Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae CNCM I‐1079 as a zootechnical feed additive for dogs and all other Canidae. The additive is intended for use in feed for dogs and all other Canidae at a proposed minimum inclusion level of 1 × 109 CFU per kg of complete feed. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. Since the identity of the active agent has been clearly established and no concerns are expected from other components of the product, the additive is considered safe for the target species. Since the additive is intended to be used only in feed for dogs and other non‐food‐producing animals, an assessment of the safety for the consumer and the environment is not needed. The non‐coated form of the additive was shown to be non‐irritant to skin and eyes. No conclusion can be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The additive in both forms, should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The Panel was not in the position to conclude on the efficacy of Saccharomyces cerevisiae CNCM I‐1079 at the proposed conditions of use.
Keywords: efficacy, gut flora stabilisers, QPS, Saccharomyces cerevisiae CNCM I‐1079, 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 Danstar Ferment AG 2 for the authorisation of the additive consisting of Saccharomyces cerevisiae CNCM I‐1079, when used as a feed additive for dogs and other Canidae (category: zootechnical additives; functional group: gut flora stabilisers).
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 11 July 2023 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2023‐000486. The particulars and documents in support of the application were considered valid by EFSA as of 18 September 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 Saccharomyces cerevisiae CNCM I‐1079, when used under the proposed conditions of use (see Section 3.1.3 ).
1.2. Additional information
The additive is a preparation containing viable cells of Saccharomyces cerevisiae CNCM I‐1079. It is currently authorised for use in feed for sows and weaned piglets, 3 all pigs other than sows and weaned piglets and all minor porcine species 4 and chickens for fattening and minor poultry species for fattening 5 as gut flora stabilisers, and for turkeys for fattening 6 as other zootechnical additives (reduction of Salmonella spp. contamination on carcasses through its decrease in faeces) (4d1703).
EFSA issued several opinions on the safety and efficacy of this product (under the tradename Levucell® SB) when used in feed for sows, weaned piglets, chickens for fattening, minor poultry species for fattening, turkeys for fattening, all pigs, calves and all other ruminant species and camelids for rearing and for fattening (EFSA FEEDAP Panel, 2016, 2017, 2019a, 2019b, 2022).
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 7 in support of the authorisation request for the use of Saccharomyces cerevisiae CNCM I‐1079 as a feed additive.
In accordance with Article 38 of the Regulation (EC) No 178/2002 8 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, 9 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 11 April to 2 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 20 September 2023 to 20 December 2023 for which the 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, peer‐reviewed scientific papers, other scientific reports and experts' 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 agent in animal feed are valid and applicable for the current application. 10
2.2. Methodologies
The approach followed by the FEEDAP Panel to assess the safety and the efficacy of Saccharomyces cerevisiae CNCM I‐1079 is in line with the principles laid down in Regulation (EC) No 429/2008 11 and the relevant guidance documents: 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 safety of feed additives for the consumer (EFSA FEEDAP Panel, 2017d), 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, 2019c), 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
The additive under assessment contains dried viable cells of Saccharomyces cerevisiae CNCM I‐1079 and is intended to be used as a zootechnical additive (functional group: gut flora stabilisers) in feed for dogs and other Canidae.
3.1. Characterisation
3.1.1. Characterisation of the active agent
The active agent was isolated from grape must and is deposited in the Collection Nationale de Cultures de Microorganismes (CNCM) under the deposit number CNCM I‐1079. 12 The applicant declared that it has not been genetically modified.
The taxonomical identification of the strain was confirmed based on the whole genome sequence (WGS) data. 13 Two sets of data were provided. The first concerned a read‐mapping approach in which sequence reads were aligned to a set of genomes of various Saccharomyces species. The reads showed the highest similarity to those of the reference genome of S. cerevisiae S288C. The second dataset consisted in the comparison of the ribosomal internal transcribed spacer (ITS) sequence with those of the type strains of the Saccharomyces genus. The results showed Saccharomyces cerevisiae NRRL Y‐12632T and CBS 1171 as the closest matches. 14
3.1.2. Characterisation of the additive
The additive under assessment consists of Saccharomyces cerevisiae CNCM I‐1079 and is presented in two formulations:
A non‐coated form, with a minimum guaranteed concentration of 2 × 1010 colony forming units (CFU) per gram.
