COMMI SSION REGUL ATION (EU) 2015/9 
of 6 Januar y 2015 
amending Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the 
European Parliament and of the Council laying down health rules as regards animal by-products 
and derived products not intended for human consumption and implementing Council Directiv e 
97/78/EC as regards certain samples and items exempt from veter inar y check s at the border under 
that Directiv e 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to the Act of Accession of Croatia, and in particular Article 50 thereof, 
Having regar d to Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 
laying down health rules as regards animal by-products and derived products not intended for human consump tion and 
repealing Regulation (EC) No 1774/2002 (Animal by-pro ducts Regulation) (1), and in particular Article 15(1)(b), (c), (d) 
and (g), Article 18(3)(b)(i), Article 19(4)(c), Article 20(11), Article 21(6)(d), Article 23(3), Article 27(c), Article 31(2), 
Article 40(f), Article 41(3) and Article 42(2) thereof, 
Whereas: 
(1)  Regulation (EC) No 1069/2009 lays down public and animal health rules for animal by-products and derived 
products, in order to prevent and minimise risks to public and animal health arising from those products. It also 
determines an end point in the manufa ctur ing chain for certain derived products, beyond which they are no 
long er subject to the requirements of that Regulation. 
(2)  Commission Regulation (EU) No 142/2011 (2) lays down implementing rules for Regulation (EC) No 1069/2009, 
including rules on the adoption of altern ative methods of use or disposal of animal by-products or derived 
products and the requirements for placing on the market of organic fertilisers and certain other animal by- 
products. 
(3)  In accordance with Article 19(1)(d) of Regulation (EC) No 1069/2009, Member State s may author ise the 
collection, transpor t and disposal of Categor y 3 mater ials, as refer red to in Article 10(f) of that Regulation, by the 
other means set out in Chapt er IV of Annex VI to Regulation (EU) No 142/2011. In accordance with 
Article 36(3) of Regulation (EU) No 142/2011, this possibility was limite d to the transitional period until 
31 December 2014. Certain Member States author ise the collection, transpor t and disposal by the other means 
set out in Chapt er IV of Annex VI to Regulation (EU) No 142/2011 of small quantities of former foodstuffs up to 
20 kg per week . 
(4)  In the absence of repor ted negat ive consequences for animal health and taking into account that in certain 
instances the disposal in accordance with Article 14 of Regulation (EC) No 1069/2009 would be unacceptably 
onerous compare d to local disposal, it appears justif ied to establish the transitional derog ation as a permanent 
option, provided such disposal does not cause unaccept able health risks. Article 15 of Regulation (EU) 
No 142/2011, providing special rules for the application of Article 19(1)(a), (b), (c), (e) and (f) of Regulation (EC) 
No 1069/2009, should theref ore be supplement ed with reference to the measures provided for in Chapt er IV of 
Annex VI to Regulation (EU) No 142/2011, which should also be amended according ly. After consultation with 
Member Stats and stakeholders organisations, the option that Member States may decide to increase the volume 
to a maximum of 50 kg per week shall be remo ved when the transitional deroga tion becomes a permanent 
option. In addition, paragraph 3 of Article 36 of Regulation (EU) No 142/2011 should be delet ed. 7.1.2015 L 3/10 Official Jour nal of the European Union EN     
(1)OJ L 300, 14.11.2009, p. 1. 
(2)Commission Regulation (EU) No 142/2011 of 25 Febr uary 2011 implementing Regulation (EC) No 1069/2009 of the European 
Parliament and of the Council laying down health rules as regards animal by-products and derived products not inten ded for human 
consump tion and implem enting Council Directive 97/78/EC as regards certain samples and items exem pt from veterinar y chec ks at the 
border under that Directive (OJ L 54, 26.2.2011, p. 1). (5)  Given the low risk of possible contacts of farmed animals with organic fertilisers and soil impro vers handled by 
certain operators and users, in particular when they operat e outside the food and feed chain, the compet ent 
author ities should be allowed to exem pt those operat ors and users from the registration obligation under 
Article 23 of Regulation (EC) No 1069/2009. Those operat ors and users should be added to the list of operat ors 
exem pted from the oblig ation to notify the compet ent author ities in accordance with Article 20(4) of Regulation 
(EU) No 142/2011. Article 20(4) of Regulation (EU) No 142/2011 should be amended according ly. 
(6)  Gro wing media, including potting soil, with a small conte nt of animal by-products or derived products packag ed 
for use by the final consumer do not present a risk of being used as feed for farmed animals. The limitation to a 
cont ent of less than 5 % in volume of derived products of Categor y 2 or 3 mater ials in the growing media, 
including potting soil, mitig ates the risk to use it as feed for farmed animals, since the high content of soil and 
other mater ials renders such products unpalatable for farmed animals. In the production of growing media, 
processed manure may be used. However , the processed manure shall not be the only compo nent of the growing 
media. It should present not more than 50 % in volume in the growing media. Processed manure shall not be 
used for the production of growing media when the place of origin is subject to prohibition due to a suspecte d 
or conf irmed outbreak of a serious transmissible disease affecting farmed animals. Theref ore, such products may 
be exem pted from veterinar y controls for placing on the mark et other than impor ts. Article 22(2) of Regulation 
(EU) No 142/2011 should be amended according ly. 
