CHAPTER I GENERAL PROVISIONS
Article 1Subject matter and scope
Article 2Definitions
Article 3End point in the manufacturing chain for certain derived products
Article 4Serious transmissible diseases
CHAPTER II DISPOSAL AND USE OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS
Article 5Restrictions on the use of animal by-products and derived products
Article 6 Disposal by incineration, disposal or recovery by co-incineration and use as a fuel for combustion
Article 7Landfilling of certain Category 1 and 3 materials
Article 8Requirements for processing plants and other establishments
Article 9Hygiene and processing requirements for processing plants and other establishments
Article 10Requirements regarding the transformation of animal by-products and derived products into biogas and composting
CHAPTER III DEROGATIONS FROM CERTAIN PROVISIONS OF REGULATION (EC) No 1069/2009
Article 11Special rules on research and diagnostic samples
Article 12Special rules on trade samples and display items
Article 13Special feeding rules
Article 14Feeding of certain species in and outside feeding stations and in zoos
Article 15Special rules on collection and disposal
CHAPTER IV AUTHORISATIONS OF ALTERNATIVE METHODS
Article 16Standard format for applications for authorisation of alternative methods
CHAPTER V COLLECTION, TRANSPORT, IDENTIFICATION AND TRACEABILITY
Article 17Requirements regarding commercial documents and health certificates, identification, the collection and transport of animal by-products and traceability
CHAPTER VI REGISTRATION AND APPROVAL OF ESTABLISHMENTS AND PLANTS
Article 18Requirements regarding the approval of one or more establishments and plants handling animal by-products on the same site
Article 19Requirements concerning certain approved establishments and plants handling animal by-products and derived products
Article 20Requirements concerning certain registered establishments and plants handling animal by-products and derived products
Article 20a Lists of establishments, plants and operators ...
CHAPTER VIIPLACING ON THE MARKET
Article 21Processing and placing on the market of animal by-products and derived products for feeding to farmed animals, excluding fur animals
Article 22Placing on the market and use of organic fertilisers and soil improvers
Article 23Intermediate products
Article 24Petfood and other derived products
CHAPTER VIIIIMPORT, TRANSIT AND EXPORT
Article 24ASpecial transitional import arrangements
Article 25Import from a third country, transit and export of animal by-products and of derived products
Article 26Placing on the market, including importation, and export of certain Category 1 materials
Article 27Importation from a third country and transit of research and diagnostic samples
Article 28Importation from a third country and transit of trade samples and display items
Article 29Specific requirements for certain movements of animal by-products between territories of the Russian Federation
Article 29a Specific requirements for transit through Croatia of animal by-products coming from Bosnia and Herzegovina and destined to third countries
Article 30Lists of establishments and plants in third countries
Article 31Models of health certificates and declarations for importation from a third country and transit
CHAPTER IX OFFICIAL CONTROLS
Article 32Official controls
Article 33Reapproval of plants and establishments after the grant of a temporary approval
CHAPTER X FINAL PROVISIONS
Article 34Restrictions on the placing on the market of certain animal by-products and derived products for reasons of public and animal health
Article 35Repeal
Article 36Transitional measures
Article 37This Regulation shall enter into force on the 20th day...
ANNEX IDEFINITIONS AS REFERRED TO IN ARTICLE 2
For the purpose of this Regulation, the following definitions shall...
‘fur animals’ means animals kept or reared for the production...
ANNEX IIRESTRICTIONS ON THE USE OF ANIMAL BY-PRODUCTS
CHAPTER IIntra-species recycling of fur animals 1.In Estonia, Latvia and Finland, the following fur animals may...2.In Estonia and Latvia, fur animals of the species American...3.The feeding referred to in points 1 and 2 shall...CHAPTER IIFeeding of farmed animals with herbage
ANNEX III DISPOSAL, RECOVERY AND USE AS A FUEL
CHAPTER IGENERAL REQUIREMENTS FOR INCINERATION AND CO-INCINERATION Section 1General conditions 1.Operators of incineration and co-incineration plants referred to in Article...2.The operator of an incineration or co-incineration plant shall take...3.Animals must not have access to the plants, animal by-products...4.If the incineration or co-incineration plant is located on a...5.The storage of animal by-products and derived products that are...6.Incompletely incinerated animal by-products must be reincinerated or disposed of...Section 2Operating conditions Section 3Incineration and co-incineration residues 1.Incineration and co-incineration residues shall be minimised in their amount...2.Transport and intermediate storage of dry residues, including dust, shall...Section 4Measurement of temperature and of other parameters 1.Techniques shall be used to monitor the parameters and conditions...2.The approval issued by the competent authority, or conditions attached...3.The functioning of any automated monitoring equipment shall be subject...4.Temperature measurement results shall be recorded and presented in an...Section 5Abnormal operating CHAPTER IIHIGH-CAPACITY INCINERATION AND CO-INCINERATION PLANTS Section 1Specific operating conditions Section 2Water discharges 1.Sites of high capacity plants, including associated storage areas for...2.Storage capacity shall be provided for contaminated rainwater run-off from...CHAPTER IIILOW-CAPACITY INCINERATION AND CO-INCINERATION PLANTS CHAPTER IVGENERAL REQUIREMENTS FOR THE USE OF ANIMAL BY-PRODUCTS AND DERIVED...Section 1General requirements regarding the combustion of animal by-products and derived...1.Operators of combustion plants referred to in Article 6(6) shall...2.Operators of the combustion plants shall take all necessary precautions...3.Animals must not have access to the combustion plant or...4.Where the combustion plant is located on a holding keeping...5.The animal by-products and derived products that are awaiting combustion...6.The combustion of animal by-products or derived products shall be...Section 2Operating conditions of combustion plants 1.Combustion plants must be designed, built, equipped and operated in...2.The gas resulting from the process is raised in a...3.Automated techniques shall be used to monitor the parameters and...4.Temperature measurement results shall be recorded automatically and presented in...5.The operator of a combustion plant shall ensure that the...Section 3Combustion residues 1.Combustion residues shall be minimised in their amount and harmfulness....2.The transport and intermediate storage of dry residues, including dust,...Section 4Breakdown or abnormal operating conditions 1.The combustion plant shall be equipped with facilities which automatically...2.Incompletely combusted animal by-products and derived products must be combusted...CHAPTER VTYPES OF PLANTS AND FUELS THAT MAY BE USED FOR...A.Stationary internal combustion engines 1.Starting material: 2.Methodology: 3.Operating conditions: B.On-farm combustion plants in which poultry manure is used as...1.Type of plant: 2.Starting material and scope: 3.Specific requirements for poultry manure used as a fuel for...4.Emission limit values and monitoring requirements: 5.Changes of operation and breakdowns: C.Combustion plants in which manure of farmed animals other than...1.Type of plant: 2.Starting material: 3.Methodology: 4.Derogation and transitional period: D.Combustion plants in which meat-and-bone meal is used as a...
