(1) In Article 15, the following paragraph is added: "By way of derogation from Article 14 of Regulation (EC) No 1069/2009, Member States may authorise the collection, transport and disposal of small quantities of Category 3 materials as referred to in Article 10(f) of that Regulation by means referred to in Article 19(1)(d) of that Regulation, subject to compliance with the requirements for disposal by other means set out in Chapter IV of Annex VI hereto." (2) In Article 19, point (c) is replaced by the following: "(c) Chapter III, where they store derived products for certain intended purposes as referred to in Article 24(1)(j) of that Regulation; (d) Chapter V, where they store on the farm animal by-products intended for subsequent disposal as referred to in Article 4 of that Regulation."
(3) Article 20(4) is amended as follows: (a) point (d) is replaced by the following: "(d) operators using small quantities of Categories 2 and 3 materials referred to in Articles 9 and 10 of Regulation (EC) No 1069/2009 or of products derived therefrom, for the purpose of direct supply of the products within the region to the final user, on the local market or to local retail establishments, if the competent authority does not consider such activity to present a risk of spreading any serious transmissible disease to humans or animals; this point shall not apply where those materials are used as feed for farmed animals other than fur animals;" (b) the following points (e) and (f) are added: "(e) users of organic fertilisers or soil improvers at premises where farmed animals are not kept; (f) operators handling and distributing organic fertilisers or soil improvers exclusively in ready-to-sell retail packaging of not more than 50 kg in weight for uses outside the feed and food chain."
(4) In Article 22, paragraph 2 is replaced by the following: "2. The placing on the market of the following is not subject to any animal health conditions: (a) guano from wild sea birds, collected in the Union or imported from third countries; (b) ready-to-sell growing media, other than that imported, with a content of less than: (i) 5 % in volume of derived products of Category 3 material or of Category 2 material other than processed manure; (ii) 50 % in volume of processed manure."
(5) In Article 23, paragraph 3 is replaced by the following: "3. The operator or owner of the establishment or plant of destination of intermediate products or his representative shall use and/or dispatch the intermediate products exclusively for use in manufacturing according to the definition of intermediate products under Point 35 of Annex I." (6) In Article 36, paragraph 3 is deleted. (7) Annexes I, III, IV, V, VI, IX, X, XI, XII, XIV, XV and XVI are amended in accordance with the Annex to this Regulation.
Commission Regulation (EU) 2015/9 of 6 January 2015 amending Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive Text with EEA relevance
(1) Annex I is amended as follows: (a) point 35 is replaced by the following: "35. " intermediate product " means a derived product:(a) which is intended for uses within the manufacturing of medicinal products, veterinary medicinal products, medical devices for medical and veterinary purposes, active implantable medical devices, in vitro diagnostic medical devices for medical and veterinary purposes, laboratory reagents or cosmetic products as follows:(i) as material in a manufacturing process or in the final production of a finished product; (ii) in validation or verification during a manufacturing process; or (iii) in quality control of a finished product;
(b) whose design, transformation and manufacturing stages have been sufficiently completed in order to be regarded as a derived product and to qualify the material directly or as a component of a product for the purposes referred to in point (a); (c) which however requires some further manufacturing or transformation, such as mixing, coating, assembling or packaging to make it suitable for placing on the market or putting into service, as applicable, a medicinal product, veterinary medicinal product, medical device for medical and veterinary purposes, active implantable medical device, in vitro diagnostic medical devices for medical and veterinary purposes, laboratory reagent or cosmetic products;"
(b) point 39 is replaced by the following: "39. " trade samples " means animal by-products or derived products intended for particular studies or analyses authorised by the competent authority in accordance with Article 17(1) of Regulation (EC) No 1069/2009 with a view to carrying out a production process, including the processing of animal by-products or derived products, the development of feedingstuff, pet food or derived products, or the testing of machinery or equipment;"(c) point 58 is replaced by the following: "58. " processing plant " means premises or facilities for the processing of animal by-products as referred to in Article 24(1)(a) of Regulation (EC) No 1069/2009, in which animal by-products are processed in accordance with Annex IV and/or Annex X;"(d) the following point 59 is added: "59. " growing media " means materials, including potting soil, other than soilin situ , in which plants are grown and which is used independently from soilin situ ."
