Biological Safety of a Process for the Hydrolysis on-farm of Dead Pigs 1. Scientific Opinion of the Panel on Biological Hazards

Transcription

1 The EFSA Journal (2008) 623, 1-15 Biological Safety of a Process for the Hydrolysis on-farm of Dead Pigs 1 Scientific Opinion of the Panel on Biological Hazards (Question No EFSA-Q ) Adopted on 23 January 2008 PANEL MEMBERS Olivier Andreoletti, Herbert Budka, Sava Buncic, Pierre Colin, John D Collins, Aline De Koeijer, John Griffin, Arie Havelaar, James Hope, Günter Klein, Hilde Kruse, Simone Magnino, Antonio Martínez López, James McLauchlin, Christophe Nguyen-The, Karsten Noeckler, Birgit Noerrung, Miguel Prieto Maradona, Terence Roberts, Ivar Vågsholm, Emmanuel Vanopdenbosch. SUMMARY Following a request from the Spanish Competent Authority, the EFSA Scientific Panel on Biological Hazards (BIOHAZ) was asked to deliver a Scientific Opinion on the biological safety of a specific process for the Hydrolysis on-farm of Dead Pigs. The application concerns the on-farm treatment of pig carcasses and other pig by-products 2, which are considered as Category 2 animal by-products according to Reg. (EC) No 1774/2002, through an enzymatic hydrolysis in mesophilic and partially anaerobic conditions within a closed vat for a period of minimum six months. The intended end-use of the processed material is represented by its utilisation as organic fertilizer or soil improver, as composting material, as biogas production material or as a material to be delivered to a waste management unit for disposal. The BIOHAZ Panel concluded that, due to some deficiencies in the provided dossier, it was not possible to assess the safety of the process for the disposal or use of Category 2 animal byproducts. The BIOHAZ Panel does not recommend this process to be applied as an alternative method of disposal or use of Category 2 animal by-products. 1 For citation purposes: Scientific Opinion of the Panel on Biological Hazards on a request from the Spanish Competent Authority on the Biological Safety of a Process for the Hydrolysis on-farm of Dead Pigs. The EFSA Journal (2008) 623, Placentas, foetuses, stillbirths, testicles and associated tissues deriving from the castration of piglets. European Food Safety Authority, 2008

2 Before the method can be re-assessed for processing pig carcasses and other pig by-products of Category 2, the Applicant should take into account the considerations expressed by the Opinion and proceed with further research in order to demonstrate the effectiveness of their method in comparison with the method currently required by Regulation (EC) No 1774/2002 for the Category 2 material under consideration (133 C / 20 min / 3 bars / 50 mm particle size). Key words: Animal By-Products, Dead Pigs, Hydrolysis on-farm The EFSA Journal (2008) 623, 2-15

3 TABLE OF CONTENTS Panel Members...1 Summary...1 Table of Contents...3 Background as provided by the Spanish Competent Authority...4 Terms of reference as provided by the Spanish Competent Authority...6 Acknowledgements...6 Assessment Introduction Risk categories Identification and characterisation of risk materials Agent risk reduction Risk containment Identification of interdependent processes Intended end-use of the products Documentary evidence...11 Conclusions and Recommendations...11 Documentation provided to EFSA...12 References...12 Appendices...13 The EFSA Journal (2008) 623, 3-15

