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STC Number - 275
Restrictions on ractopamine in beef and pork
United States of America
Brazil; Canada; Costa Rica; Ecuador; Peru
First date raised:
, paras. 8-12
Dates subsequently raised:
October 2009 (
, paras 141-147)
March 2011 (
, paras 51-55)
June 2011 (
, paras 53-59)
October 2011 (
, paras 63-66)
March 2012 (
, paras 32-35)
Number of times subsequently raised:
0203 Meat of swine, fresh, chilled or frozen.
Primary subject keyword:
Food safety; Human health; International Standards / Harmonization; Sufficiency of scientific evidence
Date reported as resolved:
Extracts from SPS Committee meeting summary reports
In October 2008, the United States stated that the US pork industry had suffered for more than a year due to the lack of science-based maximum residue limits (MRL) for ractopamine in Chinese Taipei. Chinese Taipei had previously notified the SPS Committee of its science-based decision regarding ractopamine but then had failed to implement the measure as proposed. US exports had dropped due to the need to source pork from animals not treated with ractopamine in order to meet the zero-tolerance requirements. The United States urged Chinese Taipei to implement its notified measure, which would facilitate US pork exports.
Canada stated that its authorities had approved the use of ractopamine as an ingredient in pig feed since July 2005 and in cattle feed since May 2007. Health Canada had concluded that the product was safe to use after conducting several tests. Canada encouraged all Members to accept the use of ractopamine as long as residues in edible tissues were within the safe levels.
Chinese Taipei stated that the use of ractopamine was forbidden by many WTO Members. The Codex Alimentarius Commission had also been unable to make a final decision on MRLs for ractopamine.
The representative of Codex reported that the MRLs for ractopamine had been extensively discussed but no conclusion had yet been reached. Codex invited Members to submit more information regarding ractopamine for consideration by the next Codex Commission meeting.
The European Communities reported that it had consulted the European Food Safety Authority (EFSA) on the safety of ractopamine including the establishment of MRLs. The European Communities hoped to have the information by early 2009, which could be sent to the FAO/WHO Joint Expert Committee on Food Additives (JECFA) for further evaluation.
In October 2009, Brazil noted that extensive discussions on this matter occurred during the last two sessions of the Codex Alimentarius Commission and at the 18th session of the Codex Committee on Residues of Veterinary Drugs in Foods. Despite the evidence presented by JECFA, an MRL had not been adopted by the Codex. Brazil was concerned about the repeated postponement of a decision in spite of the existence of strong scientific evidence in favour of the adoption of this MRL. Since an MRL was needed in order to facilitate international trade, Brazil hoped that a decision would be made at the next meeting of the Codex Commission.
Canada noted that Canadian exporters had also experienced trade difficulties in several markets due to the absence of an MRL for ractopamine. In 2005 Health Canada approved the use of ractopamine in swine feed and established an MRL for ractopamine in pork. Canada supported the adoption by Codex of the proposed MRLs for ractopamine and was pleased when, in September 2007, the Codex Committee on Residues of Veterinary Drugs in Foods recommended the adoption of ractopamine MRLs at step 8. Canada was disappointed that this was not adopted at the 2009 Codex Commission meeting and expressed hope that it would be adopted at the 2010 meeting.
The United States stated that adoption of international standards for ractopamine should be an important priority for all WTO Members. Years of scientific evidence proved that ractopamine could be used safely. Ractopamine had been approved by over 25 countries and was currently at Step 8 in the Codex process. Some Members, however, imposed ractopamine bans without sufficient scientific evidence to support them. Codex had not adopted the draft MRLs at the 2009 Commission meeting because of a request from a major trading partner that one further scientific review be done by JECFA. The United States urged that trading partner to provide JECFA with the necessary information so that this study could be completed, and expressed the hope that the Codex Commission would move forward with adoption of the standard once that study was complete.
The European Communities noted that last year EFSA, which was responsible for risk assessment, gave a standard opinion regarding the harmfulness of this substance. China had also conducted a study on the effect of ractopamine on the tissue of pigs. The Codex Commission decided that JECFA should evaluate the Chinese studies before coming to a decision with respect to the MRL for ractopamine.
