Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the alpha‐amylase (Ronozyme® HiStarch CT/L) produced with a genetically modified strain of Bacillus licheniformis (DSM 34315) as a zootechnical feed additive for chickens for fattening, turkeys for fattening and minor growing poultry species. The additive is available in two forms, a coated thermotolerant granulate formulation and a liquid formulation. The production strain and its DNA were not detected in an intermediate concentrated product representative of the final formulations. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the final product did not trigger safety concerns with regard to the genetic modification. The Panel concluded that Ronozyme® HiStarch CT/L is safe for chickens for fattening, turkeys for fattening and minor growing poultry species at the recommended inclusion level of 80 KNU/kg complete feed. The use of Ronozyme® HiStarch CT/L in animal nutrition under the proposed conditions of use is safe for the consumers and the environment. The additive in any form was shown to be non‐irritant to the skin and the solid form was shown to be non‐irritant to the eyes. No conclusions could be drawn on the potential of the liquid form to be irritant to the eyes or on the potential of both forms of the additive to be dermal sensitisers due to lack of data. Owing to the proteinaceous nature of the active substance, the additive in either form was considered to be a respiratory sensitiser and any exposure by inhalation is considered a risk. In the absence of data, the Panel was not in the position to conclude on the efficacy of Ronozyme® HiStarch CT/L for chickens for fattening, turkeys for fattening and minor growing poultry species.
Keywords: alpha‐amylase, chickens for fattening, digestibility enhancer, efficacy, Ronozyme® HiStarch CT/L, safety, zootechnical additive
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 DSM Nutritional Products Ltd, represented in the EU by DSM Nutritional Products Sp. z o.o., 2 for the authorisation of the additive consisting of alpha‐amylase (produced with Bacillus licheniformis DSM 34315) (Ronozyme® HiStarch CT/L) for chickens for fattening, turkeys for fattening and minor growing poultry species (category: zootechnical additives; functional group: digestibility enhancers). 3
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 26 January 2023 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2023‐00043. The particulars and documents in support of the application were considered valid by EFSA as of 16 August 2023.
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‐amylase (produced with B. licheniformis DSM 34315) (Ronozyme® HiStarch), when used under the proposed conditions of use (see Section 3.1.5).
1.2. Additional information
The additive contains alpha‐amylase which is produced with a genetically modified strain of Bacillus licheniformis (DSM 34315) and its trade name is Ronozyme® HiStarch CT/L.
It has not been previously authorised in the EU.
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 4 in support of the authorisation request for the use of alpha‐amylase (Ronozyme® HiStarch CT/L) as a feed additive.
The confidential version of the technical dossier was subject to a target consultation of the interested Member States from 16 August 2023 to 16 November 2023 for which the received comments were considered for the assessment.
In accordance with Article 38 of the Regulation (EC) No 178/2002 5 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, 6 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 14 March 2024 to 4 April 2024 for which no comments were received.
The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA and peer‐reviewed scientific papers, 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 agent in animal feed are valid and applicable for the current application. 7
2.2. Methodologies
The approach followed by the FEEDAP Panel to assess the safety and the efficacy of the alpha‐amylase (Ronozyme® HiStarch CT/L) is in line with the principles laid down in Regulation (EC) No 429/2008 8 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 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), Guidance on the assessment of the safety of feed additives for the environment (EFSA FEEDAP Panel, 2019), EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA, 2021) and Guidance on the assessment of the safety of feed additives for the users (EFSA FEEDAP Panel, 2023).
3. ASSESSMENT
This opinion assesses the safety and efficacy of the product that contains alpha‐amylase (EC 3.2.1.1) produced with Bacillus licheniformis DSM 34315 (Ronozyme® HiStarch) for use as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, turkeys for fattening and minor growing poultry species. The additive, which exists in two forms (solid/ liquid), will be hereafter referred to as Ronozyme® HiStarch CT/L.
