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STC Number - 448
EU MRLs for buprofezin, chlorothalonil, diflubenzuron, ethoxysulfuron, glufosinate, imazalil, ioxynil, iprodione, molinate, picoxystrobin and tepraloxydim
Colombia; Costa Rica; Côte d'Ivoire; Ecuador; Guatemala; India; Panama; Paraguay; United States of America
Argentina; Brazil; Canada; Chile; Dominican Republic; El Salvador; Honduras; Nicaragua; Peru; Turkey; Uruguay
First date raised:
, paras. 3.1-3.10; See also
Dates subsequently raised:
March 2019 (
, paras. 3.31-3.50)
July 2019 (
, paras. 4.31-3.46)
November 2019 (
, paras. 3.21-3.34)
Number of times subsequently raised:
, G/TBT/N/EU/418, G/TBT/N/EU/447, G/TBT/N/EU/437, G/C/W/767/Rev.1,
07 Edible vegetables and certain roots and tubers; 08 Edible fruit and nuts; peel of citrus fruit or melons; 10 Cereals
Fruits and vegetables cereals, including rice.
Primary subject keyword:
Maximum residue limits (MRLs); Pesticides; Food safety; Human health; Risk assessment; International Standards / Harmonization; Sufficiency of scientific evidence
Date reported as resolved:
Extracts from SPS Committee meeting summary reports
In November 2018, India raised a concern regarding the lowering of EU MRL for buprofezin to default levels, as notified by the European Union in G/SPS/N/EU/264 on 19 July 2018. India noted that the measure was more trade restrictive than necessary to protect against risks to human health and argued that as per Article 5.7 of the SPS Agreement, the European Union should have taken into consideration the existing Codex MRLs, as well as the MRLs of other Members. Specifically, in relation to grapes, the Codex MRL for buprofezin was 1 ppm, and in the case of rice, the limits in the United States, China and Japan were 1.5 ppm, 0.3 ppm and 0.5 ppm respectively. India requested the European Union to provide the rationale for deviating from Codex standards, and for not considering MRLs set by other countries. India further observed that the modified measure did not provide an adequate transitional time period for commodities produced in accordance with the existing EU MRL, prior to its modification. India noted that in January 2011, the European Commission had amended the Council Directive to include buprofezin as an active substance from 1 February 2012 to 31 January 2021. Following which in April 2018, the expiration of the approval for buprofezin had been postponed until 31 January 2023 for use in fruits and vegetables at 0.5 ppm, and in cereals, including rice at 0.5 ppm. However, in July 2018, the European Union had proposed default levels for buprofezin. India argued that the EU decision was based on the perceived uncertainty around genotoxic potential, relating to the heat treatment of buprofezin and the production of aniline. India underscored that this chemical was normally present in many raw fruits and vegetables. India urged the European Union to conduct broad-based stakeholder consultations, as several countries, including India, would face substantial trade impacts due to the proposed measure. India hoped that the European Union would conduct a timely and objective science-based risk assessment consistent with its obligations under the SPS Agreement.
Colombia raised similar concerns in relation to EU MRLs for several pesticides, highlighting the importance of this issue for trade in cereals and food products of animal and plant origin, including fruits and vegetables. In particular, Colombia was concerned with the lowering of the MRLs for buprofezin to the default level of 0.1 ppm, as this substance was key in controlling quarantine pests for bananas, which for Colombia and other countries was done through the use of tree bag wrappings filled with buprofezin. This approach avoided damage to the fruit and allowed lower exposure to the product, when compared with insecticide spray. Colombia observed that there was no competitive substitute for the substance, which would make it more difficult to control pests for fruits, and negatively affect Colombia's exports of banana to the European Union's market. Colombia further underscored the potential social impact due to the importance of employment in the regions where the crop was grown. Colombia highlighted the commitment of its banana producers to implementing international quality standards linked with good agricultural practices, such as GlobalGap, Rainforest Alliance and Fair Trade. Colombia noted that the EU measure had been based on the possible production of aniline, a sub-product which was carcinogenic, and could be present in foods treated with buprofezin when subject to high temperatures during processing. However, Colombia highlighted that the International Agency for Research on Cancer (IARC) had included aniline in Group 3 as non-carcinogenic for humans. In addition, the US Environmental Protection Agency and the European Union's Scientific Committee on Occupational Exposure Limit Values (SCOEL) had not given conclusive evidence regarding the carcinogenicity of aniline. Colombia requested the European Union to use a risk assessment approach in its decisions and to maintain the current MRL for buprofezin or establish a reference level of 0.3 ppm in line with Codex standards. Finally, Colombia requested the European Union to grant a transitional period sufficient for producers to adapt to the new measure.
