STC Number - 306

Maximum residue levels of pesticides

Maintained by: European Union
Raised by: India
Supported by: Argentina; Brazil; Pakistan; Thailand
First date raised: October 2010 G/SPS/R/61 paras. 17-19
Dates subsequently raised: March 2011 (G/SPS/R/62 paras. 56-58)
June 2011 (G/SPS/R/63 paras. 36-37)
October 2011 (G/SPS/R/64 paras. 67-68)
March 2012 (G/SPS/R/66 paras. 56-58)
July 2012 (G/SPS/R/67 paras. 38-39)
October 2012 (G/SPS/R/69 paras. 31-32)
March 2013 (G/SPS/R/70 paras. 3.31-3.33)
June 2013 (G/SPS/R/71 paras. 4.25-4.26)
October 2013 (G/SPS/R/73 paras. 3.23-3.25)
Number of times subsequently raised: 9
Relevant documents: G/SPS/N/EEC/196/Add.2 G/SPS/N/EEC/196/Add.10 G/SPS/N/EEC/382 EU Revised Plant Protection Regulation 1107/2009, EC Regulation 396/2005, G/SPS/GEN/1139/Add.1
Products covered:
Primary subject keyword: Food safety
Keywords: Appropriate level of protection; Food safety; Human health
Status: Not reported
Solution:
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In October 2010, India referred to three EU notifications on the adoption of Maximum Residue Limits (MRLs) for certain pesticides (G/SPS/N/EEC/196/Add.2, G/SPS/N/EEC/196/Add.10 and G/SPS/N/EEC/382) within the framework of the EU Revised Plant Protection Regulation 1107/2009. EC Regulation 396/2005 established the legislative framework for MRLs of pesticides in or on food and feed of plant and animal origin, which was notified by the European Commission in April 2005. India was concerned that the MRLs for a number of chemicals were set at the "limit of detection" (LOD). This was the residue limit which could be detected using analytical methods/testing procedures available in Europe. Different climatic conditions in India required a different use of pesticides in agricultural production. No scientific evidence had been provided to justify the setting of the MRL at the LOD, especially for imported products. For some substances, the MRLs in EU cereals was much higher than the approved level of the same substance in rice. The setting of MRLs at the LOD had impacted India's exports of agricultural products to the European Union, and India requested the European Union to provide the validated testing methods it used to arrive at the LOD as well as the scientific basis and risk assessment for the MRLs. India considered that the EU MRLs resulted in the violation of Articles 2.2, 2.3, 3.1, 5.1 and 5.4 of the SPS Agreement.
Thailand shared India's concerns, observing that in the recent EU notifications the proposed MRLs for some chemicals were much lower than the levels set by Codex. Brazil and Pakistan also shared India's concerns about the EU procedure for establishing MRLs.
The European Union explained that the new legislation on pesticide residues was in place since 1 September 2008. MRLs had undergone a common EU consumer intake assessment carried out by the European Food Safety Authority (EFSA) to make sure that all classes of consumers, including vulnerable ones such as babies and children, were sufficiently protected. The validated analytical methods used by the European Union could be found on the website of the EU Reference Laboratories for Residues of Pesticides. The model used for estimating the dietary intake of 27 EU consumer groups was available on the EFSA website. The risk assessment methodology used for setting the MRLs came from the framework established by the Codex Alimentarius, as described by a 2002 Joint FAO/WHO Meeting on Pesticide Residues' (JMPR) report. An LOD was set when there was a safety concern for consumers from the use of a pesticide at high levels or when there was no authorized use on a specific crop within the European Union or third countries. The proposed revision of the EU MRLs had been notified to the WTO in 2003, 2005 and 2007, and all WTO Members and stakeholders had also been informed about all the individual values that were proposed. The MRLs were fixed and published in the Official Journal if no reaction to the notifications had been received. Nevertheless, applicants in and outside the European Union could apply to have import tolerances set for higher MRLs in specific cases. Although the European Union was aware of the different geo-climatic conditions in India, data on the safety of imported products was still necessary.