ANNEX IVPROCESSING
CHAPTER IREQUIREMENTS FOR PROCESSING PLANTS AND CERTAIN OTHER PLANTS AND ESTABLISHMENTS...Section 1General conditions 1.Processing plants shall meet the following requirements, for processing by...2.The processing plant must have adequate facilities for cleaning and...3.Adequate facilities must be provided for the disinfecting of vehicle...4.All processing plants must have a waste-water disposal system meeting...5.The processing plant must have its own laboratory or make...6.If on the basis of a risk assessment, the volume...Section 2Wastewater treatment 1.Processing plants processing Category 1 material and other premises where...2.Wastewater from the premises as referred to in point 1...3.All animal material retained in the pre-treatment process in premises...4.Wastewater having passed the pre-treatment process in premises referred to...5.In addition to the requirements laid down in point 4,...6.Without prejudice to points 1 to 5, the disposal of...Section 3Specific requirements for the processing of Category 1 and Category...Section 4Specific requirements for the processing of Category 3 materials CHAPTER IIHYGIENE AND PROCESSING REQUIREMENTS Section 1General hygiene requirements Section 2General processing requirements 1.Accurately calibrated gauges/recorders must be used to monitor continuously the...2.Material that may not have received the specified heat treatment,...Section 3Processing methods for Category 1 and Category 2 material Section 4Processing of Category 3 material 1.The critical control points that determine the extent of the...2.In the case of chemical treatments which have been authorised...3.Records shall be maintained for at least two years to...4.Category 3 material shall be processed in accordance with any...CHAPTER IIISTANDARD PROCESSING METHODS A.Processing method 1 (pressure sterilisation) Reduction 1.If the particle size of the animal by-products to be...Time, temperature and pressure 2.The animal by-products with the particle size of no greater...3.The processing may be carried out in batch or continuous...B.Processing method 2 Reduction 1.If the particle size of the animal by-products to be...Time, temperature and pressure 2.After reduction the animal by-products must be heated in a...3.The processing must be carried out in a batch system....C.Processing method 3 Reduction 1.If the particle size of the animal by-products to be...Time, temperature and pressure 2.After reduction the animal by-products must be heated in a...3.The processing may be carried out in batch or continuous...D.Processing method 4 Reduction 1.If the particle size of the animal by-products to be...Time, temperature and pressure 2.After reduction the animal by-products must be placed in a...3.The processing may be carried out in batch or continuous...E.Processing method 5 Reduction 1.If the particle size of the animal by-products to be...Time, temperature and pressure 2.After reduction the animal by-products must be heated until they...3.The processing may be carried out in batch or continuous...F.Processing method 6 (for Category 3 animal by-products originating from...Reduction 1.The animal by-products must be reduced to a particle size...Time, temperature and pressure 2.After reduction, the mixture must be heated to: 3.The processing may be carried out in batch or continuous...G.Processing method 7 1.Any processing method authorised by the competent authority where the...2.Details of the critical control points under which each processing...3.By way of derogation from point 1, the competent authority...4.The competent authority shall permanently or temporarily suspend the application...5.The competent authority of a constituent nation shall inform the...CHAPTER IVALTERNATIVE PROCESSING METHODS Section 1General provisions 1.Materials resulting from the processing of Category 1 and 2...2.The competent authority of a constituent nation shall make the...Section 2Processing standards A.Alkaline hydrolysis process 1.Starting material 2.Processing method B.High pressure high temperature hydrolysis process 1.Starting material 2.Processing method C.High pressure hydrolysis biogas process 1.Starting material 2.Processing method D.Biodiesel production process 1.Starting material 2.Processing method E.Brookes’ gasification process 1.Starting material 2.Processing method F.Combustion of animal fat in a thermal boiler process 1.Starting material 2.Processing method G.Thermomechanical biofuel production process 1.Starting material 2.Processing method H.Hydrolysis with subsequent disposal 1.Member States concerned 2.Starting materials 3.Methodology I.Lime treatment for pig and poultry manure 1.Starting materials 2.Processing method (a)The dry matter content of the manure must be determined...(b)The amount of lime which has to be added must...(c)The particle size of the animal by-products to be processed...(d)The manure must be mixed with quick lime (CaO) which...(e)The mixture must be mixed for a period of at...(f)At monitoring points which must be introduced into the stockpile,...(g)The process must be carried out in a batch mode....(h)A permanent written procedure based on the HACCP principles must...(i)Operators may demonstrate to the competent authority, by way of...J.Multi-step catalytic process for the production of renewable fuels 1.Starting materials (a)For this process, the following materials may be used: (b)The use of rendered fats derived from Category 1 material...2.Processing method (a)The rendered fat must be submitted to a pre-treatment which...(b)The pre-treated materials must be submitted to a multi-step catalytic...K.Ensilage of fish material 1.Starting materials 2.Processing method 2.1.The materials to be treated shall be collected at aquaculture...2.2.At the processing plant the ensiled material of aquatic animals...2.3.Before authorisation is given, the operator's permanent written procedure referred...L.Multiple-step catalytic hydro-treatment for the production of renewable fuels 1.Starting materials 2.Processing method Section 3Disposal and use of derived products 1.Products derived from the processing of: 2.Materials resulting from processing in accordance with: 3.Any waste other than animal by-products and derived products provided...
ANNEX VTRANSFORMATION OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS INTO BIOGAS, COMPOSTING
CHAPTER IREQUIREMENTS APPLICABLE TO PLANTS Section 1Biogas plants 1.A biogas plant must be equipped with a pasteurisation/hygienisation unit,...2.By way of derogation from point 1, a pasteurisation /hygienisation...3.If the biogas plant is located on or next to...4.Each biogas plant must have its own laboratory or make...Section 2Composting plants 1.A composting plant must be equipped with a closed composting...2.By way of derogation from point 1, other types of...3.If the composting plant is located on or next to...4.Each composting plant must have its own laboratory or make...CHAPTER IIHYGIENE REQUIREMENTS APPLICABLE TO BIOGAS AND COMPOSTING PLANTS 1.Animal by-products must be transformed as soon as possible after...2.Containers, receptacles and vehicles used for transporting untreated material must...3.Preventive measures against birds, rodents, insects or other vermin must...4.Cleaning procedures must be documented and established for all parts...5.Hygiene control must include regular inspections of the environment and...6.Installations and equipment must be kept in a good state...7.Digestion residues and compost must be handled and stored at...CHAPTER IIITRANSFORMATION PARAMETERS Section 1Standard transformation parameters 1.Category 3 material which is used as raw material in...2.Category 3 material which is used as raw material in...Section 2Alternative transformation parameters for biogas and composting plant 1.The competent authority may authorise the use of parameters other...2.By way of derogation from point 1, pending the adoption...3.Where the materials referred to in point 2(b) or derived...4.Operators may place on the market digestion residues and compost,...Section 3Standards for digestion residues and compost 1.Representative samples of the digestion residues or compost taken during...2.Digestion residues or compost other than those referred to in...3.When animal by-products are transformed into biogas or composted together...