Argentina, Brazil, Canada, Chile, Costa Rica, Ecuador, Guatemala, Honduras, Nicaragua, Panama, Paraguay, Peru, Turkey and the United States echoed the concerns raised by Colombia and India, underscoring the need for a risk-based approach to implementing SPS measures, in line with the SPS Agreement. Some Members requested an appropriate transitional period for producers to adapt to the measure, and also urged the European Union to maintain the EU MRL of 0.5 ppm or to at least apply the Codex MRL of 0.3 ppm for buprofezin in banana. Costa Rica highlighted the economic and social impact of the lowering of EU MRLs for buprofezin given the importance of its banana exports. Costa Rica had also carried out chemical risk assessments analyzing buprofezin on bananas, which had concluded that there was no sizable health risk for consumers of the fruit. Chile and Turkey indicated that they had already submitted comments to the European Union. In addition to buprofezin, Argentina noted similar concerns with ioxynil. Panama also specifically indicated its concerns with buprofezin, diflubenzuron, ethoxysulfuron and picoxystrobin.
Brazil recalled its previous comments in the TBT Committee on the Commission Implementing Regulation (EU) 2017/360, notified under the TBT Agreement, which authorized the use of buprofezin only as an insecticide and acaricide on non-edible crops. Brazil noted that the regulation had the objective of protecting human and animal health, characterized by the attention to operators' and workers' safety and the risk to aquatic organisms. In this regard, Brazil indicated that it had previously asked the European Union to clarify the reasons for not also notifying the measure to the SPS Committee. In addition, Brazil drew Members' attention to its trade concern on picoxystrobin, which had also been raised in the TBT Committee.
Canada indicated concerns with the EU proposal to lower the MRL for picoxystrobin to the limit of analytical detection. Canada sought to better understand EFSA's rationale for publishing an inconclusive peer review for picoxystrobin, citing a lack of information to complete the risk assessment. Canada was alarmed that a consumer health concern had been raised during the assessment without conclusive evidence of the risk to human health. Canada had conducted a scientific risk assessment on picoxystrobin and determined that the active substance would not be of concern to human health when used according to label directions. Canada highlighted the importance of picoxystrobin as a key active substance used in Canada's grain and oilseed production. Canada requested the European Union to conduct a fulsome risk assessment and establish import tolerances in order to minimize the impact on international trade.
The United States noted that these substances had been subject to multiple evaluations by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), which found that the available data was acceptable for the purposes of completing risk assessments and establishing Codex MRLs. In addition, the authorization holders for these pesticides had conducted and committed to supplying additional data that would address the European Union's concerns, however, the European Union had declined to review these data before withdrawing the authorizations for these chemicals and lowering their MRLs to default levels. The United States queried how an applicant might be expected to demonstrate the safety of substances, as required by EU legislation, when the European Union was not satisfied with data that had been evaluated and accepted by other scientific authorities. The United States had submitted several import MRL applications for these substances and hoped for a timely and objective science-based risk assessment to inform decisions on these requests, consistent with the European Union's obligations under the SPS Agreement.
The European Union explained that the proposed lowering of MRLs for buprofezin was necessary to protect consumers, as an assessment by the European Food Safety Authority (EFSA) had identified important consumer health concerns. Available information showed that under high-temperature processing conditions, buprofezin was degraded into several metabolites, including aniline. The European Union noted that aniline was a carcinogen for which a genotoxic mechanism could not be excluded and therefore no threshold for acceptable exposure could be assumed. As a result, the approval of the active substance buprofezin had been restricted to uses in non-edible crops only. In this regard, Commission Implementing Regulation (EU) 2017/360 had been notified under the TBT Agreement as G/TBT/N/EU/418. The European Union also provided responses to several issues raised by its trading partners in relation to aniline originating from different sources, IARC's conclusion that aniline was not carcinogenic for human beings, and alignment of EU MRLs with existing Codex standards. The European Union underscored that it aimed to minimize the exposure of consumers to aniline; it based its risk management measures on the evaluations carried out by its own risk assessment body; and that the EU policy was to implement Codex MRLs into EU MRL legislation where Codex MRLs were found to be sufficiently protective for European consumers. The European Union further clarified that it had not introduced a reservation at the 2013 CCPR meeting, because the establishment of the Codex MRL for buprofezin predated EFSA's identification of consumer health concerns. However, the European Union would be submitting a concern form to Codex mentioning the EFSA findings and conclusions in order to raise international awareness.
