Learning curves for high tibial osteotomy using patient-specific instrumentation: a case control study.

Objectives: Three-dimensional (3D) planning and Patient Specific Instrumentation (PSI) can help the surgeon to obtain more predictable results in Medial Opening Wedge High Tibial Osteotomy (mOW-HTO) than the conventional techniques. We compared the accuracy of the PSI and standard techniques and measured the learning curve for surgery time and number of fluoroscopic shots. Methods: We included the first 12 consecutive cases of mOW-HTO performed with 3D planning and PSI cutting guides and the first 12 non-supervised mOW-HTO performed with the standard technique. We recorded surgery time and fluoroscopic time. We calculated the variation (Δ delta) between the planned target and the postoperative result for Hip Knee Ankle Angle (HKA), mechanical medial Proximal Tibia Angle (MPTA), Joint Line Convergence Angle (JLCA) and tibial slope (TS) and compared it both groups. We also recorded the complication rate. We then calculated the learning curves for surgery time, number of fluoroscopic shots, Δ from target in both groups. CUSUM analysis charts for learning curves were applied between the two groups. Results: Mean surgical time and mean number of fluoroscopic shots were lower in PSI group (48.58±7.87 vs. 58.75±6.86 min; p=0.034 and 10.75±3.93 vs. 18.16±4.93 shots; p<0.001). The postoperative ΔHKA was 0.42±0.51° in PSI vs. 1.25±0.87° in conventional, p=0.005. ΔMPTA was 0.50±0.67° in PSI vs. 3.75±1.48° in conventional, p<0.001; ΔTS was 1.00±0.82° in PSI vs. 3.50±1.57° in conventional, p<0.001. ΔJLCA was 1.83±1.11° in PSI vs. 4±1.41° in conventional, p<0.001. The CUSUM analysis favoured PSI group regarding surgery time (p=0.034) and number of shots (p<0.001) with no learning curve effect for ΔHKA, ΔMPTA, ΔJLCA and ΔTS. Conclusions: PSI cutting guides and 3D planning for HTO are effective in reducing the learning curves for operation time and number of fluoroscopic shots. Accuracy of the procedure has been elevated since the first cases.

The role of acetabular cement augmentation in 2-stage revision arthroplasty for prosthetic joint infection of the hip.

INTRODUCTION: In the treatment of chronic prosthetic joint infection (PJI) of the hip, two-stage exchange arthroplasty is commonly employed. Various spacer designs, including Hemi-Spacers and Articulating Spacers, are utilized during this process. However, these spacers are associated with a high rate of mechanical complications and pose a risk of progressive bone loss. This study aims to compare these two types of spacers in terms of mechanical complications, center of rotation (COR) restoration, and preservation of acetabular bone stock. MATERIALS AND METHODS: From 2019 to 2022, patients who underwent two-stage exchange arthroplasty for hip PJI across three hospitals were retrospectively reviewed. Data including demographic, clinical, and microbiological information were collected. Radiographic imaging was analyzed to measure acetabular bone erosion, COR, and periacetabular bone resected. Additionally, the average surgical time in the first and second stages, mechanical complications, and the mean duration of the inter-stage period were recorded. RESULTS: Forty patients were divided into two groups: Group A (Articulating Spacer, n = 23) received a preformed femur spacer with acetabular cement augmentation, while Group B (Hemi-Spacer, n = 17) received a preformed femur spacer alone. Acetabular cement augmentation slightly prolonged the first stage but facilitated a faster second stage during subsequent reimplantation. Spacer dislocation rates were 8.7% in Group A and 17.6% in Group B during the interstage period. Radiographic analysis revealed a statistically significant greater degree of acetabular erosion in Group B. A significant difference in Vertical-COR differential was observed, with a more proximalized revision cup compared to the primary cup in Group B, and Horizontal-COR values closer to the native hip in Group A. CONCLUSIONS: Dynamic spacers with acetabular cement augmentation help preserve peri-acetabular bone stock and prevent progression of acetabular bone erosion during the inter-stage period. Additionally, these spacers reduce the dislocation rates, making reimplantation easier and leading to better restoration of hip biomechanics during the second procedure.

