Efficacy of a feed additive consisting of endo‐1,4‐beta‐xylanase, endo‐1,4‐beta‐glucanase and xyloglucan‐specific‐endo‐beta‐1,4‐glucanase produced by Trichoderma citrinoviride DSM 33578 (Huvezym® neXo) for all porcine species and all poultry (Huvepharma EOOD)

TL;DR

This paper evaluates the effectiveness of a feed additive for improving digestion in pigs and poultry, concluding it works well under the proposed conditions.

Contribution

The study confirms the efficacy of the additive for all porcine species and poultry, addressing previous uncertainties.

Findings

The additive is effective for all porcine species and poultry under the proposed conditions.

The FEEDAP Panel previously confirmed the safety of the additive for animals and the environment.

The liquid form is not a skin sensitiser, but the solid form may be.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of endo‐1,4‐beta‐xylanase, endo‐1,4‐beta‐glucanase and xyloglucan‐specific‐endo‐beta‐1,4‐glucanase (produced with Trichoderma citrinoviride DSM 33578) (Huvezym® neXo), intended to be used as a zootechnical feed additive (functional group: digestibility enhancers) for all Suidae and all poultry at the recommended application level 1500 endo‐pentosanase units (EPU), 100 cellulase unit (CU) and 100 xyloglucanase unit (XGU)/kg of complete feed. The additive is available in granulated (Huvezym® neXo 100 G) and liquid (Huvezym® neXo100 L) forms, and it is authorised for use in reproductive sows and poultry for fattening, poultry reared for laying and reared for breeding, and ornamental birds. In previous opinions, the FEEDAP Panel concluded that Huvezym® neXo is safe for the target species, consumers and the environment. Additionally, the FEEDAP Panel concluded that Huvezym® neXo in either form is not an irritant to the skin and eyes; the liquid form is not a skin sensitiser, but the solid form should be considered a potential skin sensitiser. Both forms of the additive are considered respiratory sensitisers. However, in the previous assessments, the Panel could not conclude on the efficacy of weaned piglets and laying hens. Considering the previously and newly submitted data the Panel concluded that the additive has a potential to be efficacious as a zootechnical additive for all porcine species and all poultry under the proposed conditions of use.

Tables

TABLE 1. Description of the additive.

	Application FAD‐2021‐0036 SANTE‐0035‐2021	Application FEED‐2022‐3111
Category of additives	Zootechnical additives
Functional group of additive	Digestibility enhancers
Description	Endo‐1,4‐β xylanase, endo‐1,4‐β‐glucanase and xyloglucan‐specific‐endo‐β‐1,4‐glucanase produced with Trichoderma citrinoviride DSM 33578 (Huvezym® neXo)
Target animal category	Laying/breeding hens and piglets (weaned and suckling)	Suidae for fattening
Applicant	Huvepharma EOOD
Type of request	New opinion ‐ Request for scientific opinion pursuant to Article 29(1)(a) of Regulation (EC) No 178/2002

TABLE 2. Trial design and use level of the efficacy trials performed in laying hens.

Trial	Total no of animals (animals × replicate) replicates × treatment	Breed (age at start)	Duration (adaptation/collection)	Composition feed (form)	Groups (EPU‐CU‐XGU/kg feed)
					Intended	Analysed*
1	■■■■■ ■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ (mash)	0‐0‐0 1500‐100‐100	■■■■■ ■■■■■
2	■■■■■ ■■■■■ ■■■■■	■■■■■ ■■■■■	84 days ■■■■■	■■■■■ (mash)	0–0‐0 1500–100‐100	■■■■■ ■■■■■

TABLE 3. ■■■■■

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		■■■■■	■■■■■ ■■■■■
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■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■
■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■

TABLE 4. Trial design and analytical use level of the efficacy trials performed in weaned piglets.

Trial	Total no of animals (animals × replicate) replicates × treatment	Breed sex age at start	Duration	Composition feed (form)	Groups (EPU‐CU‐XGU/kg feed)
			Phase I/phase II		Intended	Analysed
1	■■■■■ ■■■■■ ■■■■■	■■■■■ ■■■■■ ■■■■■	■■■■■ ■■■■■ ■■■■■	■■■■■ ■■■■■ (pellet)	0‐0‐0 1500–100‐100	■■■■■ ■■■■■
2	■■■■■ ■■■■■ ■■■■■	■■■■■ ■■■■■ ■■■■■	■■■■■ ■■■■■ ■■■■■	■■■■■ ■■■■■ (pellet)	0‐0‐0 1500–100‐100	■■■■■ ■■■■■
3	■■■■■ ■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■ ■■■■■	■■■■■ (pellet)	0–0‐0 1500–100‐100	■■■■■ ■■■■■

