Efficacy Of Ronozyme Research Articles

Safety and efficacy of a feed additive consisting of alpha-amylase (produced with Bacillus licheniformisDSM 34315) (Ronozyme® HiStarch) for chickens for fattening, turkeys for fattening and minor growing poultry species (DSM Nutritional Products Ltd).

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.

Safety and efficacy of a feed additive consisting of serine protease produced by Bacillus licheniformisDSM 19670 (Ronozyme® ProAct) for chickens for fattening (DSM Nutritional Products Ltd.).

Ronozyme® ProAct is the trade name of the feed additive under assessment and contains serine protease produced by a genetically modified strain of Bacillus licheniformis. Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Ronozyme® ProAct when used as a zootechnical additive for chickens for fattening. The additive is available in coated thermotolerant granulated and liquid forms (Ronozyme® ProAct CT/L). The production strain and its recombinant DNA were not detected in an intermediate concentrated product used to produce the final formulations. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in a tolerance study in chickens for fattening and the data from a subchronic oral toxicity study the FEEDAP Panel concluded that the additive is safe for chickens for fattening. The FEEDAP Panel concluded that the use of Ronozyme® ProAct CT/L as a feed additive gives rise to no concern for consumers and for the environment. The additive, in either form, is not an eye irritant but should be considered a skin irritant. In the absence of data, no conclusions on the skin sensitisation potential can be reached. Owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The FEEDAP Panel also concluded that the additive has the potential to be efficacious at 15,000 PROT/kg compound feed for chickens for fattening.

Efficacy of RONOZYME®WX (endo-1,4-β-xylanase) as a feed additive for laying hens.

RONOZYME ® WX is an additive that contains endo‐1,4‐β‐xylanase which is authorised for use as a feed additive in poultry for fattening, weaned piglets and pigs for fattening. The Panel on additives and Products or Substances used in Animal Feed (FEEDAP) delivered in 2012 an opinion on the safety and efficacy of RONOZYME ® WX when used as a feed additive for poultry, piglets (weaned) and pigs for fattening and another one in 2016 on the change of the production strain proposed by the applicant. In those opinions, the FEEDAP Panel concluded that the use of the product as a feed additive raise no concerns for consumer safety or for the environment. Considering the safety for the user, the Panel concluded that the additive is not a skin or eye irritant but could not conclude on the skin sensitisation potential of the additive, however, and owing to the proteinaceous nature of the active substance the additive was considered a potential respiratory sensitiser. In a further application, the applicant requested the use of the additive in laying hens. The tolerance trial provided for that assessment allowed to conclude that the additive is safe for laying hens under the recommended conditions of use. In the same application and in order to support the efficacy of the additive in laying hens, the applicant submitted three long‐term trials. In all three trials, the groups receiving the xylanase at the recommended dose showed a lower feed intake and a better feed to egg mass ratio. However, in one of the three trials, these reductions were seen concurrently with a decrease in the laying rate. This result casted doubts on the efficacy of the additive, and therefore, the Panel considered that there was not sufficient evidence to conclude on the efficacy of the product. The applicant provided a further efficacy trial in which the results showed that the hens that received the additive had a better laying performance at the recommended level of 100 FXU/kg and allowed the Panel to conclude that the additive is efficacious as a zootechnical additive in laying hens.

Safety and efficacy of RONOZYME®WX CT/L (endo-1,4-β-xylanase) as a feed additive for sows for reproduction.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of RONOZYME ® WX CT/L as a feed additive for sows for reproduction. This additive contains endo‐1,4‐β‐xylanase produced by a genetically modified strain of Aspergillus oryzae and it is authorised in the EU as a feed additive for poultry for fattening, weaned piglets and pigs for fattening. The applicant requests the extension of use of the additive to sows for reproduction at 200 FXU/kg feed. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected from the use of RONOZYME ® WX in sows. The FEEDAP Panel concluded that the additive is not a skin or eye irritant, but it should be considered a respiratory sensitiser, but could not conclude on the skin sensitisation potential of the additive. A tolerance trial in lactating sows and two toxicological studies were made available to support the safety of the target species. Based on the data available, the FEEDAP Panel concluded that the additive is safe for sows for reproduction at the recommended level with a wide margin of safety. Three efficacy studies in lactating sows were evaluated. Sows that received RONOZYME ® WX showed improvements on the apparent faecal digestibility of the energy in the three trials. The enzyme activity in feed that showed efficacy ranged from 124 to 287 FXU/kg feed, and the FEEDAP Panel concluded that the additive has the potential to be efficacious as a zootechnical additive in lactating sows at a level of approximately 250 FXU/kg feed. No data has been provided in gestating sows, and consequently, the Panel could not conclude on this physiological stage of the productive cycle.