Different intraoperative joint laxity patterns do not impact clinical outcomes in robotic-assisted medial unicompartmental knee replacement with 1-to-1 surface reconstruction.

PURPOSE: Robotic-assisted technology in medial unicompartmental knee arthroplasty (mUKA) allows for customized adjustments of joint laxity through virtual preoperative component positioning before bone preparation. Nevertheless, the optimal balancing curve has yet to be delineated. This study sought to investigate if varying intraoperative knee laxity patterns had any impact on postoperative patient outcomes. MATERIALS AND METHODS: A retrospective analysis was conducted on prospectively collected data from 326 fixed-bearing RAUKA procedures performed between 2018 and 2022 with a minimum 2-year follow-up. Patients were categorized into three cohorts based on intraoperative joint laxity patterns (millimetres of joint gap during valgus stress) imparted at 20°, 60°, 90° and 120° of knee flexion: cohort 1 < +0.5 mm (tight); cohort 2 between 0.6 and 1.9 mm (physiologic); cohort 3 > 2 mm (loose). Wilcoxon and Kruskal-Wallis tests were conducted to assess patient-reported outcome measure (PROM) improvements and preoperative and postoperative differences across the cohorts. A Spearman's test evaluated the correlation between knee balance at all degrees of flexion and preoperative and postoperative HKA. RESULTS: No differences in preoperative and postoperative PROMs were identified across the cohorts (p > 0.05). All three cohorts with different joint laxity patterns showed a significant improvement in the postoperative PROMS (p < 0.05). The preoperative or postoperative limb alignment did not significantly affect clinical outcomes relative to different laxity patterns. CONCLUSION: No differences were found in the outcomes across different joint laxity patterns in robotic-assisted medial UKA using fixed-bearing mUKAs. There was no evident advantage for maintaining a closer to physiologic laxity compared to tighter or looser balancing. LEVEL OF EVIDENCE: Level III therapeutic study.

Safety and efficacy of a feed additive consisting of Loigolactobacillus coryniformis DSM 34345 as a silage additive for all animal species (Lactosan GmbH & Co.KG).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Loigolactobacillus coryniformis DSM 34345 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use with all fresh plant material for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material. The bacterial species L. coryniformis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established and no acquired antimicrobial resistance genes of concern were detected. Therefore, the FEEDAP Panel concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed the treated silage and for the environment. Regarding user safety, the additive containing Loigolactobacillus coryniformis DSM 34345 should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. One preparation was shown not to be irritant to skin or eyes. However, the Panel cannot assess the irritation potential of other possible preparations. The FEEDAP Panel concluded that Loigolactobacillus coryniformis DSM 34345 has the potential to improve the production of silages prepared from all fresh plant materials at a minimum concentration of 1 × 108 CFU/kg fresh material.

Assessment of the feed additive consisting of Levilactobacillus brevis DSM 16680 for all animal species for the renewal of its authorisation (Microferm Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application of renewal of Levilactobacillus brevis DSM 16680 as a technological feed additive (functional group: silage additives) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the additive should be considered as an eye irritant and a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Following the Anatomy of the Proximal Tibia With a Standard Anatomic Technique and the Use of an Asymmetrical Tibial Base Plate can Lead to a Mismatched Internal Components' Rotation in Mechanically Aligned Total Knee Arthroplasty.