ANNEX VISPECIAL RULES ON RESEARCH, FEEDING AND COLLECTION AND DISPOSAL
CHAPTER ISPECIAL RULES ON SAMPLES FOR RESEARCH AND OTHER PURPOSES Section 1Research and diagnostic samples 1.Operators shall ensure that consignments of research and diagnostic samples...2.Users that handle research and diagnostic samples shall take all...3.Any subsequent use of research and diagnostic samples for purposes...4.Unless they are kept for reference purposes, research and diagnostic...5.Users that handle research and diagnostic samples shall keep a...6.By way of derogation from points 1, 4 and 5,...Section 2Trade samples and display items 1.Trade samples and display items may only be transported, used...2.Unless trade samples are kept for reference purposes, they shall...3.After the exhibition or after the artistic activity has been...CHAPTER IISPECIAL FEEDING RULES Section 1General requirements Section 2Feeding of certain species in feeding stations 1.The competent authority may authorise the use of Category 1...2.When a Member State applies to the Commission to be...Section 3Feeding of wild animals outside feeding stations Section 4Feeding of zoo animals with Category 1 material CHAPTER IIISPECIAL RULES ON COLLECTION AND DISPOSAL Section 1Special disposal rules for animal by-products 1.If the competent authority authorises the disposal of animal by-products...2.The burning of animal by-products on the sites referred to...3.The burial of animal by-products on the sites referred to...4.In the case of disposal in accordance with Article 19(1)(a),...Section 2Burning and burial of animal by-products in remote areas Section 3Burning and burial of bees and apiculture by-products CHAPTER IVDISPOSAL BY OTHER MEANS
ANNEX VIISTANDARD FORMAT FOR APPLICATIONS FOR ALTERNATIVE METHODS
CHAPTER ILanguage regime 1.Applications for authorisation of an alternative method of use or...2.Interested parties that submit such applications in a language other...CHAPTER IIContent of applications 1.Applications shall contain all the necessary information to allow the...2.The application referred to in paragraph 1 shall moreover: 3.Validated direct measurements as referred to in paragraph 2(d) above...4.The HACCP plan referred to in paragraph 2(b) must be...5.The applications shall also contain sufficient information on: 6.Applications shall be submitted with documentary evidence, in particular: 7.Applications shall include a contact address for the interested party,...
ANNEX VIIICOLLECTION, TRANSPORT AND TRACEABILITY
CHAPTER ICOLLECTION AND TRANSPORT Section 1Vehicles and containers 1.As from the starting point in the manufacturing chain referred...2.Vehicles and reusable containers, and all reusable items of equipment...3.Reusable containers must be dedicated to the carriage of a...4.Packaging material must be disposed of, by incineration or by...Section 2Temperature conditions 1.The transport of animal by-products destined for the production of...2.Unprocessed Category 3 material destined for the production of feed...3.The design of vehicles used for refrigerated transport must ensure...Section 3Derogation for collection and transport of Category 3 material comprising...Section 4Derogation for collection and transport of manure CHAPTER IIIDENTIFICATION 1.All necessary measures must be taken to ensure that: 2.During transport and storage, a label attached to the packaging,...3.Nothing in this Regulation prevents the appropriate authority from establishing...4.Nothing in this Regulation prevents the appropriate authority from establishing...5.By way of derogation from points 3 and 4, nothing...6.However: CHAPTER IIICOMMERCIAL DOCUMENTS AND HEALTH CERTIFICATES 1.During transportation, a commercial document in accordance with the model...2.The commercial document must be produced at least in triplicate...3.Health certificates must be issued and signed by the competent...4.A commercial document in accordance with the model made available...5.Records and related commercial documents or health certificates shall be...6.Model commercial document Notes (a)Commercial documents shall be produced, according to the layout of...(b)It shall be drawn up in English, and may also...(c)The original of each commercial document shall consist of a...(d)If for reasons of identification of the items of the...(e)When the commercial document, including additional sheets of paper referred...(f)The original of the commercial document must be completed and...(g)The colour of the signature of the responsible person shall...(h)The document reference number and the local reference number shall...(i)The competent authority responsible for the place of destination referred...Commercial documentCHAPTER IVRECORDS Section 1General provisions 1.The records as referred to in Article 22(1) of Regulation...2.By way of derogation from point 1 of this Section,...3.Operators of incineration plants and co-incineration plants shall keep records...Section 2Additional requirements in case of use for special feeding purposes...Section 3Requirements in case of certain fur animals Section 4Requirements for the application of certain organic fertilisers and soil...Section 5Requirements for animal by-products derived from aquatic animals and feeding...Section 6Requirements for the burning and burial of animal by-products Section 7Requirements for photogelatine CHAPTER VMARKING OF CERTAIN DERIVED PRODUCTS 1.In processing plants for the processing of Category 1 or...2.The operators of processing plants referred to in point 1...3.The marking with GTH shall not be required for: CHAPTER VITRANSPORT OF DEAD PET ANIMALS CHAPTER VIITRANSPORT TO A DETOXIFICATION PLANT OF FISH OILS AND FISHMEAL...
ANNEX IX
REQUIREMENTS APPLICABLE TO CERTAIN APPROVED AND REGISTERED ESTABLISHMENTS AND PLANTS...CHAPTER IMANUFACTURING OF PETFOOD CHAPTER IIHANDLING OF ANIMAL BY-PRODUCTS AFTER THEIR COLLECTION Section 1General requirements 1.Premises and facilities where intermediate operations are carried out shall...2.The plant shall be equipped with adequate facilities for cleaning...Section 2Hygiene requirements 1.The sorting of animal by-products shall be carried out in...2.At all times during storage, animal by-products shall be handled...3.Animal by-products shall be stored properly, including under appropriate temperature...Section 3Processing standards for hygienisation/pasteurisation CHAPTER IIIREQUIREMENTS FOR STORAGE OF DERIVED PRODUCTS Section 1General requirements Section 2Specific requirements for storage of certain milk, milk-based products and...1.The storage of the products referred to in Part II...2.Samples of the final products taken during storage or at...CHAPTER IVREGISTERED OPERATORS 1.Operators of registered plants or establishments or other registered operators...2.Operators shall keep records in a form which is accessible...3.Registered operators transporting animal by-products or derived products, other than...CHAPTER V CONTAINMENT METHODS Section 1 General provisions 1.Materials resulting from a containment method may be used or...2.The competent authority of a constituent nation shall make the...Section 2 Methodology A.Aerobic maturation and storage of dead-on-farm pigs and certain other...1.Application 2.Starting materials 3.Methodology 3.1.General principles 3.2.Phases 3.2.1.Filling and storage phase 3.2.2.Maturing phase 3.2.3.Transport and incineration or co-incineration B.Hydrolysis with subsequent disposal 1.Application 2.Starting materials 3.Methodology
