CELEX: 
Language: en
Date: 2016-07-27
Title: COMMISSION REGULATION (EU) …/… amending Annexes IV and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies

COMMISSION REGULATION (EU) …/…
            
            
               of XXX
            
            
               amending Annexes IV and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies
            
            
               (Text with EEA relevance)
            
            
               THE EUROPEAN COMMISSION,
            
            
               Having regard to the Treaty on the Functioning of the European Union,
            
            
               Having regard to Regulation (EC) No 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
                  1
               , and in particular the first paragraph of Article 23 thereof,
            
            
               Whereas:
            
            
               (1)Regulation (EC) No 999/2001 lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies (TSEs) in animals. It applies to the production and placing on the market of live animals and products of animal origin and in certain specific cases to exports thereof.
            
            
               (2)Article 7(1) of Regulation (EC) No 999/2001 prohibits the feeding to ruminants of protein derived from animals and Chapter I of Annex IV to that Regulation extends that prohibition. Chapter II of that Annex sets out a number of derogations from that prohibition. Point (b)(ii) of Chapter II of Annex IV to Regulation (EC) No 999/2001 provides that the prohibition is not to apply to the feeding to non-ruminant farmed animals of fishmeal and compound feed containing fishmeal which are produced, placed on the market and used in accordance with Chapter III of Annex IV and the specific conditions laid down in Section A of Chapter IV of that Annex. In addition, point (d) of Chapter II of Annex IV to Regulation (EC) No 999/2001 provides that the prohibition is not to apply to the feeding to unweaned ruminants of milk replacers containing fishmeal which are produced, placed on the market and used in accordance with the specific conditions laid down in Section E of Chapter IV of that Annex.
            
            
               (3)Point (a) of Section A of Chapter IV of Annex IV to Regulation (EC) No 999/2001 requires that the fishmeal must be produced in processing plants dedicated exclusively to the production of products derived from aquatic animals, except sea mammals. Point (a) of Section E of that Chapter requires that the fishmeal used in milk replacers for the feeding of unweaned ruminants must be produced in processing plants dedicated exclusively to the production of products derived from aquatic animals, and it must comply with general conditions laid set out in Chapter III. 
            
            
               (4)Point 1(e)(ii) of Annex I to Regulation (EC) No 999/2001 defines 'aquatic animals' by reference to the definition laid down in Article 3(1)(e) of Council Directive 2006/88/EC
                  2
                as (i) fish belonging to the superclass Agnatha and to the classes Chondrichthyes and Osteichthyes, (ii) mollusc belonging to the Phylum Mollusca, and (iii) crustacean belonging to the Subphylum Crustacea. 
            
            
               (5)Therefore, since the definition of 'aquatic animals' laid down in Annex I to Regulation (EC) No 999/2001 does not cover invertebrates other than molluscs and crustaceans, the requirements of point (a) of Section A and of point (a) of Section E of Chapter IV of Annex IV to that Regulation do not allow the use of wild starfish and farmed aquatic invertebrates, other than molluscs and crustaceans, for the production of fishmeal. As the use of meal produced from wild starfish and farmed aquatic invertebrates, other than molluscs and crustaceans, in feed for non-ruminant animals does not represent a higher risk for the transmission of TSEs than the use of fishmeal in such feed, the requirements of point (a) of Section A and of point (a) of Section E of Chapter IV of Annex IV to Regulation (EC) No 999/2001 should be amended in order to add the possibility of using starfish or farmed aquatic invertebrates, other than molluscs and crustaceans, for the production of fishmeal. 
            
            
               (6)In order to protect the environment, the use of wild starfish for the production of fishmeal should be restricted to cases where starfish are multiplying and represent a threat to an aquaculture production area. Therefore, the requirements of point (a) of Section A and of point (a) of Section E of Chapter IV of Annex IV to Regulation (EC) No 999/2001 should only include starfish that are harvested in a mollusc production area. 
            
