Safety and efficacy of a feed additive consisting of alpha‐galactosidase (produced with Aspergillus tubingensis ATCC SD 6740) and endo‐1,4‐beta‐xylanase (produced with Trichoderma orientale CBS 139997) (Capsozyme SB Plus) for weaned piglets (Industrial Técnica Pecuaria, S.A.)

TL;DR

This paper evaluates the safety and effectiveness of a feed additive for weaned piglets, concluding it is safe and effective at the recommended dosage.

Contribution

The paper provides a scientific assessment of Capsozyme SB Plus for use in weaned piglets, extending its authorization from poultry.

Findings

The additive is safe for weaned piglets at the recommended inclusion level.

The additive is efficacious in improving digestibility in weaned piglets.

The additive poses a risk as a respiratory sensitiser due to inhalation exposure.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a preparation containing alpha‐galactosidase and endo‐1,4‐beta‐xylanase (Capsozyme SB Plus) as a zootechnical feed additive (functional group: digestibility enhancers). The additive is already authorised for use in feed for chickens for fattening, chickens reared for laying, minor poultry species for fattening and reared for laying and ornamental birds. The applicant is seeking an extension of use to weaned piglets at a recommended inclusion level of 20 alpha‐galactosidase activity units (GALU) and 25 endo‐1,4‐beta‐xylanase activity units (AXC) per kg of complete feed. Based on the results of a tolerance study in weaned piglets, the FEEDAP Panel concluded that the additive is considered safe at the recommended inclusion level for weaned piglets. The Panel also concluded that the use of the feed additive in weaned piglets under the proposed conditions of use is considered safe for consumers and the environment. Regarding user safety, Capsozyme SB Plus is considered a respiratory sensitiser and exposure by inhalation is considered a risk. No conclusions could be reached on the potential of the additive to be irritant to the skin or eyes or a skin sensitiser. Based on the data provided by the applicant, the FEEDAP Panel concluded that Capsozyme SB Plus is efficacious in weaned piglets at the proposed use level of 20 GALU and 25 AXC units per kg complete feed.

Tables

TABLE 1. Trial design and use level of the efficacy trials performed in weaned piglets.

Trial	Total n° of animals (animals × replicate) replicates × treatment	Breed sex duration	Composition feed (form)	Enzyme activity (GALU/AXC per kg)
				Intended	Analysed (pre‐starter; starter)
1	192 (6) 16	Topigs 20 × Tybor G 50♂:50♀ 42 days	Wheat, barley, rye, soybean meal, whey powder (pellets)	0 20/25	0 25/31; 20/28
2	112 (4) 14	Piétrain × (Landrace × Large White) 50♂:50♀ 42 days	Wheat, barley, soybean meal (pellets)	0 20/25	0 19/24; 25/30
3	504 (14) 18	Piétrain × (Large White × Landrace) 50♂:50♀ 42 days	Wheat, barley, soybean meal, maize (pellets)	0 20/25	0 21/28; 19/24

TABLE 2. Effects of CAPSOZYME SB PLUS on the performance of weaned piglets.

Trial	Enzyme activity (GALU/AXC per kg)	Average daily feed intake (g)	Final body weight (kg)	Average daily weight gain (g)	Feed to gain ratio*	Mortality and culling (%)
1	0 20/25	669 654	26.1 26.2	448 449	1.49a 1.45b	0 1.0
2	0 20/25	490 491	20.2 20.5	341 347	1.39a 1.36b	0 0
3	0 20/25	482 500	21.6b 22.6a	318b 341a	1.52a 1.47b	4.37 3.57

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 4(1) of that Regulation lays down that any person seeking authorisation for a feed additive or for a new use of feed additive shall submit an application in accordance with Article 7.

The European Commission received a request from Industrial Técnica Pecuaria, S.A. for the authorisation of the additive consisting of alpha‐galactosidase produced with Aspergillus tubingensis 2 ATCC SD 6740 and of endo‐1,4‐beta‐xylanase produced with Trichoderma orientale 3 CBS 139997 (Capsozyme SB Plus), when used as a feed additive for weaned piglets (category: zootechnical additives; functional group: digestibility enhancers).

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 4(1) (authorisation of a feed additive or new use of a feed additive). The dossier was received on 18 April 2024 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2024‐00262. The particulars and documents in support of the application were considered valid by EFSA as of 23 January 2025.

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 alpha‐galactosidase produced with A. tubingensis ATCC SD 6740 and endo‐1,4‐beta‐xylanase produced with T. orientale CBS 139997 (Capsozyme SB Plus), when used under the proposed conditions of use (see Section 3.1.3).

Additional information

1.2

The additive is a preparation containing alpha‐galactosidase and endo‐1,4‐beta‐xylanase produced by non‐genetically modified strains of A. tubingensis and T. orientale, respectively. EFSA issued three opinions on the safety and efficacy of this product when used in feed for poultry species for fattening or reared for laying or reared for breeding and ornamental birds and turkeys for fattening and reared for breeding (EFSA FEEDAP Panel, 2020, 2021, 2025).

