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«REASONED OPINION Modification of the existing MRLs for thiacloprid in table olives, olives for oil production, poppy seeds and various root ...»

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EFSA Journal 2009; 7(12):1410

REASONED OPINION

Modification of the existing MRLs for thiacloprid in table olives, olives for

oil production, poppy seeds and various root vegetables1

European Food Safety Authority2

European Food Safety Authority (EFSA), Parma, Italy

SUMMARY

According to Article 6 of the Regulation (EC) No 396/2005, the Czech Republic received an

application from Bayer s.r.o. to modify the existing MRL for thiacloprid in poppy seeds. In order to accommodate for the intended use of thiacloprid in the Czech Republic, it is proposed to raise the existing MRL in poppy seed from 0.02 mg/kg (set at the limit of quantification) to 0.3 mg/kg. The Czech Republic drafted an 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 May 2009.

According to Article 6 of the Regulation (EC) No 396/2005, Greece received an application from Bayer CropScience to modify the existing MRLs for thiacloprid in table olives and olives for oil production. In order to accommodate for the intended use of thiacloprid in the Southern Europe, it is proposed to raise the existing MRLs in table olives and olives for oil production from 0.02 mg/kg (set at the limit of quantification) to 4 mg/kg. Greece drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA on 31 July 2009.

According to Article 6 of the Regulation (EC) No 396/2005, the United Kingdom received an application from Horticultural Development Company to modify the existing MRLs for thiacloprid in various root crops: carrots, beetroot, horseradish, parsnips, parsley root and salsify. In order to accommodate for intended uses of thiacloprid in the United Kingdom, it is proposed to raise the existing MRLs for these crops from 0.02 mg/kg (set at the limit of quantification) to 0.05 mg/kg. The United Kingdom drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA on 3 September 2009.

Considering that all three applications refer to the modification of existing MRLs for thiacloprid, EFSA decided to address all MRL applications in one reasoned opinion.

EFSA derived the following conclusions based on the submitted evaluation reports prepared by Greece, the Czech Republic and the United Kingdom as well as the Draft Assessment Report (DAR) prepared by the United Kingdom under Directive 91/414/EEC.

1 On request from the European Commission, Question No EFSA-Q-2009-00741, EFSA-Q-2009-00632, EFSA-Q-2009issued on 2 December 2009.

2 Correspondence: praper.mrl@efsa.europa.eu Suggested citation: European Food Safety Authority; Modification of the existing MRLs for thiacloprid in table olives, olives for oil production, poppy seeds and various root vegetables on request. EFSA Journal 2009; 7(12):1410. [28 pp.].

doi:10.2903/j.efsa.2009.1410. Available online: www.efsa.europa.eu

–  –  –

The toxicological profile of thiacloprid was investigated in the peer review and the data were sufficient to conclude on an ADI value of 0.01 mg/kg bw/d and an ARfD value of 0.03 mg/kg bw.

Metabolism of thiacloprid in plants was investigated in three crop categories and a general residue definition for risk assessment and monitoring was proposed by the peer review as parent thiacloprid.

EFSA, however, is of the opinion that 6-chloronicotinic acid residues might occur in oilseeds in amounts requiring consideration in the consumer risk assessment. It should be noted that 6chloronicotinic acid and its precursor 6-chloropicolyl alcohol are metabolites containing 6chlorpyridinyl moiety, which is characteristic not only for thiacloprid but also for imidacloprid and acetamiprid. EFSA is of the opinion that the occurrence of 6-chloronicotinic acid in oilseeds has to be further investigated in the framework of Article 12 (2) of Regulation (EC) No 396/2005. Sufficiently validated analytical enforcement methods are available to control the compliance of the proposed MRLs for the current residue definition in all crops under consideration.

Submitted supervised residue field trials indicate that MRLs of 4 mg/kg for table olives and olives for oil production, 0.3 mg/kg for poppy seeds and 0.05 mg/kg for carrots, beetroot, horseradish, parsnips, parsley root and salsify would be necessary to accommodate the intended uses of thiacloprid.

The occurrence of thiacloprid or its metabolites in rotational crops was also investigated. EFSA concluded that significant residues in rotational crops are not expected provided that thiacloprid is applied according to the proposed GAP for root crops and poppy seeds. Residues in commodities of animal origin were not assessed in the framework of this application since crops under consideration are not livestock feeding items.

Effects of processing on the nature of thiacloprid were studied in the peer review in hydrolysis study and results indicate that thiacloprid is stable under hydrolytic conditions and no formation of toxicologically relevant metabolites occurs. No processing studies for table olives have been submitted but are recommended taking into account the contribution of table olives to the acute consumer exposure. Processing studies with olives investigating the magnitude of thiacloprid residues in refined oil are available and the following processing factor was derived and is recommended for the inclusion





in Annex VI of Regulation (EC) No 396/2005:

• Olives, refined oil: 0.02 No studies have been submitted to assess the magnitude of thiacloprid residues during the processing of carrots, beetroot, horseradish, parsley root, parsnips, salsify and poppy seeds. Such studies, however, are not necessary considering the low individual contribution of these crops to the total dietary intake The consumer risk assessment was performed with revision 2 of the EFSA PRIMo. For the chronic intake assessment EFSA used the existing MRLs as established in Annexes II and III of Regulation (EC) No 396/2005 as well as STMR values derived from the supervised residue field trials on olives, poppy seeds, carrots, beetroot, horseradish, parsley root, parsnips and salsify. In addition, for spring onions, leek, lamb`s lettuce, celery, fennel and tea EFSA used the values as obtained in the previously issued EFSA reasoned opinions on the modification of the existing MRLs for thiacloprid.

