Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the feed additive consisting of endo‐1,4‐beta‐xylanase (produced with Trichoderma reesei MUCL 49755) and endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10/AveMix® XG 10 L) for the renewal of its authorisation as a zootechnical feed additive for laying hens and minor poultry species for fattening and laying. The applicant declared a change in the carrier material used in AveMix® XG 10 from soybean meal to calcium carbonate + wheat flour or calcium carbonate + sepiolite. The applicant provided evidence that the additive AveMix® XG 10 with calcium carbonate + wheat flour and AveMix® XG 10 L comply with the conditions of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) noted that no data were submitted to support compliance of the formulation of AveMix® XG 10 with calcium carbonate + sepiolite with the conditions of the authorisation. The FEEDAP Panel concluded that both formulations of the additive (powder and liquid) remain safe for laying hens and minor poultry species for fattening and laying, consumers and the environment. AveMix® XG 10 formulated with calcium carbonate + sepiolite and AveMix® XG 10 L are not irritant to skin and eyes. No conclusions on the irritation potential of AveMix® XG 10 formulated with calcium carbonate + wheat flour could be drawn. The additive in both formulations is considered a respiratory and skin sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
Keywords: AveMix® XG 10, digestibility enhancers, laying hens, minor poultry species for fattening and laying, safety, zootechnical additives
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 14(1) of that Regulation lays down that an application for renewal shall be sent to the Commission at the latest one year before the expiry date of the authorisation.
The European Commission received a request from AVEVE BV 2 for the renewal of the authorisation of the additive consisting of endo‐1,4‐beta‐xylanase (produced with Trichoderma reesei MUCL 49755) and endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10) when used as a feed additive for laying hens and minor poultry species 3 (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 14(1) (renewal of the authorisation). The dossier was received on 12 November 2021 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2021‐00673. The particulars and documents in support of the application were considered valid by EFSA as of 10 May 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 with T. reesei MUCL 49755) and endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10), when used under the proposed conditions of use (see Section 3.1.2 ).
1.2. Additional information
The additive is a preparation containing endo‐1,4‐beta‐xylanase (produced with T. reesei MUCL 49755) and endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754). The additive is currently authorised (4a9) for use in feed for chickens for fattening, 4 weaned piglets, 5 laying hens and minor poultry species for fattening and laying, 6 pigs and minor porcine species for fattening and turkeys for fattening. 7
EFSA issued seven opinions on the safety and efficacy of the product (EFSA, 2009; EFSA FEEDAP Panel, 2010, 2011, 2012, 2013a, 2013b, 2020).
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 8 in support of the authorisation request for the use of endo‐1,4‐beta‐xylanase (produced with T. reesei MUCL 49755) and endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10) as a feed additive.
In accordance with Article 38 of the Regulation (EC) No 178/2002 9 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, 10 a non‐confidential version of the dossiers FEED‐2021‐0106 and FEED‐2022‐10,230 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 19 April to 10 May 2024 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 10 May to 10 August 2022; the comments received 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, to deliver the present output.
The European Union Reference Laboratory (EURL) considered that the conclusions and recommendations reached in previous assessments regarding the methods used for the control of the endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase in animal feed are valid and applicable for the current applications. 11
2.2. Methodologies
The approach followed by the FEEDAP Panel to assess the safety of endo‐1,4‐beta‐xylanase (produced with T. reesei MUCL 49755) and endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10) is in line with the principles laid down in Regulation (EC) No 429/2008 12 and the relevant guidance documents: Guidance on the renewal of the authorisation of feed additives (EFSA FEEDAP Panel, 2021).
3. ASSESSMENT
This assessment regards the renewal of the authorisation of the product that contains endo‐1,4‐β‐xylanase (EC 3.2.1.8; xylanase) produced with T. reesei MUCL 49755 and endo‐1,3(4)‐beta‐glucanase (EC 3.2.1.6; glucanase) produced with T. reesei MUCL 49754 for as a feed additive for laying hens and minor poultry species for fattening and laying.