4 BACKGROUND AS PROVIDED BY THE SPANISH COMPETENT AUTHORITY Explanatory statement Regulation (EC) No 1774/ of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption requires that animal carcasses be removed from farms and transported to processing sites. Traditionally, carcasses have been buried in specific areas on farms in appropriate conditions of bio-security, regulated in Spain by the 1952 Law and regulations concerning epizootic diseases. This new form of management, since the entry into force of the aforesaid Regulation (EC) No 1774/2002, gives rise to certain problems as regards application: - Firstly, due to the possible spread of disease entailed by the transportation of animal carcasses between the various farms. This can give rise to a risk, particularly for farms subject to health restrictions, much of the business of which involves the sale of diseasefree breeding stock. - Secondly, due to the cost involved in disposing of these animals using specialist companies, given that because of present numbers and locations, they are not always close to farms, numbers are not always sufficient to optimise costs, and access to farms is not always possible due to poor access conditions. In view of this situation, the leading associations representing the intensive pig farming sectors, by means of a Collaboration Agreement and with the economic support of the Ministry of Agriculture, Fisheries and Food, sponsored the development of alternative experimental techniques for in situ disposal of carcasses produced by intensive farms. This initiative involved experiments on carcass digestion, with or without the use of bio-activators, in field conditions, of pigs, considered to be low-risk, that is to say, Category 2 in the aforementioned Regulation. All the experiments were directed and carried out by independent research teams belonging to Spanish universities and public research centres having the relevant expertise and experience. The universities taking part were the University of León, the University of Valladolid, the University of Murcia and the public research centres were IMIDA (Instituto Murciano de Investigación y Desarrollo Agrario) [Murcia Institute for Agrarian Research and Development] and the Centro Superior de Investigación Científica (CSIC) [Higher Institute of Scientific Research]. Finally, we should mention the Opinion of the European Economic and Social Committee on the disposal of animal carcasses and the use of animal by-products of 14 September Conclusions No 1.3 and 1.4 highlighting the need to establish research programmes to develop methods of destroying carcasses on site, thus preventing the possible spread of disease as a result of transportation and encouraging research along the lines of the projects presented here, are of particular significance. 3 OJ L 273, , p.1. Regulation as last amended by Commission Regulation (EC) No 829/2007 (OJ L 191, , p.1). The EFSA Journal (2008) 623, 4-15

5 Objective of the study - To evaluate, under certain field conditions, the possibility of disposing of Category 2 pig carcasses on the farms of origin themselves, based on the development of methods to degrade said carcasses under differing conditions and with health and environmental safeguards. - To obtain European Commission approval of these methods as an alternative to the collection, processing and destruction of carcasses, using the possibilities provided by Regulation (EC) No 1774/2002, Articles 4(2)(e), 5 (2)(g) and 6 (2)(i), which stipulate that the Commission, after consultation of EFSA and having sought the opinion of the Standing Committee of the Food Chain and Animal Health, may approve new alternative methods. Performance of the study The studies began in September 2004 and ended in December 2005 and were carried out on 4 pig farms. The methods assessed and which are presented are as follows: - Hydrolysis of non-ruminant animal carcasses: pig farm experiment. On completion of the studies, the final results were submitted to the Dirección General de Ganadería [General Directorate for Livestock], the relevant competent authority, and the studies and the Agreement were therefore brought to a close. Subsequently, and as a preliminary stage before application to the Community authorities for approval, they were officially submitted to the Agreement Supervisory Committee and the Working Groups on collection of carcasses and technology of by-products set up within the National Commission for ABP (SANDACH) for evaluation both by the regional authorities and by the independent experts and scientists belonging to these groups. Once the observations of the groups had been taken on board, the final reports were submitted to the Plenary Session of the SANDACH National Commission for approval. The National Commission agreed to submit the studies to EFSA and the European Commission for consideration and possible approval as alternative methods of carcass disposal, once all the steps recommended in the guidelines issued by EFSA and the European Commission, as listed previously, had been taken. The EFSA Journal (2008) 623, 5-15

