EFSA evaluates pesticide chlormequat’s possible risks in grapes

Date:05-07-2010

Following information from food business operators on table grapes containing residues of the pesticide chlormequat, the European Commission has requested urgent scientific advice from EFSA on possible risks for public health. The use of the pesticide chlormequat is not permitted in the EU for use on grapes.

In a statement published today, EFSA’s experts say that if the concentration of chlormequat on grapes does not exceed the threshold of 1.06 milligrams per kilogram, it is not likely to pose a short-term risk for public health. However, the experts say that children in those EU countries with the highest consumption levels of table grapes would be the most exposed group. If children were to eat, at one time, a large amount of grapes containing chlormequat at levels above 1.06 mg/kg, health risks could not be excluded. EFSA specified that acute symptoms would include irritation to mouth or throat, vomiting, nausea, abdominal pain and headache.

EFSA also specified that this threshold should not be understood as a recommendation for a change of the current Maximum Residue Level (MRL), as it is the result of a safety assessment for a specific case and has been provided only to support EU decision makers in managing possible consumer health risks.

Risks for public health due to the presence of chlormequat in table grapes from India

On 21 April 2010 EFSA received an urgent request from the European Commission to provide a statement on the risks to public health related to the presence of chlormequat residues in table grapes originating from India which may be exceeding the current legal limit established at European level. The European Commission asked EFSA to calculate the threshold residue concentration that will not cause an exceedence of the toxicological threshold for acute exposure (Acute Reference Dose, ARfD) for any of the European Consumer groups in the EFSA PRIMo.

Chlormequat is an active substance used as plant growth regulator in plant protection products. Chlormequat was included in Annex I of Directive 91/414/EEC with the restriction to be used only on cereals and non-edible crops. The MRL for table grapes is therefore set at the limit of quantification (0.05 mg/kg).

In the peer review under Directive 91/414/EEC the toxicological profile of chlormequat chloride, the salt used in pesticide formulations, was investigated. The data were sufficient to derive an Acceptable Daily Intake value (ADI) of 0.04 mg/kg bw/d and an ARfD of 0.09 mg/kg. The recalculation of the toxicological reference values for chlormequat cation, taking into account the molecular weight correction factor, leads to an ADI of 0.031 mg/kg bw/d and ARfD of 0.07 mg/kg bw.

No information is currently available regarding the source of the chlormequat residues in grapes. In case the residues result from an agricultural use, the metabolism of chlormequat on grapes should be further investigated. In absence of appropriate metabolism studies, the presence of unknown metabolites can not be excluded. In the context of this statement, EFSA had to make the assumption that the residue of concern on grapes comprises only the parent compound chlormequat.

The calculated acute threshold residue concentration for chlormequat on table grapes is 1.06 mg/kg. Consequently, EFSA concludes that no acute consumer health risk is expected if table grapes with a mean chlormequat residue concentration of 1.06 mg/kg are consumed. The calculation is based on the most critical European consumer groups (German child, body weight 16.15 kg) eating in one eating occasion 211.5 g of table grapes (13.1 g grapes per kg body weight). The calculation also takes into account a possible inhomogeneous distribution of the residues within the lot of grapes analysed.

If this threshold concentration of 1.06 mg/kg is exceeded, a potential consumer health risk can not be excluded in case an extreme food consumption event (consumption of more than 13.1 g grapes per kg body weight) coincides with an inhomogeneous residue distribution within the lot from which the table grapes have been taken.

EFSA also performed a long-term consumer exposure assessment using the existing MRLs as input parameters in the calculation of the theoretical maximum daily intake (TMDI). For table grapes the MRL was replaced with the threshold residue derived in the iterative acute risk assessment. Regarding the long-term exposure, no potential consumer health risk was identified; the exposure accounted for maximum 77% of the ADI. The contribution of the residues in table grapes did not exceed 5% of the ADI. Assuming, there are no other non-authorised uses, it is concluded that the existing MRLs do not pose a long-term consumer health risk. There is a sufficient safety margin to exclude that a slightly higher exposure for a short period due to the consumption of table grapes with higher residues than the existing MRLs would lead to a critical intake situation.

The results of the risk assessment have to be taken as provisional and temporary, since a full data package as required for assessing the safety of residues on food resulting from the use of pesticides is not available to EFSA at this time.

The following issues have to be clarified before a final riskassessment can be performed:

• Clarification of the source of the chlormequat residues on table grapes. If it is confirmed that the residues result from an agricultural use, the description of the Good Agricultural Practice (GAP) in the country of origin has to be provided.
• Studies investigating the nature and magnitude of chlormequat residues on grapes in accordance with the use pattern described in the GAP have to be provided.
• If metabolites are identified in fruit crops, their toxicological relevance has to be clarified, and if relevant, toxicological reference values have to be derived.
 
The residue definition might need to be revised.

It is noted that therefore the calculated threshold residue should not be understood as an MRL recommendation, but it is the result of a safety assessment for a certain lot. This value is provided for use by risk managers to decide on risk management actions to be taken in order to protect European consumers with regard to the lots for which the urgent request was sent to EFSA.