Specific Trade Concerns - Sanitary and Phytosanitary Information Management System

STC Number - 382

European Union legislation on endocrine disruptors

Maintained by:	European Union
Raised by:	Argentina; China; Dominican Republic; Ecuador; Guatemala; India; Panama; Paraguay; United States of America
Supported by:	Australia; Benin; Brazil; Burkina Faso; Burundi; Canada; Central African Republic; Chile; Colombia; Costa Rica; Egypt; El Salvador; The Gambia; Ghana; Guinea; Honduras; Indonesia; Jamaica; Kenya; Korea, Republic of; Madagascar; Malaysia; Mexico; New Zealand; Nigeria; Pakistan; Peru; Philippines; Senegal; Sierra Leone; South Africa; Chinese Taipei; Thailand; Togo; Uruguay; Viet Nam; Zambia
First date raised:	March 2014 G/SPS/R/74 paras. 4.3-4.4
Dates subsequently raised:	March 2015 (G/SPS/R/78 paras. 3.20-3.22) July 2015 (G/SPS/R/79 paras. 3.50-3.52) October 2015 (G/SPS/R/81 paras. 3.34-3.37) March 2016 (G/SPS/R/82 paras. 3.15-3.20) June 2016 (G/SPS/R/83 paras. 4.32-4.37) October 2016 (G/SPS/R/84 paras. 3.18-3.23) March 2017 (G/SPS/R/86 paras. 3.16-3.20) July 2017 (G/SPS/R/87 paras. 4.19-4.26) November 2017 (G/SPS/R/88 paras. 3.47-3.52) March 2018 (G/SPS/R/90 paras. 3.24-3.30) July 2018 (G/SPS/R/92/Rev.1 paras. 4.79-4.87) November 2018 (G/SPS/R/93 paras. 3.24-3.30) March 2019 (G/SPS/R/94 paras. 3.51-3.65) July 2019 (G/SPS/R/95 paras. 4.47-4.56) November 2019 (G/SPS/R/97/Rev.1 paras. 3.35-3.48) June 2020 (G/SPS/R/99 paras. 3.202-3.231) November 2020 (G/SPS/R/100 paras. 3.101-3.108)
Number of times subsequently raised:	17
Relevant documents:	G/SPS/GEN/1448 G/SPS/N/EU/166 G/SPS/N/EU/166/Add.1 G/SPS/N/EU/166/Add.2 G/SPS/GEN/1494/Rev.1 G/TBT/N/EU/554 G/SPS/N/EU/263 G/SPS/GEN/1762 G/SPS/GEN/1846 G/SPS/GEN/1849 G/SPS/GEN/1871
Products covered:
Primary subject keyword:	Food safety
Keywords:	Food safety; Human health; International Standards / Harmonization; Sufficiency of scientific evidence; Pesticides; Risk assessment; Maximum residue limits (MRLs)
Status:	Not reported
Solution:
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In March 2014, the United States noted that the European Union planned to publish a road map outlining different options and a preliminary impact assessment in its process to assess, classify and regulate endocrine disruptors. The United States urged the European Union to swiftly notify the roadmap, any future proposals and the draft impact assessment, and to take into account comments from Members. The United States requested that the European Union explain its endocrine disruptor assessment program, particularly the timing for public consultations, as well as the timeframe for notifications and the manner in which Members' comments would be taken into consideration.

The European Union highlighted that several segments of its legislation contained provisions on endocrine disruptors; however, scientific criteria for the identification of endocrine disruptor substances were not yet available. The European Union noted that it had planned to propose scientific criteria to identify endocrine disruptors in its biocidal products regulation and plant protection products regulation by December 2013. In light of the potential impacts of a choice of criteria, however, the European Commission decided to carry out a comprehensive impact assessment to analyze the different policy options available to define criteria for the identification of endocrine disruptors, before making a revised proposal. This process was underway and the next step would be publication of a roadmap, within the coming weeks, outlining the various policy options for the criteria to be assessed. The impact assessment would follow standard EU guidelines, take into account existing scientific studies and reports, relevant international on-going work on this subject, and the impact on international trade. The European Union further clarified that a public consultation would be launched as part of the process in the course of 2014, enabling all stakeholders and trading partners to provide their input.

In March 2015, the United States raised concerns regarding the EU public consultation on defining criteria for identifying endocrine disruptors in the context of the implementation of the plant protection product regulation and biocidal products regulation. The United States questioned the scientific evidence considered in developing and selecting each of the options presented in the Roadmap and feared that risk might have not been taken into account. Implementation of any hazard-based "cut off" option that did not consider risk from actual exposure could have severe implications for EU imports of agricultural goods, including those from the United States. Furthermore, banning chemicals and pesticides solely based on endocrine-disrupting properties might incentivize the use of more dangerous products, simply because they do not present endocrine-disrupting properties. The United States encouraged the European Union to explain in a public document how significant stakeholders' comments would be taken into account and urged the Commission to adopt an approach that fully considered the vital role that pesticide chemicals play in food safety and security.

Argentina, Brazil, Canada, China, Colombia, Costa Rica, Guatemala, India, Kenya, Madagascar, Malaysia, Mexico, Nigeria, Pakistan, South Africa and Uruguay shared the US concern regarding the socio-economic effects that the EU measure would have on their countries if the legislation was to be approved. Various Members asked if the European Union had considered conducting an economic impact assessment for such a regulation and looked forward to being further informed.

The European Union noted that there was currently no new EU legislative proposal on defining criteria for identifying endocrine disruptors. The European Commission was in the process of conducting a full impact assessment, where all health, environmental and socio-economic aspects, including impacts on international trade, would be addressed. Following the publication of the Roadmap in June 2014, a public consultation had been held from September 2014 to January 2015. Over 27,000 responses had been received and published on the EU Commission website, and an analytical report of these responses would be provided in due course. A stakeholders' conference for all interested parties, including third countries, was planned for the 1 June 2015, while a dedicated webpage with information on the ongoing impact assessment would be available soon on the DG-SANTE website. In parallel, the necessary studies to support the impact assessment were ongoing. The first one would estimate which substances would be identified under each option for the criteria outlined in the Roadmap, with 700 chemicals being screened. Only when the results of these screenings would be available, the European Commission would launch the studies assessing impacts on health, environment, trade, agriculture and socio-economic effects in general and include them in the impact assessment report that would accompany any legislative proposal. If and when such proposal would be made, the legislative draft would be notified to the WTO to allow Members to present their comments, in line with the transparency obligations of the SPS Agreement that the European Union promoted and would like to reinforce.

In July 2015, the United States recalled its concerns on EU roadmap outlining possible options for defining criteria to identify endocrine disruptors, specifically as they related to plant protection products. Referring to the public consultation held in Brussels on 1 July 2015, the United States questioned the scientific evidence underlying the options, and the consideration of any hazard-based "cut off" option instead of risk from actual exposure. It encouraged the European Union to share information on the methodology used in developing EU member States' impact assessments. The United States requested that the European Union recognize risk-based endocrine programmes developed by other countries. It also request that the European Union keep the Committee informed of relevant developments, and encouraged the European Union to publish the draft legislation, once developed, including any risk and impact assessments carried out.

Australia, Brazil, Canada, Chile, China, Colombia, the Dominican Republic, Egypt, India, Kenya, Malaysia, Mexico, New Zealand, Nigeria, and Peru also spoke about the revised EU proposal on endocrine disruptors. They urged the European Union to take into account all the comments made during the public consultation and requested that the Committee be informed of any relevant developments.

The European Union recalled that it was currently conducting an all-inclusive risk assessment, including impacts on international trade, and that the report of the public consultation conducted between September 2014 and January 2015 would be made public in the coming weeks. The European Union also noted that all the relevant information about the impact assessment had been made available on their website. The European Union recalled that two studies were being conducted, one on the identification of the endocrine disruptors and another on the assessment of impacts. Once, and if, a legislative proposal was eventually made, it would be notified to the Committee and comments from Members would be taken into account before adoption of the final regulation.

In October 2015, the United States recalled its concerns about the EU "roadmap" which outlined possible options for defining criteria to identify endocrine disruptors, specifically as they related to plant protection products. It thanked the European Union for its report of the public consultation held in Brussels in July 2015 (G/SPS/GEN/1448) but questioned the scientific evidence underlying the options, and the consideration of any hazard-based "cut off" option instead of risk from actual exposure. It encouraged the European Union to share information on the methodology used in developing EU member States' impact assessments. The United States requested that the European Union recognize risk-based endocrine programmes developed by other countries. It also requested that the European Union keep the Committee informed of relevant developments, and encouraged the European Union to publish the draft legislation, once developed, including any risk and impact assessments carried out.

Argentina shared the US concern and reiterated that future actions should be taken on a case-by-case basis and based on solid scientific evidence after appropriate risk assessment. Special attention should be given to minimizing adverse impacts on international trade and especially on trade in agricultural products, but also to minimizing socioeconomic losses in commodity-producing countries, in particular developing countries. Argentina also thanked the European Union for its report of the consultation and requested that the rest of the process be conducted in a transparent manner inclusive of all relevant stakeholders.

Brazil, Burkina Faso, Canada, Chile, China, Colombia, the Dominican Republic, Egypt, India, Jamaica, Kenya, Madagascar, Malaysia, Mexico, Nigeria, Paraguay, Peru, Senegal, Sierra Leone and Viet Nam also spoke about the revised EU proposal on endocrine disruptors. They encouraged the European Union, inter alia, to follow a risk-based approach, adhere to relevant international standards and to keep informing the Committee of any relevant developments.

The European Union recalled that it was currently conducting an all-inclusive impact assessment, including impacts on international trade. The European Union also noted that all the relevant information about the impact assessment had been made available on their website. The European Union recalled that two studies were being conducted, one on the identification of the endocrine disruptors and another on the assessment of impacts. Once, and if, a legislative proposal were eventually to be made, it would be notified to the Committee and comments from Members would be taken into account before adoption of the final regulation.

In March 2016, Argentina again raised its concern with the EU revised proposal for categorization of compounds as endocrine disruptors, both on defining criteria for identifying endocrine disruptors and on the future EU approach to establishing MRLs and import tolerances for said substances. Argentina urged the European Union to adopt a risk-based rather than a hazard-based approach. Argentina requested more information on the socio-economic impact of the EU revised proposal on endocrine disruptors. Argentina also requested an update on information provided at the previous TBT Committee meeting on this topic.

China shared the concern while commending the European Union for its efforts to protect consumers' health. China urged the European Union to incorporate actual exposure in its regulations, to apply existing Codex standards to minimize trade impacts, and to notify its measures at an early stage to take into account Members' comments.

