STC Number - 212

Positive list system for pesticides, veterinary drugs and feed additives MRLs

Maintained by: Japan
Raised by: China; United States of America
Supported by: Australia; Philippines
First date raised: March 2005 G/SPS/R/36/Rev.1 paras. 19-21. See also STC 267 and STC 283
Dates subsequently raised: October 2005 (G/SPS/R/39 paras. 49-51)
June 2006 (G/SPS/R/42 paras. 22-24)
June 2009 (G/SPS/R/55 paras. 36-38)
October 2009 (G/SPS/R/56 paras. 50-52)
March 2010 (G/SPS/R/58 paras. 31-32)
June 2010 (G/SPS/R/59 paras. 37-38)
October 2010 (G/SPS/R/61 paras. 37-38)
June 2011 (G/SPS/R/63 paras. 178-180)
October 2011 (G/SPS/R/64 paras. 55-56)
Number of times subsequently raised: 9
Relevant documents: Raised orally.
Products covered: 07 Edible vegetables and certain roots and tubers
Primary subject keyword: Food safety
Keywords: Food safety; Human health; International Standards / Harmonization
Status: Partially resolved
Solution: Partial resolution applies only to China.
Date reported as resolved: 16/10/2013

Extracts from SPS Committee meeting summary reports

In March 2005, China reported that the issue of Japan's Ministry of Health, Labour and Welfare amendment to the maximum residue limits (MRLs) for pesticides, veterinary drugs and feed additives had been discussed in a bilateral meeting. Although the measure had not yet been notified to the SPS Committee, Japan had sought the opinion of the relevant departments and business communities of China on the proposed amendment in 2004. China was concerned that the proposed adoption of a single standard limit of 0.1ppm for the close to 700 types of pesticides, veterinary drugs and feed additives for which no specific residue limit had been established would jeopardize Chinese exports of vegetables to Japan. Although China respected the right of Japan to protect public health, it expected that in doing so Japan would, as specified in the SPS Agreement, assess the possible impact of such an amendment on exports to Japan, provide opportunities to discuss the results of this assessment and consider solutions to minimize its impact. China also expected that Japan would provide the science-based risk assessment that had led to the amendment of the MRLs. Should there be any notification in the future on this issue, Japan should provide a comment period of at least 60 days as of the date of distribution and extend this upon request. The representative of China further requested that, when specifying the time for the formal implementation of the proposed amendment, Japan provide an adequate adaptation period in accordance with the decision at the Doha ministerial meeting. Finally, the representative of China sought clarifications on the Japanese detection method for residues.
The Philippines supported China's concerns on this issue and requested relevant information from Japan in order to assess the possible implications of this proposed amendment on the Philippines' exports to Japan.
Japan clarified that the Japan's new positive list system, based on the revised Food Sanitation Law, was aimed at regulating the distribution of foods that contained agricultural chemicals, veterinary drugs and feed additives for which no MRLs had yet been established. Before the positive list system would enter into force, the Ministry of Health, Labour and Welfare would review the compliance of its provisional MRLs with the Codex Alimentarius standards. China's concerns on comment and implementation periods would be reported to the relevant Japanese authorities.
In October 2005, the United States reported that in June 2005, Japan's Ministry of Health, Labor and Welfare (MHLW) had notified its final draft of thousands of new provisional maximum residue limits (MRLs) for over 700 pesticides, veterinary drugs and feed additives covering all basic commodity groups.. The United States was grateful of having been consulted throughout the elaboration of this final draft and the development of implementation plans for Japan's new food sanitation law. In November 2005, the provision of a six-month transition period before official enforcement of the provisional MRLs had been notified by MHLW. Without any reference to the final draft of June 2005 or in any subsequent notification, the Ministry of Agriculture, Forestry and Fisheries of Japan (MAFF) had announced in December 2005 the implementation and enforcement of the provisional MRLs on rice, wheat, barley and possibly other commodities. The United States was concerned about the effect of these new MRLs on agricultural exports to Japan and requested Japan to clarify its plans regarding the enforcement of these MRLs.
