Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) for all Suidae (Kemin Europa N.V)

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) as a zootechnical feed additive (functional group: digestibility enhancers) for all Suidae at a recommended minimum level of 90,000 U/kg complete feed for pigs in the growing period and 45,000 U/kg complete feed for sows. The production strain is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The FEEDAP Panel concluded that the additive is safe at the minimum recommended use level for all growing Suidae and all sows in the lactating phase. Xygest™ HT was considered safe for the consumers and for the environment when used in feed for all Suidae. The additive was considered not to be irritant to eyes and skin, but was considered as a dermal and respiratory sensitiser. In the absence of sufficient data, the FEEDAP Panel was not in the position to conclude on the efficacy of Xygest™ HT for all Suidae.

1. INTRODUCTION

1.1. Background and Terms of Reference

Regulation (EC) No 1831/2003 ¹ 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 Kemin Europa N.V. ² for the authorisation of the additive consisting of endo‐1,4‐beta‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 ³ (Xygest™ HT), when used as a feed additive for all Suidae (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 19 May 2022 and the general information and supporting documentation is available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2022‐00323. The particulars and documents in support of the application were considered valid by EFSA as of 02 September 2022.

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 endo‐1,4‐beta‐xylanase produced by K. phaffii ATCC PTA‐127053 (Xygest™ HT), when used under the proposed conditions of use (see Section 3.1).

1.2. Additional information

The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued two previous opinions on the safety and efficacy of endo‐1,4‐ß‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT), when used as a zootechnical feed additive (digestibility enhancer) for poultry (EFSA FEEDAP Panel, 2022, 2023). The additive has been authorised in the European Union for all laying poultry (4a36). ⁴

2. DATA AND METHODOLOGIES

2.1. Data

The present assessment is based on data submitted by the applicant in the form of a technical dossier ⁵ in support of the authorisation request for the use of the product consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) as a feed additive for all Suidae.

In accordance with Article 38 of the Regulation (EC) No 178/2002 ⁶ and taking into account the protection of confidential information and of personal data in accordance with Articles 39–39e 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, ⁸ EFSA carried out a public consultation on the non‐confidential version of the application from 28 November to 19 December 2023, for which no comments were received.

In addition, the confidential version of the technical dossier was subject to a target consultation of the interested Member States from 2 September to 2 December 2022, for which received comments were considered for the assessment.

The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA or other expert bodies, peer‐reviewed scientific papers, other scientific reports and experts' (elicitation) knowledge, 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 substance in animal feed are valid and applicable for the current application. ⁹

2.2. Methodologies

The approach followed by the FEEDAP Panel to assess the safety and the efficacy of the product consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) is in line with the principles laid down in Regulation (EC) No 429/2008 ¹⁰ and the relevant guidance documents: Guidance on studies concerning the safety of use of the additive for users/workers (EFSA FEEDAP Panel, 2012), Guidance on the identity, characterisation and conditions of use of feed additives (EFSA FEEEDAP Panel, 2017b), Guidance on the assessment of the safety of feed additives for the target species (EFSA FEEDAP Panel, 2017c), Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2018a), Guidance on the characterisation of microorganisms used as feed additives or as production organisms (EFSA FEEDAP Panel, 2018b) and Guidance on the assessment of the safety of feed additives for the environment (EFSA FEEDAP Panel, 2019).

3. ASSESSMENT

The product containing endo‐1,4‐β‐xylanase (IUBMB EC 3.2.1.8; xylanase) produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for all Suidae. The additive under assessment will be hereafter referred to as Xygest™ HT.

3.1. Characterisation and conditions of use

The additive is available in solid form and ensures a guaranteed minimum xylanase activity of 3,000,000 U ¹¹ /g of product. The additive is produced using a genetically modified strain of Komagataella phaffii. The additive and the production strain were fully characterised in the previous assessment on the use of Xygest™ HT as a zootechnical additive for poultry (EFSA FEEDAP Panel, 2022). The production strain was considered suitable for the qualified presumption of safety (QPS) approach to safety assessment (EFSA BIOHAZ Panel, 2023). The applicant states that no modifications in the manufacturing process or composition of the additive have occurred since then. Thus, the data pertaining to the assessment of the strain genetic modification, additive composition, impurities and physico‐chemical and technological properties in feed still apply.