The United States reaffirmed the importance of plant protection products and their uses and recalled its concerns about the EU "roadmap", which outlined possible options for defining criteria to identify endocrine disruptors. The United States questioned the scientific evidence underlying the options, and the consideration of any hazard-based "cut off" option instead of risk from actual exposure. The United States encouraged the European Union to share information on the methodology used in developing EU member States' impact assessments as well as an update on the EU's intentions to include socio-economic analysis in the impact assessment. The United States requested that the European Union recognize risk-based endocrine programmes developed by other countries. It also requested that the European Union keep the Committee informed of relevant developments, and encouraged the European Union to publish the draft legislation, once developed, including any risk and impact assessments carried out, for public comment. Additionally, the United States raised a concern regarding EU regulation 1107/2009 that sets out a hazard-based approach, rather than risk-based, to determine whether substances should be authorized for use. According to this regulation, pesticides previously deemed safe under a risk-based approach would no longer be authorized if they triggered a hazard "cut-off", as described in EU regulation 1107/2009. The United States urged the European Union to communicate risks accurately to the public and reaffirmed its commitment to collaboration to reduce the potentially severe impacts on trade.

Canada shared this concern, as in the last three SPS Committee meetings. Hazard identification was an important step in risk analysis, but needed to be placed into the context of exposure. Canada continued to seek clarification on the EU regulations, as the proposed approaches could impede the use of safe crop protection products, thus restricting trade without evidence of increased safety. Canada noted that the EU impact studies would be released later in 2016 and requested clarification on how the studies would be utilized and comments would be managed.

Brazil, Burundi (on behalf of the African Group), Central African Republic, Colombia, Chile, Dominican Republic, Guatemala, Jamaica, India, Kenya, Madagascar, Mexico, New Zealand, Nigeria, Senegal, Thailand, Togo, Viet Nam, and Zambia also spoke about the revised EU proposal on endocrine disruptors. They encouraged the European Union to, inter alia, follow a risk-based approach, minimize any potential trade impacts, adhere to relevant international standards and keep informing the Committee of any relevant developments, especially the forthcoming impact assessments.

The European Union clarified that the roadmap contained two elements: the approaches to identify criteria and the approaches to regulatory measures. Two options of the latter contained elements of risk assessment. The European Union stated that in response to a judgement of the EU General Court in December 2015, the European Commission had decided to accelerate its on-going impact assessment work in order to be able to present the results in summer of 2016. The report was in its final stages and would be publically available once formally approved. Two regulatory measures were being considered: one containing criteria applied to chemical substances falling under the Plant Protection Products Regulation, and the other containing criteria applicable under the Biocidal Products Regulation. Both measures would be notified to the WTO in draft forms for comments prior to adoption. The European Union recalled that in the impact assessment the potential trade impacts were being evaluated, together with impacts on agriculture, health, environment, and socio-economic impacts. The European Union noted that the methodology used to screen which chemicals may fall under the different options for criteria to identify endocrine disruptors had been developed by the Joint Research Center of the European Commission and had been presented in November 2015. The methodology, results, and contractor's details would be published upon completion. Finally, the European Union highlighted that it was acting in a fully transparent manner and invited Members to visit the dedicated website where all relevant information was available.

In June 2016, Argentina reiterated its concern with the EU's revised proposal for categorization of compounds as endocrine disruptors, notified in G/SPS/N/EU/166. The hazard-based approach would modify MRLs of previously approved phytosanitary products to default levels that lacked scientific justification, leading to disproportionate and unnecessary trade restrictions. Argentina requested that these levels be based on risk assessments and the possibility to establish MRLs above default levels for substances posing an insignificant exposure risk. Finally, Argentina regretted that the draft regulation setting out scientific criteria for the determination of endocrine-disrupting properties for biocidal products pursuant to EU Regulation No. 528/2012 had been notified to the TBT Committee (G/TBT/N/EU/384), and not to the SPS Committee.

The United States raised its concern with three EU policies related to the approval and use of plant protection products. First, the United States joined Argentina in concern that the EU's proposed approach to endocrine disruptors (EDs) would impose unnecessary trade restrictions, and asked the European Union to provide the scientific evidence used to justify the establishment of definitive criteria to identify EDs. The United States regretted that the impact assessment on the EU proposal had been published with no opportunity for public comment. The United States formulated questions on (i) the meaning of "negligible risk" as used in the proposal, including a specific clarification as to whether the European Union would use the current standard to set MRLs under Regulation (EC) No. 396/2005 for substances that did not trigger "cut-off" criteria; (ii) whether all ED substances designated by the European Union under the World Health Organization/International Programme on Chemical Safety (WHO/IPCS) definition would be eligible for the derogation allowing for an evaluation "in light of current scientific knowledge", provided that they met the negligible risk standard; (iii) the possibility to file an application for an import tolerance, based on a risk assessment, for a substance designated as an ED and not authorized under EU regulation; (iv) whether the registration and MRL-setting of carcinogenic, mutagenic, or toxic for reproduction (CMR) substances would remain hazard-based, and the possible application for an import tolerance of a product ineligible for registration because of the hazard-based "cut off" criteria; and (v) the list of substances the European Union expects to be identified as EDs, and the role of potency and exposure in the identification process. In these questions, the United States highlighted the potential absence of a risk-based approach and use of exposure information. The United States also invited the European Union to organize an information session, in light of Members interest in this topic.

Second, the United States again expressed its concern with the hazard-based approach set out by Regulation No. 1107/2009, and asked the European Union to clarify how the hazard-based "cut off" criteria would be applied to substances approved before 2009 for which the renewal process was expected to begin in 2016. The United States again requested that the European Union place scientifically-justified risk assessments at the heart of the establishment of tolerances for pesticide residues in food. Third, the United States expressed a special concern with the French ban on fresh cherries imported from countries that had approved the use of dimethoate. The United States urged France to notify the ban to the WTO, and to provide scientific justification for it. The United States especially questioned the fact that the ban was based on the pesticide's authorization by the Member rather than on pesticide residues in the cherries. The United States asked France to use less trade-restrictive alternatives such as residue monitoring during import checks, and reaffirmed its commitment to work with both the European Union and other trading partners on these concerns.

China shared the concerns of Argentina and the United States, and again urged the European Union to incorporate assessment of actual exposure in its regulations, to apply existing Codex standards to minimize trade impacts, and to notify its measures at an early stage to take into account comments from Members.

Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, Egypt, Guatemala, India, Kenya, Malaysia, Mexico, Paraguay, Chinese Taipei, Uruguay and Viet Nam shared the concern expressed by Argentina, China and the United States. They highlighted, inter alia, the importance of this issue and its potential negative trade impacts, and the necessary support of scientific justification and risk assessment in establishing such regulation. They encouraged the European Union to adhere to relevant international standards and to continue informing the Committee of any relevant developments. Many of them joined in the request for an information session. Australia echoed Argentina's concern regarding notification of the proposed biocide regulations through an SPS notification.

The European Union recognized the international dimension of this issue and fully appreciated the concerns expressed by Members. The European Union again highlighted that the European Commission had proposed to adjust the plant protection products' derogations to base them on scientific evidence, including information on hazard, exposure and risk, to take appropriate decisions on endocrine disruptors in compliance with international obligations. The European Union reminded that the new criteria-setting proposals had been notified via the SPS and TBT channels for full transparency. The European Union further noted that although the regulation concerning biocides had been notified under the TBT Agreement and not SPS, the European Union was not dogmatic about this choice and was prepared to revise it if necessary. The European Union informed the Committee that the issue of the French ban due to dimethoate concerns was currently under internal discussion. The European Union expressed interest in holding an information session as suggested, and would consider it in due time. The European Union invited all Members to promptly submit their comments in writing.

In October 2016, Argentina reiterated its concern with the EU's revised proposal for categorization of compounds as endocrine disruptors (EDs), notified in G/SPS/N/EU/166. The EU proposed hazard-based approach would not efficiently assess risks posed by ED substances to humans and the environment. In addition, MRLs for phytosanitary products already approved following a rigorous European Food Safety Authority risk assessment would now be regulated under a mere risk identification approach inconsistent with Codex standards. Argentina further noted that the proposed hazard-based approach was incomplete as it did not include the essential elements of risk characterisation, such as potency, severity and reversibility of effects. Such elements were necessary to assess risks to humans or the environment according to the SPS Agreement and the World Health Organization/International Programme on Chemical Safety (WHO/IPCS). Argentina considered that the impact assessment option selected by the European Commission would have significant agriculture, food safety, trade and socio-economic impacts. Argentina hoped import tolerance derogations for agricultural products would be applied in a transparent and non-discriminatory manner, while avoiding technical obstacles to trade. Argentina requested the European Union to take countries' comments into account before adopting the measure. Finally, Argentina thanked the European Union for the information session held the day before, welcoming any additional information on the proposal.

China shared the concerns, and highlighted that in June 2016 13 Members had sent a joint letter to the European Union on this matter. China thanked the European Union for notifying the proposed regulation, and for holding an information session and bilateral consultations before the Committee meeting. Considering the potential significant impact of the measure, China requested that the European Union fully fulfil the transparency obligation and provide at least a six-month transition period between adoption and implementation. China asked the European Union to provide replies to the comments submitted and urged it to consider assessment of actual exposure and potency factors, rather than substances themselves in its measure as well as to apply existing Codex standards to minimize trade impacts.

The United States expressed its appreciation for the EU information session and for the extension of the comment period for the ED proposals. The United States raised concerns with two EU policies related to the approval and use of plant protection products; namely the EU's recent proposal on EDs published on 15 June 2016 (G/SPS/N/EU/166); and the reauthorisation of pesticides under Regulation No. 1107/2009. First, the United States expressed its concern that the EU's proposed approach to EDs would impose unnecessary trade restrictions and asked the European Union to provide the scientific evidence used to justify the establishment of definitive criteria to identify EDs. Neither Regulation No. 1107/2009 nor the impact assessment published on 15 June identified the scientific evidence considered in the development and selection of EDs "cut-off" criteria. The United States welcomed a revised proposal, soon to be available, that might clarify questions on the derogation process and the application of the WHO/IPCS EDs definition. The United States hoped that the updates for the derogation process would define the meaning of "negligible risk", include the important aspects of exposure and potency, and follow a risk-based approach under which all substances designated as EDs under the WHO/IPCS definition would be eligible to be registered provided they met the "negligible risk" standard. The United States further hoped that these changes would address its previous questions regarding other substances that trigger "cut-off" criteria such as carcinogenic, mutagenic or toxic for reproduction (CMR) substances. The United States further stressed the importance of non-discrimination in the implementation of this measure, and requested that the European Union implement guidelines and processes for risk assessment that were consistent for all substances, in addition to pursuing a transparent and predictable approach throughout the risk management process. The United States noted two key questions that had previously been raised regarding these proposals and were yet to be addressed: (i) the possibility to file an application for an import tolerance, based on a risk assessment, for a substance designated as an ED and not authorized under EU regulation; and (ii) the list of substances the European Union expected to be identified as EDs under the WHO/IPCS definition as well as specific information regarding when and how potency and exposure would be taken into consideration.