The European Union explained its concerns surrounding diflubenzuron, highlighting that EFSA had identified substantial safety concerns during its evaluation of the substance, due to the genotoxic carcinogenic metabolite 4-chloroaniline (PCA). Since toxicological reference values for PCA could not be set and consequently no safe residue levels could be identified, the approved use of the substance was restricted to non-edible crops only. In this regard, Commission Implementing Regulation (EU) 2017/855 had been notified as a draft to the TBT Committee, in document G/TBT/N/EU/447. The European Union further noted that since it had not been demonstrated that residues of diflubenzuron above the limit of analytical determination (LOD) were safe for EU consumers, it had been proposed to lower the MRLs to the LOD. The formal adoption of the draft legislative act was expected in January 2019, and the new MRLs were expected to be applicable from July 2019 onwards. The European Union invited interested parties, with information that, might in their view, allow the establishment of safe residue levels, to submit an application under the relevant EU legislative frameworks. The European Union indicated that it would also be submitting a concern form to Codex.
The European Union explained that during the evaluation and peer review of the substance picoxystrobin, a number of concerns had been identified and detailed in the relevant EFSA conclusion related to the clastogenic and aneugenic potential of metabolite IN-H8612 formed as a residue. The European Union indicated that, based on the data available in the dossier, it had not been possible to complete the assessment of genotoxicity for the substance. This led to the non-approval of the substance, which had been notified in G/TBT/N/EU/437, as the European Union considered that it had not been demonstrated that residues of the substance above LOD were safe for EU consumers. On this basis, it was proposed to lower the MRLs to the LOD. The formal adoption of the draft legislative act was expected in January 2019, and the new MRLs were expected to be applicable from July 2019 onwards. The European Union would also be submitting a concern form to Codex. The European Union invited interested parties, with information that might, in their view, allow the establishment of safe residue levels, to submit an application under the relevant EU legislative frameworks. The European Union also indicated that it had been made aware of the existence of an additional US study, however, this study had not been submitted in the context of a regulatory procedure provided for in the EU legislation. As such, it could not be taken into account for decision-making.
The European Union also provided information on iprodione, which had been classified as a carcinogen in line with the UN Global Harmonized System for Classification and Labelling (UNGHS). The 2016 EFSA assessment had also advised the classification of this substance as a carcinogen (Category 1B) and as toxic for reproduction (Category 2), based on concrete evidence from in vitro tests. Due to these results and several other concerns with this substance, the approval for use of this substance in the European Union had not been renewed. The draft regulation was notified to non-EU countries on 25 July 2017 under the TBT Agreement, and responses provided to comments received from the United States and Turkey. The European Union further explained that following the non-renewal decision, EU member States had to withdraw their authorizations for plant protection products containing iprodione by 5 June 2018 at the latest. A draft regulation deleting iprodione MRLs was prepared by the Commission and notified to the SPS Agreement in July 2018. The European Union indicated that comments had been received from seven countries, mainly requesting transitional measures and referring to the EFSA opinion. These comments had been shared with EU member States, prior to the last meeting of the Standing Committee on Plant, Animals, Food and Feed on pesticide MRLs which took place in September 2018. Following discussions in that meeting, the draft regulation had received a unanimous favourable opinion from EU member States. In addition, due to the genotoxicity concerns for one metabolite, EU member States had decided that transitional measures could not be granted. The European Union noted that the regulation would come into force in summer 2019, highlighting that two years would have passed since the first notification of the measure in July 2017, which had provided sufficient time for trading partners to adapt to the measure. The European Union informed the Committee that it would send a concern form to Codex requesting a re-evaluation of the substance and a revision of the MRLs. Finally, the European Union indicated that import tolerances for iprodione could still be requested, but that it would have to address the genotoxicity concern for the metabolite.
In March 2019, the United States raised concerns about various EU MRL measures that appeared to be more trade-restrictive than necessary to protect against human health risks and for which scientific justifications were pending. The United States drew attention to the pesticide glufosinate, a critical herbicide, and imazalil, an important post-harvest protection tool for the US citrus industry. The United States was concerned that the European Union could lower its MRL for glufosinate to the default level of 0.01 mg/kg in view of the European Union's hazard-based cut-off criteria and the expiration of the gluconate authorisation in 2018. The United States stressed that the identification of hazard should not override the obligation to base measures on a risk assessment and asked the European Union to refrain from implementing modifications until this had been fulfilled. Regarding imazalil, EFSA had proposed removing MRLS without completing a risk assessment. This would result in closing the EU market to California citrus without sufficient scientific evidence. The United States recalled that the 2018 Joint FAO/WHO meeting on Pesticides Residues (JMPR) had reviewed and confirmed the safety of imazalil MRLs and had recommended increasing them.
