This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability  
for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official 
Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links 
embedded in this document  
►B COMMISSION REGULATION (EU) No 142/2011  
of 25 February 2011  
implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying 
down health rules as regards animal by-products and derived products not intended for human 
consumption and implementing Council Directive 97/78/EC as regards certain samples and items 
exempt from veterinary checks at the border under that Directive  
(Text with EEA relevance)  
(OJ L 54, 26.2.2011, p. 1)  
Amended by:  
Official Journal  
No page  date  
►M1 Commission Regulation (EU) No 749/2011 of 29 July 2011  L 198  3  30.7.2011  
►M2 Commission Regulation (EU) No 1063/2012 of 13 November 2012  L 314  5  14.11.2012  
►M3 Commission Implementing Regulation (EU) No 1097/2012 of 23 
November 2012  L 326  3  24.11.2012  
►M4 Commission Regulation (EU) No 294/2013 of 14 March 2013  L  9 8  1  6.4.2013  
►M5 Commission Regulation (EU) No 555/2013 of 14 June 2013  L 164  1 1  18.6.2013  
►M6 Commission Regulation (EU) No 717/2013 of 25 July 2013  L 201  3 1  26.7.2013  
►M7 Commission Regulation (EU) No 185/2014 of 26 February 2014  L  5 7  2 1  27.2.2014  
►M8 Commission Regulation (EU) No 592/2014 of 3 June 2014  L 165  3 3  4.6.2014  
►M9 Commission Regulation (EU) 2015/9 of 6 January 2015  L  3  1 0  7.1.2015  
►M10  Commission Regulation (EU) 2017/172 of 1 February 2017  L  2 8  1  2.2.2017  
►M11  Commission Regulation (EU) 2017/786 of 8 May 2017  L 119  1  9.5.2017  
►M12  Commission Regulation (EU) 2017/893 of 24 May 2017  L 138  9 2  25.5.2017  
►M13  Commission Regulation (EU) 2017/1261 of 12 July 2017  L 182  3 1  13.7.2017  
►M14  Commission Regulation (EU) 2017/1262 of 12 July 2017  L 182  3 4  13.7.2017  
►M15  Commission Regulation (EU) 2019/319 of 6 February 2019  L  6 1  1  28.2.2019  
►M16  Commission Implementing Regulation (EU) 2019/1084 of 25 June 
2019  L 171  100  26.6.2019  
►M17  Commission Implementing Regulation (EU) 2019/1177 of 10 July 2 019 L 185  2 6  11.7.2019  
►M18  Commission Delegated Regulation (EU) 2019/2122 of 10 October 2 019 L 321  4 5  12.12.2019  
►M19  Commission Delegated Regulation (EU) 2019/2124 of 10 October 2 019 L 321  7 3  12.12.2019  
►M20  Commission Implementing Regulation (EU) 2020/207 of 14 Februar y 
2020  L 43  6 9  17.2.2020  
►M21  Commission Regulation (EU) 2020/735 of 2 June 2020  L 172  3  3.6.2020  
►M22  Commission Regulation (EU) 2020/757 of 8 June 2020  L 179  5  9.6.2020  
►M23  Commission Regulation (EU) 2020/762 of 9 June 2020  L 182  3  10.6.2020  
►M24  Commission Regulation (EU) 2020/797 of 17 June 2020  L 194  1  18.6.2020  
►M25  Commission Regulation (EU) 2020/1720 of 17 November 2020  L 386  6  18.11.2020  
►M26  Commission Regulation (EU) 2021/899 of 3 June 2021  L 197  6 8  4.6.2021  
Corrected by:  
►C1 Corrigendum, OJ L 226, 24.8.2013, p. 44 (294/2013)  02011R0142 — EN — 01.01.2021 — 021.001 — 1
COMMISSION REGULATION (EU) No 142/2011  
of 25 February 2011  
implementing Regulation (EC) No 1069/2009 of the European 
Parliament and of the Council laying down health rules as 
regards animal by-products and derived products not intended for 
human consumption and implementing Council Directive 97/78/EC 
as regards certain samples and items exempt from veterinary 
checks at the border under that Directive  
(Text with EEA relevance)  
CHAPTER I  
GENERAL PROVISIONS  
Article 1  
Subject matter and scope  
This Regulation lays down implementing measures:  
(a) for the public and animal health rules for animal by-produc ts and 
derived products laid down in Regulation (EC) No 1069/2009;  
(b) concerning certain samples and items exempt from veterinary  
checks at border inspection posts as provided for in 
Article 16(1)(e) and (f) of Directive 97/78/EC.  
Article 2  
Definitions  
For the purposes of this Regulation, the definitions set out in  Annex I 
apply.  
Article 3  
End point in the manufacturing chain for certain derived products  
The following derived products may be placed on the market, oth er than 
imported, without restrictions, as provided in Article 5(2) of Regulation 
(EC) No 1069/2009:  
(a) biodiesel which fulfils the requirements for the disposal a nd use of 
derived products set out in point 2(b) of Section 3 of Chapter IV of 
Annex IV;  
(b) processed petfood which fulfil the specific requirements fo r 
processed petfood set out in point 7(a) of Chapter II of Annex XIII;  
(c) dogchews which fulfil the specific requirements for dogchew s set 
out in point 7(b) of Chapter II of Annex XIII;  
(d) hides and skins of ungulates which fulfil the specific requ irements 
for the end point for those products set out in point C of Chap ter V 
of Annex XIII;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 2
 
(e) wool and hair, which fulfil the specific requirements for t he end point 
for those products set out in point B of Chapter VII of Annex X III; 
(f) feathers and down, which fulfil the specific requirements f or the end 
point for those products set out in point C of Chapter VII of 
Annex XIII;  
▼M1 
(g) fur which fulfils the special requirements for the end poin t for that 
product set out in Chapter VIII of Annex XIII;  
(h) fish oil for the production of medicinal products which ful fils the 
special requirements for the end point for that product set out  in 
Chapter XIII of Annex XIII;  
▼M4 
(i) gasoline and fuels which fulfil the specific requirements f or 
products from the multi-step catalytic process for the producti on 
of renewable fuels set out in point 2(c) of Section 3 of 
Chapter IV of Annex IV;  
(j) oleochemical products derived from rendered fats and which fulfil 
the requirements set out in Chapter XI of Annex XIII;  
▼M13  
(k) renewable diesel, renewable jet fuel, renewable propane and  
renewable gasoline which fulfil the specific requirements for 
products from the multi-step catalytic hydro-treatment for the 
production of renewable fuels set out in point 2(f) of Section 3 of 
Chapter IV of Annex IV.  
▼B 
Article 4  
Serious transmissible diseases  
The diseases listed by the OIE in Article 1.2.3 of the Terrestr ial Animal 
Health Code, 2010 edition, and in Chapter 1.3 of the Aquatic An imal 
Health Code, 2010 edition, shall be regarded as serious transmi ssible 
diseases for the purposes of general animal health restrictions , as 
provided for in Article 6(1)(b)(ii) of Regulation (EC) No 1069/ 2009.  
CHAPTER II  
DISPOSAL AND USE OF ANIMAL BY-PRODUCTS AND DERIVED 
PRODUCTS  
Article 5  
Restrictions on the use of animal by-products and derived products  
1. Operators in the Member States referred to in Chapter I of A nnex 
II shall comply with the conditions for the feeding of fur anim als with 
certain materials derived from bodies or parts of animals of th e same 
species set out in the same Chapter.  
2. Operators shall comply with the restrictions on the feeding of 
farmed animals with herbage from land to which certain organic 
fertilisers or soil improvers have been applied, as set out in Chapter 
II of Annex II.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 3
 
Article 6  
Disposal by incineration, disposal or recovery by co-incineration 
and use as a fuel for combustion 
▼B 
1. The competent authority shall ensure that incineration and c o- 
incineration of animal by-products and derived products shall o nly 
take place:  
(a) in incineration plants and co-incineration plants which hav e been 
granted a permit in accordance with Directive 2000/76/EC; or  
(b) for plants not required to have a permit under Directive 
2000/76/EC, in incineration and co-incineration plants which ha ve 
been approved by the competent authority to carry out disposal by 
incineration, or disposal or recovery of animal by-products or 
derived products, if they are waste, by co-incineration, in 
accordance with Article 24(1)(b) or (c) of Regulation (EC) No 
1069/2009.  
2. The competent authority shall only approve incineration plan ts and 
co-incineration plants as referred to in point 1(b), in accorda nce with 
Article 24(1)(b) or (c) of Regulation (EC) No 1069/2009, if the y 
comply with the requirements set out in Annex III hereto.  
3. Operators of incineration plants and co-incineration plants shall 
comply with the general requirements for incineration and co-in cin­
eration set out in Chapter I of Annex III.  
4. Operators of high-capacity incineration and co-incineration plants 
shall comply with the requirements of Chapter II of Annex III.  
5. Operators of low-capacity incineration and co-incineration p lants 
shall comply with the requirements of Chapter III of Annex III.  
▼M8 
6. Operators shall ensure that combustion plants other than tho se 
referred to in Section 2 of Chapter IV of Annex IV, under their  
control in which animal by-products or derived products are use d as a 
fuel, comply with the general conditions and specific requireme nts set 
out in Chapters IV and V of Annex III respectively and are appr oved by 
the competent authority in accordance with Article 24(1)(d) of Regu­
lation (EC) No 1069/2009.  
7. The competent authority shall only approve combustion plants  
referred to in paragraph 6 for the use of animal by-products an d 
derived products as fuel for combustion, provided that:  
(a) the combustion plants fall within the scope of Chapter V of  Annex 
III hereto;  
(b) the combustion plants comply with all the relevant general 
conditions and specific requirements set out in Chapters IV and  V  
of Annex III hereto;  
(c) administrative procedures are in place to ensure that the 
requirements for the approval of the combustion plants are 
checked annually.  ▼M8 02011R0142 — EN — 01.01.2021 — 021.001 — 4
 
8. For the use of manure of farmed animals or meat-and-bone mea l 
as a fuel for combustion as set out in Chapter V of Annex III, the 
following rules shall apply in addition to those referred to in  
paragraph 7 of this Article:  
(a) the application for approval that is submitted by the opera tor to the 
competent authority in accordance with Article 24(1)(d) of Regu ­
lation (EC) No 1069/2009 must contain evidence certified by the  
competent authority or by a professional organisation authorise d by 
the competent authorities of the Member State, that the combust ion 
plant in which the manure of farmed animals or meat-and-bone 
meal is used as a fuel meets the requirements laid down in poin ts 
B(3) for manure, and (D) in case of meat-and-bone meal as well as 
the requirements set out for both fuels in points B(4) and B(5)  of 
Chapter V of Annex III to this Regulation, without prejudice to  the 
possibility for the competent authorities of the Member State t o 
grant a derogation from compliance with certain provisions in 
accordance with point C(4) of Chapter V of Annex III;  
(b) the procedure for approval provided for in Article 44 of Re gulation 
(EC) No 1069/2009 shall not be completed until at least two 
consecutive checks, one of them unannounced, have been carried 
out by the competent authority or by a professional organisatio n 
authorised by that authority, during the first six months of th e 
operating of the combustion plant, including the necessary 
temperature and emission measurements. After the results of tho se 
checks showed compliance with the requirements set out in point s 
B(3), B(4) and B(5) for manure, and (D) for meat-and-bone meal 
and, where applicable, with point C(4) or point D(5) of Chapter  V  
of Annex III to this Regulation, full approval can be granted.  
(c) the combustion of meat-and-bone meal in combustion plants 
referred to in points A, B and C of Chapter V of Annex III to 
this Regulation shall not be authorised.  
▼B 
Article 7  
Landfilling of certain Category 1 and 3 materials  
By way of derogation from Article 12 and Article 14(c) of Regul ation 
(EC) No 1069/2009, the competent authority may authorise the di sposal 
of the following Category 1 and 3 materials in an authorised la ndfill:  
(a) imported petfood or petfood produced from imported material s, 
from Category 1 material referred to in Article 8(c) of Regulat ion 
(EC) No 1069/2009;  
(b) Category 3 material referred to in Article 10(f) and (g) of  Regu­
lation (EC) No 1069/2009, provided that:  
(i) such materials have not been in contact with any of the ani mal 
by-products referred to in Articles 8 and 9 and Article 10(a) t o 
(e) and (h) to (p) of that Regulation;  
(ii) at the time when they are destined for disposal, the mater ials: 
— referred to in Article 10(f) of that Regulation have 
undergone processing as defined in Article 2(1)(m) of 
Regulation (EC) No 852/2004, and  
— referred to in Article 10(g) of that Regulation have been 
processed in accordance with Chapter II of Annex X hereto 
or in accordance with the specific requirements for petfood 
set out in Chapter II of Annex XIII hereto; and  
(iii) the disposal of such materials does not pose a risk to pu blic or 
animal health.  ▼M21  02011R0142 — EN — 01.01.2021 — 021.001 — 5
 
Article 8  
Requirements for processing plants and other establishments  
1. Operators shall ensure that processing plants and other esta b­
lishments under their control comply with the following require ments 
set out in Chapter I of Annex IV:  
(a) the general conditions for processing set out in Section 1;  
(b) the requirements for wastewater treatment set out in Sectio n 2; 
(c) the specific requirements for the processing of Category 1 and 2 
materials set out in Section 3;  
(d) the specific requirements for the processing of Category 3 materials 
set out in Section 4.  
2. The competent authority shall only approve processing plants  and 
other establishments, if they comply with the conditions laid d own in 
Chapter I of Annex IV.  
Article 9  
Hygiene and processing requirements for processing plants and 
other establishments  
Operators shall ensure that establishments and plants under the ir control 
comply with the following requirements set out in Annex IV:  
(a) the hygiene and processing requirements set out in Chapter II; 
(b) the standard processing methods set out in Chapter III, pro vided 
such methods are used in the establishment or plant;  
(c) the alternative processing methods set out in Chapter IV, p rovided 
such methods are used in the establishment or plant.  
Article 10  
Requirements regarding the transformation of animal by-products 
and derived products into biogas and composting  
1. Operators shall ensure that establishments and plants under their 
control comply with the following requirements for the transfor mation 
of animal by-products and derived products into biogas or for 
composting set out in Annex V:  
(a) the requirements applicable to biogas and composting plants  set out 
in Chapter I;  
(b) the hygiene requirements applicable to biogas and compostin g 
plants set out in Chapter II;  
(c) the standard transformation parameters set out in Section 1  of 
Chapter III;  
(d) the standards for digestion residues and compost set out in  Section 3 
of Chapter III.  
2. The competent authority shall only approve biogas and 
composting plants, if they comply with the requirements laid do wn in 
Annex V.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 6
 
3. The competent authority may authorise the use of alternative  trans­
formation parameters for biogas and composting plants subject t o the 
requirements set out in Section 2 of Chapter III of Annex V.  
CHAPTER III  
DEROGATIONS FROM CERTAIN PROVISIONS OF REGULATION 
(EC) No 1069/2009  
Article 11  
Special rules on research and diagnostic samples  
1. The competent authority may authorise the transport, use and  
disposal of research and diagnostic samples under conditions wh ich 
ensure the control of the risks to public and animal health.  
The competent authority shall in particular ensure that operato rs comply 
with the requirements of Chapter I of Annex VI.  
2. Operators shall comply with the special rules on research an d 
diagnostic samples set out in Chapter I of Annex VI.  
3. Operators may dispatch research and diagnostic samples which  
consist of the following animal by-products and derived product s to 
another Member State without informing the competent authority of 
the Member State of origin in accordance with Article 48(1) of Regu­
lation (EC) No 1069/2009 and without the competent authority of  the 
Member State of destination being informed by means of the TRAC ES 
system and agreeing to accept the consignment in accordance wit h 
Article 48(1) and (3) of that Regulation:  
(a) Category 1 and 2 materials and meat-and-bone meal or animal  fat 
derived from Category 1 and 2 materials;  
(b) processed animal protein.  
Article 12  
Special rules on trade samples and display items  
1. The competent authority may authorise the transport, use and  
disposal of trade samples and display items under conditions wh ich 
ensure the control of the risks to public and animal health.  
The competent authority shall in particular ensure that operato rs comply 
with the requirements of points 2, 3 and 4 of Section 1 of Chap ter I of 
Annex VI.  
2. Operators shall comply with the special rules on trade sampl es and 
display items set out in Section 2 of Chapter I of Annex VI.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 7
 
3. Operators may dispatch trade samples which consist of the 
following animal by-products and derived products to another 
Member State without informing the competent authority of the 
Member State of origin in accordance with Article 48(1) of Regu lation 
(EC) No 1069/2009 and without the competent authority of the Me mber 
State of destination being informed by means of the TRACES syst em 
and agreeing to accept the consignment in accordance with Artic le 48(1) 
and (3) of that Regulation:  
(a) Category 1 and 2 materials and meat-and-bone meal or animal  fat 
derived from Category 1 and 2 materials;  
(b) processed animal protein.  
Article 13  
Special feeding rules  
1. Operators may feed Category 2 material to the following anim als, 
provided that such material comes from animals which were not k illed 
or did not die as a result of the presence or suspected presenc e of a 
disease communicable to humans or animals, subject to complianc e with 
the general requirements laid down in Section 1 of Chapter II o f Annex 
VI and any other conditions that may be laid down by the compet ent 
authority:  
(a) zoo animals;  
(b) fur animals;  
(c) dogs from recognised kennels or packs of hounds;  
(d) dogs and cats in shelters;  
▼M4 
(e) maggots and worms for fishing bait;  
(f) circus animals.  
▼B 
2. Operators may feed Category 3 material to the following anim als 
subject to compliance with the general requirements laid down i n 
Section 1 of Chapter II of Annex VI and any other conditions th at 
may be laid down by the competent authority:  
(a) zoo animals;  
(b) fur animals;  
(c) dogs from recognised kennels or packs of hounds;  
(d) dogs and cats in shelters;  
▼M4 
(e) maggots and worms for fishing bait;  
(f) circus animals.  
▼B 
Article 14  
Feeding of certain species in and outside feeding stations and in 
zoos 
1. The competent authority may authorise the use of Category 1 
material consisting of entire bodies or parts of dead animals c ontaining 
specified risk material for the feeding:  
(a) in feeding stations, to endangered or protected species of necrop­
hagous birds and other species living in their natural habitat,  for the 
promotion of biodiversity, subject to compliance with the condi tions 
set out in Section 2 of Chapter II of Annex VI;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 8
 
(b) outside feeding stations, if appropriate without prior coll ection of 
the dead animals, to wild animals referred to point 1(a) of Sec tion 2 
of Chapter II of Annex VI, subject to compliance with the 
conditions set out in Section 3 of that Chapter.  
2. The competent authority may authorise the use of Category 1 
material consisting of entire bodies or parts of dead animals c ontaining 
specified risk materials and the use of material derived from z oo 
animals for the feeding of zoo animals subject to compliance wi th the 
conditions set out in Section 4 of Chapter II of Annex VI.  
Article 15  
Special rules on collection and disposal 
▼M4 
If the competent authority authorises the disposal of animal by -products 
by way of the derogation provided for in Article 19(1)(a), (b),  (c), (e) 
and (f) of Regulation (EC) No 1069/2009, the disposal shall com ply 
with the following special rules set out in Chapter III of Anne x VI:  
▼B 
(a) the special disposal rules for animal by-products set out i n 
Section 1;  
(b) the rules for the burning and burial of animal by-products in remote 
areas set out in Section 2;  
(c) the rules for the burning and burial of bees and apiculture  by- 
products set out in Section 3.  
▼M9 
By way of derogation from Article 14 of Regulation (EC) No 
1069/2009, Member States may authorise the collection, transpor t and 
disposal of small quantities of Category 3 materials as referre d to in 
Article 10(f) of that Regulation by means referred to in Articl e 19(1)(d) 
of that Regulation, subject to compliance with the requirements  for 
disposal by other means set out in Chapter IV of Annex VI heret o. 
▼B 
CHAPTER IV  
AUTHORISATIONS OF ALTERNATIVE METHODS  
Article 16  
Standard format for applications for authorisation of alternative 
methods  
1. Applications for authorisation of alternative methods of use  or 
disposal of animal by-products or derived products, as referred  to in 
Article 20(1) of Regulation (EC) No 1069/2009, shall be submitt ed by 
Member States or interested parties in accordance with the requ irements 
of the standard format for applications for alternative methods  set out in 
Annex VII.  
2. Member States shall designate national contact points to pro vide 
information on the competent authority responsible for evaluati ng appli­
cations for authorisation of alternative methods of use or disp osal of 
animal by-products.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 9
 