(7)  The definitions of ‘intermediate products’ and ‘trade samples’ in points 35 and 39 respectively of Annex I to 
Regulation (EU) No 142/2011 should be clarified in order to avoid unjustified trade barriers. The definition of 
‘intermediate products’ includes also a destination of those interm ediate products. It is justified to exte nd the 
current definition with possible additional uses in the cosmetic industr y. Derived products whic h compl y with 
the requirements of Council Directive 76/768/EEC (1) may be in accordance with Article 5(1) of Regulation (EC) 
No 1069/2009 declared as the end point in the manuf actur ing chain. Further more, it is necessar y to clarify that 
pet food may be introduced into the EU as a trade sample for purposes of feeding trials, testing of machi nery or 
of equipment. The definit ion of ‘inter mediat e products’ and ‘trade sample s’ in points 35 and 39 of Annex I to 
Regulation (EU) No 142/2011 should be amended according ly. 
(8)  Although, in accordance with Article 3(6) of Regulation (EC) No 1069/2009, equidae are considered to be 
farmed animals, certain individual equine animals enjo y a particular close relationship to their keepers. It is 
theref ore justif ied to provide the possibility of cremating dead equidae in incinerat ors appro ved for that purpose 
by the compet ent author ity, provided the equidae originate from holdings which are not subject to prohibition 
orders for notifi able diseases. Council Directive 2009/156/EC (2) provides for animal health conditions governing 
amongst others the movement of equidae, including conditions for the identif ication of equidae. Only dead 
equidae whic h compl y with that Directive may be individually cremated in low-capacity incinerators. Chapt er III 
of Annex III to Regulation (EU) No 142/2011 should be amended according ly. 
(9)  Article 13(g) of Regulation (EC) No 1069/2009 provides that animal by-products originating from aquatic 
animals of Categor y 2 mate rial may be ensiled, compo sted or transf ormed into biogas. The European Food Safety 
Author ity (‘EFSA ’) published a Scientifi c Opinion on the evaluation of a new processing method for animal by- 
products of Categor y 2 mat erials of fish origin (3). According to EFSA 's opinion, risks arising from Categor y 2 
mate rials of fish origin are adequately reduced by the processing method, and derived products may theref ore be 
used for the production of orga nic fertilisers, compo sted, transf ormed into biogas or used for the manuf acture of 
feed for fur animals or other animals not intended for human consump tion. EFSA's opinion concludes that there 
is no increase in risk, if the processing method is also applied for the processing of by-products originating from 
aquatic animals of Categor y 3 mat erials. Categor y 3 mater ial obtained from aquatic animals may theref ore be 
destined for purposes listed in Article 14 of Regulation (EC) No 1069/2009. 
(10)  Follo wing the successful outcome of EFSA 's risk assessment, the ensilage of fish mate rial should be added to the 
list of alternative processing methods in Chapt er IV of Annex IV to Regulation (EU) No 142/2011. Annex IV to 
Regulation (EU) No 142/2011 should be amended according ly. 7.1.2015 L 3/11 Official Jour nal of the European Union EN     
(1)Council Directive 76/768/EEC of 27 July 1976 on the appro ximation of the laws of the Member States relating to cosmetic products 
(OJ L 262, 27.9.1976, p. 169). 
(2)Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and impo rtation from 
third countr ies of equidae (codified version) (OJ L 192, 23.7.2010, p. 1). 
(3)EFSA Journal 2011; 9(9):2389 (11 pp.). (11)  Digestion residues and compo st of animal origin may in practice be mixed with mat erials of non-animal origin. 
Operato rs should kno w which rules apply for the disposal of such digestion residues and compo st. In addition, it 
is necessar y to clarify in which cases compost and digestion residues derived from cateri ng waste may be 
disposed of in an author ised landfi ll. Chapt er III of Annex V to Regulation (EU) No 142/2011 should be 
amended according ly. 
(12)  Croatia notifi ed a list of species of wild necrophagous birds which should be subject to the derogation on special 
feeding purposes laid down in Article 18 of Regulation (EC) No 1069/2009. The list of species of necrophagous 
birds in Annex VI to Regulation (EU) No 142/2011 should be amended according ly. 
(13)  EFSA assessed the risk posed by compo sting containment and subsequent incineration of dead-on-f arm porcine 
animals (1) and concluded that the compo sting containment as refer red to in the altern ative paramete rs laid down 
in Section 2 of Chapt er III of Annex V to Regulation (EU) No 142/2011 is not a sufficient treatment for the safe 
disposal of Categor y 2 mate rial and can theref ore not be descr ibed as an alternati ve processing method in 
Chapt er IV of Annex IV to that Regulation. Follo wing the aforementioned EFSA's assessment the ‘aerobic 
maturation and storage of dead-on-f arm pigs with subsequent incineration or co-incineration’ should be seen as a 
specific containment method for the storage of animal by-pro ducts pending their subsequent disposal in 
accordance with Regulation (EC) No 1069/2009. In order to differentiat e that method from the appro ved 
methods of composting and to avoid the appro val procedure required for compo sting plants laid down in 
Annex V to Regulation (EU) No 142/2011, it is appropr iate to include that method in a new Chapt er in 
Annex IX to that Regulation together with the method ‘Hydrolysis with subsequent disposal’, currently referred to 
in point H of Section II of Chapt er IV of Annex IV, which is based on the same principles. Further more the 
reference to Annex IV in Section 11 of Chapt er II of Annex XVI should be adap ted according ly. Annex es IV, IX 
and XVI to Regulation (EU) No 142/2011 should theref ore be amended according ly. 
(14)  Rendered fats from Categor y 3 mat erial are subject to specific requirements under Section 3 of Chapt er II of 
Annex X to Regulation (EU) No 142/2011. However , there are no animal health grounds to prohibit the 
processing of Categor y 3 mate rial from aquatic animals and animal by-products from aquatic animals as refer red 
to in Article 10(i) and (j) of Regulation (EC) No 1069/2009 together with Categor y 3 animal by-products 
obtained from terrestrial animals into mixed rendered fats. Theref ore it should be possible to use Categor y 3 
mate rials from aquatic animals and animal by-products from aquatic animals as refer red to in Article 10(i) and (j) 
of Regulation (EC) No 1069/2009 for the production of rendered fat. Point A(1) of Section 3 of Chapt er II of 
Annex X to Regulation (EU) No 142/2011 should be amended according ly. 