China requested Japan to provide a transitional period before implementing this positive list system, and noted that China had also put this item on the agenda. The representative of Australia expressed appreciation for Japan's collaborative attitude when developing this comprehensive new positive list and noted that Japan's private sector was also confused about the exact nature of the testing requirements announced in December 2005 that were not included in the new positive list system of May 2005. Australia encouraged Japan to provide some clarification to Members and Japanese importers.
Japan clarified that, in accordance with the amendment of the Food Sanitation Law of May 2003, the positive list system for pesticides, veterinary drugs and feed additives in food would be implemented as of May 2006 as had been officially announced in December 2005. With regard to imports of rice, wheat and barley under the state-trading system, due to the delays for shipments to reach the domestic market and storage in Japan, Japan had introduced a new inspection system as of December 2005 in order to comply with the enforcement of the new positive list system at the end of May 2006. From August to October 2005, Japan had explained to governmental organizations of countries exporting rice, wheat and barley to Japan that the new inspection system was to be implemented in December 2005.
In June 2006, China noted that Japan's positive list system for agricultural chemical residues in food had entered into force on 29 May 2006. While recognizing Japan's right to revise its residue standards to safeguard the health of its citizens, China was concerned since Japan was the largest importer of food from China. Japan had only published testing methods for 553 agricultural chemicals; testing methods for another 200 chemicals were still lacking, which could seriously affect efforts of developing country Members to study these methods. In addition, Japan was not following the Codex guidelines for judging test results. China requested Japan to publish all testing methods, notify them, offer a 60 day comment period, provide a six month transitional period before they entered into force and offer technical training and education to China.
China asked Japan to explain why it had started implementing the positive list system in December 2005 by requiring that rice be tested according to the new MRLs, well ahead of the May 2006 implementation date. This had raised costs for Chinese rice exports and interrupted trade, since farmers had no time to adjust their chemical use. From January to June 2006, on three occasions, China had been given only two weeks to comment on certain MRLs, which was too short. China requested an explanation of the relationship between these MRLs and the positive list system. In China's view, these changes should be notified to the WTO. Finally, the representative of China noted that both the Japanese and English versions of the positive list system contained many editing errors and that therefore there were constant changes and asked Japan to provide a clear and comprehensive list of MRLs for agricultural chemicals at an early date. Previous efforts to resolve the problems had not succeeded, and China urged Japan to address China's concerns in a scientific way.
Japan confirmed that its positive list system for agricultural chemicals including pesticides, veterinary drugs and feed additives had taken effect on 29 May 2006. For the establishment of provisional MRLs, Japan had taken into account Codex standards; existing residue levels for pesticides set under the Agricultural Chemicals Regulation Law or limits of determination for veterinary drugs set under the Pharmaceutical Affairs Law; and MRLs set by other countries where residue standards were based upon the toxicological data required by the Joint WHO/FAO Expert Committee on Food Additives (JECFA) and the Joint WHO/FAO Meeting on Pesticide Residues (JMPR). Since these MRLs had been established through a globally accepted approach, Japan believed them to be consistent with WTO principles. Japan used a toxicological threshold of 1.5 ìg/day to determine the uniform limit, based on JECFA, US FDA and JMPR evaluations. The uniform limit had been set at 0.01 ppm, based on the food consumption patterns of the Japanese population. Japan had published analytical methods for 623 substances and would continue to finalize and publish the remaining analytical methods for other substances. When Japan newly established or amended standards, including MRLs, under the Food Sanitation Law, these were explained to foreign embassies in advance of WTO notification. After this meeting, comments were requested within two weeks, after which the notification was sent to WTO, with a 60-day comment period.
