STC Number - 422

France's dimethoate-related restrictions on imports

Maintained by: European Union
Raised by: United States of America
Supported by: Argentina; Canada; Turkey
First date raised: July 2017 G/SPS/R/87, paras. 27-32; See also STC 382; G/TBT/N/EU/467
Dates subsequently raised: November 2017 (G/SPS/R/88, paras. 3.53-3.55)
March 2018 (G/SPS/R/90, paras. 3.31-3.34)
July 2018 (G/SPS/R/92/Rev.1, paras. 4.88-4.90)
July 2019 (G/SPS/R/95, paras. 4.57-4.59)
Number of times subsequently raised: 4
Relevant documents: G/SPS/N/FRA/13; G/TBT/N/EU/467
Products covered: Fresh cherries
Primary subject keyword: Food safety
Keywords: Maximum residue limits (MRLs); Pesticides; Risk assessment
Status: Not reported
Solution:
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In July 2017, the Chairperson noted that this concern was first raised in June 2016 as part of the concern regarding the European Union's revised proposal for the categorization of compounds as endocrine disruptors. It was now being raised as a separate specific trade concern, and would thus be so reflected in the IMS.

The United States reiterated its concern over actions taken by France to ban the importation of fresh cherries from countries that had approved the use of the pesticide dimethoate on cherries. The United States noted that the ban had not been based on a risk assessment of the safety of residues and that the measure had been renewed despite being inconsistent with the November 2016 EFSA decision and the regulation approved in February 2017 by SCoPAFF on MRLs for dimethoate (and its metabolite omethoate). The United States recalled that the European Commission and a majority of member States deemed France's requests for a European emergency measure to be unjustified and highlighted that the measure had a significant impact on trade without achieving a significant public health benefit. The United States further added that the measure had only been notified after its implementation and after the US request. It had then been notified as an emergency measure, without a specified comment period. Finally, the United States questioned the scientific basis for applying the measure only to fresh cherries when other commodities could also contain dimethoate residues. The United States expressed its willingness to exchange scientific information with France on the safety of dimethoate and its metabolites, as well as to explore less trade-restrictive measures.

Argentina endorsed the statement of the United States, highlighting the measure's lack of scientific justification and that it was more trade-restrictive than necessary, noting alternative measures such as the use of MRLs and the monitoring of residues during import controls. Argentina urged France and other Members imposing pesticide-related restrictions, to act in accordance with the SPS Agreement.

Canada echoed the United States and remained concerned about the renewal of a temporary restriction as a national emergency measure. Canada recalled that in October 2016 and July 2017 it had asked France for evidence that the current MRL of 0.2 mg/kg was insufficient to protect human health and for alternative appropriate levels of MRL for dimethoate. Canada highlighted the lack of scientific evidence of the measures imposed by France and expressed its general concern regarding bans based on substance authorizations, regardless of residue levels. Canada urged France to conduct a risk assessment to justify the application of a more restrictive MRL than the one applied by the European Union.

The European Union recalled that on 28 April 2017, France had introduced a protective measure suspending the importation of fresh cherries for consumption from member States and non-EU countries that had approved the use of the pesticide dimethoate on cherry trees. France had justified the measure because of unacceptable toxicological risks posed by the consumption of certain dimethoate metabolites. The European Union clarified that France was particularly concerned by the identification of a possible acute risk by EFSA, leading to France's request to the European Commission for emergency measures to ban the use of dimethoate for cherry trees. In the absence of EU measures, France had introduced a national emergency measure. The European Union finally indicated that new studies had been submitted to EFSA for evaluation, expecting a conclusion in spring 2018.

The United States thanked the European Union and looked forward to further bilateral discussions. The United States added that plant metabolism studies and toxicological data on relevant dimethoate metabolites had been previously submitted to and reviewed by the United States Environmental Protection Agency (EPA), and that omethoate, the only metabolite that was found to be toxicologically relevant by the EPA for risk assessment purposes (as well as enforcement), had also been evaluated by EFSA, with separate protective MRLs voted and approved by EU member States in February 2017.