3.1. Characterisation
3.1.1. Characterisation of the production organism
The active substance is an alpha‐amylase produced with a genetically modified strain of B. licheniformis which is deposited in the Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH with the accession number DSM 34315. 9
The full genome sequence of B. licheniformis DSM 34315 was obtained and used for identification purposes by a computational approach using the average nucleotide identity (ANI). The ANI estimate showed 99.48% identity with type strain B. licheniformis DSM 13T. 10 The analysis also showed an ANI value of less than 95% to both taxonomically closely related type strains of B. paralicheniformis KJ‐16T (94.53%) and B. sonorensis NBRC 101234T (82.93%), which confirms the identification of the production strain DSM 34315 as B. licheniformis.
The susceptibility of strain DSM 34315 to the antibiotics recommended by the FEEDAP Panel ■■■■■ (EFSA FEEDAP Panel, 2018b). 11 ■■■■■ Therefore, B. licheniformis DSM 34315 is considered to be susceptible to all the antibiotics, except to ■■■■■ The whole genome sequence (WGS) data of the strain DSM 34315 were interrogated for the presence of antimicrobial resistance (AMR) genes against the ■■■■■ and ■■■■■ databases. 12 No hits were identified above the thresholds established by EFSA (2021). ■■■■■■■■■■■■■■■ ■■■■■■■■■■ it can be concluded that strain DSM 34315 does not harbour acquired AMR genes.
No cytotoxic effects were detected in strain DSM 34315 using a cytotoxicity test performed ■■■■■, in accordance with the FEEDAP guidance (EFSA FEEDAP Panel, 2018b). 13 Therefore, B. licheniformis DSM 34315 is considered to be non‐toxigenic.
3.1.1.1. Information related to the genetically modified microorganism
Characterisation of the parental microorganism
The parental strain is ■■■■■ (■■■■■). 14 The production strain B. licheniformis DSM 34315 was developed through a combination of genetic modification steps and classical mutagenesis.
Description of the genetic modification
The purpose of the genetic modifications was to enable the production of alpha‐amylase. ■■■■■ ■■■■■.
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3.1.2. Manufacturing process
The active substance, alpha‐amylase, is produced by means of submerged batch‐fed pure culture fermentation with the genetically modified strain B. licheniformis DSM 34315. The fermentation biomass is purified by using a pretreatment with acids or bases and with a flocculation agent and separated from the cell mass by filtration and centrifugation. The liquid is further purified and concentrated by ultra‐filtration and/or evaporation. To formulate the solid form, the stabilised concentrate is granulated, dried and granules are coated to reduce dustiness. To formulate the liquid form, the stabilised concentrate is blended with water, sucrose, sodium chloride and potassium sorbate.
3.1.3. Characterisation of the additive
The additive is available in two forms, a coated thermo‐tolerant granulate formulation (Ronozyme® HiStarch CT) and a liquid formulation (Ronozyme® HiStarch L). The two formulations ensure a minimum guaranteed enzyme activity of 900 KNU 15 /g of additive.
The batch‐to‐batch variation was studied in five batches of the CT form and six of the L form. 16 The mean enzyme activity in Ronozyme® HiStarch CT was 1216 KNU/g (range 1063–1297 KNU/g) and in Ronozyme® HiStarch L was 1086 KNU/g (range 990–1212 KNU/g).
Ronozyme® HiStarch CT contains the alpha‐amylase (■■■■■ 17 ), sodium sulfate (■■■■■), kaolin 18 (■■■■■), sucrose (■■■■■), cellulose (■■■■■), dextrin (■■■■■), methionine (■■■■■) and palm oil (■■■■■) used as a coating agent. Water represents ■■■■■.
Ronozyme® HiStarch L contains the alpha‐amylase (■■■■■ 19 ), water (■■■■■), sucrose (■■■■■), sodium chloride (■■■■■) and potassium sorbate (■■■■■).
Three batches of each form of the additive were analysed for impurities. 20 In the CT form, mercury and cadmium values were below the limit of quantification (LOQ) of the analytical methods, while the average level of arsenic was 2.28 mg/kg (range 1.79–2.84 mg/kg) and that of lead was 3.15 mg/kg (range 2.78–3.54 mg/kg). The L form showed levels of mercury, arsenic, cadmium and lead below the LOQ. In both forms of the additive, counts of Bacillus cereus were ≤ 10 CFU/g, Enterobacteriaceae were < 10 CFU/g, yeasts and filamentous fungi were < 10 CFU/g and no Escherichia coli or Salmonella spp. were detected in 25 g samples. Coliforms counts were < 4 CFU/g in the L form and < 10 CFU/g in the CT form and total viable counts were < 100 CFU/g in the L form and ranged 300–3.1 × 104 CFU/g in the CT form.
