Evaluation of a multi‐step catalytic co‐processing hydrotreatment for the production of renewable fuels using Category 3 animal fat and used cooking oils
2022; Wiley; Volume: 20; Issue: 11 Linguagem: Inglês
10.2903/j.efsa.2022.7591
ISSN1831-4732
AutoresKonstantinos Koutsoumanis, Ana Allende, Declan Bolton, Sara Bover‐Cid, Marianne Chemaly, Robert Davies, Alessandra De Cesare, Lieve Herman, Friederike Hilbert, Roland Lindqvist, Maarten Nauta, Luísa Peixe, Giuseppe Ru, Marion Simmons, Panagiotis Skandamis, Elisabetta Suffredini, Pablo Salvador Fernández Escámez, John M. Griffin, Angel Ortiz‐Peláez, Avelino Álvarez‐Ordóñez,
Tópico(s)Electric Vehicles and Infrastructure
ResumoEFSA JournalVolume 20, Issue 11 e07591 Scientific OpinionOpen Access Evaluation of a multi-step catalytic co-processing hydrotreatment for the production of renewable fuels using Category 3 animal fat and used cooking oils EFSA Panel on Biological Hazards (BIOHAZ), Corresponding Author EFSA Panel on Biological Hazards (BIOHAZ) [email protected] Correspondence:[email protected]Search for more papers by this authorKonstantinos Koutsoumanis, Konstantinos KoutsoumanisSearch for more papers by this authorAna Allende, Ana AllendeSearch for more papers by this authorDeclan Bolton, Declan BoltonSearch for more papers by this authorSara Bover-Cid, Sara Bover-CidSearch for more papers by this authorMarianne Chemaly, Marianne ChemalySearch for more papers by this authorRobert Davies, Robert DaviesSearch for more papers by this authorAlessandra De Cesare, Alessandra De CesareSearch for more papers by this authorLieve Herman, Lieve HermanSearch for more papers by this authorFriederike Hilbert, Friederike HilbertSearch for more papers by this authorRoland Lindqvist, Roland LindqvistSearch for more papers by this authorMaarten Nauta, Maarten NautaSearch for more papers by this authorLuisa Peixe, Luisa PeixeSearch for more papers by this authorGiuseppe Ru, Giuseppe RuSearch for more papers by this authorMarion Simmons, Marion SimmonsSearch for more papers by this authorPanagiotis Skandamis, Panagiotis SkandamisSearch for more papers by this authorElisabetta Suffredini, Elisabetta SuffrediniSearch for more papers by this authorPablo Fernández Escámez, Pablo Fernández EscámezSearch for more papers by this authorJohn Griffin, John GriffinSearch for more papers by this authorAngel Ortiz-Pelaez, Angel Ortiz-PelaezSearch for more papers by this authorAvelino Alvarez-Ordoñez, Avelino Alvarez-OrdoñezSearch for more papers by this author EFSA Panel on Biological Hazards (BIOHAZ), Corresponding Author EFSA Panel on Biological Hazards (BIOHAZ) [email protected] Correspondence:[email protected]Search for more papers by this authorKonstantinos Koutsoumanis, Konstantinos KoutsoumanisSearch for more papers by this authorAna Allende, Ana AllendeSearch for more papers by this authorDeclan Bolton, Declan BoltonSearch for more papers by this authorSara Bover-Cid, Sara Bover-CidSearch for more papers by this authorMarianne Chemaly, Marianne ChemalySearch for more papers by this authorRobert Davies, Robert DaviesSearch for more papers by this authorAlessandra De Cesare, Alessandra De CesareSearch for more papers by this authorLieve Herman, Lieve HermanSearch for more papers by this authorFriederike Hilbert, Friederike HilbertSearch for more papers by this authorRoland Lindqvist, Roland LindqvistSearch for more papers by this authorMaarten Nauta, Maarten NautaSearch for more papers by this authorLuisa Peixe, Luisa PeixeSearch for more papers by this authorGiuseppe Ru, Giuseppe RuSearch for more papers by this authorMarion Simmons, Marion SimmonsSearch for more papers by this authorPanagiotis Skandamis, Panagiotis SkandamisSearch for more papers by this authorElisabetta Suffredini, Elisabetta SuffrediniSearch for more papers by this authorPablo Fernández Escámez, Pablo Fernández EscámezSearch for more papers by this authorJohn Griffin, John GriffinSearch for more papers by this authorAngel Ortiz-Pelaez, Angel Ortiz-PelaezSearch for more papers by this authorAvelino Alvarez-Ordoñez, Avelino Alvarez-OrdoñezSearch for more papers by this author First published: 09 November 2022 https://doi.org/10.2903/j.efsa.2022.7591 Requestor European Commission Question number EFSA-Q-2021-00625 Panel members Ana Allende, Avelino Alvarez-Ordoñez, Declan Bolton, Sara Bover-Cid, Marianne Chemaly, Robert Davies, Alessandra De Cesare, Lieve Herman, Friederike Hilbert, Konstantinos Koutsoumanis, Roland Lindqvist, Maarten Nauta, Luisa Peixe, Giuseppe Ru, Marion Simmons, Panagiotis Skandamis and Elisabetta Suffredini. Declarations of interest If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact [email protected]. Acknowledgements The BIOHAZ Panel wishes to thank Maria Francesca Iulietto for the support provided to this scientific output. The scientific output published implements EFSA's decision on the confidentiality requests submitted on specific items. As certain items have been awarded