Efficacy of a feed additive consisting of 6‐phytase produced by (Komagataella phaffii CGMCC 7.370) (VTR‐phytase) for all pigs and growing poultry species (Victory Enzymes GmbH)

TL;DR

This paper evaluates the effectiveness of a feed additive containing 6-phytase for pigs and poultry, concluding it is potentially effective at specific dosages.

Contribution

The study provides new evidence supporting the efficacy of VTR-phytase in previously unconfirmed animal species and formulations.

Findings

VTR-phytase is potentially efficacious for poultry for fattening and reared for laying/breeding at 500 U phytase/kg feed.

The additive is potentially efficacious for reproductive and fattening pigs at 750 U phytase/kg feed.

Earlier data supported efficacy in laying hens at 1000 U phytase/kg feed.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of 6‐phytase produced by Komagataella phaffii CGMCC 7.370 (VTR‐phytase) as a zootechnical feed additive for all pigs and growing poultry species. The additive is intended to be commercialised in two formulations: liquid and powder. In a previous opinion the FEEDAP Panel concluded that the additive is safe for target species, consumers and environment. The FEEDAP Panel deemed that both formulations of the additive are not skin and eyes irritant but should be considered skin and respiratory sensitisers. The FEEDAP Panel concluded that VTR‐phytase has potential to be efficacious in laying hens at 1000 U phytase/kg complete feed, and this conclusion was extended to all laying and reproductive poultry. However, due to the lack of sufficient data, the Panel was not in a position to conclude on the efficacy for poultry for fattening or reared for laying/breeding, and in any porcine species. The applicant provided new trials to support the efficacy of the additive on those target species. Based on the data provided in the previous and current application, the Panel concluded that the additive has a potential to be efficacious as a zootechnical additive for all poultry for fattening and reared for laying/breeding and reproductive porcine species at 500 U phytase/kg complete feed and all porcine species for fattening and reared for reproduction at 750 U phytase/kg complete feed.

Tables

TABLE 1. Description of the additive.

	Application SANTE‐0046‐2021/FAD‐2021‐0066 & 2021‐0067	Submission FEED‐2024‐24251
Category of additives	Zootechnical additives
Functional groups of additives	Digestibility enhancers
Description	6‐phytase produced by Komagataella phaffii CGMCC 7.370
Target animal category	All pigs and growing poultry species
Applicant	Victory Enzymes GmbH
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 of the efficacy trials performed in chickens for fattening.

Trial	Total n° of animals (animals × replicate) Replicates × treatment	Breed Sex (duration)	Composition feed (form)	Groups (units/kg feed)
				Intended	Analysed
1	36 (1) 9	Ross 308 Male (28 days)	Maize, soybean meal, rapeseed meal (pellet)	0 250 500 1000	< 100 157 384 788
2	36 (1) 9	Ross 308 Male (28 days)	Maize, soybean meal, wheat, sunflower meal (pellet)	0 250 500 1000	< 100 164 335 768

TABLE 3. Effects of VTR‐phytase on the phosphorus retention in chickens for fattening.

Trial	Groups	Diet		P retention
		Total P	Ca
	(U/kg feed)	(%)	(%)	(%)
1	0	0.47	0.70	42.9
	250	0.48	0.74	46.8
	500	0.46	0.70	47.7*
	1000	0.48	0.79	48.0*
2	0	0.46	0.68	44.1
	250	0.48	0.80	49.8
	500	0.48	0.69	51.0*
	1000	0.47	0.74	50.2*

TABLE 4. Effects of VTR‐phytase on the zootechnical performance and phosphorus utilisation of weaned piglets.

Groups	Diet		Daily feed intake	Final body weight	Average daily weight gain	Feed‐to‐gain ratio	ATTD P	Tibia P	Tibia ash
	Total P	Ca
(U/kg feed)	(%)	(%)	(g)	(kg)	(g)		(%)	% FM	% FM
0	0.44	0.65	575b	22.7b	349a	1.66	36.6b	15.7	32.7b
250	0.45	0.65	642a	26.8a	447b	1.55	50.4a	15.8	42.3a
500	0.45	0.66	675a	26.1a	429b	1.62	47.5a	15.7	44.7a
1000	0.38	0.71	661a	26.5a	441b	1.57	45.9a	15.7	46.0a

TABLE 5. Trial design and use level of the efficacy trials performed in gestating and lactating sows.

