LegalizeRegulation (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 encephalopathies
(c) The blood products shall be produced in processing plants exclusively processing non-ruminant blood, and registered by the competent authority as processing exclusively non-ruminant blood. By way of derogation from that specific condition, the competent authority may authorise the production of blood products for use in feed for non-ruminant farmed animals in processing plants processing ruminant blood. That authorisation may be granted only where the competent authority is satisfied, following an inspection, concerning the effectiveness of measures aimed to prevent cross-contamination. Those measures shall include the following minimum requirements: (i) the production of non-ruminant blood products must be carried out in a closed system that is kept physically separated from that used for the production of ruminant blood products; (ii) the collection, storage, transport and packaging facilities for bulk raw material and bulk finished products of non-ruminant origin must be kept separate from those for bulk raw material and bulk finished of ruminant origin; (iii) an ongoing reconciliation process between the incoming blood respectively derived from ruminants and non-ruminants and the corresponding blood products must be applied; (iv) a regular sampling and analysis of blood products of non ruminant origin must be carried out to verify the absence of cross-contamination with blood products of ruminant origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on hazard analysis and critical control points (HACCP) principles; the results of such sampling and analysis shall be kept available to the competent authority for a period of at least five years.
(d) The words ‘non-ruminant blood products — shall not be used in feed for ruminants’ shall be clearly indicated on the accompanying commercial document or health certificate referred to in Article 21(2) of Regulation (EC) No 1069/2009, as appropriate, as well as on the label of blood products derived from non-ruminants. The words ‘contains non-ruminant blood products — shall not be fed to ruminants’ shall be clearly indicated on the label of compound feed containing blood products derived from non-ruminants.
The following specific conditions shall apply to the production and use of processed animal protein derived from non-ruminants, other than fishmeal and other than processed animal protein derived from farmed insects, and compound feed containing such protein, intended to be used for feeding aquaculture animals:
(a) The animal by-products intended to be used for the production of processed animal protein referred to in this Section shall come from one or more of the following: (i) slaughterhouses approved in accordance with Article 4 of Regulation (EC) No 853/2004 which do not slaughter ruminants and which are registered by the competent authority as not slaughtering ruminants; (ii) cutting plants approved in accordance with Article 4 of Regulation (EC) No 853/2004 which do not bone or cut up ruminant meat and which are registered by the competent authority as not boning or cutting up ruminant meat; (iii) other establishments than those referred to in point (i) or (ii), registered or approved in accordance with Article 4 of Regulation (EC) No 853/2004, which do not handle ruminant products and which are registered by the competent authority as not handling ruminant products; (iv) approved establishments referred to in Article 24(1), points (h) and (i) of Regulation (EC) No 1069/2009 which are registered by the competent authority as handling or storing only non-ruminant animal by-products coming from establishments referred to in points (i), (ii) and (iii). By way of derogation from points (i), (ii) and (iii) of the first paragraph, the competent authority may authorise the slaughter of ruminants and the handling of ruminant products in the establishments referred to in points (i), (ii) and (iii) of the first paragraph producing non-ruminant animal by-products intended for the production of processed animal protein referred to in this Section. That authorisation may be granted only where the competent authority is satisfied, following an on-site inspection, of the effectiveness of measures aimed to prevent cross-contamination between ruminant and non-ruminant by-products. Those measures shall include the following minimum requirements: (1) the slaughtering of non-ruminants must be carried out in lines that are physically separate from those used for the slaughtering of ruminants; (2) non-ruminant products must be handled on production lines that are physically separate from those used for the handling of ruminant products; (3) the collection, storage, transport and packaging facilities for animal by-products of non-ruminant origin must be kept separate from those for animal by-products of ruminant origin; (4) a regular sampling and analysis of animal by-products of non-ruminant origin must be carried out to detect the presence of ruminant proteins. The method of analysis used must be scientifically validated for that purpose. The frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles.
(b) The animal by-products of non-ruminant origin intended to be used for the production of processed animal protein referred to in this Section shall be transported to a processing plant in vehicles and containers which are not used for the transport of animal by-products of ruminant origin. By way of derogation from that specific condition, they may be transported in vehicles and containers which have been previously used for the transport of animal by-products derived from ruminants, provided that those vehicles and containers have been cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented trace of such use shall be kept available to the competent authority for a period of at least two years.
(c) The processed animal protein referred to in this Section shall be produced in processing plants that are dedicated exclusively to processing non-ruminant animal by-products sourced from slaughterhouses, cutting plants or other establishments referred to in point (a). Those processing plants shall be registered by the competent authority as processing exclusively non-ruminant animal by-products. By way of derogation from that specific condition, the competent authority may authorise the production of processed animal protein referred to in this Section in processing plants processing ruminant animal by-products. That authorisation may be granted only where the competent authority is satisfied, following an inspection, concerning the effectiveness of the measures aimed to prevent cross-contamination between processed animal protein of ruminant origin and processed animal protein of non-ruminant origin. Those preventive measures shall include the following minimum requirements: (i) the production of processed animal protein derived from ruminants must be carried out in a closed system that is physically separated from that used for the production of the processed animal protein referred to in this Section; (ii) the keeping of animal by-products derived from ruminants during storage and transport in facilities that are physically separated from those for animal by-products derived from non-ruminants; (iii) the keeping of processed animal protein derived from ruminants during storage and packaging in facilities that are physically separated from those used for finished products derived from non-ruminants; (iv) regular sampling and analysis of the processed animal protein referred to in this Section must be carried out to verify the absence of cross-contamination with ruminant processed animal protein using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on hazard analysis and critical control points (HACCP) principles; the results of such sampling and analysis shall be kept available to the competent authority for a period of at least five years.
(d) Compound feed containing processed animal protein referred to in this Section shall be produced in establishments authorised for that purpose by the competent authority and which are dedicated exclusively to the production of feed for aquaculture animals. By way of derogation from that specific condition: (i) the production of compound feed, containing processed animal protein referred to in this Section, for aquaculture animals in establishments which also produce compound feed intended for other farmed animals, other than fur animals, may be authorised by the competent authority, following an on-site inspection, subject to compliance with the following conditions: — compound feed destined for ruminants must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for non-ruminant animals are manufactured and kept; — compound feed destined for aquaculture animals must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for other non-ruminant animals are manufactured and kept; — records detailing the purchases and uses of processed animal protein referred to in this Section and the sales of compound feed containing such protein must be kept available to the competent authority for a period of at least five years; — regular sampling and analysis of the compound feed destined for farmed animals other than aquaculture animals in order to verify the absence of unauthorised constituents of animal origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of such sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles; the results must be kept available to the competent authority for a period of at least five years; (ii) a specific authorisation for the production of complete feed from compound feed containing processed animal protein referred to in this Section shall not be required for home compounders that comply with the following conditions: — they are registered by the competent authority as producing complete feed from compound feed containing processed animal protein derived from non-ruminants, other than fishmeal and other than processed animal protein derived from farmed insects, — they keep only aquaculture animals, and — the compound feed containing processed animal protein referred to in this Section used in their production contains less than 50 % crude protein.
(e) The accompanying commercial document or health certificate referred to in Article 21(2) of Regulation (EC) No 1069/2009, as appropriate, of processed animal protein referred to in this Section and the label thereof shall be clearly marked with the following words: ‘non-ruminant processed animal protein — shall not be used in feed for farmed animals except aquaculture and fur animals’. The following words shall be clearly indicated on the label of compound feed containing processed animal protein referred to in this Section: ‘contains non-ruminant processed animal protein — shall not be fed to farmed animals except aquaculture and fur animals’.
