STC Number - 457

EU amendments of MRLs for imazalil

Maintained by: European Union
Raised by: Colombia; Costa Rica; Côte d'Ivoire; Dominican Republic; Ecuador
Supported by: Brazil; Cameroon; Guatemala; Honduras; Jamaica; Nicaragua; Panama; Peru; Senegal; United States of America; Uruguay
First date raised: July 2019 G/SPS/R/95, paras. 4.2-4.15
Dates subsequently raised:
Number of times subsequently raised: 0
Relevant documents: G/SPS/N/EU/319, G/SPS/GEN/1707, G/SPS/GEN/1707/Add.1
Products covered: 08 Edible fruit and nuts; peel of citrus fruit or melons

Bananas, mango, avocado, citrus
Primary subject keyword: Food safety
Keywords: Food safety; Human health; International Standards / Harmonization; Maximum residue limits (MRLs); Pesticides; Risk assessment; Sufficiency of scientific evidence; Technical Barriers to Trade (TBT)
Status: Not reported
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In July 2019, Colombia raised a concern regarding the draft EU Commission Regulation on maximum residue limits of imazalil, notified in G/SPS/N/EU/319. Colombia referred to documents G/SPS/GEN/1707 and G/SPS/GEN/1707/Add.1 of Colombia, Côte d'Ivoire, Dominican Republic and Ecuador.

Colombia explained that the draft Regulation would lower the MRL of imazalil in bananas to a level which would make its use unfeasible, despite being a substance that had been recently evaluated and approved at the European level. Imazalil was a fungicide used by banana-producing countries, for which there was no known phytosanitary alternative. The economic, social and environmental impact would be irreversible for producing countries.

Colombia called on the European Union to maintain its current MRL of 2 mg/kg for imazalil in bananas, in accordance with Codex standards, until the European Union carried out a scientific risk assessment in accordance with the WTO SPS Agreement. Colombia also requested that the EU Regulation take into account WTO obligations under Article 2 paragraph 2; Article 3 paragraph 1; Article 5, paragraphs 2 and 3 of the SPS Agreement. Finally, Colombia requested that the concerns of a significant number of Members who formally commented on the draft Regulation be considered.

Costa Rica referred to the European Food Safety Authority (EFSA) recognition that the MRLs for imazalil in bananas should not be changed until there was more scientific evidence. Costa Rica added its concern that the draft Regulation shifted the burden of proving the safety of imazalil to its users. In this case producers from developing and least developed countries in tropical regions, countries whose institutional and budgetary constraints prevented them from commissioning their own scientific studies. Costa Rica urged the European Union to ensure sufficiently long transition periods so that the necessary studies could be conducted, and that exporting countries had the time to make those changes between crop harvests.

Ecuador highlighted that at the June 2019 meeting of the Standing Committee on Plants, Animals, Food and Feed of the European Union (SCOPAFF), EU member States and the EU Commission had agreed to an MRL of 0.02 mg/kg of imazalil for bananas. According to Annex 3 of JMPR Report 234 of 2018, the International Estimated Daily Intake (IEDI) of imazalil varied between 2 and 40 percent of the maximum Acceptable Daily Intake (ADI) for various products, including bananas. This meant that consuming agricultural products with the maximum value of imazalil residue would not have a health impact, since it would only amount to 40 percent of the maximum ADI. The aforementioned JMPR report also recommended increasing the current limit to 3 mg/kg. The report was recognized at the 51st annual meeting of CCPR, held in April 2019, and put forward for adoption at the CAC 42 meeting. Ecuador further added that a number of EU member States had approved the MRL of 2 mg/kg, but that EFSA had considered that the data contained in the JMPR report was not sufficient, creating an uncertainty which led to the decision of lowering the MRL to 0.01 mg/kg. Finally, Ecuador stressed the need of a transition period to adjust to a new fungicide, and of resources to conduct relevant scientific studies.

