | HR‐RAC |
Globe artichokes | 3 | EFSA (2018d) | 0.25 | STMR‐RAC | 1.44 | HR‐RAC |
Leeks | 0.8 | EFSA (2018d) | 0.26 | STMR‐RAC | 0.29 | HR‐RAC |
Beans | 0.3 | EFSA (2011b) | 0.04 | STMR‐RAC | 0.04 | STMR‐RAC |
Lentils | 0.5 | EFSA (2011b) | 0.13 | STMR‐RAC | 0.13 | STMR‐RAC |
Peas | 0.3 | EFSA (2011b) | 0.04 | STMR‐RAC | 0.04 | STMR‐RAC |
Lupins/lupini beans | 0.05 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | STMR‐RAC |
Other pulses | 0.3 | EFSA (2011b) | 0.04 | STMR‐RAC | ||
Linseeds | 0.2 | EFSA (2011a) | 0.04 | STMR‐RAC | 0.04 | STMR‐RAC |
Peanuts/groundnuts | 0.04 | EFSA (2011a) | 0.02 | STMR‐RAC | 0.02 | STMR‐RAC |
Poppy seeds | 0.2 | EFSA (2011a) | 0.04 | STMR‐RAC | 0.04 | STMR‐RAC |
Sesame seeds | 0.2 | EFSA (2011a) | 0.04 | STMR‐RAC | 0.04 | STMR‐RAC |
Sunflower seeds | 0.3 | EFSA (2011a) | 0.053 | STMR‐RAC | 0.053 | STMR‐RAC |
Rapeseeds/canola seeds | 0.2 | EFSA (2011a) | 0.035 | STMR‐RAC | 0.035 | STMR‐RAC |
Soya beans | 0.2 | EFSA (2018a) | 0.02 | STMR‐RAC | 0.02 | STMR‐RAC |
Mustard seeds | 0.2 | EFSA (2011a) | 0.04 | STMR‐RAC | 0.04 | STMR‐RAC |
Cotton seeds | 0.3 | EFSA (2011a) | 0.03 | STMR‐RAC | 0.03 | STMR‐RAC |
Safflower seeds | 0.2 | EFSA (2011a) | 0.04 | STMR‐RAC | 0.04 | STMR‐RAC |
Borage seeds | 0.2 | EFSA (2011a) | 0.04 | STMR‐RAC | 0.04 | STMR‐RAC |
Gold of pleasure seeds | 0.2 | EFSA (2011a) | 0.04 | STMR‐RAC | 0.04 | STMR‐RAC |
Castor beans | 0.2 | EFSA (2011a) | 0.04 | STMR‐RAC | 0.04 | STMR‐RAC |
Barley | 1 | FAO (2011) | 0.345 | STMR‐RAC | 0.345 | STMR‐RAC |
Maize/corn | 0.02 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | STMR‐RAC |
Oat | 1 | FAO (2011) | 0.345 | STMR‐RAC | 0.345 | STMR‐RAC |
Rice | 0.09 | EFSA (2018c) | 0.02 | STMR‐RAC | 0.02 | STMR‐RAC |
Rye | 0.2 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | STMR‐RAC |
Sorghum | 0.5 | FAO (2011) | 0.025 | STMR‐RAC | 0.025 | STMR‐RAC |
Wheat | 0.2 | EFSA (2011b) | 0.02 | STMR‐RAC | 0.02 | STMR‐RAC |
Coffee beans | 0.3 | EFSA (2011b) | 0.025 | STMR‐RAC | 0.025 | STMR‐RAC |
Hops (dried) | 15 | EFSA (2011b) | 3.45 | STMR‐RAC | 7.4 | HR‐RAC |
Sugar beet roots | 0.2 | EFSA (2011b) | 0.04 | STMR‐RAC | 0.11 | HR‐RAC |
Sugar canes | 0.08 | FAO (2019) | 0.027 | STMR‐RAC | 0.045 | HR‐RAC |
Chicory roots | 0.5 | EFSA (2014a) | 0.03 | STMR‐RAC | 0.08 | HR‐RAC |
Swine: Muscle/meat (c) | 0.05 | Existing MRL | 0.05 | LOQ*CF | 0.05 | LOQ*CF |
Swine: Fat tissue | 0.05 | Existing MRL | 0.05 | LOQ*CF | 0.05 | LOQ*CF |
Swine: Liver | 0.05 | Existing MRL | 0.2 | LOQ*CF | 0.2 | LOQ*CF |
Swine: Kidney | 0.05 | Existing MRL | 0.05 | LOQ*CF | 0.05 | LOQ*CF |
