Food Law News - FAO/WHO/WTO/Codex - 2011

4 - 9 July 2011

CODEX – Report of the thirty-fourth session of the Commission

The following is the Executive Summary taken from the report of the meeting.  The full report can be found at:

The Commission:

a) Adopted an amendment to the Procedural Manual (terms of reference of the Committee on Processed Fruits and Vegetables);

b) Adopted 31 new or revised Codex standards or related texts or amendments to these texts and many new or revised provisions for additives and MRLs for pesticides and veterinary drugs;

c) Adopted 8 Codex draft standards or related texts and several MRLs for pesticides at Step 5;

d) Approved several proposals for new work or discontinuation of work, and revoked several standards and related texts;

e) Considered the matters referred by its subsidiary bodies or pending from earlier sessions;

f) Noted the Codex budget and expenditures for 2010-2011 and the proposed budget for 2012-2013, including FAO/WHO related activities; expressed its thanks to FAO and WHO for their support to the Codex programme and related activities and to host governments for their contributions; and invited FAO, WHO and member countries to give high priority and provide support to scientific advice in food safety;

g) Noted the status of the implementation of the Strategic Plan 2008-2013 and the preparation of the Strategic Plan 2014-2019;

h) Made some recommendations on the proposals to respond to the Codex Trust Fund Mid-term Review;

i) Supported continued cooperation and coordination with international governmental and nongovernmental organizations;

j) Elected as Chairperson Mr Sanjay Dave (India), as Vice-Chairpersons Mr Samuel Godefroy (Canada), Mrs Awilo Ochieng Pernet (Switzerland), and Professor Samuel Sefa Dedeh (Ghana); and as Members of the Executive Committee elected on a geographical basis: Australia, China, France, Jamaica, Kenya, Tunisia, and United States of America;

k) Appointed the following regional Coordinators: Cameroon (Africa), Japan (Asia), Poland (Europe), Costa Rica (Latin America and the Caribbean), Lebanon (Near East), Papua New Guinea (North America and South-West Pacific); and

l) Designated the host governments of Codex subsidiary bodies and agreed to dissolve the Ad hoc

The Session was however most notable for the discussion on the use of Ractopamine as a growth promoter in pigs.  The following is the relevant section of the report

Draft MRLs for Ractopamine

90. The Chairperson recalled that at the 33rd session of the Commission it had not been possible to reach consensus on the draft MRLs for ractopamine and that the Commission had accepted the proposal of the Chairperson to serve as facilitator to a discussion on possible solutions through a technique, used in FAO, WTO and other UN organizations, to establish an informal group called "Friends of the Chair" (FOTC). The FOTC comprised 11 members: Brazil, China, Canada, European Union, Ghana, Japan, Mexico, Norway, South Africa, Tunisia, and the United States of America, and 2 observers: IFAH and CI.

91. The Chairperson further noted that, as indicated in document CX/CAC 11/34/4-Add.2 [For a copy, see: Codex Paper], the FOTC had met several times and had established an agreement for the way to work. However, despite open and frank discussion, the FTOC had been unable to reach a consensus but made two proposals, which left the Commission in the same position as it was at its 33rd session.

92. The Chairperson also explained that a delegation raised a question on the transparency in the way the FOTC had operated even though she had striven to ensure transparency throughout the process.

93. Several delegations appreciated the efforts of the FOTC to find solutions. The Delegation of Ghana, which participated in the FOTC, expressed their appreciation for the process, which had brought to light critical issues concerning Codex and regretted that the discussion had not resulted in a resolution. Other delegations expressed their appreciation for the efforts of the FOTC. The Delegation of the European Union stated its view that they had participated constructively and positively in the FOTC but noted that, after a promising start, it was their view that a number of irregularities in the conduct of the process had appeared and that transparency and that neutrality had not always been ensured. Another delegation, while in principle in favour of using the FOTC to reach consensus, was of the view that it should be used in accordance with the Codex guidance, should be unbiased and that Codex work should be open, transparent and inclusive.

94. The Commission had an extensive discussion on the adoption of the draft MRLs for ractopamine, which mirrored positions and arguments at its 33rd Session, with a number of delegations supporting the adoption of the draft MRLs and a number of other delegations supporting discontinuation of work or proposing to hold the draft MRLs at Step 8.

95. The delegations which supported the adoption of the draft MRLs emphasized that JECFA had reviewed the MRLs three times and fulfilled its task by considering all available data and noted that these MRLs could be reviewed in the future in the light of new scientific data. It was also pointed out that the draft MRLs were based on JECFA risk assessment, as prescribed in the Risk Analysis Principles Applied by the Codex Committee on Residues of Veterinary Drugs in Foods included in the Procedural Manual, and that the concern of China regarding residues in lung was not within the scope of the draft MRLs currently under discussion. These delegations also underlined the conclusion of JECFA that these MRLs were compliant with the ADI and safe and reiterated their confidence in the science-based work of JECFA, and expressed concern about the precedent that could be set, undermining the work of JECFA and risk assessment.

96. These delegations further highlighted their concerns on the long delay to adopt the MRLs based on non-scientific factors and stressed the need for Codex to base its decisions on science, in view of the status of Codex standards under the WTO SPS Agreement. They recalled that many countries used Codex standards as the basis for their national legislation and that failure to adopt the MRLs for ractopamine could negatively impact on food security as the establishment of MRLs for ractopamine would allow the safe use of new technologies to meet the increasing demand for food production foreseen by FAO. It was also stated by many delegations that all Codex steps had been followed in the elaboration of the MRL for ractopamine.

97. The Delegation of the United States of America noted that no government would be required to permit the use of ractopamine but would be able to allow imports, confident that the imported meats are safe for consumers when the exporting country has produced the food according to Codex standards.