The FEEDAP Panel considers that the microbial contamination and the amounts of the detected impurities do not raise safety concerns.
The L form is a semi‐transparent amber liquid preparation with a density of 1240 kg/m3, a pH of 7.4 and a viscosity lower than 11 cP (measured at 25°C).
The CT form is a free‐flowing powder with a tapped density of 1160 kg/m3. The dusting potential of three batches was determined using the Stauber–Heubach method and showed values on average of 53 mg/m3 (range 16–94 mg/m3) (g airborne dust per m3 of air). The particle size was analysed by the laser diffraction method; the results showed that there are no particles below 100 μm and 95% of the particles is in the range of 150–850 μm. 21
The presence of viable cells of the production strain was investigated in ■■■■■ 22 ■■■■■ ■■■■■ No growth was detected in any of the non‐spiked samples.
The presence of DNA from the production strain was investigated in ■■■■■ 23 ■■■■■ ■■■■■ The analysis showed no amplification in the non‐spiked samples■■■■■ ■■■■■
3.1.4. Stability and homogeneity
3.1.4.1. Shelf life
The shelf life of three batches of the solid form of the additive was studied when stored at −18, 10, 25, 30°C (packaging not described) and 30°C/65% relative humidity (RH) for up to 24 months and at 40°C (packaging not described) for up to 12 months. 24 Losses after 24 months ranged 1–7% at 10, 25, 30 and 30°C/65%, while no or negligible (≤ 1%) losses were observed after 12 months at any conditions (enzymatic activity at −18°C was taken as baseline).
The shelf life of three batches of the liquid form of the additive was studied when stored at −18, 25, 30 and 40°C for up to 13 weeks (packaging not specified). After 13 weeks, losses of 15%, 24% and 41% were observed at 25, 30 and 40°C, respectively, while those after 4 weeks were 6% at 30°C and 14% at 40°C (enzymatic activity at −18°C was taken as baseline).
3.1.4.2. Stability
The stability of the CT form of the additive was studied in two vitamin–mineral premixtures and in mash and pelleted feed for chickens for fattening.
The stability of three batches of the CT form was studied when supplemented at 8000 KNU/kg premixture and stored at 25°C for 6 months in plastic bags. Losses at the end of the storage period ranged 2%–10%. 25
The stability to the pelleting process (at 80 and 90°C) of the CT form of the additive was studied when supplemented in wheat‐maize based feed for chickens for fattening at 80 KNU/kg feed in low‐density polyethylene bags. Losses at the end of the pelleting process were 7% at 80°C and ranged 19%–30% at 90°C.
The stability of the CT form in mash and pelleted feed was studied when added to wheat–maize‐based diet for chickens for fattening at 80 KNU/kg feed and stored at room temperature in low‐density polyethylene bags for 3 months. Losses after 3 months resulted in 12% in the mash feed and 7% in the pelleted feed.
For the L form, the stability of three batches of the additive (initial enzymatic activity of 80 KNU/kg) in mash and pelleted feed for chickens for fattening was studied after storage in low‐density polyethylene bags at room temperature for 3 months. Losses at the end of the storage period resulted in 23% in the mash feed and 12% in the pelleted feed. 26
3.1.4.3. Homogeneity
The homogeneous distribution of the CT form in two pelleted feeds for chickens for fattening was studied in ten subsamples of one batch of each feed. The coefficient of variation (CV) was 10% in ■■■■■ based feed and 18% in ■■■■■based feed. 27 The homogeneous distribution of the L form in mash and pelleted feed for chickens for fattening was studied in ten subsamples of one batch of each diet. The results showed a CV of 15% in mash feed and of 11% in pelleted feed. 28
3.1.5. Conditions of use
Ronozyme® HiStarch CT/L is intended to be used in feed for chickens for fattening, turkeys for fattening and minor growing poultry species at the recommended level of 80 KNU/kg complete feed. 29
3.2. Safety
3.2.1. Safety of the production organism
The production strain B. licheniformis DSM 34315 was developed from B. licheniformis DSM 9552. B. licheniformis is a species suitable for the qualified presumption of safety (QPS) approach (EFSA BIOHAZ Panel, 2023). The genetic modifications performed to obtain the production strain DSM 34315 have the purpose to enhance the production of alpha‐amylase. None of the introduced modifications raise a safety concern. The identity of the strain has been unambiguously established. Evidence was provided on the lack of toxigenic potential of the strain and on the absence of acquired AMR genes. Therefore, the QPS approach can be extended to the genetically modified strain and B. licheniformis DSM 34315 is considered to be safe. Moreover, the production strain and its DNA were not detected in an intermediate concentrate that is representative of the final additive. Consequently, the final product does not give rise to any safety concern with regard to the genetically modified production strain B. licheniformis DSM 34315.
