Setting of import tolerance for pyraclostrobin in papayas

Abstract

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.

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

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).

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.

Appendix A – Summary of intended notified GAP triggering the amendment of existing EU MRLs

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

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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

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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

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MRL: maximum residue level; GAP: Good Agricultural Practice; Mo: monitoring; RA: risk assessment; N/A: not applicable.

^*Indicates that the MRL is proposed at the limit of quantification.

^(a)NEU: Outdoor trials conducted in northern Europe, SEU: Outdoor trials conducted in southern Europe, EU: indoor EU trials or Country code: if non‐EU trials.

^(b)Highest residue. The highest residue for risk assessment refers to the whole commodity and not to the edible portion.

^(c)Supervised trials median residue. The median residue for risk assessment refers to the whole commodity and not to the edible portion.

^(d)Conversion factor to recalculate residues according to the residue definition for monitoring to the residue definition for 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.3. Consumer risk assessment

Appendix C – Pesticide Residue Intake Model (PRIMo)

1.

Appendix D – Input values for the exposure calculations

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

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IUPAC: International Union of Pure and Applied Chemistry; SMILES: simplified molecular‐input line‐entry system; InChiKey: International Chemical Identifier Key.

^(a)The metabolite name in bold is the name used in the conclusion.

^(b)ACD/Name 2020.2.1 ACD/Labs 2020 Release (File version N15E41, Build 116563, 15 June 2020).

^(c)ACD/ChemSketch 2020.2.1 ACD/Labs 2020 Release (File version C25H41, Build 121153, 22 March 2021).

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

References