Search EFSA Journal
Refine your search
Type
All article types
Special Issue Item
Journal Editorial
Scientific opinions of Scientific/Scientific Panel
Opinion of the Scientific Committee/Scientific Panel
Statement of the Scientific Committee/Scientific Panel
Guidance of the Scientific Committee/Scientific Panel
Other scientific outputs of EFSA
Statement of EFSA
Guidance of EFSA
Conclusion on pesticides
Reasoned opinion on pesticide
Scientific report of EFSA
Technical Report
Subject
All subjects
Animal health & welfare
Biological hazards
Biological monitoring
Contaminants
Dietary & chemical monitoring
Emerging risks
Feed
Food Ingredients and Packaging
GMO
Nutrition
Pesticides
Plant health
Assessment and methodological support
Scientific Committee
Scientific cooperation
Article ID
Digital Object ID
Sort by:
Publication date
Relevance

Reasoned opinion on the modification of the existing MRL for dodine in pome fruit, apricots and olives

EFSA Journal 2013;11(2):3112 [25 pp.]. doi:10.2903/j.efsa.2013.3112
European Food Safety Authority Contact pesticides.mrl@efsa.europa.eu
Type: Reasoned Opinion On request from: European Commission Question number: EFSA-Q-2013-00092 Approved: 08 February 2013 Published: 15 February 2013 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Portugal, herewith referred to as the evaluating Member State (EMS), received an application from the company Agriphar to lower the existing MRL for dodine in apricots to reflect a less critical European use. The applicant also submitted additional residue trials on apples and a new freezer storage stability study in high oil content matrices to confirm the MRLs derived for pome fruit and olives in the previously issued EFSA reasoned opinion. The lowering of the MRL for apricots is justified as for the existing MRL acute consumer intake concerns cannot be excluded. According to EFSA, the submitted data are sufficient to confirm the MRL proposal of 0.9 mg/kg for pome fruits as derived in the previous EFSA reasoned opinion. The MRL proposal of 0.09 mg/kg for apricots has been derived, in accordance with the provisions of the EU guidance document on extrapolation from residue trials on peaches and apples. Although the data are compliant with the data requirements, EFSA recommends performing additional trials on apricots to confirm that the MRL is sufficient to cover the use on apricots. The new freezer storage stability study submitted for dodine in high oil content matrices confirms the validity of the residue trials on olives. Thus, the data gap identified in the previous opinion with regard to the MRL for olives (20 mg/kg) is sufficiently addressed. Based on the risk assessment results, EFSA concludes that the new intended less critical uses on pome fruit and apricots which result in lower MRL proposals compared to the existing MRLs, will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a public health concern.

© European Food Safety Authority, 2013

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005 , Portugal, herewith referred to as the evaluating Member State (EMS), received an application from the company Agriphar to lower the existing MRL for dodine in apricots to reflect a less critical European use. The applicant also submitted additional residue trials on apples and a new freezer storage stability study in high oil content matrices to confirm the MRLs derived for pome fruit and olives in the previously issued EFSA reasoned opinion. The lowering of the MRL for apricots is justified as for the existing MRL acute consumer intake concerns cannot be excluded. The EMS drafted an updated evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 29 January 2013.

EFSA bases its assessment on the revised evaluation report submitted by the EMS, the Draft Assessment Report (DAR) and the Additional Report prepared by the Rapporteur Member State (RMS) Portugal under Council Directive 91/414/EEC, and the EFSA conclusion on the peer review of the pesticide risk assessment of the active substance dodine.

The toxicological profile of dodine was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.1 mg/kg bw per day and an ARfD of 0.1 mg/kg bw.

The metabolism of dodine in primary crops was investigated in fruits. According to the conclusions of the peer review, the metabolism in all crops was seen to be similar and the residue definition for monitoring and risk assessment was proposed as dodine. For the uses on the crops under consideration EFSA concludes that the metabolism of dodine is sufficiently addressed and the residue definitions agreed in the peer review are applicable.

EFSA concludes that the submitted supervised residue trials are sufficient to confirm the MRL proposal of 0.9 mg/kg for pome fruits as derived in the previous EFSA reasoned opinion. The MRL proposal of 0.09 mg/kg for apricots has been derived, in accordance with the provisions of the EU guidance document on extrapolation from residue trials on peaches and apples. Although the data are compliant with the data requirements, EFSA recommends performing additional trials on apricots to confirm that the MRL is sufficient to cover the use on apricots. The new freezer storage stability study submitted for dodine in high oil content matrices confirms the validity of the residue trials on olives. Thus, the data gap identified in the previous opinion with regard to the MRL for olives (20 mg/kg) is sufficiently addressed. Adequate analytical enforcement methods are available to control the residues of dodine in the commodities under consideration.

Dodine is hydrolytically stable under the processing conditions representative for pasteurisation, boiling/cooking and sterilisation and this for processed commodities the same residue definition as for raw agricultural commodities is applicable.

Since the proposed use of dodine is on permanent crops, the investigation of dodine residues in rotational/succeeding crops is of no relevance.

Since pome fruit pomace can be fed to livestock, in principle residues of dodine in food of animal origin should be assessed. However, considering that the existing EU MRL for pome fruit is higher (5 mg/kg) than the MRL proposal derived under the current assessment (0.9 mg/kg) and that all existing MRLs for livestock are set at the limit of quantification, a detailed examination of the residue situation in livestock was considered unnecessary.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). For the calculation of the chronic exposure, EFSA used the median residue value as derived from the residue trials on pome fruit and apricots. For banana, peaches, cherries, table olives and olives for oil production the risk assessment values were available from the previously issued EFSA reasoned opinion. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annex IIIA of Regulation (EC) No 396/2005 were used as input values.

The acute exposure assessment was performed only with regard to pome fruits and apricots, assuming the consumption of a large portion of the food items as reported in the national food surveys containing residues at the highest level (or median level for olives) as observed in supervised field trials.

No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated exposure accounted for up to 23.5% of the ADI (WHO Cluster diet B). The contribution of the crops under consideration (expressed in % of the ADI) was 2.11% for apples (DE child diet), 0.12% for pears (IE adult diet), 0.018% for apricots (DE child diet), and below 0.01% for quinces, loquats and medlar.

No acute consumer intake concerns were identified with regard to the MRL proposals for the crops under consideration. The individual contribution to the ARfD accounted for 46% for apples, 42.8 % for pears, 6.9% for quinces, 5.7% for medlar and 2.2% for apricots.

EFSA concludes that the new intended less critical uses on pome fruit and apricots which result in lower MRL proposals compared to the existing MRLs, will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a public health concern.

EFSA proposes to amend the existing MRLs as reported in the summary table.
 

Keywords

Dodine, various crops, MRL application, lowering of MRLs, Regulation (EC) No 396/2005, consumer risk assessment, guanidine fungicide.