Acute intake assessment was performed only with regard to the crops under consideration. The relevant HR values for olives, poppy seeds, carrots, beetroot, horseradish, parsley root, parsnips and salsify as derived for the intended GAPs were used as input values in the acute intake calculations.

No long term intake concerns were identified for any of the European diets. The total calculated dietary intake ranged from 15 to 77.5% of the ADI. The contribution of table olives and olives for oil production to the total consumer exposure to thiacloprid residues accounted for a maximum of 0.41% and 0.2% of the ADI, respectively (WHO Cluster diet B). From roots crops under consideration, the highest consumer exposure was identified for carrots (0.27% of the ADI, FR Infant diet), for all other

–  –  –

crops being below 0.01% of the ADI. The contribution of thiacloprid residues in poppy seeds was insignificant accounting for a maximum of 0.023% of the ADI for WHO Regional European diet.

No acute intake concerns were identified with regard to the proposed MRLs for crops under consideration. The highest acute consumer exposure to thiacloprid residues was identified from table olives, accounting for 27% of the ARfD. The exposure from olives intended for oil production was insignificant (0.04% of the ARfD). From root crops the highest acute consumer exposure was identified for carrots (8.5% of the ARfD), followed by beetroot (5.8% of the ARfD), salsify (5.2% of the ARfD) and parsnips (4.8% of the ARfD). The contribution of poppy seeds to the acute consumer exposure to thiacloprid residues accounted for 0.5% of the ARfD.

Consequently, EFSA concludes that intended uses of thiacloprid on olives, carrots, horseradish, beetroot, parsnips, parsley root, salsify and poppy seeds are acceptable as they will not result in an

exceedance of toxicological reference values. EFSA derived the following recommendations:

–  –  –

KEY WORDS

Thiacloprid, table olives, olives for oil production, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, cyanamide insecticide

–  –  –

TABLE OF CONTENTS

Summary

Table of contents

Background

Terms of reference

The active substance and its use pattern

Assessment

1.  Methods of analysis

1.1.  Methods for enforcement of residues in food of plant origin

1.2.  Methods for enforcement of residues in food of animal origin

2.  Mammalian toxicology

3.  Residues

3.1.  Nature and magnitude of residues in plant

3.1.1.  Primary crops

3.1.2.  Rotational crops

3.2.  Nature and magnitude of residues in livestock

4.  Consumer risk assessment

Conclusions and recommendations

References

Appendix A – Good Agricultural Practices (GAPs)

Appendix B – Pesticide Residues Intake Model (PRIMo)

Appendix C – Existing EC MRLs

Abbreviations

–  –  –

BACKGROUND

Regulation (EC) No 396/2005 establishes the rules governing the setting of pesticide MRLs at Community level. Article 6 of that regulation lays down that a party requesting an authorisation for the use of a plant protection product in accordance with Directive 91/414/EEC, shall submit to a Member State, when appropriate, an application to set or modify an MRL in accordance with the provisions of Article 7 of that regulation.

The Czech Republic, hereafter referred to as the evaluating Member State (EMS) for poppy seeds, received an application from Bayer s.r.o. on behalf of Bayer CropScience AG3 to modify the existing MRL for the active substance thiacloprid in poppy seeds.

Greece, hereafter referred to as the evaluating Member State (EMS) for olives, received an application from the company Bayer CropScience4 to modify the existing MRLs for the active substance thiacloprid in table olives and olives for oil production.

The United Kingdom, hereafter referred to as the evaluating Member State (EMS) for root crops, received an application from the Horticultural Development Company5 to modify the existing MRL for the active substance thiacloprid in various root crops.

The above mentioned applications were notified to the European Commission and EFSA and subsequently evaluated by the EMS in accordance with Article 8 of the Regulation.

After completion, the evaluation report of the EMS Czech Republic was submitted to the European Commission who forwarded the application, the evaluation report and the supporting dossier to EFSA on 29 May 2009. The application was included in the EFSA Register of Question with the reference

number EFSA-Q-2009-00632 and the following subject:

Thiacloprid - Application to modify the existing MRL for thiacloprid in poppy seeds from 0.05*mg/kg to 0.3 mg/kg.

On 1 July 2009 some data requirements were identified for the MRL application on poppy seeds, which prevented EFSA to conclude on the consumer risk assessment. An updated evaluation report, addressing those data requirements, was submitted by the EMS on 23 September.

After completion, the evaluation report of the EMS Greece was submitted to the European Commission who forwarded the application, the evaluation report and the supporting dossier to EFSA on 31 July. The application was included in the EFSA Register of Question with the reference number

EFSA-Q-2009-00741 and the following subject:

Thiacloprid - Application to modify the existing MRLs in table olives and olives for oil production.



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