China noted his authorities' commitment to ensuring that the international standard on ractopamine was of the highest quality. China would continue to actively participate in the Codex standard development process by carrying out experiments and sharing data with JECFA. Norway supported the interventions of the European Communities and China, stressing the need for JECFA to evaluate the last data submitted by China before coming to a final conclusion.
Australia agreed with the interventions of Brazil, Canada and the United States on this issue. Codex had made a risk management decision based on a risk assessment of the available data, and Australia supported the adoption of the draft proposed MRL for ractopamine.
Codex noted that JECFA had conducted an evaluation in accordance with the procedure in place for veterinary drugs. As noted by Australia, the risk management decision made by the Committee on Residues of Veterinary Drugs was then forwarded to the Codex Commission, but at the Commission there was no consensus. Rather, at the Commission session delegates referred to further studies and scientific data on the matter. It was agreed that JECFA would review the data that it had not previously reviewed. Two meetings of JECFA were scheduled for 2010 and they would make every effort to have the outcome of the review of this data available for the next session of the Commission in July 2010.
In March 2011, the United States stated that in January 2011, Chinese Taipei had ordered the cessation of the sale of US beef in grocery stores when two shipments of US beef had tested positive for ractopamine. Ractopamine was approved for use in 26 countries and in 2007 Chinese Taipei had determined that, based on scientific evidence, ractopamine was safe for use in cattle and swine. However, Chinese Taipei's notification of the implementation of MRLs, consistent with the draft Codex standard, had been delayed by domestic opposition and had resulted in significant trade barriers to US exports.
Canada indicated that it had already raised its concerns with Chinese Taipei bilaterally and on the margins of Committee meetings. While Codex had not yet adopted MRLs for ractopamine, Canada believed that the scientific work conducted by Codex and the Joint FAO/WHO Export Committee on Food Additives fully supported their adoption. Hence, Canada requested that Chinese Taipei reconsider its current prohibition.
Chinese Taipei stated that the use of ractopamine in food-producing animals was forbidden by many Members. Although Chinese Taipei had considered establishing MRLs for ractopamine, the process had been suspended due to criticism including from the scientific community. The 33rd Session of the Codex Alimentarius Commission had also been unable to reach a decision and Chinese Taipei was therefore of the opinion that further scientific research and evaluation were needed.
WHO reported that the compilation of scientific information on ractopamine was available on the JEFCA website and that the conclusions were clear. The only outstanding issue related to consumption of and exposure to ractopamine from lung tissue. At the last Codex Committee on Residues of Veterinary Drugs several participants had requested further clarification from China concerning the variability of concentration in lung tissue.
The European Union, Norway and Switzerland stated that there were no Codex MRLs for ractopamine and that in the absence of international standards, they did not accept imported products treated with ractopamine.
In June 2011, the United States reiterated that ractopamine was approved for use in 26 countries and that Chinese Taipei's 2007 assessment concluded it was safe for use in cattle and swine. That same year, Chinese Taipei notified in G/SPS/N/TPKM/114 that it intended to implement MRLs for ractopamine use in cattle and pigs consistent with the draft Codex MRLs. However, staunch opposition of pork producers to foreign pork being imported resulted in delays in the implementation of the draft MRLs. The United States remained concerned about these actions because there was no scientific basis for questioning the safety of the use of ractopamine within the MRLs set by the United States, Canada, Japan, Korea and many other countries. Chinese Taipei's failure to ensure that its measures were science-based sent confusing signals to its own public on food safety issues. The failure to adopt ractopamine MRLs resulted in significant barriers to trade and would ultimately contribute to higher prices for consumers. In order to avoid further unjustified restrictions, Chinese Taipei should immediately implement the 10 ppb MRL that it notified in August 2007. The United States encouraged Chinese Taipei and all Members to ensure measures were based on science, and not to use media to unnecessarily scare consumers in order to maintain trade barriers.
Canada shared the concerns of the United States regarding the lack of scientific justification for the prohibition of ractopamine in pork and beef, and the creation of considerable uncertainty for beef and pork exporters. These concerns had been discussed bilaterally with Chinese Taipei, most recently at the 13 June 2011 meeting of the Canada-Chinese Taipei Agriculture Working Group in Ottawa. Based on a comprehensive risk assessment, Canada had approved the use of ractopamine as an ingredient in feed for pigs in 2005 and for cattle in 2007; administrative MRLs for ractopamine in edible swine and cattle tissues were also established. The scientific assessments conducted by Codex and JECFA supported the adoption of MRLs for ractopamine. Given the extensive scientific evidence, Canada requested Chinese Taipei to reconsider its current prohibition.