Background: Tibiofemoral components rotational congruency affects the total knee arthroplasty (TKA) success. The smart insert sensor (I-S) helps to establish tibial component rotation reciprocally to a fixed femoral rotation. We aimed (1) to validate the use of I-S as a possible tool to reach reproducible reciprocal femorotibial rotation (RftR) in TKA independently from anatomic landmarks, reducing outliers in combined and mismatched femorotibial rotation (CftR and MMftR, respectively) positioning and (2) to validate the "curve-on-curve" method for a specific type of asymmetrical tibial component. Methods: From February 2018, we conducted a prospective case-control study including 106 patients undergoing TKA. Patients were divided into 2 groups based on the method used to establish tibial component rotation: with the I-S use (group A, n = 53) and with the standard "curve-on-curve" technique (group B, n = 53). Rotational alignment was calculated using the Berger protocol with postoperative computed tomography scanning. Alignment parameters measured were tibial and femoral component rotations (tR, fR), the CftR, the MMftR, and the RftR. Results: Intraoperative rotation measured by I-S correlated the best with RftR (r = 0.84; P < .001) at the post-operative CT scanning. No significant differences were found between groups A and B regarding all types of rotation (fR: P = .774; tR: P = .467; CftR: P = .847) except for MMftR (P = .036) and RftR (P = .023). There were no outliers in group A but 27 and 12 outliers in group B for MMftR and CftR respectively (P < .001; P = .032). Conclusions: The TKA components' rotation established using a smart I-S intraoperatively is ascribable to the RftR at postoperative computed tomography scan. The I-S helps reduce outliers in the CftR and MMftR. An asymmetrical tibial base plate implanted using the curve-on-curve technique does not create a neutral reciprocal femorotibial rotation significantly increasing the number of cases with mismatched femorotibial internal rotation.

Modification of the terms of authorisation regarding the additive consisting of liquid l-lysine base produced with Corynebacterium glutamicum NRRL B-67439 and NRRL B-67535 for all animal species (ADM specialty ingredients (Europe) B.V.).

Following a request from the European Commission, the EFSA 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 liquid l-lysine base produced with a genetically modified strain of Corynebacterium glutamicum as a nutritional feed additive for all animal species. The l-lysine base liquid produced with C. glutamicum NRRL B-67535 and NRRL B-67439 is currently authorised as a nutritional additive for all animal species. The present application is aimed at modifying the current authorisation to include C. glutamicum NRRL B-68248 as a production strain. The new production strain qualifies for the qualified presumption of safety approach when used for production purposes. It was unambiguously identified as C. glutamicum and was shown not to harbour acquired antimicrobial resistance determinants for antibiotics of human and veterinary importance. All the introduced sequences or mutations were considered to be safe, and no viable cells or DNA of the NRRL B-68248 strain was detected in the final product. Therefore, the final product does not pose any safety concern associated with the production strain. l-Lysine base produced using C. glutamicum NRRL B-68248 does not represent a risk for the target species, the consumer or the environment. The additive was considered to be neither irritant to skin or the eyes, nor a dermal sensitiser. l-Lysine base produced with C. glutamicum NRRL B-68248 is considered to be an efficacious source of the essential amino acid l-lysine for non-ruminant animal species. For the supplemental l-lysine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.

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 pigs for fattening, minor porcine species for fattening and turkeys for fattening for the renewal of its authorisation (AVEVE BV).

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 zootechnical feed additive for pigs for fattening, minor porcine species for fattening and turkeys for fattening. 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 forms of the additive remain safe for pigs for fattening, minor porcine species for fattening and turkeys for fattening, consumers and the environment. Regarding the safety for the user, 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 all its 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.

Assessment of the feed additive consisting of sodium propionate for all terrestrial animal species for the renewal of its authorisation (BASF SE).

Sodium propionate is authorised containing at least 98.5% of sodium propionate. The applicants requested for the renewal of the authorisation of sodium propionate when used as a feed additive for all terrestrial animal species. The applicant has provided evidence that the additive in the market complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of sodium propionate under the current authorised conditions of use is safe for the target species, the consumers and the environment. Considering the user safety, the additive is corrosive to skin, eyes and respiratory tract, but is not a skin sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Multicenter survey about leg length discrepancy and total hip arthroplasty: preoperative and intraoperative management.