(15)  Requirements for the heat treatment of centr ifuge or separator sludge which may be later used as or in the 
production of organic fertilisers and placed on the mark et are set out in Part III of Section 4 of Chapt er II in 
Annex X to Regulation (EU) No 142/2011. It is oppor tune to introduce a derogation that the compet ent 
author ity may author ise alternati ve paramete rs for the heat treatment of centr ifuge or separator sludg e destined 
for uses within the Member States, provided that the operat ors can demonstrate that the heat treatment carried 
out according to the altern ative parameters guarant ees at least the same risk reduction as the treatment carried 
out according to the already established paramete rs applicable for placing on the market. Part III of Section 4 of 
Chapt er II of Annex X to Regulation (EU) No 142/2011 should be amended according ly. 
(16)  Intermediat e products may be used, inter alia, for the production of laborat ory reagents or in vitro diagnostic for 
animal purposes. After chec ks at the border inspection post in accordance with Article 4 of Council Directive 
97/78/EC (2) the product has to be transpor ted directly to the register ed establishment or plant of destination. In 
order to clarify the requirements for the impor tation of interm ediate products, Annex XII to Regulation (EU) 
No 142/2011 should be amended according ly. 
(17)  Blood products intended for the production of feed for farmed animals, including spra y dried blood and blood 
plasma of porcine animals, must have been produced in accordance with Section 2 of Chapt er II of Annex X to 
Commission Regulation (EU) No 142/2011. With reference to point B of that Section, blood products are to be 
submitte d to any of the processing methods 1 to 5 or processing method 7 as set out in Chapt er III of Annex IV 
to that Regulation, or another method which ensures that the blood products compl y with the microbiological 
standards for derived products set out in Chapt er I of Annex X to Commission Regulation (EU) No 142/2011. 
Regulation (EU) No 142/2011 also provides, in particular in column 6 of row 2 in Table 1 of Section 1 of 
Chapt er I of Annex XIV, that blood products not intended for human consump tion that could be used as feed are 
to be accompanied by a health certificate in accordance with the model health certificate set out in Chapt er 4(B) 
of Annex XV when they are intended for dispatc h to or transit through the Union. 7.1.2015 L 3/12 Official Jour nal of the European Union EN     
(1)EFSA Journal 2012; 10(2):2559 (11 pp.). 
(2)Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisat ion of veterinar y chec ks on 
products enteri ng the Community from third countr ies (OJ L 24, 30.1.1998, p. 9). (18)  Porcine epidemic diar rhoea, including infection of pigs with the porcine epidemic diar rhoea virus (PEDv) and 
swine delta corona virus (SDCv), has been repor ted in Asia, Nor th Amer ica, the Caribbean, Central and South 
Amer ica. SDCv has never been detect ed in the Union. Inappropr iate heat treatment or contamination after heat 
treatment of spra y dried blood and blood plasma of porcine animals, a traditional ingredient for feed for piglets, 
is incr iminated in the spread of the virus. 
(19)  The Commission, acting on its own initiative, adopt ed Commission Imple menting Regulation (EU) 
No 483/2014 (1) as an interim safeguard measure in respect of the safety of spra y dried blood and blood plasma 
of porcine animals intended for the production of feed for animals of the porcine species. Since the risk for 
animal health will remain, it is necessar y to review the requirements for imports of spra y dried blood and blood 
plasma of porcine animals intended for the production of feed for animals of the porcine species and implement 
the interim measures as a permanent requirement. 
(20)  Scientific obser vation indicates that porcine coronavir uses are inactivated in swine faeces if heated to and held at 
a temperature of 71 °C for 10 minute s or left at room temperature of 20 °C for 7 days. The virus did not survive 
in exper imentally infect ed dry feed stored at room temperature of 24 °C for at least two weeks. In the Union and 
in third countr ies the commonly applied temperature for spra y drying of blood and blood plasma is 80 °C 
throughout the substance. 
(21)  Based on the available information, it appears oppor tune to require that spra y dried blood and blood plasma of 
porcine origin introduced from third countr ies and intended for feeding of porcine animals has been subjected to 
a high temperature treatment followed by subsequent storage for a certain time at room temperature in order to 
mitig ate the risk of contamination after the treatment. 
(22)  Imports of bones and bone products (excluding bone meal), horns and horn products (excluding horn meal) and 
hoo ves and hoof products (excluding hoof meal) intended for uses other than as feed mat erial, organic fertilisers 
or soil improvers should also be author ised where those mater ials are transpor ted by plane, provided they 
compl y with requirements laid down in Article 41 of Regulation (EC) No 1069/2009. Annex XIV to Regulation 
(EU) No 142/2011 should be amended according ly. 
(23)  Follo wing the amendments of the definition of ‘inter mediat e products’ and the additional requirements for 
imports of blood products, the model of declaration to be used for imports from third countr ies of intermediate 
products and the model of health certificate for impor ts of blood products intende d as feed mater ial should be 
modified according ly. Chapt er 4(B) and Chapt er 20 of Annex XV to Regulation (EU) No 142/2011 should be 
amended according ly. 
(24)  In order to avoid disrupti ons of trade, a transitional period should be laid down during whic h impor ts of the 
intermediate products to which the provisions of Regulation (EU) No 142/2011 apply , as amended by this 
Regulation, should be accept ed by Member States in accordance with the rules in force prior to the entr y into 
force of this Regulation. 
