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Human Safety of Ractopamine Reaffirmed by Codex Scientific Expert Body International Standards for Ractopamine Held at Step 8 with a Work Plan

Ractopamine is a feed ingredient, not a growth or steroid hormone*

GREENFIELD, Ind. – Elanco, the animal health division of Eli Lilly and Company (NYSE:LLY), today expressed its understanding that the Codex Alimentarius Commission (Codex) during its 33rd session in Geneva, Switzerland, decided to hold the MRLs (Maximum Residue Limits) for Elanco’s compound ractopamine hydrochloride, or ractopamine,1 at Step 8 with a work plan. “This consensus decision respects that the Codex independent scientific advice body, the Joint FAO/WHO Expert Committee on Food Additives [JECFA], has confirmed the human safety standards for ractopamine three times,” stated Jeff Simmons, president, Elanco. “We trust the work plan will provide an opportunity for members to rise above, and bridge across, national preferences and fulfill their role in establishing international food safety standards.”

The Codex Commission delegates were considering the final adoption of the ractopamine international food safety standards based upon the scientific risk assessment provided by JECFA, which issued its report in May 2010.5 The JECFA assessment was conducted by independent experts and based upon the most recent data that was requested of all countries worldwide. The Commission discussions acknowledged the critical role of JECFA in providing scientific advice and the importance for delegates to act upon such advice.

“We are pleased that Codex has reaffirmed the scientific foundation as provided by JECFA, so that consumers can have confidence in international food safety standards,” said Simmons. “We all have a broader goal of food security and this will be achieved through domestic supply complemented by imported product. International standards serve all consumers as they are reference points to help ensure the production and availability of safe food. We commend all Commission delegates for their dedicated work to achieve consensus while seeking to serve their global food safety role.”

The Food and Agriculture Organization reports that by 2050 the global food demand will double. Simmons adds, “With limited natural resources of land and water, innovation will be essential to meet this need. Codex can help sustain innovation to meet global food needs by acting with due diligence in promptly establishing international food safety standards.”

Ractopamine is a feed ingredient used in Elanco’s products Paylean® for swine and/or Optaflexx® for cattle. Twenty-six regulatory authorities have extensively reviewed ractopamine data, and, based on stringent human food safety criteria, concluded it is safe for use in swine and cattle production. Since its first approval in 1999, ractopamine has been registered in multiple countries including Australia, Brazil, Canada, Mexico, New Zealand, the Philippines, South Korea and the United States. The product has been used in well over 300 million swine worldwide, producing more of the quality lean meat that consumers desire for a healthy diet.

The Codex Alimentarius (Codex), an international intergovernmental body under the United Nations, was established to protect the health of the consumer and facilitate trade. Codex is the joint food standards program of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). The Codex Alimentarius Commission (CAC) appoints a Joint FAO/WHO Expert Committee on Food Additives (JECFA) to provide expert advice to Codex on matters relating to food additives and residues of veterinary drugs in food. JECFA experts are government or academic scientists who serve in their individual capacities as independent experts in the fields of toxicology and residue chemistry, and not as representatives of their governments or employers. Their goal is to establish safe levels of intake for humans, an Acceptable Daily Intake (ADI) and Maximum Residue Limits (MRLs) for veterinary drugs used in food animals in accordance with good veterinary practice.