The following specific conditions shall apply to the production, placing on the market and use of milk replacers containing fishmeal in the feeding of unweaned farmed animals of the ruminant species:
(a) the fishmeal used in milk replacers shall be produced in processing plants dedicated exclusively to the production of products derived from: (i) aquatic animals, except sea mammals; (ii) farmed aquatic invertebrates other than those that fall within the definition of ‘aquatic animals’ provided for in Article 3(1)(e) of Directive 2006/88/EC; or (iii) starfish of the species Asterias rubens which are harvested in a production area as defined in Annex I point 2.5 of Regulation (EC) No 853/2004 and classified accordingly. The fishmeal used in milk replacers shall comply with general conditions laid set out in Chapter III.
(b) the words ‘fishmeal — shall not be used in feed for ruminants except unweaned ruminants’ shall be clearly indicated on the accompanying commercial document or health certificate referred to in Article 21(2) of Regulation (EC) No 1069/2009, as appropriate, as well as the label of fishmeal intended to be used in milk replacers;
(c) the use of fishmeal for unweaned farmed animals of the ruminant species shall only be authorised for the production of milk replacers, distributed in dry form and administered after dilution in a given quantity of liquid, intended for the feeding of unweaned ruminants as a supplement to, or substitute for, post-colostral milk before weaning is complete;
(d) milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species shall be produced in establishments which do not produce other compound feed for ruminants and which are authorised for this purpose by the competent authority. By way of derogation from that special condition, the production of other compound feed for ruminants in establishments which also produce milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species may be authorised by the competent authority, following an on-site inspection, subject to compliance with the following conditions: (i) other compound feed destined for ruminants must be kept in facilities that are physically separate from those used for bulk fishmeal and bulk milk replacers containing fishmeal during storage, transport and packaging; (ii) other compound feed destined for ruminants must be manufactured in facilities that are physically separate from facilities where milk replacers containing fishmeal are manufactured; (iii) records detailing the purchases and uses of fishmeal and the sales of milk replacers containing fishmeal must be kept available to the competent authority for a period of at least five years; (iv) regular sampling and analysis of the other compound feed destined for ruminants must be carried out in order to verify the absence of unauthorised constituents of animal origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of such sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles; the results must be kept available to the competent authority for a period of at least five years;
(e) before release for free circulation in the Union, importers shall ensure that each consignment of imported milk replacers containing fishmeal is analysed in accordance with methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009 in order to verify the absence of unauthorised constituents of animal origin;
(f) The label of milk replacers containing fishmeal, intended for unweaned farmed animals of the ruminant species, must be clearly marked with the words ‘contains fishmeal — shall not be fed to ruminants except unweaned ruminants’;
(g) bulk milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively for the transport or storage of other feed intended for ruminants. By way of derogation from that special condition, vehicles, containers and storage facilities which will be subsequently used for the transport or storage of other bulk feed intended for ruminants may be used for the transport or storage of bulk milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species provided that they have been cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented record of such use shall be kept available to the competent authority for a period of at least two years;
(h) on farms where ruminants are kept, on-farm measures shall be in place to prevent milk replacers containing fishmeal being fed to other ruminants than unweaned ruminants. The competent authority shall establish a list of farms where milk replacers containing fishmeal are used through a system of prior notification by the farm or another system thereby ensuring compliance with this specific condition.
The following specific conditions shall apply to the production and use of processed animal protein derived from farmed insects and compound feed containing such processed animal protein intended to be used for feeding aquaculture animals, poultry and porcine animals:
(a) Processed animal protein derived from farmed insects must be produced: (i) in processing plants approved in accordance with Article 24(1), point (a) of Regulation (EC) No 1069/2009 and dedicated exclusively to the production of products derived from farmed insects; (ii) in accordance with the requirements laid down in Annex X, Chapter II, Section 1 to Regulation (EU) No 142/2011. By way of derogation from the condition provided for in point (i) of the first paragraph, the competent authority may authorise the production of processed animal protein derived from farmed insects in processing plants processing by-products from other species. That authorisation may be granted only where the competent authority is satisfied, following an inspection, concerning the effectiveness of the measures aimed to prevent cross-contamination of processed animal protein derived from farmed insects with processed animal protein derived from other farmed animals. Those preventive measures shall include the following minimum requirements: — the production of processed animal protein derived from ruminants or non-ruminants other than insects must be carried out in a closed system that is physically separated from that used for the production of the processed animal protein derived from farmed insects; — the keeping of animal by-products derived from ruminants or non-ruminants other than insects during storage and transport in facilities that are physically separated from those for animal by-products derived from farmed insects; — the keeping of processed animal protein derived from ruminants or non-ruminants other than insects during storage and packaging in facilities that are physically separated from those used for finished products derived from farmed insects; — regular sampling and analysis of the processed animal protein derived from farmed insects must be carried out to verify the absence of cross-contamination with processed animal protein derived from ruminants or other non-ruminants using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on HACCP principles; the results of such sampling and analysis shall be kept available to the competent authority for a period of at least five years.
(b) Compound feed containing processed animal protein derived from farmed insects shall be produced in establishments: (i) authorised for that purpose by the competent authority; (ii) dedicated to the production of feed for aquaculture animals, poultry or porcine animals. By way of derogation from point (i) of the first paragraph, a specific authorisation for the production of complete feed from compound feed containing processed animal protein derived from farmed insects shall not be required for home compounders that comply with the following conditions: — they are registered by the competent authority as producing complete feed from compound feed containing processed animal protein derived from farmed insects, — they do not keep farmed animals as defined in Article 3, point 6(a) of Regulation (EC) No 1069/2009, other than aquaculture animals, poultry, porcine animals or fur animals, — the compound feed containing processed animal protein derived from farmed insects used in their production contains less than 50 % crude protein. By way of derogation from point (ii) of the first paragraph, the production of compound feed containing processed animal protein derived from farmed insects, intended for aquaculture animals, poultry or porcine animals, in establishments which also produce compound feed intended for other farmed animals, except fur animals, may be authorised by the competent authority, following an on-site inspection, subject to compliance with the following conditions: — compound feed destined for ruminants must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for non-ruminant animals are manufactured and kept, — compound feed destined for aquaculture animals, poultry or porcine animals must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for other non-ruminant animals are manufactured and kept, — records detailing the purchases and uses of processed animal protein derived from farmed insects and the sales of compound feed containing such protein must be kept available to the competent authority for a period of at least five years, — regular sampling and analysis of the compound feed destined for farmed animals other than aquaculture animals, poultry and porcine animals in order to verify the absence of unauthorised constituents of animal origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of such sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles; the results must be kept available to the competent authority for a period of at least five years.
(c) The commercial document or, as appropriate, the health certificate accompanying the processed animal protein derived from farmed insects in accordance with Article 21(2) of Regulation (EC) No 1069/2009, the label of that processed animal protein derived from farmed insects, and the label of compound feed containing processed animal protein derived from farmed insects shall be clearly marked in accordance with Chapter V, Section G of this Annex.