3.1. Characterisation
3.1.1. Characterisation of the additive
The additive is produced in powder and liquid forms. It will be hereafter referred to with their trade names AveMix® XG 10 (powder form)/AveMix® XG 10 L (liquid form).
The enzymes are produced separately by fermentation of the production strains. 13 The information submitted regarding the manufacturing process lists a series of modifications applied during the last years ■■■■■. These modifications introduced in the manufacturing process are not expected to have impact on the composition of the final formulations of the additive.
The applicant has also submitted further information regarding the downstream process that are described below.
■■■■■, 14 ■■■■■.
■■■■■.
With regard to the powder formulation AveMix® XG 10, the applicant declared a change in the carrier material (from soybean meal to calcium carbonate + wheat flour or calcium carbonate + sepiolite 15 ). The additive is now declared to contain 27–32% of the spray‐dried enzyme concentrate (which includes maltodextrin (resulting in 14–18% of the final product) and silica (resulting in ≤ 1% of the final product)) 16 and 68–73% of carrier materials.
AveMix® XG 10 L contains 77–82% of the liquid enzyme concentrate (which includes sucrose (resulting in 16–22% of the final product), sodium chloride (resulting in 3–4% of the final product), sodium benzoate (resulting in ≤ 1% of the final product), potassium sorbate (resulting in ≤ 1% of the final product)) 17 and 18–23% of the carrier material (63% water and 37% sorbitol).
The two formulations are authorised at a minimum guaranteed activity of endo‐1,4‐β‐xylanase of 40,000 XU 18 /g and of endo‐1,3(4)‐β‐glucanase of 9000 BGU 19 /g. The batch‐to‐batch variation was studied in five batches of AveMix® XG 10 (formulated with calcium carbonate + wheat flour as a carrier) 20 and AveMix® XG 10 L, respectively. 21 The mean enzyme activities for the powder formulation were 9664 BGU/g (range 9185 to 10,395 BGU/g) and 47,458 XU/g (range 42,535 to 55,490 XU/g), and for the liquid formulation 9534 BGU/g (range 9410 to 9775 BGU/g) and 51,595 XU/g (range 48,325 to 56,125 XU/g). These measured enzyme activities showed compliance with the specifications set in the authorisation. No data on AveMix® XG 10 formulated with calcium carbonate + sepiolite as a carrier were provided.
Three batches of AveMix® XG 10 (formulated with calcium carbonate + wheat flour as a carrier) 22 and AveMix® XG 10 L were analysed for impurities. The analysis included fluoride (ranging from 90.1–92.5 mg/kg in the powder formulation, below the limit of quantification (LOQ) in all three batches of the liquid formulation), lead (ranging from 1.54 to 1.58 mg/kg in the powder formulation, below the LOQ in all three batches of the liquid formulation), arsenic (ranging from 0.72 to 0.76 mg/kg in the powder formulation, below the LOQ in all three batches of the liquid formulation), cadmium and mercury (all below their corresponding LOQs in all three batches of both formulations). 23 The analysis of aflatoxins (B1, B2, G1, G2), deoxynivalenol, zearalenone, ochratoxin A, diacetoxyscirpenol, fumonisins (B1, B2, B3), HT‐2 toxin, T‐2 toxin, nivalenol and fusarenon X showed values below the corresponding LOQ in all three batches of both formulations tested (except for one batch of the liquid form in which zearalenone was 5.2 μg/kg). 24 Microbiological contamination was analysed by determination of Bacillus cereus group bacteria (ranging from < 40 CFU/g to 570 CFU/g in the powder formulation and < 10 CFU/g in the liquid formulation), Enterobacteriaceae (< 10 CFU/g), yeasts and moulds (ranging from 40 CFU/g to 75 CFU/g in the dry formulation and < 10 CFU/g in the liquid formulation) and Salmonella (not detected in 25 g). 25 No data on AveMix® XG 10 formulated with calcium carbonate + sepiolite as a carrier were provided.
