Scientific Opinion on the capacity of oleochemical processes to minimise possible risks linked to TSE in Category 1 animal by-products
2011;9(2):1976 [26 pp.]. doi:10.2903/j.efsa.2011.1976
EFSA Panel on Biological Hazards (BIOHAZ)
Panel Members Olivier Andreoletti, Herbert Budka, Sava Buncic, John D. Collins, John Griffin, Arie Havelaar, James Hope, Günter Klein, Tine Hald, James McLauchlin, Christine Mueller-Graf, Christophe Nguyen-Thé, Birgit Noerrung, Miguel Prieto Maradona, Luisa Peixe, Antonia Ricci, John Sofos, John Threlfall, Ivar Vågsholm and Emmanuel Vanopdenbosch.
The Panel wishes to thank the members of the Working Group on the capacity of oleochemical processes to minimise possible risks linked to TSE in Category 1 animal by-products: Emmanuel Vanopdenbosch, Christophe Nguyen-The, John Griffin, James Hope and Reinhard Boehm for the preparatory work on this scientific opinion and EFSA staff: Alessandro Broglia for the support provided to this scientific opinion. Contact firstname.lastname@example.org Type:
Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2010-00969
Adopted: 20 January 2011 Published: 07 February 2011 Affiliation: European Food Safety Authority (EFSA), Parma, Italy Article Full article (0.2 Mb) send print cite
The capacity of specific oleochemical processes including several steps (i.e. bleaching, fat splitting, hydrogenation, concentration, distillation and refinement) in order to minimise possible risks linked to TSE infectivity in tallow including Category 1 animal by-products (ABP) was assessed. Under the new ABP Regulation (Reg. EC No 1069/2009), the use of Category 1 tallow for oleochemical products may be also authorised, if the processes are proved to be capable of sufficiently inactivating any potential risks linked to TSEs. The processes considered in this opinion are based on different treatment steps in different combination, but with respect to infectivity reduction the major contribution derives from hydrolytic fat splitting and hydrogenation, so to obtain fatty acids and glycerol. It is concluded that if the parameters are fully met as declared by the applicant, certain processes can be considered effective in significantly reducing the TSE infectivity in the end products using Category 1 tallow. However, considering the uncertainties on the TSE infectivity reduction in oleochemical products derived from Cat. 1 material, these products cannot be reliably regarded to be free of infectivity and therefore could pose a risk if they entered the food and feed chain.
Summary (0.1 Mb) Following a request from the European Commission, the EFSA Scientific Panel on Biological Hazards (BIOHAZ) was asked to provide scientific advice on the capacity of a specific oleochemical processes to minimise possible risks linked to TSE infectivity in tallow including category 1 material.
The current Regulation (EC) No 1774/2002 on animal by-products foresees that rendered fats obtained from Category 2 and Category 3 materials may be used for the manufacture of oleochemical products.
Under the new ABP Regulation (Reg. EC No 1069/2009), the use of Category 1 material in the production of oleochemical products may be also authorised, provided that the manufacturing processes which are applied by the oleochemical industry are capable of sufficiently inactivating any potential risks linked to TSE. This would allow the use of such products in various applications, such as in soaps, cosmetic products and plastics, regardless of the category of animal by-products that are used as starting materials.
The European Oleochemicals and Allied Products Group (APAG), a sector group of the European Chemical Industry Council (Cefic), has submitted scientific evidence to the Commission regarding the capacity of oleochemical processes to inactivate possible risks linked to transmissible spongiform encephalopathies (TSEs) in animal by-products not intended for human consumption (ABPs).
The oleochemical processes considered consist mainly of hydrolytic fat splitting of tallow to obtain fatty acids and glycerol, under the conditions of 200°C, 16 bar of pressure for 20 minutes. The processes can be carried out in a unitower or multitower plant. If saturated fatty acids or hydrogenated tallow are to be obtained, hydrogenation under conditions of 160°C, 12 bar of H2 pressure for 20 minutes is applied in batch or continuous reactors. Eight different processes, consisting of a combination of different steps, can be used according to the different end products and type of reactors used.
The parameters considered are mainly temperature, time and pressure. In the opinion the reduction effects of the different steps that characterise the processes are assessed and, when possible, quantified. The two steps with experimental evidence that contribute to the TSE risk reduction are the hydrolytic fat splitting and the hydrogenation.
It is concluded that if the critical limits of the specific method considered are met, the reduction of TSE infectivity of certain processes is significant. However, considering the uncertainties on the TSE infectivity reduction in oleochemical products derived from Cat. 1 material, these products cannot be reliably regarded to be free of infectivity and therefore could pose a risk if they entered the food and feed chain.
As for efficacy of hydrogenation step, only batch processes can be compared to validated experiments, continuous processes could not be considered effective due to the lack of critical data (i.e. minimum retention time). As for the splitting step carried out in continuous reactors, the processing time represents a sufficient safety margin compared to the minimum requirement, and therefore it is considered effective.
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