In June 2009, Brazil noted that Japan imposed stricter pesticide residue limits than Codex, because it required industry-wide testing for one MRL violation and a 100 per cent test-and-hold policy in case a second violation involving the same pesticide and commodity took place within one year. Brazil had difficulty in exporting green coffee beans to Japan, as Japan's MRL was 30 times lower than that of Codex. In a bilateral meeting, Japan had stated that the revision of these MRLs would take place within two years. Brazil had requested an interim transitional mechanism as trade in coffee was worth over US$300 million per year. Brazil exported coffee to over 100 countries and requested Japan to modify their procedures in line with international standards, or provide a transitional period while the Japanese authorities decided on the revision of the requirement without any negative impact on Brazilian coffee exports.
China supported Brazil's concern, and requested that Japan's temporary standards be based on scientific justification and a risk analysis. These measures had been applied for a period of three years, adversely affecting Chinese food exports to Japan. Furthermore, Japan's uniform standard of 0.01 ppm for several pesticides was arbitrary and without scientific justification. China requested that Japan brings its requirements into line with the relevant international standards. China's exporters indicated that imported products were subjected to a greater number of random inspections. Furthermore, inspections were carried out only on certain imported products, even though the same pesticides were also used domestically in Japan. China urged Japan to apply its measures uniformly without any discrimination.
Japan clarified that the MRLs were based on scientific assessment, and Codex and other international standards were taken into account when enforcing the measures. Japan had notified the WTO before establishing these MRLs and had received comments. The SPS Agreement was taken into consideration, and the measures were applied equally to imported and domestic products. The frequency of inspections was increased based on findings of violations. Japan confirmed that the Codex MRLs would be the basis of the current revision, which would occur by December at the earliest. Japan expressed its commitment to continuing bilateral discussions with Brazil.
In October 2009, China recalled that after the implementation of Japan's positive list system for chemical residues, China and many other WTO Members had expressed concerns regarding the issue of "uniform standards". Japan had indicated that the standard would be revised on the basis of scientific evaluations and MRLs would be established for more chemical residues. In recent years, almost all notices that China received from Japan regarding products that exceeded pesticide limits were caused by the "uniform standards". These had severely affected China's trade with Japan. Also, after the implementation of Japan's positive list system, a series of regulatory measures such as intensified inspection, quarantine and supervision, had been undertaken. China urged Japan to develop science-based residue limits for the items of concern as soon as possible, to alleviate unnecessary restrictions to international trade.
Ecuador supported China's concern regarding MRLs applied by Japan. Ecuador's cacao exports had faced difficulties of market access, and although various meetings had taken place, no solution had been provided. Ecuador requested Japan to modify its MRLs in accordance with international standards.
Japan stated that the uniform standard was based on the evaluations by the FAO/WHO Joint Expert Committee on Food Additives (JECFA) and/or on the tolerance exposure amounts that the US Food and Drug Administration adopted for food additives.
In March 2010, China reiterated the concerns regarding Japan's MRLs and its enforcement system, which should be based on scientific evidence and applied in a least-trade restrictive manner. According to China, out of approximately 50 thousand MRLs in Japan, more than 40 thousand were "temporary" standards, which were neither based on scientific evidence nor risk assessments as required by the SPS Agreement. Less than 50 per cent of the "temporary" standards had been reviewed by the end of 2009, although they had been applied for almost five years, creating serious obstacles to China's food exports to Japan. Moreover, Japan's "uniform standard" of 0.01 ppm MRL for several products was not based on scientific evidence. MRLs should be set according to the different levels of exposure through different food products, toxicology evaluations and acceptable daily intake (ADI) levels consistently with international practice. In addition, Japan's enforcement system of MRLs was neither reasonable nor transparent, as sometimes Japan inspected 100 per cent of China's food exports, known as "order inspections". By way of examples, Japan set a 2 ppm MRL for pyrimethanil in scallion, while for shallots Japan applied the "uniform standard" of 0.01 ppm. Japan also applied the 0.01 ppm "uniform standard" for chlorpyrifos in matsutake, while the Codex standard for chlorpyrifos in edible fungi was 0.05 ppm. China also asserted that Japan applied a less favourable treatment to imported food products than to Japanese products.