(25)  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
the Food Chain and Animal Health, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Regulation (EU) No 142/2011 is amended as follows: 
(1)  In Article 15, the following paragraph is added: 
‘By way of derogation from Article 14 of Regulation (EC) No 1069/2009, Member States may author ise the 
collection, transpor t and disposal of small quantities of Categor y 3 mater ials as refer red to in Article 10(f) of that 
Regulation by means refer red to in Article 19(1)(d) of that Regulation, subject to compl iance with the requirements 
for disposal by other means set out in Chapt er IV of Annex VI hereto.’ 7.1.2015 L 3/13 Official Jour nal of the European Union EN     
(1)Commission Implementing Regulation (EU) No 483/2014 of 8 May 2014 on prot ection measures in relation to porcine diar rhoea 
caused by a deltacorona virus as regards the animal health requirements for the introduction into the Union of spra y dried blood and 
blood plasma of porcine origin inten ded for the production of feed for farm ed porcine animals (OJ L 138, 13.5.2014, p. 52). (2)  In Article 19, point (c) is replaced by the following: 
‘(c)  Chapt er III, where they store derived products for certain intended purposes as refer red to in Article 24(1)(j) of 
that Regulation; 
(d)  Chapt er V, where they store on the farm animal by-products intended for subsequent disposal as referred to in 
Article 4 of that Regulation.’ 
(3)  Article 20(4) is amended as follows: 
(a)  point (d) is replaced by the following: 
‘(d)  operat ors using small quantities of Categor ies 2 and 3 mater ials refer red to in Articles 9 and 10 of 
Regulation (EC) No 1069/2009 or of products derived therefrom, for the purpose of direct supply of the 
products within the region to the final user , on the local market or to local retail establishments, if the 
compet ent author ity does not consider such activity to present a risk of spreading any serious transmissible 
disease to humans or animals; this point shall not apply where those mat erials are used as feed for farmed 
animals other than fur animals;’ 
(b)  the following points (e) and (f) are added: 
‘(e)  users of organic fertilisers or soil impro vers at premises where farmed animals are not kept; 
(f)  operat ors handling and distr ibuting organic fertilisers or soil improvers excl usively in ready-to-sell retail 
packag ing of not more than 50 kg in weight for uses outside the feed and food chain.’ 
(4)  In Article 22, paragraph 2 is replaced by the following: 
‘2. The placing on the mark et of the following is not subject to any animal health conditions: 
(a)  guano from wild sea birds, collected in the Union or impor ted from third countr ies; 
(b)  ready-t o-sell growing media, other than that imported, with a cont ent of less than: 
(i)  5 % in volume of derived products of Categor y 3 mater ial or of Categor y 2 mate rial other than processed 
manure; 
(ii)  50 % in volume of processed manure.’ 
(5)  In Article 23, paragraph 3 is replaced by the following: 
‘3. The operat or or owner of the establishment or plant of destination of intermediat e products or his represen ­
tative shall use and/or dispatch the intermediate products excl usively for use in manuf actur ing according to the 
definition of intermediate products under Point 35 of Annex I.’ 
(6)  In Article 36, paragraph 3 is deleted. 
(7)  Annexes I, III, IV, V, VI, IX, X, XI, XII, XIV, XV and XVI are amended in accordance with the Annex to this 
Regulation. 
Article 2 
For a transitional period until 27 Sept ember 2015, consignments of animal by-products and of derived products 
accompan ied by a model declaration, whic h has been compl eted and signed in accordance with the model set out in 
Chapt er 20 of Annex XV to Regulation (EU) No 142/2011 in its version before the date of entr y into force of this 
Regulation, shall continue to be accept ed for importation into the Union, provided that such model declarations were 
compl eted and signed before 27 July 2015. 7.1.2015 L 3/14 Official Jour nal of the European Union EN     Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the 
European Union. 
It shall apply from 23 Febr uary 2015. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 6 Januar y 2015. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  7.1.2015 L 3/15 Official Jour nal of the European Union EN     ANNEX 
Annex es I, III, IV, V, VI, IX, X, XI, XII, XIV, XV and XVI to Regulation (EU) No 142/2011 are amended as follows: 
(1)  Annex I is amended as follows: 
(a)  point 35 is replaced by the following: 
‘35.  “inter mediate product” means a derived product: 
(a)  whic h is intended for uses within the manufactur ing of medicinal products, veteri nary medicinal 
products, medical devices for medical and vete rinar y purposes, active implantable medical devices, in 
vitro diagnostic medical devices for medical and veteri nary purposes, laborat ory reagents or cosmetic 
products as follows: 
(i)  as mate rial in a manufactur ing process or in the final production of a finished product ; 
(ii)  in validation or verification during a manuf actur ing process; or 
(iii)  in quality control of a finished product ; 
(b)  whose design, transf ormation and manufactur ing stages have been sufficiently compl eted in order to 
be regar ded as a derived product and to qualify the mat erial directly or as a compo nent of a product 
for the purposes refer red to in point (a); 
(c)  whic h however requires some further manufactur ing or transf ormation, such as mixing, coating, 
assembling or packa ging to make it suitable for placing on the mark et or putting into service, as 
applicable, a medicinal product, veteri nary medicinal product, medical device for medical and 
vete rinar y purposes, active implantable medical device, in vitro diagnostic medical devices for medical 
and veteri nary purposes, laboratory reagent or cosmetic products;’ 
(b)  point 39 is replaced by the following: 
‘39.  “trade samples” means animal by-products or derived products intended for particular studies or analyses 
author ised by the compe tent author ity in accordance with Article 17(1) of Regulation (EC) No 1069/2009 
with a view to carrying out a production process, including the processing of animal by-pro ducts or 
derived products, the development of feedingstuff, pet food or derived products, or the testing of 
machiner y or equipment ;’ 
(c)  point 58 is replaced by the following: 
‘58.  “processing plant” means premises or facilities for the processing of animal by-products as referred to in 
Article 24(1)(a) of Regulation (EC) No 1069/2009, in which animal by-products are processed in 
accordance with Annex IV and/or Annex X;’ 
(d)  the following point 59 is added: 
‘59.  “growing media” means mate rials, including potting soil, other than soil in situ, in which plants are 
grown and whic h is used independently from soil in situ.’ 