3. The Commission shall publish a list of national contact poin ts on 
its website.  
CHAPTER V  
COLLECTION, TRANSPORT, IDENTIFICATION AND TRACEABILITY  
Article 17  
Requirements regarding commercial documents and health 
certificates, identification, the collection and transport of animal 
by-products and traceability  
1. Operators shall ensure that animal by-products and derived 
products:  
(a) comply with the requirements for collection, transport and identifi­
cation set out in Chapters I and II of Annex VIII;  
(b) are accompanied during transport by commercial documents or  
health certificates in accordance with the requirements set out  in 
Chapter III of Annex VIII.  
2. Operators consigning, transporting or receiving animal by-pr oducts 
or derived products shall keep records of consignments and rela ted 
commercial documents or health certificates in accordance with the 
requirements set out in Chapter IV of Annex VIII.  
3. Operators shall comply with the requirements for the marking  of 
certain derived products set out in Chapter V of Annex VIII.  
CHAPTER VI  
REGISTRATION AND APPROVAL OF ESTABLISHMENTS AND 
PLANTS  
Article 18  
Requirements regarding the approval of one or more establishments 
and plants handling animal by-products on the same site  
The competent authority may grant approval to more than one est ab­
lishment or plant handling animal by-products on the same site,  
provided that the transmission of risks to public and animal he alth 
between the establishments or plants is excluded by their layou t and 
the handling of animal by-products and derived products within the 
establishments or plants.  
Article 19  
Requirements concerning certain approved establishments and 
plants handling animal by-products and derived products  
Operators shall ensure that establishments and plants under the ir control 
which have been approved by the competent authority, comply wit h the 
requirements set out in the following Chapters of Annex IX here to 
where they carry out one or more of the following activities re ferred 
to Article 24(1) of Regulation (EC) No 1069/2009:  
(a) Chapter I, where they manufacture petfood as referred to in  
Article 24(1)(e) of that Regulation;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 10
 
(b) Chapter II, where they store animal by-products as referred  to in 
Article 24(1)(i) of that Regulation and where they handle anima l by- 
products after their collection, by way of the following operat ions 
referred to in Article 24(1)(h) of that Regulation:  
(i) sorting;  
(ii) cutting;  
(iii) chilling;  
(iv) freezing;  
(v) salting;  
(vi) preservation by other processes;  
(vii) removal of hides and skins or removal of specified risk 
material;  
(viii) operations involving the handling of animal by-products 
which are carried out in compliance with obligations under 
Union veterinary legislation;  
(ix) hygienisation/pasteurisation of animal by-products destine d 
for transformation into biogas/composting, prior to such trans­
formation or composting in another establishment or plant in 
accordance with Annex V hereto;  
(x) sieving;  
▼M23  
(xi) phase transition processes of Category 3 materials, such a s: 
— blood thermocoagulation,  
— blood centrifugation,  
— containment as set out in Chapter V to Annex IX hereto,  
— hydrolysing of hooves, pig bristles, feathers and hair  
destined for processing with processing methods set out in 
this Regulation;  
▼M9 
(c) Chapter III, where they store derived products for certain intended 
purposes as referred to in Article 24(1)(j) of that Regulation;  
▼M23  
(d) Chapter V, where they store on the farm animal by-products as 
referred to in point (h) or (i) of Article 24(1) of that Regula tion, 
provided that unprocessed animal by-products are subsequently 
disposed of as referred to in Article 4 of that Regulation;  
(e) Where the operations referred to in points (i) to (vii) and  (xi) of point (b) 
take place on the site of the approved establishment or plant r eferred to 
in Article 26(1) of Regulation (EC) No 1069/2009 generating tho se 
materials, the competent authority may authorise the operation 
without registration in accordance with Article 23 or approval in 
accordance with Article 24(1)(h) of that Regulation, provided t hat the 
animal by-products are stored, transported and disposed of or u sed as 
unprocessed animal by-products in accordance with Regulation (E C) 
No 1069/2009.  
▼B 
Article 20  
Requirements concerning certain registered establishments and 
plants handling animal by-products and derived products  
1. Operators of registered plants or establishments or other re gistered 
operators shall handle animal by-products and derived products under 
the conditions set out in Chapter IV of Annex IX.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 11
 
2. Registered operators transporting animal by-products or deri ved 
products, other than between premises of the same operator, sha ll in 
particular comply with the conditions set out in point 2 of Cha pter IV of 
Annex IX.  
3. Paragraphs 1 and 2 shall not apply to:  
(a) approved operators who are transporting animal by-products or 
derived products as an ancillary activity;  
(b) operators who have been registered for transport activities  in 
accordance with Regulation (EC) No 183/2005.  
▼M2 
4. The competent authority may exempt the following operators f rom 
the obligation to notify, referred to in Article 23(1)(a) of Re gulation 
(EC) No 1069/2009:  
(a) operators handling or generating game trophies or other pre parations 
referred to in Chapter VI of Annex XIII hereto for private or n on- 
commercial purposes;  
(b) operators handling or disposing research and diagnostic sam ples for 
educational purposes;  
▼M3 
(c) operators transporting dry untreated wool and hair, provide d they 
are securely enclosed in packaging, and directly dispatched to a 
plant producing derived products for uses outside the feed chai n 
or to a plant carrying out intermediate operations, under condi tions 
which prevent the spreading of pathogenic agents;  
▼M9 
(d) operators using small quantities of Categories 2 and 3 mate rials 
referred to in Articles 9 and 10 of Regulation (EC) No 1069/200 9 
or of products derived therefrom, for the purpose of direct sup ply of 
the products within the region to the final user, on the local market 
or to local retail establishments, if the competent authority d oes not 
consider such activity to present a risk of spreading any serio us 
transmissible disease to humans or animals; this point shall no t 
apply where those materials are used as feed for farmed animals  
other than fur animals;  
(e) users of organic fertilisers or soil improvers at premises where 
farmed animals are not kept;  
(f) operators handling and distributing organic fertilisers or soil 
improvers exclusively in ready-to-sell retail packaging of not 
more than 50 kg in weight for uses outside the feed and food ch ain. 
▼M16  
Article 20a  
Lists of establishments, plants and operators in Member States  
The competent authority of a Member State shall ensure that up- to-date 
lists of establishments, plants and operators, referred to in t he first 
subparagraph of Article 47(1) of Regulation (EC) No 1069/2009 a re: 
(a) drawn up in accordance with the technical specifications pu blished 
on the Commission website (  1 ); 
(b) either entered in TRACES or accessible by means of TRACES a s of 
31 October 2021 at the latest.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 12  
( 1 ) https://ec.europa.eu/food/sites/food/files/safety/docs/ 
fs-animal-products-app-est-technical_spec_04032012_en.pdf
 CHAPTER VII  
PLACING ON THE MARKET  
Article 21  
Processing and placing on the market of animal by-products and 
derived products for feeding to farmed animals, excluding fur 
animals  
1. Operators shall comply with the following requirements for t he 
placing on the market, other than the import, of the animal by- products 
and derived products destined for feeding to farmed animals exc luding 
fur animals, as provided for in Article 31(2) of Regulation (EC ) No 
1069/2009, set out in Annex X hereto:  
(a) the general requirements for the processing and the placing  on the 
market set out in Chapter I;  
(b) the specific requirements for processed animal proteins and  other 
derived products set out in Chapter II;  
(c) the requirements for certain fish feed and fishing baits se t out in 
Chapter III.  
2. The competent authority may authorise the placing on the mar ket, 
other than the import, of milk, milk-based products and milk-de rived 
products categorised as Category 3 material in accordance with 
Article 10(e), (f) and (h) of Regulation (EC) No 1069/2009 and 
which have not been processed in accordance with the general 
requirements set out in Part I of Section 4 of Chapter II of An nex X 
hereto, provided that those materials comply with the requireme nts for 
the derogation for the placing on the market of milk processed in 
accordance with national standards set out in Part II of that S ection.  
▼M22  
3. The transport of fish oils and fishmeal of Category 3 materi als for 
the production of feed material, other than those imported from  a third 
country, from an approved processing plant for the production o f 
fishmeal and fish oil to a feed plant registered or approved in  
accordance with Regulation (EC) No 1069/2009 and approved in 
accordance with Article 10(3) of Regulation (EC) No 183/2005 in  
another Member State for detoxification in accordance with the 
processes referred to in Commission Regulation (EU) 2015/786 (  1 ) 
shall be carried out in accordance with the rules set out in Ch apter 
VII of Annex VIII.  
▼B 
Article 22  
Placing on the market and use of organic fertilisers and soil 
improvers  
1. Operators shall comply with the requirements for the placing  on 
the market, other than the import, of organic fertilisers and s oil 
improvers, and the use of such products, in particular their ap plication 
to land, as provided for in Articles 15(1)(i) and 32(1) of Regu lation 
(EC) No 1069/2009, set out in Annex XI hereto.  
▼M9 
2. The placing on the market of the following is not subject to  any 
animal health conditions:  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 13  
( 1 ) Commission Regulation (EU) 2015/786 of 19 May 2015 defining a ccepta­
bility criteria for detoxification processes applied to product s intended for 
animal feed as provided for in Directive 2002/32/EC of the Euro pean 
Parliament and of the Council (OJ L 125, 21.5.2015, p. 10).
 (a) guano from wild sea birds, collected in the Union or import ed from 
third countries;  
(b) ready-to-sell growing media, other than that imported, with  a  
content of less than:  
(i) 5 % in volume of derived products of Category 3 material or  of 
Category 2 material other than processed manure;  
(ii) 50 % in volume of processed manure.  
▼B 
3. The competent authority of the Member State where an organic  
fertiliser or a soil improver, which has been produced from mea t-and- 
bone meal derived from Category 2 material or from processed an imal 
protein, is to be applied to land, shall authorise one or more components 
which are to be mixed with those materials, in accordance with 
Article 32(1)(d) of Regulation (EC) No 1069/2009, according to the 
criteria set out in point 3 of Section 1 of Chapter II of Annex  XI hereto.  
4. By way of derogation from Article 48(1) of Regulation (EC) N o 
1069/2009, the competent authorities of a Member State of origi n and 
of a Member State of destination, which share a common border m ay 
authorise the dispatch of manure between farms located in borde r 
regions of those two Member States subject to appropriate condi tions 
for the control of any possible risks to public or animal healt h, such as 
obligations for the operators concerned to keep appropriate rec ords, 
which are laid down in a bilateral agreement.  
5. As provided for in Article 30(1) of Regulation (EC) No 
1069/2009, the competent authorities of the Member States shall  
encourage, where necessary, the development, dissemination and use 
of national guides for good agricultural practice for the appli cation of 
organic fertilisers and soil improvers to land.  
Article 23  
Intermediate products  
1. Intermediate products, imported into or in transit through t he 
Union shall comply with the conditions controlling potential ri sks to 
public and animal health referred to in Annex XII hereto.  
2. Intermediate products which have been transported to an esta b­
lishment or plant referred to in point 3 of Annex XII hereto, m ay be 
handled without further restrictions under Regulation (EC) No 
1069/2009 and under this Regulation, provided that:  
(a) the establishment or plant has adequate facilities for the receipt of 
the intermediate products, which prevent the transmission of 
diseases communicable to humans or animals;  
(b) the intermediate products do not pose any risk of transmiss ion of 
diseases communicable to humans or animals, due to their purifi ­
cation or to other treatments to which the animal by-products i n the 
intermediate product have been submitted, due to the concentrat ion 
of animal by-products in the intermediate product or due to 
adequate bio-security measures for the handling of the intermed iate 
products;  
(c) the establishment or plant keeps records on the amount of m aterials 
received, their category, if applicable, and the establishment,  plant 
or operator to whom they have supplied their products; and  
(d) unused intermediate products or other surplus materials fro m the 
establishment or plant, such as expired products, are disposed of 
in accordance with Regulation (EC) No 1069/2009.  
▼M9 
3. The operator or owner of the establishment or plant of desti nation 
of intermediate products or his representative shall use and/or  dispatch 
the intermediate products exclusively for use in manufacturing 
according to the definition of intermediate products under Poin t 35 of 
Annex I.  ▼M9 02011R0142 — EN — 01.01.2021 — 021.001 — 14
 
Article 24  
Petfood and other derived products  
1. The use of Category 1 material referred to in Article 8(a),( b), (d) 
and (e) of Regulation (EC) No 1069/2009 for the manufacture of 
derived products which are intended to be ingested by or applie d to 
humans or animals, other than for derived products referred to in 
Articles 33 and 36 of that Regulation shall be prohibited.  
2. Where an animal by-product or a derived product may be used for 
feeding to farmed animals or for other purposes referred to in 
Article 36(a) of Regulation (EC) No 1069/2009, they shall be pl aced 
on the market, other than imported, in accordance with the spec ific 
requirements for processed animal protein and other derived pro ducts 
set out in Chapter II of Annex X hereto, provided that Annex XI II 
hereto does not set out any specific requirements for such prod ucts. 
3. Operators shall comply with the requirements for the placing  on 
the market, other than the import, of petfood, as referred to i n Article 40 
of Regulation (EC) No 1069/2009, set out in Chapters I and II o f Annex 
XIII hereto.  
4. Operators shall comply with the requirements for the placing  on 
the market, other than the import, of derived products, as refe rred to in 
Article 40 of Regulation (EC) No 1069/2009, set out in Chapter I and 
Chapters III to XII of Annex XIII hereto.  
CHAPTER VIII  
IMPORT, TRANSIT AND EXPORT  
Article 25  
Import, transit and export of animal by-products and of derived 
products  
1. The importation into and the transit through the Union of th e 
following animal by-products shall be prohibited:  
(a) unprocessed manure;  
(b) untreated feathers and parts of feathers and down;  
(c) beeswax in the form of honeycomb.  
▼M2 
2. The importation into and the transit through the Union of th e 
following shall not be subject to any animal health conditions:  
(a) wool and hair which has been factory-washed or which has be en 
treated by another method which ensures that no unacceptable ri sks 
remain;  
(b) furs which have been dried at an ambient temperature of 18 °C for a 
period of at least two days at a humidity of 55 %;  
(c) wool and hair produced from animals other than those of the  
porcine species, which has been treated by factory-washing whic h 
consisting of the immersion of the wool and hair in series of b aths 
of water, soap and sodium hydroxide or potassium hydroxide;  
(d) wool and hair produced from animals other than those of the  
porcine species, which is dispatched directly to a plant produc ing 
derived products from wool and hair for the textile industry an d has 
been treated by at least one of the following methods:  
— chemical depilation by means of slaked lime or sodium 
sulphide,  
— fumigation in formaldehyde in a hermetically sealed chamber f or 
at least 24 hours,  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 15
 
— industrial scouring which consists of the immersion of wool a nd 
hair in a water-soluble detergent held at 60–70 °C,  
— storage, which may include the journey time, at 37 °C for eig ht 
days, 18 °C for 28 days or 4 °C for 120 days;  
(e) wool and hair that is dry and securely enclosed in packagin g, 
produced from animals other than those of the porcine species, 
which is intended for dispatch to a plant producing derived 
products from wool and hair for the textile industry and meets all 
of the following requirements:  
(i) it was produced at least 21 days before the date of entry i nto 
the Union kept in a third country or region thereof which is  
— listed in Part 1 of Annex II to Regulation (EU) No 
206/2010 and authorised for imports into the Union of 
fresh meat of ruminants not subject to supplementary guar­
antees A and F mentioned therein,  
— free of foot-and-mouth disease, and, in the case of wool 
and hair from sheep and goats, of sheep pox and goat pox 
in accordance with the basic general criteria listed in Annex 
II to Directive 2004/68/EC;  
(ii) it is accompanied by a importers' declaration as required in 
accordance with Chapter 21 of Annex XV;  
(iii) it was presented by the operator to one of the approved U nion 
border inspection posts listed in Annex I to Decision 
2009/821/EC where it passed with satisfactory result the docu­
mentary check carried out in accordance with Article 4(3) of 
Directive 97/78/EC.  
▼B 
3. Operators shall comply with the following specific requireme nts 
for the importation into and the transit through the Union of c ertain 
animal by-products and derived products, as referred to in Arti cles 41(3) 
and 42 of Regulation (EC) No 1069/2009, set out in Annex XIV he reto: 
(a) the specific requirements for the import and transit of Cat egory 3 
material and derived products for uses in the feed chain, other  than 
for petfood or feed to fur animals, set out in Chapter I of tha t 
Annex;  
(b) the specific requirements for the import and transit of ani mal by- 
products and derived products for uses outside the feed chain f or 
farmed animals, set out in Chapter II of that Annex;  
▼M24  
(c) the specific requirements for animal by-products and derive d 
products originating from, and returning to, the Union followin g a 
refusal of entry by a third country, set out in Chapter VI of t hat 
Annex.  
▼M10  
4. The rules set out in Chapter V of Annex XIV shall apply to 
exports from the Union of the derived products specified therei n. 
▼B 
Article 26  
Placing on the market, including importation, and export of certain 
Category 1 materials  
The competent authority may authorise the placing on the market , 
including the importation, and the export of hides and skins de rived 
from animals which have been submitted to an illegal treatment as 
defined in Article 1(2)(d) of Directive 96/22/EC or in Article 2(b) of 
Directive 96/23/EC, and of ruminant intestines with or without content 
and of bones and bone products containing vertebral column and skull, 
subject to compliance with the following requirements:  ▼M2 02011R0142 — EN — 01.01.2021 — 021.001 — 16
 
(a) those materials must not be Category 1 materials derived fr om any 
of the following animals:  
(i) animals suspected of being infected by a TSE in accordance 
with Regulation (EC) No 999/2001;  
(ii) animals in which the presence of a TSE has been officially  
confirmed;  
(iii) animals killed in the context of TSE eradication measures ; 
(b) those materials must not be intended for any of the followi ng uses:  
(i) feeding;  
(ii) application to land from which farmed animals are fed;  
(iii) the manufacture of:  
— cosmetic products as defined in Article 1(1) of Directive 
76/768/EEC;  
— active implantable medical devices as defined in 
Article 1(2)(c) of Directive 90/385/EEC;  
— medical devices as defined in Article 1(2)(a) of Directive 
93/42/EEC;  
— in vitro diagnostic medical devices as defined in 
Article 1(2)(b) of Directive 98/79/EC;  
— veterinary medicinal products as defined in Article 1(2) of 
Directive 2001/82/EC;  
— medicinal products as defined in Article 1(2) of Directive 
2001/83/EC;  
(c) the materials must be imported with a label and must comply  with 
the specific requirements for certain movements of animal by- 
products set out in Section 1 of Chapter IV of Annex XIV hereto ; 
(d) the materials must be imported in accordance with sanitary certifi­
cation requirements laid down in national legislation;  
▼M24  
(e) the materials originating from a Member State and returning  to that 
Member State following a refusal of entry by a third country, m ust 
comply with the specific requirements set out in Chapter VI of 
Annex XIV.  
▼B 
Article 27  
Importation and transit of research and diagnostic samples  
1. The competent authority may authorise the importation and th e 
transit of research and diagnostic samples, comprising derived 
products or animal by-products, including the animal by-product s 
referred to in Article 25(1), in accordance with conditions whi ch 
ensure the control of risks to public and animal health.  
Such conditions shall include at least the following:  
(a) the introduction of the consignment must have been authoris ed in 
advance by the competent authority of the Member State of desti ­
nation; and  
(b) the consignment must be sent directly from the point of ent ry into 
the Union to the authorised user.  
▼M18  __________  
▼B 
3. Operators handling research samples or diagnostic samples sh all 
comply with the special requirements for disposal of research a nd diag­
nostic samples set out in Section 1 of Chapter III of Annex XIV  hereto.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 17
 
Article 28  
Importation and transit of trade samples and display items  
1. The competent authority may authorise the importation and th e 
transit of trade samples in accordance with the special rules s et out in 
point 1 of Section 2 of Chapter III of Annex XIV hereto.  
2. Operators handling trade samples shall comply with the speci al 
rules for handling and disposal of trade samples set out in poi nts 2 and 
3 of Section 2 of Chapter III of Annex XIV hereto.  
3. The competent authority may authorise the importation and th e 
transit of display items in accordance with the special rules f or 
display items set out in Section 3 of Chapter III of Annex XIV hereto.  
4. Operators handling display items shall comply with the condi tions 
for packaging, handling and disposal of display items set out i n Section 
3 of Chapter III of Annex XIV hereto.  
Article 29  
Specific requirements for certain movements of animal by-products 
between territories of the Russian Federation  
1. The competent authority shall authorise specific movements o f 
consignments of animal by-products coming from and destined to the 
Russian Federation directly or via another third country, by ro ad or by 
rail through the Union, between approved Union border inspectio n posts 
listed in Annex I to Decision 2009/821/EC, provided that the fo llowing 
conditions are met:  
(a) the consignment shall be sealed with a serially numbered se al at the 
border inspection post of entry to the Union by the veterinary 
services of the competent authority.  
▼M19  __________  
__________  
▼M5 
Article 29a  
Specific requirements for transit through Croatia of animal 
by-products coming from Bosnia and Herzegovina and destined to 
third countries  
1. The movements of consignments of animal by-products and 
derived products coming from Bosnia and Herzegovina and destine d 
to third countries through the Union, by road, directly between  the 
border inspection post of Nova Sela and the border inspection p ost of 
Ploče, shall be authorised provided that the following conditio ns are 
met: ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 18
 