(2) In Annex III, Chapter III, point (a) is replaced by the following: "(a) only be used for the disposal of: (i) dead pet animals referred to in Article 8(a)(iii) of Regulation (EC) No 1069/2009; (ii) Category 1 materials referred to in Article 8(b), (e) and (f), Category 2 materials referred to in Article 9 or Category 3 materials referred to in Article 10 of that Regulation; and (iii) dead individually identified equine animals from holdings not subject to health restrictions in accordance with Article 4(5) or 5 of Directive 2009/156/EC, if authorised by the Member State;"
(3) In Annex IV, Chapter IV is amended as follows: (a) Section 2 is amended as follows: (i) point H is deleted; (ii) the following point is added: "K. Ensilage of fish material 1. Starting materials For this process, only the following by-products obtained from aquatic animals may be used: (a) Category 2 materials referred to in Article 9(f)(i) and (iii) of Regulation (EC) No 1069/2009; (b) Category 3 materials.
2. Processing method 2.1. The materials to be treated shall be collected at aquaculture farms and food processing establishments on a daily basis and without undue delays, ground or chopped, and thereafter subjected to ensiling at a pH of 4 or below, with formic acid or other organic acid authorised in accordance with the feed legislation. The resulting fish silage must be a suspension of parts of aquatic animals liquefied by the action of endogenous enzymes in the presence of the added acid. The proteins of aquatic animals must be reduced into smaller soluble units, by the enzymes and the acid, in order to prevent microbial spoilage. The ensiled material is transported to the processing plant. 2.2. At the processing plant the ensiled material of aquatic animals must be piped into closed storage tanks. The incubation time must be at least 24 hours at a pH of 4 or below before heat treatment can be conducted. Before the heat treatment the ensilage of aquatic animals must have a pH of 4 or below and have a particle size of less than 10 mm following a filtration or maceration at the plant. During processing it must be subjected to preheating to a temperature above 85 °C, followed by incubation in an insulated container to obtain 85 °C throughout the fish material for 25 minutes. The process must take place in a closed production line with tanks and pipelines. 2.3. Before authorisation is given, the operator's permanent written procedure referred to in Article 29(1) to (3) of Regulation (EC) No 1069/2009 must be assessed by the competent authority."
(b) In Section 3, point 2(d) is replaced by the following: "(d) the lime-treated mixture of pig and poultry manure may be applied to land as processed manure;" (c) In Section 3, the following point 2(e) is added: "(e) The final product derived from the ensilaging of fish material may: (i) for Category 2 materials, be used for purposes referred to in Article 13(a) to (d) and (g) to (i) of Regulation (EC) No 1069/2009 without further processing or as feed for animals referred to in Article 18 or Article 36(a)(ii) of that Regulation; or (ii) for Category 3 materials, be used for purposes referred to in Article 14 of Regulation (EC) No 1069/2009."
(4) In Annex V, Chapter III, Section 2 is amended as follows: (a) in point 2(b), point (x) is replaced by the following: "(x) animal by-products referred to in Article 10(f) of Regulation (EC) No 1069/2009, which have undergone processing as defined in Article 2(1)(m) of Regulation (EC) No 852/2004;" (b) in point 2(b), the following point (xi) is added: "(xi) mixture of animal by-products referred to in point 2(b) with non-animal by-product materials." (c) in point 3, point (b) is replaced by the following: "(b) considers that the digestion residues or compost are unprocessed material and obliges operators to handle them in accordance with Regulation (EC) No 1069/2009, with this Regulation or, in the case of compost or digestion residues derived from catering waste, to recover or dispose of in accordance with the environmental legislation."