ANNEX XFEED MATERIALS
CHAPTER IGENERAL REQUIREMENTS FOR THE PROCESSING AND PLACING ON THE MARKET...CHAPTER IISPECIFIC REQUIREMENTS FOR PROCESSED ANIMAL PROTEIN AND OTHER DERIVED PRODUCTS...Section 1Specific requirements for processed animal protein A.Raw materials 1.Only animal by-products which are Category 3 material or products...2.Processed animal protein derived from farmed insects, intended for the...B.Processing standards 1.Processed animal protein of mammalian origin must have been submitted...2.Non-mammalian processed animal protein, with the exception of fishmeal, must...3.Fishmeal must have been submitted to: C.Storage 1.Processed animal protein must be packed and stored in new...2.Products in conveyors, elevators and bins must be protected from...3.Equipment for handling processed animal protein must be maintained in...4.Processed animal protein must be kept dry. Section 2Specific requirements for blood products A.Raw material B.Processing standards Section 3Specific requirements for rendered fats, fish oil and fat derivatives...A.Raw materials 1.Rendered fats 2.Fish oil B.Processing standards C.Hygiene requirements Section 4Specific requirements for milk, colostrum and certain other products derived...Part IGeneral requirements A.Raw material B.Processing standards 1.Milk must be subjected to one of the following treatments:...2.Milk-based products and milk-derived products must either be subjected to...3.Whey to be fed to animals of species susceptible to...4.In addition to the requirements set out in points 1,...5.Raw milk must be produced under conditions offering adequate guarantees...6.Colostrum and colostrum products must: Part IIDerogation for the placing on the market of milk processed...1.The requirements laid down in points 2 and 3 of...2.The competent authority shall authorise milk processing establishments approved or...3.Milk, milk-based products and milk-derived products may be supplied and...4.The competent authority may authorise the supply of colostrum which...Part IIISpecial requirements for centrifuge or separator sludge Section 5Specific requirements for gelatine and hydrolysed protein A.Raw materials B.Processing standards for gelatine 1.Unless the gelatine has been produced in accordance with Section...2.After having been subjected to the processes referred to in...3.The use of preservatives, other than sulphur dioxide and hydrogen...C.Other requirements for gelatine D.Processing standards for hydrolysed protein Section 6Specific requirements for dicalcium phosphate A.Raw materials B.Processing standards 1.Dicalcium phosphate must be produced by a process that comprises...2.Where dicalcium phosphate is derived from defatted bones, it shall...Section 7Specific requirements for tricalcium phosphate A.Raw materials B.Processing standards Section 8Specific requirements for collagen A.Raw materials B.Processing standards 1.Unless the collagen has been produced in accordance with the...2.The use of preservatives, other than those permitted under retained...C.Other requirements Section 9Specific requirements for egg products A.Raw materials B.Processing standards Section 10Specific requirements for feeding to farmed animals, other than fur...CHAPTER IIIREQUIREMENTS FOR CERTAIN FISH FEED AND FISHING BAITS 1.Animal by-products from fish or aquatic invertebrates and derived products...2.The competent authority may lay down conditions, aimed at preventing...
ANNEX XIORGANIC FERTILISERS AND SOIL IMPROVERS
CHAPTER IREQUIREMENTS FOR UNPROCESSED MANURE, PROCESSED MANURE AND DERIVED PRODUCTS FROM...Section 1Unprocessed manure 1.Trade in unprocessed manure of species other than poultry or...2.Trade in unprocessed poultry manure between Member States shall be...3.Model health attestation to be added to the commercial document:...4.Unprocessed manure of equidae may be traded between Member States,...5.In accordance with Article 48(1)(c)(ii) of Regulation (EC) No 1069/2009,...6.The competent authority may authorise the dispatch of manure transported...Section 2Guano from bats, processed manure and derived products from processed...CHAPTER IIREQUIREMENTS FOR CERTAIN ORGANIC FERTILISERS AND SOIL IMPROVERS Section 1Conditions for the production 1.Organic fertilisers and soil improvers, other than manure, digestive tract...2.Organic fertilisers and soil improvers which consist of or which...3.The competent authority shall authorise the component referred to in...4.However, the requirements referred to in point 2 shall not...5.Producers of organic fertilisers and soil improvers must ensure that...Section 2Storage and transport Section 3Requirements for approval of establishments or plants
ANNEX XIIINTERMEDIATE PRODUCTS
In accordance with Article 34(2) of Regulation (EC) No 1069/2009,...
The import from a third country and transit of intermediate...
ANNEX XIIIPETFOOD AND CERTAIN OTHER DERIVED PRODUCTS
CHAPTER IGeneral requirements CHAPTER IISpecific requirements for petfood, including dogchews 1.Raw petfood 2.Raw material for processed petfood and for dogchews 3.Processed petfood 4.Dogchews must be subjected to a treatment that is sufficient...5.Random samples must be taken from dogchews and from processed...6.Random samples must be taken from raw petfood during production...7.End point for processed petfood and dogchews CHAPTER IIISpecific requirements for flavouring innards for the manufacture of petfood...1.Operators may only use animal by-products which may be used...2.Flavouring innards must have been submitted to a treatment method...3.The end product must be: CHAPTER IVSpecific requirements for blood and blood products from equidae CHAPTER VSpecific requirements for hides and skins of ungulates and products...A.Establishments and plants B.Placing on the market of animal by-products and of derived...1.Untreated hides and skins may be placed on the market...2.Treated hides and skins may be placed on the market,...C.End point for hides and skins 1.Hides and skins of ungulates which pursuant to the decision...2.The following treated hides and skins may be placed on...3.By way of derogation from point C.2, the competent authority...CHAPTER VISpecific requirements for game trophies and other preparations from animals...A.The provisions of this Chapter are without prejudice to the...B.Safe sourcing C.Safe treatment 1.Game trophies or other preparations from animals, where for the...2.Game trophies or other preparations, other than those referred to...CHAPTER VIISpecific requirements for wool, hair, pig bristles, feathers, parts of...A.Raw material 1.Untreated wool, untreated hair, untreated pig bristles and untreated feathers,...2.Movements of pig bristles and wool and hair of animals...3.The provisions of point 1 shall not apply to decorative...B.End point for wool and hair C.End point for feathers and down CHAPTER VIIISpecific requirements for furs CHAPTER IXSpecific requirements for apiculture by-products CHAPTER XSpecific requirements for rendered fats from Category 1 or Category...1.Rendered fats derived from Category 1 material or from Category...2.Rendered fats derived from ruminant animals must be purified in...CHAPTER XISpecific requirements for fat derivatives 1.The following processes may be used to produce fat derivatives...2.Fat derivatives produced in accordance with this Chapter may only...3.End point for products derived from rendered fats: CHAPTER XIISpecific requirements for horns and horn products, excluding horn meal,...CHAPTER XIIISpecific requirements for fish oil for the production of medicinal...