Japan responded that the "uniform limits" had been established after holding consultations and receiving opinions from health experts based on: (i) acceptable exposure levels determined by the evaluations conducted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and evaluations on indirect additives by the United States Department of Agriculture (USDA); (ii) acceptable dairy intake for pesticides and veterinary drugs evaluated by JECFA; and (iii) the default level of 0.01 ppm established by the European Union. According to the Japanese system, the Ministry of Health, Labour and Welfare conducted an evaluation before allowing pesticide residues in food products. This evaluation was based on individual pesticide residue data for each commodity. Any exporter could apply to the Ministry of Health, Labour, and Welfare to request the evaluation of specific data on MRLs.
In June 2010, China reiterated its concerns regarding Japan's MRLs and their enforcement system. China welcomed the SPS cooperation arrangement recently signed between Japan and China and the first round of technical consultations which had taken place under the new arrangement. Nevertheless, China wished to reiterate its concerns regarding the temporary standards under Japan's Positive List scheme, the lack of scientific basis for those standards, and a lagging review process.
Japan responded that its Positive List system had been established in 2006 after consulting existing MRLs from Codex, Australia, Canada, New Zealand, the European Union and the United States, based on a scientific evaluation. Japan stated that its standard-setting process was in line with the SPS Agreement, and that it had notified its draft MRLs to the WTO, providing Members an opportunity to submit comments.
In October 2010, Ecuador raised concerns over Japan's 2006 Food Health Act establishing new MRLs for food products of plant and animal origin, intended for human consumption. Products with concentrations of residues above those limits could not be imported, processed, used or stored for sale in Japan. The Food Health Act established a list of 158 chemicals and their corresponding MRL for food, and substances. The establishment of such stringent limits had meant that shipments of Ecuadorian cocoa in which 24D was present had been rejected by Japan, causing significant costs to Ecuador cocoa exporters and producers. Despite constructive bilateral discussions, no solution had been found, and Ecuador requested more information on the process used by Japan to set its MRLs measures and asked for swift notification by Japan of anomalies or lack of compliance with cocoa exports regulations.
Japan stated that based on the Japanese Positive List System, the Ministry oh Health, Labour and Welfare (MHLW) established individual MRLs in food commodities through safety evaluations and residue studies. Japan adopted Codex MRLs as Japanese MRLs where the necessary requirements were met. If Ecuador wanted Japan to establish MRLs for specific pesticides, an application had to be submitted to the MHLW. In addition, Japan would consider relevant applications for modifications and revise current MRLs as appropriate.
In June 2011, Ecuador expressed concern about Japan's decision to apply MRLs to additives based on a positive list system. Similar concerns had been raised by Paraguay (G/SPS/GEN/1091), and Ecuador was hopeful that a solution could be found. The current approach was particularly damaging to the livelihood of Ecuador's small producers and exporters of cocoa.
Brazil expressed their support of the interventions by Ecuador and Paraguay.
Japan observed that they had not previously received information from Ecuador regarding this issue, but were keen to work with Ecuador on this issue bilaterally.
In October 2011, Ecuador recalled that in June 2005, Japan had notified its intention to apply a positive list system for the adoption of MRLs, however, the document annexed to the notification did not indicate that the MRLs would be 0.01 ppm. The result was that while 12 companies used to export cacao to Japan, now only five could do so. In 2006, sales to Japan were US$20.7 million, and accounted for 12.4 million metric tons. However, between 2007 and 2010 both the volume and value of exports dropped by more than 60 per cent. Since the issue was first raised, many Members had repeatedly asked Japan to provide its risk analysis to scientifically justify the application of the MRLs. Ecuador urged Japan to consider the EU methodology of analyzing residues in the kernel and not on the husk, and to accept the International Cocoa Organization (ICCO) standards. Paraguay shared the views of Ecuador and emphasized that the MRLs must be science-based.
Japan observed that it had repeatedly requested the Government of Ecuador to file an application with the relevant Japanese authorities to revise the MRLs, providing sufficient data. The current 0.01 ppm limit was the same used by the European Union. Before the MRL was set, Japan had notified the WTO in accordance with the SPS Agreement.