6 TERMS OF REFERENCE AS PROVIDED BY THE SPANISH COMPETENT AUTHORITY This Agency hereby submits for your consideration the attached experimental method that has been assessed on pig farms, after having been submitted to the competent Spanish authorities for consideration and having been approved thereby, along with a copy of the corresponding studies and the results thereof. We would ask you to issue your Opinion within six months of receipt of the studies. Clarification to the terms of reference and request for additional documentation The mandate was tabled during the Plenary meeting of the EFSA Scientific Panel on Biological Hazards (BIOHAZ), which was held on January During the meeting some questions were raised by the BIOHAZ Panel. The EFSA secretariat then contacted the Spanish Competent Authority in order: - to ask for the possibility to provide an English translation of the application and of the report (originally delivered in Spanish), in order to speed up the evaluation process; - to ask some preliminary clarifications and further documentation on the report provided. Following these requests, the Spanish Competent Authority provided EFSA with the English translation of the report and the replies to EFSA s requests, together with some additional information delivered by the Applicant. ACKNOWLEDGEMENTS The European Food Safety Authority wishes to thank the members of the Working Group for the preparation of this Opinion: John Griffin, Christophe Nguyen-The (Rapporteur). The EFSA Journal (2008) 623, 6-15

7 ASSESSMENT 1. Introduction The application received concerns the enzymatic hydrolysis of pig carcasses and other pig byproducts 4 in mesophilic and partially anaerobic conditions within a closed vat for a period of minimum six months. The process is performed in a dedicated area within the farm and consists of different stages, summarised below. - Loading of the vat Carcasses of pigs dead on farm and other pig by-products originating in the same farm are gradually loaded into a polyester and thermo-stable fibreglass vat. Prior to loading an incision is performed on carcasses in order to expose the thoracic and abdominal cavities and hence speed up the autolysis process. At the time of loading the by-products into the vat, autolysis natural activator and water are added in specific proportions. The bioactivator used in the process is Gel-60, containing alginic acid under the form of sodium alginate. The vat is open only when the by-products are loaded into it and remains closed between two consecutive loadings. The loading phase lasts until filling of the whole vat. Its duration therefore depends on the size of the vat and on the amount of material introduced into it (therefore on the characteristics of the farm: size, mortality etc.). - Hydrolysis process within the vat After completion of the loading, the vat is closed and the hydrolysis process proceeds for a period of at least six months, named by the Applicant Hydraulic Retention Time (HRT). The inside temperature is constantly maintained at C by means of an electrical resistance. The only communication with the outside environment is represented by a chimney, provided with an activated charcoal filter. The estimated percentage of the initial vat content that evaporates during the whole process is 20% of the total. It is not always clear in the report whether the minimal duration of the HRT is six months or three months. After a request for clarification, the Applicant indicated that the HRT minimal duration is six months and amended accordingly some parts of the report. However, some other parts of the report have not been amended and still mention a HRT of three months. - Unloading of the vat At the end of the hydrolysis process, the end-products remaining in the vat are represented by: i) superficial layer of fats and soaps (8% of the initial vat content), that remains in the vat for further degradation during the following hydrolysis cycles; ii) intermediate layer of organic-mineral broth (71% of the initial vat content), that is partially removed and is intended for use or disposal; iii) sediment layer of partially degraded bones (1% of the initial vat content), that remains in the vat for further degradation during the following hydrolysis cycles. The intermediate layer (broth), after being removed from the vat by means of a motor pump, is submitted to different possible fates, as described in detail in paragraph 7 of the Opinion. 4 Placentas, foetuses, stillbirths, testicles and associated tissues deriving from the castration of piglets. The EFSA Journal (2008) 623, 7-15