The Dominican Republic joined this concern. Imazalil was key to its banana, mango and avocado exports, which accounted for 20 percent of its annual food exports, the main destination of which was the European Union. The Dominican Republic drew Members' attention to the Communication from India in document G/SPS/W/284 of April 2015, which noted that the practice of adopting MRLs for pesticides that were not registered or not used in the territory of the importing Member had negative trade impacts. As a result of that Communication, the SPS Committee had held several technical workshops to discourage such practice. The Dominican Republic regretted that the European Union had not taken into account the recommendations of those workshops.

The United States noted that unnecessarily restrictive MRLs were already impacting United States production costs and resulting in unnecessary crop loss and food waste. The United States regretted the European Union move towards reducing imazalil MRLs for citrus when Codex had just approved increased MRLs for those commodities, and expressed concern that such actions were causing uncertainty for scientists and innovators in the plant protection sector, who faced rapidly rising costs and extended decision timeframes for maintaining authorisations and bringing new tools and products to the market.

Peru indicated that it was following these discussions as imazalil was used in its production of asparagus, grapes, and citrus fruits.

Jamaica delivered its statement on behalf of the ACP group. It shared with Members that Spain had new scientific evidence that would allow to address the data-gap and conclude the safe use of imazalil, and emphasized the need for a 36-month transition period. Jamaica also regretted that the EU vote on the measure had taken place ten days after the deadline for the submission of comments to the EU notification to the SPS Committee, which was insufficient time to properly review and analyse submitted comments.

Côte d'Ivoire joined Members presenting this STC. It underlined that it had been the largest African banana exporter and that the EU market was its main market. It also referred to the employment generated by banana production, and expressed concern that the EU measure would affect its development. Côte d'Ivoire called on the European Union to defer the implementation of the measure and requested for technical assistance to seek alternative fungicides. Côte d'Ivoire also supported Jamaica's comments on behalf of the ACP.

Uruguay informed Members that it would closely follow the evolution of the MRLs and appealed to the European Union that until new scientific evidence was provided, to continue maintaining the MRL for citrus fruits established by Codex.

Several other WTO Members including Brazil, Cameroon, Guatemala, Honduras, Jamaica on behalf of ACP countries, Nicaragua, Panama, Peru, Senegal, and Uruguay, supported this STC and expressed their concern with the MRL reduction, noting that the limit was lower to Codex standards. Some Members emphasized the lack of alternatives to imazalil and recalled the SPS principles supporting science-based measures, risk analysis, and the avoidance of unnecessary restrictions to trade. They also emphasized the importance of continuing work with Codex and the JMPR on the topic of MRLs.

The European Union considered that the new proposed MRLs were necessary to ensure the appropriate level of protection in the European Union. The 2017 assessment by EFSA had identified consumer health concerns and its subsequent assessments did not produce more favourable results for none of the good agricultural practices for which information was available to EFSA, it was demonstrated that and MRL could be established that would be sufficiently protective for consumers. The assessment had included current Codex MLRs. As information on alternative practices was not available, the European Union had proposed lowering the MRL to the limit of analytical determination. The European Union invited Members who had information that would allow establishing safe residue levels, to submit applications under the relevant legislative framework, and clarified that such applications would not suspend the ongoing process of lowering MLRs.

The European Union acknowledged that other risk assessment bodies might arrive at different conclusions due to factors such as different databases, methodologies in risk assessments and protection limits chosen by risk managers. The European Union reserved the right to base its measures on evaluations by its own risk assessment body and clarified that the current Codex MRL predated both the identification of consumer health concerns by EFSA and the EU membership of Codex, which explained the absence of an EU reservation at the CCPR meeting. At the 2019 CCPR meeting, the European Union introduced a reservation to the advancement of the new draft Codex MRL for bananas of 3 mg/kg. The European Union added that its draft act lowering the MRL of imazalil in bananas had received a favourable opinion in the relevant Standing Committee. Formal adoption of the measure was expected for October 2019 and would apply from 2020 onwards. Precise dates would be published upon publication of the measure in the Official Journal of the European Union, allowing food business operators to adapt to the new requirements. The European Union underlined its respect to transparency obligations under the SPS and TBT Agreements, and ensured Members that all comments sent to its SPS contact points were being addressed in writing.