The following specific conditions shall apply to the production and use of processed animal protein derived from porcine animals and compound feed containing such protein, intended to be used for feeding poultry (‘processed animal protein derived from porcine animals’):
(a) The animal by-products intended to be used for the production of processed animal protein derived from porcine animals shall come from one or more of the following: (i) slaughterhouses approved in accordance with Article 4 of Regulation (EC) No 853/2004 which do not slaughter ruminants and poultry and which are registered by the competent authority as not slaughtering ruminants and poultry; (ii) cutting plants approved in accordance with Article 4 of Regulation (EC) No 853/2004 which do not bone or cut up ruminant and poultry meat and which are registered by the competent authority as not boning or cutting up ruminant and poultry meat; (iii) other establishments than those referred to in point (i) or (ii), registered or approved in accordance with Article 4 of Regulation (EC) No 853/2004, which do not handle ruminant and poultry products and which are registered by the competent authority as not handling ruminant and poultry products; (iv) approved establishments referred to in Article 24(1), points (h) and (i) of Regulation (EC) No 1069/2009 which are registered by the competent authority as handling or storing only non-ruminant animal by-products coming from establishments referred to in points (i), (ii) and (iii). By way of derogation from points (i), (ii) and (iii) of the first paragraph, the competent authority may authorise the slaughter of ruminants or poultry and the handling of ruminant or poultry products in the establishments referred to in points (i), (ii) and (iii) of the first paragraph producing porcine animal by-products intended for the production of processed animal protein derived from porcine animals. That authorisation may be granted only where the competent authority is satisfied, following an on-site inspection, of the effectiveness of measures aimed to prevent cross-contamination between ruminant or poultry and porcine animal by-products. Those measures shall include the following minimum requirements: (1) the slaughtering of porcine animals must be carried out in lines that are physically separate from those used for the slaughtering of ruminants or poultry; (2) products of porcine origin must be handled on production lines that are physically separate from those used for the handling of ruminant or poultry products; (3) the collection, storage, transport and packaging facilities for animal by-products of porcine origin must be kept separate from those for animal by-products of ruminant or poultry origin; (4) a regular sampling and analysis of animal by-products of porcine origin must be carried out to detect the presence of ruminant or poultry proteins. The method of analysis used must be scientifically validated for that purpose. The frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles.
(b) The animal by-products of porcine origin intended to be used for the production of processed animal protein derived from porcine animals shall be transported to a processing plant in vehicles and containers which are not used for the transport of animal by-products of ruminant or poultry origin. By way of derogation from the first paragraph, they may be transported in vehicles and containers which have been previously used for the transport of animal by-products derived from ruminants or poultry, provided that those vehicles and containers have been cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented trace of such use shall be kept available to the competent authority for a period of at least two years.
(c) The processed animal protein derived from porcine animals shall be produced in processing plants: (i) dedicated to processing by-products sourced from slaughterhouses, cutting plants or other establishments referred to in point (a); (ii) registered by the competent authority as not processing ruminant animal or poultry by-products. By way of derogation from point (ii) of the first paragraph, the competent authority may authorise the production of processed animal protein derived from porcine animals in processing plants processing ruminant animal or poultry by-products. That authorisation may be granted only where the competent authority is satisfied, following an inspection, concerning the effectiveness of the measures aimed to prevent cross-contamination between processed animal protein of ruminant or poultry origin and processed animal protein of porcine origin. Those preventive measures shall include the following minimum requirements: (1) the production of processed animal protein derived from ruminants or poultry must be carried out in a closed system that is physically separated from that used for the production of the processed animal protein derived from porcine animals; (2) the keeping of animal by-products derived from ruminants and poultry during storage and transport in facilities that are physically separated from those for animal by-products derived from porcine animals; (3) the keeping of processed animal protein derived from ruminants or poultry during storage and packaging in facilities that are physically separated from those used for finished products derived from porcine animals; (4) regular sampling and analysis of the processed animal protein derived from porcine animals must be carried out to verify the absence of cross-contamination with ruminant or poultry processed animal protein using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on HACCP principles; the results of such sampling and analysis shall be kept available to the competent authority for a period of at least five years.
(d) Compound feed containing processed animal protein derived from porcine animals shall be produced in establishments: (i) authorised for that purpose by the competent authority; (ii) dedicated exclusively to the production of feed for poultry, aquaculture or fur animals. By way of derogation from point (i) of the first paragraph, a specific authorisation for the production of complete feed from compound feed containing processed animal protein derived from porcine animals shall not be required for home compounders that comply with the following conditions: — they are registered by the competent authority as producing complete feed from compound feed containing processed animal protein derived from porcine animals, — they do not keep farmed animals as defined in Article 3, point 6(a) of Regulation (EC) No 1069/2009, other than poultry, aquaculture animals or fur animals, — the compound feed containing processed animal protein derived from porcine animals used in their production contains less than 50 % crude protein. By way of derogation from point (ii) of the first paragraph, the production of compound feed for poultry, containing processed animal protein derived from porcine animals, in establishments which also produce compound feed intended for farmed animals other than aquaculture and fur animals, may be authorised by the competent authority, following an on-site inspection, subject to compliance with the following conditions: — compound feed destined for ruminants must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for non-ruminant animals are manufactured and kept, — compound feed destined for porcine animals must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for other non-ruminant animals are manufactured and kept, — records detailing the purchases and uses of processed animal protein derived from porcine animals and the sales of compound feed containing such protein must be kept available to the competent authority for a period of at least five years, — regular sampling and analysis of the compound feed destined for farmed animals other than poultry, aquaculture and fur animals in order to verify the absence of unauthorised constituents of animal origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of such sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles; the results must be kept available to the competent authority for a period of at least five years.
(e) The commercial document or, as appropriate, the health certificate accompanying the processed animal protein derived from porcine animals in accordance with Article 21(2) of Regulation (EC) No 1069/2009, the label of that processed animal protein derived from porcine animals, and the label of compound feed containing processed animal protein derived from porcine animals shall be clearly marked in accordance with Chapter V, Section G of this Annex.
The following specific conditions shall apply to the production and use of processed animal protein derived from poultry and compound feed containing such protein, intended to be used for feeding porcine animals (‘processed animal protein derived from poultry’):
(a) The animal by-products intended to be used for the production of processed animal protein derived from poultry shall come from one or several of the following: (i) slaughterhouses approved in accordance with Article 4 of Regulation (EC) No 853/2004 which do not slaughter ruminants and porcine animals and which are registered by the competent authority as not slaughtering ruminants and porcine animals; (ii) cutting plants approved in accordance with Article 4 of Regulation (EC) No 853/2004 which do not bone or cut up ruminant meat and pork and which are registered by the competent authority as not boning or cutting up ruminant meat and pork; (iii) other establishments than those referred to in point (i) or (ii), registered or approved in accordance with Article 4 of Regulation (EC) No 853/2004, which do not handle ruminant and porcine products and which are registered by the competent authority as not handling ruminant and porcine products; (iv) approved establishments referred to in Article 24(1), points (h) and (i) of Regulation (EC) No 1069/2009 which are registered by the competent authority as handling or storing only non-ruminant animal by-products coming from establishments referred to in points (i), (ii) and (iii). By way of derogation from points (i), (ii) and (iii) of the first paragraph, the competent authority may authorise the slaughter of ruminants or porcine animals and the handling of ruminant or porcine products in the establishments referred to in points (i), (ii) and (iii) of the first paragraph producing poultry animal by-products intended for the production of processed animal protein derived from poultry. That authorisation may be granted only where the competent authority is satisfied, following an on-site inspection, of the effectiveness of measures aimed to prevent cross-contamination between ruminant or porcine and poultry animal by-products. Those measures shall include the following minimum requirements: (1) the slaughtering of poultry must be carried out in lines that are physically separate from those used for the slaughtering of ruminants or porcine animals; (2) poultry products must be handled on production lines that are physically separate from those used for the handling of ruminant or porcine products; (3) the collection, storage, transport and packaging facilities for animal by-products of poultry origin must be kept separate from those for animal by-products of ruminant or porcine origin; (4) a regular sampling and analysis of animal by-products of poultry origin must be carried out to detect the presence of ruminant or porcine proteins. The method of analysis used must be scientifically validated for that purpose. The frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles.