98. The delegations which opposed to the adoption of the draft MRLs continued to be concerned with the safety of ractopamine, as there were still unanswered safety questions, particularly with respect to the residues in lung tissue and scientific concerns linked to the use of ractopamine, which required further studies. It was noted that many countries did not allow the use of veterinary drugs solely for growth promotion, without any therapeutic purposes and that Codex, as risk management body, should base its decision not only on science but also take into account other factors, such as consumer concerns. They further noted that it was essential for Codex to base its decision on a broad consensus not to undermine its credibility.

99. The Delegation of the European Union underlined that they highly respected the work of JECFA but could not ignore the opinion provided by EFSA, which is at the basis of their food safety system, established according to the principles of risk analysis. The Delegation of China pointed out that they were the largest producer and consumers of pork; it was further pointed out that China and the European Union represented together 70% of the pork production in the world and that more than 70% of the pork was consumed in these countries; therefore, adopting a standard without the support of these two major actors would undermine the credibility of Codex.

100. The Delegation of China referred to their experiment findings on residues in pig lungs and voiced their concern with the safety of ractopamine, especially their concern with the risks related to residues in lung tissue and other offal tissues. Therefore, China expressed the view that if the relevant risk assessment is completed and safety issues are fully addressed, the adoption of ractopamine MRLs could be considered.

101. The WHO JECFA Secretary recalled that JECFA had evaluated an extensive toxicological database, including human studies at its 62nd meeting (2004) and established an ADI 0-1 μg/kg bw. Extensive residue data were also assessed and formed the base for the MRLs recommended for tissues of pig and cattle (i.e. muscle, liver, kidney and fat), as requested by the CCRVDF. At the 66th meeting (2006), JECFA reviewed the establishment of the ADI on request of the 15th CCRVDF and confirmed the scientific basis and soundness of its previous decision.

102. The analysis conducted by JECFA in 2010 of additional residue studies in pigs, submitted by the People's Republic of China, confirmed the previously recommended MRLs. Estimated dietary exposure taking the food basket and standard tissues into account led to about 50% of the safe intake level (the ADI). Data on residues in non-standard tissues, including lungs, from these new studies were also evaluated. However, it was noted that residues in these tissues were not routinely measured and were not available from the previous studies assessed at the 62nd and 66th meetings of JECFA. The JECFA Secretary further noted that, when consumed, lung and other non standard tissues generally replaced the standard tissues (e.g. muscle meat) and were not added to the daily consumption of products of animal origin. Even if residue levels in lung were higher than in the other tissues, based on the estimated dietary exposure, they did not indicate a health concern.

103. The JECFA Secretariat emphasized that JECFA's mandate was to evaluate residues in foods when veterinary drugs were used in accordance with good veterinary practice, i.e. used as recommended, while residues due to misuse could not be considered. Setting an MRL was one aspect of risk management, but the important responsibility of Governments was to put appropriate control and surveillance measures in place.

104. The JECFA Secretariat further clarified that EFSA had not undertaken a risk assessment by considering the original raw data, but had undertaken a review of the JECFA assessment based on the published JECFA evaluation.

105. The Chairperson noted that the extensive debate had essentially presented three main options on the way to proceed, i.e.: (i) continue to hold the draft MRLs at Step 8; (ii) discontinue work on the draft MRLs; and (iii) vote on the adoption of the draft MRLs. The Chairperson clarified that, in case of voting, the question to be answered was whether every effort had been made to achieve consensus.

106. The Delegation of the United States of America called for a roll call vote on the adoption of the draft MRLs for ractopamine.

107. The Chairperson raised the question whether every effort had been made to reach consensus before proceeding with such a vote, as required by the Rule XII.2 of the Rules of the Procedure of the Codex Alimentarius Commission.

108. The discussion which followed showed that delegations were divided among (i) delegations which considered that all efforts had been made to achieve consensus, that Codex was based on science and it was necessary to take a decision at the present session and, therefore, supported proceeding with a vote; (ii) delegations which opposed the adoption of the draft MRLs and proposed discontinuation of work; and (iii) delegations which were prepared to adopt the draft MRLs in substance but did not agree with proceeding with a vote considering that not every effort had been made to reach consensus and that a vote would undermine the credibility of Codex and the MRLs under discussion.

109. The Chairperson said that her observation was that more delegations felt that there were still possibilities to find consensus. In this context, the FAO Legal Counsel clarified that the determination whether or not the requirements of Rule XII.2 had been met rests with the Chairperson. He specified, however, that the Commission could overrule the Chairperson.

110. Following some further debate and in the apparent absence of consensus on whether the requirements of Rule XII.2 had been met, the Chairperson proposed to vote on the following question: Do you want to proceed with a vote on adoption of the MRLs for ractopamine at this session of the Commission? (Vote 1). The FAO Legal Counsel clarified that voting would be conducted either by a show of hands, a rollcall vote, if requested by a Member, or a secret ballot, if so determined by the Commission.

111. A number of delegations wished that the vote be conducted by secret ballot. However, in the absence of consensus on the manner of voting, he Commission carried out a roll-call vote to decide on how to conduct Vote 1.

112. It was noted that, as the European Union was competent to vote on this matter on behalf of its Member States (see CRD1), the European Union cast 27 votes, one for each of the European Union Member States present at the session (at the starting of the voting the presence of the 27 European Union Member States was confirmed by the Secretariat).

113. In view of the above result, the Commission proceeded with Vote 1 by secret ballot. The presence of the 27 European Union Member States was verified again by the Secretariat.

114. The result of the secret ballot was:


115. Following the result of the vote, the draft MRLs for ractopamine in bovine and pig tissues were retained at Step 8.

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