A coated or microencapsulated form, with a minimum guaranteed concentration of 1 × 1010 CFU/g and vegetable oil fatty acids (■■■■■) used as coating agents (40%–50%).
The additive under assessment has the same composition and method of manufacture as that considered in previous applications, ■■■■■ 15 (EFSA FEEDAP Panel, 2016, 2017, 2019a, 2019b, 2022). Therefore, all the information/data pertaining to composition, purity, physico‐chemical properties and shelf‐life described thereof are also considered valid for this application. New data on batch‐to‐batch variation, purity, dusting potential, stability and homogeneous distribution in pet food of both forms of the additive have been provided and are described below.
The data provided on batch to batch variation (based on five batches) demonstrated compliance with the minimum specifications, showing an average value of 3.5 × 1010 CFU/g (3 × 1010–4 × 1010 CFU/g) for the non‐coated form and 1.6 × 1010 CFU/g (1.5 × 1010–1.6 × 1010 CFU/g) for the encapsulated form. 16
Specifications are set by the applicant for Escherichia coli (< 10 CFU/g additive), Salmonella spp. (no detection in 25 g additive), Enterobacteriaceae and coliforms (< 1000 CFU/g additive). The analysis of three batches of each form of the additive showed compliance with the specifications. 17
The FEEDAP Panel considers that the results of the microbial contamination analyses do not raise safety concerns.
The non‐coated form appears as brown/beige granular particles and the coated form as brown/beige beadlets with glossy appearance.
The dusting potential of three batches of each form of the additive was determined using the Stauber–Heubach method. 18 The non‐coated form showed an average value of 433 mg airborne dust per m3 of air (range 300–600 mg/m3), while the coated form was dust‐free.
The stability of both forms of the additive (three batches each) in complementary feed for dogs was investigated in three studies. In the three studies, dog chews (mainly composed of salmon meal, vegetable oil and gelatine) were prepared with a cold extrusion process (maximum temperature 50°C). The additive was included before extrusion in order to reach a nominal concentration of 1.8 × 1011, 1.4 × 1012 and 2 × 1011 CFU/kg feed, respectively (confirmed by analysis). The samples were stored in high‐density polyethylene (HDPE) plastic jars at room temperature (20–25°C) and ambient relative humidity for up to 6 months for the coated form and 24 months for the non‐coated form. No losses (< 0.5 log of the initial counts) were observed at the end of the storage period in any of the samples tested. 19
The homogeneous distribution of the additive (two batches of each form) in complementary feed was evaluated in 10 subsamples of the feeds prepared in the study described above. The coefficient of variation was 14.4% for the coated form and 18.9% for the non‐coated form. 20
3.1.3. Conditions of use
The additive is intended for use in feed for dogs and all other Canidae at the minimum proposed use level of 1 × 109 CFU/kg complete feed. 21
3.2. Safety
The additive is intended to be used only in feed for dogs and other Canidae, and therefore, there is no need to perform an assessment of the safety for the consumer and the environment.
In the view of the FEEDAP Panel, the identity of the active agent (CNCM I‐1079) has been established as S. cerevisiae. Accordingly, this strain is considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach and therefore it is presumed safe for the target species (EFSA BIOHAZ Panel, 2023). Since no concerns are expected from other components of the product, the additive Saccharomyces cerevisiae CNCM I‐1079 is also considered to be safe for the target species.
3.2.1. Safety for the user
No specific studies investigating the effects of the additive on the respiratory system were submitted. The highest dusting potential analysed for the non‐coated form of the additive was 600 mg/m3. Therefore, the FEEDAP Panel considers that exposure by inhalation is possible. Since the coated form is dust‐free, exposure by inhalation is unlikely.
To support the safety of the additive, three experiments were conducted with the non‐coated form of the additive (one batch) as the test item. 22 These included an eye 23 and a skin 24 irritation study, performed according to the OECD Testing Guidelines (TG) 404 and 405, respectively, and a skin sensitisation study 25 performed according to the OECD TG 429. Based on the results of these studies, the non‐coated form of the additive is considered to be neither irritant to skin or eyes, nor a dermal sensitiser.