Safety and efficacy of RONOZYME®WX (endo-1,4-β-xylanase) as a feed additive for laying hens.

RONOZYME ® WX is an additive that contains endo‐1,4‐β‐xylanase which is authorised for use as a feed additive in poultry for fattening, weaned piglets and pigs for fattening. The applicant has requested for an extension of the use to laying hens. The Panel on additives and Products or Substances used in Animal Feed (FEEDAP) delivered in 2012 an opinion on the safety and efficacy of RONOZYME ® WX when used as a feed additive for poultry, piglets (weaned) and pigs for fattening and another one in 2016 on the change of the production strain proposed by the applicant. In those opinions, the FEEDAP Panel concluded that the use of the product as a feed additive raises no concerns for consumer safety or for the environment. Considering the safety for the user, the Panel concluded that the additive is not a skin or eye irritant but could not conclude on its skin sensitisation potential; however, the additive was considered a potential respiratory sensitiser. The Panel considered that the new use of RONOZYME ® WX would not modify those conclusions. The applicant submitted a tolerance study in laying hens the results of which permitted the Panel to conclude that the additive is safe for laying hens at the recommended dose of 100 FXU/kg feed. In order to support the efficacy of the additive in laying hens, the applicant submitted three long‐term trials. In all three trials, the groups receiving the xylanase at the recommended dose showed a lower feed intake and a better feed to egg mass ratio. However, in one of the three trials, these reductions were seen concurrently with a decrease in the laying rate. This result casts doubts on the efficacy of the additive, and therefore, the Panel considered that there was not sufficient evidence to conclude on the efficacy of the product.

Safety and efficacy of RONOZYME® WX (endo-1,4-beta-xylanase) as a feed additive for chickens and turkeys for fattening, minor poultry species for fattening, weaned piglets and pigs for fattening

The additive RONOZYME® WX is a preparation of endo-1,4-beta-xylanase produced with a genetically modified strain of Aspergillus oryzae, currently authorised for poultry for fattening, weaned piglets and pigs for fattening. The applicant has requested to change the production strain. The manufacturing process and the composition of the additive have not been modified and therefore the formulations of the additive remain as those previously reported. The new production strain derives from the same parental strain as the previous one and harbours the same xylanase gene, but the sequence of genetic modifications is different. The safety of the recipient strain was previously evaluated by EFSA. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) concluded that RONOZYME® WX, manufactured with the new production strain, does not give rise to safety concerns with regard to genetic modification. Neither the production strain nor its recombinant DNA was detected in the fermentation product used to formulate the additive. Based on tolerance and efficacy studies performed with the additive obtained with the previous production strain, the Panel concluded that the additive is safe for poultry for fattening at 200 FXU/kg feed and in weaned piglets and pigs for fattening at 400 FXU/kg feed and efficacious in poultry species for fattening at 100 FXU/kg feed and in weaned piglets and pigs for fattening at 200 FXU/kg. Based on toxicological studies performed with the fermentation product obtained with the new production strain, the Panel concluded that there is no reason for concern for consumer safety arising from the use of the product as a feed additive. The additive poses no risk to the environment. The additive is not a skin or an eye irritant but the Panel could not conclude on its skin sensitisation potential. Because of the proteinaceous nature of the active substance, the additive is considered a potential respiratory sensitiser.

