The Authority extended that finding to all animal species, when the additive is used in feed at the respective authorized zinc maximum levels:
- 200 mg Zn/kg for dogs and cats
- 180 mg Zn/kg for salmonids and milk replacers for calves
- 150 mg Zn/kg for piglets, sows, rabbits and all fish species other than salmonids, and
- 120 mg Zn/kg for other species and categories.
The additive is zinc chelated with methionine in a molar ratio 1:1 and is designed to supply zinc as a nutritional additive to all animal species and categories.
EFSA’s Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), in an earlier opinion, had determined the additive was efficacious as an available source of zinc for all animal species. However, the EFSA experts then drew a blank on the safety of the additive for the target animals at the time, citing the limitations of the tolerance study provided.
The Commission gave Norel the possibility of submitting additional information to allow the FEEDAP Panel to complete its assessment.
Norel provided a new tolerance study broilers to EFSA for assessment; the results of the trial indicate that the additive does not promote adverse effects in the birds as compared to an inorganic source of zinc, according to the Panel.
'Sow to piglet benefit of additive not proven'
In another scientific opinion published this month, EFSA flagged up data gaps.
The Commission also asked the EU feed and food risk assessor to deliver a scientific opinion on the safety and efficacy of HOSTAZYM X as a feed additive for sows in order to have benefit in piglets.
The additive, which contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations, is already authorized as a feed additive for chickens for fattening, turkeys for fattening, laying hens, minor poultry species for fattening and laying, weaned piglets, pigs for fattening and carps.
Huvepharma was aiming to extend the authorization to sows in order to have a benefit in piglets.
The FEEDAP Panel concluded, as before, there are no concerns for consumer safety and no risks for the environment are expected from the application of this additive in sow feed.
Huvepharma submitted a tolerance study to support the safety of the additive in the new target species. The results showed that sows tolerated well a 100‐fold the recommended enzyme activity level in feed, said the Panel, with the experts concluding the additive is safe for sows at 1,500 EPU/kg feed.
EFSA said the company submitted four studies to document the efficacy of the product. The Panel said it did not consider one on those further in the assessment due to the high mortality seen in piglets.
“In the other three, a significant and positive effect on a relevant parameter was found in only one trial. Therefore, the Panel concluded that there is insufficient information to conclude on the efficacy of the additive.”
Amino acid assessment
German company, Welding GmbH & Co, has received a positive opinion from EFSA on its product - L‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). The additive is meant to be used in feed and water for drinking for all animal species and categories.
EFSA said the production strain and its recombinant DNA were not detected in the additive, and that the product does not raise any safety concern with regard to the genetic modification of the production strain.
It added that the additive is safe for the target species. The FEEDAP Panel did highlight concerns regarding the safety of the simultaneous administration of L‐threonine via water for drinking and feed.
L‐Threonine produced using E. coli CGMCC 7.232 is also safe for the consumer and the environment, said EFSA.
For L‐threonine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen, added the Panel.