Both Brazil and Costa Rica expressed systemic concerns on the prohibition of ractopamine, including the lack of a scientific basis for such prohibitions. They were also concerned that the MRLs for ractopamine had not yet been adopted by Codex.
The European Union highlighted that as there was no international standard for ractopamine, every Member was free to adopt its own national measures as long as they were in line with the SPS Agreement. The European Union did not allow the use of ractopamine, nor any similar substances, and did not accept imports of products from animals treated with ractopamine. In the interest of protecting the health of its consumers, the European Union maintained a preference for meat and meat products not treated by substances such as ractopamine, a fact which was widely known by those countries seeking to export meat and meat products to the European Union.
China and Norway supported the views of the European Union. China stated that more scientific work was needed to address the concerns of Members, and that a consensus must be reached before international standards were adopted. All Members had the right to adopt SPS measures as long as a risk assessment had been completed.
Switzerland stated that as a general rule it only authorized the administration of veterinary drugs to animals for therapeutic purposes; other chemical substances with no vital benefits were strictly regulated, and growth promoters like ractopamine were prohibited. The current Codex debate clearly showed that no scientific consensus existed regarding the safety of ractopamine. The lack of certainty in the risk assessment, as identified by EFSA in April 2009, combined with questions on risk management, led Switzerland to oppose the adoption of Codex MRLs for ractopamine.
Chinese Taipei responded that it had first prohibited ractopamine in 2006, and no MRL had been established. According to its legislation, therefore, any detection of ractopamine in meat products constituted a breach of the law. While it had notified in 2007 that it was considering the establishment of an MRL for ractopamine, the draft proposal had attracted considerable criticism and questioning from the scientific community, consumer groups, and other interested parties. For these reasons, Chinese Taipei concluded that it must continue to investigate the adverse effects of this drug on human health, while increasing its efforts regarding risk communication.
In October 2011, the United States restated the concerns raised during the 2011 June meeting. The United States encouraged Chinese Taipei and all Members to ensure that measures were based on science, and not to use media to unnecessarily scare consumers in order to maintain trade barriers. Canada shared the concerns of the United States and restated the observations it had presented during the 2011 June meeting.
Brazil, Costa Rica, Ecuador and Peru expressed systemic concerns on the prohibition of ractopamine, including the lack of a scientific basis for such prohibitions, and were also concerned that the MRLs for ractopamine had not yet been adopted by Codex. Brazil emphasized that ractopamine had been proven safe and effective as a veterinary drug that increased feed efficiency, had undergone human and animal safety studies and been approved in 26 countries.
Chinese Taipei responded that it was continuing to investigate the adverse effects of this drug on human health, as it had fully explained at previous SPS Committee meetings, while increasing its efforts regarding risk communication.
In March 2012, the United States restated the concerns raised during the 2011 June and October meetings. It concluded urging Chinese Taipei to immediately implement the MRL it had notified in 2007, and to, along with all Members, ensure that measures were based on science.
Canada shared the US concerns. Based on a comprehensive risk assessment, Canada had approved the use of ractopamine in animal production. Although Codex had not yet adopted MRLs for ractopamine, Canada was of the view that the scientific work conducted by JECFA fully supported their adoption. Canada was encouraged by Chinese Taipei's establishment of a cross-departmental task force in early 2012 to consult with stakeholders and to provide expert scientific opinion on ractopamine. To avoid further unnecessary trade disruptions, Canada requested that Chinese Taipei proceed as soon as possible with the adoption of MRLs for ractopamine for meat and meat products as notified to the Committee in 2007.
Brazil highlighted its concern that MRLs for ractopamine had not yet been adopted by Codex, despite the technical justifications available regarding the use of ractopamine.
Chinese Taipei took note of the remarks, which it would convey to its competent authorities.
In July 2012, Codex highlighted information from various Codex committees (G/SPS/GEN/1182) and reported that the 35th session of the Codex Alimentarius Commission adopted a number of standards and related texts, including the MRL for ractopamine, which was exceptionally adopted by vote as opposed to the usual adoption by consensus.
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