No data were provided regarding the eye irritancy potential of the coated form of the additive.
The FEEDAP Panel notes that the OECD test guidelines available at present are designed to assess the skin sensitisation potential of chemical substances only, and that currently no validated assays for assessing the sensitisation potential of microorganisms are available. Therefore, no conclusion can be drawn from the skin sensitisation study submitted (EFSA FEEDAP Panel, 2023).
The additive in both formulations should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk.
3.2.1.1. Conclusions on safety for the user
The non‐coated form of the additive was shown to be non‐irritant to skin and eyes. No conclusion can be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The additive in both formulations, should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk.
3.3. Efficacy
The additive under assessment consists of dried viable cells of Saccharomyces cerevisiae CNCM I‐1079 and is intended to be used as a zootechnical additive (functional group: gut flora stabilisers). The additive is already authorised in sows to have benefits in piglets (4d1703). The applicant claims that, due to the polytocous condition of both of pigs and dogs and the stressful situation of the periparturient period both for mother and puppies, the improved zootechnical performance observed in piglets following the administration of the additive to the sows (EFSA FEEDAP Panel, 2016) might also be seen in the puppies, when bitches are fed with the additive. The FEEDAP Panel notes that effects on growth in pets might be considered relevant endpoints when related to the health status of the animals, e.g. reflected in a measurable effect on morbidity/mortality, but not alone. The applicant has provided one efficacy study to support the efficacy for the target species that is described below.
A total of 36 dog bitches (Canis familiaris) from breeds ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■. The analysed counts of the additive ■■■■■ were confirmed in one random sample. 30 No leftovers of the ■■■■■ were found. ■■■■■.
The health status and veterinary medical interventions of the bitches and the litters were daily monitored, and the puppies' mortality recorded. The bodyweight (BW) and body condition score (BCS) 31 of the bitches were recorded on days 28 (start of the trial) and 56 of gestation, and at days 1, 28 and 56 post‐partum. The individual feed intake was daily monitored. Regarding the litters' performance, the number of puppies born per litter, stillborn and alive, the litter feed intake, the quartile of individual birth weight distribution 32 and the weight of the puppies at birth and at weaning were recorded. The average daily gain (ADG) and average daily solid feed intake (ADFI) of the litter were calculated.
■■■■■ ■■■■■ The statistical level was set at 0.10 (Tables 1 and 2).
TABLE 1.
Effects of Saccharomyces cerevisiae CNCM I‐1079 supplementation of bitches.
| Groups | Body weight | Body condition score | Feed intake 1 | |||
|---|---|---|---|---|---|---|
| Day 56 of gestation | Day 56 post‐ partum | Day 56 of gestation | Day 56 post‐partum | Gestation | Lactation | |
| CFU/kg complete feed | kg | kg | g/day | g/day | ||
| 0 | 33.5 | 29.0a | 5.21 | 5.16 | 524 | 936 |
| 1.0 × 109 | 30.6 | 26.7b | 4.77 | 5.10 | 529 | 838 |
Means in a column with different superscript letters are significantly different p < 0.1.
94.3% dry matter.
TABLE 2.
Effects of Saccharomyces cerevisiae CNCM I‐1079 supplementation of bitches on the litter.
| Groups | Total number of puppies born | Stillborns | Litter initial weight | Litter final weight | Litter average daily gain | Litter solid feed intake 1 | Pre‐weaning mortality |
|---|---|---|---|---|---|---|---|
| CFU/kg complete feed | n | n (%) | kg | kg | % | g/day | n (%) |
| 0 | 142 | 17 (12.0%) | 2.93b | 23.7 | 781 | 326 | 14 (11.2%) |
| 1.0 × 109 | 142 | 13 (9.2%) | 3.07a | 25.1 | 778 | 289 | 18 (14.0%) |
Means in a column with different superscript letters are significantly different p < 0.1.
93.7% dry matter; the intake of feed corresponds to the period 28–56 days, in which solid feed was offered to the puppies.
No bitch died during the trial. From litters, the rates of stillborn were 12.0% and 9.2%, and the pre‐weaning mortality was 11.2% and 14.0% for the control and supplemented groups, respectively. No differences were observed between groups in any case. The morbidity rate was within commercial breeding levels both for the bitches and the litters.