3.2.2. Safety for the target species
Safety concerns from the additive may derive either from the enzyme or from the residues of the fermentation process/production strain remaining in the final product. However, the production strain is safe, and the manufacturing process does not raise concerns. The only safety concerns for the target species may derive from the enzyme.
A subchronic oral toxicity study was conducted to support the safety of the enzyme for the target species. 30 ■■■■■. 31
The subchronic oral toxicity study was conducted according to OECD Testing Guideline (TG) 408. Groups of 10 Crl:CD® (SD)IGS BR rats of each sex were given the test material for 13 weeks by gavage at dosages of 1.0, 3.3 or 10.0 mL/kg body weight (bw) per day (equivalent to 1669; 5507; 16,689 KNU/kg bw per day, or 0.07, 0.22 or 0.66 g total organic solid/kg bw per day, respectively). The control group received the vehicle (purified water) at the same volume‐dosage.
No adverse effects were reported. Two females died during the study, but these deaths were considered incidental and not related to the treatment. Water consumption was slightly higher in weeks 6 and 12 in females receiving 3.3 mL/kg bw per day and in males and females receiving 10 mL/kg bw per day, compared to the control. Blood chemistry during week 13 indicated higher phosphorus and calcium concentrations in males receiving 10.0 mL/kg bw per day and higher calcium concentrations in males receiving 3.3 mL/kg bw per day, compared to the control. In the absence of histopathological finding in the kidney, these changes were considered a functional rather than a toxic response. Distension of the caecum (in four males and two females) and luminal dilation of the caecum (in four males and three females) were observed in animals given the highest dosage. These changes were attributed to the osmolarity or electrolyte composition of the test material at the highest concentration causing adaptive changes in the organs in which reabsorption of water takes place (i.e. the kidney and the caecum).
The FEEDAP Panel considers that the no observed adverse effect level (NOAEL) was at the highest dose tested of 10.0 mL/kg bw per day, equivalent to 16,689 KNU/kg bw per day.
■■■■■ the safe daily doses for the target species were derived following the EFSA Guidance on the safety of feed additives for the target species (EFSA FEEDAP Panel, 2017b). ■■■■■ Therefore, the Panel concludes that the additive is safe for chickens for fattening, turkeys for fattening and minor growing poultry species.
The applicant also conducted two extensive literature searches to provide information on the safety of the enzyme for the target species. 32 However, since none specifically referred to the additive under assessment and they were poorly reported, these have not been further considered.
3.2.3. Safety for the consumer
The enzyme is produced with a genetically modified strain of B. licheniformis; a species that is considered to qualify for the QPS approach. 33 The identity of the production strain was established, the qualifications were met, and the genetic modifications introduced in the DSM 34315 strain raise no concerns as regards its toxicological profile. Therefore, B. licheniformis DSM 34315 is presumed safe and no safety concerns would raise for the consumer from the fermentation product obtained from this strain. Therefore, the FEEDAP Panel considers that Ronozyme® HiStarch CT/L raises no concerns for the consumer of the products obtained from animals fed the additive.