            
               (7)Annex I of Regulation (EC) No 999/2001 should therefore be amended accordingly.
            
            
               (8)Section A of Chapter III of Annex IV to Regulation (EC) No 999/2001 lays down requirements to prevent cross-contamination during transport in bulk between on the one hand fishmeal, dicalcium and tricalcium phosphate of animal origin, blood products derived from non-ruminants as well as compound feed containing these products, which are intended for feeding non-ruminant farmed animals, and on the other hand feed intended for ruminants. Considering that a similar risk of cross contamination exists when those materials are stored in bulk, the requirements of Section A of Chapter III of Annex IV to Regulation (EC) No 999/2001 should be extended to the storage in bulk of fishmeal, dicalcium and tricalcium phosphate of animal origin, blood products derived from non-ruminants and compound feed containing these materials.
            
            
               (9)Section B of Chapter V of Annex IV to Regulation (EC) No 999/2001 lays down requirements to prevent cross contamination during transport between on the one hand bulk feed materials and bulk compound feed containing products derived from ruminants other than milk and milk based products, dicalcium and tricalcium phosphate of animal origin and hydrolysed proteins derived from ruminant hides and skins, and on the other hand feed intended for farmed animals other than fur animals. Considering that a similar risk of cross contamination exists when those materials are stored in bulk, the requirements of Section B of Chapter V of Annex IV to Regulation (EC) No 999/2001, should be extended to the storage in bulk of feed materials and compound feed containing products derived from ruminants other than milk and milk based products, dicalcium and tricalcium phosphate of animal origin and hydrolysed proteins derived from ruminant hides and skins. 
            
            
               (10)Point (a) of Section D of Chapter IV of Annex IV to Regulation (EC) No 999/2001 requires that animal by-products used for the production of processed animal protein, other than fishmeal, derived from non-ruminants and intended to be used in feed for aquaculture animals, are sourced in slaughterhouses and cutting plants dedicated to the slaughtering or cutting of non-ruminants or non-ruminant meat. Point (a) provides the possibility of a derogation from that requirement for slaughterhouses which use physically separate slaughter lines for ruminants and non-ruminants, which have separate collection, storage, transport and packaging facilities, which carry out regular sampling and analysis to verify the absence of ruminant proteins, and which are inspected and authorised for that purpose by the competent authority.
            
            
               (11)It is appropriate to amend point (a) of Section D of Chapter IV of Annex IV to Regulation (EC) No 999/2001 in order to allow the use of animal by-products originating from establishments other than slaughterhouses or cutting plants, provided that those other establishments are dedicated exclusively to the handling of non-ruminant materials, or are authorised by the competent authority, following an on-site inspection, based on the same channelling requirements as those provided for in the existing derogation for slaughterhouses, given that those channelling requirements provide the necessary guarantees that cross-contamination is prevented and controlled. It is also appropriate to extend to cutting plants the derogation existing for slaughterhouses, provided that the same channelling requirements are applied. Section D of Chapter IV of Annex IV to Regulation (EC) No 999/2001 should therefore be amended accordingly. 
            
         
         
            
               (12)Point (b) of section A of Chapter IV of Annex IV to Regulation (EC) No 999/2001 requires that the accompanying commercial document or health certificate of fishmeal and of compound feed containing fishmeal be marked with the words "contains fishmeal – shall not be fed to ruminants". However, the commercial document or health certificate referred to in Article 21 of Regulation (EC) No 1069/2009 is irrelevant for compound feed and instead Regulation (EC) No 767/2009 establishes mandatory labelling requirements for compound feed placed on the EU market. Such information must be put on the label of packaged compound feed or on the accompanying document in case of bulk deliveries. It is therefore appropriate to amend point (b) of Section A of Chapter IV of Annex IV to Regulation (EC) No 999/2001 to clarify that, for compound feed containing fishmeal, the words "contains fishmeal - shall not be fed to ruminants" should be added on the packaging of the compound feed. Section B of Chapter IV of Annex IV to Regulation (EC) No 999/2001, point (d) of Section C of that Chapter and point (e) of Section D of that Chapter should also be amended in this respect. 
            