Trial	Total n° of animals (animals × replicate) Replicates × treatment	Breed	Phase		Composition feed (form)	Groups (units/kg feed)
			Adaptation	Collection		Intended	Analysed
1	32 (1) 16	Topigs TN 70 × PIC 408	Gestation		Maize, barley and rapeseed meal (mash)	0 500	< 100 433
			21 days (from day 85 of gestation to 108)	5 days (from day 109 to 113)
2	26 (1) 13	Topigs TN 70 × PIC 408	Gestation		Maize, barley and rapeseed meal (mash)	0 500	< 100 515
			21 days (from day 85 to 108)	5 days (from day 109 to 113)
3	28 (1) 14	Topigs TN 70 × PIC 408	Lactation		Maize, soybean meal and rapeseed meal (mash)	0 500	< 100 360
			27 days (from day 108 of gestation to day 137)	5 days (from day 138 to 142)
4	28 (1) 14	Topigs TN 70 × PIC 408	Lactation		Maize, soybean meal and rapeseed meal (mash)	0 500	< 100 404
			27 days (from day 109 of gestation to day 136)	5 days (from day 137 to 141)

TABLE 6. Effects of VTR‐phytase on the apparent total tract digestibility of phosphorus in gestating and lactating sows.

Trial	Groups	Diet		ATTD P
		Total P	Ca
	(U/kg feed)	(%)	(%)	(g)
1	0	0.40	0.65	29.9b
	500	0.41	0.65	45.4a
2	0	0.40	0.65	36.0b
	500	0.40	0.66	43.6a
3	0	0.45	0.85	40.3b
	500	0.40	0.77	51.2a
4	0	0.45	0.85	39.8b
	500	0.44	0.79	52.7a

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.

The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), in its opinion on the safety and efficacy of a feed additive consisting of 6‐phytase produced by Komagataella phaffii CGMCC 7.370 as a zootechnical additive for all avian species and ornamental, exotic & game birds and all pigs, could not conclude on the efficacy for all pigs and growing poultry species. 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 have been transmitted by the applicant using the E‐Submission Food Chain Platform and received the submission number FEED‐2024‐24251.

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 6‐phytase produced by K. phaffii CGMCC 7.370 as a zootechnical additive for all pigs and growing poultry species 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 6‐phytase produced by K. phaffii CGMCC 7.370 and it is intended to be used in all poultry and porcine species. It has not been previously authorised as a feed additive in the European Union. EFSA issued one opinion regarding the safety and efficacy of this product when used in feed for all pigs1 and all avian species2 (EFSA FEEDAP Panel, 2022).

DATA AND METHODOLOGIES

2

Data

2.1

The present assessment is based on data submitted by the applicant in the form of supplementary information3 to a previous application on the same product.4 The dossier was received on 16/12/2024 and the general information and supporting documentation are available on Open.EFSA at https://open.efsa.europa.eu/questions/EFSA‐Q‐2024‐00714.

Methodologies

2.2

The approach followed by the FEEDAP Panel to assess the efficacy of 6‐phytase produced by K. phaffii CGMCC 7.370 (VTR‐phytase) is in line with the principles laid down in Regulation (EC) No 429/20085 and the relevant guidance documents: Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2024).

ASSESSMENT

3

The additive under assessment consists of 6‐phytase produced by a genetically modified strain of K. phaffii CGMCC 7.370. The additive is intended to be used in feed for all avian species, and all pigs as a zootechnical additive (functional group: digestibility enhancer) at a minimum recommended level of 500 U phytase/kg complete feed. The VTR‐phytase is available in two formulations: powder and liquid.

The additive was fully characterised in a previous opinion (EFSA FEEDAP Panel, 2022). 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 formulations are not‐skin and eye irritants but should be considered skin and respiratory sensitisers.

In that opinion, the FEEDAP Panel concluded that the additive has the potential to be efficacious in laying hens and other birds for egg production or breeding at 1000 U phytase/kg complete feed. Due to the lack of sufficient data, the Panel was not in the position to conclude on efficacy for growing poultry species and porcine species. The applicant has submitted new efficacy trials which are assessed below.