(5) Annex VI is amended as follows: (a) in Chapter II, Section 2, point 1(a)(i) is replaced by the following: "(i) one of the following species of necrophagous birds in the following Member States: Country code Member State Animal species Local name Latin name BG Bulgaria bearded vulture black vulture Egyptian vulture griffon vulture golden eagle imperial eagle white-tailed eagle black kite red kite Gypaetus barbatus Aegypius monachus Neophron percnopterus Gyps fulvus Aquila chrysaetos Aquila helíaca Haliaeetus albicilla Milvus migrans Milvus milvus EL Greece bearded vulture black vulture Egyptian vulture griffon vulture golden eagle imperial eagle white-tailed eagle black kite Gypaetus barbatus Aegypius monachus Neophron percnopterus Gyps fulvus Aquila chrysaetos Aquila heliaca Haliaeetus albicilla Milvus migrans ES Spain bearded vulture black vulture Egyptian vulture griffon vulture golden eagle Spanish imperial eagle black kite red kite Gypaetus barbatus Aegypius monachus Neophron percnopterus Gyps fulvus Aquila chrysaetos Aquila adalberti Milvus migrans Milvus milvus FR France bearded vulture black vulture Egyptian vulture griffon vulture golden eagle white-tailed eagle black kite red kite Gypaetus barbatus Aegypius monachus Neophron percnopterus Gyps fulvus Aquila chrysaetos Haliaeetus albicilla Milvus migrans Milvus milvus HR Croatia bearded vulture black vulture Egyptian vulture griffon vulture Gypaetus barbatus Aegypius monachus Neophron percnopterus Gyps fulvus IT Italy bearded vulture black vulture Egyptian vulture griffon vulture golden eagle black kite red kite Gypaetus barbatus Aegypius monachus Neophron percnopterus Gyps fulvus Aquila chrysaetos Milvus migrans Milvus milvus CY Cyprus black vulture griffon vulture Aegypius monachus Gyps fulvus PT Portugal black vulture Egyptian vulture griffon vulture golden eagle Aegypius monachus Neophron percnopterus Gyps fulvus Aquila chrysaetos SK Slovakia golden eagle imperial eagle white-tailed eagle black kite red kite Aquila chrysaetos Aquila heliaca Haliaeetus albicilla Milvus migrans Milvus milvus" (b) In Chapter IV, the second paragraph is deleted.
(6) In Annex IX, the following Chapter V is added: "CHAPTER V CONTAINMENT METHODS Section 1 General provisions 1. Materials resulting from a containment method may be used or disposed of only within the Member State where that containment method is authorised by the competent authority. 2. The competent authority of a Member State shall make the results of official controls available to the competent authority of another Member State upon request, where a containment method is used for the first time in that Member State, in order to facilitate the introduction of the new containment method. Section 2 Methodology A. Aerobic maturation and storage of dead-on-farm pigs and certain other porcine material with subsequent incineration or co-incineration. 1. Member States concerned The process of aerobic maturation and storage of dead-on-farm pigs and certain other porcine material with subsequent incineration or co-incineration may be used in France, Ireland, Latvia, Portugal and the United Kingdom. Following aerobic maturation and storage of material, the competent authority of the Member State concerned must ensure that the materials are collected and disposed of within the territory of that Member State. 2. Starting materials For this process, only the following materials of animals of the porcine species may be used: (a) Category 2 materials referred to in Article 9(f)(i) to (iii) of Regulation (EC) No 1069/2009; (b) Category 3 materials referred to in Article 10(h) of Regulation (EC) No 1069/2009.
This method is only applicable to the disposal of animals of the porcine species originating in the same holding, provided this holding is not subject to restrictions due to a suspected or confirmed outbreak of a serious transmissible disease affecting animals of the porcine species. This method may not be used for animals which have died due to those diseases or have been killed for diseases control purposes, or parts of those animals. 3. Methodology 3.1. General principles The method is a process authorised by the competent authority. The site must be constructed and laid out in accordance with Union legislation for the protection of the environment, in order to prevent odours and risks to soil and groundwater. The operator must: (a) take preventive measures against access of animals and put in place a documented pest control programme; (b) put in place procedures to prevent the spreading of diseases; (c) put in place procedures to prevent the spreading of used sawdust outside the closed system.