The additive is intended for use in feed for all Suidae at a minimum proposed use level of 90,000 U/kg complete feed for pigs for fattening, piglets (suckling and weaned) and minor porcine species (suckling piglets, weaned piglets and pigs for fattening), and 45,000 U/kg complete feed for sows for reproduction and minor porcine species (sows for reproduction).

3.2. Safety

3.2.1. Safety for the consumer, user and environment

The safety of the production strain was reviewed in a previous assessment (EFSA FEEDAP Panel, 2022); the production strain was suitable for the QPS approach to safety assessment. Moreover, no cells or DNA of the production strain were detected in the final product. In that same opinion, in which the use of the same additive for poultry was evaluated, the Panel concluded that the additive is safe for consumers and environment. The Panel also concluded that the additive is not irritant to skin or eyes, but it is considered as a dermal and respiratory sensitiser. Since the proposed new use in pigs would not introduce risks not already evaluated in the previous opinions, the Panel considers that the conclusions of the previous assessment regarding the safety for the consumers, users and environment still apply to the present one. Therefore, the additive is considered safe for the consumers and the environment when used in all Suidae. The additive is not irritant to skin or eyes, but it is considered as a dermal and respiratory sensitiser.

3.2.2. Safety for the target species

Two tolerance–efficacy trials, one in weaned piglets ¹² and one in sows, ¹³ were submitted to support the safety for all Suidae.

3.2.2.1. Weaned piglets

A total of ■■■■■ weaned piglets ■■■■■; 26 days of age; average body weight 6.9 kg) were included in the experiment ■■■■■ ¹⁴ ■■■■■ Two basal diets (pre‐starter from day 1 to 14; and starter from day 15 to 42) ■■■■■ were either not supplemented (control) or supplemented with Xygest™ HT to provide 45,000 (0.5× the minimum use level), 90,000 (1×) or 13,500,000 U/kg feed (150×), confirmed by analysis. ¹⁵ The experimental diets were offered ad libitum as pellets for 42 days.

General health, medical treatments and mortality were daily recorded. Average pen body weight was recorded at the start of the trial (day 1). Thereafter, the average pen body weight and feed intake were measured at days 14 and 42. The average daily growth, average daily feed intake and feed‐to‐gain ratio were calculated and corrected for mortality the whole period (1–42 days).

■■■■■ The significance level was set at 0.05.

No adverse effects were observed in any of the performance parameters measured in piglets. The overall mortality and culling rate represented 3.3, 1.7, 0.8 and 1.7% for the control, 0.5×, 1× and 150× groups, respectively, with no significant differences among treatments. At the end of the study, a higher average daily gain (366, 377 and 379 vs. 335 g/day) and average daily feed intake (574, 580 and 582 vs. 539 g/day) were observed in 0.5×, 1× and 150× groups, and higher final body weight (22.7 and 22.9 vs. 21.2 kg) and better feed‐to‐gain ratio (1.54 and 1.53 vs. 1.61) in the 1× and 150× groups compared to the control.

Xygest™ HT supplemented at 13,500,000 U/kg feed was tolerated by weaned piglets and, therefore, the Panel considers that Xygest™ HT is safe when included in the feed for weaned piglets at 90,000 U/kg, with a wide margin of safety. This conclusion is extended to suckling piglets for the period in which solid feed is given and to pigs for fattening, and extrapolated to all minor growing porcine species.

3.2.2.2. Sows

A total of ■■■■■ ^{■■■■■} sows, ■■■■■ ¹⁷ A basal diet ■■■■■ was either not supplemented (control) or supplemented with Xygest™ HT at 45,000 (1× the minimum use level), 90,000 (2×) or 13,500,000 U/kg feed (300×), confirmed by analysis. ¹⁸ ■■■■■ The study duration was approximately 63 days, ■■■■■ ending ■■■■■ (weaning■■■■■

General health status and mortality were monitored daily. Body weight and backfat thickness were measured at the start of the trial, ■■■■■ piglets were weighed at birth and at weaning. ■■■■■ Creep feed consumption ■■■■■ was recorded. ■■■■■ Feed and faecal samples were analysed for the content of dry matter and energy to calculate the apparent total tract energy digestibility. ■■■■■ was used as marker for digestibility measurements.

Data were statistically analysed ■■■■■ ^{■■■■■} When differences were found, ■■■■■ The significance level was set at 0.05.