8 It is not clear in the report when the process has to be considered completed and the unloading stage can therefore start. For instance, the manual of procedure states that the value of the final ph before conclusion of the process has to be higher than 8, but the data provided show that such value was never reached during the trial. 2. Risk categories The Applicant requested the approval of the above mentioned hydrolysis process for the processing of pig carcasses and other pig by-products on-farm. According to Regulation (EC) No 1774/2002, article 5(1)(e), such material has to be classified as Category 2 material. 3. Identification and characterisation of risk materials Any possible risk deriving from processing pig carcasses and other pig by-products should be considered and analysed as stated under section 4 of the Opinion on the safety vis-à-vis biological risks of biogas and compost treatment standards of animal by-products (EFSA, 2005). This point is not properly addressed by the report and a comprehensive list of all possible risks identified is not provided. In particular, as regards biological risks, the Applicant assumes a high sanitary security is assured, due to decontamination happening during the process, as demonstrated by the results of the laboratory tests performed on certain species of bacteria (Clostridium spp., Clostridium perfringens, Salmonella spp., Shigella spp., Vibrio cholerae and Escherichia coli O157:H7) and on parasites (generic parasite testing by routine parasitology techniques i.e. McMaster s and Baermann techniques). Tests on other pathogenic species of bacteria, as well as on viruses, are not included. In addition, the Applicant indicates that the method will not be used for the hydrolysis of carcasses and by-products deriving from pigs affected by any animal disease listed by OIE or subject to mandatory declaration. However, it is not explained how this can be avoided in practical terms, due to the fact that diagnosis is often not available at the time of death and that pigs can be in the incubation period of a disease without showing evident clinical signs at the time of death. The Applicant has identified a series of other possible hazards to be considered throughout the different stages of the process, such as gas emissions, physical agents and chemical agents. As regards gas emissions, it is not clear whether the gases deemed relevant by the Applicant (and thus analysed) might represent a risk in terms of environment or also in terms of safety of the personnel, especially while opening the vat. Safety concerns deriving from gas emissions are not clearly listed, even if they seem to possibly represent a risk, due to the fact that wearing gas masks when opening the vat is recommended in the manual. The report considers that risks may arise following direct human or animal exposure to those hazards during the process (also due to possible breaking or malfunctioning of the system), environmental contamination (spills from the vat or accidents during the unloading phase), accidental falls of the personnel inside the vat during operational procedures. In some cases human and animal exposure was not deemed to be significant, whether in other ones it was deemed to be significant and therefore the risk was assessed to different extents. The EFSA Journal (2008) 623, 8-15

9 4. Agent risk reduction Biological Safety of a Process for the Hydrolysis on-farm of Dead Pigs The Applicant reported the results of a series of laboratory analyses performed periodically (once every fifteen days) on the material within the vat throughout the whole hydrolysis stage of the process. The parameters analysed include: - toxic gas emissions (NH 3, CH 4, H 2 S, O 2 ); - physical and chemical parameters (temperature, ph, electrical conductivity, REDOX index, density, humidity, dry matter, organic carbon, organic matter, BOD 5, OCD, nitrogen, soluble anions, several chemical elements including heavy metals); - bacteriological analysis (Clostridium spp., Clostridium perfringens, Salmonella spp., Shigella spp., Vibrio cholerae and Escherichia coli O157:H7); - parasitological analysis (generic parasite testing by routine parasitology techniques i.e. McMaster s and Baermann techniques). Documentary evidence of the results of the analysis performed has been provided to EFSA. The overall conclusion of the Applicant is that risk reduction with regard to human health, animal health and environment is achieved by the described hydrolysis process, estimated according to the results of the abovementioned laboratory analyses performed. The following considerations need to be made: - The Applicant measured the agent risk reduction by counting during the process the number of naturally occurring pathogenic bacteria (listed above under the item bacteriological analysis). Among the pathogenic bacteria considered, only Clostridium spp. was detected in the raw material. Therefore, no risk reduction could be measured for the other bacteria. An initial challenge of the material introduced into the vat with a known quantity of specific agents was not performed. - No measurements are described in the report concerning risks arising from possible virus contamination. - The report provides some considerations based on available scientific bibliography concerning risk reduction relating to bacteria, parasites and viruses. However, the main parameters relevant for the reduction or inactivation of the relevant pathogens are not always defined. In certain cases only temperature is mentioned. As the application concerns a mesophilic process, temperature alone cannot be used to predict the inactivation of infectious agents. The available publications do not permit to identify the factors and parameters which could cause reduction of infectious agents in the process described in the dossier. It is not possible to assess the safety of any process without knowing the exact parameters and the validation data. More generally, according to scientific publications (EFSA, 2007) it is known that mesophilic processes may not sufficiently decrease the relevant biological hazards and may not fulfil the requirements of Regulation (EC) No 1774/2002, unless they are combined with other validated treatments. - The procedure followed for handling the samples collected during the trial (i.e. freezing of samples prior to analysis) might not be appropriate for measuring all the possible biological risks present. Based on these considerations, the report on the trial does not allow the effectiveness of the process in reducing the risks possibly presented by pig carcasses and other pig by-products in natural farm conditions to be measured. The EFSA Journal (2008) 623, 9-15

