(4)

Chapter IV is amended as follows: (a) in Section D, point (a) is replaced by the following: ‘(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) Section F is replaced by the following: ‘ SECTION F Specific conditions applicable to the production and use of processed animal protein derived from farmed insects and compound feed containing such protein intended to be used for feeding aquaculture animals, poultry and porcine animals 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.’ (c) the following sections are added: ‘ SECTION G Specific conditions applicable 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 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. SECTION H Specific conditions applicable 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 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 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 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.’;