The applicant provided new data on the dusting potential of AveMix® XG 10 (formulated with calcium carbonate + wheat flour as carrier). 26 The dusting potential was analysed in three batches using the Stauber–Heubach method and was on average 14,007 mg/m3 air (ranging from 13,779 to 14,325 mg/m3 air).
No data on the stability and homogeneity of AveMix® XG 10 formulated with calcium carbonate + wheat flour as a carrier were submitted.
Physico‐chemical properties, stability and homogeneity of AveMix® XG 10 L were addressed in a previous opinion (EFSA, 2009). The modifications introduced in the manufacturing process are not expected to impact on these properties.
A study on the shelf life of one batch of AveMix® XG 10 formulated with calcium carbonate + sepiolite as a carrier was provided; the study showed losses after 19 months of 8% and 17% in glucanase and xylanase activity, respectively 27 ; however, no information on the storage conditions was provided. The Panel noted that, due to the lack of data on the batch‐to‐batch variation, purity and physico‐chemical properties of AveMix® XG 10 formulated with calcium carbonate + sepiolite as a carrier, this formulation of the additive cannot be fully characterised.
The xylanase and glucanase present in the additive are produced with two non‐genetically modified strains of T. reesei which are deposited at the Belgian Coordinated Collection of Microorganisms with accession numbers MUCL 49755 and MUCL 49754, respectively. 28
The production strain MUCL 49754 ■■■■■ MUCL 49754 ■■■■■ MUCL 49755. 29
The genomes of MUCL 49755 and MUCL 49754 were sequenced and used for taxonomic identification purposes. The taxonomic identification of both strains as T. reesei was confirmed by phylogenetic analysis using concatenated amino acid sequences of 500 conserved core proteins which grouped MUCL 49755 and MUCL 49754 with T. reesei QM6a and its derivative RUT‐C30. 30
The presence of antimicrobial activity was tested in three culture supernatants of T. reesei MUCL 49755 and MUCL 49754, respectively. This was done using a disc‐diffusion agar method against the following reference strains: Staphylococcus aureus ATCC 6538, Streptococcus pyogenes ATCC 12344, B. cereus ATCC 2, Bacillus circulans ATCC 4516, Escherichia coli ATCC 11229 and Serratia marcescens ATCC 14041. 31 No antimicrobial activity was detected.
Since some Trichoderma species are known to be capable of producing various mycotoxins and antifungal metabolites, the whole genome sequence (WGS) data of MUCL 49755 and MUCL 49754 were screened using antiSMASH. 32 The bioinformatic analyses showed no clusters coding for compounds of foreseeable concern. Moreover, the presence of trichodermin was not detected in three batches of the solid glucanase and xylanase concentrates (representative of the final formulations of the additive) by LC–MS/MS analysis (results were below the limit of detection (LOD) of 14 μg/kg).
The applicant submitted data to exclude the presence of viable cells of the xylanase (T. reesei MUCL 49755) and glucanase (T. reesei MUCL 49755) strains in at least three batches of the solid and liquid intermediate xylanase (solid: 178,688 XU/g (172,667–183,818 XU/g); liquid: 68,951 XU/g (65,633–71,660 XU/g)) and glucanase (solid: 38,407 BGU/g (37,222–39,814 BGU/g); liquid: 17,457 BGU/g (16,908–17,558 BGU/g)) products used to formulate AveMix® XG 10 and AveMix® XG 10 L, respectively. 33
■■■■■. For each batch of the xylanase and glucanase liquid intermediate products, ■■■■■. No viable cells of the xylanase and glucanase production strains were detected.
Regarding the glucanase solid intermediate product, ■■■■■. The FEEDAP Panel notes that the amount of sample tested for the presence of the production strain T. reesei MUCL 49755 is very low (below 1 g). For the xylanase solid intermediate product ■■■■■. However, the results of the negative control were not provided, and the method used (■■■■■) may not enable the detection of all possible viable cells remaining in the product. Although, no viable cells of the xylanase and glucanase production strains were detected, considering the methodological limitations described above, the FEEDAP Panel is not in the position to exclude the presence of viable cells of T. reesei MUCL 49755 and T. reesei MUCL 49754 in the solid intermediate products.