Safety and efficacy of RONOZYME® NP (6‐phytase) as a feed additive for pigs for fattening

The additive RONOZYME® NP is a preparation of 6-phytase produced by a genetically modified strain of Aspergillus oryzae. This product is authorised in the European Union as a feed additive for poultry, weaned piglets, pigs for fattening and sows. The authorisation of RONOZYME® NP for use in pigs for fattening is at a minimum dose of 1,500 FYT/kg feed (recommended range 1,500–3,000 FYT/kg feed). The applicant requested to modify the terms of the authorisation for this species/category of animals, by lowering the minimum recommended dose from 1,500 to 1,000 FYT/kg feed. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded in previous assessments that the additive is safe for the target species, the consumers and the environment, and that the solid forms of the additive are regarded as dermal and eye irritants and all forms are assumed to be respiratory sensitisers. The reduction in the dose proposed would not change the previous conclusions regarding the safety for the target animals, consumer, user and environment. Three trials carried out with growing pigs were submitted in order to support the efficacy at the new recommended dose. In all the trials faecal apparent digestibility of phosphorus was measured, retention was measured only in one trial. The demonstration of efficacy for a phytase requires three studies showing positive and significant effects on the retention of phosphorus. In the trials submitted, the phosphorus retention was studied only in one trial; consequently the efficacy at the newly recommended dose was not demonstrated.

Safety and efficacy of RONOZYME® HiPhos (6‐phytase) as a feed additive for sows and fish

Safety and efficacy of RONOZYME® HiPhos (6‐phytase) as a feed additive for sows and fish

Scientific Opinion on the efficacy of Ronozyme® Rumistar (alpha‐amylase) as a feed additive for dairy cows

Ronozyme® Rumistar is a preparation of alpha-amylase produced by a genetically modified strain of Bacillus licheniformis which is intended for use as a zootechnical feed additive for dairy cows. The FEEDAP Panel issued an opinion on the safety and efficacy of this product as a feed additive for dairy cows. The assessment performed considered the characterisation of the product, the safety aspects for the consumer, user and environment, as well as for the genetic modification of the production strain and the efficacy of the product for the target species. However, the Panel could not draw conclusions on the efficacy of the product. The additive is intended to be used in lactating dairy cows fed a plant-based diet of “medium starch content”. The applicant provided additional data on one study already evaluated. In a reduced set of data, the results showed a significant increase in cows fed Ronozyme® Rumistar compared with control cows when fed a total mixed ration diet with a normal starch content. Additionally, one digestibility study was provided but cannot be considered because of the parameters measured. Considering all the data made available by the applicant, no conclusions can be drawn on the efficacy of Ronozyme® Rumistar in dairy cows.

Scientific Opinion on the safety and efficacy of Ronozyme®HiPhos M/L (6-phytase) as a feed additive for poultry and pigs

Scientific Opinion on the safety and efficacy of Ronozyme^®HiPhos M/L (6-phytase) as a feed additive for poultry and pigs

Scientific Opinion on the safety and efficacy of Ronozyme®P (6‐phytase) as a feed additive for salmonids

Ronozyme®P is a liquid preparation of 6-phytase produced by a genetically modified strain of Aspergillus oryzae. The safety of the genetic modification of the current production strain has been previously established by EFSA in 2004. The product has been fully described in previous opinions and the safety of the product for the consumers, users and the environment has been assessed. In the view of the FEEDAP Panel, the use of the product in salmonids would not affect the conclusions reached in previous opinions. The results from a tolerance trial performed in rainbow trout (Oncorhynchus mykiss), where fish were fed 100-fold the maximum recommended dose, showed that Ronozyme®P is safe for salmonids at the maximum dose of 2000 FYT/kg. Five short-term efficacy studies (four with rainbow trout and one with Atlantic salmon (Salmo salar)) were performed with the additive. Phosphorus utilisation was improved in two trials performed in rainbow trout at a dose level of 500 FYT/kg and above, and in one trial performed in Atlantic salmon at a dose of 750 FYT/kg and above. Therefore, it is concluded that Ronozyme®P is efficacious in salmonids at the minimum recommended dose of 750 FYT/kg. The use of the additive allows the use of diets with a lower level of inorganic P, which may in turn reduce the excretion of P.

Scientific Opinion on the safety and efficacy of Ronozyme® NP (6‐phytase) as a feed additive for sows

Scientific Opinion on the safety and efficacy of Ronozyme® NP (6‐phytase) as a feed additive for sows

Safety and efficacy of Ronozyme® ProAct (serine protease) for use as feed additive for chickens for fattening

Safety and efficacy of Ronozyme® ProAct (serine protease) for use as feed additive for chickens for fattening