EU feed additive registration renewals: Only one cobalt salt dossier submitted to EFSA

There were five cobalt salts for which renewal dossiers were due by July 15, 2022, to the EU and UK. Only one submission was made, for coated granulated cobalt carbonate (3b034), by the deadline.  The company, Dox-al Italia, is the applicant in question.

In the EU, the most common cobalt sources used include sulphate and carbonate.

Ruminants require cobalt supplementation to be able to synthesize sufficient levels of vitamin B12. Lactating cows and calves with low cobalt and B12 levels are at risk of low growth, lower milk yield, anemia, and fatty liver. 

Mauro Veneroni, a member of the Dox-al Italia board of directors, told us he expects the renewal process to go smoothly: “We submitted the re-registration dossier for 3b304 to the European Food Safety Authority (EFSA) on schedule. We have had regular contact with EFSA officials since September last year, submitting additional data on request.”

The registration of 3b304 is not a company specific registration, however. So, when the approval is finalized, any product that meets the specifications of 3b304 may be placed into the market.  

Dox-al has exported Cobalt 3b304 to at least 50 countries around the world over the past 25 years and it maintains that its additive has “undisputed value” in terms of limited fine dust emissions so much so that feed labels do not need to carry safety instructions as regards its use. “We monitor every batch very closely for fine particles,” said Veneroni.

Sufficient volumes​

The Dox-al representative said there would be sufficient volumes of cobalt salts in the EU market for ruminant feed requirements. Production capacity at the Italian company’s facility for 3b304 can cover the needs of the European feed market, he confirmed. “We don’t anticipate any problems regarding volumes and deliveries.”

A spokesperson for DSM, another cobalt salt player, told this site that while the company cannot speculate on the overall market developments in future years, it said it "has secured appropriate supply to fulfill our customers’ needs at present, and we continue to engage on the topic to support the ruminant industry.”

Transition period ​

So it is unlikley then that there would be any market disruption arising out of the failure of other cobalt salt suppliers to meet the July 2022 deadline for dossier submission.

Whether or not those other cobalt salts can continue to be used for a transition period, until the end of their shelf life, is not certain.

On that question, FEFAC said it "regrets that the legislator when reviewing the feed additives legislation in 2003 did not anticipate that a transition period was needed for those feed additives whose market authorization is not renewed (art. 14 of R1831/2003). This is all the more difficult to understand given that such a transition period has been granted to additives that were not re-authorised (art. 10 of R1831/2003).”