(b) The animal by-products of poultry origin intended to be used for the production of processed animal protein derived from poultry shall be transported to a processing plant in vehicles and containers which are not used for the transport of animal by-products of ruminant or porcine origin. By way of derogation from the first paragraph, they may be transported in vehicles and containers which have been previously used for the transport of animal by-products derived from ruminants or porcine animals, provided that those vehicles and containers have been cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented trace of such use shall be kept available to the competent authority for a period of at least two years.
(c) The processed animal protein derived from poultry shall be produced in processing plants: (i) dedicated to processing animal by-products sourced from slaughterhouses, cutting plants or other establishments referred to in point (a); (ii) registered by the competent authority as not processing ruminant or porcine animal by-products. By way of derogation from point (ii) of the first paragraph, the competent authority may authorise the production of processed animal protein derived from poultry in processing plants processing ruminant or porcine animal by-products. That authorisation may be granted only where the competent authority is satisfied, following an inspection, concerning the effectiveness of the measures aimed to prevent cross-contamination between processed animal protein of ruminant or porcine origin and processed animal protein of poultry origin. Those preventive measures shall include the following minimum requirements: (1) the production of processed animal protein derived from ruminants or porcine animals must be carried out in a closed system that is physically separated from that used for the production of the processed animal protein derived from poultry; (2) the keeping of animal by-products derived from ruminants or porcine animals during storage and transport in facilities that are physically separated from those for animal by-products derived from poultry; (3) the keeping of processed animal protein derived from ruminants or porcine animals during storage and packaging in facilities that are physically separated from those used for finished products derived from poultry; (4) regular sampling and analysis of the processed animal protein derived from poultry must be carried out to verify the absence of cross-contamination with ruminant or porcine processed animal protein using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on HACCP principles; the results of such sampling and analysis shall be kept available to the competent authority for a period of at least five years.
(d) Compound feed containing processed animal protein derived from poultry shall be produced in establishments: (i) authorised for that purpose by the competent authority; (ii) dedicated exclusively to the production of feed for porcine, aquaculture or fur animals. By way of derogation from point (i) of the first paragraph, a specific authorisation for the production of complete feed from compound feed containing processed animal protein derived from poultry shall not be required for home compounders that comply with the following conditions: — they are registered by the competent authority as producing complete feed from compound feed containing processed animal protein derived from poultry, — they do not keep farmed animals as defined in of Article 3, point 6(a) of Regulation (EC) No 1069/2009, other than porcine animals, aquaculture animals or fur animals, — the compound feed containing processed animal protein derived from poultry used in their production contains less than 50 % crude protein. By way of derogation from point (ii) of the first paragraph, the production of compound feed for porcine animals, containing processed animal protein derived from poultry, in establishments which also produce compound feed intended for farmed animals other than aquaculture and fur animals may be authorised by the competent authority, following an on-site inspection, subject to compliance with the following conditions: — compound feed destined for ruminants must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for non-ruminant animals are manufactured and kept, — compound feed destined for poultry must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for other non-ruminant animals are manufactured and kept, — records detailing the purchases and uses of processed animal protein derived from poultry and the sales of compound feed containing such protein must be kept available to the competent authority for a period of at least five years, — regular sampling and analysis of the compound feed destined for farmed animals other than porcine animals, aquaculture and fur animals in order to verify the absence of unauthorised constituents of animal origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of such sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles; the results must be kept available to the competent authority for a period of at least five years.
(e) The commercial document or, as appropriate, the health certificate accompanying the processed animal protein derived from poultry in accordance with Article 21(2) of Regulation (EC) No 1069/2009, the label of that processed animal protein derived from poultry, and the label of compound feed containing processed animal protein derived from poultry shall be clearly marked in accordance with Chapter V, Section G of this Annex.
CHAPTER V
General requirements
1.Member States shall keep up-to-date and make publicly available lists of:
(a) slaughterhouses registered as not slaughtering ruminants in accordance with Chapter IV, Section C, point (a), first paragraph, as well as authorised slaughterhouses from which blood produced in accordance with Chapter IV, Section C, point (a), second, third and fourth paragraphs can be sourced;
(b) slaughterhouses, cutting plants, other food establishments and animal by-products establishments registered as, respectively, not slaughtering ruminants, not boning or cutting up ruminant meat, not handling ruminant products, and handling or storing only animal by-products coming from these food establishments, from which animal by-products intended to be used for the production of processed animal protein derived from non-ruminants in accordance with Chapter IV, Section D, point (a), first paragraph can be sourced, as well as authorised slaughterhouses, cutting plants and other food establishments, from which animal by-products intended to be used for the production of processed animal protein derived from non-ruminants in accordance with Chapter IV, Section D, point (a), second, third and fourth paragraphs can be sourced;
(c) slaughterhouses, cutting plants and other food establishments and animal by-products establishments registered as, respectively, not slaughtering ruminants and poultry, not boning or cutting up ruminant and poultry meat, not handling ruminant and poultry products, and handling or storing only animal by-products coming from these food establishments, from which animal by-products intended to be used for the production of processed animal protein derived from porcine animals in accordance with Chapter IV, Section G, point (a), first paragraph can be sourced, as well as authorised slaughterhouses, cutting plants and other food establishments, from which animal by-products intended to be used for the production of processed animal protein derived from porcine animals in accordance with Chapter IV, Section G, point (a), second, third and fourth paragraphs can be sourced;
(d) slaughterhouses, cutting plants and other food establishments and animal by-products establishments registered as, respectively, not slaughtering ruminants and porcine animals, not boning or cutting up ruminant meat and pork, not handling ruminant and porcine products, and handling or storing only animal by-products coming from these food establishments, from which animal by-products intended to be used for the production of processed animal protein derived from poultry in accordance with Chapter IV, Section H, point (a), first paragraph can be sourced, as well as authorised slaughterhouses, cutting plants and other food establishments, from which animal by-products intended to be used for the production of processed animal protein derived from poultry in accordance with Chapter IV, Section H, point (a), second, third and fourth paragraphs can be sourced;
(e) processing plants registered as processing exclusively non-ruminant blood in accordance with Chapter IV, Section C, point (c), first paragraph, as well as authorised processing plants producing blood products in accordance with Chapter IV, Section C, point (c), second, third and fourth paragraphs;
(f) processing plants registered as not processing ruminant animal by-products in accordance with Chapter IV, Section D, point (c), first paragraph, as well as authorised processing plants producing processed animal protein derived from non-ruminants which operate in accordance with Chapter IV, Section D, point (c), second, third and fourth paragraphs;
(g) processing plants registered as not processing ruminant and poultry animal by-products in accordance with Chapter IV, Section G, point (c), first paragraph, as well as authorised processing plants producing processed animal protein derived from porcine animals which operate in accordance with Chapter IV, Section G, point (c), second, third and fourth paragraphs;
(h) processing plants registered as not processing ruminant and porcine animal by-products in accordance with Chapter IV, Section H, point (c), first paragraph, as well as authorised processing plants producing processed animal protein derived from poultry which operate in accordance with Chapter IV, Section H, point (c), second, third and fourth paragraphs;
(i) authorised compound feed establishments producing, in accordance with Chapter III, Section B, compound feed containing fishmeal, dicalcium and tricalcium phosphate of animal origin and blood products derived from non-ruminants;
(j) authorised compound feed establishments producing, in accordance with Chapter IV, Section D, point (d), compound feed containing processed animal protein derived from non-ruminants; as well as authorised compound feed establishments producing, in accordance with Chapter V, Section E, point 3(b)(ii) exclusively compound feed for export from the Union or compound feed for export from the Union and compound feed for aquaculture animals to be placed on the market;
(k) authorised compound feed establishments producing, in accordance with Chapter IV, Section E, point (d), milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species;
(l) authorised compound feed establishments producing, in accordance with Chapter IV, Section F, point (b), compound feed containing processed animal protein derived from farmed insects;
(m) authorised compound feed establishments producing, in accordance with Chapter IV, Section G, point (d), compound feed containing processed animal protein derived from porcine animals intended for poultry;
(n) authorised compound feed establishments producing, in accordance with Chapter IV, Section H, point (d), compound feed containing processed animal protein derived from poultry intended for porcine animals;
(o) storage plants authorised in accordance with Chapter III, Section A, point 3, or in accordance with Chapter V, Section E, point 3(d), third paragraph.