confidential status by EFSA they are consequently withheld from public disclosure by redaction. Adopted: 28 September 2022 AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract An alternative method for the production of renewable fuels from rendered animal fats (pretreated using methods 1–5 or method 7 as described in Annex IV of Commission Regulation (EC) No 2011/142) and used cooking oils, derived from Category 3 animal by-products, was assessed. The method is based on a catalytic co-processing hydrotreatment using a middle distillate followed by a stripping step. The materials must be submitted to a pressure of at least 60 bars and a temperature of at least 270°C for at least 4.7 min. The application focuses on the demonstration of the level of reduction of spores from non-pathogenic spore-forming indicator bacterial species (Bacillus subtilis and Desulfotomaculum kuznetsovii), based on a non-systematic review of published data and additional extrapolation analyses. The EFSA BIOHAZ Panel considers that the application and supporting literature contain sufficient evidence that the proposed alternative method can achieve a reduction of at least 5 log10 in the spores of B. subtilis and a 12 log10 reduction in the spores of C. botulinum. The alternative method under evaluation is considered at least equivalent to the processing methods currently approved in the Commission Regulation (EU) No 2011/142. Summary On 11 October and on 25 October 2021, the European Food Safety Authority (EFSA) received from the Dutch Competent Authority (Ministry of Agriculture, Nature and Food Quality) the application (EFSA-Q-2021-00625) under Regulation (EC) No 1069/2009 referring to the alternative processing method for animal by-products (ABP Category 3 material) submitted by BP Raffinaderij Rotterdam B.V. (referred to as bpRR). The proposed new method has been designed for two specific units (hydrofiners) in the facilities the applicant has in its refinery in Rotterdam (The Netherlands) and involves a catalytic hydrotreatment co-processing using a middle distillate such as light gasoil (LGO) followed by a stripping step. The materials must be submitted to a pressure of at least 60 bars at a temperature of at least 270°C for at least 4.7 min. The materials to be treated are rendered animal fats derived from Category 3 materials that have been processed using any of the processing methods 1–5 or processing method 7 (as described in Annex IV of Com Reg (EU) No 142/2011) and used cooking oil (UCO) not treated with any processing method. The BIOHAZ Panel clarified that UCO is considered catering waste and catering waste could be Category 1 or Category 3 animal by-products (ABP), as per Article 10 (p) of Regulation (EC) No 1069/2009. Only Category 3 UCO must be used to produce renewable fuels with the proposed method. The EFSA BIOHAZ Panel considered that a reduction of 5 log10 and 3 log10 of the relevant pathogenic bacteria and thermoresistant viruses, respectively, as defined in the hazard identification, should be demonstrated to validate the alternative method. If spore-forming pathogenic bacteria are considered relevant in the hazard identification, the required level of inactivation should be a 5 log10 reduction of spores from pathogenic bacteria, with the exception of spores of C. botulinum, for which a 12 log10 reduction will be required, as for processing canned petfood. If needed/appropriate, for both spore-forming and non-spore-forming bacteria and viruses, adequately justified alternative non-pathogenic indicator organisms with at least the same level of resistance may be used, demonstrating at least a similar level of reduction of all biological hazards possibly present in the Category 3 material. Given the possibility of the presence of various pathogens including spore-forming bacteria, depending on source and location, the applicant used, based on a literature search and due to their high thermal resistance, spores of Bacillus subtilis and Desulfotomaculum kuznetsovii as indicator organisms to demonstrate the level of hazard reduction. Despite not conducting a full hazard identification process, the approach followed by the applicant is consistent with one of the possible scenarios considered acceptable: when no full hazard identification is conducted, the selection of spores from non-pathogenic spore-forming indicator bacterial species as a primary target to demonstrate a sufficient level of hazard reduction, considering that any process achieving a significant level of inactivation of them will ensure at least a similar level of reduction of all biological hazards possibly present in the Category 3 material. The applicant presented a body of evidence for the level of hazard reduction based on a non-systematic literature review and the estimation of the log10 reduction at the minimum temperature proposed by the alternative method (270°C) through extrapolating from available data at lower heating temperatures in