In March 2011, India stated that the European Union had harmonised its pesticide residue levels under Regulation No. 396/2005 on MRLs for pesticides on food and feed of plant and animal origin. A default level of 0.01 mg/kg had been applied on many chemicals, and the European Union had claimed that the MRLs had been set at the Level of Determination (LOD). However, without a validated test, it was not clear how the LOD was set and consequently the scientific evidence for the MRL had not been provided despite substantially higher levels for the same chemicals existing in other countries. India re-stated its concerns relating to: (i) non- harmonization with international standards; (ii) lack of risk assessment; (iii) misuse of Article 5.7 of the SPS Agreement; (iv) lack of attempt to minimize negative trade effects; and (v) European laws and regulations.
The European Union noted that trading partners could apply for higher MRLs by providing scientific evidence. With respect to the commodities of interest to India, the European Union had indicated that given the economic significance of those commodities, it was prepared to modify the relevant MRLs. India had already submitted an application for a higher MRL which was under evaluation and, pending the outcome of that evaluation, an import tolerance would be set.
In June 2011, India recalled that the European Union had previously indicated that its trading partners could apply for higher MRLs by providing scientific evidence. However, the application of the precautionary principle in the case of chemicals that had been used for decades without any negative effects resulted in an unjustified trade barrier. The MRLs had been set at the level of detection (LOD) without a risk assessment. The LOD was the limit below which residues could not be detected by using sophisticated analytical methods, virtually a zero tolerance, and imported food items containing small traces of pesticides were being adversely affected. In addition, the European Union had not made, or not shared, any scientific assessments that justified the default MRL for some pesticides. The default MRLs created distrust as private labs were being used to run the assessments and at times they used testing methods which were not in line with the European Commission guidelines on method validation and quality control procedures for pesticide residue analysis in food and feed. Furthermore, the aggressive business behaviour by private labs in approaching exporting countries like India for pre-screening services was a cause for concern. India requested that the European Union provide the scientific justification for the current MRLs for certain pesticides, rather than shifting the burden of proof onto exporters by requiring that they provide justifications when applying for higher MRLs. India urged the European Union to take effective steps to remove these trade restrictive measures.
The European Union stated that since 2008, a new legislative framework had been in operation which completed the harmonization and simplification of pesticide MRLs and eliminated all technical barriers to trade. The full details of the EU policy on pesticides had been presented at the March SPS Committee meeting. Trading partners could apply for an MRL that was greater than what was foreseen in the EU legislation by providing scientific evidence justifying the higher level. Regarding the commodities of interest to India, the European Union was prepared to modify relevant MRLs assuming that the requisite information was provided. India had in fact already submitted an application for a higher MRL for Isoprothiolane on rice which was being evaluated by EFSA, however, further information was required from India. As far as grapes were concerned, data from 2011 indicated that no obstacles had been identified.
In October 2011, India recalled that the European Union had previously claimed to have a non-discriminatory, open, transparent and predictable procedure for setting MRLs. However, India questioned the scientific basis for using the level of detection (LOD) method and for setting MRLs for certain pesticides at default levels of 0.01 mg/kg, as well as the validation testing methods used by the European Union to arrive at the level of detection. The EU method of setting MRLs was discriminatory as it affected the trade of certain products and did not conform to the SPS Agreement. India had been informed that a Member could apply for a higher MRL, however the EU procedure was lengthy, costly and burdensome. India urged the European Union to replace its ad hoc discriminatory, opaque, and unscientific measures with more predictable and science-based ones.
The European Union recalled its statement at the June 2011 meeting and noted that setting the MRLs at the default level for some pesticides facilitated trade, in contrast to a zero-tolerance approach. Trade had not been interrupted as a result of this legislation, and particularly not in commodities of interest to India. In line with the EU legislation, India had applied for a higher MRL for Isoprothiolane on rice, and submitted complementary information. An opinion from the EFSA was expected in the first quarter of 2012, and on the basis of this evaluation, the European Union would decide whether a higher MRL could be safely set.