The FEEDAP Panel concludes that no viable cells of the production strains were detected in the intermediate products representative of the liquid formulation, AveMix® XG 10 L. Uncertainties remain on the presence of viable cells in the solid intermediate products. However, considering the manufacturing process, the FEEDAP Panel concludes that the results of the analysis with the liquid intermediate products can be extended to the powder formulation, AveMix® XG 10.
3.1.2. Conditions of use
The additive is currently authorised for use as a zootechnical additive in feed for laying hens and minor poultry species for laying at a minimum recommended level of 4000 XU and 900 BGU/kg complete feed and for minor poultry species for fattening at a minimum recommended level of 3000 XU and 675 BGU/kg complete feed.
The authorisation under other provisions foresees:
In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.
For use in feed rich in starch and non‐starch polysaccharides (mainly beta‐glucans and arabinoxylans).
For safety: breathing protection, glasses and gloves shall be used during handling.
The applicant did not request any changes in the current conditions of authorisation.
3.2. Safety
The safety of AveMix® XG 10 and AveMix® XG 10 L for the target species, consumers, users and the environment, including the safety of the production strains, has been evaluated in previous opinions (EFSA, 2009; EFSA FEEDAP Panel, 2012). The Panel concluded that the additive is safe for the target species assessed, and the use of the product as a feed additive would be of no concern for the consumers of products derived from animals fed with the additive, or for the environment. Regarding the safety for the user, tests conducted with the enzymes' concentrates were provided, and it was concluded that the additive was not a skin or eye irritant but should be considered a dermal and respiratory sensitiser.
For the present dossier the applicant (i) states that no adverse events in any of the target animal species, consumers, users and the environment have been reported since the first authorisation, 34 (ii) performed a literature search, (iii) submitted in vitro micronucleus tests, and (iv) provided new tests to support the safety for the users. The Panel assessed all these data.
3.2.1. Literature search
The applicant performed a literature search in order to provide evidence that in the light of the current knowledge, the additive remains safe under the approved conditions for target species, consumers, users and the environment. 35 The applicant searched in a total of seven databases (Medline, Scopus, Web of Science, SciFinder, ProQuest, EBSCOhost Academic Search Premier and Google scholar). The search terms and strategy were provided, and no time limitation was used in the search. The main search terms regarded the additive, the active substances or were related to the production strains. The search identified 4 hits which were further excluded because they were not relevant for safety.
3.2.2. Toxicological studies
3.2.2.1. In vitro mammalian cell micronucleus test
Toxicological studies were submitted in the previous dossiers, aimed at assessing the genotoxic potential of the additive; however, they did not allow to properly assess the potential numerical chromosome aberrations induced by the test item (EFSA, 2009). In the current application, the applicant submitted two in vitro micronucleus tests performed in human peripheral blood lymphocytes to evaluate the potential of the xylanase and glucanase ultrafiltered enzyme concentrates to induce chromosomal damage. 36 Both test items used are considered representative of the final formulations of the additive. 37 The two studies followed the OECD Guideline 487 and were claimed to be GLP compliant.
The xylanase ultrafiltered enzyme concentrate (■■■■■ TOS, ■■■■■ XU/g) as well as the glucanase ultrafiltered enzyme concentrate (■■■■■ TOS, ■■■■■ BGU/g) were tested at 312.5, 1250 and 5000 μg TOS/mL in the presence and absence of metabolic activation. The test items did not induce significant increases in the frequency of binucleated micronucleated cells compared to the vehicle control cultures. Therefore, the FEEDAP Panel concluded that the two test items did not induce structural and numerical chromosome aberrations in vitro in mammalian cells under the experimental conditions employed in these studies.