No adverse effects were observed in any of the performance parameters measured in sows or their litters. At the end of the study, similar results were observed in terms of daily feed intake during lactation (2.6 kg), body weight loss (39 kg), backfat loss (3.6 mm) and gross energy digestibility during gestation (81%) and lactation (84%) in the 1×, 2× and 300× groups compared to the control. The main results of the sows' performance and digestibility is included in Table 2, and the litters' performance in Table 3.

TABLE 2.

Effects of Xygest™ HT on the performance and energy utilisation of sows.

Trial	Groups	Daily feed intake lactation	Body weight loss 1	Backfat loss 1	Weaning‐to‐oestrus interval	ATTD GE 2
						Gestation	Lactation
	(U/kg feed)	(kg)	(kg)	(mm)	(days)	%	%
1	0 45,000 90,000 13,500,000	2.6 3 2.6 2.6 2.6	39.0 46.4 42.2 38.6	3.6 3.8 2.6 3.7	n/a	80.5 80.1 80.6 80.9	83.8 84.2 84.4 84.4
2	0 45,000 90,000	5.1 5.7 4.6	22.6 10.7 25.1	2.8 1.9 3.3	n/a	n/a	77.5b 80.9a 82.3a
3	0 45,000	6.7b 7.2a	52.5a 38.7b	6.0a 4.5b	7.9 6.9	n/a	n/a
4	0 45,000	5.2 5.2	1.8 4.7	3.1 3.4	4.3 4.5	75.6 75.4	83.9b 84.8a

^a,b,c Mean values between the respective control and treatment within a column with a different superscript are significantly different p < 0.05.

¹ Body weight loss for all trials, values calculated for the lactation period (from farrow to weaning); Backfat loss – trial 1 and 2, values are calculated for the lactation period; for trial 3 and 4, values calculated for the whole period (−1 to 4 weeks post‐farrowing and −3 to 3 post‐farrowing).

² Apparent total tract digestibility of gross energy.

³ Feed amounts provided to the sows were restricted during gestation and lactation.

TABLE 3.

Effects of Xygest™ HT on litter productive performance.

Trial	Groups	Liveborn piglets	Creep feed intake	Piglet weight at birth	Piglet weight at weaning	Mortality and culling
	(units/kg feed)	n	(g)	(kg)	(kg)	%
1	0 45,000 90,000 13,500,000	16.8 17.5 17.5 17.7	251.6 203.8 223.1 208.4	1.3 1.3 1.4 1.3	7.8 8.0 7.6 7.5	7.5 6.2 8.2 8.5
2	0 45,000 90,000	15.4 14.0 15.0	–	1.5 1.5 1.5	6.1 6.3 6.3	2.9 4.2 2.8
3	0 45,000	15.6 16.4	–	1.5 1.6	7.6 7.6	1.7 1.0
4	0 45,000	13.1 12.1	255 258	1.5 1.5	6.1 6.5	12.7 15.6

^a,b Mean values within a trial and within a column with a different superscript are significantly different p < 0.05.

Xygest™ HT supplemented at 13,500,000 U/kg feed was tolerated by sows and, therefore, the Panel considers that Xygest™ HT is safe at 45,000 U/kg, with a wide margin of safety. However, the current application refers to all sows, and this would include the whole reproductive cycle. The tolerance trial submitted covered only the farrowing/lactation period (from ca. 5 weeks before farrowing to weaning). The Panel considers that the data provided support the safety of the additive during the lactation phase but are not enough for the whole cycle of the sows. Therefore, the Panel concludes that the additive is safe for lactating sows and extrapolate this conclusion to all minor lactating Suidae. No conclusions can be drawn on the safety of the additive for gestating sows.

3.2.2.3. Conclusions on safety for the target species

The additive is safe at the minimum recommended use level for weaned piglets with a wide margin of safety. The conclusions can be extrapolated to all growing Suidae. For sows, the additive is considered safe during the lactation phase at the recommended use level with a wide margin of safety. The conclusions can be extrapolated to all lactating Suidae. No conclusions can be drawn on the safety of the additive for gestating Suidae.

3.3. Efficacy

3.3.1. Weaned piglets

The applicant submitted three trials with weaned piglets (including the tolerance–efficacy trial previously described) aiming at demonstrating the effect of the additive on the zootechnical performance and/or the energy utilisation of the diets. However, two of them could not be further considered as evidence of the efficacy because the copper content of the diets was above the maximum authorised levels in the EU. ²⁰ Besides, one of those was also too short (35 days) to be considered for the evaluation of the zootechnical performance of the piglets, and the digestibility endpoints provided were considered inadequate according to the current Guidance on the assessment of the efficacy of feed additives (2018). ²¹

The tolerance–efficacy trial is described above in Section  3.2.2 Safety for the target species. The results showed an improved zootechnical performance (higher final body weight and average daily gain, and better feed‐to‐gain ratio) of the piglets fed the additive at the minimum recommended use level (90,000 U/kg feed) in comparison with the control.