The additive is currently authorised for use in feed for chickens for fattening, chickens reared for laying, minor poultry species for fattening and reared for laying and for ornamental birds (4a33).4

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 alpha‐galactosidase and endo‐1,4‐beta‐xylanase (Capsozyme SB Plus) as a feed additive.

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 30 April to 21 May 2025 for which no comments were received.

The confidential version of the technical dossier was subject to a target consultation of the interested Member States from 28 January to 28 April 2025 for which the received comments were considered for the assessment.

The European Union Reference Laboratory (EURL) considered that the conclusions and recommendations reached in the previous assessments regarding the methods used for the control of the active substance 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 alpha‐galactosidase and endo‐1,4‐beta‐xylanase (Capsozyme SB Plus) is in line with the principles laid down in Regulation (EC) No 429/20089 and the relevant guidance documents: Guidance on the assessment of the safety of feed additives for the consumer (EFSA FEEDAP Panel, 2017a), Guidance on the identity, characterisation and conditions of use of feed additives (EFSA FEEDAP Panel, 2017b), Guidance on the assessment of the safety of feed additives for the target species (EFSA FEEDAP Panel, 2017c), Guidance on the characterisation of microorganisms used as feed additives or as production organisms (EFSA FEEDAP Panel, 2018), Guidance on the assessment of the safety of feed additives for the environment (EFSA FEEDAP Panel, 2019), Guidance on studies concerning the safety of use of the additive for users/workers (EFSA FEEDAP Panel, 2023), Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2024) and EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA, 2024).

ASSESSMENT

3

The feed additive containing alpha‐galactosidase (Enzyme Commission number 3.2.1.22; galactosidase) produced by A. tubingensis ATCC SD 6740 and endo‐1,4‐β‐xylanase (Enzyme Commission number 3.2.1.8; xylanase) produced by T. orientale CBS 139997 is currently authorised for use in feed for chickens for fattening, chickens reared for laying, minor poultry species for fattening and reared for laying and for ornamental birds as a zootechnical additive (functional group: digestibility enhancers). The applicant is requesting the extension of use to weaned piglets. The additive will be hereafter referred to as Capsozyme SB Plus.

Characterisation

3.1

Characterisation of the production microorganisms

3.1.1

The active substances in Capsozyme SB Plus are produced by two non‐genetically modified strains, an A. tubingensis strain producing alpha‐galactosidase and a T. orientale strain producing endo‐1,4‐beta‐xylanase.10 The first has been deposited at the American Type Culture Collection with the accession number ATCC SD 674011 and the second at the Centraalbureau voor Schimmelcultures (CBS) with the accession number CBS 139997.12

The production strains were assessed and fully characterised in the context of a previous opinion (EFSA FEEDAP Panel, 2025). The identification of both production strains as A. tubingensis and T. orientale, respectively, and their characterisation is still considered valid for this assessment.

Characterisation of the additive

3.1.2

Capsozyme SB Plus is a solid product that contains fermentation products (■■■■■) and kieselgur (■■■■■) and dextrin (■■■■■) as carriers. The additive ensures a minimum enzyme activity of 40 alpha‐galactosidase activity units (GALU13) and 50 endo‐1,4‐beta‐xylanase activity units (AXC14) per gram of product.15

The additive under assessment has the same formulation and manufacturing process as that considered in a previous opinion, where it was fully characterised (EFSA FEEDAP Panel, 2025).16 The dataset submitted for the characterisation is the same as previously submitted and, therefore, the data described in the previous opinion still applies.

Conditions of use

3.1.3

The additive is proposed to be used in feed for weaned piglets at a recommended inclusion level of 20 GALU and 25 AXC units per kg of complete feed.17

Safety

3.2

Safety for the target species

3.2.1

The applicant submitted one tolerance study in weaned piglets to support the safety for the target species.18

A total of 216 25‐day‐old male and female weaned piglets (Topigs 20 × Tybor G) were distributed to 24 pens in groups of six animals each and randomly allocated to three dietary treatments (12 replicates per treatment). Two basal diets (pre‐starter, from day 1 to 14; and starter, from day 14 to 42) based on wheat, barley, rye and soybean meal were prepared and were either not supplemented (control) or supplemented with the additive Capsozyme SB Plus to provide 20/25 (1× proposed use level) or 2000/2500 GALU/AXC (100×) per kg of complete feed (enzyme activities confirmed by analyses).19 The diets were offered on ad libitum basis in pelleted form for 42 days. Health status of the animals was checked every day.

Mortality was recorded. Animals were weighed at the start of the trial. Thereafter, the body weight and the feed intake were measured on days 14 and 42. The average daily gain, average daily feed intake and feed to gain ratio were calculated and corrected for mortality for the overall period. The data were analysed with a one‐way analysis of variance (ANOVA), using the diet and block as fixed effects. The experimental unit was the pen. Initial body weight was considered as a covariate. Group means were compared with Bonferroni test. Significance level was set at 0.05.