2.Member States shall keep up-to-date lists of home compounders registered in accordance with Chapter III, Section B, point 3, and with Chapter IV, Section D, point (d)(ii), Section F, point (b)(ii), Section G, point (d)(ii), and Section H, point (d)(ii).
1.Bulk feed materials and bulk compound feed containing products derived from ruminants other than those listed in the following points (a) to (d) shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively, for the transport or storage of feed intended for farmed animals other than fur animals:
(a) milk, milk-based products, milk-derived products, colostrum and colostrum products;
(b) dicalcium and tricalcium phosphate of animal origin;
(c) hydrolysed proteins derived from ruminant hides and skins;
(d) rendered fat from ruminants with a maximum level of insoluble impurities of 0,15 % in weight and derivatives made from such fat.
2.By way of derogation from point 1, vehicles, containers and storage facilities which have been previously used for the transport or storage of bulk feed materials and bulk compound feed listed in that point, may be used for the transport or storage of feedingstuffs intended for farmed animals other than fur animals provided that they have been cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority.
Whenever such a procedure is used, a documented record of this use shall be kept available to the competent authority for a period of at least two years.
1.Compound feed intended for fur animals or for pet animals which contains products derived from ruminants other than those listed in the following points (a) to (d) shall not be produced in establishments which produce feed for farmed animals other than fur animals:
(a) milk, milk-based products, milk-derived products, colostrum and colostrum products;
(b) dicalcium and tricalcium phosphate of animal origin;
(c) hydrolysed proteins derived from ruminant hides and skins;
(d) rendered fat from ruminants with a maximum level of insoluble impurities of 0,15 % in weight and derivatives made from such fat.
2.Compound feed intended for fur animals or for pet animals, which contains processed animal protein derived from non-ruminants, shall not be produced in establishments which produce feed for farmed animals other than fur animals or aquaculture animals.
3.By way of derogation from point 2:
(i) compound feed intended for fur animals or for pet animals, which contains fishmeal may be produced in establishments which produce feed for non-ruminant farmed animals and milk replacers for the feeding of unweaned ruminants;
(ii) compound feed intended for fur animals or for pet animals, which contains processed animal protein derived from farmed insects, may be produced in establishments which produce feed for poultry or porcine animals provided the processed animal protein derived from farmed insects comply with Chapter IV, Section F, point (a);
(iii) compound feed intended for fur animals or for pet animals, which contains processed animal protein derived from porcine animals, may be produced in establishments which produce feed for poultry, provided the processed animal protein derived from porcine animals comply with Chapter IV, Section G, points (a), (b) and (c);
(iv) compound feed intended for fur animals or for pet animals, which contains processed animal protein derived from poultry, may be produced in establishments which produce feed for porcine animals, provided the processed animal protein derived from poultry comply with Chapter IV, Section H, points (a), (b) and (c).
The use and storage of feed materials and compound feed for farmed animals containing products derived from ruminants other than those listed in points (a) to (d) shall be prohibited in farms keeping farmed animals other than fur animals:
(a) milk, milk-based products, milk-derived products, colostrum and colostrum products;
(b) dicalcium and tricalcium phosphate of animal origin;
(c) hydrolysed proteins derived from ruminant hides and skins;
(d) rendered fat from ruminants with a maximum level of insoluble impurities of 0,15 % in weight and derivatives made from such fat.
1.The export of processed animal protein derived from ruminants, or of processed animal protein derived from both ruminants and non-ruminants, shall be subject to compliance with the following conditions:
(a) The processed animal protein shall be transported in sealed containers, directly from the processing plant of production to the point of exit from the Union territory, which shall be a border inspection post listed in Annex I to Commission Decision 2009/821/EC (25). Before leaving the Union territory, the operator responsible for arranging the transport of the processed animal protein shall inform the competent authority at that border inspection post of the arrival of the consignment at the point of exit.
(b) The consignment shall be accompanied by a duly completed commercial document produced according to the model set out in point 6 of Chapter III of Annex VIII to Regulation (EU) No 142/2011 and issued from the integrated computerised veterinary system (TRACES) introduced by Commission Decision 2004/292/EC (26). On that commercial document, the border inspection post of exit must be indicated as exit point in box I.28.
(c) When the consignment arrives at the point of exit, the competent authority at the border inspection post shall verify the seal of each of the containers presented at the border inspection post. By way of derogation, based on an analysis of the risk, the competent authority at the border inspection post may decide to verify the seal of the container on a random basis. If the seal verification is not satisfactory, the consignment must either be destroyed or must be re-dispatched to the establishment of origin. The competent authority at the border inspection post shall inform, via TRACES, the competent authority responsible for the establishment of origin of the arrival of the consignment at the point of exit and, where applicable, of the outcome of the verification of the seal and of any corrective action taken.
(d) The competent authority responsible for the establishment of origin shall carry out regular official controls to verify the correct implementation of points (a) and (b) and to verify that, for each consignment of processed animal protein of ruminant origin intended for export, the confirmation of the control carried out at the exit point was received from the competent authority of the border inspection post, through TRACES.
2.Without prejudice to point 1, the export of products containing processed animal protein derived from ruminants shall be prohibited.
By way of derogation, that prohibition shall not apply to:
(a) processed petfood containing processed animal protein derived from ruminants which: (i) has been processed in establishments or plants approved in accordance with Article 24(1)(e) of Regulation (EC) No 1069/2009; and (ii) is packaged and labelled in accordance with Union legislation.