Second, the United States again expressed its concerns with EU Regulation No. 1107/2009. The United States reiterated that in the European Union, original approvals appeared to be for ten years, while renewals were for 15 years. Substances approved before 2009 would therefore be scheduled to be renewed in 2019, and the process would begin in 2016. The United States also highlighted that under Regulation No. 1107/2009, pesticides approved for several years and determined to be safe under a risk-based system would no longer be subject to a risk assessment if a pre-determined hazard criterion was identified. The United States asked the European Union to explain how the hazard-based "cut-off" criteria would be applied in practice to substances undergoing the renewal process. The United States also raised concerns with the important trade impact that the regulation might have in the future, and requested that the measure be based on a risk assessment. The United States finally highlighted the need for close collaboration with trading partners and expressed its commitment to continue working with the European Union on this issue.

Australia, Brazil, Canada, Chile, Colombia, Costa Rica, the Dominican Republic, Ecuador, Egypt, Guatemala, Indonesia, Kenya, Mexico, New Zealand, Paraguay, Chinese Taipei, Thailand, Uruguay and Viet Nam shared the concerns expressed by Argentina, China and the United States. They highlighted, inter alia, the significance of the issue and the potential negative trade impact while also recognising the European Union's right to protect its citizens. They expressed concern over the hazard-based approach and called on the European Union to adopt a risk-based approach. They all expressed their appreciation to the European Union for the information session held the day before.

The European Union referred to the information session that had taken place prior to the Committee meeting and where experts from the European Commission had provided detailed information and answered questions from WTO Members on all the elements of the proposals. The European Union informed the Committee that a compilation of the responses to comments received would be circulated and noted that regarding implementation and practical consequences, uncertainty remained as to if and when the proposal would be adopted. The European Union would continue to be as transparent as possible on the matter, and take proportionate and appropriate decisions in compliance with international obligations. The proposals were going through the relevant regulatory procedures and the European Union would consider all the comments received.

In March 2017, the United States reiterated its concern regarding the European Union's proposal for categorization of compounds as endocrine disruptors (EDs) and amending Regulation No. 1107/2009, which would require the withdrawal of existing authorizations for certain substances without a risk assessment. The United States thanked the European Union for their written responses, while noting that they did not provide scientific justification for the establishment of hazard-based criteria. While the proposed criteria for identifying EDs did not consider potency and exposure factors, they would still be used to both identify hazard and deny authorization for certain pesticides. The United States again asked the European Union to explain how the hazard-based "cut-off" criteria would be applied in practice to pesticides determined to be safe under a risk-based approach and undergoing the renewal process. In particular, the United States expressed concerns with the European Union setting MRLs at low default levels without scientific justification for substances no longer approved under the hazard-based approach.

The United States also expressed its concern with the European Union's decision in December 2016 to split the proposal into two stand-alone policies: a proposal to establish criteria for identifying EDs; and another one to amend the derogation criteria from "negligible exposure" to "negligible risk". The split approach could impact more importantly on trade if the two policies were not finalized simultaneously. In this context, the United States asked if it would be possible to file an import tolerance for a substance designated as ED or carcinogenic, mutagenic, or toxic for reproduction (CMR), and which did not benefit from the European Union's derogation. The United States again urged the European Union to base its SPS measures on a transparent and risk based approach and highlighted that the proposal would severely impact trade while marginally improving human or environmental health. The United States indicated that it would provide additional written questions regarding the proposed derogation process.

Argentina echoed the statement made by the United States, emphasizing that the European Union's proposed hazard-based approach would not efficiently assess risks posed by ED substances and did not include essential elements of risk characterization such as potency, severity and reversibility of effects. Argentina questioned the selection of criteria under option 2 rather than option 4, which would have been less trade burdensome while guaranteeing a similar level of human health protection. It shared the concern voiced by the United States regarding the European Union's recent decision to split the original draft regulation notified in G/SPS/N/EU/166 into two proposals, leaving out the derogation process. If the European Union approved the proposal based on this new approach, it would need to notify it, as it would constitute a different measure severely impacting on trade without scientific justification.

Australia, Brazil, Burkina Faso, Canada, Chile, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, Ghana, Guatemala, Guinea, India, Kenya, Madagascar, Malaysia, Nigeria, the Philippines, South Africa, Chinese Taipei, Thailand, Uruguay and Viet Nam shared the concerns expressed by Argentina and the United States, and called upon the European Union to adopt a risk-based approach in compliance with the SPS Agreement. They underlined, inter alia, their special concerns over the hazard-based approach, the split of the proposal between identification criteria and derogations, and the importance of this issue and its potential negative trade impacts. In particular, Canada estimated that the proposed regulation could affect 60% of their plant protection products for wheat and soy crops, and up to 75% in the case of canola production. Australia and Kenya also noted that under the proposed regulation, many plant protection products which presented no alternatives would be banned. Many Members expressed their appreciation to the European Union for their transparency efforts, and Australia encouraged the European Union to provide updates on the work of the European Food Safety Authority and European Chemicals Agency in reviewing and prioritizing chemicals as EDs.

The European Union reiterated its commitment to transparency, recalling that it had duly notified the proposals and circulated a compilation of the responses to comments received in February 2017. The proposals, which were going through the relevant regulatory procedures, had been revised to clarify burden of proof and criteria scope, but no substantial change had been introduced to the proposal originally notified. The decision to split the plant protection products proposal into two separate texts, one on identification criteria and another on the technical amendment to the clause on negligible exposure, was to facilitate decision-making. The European Union encouraged Members to share their statements in writing and reiterated its commitment to continue informing the Committee of further developments.

In July 2017, Argentina reiterated its concern over the European Union's policy on pesticides which established criteria to identify substances with endocrine disrupting properties, emphasizing the policy's hazard-based rather than risk-based approach and its potential trade impact. Argentina added that the European Union Standing Committee on Plants, Animal, Food and Feed (SCoPAFF) had approved the proposed criteria in July 2017, and that without a veto from the European Parliament and the EU Council of Ministers, the proposal would enter into force in October 2017, to be implemented six months later. Argentina observed that substances currently authorized after having gone through a European Food Safety Authority (EFSA) risk assessment, could later be banned, including substances with an insignificant risk of endocrine disruption - even in contradiction with Codex standards. Argentina also questioned the division of the original proposal into two texts. Argentina further echoed the questions posed by the United States in the past and urged the European Union to provide practical information on the procedure it would follow for the withdrawal of authorizations.

China reiterated its concern regarding the European Union proposal and questioned the hazard-based approach of the EU proposal. China argued that the proposal would have a severe impact on trade while marginally improving human or environmental health, and expressed a special concern on the division of the proposal. China underscored the market uncertainty created by the reduction of allowed substances.

The United States reiterated its concern that the pesticide policy in the European Union was insufficiently grounded in science and risk, and could potentially disrupt international trade without providing a meaningful benefit to public health. The United States expressed particular concern over the lack of transparency and predictability in the implementation of the hazard provisions of Regulation (EC) No. 1107/2009 and queried about MRLs that would be set at trade-restrictive default levels. The United States noted cases where the decisions of the European Food Safety Authority (EFSA) failed to take all available data into consideration and differed substantially from the findings of other national and international authorities, resulting in the proposed withdrawal of authorizations for use of these substances for a wide range of food crops. The United States was additionally concerned that measures to withdraw authorizations of pesticides and prohibit crops treated with those pesticides were being notified to the TBT Committee and the decision to withdraw the corresponding MRL would only be notified to the SPS Committee after the decisions to withdraw authorizations had been finalized. The United States requested that these measures be notified to the SPS Committee when comments and additional data could still be taken into consideration and queried about the procedures for setting MRLs and import tolerances under Regulation (EC) No. 396/2005.

The United States remained concerned with the division of the draft legal text into two stand-alone components, one proposal to establish criteria for identifying endocrine disruptors and another to amend the derogation criteria. The United States thanked the European Union for engaging in bilateral consultations, looked forward to receiving responses to the questions submitted to the European Union following the March 2017 SPS Committee Meeting, and remained open to sharing those questions with other interested Members.

Australia, Benin, Brazil, Burkina Faso, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, The Gambia, Guatemala, India, Israel, Kenya, Madagascar, Mexico, Nigeria, Paraguay, Peru, Senegal, South Africa, Chinese Taipei, Thailand, Togo, Uruguay, and Zambia indicated that they shared this concern and called upon the European Union to adopt a risk-based approach in compliance with the SPS Agreement. Members underlined, inter alia, their special concerns over the hazard-based approach; the split of the proposal between criteria to identify endocrine disruptors and the criteria for derogations; the approval of the proposal on the reduction in allowed pesticides and its potential negative trade impact. Australia encouraged the European Union to provide updates on the work of the European Food Safety Authority and European Chemicals Agency in reviewing and prioritizing chemicals as endocrine disruptors.

Canada expressed concern over the language introduced in the Revised Plant Protection Products Draft criteria, presented on 30 May, referring to "known" and "presumed" endocrine disruptors. Canada requested the European Union to clarify that these terms would not result in a wider scope of endocrine disruptors. Canada also enquired whether the decisions for setting MRLs and import tolerance levels would continue to be made on the basis of risk assessments, as set out in Regulation (EC) No. 396/2005. Canada appreciated the European Union's efforts in developing this proposal as well as the intense consultations that had taken place around the SPS Committee meetings.

India emphasised that the "hazard based cut-off criteria" approach of the regulation would disrupt international trade without providing a meaningful benefit to public health. Further, this approach would not include a risk assessment, and has left open the scope for the interpretation of "negligible risk" and other terms, which would result in lack of clarity in its implementation.

The European Union reiterated its commitment to transparency, recalling that it had duly notified its draft acts, received and responded to Members' comments. The European Union recalled the information session of October 2016 and document G/SPS/GEN/1494/Rev.1 about the ongoing review of pesticides MRLs. The proposed criteria had been endorsed by its member States and, barring any objection by the European Council and Parliament, the criteria would be adopted by the European Commission in three months. They would then enter into force 20 days after their publication, and become applicable six months after that date. Regarding concerns raised on the criteria, the European Union recalled that in the absence of these criteria, its legislation would require the application of the so-called interim criteria, leading to more stringent conditions. Finally, the European Union had taken note of specific questions received, in particular those submitted by the United States, and confirmed it would provide responses. With respect to the concerns raised regarding a possible change in the European Union policy on pesticides in general and their MRLs, the European Union confirmed that there had been no such change. The European Union reiterated its commitment to keeping the SPS Committee informed about any future developments.