In the absence of three studies showing significant and positive effects on weaned piglets, the FEEDAP Panel is not in a position to conclude on the efficacy of the additive when used in feed for all growing Suidae.

3.3.2. Sows

A total of four trials were submitted (including the tolerance–efficacy previously described) aiming to demonstrate the efficacy of Xygest™ HT in the performance of sows and their litter, and energy utilisation. A summary of the experimental design is included in Table 1, the main results of the sows' performance and digestibility in Table 2 and the litters' performance in Table 3.

TABLE 1.

Trial design and use level of Xygest™ HT on the efficacy trials performed in sows.

Trial	Total no of animals (animals/replicate) Replicates/treatment	Breed parities (duration)	Composition feed (form)	Groups (U/kg feed)
				Intended		Analysed 1
1 22	■■■■■ ■■■■■ ■■■■■	■■■■■ ■■■■■ (≈ 63 days)	■■■■■	0 45,000 90,000 13,500,000		– 44,443 89,791 13,184,640
2 23	■■■■■ ■■■■■ ■■■■■	■■■■■ ■■■■■ (28 days)	■■■■■	0 45,000 90,000		2466 55,898 115,311
3 23	■■■■■ ■■■■■ ■■■■■	■■■■■ ■■■■■ (35 days)	■■■■■	LF 2	0 45,000	– 48,720
				HF	0 45,000	– 47,439
4 24	■■■■■ ■■■■■ ■■■■■	■■■■■ ■■■■■ (42 days)	■■■■■	0 45,000		– 36,450

¹ For trials 1 and 4, average values of the gestation and lactation diets.

² LF/HF: low/high‐fibre diets according to the experimental design.

Trial 1 corresponds to the tolerance–efficacy trial described in Section  3.2.2 Safety for the target species. No differences were observed in any of the performance parameters monitored in sows or the litter, or in the energy digestibility during gestation or lactation.

In trial 2, ²⁶ the experimental feeds, containing an external marker for digestibility analysis, were offered ad libitum for 28 days: ■■■■■

Sows' health status and mortality were monitored daily. The sows' body weight and backfat were measured ■■■■■ and the body weight and backfat loss calculated for the lactation period. Feed intake was recorded during the lactation. Faecal samples were taken ■■■■■. The feed and faecal samples were analysed for the content of the external marker, dry matter and energy, and the apparent total tract digestibility (ATTD) of gross energy calculated.

Regarding the litter, the piglets' health status and mortality were daily checked, and monitored from birth to weaning. The total number of piglets born per litter, born alive, stillbirths and mummies was recorded. The individual piglet's body weight was measured after birth and at weaning, and the average daily gain calculated.

Data were analysed statistically with an analysis of variance including treatment and batch as fixed effects. ■■■■■ Mean group comparisons were performed using Tukey's test. Significance was set at 0.05.

One sow from the 90,000 U/kg group was removed from the trial due to anorexia. No differences were observed in the monitored sows' and litter's performance parameters between groups. The supplementation of the sows' feed with the additive at 45,000 U/kg and above resulted in higher energy digestibility of the diet during lactation (Table 2).

Trial 3 ²⁷ ■■■■■ including two diets with different fibre content (low, ■■■■■ and high, ■■■■■ of crude fibre) and two levels of Xygest™ HT (non‐supplemented (control) or supplemented to provide 45,000 U/kg feed – confirmed by analysis). The experimental diets were fed ■■■■■ ■■■■■

Sows' health status and mortality were monitored daily. The sows' body weight and backfat were recorded ■■■■■ and the body weight and backfat loss calculated ■■■■■. The average daily feed intake was calculated during gestation and lactation. The weaning‐to‐oestrus interval was determined. Regarding the litter, the total number of piglets born, stillbirths, number of weaned piglets, pre‐weaning mortality and litter weight at birth and at weaning were recorded, and the piglet weight gain during lactation calculated.