(b) organic fertilisers or soil improvers, as defined in Article 3, point 22, of Regulation (EC) No 1069/2009, that contain in their composition processed animal proteins derived from ruminants or a mixture of processed animal proteins from ruminants and non-ruminants provided that either they have reached the end point as defined in Article 4, point 1(c) or in Article 4, point 2, of Commission Delegated Regulation (EU) 2023/1605 (27), or: (i) they do not contain Category 1 material and products derived therefrom or Category 2 material and products derived therefrom, other than manure, as defined in point 20 of Article 3 of Regulation (EC) No 1069/2009, processed in accordance with the rules for placing on the market of processed manure, laid down in Section 2(a), (b), (d) and (e) of Chapter I of Annex XI to Commission Regulation (EU) No 142/2011; (ii) the processed animal proteins contained in the organic fertilisers or soil improvers are in compliance with the specific requirements described in Section 1 of Chapter II of Annex X to Regulation (EU) No 142/2011; (iii) the organic fertilisers or soil improvers may contain other category 3 materials, that have been processed in accordance to: — any of the processing methods 1 to 7 set out in Chapter III of Annex IV to Regulation (EU) No 142/2011, or — the requirements laid down in Section 1 Chapter III of Annex V to Regulation (EU) No 142/2011 in the case of compost or digestion residues from the transformation of animal by-products into biogas, or; — the specific requirements set out in Annex XIII to Regulation (EU) No 142/2011, where such materials may be used for organic fertilisers and soil improvers in accordance to that Regulation. (iv) they have been produced in establishments or plants approved in accordance with Article 24(1)(f) of Regulation (EC) No 1069/2009; (v) are mixed with a sufficient proportion of a component, authorised by the competent authority of the Member State where the organic fertilisers or soil improvers are produced, which renders the product unpalatable to animals or is otherwise effective to prevent misuse of the mixture for feeding purposes. This component is to be mixed with the organic fertilizers or soil improvers in the plant manufacturing them or in a plant registered for this purpose in accordance with point 2 of Section 1 of Chapter II of Annex XI to Regulation (EU) No 142/2011. If required by the competent authority of the third country of destination, the competent authority of the Member State where the organic fertilisers or soil improvers are produced may accept the use of other components or other methods to prevent the use of the organic fertilisers or soil improvers as feed, different than those authorised in this Member State, provided that these are not in contradiction with the rules laid down in point 3 of Article 22 and point 3 of Section 1 of Chapter II of Annex XI to Regulation (EU) No 142/2011; (vi) they have been processed to ensure decontamination of pathogens in accordance with point 5 of Section 1 of Chapter II of Annex XI to Regulation (EU) No 142/2011; (vii) they have a label attached to the packaging or container bearing the words ‘organic fertilisers or soil improvers/no grazing of farmed animals or use of crops as herbage during at least 21 days following application’; (viii) they are exported in compliance with the following conditions: — they shall be transported in sealed containers, directly from the plant manufacturing the organic fertilisers or soil improvers or the registered plant where the component which renders the product unpalatable to animals is added, to the point of exit from the Union territory, which shall be a border control post listed in Annex I to Commission Decision 2009/821/EC. Before leaving the Union territory, the operator responsible for arranging the transport of the organic fertilisers or soil improvers shall inform the competent authority at that border control post of the arrival of the consignment at the point of exit; — the consignment shall be accompanied by a duly completed commercial document produced according to the model set out in point 6 of Chapter III of Annex VIII to Regulation (EU) No 142/2011 and issued from the integrated computerised veterinary system (TRACES) introduced by Commission Decision 2004/292/EC. On that commercial document, the border control post of exit must be indicated in Box I.28; — when the consignment arrives at the point of exit, the competent authority at the border control post shall, on a risk basis, verify the seal of the containers presented at the border control post. If the seal is verified and the verification is not satisfactory, the consignment must either be destroyed or must be re-dispatched to the establishment of origin, indicated in box I.12 of the commercial document; — the competent authority at the border control post shall inform, via TRACES, the competent authority indicated in box I.4 of the commercial document of the arrival of the consignment at the point of exit and, where applicable, of the outcome of the verification of the seal and of any corrective action taken; — The competent authority responsible for the manufacturing plant of origin or the registered plant where the component which renders the product unpalatable to animals is added shall carry out risk based official controls to verify compliance with the first and second indents and to verify that, for each consignment of organic fertilisers and soil improvers that contain in their composition processed animal proteins derived from ruminants or a mixture of processed animal proteins from ruminants and non-ruminants exported, the confirmation of the control carried out at the exit point was received from the competent authority of the border control post, through TRACES. The conditions set out in points (v), (vii) and (viii) of point 2(b) shall not apply to organic fertilisers or soil improvers which are in ready-to-sell packages of not more than 50 kg in weight for use by the final consumer.
3.The export of processed animal protein derived from non-ruminants, or compound feed containing such protein, shall be subject to compliance with the following conditions:
(a) The processed animal protein derived from non-ruminants shall be produced in processing plants which fulfil the requirements of Chapter IV, Section D, point (c), or of Chapter IV, Section F, point (a)(i), or of Chapter IV, Section G, point (c), or of Chapter IV, Section H, point (c).
(b) The compound feed containing processed animal protein derived from non-ruminants shall be produced in compound feed establishments which: (i) produce in accordance with Chapter IV, Section D, point (d), or with Chapter IV, Section F, point (b), or with Chapter IV, Section G, point (d), or with Chapter IV, Section H, point (d); or (ii) source the processed animal protein used in compound feed destined for export in processing plants that comply with point (a) and, either: — are dedicated exclusively to the production of compound feed for export from the Union and are authorised for that purpose by the competent authority, or — are dedicated exclusively to the production of compound feed for export from the Union and to the production of compound feed for aquaculture, poultry or porcine animals to be placed on the market in the Union, and authorised for that purpose by the competent authority.
(c) The compound feed containing processed animal protein derived from non-ruminants shall be packaged and labelled in accordance with Union legislation or with the legal requirements of the importing country. Where the compound feed containing processed animal protein derived from non-ruminants is not labelled in accordance with Union legislation, the following words shall be indicated on the labelling: ‘contains non-ruminant processed animal protein’.
(d) Bulk processed animal protein derived from non-ruminants and bulk compound feed containing such protein, and intended for export from the Union, shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively, for the transport or storage of feed for placing on market and intended for feeding to ruminants or non-ruminant farmed animals other than aquaculture animals. Records detailing the type of products that were transported or stored shall be kept available to the competent authority for a period of at least two years. By way of derogation from the first paragraph, vehicles, containers and storage facilities which have been previously used for the transport or storage of bulk processed animal protein derived from non-ruminants and bulk compound feed containing such protein, and intended for export from the Union, may be subsequently used for the transport or storage of feed for placing on the market and intended for feeding to ruminants or non-ruminant farmed animals other than aquaculture animals, provided that they are cleaned beforehand in order to avoid cross-contamination, in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented record of such use shall be kept available to the competent authority for a period of at least two years. Storage plants storing bulk processed animal protein derived from non-ruminants and bulk compound feed containing such protein under the conditions set out in the second paragraph of point (d) shall be authorised by the competent authority based on verification of their compliance with the requirements listed in that paragraph.
4.By way of derogation from point 3, the conditions laid down in that point shall not apply to:
(a) petfood which contains processed animal protein derived from non-ruminants and which has been processed in petfood establishments approved in accordance with Article 24 of Regulation (EC) No 1069/2009 and which is packaged and labelled in accordance with Union legislation;
(b) fishmeal, provided that it is produced in accordance with this Annex;
(c) processed animal protein derived from farmed insects, provided that it is produced in accordance with this Annex;
(d) compound feed containing no other processed animal protein than fishmeal and processed animal protein derived from farmed insects, provided that it is produced in accordance with this Annex;
(e) processed animal protein derived from non-ruminants destined for the manufacturing of petfood or of organic fertilisers and soil improvers in the third country of destination, provided that, before export, the exporter ensures that each consignment of processed animal protein is analysed in accordance with the method of analysis set out in point 2.2 of Annex VI to Regulation (EC) No 152/2009 in order to verify the absence of constituents of ruminant origin.
5.The export of organic fertilisers or soil improvers that contain in their composition processed animal proteins derived only from non-ruminants and do not contain any materials of ruminant origin, shall be subject to compliance with the following conditions:
(a) the requirements set out in points 2(b)(i), (ii), (iii), (iv), (v), (vi) and (vii) of this section shall apply. The conditions set out in points 2(b)(v) and (vii) shall not apply to organic fertilisers or soil improvers which are in ready-to-sell packages of not more than 50 kg in weight for use by the final consumer.