In November 2017, Argentina reiterated its concern over the European Union's process to define criteria to identify endocrine disrupting properties. Argentina noted the European Parliament's recent rejection of the draft implementing regulation that would have amended Regulation (EU) No. 1107/2009 Annex 2, which established definitive and specific scientific criteria for the determination of endocrine disruptive properties, as adopted by the European Union Standing Committee on Plants, Animal, Food and Feed (SCoPAFF) in July 2017. Argentina requested an update of the following steps. Argentina was concerned about current discussions in the European Union about restricting imports of substances on the basis of hazard identification rather than of a comprehensive risk assessment. Argentina reiterated its request that the European Union maintain import tolerances with MRLs above default values, in accordance with its Regulation (EC) 396/2005.

China echoed the Argentina's concern and recommended that the European Union adopt the Codex standards, in accordance with the SPS Agreement.

The United States reiterated its concerns on the EU pesticides policy. The United States argued that the EU hazard-based pesticide regulations were insufficiently grounded on science and risk, and would harm global agriculture production, food security and international trade, without making a meaningful contribution to public health. The United States reaffirmed its stance against the hazard-based criteria of the European Union to ban substances identified as endocrine disruptors, and its concern over the effects that the prolonged uncertainty on the matter was having on producers. The United States recalled that the European Union would apply interim criteria in the absence of adoption of the proposed criteria, and therefore asked about the difference between the list of substances that would fall under the interim criteria and those that would fall under the criteria rejected by the European Parliament. The United States emphasised the existence of other approaches that could provide the high level of human health and environmental protection sought by the European Union without disrupting international trade and asked the European Union how it would ensure consistency with the SPS Agreement if it withdrew MRLS without conducting risk assessments or considering import tolerances or relevant Codex MRLs. Finally, the United States looked forward to receiving responses to the written question submitted to the European Union after the March 2017 SPS Committee meeting.

Canada stated its concern over the EU approach to the categorization of compounds as endocrine disruptors. Canada expressed its disappointment that a regulatory amendment for derogation based on negligible risk had not been introduced in the European Parliament, and the delay and uncertainty this created. Canada sought assurances from the European Union that decisions on setting MRLs would continue to be made on the basis of risk assessments, as set out in Regulation (EC) 396/2005.

Australia, Brazil, Colombia, Costa Rica, Guatemala, India, Israel, Madagascar, Mozambique, New Zealand, Nigeria, Peru, Senegal, Thailand, Togo, and Uruguay indicated that they shared this concern and called upon the European Union to base its measures on adequate scientific risk assessments and to consider Codex MRLs. They also requested the European Union to keep Members abreast of their next steps on this issue.

The European Union reiterated its commitment to transparency, noting that all the information regarding this matter was available on the European Commission's website. The proposal on defining the criteria to identify endocrine disruptors for plant protection products had been recently rejected by the European Parliament and the European Commission was considering the next steps. Import tolerance requests for substances falling under the cut-off criteria would be carefully evaluated on a case-by-case basis, considering the objectives of consumer protection as well as the European Union's obligations under the SPS Agreement. Due to transitional measures of Regulation (EC) No. 1107/2009 and the delays in the renewal programmes of the approved active substances, the European Union did not yet have experience on MRL and import tolerance setting for substances falling under the cut-off criteria. The European Union reiterated that its measures were neither discriminatory nor a disguised restriction to trade, but would be applied domestically and internationally. Finally, the European Union undertook to keep Members duly informed abouth further developments.

In March 2018, Argentina reiterated its concern over the European Union's process to define criteria to identify endocrine disrupting properties. Argentina thanked the European Union for the update provided in December 2017 through document G/SPS/GEN/1594, and further requested the European Union to notify the substantive changes which had been made to the proposal. Argentina remained concerned that the EU policy continued to be based on a hazard identification approach instead of a complete scientific risk assessment, which was counter to the principles of the SPS Agreement. Argentina emphasized the systemic impact that this policy would have on agricultural exports to the EU market, specifically highlighting that 39% of Argentine exports to the European Union could be affected by this policy. Argentina further observed that phytosanitary products currently authorized, after having gone through an EFSA risk assessment, could later be regulated on the basis of hazard identification, which could lead to MRLs being established at limits of detection, without corresponding scientific basis - and even in contradiction of Codex standards. Argentina reiterated its request that the European Union maintain import tolerances with MRLs above default values, in accordance with its Regulation (EC) 396/2005.

China echoed Argentina's concern, also noting that the criteria appeared to be policy-oriented, rather than based on rigorous scientific risk assessment as required under the SPS Agreement. China urged the European Union to consider the existing scientific basis when assessing risks to life or health and to minimize the negative effects of trade. China also recommended that "negligible risk" be modified to "be acceptable to human and environmental risks", and that the European Union adopt Codex standards where they exist, in accordance with the harmonization principle of the SPS Agreement. China also signalled its interest in following the developments on this issue and further encouraged the European Union to update the SPS Committee.

India supported the concerns raised, and requested the European Union to adopt a risk assessment approach for regulating pesticides and establishing import tolerances, without creating unnecessary barriers to trade.

The United States reiterated its concerns on the EU pesticides policy. The United States argued that the hazard-based pesticide regulations were insufficiently grounded on science and risk, and would harm agricultural trade, without making a meaningful contribution to public health or environmental protection. The United States requested clarification on the appropriate level of protection being sought by the European Union through implementation of Regulation 1107/2009. In addition, the United States noted that adoption of the revised criteria, currently under review by the European Parliament, would lead to a ban on many more substances than those previously suggested in the European Union's 2016 notification. The United States further queried how the European Union would ensure consistency with the SPS Agreement if it withdrew MRLs without conducting risk assessments. The United States emphasized the existence of other approaches that could provide the high levels of public health and environmental protection being sought by the European Union, without forgoing the scientific risk assessment framework. The United States welcomed the European Union's efforts to update the Committee (G/SPS/GEN/1594), but registered its regret that the substantive concerns of over 30 Members had still not been addressed. Finally, the United States looked forward to receiving responses to the written questions that had been submitted after the March 2017 SPS Committee meeting, and also hoped that the comments submitted on related texts in other fora (i.e. EU's REFIT consultation on legislation, EFSA/ECHA guidance) would be taken into consideration.

Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Guatemala, Kenya, Korea, New Zealand, Nigeria, Panama, Peru, Chinese Taipei, Thailand and Uruguay indicated that they shared this concern and called upon the European Union to reconsider their measure considering the significant negative impact that it would have on trade. They also called upon the European Union to base its measures on adequate scientific risk assessments and to consider Codex MRLs. Brazil further noted that it had conducted its own impact assessment of pesticides using the criteria being discussed by the European Commission, but with different outcomes. In this regard, Brazil underscored the challenges arising from establishing criteria to define endocrine disruptors.

Canada further expressed its disappointment that a regulatory amendment for derogation based on negligible risk had not been introduced in the revised regulatory proposal which had been approved by the Standing Committee on Plants, Animals, Food and Feed in December 2017. Canada sought assurances from the European Union that decisions on setting MRLs would continue to be made on the basis of complete risk assessments, as set out in Regulation (EC) 396/2005. Canada looked forward to continued updates from the European Union on the next steps for the criteria, as well as information on the timelines for the entry into the force of the proposal. Canada also sought information on how the European Union planned to work with its trading partners to develop a revised measure in a manner which was consistent with its international obligations and which avoided unnecessary disruptions to market access.

The European Union reiterated its commitment to transparency, noting that it had communicated the latest state of play in document G/SPS/GEN/1594. The European Union recalled that in October 2017, the European Parliament had rejected the criteria for plant protection products which had been agreed by EU member States. A new version of the draft criteria for plant protection products had subsequently been developed and was currently under the scrutiny of the European Parliament. The European Union also reminded the Committee that the proposed regulation criteria for identifying endocrine disruptors in biocidal products had been adopted and subsequently published in November 2017 as regulation (EU) 2017/21003. The criteria would be applicable from 7 June 2018. A technical guidance document was also being developed by the European Chemicals Agency (ECHA) and EFSA for the implementation of the new scientific criteria for pesticides and biocides, with an expected completion date in June 2018. Several Members had submitted comments on this guidance document which were being taken into consideration. The European Union reminded the Committee that the proposal to amend the derogation, based on negligible risk of exposure, remained on hold until agreement on the criteria was adopted. Import tolerance requests for substances falling under the cut-off criteria would also be carefully evaluated on a case-by-case basis, considering the objectives of consumer protection, as well as the European Union's obligations under the SPS Agreement. Finally, the European Union undertook to keep Members duly informed about further developments.

In July 2018, the United States reiterated its concern on the European Union's hazard-based approach to regulating substances identified as endocrine disruptors, and noted that on 20 April 2018 the European Commission had formally adopted criteria for identifying endocrine disruptors in plant protection products, that would be implemented as of 10 November 2018. The United States requested clarification on how the interim criteria would be applied between now and November 2018, in light of the EU Commissioner's 2017 statement which called into question whether the interim criteria were fit for purpose. The United States also drew Members' attention to the EU notification (G/TBT/N/EU/554) of a proposal to withdraw authorization for the active substance pymetrozine, which was considered to have endocrine disrupting properties in accordance with Regulation (EC) No. 1107/2009, despite not having a final EFSA assessment on the potential for endocrine disruption. The United States requested clarification on the appropriate level of protection that these actions would achieve, underscoring that the identification of hazards without identifying potential risks would likely be more trade-restrictive than necessary.

The United States noted the European Union's efforts to clarify its policy for managing import tolerances for substances that triggered the hazard-based cut-offs. However, the case-by-case approach to consider import tolerances, while factoring in legitimate factors and the precautionary principle, would not address Members' concerns, and would cause considerable uncertainty for applicants and producers. The United States requested clarification on the "legitimate factors", other than risk, that would be considered by the European Union in establishing import tolerances and how these other factors related to achieving an appropriate level of protection. The United States recalled the Dispute Settlement Body rulings which indicated that precaution did not override Members' risk assessment obligations arising from Articles 5.1 and 5.2. The United States also queried how the European Union's reliance on the precautionary principle would conform with the requirement in Regulation (EC) No. 396/2005 to conduct risk assessments in establishing import tolerances. The United States further highlighted that many of the substances impacted by the EU regulation were effectively and transparently managed under risk-based systems in other countries, thus querying the European approach to manage these substances through a ban or by establishing limited case-by-case import tolerances.

The United States also expressed concerns regarding the newly proposed revisions to the European Union's transitional arrangements for products that had been produced prior to the modification of MRLs. According to this proposal, domestic products could still be placed on the EU market under previous MRLs, even after new MRLs had been implemented, unlike imported products which would not be able to benefit from previous MRLs. The United States explained that this revision would particularly affect products with long production and distribution cycles, since the proposed transition periods were insufficient for these products to clear the channels of trade. In particular, this would create cases where third-country products, legally produced in accordance with EU standards, would no longer be eligible for import into the European Union. The United States emphasized the existence of other approaches that could provide the high level of human health and environmental protection being sought by the European Union, without posing unnecessary barriers to trade. Finally, the United States noted that it remained unclear how the European Union would ensure consistency of its regulatory approach with the SPS Agreement.