3.2.3. Safety for the user
The highest measured dusting potential of AveMix® XG 10 formulated with calcium carbonate + wheat flour as a carrier was 14,325 mg/m3. Therefore, exposure of the users by inhalation is likely. No data on the dusting potential of AveMix® XG 10 formulated with calcium carbonate + sepiolite were available.
The applicant provided new tests to study the skin and eye irritation potential for AveMix® XG 10 formulated with calcium carbonate + sepiolite as a carrier 38 and AveMix® XG 10 L.
The skin irritation potential of the additive was investigated using both powder and liquid final formulations, respectively, in an in vitro test performed according to OECD TG 439 (2021). 39 The results of the study showed that both formulations of the additive are classified as non‐irritant to the skin.
The eye irritation potential of the additive was investigated using both powder and liquid final formulations, respectively, in an in vitro test performed according to OECD TG 492 (2023). 40 The results of the study showed that both formulations of the additive are classified as non‐irritant to the eyes.
Considering the proteinaceous nature of the active substances, and the positive results observed in the skin sensitisation studies in the previous opinion (EFSA, 2009), AveMix® XG 10 (formulated either with calcium carbonate + sepiolite or with calcium carbonate + wheat flour as carrier) and AveMix® XG 10 L are considered skin and respiratory sensitisers. Therefore, any exposure is considered to be a risk.
In the absence of data, the FEEDAP Panel cannot conclude on the irritation potential of AveMix® XG 10 formulated with calcium carbonate + wheat flour as a carrier.
Conclusions on safety for the user
AveMix® XG 10 formulated with calcium carbonate + sepiolite as a carrier and AveMix® XG 10 L are not irritant to skin and eyes. Due to the lack of data, no conclusions on the irritation potential of AveMix® XG 10 formulated with calcium carbonate + wheat flour can be drawn. All formulations of AveMix® XG 10 and Avemix® XG 10 L are considered respiratory and skin sensitisers.
3.2.4. Safety aspects linked to the renewal of the authorisation
Based on the information provided by the applicant and the fact that the manufacturing and composition of AveMix® XG 10 L have not been substantially modified, the FEEDAP Panel concludes that there is no evidence to reconsider the conclusions reached in the previous opinions on the safety of AveMix® XG 10 L for laying hens and minor poultry species for fattening and laying. Therefore, the Panel concludes that AveMix® XG 10 L remains safe under the approved conditions for these target species, consumers and the environment.
AveMix® XG 10 formulated with calcium carbonate + wheat flour as a carrier has been characterised in terms of compliance with specifications and purity. The FEEDAP Panel considers that the inclusion of these new carriers would not impact the safety of the additive for target species, consumers and the environment.
AveMix® XG 10 formulated with calcium carbonate + sepiolite as a carrier has not been characterised in terms of compliance with specifications and purity. However, the FEEDAP Panel considers that the inclusion of these new carriers would not impact the safety of the additive for target species, consumers and the environment.
AveMix® XG 10 L is not irritant to skin or eyes but should be considered a dermal and respiratory sensitiser.
AveMix® XG 10 formulated with calcium carbonate + wheat flour as a carrier should be considered a dermal and respiratory sensitiser. No conclusions can be drawn on the irritation potential.
AveMix® XG 10 formulated with calcium carbonate + sepiolite as a carrier is not irritant to skin or eyes but should be considered a dermal and respiratory sensitiser.
3.3. Efficacy
The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the 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.
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 41 and Good Manufacturing Practice.
4. CONCLUSIONS
The applicant provided evidence that the additive AveMix® XG 10 formulated with calcium carbonate + wheat flour and AveMix® XG 10 L comply with the conditions of the authorisation. The Panel notes that no data were submitted to support compliance of the formulation of AveMix® XG 10 formulated with calcium carbonate + sepiolite with the conditions of the authorisation.
The FEEDAP Panel concludes that both formulations of the additive (powder and liquid) remain safe for the target species, consumers and the environment.