publicly available studies. However, data extrapolated beyond the interpolation region was not considered in the assessment since the extrapolation analyses performed by the applicant have limitations. Despite these considerations, the dossier and additional literature contain sufficient evidence to support that the proposed alternative method can achieve a sufficient level of hazard reduction (e.g. a reduction of at least 5 log10 in the spores of B. subtilis and a 12 log10 reduction in the spores of C. botulinum). In the Hazard Analysis and Critical Control Point (HACCP) plan, the reactors and product strippers were identified by the applicant as CCPs and this was considered to be correct. The critical limits, means of monitoring and verification, and corrective actions associated to the CCPs were clear, except for the means of verification of the successful entry and exit of the materials in the stripper tower. The applicant identified the acceptance of the material on site as a CCP while this should be a prerequisite. The information provided by the applicant indicates that comprehensive and adequate procedures are in place for dealing with any risks associated with interdependent processes and the end use of the product. Overall, the alternative method under assessment is considered at least equivalent to the processing methods currently approved in the legislation. 1 Introduction Background On 11 October and 25 October 2021, the European Food Safety Authority (EFSA) received from the Dutch Competent Authority (Ministry of Agriculture, Nature and Food Quality) the application (EFSA-Q-2021-00625) under Regulation (EC) No 1069/20091 referring to the alternative processing method for animal by-products (ABP Category 3 material) submitted by BP Raffinaderij Rotterdam B.V. (referred to as bpRR). The applicant submitted an application as required in the procedure for authorisation of an alternative method of use or disposal of animal by-products (ABP) or derived products, laid down in Article 20 of the Regulation (EC) No 1069/2009. During the completeness check, performed according to Regulation (EC) No 1069/2009, it was noticed that some information was missing or incomplete. On 8 December 2021, EFSA sent a letter to the applicant with the following five requests, which referred to the sections of the dossier as provided: In Section 4.1.1 of Annex 1, the applicant listed the microbiological hazards that could remain in the rendered fats derived from Category 3 materials (AF), 'that may include Salmonella, Enterobacteriaceae and spore-forming bacteria such as Clostridium perfringens'. We ask the applicant to please clarify the selection criteria of these microbiological hazards, keeping into consideration the provisions of the EFSA guidelines (p. 6 – https://www.efsa.europa.eu/en/efsajournal/pub/1680) that indicate that the relevant biological hazards for human and animal health should be related to the category and subcategory of the material to be processed and that the biological agent/s that are the most difficult to be inactivated by the critical parameters defined in the full description of the process (e.g. thermoresistant micro-organisms) should be retained as the primary target/s for demonstrating the risk reduction achieved by the process. According to the description in Section 2.6, two hydrofiners (GOH1 and GOH3) will be used to process the mixture of hydrocarbons and animal fats (AF) and used cooking oils (UCO). The specifications of these units result in different operating conditions. Therefore, there are two described processes with similar steps and reactions but with different combinations of time/temperature/pressure, which are critical parameters for the evaluation of the level of risk reduction. As described in the EFSA guidelines (link above): 'The parameters that are critical for the inactivation of the pathogens (e.g. temperature, pressure, exposure time, pH, particle size) shall be stated in relation to the process'. Even though, in Section 5.2, the applicant applied the worst case scenario of the conditions in the two hydrofiners: 'in the environments described in both hydrofiners the temperature exceeds 270°C and exhibit pressures of at least 60 barg for at least 4.7 min', we ask the applicant to include in the dossier (in the section 'Full description of the process') a univocal generic description of the physical/chemical steps of the process with the parameters that are critical for the inactivation of the pathogens, irrespective of its implementation in the two hydrofiners. The applicant provided in Sections 4 and 6 some information on the risk associated with interdependent processes and the risk associated with intended end use of the products. However, these two points should be covered separately in stand-alone sections of the application, as indicated in the above-mentioned EFSA guidelines (page 8) and in Regulation 142/20112, Annex VII, Chapter II: Content of applications. Therefore, we