            
               (13)Section E of Chapter V of Annex IV to Regulation (EC) No 999/2001 requires that compound feed containing processed animal proteins derived from non-ruminants and intended for export are produced in accordance with certain requirements, referring notably to point (e) of Section A of Chapter V of Annex IV to that Regulation, which in turns refer to Section D of Chapter IV of that Annex. As those cross-references have led to diverging interpretations, it is appropriate to reformulate point 2 of Section E of Chapter V of Annex IV to Regulation (EC) No 999/2001 in order to clarify the requirements applicable for the production of processed animal proteins derived from non-ruminants, or compound feed containing such proteins, intended for export from the Union. 
            
            
               (14)In particular, the reference, in point 2(b) of Section E of Chapter V of Annex IV to Regulation (EC) No 999/2001, which concerns exports of compound feed containing processed animal protein derived from non-ruminants, to point (d) of Section D of Chapter IV of that Annex, which concerns the production of compound feed containing processed animal protein derived from non-ruminants for feeding aquaculture animals, is not adapted to all cases. Indeed, while point (d) of Section D of Chapter IV of Annex IV to Regulation (EC) No 999/2001 requires that the compound feed establishment be dedicated exclusively to the production of feed for aquaculture animals, or be authorised by the competent authority following verification of a series of requirements aimed at avoiding cross-contamination between feed intended for aquaculture animals and feed intended for other farmed animals than aquaculture animals, in the case of exports, Annex IV to Regulation (EC) No 999/2001 does not restrict the species of destination, in the third country, of the exported compound feed containing processed animal protein derived from non-ruminants, since any such restrictions are to be set by the importing third country. Point 2 of Section E of Chapter V of Annex IV to Regulation (EC) No 999/2001 should therefore be amended to clarify the requirements applicable in the case of export. 
            
            
               (15)Point 4 of Chapter C of Annex X to Regulation (EC) No 999/2001 sets out the lists of rapid tests approved for the monitoring of TSEs in bovine, ovine and caprine animals. On 8 April 2016, the Prionics group informed the Commission that it would cease the manufacture of the Prionics Check PrioSTRIP SR diagnostic kit as of 15 April 2016. This diagnostic kit should therefore be deleted from the list of approved TSE rapid tests in ovine and caprine animals. Point 4 of Chapter C of Annex X should therefore be amended accordingly. 
            
            
               (16)As Member States need sufficient time to adapt to the changes introduced by this Regulation in Section A of Chapter III and in Sections A and B of Chapter V of Annex IV to Regulation (EC) No 999/2001, those changes should apply on 1 January 2018.
            
            
               (17)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
            
            
               HAS ADOPTED THIS REGULATION:
            
            
               Article 1
            
            
               Annexes IV and X to Regulation (EC) No 999/2001 are amended in accordance with the Annex to this Regulation.
            
            
               Article 2
            
            
               This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            
            
               The amendments made to Section A of Chapter III of Annex IV to Regulation (EC) No 999/2001 by point 1(a) of the Annex to this Regulation, the amendments made to Sections A and B of Chapter V of Annex IV to Regulation (EC) No 999/2001 by point 1(c) of the Annex to this Regulation shall apply from 1 January 2018. 
            
            
               This Regulation shall be binding in its entirety and directly applicable in all Member States.
            
            
               Done at Brussels,
            
            
               
                     For the Commission
               
               
                     The President
               
               
                     Jean-Claude JUNCKER
               
            
         
         
            
                  
                     (1)
                  OJ L 147, 31.5.2001, p. 1.
               
               
                  
                     (2)
                  Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (OJ L 328, 24.11.2006, p.14).
               