(2)  In Annex III, Chapt er III, point (a) is replaced by the following: 
‘(a)  only be used for the disposal of: 
(i)  dead pet animals refer red to in Article 8(a)(iii) of Regulation (EC) No 1069/2009; 
(ii)  Categor y 1 mat erials refer red to in Article 8(b), (e) and (f), Categor y 2 mate rials refer red to in Article 9 or 
Categor y 3 mate rials referred to in Article 10 of that Regulation; and 
(iii)  dead individually identif ied equine animals from holdings not subject to health restr ictions in accordance 
with Article 4(5) or 5 of Directive 2009/156/EC, if author ised by the Member State ;’ 7.1.2015 L 3/16 Official Jour nal of the European Union EN     (3)  In Annex IV, Chapt er IV is amended as follows: 
(a)  Section 2 is amended as follows: 
(i)  point H is delet ed; 
(ii)  the following point is added:  
‘K. Ensilage of fish mater ial 
1.  Star ting mater ials 
For this process, only the following by-products obtained from aquatic animals may be used: 
(a)  Categor y 2 mate rials referred to in Article 9(f)(i) and (iii) of Regulation (EC) No 1069/2009; 
(b)  Categor y 3 mate rials. 
2.  Processing method 
2.1.  The mater ials to be treated shall be collect ed at aquaculture farms and food processing 
establishments on a daily basis and without undue dela ys, ground or chopped, and thereaf ter 
subjecte d to ensiling at a pH of 4 or belo w, with formic acid or other organic acid author ised in 
accordance with the feed legislation. The resulting fish silage must be a suspension of parts of 
aquatic animals liquefied by the action of endog enous enzymes in the presence of the added 
acid. The proteins of aquatic animals must be reduced into smaller soluble units, by the enzymes 
and the acid, in order to prevent microbial spoilage. The ensiled mat erial is transpor ted to the 
processing plant. 
2.2.  At the processing plant the ensiled mater ial of aquatic animals must be piped into closed storag e 
tanks. The incubation time must be at least 24 hours at a pH of 4 or belo w before heat 
treatment can be conducted. Before the heat treatment the ensilage of aquatic animals must have 
a pH of 4 or belo w and have a particle size of less than 10 mm following a filtration or 
maceration at the plant. Dur ing processing it must be subjecte d to preheating to a temperature 
above 85 °C, followed by incubation in an insulated container to obtain 85 °C throughout the 
fish mater ial for 25 minut es. The process must take place in a closed production line with tank s 
and pipelines. 
2.3.  Before author isation is given, the operat or's permanent written procedure refer red to in 
Article 29(1) to (3) of Regulation (EC) No 1069/2009 must be assessed by the compet ent 
author ity.’ 
(b)  In Section 3, point 2(d) is replaced by the following: 
‘(d)  the lime-treated mixture of pig and poultr y manure may be applied to land as processed manure;’ 
(c)  In Section 3, the following point 2(e) is added: 
‘(e)  The final product derived from the ensilaging of fish mater ial may: 
(i)  for Categor y 2 mat erials, be used for purposes refer red to in Article 13(a) to (d) and (g) to (i) of 
Regulation (EC) No 1069/2009 without further processing or as feed for animals referred to in 
Article 18 or Article 36(a)(ii) of that Regulation; or 
(ii)  for Categor y 3 mater ials, be used for purposes referred to in Article 14 of Regulation (EC) 
No 1069/2009.’ 
(4)  In Annex V, Chapt er III, Section 2 is amended as follows: 
(a)  in point 2(b), point (x) is replaced by the following: 
‘(x)  animal by-products refer red to in Article 10(f) of Regulation (EC) No 1069/2009, which have undergone 
processing as defined in Article 2(1)(m) of Regulation (EC) No 852/2004;’ 
(b)  in point 2(b), the following point (xi) is added: 
‘(xi)  mixture of animal by-products referred to in point 2(b) with non-animal by-product mater ials.’ 7.1.2015 L 3/17 Official Jour nal of the European Union EN     (c)  in point 3, point (b) is replaced by the following: 
‘(b)  considers that the dige stion residues or compo st are unpro cessed mater ial and obliges operators to handle 
them in accordance with Regulation (EC) No 1069/2009, with this Regulation or, in the case of compo st 
or digestion residues derived from catering waste, to reco ver or dispose of in accordance with the environ ­
mental legislation.’ 