Swine: Edible offals (other than liver and kidney) | 0.05 | Existing MRL | 0.2 | LOQ*CF | 0.2 | LOQ*CF |
Bovine: Muscle/meat (c) | 0.05 | Existing MRL | 0.05 | LOQ*CF | 0.05 | LOQ*CF |
Bovine: Fat tissue | 0.05 | Existing MRL | 0.05 | LOQ*CF | 0.05 | LOQ*CF |
Bovine: Liver | 0.05 | Existing MRL | 0.2 | LOQ*CF | 0.2 | LOQ*CF |
Bovine: Kidney | 0.05 | Existing MRL | 0.05 | LOQ*CF | 0.05 | LOQ*CF |
Bovine: Edible offals (other than liver and kidney) | 0.05 | Existing MRL | 0.2 | LOQ*CF | 0.2 | LOQ*CF |
Sheep: Muscle/meat (c) | 0.05 | Existing MRL | 0.05 | LOQ*CF | 0.05 | LOQ*CF |
Sheep: Fat tissue | 0.05 | Existing MRL | 0.05 | LOQ*CF | 0.05 | LOQ*CF |
Sheep: Liver | 0.05 | Existing MRL | 0.2 | LOQ*CF | 0.2 | LOQ*CF |
Sheep: Kidney | 0.05 | Existing MRL | 0.05 | LOQ*CF | 0.05 | LOQ*CF |
Sheep: Edible offals (other than liver and kidney) | 0.05 | Existing MRL | 0.2 | LOQ*CF | 0.2 | LOQ*CF |
Goat: Muscle/meat (c) | 0.05 | Existing MRL | 0.05 | LOQ*CF | 0.05 | LOQ*CF |
Goat: Fat tissue | 0.05 | Existing MRL | 0.05 | LOQ*CF | 0.05 | LOQ*CF |
Goat: Liver | 0.05 | Existing MRL | 0.2 | LOQ*CF | 0.2 | LOQ*CF |
Goat: Kidney | 0.05 | Existing MRL | 0.05 | LOQ*CF | 0.05 | LOQ*CF |
Goat: Edible offals (other than liver and kidney) | 0.05 | Existing MRL | 0.2 | LOQ*CF | 0.2 | LOQ*CF |
Poultry: Muscle/meat (c) | 0.05 | Existing MRL | 0.05 | LOQ | 0.05 | LOQ |
Poultry: Fat tissue | 0.05 | Existing MRL | 0.05 | LOQ | 0.05 | LOQ |
Poultry: Liver | 0.05 | Existing MRL | 0.05 | LOQ | 0.05 | LOQ |
Poultry: Kidney | 0.05 | Existing MRL | 0.05 | LOQ | 0.05 | LOQ |
Poultry: Edible offals (other than liver and kidney) | 0.05 | Existing MRL | 0.05 | LOQ | 0.05 | LOQ |
Milk: Cattle | 0.01 | Existing MRL | 0.068 | STMR‐RAC*CF | 0.068 | STMR‐RAC*CF |
Milk: Sheep | 0.01 | Existing MRL | 0.068 | STMR‐RAC*CF | 0.068 | STMR‐RAC*CF |
Milk: Goat | 0.01 | Existing MRL | 0.068 | STMR‐RAC*CF | 0.068 | STMR‐RAC*CF |
Milk: Horse | 0.01 | Existing MRL | 0.068 | STMR‐RAC*CF | 0.068 | STMR‐RAC*CF |
Milk: Others | 0.01 | Existing MRL | 0.068 | STMR‐RAC*CF | 0.068 | STMR‐RAC*CF |
Eggs: Chicken | 0.05 | Existing MRL | 0.05 | LOQ | 0.05 | LOQ |
Eggs: Duck | 0.05 | Existing MRL | 0.05 | LOQ | 0.05 | LOQ |
Eggs: Goose | 0.05 | Existing MRL | 0.05 | LOQ | 0.05 | LOQ |
Eggs: Quail | 0.05 | Existing MRL | 0.05 | LOQ | 0.05 | LOQ |
Eggs: Others | 0.05 | Existing MRL | 0.05 | LOQ |
STMR‐RAC: supervised trials median residue in raw agricultural commodity; HR‐RAC: highest residue in raw agricultural commodity; PeF: Peeling factor; CF: conversion factor for enforcement to risk assessment residue definition; ARfD: acute reference dose.