TABLE 5. ■■■■■

■■■■■	■■■■■	■■■■■	■■■■■	■■■■■	■■■■■	■■■■■	■■■■■
	■■■■■	■■■■■	■■■■■	■■■■■	■■■■■		■■■■■
■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■
■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■
■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■	■■■■■ ■■■■■

Full text

INTRODUCTION

1

Background and Terms of Reference as provided by the requestor

1.1

Regulation (EC) No 1831/2003 establishes the rules governing the Union authorisation of additives for use in animal nutrition; in particular, Article 9 defines the terms of the authorisation by the Commission.

The applicant is seeking a Union authorisation of the feed additive described in Table 1, via two separate applications.

The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), in its opinions on the safety and efficacy of a feed additive consisting of endo‐1,4‐β xylanase, endo‐1,4‐β‐glucanase and xyloglucan‐specific‐endo‐β‐1,4‐glucanase produced with Trichoderma citrinoviride DSM 33578 (Huvezym® neXo) as a zootechnical additive, could not conclude on the following elements:

• Opinion of 23.11.2022: the efficacy of the additive for laying hens and weaned piglets, due to a lack of sufficient data.
• Opinion adopted on 01.02.2024: the efficacy of the additive for Suidae for fattening, due to a lack of sufficient data.

In both cases, the European Commission gave the possibility to the applicant to submit supplementary information and data to complete the assessment and to allow a revision of the EFSA's opinion.

The new supplementary information and data, addressing the shortcomings of both opinions, have been transmitted in one single submission1 by the applicant using the E‐Submission Food Chain Platform.

In view of the above and in accordance with Article 29(1)(a) of Regulation (EC) No 178/2002, the European Commission requests EFSA to deliver a new scientific opinion on a feed additive consisting of endo‐1,4‐beta xylanase, endo‐1,4‐beta‐glucanase and xyloglucan‐specific‐endo‐beta‐1,4‐glucanase for its use in all porcine species and all poultry under the conditions of Regulation (EC) No 1831/2003, based on the supplementary information and data submitted by the applicant.

Additional information

1.2

The additive is a preparation containing endo‐1,4‐beta‐xylanase, endo‐1,4‐beta‐glucanase and xyloglucan‐specific‐endo‐β‐1,4‐glucanase produced with a non‐genetically modified strain DSM 33578 of Trichoderma citrinoviride and it is intended to be used in all poultry and porcine species.

The additive is currently authorised for use in feed for poultry for fattening, poultry reared for laying and reared for breeding, ornamental birds (4a.39)2 and sows (4a.39).3

EFSA issued two opinions on the safety and efficacy of this product when used in feed for all Suidae and all poultry species, ornamental birds and piglets (weaned and suckling) (EFSA FEEDAP Panel, 2022, 2024b).

DATA AND METHODOLOGIES

2

Data

2.1

The present assessment is based on data submitted by the applicant in the form of supplementary information4 to two previous applications on the same product.5 ^,^ 6 The dossier was received on 27/9/2024 and the general information and supporting documentation are available on Open.EFSA. https://open.efsa.europa.eu/questions/EFSA‐Q‐2024‐00591.

Methodologies

2.2

The approach followed by the FEEDAP Panel to assess the safety and the efficacy endo‐1,4‐β xylanase, endo‐1,4‐β‐glucanase and xyloglucan‐specific‐endo‐β‐1,4‐ glucanase produced by T. citrinoviride DSM 33578 (Huvezym® neXo) is in line with the principles laid down in Regulation (EC) No 429/20087 and the relevant guidance documents: Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2024a, 2024b).

ASSESSMENT

3

The additive Huvezym® neXo is a preparation containing endo‐1,4‐beta‐xylanase, endo‐1,4‐beta‐glucanase and xyloglucan‐specific‐endo‐β‐1,4‐ glucanase produced with T. citrinoviride DSM 33578 intended for used as a zootechnical additive (functional group: digestibility enhancers) in feed for all poultry and porcine species at a minimum level of 1500 EPU, 100 CU and 100 XGU/kg complete feed. It is available in two forms, solid (100G) and liquid (100L), with both formulations having a guaranteed minimum activity per gram of product of 15,000 xylanase units (EPU), 1000 glucanase units (CU) and 1000 xyloglucanase units (XGU) (enzyme ratio = 15:1:1). The additive is currently authorised for use in poultry for fattening, poultry reared for laying and reared for breeding, ornamental birds and sows.