ask the applicant to please update the application accordingly. During its review, EFSA has identified no specific claims for confidentiality (Annex 1 is marked with a generic 'Draft – Confidential' in each page). If applicable and in accordance with Art. 39 of Regulation 178/20023, we ask the applicant to please clearly identify the specific aspects of the application for which confidentiality treatment is requested by specifying the applicable excerpt(s) or data sets, and figure(s) or diagram(s) in the dossier as well as a verifiable justification(s)/reasons(s) for the confidentiality requests. The confidential parts should be clearly boxed or earmarked or highlighted in the application. Alternatively, the applicant is asked to confirm that no claims for confidentiality are made for this application. The applicant has indicated 'Draft' at the bottom of each page of Annex 1. If Annex 1 is considered as the final application, the wording 'draft' should be removed. We ask the applicant to please clarify the meaning of this wording or to remove it from the application. On 26 January 2022, EFSA received a new version of the dossier in which the points above had been addressed. The list of documents submitted to EFSA is available in Section 5. After checking the content of the full dossier, EFSA considered that the application EFSA-Q-2021-00625 was valid on 9 February 2022. According to Regulation (EC) No 1069/2009, EFSA shall respect the deadline of 6 months to deliver the scientific opinion. Therefore, the opinion must be delivered by 9 August 2022. Additional information During the discussions of the content of the dossier, the Working Group (WG) agreed on two separate occasions that there was a need to request to the applicant further clarifications and additional information on specific points. The first request was sent on 3 March 2022, to which the applicant submitted on 18 March 2022 a modified version of the application addressing the questions accordingly and for purposes of clarity, as requested, including information about pretreatments and production of by-products, the HACCP plan, the co-processing using light gas oil (LGO) and the preprocessing of UCOs. After a further review on 18 May 2022, the WG decided to stop the clock until the receipt of an amended dossier with further clarifications on the hazard identification, demonstration of the level of risk reduction, and details of the HACCP plan and of the risk of interdependent processes. The applicant submitted an amended Annex I (Application for alternative method for the processing of ABP at BP Rotterdam Refinery) and three new Appendices (7, 8, 9) on 12 July 2022. The clock restarted again on the 18 July 2022, when EFSA confirmed the acceptance of the amended dossier by letter. The new deadline for delivery of the opinion was set at the 10 October 2022. 2 Data and methodologies Data The data used in the assessment were provided by the applicant as requested in Annex VII of Commission Regulation (EU) No 142/2011 and its amendment by Regulation (EU) No 749/20114. A process flow diagram (Figure 1 and Appendix A) and a Hazard Analysis and Critical Control Points (HACCP) plan were included in the application dossier. The report submitted by the Dutch Competent Authority (CA) related to the application was also considered. Relevant scientific papers provided by experts of the WG and previous EFSA opinions were also considered during the assessment. Figure 1Open in figure viewerPowerPoint Flow diagram of the process to produce renewable fuels from AF and UCO Methodologies The EFSA BIOHAZ Panel evaluated the application for an alternative processing method for Category 3 ABP by individually assessing the following steps as set out in the 'Statement on technical assistance on the format for applications for new alternative methods for animal by-products' (EFSA BIOHAZ Panel, 2010). These steps are: a full description of the process; a full description of the material to be treated; hazard identification; the level of risk reduction5; the HACCP plan; the risk associated with interdependent processes; the risk associated with the intended end use of the products. The applicant is required to document as fully as possible the different aspects of each of these steps. According to the CA assessment, the application meets the requirements as laid down in the EFSA Statement (EFSA BIOHAZ Panel, 2010). As set out in subparagraph 5 of Article 20 of Regulation (EC) No 1069/2009, EFSA shall assess whether the method submitted ensures that the risks to public or animal health are: 'controlled in a manner that prevents their proliferation before disposal in accordance with this Regulation or their implementing measures; or reduced to a degree that is at least equivalent, for the relevant category of ABP, to the processing methods laid down pursuant to point (b) of the first subparagraph of Article 15(1)'. 