Appendix E – Used compound codes
1.
Code/trivial name (a) | IUPAC name/SMILES notation/InChiKey (b) | Structural formula (c) |
---|---|---|
Pyraclostrobin |
methyl 2‐[1‐(4‐chlorophenyl)‐1H‐pyrazol‐3‐yloxymethyl]‐N‐methoxycarbanilate O=C(OC)N(OC)c1ccccc1COc1ccn(n1)c1ccc(Cl)cc1 HZRSNVGNWUDEFX‐UHFFFAOYSA‐N |
![]() |
Desmethoxy metabolite (500 M07, BF 500–3) |
methyl [2‐({[1‐(4‐chlorophenyl)‐1H‐pyrazol‐3‐yl]oxy}methyl)phenyl]carbamate O=C(OC)Nc1ccccc1COc1ccn(n1)c1ccc(Cl)cc1 SEUOYURJKYLAPC‐UHFFFAOYSA‐N |
![]() |
IUPAC: International Union of Pure and Applied Chemistry; SMILES: simplified molecular‐input line‐entry system; InChiKey: International Chemical Identifier Key.
Notes
Suggested citation: EFSA (European Food Safety Authority) , Bellisai G, Bernasconi G, Brancato A, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M and Verani A, 2023. Reasoned Opinion on the setting of import tolerance for pyraclostrobin in papayas. EFSA Journal 2023;21(6):8056, 28 pp. 10.2903/j.efsa.2023.8056 [CrossRef] [Google Scholar]
Requestor European Commission
Question number EFSA‐Q‐2022‐00184
Declarations of interest If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact ue.aporue.asfe@tnemeganamtseretni.
Acknowledgements EFSA wishes to thank: Stathis Anagnos, Javier Martinez Perez, Andrea Mioč, Marta Szot, for the support provided to this scientific output.
EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source.
Adopted: 17 May 2023
Notes
1 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, 19.8.1991, p. 1–32.
2 Commission Directive 2004/30/EC of 10 March 2004 amending Council Directive 91/414/EEC to include benzoic acid, flazasulfuron and pyraclostrobin as active substances. OJ L 77, 13.3.2004, p. 50–53.
3 Commission Directive 2009/25/EC of 2 April 2009 amending Council Directive 91/414/EEC as regards an extension of the use of the active substance pyraclostrobin. OJ L 91, 3.4.2009, p. 20–22.
4 Regulation (EC) No 396/2005 of the Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. OJ L 70, 16.3.2005, p. 1–16.
5 For an overview of all MRL Regulations on this active substance, please consult: https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=search.as
6 Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC, PE/41/2019/REV/1. OJ L 231, 6.9.2019, p. 1–28.
7 Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances. OJ L 155, 11.6.2011, p. 1–66.
8 Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. OJ L 155, 11.6.2011, p. 127–175.