(5)  Annex VI is amended as follows: 
(a)  in Chapt er II, Section 2, point 1(a)(i) is replaced by the following: 
‘(i)  one of the following species of necrophagous birds in the following Member States: 
Countr y 
code Member State Animal species 
Local name Latin name 
BG Bulg aria bearded vulture 
blac k vulture 
Egypti an vulture 
griffon vulture 
golden eagle 
imp erial eagle 
whit e-tailed eagle 
blac k kite 
red kite Gypaetus barbatus 
Aegyp ius monachus 
Neophro n percnopter us 
Gyps fulvus 
Aquila chrysaetos 
Aquila helíaca 
Haliaeetus albicilla 
Milvus migrans 
Milvus milvus 
EL Greece bearded vulture 
blac k vulture 
Egypti an vulture 
griffon vulture 
golden eagle 
imp erial eagle 
whit e-tailed eagle 
blac k kite Gypaetus barbatus 
Aegyp ius monachus 
Neophro n percnopter us 
Gyps fulvus 
Aquila chrysaetos 
Aquila heliaca 
Haliaeetus albicilla 
Milvus migrans 
ES Spain bearded vulture 
blac k vulture 
Egypti an vulture 
griffon vulture 
golden eagle 
Spanish imperial eagle 
blac k kite 
red kite Gypaetus barbatus 
Aegyp ius monachus 
Neophro n percnopter us 
Gyps fulvus 
Aquila chrysaetos 
Aquila adalber ti 
Milvus migrans 
Milvus milvus 
FR France bearded vulture 
blac k vulture 
Egypti an vulture 
griffon vulture 
golden eagle 
whit e-tailed eagle 
blac k kite 
red kite Gypaetus barbatus 
Aegyp ius monachus 
Neophro n percnopter us 
Gyps fulvus 
Aquila chrysaetos 
Haliaeetus albicilla 
Milvus migrans 
Milvus milvus 
HR Croatia bearded vulture 
blac k vulture 
Egypti an vulture 
griffon vulture Gypaetus barbatus 
Aegyp ius monachus 
Neophro n percnopter us 
Gyps fulvus 7.1.2015 L 3/18 Official Jour nal of the European Union EN     Countr y 
code Member State Animal species 
Local name Latin name 
IT Italy bearded vulture 
blac k vulture 
Egypti an vulture 
griffon vulture 
golden eagle 
blac k kite 
red kite Gypaetus barbatus 
Aegyp ius monachus 
Neophro n percnopter us 
Gyps fulvus 
Aquila chrysaetos 
Milvus migrans 
Milvus milvus 
CY Cypr us blac k vulture 
griffon vulture Aegyp ius monachus 
Gyps fulvus 
PT Portugal blac k vulture 
Egypti an vulture 
griffon vulture 
golden eagle Aegyp ius monachus 
Neophro n percnopter us 
Gyps fulvus 
Aquila chrysaetos 
SK Slovakia golden eagle 
imp erial eagle 
whit e-tailed eagle 
blac k kite 
red kite Aquila chrysaetos 
Aquila heliaca 
Haliaeetus albicilla 
Milvus migrans 
Milvus milvus’  
(b)  In Chapt er IV, the second paragraph is deleted. 
(6)  In Annex IX, the following Chapt er V is added: 
‘CHAPTER V 
CONT AINMENT METHODS 
Section 1 
General provisions 
1.  Materi als resulting from a containment method may be used or disposed of only within the Member State 
where that containment method is author ised by the compet ent author ity. 
2.  The compet ent author ity of a Member State shall make the results of official controls available to the compet ent 
author ity of another Member State upon request, where a containment method is used for the first time in that 
Member State , in order to facilitat e the introduction of the new containment method. 
Section 2 
Methodology  
A. Aerobic maturation and stora ge of dead-on-far m pigs and certain other porcine mate rial with subsequent 
incineration or co-incineration. 
1.  Member State s concer ned 
The process of aerobic maturation and storag e of dead-on-f arm pigs and certain other porcine mat erial 
with subsequent incineration or co-incineration may be used in France, Ireland, Latvia, Portugal and the 
Unit ed Kingdom. 
Follo wing aerobic maturation and storage of mater ial, the compet ent author ity of the Member State 
concer ned must ensure that the mater ials are collect ed and disposed of within the territory of that 
Member State . 7.1.2015 L 3/19 Official Jour nal of the European Union EN     2.  Star ting mate rials 
For this process, only the following mater ials of animals of the porcine species may be used: 
(a)  Categor y 2 mater ials refer red to in Article 9(f)(i) to (iii) of Regulation (EC) No 1069/2009; 
(b)  Categor y 3 mater ials refer red to in Article 10(h) of Regulation (EC) No 1069/2009. 
This method is only applicable to the disposal of animals of the porcine species originating in the same 
holding, provided this holding is not subject to restr ictions due to a suspected or conf irmed outbreak of 
a serious transmissible disease affecting animals of the porcine species. This method may not be used 
for animals whic h have died due to those diseases or have been killed for diseases control purposes, or 
parts of those animals. 
3.  Methodology 
3.1.  General principles 
The method is a process author ised by the compet ent author ity. 
The site must be constr ucted and laid out in accordance with Union legislation for the prot ection of the 
environment, in order to prevent odours and risks to soil and groundwater . 
The operat or must : 
(a)  take preventive measures against access of animals and put in place a documented pest control 
programme; 
(b)  put in place procedures to prevent the spreading of diseases; 
(c)  put in place procedures to prevent the spreading of used sawdust outside the closed system. 
The process must be carried out in a closed syste m which consist of several cells, with a waterpr oof 
floor and delimited by solid walls. Any waste water must be collect ed; the cells must be connecte d with 
a drain pipe fitted with a 6 mm grid to capture solids. 
Size and number of the cells must be adap ted to the mor tality level defined in the permanent written 
procedure refer red to in Article 29(1) to (3) of Regulation (EC) No 1069/2009 with sufficient capacity 
for farm mor talities occur ring during an eight-month period at least. 
3.2.  Phases 
3.2.1.  Filling and storag e phase 
The fallen pigs and other porcine mat erial must be individually covered in sawd ust and piled up until 
the cell is full. First a layer of at least 30 centimetres of sawd ust must be placed on the ground. The 
carcasses and other porcine mater ial must then be placed on this first layer of sawdust and each layer of 
carcasses and other porcine mater ial must be covered with a layer of sawdust at least 30 cm thick. 