(a) the consignment is sealed with a serially numbered seal by the 
official veterinarian at the border inspection post of entry.  
▼M19  __________  
__________  
▼B 
Article 30  
Lists of establishments and plants in third countries  
Lists of establishments and plants in third countries shall be entered into 
the TRACES system in accordance with technical specifications w hich 
are published by the Commission on its website.  
Each list shall be kept up to date regularly.  
▼M16  
This Article does not apply to the specific movements of consig nments 
of animal by-products coming from and destined to the Russian 
Federation as referred to in Article 29 and to the movements of  
consignments of animal by-products and derived products coming 
from Bosnia and Herzegovina and destined to third countries as 
referred to in Article 29a.  
▼B 
Article 31  
Models of health certificates and declarations for importation and 
transit  
Consignments of animal by-products and derived products for 
importation into or transit through the Union shall be accompan ied by 
health certificates and declarations, in accordance with the mo dels set 
out in Annex XV hereto, at the point of entry into the Union wh ere the 
veterinary checks take place, as provided for in Directive 97/7 8/EC.  
▼M24  
By way of derogation from the first paragraph, animal by-produc ts and 
derived products originating from, and returning to, the Union following 
a refusal of entry by a third country, must comply with the spe cific 
requirements set out in Chapter VI of Annex XIV.  
▼B 
CHAPTER IX  
OFFICIAL CONTROLS  
Article 32  
Official controls  
1. The competent authority shall take the necessary measures to  
control the entire chain of collection, transport, use and disp osal of 
animal by-products and derived products, as referred to in 
Article 4(2) of Regulation (EC) No 1069/2009.  
Those measures shall be carried out in accordance with the prin ciples 
for official controls laid down in Article 3 of Regulation (EC)  No 
882/2004.  
2. The official controls referred to in paragraph 1 shall inclu de 
checks on the keeping of records and other documents required b y 
the rules laid down in this Regulation.  ▼M5 02011R0142 — EN — 01.01.2021 — 021.001 — 19
 
3. The competent authority shall carry out the following offici al 
controls, as referred to in Article 45(1) of Regulation (EC) No  
1069/2009, in accordance with the requirements set out in Annex  
XVI hereto:  
(a) official controls in processing plants as set out in Chapte r I; 
(b) official controls of other activities which involve the han dling of 
animal by-products, and derived products as set out in Sections  1 to 
9 of Chapter III.  
4. The competent authority shall carry out checks on seals whic h are 
applied to consignments of animal by-products or derived produc ts. 
When the competent authority applies a seal to such consignment  which 
is transported to a place of destination, it must inform the co mpetent 
authority of the place of destination.  
5. The competent authority shall draw up the lists of establish ments, 
plants and operators referred to in Article 47(1) of Regulation  (EC) No 
1069/2009 in accordance with the format set out in Chapter II o f Annex 
XVI hereto.  
6. The competent authority of the Member State of destination s hall 
decide upon the application by an operator concerning the accep tance or 
refusal of certain Category 1, Category 2 material and meat-and -bone 
meal or animal fat derived from Category 1 and Category 2 mater ials, 
within 20 calendar days from the date of receipt of such applic ation 
provided that it has been submitted in one of the official lang uages of 
that Member State.  
▼M16  
7. Operators shall submit applications for the authorisation re ferred to 
in paragraph 6 in accordance with the standard format set out i n Section 
10 of Chapter III of Annex XVI hereto by means of TRACES.  
▼B 
Article 33  
Reapproval of plants and establishments after the grant of a 
temporary approval  
1. Where a plant or establishment approved for the processing o f 
Category 3 material is subsequently granted temporary approval for 
the processing of Category 1 or Category 2 material, in accorda nce 
with Article 24(2)(b)(ii) of Regulation (EC) No 1069/2009, it s hall be 
prohibited from recommencing the processing of Category 3 mater ial, 
without first obtaining the approval of the competent authority  to 
recommence processing of Category 3 material in accordance with  
Article 44 of that Regulation.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 20
 
2. Where a plant or establishment approved for the processing o f 
Category 2 material is subsequently granted temporary approval for 
the processing of Category 1 material, in accordance with 
Article 24(2)(b)(ii) of Regulation (EC) No 1069/2009, it shall be 
prohibited from recommencing the processing of Category 2 mater ial, 
without first obtaining the approval of the competent authority  to 
recommence processing of Category 2 material in accordance with  
Article 44 of that Regulation.  
CHAPTER X  
FINAL PROVISIONS  
Article 34  
Restrictions on the placing on the market of certain animal by- 
products and derived products for reasons of public and animal 
health  
The competent authority shall not prohibit or restrict the plac ing on the 
market of the following animal by-products and derived products  for 
public health or animal health reasons other than the rules lai d down in 
Union legislation, and in particular those laid down in Regulat ion (EC) 
No 1069/2009 and in this Regulation:  
(a) processed animal protein and other derived products referre d to in 
Chapter II of Annex X hereto;  
(b) petfood and certain other derived products referred to in A nnex XIII 
hereto;  
(c) animal by-products and the derived products imported into o r in 
transit through the Union as referred to in Annex XIV hereto.  
Article 35  
Repeal  
1. The following acts are repealed:  
(a) Regulation (EC) No 811/2003;  
(b) Decision 2003/322/EC;  
(c) Decision 2003/324/EC;  
(d) Regulation (EC) No 878/2004;  
(e) Decision 2004/407/EC;  
(f) Regulation (EC) No 79/2005;  
(g) Regulation (EC) No 92/2005;  
(h) Regulation (EC) No 181/2006;  
(i) Regulation (EC) No 197/2006;  
(j) Regulation (EC) No 1192/2006;  
(k) Regulation (EC) No 2007/2006.  
2. References to the repealed acts shall be construed as refere nces to 
this Regulation.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 21
 
Article 36  
Transitional measures  
1. For a transitional period until 31 December 2011, operators may 
place on the market organic fertilisers and soil improvers whic h were 
produced before 4 March 2011 in accordance with Regulations (EC ) 
No 1774/2002 and (EC) No 181/2006:  
(a) provided that they have been produced from one of the follo wing:  
(i) meat-and-bone meal derived from Category 2 material;  
(ii) processed animal protein;  
(b) even though they have not been mixed with a component to ex clude 
the subsequent use of the mixture for feeding purposes.  
2. For a transitional period until 31 January 2012, consignment s of 
animal by-products and of derived products accompanied by a hea lth 
certificate, declaration or commercial document, which has been  
completed and signed in accordance with the appropriate model s et 
out in Annex X to Regulation (EC) No 1774/2002 shall continue t o 
be accepted for importation into the Union, provided that such 
certificates, declarations or documents were completed and sign ed 
before 30 November 2011.  
▼M9 __________  
▼B 
Article 37  
This Regulation shall enter into force on the 20th day followin g its 
publication in the  Official Journal of the European Union . 
It shall apply from 4 March 2011.  
This Regulation shall be binding in its entirety and directly a pplicable in 
all Member States.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 22
 
ANNEX I  
DEFINITIONS AS REFERRED TO IN ARTICLE 2  
For the purpose of this Regulation, the following definitions s hall apply:  
1. ‘ fur animals ’ means animals kept or reared for the production of fur and no t 
used for human consumption;  
2. ‘ blood ’ means fresh whole blood;  
3. ‘ feed material ’ means those feed materials, as defined in Article 3(2)(g) of 
Regulation (EC) No 767/2009, that are of animal origin, includi ng processed 
animal proteins, blood products, rendered fats, egg products, f ish oil, fat 
derivatives, collagen, gelatine and hydrolysed proteins, dicalc ium phosphate, 
tricalcium phosphate, milk, milk-based products, milk-derived p roducts, 
colostrum, colostrum products and centrifuge or separator sludg e; 
4. ‘ blood products ’ means derived products from blood or fractions of blood, 
excluding blood meal; they include dried/frozen/liquid plasma, dried whole 
blood, dried/frozen/liquid red cells or fractions thereof and m ixtures;  
5. ‘ processed animal protein ’ means animal protein derived entirely from 
Category 3 material, which have been treated in accordance with  
Section 1 of Chapter II of Annex X (including blood meal and fi shmeal) 
so as to render them suitable for direct use as feed material o r for any other 
use in feedingstuffs, including petfood, or for use in organic fertilisers or soil 
improvers; however, it does not include blood products, milk, m ilk-based 
products, milk-derived products, colostrum, colostrum products,  centrifuge or 
separator sludge, gelatine, hydrolysed proteins and dicalcium p hosphate, 
eggs and egg-products, including eggshells, tricalcium phosphat e and 
collagen;  
6. ‘ blood meal ’ means processed animal protein derived from the heat 
treatment of blood or fractions of blood in accordance with Sec tion 1 of 
Chapter II of Annex X;  
▼M11  
7. ‘ fishmeal ’ means processed animal protein derived from aquatic animals 
except sea mammals, including farmed aquatic invertebrates, inc luding 
those covered by Article 3(1)(e) of Council Directive 2006/88/E C (  1 ), and 
starfish of the species  Asterias rubens  which are harvested in a mollusc 
production area;  
▼B 
8. ‘ rendered fats ’ means either fats derived from the processing of:  
(a) animal by-products; or  
(b) products for human consumption, which an operator has desti ned for 
purposes other than human consumption;  
▼M11  
9. ‘fish oil ’ means oil derived from the processing of aquatic animals exce pt 
sea mammals, including farmed aquatic invertebrates, including those 
covered by Article 3(1)(e) of Directive 2006/88/EC, and starfis h of the  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 23  
( 1 ) Council Directive 2006/88/EC of 24 October 2006 on animal hea lth 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).
 species  Asterias rubens  which are harvested in a mollusc production area, or 
oil from the processing of fish for human consumption, which an  operator 
has destined for purposes other than human consumption;  
▼B 
10. ‘ apiculture by-products ’ means honey, beeswax, royal jelly, propolis or 
pollen not intended for human consumption;  
11. ‘ collagen ’ means protein-based products derived from hides, skins, bones  
and tendons of animals;  
12. ‘ gelatine ’ means natural, soluble protein, gelling or non-gelling, obtai ned by 
the partial hydrolysis of collagen produced from bones, hides a nd skins, 
tendons and sinews of animals;  
13. ‘ greaves ’ means the protein-containing residue of rendering, after part ial 
separation of fat and water;  
14. ‘ hydrolysed proteins ’ means polypeptides, peptides and aminoacids, and 
mixtures thereof, obtained by the hydrolysis of animal by-produ cts; 
15. ‘ white water ’ means a mixture of milk, milk-based products or products 
derived thereof with water which is collected during the rinsin g of dairy 
equipment including containers used for dairy products, prior t o their 
cleaning and disinfection;  
16. ‘ canned petfood ’ means heat-processed petfood contained within a 
hermetically sealed container;  
17. ‘ dogchews ’ means products for pet animals to chew, produced from 
untanned hides and skins of ungulates or from other material of  animal 
origin;  
18. ‘ flavouring innards ’ means a liquid or dehydrated derived product of 
animal origin used to enhance the palatability values of petfoo d; 
▼M4 
19. ‘ petfood ’ means feed, other than material referred to in Article 24(2),  for use 
as feed for pet animals, and dogchews consisting of animal by-p roducts or 
derived products which:  
(a) contain Category 3 material, other than material referred t o in 
Article 10(n), (o) and (p) of Regulation (EC) No 1069/2009; and  
(b) may contain imported Category 1 material comprising of anim al 
by-products derived from animals which have been submitted to i llegal 
treatment as defined in Article 1(2)(d) of Directive 96/22/EC o r 
Article 2(b) of Directive 96/23/EC;  
▼B 
20. ‘ processed petfood ’ means petfood, other than raw petfood, which has been 
processed in accordance with point 3 of Chapter II of Annex XII I; 
21. ‘ raw petfood ’ means petfood containing certain Category 3 material which 
has not undergone any preserving process other than chilling or  freezing;  
22. ‘ catering waste ’ means all waste food, including used cooking oil orig­
inating in restaurants, catering facilities and kitchens, inclu ding central 
kitchens and household kitchens;  
▼M4 
23. ‘ digestion residues ’ means residues, including the liquid fraction, resulting 
from the transformation of animal by-products in a biogas plant ; ▼M11  02011R0142 — EN — 01.01.2021 — 021.001 — 24
 
24. ‘ digestive tract content ’ means the content of the digestive tract of 
mammals and ratites;  
25. ‘ fat derivatives ’ means derived products from rendered fats, which, as 
regards rendered fats of Category 1 or Category 2 material, hav e been 
processed in accordance with Chapter XI of Annex XIII;  
26. ‘ guano ’ means a natural product which has been collected from the 
excrements of bats or wild sea birds and which is not mineralis ed; 
27. ‘ meat-and-bone meal ’ means animal protein derived from the processing of 
Category 1 or Category 2 materials in accordance with one of th e processing 
methods set out in Chapter III of Annex IV;  
28. ‘ treated hides and skins ’ means derived products from untreated hides and 
skins, other than dogchews, that have been:  
(a) dried;  
(b) dry-salted or wet-salted for a period of at least 14 days p rior to dispatch;  
(c) salted for a period of at least seven days in sea salt with  the addition of 
2 % of sodium carbonate;  
(d) dried for a period of at least 42 days at a temperature of at least 20 °C; 
or 
(e) subject to a preservation process other than tanning;  
29. ‘ untreated hides and skins ’ means all cutaneous and subcutaneous tissues 
that have not undergone any treatment, other than cutting, chil ling or 
freezing;  
30. ‘ untreated feathers and parts of feathers ’ means feathers and parts of 
feathers, other than feathers or parts of feathers, which have been treated:  
(a) with a steam current; or  
(b) by another method that ensures that no unacceptable risks r emain;  
▼M2 
31. ‘ untreated wool ’ means wool, other than wool which has:  
(a) undergone factory washing;  
(b) been obtained from tanning;  
(c) been treated by another method that ensures that no unaccep table risks 
remain;  
(d) been produced from animals other than those of the porcine species, and 
has undergone factory-washing which consisting of the immersion  of the 
wool in series of baths of water, soap and sodium hydroxide or 
potassium hydroxide; or  
(e) been produced from animals other than those of the porcine species, is 
intended for being dispatched directly to a plant producing der ived 
products from wool for the textile industry and has undergone a t least 
one of the following treatments:  
(i) chemical depilation by means of slaked lime or sodium sulph ide; 
(ii) fumigation in formaldehyde in a hermetically sealed chambe r for at 
least 24 hours;  
(iii) industrial scouring which consists of the immersion of wo ol in 
a water-soluble detergent held at 60–70 °C;  
(iv) storage, which may include the journey time, at 37 °C for eight 
days, 18 °C for 28 days or 4 °C for 120 days;  
32. ‘ untreated hair ’ means hair, other than hair which has:  
(a) undergone factory washing;  
(b) been obtained from tanning;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 25
 
(c) been treated by another method that ensures that no unaccep table risks 
remain;  
(d) been produced from animals other than those of the porcine species, and 
has undergone factory-washing which consisting of the immersion  of the 
hair in series of baths of water, soap and sodium hydroxide or potassium 
hydroxide; or  
(e) been produced from animals other than those of the porcine species, is 
intended for being dispatched directly to a plant producing der ived 
products from hair for the textile industry and has undergone a t least 
one of the following treatments:  
(i) chemical depilation by means of slaked lime or sodium sulph ide; 
(ii) fumigation in formaldehyde in a hermetically sealed chambe r for at 
least 24 hours;  
(iii) industrial scouring which consists of the immersion of ha ir in 
a water-soluble detergent held at 60–70 °C;  
(iv) storage, which may include the journey time, at 37 °C for eight 
days, 18 °C for 28 days or 4 °C for 120 days;  
▼B 
33. ‘ untreated pig bristles ’ means pig bristles, other than pig bristles which 
have:  
(a) undergone factory washing;  
(b) been obtained from tanning; or  
(c) been treated by another method that ensures that no unaccep table risks 
remain;  
34. ‘ display item ’ means animal by-products or derived products intended for 
exhibitions or artistic activities;  
▼M9 
35. ‘ intermediate product ’ means a derived product:  
(a) which is intended for uses within the manufacturing of medi cinal 
products, veterinary medicinal products, medical devices for me dical 
and veterinary purposes, active implantable medical devices,  in vitro  
diagnostic medical devices for medical and veterinary purposes,  
laboratory reagents or cosmetic products as follows:  
(i) as material in a manufacturing process or in the final prod uction of 
a finished product;  
(ii) in validation or verification during a manufacturing proce ss; or  
(iii) in quality control of a finished product;  
(b) whose design, transformation and manufacturing stages have been 
sufficiently completed in order to be regarded as a derived pro duct 
and to qualify the material directly or as a component of a pro duct for 
the purposes referred to in point (a);  
(c) which however requires some further manufacturing or transf ormation, 
such as mixing, coating, assembling or packaging to make it sui table for 
placing on the market or putting into service, as applicable, a  medicinal 
product, veterinary medicinal product, medical device for medic al and 
veterinary purposes, active implantable medical device,  in vitro  diag­
nostic medical devices for medical and veterinary purposes, lab oratory 
reagent or cosmetic products;  
▼B 
36. ‘ laboratory reagent ’ means a packaged product, ready for use, containing 
animal by-products or derived products and intended as such or in combi­
nation with substances of non-animal origin for specific labora tory use as a 
reagent or reagent product, calibrator or control material to d etect, measure, 
examine or produce other substances;  ▼M2 02011R0142 — EN — 01.01.2021 — 021.001 — 26
 
37. ‘ product used for in vitro diagnosis ’ means a packaged product, ready for 
use, containing a blood product or another animal by-product, a nd used as a 
reagent, reagent product, calibrator, kit or any other system, whether used 
alone or in combination, intended to be used in vitro for the e xamination of 
samples of human or animal origin, solely or principally with a  view to the 
diagnosis of a physiological state, state of health, disease or  genetic abnor­
mality or to determine safety and compatibility with reagents; it does not 
include donated organs or blood;  
38. ‘ research and diagnostic samples ’ means animal by-products and derived 
products intended for the following purposes: examination in th e context of 
diagnostic activities or analysis for the promotion of progress  in science and 
technology, in the context of educational or research activitie s; 
▼M9 
39. ‘ trade samples ’ means animal by-products or derived products intended for 
particular studies or analyses authorised by the competent auth ority in 
accordance with Article 17(1) of Regulation (EC) No 1069/2009 w ith a 
view to carrying out a production process, including the proces sing of 
animal by-products or derived products, the development of feed ingstuff, 
pet food or derived products, or the testing of machinery or eq uipment;  
▼B 
40. ‘ co-incineration ’ means the recovery or disposal of animal by-products or 
derived products, if they are waste, in a co-incineration plant ; 
41. ‘ combustion ’ means a process involving the oxidisation of fuel in order to  
use the energy value of the animal by-products or derived produ cts, if they 
are not waste;  
42. ‘ incineration ’ means the disposal of animal by-products or derived products 
as waste, in an incineration plant, as defined in point 4 of Ar ticle 3 of 
Directive 2000/76/EC;  
43. ‘ incineration and co-incineration residues ’ means any residues as defined 
in point 13 of Article 3 of Directive 2000/76/EC, which are gen erated by 
incineration or co-incineration plants treating animal by-produ cts or derived 
products;  
44. ‘ colour-coding ’ means the systematic use of colours as set out in point 1(c) 
of Chapter II of Annex VIII for displaying information as provi ded for in 
this Regulation on the surface or on part of the surface of a p ackaging, 
container or vehicle, or on a label or symbol applied to them;  
45. ‘ intermediate operations ’ means the operations, other than storage, referred 
to in Article 19(b);  
46. ‘ tanning ’ means the hardening of hides, using vegetable tanning agents,  
chromium salts or other substances such as aluminium salts, fer ric salts, 
silicic salts, aldehydes and quinones, or other synthetic harde ning agents;  
47. ‘ taxidermy ’ means the art of preparing, stuffing and mounting the skins o f 
animals with lifelike effect, so that no unacceptable risks to public and 
animal health may be transmitted through the mounted skin;  
48. ‘ trade ’ means trade in goods between Member States as referred to in 
Article 28 of the Treaty on the Functioning of the European Uni on; 
49. ‘ processing methods ’ means the methods listed in Chapters III and IV of 
Annex IV;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 27
 
50. ‘ batch ’ means a unit of production produced in a single plant using u niform 
production parameters, such as the origin of the materials, or a number of 
such units, when produced in continuous order in a single plant  and stored 
together as a shipping unit;  
51. ‘ hermetically sealed container ’ means a container that is designed and 
intended to be secure against the entry of micro-organisms;  
52. ‘ biogas plant ’ means a plant in which animal by-products or derived 
products are at least part of the material which is submitted t o 
biological degradation under anaerobic conditions;  
53. ‘ collection centres ’ means premises other than processing plants in which 
the animal by-products referred to in Article 18(1) of Regulati on (EC) 
No 1069/2009 are collected with the intention to be used for fe eding to 
the animals referred to in the same Article;  
54. ‘ composting plant ’ means a plant in which animal by-products or derived 
products are at least part of the material which is submitted t o 
biological degradation under aerobic conditions;  
55. ‘ co-incineration plant ’ means any stationary or mobile plant whose main 
purpose is the generation of energy or the production of materi al products as 
defined in point 5 of Article 3 of Directive 2000/76/EC;  
56. ‘ incineration plant ’ means any stationary or mobile technical unit and 
equipment dedicated to the thermal treatment of waste as define d in point 
4 of Article 3 of Directive 2000/76/EC;  
57. ‘ petfood plant ’ means premises or facilities for the production of petfood or  
flavouring innards, as referred to in Article 24(1)(e) of Regul ation (EC) 
No 1069/2009;  
▼M9 
58. ‘ processing plant ’ means premises or facilities for the processing of animal 
by-products as referred to in Article 24(1)(a) of Regulation (E C) 
No 1069/2009, in which animal by-products are processed in acco rdance 
with Annex IV and/or Annex X;  
▼M23  
59. ‘ growing media ’ means materials, including potting soil, other than soil  in 
situ, in which plants or mushrooms are grown and which is used inde ­
pendently from soil  in situ ; 
60. ‘ process hygiene criterion ’ means a criterion indicating the acceptable func­
tioning of the production process. Such a criterion is not appl icable to 
products placed on the market. It sets an indicative contaminat ion value 
above which corrective actions are required in order to maintai n the 
hygiene of the process in compliance with general requirements for the 
safety of feed.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 28
 