In November 2017, the United States reiterated its concern over actions taken by France to ban the importation of fresh cherries from the United States and other countries that had approved the use of the pesticide dimethoate on cherries. The United States expressed concern over the decision to restrict imports of commodities based on the authorization of a pesticide in the country of origin rather than based on a scientific assessment of risk, and regardless of whether or not residues of the pesticide were present in the imported commodities. The United States noted that publicly available evaluations from other regulatory authorities had determined that dimethoate metabolites were not toxicologically relevant, as did the draft Rapporteur Assessment Report of the European Food Safety Authority (EFSA). The United States informed it had received from France a response to its comments, but regretted that it referred to data gaps when the United States argued the data was available. Finally, the United States requested France not to renew its ban for a third consecutive year.

Canada echoed the US concern, requested information about the measures that would apply from 1 January 2018, and encouraged France to adopt measures in line with those of the European Commission, which were scientifically justified and not discriminatory against products from countries where dimethoate was authorised for use. Canada urged France to conduct a risk assessment to determine if the current MRL established by the European Union was insufficient before enacting more trade restrictive measures.

The European Union referred to the response provided in the July 2017 SPS Committee meeting. To the question on the rationale behind the application of the measure only to fresh cherries when other commodities could also contain dimethoate residues, the European Union stated that it was based on consumption patterns, which were higher for cherries than for other commodities which could contain dimethoate residues. The European Union finally indicated that new studies had been submitted for evaluation to EFSA, with a conclusion expected in spring of 2018.

In March 2018, the United States reiterated its concern regarding actions taken by France to ban the importation of fresh cherries from the United States and other countries that had approved the use of the pesticide dimethoate on cherries. The United States expressed concern over the decision to restrict imports of commodities based on the authorization of a pesticide in the country of origin rather than based on a scientific assessment of risk, and regardless of whether or not residues of the pesticide were present in the imported commodities. The United States indicated that it had provided data, in response to France's notification (G/SPS/N/FRA/13), showing that dimethoate had not been used in the State of California for over five years. Furthermore, the United States argued that in regions where dimethoate might be used, it had been applied as a post-harvest application, which did not result in residues on the fruit. The United States noted that it had received from France a response to its submitted comments, but regretted that its substantive concerns had not been addressed. The United States indicated that it had demonstrated that pesticide authorization status was not a reliable indicator of actual exposure to residues and on this basis, requested France to clarify whether less trade restrictive measures had been considered. The United States also highlighted that it had satisfied the data-gaps for dimethoate metabolites and further urged France to follow the MRLs established by the European Commission, upon completion of the EU re-evaluation of dimethoate. Finally, the United States requested France not to renew its ban for a third consecutive year.

Canada echoed the US concern, requested information about any new measure that would apply later in 2018, and encouraged France to adopt measures in line with those of the European Commission. Canada noted that France had lifted its ban on cherries from countries where dimethoate use was authorized, but remained concerned that France might implement another temporary measure banning cherries from countries that had registered dimethoate use. Canada urged France to conduct a risk assessment to determine if the current MRL established by the European Union was insufficient, before implementing more trade restrictive measures.

Turkey supported the concerns raised, indicating that although dimethoate use had been prohibited in Turkey, it still had been unable to export cherries to France. Turkey urged France to apply the least trade restrictive measures and indicated its willingness to continue bilateral discussions on the issue.

The European Union referred to its previous responses provided in the 2017 SPS Committee meetings and indicated that the measure, which had been introduced in April 2017, had expired at the end of 2017. In terms of the next steps, the European Union explained that EFSA would evaluate new studies, particularly in view of the open questions on metabolites, and that an EFSA conclusion was expected later in 2018. The European Union noted that it was too early to know whether new measures would be introduced by France in 2018. The European Union further indicated that any such measure would be notified to the Committee.

In July 2018, the United States reiterated its concern raised in previous SPS Committee meetings regarding actions taken by France in 2016 and 2017 to ban the importation of fresh cherries from the United States and other countries that had approved the use of the pesticide dimethoate on cherries. The United States expressed regret that France had renewed this ban for 2018 and noted its concern that a precedent was being set where the decision to restrict imports of commodities was solely being based on the authorization of a pesticide in the country of origin, regardless of whether pesticide residues were actually present in the imported commodities. The United States indicated that it had provided France with usage data, showing that dimethoate had not been used in the State of California for over five years. Furthermore, the United States argued that in regions where dimethoate might be used, it had been applied as a post-harvest application, which was unlikely to result in residues on the fruit. The United States requested France to explain how the health of French consumers was enhanced by restricting US cherries that had never been treated with dimethoate and contained no dimethoate residues. The United States further requested France to clarify whether less trade restrictive measures had been considered. The United States noted that the ban had been notified as an emergency measure on 4 May 2018, and invited France to explain how the current scientific evidence was insufficient and to identify the actions undertaken over the past years to obtain the scientific evidence that could justify the emergency measure. The United States indicated that US cherry producers were able to supply French consumers with high quality products that complied with the European food safety standards, and urged France to minimize unnecessary trade barriers by ensuring that measures were only applied to the extent necessary to protect health.