The additive was characterised in the previous opinions of the Panel (EFSA FEEDAP Panel, 2022, 2024b). The Panel concluded that the use of the additive at the proposed conditions of use is safe for the target species, the consumers and the environment. The Panel concluded that both forms of the additive are not irritant to skin or eyes but should be considered respiratory sensitisers. The solid form should be considered a potential skin sensitiser. The liquid form is not a skin sensitiser.

In those opinions, the Panel could not conclude on the efficacy of the additive for laying hens and weaned piglets due to the lack of sufficient evidence. Consequently, the Panel could not conclude on the efficacy for all poultry and all porcine species. The applicant has provided new efficacy studies which are assessed below.

Efficacy

3.1

Poultry

3.1.1

In a previous opinion (EFSA FEEDAP Panel, 2022), the Panel concluded that the additive has the potential to be efficacious in chickens for fattening at the proposed conditions of use, and this conclusion was extended to chickens reared for laying and breeding and extrapolated to all growing poultry and ornamental birds. However, the Panel was not in the position to conclude on the efficacy for laying hens because only two of the three studies submitted supported the efficacy of the additive in increasing the metabolisable energy content of the diets.

The applicant submitted two studies in laying hens.8 ^,^ 9 Their study design is provided in Table 2, and the main results are in Table 3. The first study was a short‐term trial, and the second one was a long‐term trial.

The trials aimed at demonstrating the additive's effect on the diets' energy utilisation. Moreover, trial 2 assessed the effect of the additive on the laying performance of the hens.

In both trials, the hens were placed in cages and randomly allocated to two experimental groups: one receiving the non‐supplemented basal diet (control) and one supplemented with Huvezym® neXo 100 G at the recommended use level. ■■■■■

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Conclusions on efficacy in poultry

3.1.2

Based on the results of the studies submitted in the context of the previous application and the short‐term trial submitted in the current one, the Panel concludes that the additive has the potential to be efficacious in laying hens at the proposed minimum use level (1500 EPU, 100 CU and 100 XGU per kg complete feed). Considering that the efficacy was already demonstrated in chickens for fattening at the same level, the Panel extrapolates this conclusion to all poultry.

Porcine species

3.1.3

In 2022 (EFSA FEEDAP Panel, 2022), the Panel evaluated the efficacy of the additive for piglets. In its first opinion (EFSA FEEDAP Panel, 2022), the Panel assessed three studies in weaned piglets, two of which showed positive and significant effects on the feed‐to‐gain ratio, while the other one was not considered in the assessment due to the high number of medical treatments applied during the experiment and the high mortality and culling rate. Therefore, due to lack of sufficient data, the Panel could not conclude on the efficacy for piglets (weaned and suckling). In 2024 (EFSA FEEDAP Panel,  2024b), the Panel concluded that the additive has the potential to improve the digestibility of the energy of the diets in gestating and lactating sows when supplemented at the proposed use level, and this conclusion was extrapolated to all reproductive porcine species. In that opinion, no further data was submitted to support the efficacy for other categories of the porcine species.

In the current submission, four new long‐term trials have been submitted to evaluate the effect of the additive on the zootechnical performance of weaned piglets. However, one of the trials was not further considered as evidence of efficacy due to the level of copper in the diets greatly exceeding the maximum authorised level in the EU.10

A summary of the study design of the other three studies (trials 1,11 212 and 313) is provided in Table 4, and the main results are in Table 5.

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Conclusions on efficacy in porcine species

3.1.3.1

Based on the results of the studies submitted in the previous application and the current one, the Panel concludes that the additive has the potential to be efficacious in weaned piglets at the proposed minimum use level (1500 EPU, 100 CU and 100 XGU per kg complete feed). Considering that the efficacy was already demonstrated in sows in a previous opinion at the same level, the Panel extrapolates the conclusion to all porcine species.

CONCLUSIONS

4

The FEEDAP Panel concludes that the additive Huvezym® neXo is considered efficacious for all poultry and all porcine species at the proposed use level of 1500 EPU, 100 CU and 100 XGU/kg feed.ABBREVIATIONSAME_N_ apparent metabolisable energy corrected for nitrogenCUcellulase unitFEEDAPEFSA Scientific Panel on Additives and Products or Substances used in Animal FeedEPUendo‐pentosanase unitsXGUxyloglucanase unit

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2024‐00591

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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.

LEGAL NOTICE

Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by EFSA. The full output has been shared with the European Commission, EU Member States (if applicable) and the applicant. The blackening may be subject to review once the decision on the confidentiality requests is adopted by EFSA and in case it rejects some of the confidentiality requests.