            
      
    ---documentbreak--- 
      
         
         
            
               ANNEX
            
            
               Annexes IV and X to Regulation (EC) No 999/2001 are amended as follows: 
            
            
               (1)Annex IV is amended as follows:
            
            
               (a)In Chapter III, Section A is replaced by the following: 
            
            
               SECTION A
            
            
               Transport and storage of feed materials and compound feed intended to be used for feeding non-ruminant farmed animals
            
            
               1.The following products intended to be used for feeding non-ruminant farmed animals 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 ruminants:
            
            
               (a)bulk processed animal protein derived from non-ruminants, including fishmeal;
            
            
               (b)bulk dicalcium and tricalcium phosphate of animal origin;
            
            
               (c)bulk blood products derived from non-ruminants;
            
            
               (d)bulk compound feed containing the feed materials listed in (a), (b) and (c).
            
            
               Records detailing the type of products that were transported or stored in a storage plant shall be kept available to the competent authority for a period of at least two years.
            
            
               2.By way of derogation from point 1, vehicles, containers and storage facilities which have been previously used for the transport or storage of the products listed in that point, may be subsequently used for the transport or storage of feed intended for ruminants 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 trace of such use shall be kept available to the competent authority for a period of at least two years.
            
            
               3.Bulk processed animal protein derived from non-ruminants, other than fishmeal, and bulk compound feed containing such processed animal protein, 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 non-ruminant farmed animals other than aquaculture animals.
            
            
               4.By way of derogation from point 3, vehicles, containers and storage facilities which have been previously used for the transport or storage of the products referred to in that point may be subsequently used for the transport or storage of feed intended for 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 trace of such use shall be kept available to the competent authority for a period of at least two years.
            
            
               5.Storage plants storing feed materials and compound feed in accordance with this Section shall be registered by the competent authority as fulfilling the requirements of this Section.'
            
            
               (b)Chapter IV is amended as follows: 
            
         
         
            
               (i)In Section A, points (a) and (b) are replaced by the following: 
            
            
               '(a)the fishmeal must be produced in processing plants dedicated exclusively to the production of products derived from aquatic animals, except sea mammals, from 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 from starfish of the species Asterias rubens which are harvested in a production area as defined in Annex I point 2.5 of Regulation 853/2004 and classified accordingly;
            
            
               (b)The words "contains fishmeal — shall not be fed to ruminants" shall be clearly indicated on: 
            
            
               (i)the accompanying commercial document or health certificate referred to in Article 21(2) of Regulation (EC) No 1069/2009, as appropriate, as well as any packaging of fishmeal;
            
            
               (ii)the packaging of compound feed containing fishmeal. '
            
            
               (ii)Section B is replaced by the following: 
            
            
               'SECTION B
            
            
               Specific conditions applicable to the use of dicalcium phosphate and tricalcium phosphate of animal origin and compound feed containing such phosphates intended to be used for feeding non-ruminant farmed animals other than fur animals
            
            
               'The words "contains dicalcium/tricalcium phosphate of animal origin — shall not be fed to ruminants" shall be clearly indicated on: 
            
            
               (a)the accompanying commercial document or health certificate referred to in Article 21(2) of Regulation (EC) No 1069/2009, as appropriate, as well as any packaging of dicalcium/tricalcium phosphate of animal origin;
            
            
               (b)the packaging of compound feed containing dicalcium/tricalcium phosphate of animal origin.'
            
            
               (iii)In Section C, the first paragraph of point (c) is replaced by the following: 
            
            
               '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.'
            
            
               (v)In Section C, point (d) is replaced by the following: 
            
            
               '(d)The words "contains blood products — shall not be fed to ruminants" shall be clearly indicated on: 
            
            
               (i)the accompanying commercial document or health certificate referred to in Article 21(2) of Regulation (EC) No 1069/2009, as appropriate, as well as any packaging of blood products;
            
            
               (ii)the packaging of compound feed containing blood products.'
            