BACKGROUND: We created a multicenter survey for Italian orthopedic surgeons on how they approach leg length discrepancy (LLD) when dealing with primary total hip arthroplasty. Aim of the study was to show how surgeons manage LLD and follow the literature recommendations during clinical practice. METHODS: The survey was composed of 25 questions divided into four sections: 1-surgeon's profile, 2-preoperative and 3-intraoperative evaluation, and 4-postoperative management. In this paper, we report results to answer Sects. 1 and 2. Absolute and relative frequencies of answers to Sects. 2 and 3 are reported. We divided the participants in subgroups based on the "surgeon's profile" and evaluated difference in the answers given. RESULTS: Absolute and relative frequencies demonstrate low agreement among participants in all phases of LLD management. We demonstrated a statistically significant difference based on the surgeon's profile regarding these questions: radiographic measure of LLD depending on working experience, p = 0.008; digital planning based on surgeons' age, p < 0.001, and workplace, p = 0.026; intraoperative anatomical landmarks based on numbers of procedures per year, p = 0.020; and use of intraoperative X-rays based on working experience, p = 0.002. CONCLUSIONS: LLD is a debated topic with no definitive recommendations. Many decisions still depend on tradition and surgeons' preference.

Assessment of the feed additive consisting of Saccharomyces cerevisiae CNCM I-4407 (Actisaf® Sc 47) for rabbits for fattening and non-food producing rabbits for the renewal of its authorisation (S. I. Lesaffre).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of a preparation of dried cells of Saccharomyces cerevisiae CNCM I-4407 (Actisaf® Sc 47) as a zootechnical additive for rabbits for fattening and non-food producing rabbits. The applicant provided evidence that the additive currently in the market complies with the existing terms of the authorisation. The Panel concluded that the additive remains safe for the target species, consumers and the environment. Regarding the safety for the user, the additive is not a skin or eye irritant. However, it should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Safety and efficacy of a feed additive consisting of Lactococcus lactis DSM 34262 as a silage additive for all animal species (Lactosan GmbH & Co.KG).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Lactococcus lactis DSM 34262 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in easy and moderately difficult to ensile fresh plant material for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material. The bacterial species L. lactis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established and no acquired antimicrobial resistance genes of concern were detected. Therefore, the FEEDAP Panel concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed the treated silage and for the environment. Regarding user safety, the additive containing Lactococcus lactis DSM 34262 should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. One preparation was shown not to be irritant to skin or eyes. However, the Panel cannot assess the irritation potential of other possible preparations. The FEEDAP Panel concluded that Lactococcus lactis DSM 34262 has the potential to improve the fermentation of the silage prepared from fresh plant material with a DM range of 30-35% at a minimum concentration of 1 × 108 CFU/kg fresh material.

Safety and efficacy of a feed additive consisting of Lactiplantibacillus plantarum DSM 34271 as a silage additive for all animal species (Lactosan GmbH & Co.KG).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Lactiplantibacillus plantarum DSM 34271 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in easy and moderately difficult to ensile fresh plant material for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established and no acquired antimicrobial resistance genes of concern were detected. Therefore, the FEEDAP Panel concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed the treated silage and for the environment. Regarding user safety, the additive containing Lactiplantibacillus plantarum DSM 34271 should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. One preparation was shown not to be irritant to skin or eyes. However, the Panel cannot assess the irritation potential of other possible preparations. The FEEDAP Panel concluded that Lactiplantibacillus plantarum DSM 34271 has the potential to improve the fermentation of the silage prepared from fresh plant material with a DM range of 30%-35% at a minimum concentration of 1 × 108 CFU/kg fresh material.

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).

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.

Safety of a feed additive consisting of sepiolite for all animal species (Sepiol S.A. and Tolsa S.A.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of sepiolite as a technological feed additive for all animal species. In 2022, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an Opinion on the safety and efficacy of the same additive. The Panel concluded that sepiolite used as a feed additive is safe for the consumers and the environment, and efficacious as a thickener-suspending agent, binder and anticaking agent in feed for all animal species under the proposed conditions of use. The additive was not considered an eye or skin irritant. However, it was considered a respiratory irritant, a respiratory and dermal sensitiser; owing to the dusting potential and its silica content, the additive was considered a risk by inhalation. Regarding the target species, in the previous Opinion, the Panel concluded on the safety of the additive for dairy ruminants. However, no conclusion could be drawn for all other species/categories. Based on the tolerance studies in chickens for fattening, weaned piglets and trout evaluated in the current assessment, and the one in dairy cows previously assessed, the Panel concluded that the inclusion of sepiolite at the maximum recommended level of 20,000 mg/kg complete feed is safe for all animal species.