9 Background documents to this reasoned opinion are published on OpenEFSA portal and are available at the following link: https://open.efsa.europa.eu/study-inventory/EFSA-Q-2022-00184
References
- EFSA (European Food Safety Authority) , 2011a. Reasoned opinion on the modification of the existing MRLs for pyraclostrobin in various crops. EFSA Journal 2011;9(3):2120, 41 pp. 10.2903/j.efsa.2011.2120 [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2011b. Reasoned opinion on the review of the existing maximum residue levels (MRLs) for pyraclostrobin according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2011;9(8):2344, 92 pp. 10.2903/j.efsa.2011.2344 [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2012a. Reasoned opinion on the modification of the existing MRLs for pyraclostrobin in leafy brassica and various cereals. EFSA Journal 2012;10(3):2606, 36 pp. 10.2903/j.efsa.2012.2606 [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2012b. Scientific support for preparing an EU position in the 44th Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2012;10(7):2606, 155 pp. 10.2903/j.efsa.2012.2859 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2013. Reasoned opinion on the modification of the existing MRLs for pyraclostrobin in cucumbers and Jerusalem artichokes. EFSA Journal 2013;11(2):3109, 27 pp. 10.2903/j.efsa.2013.3109 [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2014a. Reasoned opinion on the modification of the existing MRLs for pyraclostrobin in chicory roots. EFSA Journal 2014a;12(5):3685, 23 pp. 10.2903/j.efsa.2014.3685 [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2014b. Reasoned opinion on the modification of the existing MRLs for pyraclostrobin in swedes and turnips. EFSA Journal 2014b;12(10):3872, 19 pp. 10.2903/j.efsa.2014.3872 [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2016. Reasoned opinion on the modification of the existing MRLs for pyraclostrobin in beet leaves (chards). EFSA Journal 2016;14(8):4552, 14 pp. 10.2903/j.efsa.2016.4552 [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2017. Reasoned opinion on the modification of the existing MRLs for pyraclostrobin in various crops. EFSA Journal 2017;15(1):4686, 19 pp. 10.2903/j.efsa.2017.4686 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2018a. Reasoned opinion on the modification of the existing MRL for pyraclostrobin in soyabean. EFSA Journal 2018;16(11):5466, 29 pp. 10.2903/j.efsa.2018.5466 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2018b. Reasoned opinion on the Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin. EFSA Journal 2018b;16(11):5472, 21 pp. 10.2903/j.efsa.2018.5472 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2018c. Setting of an import tolerance for pyraclostrobin in rice. EFSA Journal 2018;16(11):5483, 23 pp. 10.2903/j.efsa.2018.5483 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2018d. Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops. EFSA Journal 2018;16(11):5488, 38 pp. 10.2903/j.efsa.2018.5488 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , Brancato A, Brocca D, Ferreira L, Greco L, Jarrah S, Leuschner R, Medina P, Miron I, Nougadere A, Pedersen R, Reich H, Santos M, Stanek A, Tarazona J, Theobald A and Villamar‐Bouza L, 2018e. Guidance on use of EFSA Pesticide Residue Intake Model (EFSA PRIMo revision 3). EFSA Journal 2018;16(1):5147, 43 pp. 10.2903/j.efsa.2018.5147 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2019a. Reasoned Opinion on the modification of the existing maximum residue level for pyraclostrobin in sweet corn. EFSA Journal 2019;17(10):5841, 24 pp. 10.2903/j.efsa.2019.5841 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2019b. Scientific Report on scientific support for preparing an EU position in the 51st Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2019;17(7):5797, 243 pp. 10.2903/j.efsa.2019.5797I [PMC free article] [PubMed] [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , Anastassiadou M, Brancato A, Carrasco Cabrera L, Ferreira L, Greco L, Jarrah S, Kazocina A, Leuschner R, Magrans JO, Miron I, Pedersen R, Raczyk M, Reich H, Ruocco S, Sacchi A, Santos M, Stanek A, Tarazona J, Theobald A and Verani A, 2019c. Pesticide Residue Intake Model‐ EFSA PRIMo revision 3.1 (update of EFSA PRIMo revision 3). EFSA supporting publication 2019:1605, 15 pp. 10.2903/sp.efsa.2019.EN-1605 [CrossRef] [Google Scholar]
- EFSA (European Food Safety Authority) , 2021. Scientific support for preparing an EU position for the 52nd Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2021;19(8):6766, 342 pp. 10.2903/j.efsa.2021.6766 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
- European Commission , 1996. Appendix G. Livestock feeding studies. 7031/VI/95‐rev 4, 22 July 1996.
