ALINORM 03/26/1 - codex - BSN

14 REP12/CAC
70. Delegations in favour of adoption of the draft MRLs recalled that the MRLs had been held at Step 8
for more than thirteen years and that all scientific information, available at the time of the evaluations, had
been considered by JECFA. They noted that the JECFA evaluation had shown that, if used according to Good
Veterinary Practices, bST did not represent a risk to human health. They recalled that the 40 th JECFA had
established an ADI ‘not specified’ and that the margin of safety was extremely high with no impact on food
safety; and that the 50 th JECFA had concluded that “rbSTs could be used without appreciable health risk to
consumers”. The delegations noted that no new data, which could challenge the JECFA evaluation, had been
submitted to the CCRVDF for evaluation by JECFA. They further noted that bST was already registered and
authorised for use in many countries and that the adoption of the draft MRLs would contribute to ensure the
safety of milk, especially in countries which depended largely on milk imports. They noted that access to
tools, such as bST, could contribute to an increase in the production of milk and, thus, contribute to food
security.
71. Some delegations, while stating that they had no particular interest in bST, because it was either not
used or not authorised for use in their countries, supported the adoption of the draft MRLs for bST, which
had been developed according to the Risk Analysis Principles applied by the CCRVDF.
72. Delegations noted that failure to adopt the draft MRLs would undermine Codex work and make it
difficult to achieve harmonisation of national legislation. They recommended that consideration of ‘other
legitimate factors’ should not overshadow the scientific basis of Codex work and recalled that Codex had
developed criteria for the consideration of other legitimate factors. Delegations recommended that countries
not using bST should not prevent other countries from using it; they noted that striving to reach consensus
should not prevent the adoption of Codex texts.
73. Other delegations recalled that bST had not been evaluated for some years and encouraged submission
of data to allow a JECFA re-evaluation, while not preventing countries to adopt the draft MRLs. One
delegation, proposed to retain the draft MRLs at Step 8 and wait for the outcome of a JECFA re-evaluation of
the new information.
74. Delegations, which were not in support of the adoption of the draft MRLs, noted that countries had
banned bST because they considered it harmful. They recalled that many countries banned the use of
veterinary products for non-therapeutic use and that the use of bST increased the potential risk of mastitis,
with consequential increased use of antibiotics and, thereby, increased risks of antimicrobial resistance.
Delegations expressed concerns for animal health and welfare issues related to the use of bST and were of
the view that risk managers should take these concerns into account when taking risk management decisions.
They recalled that Codex should work only on matters where consensus is achievable, thus allowing better
use of Codex resources. They also noted that since bST had not been evaluated for more than thirteen years,
it needed to be re-evaluated and that animal health issues related to the use of bST should also be taken into
account. They noted that there was no trade problem related to the use of bST, but concrete indications of
animal health and animal welfare associated with bST use, which could not be ignored. They were of the
opinion that the adoption of the MRLs would undermine the credibility of Codex. One Observer spoke out
against the adoption of these MRLs, noting that the use of bST cannot lead to better food security where it
makes animals less healthy and the world food supply more fragile. Another Observer noted that new
scientific information had become available since September 1997 that calls into question the conclusions of
the 50 th JECFA.
75. The Chairperson, while noting the above discussion, observed that the scientific assessment of bST, on
which the Commission was asked to make a decision, was dated back to the 1990s and that Codex risk
management decisions should be based on sound, relevant and up-to-date information.
76. In view of the general discussion and the above consideration, the Chairperson proposed, as a way
forward, to request JECFA to update the risk assessment upon which the MRLs for bST had been
recommended, including consideration of the impact on human health and the potential for antimicrobial
resistance. He further highlighted the need for the risk assessment to remain within the scope of the Codex
mandate and to focus on impacts on human health. The Chairperson proposed to continue holding the draft
MRLs at Step 8 and to reconsider them in light of the JECFA re-evaluation.
77. Delegations generally supported the proposal and pointed out the importance for Codex to base its
decisions on updated scientific information; delegations also highlighted the need to focus the re-evaluation
on aspects relevant to Codex work, while recognizing that animal health and welfare were outside the Codex
mandate. It was also noted that JECFA had already established the safety of bST and that the JECFA re-