The data were analysed ■■■■■ Significance was set at 0.05. ■■■■■

Regardless the fibre content in the diet, the supplementation of the feed with Xygest™ HT at the use level resulted in lower body weight loss during the whole period, lower backfat losses and higher feed intake during lactation, when compared to the control (Table 2). The Panel considers that the reduction of the body weight and backfat losses could be related to the higher feed intake during the lactation phase and not to the effect of the additive. Consequently, the Panel considers that this effect should not be retained to support the efficacy of the additive. No other differences in sows' or litter's performance parameters were observed between groups.

In trial 4, ²⁸ ■■■■■ The experimental diets, which included an external marker for digestibility analysis, were fed ■■■■■ for 42 days: ■■■■■ Piglets were fed a commercial creep feed from day 10 of age until weaning.

Sows' health and mortality were daily recorded. The sows' body weight, backfat thickness and feed intake were measured ■■■■■ The average feed intake and the body weight and backfat losses were calculated ■■■■■ The weaning‐to‐oestrus interval was also recorded. Regarding the litter, the number and total weight of piglets born (alive and stillborn, after cross‐fostering and at weaning), litter weight (at birth, after cross‐fostering and at weaning) and creep feed intake per litter were recorded, and the average daily gain of piglets during lactation calculated. ■■■■■ Feed and faecal samples were analysed for the content of the external marker, dry matter and gross energy and the ATTD of the gross energy calculated.

■■■■■ The significance level was set at 0.05.

Four sows were removed from the trial, two from each group. No differences in any of the sows' or litter's performance parameters were observed between groups. The supplementation with the additive at the use level resulted in a higher ATTD of energy in sows during lactation. No differences were observed in the energy digestibility during gestation.

Overall, in two of the trials submitted, the sows receiving the minimum use level of Xygest™ HT (45,000 U/kg complete feed) showed an improvement in the ATTD of gross energy in the lactation period. No other relevant effects were observed.

In the absence of a third study showing positive effects of the supplementation of the sows diets with the additive, the FEEDAP Panel cannot conclude on the efficacy of the additive in Suidae for reproduction.

3.3.3. Conclusions on efficacy

Efficacy was demonstrated in one trial in weaned piglets and in two trials in lactating sows. In the absence of sufficient data, the FEEDAP Panel is not in the position to conclude on the efficacy of Xygest™ HT for all Suidae.

3.4. Post‐market monitoring

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 Regulation ²⁹ and good manufacturing practice.

4. CONCLUSIONS

The production strain is genetically modified. No cells or DNA of the production strain were detected in the final product. The additive is of no concern regarding the production strain.

The additive is safe at 90,000 U/kg feed for weaned piglets with a wide margin of safety. The conclusions can be extrapolated to all growing Suidae. For sows, the additive is considered safe at 45,000 U/kg feed during the lactation phase with a wide margin of safety. The conclusions can be extrapolated to all lactating Suidae. The Panel cannot conclude on the safety of the additive for gestating sows.

The FEEDAP Panel concludes that the additive does not pose any safety concern for the consumers and for the environment.

The additive is not irritant to skin or eyes, but it is considered as a dermal and respiratory sensitiser.

In the absence of sufficient data, the FEEDAP Panel is not in the position to conclude on the efficacy of Xygest™ HT for all Suidae.

Abbreviations

ADFI

average daily feed intake

ADG

average daily gain

ATCC

American Type Culture Collection

ATTD

apparent total tract digestibility

BW

body weight

EURL

European Union Reference Laboratory

F:G

feed‐to‐gain ratio

FEEDAP

EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed

GE

gross energy

QPS

qualified presumption of safety

CONFLICT OF INTEREST

If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu.

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2022‐00323

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PANEL MEMBERS

Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Roberto Edoardo Villa, and Ruud Woutersen.

LEGAL NOTICE

The scientific output published implements EFSA's decision on the confidentiality requests submitted on specific items. As certain items have been awarded confidential status by EFSA, they are consequently withheld from public disclosure by redaction.

EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Bampidis, V. , Azimonti, G. , Bastos, M. L. , Christensen, H. , Durjava, M. , Dusemund, B. , Kouba, M. , López‐Alonso, M. , López Puente, S. , Marcon, F. , Mayo, B. , Pechová, A. , Petkova, M. , Ramos, F. , Villa, R. E. , Woutersen, R. , Dierick, N. , Anguita, M. … Firmino, J. P. (2024). Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) for all Suidae (Kemin Europa N.V). EFSA Journal, 22(2), e8579. 10.2903/j.efsa.2024.8579