Canada echoed the US concern regarding France's renewal of the measure, noting that dimethoate was authorized for use in Canada to control a wide number of pests on agricultural crops, including cherries. While Canada acknowledged France's right to take SPS measures, Canada had concerns regarding the scientific basis and the unnecessary trade-restrictive nature of the renewed measure. Between 2016 to 2018, Canada had submitted comments on France's emergency measures, indicating its concerns with the lack of evidence provided by France to demonstrate that the current EU MRL was insufficient to protect consumers, and with the lack of consideration of an appropriate MRL for dimethoate. Canada noted that if there was a scientific basis for the zero-tolerance approach to dimethoate, WTO Members should only require that the product be free of any residues of that substance, and not ban imports from countries that allow the use of the substance. Given that this emergency measure had been notified for the third time since 2016, Canada urged France to conduct a comprehensive risk assessment to determine if the current EU MRL was insufficient before implementing the trade restrictive measure. Canada also requested that, if the current MRL was found to be insufficient, that France conduct a risk assessment to determine a more appropriate MRL.

The European Union explained that France had published on 6 April 2018, a protective measure suspending the importation and placing on the market of fresh cherries from member States or non EU countries where the use of plant protection products containing the active substance dimethoate was authorized for the treatment of cherry trees. The measure had entered into force on 11 April 2018 and would expire after 12 months. The measure had been notified and the French authorities would shortly send a response to the comments received from Canada. The European Union explained that France had justified the measure on the basis of concerns related to the unacceptable toxicological risk of certain metabolites. In terms of the next steps, the European Union indicated that EFSA would evaluate new studies, particularly in view of the open questions on the metabolites, and that an EFSA conclusion was expected later in 2018. Following which, the measure would be reviewed in light of the EFSA conclusions.

In July 2019, the United States reiterated its concern that France banned the import of cherries based on the authorization status of dimethoate in the country of origin, regardless of whether or not the cherries had been treated with dimethoate or contained dimethoate residues. The measure unjustly restricted access to the French market and harmed US cherry producers without adequately clarifying its scientific basis.

Canada reiterated its concern regarding the French emergency measures, in particular the lack of evidence to demonstrate that the EU's existing MRL for dimethoate was insufficient to protect consumers and whether another MRL would be more appropriate; and that a science-based ban of a substance should require the lack of residues of said substance in imported products, not ban imports from countries that permit the use of that substance, regardless of whether there is any residue on a particular shipment. Given that this was the fourth emergency measure notified by France since 2016 regarding the use of dimethoate in the production of cherries, Canada requested France that, if the current EU MRL was considered insufficient, to conduct a full scientific risk assessment to determine a more appropriate MRL.

The European Union explained that this was an emergency measure adopted by France on 18 April 2019. It entered into force on 20 April 2019, and would expire after twelve months. It was notified to the SPS Committee as an emergency measure on 8 May 2019. The measure suspended the importation and placing in the market of fresh cherries produced in EU member States or in non-EU countries where the use of plant protection products containing dimethoate was authorised for the treatment of cherry trees. France justified the measure due to public health risks associated with the consumption of cherries treated with dimethoate because of toxicological risks of certain metabolites. In October 2018, EFSA's review of dimethoate identified several areas of concern, including risks to humans from exposure to dimethoate because of its genotoxic and mutagenic potential. On this basis, the European Union submitted notification G/TBT/N/EU/467 in March 2019 regarding a draft measure on the non-renewal of dimethoate. The measure was adopted and published on 26 June 2019 as Commission Implementing Regulation (EU) 2019/1090, which provided for a short grace period for plant protection products intended to be used on cherries, because of the risks identified for these products. In view of health concerns, a proposal to reduce MRLs for cherries had been notified under the SPS Agreement in July 2019. The French measure would be reviewed following the European Union-wide developments.