March 29, 2013
EU to suspend Rubinum''s toyocerin product
This week''s decision of the European Commission to suspend its product toyocerin was criticised by Spanish-based feed additives company Rubinum.
The feed additive is based on the strain Bacillus cereus var. toyoi (NCIMB 40112/ CNCM I-1012). As a consequence of a negative opinion by the European Feed Safety Authority (EFSA) on the product in October last year, the European Commission this week asked for the product to be withdrawn from the European market by June 14, 2013.
Feed materials and compound feed produced with the preparation or with pre-mixtures containing the preparation before June 14, 2013 shall also have to be withdrawn from the market by October 15, 2013.
The October EFSA opinion concluded that the toyocerin strain would harbour resistance determinants to two antibiotics used in human and veterinary medicine. Due to the presence of genes having the same organisation as pathogenic Bacillus cereus strains, EFSA said it had to be assumed that the Bacillus cereus strain contained in the preparation subject to the application has the capacity to elaborate functional toxins involved in food-borne diseases.
Dag Andersen, general manager for Rubinum, said that this negative opinion on toyocerin came as a surprise in October. He said more questions could have been asked by EFSA at the time in order to clarify any doubts.
Andersen said, "Rubinum has already counter-argued the scientific opinion with the support of several recognised experts to all the assumptions made in the scientific opinion with studies, but the authorities have decided not to oppose to the scientific opinion. Luckily, the company has been given the right to submit additional data and therefore, we are optimistic that this temporary situation in EU will be forgotten very soon."
The company also pointed to the brand being a worldwide known probiotic with most scientific data behind supporting the safety, with more than 35 years of use in animals, and without any incidence reported.