No difference (p > 0.10) in any of the parameters recorded in the bitches was observed between groups.
The supplementation of the bitches with the additive at the proposed use level showed, at birth, a higher litter BW and a higher number of puppies on the heavier quartiles of BW (Q1: 41 vs. 19; Q2: 39 vs. 26; Q3: 26 vs. 51; Q4: 19 vs. 33 for the control vs supplemented group, respectively; p < 0.10 in all cases). However, the litter BW at weaning, the ADG and the ADFI showed no differences between groups. Therefore, as the higher weight of the puppies at birth was not confirmed at weaning and did not result in a better health status (morbidity/mortality rates) during the lactation period, the FEEDAP Panel considers that the potential efficacy of the additive in dogs is not demonstrated.
3.3.1. Conclusion on the efficacy for dogs
The FEEDAP Panel is not in the position to conclude on the efficacy of S. cerevisiae CNCM I‐1079 for dogs and other Canidae at the proposed conditions of use.
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 33 and Good Manufacturing Practice.
4. CONCLUSIONS
Saccharomyces cerevisiae CNCM I‐1079 is considered safe for the target species.
The non‐coated form of the additive was shown to be non‐irritant to skin and eyes. No conclusion can be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The additive in both forms, should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk.
The FEEDAP Panel is not in the position to conclude on the efficacy of Saccharomyces cerevisiae CNCM I‐1079 for dogs and other Canidae at the proposed conditions of use.
ABBREVIATIONS
- ADFI
average daily feed intake
- ADG
average daily gain
- BW
body weight
- CFU
colony forming unit
- CV
coefficient of variation
- EURL
European Union Reference Laboratory
- FEEDAP
EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed
- LOD
limit of detection
- LOQ
limit of quantification
- OECD
Organisation for Economic Co‐operation and Development
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‐2023‐00486
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. , Yurkov, A. , Anguita, M. , … Brozzi, R. (2024). Safety and efficacy of a feed additive consisting of Saccharomyces cerevisiae CNCM I‐1079 for dogs and all other Canidae (Danstar Ferment AG). EFSA Journal, 22 (7), e8847. 10.2903/j.efsa.2024.8847
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.
Danstar Ferment AG, represented in the EU by Lallemand SAS, Rue des Briquetiers 19, BP59–31702, Blagnac Cedex, France.
Commission Implementing Regulation (EU) 2018/347 of 5 March 2018 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I‐1079 as a feed additive for piglets and sows and amending Regulations (EC) No 1847/2003 and (EC) No 2036/2005 (holder of authorisation Danstar Ferment AG represented by Lallemand SAS). OJ L 67, 09.03.2018, p. 21.
Commission Implementing Regulation (EU) 2019/892 of 28 May 2019 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I‐1079 as a feed additive for all pigs other than weaned piglets and sows and all minor porcine species (holder of authorisation Danstar Ferment AG represented by Lallemand SAS). OJ L 142, 29.5.2019, p. 57.
Commission Implementing Regulation (EU) 2017/1905 of 18 October 2017 concerning an authorisation of the preparation of Saccharomyces cerevisiae CNCM I‐1079 as a feed additive for chickens for fattening and for minor poultry species for fattening (holder of authorisation Danstar Ferment AG represented by Lallemand SAS). OJ L 269, 19.10.2017, p. 30.
Commission Implementing Regulation (EU) 2020/162 of 5 February 2020 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I‐1079 as a feed additive for turkeys for fattening (holder of authorisation Danstar Ferment AG represented by Lallemand SAS).
Dossier reference: FEED‐2023‐15136.
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_4b.
Annex_II_4c and 2023‐12‐20_reply_sin_request_q1.
Annex_II_4c.
Sect_II_identity_part_2 and 2024‐05‐14_SIn_reply.
Annex_II_2.
Annex_II_2.
Annex_II_3.
Annex_II_5i_stab_homogeneity_petfood.
Annex_II_5i_stab_homogeneity_petfood.
Section_II_part_4.
Sect_III_safety_part_3.
Annex_III_4a.
Annex_III_1a.