Three piglets died during the study, with no differences observed between groups (two from control and one animal from 1× group). Overall average feed intake was 664, 685 and 672 g/day, for control and the supplemented groups, respectively. Overall average daily weight gain was 421, 434 and 441 g/day, for control and the supplemented groups, respectively. The piglets in the 100× group showed better overall feed to gain ratio (1.53) compared to control (1.58) and the 1× group (1.58).

The results of the study showed no adverse effects on the performance of the weaned piglets when the piglets were fed up to 100‐fold the proposed use level.

Conclusions on safety for the target species

3.2.1.1

The FEEDAP Panel concludes that the feed additive is safe for weaned piglets at the recommended inclusion level of 20 GALU and 25 AXC units per kg of complete feed.

Safety for consumers, users and the environment

3.2.2

The safety of the additive for consumers, users and the environment was evaluated in previous assessments (EFSA FEEDAP Panel, 2020, 2021, 2025).

The use of the additive was considered safe for the consumers and the environment. Regarding user safety, the Panel concluded that Capsozyme SB Plus is considered a respiratory sensitiser and exposure by inhalation is considered a risk. No conclusions could be reached on the potential of the additive to be irritant to the skin or eyes or a skin sensitiser. No additional data were submitted in the current application.

The FEEDAP Panel considers that the proposed new use would not introduce risks not already considered in the previous assessments, and therefore the same conclusions apply also to the newly proposed use of the additive in weaned piglets. Therefore, the FEEDAP Panel concludes that the use of the additive in weaned piglets is safe for the consumers and the environment. Regarding user safety, the additive should be considered as a respiratory sensitiser and exposure by inhalation is considered a risk. No conclusions can be reached on the potential of the additive to be irritant to the skin or eyes, or a skin sensitiser.

Efficacy

3.3

The applicant submitted a total of four trials in weaned piglets to support the efficacy of the feed additive in the target species. One of the trials was not performed according to common farming practices in the EU, since antibiotic growth promoters were included in the diet of the piglets and was not considered further in the assessment.20 The other three trials21 were conducted following a similar design, which is summarised in Table 1.

In all trials, weaned piglets22 were allotted to pens (mixed sex per pen in trials 1 and 3; single‐sex per pen in trial 2), and randomly allocated to 2 experimental groups. Two basal diets (pre‐starter diets: day 1–14; starter diets: day 14–42) were offered to the piglets either non‐supplemented (control) or supplemented with Capsozyme SB PLUS to provide 20/25 GALU/AXC per kg feed. The experimental diets were offered ad libitum in pelleted form for 42 days.

Health status and mortality were monitored throughout the studies and the body weight (individually) and feed intake (pen basis) were recorded (days 1, 14, 42). The average daily feed intake, average daily weight gain and the feed to gain ratio were calculated and corrected for mortality (when relevant).

In all cases, the data were analysed with a mixed model considering the diet as fixed effect and the block (location in the room or initial body weight) or room as random effects. The experimental unit was the pen. The significance level was set at 0.05. When differences were detected, group means were compared with Bonferroni (trial 1) or Tukey test (trial 2 and 3). The main results are presented in Table 2.

In all trials, the animals that received the additive at the proposed use level showed better feed to gain ratio compared to control group. In trial 3, supplemented animals also showed higher final body weight and average daily gain compared to control.

Conclusions on efficacy

3.3.1

Based on the data submitted, the FEEDAP Panel concludes that the feed additive has the potential to be efficacious as a zootechnical additive in weaned piglets when supplemented to the diet at 20/25 GALU/AXC per kg of complete feed.

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 Regulation23 and Good Manufacturing Practice.

CONCLUSIONS

4

Capsozyme SB Plus is safe for weaned piglets at the recommended level of 20 GALU and 25 AXC units per kg complete feed.

The use of the feed additive in weaned piglets under the proposed conditions of use is considered safe for consumers and the environment.

Regarding safety for the user, Capsozyme SB Plus is considered a respiratory sensitiser and exposure by inhalation is considered a risk. No conclusions can be reached on the potential of the additive to be irritant to the skin or eyes or a skin sensitiser.

Capsozyme SB Plus is considered to be efficacious in weaned piglets at the recommended use level of 20 GALU and 25 AXC units per kg complete feed.

ABBREVIATIONSAXCendo‐1,4‐beta‐xylanase activity unitsEURLEuropean Union Reference LaboratoryFEEDAPEFSA Scientific Panel on Additives and Products or Substances used in Animal FeedGALUalpha‐galactosidase activity unitsLOQlimit of quantificationOECDOrganisation for Economic Co‐operation and Development

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2024‐00262

COPYRIGHT FOR NON‐EFSA CONTENT

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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.