10 In addition, the technical parameters applied during the process do not give guarantees equivalent to processing methods for Category 2 materials in order to be used as organic fertilizers and soil improvers and be possibly spread on pastures (subject to further specific conditions) or transformed in a biogas or composting plant as requested by Regulation (EC) No 1774/2002 (i.e. reduction to particle size of 50 mm and heat-treated at 133 C for 20 minutes at a pressure of 3 bars). 5. Risk containment The hydrolysis process described consists of a closed process during which risks could arise mainly because of the exit of any material from the vat at different times and for different reasons. The main consequence of a temporary breakdown of the system would be a decrease in the processing temperature. This implies that the only negative effect of such a breakdown would be a slowing down of the process and therefore an additional time would be required for the process to be completed. The Applicant analyses the critical points with regard to the containment of the risks during the different phases of the process as well as during the initial installation of the equipment and during the transport of carcasses from the farming area to the location of the vat. The report describes the possible situations leading to the propagation of the risks, the precautionary measures to be taken in order to avoid them and the corrective measures to be taken in case any risk is detected. Monitoring and surveillance procedures in order to ensure risk containment throughout the process are specified in the report. However, it is not clear when the process has to be considered completed and the unloading stage can therefore start. For instance, as mentioned before, the manual of procedure states that the value of the final ph before conclusion of the process has to be higher than 8, but the data provided show that such value was never reached during the process. In addition, the manual of procedure indicates that certain analyses will be regularly performed during the process, but only mentions ph and other physical and chemical parameters, without mentioning any microbiological routine monitoring. 6. Identification of interdependent processes No by-products are temporarily stored or intended for specific uses or means of disposal during the process, even if a gas loss from the system does occur during the process. End-products of the process can have, according to the report, different possible fates, including use, further processing or disposal. The Applicant states that the end-products (i.e. broth) of the process can be easily transferred inside hermetic vats and transported outside the farm towards centralised plants for composting or for biogas production. However, the report does not mention what possible risks could arise during storage and transport and what procedures have to be followed. Another possibility indicated by the Applicant is the delivery of the end-product to a waste management unit for disposal, possibly after a prior reduction of the volume through evaporation in the plant of origin. However, the way such evaporation process would take place as well as the hazards and risks linked with it are not mentioned in the report. In addition, no consideration is given to the procedures to be followed during the transport and possible storage of the end-products when intended to be mixed with manure. The remaining part of the end-products remains in the vat for further hydrolysis cycles but its final fate is not addressed. The EFSA Journal (2008) 623, 10-15

11 7. Intended end-use of the products The report indicates four possible fates for the end-products of the process: i) mixing with the dung generated in the farm and further use as organic fertilizer or soil improver; ii) composting in the farm or in other centralized plants and following use as organic fertilizer or soil improver; iii) biogas production in a centralized plant; iv) delivery to a waste management unit for disposal, possibly after a reduction of its volume in the farm by evaporation. The Applicant states that such uses can be envisaged considering the results of the bacteriological, parasitological and biochemical data. The end-product is considered by the Applicant free of any pathogenic agent as well as of any toxic compound and heavy metal. As commented previously under point 4 dealing with the agent risk reduction, this cannot be supported because an appropriate risk reduction study is lacking and the available information does not allow a conclusion to be made on whether all the likely risks involved are removed by the process. Therefore the end-product as indicated in the report might not pose the necessary safety guarantees in order to be used or further processed by the means indicated in the report. 8. Documentary evidence A flow diagram of the process and documentary evidence of the analysis performed by the Applicant during the experience were provided with the initial report and after the request for additional information from EFSA. However, documentary evidence is lacking for certain points and in particular concerning the agent risk reduction (see paragraph 4) and the risk containment (see paragraph 5). CONCLUSIONS AND RECOMMENDATIONS CONCLUSIONS The application concerns treatment of animal by-products of Category 2. Risk identification and characterisation was not properly addressed in the trial and a comprehensive list of possible risks was not provided. Because of a lack of information in the report, it is not possible to judge the degree of risk reduction of pathogenic bacterial, viral and parasitological agents by the process. Some deficiencies were noted in relation to risk containment and in the procedures for identifying and dealing with risks arising from interdependent processes. Therefore, it is not possible to assess the safety of the process for the disposal or use of Category 2 animal by-products. The EFSA Journal (2008) 623, 11-15