China echoed the concerns of the United States, noting that the criteria in Regulation (EU) No. 2018/605 appeared to be based on a hazard assessment. EFSA had published the Guidance for the Identification of Endocrine Disruptors in the context of Regulations (EU) No. 528/2012 and (EC) No. 1107/2009 on 7 June 2018, in collaboration with the European Chemicals Agency (ECHA). China urged the European Union to notify the EFSA Guidance to WTO Members with a comment period, and to adopt Codex MRLs to minimize the impact on international trade.

India shared the concerns raised, and requested the European Union to adopt a risk assessment approach for regulating pesticides and establishing import tolerances, without creating unnecessary barriers to trade. India also reminded Members that Codex followed a risk assessment approach for the safety evaluation of pesticides, and that approach ensured health protection of consumers. Finally, India emphasized that a hazard-based approach was unjustified and would create unnecessary barriers to trade.

Argentina reiterated its concern over the European Union's policy on pesticides and the adoption of a hazard-based approach for identifying substances with endocrine disrupting properties. Argentina noted the adoption of Regulation (EU) No. 2018/605, modifying Annex II to Regulation (EC) No. 1107/2009, which would come into force as of 10 November 2018. Argentina expressed concern about the systemic and trade impact of the measure, which violated core provisions of the SPS Agreement, such as the obligation to undertake a risk assessment and to apply the least trade restrictive measure. Argentina indicated that following the discussions in the June meeting of the EU Standing Committee on Plants, Animals, Food and Feed, the procedures for granting import tolerances under Regulation (EC) No. 396/2005 would continue to be applied, including the undertaking of risk assessments by the relevant member State and EFSA, on a case-by-case basis. Argentina urged the European Union to comply with this requirement. Argentina argued that import tolerances should be maintained both for substances that would ultimately be covered by the criteria for determining endocrine disrupting properties, and for any other substance banned by the European Union on the basis of the hazard identification criteria set forth in Regulation (EC) No. 1107/2009. Argentina asked the European Union to provide information on the approach that would finally be applied, and to examine the proposal on waivers in order to at least exempt the substances that represented a minimal risk to public health, due to low exposure levels. In this regard, Argentina reminded the European Union of its statements at previous SPS Committee meetings.

Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ghana, Guatemala, Kenya, Korea, New Zealand, Nigeria, Panama, Peru, Chinese Taipei, Thailand and Uruguay indicated that they shared this concern and called upon the European Union to reconsider the measure considering the significant negative impact that it would have on trade. They also called upon the European Union to base its measures on adequate scientific risk assessments and to consider Codex MRLs. Brazil reminded the Committee that the WHO International Programme on Chemical Safety's definition of endocrine disruptors could serve as a basis for discussions. Australia, New Zealand and Thailand also sought additional information on the Commission's plans for the derogation. In particular, Thailand requested the European Union to develop draft criteria for derogation by defining the meaning of negligible risk and establishing negligible risk criteria. Ghana and Kenya stressed that the EU policy would lead to the withdrawal of many important pesticides currently used in commodity-producing countries. As a result, farmers would have to use expensive alternatives which were not readily available in developing countries. Ghana underscored that this would have far-reaching consequences on the pest management gains made over the years and also negatively impact food security, distort trade in agriculture and lead to socio-economic losses, which would be in contradiction with the UN Millennium Development Goals, aimed at reducing poverty and eliminating hunger.

Canada reiterated its disappointment that the technical amendment for derogation based on negligible risk had not been included in the final regulatory amendment of Regulation (EU) No. 2018/605. Canada explained that without the inclusion of this technical amendment, default MRLs for food and feeds would be required once a substance was identified as an endocrine disrupting chemical, regardless of the actual risk under real world exposure scenario. Canada sought assurances from the European Union that once a substance was identified as an endocrine disruptor, import tolerances would continue to be based on complete risk assessments, as set out in Regulation (EC) No. 396/2005. Canada expressed its appreciation for EU efforts to inform the Committee on developments in this area, but also sought information on how the European Union planned to work with its trading partners to implement the measure in a manner consistent with its international obligations and without unnecessary disruptions to market access.

The European Union explained that the adoption of the criteria for plant protection products had been notified in G/SPS/N/EU/166/Add.2 and would apply as of 10 November 2018, also to ongoing approvals or renewals of active substances. The European Union also confirmed that the guidance document for the implementation of the adopted criteria had been published by EFSA and ECHA on 7 June 2018. The criteria were the same for biocides as for plant protection products in order to ensure a harmonized approach. The European Union recalled that the criteria were based on the WHO definition, required consideration of all relevant scientific information, and applied a weight of evidence approach. Regarding the proposals for derogation (i.e. the technical amendment to the clause on negligible exposure), discussions with member States would begin soon. In relation to import tolerances, the European Union confirmed that the procedures of Regulation (EC) No. 396/2005 would apply, including a full risk assessment, followed by a case-by-case decision, taking into account the scientific advice and other relevant legitimate factors, in accordance with risk analysis principles. The European Union also explained that the consideration of other legitimate factors was not new, as it was already included in Article 14.2(f) of Regulation (EC) No. 396/2005. The procedure for import tolerances would be published on the Commission website.

In November 2018, Argentina reiterated its concern over the European Union's policy on pesticides and the adoption of a hazard-based approach for identifying substances with endocrine disrupting properties. Argentina noted the adoption of Regulation (EU) No. 2018/605, modifying Annex II to Regulation (EC) No. 1107/2009, which would come into force as of 10 November 2018. Argentina expressed concern about the systemic and trade impact of the measure, which violated core provisions of the SPS Agreement, such as the obligation to undertake a risk assessment and to apply the least trade restrictive measure. Argentina requested again that the European Union continue applying the procedures for granting import tolerances under Regulation (EC) No. 396/2005. Argentina queried how the EU reliance on the precautionary principle would conform with the requirement in Regulation (EC) No. 396/2005 to conduct risk assessments in establishing import tolerances and recalled that any precautionary measure would need to comply with Article 5.7 of the SPS Agreement. Argentina also queried when import tolerances guidance under discussion in the EU Standing Committee on Plants, Animals, Food and Feed would be published and applied. Argentina referred to the GMO case and emphasized the need to carry out assessment procedures for import tolerances without undue delay. Argentina asked the European Union to provide information on the approach that would finally be applied, and to examine the proposal on waivers in order to at least exempt the substances that represented a minimal risk to public health, due to low exposure levels. Finally, Argentina urged the European Union to reconsider its hazard-based regulatory approach to pesticides.

The United States reiterated its concern on the EU hazard-based approach to pesticide regulation, and the implementation of criteria for identifying and subsequently banning endocrine-active substances. The United States requested clarification on the appropriate level of protection that these actions would achieve, underscoring that the identification of hazards without identifying potential risks would likely be more trade-restrictive than necessary. Furthermore, the United States again requested an explanation of the "legitimate factors", other than risk, considered when evaluating import tolerances, and how these factors rationally related to achieving an appropriate level of protection. The United States also drew Members' attention to the EU notification (G/SPS/N/EU/263) of a proposal to lower the maximum residue limits (MRLs) for iprodione to trade-restrictive default levels, despite a final EFSA assessment which found no risks to consumers for a number of commodities, many of which also had Codex MRLs. Iprodione was an important crop protection tool for US agricultural producers, being highly effective against a number of fungal diseases. Finally, the United States noted that it remained unclear how the European Union would ensure consistency of its regulatory approach to pesticides with the SPS Agreement.

China reiterated its concerns over the European Union's process to define criteria to identify endocrine disrupting properties in Regulation (EU) No. 2018/605, which appeared to be based on a hazard assessment. China urged the European Union to consider the existing scientific evidence when assessing risks to life or health and to adopt Codex standards where they exist, to minimize the impact on international trade.

India echoed the concerns raised, in particular on the hazard-based regulation approach, which was highly trade restrictive.

Australia, Brazil, Canada, Chile, Colombia, Costa Rica, ECOWAS, El Salvador, Guatemala, Honduras, Korea, Malaysia, New Zealand, Panama, Paraguay, Peru, Chinese Taipei and Thailand indicated that they shared this concern and called upon the European Union to reconsider their measure, considering the significant negative impact that it would have on trade. They also called upon the European Union to base its measures on adequate scientific risk assessments and to consider Codex MRLs. Brazil reiterated the view that safe and modern plant protection products could be of the upmost importance for the protection of plants while promoting agricultural yield and productivity in tropical regions. Guatemala highlighted that certain products were necessary given the climate conditions in such regions, in particular as a consequence to climate change.

Canada reiterated its disappointment that the technical amendment for derogations based on negligible risk had not been included in the final regulatory amendment of Regulation (EU) No. 2018/605. Canada sought assurances from the European Union that once a substance was identified as an endocrine disruptor, import tolerances would continue to be based on complete risk assessments, as set out in Regulation (EC) No. 396/2005. Finally, Canada sought information on how the European Union planned to work with its trading partners to implement the measure in a manner consistent with its international obligations and without unnecessary disruptions to market access.

The European Union confirmed that new criteria to identify endocrine disruptors for biocides applied from 7 June 2018 (Delegated Regulation (EU) 2017/2100), whereas for pesticides they would apply as of 10 November 2018 (Regulation (EU) 2018/605). The criteria would also apply to ongoing renewal or approval procedures of active substances. The European Union also confirmed that the guidance document for the implementation of the adopted criteria had been published by EFSA and ECHA on 7 June 2018. The criteria were the same for biocides as for pesticides in order to ensure a harmonized approach. The criteria were based on the WHO definition, required consideration of all relevant scientific information and applied a weight of evidence approach. Regarding the proposals for derogation (i.e. the possible inclusion of the clause on negligible risk from exposure), discussions with member States had started, and a qualified majority in favour of the derogation was needed to proceed with the inclusion. In relation to import tolerances, the European Union confirmed that the procedures of Regulation (EC) No. 396/2005 would apply, including a full risk assessment, followed by a case-by-case decision, taking into account all relevant factors, in accordance with risk analysis principles. In addition, the Regulation included transitional measures for products produced prior to the modification of MRLs to remain on the market until the end of their shelf life, even after the date of application of the new MRLs, six months after the date of entry into force. However, when a health concern was identified, such transition measures would not be provided. The European Union reminded that early warning was available. As an example, TBT notifications on the non-renewal of active substance approval were accompanied by a statement on possible impact on MRLs. Recent examples had shown that two years could elapse between such notifications and the application of the lowered MRLs. The procedure for import tolerances would be published on the Commission website.