Efficacy

3.1

Efficacy for poultry

3.1.1

In the previous opinion (EFSA FEEDAP Panel, 2022), the applicant provided three trials in chickens for fattening to support the efficacy of the additive in growing poultry. One of the trials was not considered further due to the high mortality registered. Regarding the other two, the results of the phosphorus retention evaluation showed a positive significant effect of the additive from 500 U phytase/kg complete feed in one of these studies. No effect was observed in the other trial.

In the current application, the applicant submitted two short‐term trials in chickens for fattening6 aiming at evaluating the potential on the phosphorus utilisation. The two trials followed a similar design which has been summarised in Table 2, and the results of the most relevant parameters are shown in Table 3.

In both trials, 36 chickens were randomly allocated to four experimental groups based on the level of the additive supplementation: control (not supplemented) or supplemented with 250, 500 and 1000 U phytase/kg complete feed. The supplementation level of the additive was confirmed analytically (see Table 2). The feed was offered on ad libitum basis for 28 days. The birds from the same group were kept in collective pens for 20 days. On day 21, the chickens were placed in individual cages, and after an adaptation of 3 days, the excreta were collected per cage for 5 days (total collection method). Feed and excreta samples were analysed for the content of dry matter and phosphorus. The general health status and the zootechnical performance of the animals were monitored throughout the whole duration of the trial. The experimental data was analysed using a one‐way ANOVA, with the cage as the experimental unit and the diet as the fixed effect. Group means were compared with orthogonal contrasts of the supplemented groups versus the control. The significance level was set at 0.05. The general health status was good, and no mortality was reported during the experiments. No significant differences were observed in the zootechnical performance of the animals between groups. In both trials, the inclusion of the additive in the feed of chickens for fattening from 500 U phytase/kg complete feed resulted in higher phosphorus retention compared to the control group.

Based on the data provided in the previous and current applications, the Panel concludes that the additive has the potential to be efficacious in chickens for fattening from 500 U phytase/kg complete feed. This conclusion is extended to chickens reared for laying/breeding and extrapolated to other poultry for fattening, reared for laying/breeding and to ornamental birds.

Efficacy for porcine species

3.2

Efficacy for weaned piglets

3.2.1

In the previous application, three trials were provided to support the efficacy of the additive (EFSA FEEDAP Panel, 2022). However, one of the studies provided was not further considered for the assessment due to a poor adaptation of the piglets to the experimental conditions and inconsistencies in the phosphorus retention values at the different levels tested. The other two trials showed an improvement of the zootechnical performance of the piglets (average daily weight gain, feed‐to‐gain ratio) compared to the control group when the additive was included in the diet from 500 U phytase/kg in one of them (trial 2) or from 750 U phytase/kg complete feed in the other one (trial 1). In addition, in trial 2, higher phosphorus retention was also observed from 500 U phytase/kg complete feed in comparison to the control.

In the current dossier, the applicant submitted one long term study,7 which included a balance trial, aiming to evaluate the potential effect of the additive on the zootechnical performance and on the phosphorus retention (apparent total tract digestibility and partial bone retention) when added to the feed of weaned piglets.

A total of 128 hybrid8 piglets (28 days‐old; initial bodyweight: 8 ± 0.5 kg) were distributed based on initial body weight and sex (two females and two castrated males per pen) in 32 pens (eight replicate pens per group). The pens were randomly allocated to four experimental groups. The basal diet based on maize, soybean meal, rapeseed meal and sunflower meal were either not supplemented (control) or supplemented with VTR‐phytase at 250, 500 and 1000 U phytase/kg complete feed (confirmed analytically9). The feed, including an external marker, was offered on an ad libitum basis in pelleted form for 42 days.

The mortality and health status were checked daily. The piglets were individually weighed at the start of the trial. Thereafter, body weight and feed consumption were recorded weekly on a pen basis. The average body weight gain, feed intake and feed‐to‐gain ratio were calculated and corrected for mortality for the overall period. From days 38 to 42 of the study, faecal samples were collected per pen. Feed and faecal samples were analysed for the content of dry matter, external marker, ash and phosphorus content, and the apparent total tract digestibility of phosphorus was calculated. On day 35, six piglets per group were killed and the femur sampled for the analysis of dry matter, ash and phosphorus content. The experimental data were analysed with a generalised linear model, including the diet as fixed effects. When a difference between groups was observed, group means were compared with Tukey test. The significance level was set at 0.05 (Table 4).