2.2.1 Review of the standards applied in previous EFSA opinions According to point 2d, Chapter II, Annex VII of Commission Regulation (EU) No 142/2011, any application for the evaluation of alternative methods shall 'show that the most resistant biological hazards associated with the category of materials to be processed are reduced in any products generated during the process, including the wastewater, at least to the degree achieved by the processing standards laid down in this Regulation for the same category of animal by-products. The degree of risk reduction must be determined with validated direct measurements, unless modelling or comparisons with other processes are acceptable'. According to the EFSA Statement (EFSA BIOHAZ Panel, 2010) and to point 3, Chapter II, Annex VII of Commission Regulation (EU) No 142/2011, validated direct measurements as referred to above shall mean: 'measuring the reduction of viability/infectivity of endogenous indicator organisms during the process, where the indicator is: consistently present in the raw material in high numbers, not less resistant to the lethal aspects of the treatment process, but also not significantly more resistant, than the pathogens for which it is being used to monitor, relatively easy to quantify and relatively easy to identify and to confirm; or using a well-characterised test organism or virus introduced in a suitable test body into the starting material'. The EFSA Statement (EFSA BIOHAZ Panel, 2010) also asserts that 'results should be accompanied by evidence'. Such evidence 'includes, for measurements, information on the methodology used, nature of samples that have been analysed and evidence that samples are representative (e.g. number of samples, number of tests performed and selection of measuring points). If several treatment steps are involved, an assessment should be performed on the degree to which individual titre reduction steps are additive, or whether early steps in the process may compromise the efficacy of subsequent steps. In any case it is necessary to provide the sensitivity and specificity of the detection methods applied. Data on the repeatability and statistical variability of the measures obtained during the experiments should also be presented'. It also states that 'generally, the level of risk reduction for human and animal health which can be achieved by the process should be evaluated on the basis of direct measurements (validation)'. 'In case no direct measurements of the risk reduction be available (i.e. no validation as defined above is feasible), modelling or comparison with other processes may be acceptable if: the factors leading to the risk reduction are well known; the model of risk reduction is well established; and continuous direct measurements of the factors leading to the risk reduction are provided for the full-scale process which demonstrate that these factors are homogeneously applied throughout the treated batch'. In point 2d, 'Level of risk reduction' of Section 2.1.2.1 'Content of applications' of the EFSA Statement (EFSA BIOHAZ Panel, 2010), it is stated that 'in principle, the new proposed process should be able to reduce the amount of the most resistant biological hazards associated with the category of the material to be processed for a defined final use to an acceptable level'. Although Chapter II of Annex VII of Commission Regulation (EU) No 142/2011 adopted the proposal of the EFSA Statement to use 'the level of risk reduction' and 'the level of reduction of the most resistant biological hazards' interchangeably, it is acknowledged that these are different terms and that the purpose of the evaluation of alternative methods is not the estimation of the level of any risk, but the level of hazard reduction. It is acknowledged that the level of reduction described above may result in different levels of safety for humans and animals according to the ultimate end use of the product: renewable fuels, biogas, composted material, organic fertiliser, or any other. The standard processing methods for the different categories of ABP are described in Chapter III, Annex IV of Commission Regulation (EU) No 142/2011. There are no hazard reduction standards for proposed alternative methods for biodiesel or renewable fuels production using ABP. However, in previous EFSA opinions (EFSA BIOHAZ Panel, 2015a, 2017, 2020a) dealing with proposed alternative processing methods including Category 1 ABP, the BIOHAZ Panel concluded that a reduction of 6 log10 in prion infectivity by the alternative method is required to consider it at least equivalent to the method approved in the legislation, disregarding the level of inactivation achieved by the pretreatment (method 1). When the starting material is Category 3, the degree of hazard reduction (or level of risk reduction) achieved by the approved methods is not specified, and no definitive standards have been set down either in relation to hazard reduction for alternative methods dealing with Category 3 materials. This