The United States also drew attention to the European Union's finalized MRL regulations for buprofezin, picoxystrobin, diflubenzuron and iprodione, published in January 2019. The United States regretted that the European Union had finalized the regulations as originally proposed despite the concerns expressed by Members. Numerous scientific authorities and standard-setting bodies (including JMPR and the Codex Committee on Pesticides Residues (CCPR)) had reviewed the same substances and found there was enough acceptable scientific data available for purposes of establishing MRLs. In addition, the United States requested that import tolerance requests be addressed within a reasonable period of time, particularly in instances where the European Union had not maintained temporary MRLs during the period when dossiers were under evaluation. US fruit, nut and sweet potato producers were reporting increased crop damage and post-harvest losses due to the removal of MRLs.
Colombia expressed concern that amendments for buprofezin would affect the commercialization of bananas. The transition period for reducing the MRL for buprofezin to the minimum detection limit (0.01 mg/kg) was too short for producers to find alternatives. Colombia questioned the European Union's reasoning based on the potential presence of aniline (classified as a carcinogen in the European Union) in food products treated with buprofezin and subject to high temperatures during processing. Colombia argued that there was no conclusive evidence of the non-threshold carcinogenicity of aniline. Colombia therefore urged the European Union to conduct a risk assessment and either maintain the current MRL of 0.5 ppm for buprofezin or adopt the CAC reference value; and to postpone the entry into force of the new MRLs for buprofezin.
Colombia also expressed concerns regarding an amendment to the EU MRL for imazalil to the limit of quantification which would affect its trade of banana and citrus. Colombia noted that EFSA had found no scientific evidence demonstrating the genotoxicity of the three metabolites of imazalil. Colombia added that the EU measure would contradict the 2016 Codex MRLs, which were above the limit of quantification. Colombia stressed the importance of an appropriate risk analysis.
Costa Rica emphasised the urgency of the concern, since the reduction of the MRL for buprofezin to 0.01 mg/kg would apply as of 13 August 2019. The European Union's decision seemed to be based on the potential presence of aniline (which had been classified as a carcinogen by a 2004 ECHA report). Costa Rica wished to clarify that the chemical only occurred under specific circumstances, including very high processing temperatures and acidic conditions, not present in banana crops.
Costa Rica further argued that analyses were required to detect aniline residues in the pulp, protected by the non-edible skin. The WHO International Agency for Research on Cancer (IARC) had not classified the carcinogenicity of aniline and the US Environmental Protection Agency and the Scientific Committee on Occupational Exposure Limit (SCOEL) had not found conclusive evidence on the non-threshold carcinogenicity of aniline. Reducing the MRL for buprofezin would seriously impact banana exports from Costa Rica, where the substance was used to effectively control pests. There were currently no alternatives to control quarantine pests in the field that fulfilled EU requirements. The chemical characteristics of buprofezin allowed for its application in a safe manner for the user and the environment. Costa Rica did not think it possible to comply with the transition period established by the European Union and the date of entry into force of the new tolerance level. Costa Rica therefore urged the European Union to extend the transition period by at least 24 months in order to adapt its banana production systems to the new EU requirements.
India had concerns that the EU measures, which particularly affected its rice and grape crops, were more trade-restrictive than necessary to protect human health. India requested that the measures be based on scientific evidence and realistic exposure scenarios rather than a presumption of hazard, taking the potential impact on trade into account as well. India further enquired on the rationale for deviating from international standards set by the CAC and from MRLs set by other countries. India stressed that EU measures did not provide adequate time for commodities trade to adjust, quoting buprofezin as a specific instance of this.
Brazil, Canada, Chile, Ecuador, Honduras, Japan, Nicaragua, Panama, Paraguay, Uruguay and Turkey shared the concern. Many called on the European Union to undertake an appropriate risk assessment, underlining that the evaluations that had been carried out by EU agencies themselves had not been conclusive about genotoxicity. Additionally, Members urged the European Union to avoid departing from international standards and criteria in setting its MRLs, and insisted on the need for feasible transitional periods for exporters.
Japan requested the European Union to defer the implementation of its MRLs, since Japanese manufacturers had submitted to Italy the results of new studies on the scientific rationale for establishing an import tolerance for buprofezin, in November 2018 and February 2019.
Panama echoed concerns with regards to EU MRLs for ethoxysulfuron, picoxystrobin, diflubenzuron and buprofezin, arguing they were more trade-restrictive than necessary and that the EU market was the main destination for Panamanian agricultural exports. Panama emphasized that there were geographical differences with the European Union, which was why the substances were key to protect Panamanian crops. Producers had estimated a loss of 40% of production. Buprofezin was used in banana plantations, the country's main agricultural export. The level of buprofezin present in banana production was controlled by national authorities in accordance with Codex standards and recommendations of 0.3 ppm, which was lower than current EU levels. The product was not sprayed directly on the fruit but on the bags covering the crops, and studies had shown that residues were located in the banana skin as opposed to the pulp. There was currently no alternative to buprofezin for pest control, and the substance aniline could only be detected at extreme temperatures.