12 RECOMMENDATIONS The BIOHAZ Panel does not recommend the process described in the report to be applied as an alternative method of disposal or use of Category 2 animal by-products. Before the method can be re-assessed for processing pig carcasses and other pig by-products of Category 2, the Applicant should take into account the considerations expressed by the Opinion and proceed with further research in order to demonstrate the effectiveness of the method in comparison with the method currently required by Regulation (EC) No 1774/2002 for the Category 2 material under consideration (133 C / 20 min / 3 bars / 50 mm particle size). DOCUMENTATION PROVIDED TO EFSA 1. Letter Solicitud de España para la aprobación de métodos alternatives de eliminación de cadáveres en las explotaciones ganaderas intensivas. November Submitted by Spanish Ministerio de Agricultura, Pesca y Alimentación, Dirección General de Ganadería. 2. Report Informe final de resultados sobre la hidrolización de cadáveres animales no ruminantes: experiencia en ganado porcino. November Submitted by Spanish Ministerio de Agricultura, Pesca y Alimentación, Dirección General de Ganadería. 3. Letter and report on the main actions taken for Spanish Competent Authorities regarding applications for new alternative methods of disposal or use of animal by-products under Regulation 1774/2002. September Submitted by Spanish Ministerio de Agricultura, Pesca y Alimentación, Dirección General de Ganadería. 4. Report Final report about the results on monogastric animal corpse hydrolyzation: experience based on pigs production [English version of the report mentioned at point 2]. September Submitted by Spanish Ministerio de Agricultura, Pesca y Alimentación, Dirección General de Ganadería. 5. Answers to EFSA s requested explanations. September Submitted by Spanish Ministerio de Agricultura, Pesca y Alimentación, Dirección General de Ganadería. 6. Scientific-technical memory of the project. September Submitted by Spanish Ministerio de Agricultura, Pesca y Alimentación, Dirección General de Ganadería. REFERENCES EFSA Opinion on the safety vis-à-vis biological risks of biogas and compost treatment standards of animal by-products. The EFSA Journal 264: EFSA Opinion of the Scientific Panel on Biological Hazards on a request from the European Commission on the safety vis-à-vis biological risk of the mesophilic process of biogas and compost treatment of Animal By-Products (ABPs). The EFSA Journal 465: The EFSA Journal (2008) 623, 12-15