ANNEX XIVIMPORTATION, EXPORT AND TRANSIT
CHAPTER ISPECIFIC REQUIREMENTS FOR THE IMPORTATION FROM A THIRD COUNTRY INTO...Section 1As referred to in Article 41(1)(a) and Article 41(3) of...Section 2Imports from a third country of processed animal protein, including...Section 3Imports from a third country of rendered fats Section 4Imports from a third country of milk, milk-based products, milk-derived...A.The following requirements shall apply to the importation from a...B.The following requirements shall apply to the importation from a...Section 5Imports from a third country of blood products for the...CHAPTER IISPECIFIC REQUIREMENTS FOR THE IMPORTATION FROM A THIRD COUNTRY INTO...Section 1Specific requirements Section 2Imports from a third country of blood and blood products,...Section 3Imports from a third country of blood and blood products...Section 4Imports from a third country of hides and skins of...Section 5Imports from a third country of game trophies and other...Section 6Imports from a third country of treated feathers, parts of...Section 7Imports from a third country of bones and bone products...1.Bones and bone products (excluding bone meal), horns and horn...2.Each consignment must be accompanied by a commercial document stamped...3.On dispatch to Great Britain, the material must be enclosed...4.Following the veterinary checks provided for in the Official Controls...Section 8Imports from a third country of animal by-products for the...Section 9Imports from a third country of rendered fats for certain...Section 10Imports from a third country of fat derivatives 1.Fat derivatives may be imported from a third country if...2.The health certificate referred to in point 1 must be...3.Following the veterinary checks provided for in the Official Controls...Section 11Imports from a third country of photogelatine 1.Gelatine which has been produced from material containing bovine vertebral...2.Once the photogelatine has entered Great Britain, it ... shall...3.Following the veterinary checks provided for in the Official Controls...4.The transport referred to in point 3 shall be carried...5.In the approved photographic factory of destination, the operator shall...6.Photogelatine shall be produced according to the following requirements: Section 12Imports from a third country of horns and horn products,...CHAPTER IIISPECIAL RULES FOR CERTAIN SAMPLES Section 1Research and diagnostic samples Section 2Trade samples 1.The competent authority may authorise the import from a third...2.Unless the trade samples are kept for reference purposes, they...3.If trade samples are used for testing of machinery, the...Section 3Display items 1.Import from a third country and transit of display items...2.Each consignment must be packed in packaging preventing any leakage...3.After the exhibition or after the artistic activity has been...CHAPTER IVSPECIFIC REQUIREMENTS FOR CERTAIN MOVEMENTS OF ANIMAL BY-PRODUCTS Section 1Imports from a third country of certain Category 1 materials...Section 2Imports from a third country of certain materials for purposes...1.The competent authority may authorise the import from a third...2.Imports of consignments of the materials referred to in point...CHAPTER VRULES FOR THE EXPORT OF CERTAIN DERIVED PRODUCTS CHAPTER VIREQUIREMENTS FOR THE ENTRY OF CONSIGNMENTS OF ANIMAL BY-PRODUCTS AND...Section 1Unpackaged or in bulk animal by-products and derived products, originating...1.The competent authority ... shall only authorise the entry into...2.By way of derogation from point 1(a), in the case...3.The transport of consignments of products referred to in point...Section 2Unpackaged or in bulk animal by-products and derived products originating...1.The competent authority ... shall only authorise the entry into...2.Where the products referred to in point 1 have been...Section 3Packaged animal by-products and derived products originating from, and returning...1.The competent authority ... shall only authorise the entry into...2.Where the products referred to in point 1 have been...
ANNEX XVMODEL HEALTH CERTIFICATES
The model health certificates made available or published for the...
Notes (a)Veterinary certificates shall be produced by the exporting third country,...(b)Where the model certificate states that certain statements shall be...(c)The original of each certificate shall consist of a single...(d)It shall be drawn up in at least English. However,...(e)If for reasons of identification of the items of the...(f)When the certificate, including additional schedules referred to in e),...(g)The original of the certificate must be completed and signed...(h)The colour of the signature shall be different to that...(i)The original of the certificate must accompany the consignment at...(j)If health certificates are used for consignments in transit, box...CHAPTER 1Health certificate CHAPTER 1aHealth certificate CHAPTER 2(A)Health certificate CHAPTER 2(B)Health certificate CHAPTER 3(A)Health certificate CHAPTER 3(B)Health certificate CHAPTER 3(C)Health certificate CHAPTER 3(D)Health certificate CHAPTER 3(E)Health certificate CHAPTER 3(F)Health certificate CHAPTER 4(A)Health certificate CHAPTER 4(B)Health certificate CHAPTER 4(C)Health certificate CHAPTER 4(D)Health certificate CHAPTER 5(A)Health certificate CHAPTER 5(B)Health certificate CHAPTER 5(C)Official declaration CHAPTER 6(A)Health certificate CHAPTER 6(B)Health certificate CHAPTER 7(A)Health certificate CHAPTER 7(B)Health certificate CHAPTER 8Health certificate CHAPTER 9Health certificate CHAPTER 10(A)Health certificate CHAPTER 10(B)Health certificate CHAPTER 11Health certificate CHAPTER 12Health certificate CHAPTER 13Health certificate CHAPTER 14(A)Health certificate CHAPTER 14(B)Health certificate CHAPTER 15Health certificate CHAPTER 16Model declaration CHAPTER 17Health certificate CHAPTER 18Health certificate CHAPTER 19Health certificate CHAPTER 20Model declaration CHAPTER 21Model declaration
ANNEX XVIOFFICIAL CONTROLS
CHAPTER IOFFICIAL CONTROLS IN PROCESSING PLANTS Section 1Supervision of the production 1.The competent authority shall supervise processing plants to ensure compliance...2.To allow it to carry out its responsibilities under point...Section 2Validation procedures 1.Prior to issuing an approval for a processing plant, as...2.In the case of a batch pressure system: 3.In the case of a continuous pressure system: 4.The competent authority must repeat the checks on the validation...CHAPTER IILISTS OF REGISTERED AND APPROVED ESTABLISHMENTS, PLANTS AND OPERATORS 1.Access to lists of registered and approved establishments, plants and...2.Format for national websites 3.The layout, including the relevant information and codes, of master...CHAPTER IIISPECIFIC REQUIREMENTS FOR OFFICIAL CONTROLS Section 1Official controls regarding marking of derived products Section 2Official controls in low-capacity incineration plants Section 3Official controls in remote areas Section 4Official controls in registered farms for the feeding of fur...
. . . . . . . . . ....
Section 5Official controls regarding collection centres 1.The competent authority shall: 2.The competent authority shall carry out official controls at collection...Section 6Official controls regarding the feeding of wild animals and certain...Section 7Official controls regarding the application of certain organic fertilisers and...Section 8Official controls regarding approved photographic factories Section 9Official controls regarding certain imported rendered fats Section 10Standard format for applications for certain authorisations in intra-Union trade...Section 11Official controls regarding hydrolysis with subsequent disposal Section 12Official controls regarding plants approved for the combustion of animal...