Personnel must not walk on the stored mater ial. 
3.2.2.  Matur ing phase 
When the cell is full and a rise in temperature allows the degradation of all the soft tissues, the 
maturation period starts and must last at least 3 months. 
At the end of the filling and storag e phase and during all of the maturation phase, the operat or must 
monitor the temperature in each cell with a temperature sensor placed between 40 cm and 60 cm 
beneath the pile surface of the lates t built layer. 
The electronic reading and monitori ng of the temperature must be recorded by the operat or. 
At the end of the filling and stora ge phase, the temperature monitoring is an indicator of a satisf actor y 
pile layout. The temperature must be measured by an automatic recording device. The aim is to reac h 
55 °C during 3 consecutive days, revealing that the matur ing process is active and that the pile layout is 
effective and that the matur ing phase has started. 7.1.2015 L 3/20 Official Jour nal of the European Union EN     The operat or must monit or the temperature once a day and the following measures shall be take n 
depending on the outcome of these measurements: 
(a)  where the temperature of 55 °C or more is maintained during 3 consecutive days, the pile may be 
remo ved after a 3 consecutive months matur ing phase, or may remain stored on the premises 
awai ting a later remo val; 
(b)  where the temperature of 55 °C is not reac hed during 3 consecutive days, measures defined in the 
permanent written procedure refer red to in Article 29(1) to (3) of Regulation (EC) No 1069/2009 
must be set by the operat or; if needed, the compet ent author ity may stop the processing method 
and the mater ial must be disposed of in compl iance with Article 13 of the aforementioned 
Regulation. 
A time limit for the storage phase may be determined by the compe tent author ity. 
3.2.3.  Transpor t and incineration or co-incineration 
The transpor t of the resulted mater ial after the maturation phase to the appro ved incineration or co- 
incineration plant is subject to controls referred to in Regulation (EC) No 1069/2009 or Directive 
2008/98/EC.  
B. Hydrolysis with subsequent disposal  
1. Member States concer ned 
The process of hydrolysis with subsequent disposal may be used in Ireland, Spain, Latvia, Portugal and the 
Unit ed Kingdom. 
Follo wing hydrolysis, the author ising compet ent author ity must ensure that the mater ials are collect ed and 
disposed of within the same Member State refer red to above.  
2. Star ting mat erials 
For this process, only the following mater ials of porcine origin may be used: 
(a)  Categor y 2 mater ials refer red to in Article 9(f)(i) to (iii) of Regulation (EC) No 1069/2009; 
(b)  Categor y 3 mater ials refer red to in Article 10(h) of that Regulation. 
This method is only applicable to the disposal of animals of the porcine species originating in the same 
holding and provided this holding is not subject to prohibition due to a suspect ed or conf irmed outbreak of 
a serious transmissible disease affect ing animals of the porcine species, or animals that have been killed for 
disease control purposes.  
3. Methodology 
Hydrolysis with subsequent disposal is a temporar y storag e on the spot. It shall be carried out according to 
the following standards: 
(a)  Follo wing their collection on a holding for which the compet ent author ity has author ised the use of the 
processing method, based on an assessment of the animal density of the holding, the likely mor tality 
rate and the pote ntial risks for public and animal health whic h may arise, the animal by-products must 
be placed into a container whic h has been constr ucted in accordance with point (b) (“the container”) 
and which has been placed at a dedicat ed site in accordance with points (c) and (d) (“the dedicate d site”). 
(b)  The container must: 
(i)  have a device to close it; 
(ii)  be waterpr oof, leak -proof and hermetically sealed; 
(iii)  be coated in a way whic h prevents corrosion; 
(iv)  be equipped with a device for controlling emissions in accordance with point (e). 
(c)  The container must be placed in a dedicate d site whic h is physically separate from the holding. 
That site must have dedicat ed access route s for the movement of mater ials and for collection vehicles. 7.1.2015 L 3/21 Official Jour nal of the European Union EN     (d)  The container and the site must be constr ucted and laid out in accordance with Union legislation for 
the protection of the environment, in order to prevent odours and risks to soil and groundwater . 
(e)  The container must be linke d to a pipe for gaseous emissions, which must be equipped with 
appropr iate filters to prevent the transmission of diseases communicable to humans and animals. 
(f)  The container must be closed for the process of hydrolysis for a period of at least three months, in such 
a way that any unauthor ised opening is prevente d. 
(g)  The operat or must put in place procedures to prevent the transmission of diseases communicable to 
humans or animals by movements of personnel. 
(h)  The operat or must : 
(i)  take preventive measures against birds, rodents, insects and other vermin; 
(ii)  put in place a documented pest control programme. 
(i)  The operat or must keep records of: 
(i)  any placing of mat erial into the container; 
(ii)  any collection of hydrolysed mater ial from the container . 
(j)  The operat or must emp ty the container at regular intervals for a check: 
(i)  for the absence of corrosion; 
(ii)  to detect and prevent possible leakage of liquid mate rials into the ground. 
(k)  Follo wing hydrolysis, the mat erials must be collect ed, used and disposed of in accordance with 
Article 13(a), (b), (c) or Article 13(e)(i) of Regulation (EC) No 1069/2009 or Article 14 of that 
Regulation for Categor y 3 mater ials. 
(l)  The process must be carried out in a batch mode. 
(m)  Any other handling or use of the hydrolysed mater ials, including their application to land, shall be 
prohibited.’ 
(7)  In Annex X, Chapt er II is amended as follows: 
(a)  in Section 3, point A, point 1 is replaced by the following:  
‘1. Rendered fats 
Only Categor y 3 mater ial, other than Categor y 3 mater ials referred to in Article 10(n), (o) and (p) of 
Regulation (EC) No 1069/2009, may be used for the production of rendered fat.’ 