Chile supported the concern regarding the proposed reduction of MRLs for citrus. Chile noted that EFSA had not released a categorical opinion in its recommendations to reduce the MRL, which meant additional studies were required. Chile also recalled that JMPR had issued an MRL recommendation for imazalil in September 2018.
Paraguay requested the United Kingdom to refrain from applying measures deviating from international standards before completion of a risk assessment.
Brazil regretted the European Union's hazard-based approach and its measures in contradiction with findings of the JMPR and the CCPR.
Ecuador shared the concern with regard to the MRL reduction for buprofezin from 0.5 ppm to 0.01 ppm, as it would affect its banana trade. Buprofezin was needed to control quarantine pests in bananas and was used through impregnated plastic bags to avoid damaging the fruit and reduce its exposure, unlike sprayed insecticides. Ecuador requested the European Union to maintain its current 0.5 ppm MLR for buprofezin or to adopt the Codex reference limit of 0.3 ppm.
Canada expressed concern with the European Union's decision to lower the MRL for picoxystrobin to the limit of analytical detection as from 13 August 2019, without conclusive evidence of the risk to human health. Canada queried on the EU process to obtain the information it considered necessary to complete a scientifically valid risk assessment on which to subsequently base its regulatory decision. Canada had itself conducted such a risk assessment for picoxystrobin, determining in the process that the active substance was not a danger to human health when used according to label directions. The product was registered and marketed in 65 countries. Finally, Canada requested the European Union to only set import tolerances after a full risk assessment as per Regulation (EC) No 396/2005 in order to minimize the impact on international trade.
Honduras explained that its banana plantations commonly used buprofezin for pest control. The MRL reduction to the limit of detection (Article 18 (b) of Regulation (EC) No 396/2005), with shorter transition periods, posed a challenge for producers who had few alternatives to control pests and diseases. With the entry into force of the MRL in August 2019, Honduran exports to the European Union would be affected. Current banana exports exceeded 9,000 tonnes, generated 12 million dollars in revenue and created a high number of jobs. Honduras recalled that experts from JMPR and the CCPR — bodies in which the European Union took part — had evaluated buprofezin in 2013 (molecule N° 173 in the Codex list of pesticides) and recommended an MRL of 0.3 mg/kg in bananas. Honduras therefore urged the European Union to either follow this recommendation or maintain the current MLR of 0.5 ppm. Finally, based on Article 10 of the SPS Agreement, Honduras requested an extension of at least 36 months before the entry into force of the new MRL.
Uruguay expressed concerns on the MRL reduction for imazalil, which would affect its citrus production, a third of which was exported to the European Union. Imazalil was used to control Penicillum digitatum in packaging plants. Uruguay noted that JMPR reported no evidence of genotoxicity of imazalil metabolites R014821, FK-772 y FK-284 in in vitro tests, and that further data was needed before reaching decisions on MRLs. In the meantime, Uruguay called on the European Union to adhere to the current MLR of 5 kg/mg in citrus established by Codex.
Nicaragua shared the concern with regard to the MRL modification for buprofezin given the possible effects on its banana trade.
Turkey requested an update on the EU Codex initiative on buprofezin, which had been discussed during the previous Committee meeting.
The European Union referred Members to its detailed statement at the November 2018 Committee meeting. The European Union highlighted that its measures were based on science and had involved a risk assessment procedure, consistent with the SPS Agreement. EU scientific authorities had identified enough health concerns during the risk assessment to conclude that the use of the substances at issue did not meet the European Union's appropriate level of protection (ALOP). The European Union added that the burden of proof in a pre-market approval system did not necessarily fall on the country receiving import authorization requests. The European Union noted it had met its transparency obligations. All of its regulatory amendments had been duly notified and replies had been sent to all comments received. The European Union had also informed the Codex Committee of EFSA's evaluation to raise international awareness. Finally, the European Union informed the Committee that current and future import tolerance requests would be decided on the basis of a risk assessment, in line with the SPS Agreement.
In July 2019, Colombia made reference to the most recent meetings of the TBT Committee and of the Council for Trade in Goods, where 90 Members had expressed their concerns over EU measures. Colombia highlighted the importance of basing measures on international standards, risk assessments, and scientific evidence, and not arbitrarily applying unnecessary distinctions on MRLs; and that these measures should not unnecessarily restrict trade and should provide a reasonable period of time before their entry into force.