ANNEX II  
RESTRICTIONS ON THE USE OF ANIMAL BY-PRODUCTS  
CHAPTER I  
Intra-species recycling of fur animals  
1. In Estonia, Latvia and Finland, the following fur animals ma y be fed with 
meat-and-bone meal or other products which have been processed in 
accordance with Chapter III of Annex IV and which are derived f rom 
bodies or parts of bodies of animals of the same species:  
▼M1 
(a) foxes ( Vulpes vulpes  and Alopex lagopus ); 
▼B 
(b) raccoon dogs ( Nyctereutes procyonides ). 
2. In Estonia and Latvia, fur animals of the species American m ink ( Mustela 
vison ) may be fed with meat-and-bone meal or other products which ha ve 
been processed in accordance with the processing methods set ou t in 
Chapter III of Annex IV and which are derived from bodies or pa rts of 
bodies of animals of the same species.  
3. The feeding referred to in points 1 and 2 shall take place u nder the following 
conditions:  
(a) Feeding shall only take place in farms:  
(i) which have been registered by the competent authority on th e basis 
of an application that is accompanied by documentation proving that 
there is no reason to suspect the presence of the TSE agent in the 
population of the species covered by the application;  
(ii) where an appropriate surveillance system for transmissible  spon­
giform encephalopathies (TSEs) in fur animals is in place on th e 
farm and includes regular laboratory testing of samples for TSE ; 
(iii) which have provided appropriate guarantees that no animal  
by-product or meat-and-bone meal or other products which have 
been processed in accordance with Chapter III of Annex IV and 
which are derived from those animals or their offspring may ent er 
the food or feed chain of other animals than fur animals;  
(iv) which have had no known contact with any farm with a suspe cted 
or confirmed outbreak of TSE;  
(v) where the operator of the registered farm ensures that:  
— the carcases of fur animals intended for feeding to animals o f 
the same species are handled and processed separately from 
carcases not authorised for that purpose,  
— fur animals fed with meat-and-bone meal or other products 
which have been processed in accordance with Chapter III of 
Annex IV and which are derived from animals of the same 
species are kept separate from animals not being fed with 
products derived from animals of the same species,  
— the farm complies with the requirements set out in point 2 of  
Section 1 of Chapter II of Annex VI and point (2)(b)(ii) of 
Chapter II of Annex VIII.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 29
 
(b) The operator of the farm shall ensure that meat-and-bone me al or other 
products derived from one species and intended for the feeding of the 
same species must:  
(i) have been processed in a processing plant approved under 
Article 24(1)(a) of Regulation (EC) No 1069/2009 and using only  
processing methods 1 to 5 or processing method 7 as set out in 
Chapter III of Annex IV to this Regulation;  
(ii) have been produced from healthy animals killed for the pro duction 
of fur.  
(c) In the event of any known or suspected contact with any far m with a 
suspected or confirmed outbreak of TSE, the operator of the far m must 
immediately:  
(i) inform the competent authority of such contact;  
(ii) cease the dispatch of fur animals to any destination witho ut a written 
authorisation of the competent authority.  
CHAPTER II  
Feeding of farmed animals with herbage  
The following conditions shall apply to the feeding of farmed a nimals with 
herbage from land, either by direct access of the animals to th at land or by 
using cut herbage as feed, provided that organic fertilisers or  soil improvers 
have been applied to that land:  
(a) The waiting period of at least 21 days referred to in Artic le 11(1)(c) of 
Regulation (EC) No 1069/2009 must have been observed,  
(b) Only organic fertilisers and soil improvers have been used which comply 
with Article 32(1) and (2) of Regulation (EC) No 1069/2009 and with 
Chapter II of Annex XI hereto.  
However, those conditions shall not apply, provided only the fo llowing organic 
fertilisers or soil improvers have been applied to land:  
(a) manure and guano;  
(b) digestive tract content, milk, milk-based products, milk-de rived products, 
colostrum and colostrum products, which the competent authority  does not 
consider to present a risk for the spread of any serious animal  disease.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 30
 
ANNEX III  
DISPOSAL, RECOVERY AND USE AS A FUEL  
▼B 
CHAPTER I  
GENERAL REQUIREMENTS FOR INCINERATION AND 
CO-INCINERATION  
Section 1  
General conditions  
1. Operators of incineration and co-incineration plants referre d to in 
Article 6(1)(b) of this Regulation shall ensure that the follow ing hygiene 
conditions are met in the plants under their control:  
(a) Animal by-products and derived products must be disposed of  as soon as 
possible after arrival, in accordance with conditions laid down  by the 
competent authority. They shall be stored properly until dispos al, in 
accordance with conditions laid down by the competent authority . 
(b) Plants must have appropriate arrangements for the cleaning and disin­
fection of containers and vehicles in place, in particular in a  designated 
area from which wastewater is disposed of in accordance with Un ion 
legislation, to avoid risks of contamination.  
(c) Plants must be located on a well-drained hardstanding.  
(d) Plants must have appropriate arrangements for protection ag ainst pests, 
such as insects, rodents and birds. A documented pest control p rogramme 
must be used for that purpose.  
(e) Staff must have access to adequate facilities for personal hygiene such as 
lavatories, changing rooms and washbasins, if necessary to prev ent risks 
of contamination.  
(f) Cleaning procedures must be established and documented for all parts of 
the premises. Suitable equipment and cleaning agents must be pr ovided 
for cleaning.  
(g) Hygiene control must include regular inspections of the env ironment and 
equipment. Inspection schedules and results must be documented and 
maintained for at least two years.  
2. The operator of an incineration or co-incineration plant sha ll take all 
necessary precautions concerning the reception of animal by-pro ducts or 
derived products to prevent, or limit as far as practicable, di rect risks to 
human or animal health.  
3. Animals must not have access to the plants, animal by-produc ts and derived 
products that are awaiting incineration or co-incineration or t o ash resulting 
from the incineration or co-incineration of animal by-products.  
4. If the incineration or co-incineration plant is located on a  livestock holding:  
(a) there must be total physical separation between the inciner ation or 
co-incineration equipment and the livestock and their feed and 
bedding, with fencing where necessary;  ▼M8 02011R0142 — EN — 01.01.2021 — 021.001 — 31
 
(b) equipment must be dedicated entirely to the operation of th e incinerator 
and not used elsewhere on the holding or, alternatively, cleane d and 
disinfected before such use;  
(c) personnel working in the plant must change their outer clot hing and 
footwear before handling livestock or livestock feed.  
5. The storage of animal by-products and derived products that are awaiting 
incineration or co-incineration and of ashes must be in covered , correctly 
identified and, if appropriate, leak proof containers.  
6. Incompletely incinerated animal by-products must be reincine rated or 
disposed of by other means, other than by disposal in an author ised 
landfill, in accordance with Articles 12, 13 and 14, as applica ble, of 
Regulation (EC) No 1069/2009.  
Section 2  
Operating conditions  
Incineration or co-incineration plants shall be designed, equip ped, built and 
operated in such a way that the gas resulting from the process is raised in a 
controlled and homogeneous fashion, even under the most unfavou rable 
conditions, to a temperature of 850 °C for at least 2 seconds o r to a temperature 
of 1100 °C for 0.2 seconds, as measured near the inner wall or at another 
representative point of the chamber where the incineration or t he 
co-incineration is carried out, as authorised by the competent authority.  
Section 3  
Incineration and co-incineration residues  
1. Incineration and co-incineration residues shall be minimised  in their amount 
and harmfulness. Such residues must be recovered, where appropr iate, 
directly in the plant or outside it in accordance with relevant  Union legis­
lation or disposed of in an authorised landfill.  
2. Transport and intermediate storage of dry residues, includin g dust, shall take 
place in such a way as to prevent dispersal in the environment,  such as in 
closed containers.  
Section 4  
Measurement of temperature and of other parameters  
1. Techniques shall be used to monitor the parameters and condi tions relevant 
to the incineration or co-incineration process.  
2. The approval issued by the competent authority, or condition s attached to it, 
shall lay down temperature measurement requirements.  
3. The functioning of any automated monitoring equipment shall be subject to 
control and to an annual surveillance test.  
4. Temperature measurement results shall be recorded and presen ted in an 
appropriate fashion to enable the competent authority to verify  compliance 
with the permitted operating conditions laid down in this Regul ation in 
accordance with procedures to be decided upon by that authority . ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 32
 
Section 5  
Abnormal operating  
In the case of a breakdown, or abnormal operating conditions of  an incineration 
plant or a co-incineration plant, the operator shall reduce or close down 
operations as soon as practicable until normal operations can b e resumed.  
CHAPTER II  
HIGH-CAPACITY INCINERATION AND CO-INCINERATION PLANTS  
Section 1  
Specific operating conditions  
Incineration or co-incineration plants treating only animal by- products and 
derived products with a capacity of more than 50 kg per hour (h igh-capacity 
plants) and which are not required to have a permit to operate in accordance with 
Directive 2000/76/EC shall comply with the following conditions : 
(a) The plants must be equipped for each line with at least one  auxiliary burner. 
This burner shall be switched on automatically when the tempera ture of the 
combustion gases after the last injection of combustion air fal ls below 
850 °C or 1100 °C, as applicable. It must also be used during p lant 
start-up and shut-down operations to ensure that the temperatur e of 850 °C 
or of 1100 °C, as applicable, is maintained at all times during  these 
operations and as long as unburned material is in the chamber w here the 
incineration or co-incineration is carried out.  
(b) When animal by-products or derived products are introduced into the 
chamber where the incineration or co-incineration is carried ou t by a 
continuous process, the plant must operate an automatic system to prevent 
the introduction of animal by-products or derived products at s tart-up, until 
the temperature of 850 °C or of 1100 °C, as applicable, has bee n reached, 
and whenever the temperature is not maintained.  
(c) The operator must operate the incineration plant in such ma nner that a level 
of incineration is achieved such that the slag and bottom ashes  total organic 
carbon content is less than 3 % or their loss on ignition is le ss than 5 % of 
the dry weight of the material. If necessary, appropriate techn iques of 
pre-treatment shall be used.  
Section 2  
Water discharges  
1. Sites of high capacity plants, including associated storage areas for animal 
by-products, shall be designed in such a way as to prevent unau thorised and 
accidental release of any polluting substances into soil, surfa ce water and 
groundwater.  
2. Storage capacity shall be provided for contaminated rainwate r run-off from 
the plant site or for contaminated water arising from spillage or firefighting 
operations.  
The operator shall, if necessary, ensure that such rainwater an d such water 
can be tested and treated before discharge, when necessary.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 33
 
CHAPTER III  
LOW-CAPACITY INCINERATION AND CO-INCINERATION PLANTS  
Incineration and co-incineration plants treating only animal by -products and 
derived products with a maximum capacity of less than 50 kg of animal 
by-products per hour or per batch (low-capacity plants) and whi ch are not 
required to have a permit to operate in accordance with Directi ve 2000/76/EC 
shall:  
▼M9 
(a) only be used for the disposal of:  
(i) dead pet animals referred to in Article 8(a)(iii) of Regula tion (EC) 
No 1069/2009;  
(ii) Category 1 materials referred to in Article 8(b), (e) and (f), Category 2 
materials referred to in Article 9 or Category 3 materials refe rred to in 
Article 10 of that Regulation; and  
(iii) dead individually identified equine animals from holdings  not subject to 
health restrictions in accordance with Article 4(5) or 5 of Dir ective 
2009/156/EC, if authorised by the Member State;  
▼B 
(b) when Category 1 materials referred to in Article 8(b) of Re gulation (EC) 
No 1069/2009 are introduced into the low-capacity plant, be equ ipped with 
an auxiliary burner;  
(c) operate in such way that the animal by-products are complet ely reduced to 
ash. 
▼M8 
CHAPTER IV  
GENERAL REQUIREMENTS FOR THE USE OF ANIMAL 
BY-PRODUCTS AND DERIVED PRODUCTS AS A FUEL  
Section 1  
General requirements regarding the combustion of animal by-products and 
derived products as a fuel  
1. Operators of combustion plants referred to in Article 6(6) s hall ensure that 
the following conditions are met in the combustion plants under  their control:  
(a) Animal by-products and derived products intended to be used  as a fuel 
must be utilised for that purpose as soon as possible or safely  stored until 
used.  
(b) The combustion plants must have in place appropriate measur es to 
ensure that cleaning and disinfection of containers and vehicle s are 
carried out in a designated area of their premises from which t he 
wastewater can be collected and disposed of in accordance with Union 
legislation, to avoid risks of contamination of the environment . 
By way of derogation from the requirements set out in the first  
subparagraph, containers and vehicles used for the transport of  
rendered fats may be cleaned and disinfected at the plant of lo ading or 
at any other plant approved or registered under Regulation (EC)  
No 1069/2009.  
(c) The combustion plants must be located on a well-drained har d standing.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 34
 
(d) The combustion plants must have appropriate measures in pla ce for the 
protection against pests. A documented pest control programme m ust be 
used for that purpose.  
(e) Staff must have access to adequate facilities for personal hygiene such as 
lavatories, changing rooms and washbasins, if necessary, to pre vent risks 
of contamination of equipment for handling of farmed animals or  their 
feedstuffs.  
(f) Cleaning and disinfection procedures, must be established a nd docu­
mented for all parts of the combustion plant. Suitable equipmen t and 
cleaning agents must be provided for cleaning.  
(g) Hygiene control must include regular inspections of the env ironment and 
equipment. Inspection schedules and results must be documented and 
retained for a period of at least two years.  
(h) Where rendered fats are used as a fuel for combustion in st ationary 
internal combustion engines located within approved or register ed food 
or feed processing plants, the processing of food or feed on th e same site 
must take place under strict conditions of separation.  
2. Operators of the combustion plants shall take all necessary precautions 
concerning the reception of animal by-products or derived produ cts to 
prevent or limit as far as practicable, risks to human or anima l health and 
the environment.  
3. Animals must not have access to the combustion plant or to t he animal 
by-products and derived products awaiting combustion or the ash  resulting 
from the combustion.  
4. Where the combustion plant is located on a holding keeping a nimals of food 
producing species:  
(a) there must be total physical separation between the combust ion 
equipment and the animals including their feed and bedding;  
(b) equipment must be dedicated entirely to the operation of th e combustion 
plant and not used elsewhere on the holding unless it had been 
effectively cleaned and disinfected before such use;  
(c) personnel working in the combustion plant must change their  outer 
clothing and footwear and take personal hygiene measures before  
handling animals on this or any other holding or their feed or bedding 
material.  
5. The animal by-products and derived products that are awaitin g combustion as 
a fuel and the combustion residues must be stored in a closed a nd covered 
dedicated area, or in covered and leak-proof containers.  
6. The combustion of animal by-products or derived products sha ll be carried 
out under conditions which prevent cross-contamination of feed for animals.  ▼M8 02011R0142 — EN — 01.01.2021 — 021.001 — 35
 
Section 2  
Operating conditions of combustion plants  
1. Combustion plants must be designed, built, equipped and oper ated in such a 
way that even under the most unfavourable conditions the animal  by-products 
and derived products are treated for at least for 2 seconds at a temperature of 
850 °C or for at least 0,2 seconds at a temperature of 1 100 °C . 
2. The gas resulting from the process is raised in a controlled  and homogeneous 
fashion for 2 seconds to a temperature of 850 °C or for 0,2 sec onds to a 
temperature of 1 100 °C.  
The temperature must be measured near the inner wall or at anot her repre­
sentative point of the combustion chamber, as authorised by the  competent 
authority.  
3. Automated techniques shall be used to monitor the parameters  and conditions 
relevant to the combustion process.  
4. Temperature measurement results shall be recorded automatica lly and 
presented in an appropriate fashion to enable the competent aut hority to 
verify compliance with the permitted operating conditions refer red to in 
points 1 and 2 in accordance with procedures to be decided upon  by the 
relevant authority.  
5. The operator of a combustion plant shall ensure that the fue l is combusted in 
such a way that the total organic carbon content of the slags a nd bottom 
ashes is less than 3 % or their loss on ignition is less than 5  % of the dry 
weight of the material.  
Section 3  
Combustion residues  
1. Combustion residues shall be minimised in their amount and h armfulness. 
Such residues must be recovered, or where it is not appropriate , disposed of 
or used in accordance with relevant Union legislation.  
2. The transport and intermediate storage of dry residues, incl uding dust, shall 
take place in closed containers or in another way which prevent s dispersal 
into the environment.  
Section 4  
Breakdown or abnormal operating conditions  
1. The combustion plant shall be equipped with facilities which  automatically 
shut down operations in the case of a breakdown or abnormal ope rating 
conditions until normal operations can be resumed.  
2. Incompletely combusted animal by-products and derived produc ts must be 
combusted again or disposed of by means referred to in Articles  12, 13 and 
14 of Regulation (EC) No 1069/2009 other than disposal in an au thorised 
landfill.  ▼M8 02011R0142 — EN — 01.01.2021 — 021.001 — 36
 
CHAPTER V  
TYPES OF PLANTS AND FUELS THAT MAY BE USED FOR 
COMBUSTION AND SPECIFIC REQUIREMENTS FOR PARTICULAR 
TYPES OF PLANTS  
A. Stationary internal combustion engines  
1. Starting material:  
For this process, a fat fraction derived from animal by-product s of all 
categories may be used provided it meets the following conditio ns: 
(a) unless fish oil or rendered fat is used which has been prod uced in 
accordance with Section VIII or XII of Annex III to Regulation (EC) 
No 853/2004, respectively, the fat fraction derived from animal  
by-products must first be processed using:  
(i) in the case of a fat fraction of Category 1 and 2 materials , any of 
the processing methods 1 to 5 as set out in Chapter III of 
Annex IV.  
Where this fat is moved by a closed conveyer system, which may 
not be by-passed, and provided such a system has been auth­
orised by the competent authority, from the processing plant fo r 
immediate direct combustion the permanent marking with 
glyceroltriheptanoate (GTH) referred to in point 1 of Chapter V  
of Annex VIII shall not be required;  
(ii) in the case of a fat fraction of Category 3 material, any of the 
processing methods 1 to 5 or processing method 7 as set out in 
Chapter III of Annex IV;  
(iii) in the case of the materials derived from fish, any of th e 
processing methods 1 to 7 as set out in Chapter III of Annex IV ; 
(b) the fat fraction must be separated from the protein and in the case of 
fat from ruminant origin which is intended to be combusted in a nother 
plant, insoluble impurities in excess of 0,15 % by weight must be 
removed.  
2. Methodology:  
Combustion of animal fat as a fuel in a stationary internal com bustion 
engine shall be carried out as follows:  
(a) the fat fractions referred to in points 1(a) and (b) must b e combusted:  
(i) under the conditions laid down in Section 2(1) of Chapter I V; or  
(ii) using process parameters achieving an equivalent outcome a s the 
conditions under (i) and which are authorised by the competent 
authority;  
(b) the combustion of material of animal origin other than anim al fat must 
not be permitted;  ▼M8 02011R0142 — EN — 01.01.2021 — 021.001 — 37
 
(c) the animal fat derived from Category 1 or Category 2 combus ted in 
premises approved or registered in accordance with Regulations (EC) 
No 852/2004, (EC) No 853/2004, 183/2005, or in public places mu st 
have been processed with processing method 1 as set out in Chap ter 
III of Annex IV;  
(d) the combustion of animal fat must be carried out in accorda nce with 
Union legislation for the protection of the environment, in par ticular, 
with reference to the standards and requirements of that legisl ation and 
the requirements regarding best available techniques for the co ntrol 
and monitoring of emissions.  
3. Operating conditions:  
By way of derogation from the requirements set out in the first  paragraph 
of point 2 of Section 2 of Chapter IV, requirements based on ot her process 
parameters, which ensure an equivalent environmental outcome ma y be 
authorised by the competent authority responsible for environme ntal 
issues.  
B. On-farm combustion plants in which poultry manure is used as  a fuel  
1. Type of plant:  
On-farm combustion plant with a total rated thermal input not e xceeding 
5 MW.  
2. Starting material and scope:  
Exclusively unprocessed poultry manure, as referred to in Artic le 9(a) of 
Regulation (EC) No 1069/2009, to be used as a fuel for combusti on in 
accordance with the requirements set out in point 3 to 5.  
The combustion of other animal by-products or derived products and of 
manure of other species or generated outside the holding shall not be 
allowed for use as a fuel in on-farm combustion plants referred  to in 
point 1.  
3. Specific requirements for poultry manure used as a fuel for combustion:  
(a) The manure shall be stored securely in a closed storage are a to 
minimise the need for further handling and to prevent cross con tami­
nation with other areas on a holding keeping animals of food 
producing species.  
(b) The on-farm combustion plant must be equipped with:  
(i) an automatic fuel management system to place the fuel direc tly in 
the combustion chamber without further handling;  
(ii) an auxiliary burner which must be used during start-up and  
shut-down operations to ensure that the temperature requirement s 
set out in Section 2(2) of Chapter IV are met at all times duri ng 
those operations and as long as unburned material is in the 
combustion chamber.  ▼M8 02011R0142 — EN — 01.01.2021 — 021.001 — 38
 