- European Commission , 1997a. Appendix A. Metabolism and distribution in plants. 7028/VI/95‐rev.3, 22 July 1997.
- European Commission , 1997b. Appendix B. General recommendations for the design, preparation and realization of residue trials. Annex 2. Classification of (minor) crops not listed in the Appendix of Council Directive 90/642/EEC. 7029/VI/95‐rev. 6, 22 July 1997.
- European Commission , 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95‐rev. 2, 22 July 1997. [Google Scholar]
- European Commission , 1997d. Appendix E. Processing studies. 7035/VI/95‐rev. 5, 22 July 1997. [Google Scholar]
- European Commission , 1997e. Appendix F. Metabolism and distribution in domestic animals. 7030/VI/95‐rev. 3, 22 July 1997. [Google Scholar]
- European Commission , 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95‐rev. 5, 22 July 1997. [Google Scholar]
- European Commission , 1997g. Appendix I. Calculation of maximum residue level and safety intervals. 7039/VI/95 22 July 1997. As amended by the document: classes to be used for the setting of EU pesticide maximum residue levels (MRLs). SANCO 10634/2010, finalised in the Standing Committee on the Food Chain and Animal Health at its meeting of 23–24 March 2010.
- European Commission , 2004. Review report for the active substance pyraclostrobin. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 28 November 2003 in view of the inclusion of pyraclostrobin in Annex I of Council Directive 91/414/EEC. SANCO/1420/2001‐Final, 8 September 2004.
- European Commission , 2010. Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SANCO 10634/2010‐rev. 0, Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting of 23–24 March 2010. [Google Scholar]
- European Commission , 2017.Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods. SANTE 2017/10632, Rev. 4, 23 February 2022. [Google Scholar]
- European Commission , 2020. Technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and extrapolation on residue data on products from plant and animal origin. SANTE/2019/12752, 23 November 2020. [Google Scholar]
- European Commission , 2021. Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post‐approval Control and Monitoring Purposes. SANTE/2020/12830, Rev.1 24 February 2021. [Google Scholar]
- FAO (Food and Agriculture Organization of the United Nations) , 2011. Pesticide residues in food – 2011. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues. FAO Plant Production and Protection Paper 211. Available online: http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/jmpr/jmpr-rep/en/ [Google Scholar]
- FAO (Food and Agriculture Organization of the United Nations) , 2016. Submission and evaluation of pesticide residues data for the estimation of Maximum Residue Levels in food and feed. Pesticide Residues. 3re Edition. FAO Plant Production and Protection Paper 225, 298 pp.
- FAO (Food and Agriculture Organization of the United Nations) , 2018. Pyraclostrobin. In: Pesticide residues in food – 2018. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues. FAO Plant Production and Protection Paper 234. 668 pp.
- FAO (Food and Agriculture Organization of the United Nations) , 2019. Report of the extra 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. Ottawa, Canada, 7–17 May 2019. Pesticide residue in food 2019, 360 pp.
- FAO (Food and Agriculture Organization of the United Nations) , 2021. 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, 17–21 May and 7–11 June 2021. Pesticide residue in food 2021. 493 pp. [Google Scholar]
- Germany , 2001. Draft assessment report on the active substance pyraclostrobin prepared by the rapporteur Member State Germany in the framework of Council Directive 91/414/EEC August 2001.
- Germany , 2003. Addendum to the draft assessment report on the active substance pyraclostrobin prepared by the rapporteur Member State Germany in the framework of Council Directive 91/414/EEC, October 2003.
- Germany , 2023. Evaluation report on the modification of MRLs for pyraclostrobin in papayas. January 2023, revised in March 2023. Available online: www.efsa.europa.eu [Google Scholar]
- OECD (Organisation for Economic Co‐operation and Development) , 2011. OECD MRL calculator: spreadsheet for single data set and spreadsheet for multiple data set, 2 March 2011. In: Pesticide Publications/Publications on Pesticide Residues. Available online: https://www.oecd.org [Google Scholar]