Annex_III_2: Available online: https://www.unece.org/fileadmin/DAM/trans/danger/publi/ghs/ghs_rev04/English/ST‐SG‐AC10‐30‐Rev4e.pdf.
■■■■■
■■■■■
■■■■■
■■■■■
annex_IV_10_coa_caps.
■■■■■
For each breed, birth weights were divided in four quartiles according to their distribution based on historical data from the breeding facility (2024‐03‐11_SIn_reply).
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
- EFSA (European Food Safety Authority) . (2021). EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain. EFSA Journal, 19(7), 6506. 10.2903/j.efsa.2021.6506 [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards) , Koutsoumanis, K. , Allende, A. , Álvarez‐Ordóñez, A. , Bolton, D. , Bover‐Cid, S. , Chemaly, M. , De Cesare, A. , Hilbert, F. , Lindqvist, R. , Nauta, M. , Peixe, L. , Ru, G. , Simmons, M. , Skandamis, P. , Suffredini, E. , Cocconcelli, P. S. , Fernández Escámez, P. S. , Prieto Maradona, M. , … Herman, L. (2023). Scientific Opinion on the update of the list of qualified presumption of safety (QPS) recommended microorganisms intentionally added to food or feed as notified to EFSA. EFSA Journal, 21(1), 7747. 10.2903/j.efsa.2023.7747 [DOI] [Google Scholar]
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) . (2016). Scientific Opinion on the safety and efficacy of Levucell® SB (Saccharomyces cerevisiae CNCM I‐1079) as a feed additive for weaned piglets and sows. EFSA Journal, 14(6), 4478. 10.2903/j.efsa.2016.4478 [DOI] [Google Scholar]
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Rychen, G. , Aquilina, G. , Azimonti, G. , Bampidis, V. , Bastos, M. L. , Bories, G. , Chesson, A. , Cocconcelli, P. S. , Flachowsky, G. , Gropp, J. , Kolar, B. , Kouba, M. , Alonso, M. L. , Puente, S. L. , Mantovani, A. , Mayo, B. , Ramos, F. , Villa, R. E. , … Saarela, M. (2017a). Scientific Opinion on the safety and efficacy of Levucell® SB (Saccharomyces cerevisiae CNCM I‐1079) as a feed additive for chickens for fattening and minor poultry species. EFSA Journal, 15(1), 4674. 10.2903/j.efsa.2017.4674 [DOI] [Google Scholar]
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Rychen, G. , Aquilina, G. , Azimonti, G. , Bampidis, V. , Bastos, M. L. , Bories, G. , Chesson, A. , Cocconcelli, P. S. , Flachowsky, G. , Gropp, J. , Kolar, B. , Kouba, M. , López‐Alonso, M. , López Puente, S. , Mantovani, A. , Mayo, B. , Ramos, F. , Saarela, M. , … Innocenti, M. L. (2017b). Guidance on the identity, characterisation and conditions of use of feed additives. EFSA Journal, 15(10), 5023. 10.2903/j.efsa.2017.5023 [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Rychen, G. , Aquilina, G. , Azimonti, G. , Bampidis, V. , Bastos, M. L. , Bories, G. , Chesson, A. , Cocconcelli, P. S. , Flachowsky, G. , Gropp, J. , Kolar, B. , Kouba, M. , López‐Alonso, M. , López Puente, S. , Mantovani, A. , Mayo, B. , Ramos, F. , Saarela, M. , … Martino, L. (2017c). Guidance on the assessment of the safety of feed additives for the target species. EFSA Journal, 15(10), 5021. 10.2903/j.efsa.2017.5021 [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Rychen, G. , Aquilina, G. , Azimonti, G. , Bampidis, V. , Bastos, M. L. , Bories, G. , Chesson, A. , Cocconcelli, P. S. , Flachowsky, G. , Gropp, J. , Kolar, B. , Kouba, M. , López‐Alonso, M. , López Puente, S. , Mantovani, A. , Mayo, B. , Ramos, F. , Saarela, M. , … Innocenti, M. L. (2017d). Guidance on the assessment of the safety of feed additives for the consumer. EFSA Journal, 15(10), 5022. 10.2903/j.efsa.2017.5022 [DOI] [Google Scholar]
