Assessment of the feed additive consisting of Saccharomyces cerevisiae CBS 493.94 (Yea‐Sacc®) for dairy cows, minor dairy ruminant species, cattle for fattening and minor ruminant species for fattening for the renewal of its authorisation (ALL‐TECHNOLOGY (IRELAND) LIMITED [Alltech Ireland])

TL;DR

This paper assesses the safety of a yeast-based feed additive for dairy cows and other ruminants, confirming it is safe for animals and consumers but poses some risks to users.

Contribution

The study confirms the ongoing safety of Saccharomyces cerevisiae CBS 493.94 for target species and consumers, while identifying specific user safety concerns.

Findings

The additive is safe for target species, consumers, and the environment.

Yea-Sacc® TS is non-irritant to skin and eyes, while Yea-Sacc® C is non-irritant to skin but irritant to eyes.

Both formulations are skin and respiratory sensitizers, posing risks with exposure.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of a preparation of dried cells of Saccharomyces cerevisiae CBS 493.94 (Yea‐Sacc®) as a zootechnical additive for dairy cows, minor dairy ruminant species, cattle for fattening and minor ruminant species for fattening. The feed additive is marketed in two solid forms (Yea‐Sacc® C and Yea‐Sacc® TS) differing by the granulometry. The applicant provided evidence that the additive currently in the market complies with the existing terms of the authorisation. The Panel concluded that the additive remains safe for the target species, consumers and the environment. Regarding the safety for the user, Yea‐Sacc® TS is non‐irritant to the skin or eyes while Yea‐Sacc® C is not irritant to the skin but irritant to the eyes. The additive in both formulations should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation.

Tables

TABLE 1. Data on the batch‐to‐batch variation, impurities and physical properties of Yea‐Sacc® C and Yea‐Sacc® TS. The data presented are average values and (range) for batch‐to‐batch variation and ranges for all other parameters, except for particle size and homogeneity. The number of batches analysed per group of parameters are indicated between square brackets [].

	Yea‐Sacc C	Yea‐Sacc TS
Specifications 1
S. cerevisiae CBS 493.94 (CFU/g additive)	≥ 1 × 109	≥ 1 × 109
Batch‐to‐batch variation	[5]	[5]
S. cerevisiae CBS 493.94 (CFU/g additive)	8.9 × 109 (7.2–11 × 109)	8.9 × 109 (7–12 × 109)
Impurities (mg/kg)	[5]	[5]
Lead	0.009–0.020	0.009–0.010
Mercury	< 0.0017	< 0.0017
Cadmium	0.011–0.018	0.013–0.015
Arsenic	0.126–0.318	0.300–0.322
Mycotoxins	[5]	[5]
Aflatoxins B1, B2, G1, G2 (μg/kg)	< 0.5	< 0.5
Deoxynivalenol (mg/kg)	< 0.02	< 0.02
HT‐2‐toxin (μg/kg)	< 5	< 5
T2‐toxin (μg/kg)	< 2.5	< 2.5
Fumonisins B1, B2 (mg/kg)	< 0.01	< 0.01
Ochratoxin A (mg/kg)	< 0.0005–0.0015	0.0011–0.0021
Microbial contamination	[5]	[5]
Salmonella spp. (per 25g)	Not detected	Not detected
Listeria monocytogenes (per 25g)	Not detected	Not detected
Escherichia coli (CFU/g)	< 10	< 10
Coliforms (CFU/g)	< 10	< 10
Anaerobic sulphite reducing bacteria (CFU/g)	< 10	< 10
Coagulase‐positive staphylococci (CFU/g)	< 100	< 100
Moulds (CFU/g)	< 10	< 10
Physical properties	[3]	[3]
Bulk density (kg/m3)	766–785	799–818
Solid density (kg/m3)	1344–1413	1288–1301
Dusting potential (Stauber Heubach) (mg/m3)	5–10	5
Particle size distribution (laser diffraction) % of particles below 100 μm (v/v)	0	0
Average particle size (μm)	620	1562
Homogeneity (coefficient of variation, %)
Feed for dairy cows (10 subsamples)	2.2	14.8
Feed for cattle for fattening (10 subsamples)	–	2.67

Full text

INTRODUCTION

1

Background and Terms of Reference

1.1

Regulation (EC) No 1831/20031 establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 14(1) of that Regulation lays down that an application for renewal shall be sent to the Commission at the latest 1 year before the expiry date of the authorisation.