3.2.4. Safety for the user
The highest dusting potential of Ronozyme® HiStarch CT measured was 94 mg/m3 indicating that exposure of users by inhalation is likely. Owing to the proteinaceous nature of the active substance, the additive should be considered a respiratory sensitiser
The applicant submitted studies on the potential of both forms of the additive (with an enzyme activity of 1212 KNU/g and 1040 KNU/g, respectively, for L and CT) to cause eyes and skin irritation. 34
Ronozyme® HiStarch CT was tested in an in vitro test conducted in compliance with OECD TG 439. 35 The test item was classified as non‐irritant to the skin according to the results obtained. Ronozyme® HiStarch L was tested in an in vitro study conducted in compliance with OECD TG 439 and was also classified as non‐irritant according to the results obtained. 36
Ronozyme® HiStarch CT was tested for eye irritation in compliance with OECD TG 437. According to the results obtained the test item is non‐irritant to the eyes. 37 Ronozyme® HiStarch L was tested in a similar assay and from the results it was not possible to apply a stand‐alone classification of irritancy. Therefore, in the absence of data, no conclusions can be drawn on the eye irritation potential of the liquid form of the additive. 38
No skin sensitisation study was provided; therefore, no conclusions can be drawn on the skin sensitisation potential of the additive.
3.2.4.1. Conclusions on safety for the user
Based on the studies submitted, the additive was shown to be non‐irritant to the skin in both forms and the solid form was shown to be non‐irritant to the eyes. No conclusions can be drawn on the potential of the liquid form to be irritant to the eyes. Due to the lack of data, no conclusions can be drawn on the potential of both forms of the additive to be dermal sensitisers. Both forms of the additive should be considered respiratory sensitisers, and any exposure by inhalation is considered a risk.
3.2.5. Safety for the environment
Viable cells of the production strain and DNA were not detected in a liquid concentrate representative of both final formulations. The additive does not raise safety concerns for the environment with regard to the genetic modification of the production strain B. licheniformis DSM 34315. The active substance of the additive is a protein, and as such will be degraded/inactivated during passage through the digestive tract of animals or in the environment. Therefore, no risks to the environment are expected from the use of the additive in animal nutrition.
3.3. Efficacy
Three in vivo studies with chickens for fattening were provided to support the efficacy of Ronozyme® HiStarch. One of the studies 39 was aimed at evaluating the zootechnical performance of the chickens and the digestibility of nutrients. However, the zootechnical performance data obtained from this study could not be further considered since the animals were not reared under EU standard farming practices (birds were individually housed in cages). Morevover, regarding the digestibility data, the end‐points recorded in this study were not adequate (only starch digestibility was measured), as no data on the metabolisable energy of the diets were provided as requested by the Guidance on the assessment of efficacy of feed additives (EFSA FEEDAP Panel, 2018a).
The remaining two studies 40 were conducted in the same facilities, overlapping in time and with similar diets; therefore, they are considered to be non‐independent. In the absence of the analysis pooling the data, these studies cannot be further considered.
3.3.1. Conclusions on efficacy
In the absence of data, the FEEDAP Panel is not in the position to conclude on the efficacy of Ronozyme® HiStarch for chickens for fattening, turkeys for fattening and minor growing poultry species.
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
Ronozyme® HiStarch, manufactured with the production strain B. licheniformis DSM 34315, does not raise safety concerns with regard to the genetic modification of the production strain. No viable cells or DNA of the production strain were detected in an intermediate concentrate representative of the final formulations.
Ronozyme® HiStarch is considered safe for chickens for fattening, turkeys for fattening and minor growing poultry species at the recommended use level of 80 KNU/kg complete feed.
The use of Ronozyme® HiStarch in animal nutrition under the proposed conditions of use is safe for the consumers and the environment.
The additive in any form was shown to be non‐irritant to the skin and the solid form was shown to be non‐irritant to the eyes. No conclusions can be drawn on the potential of the liquid form to be irritant to the eyes or on the potential of both forms of the additive to be dermal sensitisers due to lack of data. Owing to the proteinaceous nature of the active substance, the additive in either form should be considered a respiratory sensitiser and any exposure by inhalation is considered a risk.
The Panel is not in the position to conclude on the efficacy of Ronozyme® HiStarch for chickens for fattening, turkeys for fattening and minor growing poultry species.