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Rychen, G. , Aquilina, G. , Azimonti, G. , Bampidis, V. , Bastos, M. L. , Bories, G. , Chesson, A. , Cocconcelli, P. S. , Flachowsky, G. , Gropp, J. , Kolar, B. , Kouba, M. , López‐Alonso, M. , López Puente, S. , Mantovani, A. , Mayo, B. , Ramos, F. , Saarela, M. , … Martino, L. (2018a). Guidance on the assessment of the efficacy of feed additives. EFSA Journal, 16(5), 5274. 10.2903/j.efsa.2018.5274 [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Rychen, G. , Aquilina, G. , Azimonti, G. , Bampidis, V. , Bastos, M. L. , Bories, G. , Chesson, A. , Cocconcelli, P. S. , Flachowsky, G. , Gropp, J. , Kolar, B. , Kouba, M. , López‐Alonso, M. , López Puente, S. , Mantovani, A. , Mayo, B. , Ramos, F. , Saarela, M. , … Galobart, J. (2018b). Guidance on the characterisation of microorganisms used as feed additives or as production organisms. EFSA Journal, 16(3), 5206. 10.2903/j.efsa.2018.5206 [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Bampidis, V. , Azimonti, G. , Bastos, M. , Christensen, H. , Dusemund, B. , Kouba, M. , Kos Durjava, M. , López‐Alonso, M. , López Puente, S. , Marcon, F. , Mayo, B. , Pechová, A. , Petkova, M. , Ramos, F. , Sanz, Y. , Villa, R. , Woutersen, R. , & Brozzi, R. (2019a). Scientific Opinion on the safety and efficacy of Levucell® SB (Saccharomyces cerevisiae CNCM I‐1079) as a feed additive for all pigs. EFSA Journal, 17(1), 5535. 10.2903/j.efsa.2019.5535 [DOI] [Google Scholar]
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Bampidis, V. , Azimonti, G. , de Lourdes Bastos, M. , Christensen, H. , Dusemund, B. , Kouba, M. , Kos Durjava, M. , López‐Alonso, M. , López Puente, S. , Marcon, F. , Mayo, B. , Pechová, A. , Petkova, M. , Ramos, F. , Sanz, Y. , Villa, R. E. , Woutersen, R. , Anguita, M. , … Pizzo, F. (2019b). Scientific Opinion on the safety and efficacy of Levucell® SB (Saccharomyces cerevisiae CNCM I‐1079) as a feed additive for turkeys for fattening. EFSA Journal, 17(4), 5693. 10.2903/j.efsa.2019.5693 [DOI] [Google Scholar]
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Bampidis, V. , Bastos, M. , Christensen, H. , Dusemund, B. , Kouba, M. , Kos Durjava, M. , López‐Alonso, M. , López Puente, S. , Marcon, F. , Mayo, B. , Pechová, A. , Petkova, M. , Ramos, F. , Sanz, Y. , Villa, R. E. , Woutersen, R. , Brock, T. , de Knecht, J. , … Azimonti, G. (2019c). Guidance on the assessment of the safety of feed additives for the environment. EFSA Journal, 17(4), 5648. 10.2903/j.efsa.2019.5648 [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Bampidis, V. , Azimonti, G. , Bastos, M. L. , Christensen, H. , Dusemund, B. , Fasmon Durjava, M. , Kouba, M. , López‐Alonso, M. , López Puente, S. , Marcon, F. , Mayo, B. , Pechová, A. , Petkova, M. , Ramos, F. , Sanz, Y. , Villa, R. E. , Woutersen, R. , Anguita, M. , … Brozzi, R. (2022). Scientific Opinion on the safety and efficacy of a feed additive consisting of Saccharomyces cerevisiae CNCM I1079 for calves, all other ruminant species and camelids for rearing and for fattening (Danstart ferment AG). EFSA Journal, 20(10), 7605. 10.2903/sp.efsa.2022.7605 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 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. , Chesson, A. , … Galobart, J. (2023). Guidance on the assessment of the safety of feed additives for the users. EFSA Journal, 21(12), e8469. 10.2903/j.efsa.2023.8469 [DOI] [PMC free article] [PubMed] [Google Scholar]