4. Emission limit values and monitoring requirements:  
(a) The emissions of sulphur dioxide, nitrogen oxides (namely t he sum of 
nitrogen monoxide and nitrogen dioxide, expressed as nitrogen 
dioxide) and particulate matter shall not exceed the following 
emission limit values, expressed in mg/Nm  3 at a temperature of 
273,15 K, a pressure of 101,3 kPa and an oxygen content of 11 p er 
cent, after correction for the water vapour content of the wast e gases:  
Pollutant  Emission limit value in mg/Nm  3 
Sulphur dioxide  5 0  
Nitrogen oxides (as NO  2 ) 200  
Particulate matter  1 0  
(b) The operator of the on-farm combustion plant shall carry ou t at least 
annual measurements of sulphur dioxide, nitrogen oxides and 
particulate matter.  
As an alternative to the measurements referred to in the first 
subparagraph, other procedures, verified and approved by the 
competent authority, may be used to determine the emissions of 
sulphur dioxide.  
Monitoring shall be carried out by or on behalf of the operator  in 
accordance with CEN standards. Where CEN standards are not 
available, ISO, national or other international standards which  ensure 
the provision of data of an equivalent scientific quality shall  apply.  
(c) All results shall be recorded, processed and presented in s uch a way as 
to enable the competent authority to verify compliance with the  
emission limit values.  
(d) For on-farm combustion plants applying secondary abatement 
equipment in order to meet the emission limit values, the effec tive 
operation of that equipment shall be monitored continuously and  the 
results thereof recorded.  
(e) In the event of non-compliance with the emission limit valu es referred 
to in point (a) or where an on-farm combustion plant does not m eet 
the requirements of point 1 of Section 2 of Chapter IV, operato rs shall 
immediately inform the competent authority and take the measure s 
necessary to ensure that compliance is restored within the shor test 
possible time. Where compliance cannot be restored, the compete nt 
authority shall suspend the operation of the plant and withdraw  its 
approval.  
5. Changes of operation and breakdowns:  
(a) The operator shall notify the competent authority of any pl anned 
change of the on-farm combustion plant which would affect its 
emissions at least one month before the date on which the chang e 
takes place.  
(b) The operator shall take the necessary measures to ensure th at the 
periods of start-up and shut-down of the on-farm combustion pla nt 
and of any malfunctions are kept as short as possible. In the c ase of a 
malfunction or a breakdown of secondary abatement equipment, th e 
operator shall immediately inform the competent authority.  ▼M8 02011R0142 — EN — 01.01.2021 — 021.001 — 39
 
C. Combustion plants in which manure of farmed animals other th an poultry 
manure set out in point B is used as a fuel for combustion  
1. Type of plant:  
Combustion plants with a total rated thermal input not exceedin g 50 MW.  
2. Starting material:  
Exclusively manure of farmed animals other than poultry manure set out 
in point B, to be used as a fuel for combustion in accordance w ith the 
requirements set out in point 3.  
The combustion of other animal by-products or derived products shall not 
be allowed for use as a fuel in combustion plants referred to i n point 1. 
Manure of farmed animals other than poultry manure set out in p oint B 
generated outside the holding should not come in contact with f armed 
animals.  
3. Methodology:  
Combustion plants in which manure of farmed animals other than poultry 
manure set out in point B is used as a fuel shall comply with r equirements 
set out in points B(3), B(4) and B(5).  
4. Derogation and transitional period:  
The Member State competent authority responsible for environmen tal 
issues may:  
(a) by way of derogation from point B(3)(b)(ii), grant combusti on plants 
operating on 2 August 2017 an additional time period of maximum  6  
years to comply with the first paragraph of point 2 of Section 2 of 
Chapter IV of Annex III to this Regulation;  
(b) by way of derogation from point B(4), authorise emissions o f 
particulate matter not exceeding 50 mg/m  3 , provided the total rated 
thermal input of the combustion plants does not exceed 5 MW;  
(c) by way of derogation from point B(3)(b)(i), authorise manua l 
placement of horse manure as fuel in the combustion chamber whe n 
a total rated thermal input not exceeding 0,5 MW.  
▼M21  
D. Combustion plants in which meat-and-bone meal is used as a f uel for 
combustion  
1. Type of plant:  
Combustion plants with a total rated thermal input not exceedin g 50 MW.  
2. Starting material:  
Meat-and-bone meal of Category 1 and Category 2 materials, to b e used 
as a fuel for combustion in accordance with the requirements se t out in 
point 3 alone or in a mixture of meat-and-bone meal, rendered f at and 
manure.  
3. Specific requirements for meat-and-bone meal used as a fuel for 
combustion:  
(a) meat-and-bone meal shall be stored in the combustion plant securely 
in a closed storage protected from access of animals and shall not be 
sent to another destination unless authorised by the competent 
authority in case of break down or abnormal operating condition s; ▼M14  02011R0142 — EN — 01.01.2021 — 021.001 — 40
 
(b) the combustion plant must be equipped with:  
(i) an automatic or continuous fuel management system to place the 
fuel directly in the combustion chamber without further handlin g; 
(ii) an auxiliary burner which must be used during start-up and  shut- 
down operations to ensure that the temperature requirements set  
out in Section 2(2) of Chapter IV are met at all times during t hose 
operations and as long as unburned material is in the combustio n 
chamber.  
4. Methodology:  
Combustion plants in which meat-and-bone meal of Category 1 or 
Category 2 materials is used as a fuel shall comply with the ge neral 
requirements set out in Chapter IV and the specific requirement s set out 
in points B(4) and B(5) of this Chapter.  
5. Derogation and transitional period:  
The Member State competent authority responsible for environmen tal 
issues may by way of derogation from point 3(b)(ii), grant comb ustion 
plants operating on 3 June 2020 an additional time period of ma ximum 4 
years to comply with the second subparagraph of point 2 of Sect ion 2 of 
Chapter IV.  ▼M21  02011R0142 — EN — 01.01.2021 — 021.001 — 41
 
ANNEX IV  
PROCESSING  
CHAPTER I  
REQUIREMENTS FOR PROCESSING PLANTS AND CERTAIN OTHER 
PLANTS AND ESTABLISHMENTS  
Section 1  
General conditions  
1. Processing plants shall meet the following requirements, for  processing by 
pressure sterilisation or in accordance with the processing met hods referred to 
in Article 15(1)(b) of Regulation (EC) No 1069/2009:  
(a) Processing plants must not be situated on the same site as slaughter­
houses or other establishments which have been approved or regi stered 
in accordance with Regulation (EC) No 852/2004 or Regulation (E C) 
No 853/2004, unless the risks to public and animal health resul ting 
from the processing of animal by-products, which originate from  such 
slaughterhouses or other establishments, are mitigated by compl iance 
with at least the following conditions:  
(i) the processing plant must be physically separated from the slaught­
erhouse or other establishment, where appropriate by locating t he 
processing plant in a building that is completely separated fro m 
the slaughterhouse or other establishment;  
(ii) the following must be installed and operated in the proces sing plant:  
— a conveyer system which links the processing plant to the 
slaughterhouse or other establishment and which may not be 
by-passed,  
— separate entrances, reception bays, equipment and exits for b oth 
the processing plant and the slaughterhouse or establishment;  
(iii) measures must be taken to prevent the spreading of risks through the 
operation of personnel which is employed in the processing plan t 
and in the slaughterhouse or other establishment;  
(iv) unauthorised persons and animals must not have access to t he 
processing plant.  
By way of derogation from points (i) to (iv), in the case of pr ocessing 
plants processing Category 3 material, the competent authority may 
authorise other conditions instead of those set out in those po ints, 
aimed at mitigating the risks to public and animal health, incl uding the 
risks arising from the processing of Category 3 material, which  originates 
from off-site establishments approved or registered in accordan ce with 
Regulation (EC) No 852/2004 or Regulation (EC) No 853/2004.  
Member States shall inform the Commission and the other Member States 
in the framework of the Standing Committee on the Food Chain an d 
Animal Health referred to in Article 52(1) of Regulation (EC) 
No 1069/2009 of the use made of this derogation by their compet ent 
authorities;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 42
 
(b) The processing plant must have a clean and unclean sector, adequately 
separated. The unclean sector must have a covered place to rece ive 
animal by-products and must be constructed in such a way that i t is 
easy to clean and disinfect. Floors must be laid in such a way as to 
facilitate the draining of liquids;  
(c) The processing plant must have adequate facilities includin g lavatories, 
changing rooms and washbasins for staff;  
(d) The processing plant must have sufficient production capaci ty for hot 
water and steam for the processing of animal by-products;  
(e) The unclean sector must, if appropriate, contain equipment to reduce the 
size of animal by-products and equipment for loading the crushe d animal 
by-products into the processing unit;  
(f) Where heat treatment is required, all installations must be  equipped with:  
(i) measuring equipment to monitor temperature against time and , if 
applicable for the processing method used, pressure at critical  points;  
(ii) recording devices to record continuously the results of th ese 
measurements in a way so that they remain accessible for the 
purpose of checks and official controls;  
(iii) an adequate safety system to prevent insufficient heating ; 
(g) To prevent recontamination of the derived product by the in troduction of 
animal by-products, there must be a clear separation between th e area of 
the plant where incoming material for processing is unloaded an d the 
areas set aside for the processing of that product and the stor age of the 
derived product.  
2. The processing plant must have adequate facilities for clean ing and disin­
fecting the containers or receptacles in which animal by-produc ts are received 
and the means of transport, other than ships, in which they are  transported.  
3. Adequate facilities must be provided for the disinfecting of  vehicle wheels 
and the other parts of the vehicle, as appropriate, on leaving the unclean 
sector of the processing plant.  
4. All processing plants must have a waste-water disposal syste m meeting the 
requirements set out by the competent authority in accordance w ith Union 
legislation.  
5. The processing plant must have its own laboratory or make us e of the 
services of an external laboratory. The laboratory must be equi pped to 
carry out necessary analyses and be approved by the competent a uthority 
on the basis of an assessment of the capacity of the laboratory  to carry out 
those analyses, be accredited according to internationally reco gnised 
standards or be subject to regular controls by the competent au thority, to 
assess the capacity of the laboratory to carry out those analys es. ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 43
 
6. If on the basis of a risk assessment, the volume of products  treated requires 
the regular or permanent presence of the competent authority, t he processing 
plants must have an adequately equipped lockable room for the e xclusive use 
of the inspection service.  
Section 2  
Wastewater treatment  
1. Processing plants processing Category 1 material and other p remises where 
specified risk material is removed, slaughterhouses and process ing plants 
processing Category 2 material shall have a pre-treatment proce ss for the 
retention and collection of animal material as an initial step in the 
treatment of wastewater.  
The equipment used in the pre-treatment process shall consist o f drain traps 
or screens with apertures with a filter pore or a mesh size of no more than 
6 mm in the downstream end of the process or equivalent systems  that ensure 
that the solid particles in the wastewater passing through them  are no more 
than 6 mm.  
2. Wastewater from the premises as referred to in point 1 must enter 
a pre-treatment process which shall ensure that all wastewater has been 
filtered through the process before being drained off the premi ses. 
No grinding, maceration or any other processing or application of pressure 
shall be carried out which could facilitate the passage of soli d animal material 
through the pre-treatment process.  
3. All animal material retained in the pre-treatment process in  premises as 
referred to in point 1 shall be collected and transported as Ca tegory 1 or 
Category 2 material, as appropriate, and disposed of in accorda nce with 
Regulation (EC) No 1069/2009.  
4. Wastewater having passed the pre-treatment process in premis es referred to in 
point 1 and wastewater from other premises handling or processi ng animal 
by-products shall be treated in accordance with Union legislati on, without 
restrictions in accordance with this Regulation.  
5. In addition to the requirements laid down in point 4, the co mpetent authority 
may oblige operators to treat wastewater originating in the unc lean sector of 
processing plants and in plants or establishments carrying out intermediate 
operations with Category 1 material or Category 2 material or s toring 
Category 1 material or Category 2 material, in accordance with conditions 
which ensure that risks from pathogens are mitigated.  
6. Without prejudice to points 1 to 5, the disposal of animal b y-products, 
including blood and milk, or derived products through the waste water 
stream shall be prohibited.  
However, Category 3 material comprising of centrifuge or separa tor sludge 
may be disposed of through the wastewater stream, provided that  it has been 
subject to one of the treatments for centrifuge or separator sl udge set out in 
Part III of Section 4 of Chapter II of Annex X hereto.  
Section 3  
Specific requirements for the processing of Category 1 and Category 2 
materials  
The layout of processing plants processing Category 1 and Categ ory 2 materials 
must ensure the total separation of Category 1 material from Ca tegory 2 material 
from reception of the raw material until dispatch of the result ing derived product, 
unless a mixture of Category 1 material and Category 2 material  is processed as 
Category 1 material.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 44
 
Section 4  
Specific requirements for the processing of Category 3 materials  
The following requirements shall apply in addition to the gener al conditions set 
out in Section 1:  
1. Processing plants processing Category 3 materials shall not be located at the 
same site as processing plants processing Category 1 or Categor y 2 materials, 
unless located in a completely separate building.  
2. However, the competent authority may authorise the processin g of Category 3 
material on a site where handling or processing of Category 1 o r Category 2 
material takes place, if cross-contamination is prevented due t o: 
(a) the layout of the premises, in particular the arrangements for the 
reception, and by way of the further handling of raw materials;  
(b) the layout and the management of the equipment used for pro cessing, 
including the layout and the management of separate processing lines 
or of cleaning procedures which are excluding the propagation o f any 
possible risks to public and animal health; and  
(c) the layout and the management of the areas for the temporar y storage of 
the end products.  
3. Processing plants processing Category 3 material shall have in place an instal­
lation to check the presence of foreign bodies, such as packagi ng material or 
metallic pieces, in the animal by-products or derived products,  if they are 
processing materials which are destined for feeding. Such forei gn bodies 
shall be removed before or during processing.  
CHAPTER II  
HYGIENE AND PROCESSING REQUIREMENTS  
Section 1  
General hygiene requirements  
In addition to the general hygiene requirements provided for in  Article 25 of 
Regulation (EC) No 1069/2009, processing plants shall have a do cumented pest 
control programme in place for the implementation of the arrang ements for 
protection against pests, such as insects, rodents and birds, r eferred to in 
Article 25(1)(c) of that Regulation.  
Section 2  
General processing requirements  
1. Accurately calibrated gauges/recorders must be used to monit or continuously 
the processing conditions. Records must be kept to show the dat e of cali­
bration of gauges/recorders.  
2. Material that may not have received the specified heat treat ment, such as 
material discharged at start up or leakage from cookers, must b e recirculated 
through the heat treatment or collected and reprocessed or disp osed of in 
accordance with Regulation (EC) No 1069/2009.  
Section 3  
Processing methods for Category 1 and Category 2 material  
Unless the competent authority requires the application of pres sure sterilisation 
(method 1), Category 1 and Category 2 material shall be process ed in accordance 
with processing methods 2, 3, 4 or 5 as referred to in Chapter III. ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 45
 
Section 4  
Processing of Category 3 material  
1. The critical control points that determine the extent of the  heat treatments 
applied in processing shall include for each processing method as specified in 
Chapter III:  
(a) raw material particle size;  
(b) temperature achieved in the heat treatment process;  
(c) pressure, if applied to the raw material;  
(d) duration of the heat treatment process or feed rate to a co ntinuous system. 
Minimum processing standards must be specified for each applica ble 
critical control point.  
2. In the case of chemical treatments which have been authorise d by the 
competent authority as processing method 7 in accordance with p oint G of 
Chapter III, the critical control points that determine the ext ent of the chemical 
treatments applied shall include the pH adjustment achieved.  
3. Records shall be maintained for at least two years to show t hat the minimum 
process values for each critical control point are applied.  
4. Category 3 material shall be processed in accordance with an y of the 
processing methods 1 to 5 or processing method 7, or, in the ca se of 
material originating from aquatic animals, with any of the proc essing 
methods 1 to 7, as referred to in Chapter III.  
CHAPTER III  
STANDARD PROCESSING METHODS  
A. Processing method 1 (pressure sterilisation)  
Reduction  
1. If the particle size of the animal by-products to be process ed is more 
than 50 millimetres, the animal by-products must be reduced in size 
using appropriate equipment, set so that the particle size afte r 
reduction is no greater than 50 millimetres. The effectiveness of the 
equipment must be checked daily and its condition recorded. If checks 
disclose the existence of particles larger than 50 millimetres,  the process 
must be stopped and repairs made before the process is resumed.  
Time, temperature and pressure  
2. The animal by-products with the particle size of no greater than 50 
millimetres must be heated to a core temperature of more than 1 33 °C 
for at least 20 minutes without interruption at a pressure (abs olute) of at 
least 3 bars. The pressure must be produced by the evacuation o f all air 
in the sterilisation chamber and the replacement of the air by steam 
(‘saturated steam’); the heat treatment may be applied as the s ole 
process or as a pre- or post-process sterilisation phase.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 46
 
3. The processing may be carried out in batch or continuous sys tems.  
B. Processing method 2  
Reduction  
1. If the particle size of the animal by-products to be process ed is more 
than 150 millimetres, the animal by-products must be reduced in  size 
using appropriate equipment, set so that the particle size afte r reduction 
is no greater than 150 millimetres. The effectiveness of the eq uipment 
must be checked daily and its condition recorded. If checks dis close the 
existence of particles larger than 150 millimetres, the process  must be 
stopped and repairs made before the process is resumed.  
Time, temperature and pressure  
2. After reduction the animal by-products must be heated in a m anner 
which ensures that a core temperature greater than 100 °C is ac hieved 
for at least 125 minutes, a core temperature greater than 110 ° C is 
achieved for at least 120 minutes and a core temperature greate r that 
120 °C is achieved for at least 50 minutes.  
The core temperatures may be achieved consecutively or through a 
coincidental combination of the time periods indicated.  
3. The processing must be carried out in a batch system.  
C. Processing method 3  
Reduction  
1. If the particle size of the animal by-products to be process ed is more 
than 30 millimetres, the animal by-products must be reduced in size 
using appropriate equipment, set so that the particle size afte r 
reduction is no greater than 30 millimetres. The effectiveness of the 
equipment must be checked daily and its condition recorded. If checks 
disclose the existence of particles larger than 30 millimetres,  the process 
must be stopped and repairs made before the process is resumed.  
Time, temperature and pressure  
2. After reduction the animal by-products must be heated in a m anner 
which ensures that a core temperature greater than 100 °C is ac hieved 
for at least 95 minutes, a core temperature greater than 110 °C  is 
achieved for at least 55 minutes and a core temperature greater  that 
120 °C is achieved for at least 13 minutes.  
The core temperatures may be achieved consecutively or through a 
coincidental combination of the time periods indicated.  
3. The processing may be carried out in batch or continuous sys tems.  
D. Processing method 4  
Reduction  
1. If the particle size of the animal by-products to be process ed is more 
than 30 millimetres, the animal by-products must be reduced in size 
using appropriate equipment, set so that the particle size afte r 
reduction is no greater than 30 millimetres. The effectiveness of the 
equipment must be checked daily and its condition recorded. If checks 
disclose the existence of particles larger than 30 millimetres,  the process 
must be stopped and repairs made before the process is resumed.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 47
 
Time, temperature and pressure  
2. After reduction the animal by-products must be placed in a v essel with 
added fat and heated in a manner which ensures that a core temp erature 
greater than 100 °C is achieved for at least 16 minutes, a core  
temperature greater than 110 °C is achieved for at least 13 min utes, a 
core temperature greater than 120 °C is achieved for at least e ight 
minutes and a core temperature greater that 130 °C is achieved for at 
least three minutes.  
The core temperatures may be achieved consecutively or through a 
coincidental combination of the time periods indicated.  
3. The processing may be carried out in batch or continuous sys tems.  
E. Processing method 5  
Reduction  
1. If the particle size of the animal by-products to be process ed is more 
than 20 millimetres, the animal by-products must be reduced in size 
using appropriate equipment, set so that the particle size afte r 
reduction is no greater than 20 millimetres. The effectiveness of the 
equipment must be checked daily and its condition recorded. If checks 
disclose the existence of particles larger than 20 millimetres,  the process 
must be stopped and repairs made before the process is resumed.  
Time, temperature and pressure  
2. After reduction the animal by-products must be heated until they 
coagulate and then pressed so that fat and water are removed fr om the 
proteinaceous material. The proteinaceous material must then be  heated 
in a manner which ensures that a core temperature greater than 80 °C is 
achieved for at least 120 minutes and a core temperature greate r that 
100 °C is achieved for at least 60 minutes.  
The core temperatures may be achieved consecutively or through a 
coincidental combination of the time periods indicated.  
3. The processing may be carried out in batch or continuous sys tems.  
F. Processing method 6 (for Category 3 animal by-products origi nating from 
aquatic animal or aquatic invertebrates only)  
Reduction  
1. The animal by-products must be reduced to a particle size wh ich is no 
greater than:  
(a) 50 mm, in case of heat treatment in accordance with point 2 (a); or  
(b) 30 mm, in case of heat treatment in accordance with point 2 (b). 
They must then be mixed with formic acid to reduce and maintain  the 
pH to 4,0 or lower. The mixture must be stored for at least 24 hours 
pending further treatment.  
Time, temperature and pressure  
2. After reduction, the mixture must be heated to:  
(a) a core temperature of at least 90 °C for at least 60 minute s; or ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 48
 