In March 2012, India reiterated that no Member should set MRLs without scientific justification. India welcomed the EU MRL for Isoprothiolane in rice, and sought clarification on the status of an import licence application for Tricyclazole by Dow Agro Sciences. India urged the European Union to replace default MRLs for a variety of pesticides, as the default levels of 0.01 mg/kg, meant that imported foodstuffs containing even the smallest trace of pesticides (e.g., Cerbandazim) were banned in the European Union. India requested the scientific justification for fixing any MRLs at the level of detection, and recalled that under Article 12.6 the Committee could invite a relevant international body, such as Codex, to examine the scientific basis of a standard set by the European Union.
Pakistan stressed the importance of this issue for developing countries, and expressed hope that it would be soon resolved.
The European Union recalled that in September 2008 it had introduced a new legislative framework on pesticide residues (Regulation EC 396/2005) under which many pesticides MRLs had been set at the default level in order not to hinder trade. Trading partners that felt that a higher MRL was necessary should submit an application, with the appropriate scientific justification. The European Union would set a higher MRL where this was scientifically justified, as had been done for Isoprothiolane, where the MRL in rice had been raised to 5 mg/kg from its default level. This was done on the basis of a scientific opinion from EFSA, which stated that authorized use at that level would not pose a public health concern. The European Union also noted that EFSA strongly recommended that studies be carried out to investigate the effect of processing on the nature of Isoprothiolane residues. Following a decision by the EU member States, it was agreed that the MRL would therefore be fixed on a temporary basis on the understanding that it may be reviewed in the light of the results of the requested study on processing.
In July 2012, India reiterated that no Member should set MRLs without scientific justification, as doing so violated the SPS Agreement. India requested the European Union to provide scientific justification for fixing any MRLs at the Level of Determination (LoD) for pesticides such as Carbendazim. The developer of Tricyclazole (Dow Agro Sciences) had filed an application for an import tolerance in accordance with Art. 6 (4) of Regulation (EC) No. 396/2005, however, it was unclear whether the data submitted was acceptable or not. India requested the European Union to clarify the situation and to work constructively on resolving the issue as the uncertainty and unpredictability adversely affected India's exports.
The European Union recalled that Regulation (EC) No 396/2005, which had entered into force in 2008, essentially stated that before an MRL could be set for a pesticide, its safety must be confirmed on the basis of a scientific assessment. In the spirit of the SPS Agreement, when drawing up this legislation, the European Union had sought to eliminate any inappropriate technical barriers to trade in the setting of MRLs by setting MRLs, for many pesticides - not in use in the European Union - at the default level. By doing this, the European Union, de facto, had also established a 'tolerance' - albeit a very low one - for pesticides that were not in use in the EU territory, and for which it was not in position to verify their safety or otherwise. The modification of such tolerance levels was not possible unless solid scientific data demonstrated the safety of the product. India could apply for an import tolerance in cases where it believed that an MRL higher than the default level was warranted. This procedure had been used successfully by India to apply for a higher import tolerance for Isoprothiolane, a pesticide used by India in the production of rice, a major export crop of interest to India. The case of Isoprothiolane demonstrated that the procedure in place was non-discriminatory, transparent, delivered results and offered predictability to exporters.
In October 2012, India noted that no solution had yet been found to this concern. The European Union continued to set MRL levels at the Limit of Detection (LOD) for pesticides such as Carbendazim and Isoprothiolane, without any scientific justification contrary to the provisions of the SPS Agreement. India reiterated its request for the European Union to provide scientific justification for fixing MRLs at the limits of detection without scientific evidence.
The European Union stated that trading partners must follow the EU procedure for requesting the setting of MRLs based on actual use of a pesticide. Where a pesticide was not used within the European Union or was unknown, the European Union set the MRL at the lowest analytical level rather than apply a zero tolerance approach, to give traders some legal certainty. Before setting an MRL for a pesticide, the scientific opinion of EFSA was sought on each occasion. The European Union reiterated that its legislation was balanced, non-discriminatory, based on sound scientific assessments and predictable. The European Union suggested that India provide a list of the chemical substances used in India that it considered were not harmful to human health, so that the same could be the subject of an EFSA risk assessment.