The process must be carried out in a closed system which consist of several cells, with a waterproof floor and delimited by solid walls. Any waste water must be collected; the cells must be connected with a drainpipe fitted with a 6 mm grid to capture solids. Size and number of the cells must be adapted to the mortality level defined in the permanent written procedure referred to in Article 29(1) to (3) of Regulation (EC) No 1069/2009 with sufficient capacity for farm mortalities occurring during an eight-month period at least. 3.2. Phases 3.2.1. Filling and storage phase The fallen pigs and other porcine material must be individually covered in sawdust and piled up until the cell is full. First a layer of at least 30 centimetres of sawdust must be placed on the ground. The carcasses and other porcine material must then be placed on this first layer of sawdust and each layer of carcasses and other porcine material must be covered with a layer of sawdust at least 30 cm thick. Personnel must not walk on the stored material. 3.2.2. Maturing phase When the cell is full and a rise in temperature allows the degradation of all the soft tissues, the maturation period starts and must last at least 3 months. At the end of the filling and storage phase and during all of the maturation phase, the operator must monitor the temperature in each cell with a temperature sensor placed between 40 cm and 60 cm beneath the pile surface of the latest built layer. The electronic reading and monitoring of the temperature must be recorded by the operator. At the end of the filling and storage phase, the temperature monitoring is an indicator of a satisfactory pile layout. The temperature must be measured by an automatic recording device. The aim is to reach 55 °C during 3 consecutive days, revealing that the maturing process is active and that the pile layout is effective and that the maturing phase has started. The operator must monitor the temperature once a day and the following measures shall be taken depending on the outcome of these measurements: (a) where the temperature of 55 °C or more is maintained during 3 consecutive days, the pile may be removed after a 3 consecutive months maturing phase, or may remain stored on the premises awaiting a later removal; (b) where the temperature of 55 °C is not reached during 3 consecutive days, measures defined in the permanent written procedure referred to in Article 29(1) to (3) of Regulation (EC) No 1069/2009 must be set by the operator; if needed, the competent authority may stop the processing method and the material must be disposed of in compliance with Article 13 of the aforementioned Regulation.
A time limit for the storage phase may be determined by the competent authority. 3.2.3. Transport and incineration or co-incineration The transport of the resulted material after the maturation phase to the approved incineration or co-incineration plant is subject to controls referred to in Regulation (EC) No 1069/2009 or Directive 2008/98/EC. B. Hydrolysis with subsequent disposal 1. Member States concerned The process of hydrolysis with subsequent disposal may be used in Ireland, Spain, Latvia, Portugal and the United Kingdom. Following hydrolysis, the authorising competent authority must ensure that the materials are collected and disposed of within the same Member State referred to above. 2. Starting materials For this process, only the following materials of porcine origin may be used: (a) Category 2 materials referred to in Article 9(f)(i) to (iii) of Regulation (EC) No 1069/2009; (b) Category 3 materials referred to in Article 10(h) of that Regulation.
This method is only applicable to the disposal of animals of the porcine species originating in the same holding and provided this holding is not subject to prohibition due to a suspected or confirmed outbreak of a serious transmissible disease affecting animals of the porcine species, or animals that have been killed for disease control purposes. 3. Methodology Hydrolysis with subsequent disposal is a temporary storage on the spot. It shall be carried out according to the following standards: (a) Following their collection on a holding for which the competent authority has authorised the use of the processing method, based on an assessment of the animal density of the holding, the likely mortality rate and the potential risks for public and animal health which may arise, the animal by-products must be placed into a container which has been constructed in accordance with point (b) ("the container") and which has been placed at a dedicated site in accordance with points (c) and (d) ("the dedicated site"). (b) The container must: (i) have a device to close it; (ii) be waterproof, leak-proof and hermetically sealed; (iii) be coated in a way which prevents corrosion; (iv) be equipped with a device for controlling emissions in accordance with point (e).
(c) The container must be placed in a dedicated site which is physically separate from the holding. That site must have dedicated access routes for the movement of materials and for collection vehicles. (d) The container and the site must be constructed and laid out in accordance with Union legislation for the protection of the environment, in order to prevent odours and risks to soil and groundwater. (e) The container must be linked to a pipe for gaseous emissions, which must be equipped with appropriate filters to prevent the transmission of diseases communicable to humans and animals. (f) The container must be closed for the process of hydrolysis for a period of at least three months, in such a way that any unauthorised opening is prevented. (g) The operator must put in place procedures to prevent the transmission of diseases communicable to humans or animals by movements of personnel. (h) The operator must: (i) take preventive measures against birds, rodents, insects and other vermin; (ii) put in place a documented pest control programme.
(i) The operator must keep records of: (i) any placing of material into the container; (ii) any collection of hydrolysed material from the container.
(j) The operator must empty the container at regular intervals for a check: (i) for the absence of corrosion; (ii) to detect and prevent possible leakage of liquid materials into the ground.
(k) Following hydrolysis, the materials must be collected, used and disposed of in accordance with Article 13(a), (b), (c) or Article 13(e)(i) of Regulation (EC) No 1069/2009 or Article 14 of that Regulation for Category 3 materials. (l) The process must be carried out in a batch mode. (m) Any other handling or use of the hydrolysed materials, including their application to land, shall be prohibited."
