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This document is a complete report of the Italian Legislation on Animal-Assisted Interventions

EFSA received an application from the Dutch Competent Authority, under Article 20 of Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011, for the evaluation of an alternative method for treatment of Category 3 animal by‐products (ABP). It consists of the hydrolysis of the material to short‐carbon chains, resulting in medium‐chain fatty acids that may contain up to 1% hydrolysed protein, for use in animal feed. A physical process, with ultrafiltration followed by nanofiltration to remove hazards, is also used. Process efficacy has been evaluated based on the ability of the membrane barriers to retain potential biological hazards present. Small viruses passing the ultrafiltration membrane will be retained at the nanofiltration step, which represents a Critical Control Point (CCP) in the process. This step requires the Applicant to validate and provide certification for the specific use of the nanofiltration membranes used. Continuous monitoring and membrane integrity tests should be included as control measures in the HACCP plan. The ultrafiltration and nanofiltration techniques are able to remove particles of the size of virus, bacteria and parasites from liquids. If used under controlled and appropriate conditions, the processing methods proposed should reduce the risk in the end product to a degree which is at least equivalent to that achieved with the processing standards laid down in the Regulation for Category 3 material. The possible presence of small bacterial toxins produced during the fermentation steps cannot be avoided by the nanofiltration step and this hazard should be controlled by a CCP elsewhere in the process. The limitations specified in the current legislation and any future modifications in relation to the end use of the product also apply to this alternative process, and no hydrolysed protein of ruminant origin (except ruminant hides and skins) can be included in feed for farmed animals or for aquaculture.

EFSA received an application from the Dutch Competent Authority, under Article 20 of Regulation (EC)No 1069/2009 and Regulation (EU) No 142/2011, for the evaluation of an alternative method fortreatment of Category 3 animal by-products (ABP). It consists of the hydrolysis of the material to short-carbon chains, resulting in medium-chain fatty acids that may contain up to 1% hydrolysed protein, foruse in animal feed. A physical process, with ultrafiltration followed by nanofiltration to remove hazards, isalso used. Process efficacy has been evaluated based on the ability of the membrane barriers to retainpotential biological hazards present. Small viruses passing the ultrafiltration membrane will be retained atthe nanofiltration step, which represents a Critical Control Point (CCP) in the process. This step requiresthe Applicant to validate and provide certification for the specific use of the nanofiltration membranesused. Continuous monitoring and membrane integrity tests should be included as control measures in theHACCP plan. The ultrafiltration and nanofiltration techniques are able to remove particles of the size ofvirus, bacteria and parasites from liquids. If used under controlled and appropriate conditions, theprocessing methods proposed should reduce the risk in the end product to a degree which is at leastequivalent to that achieved with the processing standards laid down in the Regulation for Category 3material. The possible presence of small bacterial toxins produced during the fermentation steps cannotbe avoided by the nanofiltration step and this hazard should be controlled by a CCP elsewhere in theprocess. The limitations specified in the current legislation and any future modifications in relation to theend use of the product also apply to this alternative process, and no hydrolysed protein of ruminantorigin (except ruminant hides and skins) can be included in feed for farmed animals or for aquaculture. ; publishedVersion

EFSA received an application from the Dutch Competent Authority, under Article 20 of Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011, for the evaluation of an alternative method for treatment of Category 3 animal by‐products (ABP). It consists of the hydrolysis of the material to short‐carbon chains, resulting in medium‐chain fatty acids that may contain up to 1% hydrolysed protein, for use in animal feed. A physical process, with ultrafiltration followed by nanofiltration to remove hazards, is also used. Process efficacy has been evaluated based on the ability of the membrane barriers to retain potential biological hazards present. Small viruses passing the ultrafiltration membrane will be retained at the nanofiltration step, which represents a Critical Control Point (CCP) in the process. This step requires the Applicant to validate and provide certification for the specific use of the nanofiltration membranes used. Continuous monitoring and membrane integrity tests should be included as control measures in the HACCP plan. The ultrafiltration and nanofiltration techniques are able to remove particles of the size of virus, bacteria and parasites from liquids. If used under controlled and appropriate conditions, the processing methods proposed should reduce the risk in the end product to a degree which is at least equivalent to that achieved with the processing standards laid down in the Regulation for Category 3 material. The possible presence of small bacterial toxins produced during the fermentation steps cannot be avoided by the nanofiltration step and this hazard should be controlled by a CCP elsewhere in the process. The limitations specified in the current legislation and any future modifications in relation to the end use of the product also apply to this alternative process, and no hydrolysed protein of ruminant origin (except ruminant hides and skins) can be included in feed for farmed animals or for aquaculture.

Food safety criteria for Listeria monocytogenes in ready‐to‐eat (RTE) foods have been applied from 2006 onwards (Commission Regulation (EC) 2073/2005). Still, human invasive listeriosis was reported to increase over the period 2009–2013 in the European Union and European Economic Area (EU/EEA). Time series analysis for the 2008–2015 period in the EU/EEA indicated an increasing trend of the monthly notified incidence rate of confirmed human invasive listeriosis of the over 75 age groups and female age group between 25 and 44 years old (probably related to pregnancies). A conceptual model was used to identify factors in the food chain as potential drivers for L. monocytogenes contamination of RTE foods and listeriosis. Factors were related to the host (i. population size of the elderly and/or susceptible people; ii. underlying condition rate), the food (iii. L. monocytogenes prevalence in RTE food at retail; iv. L. monocytogenes concentration in RTE food at retail; v. storage conditions after retail; vi. consumption), the national surveillance systems (vii. improved surveillance), and/or the bacterium (viii. virulence). Factors considered likely to be responsible for the increasing trend in cases are the increased population size of the elderly and susceptible population except for the 25–44 female age group. For the increased incidence rates and cases, the likely factor is the increased proportion of susceptible persons in the age groups over 45 years old for both genders. Quantitative modelling suggests that more than 90% of invasive listeriosis is caused by ingestion of RTE food containing > 2,000 colony forming units (CFU)/g, and that one‐third of cases are due to growth in the consumer phase. Awareness should be increased among stakeholders, especially in relation to susceptible risk groups. Innovative methodologies including whole genome sequencing (WGS) for strain identification and monitoring of trends are recommended.