(b)  in Section 4, Part III, the following paragraph is added: 
‘By way of derog ation from the first paragraph, the compet ent author ity may author ise alternati ve parameter s 
for the heat treatment of centr ifuge or separator sludg e destined for uses within Member State s which have 
author ised those altern ative parameter s, provided operators can demonstrate that the heat treatment according 
to the alternative parameter s guarant ees at least the same risk reduction as the treatment carried out according 
to the parameter s set out in the first paragraph.’ 
(8)  In Annex XI, Chapt er II, a new Section 3 is added: 
‘Section 3 
Requirements for appro val of establishments or plants 
In order to be appro ved in accordance with Article 24(1)(f) of Regulation (EC) No 1069/2009, operat ors shall 
ensure that establishments or plants carrying out the activities refer red to in point 1 of Section 1 meet the 
requirements laid down in Article 8 of this Regulation and: 
(a) have adequate facilities for storage of incoming ingredients to prevent cross-contamination and avoid contami ­
nation during storage; 
(b)  dispose of unused animal by-products or derived products in accordance with Articles 13 and 14 of Regulation 
(EC) No 1069/2009.’ 7.1.2015 L 3/22 Official Jour nal of the European Union EN     (9)  In Annex XII, point 3(a) is replaced by the following: 
‘3.  The interm ediate products imported into the Union shall be check ed at the border inspection post in 
accordance with Article 4 of Directive 97/78/EC and transpor ted directly from the border inspection post 
either to: 
(a)  a registe red establishment or plant for the production of laborat ory reagents, medical devices and in vitro 
diagnostic medical devices for veteri nary purposes or the derived products refer red to in Article 33 of 
Regulation (EC) No 1069/2009, where the interm ediat e products must be further mixe d, used for coating, 
assembled or packag ed before they are placed on the market or put into services in accordance with the 
Union legislation applicable to the derived product ;’. 
(10)  Annex XIV is amended as follows: 
(a)  Chapt er I is amended as follows: 
(i)  In Section 1, in row 2 of Table 1, the text in the fourth column is replaced by the following: 
‘The blood products must have been produced in accordance with Section 2 of Chapt er II of Annex X and 
Section 5 of Chapt er I of Annex XIV.’ 
(ii)  a new Section 5 is added: 
‘Section 5 
Impor ts of blood products for the feeding of farmed animals 
The following requirements shall apply to the impor tation of blood products, including spra y dried blood 
and blood plasma which have been derived from porcine animals intended for the feeding of porcine 
animals: 
These derived products must be: 
(a)  subjected to a heat treatment at a temperature of at least 80 °C throughout the substance and the dry 
blood and blood plasma is of not more than 8 % moisture with a wate r activity (Aw) of less than 0,60; 
(b)  stored in dry warehouse conditions under room temperature for at least 6 weeks.’ 
(b)  in Chapt er II, Section 7, point 1(b) is replaced by the following: 
‘(b)  the products are conve yed from the third countr y of origin directly to a border inspection post of entr y 
into the Union and are not transhipped at any port or place outside the Union;’  7.1.2015 L 3/23 Official Jour nal of the European Union EN     (11)  Annex XV is amended as follows: 
(a)  Chapt er 4(B) is replaced by the following: 
‘CHAPTER 4(B) 
Health certificate 
For blood products not intended for human consumption that could be used as feed mater ial, intended for dispatch to or 
for transit through (2) the European Union 
7.1.2015 L 3/24 Official Jour nal of the European Union EN     7.1.2015 L 3/25 Official Jour nal of the European Union EN     7.1.2015 L 3/26 Official Jour nal of the European Union EN     7.1.2015 L 3/27 Official Jour nal of the European Union EN     (b) Chapt er 20 is replaced by the following: 
‘CHAPTER 20 
Model declaration 
Declar ation for the impor t from third countr ies and for the transit through the European Union of inter mediate products to 
be used for the manuf acture of medicinal products, veterin ary medicinal products, medical devices for medical and 
veterinary purposes, activ e implantable medical devices, in vitro diagnostics medical devices for medical and veterin ary 
purposes, labor atory reagents and cosmetic products 
7.1.2015 L 3/28 Official Jour nal of the European Union EN     7.1.2015 L 3/29 Official Jour nal of the European Union EN     7.1.2015 L 3/30 Official Jour nal of the European Union EN     7.1.2015 L 3/31 Official Jour nal of the European Union EN     7.1.2015 L 3/32 Official Jour nal of the European Union EN     (12) In Annex XVI, Chapt er III, Section 11 is replaced by the following: 
‘Section 11 
Official controls regarding hydrolysis with subsequent disposal 
The compet ent author ity shall carry out controls at sites where hydrolysis with subsequent disposal is carried out 
in accordance with point B of Section 2 of Chapt er V of Annex IX. 
Such controls shall, for the purpose of reconciliation of the quantities of hydrolysed mater ials dispatche d and 
disposed of, include documentar y checks: 
(a)  of the amount of mate rials whic h are hydrolysed at the site; 
(b)  in the establishments or plants where the hydrolysed mater ials are disposed of. 
Controls shall be carried out regularly on the basis of a risk assessment. 
Dur ing the period of the first 12 months of operation, a control visit to a site, where a container for the hydrolysis 
is locat ed, shall be carried out ever y time hydrolysed mat erial is collect ed from the container . 
Follo wing the period of the first 12 months of operation, a control visit to such sites shall be carried out 
ever y time the container is emp tied and check ed for the absence of corrosion and leaking in accordance with 
point B(3)(j) of Section 2 of Chapt er V of Annex IX.’  7.1.2015 L 3/33 Official Jour nal of the European Union EN