STC Number - 342

Restrictions on shrimp due to anti-oxidant residues

Maintained by: Japan
Raised by: India
Supported by:
First date raised: October 2012 G/SPS/R/69, paras. 24-25
Dates subsequently raised: March 2013 (G/SPS/R/70, paras. 3.53-3.54)
June 2013 (G/SPS/R/71, paras. 4.31-4.32)
October 2013 (G/SPS/R/73, paras. 3.39-3.41)
Number of times subsequently raised: 3
Relevant documents: Raised orally.
Products covered:
Primary subject keyword: Food safety
Keywords: Food safety; Human health
Status: Resolved
Solution:
Date reported as resolved: 15/10/2014

Extracts from SPS Committee meeting summary reports

In October 2012, India expressed concern regarding Japan's introduction of mandatory testing for residue levels of Ethoxyquin, an anti-oxidant commonly used as a preservative in feed for aquatic animals. In 2005, Japan had notified a measure based on its Food Sanitation Act that regulated a positive list of agricultural chemicals and additives in food. This defined permissible residue levels of Ethoxyquin at 0.01 ppm for some products, but did not include MRLs in shrimp. Japan's new MRLs for shrimp was too stringent compared to the Codex MRL of 3 ppm, was not based on scientific evidence and did not take into account the objective of minimizing negative trade effects.
Japan observed that no Codex standard for Ethoxyquin in shrimp had existed at the time it changed its legislation. As India had not requested the establishment of a specific MRL for this product, the default tolerance level of 0.01 ppm applied. A risk assessment for Ethoxyquin in shrimp was currently underway, so the default level was applied in the meantime. Japan remained committed to continuing consultations with India to resolve this matter.

In March 2013, India raised concerns regarding the systemic issue of setting arbitrary MRLs at the level of determination or detection, without scientific evidence. On 1 August 2012, Japan had introduced limits for residues of the pesticide Ethoxyquin in shrimp with a threshold level set at 0.01ppm, the level of determination. In contrast, the MRL for Ethoxyquin in fish, including salmon, trout, eel and tuna, had been set at 1ppm. Furthermore, Codex had only set MRLs for Ethoxyquin for pears, at 3 ppm. No other Member had prescribed MRLs for Ethoxyquin in shrimp and no other international agencies had regulated Ethoxyquin in fish. There was also no scientific evidence on the toxicity or carcinogenicity of the pesticide. India was the largest supplier of shrimp to Japan and this measure had an adverse effect on its exports. India urged Japan to base its decisions on scientific principles. Information was also requested on the status of the MRL review undertaken by the Food Safety Commission of Japan.
Japan explained that in response to India's request, it had conducted a risk assessment to review the existing MRLs for Ethoxyquin in shrimp. There was concern that Ethoxyquin was genotoxic and Japan's Ministry of Health, Labour and Welfare was now conducting additional studies to generate data on the genotoxicity. India would be informed as soon as the data was available. Ethoxyquin was also under review for genotoxicity by the European Food Safety Authority.

In June 2013, India raised its concern over Japan's MRLs of Ethoxyquin in shrimp. India understood that there had been evidence raising concerns over the genotoxicity of Ethoxyquin, but did not understand why the MRLs for fish (1 ppm) were higher than those for shrimp (0.01 ppm). India had experienced a substantial economic loss due to Japan's MRLs, which were without scientific justification.
Japan reiterated that it set individual MRLs in food based on scientific data. The MRL in fish was based on residue trial data for fish, but there was no such data for shrimp. Furthermore, as there was no Codex standard for Ethoxyquin in shrimp, nor had any foreign country requested that Japan set a specific maximum level in shrimp, the uniform limit of 0.01 ppm had been applied. Japan was reviewing the uniform limit pursuant to a request for a specific limit from India, received September 2012. Multiple reports from Japanese authorities, as well as the European Food Safety Authority, had raised concern about the potential genotoxicity of Ethoxyquin. Japan reiterated that it would continue to review the status of this limit and consider new data and reports as they became available. Japan expressed its desire to continue working with India on this issue through bilateral channels.

In October 2013, India noted that Japan had been examining consignments of shrimp for Ethoxyquin levels since August 2012. India asserted that the Ethoxyquin levels in these consignments was extremely low, ranging from 0.02 ppm to 0.05 ppm, according to the information provided by the relevant Japanese authority. India noted that Japan had fixed a provisional MRL of 0.01 ppm on finfish claiming that they did not have sufficient data to fix a final MRL on fish. India suggested that a provisional MRL be fixed also for shrimps based on preliminary study results, until reliable data could be obtained. India urged Japan to expedite their consideration and to indicate the timeframe for a final decision on this issue.
Japan stated that it had been conducting risk assessments and, in the process, the concern about genotoxicity of Ethoxyquin had been raised. Japan had prepared a draft assessment report which it had made available to the public, and it was in the process of evaluating the comments submitted. Japan had proposed a draft MRL of 0.2 ppm based on the assessment report. Japan was willing to continue working with India on this issue through bilateral channels.
Codex informed the Committee that Ethoxyquin had been placed on Codex's priority list for evaluation and thus would be considered at the international level.