13 APPENDICES APPENDIX A: FULL LIST OF CATEGORY 1, 2 AND 3 MATERIAL AS CATEGORISED BY REGULATION (EC) NO 1774/2002. Article 4: Category 1 material 1. Category 1 material shall comprise animal by-products of the following description, or any material containing such by-products: (a) all body parts, including hides and skins, of the following animals: (i) animals suspected of being infected by a TSE in accordance with Regulation (EC) No 999/2001 or in which the presence of a TSE has been officially confirmed, (ii) animals killed in the context of TSE eradication measures, (iii) animals other than farmed animals and wild animals, including in particular pet animals, zoo animals and circus animals, (iv) experimental animals as defined by Article 2 of Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes, and (v) wild animals, when suspected of being infected with diseases communicable to humans or animals; (b) (i) specified risk material, and (ii) where, at the time of disposal, specified risk material as not been removed, entire bodies of dead animals containing specified risk material; (c) products derived from animals to which substances prohibited under Directive 96/22/EC have been administered and products of animal origin containing residues of environmental contaminants and other substances listed in Group B(3) of Annex I to Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC, if such residues exceed the permitted level laid down by Community legislation or, in the absence thereof, by national legislation; (d) all animal material collected when treating waste water from Category 1 processing plants and other premises in which specified risk material is removed, including screenings, materials from desanding, grease and oil mixtures, sludge and materials removed from drains from those premises, unless such material contains no specified risk material or parts of such material; (e) catering waste from means of transport operating internationally; and (f) mixtures of Category 1 material with either Category 2 material or Category 3 material or both, including any material destined for processing in a Category 1 processing plant. The EFSA Journal (2008) 623, 13-15

14 Article 5: Category 2 material 1. Category 2 material shall comprise animal by-products of the following description, or any material containing such by-products: (a) manure and digestive tract content; (b) all animal materials collected when treating waste water from slaughterhouses other than slaughterhouses covered by Article 4(1) (d) or from Category 2 processing plants, including screenings, materials from desanding, grease and oil mixtures, sludge and materials removed from drains from those premises; (c) products of animal origin containing residues of veterinary drugs and contaminants listed in Group B(1) and (2) of Annex I to Directive 96/23/EC, if such residues exceed the permitted level laid down by Community legislation; (d) (e) (f) (g) products of animal origin, other than Category 1 material, that are imported from non-member countries and, in the course of the inspections provided for in Community legislation, fail to comply with the veterinary requirements for their importation into the Community, unless they are returned or their importation is accepted under restrictions laid down under Community legislation; animals and parts of animals, other than those referred to in Article 4, that die other than by being slaughtered for human consumption, including animals killed to eradicate an epizootic disease; mixtures of Category 2 material with Category 3 material, including any material destined for processing in a Category 2 processing plant; and animal by-products other than Category 1 material or Category 3 material. The EFSA Journal (2008) 623, 14-15

15 Article 6: Category 3 material 1. Category 3 material shall comprise animal by-products of the following description, or any material containing such by-products: (a) parts of slaughtered animals, which are fit for human consumption in accordance with Community legislation, but are not intended for human consumption for commercial reasons; (b) parts of slaughtered animals, which are rejected as unfit for human consumption but are not affected by any signs of diseases communicable to humans or animals and derive from carcases that are fit for human consumption in accordance with Community legislation; (c) hides and skins, hooves and horns, pig bristles and feathers originating from animals that are slaughtered in a slaughterhouse, after undergoing ante-mortem inspection, and were fit, as a result of such inspection, for slaughter for human consumption in accordance with Community legislation; (d) blood obtained from animals other than ruminants that are slaughtered in a slaughterhouse, after undergoing ante-mortem inspection, and were fit, as a result of such inspection, for slaughter for human consumption in accordance with Community legislation; (e) (f) (g) animal by-products derived from the production of products intended for human consumption, including degreased bones and greaves; former foodstuffs of animal origin, or former foodstuffs containing products of animal origin, other than catering waste, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects which do not present any risk to humans or animals; raw milk originating from animals that do not show clinical signs of any disease communicable through that product to humans or animals; (h) fish or other sea animals, except sea mammals, caught in the open sea for the purposes of fishmeal production; (i) (j) (k) (l) fresh by-products from fish from plants manufacturing fish products for human consumption; shells, hatchery by-products and cracked egg by-products originating from animals which did not show clinical signs of any disease communicable through that product to humans or animals; blood, hides and skins, hooves, feathers, wool, horns, hair and fur originating from animals that did not show clinical signs of any disease communicable through that product to humans or animals; and catering waste other than as referred to in Article 4(1)(e). The EFSA Journal (2008) 623, 15-15