Costa Rica emphasised the urgency of the concern for the agricultural products affected, as the concerned pesticides were essential in tropical climates. Costa Rica noted the EU regulations' deviation from Codex standards, and the lack of conclusive evidence on toxicology and doses for chlorothalonil. Costa Rica also highlighted the banana sector creation of 40,000 direct jobs and 100,000 indirect jobs; and that 50 per cent of its fruit exports went to the EU market, which would therefore also be affected. Costa Rica referred to communication G/C/W/767, which presented the same concern to the Council for Trade in Goods. Costa Rica requested the European Union to apply Codex-set MRLs, to carry out risk assessments for each product and substance at issue, and to base its measures on conclusive scientific evidence. It also requested a transition period of at least 24 months for new measures, to provide sufficient time between harvests. Costa Rica urged the European Union to establish an effective, broad-based dialogue with affected Members to limit the impact of new regulations.
Panama joined the concern regarding the substances used in Panama: buprofezin, chlorothalonil, diflubenzuron, ethoxysulfuron and picoxystrobin. Panama had signed joint declarations on MRLs in 2017 in Buenos Aires with Ministers of a dozen Members, and in June 2019 in Antigua, Guatemala with Central American neighbours, and was a co-sponsor of document G/C/W/767.
Paraguay joined the concern, underscoring that its agricultural sector represented 80 percent of its exports; and the employment numbers it generated. It added that these measures could lead to unpredictability for food exporters. The relevance of the matter was noted in that 14 delegations had taken the floor to express their concern at the March SPS Committee meetings, and that the issue had also been raised in the TBT Committee meeting and at the Council for Trade in Goods.
India joined the concern, especially regarding the use of bufoprezin for rice and grapes. India requested the European Union to share the rationale for deviating from international standards set by the CAC and from MRLs set by other countries. India noted that the European Union had based its decisions on the perceived uncertainty around genotoxic potential, and that upon heating treatment, buprofezin tended to produce aniline; whereas the chemical was also naturally present in many raw fruits and vegetables.
Brazil, Canada, Chile, Dominican Republic, Ecuador, Guatemala, Honduras, Malaysia, Nicaragua, Peru, the United States, and Uruguay supported this concern. Several Members regretted that EU measures were based on a hazard-based approach instead of a risk-based approach grounded in science, in line with Codex standards. Many Members also expressed their concern that the transition period granted for the measure's entry into force was too short for producers to find and implement alternatives, thus restricting trade and creating serious socioeconomic impacts.
The United States noted that EU MRLs were impacting US production costs and resulting in unnecessary crop loss and food waste. The United States drew attention to the sweet potato and cranberry industries, which had suffered as a result of the EU removal of the MRL for thiabendazole and the lowering of its MRL for chlorothalonil, respectively. The United States awaited the European Union's review of import tolerance applications for substances like buprofezin. It remained concerned that the European Union was requiring additional genotoxicity studies that involved significant costs and live animal testing for substances like imazalil, diflubenzuron, and picoxystrobin, when other authorities, including Codex, had found existing data to be sufficient and acceptable for completing risk assessments and establishing MRLs. The European Union's current glufosinate MRLs had been confirmed on the basis of a risk assessment in 2016 but would likely be lowered to the default level of 0.01 mg/kg based on the hazard-based criteria and the expiration of the European Union glufosinate authorization in 2018. The United States concluded that the European Union's actions were causing uncertainty for scientists and innovators in the plant protection sector.
Honduras recalled that experts from JMPR and the CCPR had evaluated buprofezin in 2013 and had recommended an MRL of 0.3 mg/kg in bananas. Honduras therefore urged the European Union to either follow this recommendation or maintain their current MLR of 0.5 mg/kg. It also requested an extension of at least 36 months before the entry into force of the new MRL, availing itself of Article 10 of the SPS Agreement.
Canada urged the European Union to provide Members with clarity on whether any changes were anticipated with regard to the EU's MRLs for glufosinate; the scientific basis for any such changes; and the transition periods that would be available for EU and non-EU farmers in the case of any new MRLs for glufosinate. If changes to the EU's glufosinate MRLs were anticipated, Canada requested that the European Union notify the SPS Committee well in advance, including a clear indication of the scientific basis and transition periods, to provide Members with the opportunity to comment and have those comments taken into account.
Guatemala regretted that its communications with the European Union had not yielded satisfactory results. It called on the European Union to respond to the concerns of tropical developing countries and requested a longer transition period of 24 months.
The Dominican Republic shared its concern that the only alternatives for buprofezin, diflubenzuron and chlorothalonil, used for mango production, was imazalil, which was also being restricted by the European Union.
