A method alternative to the ones already approved in the current legislation, called ‘Biomation’ process, for the treatment of Category (Cat.) 2 and 3 Animal By-Products (ABP) was assessed. The process consists of an alkaline treatment. The target parameters are: particle size ≤ 5mm, temperature 70 °C, pH 12.5, exposure time 20 minutes. According to the application received also Cat. 1 ABP can enter the processing plant and it has then to be removed from the rest of the ABP material and treated according to current legislation. The end product generated by the ‘Biomation’ process is intended to be used as an organic fertiliser and soil improver. According to the legislation in force, before being used as an organic fertiliser, Cat. 2 (and mixes of Cat. 2 and 3) material should be treated with a sterilisation process (i.e. 133 °C / 20 min / 3 bars / 50 mm particle size). The hazard identification provided by the applicant was not adequately addressed, since the most resistant organisms (including TSE agents) were not properly identified, and an experimental validation with representative test-organisms under practical conditions was not performed. A laboratory experiment was performed but its results were not clear and did not allow a proper assessment of the level of risk reduction of the relevant biological hazards achieved by the process. Moreover, it was noticed that it is not certain that the values of the parameters used in the laboratory experiment would be homogenously reached in all the material under real scale conditions. Major deficiencies were noticed in the HACCP plan provided. It was concluded that there is no evidence that the proposed alternative method is equivalent to the sterilization process defined in the current legislation.