(b) a core temperature of at least 70 °C for at least 60 minute s. 
When using a continuous flow system, the progression of the pro duct 
through the heat converter must be controlled by means of mecha nical 
commands limiting its displacement in such way that at the end of the 
heat treatment operation the product has undergone a cycle whic h is 
sufficient in both time and temperature.  
3. The processing may be carried out in batch or continuous sys tems.  
G. Processing method 7  
1. Any processing method authorised by the competent authority where the 
following have been demonstrated by the operator to that author ity: 
(a) the identification of relevant hazards in the starting mate rial, in view 
of the origin of the material, and of the potential risks in vi ew of the 
animal health status of the Member State or the area or zone wh ere 
the method is to be used;  
(b) the capacity of the processing method to reduce those hazar ds to a 
level which does not pose any significant risks to public and a nimal 
health;  
(c) the sampling of the final product on a daily basis over a p eriod of 30 
production days in compliance with the following microbiologica l 
standards:  
(i) Samples of material taken directly after the treatment:  
Clostridium perfringens  absent in 1 g of the products  
(ii) Samples of material taken during or upon withdrawal from 
storage:  
Salmonella: absence in 25g: n = 5, c = 0, m = 0, M = 0  
Enterobacteriaceae: n = 5, c = 2; m = 10; M = 300 in 1 g  
where:  
n = number of samples to be tested;  
m = threshold value for the number of bacteria; the result is 
considered satisfactory if the number of bacteria in all 
samples does not exceed m;  
M = maximum value for the number of bacteria; the result is 
considered unsatisfactory if the number of bacteria in one 
or more samples is M or more; and  
c = number of samples the bacterial count of which may be 
between m and M, the samples still being considered 
acceptable if the bacterial count of the other samples is 
m or less.  
2. Details of the critical control points under which each proc essing plant 
satisfactorily complies with the microbiological standards must  be 
recorded and maintained so that the operator and the competent 
authority can monitor the operation of the processing plant. Th e 
information to be recorded and monitored must include the parti cle 
size, and, as appropriate, the critical temperature, the absolu te time, 
pressure profile, raw material feed rate and fat recycling rate . ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 49
 
3. By way of derogation from point 1, the competent authority m ay 
authorise the use of processing methods which have been approve d 
prior to the date of entry into application of this Regulation,  in 
accordance with Chapter III of Annex V to Regulation (EC) 
No 1774/2002.  
4. The competent authority shall permanently or temporarily sus pend the 
application of processing methods referred to in points 1 and 3 , if it 
obtains evidence that any of the circumstances specified in poi nt 1(a) or 
(b) have substantially changed.  
5. The competent authority shall inform the competent authority  of another 
Member State upon request about the information at its disposal  under 
points 1 and 2 in relation to an authorised processing method.  
CHAPTER IV  
ALTERNATIVE PROCESSING METHODS  
Section 1  
General provisions  
▼M1 
1. Materials resulting from the processing of Category 1 and 2 materials shall 
be permanently marked in accordance with the requirements for t he marking 
of certain derived products set out in Chapter V of Annex VIII.  
However, such marking shall not be required for the following m aterials 
referred to in Section 2:  
(a) biodiesel produced in accordance with point D;  
(b) hydrolysed materials referred to in point H;  
(c) mixtures of pig and poultry manure with quick lime produced  in 
accordance with point I;  
▼M13  
(d) renewable fuels produced from rendered fats, which are deri ved from 
Category 1 and Category 2 materials, in accordance with point J  and L.  
▼B 
2. The competent authority of a Member State shall make the res ults of official 
controls available to the competent authority of another Member  State upon 
request, when an alternative method is used for the first time in that Member 
State, in order to facilitate the introduction of the new alter native method.  
Section 2  
Processing standards  
A. Alkaline hydrolysis process  
1. Starting material  
For this process, animal by-products of all categories may be u sed. ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 50
 
2. Processing method  
Alkaline hydrolysis shall be carried out according to the follo wing 
processing standards:  
(a) Either a sodium hydroxide (NaOH) or potassium hydroxide (KO H) 
solution (or a combination thereof) must be used in an amount t hat 
assures approximate molar equivalency to the weight, type and 
composition of the animal by-products to be digested.  
In the case of high fat in the animal by-products that neutrali ses the 
base, the added base must be adjusted so that the molar equival ency 
referred to is achieved.  
(b) Animal by-products must be placed in a steel alloy containe r. The 
measured amount of alkali must be added either in solid form or  as a 
solution as referred to in point (a).  
(c) The container must be closed and the animal by-products and  alkali 
mixture must be heated to a core temperature of at least 150 °C  and 
at a pressure (absolute) of at least 4 bars for at least:  
(i) three hours without interruption;  
(ii) six hours without interruption in case of treatment of ani mal 
by-products referred to in Article 8(a)(i) and (ii) of 
Regulation (EC) No 1069/2009.  
However, materials derived from Category 1 materials 
comprising of animals killed in the context of TSE eradication 
measures which are either ruminants not requiring TSE testing 
or ruminants which have been tested with a negative result in 
accordance with Article 6(1) of Regulation (EC) No 999/2001 
may be processed in accordance with point 2(c)(i) of this 
Section; or  
(iii) one hour without interruption in the case of animal by-pr oducts 
consisting of fish or of poultry materials.  
(d) The process must be carried out in a batch system and the m aterial 
in the vessel must be constantly mixed in order to facilitate t he 
digestion process until the tissues are dissolved and bones and  
teeth are softened; and  
(e) The animal by-products must be treated in such way that the  
requirements regarding time, temperature and pressure are 
achieved at the same time.  
B. High pressure high temperature hydrolysis process  
1. Starting material  
For this process, Category 2 and Category 3 materials may be us ed. 
2. Processing method  
High pressure high temperature hydrolysis shall be carried out according 
to the following processing standards:  
(a) The animal by-products must be heated to a core temperature  of at 
least 180 °C for at least 40 minutes without interruption at a 
pressure (absolute) of at least 12 bar, heated by indirect stea m 
application to the biolytic reactor;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 51
 
(b) The process must be carried out in a batch and the material  in the 
vessel must be constantly mixed; and  
(c) The animal by-products must be treated in such a manner tha t the 
requirements regarding time, temperature and pressure are achie ved 
at the same time.  
C. High pressure hydrolysis biogas process  
1. Starting material  
For this process, animal by-products of all categories may be u sed. 
2. Processing method  
The high pressure hydrolysis biogas process shall be carried ou t 
according to the following processing standards:  
(a) The animal by-products must be first processed using proces sing 
method 1 (pressure sterilisation) as set out in Chapter III in an 
approved processing plant;  
(b) Following the process referred to in point (a), the defatte d materials 
must be treated at a temperature of at least 220 °C for at leas t 20 
minutes at a pressure (absolute) of at least 25 bar, heated in 
a two-step procedure, first by direct steam injection, secondly  
indirect in a coaxial heat exchanger;  
(c) The process must be carried out in a batch or continuous sy stem and 
the material is constantly mixed;  
(d) The animal by-products must be treated in such a manner tha t the 
requirements regarding time, temperature and pressure are achie ved 
at the same time;  
(e) The resulting material must then be mixed with water and 
anaerobically fermented (biogas transformation) in a biogas rea ctor; 
(f) In the case of starting material of Category 1, the entire process 
must take place on the same site and in a closed system and the  
biogas produced during the process must be combusted rapidly in  
the same plant at a minimum of 900 °C followed by rapid chillin g 
(‘quenching’).  
D. Biodiesel production process  
1. Starting material  
For this process, a fat fraction derived from animal by-product s of all 
categories may be used.  
2. Processing method  
Biodiesel production shall be carried out according to the foll owing 
processing standards:  
(a) Unless fish oil or rendered fat are used which have been pr oduced in 
accordance with Sections VIII or XII of Annex III to 
Regulation (EC) No 853/2004, respectively, the fat fraction 
derived from animal by-products must be first processed using:  
(i) in the case of Category 1 or 2 materials, processing method  1  
(pressure sterilisation) as set out in Chapter III; and  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 52
 
(ii) in the case of Category 3 materials, any of the processing  
methods 1 to 5 or processing method 7 or, in the case of 
material derived from fish, processing methods 1 to 7 as set 
out in Chapter III;  
(b) The processed fat must then be processed further using one of the 
following methods:  
(i) a process whereby the processed fat must be separated from the 
protein and in the case of fat from ruminant origin, insoluble 
impurities in excess of 0,15 % by weight must be removed, and 
the processed fat must be subsequently submitted to esterficati on 
and transesterfication.  
However, esterfication is not required for processed fat derive d 
from Category 3 material. For esterfication the pH must be 
reduced to less than 1 by adding sulphuric acid (H  2 SO 4 ) or an 
equivalent acid and the mixture must be heated to 72 °C for at 
least two hours during which it must be intensely mixed.  
Transesterfication must be carried out by increasing the pH to 
about 14 with potassium hydroxide or with an equivalent base at  
35 °C to 50 °C for at least 15 minutes. Transesterfication shal l 
be carried out twice under the conditions described in this poi nt 
using a new base solution. This process must be followed by 
refinement of the products including vacuum distillation at 
150 °C, leading to biodiesel;  
(ii) a process using equivalent process parameters authorised b y the 
competent authority.  
E. Brookes’ gasification process  
1. Starting material  
For this process, Category 2 and Category 3 material may be use d. 
2. Processing method  
Brookes’ gasification shall be carried out according to the fol lowing 
processing standards:  
(a) The afterburner chamber must be warmed up using natural gas ; 
(b) The animal by-products must be loaded into the primary cham ber of 
the gasificator and the door must be closed. The primary chambe r 
must have no burners and must be heated instead by the transfer  of 
heat by conduction from the afterburner, which must be undernea th 
the primary chamber. The only air admitted to the primary chamb er 
must be via three inlet valves mounted on the main door to enha nce 
the efficiency of the process;  
(c) The animal by-products must be volatilised into complex hyd ro­
carbons and the resultant gases must pass from the primary 
chamber via a narrow opening at the top of the back wall to the  
mixing and cracking zones, where they must be broken down into 
their constituent elements. Finally the gases must pass into th e after­
burner chamber where they must be burned in the flame of a natu ral 
gas fired burner in the presence of excess air;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 53
 
(d) Each process unit must have two burners and two secondary a ir fans 
for back-up in case of burner or fan failure. The secondary cha mber 
must be designed to give a minimum residence time of two second s 
at a temperature of at least 850 °C under all conditions of 
combustion;  
▼B 
(e) On leaving the secondary chamber the exhaust gases must pas s 
through a barometric damper at the base of the stack, which coo ls 
and dilutes them with ambient air, maintaining a constant press ure in 
the primary and secondary chambers;  
(f) The process must be carried out over a 24-hour cycle, which  
includes loading, processing, cool down and ash removal. At the  
end of the cycle the residual ash must be removed from the prim ary 
chamber by a vacuum extraction system into enclosed bags and 
sealed before transporting;  
(g) The gasification of material other than animal by-products must not 
be permitted.  
F. Combustion of animal fat in a thermal boiler process  
1. Starting material  
For this process, a fat fraction derived from animal by-product s of all 
categories may be used.  
2. Processing method  
Combustion of animal fat in a thermal boiler shall be carried o ut 
according to the following processing standards:  
(a) Unless fish oil or rendered fat are used which has been pro duced in 
accordance with Sections VIII or XII of Annex III to 
Regulation (EC) No 853/2004, respectively, the fat fraction 
derived from animal by-products must first be processed using:  
(i) in the case of fat fraction of Category 1 and 2 materials w hich is 
intended to be combusted in another plant,  
— for the fat fraction from the processing of ruminants which 
have been tested with a negative result in accordance with 
Article 6(1) of Regulation (EC) No 999/2001 and from the 
processing of animals, other than ruminants which require 
TSE testing, any of the processing methods 1 to 5 as set out 
in Chapter III of this Annex.  
— for the fat fraction from the processing of other ruminants, 
processing method 1 as referred in Chapter III; and  
(ii) in the case of Category 1 and 2 materials intended for 
combustion within the same plant and in the case of Category 
3 material, any of the processing methods 1 to 5 or processing 
method 7; in the case the materials are derived from fish, 
processing methods 1 to 7 as set out in Chapter III;  
(b) The fat fraction must be separated from the protein and in the case 
of fat from ruminant origin which is intended to be combusted i n 
another plant, insoluble impurities in excess of 0,15 % by weig ht 
must be removed;  ▼M23  02011R0142 — EN — 01.01.2021 — 021.001 — 54
 
(c) Following the process referred to in points (a) and (b), th e fat must be:  
(i) vaporised in a steam-raising boiler and combusted at a 
temperature of at least 1100 °C for at least 0,2 seconds; or  
(ii) processed using equivalent process parameters authorised b y the 
competent authority;  
(d) The combustion of material of animal origin other than anim al fat 
must not be permitted;  
(e) The combustion of the fat derived from Category 1 and Categ ory 2 
materials shall take place in the same plant where the fat is r endered 
with the aim of utilising the energy generated for the renderin g 
processes. However, the competent authority may authorise the 
movement of that fat to other plants for combustion provided th at: 
(i) the plant of destination is authorised for the combustion;  
(ii) the processing of food or feed in an approved plant on the  same 
premises takes place under strict conditions of separation;  
(f) The combustion must be carried out in accordance with Union  legis­
lation for the protection of the environment, in particular, wi th 
reference to the standards of that legislation regarding best 
available techniques for the control and monitoring of emission s. 
G. Thermomechanical biofuel production process  
1. Starting material  
For this process, manure and digestive tract content and Catego ry 3 
material may be used.  
2. Processing method  
Thermomechanical biofuel production shall be carried out accord ing to 
the following processing standards:  
(a) The animal by-products must be loaded into a converter and 
subsequently treated at a temperature of 80 °C for a period of 
eight hours. During this period, the material must be constantl y 
reduced in size using appropriate mechanical abrasion equipment . 
(b) The material must be subsequently treated at a temperature of 
100 °C for at least two hours.  
(c) The particle size of the resulting material must not be lar ger than 20 
millimetres;  
(d) The animal by-products must be treated in such a manner tha t the 
requirements regarding time, temperature and pressure set out i n 
points (a) and (b) are achieved at the same time;  
(e) During the heat treatment of the material, evaporated water  must be 
continually extracted from the air-space above the biofuel and must 
be passed through a stainless steel condenser. The condensate m ust 
be kept at a temperature of at least 70 °C for at least one hou r before 
being discharged as wastewater;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 55
 
(f) After the heat treatment of the material, the resulting bio fuel from 
the converter must then be discharged and automatically conveye d 
by a fully covered and interlocked conveyor to incineration or 
co-incineration on the same site;  
(g) The process must be carried out in a batch mode.  
▼M9 __________  
▼M1 
I. Lime treatment for pig and poultry manure  
1. Starting materials  
For this process, manure, as referred to in Article 9(a) of 
Regulation (EC) No 1069/2009, of pig and poultry origin may be used.  
2. Processing method  
(a) The dry matter content of the manure must be determined by using 
the CEN EN 12880:2000 (  1 ) method ‘Characterization of sludges. 
Determination of dry residue and water content’.  
For this process, the dry matter content must be between 15 % a nd 
70 %.  
(b) The amount of lime which has to be added must be determined  in 
such way that one of the combinations of time and temperature s et 
out in point (f) is achieved.  
(c) The particle size of the animal by-products to be processed  must be 
no greater than 12 mm.  
If necessary, the particles of the manure must be reduced in si ze in 
such a way that that maximum particle size is achieved.  
(d) The manure must be mixed with quick lime (CaO) which has a 
medium to high reactivity of less than six minutes to achieve a  
40 °C rise in temperature as per the criteria in the reactivity  test 
5.10 in the CEN EN 459-2:2002 method (  2 ). 
The mixing must be carried out with two mixers which are operat ing 
in line, with two screws per mixer.  
Both mixers must:  
(i) have a screw diameter of 0,55 m and a screw length of 3,5 m ; 
(ii) operate with a power of 30 kW and a rotation speed of the 
screw of 156 rpm;  
(iii) have a treatment capacity of 10 tonnes per hour.  
The mean blending duration must be approximately two minutes.  
(e) The mixture must be mixed for a period of at least six hour s into a 
stockpile with a minimum size of two tonnes.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 56  
( 1 ) BS EN 12880:2000, Characterization of sludges. Determination of dry residue and water 
content. European Committee for Standardisation, 
( 2 ) CEN EN 459-2:2002 method CEN/TC 51 - Cement and building lime s. European 
Committee for Standardisation,
 (f) At monitoring points which must be introduced into the stoc kpile, 
continuous measurements must be carried out to demonstrate that  the 
mixture in the stockpile reaches a pH of at least 12 during one  of the 
following periods of time, during which period one of the corre ­
sponding following temperatures must be achieved:  
(i) 60 °C for 60 minutes; or  
(ii) 70 °C for 30 minutes.  
(g) The process must be carried out in a batch mode.  
(h) A permanent written procedure based on the HACCP principles  
must be put in place.  
(i) Operators may demonstrate to the competent authority, by wa y of a 
validation according to the following requirements, that a proc ess 
using a mixing device which is different from the mixing device  
referred to in point (d) or using dolime (CaOMgO) instead of qu ick 
lime is at least as efficient as the process set out in points (a) to (h):  
That validation must:  
— demonstrate that by using the different mixing device to that  
referred to in point (d) or the dolime, as applicable, a mixtur e 
with manure can be produced which achieves the parameters for 
pH, time and temperature referred to in point (f);  
— be based on monitoring of time and temperature at the base, t he 
middle and at the top of the stockpile, with a representative 
number of monitoring points (at least four monitoring points 
in the basal zone, which are located at a maximum of 10 cm 
above the base and at a maximum of 10 cm below the top, one 
monitoring point in the middle half way between base and the 
top of stockpile, and four monitoring points in the marginal zo ne 
at the top of the pile, which are located at a maximum of 10 cm  
below the surface and at a maximum of 10 cm below the top of 
the stockpile);  
— be carried out during two periods of at least 30 days, of whi ch 
one must be in the cold season of the year at the geographical 
place where the mixing device is to be used.  
J. Multi-step catalytic process for the production of renewable  fuels  
1. Starting materials  
(a) For this process, the following materials may be used:  
(i) rendered fats derived from Category 2 material, which have 
been processed using processing method 1 (pressure sterili­
sation);  
(ii) fish oil or rendered fats derived from Category 3 material , 
which have been processed using:  
— any of the processing methods 1 to 5 or processing method 
7; or  
— in the case of material derived from fish oil, any of the 
processing methods 1 to 7;  
(iii) fish oil or rendered fat which have been produced in 
accordance with Sections VIII or XII of Annex III to 
Regulation (EC) No 853/2004, respectively.  ▼M1 02011R0142 — EN — 01.01.2021 — 021.001 — 57
 
(b) The use of rendered fats derived from Category 1 material f or this 
process shall be prohibited.  
2. Processing method  
(a) The rendered fat must be submitted to a pre-treatment which  consists 
of: 
(i) the bleaching of the centrifuged materials by passing them 
through a clay filter;  
(ii) the removal of remaining insoluble impurities by filtratio n. 
(b) The pre-treated materials must be submitted to a multi-step  catalytic 
process which consists of a hydro-deoxygenisation step, followe d by 
an isomerisation step.  
The materials must be submitted to a pressure of at least 20 ba rs at a 
temperature of at least 250 °C for at least 20 minutes.  
▼M9 
K. Ensilage of fish material  
1. Starting materials  
For this process, only the following by-products obtained from 
aquatic animals may be used:  
(a) Category 2 materials referred to in Article 9(f)(i) and (ii i) of 
Regulation (EC) No 1069/2009;  
(b) Category 3 materials.  
2. Processing method  
2.1. The materials to be treated shall be collected at aquacult ure farms 
and food processing establishments on a daily basis and without  
undue delays, ground or chopped, and thereafter subjected to 
ensiling at a pH of 4 or below, with formic acid or other organ ic 
acid authorised in accordance with the feed legislation. The 
resulting fish silage must be a suspension of parts of aquatic 
animals liquefied by the action of endogenous enzymes in the 
presence of the added acid. The proteins of aquatic animals mus t 
be reduced into smaller soluble units, by the enzymes and the a cid, 
in order to prevent microbial spoilage. The ensiled material is  trans­
ported to the processing plant.  
2.2. At the processing plant the ensiled material of aquatic an imals must 
be piped into closed storage tanks. The incubation time must be  at 
least 24 hours at a pH of 4 or below before heat treatment can be 
conducted. Before the heat treatment the ensilage of aquatic an imals 
must have a pH of 4 or below and have a particle size of less t han 
10 mm following a filtration or maceration at the plant. During  
processing it must be subjected to preheating to a temperature 
above 85 °C, followed by incubation in an insulated container t o 
obtain 85 °C throughout the fish material for 25 minutes. The 
process must take place in a closed production line with tanks 
and pipelines.  
2.3. Before authorisation is given, the operator's permanent wr itten 
procedure referred to in Article 29(1) to (3) of Regulation (EC ) 
No 1069/2009 must be assessed by the competent authority.  ▼M1 02011R0142 — EN — 01.01.2021 — 021.001 — 58
 