Regarding user safety, AveMix® XG 10 formulated with calcium carbonate + sepiolite as a carrier and AveMix® XG 10 L are not irritant to skin and eyes. Due to the lack of data, no conclusions on the irritation potential of AveMix® XG 10 formulated with calcium carbonate + wheat flour can be drawn. Considering the proteinaceous nature of the active substances, AveMix® XG 10 (formulated either with calcium carbonate + sepiolite or with calcium carbonate + wheat flour as a carrier) and AveMix® XG 10 L are considered respiratory and skin sensitisers.
There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
ABBREVIATIONS
- CFU
colony forming unit
- EURL
European Union Reference Laboratory
- FEEDAP
EFSA Panel on Additives and Products or Substances used in Animal Feed
- GLP
Good Laboratory Practice
- LC–MS/MS
liquid chromatography with tandem mass spectrometry
- LOD
limit of detection
- LOQ
limit of quantification
- TOS
total organic solids
- WGS
whole genome sequence
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‐2021‐00673
COPYRIGHT FOR NON‐EFSA CONTENT
EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source
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
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.
ACKNOWLEDGEMENTS
The Panel wishes to thank the following for the support provided to this scientific output (in alphabetical order of the last name): Jaume Galobart and Maria Vittoria Vettori.
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. , Brantom, P. , Glandorf, B. , … Pettenati, E. (2024). Assessment of the feed additive consisting of endo‐1,4‐beta‐xylanase (produced with Trichoderma reesei MUCL 49755) and endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10) for laying hens and minor poultry species for fattening and laying for the renewal of its authorisation (AVEVE BV). EFSA Journal, 22(7), e8853. 10.2903/j.efsa.2024.8853
Adopted: 5 June 2024
Notes
Regulation (EC) No 1831/2003 of the European Parliament and of the council of 22 September 2003 on the additives for use in animal nutrition. OJ L 268, 18.10.2003, p. 29.
AVEVE BV, Aarschotsesteenweg 84, 3012, Leuven (Belgium).
Following the request for Supplementary information dated 13 March 2024, the applicant clarified the target species for which the application was made, restricting it to laying hens and minor poultry species for fattening and laying.
COMMISSION IMPLEMENTING REGULATION (EU) No 2021/329 of 24 February 2021 concerning the renewal of the authorisation of a preparation of endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase for chickens for fattening (holder of the authorisation: AVEVE NV), and repealing Regulation (EC) No 1091/2009.
COMMISSION IMPLEMENTING REGULATION (EU) No 1088/2011 of 27 October 2011 concerning the authorisation of an enzyme preparation of endo‐1,4‐beta‐xylanase produced by Trichoderma reesei (MULC 49755) and endo‐1,3(4)‐beta‐glucanase produced by Trichoderma reesei (MULC 49754) as a feed additive for weaned piglets (holder of authorisation Aveve NV).
COMMISSION IMPLEMENTING REGULATION (EU) No No 989/2012 of 25 October 2012 concerning the authorisation of endo‐1,4‐beta‐xylanase produced by Trichoderma reesei (MULC 49755) and endo‐1,3(4)‐beta‐glucanase produced by Trichoderma reesei (MULC 49754) as a feed additive for laying hens and minor poultry species for fattening and laying (holder of authorisation Aveve NV).
COMMISSION IMPLEMENTING REGULATION (EU) No 1040/2013 of 24 October 2013 concerning the authorisation of a preparation of endo‐1,4‐beta‐xylanase produced by Trichoderma reesei (MUCL 49755) and endo‐1,3(4)‐beta‐glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive for pigs for fattening and minor porcine species for fattening other than Sus scrofa domesticus and turkeys for fattening (holder of authorisation Aveve NV).
Dossier reference: FEED‐2021‐0106.
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31, 1.2.2002, p.1–48.
Decision available at: https://www.efsa.europa.eu/en/corporate‐pubs/transparency‐regulation‐practical‐arrangements.