Guidance on the assessment of the efficacy of feed additives.

This guidance document is intended to assist the applicant in preparing and presenting an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the efficacy of feed additives.

Scientific opinion on the characterisation of Ensifer adhaerens CGMCC 19596 used in the production of the feed additive consisting of vitamin B12 (cyanocobalamin) for all animal species (Hebei Huarong Pharmaceutical Co., ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the characterisation of the feed additive consisting of vitamin B12 (cyanocobalamin) produced by fermentation with Ensifer adhaerens (CGMCC 19596). The additive is intended to be used as a nutritional additive for all animal species. In a previous opinion, the FEEDAP Panel could not conclude on the characterisation of the production strain, due to uncertainties on whether the production strain E. adhaerens CGMCC 19596 was genetically modified. However, since viable cells and DNA were not detected in the product, the FEEDAP Panel concluded that vitamin B12 (cyanocobalamin), produced with E. adhaerens CGMCC 19596 would not raise safety concerns as regards the production strain. In the present submission, the applicant provided supplementary information regarding the origin and history of modifications of the strain. Based on the data provided, the FEEDAP Panel concluded on the characterisation of the production strain E. adhaerens CGMCC 19596, which can be considered not to be genetically modified.

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 weaned piglets for the renewal of its authorisation and for its extension of use to suckling piglets (AVEVE BV).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy 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) as a zootechnical feed additive for weaned and suckling piglets. The additive is already authorised for use in weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation of the additive for weaned piglets and the extension of use to suckling piglets. 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 the target species, consumers and the environment, and that the extension of use to suckling piglets would not affect these conclusions. 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 all its 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 for weaned piglets. The Panel concluded that the additive is efficacious in suckling piglets at 4000 XU and 900 BGU/kg complete feed.

Assessment of the feed additive consisting of endo-1,4-beta-xylanase (produced with Trichoderma reesei MUCL 49755), endo-1,3(4)-beta-glucanase (produced with T. reesei MUCL 49754) and polygalacturonase (produced with Aspergillus fijiensis CBS 589.94) (AveMix® 02 CS) for weaned piglets for the renewal of its authorisation and for its extension of use to suckling piglets (AVEVE BV).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of endo-1,4-beta-xylanase (produced with Trichoderma reesei MUCL 49755), endo-1,3(4)-beta-glucanase (produced with T. reesei MUCL 49754) and polygalacturonase (produced with Aspergillus fijiensis CBS 589.94) (AveMix® 02 CS/ AveMix® 02 CS L) as a zootechnical feed additive for weaned and suckling piglets. The additive is already authorised for use with weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation of the additive for weaned piglets and the extension of use to suckling piglets. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There was no new evidence that would lead the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider its previous conclusions that the additive is safe for weaned piglets, the consumer and the environment under the authorised conditions of use. This conclusion applied also to the new target species (suckling piglets) for which a request for an extension of use was made. The additive in both formulations (powder and liquid) is not irritant to skin or eyes but should be considered a dermal and respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for weaned piglets. The Panel concluded that the additive is efficacious in suckling piglets at 2140 XU, 1230 BGU and 46 PGLU/kg complete feed.

Animal dietary exposure in the risk assessment of contaminants in feed.

EFSA performs dietary exposure assessments for food-producing and non-food-producing animals to deliver risk assessment for mandates on the presence of contaminants in feed. The CONTAM and FEEDAP Panels identified the need to update the animal dietary exposure assessment model used in those assessments in CONTAM Scientific Opinions since 2011 in cases where insufficient occurrence data are available on species specific compound feeds. The Panels proposed in this statement a series of model diets based on groups of feed materials with the possibility to use different feed materials in their formulation. The Panels considered that the currently proposed model diets cover the need of the CONTAM Panel to assess the dietary exposure of animals to contaminants in feed.