L. Multiple-step catalytic hydro-treatment for the production o f renewable 
fuels  
1. Starting materials  
For this process, the following materials may be used:  
(a) rendered fats derived from Category 1 material, which have been 
processed using processing method 1 (pressure sterilisation);  
(b) rendered fats and fish oil complying with point J(1)(a) of this 
Section.  
2. Processing method  
(a) The rendered fat must be submitted to a pre-treatment which  
consists at least of bleaching of the starting material, includ ing 
rendered fats, with acid in the presence of bleaching clay and 
subsequent removal of the used bleaching clay and insoluble 
impurities by filtration.  
Prior to this treatment rendered fat may be degummed with acid 
and/or caustic solution in order to remove impurities from the 
rendered fat by forming gums and subsequently separating those 
gums by centrifugation.  
(b) The pre-treated materials must be submitted to a hydro-trea tment 
process which consists of a catalytic hydro-treatment step, a 
stripping step followed by an isomerisation step.  
The materials must be submitted to a pressure of at least 30 ba rs at 
a temperature of at least 265 °C for at least 20 minutes.  
▼B 
Section 3  
Disposal and use of derived products  
1. Products derived from the processing of:  
(a) Category 1 material shall be:  
(i) disposed of in accordance with Article 12(a) or (b) of 
Regulation (EC) No 1069/2009;  
(ii) disposed of by burial in an authorised landfill;  
▼M4 
(iii) transformed into biogas. In such case the digestion resid ues must 
be disposed of in accordance with point (i) or (ii), except whe re 
the material results from processing in accordance with point 2 (a) 
or (b) where the residues can be used in accordance with the 
conditions set out in point 2(a) or point 2(b)(iii) as appropri ate; or  
▼B 
(iv) further processed into fat derivatives for uses other than  feeding.  
(b) Category 2 or Category 3 material shall be:  
▼M4 
(i) disposed of as provided for in point 1(a)(i) or (ii), with or without 
prior processing as provided for in Article 13(a) and (b) and 
Article 14(a) and (b) of Regulation (EC) No 1069/2009;  
▼B 
(ii) further processed into fat derivatives for uses other than  feeding;  ▼M13  02011R0142 — EN — 01.01.2021 — 021.001 — 59
 
(iii) used as an organic fertiliser or soil improver; or  
(iv) composted or transformed into biogas.  
2. Materials resulting from processing in accordance with:  
(a) the alkaline hydrolysis process defined in point A of Secti on 2 may be 
transformed in a biogas plant and subsequently combusted rapidl y at a 
minimum of 900°C, followed by rapid chilling (‘quenching’); whe re 
material referred to in Article 8(a) and (b) of Regulation (EC)  
No 1069/2009 has been used as starting material, the transforma tion 
into biogas shall take place on the same site as the processing  and in a 
closed system;  
(b) the biodiesel production process may be:  
(i) in the case of biodiesel and of residues from the distillat ion of 
biodiesel, used as a fuel without restrictions under this Regul ation 
(end point);  
▼M4 
(ii) in the case of potassium sulphate, used for direct applica tion to 
land or for the production of derived products for application to 
land;  
(iii) in the case of glycerine derived from Categories 1 and 2 material 
which has been processed in accordance with processing method 1  
as set out in Chapter III:  
— used for technical purposes,  
— transformed into biogas, in which case the digestion residues  
may be applied to land within the national territory of the 
producing Member State, subject to the decision of the 
competent authority, or  
— used for denitrification in a waste water treatment plant, in  
which case the residues of the denitrification may be applied 
to land in accordance with Council Directive 91/271/EEC (  1 ); 
(iv) in the case of glycerine derived from Category 3 material:  
— used for technical purposes,  
— transformed into biogas, in which case the digestion residues  
may be applied to land, or  
— used for feeding, provided that the glycerine is not derived 
from Category 3 material referred to in Article 10(n), (o) 
and (p) of Regulation (EC) No 1069/2009;  
▼M1 
(c) the multi-step catalytic process for the production of rene wable fuels 
may be:  
(i) in the case of gasoline and the other fuels resulting from the 
process, used as a fuel without restrictions under this Regulat ion 
(end point);  
(ii) in the case of used clay from bleaching and sludge from th e 
pre-treatment process referred to in point J(2)(a) of Section 2 : 
— disposed of by incineration or co-incineration,  
— transformed into biogas,  
— composted or used for the manufacture of derived products 
referred to in Article 36(a)(i) of Regulation (EC) No 1069/2009 ; ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 60  
( 1 ) OJ L 135, 30.5.1991, p. 40.
 (d) the lime-treated mixture of pig and poultry manure may be a pplied to 
land as processed manure;  
(e) The final product derived from the ensilaging of fish mater ial may:  
(i) for Category 2 materials, be used for purposes referred 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 Regulati on; or  
(ii) for Category 3 materials, be used for purposes referred to  in 
Article 14 of Regulation (EC) No 1069/2009;  
▼M13  
(f) the multiple-step catalytic hydro-treatment for the product ion of 
renewable fuels may be:  
(i) in the case of renewable diesel, renewable jet fuel, renewa ble 
propane and renewable gasoline resulting from the process, used  
as a fuel without restrictions under this Regulation (end point ); 
(ii) in the case of gum sludge and used bleaching clay from the  
pre-treatment process referred to in point L(2)(a) of Section 2 : 
— disposed of in accordance with Article 12(a) or (b) of 
Regulation (EC) No 1069/2009,  
— disposed of by burial in an authorised landfill,  
— transformed into biogas, provided the digestion residues from  
the biogas transformation are disposed of by incineration, 
co-incineration or burial in an authorised landfill,  
— used for technical purposes referred to in Article 36(a)(i) o f 
Regulation (EC) No 1069/2009.  
▼M4 
3. Any waste other than animal by-products and derived products  provided for 
in point 2, resulting from the processing of animal by-products  in 
accordance with this Section, such as sludge, filter contents, ash and 
digestion residues, shall be disposed of in accordance with 
Regulation (EC) No 1069/2009 and with this Regulation.  ▼M9 02011R0142 — EN — 01.01.2021 — 021.001 — 61
 
ANNEX V  
TRANSFORMATION OF ANIMAL BY-PRODUCTS AND DERIVED 
PRODUCTS INTO BIOGAS, COMPOSTING  
CHAPTER I  
REQUIREMENTS APPLICABLE TO PLANTS  
Section 1  
Biogas plants  
1. A biogas plant must be equipped with a pasteurisation/hygien isation unit, 
which cannot be by-passed for the animal by-products or derived  products 
introduced with a maximum particle size of 12 mm before enterin g the unit, 
with:  
(a) installations for monitoring that the temperature of 70 °C is reached 
during the time of one hour;  
(b) recording devices to record continuously the results of the  monitoring 
measurements referred to in point (a); and  
(c) an adequate system to prevent insufficient heating.  
2. By way of derogation from point 1, a pasteurisation /hygieni sation unit shall 
not be mandatory for biogas plants that transform only:  
(a) Category 2 material that has been processed in accordance w ith 
processing method 1 as set out in Chapter III of Annex IV;  
(b) Category 3 material that has been processed in accordance w ith any of 
the processing methods 1 to 5 or processing method 7, or in the  case of 
material originating from aquatic animals, any of the processin g methods 
1 to 7, as set out in Chapter III of Annex IV;  
(c) Category 3 material that has undergone pasteurisation/hygie nisation in 
another approved plant;  
▼M4 
(d) animal by-products which may be applied to land without pro cessing in 
accordance with Article 13(f) of Regulation (EC) No 1069/2009 a nd with 
this Regulation, if the competent authority does not consider t hem to 
present a risk of spreading any serious transmissible disease t o humans 
or animals;  
▼B 
(e) animal by-products which have been subject to the alkaline hydrolysis 
process set out in point A of Section 2 of Chapter IV of Annex IV; 
(f) the following animal by-products, if authorised by the comp etent 
authority:  
(i) the animal by-products referred 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 at  the 
time when they are destined for purposes other than human 
consumption;  
(ii) the animal by-products referred to in Article 10(g) of 
Regulation (EC) No 1069/2009; or  
(iii) animal by-products which are transformed into biogas, whe re the 
digestion residues are subsequently composted or processed or 
disposed of in accordance with this Regulation.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 62
 
3. If the biogas plant is located on or next to premises where farmed animals are 
kept and the biogas plant does not only use manure, milk or col ostrum which 
accrues from those animals, the plant shall be located at a dis tance from the 
area where such animals are kept.  
That distance shall be determined in a manner which ensures tha t there is no 
unacceptable risk for the transmission of a disease communicabl e to humans 
or animals from the biogas plant.  
In all cases, there must be total physical separation between t hat biogas plant 
and the animals and their feed and bedding, with fencing where necessary.  
4. Each biogas plant must have its own laboratory or make use o f an external 
laboratory. The laboratory must be equipped to carry out necess ary analyses 
and be approved by the competent authority, be accredited accor ding to 
internationally recognised standards or be subject to regular c ontrols by the 
competent authority.  
Section 2  
Composting plants  
1. A composting plant must be equipped with a closed composting  reactor or 
closed area, which cannot be by-passed for the animal by-produc ts or derived 
products introduced into the plant, and it must be equipped wit h the 
following:  
(a) installations for monitoring temperature against time;  
(b) recording devices to record, where appropriate continuously , the results 
of the monitoring measurements referred to in point (a);  
(c) an adequate safety system to prevent insufficient heating.  
2. By way of derogation from point 1, other types of composting  systems may 
be allowed provided they:  
(a) are managed in such a way that all the material in the syst em achieves 
the required time and temperature parameters, including, where appro­
priate, continuous monitoring of the parameters; or  
(b) transform only materials referred to in point 2 of Section 1; and  
(c) comply with all other relevant requirements of this Regulat ion. 
3. If the composting plant is located on or next to premises wh ere farmed 
animals are kept and the composting plant does not only use man ure, milk 
or colostrum which accrues from those animals, the composting p lant shall be 
located at a distance from the area where animals are kept.  
That distance shall be determined in a manner which ensures tha t there is no 
unacceptable risk for the transmission of a disease communicabl e to humans 
or animals from the composting plant.  
In all cases, there must be total physical separation between t hat composting 
plant and the animals and their feed and bedding, with fencing where 
necessary.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 63
 
4. Each composting plant must have its own laboratory or make u se of an 
external laboratory. The laboratory must be equipped to carry o ut necessary 
analyses and be approved by the competent authority, be accredi ted according 
to internationally recognised standards or be subject to regula r controls by the 
competent authority.  
CHAPTER II  
HYGIENE REQUIREMENTS APPLICABLE TO BIOGAS AND 
COMPOSTING PLANTS  
1. Animal by-products must be transformed as soon as possible a fter arrival at 
the biogas or composting plant. They must be stored properly un til treated.  
2. Containers, receptacles and vehicles used for transporting u ntreated material 
must be cleaned and disinfected in a designated area.  
That area must be situated or designed so as to prevent risk of  contamination 
of treated products.  
3. Preventive measures against birds, rodents, insects or other  vermin must be 
taken systematically.  
A documented pest-control programme must be used for that purpo se. 
4. Cleaning procedures must be documented and established for a ll parts of the 
premises. Suitable equipment and cleaning agents must be provid ed for 
cleaning.  
5. Hygiene control must include regular inspections of the envi ronment and 
equipment. Inspection schedules and results must be documented.  
6. Installations and equipment must be kept in a good state of repair and 
measuring equipment must be calibrated at regular intervals.  
7. Digestion residues and compost must be handled and stored at  the biogas or 
composting plant in such way as to prevent recontamination.  
CHAPTER III  
TRANSFORMATION PARAMETERS  
Section 1  
Standard transformation parameters  
1. Category 3 material which is used as raw material in a bioga s plant equipped 
with a pasteurisation/hygienisation unit must be submitted to t he following 
minimum requirements:  
(a) maximum particle size before entering the unit: 12 mm;  
(b) minimum temperature in all material in the unit: 70 °C; and  
(c) minimum time in the unit without interruption: 60 minutes.  
However, Category 3 milk, milk-based products, milk-derived pro ducts, 
colostrum and colostrum products may be used without pasteurisa tion/­
hygienisation as raw material in a biogas plant, if the compete nt authority 
does not consider them to present a risk of spreading any serio us trans­
missible disease to humans or animals.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 64
 
The minimum requirements set out in points (b) and (c) of this point shall 
also apply to Category 2 material which is introduced into a bi ogas plant 
without prior processing in accordance with Article 13(e)(ii) o f 
Regulation (EC) No 1069/2009.  
2. Category 3 material which is used as raw material in a compo sting plant must 
be submitted to the following minimum requirements:  
(a) maximum particle size before entering the composting reacto r: 12 mm;  
(b) minimum temperature in all material in the reactor: 70 °C; and 
(c) minimum time without interruption: 60 minutes.  
The minimum requirements set out in points (b) and (c) of this point shall 
also apply to Category 2 material which is composted without pr ior 
processing in accordance with Article 13(e)(ii) of Regulation ( EC) 
No 1069/2009.  
Section 2  
Alternative transformation parameters for biogas and composting plant  
1. The competent authority may authorise the use of parameters other than the 
parameters set out in point 1 of Section 1 of Chapter I and oth er than the 
standard transformation parameters, provided that the applicant  for such use 
demonstrates that such parameters ensure adequate reduction of biological 
risks. That demonstration shall include a validation, which sha ll be carried 
out in accordance with the following requirements:  
(a) Identification and analysis of possible hazards, including the impact of 
input material, based on a full description of the transformati on 
conditions and parameters;  
(b) A risk assessment, which evaluates how the specific transfo rmation 
conditions referred to in point (a) are achieved in practice un der 
normal and atypical situations;  
(c) Validation of the intended process by measuring the reducti on of 
viability/infectivity of:  
(i) endogenous indicator organisms during the process, where th e 
indicator is:  
— consistently present in the raw material in high numbers,  
— not less heat resistant to the lethal aspects of the transfor mation 
process, but also not significantly more resistant than the 
pathogens for which it is being used to monitor,  
— relatively easy to quantify and to identify and to confirm; o r 
(ii) a well-characterised test organism or virus, during exposu re, 
introduced in a suitable test body into the starting material.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 65
 
(d) The validation of the intended process referred to in point  (c) must 
demonstrate that the process achieves the following overall ris k 
reduction:  
(i) for thermal and chemical processes by:  
— a reduction of 5 log10 of  Enterococcus faecalis  o r Salmonella 
Senftenberg  (775W, H2S negative),  
— reduction of infectivity titre of thermoresistant viruses suc h as 
parvovirus by at least 3 log10, whenever they are identified as  
a relevant hazard; and  
(ii) as regards chemical processes also by:  
— a reduction of resistant parasites such as eggs of  Ascaris  sp. by at 
least 99,9 % (3 log10) of viable stages;  
(e) Designing a complete control programme including procedures  for moni­
toring the functioning of the process referred to in point (c);  
(f) Measures ensuring continuous monitoring and supervision of the relevant 
process parameters fixed in the control programme when operatin g the 
plant.  
Details on the relevant process parameters used in a biogas or composting 
plant as well as other critical control points must be recorded  and main­
tained so that the owner, operator or their representative and the 
competent authority can monitor the operation of the plant.  
Records must be made available by the operator to the competent  
authority on request. Information relating to a process authori sed under 
this point must be made available to the Commission on request.  
2. By way of derogation from point 1, pending the adoption of r ules as referred 
to in Article 15(2)(a)(ii) of Regulation (EC) No 1069/2009, the  competent 
authority may authorise the use of specific requirements other than those laid 
down in this Chapter, provided that they guarantee an equivalen t effect 
regarding the reduction of pathogens, for:  
(a) catering waste used as the only animal by-product in a biog as or 
composting plant; and  
(b) mixtures of catering waste with the following materials:  
(i) manure;  
(ii) digestive tract content separated from the digestive tract ; 
(iii) milk;  
(iv) milk-based products;  
(v) milk-derived products;  
(vi) colostrum;  
(vii) colostrum products;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 66
 
(viii) eggs;  
(ix) egg products;  
▼M9 
(x) animal by-products referred to in Article 10(f) of Regulati on (EC) 
No 1069/2009, which have undergone processing as defined in 
Article 2(1)(m) of Regulation (EC) No 852/2004;  
(xi) mixture of animal by-products referred to in point 2(b) wi th 
non-animal by-product materials.  
▼B 
3. Where the materials referred to in point 2(b) or derived pro ducts referred to 
in Article 10(g) of Regulation (EC) No 1069/2009 are the only s tarting 
material of animal origin being treated in a biogas or composti ng plant, the 
competent authority may authorise the use of specific requireme nts other than 
those specified in this Chapter provided that it:  
(a) does not consider that those materials present a risk of sp reading any 
serious transmissible disease to humans or animals;  
▼M9 
(b) considers that the digestion residues or compost are unproc essed material 
and obliges operators to handle them in accordance with Regulat ion (EC) 
No 1069/2009, with this Regulation or, in the case of compost o r 
digestion residues derived from catering waste, to recover or d ispose of 
in accordance with the environmental legislation.  
▼B 
4. Operators may place on the market digestion residues and com post, which 
have been produced according to parameters which have been auth orised by 
the competent authority:  
(a) in accordance with point 1;  
(b) in accordance with points 2 and 3, only within the Member S tate where 
those parameters have been authorised.  
Section 3  
Standards for digestion residues and compost  
1. (a) Representative samples of the digestion residues or comp ost taken during 
or immediately after transformation at the biogas plant or comp osting at 
the composting plant in order to monitor the process must compl y with 
the following standards:  
Escherichia coli : n = 5, c = 1, m = 1 000, M = 5 000 in 1 g;  
or 
Enterococcaceae: n = 5, c = 1, m = 1 000, M = 5 000 in 1 g;  
and 
(b) Representative samples of the digestion residues or compost  taken during 
or on withdrawal from storage must comply with the following st andards:  
Salmonella: absence in 25 g: n = 5; c = 0; m = 0; M = 0  
Where in the case of point (a) or (b):  
n = number of samples to be tested;  
m = threshold value for the number of bacteria; the result is c onsidered 
satisfactory if the number of bacteria in all samples does not exceed m;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 67
 
M = maximum value for the number of bacteria; the result is con sidered 
unsatisfactory if the number of bacteria in one or more samples  is M or 
more; and  
c = number of samples the bacterial count of which may be betwe en m and 
M, the sample still being considered acceptable if the bacteria l count of 
the other samples is m or less.  
▼M10  
2. Digestion residues or compost other than those referred to i n point 3(b) of 
Section 2, which do not comply with the requirements set out in  this Section, 
shall be resubmitted to transformation or composting, and in th e case of 
Salmonella handled or disposed of in accordance with the instru ctions of 
the competent authority.  
▼M1 
3. When animal by-products are transformed into biogas or compo sted together 
with materials which are not of animal origin, the competent au thority may 
authorise operators to take representative samples after the pa steurisation 
referred to in point 1(a) of Section 1 of Chapter I or after co mposting 
referred to in point 1 of Section 2, as applicable, and before the mixing 
with materials which are not of animal origin takes place, in o rder to 
monitor the efficiency of the transformation or composting of t he animal 
by-products, as applicable.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 68
 
ANNEX VI  
SPECIAL RULES ON RESEARCH, FEEDING AND COLLECTION AND 
DISPOSAL  
CHAPTER I  
SPECIAL RULES ON SAMPLES FOR RESEARCH AND OTHER 
PURPOSES  
Section 1  
Research and diagnostic samples  
1. Operators shall ensure that consignments of research and dia gnostic samples 
are accompanied by a commercial document, which must specify:  
(a) the description of the material and the animal species of o rigin;  
(b) the category of the material;  
(c) the quantity of the material;  
(d) the place of origin and the place of dispatch of the materi al; 
(e) the name and the address of the consignor;  
(f) the name and the address of the consignee and/or user.  
2. Users that handle research and diagnostic samples shall take  all necessary 
measures to avoid the spreading of diseases communicable to hum ans or 
animals during the handling of the materials under their contro l, in particular 
by way of the application of good laboratory practice.  
3. Any subsequent use of research and diagnostic samples for pu rposes other 
than those referred to in point 38 of Annex I shall be prohibit ed. 
4. Unless they are kept for reference purposes, research and di agnostic samples 
and any products derived from the use of those samples shall be  disposed of:  
(a) as waste by incineration or co-incineration;  
(b) in case of the animal by-products or derived products refer red to in 
Article 8 (a)(iv), Article 8(c) and (d) and Article 9 and Artic le 10 of 
Regulation (EC) No 1069/2009 which are part of cell cultures, l aboratory 
kits or laboratory samples, by a treatment under conditions whi ch are at 
least equivalent to the validated method for steam autoclaves (  1 ) and 
subsequent disposal as waste or wastewater in accordance with r elevant 
Union legislation;  
(c) by pressure sterilisation and subsequent disposal or use in  accordance 
with Articles 12, 13 and 14 of Regulation (EC) No 1069/2009.  
5. Users that handle research and diagnostic samples shall keep  a register of 
consignments of such samples.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 69  
( 1 ) CEN TC/102 – Sterilisers for medical purposes – EN 285:2006 +  A2:2009 – Sterilization 
- Steam Sterilisers - Large Sterilisers, reference published in  OJ C 293, 2.12.2009, p. 39.
 The register shall include the information referred to in point  1 and the date 
and method of disposal of the samples and of any derived produc ts. 
6. By way of derogation from points 1, 4 and 5, the competent a uthority may 
accept the handling and disposal of research and diagnostic sam ples for 
educational purposes under other conditions which ensure that n o unac­
ceptable risks for public or animal health arise.  
Section 2  
Trade samples and display items  
1. Trade samples and display items may only be transported, use d and disposed 
of in accordance with points 1 to 4 and 6 of Section 1.  
2. Unless trade samples are kept for reference purposes, they s hall be, after the 
particular studies or analyses have been concluded:  
(a) redispatched to the Member State of origin;  
(b) dispatched to another Member State or third country, if suc h dispatch has 
been authorised by the competent authority of the Member State or third 
country of destination in advance; or  
(c) disposed of or used in accordance with Articles 12, 13 and 14 of 
Regulation (EC) No 1069/2009.  
3. After the exhibition or after the artistic activity has been  concluded, display 
items shall be redispatched to the Member State of origin, disp atched or 
disposed of, in accordance with point 2.  
CHAPTER II  
SPECIAL FEEDING RULES  
Section 1  
General requirements  
▼M4 
Categories 2 and 3 materials as referred to in Article 18(1) of  Regulation (EC) 
No 1069/2009 may be fed to the animals referred to in paragraph  (1)(a), (b), (d), 
(f), (g) and (h) of that Article subject to compliance with at least the following 
conditions, in addition to any conditions laid down by the comp etent authority in 
accordance with Article 18(1) of that Regulation:  
▼B 
1. The animal by-products shall be transported to the users or to collection 
centres in accordance with Sections 1 and 3 of Chapter I of Ann ex VIII.  
2. Collection centres shall be registered by the competent auth ority, provided 
that: 
(a) they comply with the requirements for plants carrying out t he intermediate 
operations set out in Chapter II of Annex IX; and  
(b) they have adequate facilities for destroying unused materia l, or send it to 
an approved processing plant or to an approved incineration or 
co-incineration plant in accordance with this Regulation.  
3. Member States may authorise the use of a processing plant fo r Category 2 
material as a collection centre.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 70
 
