Science-based Global Food Safety Standards for Ractopamine Hydrochloride Held at Step 8 by Codex

Elanco Committed to Work with Regulatory Authorities, Scientific Experts and the Food Chain to Advance Acceptance of Ractopamine

GENEVA, SWITZERLAND – 9 July 2011 – The Codex Alimentarius Commission decided to hold at Step 8 the global food safety standards for ractopamine hydrochloride (ractopamine) at its 34th Session that concluded today in Geneva. Codex global food safety standards are designed to ensure that public health is protected and to facilitate the fair trade of safe food products, providing international food safety reference points for all countries. Ractopamine is a feed ingredient for pigs that improves carcass leanness, increases average daily gain and improves feed efficiency, and for cattle that increases live weight gain and red meat yield and improves feed efficiency. Ractopamine is not a hormone, antibiotic or genetically modified organism.

“The human safety of meat from pigs and cattle fed ractopamine hydrochloride has been established and twice reaffirmed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), Codex’s own scientific advisory committee, and by 27 regulatory authorities from around the world. Based upon these safety assessments by scientific experts and regulatory authorities, Elanco is strongly committed to work on global acceptance of ractopamine in collaboration with the entire food chain so that consumers have access to the most affordable and abundant supplies of pork and beef,” 1, 2, 3 said Jeff Simmons, president of Elanco.

There are currently close to one billion people in the world today who do not get enough food to lead healthy and productive lives. As the population grows toward nine billion by 2050, experts predict that food production will need to double, yet there is only 10 percent more land available to meet this staggering need. The UN Food and Agriculture Organization states that 70 percent of the anticipated increase in food production must come from technology.4

“Adoption by Codex of the ractopamine standards would have been a major step towards helping address worldwide hunger and enabling sustainable meat production as experts predict that ractopamine’s worldwide adoption, based on the increased meat yields, could result in billions of additional servings of pork and beef per year,”5 said Simmons.

“We are disappointed that due to national interests and procedural matters Codex did not adopt the global food safety standards for ractopamine. Codex standards for ractopamine would help countries to differentiate ractopamine, a beta-agonist that can be safely used in food animal production, from other beta-agonists,” said Dennis Erpelding, director, corporate affairs of Elanco.

Ractopamine is manufactured and marketed by Elanco under the trade names of Paylean® for swine and Optaflexx® for cattle. Paylean use yields about 3 kilograms (or about 6 pounds) of additional lean pork and improves feed efficiency by 10%.6 Optaflexx use increases hot carcass weight by about 5.5 kilograms (or about 12 pounds) in steers and by about 5 kilograms (or about 11 pounds) in heifers.7, 8

Standards for Other Elanco Compounds Adopted at Codex Meeting

The Codex Alimentarius Commission adopted global food safety standards for narasin for pigs and tilmicosin for chicken and turkey. Adoption of these standards for narasin and tilmicosin underscores Elanco’s long-term commitment to supporting JECFA scientific assessments and the importance of establishing global food safety standards via Codex.

Paylean® for swine and Optaflexx® for cattle are trademarks for Elanco’s brand of ractopamine hydrochloride. The Paylean® and Optaflexx® labels contain complete use information including cautions and warnings. Always read, understand and follow the label and use directions. Indications and specifications vary by registration. Label information is available at: http://www.elanco.us/products/index.htm or http://www.elanco.com/products.html.

About Elanco

Elanco is a global innovation-driven company that develops and markets products to improve animal health and food animal production in more than 75 countries. Elanco employs more than 2,400 people worldwide, with offices in more than 40 countries, and is a division of Eli Lilly and Company, a leading global pharmaceutical corporation. Additional information about Elanco is available at www.elanco.com.

References

1 Evaluation of Certain Veterinary Drug Residues in Food (Sixty-second report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series. No. 925, 2004.

2 Evaluation of Certain Veterinary Drug Residues in Animals and Foods (Sixty-sixth report of the Joint FAO/WHO Expert Committee on Food Additives). WHO Technical Report Series. No. 939, 2006.

3 Residue Evaluation of Certain Veterinary Drugs. Joint FAO/WHO Expert Committee on Food Additives. FAO JECFA Monographs 9. 2010.

4 United Nations FAO. World Agriculture: toward 2015/2030. Rome, Italy. 2002. Last accessed on 5 March 2009: http://www.fao.org/docrep/004/Y3557E/Y3557E00.htm

5 Raymond R et al. Ractopamine Hydrochloride (Paylean® and Optaflexx®) in Pig and Cattle Feed: an Expert Review of the Global Benefits and Human Safety. 14 June 2011.

6 Apple JK et al. Meta-analysis of the ractopamine response in finishing swine. Prof. Anim. Sci. 2007. 23:179-196.

7 Elanco Study Nos. T4V200321, T4V080342, T4V160328, T4V480326, T4V080325 & T4V200324.

8Projection based upon a summary of Optaflexx Post-approval Research in Heifers. October 2006. Data on file.

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