EFSA feed additive assessments thwarted by data gaps

By Jane Byrne contact

- Last updated on GMT

© GettyImages/a-poselenov
© GettyImages/a-poselenov
EFSA said it was unable to determine the efficacy of a yeast strain from Phileo Lesaffre Animal Care when used in dairy and beef cattle, due to gaps in studies provided to it by the applicants.

However, the European Food Safety Authority (EFSA), in its latest opinion​, said the additive from, branded as Actisaf Sc47, has the potential to be efficacious in weaned piglets and sows to have benefits in piglets at the recommended dose of 5 × 109 CFU/kg feed.

The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to re-evaluate the safety and efficacy of the yeast product for dairy cows, beef cattle, weaned piglets and sows when used as a zootechnical additive.

The additive is a preparation consisting of dried cells of Saccharomyces cerevisiae CNCM I‐4407.

Actisaf Sc47 comes in three formulations. The FEEDAP Panel said it the three available formulations are equivalent when used to deliver the same dose of the microorganism in feed. The experts said the active agent fulfils the requirements of the qualified presumption of safety approach to the assessment of safety.

“Since the additive is composed of the active agent only, Actisaf Sc47 is also presumed safe for the target animals, consumers of products derived from treated animals and the environment.”

Efficacy studies in dairy and beef cows

Three studies were performed in two European countries aiming to demonstrate the efficacy of the additive on beef cattle performance. However, the EU risk assessor said none could be further considered due to flaws in the experimental design.

“There is no evidence to conclude on the efficacy of Actisaf Sc47 in cattle for fattening.”

Four trials were performed in two different EU countries aiming to demonstrate the efficacy of the yeast strain in dairy cows. However, EFSA said one was not considered due to lack of replication and due to a bias introduced in the study, while it said a second study could not be further considered, also due to lack of replication.

“As Actisaf Sc47 only showed positive effects on the performance of dairy cows in two studies, the Panel cannot conclude on the efficacy of Actisaf Sc47 for this target species.”

No conclusion drawn on efficacy of BASF product in sows and cows 

A lack of data again hindered EFSA in being able to assess a BASF product – omega‐6‐fatty acid as octadecadienoic acid (conjugated linoleic acid‐methylester) – in terms of efficacy.

The FEEDAP panel previously issued an opinion on the safety and efficacy of the product, in which it then said it could not conclude on the efficacy of the additive for sows for reproduction and for cows for reproduction.

EFSA was subsequently asked to deliver a new opinion​ on the efficacy of this additive for sows and cows for reproduction, based on additional data submitted by BASF.

The panel said it “has performed the assessment of the new data following an approach in line with the principles laid down in Regulation (EC) No 429/2008 and the relevant guidance documents.”

In relation to the data on efficacy in sows for reproduction, owing to methodological shortcomings of the study submitted, including the duration of the study and the limited biological relevance of the effect observed, the EFSA panel said it is unable to determine the efficacy of the product for sows for reproduction.

The EFSA experts said the data related to dairy cows indicate that methyl ester of conjugated linoleic acid (t10, c12 isomer) supplementation in the late dry period and/or lactation period showed an increase of the probability of pregnancy and a reduction of time to conception in the same reproductive cycle.

“However, considering that the minimum duration of efficacy studies for reproductive parameters is of at least two reproductive cycles, the FEEDAP Panel is not in a position to conclude on the efficacy of the additive for cows for reproduction.”

Enzyme product passes muster

Meanwhile, the FEEDAP Panel found a xylanase product from Puratos, Beltherm MP/ML, has the potential to be efficacious as a zootechnical additive in weaned piglets and pigs for fattening at 100 ADXU/kg feed. It said the finding was extrapolated to minor porcine species.

That opinion can be read here​.

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