Ecuador added its concern over the reduction of the MRLs of buprofezin and chlorothalonil, essential for its control of quarantine pests in bananas.
Chile requested the European Union to share the scientific basis for its measure, and to review whether it had faced problems in the past with those substances.
Regarding buprofezin, diflubenzuron, ethoxysulfuron, ioxynil, molinate, picoxystrobin and tepraloxydim, the European Union referred to the statements made at the November 2018 and March 2019 Committee meetings, where the rationale for the reductions of those MRLs had been explained. Regulation (EU) 2019/91 had been adopted in January 2019, and MRL changes for the mentioned substances were therein explained. On the restriction of approval of bufoprezin and diflubenzuron, the expiry of ethoxysulfuron, ioxynil, molinate, and tepraloxydim; and the non-renewal of the approval of picoxystrobin, MRLs had been set at the relevant limit of determination in accordance with Article 18 of Regulation (EC) 396/2005, which would apply as of August 2019. The European Union reminded Members that import tolerance requests could be submitted in accordance with Article 6 of Regulation (EC) 396/2005.
Regarding iprodione, the European Union reiterated the explanation given at the March 2019 SPS Committee meeting, notably that its approval had not been renewed because EFSA's evaluation concluded that acute intake concerns could not be excluded, and that genotoxicity concerns could not be excluded regarding its major residue metabolite. In a follow up assessment, EFSA had identified the commodities of concern for these risks. The substance also fell under the cut-of criteria established by Regulation (EC) 1107/2009, though even without the additional criteria, renewal of the substance would not have been approved due to the concerns raised. As per Regulation (EC) 2017/2091 of 14 November 2017, the non-renewal of the substance had been established, transitional measures for the withdrawal of authorisations had been granted until March 2018 and a grace period for the removal from the market had been granted until 5 June 2018. The reduction in MRLS had been adopted by a Regulation of January 2019, established at the limit of determination, and would apply from 31 July 2019. Requests for import tolerances could be submitted and would follow a risk assessment process as established in Regulation (EC) 396/2005.
Regarding glufosinate, its approval had expired on 31 July 2018, and the applicant had withdrawn the application for renewal. EU member states could grant grace periods for the use of glufosinate in plant production products until 31 January 2020. Its MRL had last been modified in 2016. In response to the questions from Canada, the European Union responded that there was currently no proposal to modify the MRL for glufosinate, but that any possible modifications would be notified in due course, and applications for import tolerances would always be possible.
In November 2019, Colombia referred to document G/SPS/GEN/1740/Rev.1 which contained questions by Colombia, Costa Rica, Côte d'Ivoire, Ecuador, and Guatemala in relation to the EU MRLs and, specifically, to imazalil. Colombia requested the European Union to provide written responses to those questions, if possible. Costa Rica reiterated its concern on the EU measures. Regarding chlorothalonil, Costa Rica underscored its use for the control of black sigatoka in bananas and the acknowledgement by the European Union of the lack of conclusive evidence on dietary dosage, MRLs in plants, and exposure in animals. Costa Rica again invited the European Union to apply Codex MRLs or to provide conclusive scientific evidence to support lower levels; to perform a substance- and product-specific risk assessment, based on the provisions of the SPS Agreement, to identify less trade restrictive measures; and to grant a minimum transition period of 24 months.
Côte d'Ivoire reiterated its statement from the last Committee meeting, emphasizing the socioeconomic impact of the measure due to the importance of the banana industry and its exports to the European Union. Côte d'Ivoire called the European Union to abide by the principles of the SPS Agreement, and requested a change in the transition period, taking into consideration the interests of the developing countries, as there was no product that could replace imazalil.
Ecuador reiterated its concern, particularly for substances used in Ecuador: buprofezin, chlorothalonil, and imazalil. Ecuador highlighted that, due to its tropical climate, the spread of pests and diseases followed different patterns from those in European countries. Ecuador also referred to document G/SPS/GEN/1740/Rev.1 and requested that the European Union provide written answers. Ecuador emphasized that the SPS Agreement required that Members' measures not restrict trade more than necessary to achieve the appropriate level of protection, considering technical and economic viability. The European Union was adopting a policy of suspension of approvals of several active substances and the reduction of the MRLs to the minimum detection level, without sound scientific evidence. The European Union was departing from Codex standards. Ecuador invited the European Union to keep its MRLs only on a provisional basis until it had the necessary information to establish safe, science-based MRLs that offered adequate protection and avoided unnecessary barriers to trade.