was already highlighted by previous EFSA opinions. For example, in the EFSA Statement on technical assistance related to the EFSA Opinion on transformation of ABPs into biogas and compost (EFSA BIOHAZ Panel, 2009), the Panel recommended that 'requirements for the reduction of the representative pathogens or indicators should be defined according to the final use of the different ABP categories to be processed, with the different ABP categories representing different risks of microbiological contamination of the input material'. There have been precedents of assessments conducted by EFSA on alternative methods for Category 3 ABP in combination with other categories or alone, but not for the production of biodiesel or renewable fuels, in which different levels of risk reduction were required, depending on the end use and the legal requirements. For feed, the EFSA Scientific Opinion on an alternative method for the hygienic treatment of bovine colostrum through a series of filtration steps (EFSA BIOHAZ Panel, 2015b) compared the level of inactivation with the one achieved by the standard required, which in that case was high-temperature short time (HSTS) pasteurisation at 72°C for at least 15 s or an equivalent pasteurisation effect achieving a negative reaction to a phosphatase test. More recently, in the EFSA Opinion on evaluation of the application for a new alternative processing method for ABP of Category 3 material (ChainCraft B.V.) for feed use (EFSA BIOHAZ Panel, 2018), the efficacy of the process was evaluated based on the ability of that physical process to remove potential biological hazards present in the material. The standard applied followed the level of agent risk reduction applied in the 2005 EFSA Opinion on the safety vis-à-vis biological risks of biogas and compost treatment standards of animal by-products (ABP) (EFSA BIOHAZ Panel, 2005) (see below). The EFSA Scientific Opinion on hatchery waste as animal by-products (EFSA BIOHAZ Panel and EFSA AHAW Panel, 2011) is also relevant in this discussion even though hatchery waste is officially designated as Category 2. This opinion stated that the risk related to the use of dead-in-shell chicks for the production of processed petfood submitted to a conventional heat treatment to a minimum of 121°C for 3 min in a moist environment, was considered negligible. However, the level of inactivation of the identified biological hazards achieved by any of the methods assessed was not specified and it was concluded that 'a treatment of at least 90°C throughout the substance of the final product is not able to inactivate other relevant hazards such as bacterial spores, thermoresistant viruses and some toxins. The final risk posed by the agents that may survive this treatment additionally depends on several factors and cannot be considered to be negligible'. For organic fertilisers and soil improvers, the opinion of the Scientific Panel on Biological Hazards of the European Food Safety Authority on the safety vis-à-vis biological risk, including for transmissible spongiform encephalopathies (TSEs), of the application on pastureland of organic fertilisers and soil improvers (EFSA BIOHAZ Panel, 2004) stated that 'despite the fact that the ABP classed as Category 3 come from animals considered fit for human consumption, there is no absolute guarantee that TSE infective material would not be present in the material (e.g. animals in early stage of incubation not picked up by rapid testing)'. It was recommended that 'the validation studies should be carried out using test organisms that have shown to be a good model for microbiological hazards potentially present in the process and/or product. The test organisms used should at least be as resistant as micro-organisms potentially present. The test organisms should be applied under the same conditions as how they appear to be in the raw material. The decontamination must achieve a 5 log10 reduction'. For biogas and compost, the 2005 EFSA Opinion on the safety vis-à-vis biological risks of biogas and compost treatment standards of ABPs (EFSA BIOHAZ Panel, 2005) considered the process under evaluation equivalent to the processing standards laid down in Regulation6, 'if the treatment was capable of reducing the concentration of the relevant pathogenic bacteria by at least 5 log10 and the infectious titre of the relevant viruses by at least 3 log10'. This opinion recommended that any process for hazard reduction should be validated with representative agents in relation to the reduction target defined and must prove that 'the process achieves the following (for thermal processes, condition (a) and (b) have to be fulfilled; for chemical processes condition (c) also has to be fulfilled): Reduction of 5 log10 of non-spore forming pathogenic bacteria, of parasites and of non-thermoresistant viruses. Reduction of Enterococcus faecalis indicates an equivalent or eve
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