(b) the processed animal protein derived from non-ruminants contained in them shall be produced in processing plants which fulfil the requirements point (c) of Section D of Chapter IV, and are listed in accordance with point 1(d) of Section A of Chapter V.
(c) they have been produced in establishments or plants that are dedicated exclusively to processing non-ruminant organic fertilisers or soil improvers. By way of derogation from this specific condition, the competent authority may authorise the export of organic fertilisers or soil improvers referred to in this point produced in establishments or plants processing organic fertilisers or soil improvers containing ruminant material, if effective measures to prevent cross contamination between organic fertilisers or soil improvers containing only non-ruminant material and organic fertilisers or soil improvers containing ruminant material are implemented;
(d) they are transported to the point of exit from the Union territory in new packaging material, or in bulk containers which are not used for the transport of materials of ruminant origin or that have been cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority. The conditions set out in points (c) and (d) of point 5 shall not apply to organic fertilisers or soil improvers which are in ready-to-sell packages of not more than 50 kg in weight for use by the final consumer.
The organic fertilisers or soil improvers that have reached the end point as defined in Article 4, point 1(c) or in Article 4, point 2, of Delegated Regulation (EU) 2023/1605 shall be exempted from the conditions set out in the first paragraph of this point.
1.Official controls carried out by the competent authority in order to verify compliance with the rules laid down set out in this Annex shall include inspections and sampling for analysis on processed animal protein and feed in compliance with the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009.
2.The competent authority shall verify on a regular basis the competence of laboratories carrying out analyses for such official controls, in particular by evaluating the results of inter-proficiency tests.
If the competence is considered unsatisfactory, a retraining of the laboratory staff shall be undertaken by the laboratory as the minimal corrective measure, prior to carrying out further analyses.
1.The commercial document or, as appropriate, the health certificate accompanying the processed animal protein derived from farmed insects, porcine animals or poultry in accordance with Article 21(2) of Regulation (EC) No 1069/2009, and the label of that processed animal protein derived from farmed insects, porcine animals or poultry shall be clearly marked with the following words: ‘Processed animal protein derived from … [please insert relevant farmed animals from which the processed animal protein is derived listed in the first column of Table 1] – shall not be used in feed for farmed animals except … [please insert corresponding farmed animals to which the processed animal protein may be fed listed in the second column of Table 1]’;
2.The following words shall be clearly indicated on the label of compound feed containing processed animal protein derived from farmed insects, porcine animals or poultry: ‘contains processed animal protein derived from … [please insert relevant farmed animals from which the processed animal protein is derived listed in the first column of Table 1] – shall not be fed to farmed animals except … [please insert corresponding farmed animals to which the processed animal protein may be fed listed in the second column of Table 1]’;
| Farmed animals from which the processed animal protein is derived | Farmed animals to which the processed animal protein may be fed |
|---|---|
| Farmed insects | Aquaculture animals, fur animals, porcine animals, poultry |
| Porcine animals | Aquaculture animals, fur animals, poultry |
| Poultry | Aquaculture animals, fur animals, porcine animals |
| Farmed insects and porcine animals | Aquaculture animals, fur animals, poultry |
| Farmed insects and poultry | Aquaculture animals, fur animals, porcine animals |
| Porcine animals and poultry | Aquaculture animals, fur animals |
| Farmed insects, porcine animals and poultry | Aquaculture animals, fur animals |
ANNEX V
SPECIFIED RISK MATERIAL
1. Definition of specified risk material
The following tissues shall be designated as specified risk material if they come from animals whose origin is in a Member State or third country or of one of their region with a controlled or undetermined BSE risk:
(a) as regards bovine animals: (i) the skull excluding the mandible and including the brain and eyes, and the spinal cord of animals aged over 12 months; (ii) the vertebral column excluding the vertebrae of the tail, the spinous and transverse processes of the cervical, thoracic and lumbar vertebrae and the median sacral crest and wings of the sacrum, but including the dorsal root ganglia, of animals aged over 30 months; and (iii) the tonsils, the last four meters of the small intestine, the caecum and the mesentery of animals of all ages.
(b) as regards ovine and caprine animals: the skull, including the brain and eyes, and the spinal cord of animals aged over 12 months or which have a permanent incisor erupted through the gum.
2. Specific requirements for Member States with negligible BSE risk status
Tissues listed in point 1.(a)(i) and 1.(b), which are derived from animals whose origin is in Member States with a negligible BSE risk, shall be considered as specified risk material.
3. Marking and disposal
Specified risk material shall be stained with a dye or, as appropriate, otherwise marked, immediately on removal, and disposed of in accordance with the rules laid down in Regulation (EC) No 1069/2009, and in particular in Article 12 thereof.
4. Removal of specified risk material
4.1.Specified risk material shall be removed at:
(a) slaughterhouses, or, as appropriate, other places of slaughter;
(b) cutting plants, in the case of vertebral column of bovine animals;
(c) where appropriate, in approved establishments or plants referred to in Article 24(1)(h) of Regulation (EC) No 1069/2009.
4.2.By way of derogation from point 4.1, the use of an alternative test to the removal of specified risk material, referred to in Article 8(2), may be authorised in accordance with the procedure referred to in Article 24(3) of this Regulation, provided that that alternative test is listed in Annex X, in accordance with the following conditions:
(a) the alternative tests must be carried out in slaughterhouses on all animals eligible for the removal of specified risk material;
(b) no bovine, ovine or caprine product intended for human consumption or animal feed may leave the slaughterhouse before the competent authority has received and accepted the results of the alternative tests on all slaughtered animals potentially contaminated if BSE has been confirmed in one of them;
(c) when an alternative test gives a positive result, all bovine, ovine and caprine material which has been potentially contaminated in the slaughterhouse must be destroyed in accordance with point 3, unless all parts of the body including the hide of the affected animal can be identified and kept separate.
4.3.By way of derogation from point 4.1, Member States may decide to allow:
(a) the removal of the spinal cord of ovine and caprine animals in cutting plants specifically authorised for that purpose;
(b) the removal of the vertebral column of bovine animals from carcasses or parts of carcasses in butcher shops specifically authorised, monitored and registered for that purpose;
(c) the harvesting of head meat from bovine animals in cutting plants specifically authorised for that purpose in accordance with point 9.
4.4.The rules on the removal of specified risk material set out in this Chapter shall not apply to Category 1 material used in accordance with Article 18(2)(a) of Regulation (EC) No 1069/2009 for feeding to zoo animals, as well as to Category 1 material used in accordance with Article 18(2)(b) of that Regulation for feeding to endangered or protected species of necrophagous birds and other species living in their natural habitat, for the promotion of biodiversity.
5. Measures concerning mechanically separated meat
Notwithstanding the individual decisions referred to in Article 5(2), and by way of derogation from Article 9(3), it shall be prohibited in all Member States to use bones or bone-in cuts of bovine, ovine and caprine animals for the production of mechanically separated meat.
6. Measures concerning laceration of tissues
In addition to the prohibition laid down in Article 8(3) against the use, in Member States, or regions thereof, with a controlled or undetermined BSE risk, of laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injection into the cranial cavity, in bovine, ovine or caprine animals whose meat is intended for human or animal consumption, that prohibition shall also be applicable in Member States with a negligible BSE risk.
7. Harvesting of tongues from bovine animals
The tongues of bovine animals of all ages intended for human or animal consumption shall be harvested at the slaughterhouse by a transverse cut rostral to the lingual process of the basihyoid bone, except for tongues of bovine animals whose origin is in Member States with a negligible BSE risk.