Guatemala shared the concern, underscoring that these measures could have a negative impact on exports of agricultural products, affecting food safety and rural development; key cooperation topics with the European Union. Guatemala requested the European Union to grant an implementation period of at least 24 months to allow studies to identify alternative substances, which would be less trade restrictive. The current 6-month transition period was not enough to adapt production and comply with existing exportation contracts. Guatemala also referred to document G/SPS/GEN/1740/Rev.1 and added two questions. First, whether there was enough scientific evidence to characterize imazalil as a carcinogen and, if so, if the information could be shared. Second, whether there were clinical trials that demonstrated the carcinogenic potential of imazalil.
India reiterated its concern and considered that regulations must be grounded in sound science and based on determinations of actual risk that considered realistic exposure scenarios, rather than the presumption of hazard. India noted that, in addition to setting MRLs at trade restrictive default levels, the EU measures did not provide adequate transition times.
Panama emphasized that the European Union was its main export market for bananas and pineapples, and that the main producers were vulnerable populations. Panama noted that these measures would affect their socio-economic welfare, as several substances, such as buprofezin, chlorothalonil, diflubenzuron, and picoxystrobin, were key to protect their crops. Panama requested that all Members abide by international standards to ensure rules-based, safe, and fair trade and called on the European Union to provide the risk analysis underlying the measures, as well as to consider the climatic and environmental differences between the regions.
Paraguay reiterated its concern, particularly on diflubenzuron, chlorothalonil, glufosinate, and picoxystrobin, used to produce key export products such as corn, sesame, soy, and wheat. Paraguay requested that the European Union provide sound scientific evidence justifying the measures and abide by the international standards set by Codex, to ensure that trade was not restricted more than necessary.
Argentina, Brazil, Canada, the Dominican Republic, El Salvador, Honduras, Peru, the United States and Uruguay also shared this concern. Several Members highlighted the need for sound scientific evidence and the importance of basing the measures on risk assessments, as opposed to the use of a hazard-based or precautionary approach. They called upon the European Union to abide by the international standards set by Codex to ensure public health and avoid unnecessary barriers to trade. Several Members also referred to the transitional periods and requested that the European Union notify the SPS Committee well in advance about changes in its measures, to allow for comments from other Members and to consider the need of exporters to adapt their products and methods of production to the requirements.
The United States statement can be found in document G/SPS/GEN/1749.
The Dominican Republic reiterated the intervention made during the last Committee meeting and mentioned that the EU measures would affect its exports, particularly of bananas, mangos, and avocados, that represent around 20% of the total annual exportations of food products, whose main market is the European Union.
Canada recognized that Members have the right to apply food safety measures necessary to protect human health while not unjustifiably restricting international trade. Canada invited the European Union to ensure that the requirements did not unjustifiably discriminate between domestic producers and foreign exporters.
Uruguay referred to the recent adoption, during the 20th Ordinary Meeting of the Inter-American Board of Agriculture held in Costa Rica, of a resolution emphasizing the need to promote agricultural regulations based on science and risk analysis to facilitate international trade in safe food and agricultural products. The objective was to avoid the proliferation of non-tariff barriers such as MRLs that lacked scientific and technical justification and generated a negative impact on production, productivity, and trade. Uruguay urged the European Union to reflect on the concerns expressed by an important number of Members and to reconsider its regulatory approach to avoid serious socioeconomical consequences this entailed for other Members, particularly for developing countries and LDCs.
Brazil thanked the United States for the update on JMPR activities. Brazil explained that some of the substances were commonly used in a variety of crops; for instance, buprofezin was used in the integrated pest management control of the white fly in soybean crops and of the Asian citrus psyllid in citrus. Brazil highlighted that the evaluations by EMA and EFSA were not conclusive regarding the genotoxic and carcinogenic qualities of buprofezin and related it to the production of aniline, a substance present naturally in plant products in higher concentrations. Brazil referred to the EU procedures adopted to establish the measures and, specifically, to the notification of Commission Implementing Regulation (EU) 2017/360, with the objective of protecting human and animal health, characterized by the attention provided to "operators' and workers' safety" and the "risk to aquatic organisms", submitted to the TBT Committee.
The European Union recalled its previous statements, highlighting that its decisions were based on a thorough risk assessment and followed rigorous procedures, as stated in publicly available EU legislation. The European Union noted that, despite its high levels of protection, it was one of the largest importers of agri-food products, with increasing import volumes from several Members since 2008, when the systematic review process of MRLs had started. Regarding specific substances, the European Union referred to its statements in previous meetings. The European Union indicated that the longest possible transition periods had already been provided, without compromising on its level of protection, since health concerns prevailed over other considerations. Finally, the European Union announced its intention to notify the approval or non-renewal of substances under the TBT and the SPS Agreements in parallel, to further improve transparency and predictability.
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