Evaluation report available on the EU Science Hub https://joint‐research‐centre.ec.europa.eu/eurl‐fa‐eurl‐feed‐additives/eurl‐fa‐authorisation/eurl‐fa‐evaluation‐reports_en.
Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives. OJ L 133, 22.5.2008, p. 1.
Annex_II_3_1_1_updated_RFI_Q1_enz prod, Annex_II_RFI_Q1_1_answer, Annex_II_RFI_Q1_1_COA crude protein, Annex_II_3_1_RFI_Q5_1_defoamer analysis and Annex_II_RFI_2405Q4_1_answer filtration.
Currently under re‐evaluation by the FEEDAP Panel.
Currently under re‐evaluation by the FEEDAP Panel.
Annex_II_3_RFI_2405Q1_Answer.
Annex_II_3_RFI_2405Q1_Answer.
One XU is the amount of enzyme which releases 1 μmol of reducing sugar per minute from xylan of oat spelt at pH 4,8 and 50°C.
One BGU is the amount of enzyme which releases 1 μmol of reducing sugar per minute from β‐glucan of barley at pH 5,0 and 50°C.
Annex_II_3_RFI_2405Q2_01_ Answer carrier.
Annex_II_1_3_RFI_Q2_1_Enz analyse powder and Annex_II_1_3_RFI_Q2_2_Enz analyse liquid.
Annex_II_3_RFI_2405Q2_01_ Answer carrier.
Annex_II_1_4_RFI_Q4 COA_impurities1. LOQ in mg/kg were: 0.50 for lead and arsenic, 0.20 for cadmium, 0.02 for mercury.
Annex_II_1_4_RFI_Q4 COA_impurities1. LOQ in μg/kg were: 1 for aflatoxins (B1, B2, G1, G2) and ochratoxin A, 0.05 for deoxynivalenol and nivaleonol, 5 for zearalenone and T‐2 toxin, 10 for diacetoxyscirpenol and HT‐2 toxin, 100 for fumonisins (B1, B2, B3), and 50 for fusarenon X.
Annex_II_1_4_RFI_Q4 COA_impurities2.
From Annex_II_1_5_6 to Annex_II_1_5_9.
Annex II_3_RFI_2405Q2_02_COA XG shelf life.
From Annex_II_1_3_1 to Annex_II_1_3_4.
Annex_II_1_3_5.
From Annex_II_1_3_6 to Annex_II_1_3_8.
Annex_II_RFI_Q8_1_antimicrobial act G and Annex_II_RFI_Q8_2_antimicrobial act X.
Annex_II_RFI_Q7_1_answer, Annex_II_RFI_Q7_2_sec_met_clusters_X, Annex_II_RFI_Q7_3_sec_met_clusters_G and Annex_II_RFI_Q7_5_sec_met_Trichodermin.
Annex II_1_4_9_RFI_2405Q3_05_viable cells answer, Annex II_1_4_9_RFI_2403Q3_01_viable cells G P, Annex II_1_4_9_RFI_2403Q3_02_viable cells G L, Annex II_1_4_9_RFI_2403Q3_03_viable cells X L and Annex II_1_4_9_RFI_2403Q3_04_viable cells X P.
Safety of use of the additive for users 20,210,729, Annex III_RFI_2405Q6_answer, Annex III_RFI_2405Q7_answer and Annex II_RFI_2403Q9_answer.
Annex_III_RFI_Q9_01_Ext_literature_report_2023.
Annex_III_2_2_5_A_micronucleus_xyl and Annex_III_2_2_5_B_micronucleus_gluc.
Annex II_RFI_2405Q8_01_micronucleus enz act.
Annex_II_3_RFI_2405Q2_01_ Answer carrier.
Annex_III_RFI_Q11_1_Skin_irr_study_P and Annex_III_RFI_Q11_2_Skin_irr_study_L.
Annex_III_RFI_Q11_3_Eye_irr_study_P and Annex_III_RFI_Q11_4_Eye_irr_study_L.
Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene. OJ L 35, 8.2.2005, p. 1.
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