The European Commission received a request from ALL‐TECHNOLOGY (IRELAND) LIMITED [Alltech Ireland]2 for the renewal of the authorisation of the additive consisting of Saccharomyces cerevisiae CBS 493.94 (Yea‐Sacc®), when used as a feed additive for dairy cows, minor dairy ruminant species, cattle for fattening and minor ruminant species for fattening (category: zootechnical additives; functional group: gut flora stabilisers).

According to Article 7(1) of Regulation (EC) No 1831/2003, the Commission forwarded the application to the European Food Safety Authority (EFSA) as an application under Article 14(1) (renewal of the authorisation). The dossier was received on 18 December 2023 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2023‐00887. The particulars and documents in support of the application were considered valid by EFSA as of 06 May 2024.

According to Article 8 of Regulation (EC) No 1831/2003, EFSA, after verifying the particulars and documents submitted by the applicant, shall undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of the feed additive consisting of active agent (Yea‐Sacc®), when used under the proposed conditions of use (see Section 3.1.3).

Additional information

1.2

The additive is a preparation containing living cells of Saccharomyces cerevisae CBS 493.94. Yea‐Sacc® is currently authorised for use in feed for cattle for fattening, minor ruminant species for fattening, dairy cows and minor dairy ruminant species3 and horses4 (4a1704).

EFSA issued three opinions on the safety and efficacy of this product when used in feed for the above‐mentioned species (EFSA, 2009; EFSA FEEDAP Panel, 2014, 2019).

DATA AND METHODOLOGIES

2

Data

2.1

The present assessment is based on data submitted by the applicant in the form of a technical dossier5 in support of the authorisation request for the use of S. cerevisiae CBS 493.94 (Yea‐Sacc®) as a feed additive.

The confidential version of the technical dossier was subject to a target consultation of the interested Member States from 14 May 2024 to 14 August 2024; the comments received were considered for the assessment.

In accordance with Article 38 of the Regulation (EC) No 178/20026 and taking into account the protection of confidential information and of personal data in accordance with Articles 39 to 39e of the same Regulation, and of the Decision of EFSA's Executive Director laying down practical arrangements concerning transparency and confidentiality,7 a non‐confidential version of the dossier has been published on Open.EFSA.

According to Article 32c(2) of Regulation (EC) No 178/2002 and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre‐submission phase and public consultations, EFSA carried out a public consultation on the non‐confidential version of the technical dossier from 22 August 2024 to 12 September 2024. The comments received have been carefully evaluated and considered during the current assessment (Annex A).

The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA, to deliver the present output.

The European Union Reference Laboratory (EURL) considered that the conclusions and recommendations reached in the previous assessment regarding the methods used for the control of the active agent in animal feed are valid and applicable for the current application.8

Methodologies

2.2

The approach followed by the FEEDAP Panel to assess the safety and the efficacy of S. cerevisiae CBS 493.94 (Yea‐Sacc®) is in line with the principles laid down in Regulation (EC) No 429/20089 and the relevant guidance documents: Guidance on the renewal of the authorisation of feed additives (EFSA FEEDAP Panel, 2021) and EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA, 2021).

ASSESSMENT

3

The additive Yea‐Sacc® is a preparation of viable cells of S. cerevisiae CBS 493.94 and is currently authorised for use as a zootechnical additive (functional group: gut flora stabilisers) in feed for dairy cows and minor dairy ruminant species and cattle for fattening and minor ruminant species for fattening. The current assessment regards the renewal of this authorisation.

Characterisation

3.1

Characterisation of the additive

3.1.1

The additive is currently authorised as a solid preparation of S. cerevisiae CBS 493.94 containing a minimum of 1 × 10^9^ colony forming units (CFU)/g additive.

The feed additive is marketed in two forms: Yea‐Sacc® C (in prills form) and Yea‐Sacc® TS (in larger prills form), both containing only the active agent with a minimum content of 1 × 10^9^ CFU/g additive. The only difference between the forms is the granulometry.

The applicant stated that the manufacturing and the composition of the additive have not been modified since the original authorisation.10

Considering that the manufacturing and composition of the additive have not been changed since the original authorisation, the data on the physico‐chemical properties already assessed in the previous opinions (EFSA, 2009; EFSA FEEDAP Panel, 2014, 2019) are still considered valid.