In March 2019, the United States reiterated its concern on the EU pesticide regulation, arguing that it was hazard-based, and that the criteria to define endocrine disruptors were more stringent than those initially notified to the WTO. The United States considered that the level of protection sought by the European Union was not adequately articulated, and that the EU regulatory approach was already proving to be more trade restrictive than necessary. The United States requested the European Union to carry out a transparent, timely, and risk-based process for evaluating and setting MRLs and import tolerances. The United States referred to a lack of evidence of the use of the import tolerance process, and was concerned that import tolerances would only be granted on a case-by-case basis, factoring in "legitimate factors" and based on a precautionary principle.

The United States queried on the "legitimate factors", other than risk, that the European Union would consider when evaluating import tolerance requests and whether the list of factors would be available. Further, the United States asked the European Union to explain how these factors and the precautionary principle would achieve an appropriate level of protection. Lastly, the United States invited Members maintaining policies of national alignment or harmonization with EU legislation, including implementation of EU regulations, to notify all changes to their national measures on pesticide MRLs and import tolerances, as these might also have a significant impact on trade.

India echoed the concern and urged the European Union to consider the available scientific data and adopt existing Codex standards. India noted that the final notified criteria included several changes and sought clarification on how the relevance of data would be determined, among other issues.

China shared the concern and suggested that the European Union seek the establishment of standards for pesticides with endocrine disrupting properties in Codex. China also called on the European Union to adopt Codex MRLs as much as possible to minimize impacts on international trade, and to take into account available scientific evidence in the assessment of risks.

Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Guatemala, Honduras, Kenya, Korea, Malaysia, Panama, Paraguay, Peru, Senegal, Chinese Taipei, Thailand and Uruguay shared the concern. They called on the European Union to amend its hazard-based regulation, which threatened to restrict trade unnecessarily, and reintroduce complete risk assessments based on scientific techniques developed by the relevant international organizations. Several Members also urged the European Union to follow Codex recommendations on MRLs, while others called for more clarity on relevant factors that the European Union would take into consideration when undertaking risk assessments for the establishment of import tolerances.

Colombia reiterated the need to consider scientific evidence, production processes and methods, international recommendations on MRLs by Codex and ecological and environmental conditions in countries that could be affected by the measure, to avoid unnecessarily restricting trade.

Canada noted that the European Union's approach could impact the use of internationally accepted pesticides, preventing producers from accessing important plant protection tools. Canada added that the EU process to allow for the consideration of import tolerances remained unclear and feared it would be lengthy and unpredictable. A case-by-case approach did not provide the certainty required for international trade. Canada insisted on the need for a transparent, predictable and commercially viable import tolerance process for plant protection products which had not been re-approved and requested the European Union to maintain, until such a process was implemented, the import tolerances for active substances at prior levels to allow trade to continue.

Thailand requested the European Union to expedite the drafting process of the criteria for derogations by determining the meaning and criteria of "neglectable risk" and to notify them for comments.

Panama and Guatemala recalled Ministerial Declaration WT/MIN(17)/50, signed by seventeen WTO Members to increase predictability and transparency on MRLs in the SPS Committee. Panama and Guatemala urged the European Union and other WTO Members to work towards global SPS standards instead of unilateral measures.

Brazil referred to its previous statements. Brazil highlighted that the use of plant protection products in agriculture in the tropical regions promoted technology, investment, innovation and research, important drivers for the development of resilient, stable and sustainable agricultural practices, which in turn promoted growth and trade in agricultural products.

Korea regretted the European Union's hazard-based criteria for categorization of compounds as endocrine disruptors that had been in place since November 2018 in spite of the concerns expressed by Members. Korea requested the European Union to consider maintaining import tolerances with MRLs above default levels, in accordance with Regulation (EC) 396/2005.

Kenya referred to its tropical location and to the consequences of the removal of currently used chemicals on food security for an ever-increasing population. While acknowledging that the European Union had been providing updates, Kenya asked that the length of the process required to authorize new molecules be taken into consideration, among other issues.

The European Union responded that it had kept the Committee regularly updated on relevant developments. In previous meetings, the European Union had provided information on the discussions about possible derogations where there was negligible risk of exposure, and, following the agreement on the criteria, about the possible adoption of that derogation. In November 2018, the European Union had reported on the lack of internal agreement. The European Union now had to report that no further discussions would be held, since the qualified majority of EU member States to support such a clause could not be reached.

The European Union highlighted the following developments: First, on import tolerances, the procedures laid down in Regulation 396/2005 for the management of import tolerance requests would be applied also for active substances falling under the cut-off criteria. The procedure included a risk assessment by an evaluating EU member State and EFSA. Import tolerances would be granted in line with risk analysis principles on a case-by-case basis. For transparency purposes, the approach would be published on EU websites as part of the Guidance on the MRL Setting Procedures. In relation to the references to the precautionary principle and the legitimate factors, the European Union reminded Members that the standard clause had been in force since 2005.

Second, on transitional arrangements, Article 49 of Regulation (EC) No 396/2005 provided for the possibility of transitional measures for the implementation of certain MRLs, while ensuring a high level of consumer protection. As a general rule, transitional measures are consistently applied allowing products already on the EU market before the date of entry into force of a Regulation to remain on the market until the end of their shelf life. Nevertheless, when a health concern was identified, transition measures were not provided and the new MRLs applied usually six months after the entry into force of the Regulation. The European Union reiterated its commitment to fulfilling its transparency obligations and reminded Members that draft measures are regularly notified under the relevant WTO agreements.

In July 2019, the United States reiterated its ongoing concern with the European Union's approach to regulating pesticides and MRLs. The United States regretted that despite repeated concerns expressed by more than 40 Members of the SPS Committee, questions remained about the consistency of the EU regulatory approach with the obligation to base measures on an assessment of risk. The European Union had previously informed the SPS Committee that the procedures of Regulation (EC) 396/2005 would apply to import tolerance requests, followed by case-by-case decision-making, taking into account "other relevant factors" without clarifying how those "other factors" would rationally relate to achieving an appropriate level of protection. The United States added that a 2017 study commissioned by the European Crop Protection Association had estimated that the European Union's hazard-based pesticide policies could adversely affect trade flows valued at approximately $86 billion, with a disproportionate impact to growers in Central and South America and Sub-Saharan Africa. The European Union's suggestion that those producers would find alternative crop protection methods was insufficient as, in many cases, viable alternatives did not currently exist or carried higher risks than those being banned by the European Union. The United States asked the European Union to reconsider its approach to regulating pesticides and to ensure that its actions with regard to MRLs and import tolerances were consistent with the European Union's WTO obligations.

Paraguay reiterated its concern that the EU hazard-based measures affected Paraguay's agricultural exports. It also highlighted that 22 delegations had intervened on this concern in the March 2019 SPS Committee meeting, 16 delegations in the relevant TBT STC at the June 2019 TBT Committee meeting, and 30 delegations representing 90 Members at the July 2019 meeting of the Council for Trade in Goods.

Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, Guatemala, Honduras, India, Kenya, Malaysia, New Zealand, Panama, Peru, the Russian Federation, Senegal, Chinese Taipei, Thailand and Uruguay supported the concern and called upon the European Union to take a risk-based approach, carry out risk assessments for the identification and regulation of endocrine disruptors, and apply criteria supported by sufficient scientific evidence in line with the commitments of the SPS Agreement. There were also requests for updates of the discussions, including those held in JPMR and the prospects for adoption.

Argentina also requested the European Union to allow waivers for at least those substances that represented an insignificant risk to human health, due to low exposure.

Brazil stated that the promotion of technology, investment, innovation and research on plant protection products were important drivers for the development of a resilient, stable and sustainable agriculture in tropical regions; and added that scientific evaluations should be able to separate chemicals with the potential to cause harm due to their endocrine mode of action from those without that potential. Finally, Brazil expressed its appreciation for the information on endocrine disruptors provided by the European Union, contained in documents G/SPS/GEN/1594 and G/TBT/GEN/241.

Canada expressed its concern on the growing number of plant protection products not being renewed by the European Union, without a clear scientifically-sound risk-based justification. Canada noted the different approaches between Regulation (EC) 396/2005 provisions which allowed for the establishment of an import tolerance based on a risk assessment, in the event of an active ingredient's non-renewal; and Regulation (EC) 1107/2009 specific hazard-based cut-off criteria to identify substances with endocrine disrupting or carcinogenic, mutagenic, or reproductive toxicant properties. Canada also referred to the European Union's statements at the Council for Trade in Goods, that import tolerances for active substances falling under the cut-off criteria would be established based on a risk assessment as per Regulation (EC) 396/2005, on a "case-by-case basis" and would take into account "other considerations". Canada requested the European Union to provide detailed information on the process it would follow when setting an import tolerance for an active substance falling under the cut-off criteria, as well as clarity on how Regulation (EC) 396/2005 and Regulation (EC) 1107/2009 would be implemented in a coherent and transparent way. Canada finally requested that import tolerances for active substances which were not re-authorized in the European Union be maintained at existing levels to allow for trade to continue.

Ecuador stressed the difficulties posed for its producers by the lack of clarity around the process of requesting import tolerances, as well as the cost for developing countries to provide the data required for import tolerance requests.

India noted that the European Union measures did not refer to the processes for establishing import tolerances for substances identified as endocrine disruptors.

The Russian Federation explained that there was still a lack of conclusive scientific evidence to restrict the use of chemicals that disrupt the endocrine system, and expressed concern about how the European Union would move forward with its regulations on endocrine disruptors.

The European Union referred Members to its statement at the March 2019 SPS Committee meeting and recalled that Regulation (EC) 396/2005 would apply to requests for import tolerances. Regarding the "other legitimate factors" to be taken into consideration, the European Union explained that this provision was part of the same Regulation. Such import tolerance requests would be followed by risk assessments carried out by EU member States and an evaluation by EFSA. On transitional arrangements, the European Union explained that it applied as a general rule a deferral period of six months and a transitional period for products on the market, if there were not health concerns, until the end of their shelf-life. The use of substances falling under the cut off criteria was not allowed in the European Union, but import tolerance requests would be nevertheless processed under Regulation (EC) 396/2005, and a risk assessment would be carried out. The European Union further explained that the possibility of introducing a derogation on negligible exposure had not been supported by EU member States.

In November 2019, Ecuador reiterated its concern and requested that the European Union base its measures on the SPS Agreement, without disguised restrictions on trade. Ecuador considered that the classification criteria for endocrine disruptors could be a good starting point to characterize the toxicity of a chemical substance, especially for pesticides, but that it was important to consider in vivo, in vitro and in silico trials. Ecuador noted that these criteria would also need to consider scientific evidence based on animal testing and epidemiological analyses of exposed populations to avoid assuming the existence of adverse effects. The EU Regulation did not consider the definition of MRLs to ensure minimum risk under specific exposure conditions and whereby appropriate levels of protection were established. Ecuador highlighted the importance of using the three pillars of risk analysis - namely risk assessment, management, and communication -for decision-making. Finally, Ecuador invited the European Union to revise its criteria using the risk analysis principle, and to develop a methodological tool that allowed to determine the actual adverse effects on human health based on real scenarios.