Commission Regulation (EU) No 142/2011

of 25 February 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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation)1, and in particular Articles 5(2) and 6(1)(b)(ii) and the second subparagraph of Article 6(1), the second subparagraph of Article 6(2), Article 11(2)(b) and (c) and the second subparagraph of Article 11(2), Article 15(1)(b), (d), (e), (h) and (i) and the second subparagraph of Article 15(1), Articles 17(2) and 18(3), Article 19(4)(a), (b) and (c) and the second subparagraph of Article 19(4), Article 20(10) and (11), Article 21(5) and (6), Articles 22(3) and 23(3), Article 27(a), (b), (c) and (e) to (h) and the second subparagraph of Article 27, Articles 31(2), 32(3), Article 40, the first and third subparagraph of Article 41(3), Article 42, Articles 43(3), 45(4), 47(2), Article 48(2), Article 48(7)(a) and (8)(a) and the second subparagraph of Article 48(8) thereof,

Having regard to Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries2, and in particular Article 16(3) thereof,

Whereas:

(1)

Regulation (EC) No 1069/2009 lays down animal and public health rules for animal by-products and products derived thereof. That Regulation determines the circumstances under which animal by-products are to be disposed of, in order to prevent the spreading of risks for public and animal health. In addition, that Regulation specifies under which conditions animal by-products may be used for applications in animal feed and for various purposes, such as in cosmetics, medicinal products and technical applications. It also lays down obligations for operators to handle animal by-products within establishments and plants which are subject to official controls.

(2)

Regulation (EC) No 1069/2009 provides that detailed rules for the handling of animal by-products and derived products, such as processing standards, hygiene conditions and the format for documentary evidence which has to accompany consignments of animal by-products and derived products for the purposes of traceability are to be adopted by means of implementing measures.

(3)

The detailed rules for the use and disposal of animal by-products in this Regulation should be laid down with a view to the achievement of the objectives of Regulation (EC) No 1069/2009, notably the sustainable use of animal materials, and a high level of protection of public and animal health in the European Union.

(4)

Regulation (EC) No 1069/2009 does not apply to entire bodies or parts of wild animals, which are not suspected of being infected or affected with a disease communicable to humans or animals, except for aquatic animals landed for commercial purposes. In addition, it does not apply to entire bodies or parts of wild game which are not collected after killing, in accordance with good hunting practice. Regarding those animal by-products from hunting, disposal should be carried out in a way which prevents the transmission of risks, as appropriate for specific hunting practices and in accordance with the good practice as it has been described by the hunting profession.

(5)

Regulation (EC) No 1069/2009 applies to animal by-products for the preparation of game trophies. The preparation of such trophies, as well as the preparations of animals and parts of animals for which other methods, such as plastination, are used, should take place under conditions which prevent the transmission of risks for human or animal health.

(6)

Regulation (EC) No 1069/2009 applies to catering waste if it originates from means of transport operating internationally, such as materials derived from foodstuffs served on board an airplane or a ship arriving in the European Union from a third country destination. Catering waste also falls within the scope of that Regulation, if it is destined for feeding purposes, for processing in accordance with one of the authorised processing methods under this Regulation or for transformation into biogas or for composting. Regulation (EC) No 1069/2009 prohibits the feeding of catering waste to farmed animals, other than fur animals. Therefore, in accordance with Regulation (EC) No 1069/2009, catering waste may be processed and subsequently used, provided that the derived product is not fed to such animals.

(7)

For the sake of consistency of Union legislation, the definition of feed materials in Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EEC and 96/25/EC and Commission Decision 2004/217/EC3 should be used as a basis for defining feed materials of animal origin in this Regulation.

(8)

Regulation (EC) No 1069/2009 prohibits the dispatch of animal by-products and of derived products from susceptible species from holdings, establishments, plants or zones which are subject to restrictions due to the presence of a serious transmissible disease. In order to provide for a high level of protection of animal health in the Union, the list of diseases in the Terrestrial and Aquatic Animal Health Codes of the World Organisation of Animal Health (hereinafter referred to as ‘OIE’) should be specified as the list of serious transmissible diseases for the purpose of determining the scope of this prohibition.

(9)

Since the incineration and the co-incineration of certain animal by-products do not fall within the scope of Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of waste4, adequate rules for the prevention of health risks arising from such operations should be laid down in this Regulation, taking into account the possible effects on the environment. Residues from the operation of the incineration or co-incineration of animal by-products or derived products should be recycled or disposed of, in accordance with Union environmental legislation, since in particular, that legislation allows for the use of the phosphorous component of ashes in fertilisers and for the handover of ashes from the cremation of pet animals to the owners.

(10)

Products of animal origin or foodstuffs containing such products, should only be disposed of in a landfill, in accordance with Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste5, if they have been processed as defined in Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs6, in order to mitigate potential health risks.

(11)

The disposal of animal by-products or derived products via the wastewater stream should be prohibited, since that stream is not subject to requirements which would ensure an appropriate control of public and animal health risks. Appropriate measures should be taken to prevent unacceptable risks from accidental disposal of liquid animal by-products, such as from the cleaning of floors and equipments used for processing.

(12)

Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives7 lays down certain measures to protect the environment and human health. Article 2(2)(b) of that Directive provides that certain matters are excluded from the scope of that Directive to the extent that they are covered by other Union legislation, including animal by-products covered by Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption8, except those which are destined for incineration, landfilling or use in a biogas or composting plant. That Regulation has now been repealed and replaced by Regulation (EC) No 1069/2009 from 4 March 2011. In the interests of coherency of Union legislation, the processes whereby animal by-products and derived products are transformed into biogas and composted should comply with the health rules laid down in this Regulation, as well as the measures for the protection of the environment laid down in Directive 2008/98/EC.

(13)

The competent authority of a Member State should be able to authorise alternative parameters for the transformation of animal by-products into biogas or for their composting on the basis of a validation according to a harmonised model. In that case, it should be possible to place digestion residues and compost on the market in the whole European Union. In addition, the competent authority of a Member State should be able to authorise certain parameters for specific animal by-products, such as catering waste and mixtures of catering waste with certain other materials, which are transformed into biogas or composted. Since such authorisations are not issued according to a harmonised model, digestion residues and compost should only be placed on the market within the Member State where the parameters have been authorised.

(14)

In order to prevent the contamination of foodstuffs with pathogenic agents, establishments or plants processing animal by-products should operate on a separate site from slaughterhouses or other establishments in which foodstuffs are processed, in particular in accordance with Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin9, unless the processing of the animal by-products takes place under conditions which have been approved by the competent authority, with a view to preventing the transmission of risks to public and animal health into the food-processing establishments.