            
               (vi)In Section D, the title of the Section, the first paragraph and point (a) are replaced by the following: 
            
            
               'SECTION D
            
            
               Specific conditions applicable to the production and use of processed animal protein derived from non-ruminants, other than fishmeal and other than processed animal protein derived from insects, and compound feed containing such processed animal protein, intended to be used for feeding aquaculture animals 
            
         
         
            
               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 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 be derived from:
            
            
               (i)slaughterhouses which do not slaughter ruminants and which are registered by the competent authority as not slaughtering ruminants, or
            
            
               (ii)cutting plants 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, or 
            
            
               (iii)other establishments which do not handle ruminant products and which are registered by the competent authority as not handling ruminant products.
            
            
               By way of derogation from that specific condition, the competent authority may authorise the slaughter of ruminants in a slaughterhouse producing non-ruminant animal by-products intended for the production of processed animal protein referred to in this Section, and the handling of ruminant products in a cutting plant or another establishment 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 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:
            
            
               (i)the slaughtering of non-ruminants must be carried out in lines that are physically separate from those used for the slaughtering of ruminants;
            
            
               (ii)non-ruminant products must be handled on production lines that are physically separate from those used for handling ruminant products;
            
            
               (iii)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;
            
            
               (iv)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.'
            
            
               (vii)In Section D, the first paragraph of point (c) is replaced by the following: 
            
            
               '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.'
            
            
               (viii)In Section D, the first paragraph of point (d)(i) is replaced by the following: 
            
            
               '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, except fur animals, may be authorised by the competent authority, following an on-site inspection, subject to compliance with the following conditions:'
            
            
               (ix)In Section D, the second paragraph of point (e) is replaced by the following: 
            
            
               The words "contains processed animal protein derived from non ruminants – shall not be fed to farmed animals except aquaculture animals and fur animals" shall be clearly indicated on the packaging of compound feed containing processed animal protein referred to in this Section.'
            
            
               (x)In Section E, point (a) is replaced by the following: 
            
            
               '(a)the fishmeal used in milk replacers shall be produced in processing plants dedicated exclusively to the production of products derived from aquatic animals, except sea mammals, from 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 from starfish of the species Asterias rubens which are harvested in a production area as defined in Annex I point 2.5 of Regulation 853/2004 and classified accordingly. The production of fishmeal shall comply with general conditions laid set out in Chapter III.'
            
         
         
            
               (c)In Chapter V, Sections A and B are replaced by the following: 
            
            
               'SECTION A
            
            
               Listing
            
            
               Member States shall keep up-to-date and make publicly available lists of:
            
            
               (a)registered and authorised slaughterhouses from which blood produced in accordance with point (a) of Section C of Chapter IV can be sourced;
            
            
               (b)registered and authorised processing plants producing blood products in accordance with point (c) of Section C of Chapter IV;
            
            
               (c)registered and authorised slaughterhouses, cutting plants and other establishments, from which animal by-products intended to be used for the production of non-ruminant processed animal protein in accordance with point (a) of Section D of Chapter IV can be sourced;
            
            
               (d)registered and authorised processing plants producing processed animal protein derived from non-ruminants which operate in accordance with point (c) of Section D of Chapter IV; 
            
            
               (e)authorised compound feed establishments producing, in accordance with Section B of Chapter III, compound feed containing fishmeal, dicalcium and tricalcium phosphate of animal origin, or blood products derived from non-ruminants; 
            
            
               (f)authorised compound feed establishments producing, in accordance with point (d) of Section D of Chapter IV, compound feed containing processed animal proteins derived from non-ruminants, other than fishmeal and other than processed animal protein derived from insects, and intended to be used for feeding aquaculture animals; 
            
            
               (g)authorised compound feed establishments producing, in accordance with point (c) of Section E of Chapter IV, milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species; 
            
            
               (h)registered and authorised compound feed establishments producing, in accordance with point 2(b)(ii) of Section E of Chapter V, compound feed containing processed animal proteins derived from non-ruminants destined for export from the Union;
            
