RESUMEN
Two alternative methods for producing compost in a tunnel, from certain category (Cat.) 3 animal by-products (ABP) and other non-ABP material, were assessed. The first method proposed a minimum temperature of 55°C for 72 h and the second 60°C for 48 h, both with a maximum particle size of 200 mm. The assessment of the Panel on Biological Hazards (BIOHAZ) exclusively focused on Cat. 3 ABP materials (catering waste and processed foodstuffs of animal origin no longer intended for human consumption). The proposed composting processes were evaluated for their efficacy to achieve a reduction of at least 5 log10 of Enterococcus faecalis and Salmonella Senftenberg (775W, H2S negative) and at least 3 log10 of relevant thermoresistant viruses. The applicant provided a list of biological hazards that may enter the composting process and selected parvoviruses as the indicator of the thermoresistant viruses. The evidence provided by the applicant included: (a) literature data on thermal inactivation of biological hazards; (b) results from validation studies on the reduction of E. faecalis, Salmonella Senftenberg 775W H2S negative and canine parvovirus carried out in composting plants across Europe; (c) and experimental data from direct measurements of reduction of infectivity of murine parvovirus in compost material applying the time/temperature conditions of the two alternative methods. The evidence provided showed the capacity of the proposed alternative methods to reduce E. faecalis and Salmonella Senftenberg 775W H2S negative by at least 5 log10, and parvoviruses by at least 3 log10. The BIOHAZ Panel concluded that the two alternative methods under assessment can be considered to be equivalent to the processing method currently approved in the Commission Regulation (EU) No 142/2011.
RESUMEN
An alternative method for the production of biodiesel from processed fats derived from Category 1, 2 and 3 animal by-products was assessed. The method is based on a pre-cleaning process, acidic esterification/transesterification of tallow using 1.5% methanesulfonic acid w/w; 140°C; 5.5 bar absolute pressure (bara); 4 h, followed by fractional distillation. The application focuses on the capacity of the alternative method to inactivate prions. Given the limitations that biodiesel presents for direct measurement of prion infectivity, the BIOHAZ Panel considered, based on the outcome of previous EFSA Opinions and current expert evaluation, that a reduction of 6 log10 in detectable PrPS c signal would be necessary to consider the process at least equivalent to previously approved methods for Category 1 animal by-products. This is in addition to the inactivation achieved by the pressure sterilisation method applied before the application of any biodiesel production method. Experimental data were provided via ad hoc studies commissioned to quantify the reduction in detectable PrPS c in material spiked with scrapie hamster strain 263K, as measured by western blot, for the first two steps, with distillation assumed to provide at least an additional 3 log10 reduction, based on published data. Despite the intrinsic methodological caveats of the detection of PrPS c in laboratory studies, the BIOHAZ Panel considers that the alternative method, including the final fractional distillation, is capable of achieving the required 6 log10 reduction of the strain 263K PrPS c signal. Therefore, the method under assessment can be considered at least equivalent to the processing methods previously approved for the production of biodiesel from all categories of animal by-product raw materials. It is recommended to check the feasibility of the proposed HACCP plan by recording the main processing parameters for a certain time period under real industrial conditions.
RESUMEN
Two alternative methods for the production of compost from certain category 3 animal by-products (catering waste and processed foodstuffs of animal origin) were assessed. The first proposed a minimum temperature of 55°C for 72 h; the second 60°C for 48 h, each with a maximum particle size of 200 mm. The proposed composting processes were assessed by the BIOHAZ Panel for their efficacy to achieve a reduction of 5 log10 of Enterococcus faecalis or Salmonella Senftenberg (775W, H2S negative) and a 3 log10 reduction of the infectivity titre of thermoresistant viruses, such as parvovirus, in the composted material, as set out in Annex V, Chapter 3, Section 2 of Commission Regulation (EU) No 142/2011. The assessment of the BIOHAZ Panel exclusively focused on the ABP raw materials (catering waste and processed foodstuffs) intended for human consumption. The applicant did not provide any validation experiments with direct measurement of the reduction of viability of endogenous indicators or spiked surrogate bacteria. However, from thermal inactivation parameters reported in the literature, it can be concluded that the proposed composting standards can achieve at least a 5 log10 reduction of Enterococcus faecalis or Salmonella Senftenberg 775W. The applicant did not consider thermoresistant viruses as a relevant hazard and therefore did not provide any data from direct measurements of the reduction of infectivity of spiked thermoresistant viruses, nor provide data from validation studies undertaken at national level or data from literature supporting the efficacy of the proposed composting standards on thermoresistant viruses. However, thermoresistant viruses should be considered to be a relevant hazard in this context and validation data should have been provided accordingly. The BIOHAZ Panel considers that the evidence provided by the applicant does not demonstrate that the requirements of Annex V, Chapter 3, Section 2 of Commission Regulation (EU) No 142/2011 are achieved.