Evaluation of the application for new alternative biodiesel production process for rendered fat including Category 1 animal by‐products (BDI‐RepCat® process, AT)

Abstract

A new alternative method for the production of biodiesel from rendered fat, including animal by‐product ( ABP ) Category 1 tallow, was evaluated. The method consists of a conversion phase, based on esterification and transesterification in a single step (at temperature ≥ 200°C, pressure ≥ 70 bar with a retention time ≥ 15 min), using MgO as a catalyst and in the presence of methanol (10–15%), followed by vacuum distillation (at ≥ 150°C, ≤ 10 mbar) of the end‐product, biodiesel and the co‐product, glycerine. Prions (Pr P S c ), which are abnormal isoforms of the prion protein, were considered by the applicant to be the most resistant hazard. In accordance with previous EFSA Opinions and current expert evaluation, a reduction in prion infectivity, or detectable Pr P S c , of at least 6 log 10 should be achieved for the process to be considered equivalent to the processing method laid down in the Regulation ( EU ) No 142/2011. Published data from an experimental replication of the conversion step of the biodiesel production process under consideration were provided, which showed an at least 6 log 10 reduction in detectable Pr P S c , by Western blot, in tallow that had been spiked with murine and human prion strains. In addition, it was demonstrated that the presence of methanol does not affect the recovery or detection of Pr P S c from a biodiesel substrate. Based on scientific literature, the vacuum distillation step has been shown to be capable of achieving an additional 3 log 10 reduction in Pr P S c . Therefore, the proposed alternative method is considered to be at least equivalent to the processing method laid down in the legislation for the production of biodiesel from raw materials including Category 1 ABP .

Inactivation of indicator microorganisms and biological hazards by standard and/or alternative processing methods in Category 2 and 3 animal by‐products and derived products to be used as organic fertilisers and/or soil improvers

“…A wide range of bacterial, viral, parasitic, protozoan and fungal pathogens can be found in the feedstock materials used for biodiesel production. However, the esterification and transesterification steps and the final vacuum distillation during biodiesel production have been considered to achieve a relevant reduction of biological hazards, including TSE agents, the most resilient pathogens (EFSA BIOHAZ Panel, 2015 , 2017 , 2020 , 2021 ).…”

“…It is worth highlighting that, as set out in Article 20 of Regulation (EC) No 1069/2009, alternative methods for the production of biodiesel and renewable fuels have been assessed by EFSA to ensure that any risks to public or animal health are reduced to a degree that is at least equivalent to that achieved by the processing methods that have already been approved for the same category of ABP. This is carried out by assessing whether the alternative methods achieve a relevant reduction, even for TSE agents, which are considered to be the most resistant biological hazards (EFSA BIOHAZ Panel, 2011, 2017 , 2020 , 2021 ).…”