            
               (i)registered home compounders producing complete feed from compound feed containing fishmeal, dicalcium and tricalcium phosphate of animal origin, or blood products derived from non-ruminants, which operate in accordance with the conditions laid down in point 3 of Section B of Chapter III;
            
            
               (j)registered home compounders producing complete feed from compound feed containing processed animal proteins derived from non-ruminants, other than fishmeal and other than processed animal protein derived from insects, which operate in accordance with the conditions laid down in point (d)(ii) of Section D of Chapter IV;
            
            
               (k)registered storage plants storing feed materials and compound feed in accordance with Section A of Chapter III or point 2(d) of Section E of Chapter V.
            
            
               SECTION B
            
            
               Transport and storage of feed materials and compound feed containing products derived from ruminants
            
            
               1.Bulk feed materials and bulk compound feed containing products derived from ruminants other than those listed in the following points (a), (b) and (c) 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.
            
            
               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 trace of this use shall be kept available to the competent authority for a period of at least two years.'
            
            
               (d)In Chapter V, in Section E, points 2 and 3 are replaced by the following: 
            
            
               '2.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 are listed in the publicly available lists referred to in point (d) of Section A of Chapter V;
            
            
               (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 point (d) of Section D of Chapter IV; or 
            
            
               (ii)source the processed animal protein used in compound feed destined for export in processing plants that comply with point (a) and: 
            
            
                     
                        –are dedicated exclusively to the production of compound feed for export from the Union and registered by the competent authority as dedicated exclusively to such production, or
                     
                     
                        –are dedicated exclusively to the production of compound feed for export from the Union and to the production of compound feed for aquaculture animals to be placed on the market in the Union, and registered by the competent authority as dedicated exclusively to such production, or
                     
                     
                        –produce compound feed for export as well as compound feed to be placed on the market in the Union and are authorised for that purpose by the competent authority of the Member State, following an on-site inspection aimed at verifying the effectiveness of measures taken to prevent cross-contamination between compound feed for export and compound feed, other than feed for aquaculture animals, for marketing in the Union. Those measures shall include separate storage, transport and packaging facilities to separate compound feed for export and compound feed, other than feed for aquaculture animals, for marketing in the Union, regular sampling and analysis using the methods set out in Annex VI to Regulation (EC) No 152/2009 in order to verify the absence of unauthorised constituents of animal origin, as well as the keeping of records of purchases and uses of processed animal proteins and of the sales of compound feed containing such proteins for a period of at least five years.
                     
                  
               
               (c)The compound feed containing processed animal protein derived from non-ruminants shall be packaged and labelled in accordance with Union legislation and/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 words "contains processed animal protein derived from non ruminants and is intended only for export to non-EU countries" shall be indicated on the labelling. 
            
            
               (d)Bulk processed animal protein derived from non-ruminants and bulk compound feed containing such proteins, 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 to be placed on the Union 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 of point (d), 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 proteins, and intended for export from the Union, may be subsequently used for the transport or storage of feed to be placed on the Union 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 trace 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 proteins in accordance with this point shall be registered by the competent authority as fulfilling the requirement of this point. 
            
            
               3.By way of derogation from point 2, 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 is packaged and labelled in accordance with Union legislation;
            
            
               (b)fishmeal and compound feed containing no other processed animal protein than fishmeal, provided it is produced in accordance with this Annex.
            
            
               (c)processed animal protein derived from non-ruminants destined for the manufacturing of petfood, of organic fertilisers and soil improvers or destined for technical uses in the third country of destination, provided that the processed animal protein is transported directly from the processing plant to the point of exit from the Union in sealed containers, and provided that the words "contains processed animal protein derived from non ruminants and is intended only for export to non-EU countries" are clearly marked on the labelling of the processed animal protein.'
            
            
               (2)In Annex X, in Chapter C, the fourth indent of the second paragraph of point 4 is deleted.