ABBREVIATIONS
- ADFI
average daily feed intake
- ADG
average daily gain
- BW
body weight
- CFU
colony‐forming unit
- CV
coefficient of variation
- DM
dry matter
- EURL
European Union Reference Laboratory
- FAO
Food Agricultural Organization
- FEEDAP
EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed
- LOD
limit of detection
- LOQ
limit of quantification
- MIC
minimum inhibitory concentration
- NOAEL
no observed adverse effect level
- OECD
Organisation for Economic Co‐operation and Development
- RH
relative humidity
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‐2023‐00043
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.
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. , Prieto, M. , … Brozzi, R. (2024). Safety and efficacy of a feed additive consisting of alpha‐amylase (produced with Bacillus licheniformis DSM 34315) (Ronozyme® HiStarch) for chickens for fattening, turkeys for fattening and minor growing poultry species (DSM Nutritional Products Ltd). EFSA Journal, 22(7), e8846. 10.2903/j.efsa.2024.8846
Adopted: 4 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.
DSM Nutritional Products Ltd, represented in the EU by DSM Nutritional Products Sp. z o.o. (Poland), Wurmisweg 5,764,303 Kaiseraugst Switzerland, represented in the EU by DSM Nutritional Products Sp. z o.o., Tarczyńska 113 96–320 Mszczonów Poland.
RONO HiStarch_SECTION 2.5. and RFI II.2024 – Answers to additional questions on Species. The original application (Annex I) referred to ‘all growing poultry species’. In the course of the assessment, the applicant clarified that all growing poultry species include chickens for fattening, turkeys for fattening and minor growing poultry species.
Dossier reference: FEED‐2022‐12650.
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 2.1.2.
Annex 2.XX.
Annex A5.
Annex 2.XX, Annex 6.1 and Annex 6.2.
Annex 2.XX.
Annex A3 and Annex 2.XX.
KNU is the amount of enzyme that releases in a two‐step reaction 6 μmol p‐nitrophenol per minute from 1.86 mM ethylidene‐G7‐p‐nitrophenyl‐maltoheptaoside at pH 7.0 and 37°C.
Annex 2.1.1, RFI I.2024 Answer Q1‐5, RFI I.2024 Annex 1 and RFI I.2024 Annex 2.
Annex 2.3.1 and RFI I.2024_Answer Q1‐Q5.
Currently under re‐evaluation.
Annex 2.3.1 and RFI I.2024_Answer Q1‐Q5.
Annex 2.1.1, RFI I.2024 Answer Q1‐5, RFI I.2024 Annex 1 and RFI I.2024 Annex 2. Limit of detection: coliforms (< 10 mg/g of mL), total viable counts (100 CFU/g), Bacillus cereus (10 CFU/g), Enterobacteriaceae (10 CFU/g), yeasts and filamentous fungi (< 10 CFU/g). Limit of quantification: lead (< 0.5 mg/kg), arsenic (0.30 mg/kg), cadmium (0.05 mg/kg) and mercury (0.05 mg/kg).
Annex 2.4.1e, Physical properties of solid alpha amylase.
Annex 2.XX and RFI I.2024 Answer Q1‐5.
Annex 2.XX RFI I.2024 Answer Q1‐5.
RONO HiStarch_SECTION 2.4 and Annex 2.4.3_stab per se solid.
RONO HiStarch_SECTION 2.4 and Annex 2.4.1d.
RONO HiStarch_SECTION 2.4 and Annex 2.4.2.
Annex 2.4.1a.
Annex 2.4.1c.
RONO HiStarch_SECTION 2.5. and RFI II.2024 – Answers to additional questions on Species.
RFI I.2024 Annex 3.
RFI I.2024 – Answer Q7.
Annexes 3.4, 3.5, 3.6, 3.7, 3.8 and RFI I.2024_Answer Q7.
RONO HiStarch_SECTION 3.2.
RONO HiStarch_SECTION 3.3_July 2023.
Annexes 3.7 and 3.8.
Annex 3.6.
Annex 3.9.
Annex 3.5.
Annexes 4.3.
Annexes 4.1, Annexes 4.2, RFI II.2024 – Answers to additional questions on Efficacy, RFI II.2024 – Certificate of analysis B‐560 and RFI II.2024 – Certificate of analysis B‐570.
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.
REFERENCES
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