In March 2013, India again requested the European Union to provide scientific justification for fixing MRLs for pesticides at the level of detection (LOD). The burden of proof could not be shifted to the exporting country. India asked the European Union to provide updates on the import allowance level for pesticides such as Tricyclazole for which India had submitted data and urged the European Union to work constructively on resolving this issue.
Argentina shared India's concern and recalled its position on this point in G/SPS/W/211.
The European Union stated that it had done its utmost to address India's concerns by providing a comprehensive overview of the legislation in place in the European Union, organizing several meetings with Indian representatives and providing technical support with respect to MRL-setting and testing (see G/SPS/GEN/1139/Add.1). The European Union was not in a position to know whether pesticides that were unknown or not used in the European Union were safe or not, without the benefit of a proper risk assessment. In the absence of solid, scientific data that demonstrated the safety of a given pesticide, the European Union could not set arbitrary MRL values. If India would provide a list of the chemical substances used in India that it considered were not harmful to human health, the European Union and India could work together to understand the extent of the concerns and seek to resolve them. Tricyclazole may no longer be used in the European Union, as the scientific information on its toxicity was not sufficient to assess the risk to operators and the environment. The European Union had notified to the SPS Committee its intention to reduce the MRL for Tricyclazole, which was followed by an application from India to maintain the MRL on rice. This application was under assessment by EFSA and the outcome was expected shortly. The European Union reminded India that the decision-making procedure on the setting of import tolerances was balanced, transparent and predictable, and fully in line with the SPS Agreement.
In June 2013, India raised its concern over the EU MRLs of pesticides. The EU MRLs for imported foods and agricultural products did not follow any international standards and had no scientific basis, and were therefore in contravention of the SPS Agreement. India requested that the European Union provide scientific justification for its MRLs and that it change those levels that were not scientifically justified. India also requested an update within regard to tricyclazole.
The European Union noted India's concern, and regretted that there was little new to say with regard to this issue. When there was no use of a particular substance within the European Union and no third country had requested the European Union to set an import tolerance, it was the EU practice to set MRLs at the lowest analytical level - the level of determination. This practice was widespread and followed elsewhere in the world. With regard to tricyclazole, in 2011 there had been a proposed reduction of the MRL from its current level of 1 mg/kg to 0.01 mg/kg. A request for an import tolerance for rice was filed by one of the manufacturers of tricyclazole upon which the European Food Safety Authority had issued an opinion on 18 April 2013 that the request was not properly justified and therefore the European Union was considering lowering the existing MRL to the limit of determination (0.01 mg/kg) for rice. The European Union invited India to work with the EU authorities to resolve any concerns regarding tricyclazole and MRLs generally.
In October 2013, India reiterated its concern over EU MRLs of pesticides claiming that the EU MRLs for imported foods and agricultural products did not follow international standards and had no scientific basis, and were therefore in contravention of the SPS Agreement. India requested that the European Union provide scientific justification for its MRLs and that it adjust those levels that were not scientifically justified. India also requested an update with regard to tricyclazole.
Argentina shared India's concerns and highlighted the work undertaken by Codex on pesticides. There was a need to base new MRLs on Codex standards. Establishment of MRLs of pesticides without a scientific basic was in contradiction to the SPS Agreement and has become an unnecessary restriction on trade damaging agricultural exporting countries, such as Argentina.
The European Union stated that its policy regarding pesticides was to provide a maximum level of safety for European consumers while remaining open towards its trading partners. The EU system was transparent and had proved to be effective as the European Union remained the world's largest importer of agri-food products. India's allegations were evidently unfounded and incorrect as could be seen by virtue of the increase in rice exports from India to the European Union, which had doubled in tonnage in the past year. The European Union was open to continue cooperating closely with India and to consider any specific requests to modify the MRLs for pesticides used in India, insofar as those pesticides had been proven to be safe on the basis of adequate scientific data.