Guatemala expressed the concern that the EU measure was hazard-based as opposed to risk-based. Guatemala invited the European Union to adopt a risk assessment approach to determine and regulate endocrine disruptors, applying criteria supported by adequate scientific data, according to its commitments under the SPS Agreement.

Panama recalled that this concern had been on the agenda for more than two years and that, the measures could carry serious consequences, especially for the farmers, who were the most vulnerable populations in developing countries. Panama invited the European Union to provide conclusive risk analyses and not to take hazard-based decisions.

Paraguay reiterated its concern that the EU measure could affect a high volume of its exports, with the economic implications that this entailed for a developing country. Panama requested that the European Union adopt levels of protection that did not restrict trade more than necessary, to adopt the Codex standards and, where this was not possible, to provide conclusive scientific evidence, as well as to ensure tolerance to importations. Paraguay urged the European Union to send its full statements and answers in written to the Committee.

The United States reiterated its concern on this matter. The statement can be found in document G/SPS/GEN/1750.

Argentina, Australia, Brazil, Canada, Chinese Taipei, Colombia, Costa Rica, Honduras, Malaysia, Uruguay, and Peru also supported this STC and called upon the European Union to set criteria based on risk assessments and sound scientific evidence, and to reconsider its hazard-based approach to regulating active substances in plant protection products. Some Members requested that the European Union harmonize its MRLs with Codex standards, as required by the SPS Agreement, and to avoid the removal of plant protection chemicals from the market, despite their previously established safety, which could lead to future trade concerns. They invited the European Union to take Members' concerns and comments into consideration and avoid imposing trade-restrictive measures when setting import tolerances.

Canada reiterated its concern with the trade implications of the EU approach to the regulation of active substances in plant protection products, and, specifically, to setting import tolerances. The current case-by-case approach did not provide clarity or predictability to producers and did not address timing and transition measures. Canada emphasized that the European Union should clarify its approach and urged it to consider both hazards and risks for all active substances in its regulatory decision-making. Finally, Canada welcomed the EU offer to hold seminars to address concerns and answer questions on the hazard-based approach and hoped that they would provide detailed information on the process to set an import tolerance for an active substance falling under the cut-off criteria.

Chinese Taipei supported enhancing public health and environmental protection by properly regulating endocrine disrupting substances but emphasized that the precautionary principle could cause trade uncertainty.

Australia highlighted that the EU legislation for plant protection products provided that active substances which were endocrine disruptors should not be approved unless there was negligible exposure, in which case they could be approved under restricted conditions.

Argentina noted that the EU's hazard-based approach did not consider essential elements in hazard characterization, such as potential, severity, and reversibility of the effects. Argentina recalled the existence of less trade restrictive options in the original EU proposal, which granted the same level of protection as the criteria finally adopted.

Uruguay reiterated its commercial and systemic concern and evoked the statement of India during the past Codex committee on pesticides residues regarding the need to implement a risk-based approach to allow the use of pesticides whose withdrawal could affect sustainable agricultural production, food safety and international trade of food products. Uruguay supported the work of Codex for the development of a harmonized risk-based approach.

Brazil reiterated its concern and mentioned that an analysis carried out in a precautionary manner could result in the identification of endocrine active compounds of no relevance to health. Although Members had the right to establish a higher level of protection Brazil was of the view that a Member deviating from a well-established international standard had to gather the necessary information when studies were inconclusive. Brazil was also concerned that the European Union reaffirmed its position and announced more restrictive measures in the future.

The European Union explained that there had been no significant changes since the last meeting. The European Union recognized that endocrine disruptors were one category of the cut off criteria substances it had identified and that there was no detailed guidance for related requests, as there was not a single instance where MRLs were reduced due to cut off criteria. The European Union further noted that the current criteria for endocrine disruptors had been in place for a long time, were based on WHO criteria, and that there was no plan to revisit them. Regarding the hazard-based approach, the European Union noted that it was limited to a few categories of hazards. Substances for which the regulators decided that it was not possible to establish safe levels of exposure could not be approved. The European Union reminded Members that import tolerance requests underwent the risk assessment process established in its regulation on residues.

Regarding the precautionary principle, the European Union explained that the level of tolerance to risk from residues of pesticides in the EU was low and, therefore, its levels of protection were high. Regarding "other factors", the European Union stated that relevant legislation referred to legitimate factors, although they had not been codified. The European Union reiterated its intention to remain transparent. All decisions had been and would be in the public domain, with an opportunity to comment. In response to Brazil's comments, the European Union noted that, in the context of a pre-market approval system, the applicant needed to demonstrate that it reached the importer's level of protection, even when the latter had set a higher one. The European Union reiterated that it would continue engaging in discussions with Members. Finally, the European Union announced an international conference on pesticides, where its policies would be discussed. The relevant information would be circulated once the date had been set.

In June 2020, Paraguay provided the following statement: As in the previous trade concern, my delegation has submitted written questions to the European Union, which were circulated in document G/SPS/GEN/1762. In those questions we asked the European Union for information on: how it distinguishes between relevant scientific evidence and non-relevant scientific evidence; which protocols form the basis for studies that are not based on internationally agreed study protocols; how Commission Regulation (EU) No. 2018/605 is in conformity with Article 5.1 and 5.2 of the SPS Agreement; how risk assessments carried out by the European Union take account of strength, severity and reversibility of effects; whether presumed endocrine disrupting substances are covered under Article 5.7 of the SPS Agreement; whether it considers that the prohibition of substances to which exposure represents a negligible risk of endocrine disruption is scientifically justified; how import tolerance mechanisms will function; how it can reconcile analysing import tolerances on a case-by-case basis if they are to be based on a risk analysis; and, lastly, applications for import tolerances that have been received and the number that have been approved to date. We would appreciate receiving a full response to our questions from the European Union. We would specifically request further information on the functioning of the mechanisms of import tolerances, in light of the recently published Farm to Fork Strategy.

Brazil, Canada, Colombia, Costa Rica, the Dominican Republic, Guatemala, Honduras, Panama, Peru, Chinese Taipei, the United States and Uruguay supported the concern.

Brazil provided the following statement : Brazil would like to thank Paraguay for maintaining this important trade concern on the agenda. Brazil shares the concerns and refers to its statements delivered at the four previous meetings which discussed this STC. Brazil urges the European Union to take into consideration the concerns of a large number of WTO Members regarding the scientific criteria for the determination of endocrine disrupting properties, highlighting the importance of conducting assessments appropriate to the circumstances and the need to obtain the additional information necessary for a more objective assessment of risk that does not create measures more trade-restrictive than required.

Canada provided the following statement: Canada continues to ask the European Union to amend its hazard-based regulation for active substances in plant protection products, and to consider both hazards and risks for all active substances in its regulatory decision-making. As a major agricultural producing nation, Canada is concerned with the trade implications of the European Union's approach to the regulation of active substances in plant protection products, and in particular the impact of this approach on setting import tolerances. While the European Union has indicated that a process for establishing import tolerances for actives which have triggered the hazard based cut-off criteria exists, we remain keen to understand how it will be implemented. Specifically, Canada continues to seek information on how the European Union will base the setting of an import tolerance for an active substance falling under the cut-off criteria on an assessment of risk, and on how the European Union will take into account risk assessment techniques developed by the relevant international organizations. Canada takes this opportunity to ask the European Union whether it could provide an update on the timing of the third countries and stakeholder seminars. As mentioned in the last Committee, Canada hopes that these seminars will provide detailed information on the process that the European Union will follow when setting an import tolerance for an active substance falling under their cut-off criteria. Until such a clear and predictable process is implemented, Canada requests that import tolerances for active substances which are not re-authorized in the European Union be maintained at existing levels to allow trade to continue. Canada shares the objectives outlined in the EU Farm to Fork Strategy and looks forward to the announcement of specific policies that will be used to address these ambitious goals related to pesticides. It is important to Canada to see trade aspects included in the impact assessments that will be developed throughout the progression of the Farm to Fork Strategy. Canada encourages the European Union to notify to the WTO SPS Committee of all proposed regulations arising from legislative and regulatory changes stemming from the Farm to Fork Strategy, and to allow sufficient time for WTO Members to comment and have their comments taken into account in the finalization of the regulations. Canada would like to underline the importance of providing significant advance notice between the adoption of regulations and entry into force, to enable industry sufficient time to adapt to any legislative and regulatory changes. Finally, we hope that any regulatory changes arising from new policies, including the Farm to Fork Strategy, will be commensurate with the risk involved, be established in a coherent and transparent way that will minimize negative and unnecessary trade effects that enable producers and exporters to make timely business decisions.

Costa Rica provided the following statement: As we have indicated previously, we are concerned by the approach taken by the European Union in the implementation of Regulation (EC) No. 1107/2009, which led to the adoption of a hazard-based decision criterion. We once again urge the European Union to ensure that the implementation of its regulation is based on the use of risk assessments for the identification and regulation of endocrine disruptors, using criteria supported by sufficient scientific evidence, in line with the commitments established in the SPS Agreement.

The Dominican Republic provided the following statement: The Dominican Republic would again like to confirm its support for this item, and to reiterate its concern over this EU regulation, which has been on this Committee's agenda for over two years. This measure assesses the substances concerned based on a hazard-identification approach, rather than on the basis of a scientific risk assessment, as provided for in the WTO SPS Agreement. The European Union has therefore been unable to demonstrate a level of objective risk. We are particularly concerned about the systemic and trade impact of these measures on our country's exports. We urge the European Union to reduce the negative effects on international trade, taking Members' concerns and comments into consideration to avoid imposing unnecessarily trade-restrictive measures. We refer in particular to measures that affect agricultural products, so as to minimize the social and economic consequences for farmers in countries exporting commodities and special products, who are the most vulnerable populations in developing countries such as the Dominican Republic.

Guatemala provided the following statement: We thank Paraguay for including this item on the agenda. We reiterate our concern over the European Union's approach to regulating pesticides and MRLs. Despite the concerns repeatedly expressed by more than 40 Members at the SPS Committee, the European Union is pursuing its actions. We ask the European Union to reconsider its approach and to base its measures on a risk assessment.

Peru provided the following statement: Peru supports this concern, as the EU regulation would not be based on certain risk, in accordance with Article 5 of the WTO SPS Agreement, but rather on a hazard-based approach. In taking such an approach, the European Union would be implementing measures that were more restrictive than necessary, causing unnecessary damage to trade.