8. Harvesting of bovine head meat
8.1.Head meat of bovine animals above 12 months of age shall be harvested at slaughterhouses, in accordance with a control system, recognised by the competent authority, to ensure the prevention of possible contamination of head meat with central nervous system tissue. The system shall include at least the following provisions:
(a) harvesting shall take place in a dedicated area, physically separated from the other parts of the slaughterline;
(b) where the heads are removed from the conveyor or hooks before harvesting the head meat, the frontal shot hole and foramen magnum shall be sealed with an impermeable and durable stopper. Where the brainstem is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling;
(c) head meat shall not be harvested from heads where the eyes are damaged or lost immediately prior to, or after slaughter, or which are otherwise damaged in a way which might result in contamination of the head with central nervous tissue;
(d) head meat shall not be harvested from heads which have not been properly sealed in accordance with the second indent;
(e) without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent contamination of the head meat during the harvesting, in particular in the case when the seal referred to in the second indent is lost or the eyes damaged during the activity:
(f) a sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented.
8.2.By way of derogation from the requirements of point 8.1, Member States may decide to apply at the slaughterhouse an alternative control system for the harvesting of bovine head meat, leading to an equivalent reduction in the level of contamination of head meat with central nervous system tissue. A sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented. Member States using this derogation shall inform the Commission and the other Member States in the framework of the Standing Committee of the Food Chain and Animal Health of their control system and the results of the sampling.
8.3.If the harvesting is performed without removing the bovine head from the conveyor or hooks, points 8.1 and 8.2 shall not apply.
9. Harvesting of bovine head meat in authorised cutting plants
By way of derogation from point 8, Member States may decide to allow the harvesting of head meat from bovine in cutting plants specifically authorised for this purpose and provided that the following conditions are complied with:
(a) the heads intended for transport to the cutting plant shall be suspended on a rack during the storing period and the transport from the slaughterhouse to the cutting plant;
(b) the frontal shot hole and the foramen magnum shall be properly sealed with an impermeable and durable stopper before being moved from the conveyor or hooks to the racks. Where the brainstem is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling;
(c) the heads which have not been properly sealed in accordance with point (b), where the eyes are damaged or lost immediately prior to or after slaughter or which were otherwise damaged in a way which might result in contamination of the head meat with central nervous tissue shall be excluded from transport to the specifically authorised cutting plants;
(d) a sampling plan for the slaughterhouse using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify the proper implementation of the measures to reduce contamination;
(e) the harvesting of head meat shall be carried out in accordance with a control system, recognized by the competent authority, to ensure the prevention of possible contamination of head meat. The system shall include at least: (i) all heads shall be visually checked for signs of contamination or damage and proper sealing before the harvesting of the head meat begins; (ii) head meat shall not be harvested from heads which have not been properly sealed, where the eyes are damaged or which were otherwise damaged in a way which might result in contamination of the head meat with central nervous tissue. Head meat shall also not be harvested from any head where contamination from such heads is suspected; (iii) without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent contamination of the head meat during transport and harvesting, in particular where the seal is lost or the eyes damaged during the activity;
(f) a sampling plan for the cutting plant using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented.
10. Rules on trade and export
10.1.Member States may allow dispatch of heads or of un-split carcasses containing specified risk material to another Member State only after that Member State has agreed to receive the material and has approved the conditions of dispatch and transport.
10.2.By way of derogation from point 10.1, carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be dispatched from one Member State to another without the latter's prior agreement.
10.3.Exports outside the Community of heads and of fresh meat of bovine, ovine or caprine animals containing specified risk materials shall be prohibited.
11. Controls
11.1.Member States shall carry out frequent official controls to verify the correct application of this Annex and shall ensure that measures are taken to avoid any contamination, particularly in slaughterhouses, cutting plants or other places where specified risk material is removed, such as butcher shops or establishments referred in point 4.1(c).
11.2.Member States shall in particular set up a system to ensure and check that specified risk material is handled and disposed of in accordance with this Regulation and Regulation (EC) No 1069/2009.
11.3.A control system shall be put in place for the removal of the vertebral column as specified in point 1(a). That control system shall include at least the following measures:
(a) Until 30 June 2017, when removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column shall be identified by a clearly visible blue stripe on the label referred to in Article 13 of Regulation (EC) No 1760/2000. From 1 July 2017, when the removal of the vertebral column is required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column shall be identified by a clearly visible red stripe on the label referred to in Article 13 of Regulation (EC) No 1760/2000.
(b) Where applicable, specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which the removal of the vertebral column is required, shall be added on the commercial document relating to consignments of meat. Where applicable, that specific information shall be added to the Common Veterinary Entry Document (CVED) referred to in Article 2(1) of Commission Regulation (EC) No 136/2004 (28) in the case of imports.
(c) Butcher shops shall keep, for at least one year, the commercial documents referred to in (b).
ANNEX VI
ANNEX VII
CONTROL AND ERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES
CHAPTER A
Measures following the suspicion of the presence of a TSE in ovine and caprine animals
If a TSE is suspected in an ovine or caprine animal on a holding in a Member State and until the results of the confirmatory examinations are available, all other ovine and caprine animals on that holding shall be placed under an official movement restriction.
If there is evidence that the holding where the animal was present when the TSE was suspected is unlikely to be the holding where the animal could have been exposed to the TSE, the Member State may decide that other holdings or only the holding of exposure shall be placed under official control, depending on the epidemiological information available.
The milk and the milk products derived from the ovine and caprine animals of a holding placed under official control, which are present on that holding from the date when the presence of the TSE is suspected until the results of the confirmatory examinations are available, shall only be used within that holding.
CHAPTER B
Measures following confirmation of the presence of a TSE in bovine, ovine and caprine animals
1.The inquiry referred to in Article 13(1)(b) must identify:
(a) in the case of bovine animals: — all other ruminants on the holding of the animal in which the disease was confirmed, — where the disease was confirmed in a female animal, its progeny born within a period of two years prior to, or after, the clinical onset of the disease, — all animals of the cohort of the animal in which the disease was confirmed, — the possible origin of the disease, — other animals on the holding of the animal in which the disease was confirmed or on other holdings which may have become infected by the TSE agent or been exposed to the same feed or contamination source, — the movement of potentially contaminated feedingstuffs, of other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question;
(b) in the case of ovine and caprine animals: — all ruminants other than ovine and caprine animals on the holding of the animal in which the disease was confirmed, — insofar as they are identifiable, the parents, and in the case of females all embryos, ova and the last progeny of the female animal in which the disease was confirmed, — all other ovine and caprine animals on the holding of the animal in which the disease was confirmed in addition to those referred to in the second indent, — the possible origin of the disease and the identification of other holdings on which there are animals, embryos or ova which may have become infected by the TSE agent or been exposed to the same feed or contamination source, — the movement of potentially contaminated feedingstuffs, other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question.
2.The measures laid down in Article 13(1)(c) shall comprise at least the following:
2.1. In the case of confirmation of BSE in a bovine animal, the killing and complete destruction of bovine animals identified by the inquiry referred to in the second and third indents of point 1(a); however, the Member State may decide: — not to kill and destroy animals of the cohort referred to in the third indent of point 1(a) if evidence has been provided that such animals did not have access to the same feed as the affected animal, — to defer the killing and destruction of animals of the cohort referred to in the third indent of point 1(a) until the end of their productive life, provided that they are bulls continuously kept at a semen collection centre and it can be ensured that they are completely destroyed following death.
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