(15)

Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies10 provides that Member States are to carry out annual monitoring programmes for transmissible spongiform encephalopathies (TSEs). Bodies of animals which are used for feeding to certain species, for the purposes of promotion of bio-diversity, should be included in those monitoring programmes to the extent necessary to ensure that those programmes provide sufficient information regarding the prevalence of TSE in a particular Member State.

(16)

Regulation (EC) No 1069/2009 allows the feeding of certain Category 1 material to endangered or protected species of necrophagous birds and to other species living in their natural habitat, for the promotion of biodiversity. Such feeding should be authorised for certain carnivore species referred to in Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora11 and for certain species of birds of prey referred to in Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds12, in order to take into account the natural feeding patterns of those species.

(17)

Regulation (EC) No 1069/2009 has introduced a procedure for the authorisation of alternative methods of use or disposal of animal by-products or derived products. Such methods may be authorised by the Commission following receipt of an opinion from the European Food Safety Authority (hereinafter referred to as ‘EFSA’). In order to facilitate the evaluation of applications by EFSA, a standard format should be laid down which illustrates to applicants the nature of the evidence to be submitted. In accordance with the Treaties, it should be possible to submit applications for alternative methods in the official languages of the Union, as laid down in EEC Council Regulation No 1 determining the languages to the used by the European Economic Community13.

(18)

In accordance with Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene14, feed business operators, other than primary producers, are required to store and transport feed under certain hygienic conditions. Since those conditions provide for an equivalent mitigation of potential risks, compound feedingstuffs derived from animal by-products should not be subject to the requirements of this Regulation regarding storage and transport.

(19)

For the promotion of science and research and to ensure the best possible use of animal by-products and of derived products in the diagnosis of human or animal diseases, the competent authority should be authorised to lay down conditions for samples of such materials for research, educational and diagnostic purposes. However, those conditions should not be laid down for samples of pathogenic agents for which special rules are provided in Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC15.

(20)

Directive 97/78/EC exempts animal by-products which are intended for exhibitions, provided that they are not intended to be marketed, and animal by-products intended for particular studies or analyses from veterinary checks in the border inspection post of entry into the Union. That Directive allows for the adoption of implementing measures for those exemptions. In this Regulation, appropriate conditions should be set out for the import of animal by-products and derived products intended for exhibitions and particular studies or analyses, to ensure that no unacceptable risks to public or animal health are spread where such products enter the Union. In the interests of coherency of Union legislation, and in order to provide legal certainty to operators, those conditions and the implementing measures for Directive 97/78/EC should be laid down in this Regulation.

(21)

Following collection, animal by-products should be handled under appropriate conditions which ensure that no unacceptable risks to public or animal health are transmitted. Establishments or plants in which certain operations are carried out before animal by-products are submitted to further processing should be constructed and should operate in a manner which prevents such transmission. This should include establishments or plants where operations involving the handling of animal by-products in accordance with Union veterinary legislation, other than the handling of animal by-products in the course of curative activities of private veterinarians, are carried out.

(22)

Pursuant to Regulation (EC) No 1069/2009, operators are to ensure that animal by-products and derived products are traceable at all stages of the chain of manufacturing, use and disposal, so as to avoid unnecessary disruptions of the internal market in the case of events which are linked to actual or potential risks to public or animal health. Traceability should therefore not only be ensured by operators generating, collecting or transporting animal by-products, but also by operators disposing of animal by-products or derived products, by incineration, co-incineration or landfilling.

(23)

Containers and means of transport which are used for animal by-products or derived products should be maintained in a clean state, so as to prevent contamination. When they are dedicated to the transport of a particular material, such as a liquid animal by-product which does not pose an unacceptable health risk, operators may adjust their measures to ensure the prevention of contamination to the actual risk arising from that material.

(24)

Member States should be authorised to require operators to use the integrated computerised veterinary system (Traces) introduced by Commission Decision 2004/292/EC of 30 March 2004 on the introduction of the Traces system and amending Decision 92/486/EEC16 (hereinafter referred to as ‘the TRACES system’) in order to provide proof for the arrival of consignments of animal by-products or derived products at the place of destination. Alternatively, proof for the arrival of consignments should be provided by way of a fourth copy of the commercial document, which is returned to the producer. The experience with the two alternatives should be evaluated after the first year of implementation of this Regulation.

(25)

Regulation (EC) No 853/2004 specifies certain parameters for the treatment of rendered fats, fish oil and egg products which provide an adequate control of possible health risks, when such products are used for purposes other than human consumption. Those parameters should therefore be authorised as alternatives to the treatments for animal by-products which are set out in this Regulation.

(26)

Colostrum and colostrum products should originate from bovine herds which are free of certain diseases as referred to in Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine17.

(27)

The references to Council Directive 76/768/EEC of 27 July 1976 on the approximation of laws of the Member States relating to cosmetic products18, to Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists19, to Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products20 should be updated and the reference to Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs21 in the health rules for the trade in unprocessed manure should be updated.

(28)

Certain imported materials for the production of petfood should be handled and used under conditions which are appropriate to the risk which such materials may pose. In particular, provision should be made for their safe channelling to establishments or plants of destination where such materials, as well as Category 3 material, are incorporated into petfood. With respect to the establishments or plants of destination, the competent authority should be authorised to allow the storage of imported materials together with Category 3 material, provided the imported materials can be traced.

(29)

Regulation (EC) No 1069/2009 refers to certain derived products which may be placed on the market in accordance with conditions laid down in certain other Union legislation. That legislation also lays down conditions for the import, collection and movement of animal by-products and derived products for the manufacture of such derived products. However, Regulation (EC) No 1069/2009 applies where that other Union legislation does not lay down conditions concerning risks to public and animal health which may arise from such raw materials. Since such conditions have not been laid down regarding materials which have undergone certain stages of processing prior to their fulfilling the conditions for placing on the market under that other Union legislation, they should be laid down in this Regulation. In particular, the conditions for the import and handling of such materials inside the Union under strict control and documentation requirements should be laid down, so as to prevent the transmission of potential health risks from such materials.

(30)

In particular, adequate health conditions should be laid down in this Regulation for materials which are used for the manufacture of medicinal products in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use22, of veterinary medicinal products in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products23, of medical devices in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices24, of in vitro diagnostic medical devices in accordance with Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices25, active implantable medical devices in accordance with Council Directive 90/385/EEC of 20 June 1990 on the approximation of laws of the Member States relating to active implantable medical devices26 or laboratory reagents (‘the finished products’). If the risks arising from such materials are mitigated due to the purification, concentration in the product or due to the conditions under which they are handled and disposed of, only the requirements of Regulation (EC) No 1069/2009 and of this Regulation in relation to traceability should apply. In such case, the requirements related to the separation of animal by-products of different categories within the establishment or plant producing the finished products should not apply, since the subsequent use of materials for other purposes, in particular their diversion into food or feed can be excluded by the proper application of the rules by the operator, under the responsibility of the competent authority. Consignments of such materials which are to be imported into the Union should be subject to veterinary checks at the border inspection post of entry in accordance with Directive 97/78/EC, in order to ascertain that those products comply with the requirements for their placing on the market within the Union.