The applicant provided data on the batch‐to‐batch variation,11 impurities12 and some physico‐chemical properties13 for the two forms of the additive that are described in Table 1.

The data provided showed compliance with the specifications set in the authorising regulation with regards the content of the active agent. The Panel notes that the levels of the impurities and microbial contamination of both forms of the additive are of no concern.

Characterisation of the active agent

3.1.2

The active agent, isolated from a British brewery, is deposited both in the National Collection of Yeast Cultures (UK) with the designation NCYC 1026 and the Centraalbureau voor Schimmelcultures (NL) with the accession number CBS 493.94.14

A bioinformatic analysis of the whole genome sequence of the active agent confirmed its identity as S. cerevisiae.15 This was based on an average nucleotide identity analysis against other S. cerevisiae strains which showed 99.4% identity with the reference genome of S. cerevisiae S288C and values above 98% with the other strains from the same species. These findings were in line with a phylogenomic analysis performed on the core genome alignment of 82.2% of gene sequences present in Saccharomyces genomes. The dendrogram built on single nucleotide polymorphisms (SNPs) of genome core genes demonstrated high similarity of the active agent with other well‐characterised S. cerevisiae strains.

Conditions of use

3.1.3

The additive is currently authorised for use in feed for dairy cows and minor dairy ruminant species at a minimum content of 1 × 10^7^ CFU/kg and for cattle for fattening and minor ruminant species for fattening at 1 × 10^8^ CFU/kg.

Under other provisions of the authorisation, it is specified that:

1. In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.
2. For safety: breathing protection shall be used during handling.

The applicant did not request any change in the current conditions of the authorisation.

Safety

3.2

In the previous opinion, the Panel concluded based on the qualified presumption of safety (QPS) approach, that S. cerevisiae CBS 493.94 was safe for the target species, consumers and the environment (EFSA FEEDAP Panel, 2014). With regards to user safety, the FEEDAP Panel concluded, based on studies, that both formulations are non‐irritant to skin, Yea‐Sacc® TS is non‐irritant to the eye while Yea‐Sacc® is a moderate irritant. In addition, the Panel concluded that both formulations should be considered as skin and respiratory sensitisers.

The applicant declared that no incidents or safety issues have been documented or reported for target animal species, consumers, users and environment since the market authorisation of Yea‐Sacc®.16

In the present application, up to date data have allowed to confirm the taxonomical identification of the active agent as S. cerevisiae, confirming the suitability of the QPS approach to safety assessment. Consequently, since the additive is composed of the active agent only, the FEEDAP Panel concludes that Yea‐Sacc® remains safe for the target species, the consumer and the environment under the current conditions of the authorisation.

No new data were submitted on user safety. Considering the studies previously assessed and the nature of the additive, the Panel reiterates its previous conclusions. Yea‐Sacc® TS is non‐irritant to the skin and eye while Yea‐Sacc® C is not irritant to skin but irritant to the eyes. The additive in both formulations should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk.

Efficacy

3.3

The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Post‐market monitoring

3.4

The FEEDAP Panel considers that there is no need for specific requirements for a post‐market monitoring plan other than those established in the Feed Hygiene Regulation17 and Good Manufacturing Practice.

CONCLUSIONS

4

The applicant has provided evidence that the additive currently in the market complies with the terms of the authorisation.

Yea‐Sacc® remains safe for the target species, the consumers and the environment under the current authorised conditions of use.

Yea‐Sacc® TS is non‐irritant to the skin or eyes while Yea‐Sacc® C is not irritant to the skin but irritant to the eyes. The additive in both formulations should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk.

There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation.ABBREVIATIONSCFUcolony forming unitCVcoefficient of variationEURLEuropean Union Reference LaboratoryFAOFood Agricultural OrganizationFEEDAPEFSA Scientific Panel on Additives and Products or Substances used in Animal FeedLODlimit of detectionOECDOrganisation for Economic Co‐operation and DevelopmentQPSqualified presumption of safetySNPssingle nucleotide polymorphismsWHOWorld Health Organization

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2023‐00887

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PANEL MEMBERS

Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López‐Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona, Ilen Röhe and Katerina Theodoridou.