Chinese Taipei provided the following statement: The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu shares the concern raised by Paraguay regarding the European Union's legislation on endocrine disruptors. At the present time, the main body of research undertaken by the international academic community into the endocrine-disrupting effects of most chemicals is still ongoing, and there are no clear conclusions yet in terms of assessment and differentiation. In June 2018, the European Food Safety Agency (EFSA) and the European Chemicals Agency (ECHA) of the European Union issued guidelines on the identification of endocrine-disrupting substances in chemicals (pesticides and fungicides), which suggests various methods of collecting and evaluating the relevant research data, as well as analysing and applying the MoA (mode of action) to ensure that EU member States use the same standards in their evaluations. The latest EU research report shows that endocrine-disrupting effects have the characteristics of non-monotonic dose responses (NMDRs). That is to say, they do not have the traditional dose-response relationship, but something more similar to the non-threshold concept of tumorigenesis. However, the European Union has not yet completed or disclosed its findings on how the key elements of risk characterization should be considered, such as the intensity, severity and reversibility of their influence on the endocrine system. In view of the widely differing endocrine disrupting effects of the various compounds, NMDRs should not be the only model used to address the effect of the endocrine disrupting chemicals. For this reason alone, it is clear to us that more research is needed in order to properly distinguish between, and manage, the different varieties of endocrine-disrupting compounds. To conclude therefore, in line with Paraguay's concern, our recommendation is that the European Union be asked to submit more convincing scientific evidence regarding the effects of endocrine-disrupting compounds. We also look forward to the European Union taking greater consideration of WTO Members' concerns in the future, as well as implementing SPS measures that are consistent with its own WTO commitments.

Uruguay provided the following statement: Uruguay thanks Paraguay for keeping this concern on the Committee's agenda. We would like to reiterate our trade and systemic concern relating to the European Union's adoption and implementation of a hazard based approach, instead of an approach based on full scientific risk assessments, in its regulatory determinations concerning products with endocrine disrupting properties. We reiterate the need to base such determinations on conclusive scientific evidence, gathered from an assessment of the actual risks associated with pesticides, to avoid some of these products, which remain important components of pest management systems, being withdrawn despite their safe use. An approach based on hazard rather than on actual risk contributes little or nothing to the cited aim of effectively protecting public health, while at the same time having a significantly negative impact on sustainable agricultural production, food security and international trade in food products. Uruguay continues to support any multilateral work undertaken by the Codex Alimentarius to develop a harmonized, risk based approach that ensures the protection of health while facilitating international trade in food and agricultural products. In the meantime, we once again urge the European Union to listen to and address the concerns expressed by a number of Members, and to reconsider its regulatory approach with a view to preventing the unjustified proliferation of barriers to international trade in agricultural products and the serious social and economic consequences of such an approach for other Members, in particular developing and least developed countries.

The European Union provided the following response: The European Union has explained previously the principles behind the regulatory measures for substances having endocrine disrupting properties and how the European Union intends to deal with import tolerance requests. Even though no new information is available at this stage, the European Union is pleased to address the latest questions received as follows:
1) Definition of endocrine disruptors (ED): The European Union regulatory criteria as enshrined in Regulation (EU) 2018/605 are based on the WHO definition, which is the following: "An endocrine disruptor is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations".
2) Relevant scientific evidence: A Guidance Document published in 2018 and developed by EFSA, ECHA and JRC provides guidance to how to interpret the ED-criteria. The relevance of data refers to whether data are pertinent and can be used to demonstrate or exclude one of the three elements of the ED-criteria: i.e. either adverse effect, mode of action, or a link among the two. Under the European Union regulations, data requirements based on international study protocols need to be fulfilled. Some of those data need to allow to determine whether the substance is potentially an ED. However, scientific peer review literature could also be used, if relevant. In particular, all available relevant scientific data (in vivo studies or adequately validated alternative test systems predictive of adverse effects in humans or animals; as well as in vivo, in vitro, or, if applicable, in silico studies informing about endocrine modes of action): (a) scientific data generated in accordance with internationally agreed study protocols; in particular, those listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation; (b) other scientific data selected applying a systematic review methodology, in particular following guidance on literature data listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation.
3) Consistency with Article 5: When assessing a request for the authorisation of a plant protection product or for an import tolerance, the European Union carries out a rigorous product specific and step-by-step risk assessment taking into account all relevant data. As such, the European Union is in compliance with the relevant provisions of article 5 of the SPS Agreement.
4) Risk assessments: A Guidance Document published in 2018 and developed by EFSA, ECHA and JRC provides guidance to how to interpret the ED-criteria.
5) Relationship with Article 5.7: The European Union does not see a direct link between recital 4 of Regulation (EU) 2018/65 and Article 5.7 of the SPS Agreement. Where the European Union considers that the available pertinent information is not sufficient to implement definitive measures, the European Union may need to adopt and apply provisional measures to protect consumers, animals and/or plant life or health. This decision-making process complies with the relevant SPS Agreement provisions
6) Negligible risk: Substances which are identified as endocrine disruptors under the EU legislation and for which exposure is negligible can be placed on the market if negligible exposure is demonstrated.
7) Import tolerance mechanisms and 8) Import tolerance case by case: Import tolerance requests can be submitted for active substances approved in the European Union or for active substances that are not approved in the European Union. Interested parties may submit an "import tolerance" request according to Article 6(4) of Regulation (EC) No. 396/2005. This allows setting EU-MRLs based on Good Agricultural Practices (GAPs) authorised in non-EU countries at a level sufficiently high to meet the needs of international trade, provided that a risk assessment demonstrates that the protection of European Union consumers is ensured. The data requirements and stringency of assessment (e.g. regarding the need to demonstrate safety for all European consumer groups) for import tolerance requests are identical to those for MRL applications based on authorisations in the European Union and its member States (EUMS). An MRL can be set only when there is sufficient information to support a risk assessment demonstrating that the MRL is sufficiently protective for consumers. The burden lies with the applicant to show that residues of the active substance from use in accordance with the good agricultural practice under evaluation are safe. The European Union will assess each import tolerance request in its own merit and will carry out a thorough, product-specific, risk assessment, which will take into account the data submitted for each request.
9) Import tolerances, state of play: Since 2008, 94 applications for import tolerances have been submitted, among which 80 were assessed positively by EFSA and nine received a negative opinion. The remaining five applications are still under assessment.

In November 2020, Paraguay reiterated its concern regarding the EU legislation on endocrine disruptors. Paraguay referred to its communication in document G/SPS/GEN/1846, containing a series of questions submitted to the European Union, mainly on scientific criteria for the determination of endocrine disrupting properties for plant protection products.

Noting that this issue had been on the agenda of the Committee for over two years, the Dominican Republic reiterated its concern about the approach adopted by the European Union based on hazard instead of an assessment of risk. The Dominican Republic noted that the European Union had not demonstrated the existence of a risk or how its measures would reduce this risk. The Dominican Republic expressed concerns about the impacts of the EU approach on its exports, in particular in light of the COVID-19 pandemic. The Dominican Republic urged the European Union to avoid imposing unnecessarily trade restrictive measures. In that context, the Dominican Republic highlighted the socioeconomic consequences of the measures for farmers, who were particularly vulnerable.

Supporting the concern, Brazil stated that technology, innovation, and research on plant protection products were important drivers for the development of a resilient, stable, and sustainable agriculture in tropical regions. Brazil urged the European Union to keep in mind the importance of conducting assessments appropriate to the circumstances and the need to obtain the information necessary for an objective assessment of risk that does not create measures more trade restrictive than required. In addition, Brazil asked the European Union to clarify how it will apply the cut-off criteria set out in Regulation (EU) 528/2012 and Annex II to Regulation (EC) 1107/2009 for the establishment of effective and science-based import tolerances, as well as on the definition of transition periods.

Chinese Taipei thanked Paraguay and the Dominican Republic for raising this issue and recalled its suggestion at the previous Committee meeting to have additional research on endocrine disruptors. Chinese Taipei had just received a response from the European Union, which its experts were reviewing. In the interim, Chinese Taipei noted that EFSA and the European Chemicals Agency had prepared guidance for the identification of endocrine disruptors, but that the criteria of endocrine disrupting activity remained unclear. Chinese Taipei recommended that EFSA provide clear criteria on endocrine disrupting activity induced by plant protection products and requested a list of plant protection products exhibiting endocrine disrupting activity classified in terms of their effects. Chinese Taipei also requested the European Union to submit further scientific evidence regarding the effects of endocrine disrupting compounds.

As set out in its statement in document G/SPS/GEN/1849, Chile took issue with the potential unnecessary restrictions on the use of pesticides and with the European Union's hazard-based approach. Reiterating its concern regarding the EU approach to regulating pesticides and MRLs, Guatemala requested the European Union to reconsider its approach and base its measures on a risk evaluation. Costa Rica equally deplored that the European Union adopted a hazard-based approach, instead of relying on a risk assessment and scientific evidence in accordance with the SPS Agreement.

Canada continued to ask the European Union to amend its hazard-based regulation and consider both hazards and risks for all active substances in its regulatory decision-making. The European Union had referred to its process for establishing import tolerances for active substances triggering cut-off criteria and Canada sought information on how the European Union would base the setting of an import tolerance for an active substance falling under the cut-off criteria on an assessment of risk and how it would take into account risk assessment techniques developed by relevant international organizations. While waiting for a clear and predictable process, Canada requested that import tolerances for active substances not re authorized in the European Union be maintained at existing levels to allow trade to continue. In addition, Canada encouraged the European Union to notify proposed regulations stemming from its Farm to Fork Strategy, underlining the importance of providing significant advance notice between adoption and entry into force of regulations to enable the industry to adapt. Canada also expressed hope that any regulatory changes would be commensurate with the level of risk and be established in a coherent and transparent way.

Uruguay, Peru, Honduras, and Colombia also took the floor supporting the concern. Uruguay reiterated its systemic concerns with the EU hazard-based approach instead of a risk-based approach built on conclusive scientific evidence. Uruguay considered such an approach to contribute little, if anything, to protecting public health. Uruguay expressed support for the work of Codex to develop harmonized risk-based approaches to protect health while facilitating trade. Noting the serious consequences for developing countries, Uruguay encouraged the European Union to listen to the concerns expressed by Members and reconsider its approach. In the same vein, Peru deplored that the European Union maintained a hazard-based approach instead of basing its regulations on a risk assessment, leading to measures that are more restrictive than necessary. Honduras joined other Members requesting the European Union to establish criteria based on an assessment of risk and harmonization with Codex MRLs.

The European Union thanked Members who showed interest in the ongoing work on endocrine disruptors. The European Union recalled that scientific criteria to identify endocrine disruptors, based on the WHO definition of endocrine disruptors, had been put in place in the European Union and that criteria to identify pesticides had been applicable since November 2018. The European Union specified that the criteria also apply to on-going procedures for the approval or renewal of approval of active substances. The European Union indicated that it had answered questions and regularly informed Members of relevant developments, and that no new information was available with respect to what has previously been communicated. The European Union indicated that it would respond to Paraguay's questions in writing after the meeting; the responses were subsequently circulated as document G/SPS/GEN/1871.

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European Union legislation on endocrine disruptors

Extracts from SPS Committee meeting summary reports

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