(31)

Pursuant to Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and import from third countries of equidae27, certain diseases to which equidae are susceptible are compulsorily notifiable. Blood products from equidae which are intended for purposes other than for feeding, such as blood products intended for veterinary medicinal products, should originate from equidae which did not show clinical signs of those diseases, in order to mitigate the risk of transmission of those diseases.

(32)

It should be permissible to place on the market fresh hides and skins for purposes other than human consumption, provided they comply with the animal health conditions for fresh meat laid down in accordance with Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption28, since those conditions provide for an appropriate mitigation of possible health risks.

(33)

The health rules laid down in this Regulation for the manufacture and placing on the market of game trophies and other preparations from animals which eliminate potential risks should be in addition to the rules for the protection of certain species of wild animals laid down in Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein29, due to the different objective of that Regulation. Anatomical preparations of animals or animal by-products which have been submitted to a process such as plastination which equally eliminates potential risks should not be subject to animal health restrictions, in order to facilitate the use of such preparations, in particular in education.

(34)

Apiculture by-products which are to be placed on the market should be free of certain diseases to which bees are susceptible that are listed in Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC30.

(35)

The European Parliament and the Council have called upon the Commission to determine an end point in the manufacturing chain for oleochemical products, beyond which they are no longer subject to the requirements of Regulation (EC) No 1069/2009. The decision regarding that end point should be taken as soon as an assessment has become available which evaluates the capacity of the oleochemical processes to mitigate potential health risks which may be present in animal fats of any category of material which are processed.

(36)

Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements31 should be referred to in this Regulation, in so far as those third countries and other territories should be authorised for the importation of certain animal by-products or derived products, since the risks which arise from those products are identical to those which potentially arise from the import of live animals or fresh meat.

(37)

Further lists of third countries from which certain materials of animal origin may be imported should be referred to for the purposes of determining the third countries from which animal by-products of the respective species may be imported, on the basis of similar considerations concerning health risks and in order to ensure coherency of Union legislation. Such lists have been laid down in Commission Decision 2004/211/EC of 6 January 2004 establishing the list of third countries and parts of territory thereof from which Member States authorise imports of live equidae and semen, ova and embryos of the equine species and amending Decisions 93/195/EEC and 94/63/EC32, Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certifications conditions for introduction into the European Union of raw milk and dairy products intended for human consumption33, Commission Decision 2006/766/EC of 6 November 2006 establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted34, Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements35 and Commission Regulation (EC) No 119/2009 of 9 February 2009 laying down a list of third countries or parts thereof, for imports into, or transit through, the Community of meat of wild leporidae, of certain wild land mammals and of farmed rabbits and the veterinary certification requirements36.

(38)

Since waste from the photographic industry which uses certain animal by-products such as bovine vertebral column does not only pose risks to public and animal health, but also risks to the environment, it should either be disposed of or exported to the third country of origin of the animal by-products in accordance with Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste37.

(39)

The list of border inspection posts laid down in Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border inspection posts, laying down certain rules on the inspections carried out by Commission veterinary experts and laying down the veterinary units in Traces38 should be referred to in the rules for the transit of certain animal by-products and derived products through the European Union between territories of the Russian Federation. The Common Veterinary Entry Document laid down in Commission Regulation (EC) No 136/2004 of 22 January 2004 laying down procedures for veterinary checks at Community border inspection posts on products imported from third countries39 should be used for the purposes of that transit.

(40)

This Regulation should provide that the health certificates which are to accompany consignments of animal by-products or derived products at the point of entry into the Union where the veterinary checks take place should be issued in accordance with principles of certification equivalent to those laid down in Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products40.

(41)

In the interests of consistency of Union legislation, official controls on the entire chain of animal by-products and derived products should be carried out in accordance with the general obligations for official controls which are laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules41.

(42)

It is therefore necessary to lay down implementing measures for Regulation (EC) No 1069/2009 in this Regulation.

(43)

Regulation (EC) No 1069/2009 repeals Regulation (EC) No 1774/2002 with effect from 4 March 2011.

(44)

Following the adoption of Regulation (EC) No 1774/2002, certain implementing acts were adopted, namely Commission Regulation (EC) No 811/200342 on the intra-species recycling ban for fish, and the burial and burning of certain animal by-products, Commission Decision 2003/322/EC43 on the feeding of certain necrophagous birds with certain Category 1 materials, Commission Decision 2003/324/EC44 on a derogation from the intra-species recycling ban for fur animals, Commission Regulations (EC) No 79/200545 on milk and milk-based products, (EC) No 92/200546 on means of disposal or uses, (EC) No 181/200647 on organic fertilisers and soil improvers other than manure, (EC) No 1192/200648 on lists of approved plants and (EC) No 2007/200649 on the importation and transit of certain Category 3 intermediate products.

(45)

In addition, certain transitional measures were adopted, in particular Commission Regulation (EC) No 878/200450 on the import and handling of certain Category 1 and Category 2 materials, Commission Decision 2004/407/EC51 on the import of certain materials for the production of photogelatine and Commission Regulation (EC) No 197/200652 on handling and disposal of former foodstuffs, to lay down risk-proportionate measures for certain specific uses of animal by-products.

(46)

In order to further simplify Union rules for animal by-products, as requested by the Presidency of the Council at the time of the adoption of Regulation (EC) No 1069/2009, those implementing and transitional measures were reviewed. They should now be repealed and replaced, as necessary, by this Regulation, so as to constitute a coherent legal framework for animal by-products and derived products.

(47)

Regulation (EC) No 1069/2009 applies from 4 March 2011 and accordingly this Regulation should also apply from that date. In addition, it is necessary to provide for a transitional period, in order to give stakeholders time to adjust to the new rules laid down in this Regulation and to place on the market certain products which were produced in accordance with Union health rules applicable before that date, and to allow for a continuation of imports when the requirements of this Regulation become applicable.

(48)

The placing on the market and the export of certain products referred to in Regulation (EC) No 878/2004 should continue to be carried out in accordance with national measures, since the associated risks for the limited amount of materials involved currently allow their regulation at national level, pending possible future harmonisation. Pending the adoption of measures for the collection and disposal of certain limited amounts of products of animal origin from the retail sector on the basis of further evidence, the competent authority should continue to be able to authorise the collection and disposal of such products by other means, provided that an equivalent protection of public and animal health is ensured.

(49)

In accordance with the request expressed by the European Parliament at the time of its agreement to Regulation (EC) No 1069/2009 at first reading, and taking into account the Parliament's more specific suggestions for addressing certain technical issues, a draft of this Regulation has been presented on 27 September 2010 to its Committee for the Environment, Public Health and Food Safety for an exchange of views.

(50)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION: