The European Food Safety Authority has aligned with 26 other regulatory authorities in determining that "... ractopamine is not mutagenic and is not likely to present a carcinogenic risk to consumers."

"The safety of ractopamine for use in swine and beef has been well established through rigorous scientific studies and regulatory reviews," said William Weldon, senior director of research and development for Elanco Animal Health.

He adds that Elanco will be meeting with EFSA scientific experts to address their technical questions related to ractopamine-study design, purpose and statistical aspects. The FEEDAP Panel under EFSA has been reviewing the human-safety data as part of the process toward establishing a Codex international food-safety standard for ractopamine. Normally, the regulatory process involves the exchange of data, questions and responses, but due to time constraints the interaction between Elanco and FEEDAP has not been possible, according to a news release.

Also, the FEEDAP Panel report notes that it reaches a similar conclusion to other entities that consumer safety would be ensured without applying a withdrawal period to swine and cattle receiving ractopamine..

The FEEDAP Panel did raise several  technical questions as the reason for not supporting the international food-safety standard for ractopamine determined by another agency. Elanco officials recognize that there can be varying interpretations of scientific data amongst experts. However, Elanco believes that the questions can be resolved through further scientific review and interaction with EFSA and FEEDAP scientists.

"Elanco is looking forward to working with the EFSA and FEEDAP scientists to resolve all these technical questions," Weldon said. "With the extensive human safety-record already established for ractopamine worldwide, we are confident that we will be able to come to a similar assessment outcome with EFSA".

For background, ractopamine hydrochloride (ractopamine) is the compound used in Elanco's brands Paylean and Optaflexx that are used as feed ingredients in swine and cattle production.

Twenty-six regulatory authorities have extensively reviewed the full ractopamine data submission and based on a series of stringent human and animal food safety criteria concluded it is safe for use in swine and/or cattle production. It is registered in countries including the United States, Canada, Australia, New Zealand, Mexico, Brazil, South Korea, the Philippines and Hong Kong. Since first approval in 1999 in the United States, the product has been used in well more than 300 million swine worldwide producing more of the quality lean meat that consumers desire.

An international food safety standard is established by Codex for compounds used in food animal production to ensure a common threshold for food safety for consumers around the world.

Source: Elanco Animal Health