Overall mortality was 4.7%, with no statistical differences between groups. The piglets receiving the additive from 250 U phytase/kg feed showed improved zootechnical performance (higher daily feed intake, average daily weight gain and final body weight), phosphorus apparent total tract digestibility and tibia bone ash content compared to the control group.

Efficacy for sows

3.2.1.1

In the previous application, three studies were provided to support the efficacy of the additive in sows (EFSA FEEDAP, 2022). However, two of the trials could not be further considered because of the short period of collection of faecal samples and no considerations were given to required endpoints (litter and sows' body weight). The other trial showed an improvement of the phosphorus apparent total tract digestibility when the additive was supplemented to lactating and gestating sows from 500 U phytase/kg of complete feed.

The applicant provided four short‐term trials aimed at assessing the potential effect of the additive to improve the dietary phosphorus utilisation when supplemented in the feed of gestating (trials 110 and 211) and lactating (trials 312 and 413) sows. A summary of the experimental design of the trials is included in Table 5 and the most relevant results are included in Table 6.

In trials 1 and 2, all gestating sows from the same group were housed together in the same pen and the feed intake was recorded individually. In trials 3 and 4, the lactating sows were housed individually. In all trials, sows were randomly allocated to two experimental groups based on the level of the additive supplementation: not supplemented (control) and 500 U phytase/kg complete feed. The enzyme activity was confirmed analytically (see Table 5). The experimental feeds contained an external marker and were offered following a restricted regime based on the animals' requirements. The health status was checked daily and the piglets' mortality recorded. The zootechnical performance of the sows and the litters were monitored throughout the trial until weaning. The feed and faecal samples were analysed for dry matter, phosphorus and external marker content, and the phosphorus apparent total tract digestibility was calculated. The experimental data was statistically analysed with one‐way ANOVA, with the sow as the experimental unit and the diet as fixed effect. The statistical significance was set at 0.05.

No adverse health issues occurred in the sows and their litter, and no sow died during the experiment. No differences between groups were observed in the zootechnical performance of sows, litters or in the piglets' mortality before weaning. In all trials, the groups supplemented with the additive at 500 U phytase/kg complete feed showed higher apparent total tract digestibility of phosphorus compared to the control.

Conclusion on efficacy in porcine species

3.2.2

Based on the data provided in the previous and current applications, the Panel concludes that the additive has potential to be efficacious in weaned piglets at 750 U phytase/kg and in sows at 500 U phytase/kg complete feed. This conclusion can be extrapolated to all porcine species for fattening and reared for reproduction at 750 U phytase/kg complete feed, and to all reproductive porcine species at 500 U phytase/kg complete feed.

Conclusions on efficacy

3.3

The additive has the potential to be efficacious when added to feed on poultry species for fattening, poultry species reared for rearing/breeding, ornamental birds and to all reproductive porcine species at 500 U phytase/kg complete feed, and on all porcine species for fattening and reared for reproduction at 750 U phytase/kg 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 Regulation14 and Good Manufacturing Practice.

CONCLUSIONS

4

The additive has the potential to be efficacious when added to feed for poultry species for fattening at 500 U phytase/kg complete feed. This conclusion is extended to chickens reared for laying/breeding and extrapolated to other poultry for fattening, reared for laying/breeding. The Panel notes that this conclusion would also apply to ornamental birds. In addition, the additive has potential to be efficacious for all reproductive porcine species at 500 U phytase/kg complete feed, and for all porcine species for fattening and reared for reproduction at 750 U phytase/kg complete feed.ABBREVIATIONSANOVAanalysis of varianceATTDapparent total tract digestibilityECEuropean CommissionEURLEuropean Union Reference LaboratoryFEEDAPEFSA Scientific Panel on Additives and Products or Substances used in Animal FeedFMfresh matter

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2024‐00714

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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.