(7) In Annex X, Chapter II is amended as follows: (a) in Section 3, point A, point 1 is replaced by the following: "1. Rendered fats Only Category 3 material, other than Category 3 materials referred to in Article 10(n), (o) and (p) of Regulation (EC) No 1069/2009, may be used for the production of rendered fat." (b) in Section 4, Part III, the following paragraph is added: "By way of derogation from the first paragraph, the competent authority may authorise alternative parameters for the heat treatment of centrifuge or separator sludge destined for uses within Member States which have authorised those alternative parameters, provided operators can demonstrate that the heat treatment according to the alternative parameters guarantees at least the same risk reduction as the treatment carried out according to the parameters set out in the first paragraph."
(8) In Annex XI, Chapter II, a new Section 3 is added: "Section 3 Requirements for approval of establishments or plants In order to be approved in accordance with Article 24(1)(f) of Regulation (EC) No 1069/2009, operators shall ensure that establishments or plants carrying out the activities referred to in point 1 of Section 1 meet the requirements laid down in Article 8 of this Regulation and: (a) have adequate facilities for storage of incoming ingredients to prevent cross-contamination and avoid contamination during storage; (b) dispose of unused animal by-products or derived products in accordance with Articles 13 and 14 of Regulation (EC) No 1069/2009."
(9) In Annex XII, point 3(a) is replaced by the following: "3. The intermediate products imported into the Union shall be checked at the border inspection post in accordance with Article 4 of Directive 97/78/EC and transported directly from the border inspection post either to: (a) a registered establishment or plant for the production of laboratory reagents, medical devices and in vitro diagnostic medical devices for veterinary purposes or the derived products referred to in Article 33 of Regulation (EC) No 1069/2009, where the intermediate products must be further mixed, used for coating, assembled or packaged before they are placed on the market or put into services in accordance with the Union legislation applicable to the derived product;"
(10) Annex XIV is amended as follows: (a) Chapter I is amended as follows: (i) In Section 1, in row 2 of Table 1, the text in the fourth column is replaced by the following: "The blood products must have been produced in accordance with Section 2 of Chapter II of Annex X and Section 5 of Chapter I of Annex XIV." (ii) a new Section 5 is added: "Section 5 Imports of blood products for the feeding of farmed animals The following requirements shall apply to the importation of blood products, including spray dried blood and blood plasma which have been derived from porcine animals intended for the feeding of porcine animals: These derived products must be: (a) subjected to a heat treatment at a temperature of at least 80 °C throughout the substance and the dry blood and blood plasma is of not more than 8 % moisture with a water activity (Aw) of less than 0,60; (b) stored in dry warehouse conditions under room temperature for at least 6 weeks."
(b) in Chapter II, Section 7, point 1(b) is replaced by the following: "(b) the products are conveyed from the third country of origin directly to a border inspection post of entry into the Union and are not transhipped at any port or place outside the Union;"
(11) Annex XV is amended as follows: (a) Chapter 4(B) is replaced by the following: "CHAPTER 4(B) Health certificate For blood products not intended for human consumption that could be used as feed material, intended for dispatch to or for transit through (2 )the European Union 
"(b) Chapter 20 is replaced by the following: "CHAPTER 20 Model declaration Declaration for the import from third countries and for the transit through the European Union of intermediate products to be used for the manufacture of medicinal products, veterinary medicinal products, medical devices for medical and veterinary purposes, active implantable medical devices, in vitro diagnostics medical devices for medical and veterinary purposes, laboratory reagents and cosmetic products 
"
(12) In Annex XVI, Chapter III, Section 11 is replaced by the following: "Section 11 Official controls regarding hydrolysis with subsequent disposal The competent authority shall carry out controls at sites where hydrolysis with subsequent disposal is carried out in accordance with point B of Section 2 of Chapter V of Annex IX. Such controls shall, for the purpose of reconciliation of the quantities of hydrolysed materials dispatched and disposed of, include documentary checks: (a) of the amount of materials which are hydrolysed at the site; (b) in the establishments or plants where the hydrolysed materials are disposed of.
Controls shall be carried out regularly on the basis of a risk assessment. During the period of the first 12 months of operation, a control visit to a site, where a container for the hydrolysis is located, shall be carried out every time hydrolysed material is collected from the container. Following the period of the first 12 months of operation, a control visit to such sites shall be carried out every time the container is emptied and checked for the absence of corrosion and leaking in accordance with point B(3)(j) of Section 2 of Chapter V of Annex IX."