4. Operators of collection centres supplying material, other th an animal 
by-products originating from aquatic animals and from aquatic i nvertebrates, 
to final users must ensure that it undergoes one of the followi ng treatments:  
(a) denaturing with a solution of a colouring agent; the soluti on must be of 
such a strength that the colouring on the stained material is c learly visible 
and does not disappear when the coloured materials are subject to freezing 
or chilling, and the whole surface of all pieces of material mu st have been 
covered with such solution either by immersing the material in,  or 
spraying or otherwise applying the solution;  
(b) sterilisation by boiling or steaming under pressure until e very piece of 
material is cooked throughout; or  
(c) any other handling or treatment authorised by the competent  authority 
responsible for the operator.  
Section 2  
Feeding of certain species in feeding stations  
1. The competent authority may authorise the use of Category 1 material referred 
to in Article 18(2)(b) of Regulation (EC) No 1069/2009 for the feeding of the 
following endangered and protected species in feeding stations under the 
following conditions:  
(a) The material must be fed to:  
▼M9 
(i) one of the following species of necrophagous birds in the f ollowing 
Member States:  
Country 
code  Member State  Animal species  
Local name  Latin name  
BG Bulgaria  bearded vulture 
black vulture 
Egyptian vulture 
griffon vulture 
golden eagle 
imperial eagle 
white-tailed eagle 
black kite 
red kite  Gypaetus barbatus 
Aegypius monachus 
Neophron percnopterus 
Gyps fulvus 
Aquila chrysaetos 
Aquila helíaca 
Haliaeetus albicilla 
Milvus migrans 
Milvus milvus  
EL Greece  bearded vulture 
black vulture 
Egyptian vulture 
griffon vulture 
golden eagle 
imperial eagle 
white-tailed eagle 
black kite  Gypaetus barbatus 
Aegypius monachus 
Neophron percnopterus 
Gyps fulvus 
Aquila chrysaetos 
Aquila heliaca 
Haliaeetus albicilla 
Milvus migrans  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 71
 
Country 
code  Member State  Animal species  
Local name  Latin name  
ES Spain  bearded vulture 
black vulture 
Egyptian vulture 
griffon vulture 
golden eagle 
Spanish imperial 
eagle 
black kite 
red kite  Gypaetus barbatus 
Aegypius monachus 
Neophron percnopterus 
Gyps fulvus 
Aquila chrysaetos 
Aquila adalberti 
Milvus migrans 
Milvus milvus  
FR France  bearded vulture 
black vulture 
Egyptian vulture 
griffon vulture 
golden eagle 
white-tailed eagle 
black kite 
red kite  Gypaetus barbatus 
Aegypius monachus 
Neophron percnopterus 
Gyps fulvus 
Aquila chrysaetos 
Haliaeetus albicilla 
Milvus migrans 
Milvus milvus  
HR Croatia  bearded vulture 
black vulture 
Egyptian vulture 
griffon vulture  Gypaetus barbatus 
Aegypius monachus 
Neophron percnopterus 
Gyps fulvus  
IT Italy  bearded vulture 
black vulture 
Egyptian vulture 
griffon vulture 
golden eagle 
black kite 
red kite  Gypaetus barbatus 
Aegypius monachus 
Neophron percnopterus 
Gyps fulvus 
Aquila chrysaetos 
Milvus migrans 
Milvus milvus  
CY Cyprus  black vulture 
griffon vulture  Aegypius monachus 
Gyps fulvus  
PT Portugal  black vulture 
Egyptian vulture 
griffon vulture 
golden eagle  Aegypius monachus 
Neophron percnopterus 
Gyps fulvus 
Aquila chrysaetos  
SK Slovakia  golden eagle 
imperial eagle 
white-tailed eagle 
black kite 
red kite  Aquila chrysaetos 
Aquila heliaca 
Haliaeetus albicilla 
Milvus migrans 
Milvus milvus  
▼B 
(ii) one of the species of the order Carnivora which are listed  in Annex II 
to Directive 92/43/EEC, in special areas of conservation which have 
been set up under that Directive; or  ▼M9 02011R0142 — EN — 01.01.2021 — 021.001 — 72
 
(iii) one of the species of the orders Falconiformes or Strigif ormes, which 
are listed in Annex I to Directive 2009/147/EC, in special prot ection 
areas which have been set up under that Directive;  
(b) The competent authority has granted an authorisation to the  operator 
responsible for the feeding station.  
The competent authority shall grant such authorisations provide d that:  
(i) the feeding is not used as an alternative way of disposal o f specified 
risk materials or the disposal of fallen ruminant stock contain ing such 
material posing a TSE risk;  
(ii) an appropriate surveillance system for TSEs as laid down i n 
Regulation (EC) No 999/2001 is in place involving regular labor atory 
testing of samples for TSE;  
(c) The competent authority must ensure coordination with any o ther 
competent authorities responsible for the supervision of the re quirements 
laid down in the authorisation;  
(d) The competent authority must be satisfied, on the basis of an assessment 
of the specific situation of the species concerned and their ha bitat, that the 
conservation status of the species will be improved;  
(e) The authorisation granted by the competent authority must:  
(i) refer to and name the species actually concerned;  
(ii) describe in detail the location of the feeding station in the 
geographical area where feeding shall take place; and  
(iii) be immediately suspended in the case of:  
— a suspected or confirmed link to the spread of TSE until the risk 
can be excluded, or  
— non-compliance with any of the rules provided for in this Reg u­
lation.  
(f) The operator responsible for the feeding shall:  
(i) dedicate an area to the feeding that is enclosed and to whi ch access is 
limited to animals of the species to be conserved, if appropria te by 
fences or by other means which correspond to the natural feedin g 
patterns of those species;  
(ii) ensure that eligible bodies of bovine animals and at least  4 % of 
eligible bodies of ovine and caprine animals intended to be use d for 
feeding are tested prior to that use with a negative result, in  the TSE 
monitoring programme carried out in accordance with Annex III t o 
Regulation (EC) No 999/2001 and, if applicable, in accordance w ith 
a Decision adopted in accordance with the second subparagraph o f 
Article 6(1b) of that Regulation; and  
(iii) keep records at least of the number, nature, estimated we ight and 
origin of the carcases of the animals used for feeding, the dat e of the 
feeding, the location where feeding took place and if applicabl e, the 
results of the TSE tests.  
2. When a Member State applies to the Commission to be included  into the list 
set out under point 1(a), it shall submit:  
(a) a detailed justification for the extension of the list to i nclude certain 
species of necrophagous birds in that Member State, including a n expla­
nation of the reasons why it is necessary to feed such birds wi th Category 
1 material instead of with Category 2 or Category 3 material;  
(b) an explanation of the measures which will be taken in order  to ensure 
compliance with point 1.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 73
 
Section 3  
Feeding of wild animals outside feeding stations  
The competent authority may authorise the use of Category 1 mat erial 
comprising of entire bodies or parts of dead animals containing  specified risk 
materials outside feeding stations, if appropriate without prio r collection of the 
dead animals, for feeding to wild animals referred to in point 1(a) of Section 2 
under the following conditions:  
1. The competent authority must be satisfied, on the basis of a n assessment of 
the specific situation of the species concerned and their habit at, that the 
conservation status of the species will be improved;  
2. The competent authority must identify in the authorisation, holdings or herds 
within a geographically defined feeding zone under the followin g conditions:  
(a) The feeding zone must not extend to areas where intensive f arming of 
animals takes place;  
(b) Farmed animals in holdings or herds in the feeding zone mus t be under 
the regular surveillance of an official veterinarian regarding the prevalence 
of TSE and of diseases transmissible to humans or animals;  
(c) Feeding must be immediately suspended in the case of:  
(i) a suspected or confirmed link to the spread of TSE in a hol ding or 
herd, until the risk can be excluded;  
(ii) a suspected or confirmed outbreak of a serious disease tra nsmissible 
to humans or animals in a holding or herd, until the risk can b e 
excluded; or  
(iii) non-compliance with any of the rules provided for in this  Regulation;  
(d) The competent authority must specify in the authorisation:  
(i) appropriate measures to prevent the transmission of TSE and  of 
transmissible diseases from the dead animals to humans or other  
animals, such as measures targeted at the feeding patterns of t he 
species to be conserved, seasonal feeding restrictions, movemen t 
restrictions for farmed animals and other measures intended to 
control possible risks of transmission of a disease communicabl e to 
humans or animals, such as measures relating to species present  in 
the feeding zone for the feeding of which the animal by-product s are 
not used;  
(ii) the responsibilities of persons or entities in the feeding  zone who are 
assisting with the feeding or responsible for farmed animals, i n 
relation to the measures referred to under point (i);  
(iii) the conditions for the imposition of penalties as referre d to in 
Article 53 of Regulation (EC) No 1069/2009 which are applicable  
to infringements of measures referred to under point (i) by the  
persons or entities referred to under point (ii) of this point (d); 
(e) Where the feeding is carried out without the prior collecti on of the dead 
animals, an estimate of the likely mortality rate of farmed ani mals in the 
feeding zone and of the likely feeding requirements of the wild  animals 
must be carried out, as a basis for the assessment of the poten tial risks of 
disease transmission.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 74
 
Section 4  
Feeding of zoo animals with Category 1 material  
The competent authority may authorise the use of Category 1 mat erial 
comprising of entire bodies or parts of dead animals containing  specified risk 
materials and the use of material derived from zoo animals, for  the feeding of 
zoo animals under the following conditions:  
(a) The competent authority must have granted an authorisation to the operator 
responsible for the feeding. The competent authority shall gran t such auth­
orisations provided that:  
(i) the feeding is not used as an alternative way of disposal o f specified risk 
materials or disposal of fallen ruminant stock containing such material 
posing a TSE risk;  
(ii) when Category 1 material comprising of entire bodies or pa rts of dead 
animals containing specified risk material, which originates fr om bovine 
animals is used, an appropriate surveillance system for TSEs as  laid 
down in Regulation (EC) No 999/2001 is in place involving regul ar 
laboratory testing of samples for TSEs;  
(b) The authorisation granted by the competent authority must b e immediately 
suspended in the case of:  
(i) a suspected or confirmed link to the spread of TSEs until t he risk can be 
excluded; or  
(ii) non-compliance with any of the rules provided for in this Regulation;  
(c) The operator responsible for the feeding shall:  
(i) store the material to be used for the feeding and carry out  the feeding in 
an enclosed and fenced area to ensure that no carnivorous anima l other 
than the zoo animals for which the authorisation has been grant ed have 
access to the material for the feeding;  
(ii) ensure that ruminant animals intended to be used for feedi ng are 
included in the TSE monitoring programme carried out in accorda nce 
with Annex III to Regulation (EC) No 999/2001 and, if applicabl e, in 
accordance with a Decision adopted in accordance with the secon d 
subparagraph of Article 6(1b) of that Regulation;  
(iii) keep records at least of the number, nature, estimated we ight and origin 
of the bodies of the animals used for feeding, the results of t he TSE 
tests and the date of the feeding.  
CHAPTER III  
SPECIAL RULES ON COLLECTION AND DISPOSAL  
Section 1  
Special disposal rules for animal by-products  
1. If the competent authority authorises the disposal of animal  by-products on 
site in accordance with Article 19(1)(a), (b), (c) and (e) of R egulation (EC) 
No 1069/2009, such disposal may take place:  
(a) by burning or burial on the premises on which the animal by -products 
originate;  
(b) in an authorised landfill; or  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 75
 
(c) by burning or burial at a site which minimises the risk to animal and 
public health and the environment, provided that the site is lo cated 
within a range of distance sufficient to enable the competent a uthority 
to manage the prevention of the risk to animal and public healt h and the 
environment.  
2. The burning of animal by-products on the sites referred to i n Article 19(1)(b), 
(c) and (e) of Regulation (EC) No 1069/2009 must be carried out  in such a 
way to ensure that they are burnt:  
(a) on a properly constructed pyre and the animal by-products r educed to 
ash; 
(b) without endangering human health;  
(c) without using processes or methods which could harm the env ironment, 
in particular when they could result in risks to water, air, so il and plants 
and animals or through noise or odours;  
(d) under conditions which ensure that any resulting ash is dis posed of by 
burial in an authorised landfill.  
3. The burial of animal by-products on the sites referred to in  Article 19(1)(a), 
(b), (c) and (e) of Regulation (EC) No 1069/2009 must be carrie d out to 
ensure that they are buried:  
(a) in such a way that carnivorous or omnivorous animals cannot  gain access 
to them;  
(b) in an authorised landfill or in another site without endang ering human 
health and using processes or methods which do not harm the 
environment, in particular when they could result in risks to w ater, air, 
soil and plants and animals, or through noise or odours.  
4. In the case of disposal in accordance with Article 19(1)(a),  (b), (c) and (e) of 
Regulation (EC) No 1069/2009, the movement of the animal by-pro ducts 
from the place of origin to the place of disposal must be carri ed out under 
the following conditions:  
(a) the animal by-products are transported in secure, leak-proo f containers or 
vehicles;  
(b) the loading and unloading of the animal by-products is supe rvised by the 
competent authority, if appropriate;  
(c) the vehicle wheels are disinfected upon leaving the site of  origin;  
(d) containers and vehicles used for transporting animal by-pro ducts are 
thoroughly cleansed and disinfected after unloading of the anim al 
by-products; and  
(e) adequate escorts for the vehicles, leak testing and double covering are 
provided, if appropriate.  
Section 2  
Burning and burial of animal by-products in remote areas  
The maximum percentage as referred to in Article 19(2) of Regul ation (EC) 
No 1069/2009 shall not exceed the following:  
(a) 10 % of the bovine population of the Member State concerned ; 
(b) 25 % of the ovine and caprine population of the Member Stat e concerned;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 76
 
(c) 10 % of the porcine population of the Member State concerne d; and  
(d) a percentage of the population of other species which is de termined by the 
competent authority, on the basis of an assessment of the possi ble risks for 
public and animal health which arise from the disposal of anima ls of those 
species by burning or burial on site.  
Section 3  
Burning and burial of bees and apiculture by-products  
In the case of bees and apiculture by-products, the competent a uthority may 
authorise the disposal by burning or burial on site, as referre d to in 
Article 19(1)(f) of Regulation (EC) No 1069/2009, provided that  all necessary 
measures are taken to ensure that the burning or burial does no t endanger animal 
or human health or the environment.  
CHAPTER IV  
DISPOSAL BY OTHER MEANS  
By way of derogation from Article 14 of Regulation (EC) No 1069 /2009, 
Member States may authorise the collection, transport and dispo sal of the 
Category 3 materials referred to in Article 10(f) of that Regul ation by means 
other than burning or burial on site provided that:  
(a) the materials do not exceed a volume of 20 kg per week from  the estab­
lishment or plant where the materials are collected, regardless  of the species 
of origin of the materials;  
(b) the materials are collected, transported and disposed of by  means which 
prevent the transmission of unacceptable risks to public and an imal health;  
(c) the competent authority carries out regular checks, includi ng checks on the 
records kept by operators, in the establishments or plants wher e the materials 
are collected, to ensure compliance with the provisions of this  Section.  
▼M9 __________  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 77
 
ANNEX VII  
STANDARD FORMAT FOR APPLICATIONS FOR ALTERNATIVE 
METHODS  
CHAPTER I  
Language regime  
1. Applications for authorisation of an alternative method of u se or disposal of 
animal by-products or derived products as referred to in Articl e 20 of 
Regulation (EC) No 1069/2009 (applications) shall be submitted in one of 
the official languages of the European Union as referred to in Article 1 of 
Regulation No 1 of 1958.  
2. Interested parties that submit such applications in a langua ge other than 
English shall validate the official translation of their applic ation, which 
EFSA shall provide, prior to the assessment.  
The period referred to in Article 20(5) of Regulation (EC) No 1 069/2009 
shall only start once the interested party has validated the of ficial translation 
of the application.  
CHAPTER II  
Content of applications  
▼M1 
1. Applications shall contain all the necessary information to allow EFSA to 
assess the safety of the proposed alternative method, and in pa rticular 
describe:  
— the categories of animal by-products intended to be submitted  to the 
method,  
— the entire process,  
— the biological hazards for human and animal health involved, and 
— the degree of risk reduction to be achieved by the process.  
2. The application referred to in paragraph 1 shall moreover:  
(a) indicate the applicable points in Articles 8, 9 and 10 of R egulation (EC) 
No 1069/2009 including the physical status of those materials a nd, if 
applicable, any pre-treatment to which those materials have bee n 
submitted and indicating any materials other than animal by-pro ducts 
which are to be used in the process.  
(b) include a HACCP protocol and a flow diagram which clearly i ndicates 
the individual steps of the process, identifies the parameters critical for 
the inactivation of relevant pathogens such as temperature, pre ssure, 
exposure time, adjustment of the pH value and particle size and  is 
complemented by technical data sheets of the equipment used dur ing 
the process;  
(c) identify and characterize biological hazards for human and animal health 
represented by the categories of animal by-products intended to  be 
submitted to the method;  
(d) show that the most resistant biological hazards associated with the 
category of materials to be processed are reduced in any produc ts 
generated during the process, including the waste water, at lea st to 
the degree achieved by the processing standards laid down in th is Regu­
lation for the same category of animal by-products. The degree of risk 
reduction must be determined with validated direct measurements , unless 
modelling or comparisons with other processes are acceptable.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 78
 
3. Validated direct measurements as referred to in paragraph 2( d) above shall 
mean:  
(a) measuring the reduction of viability/infectivity of: endoge nous indicator 
organisms during the process, where the indicator is:  
— consistently present in the raw material in high numbers;  
— not less resistant to the lethal aspects of the treatment pro cess, but 
also not significantly more resistant than the pathogens for wh ich it is 
being used to monitor;  
— relatively easy to quantify, to identify and to confirm; or  
(b) using a well-characterised test organism or virus introduce d in a suitable 
test body into the starting material.  
If several treatment steps are involved, an assessment must be performed 
on the degree to which individual titre reduction steps are add itive, or 
whether early steps in the process may compromise the efficacy of 
subsequent steps;  
(c) reporting complete results by  
(i) describing in detail the used methodology;  
(ii) describing the nature of samples which have been analysed;  
(iii) showing that the number of samples analysed is representa tive; 
(iv) justifying the number of tests performed and the selection  of 
measuring points;  
(v) indicating the sensitivity and the specificity of the detec tion 
methods used;  
(vi) providing data on the repeatability and statistical variab ility of the 
measurements obtained during the experiments;  
(vii) justifying, if used the significance of prion surrogates;  
(viii) showing, where in absence of direct measurements, models  or 
comparisons with other processes are used, that the factors 
leading to risk reduction are well known and the model of risk 
reduction is well established;  
(ix) providing data for the entire process on direct measuremen ts of all 
factors leading to the risk reduction which demonstrate that th ese 
factors are homogenously applied throughout the treated batch.  
4. The HACCP plan referred to in paragraph 2(b) must be based o n the critical 
parameters which are used to obtain the risk reduction, in part icular:  
— temperature,  
— pressure,  
— time, and  
— microbiological criteria.  ▼M1 02011R0142 — EN — 01.01.2021 — 021.001 — 79
 
The critical limits retained in the HACCP plan must be defined,  based on the 
results of the experimental validation and/ or of the model pro vided.  
If the successful functioning of the process can only be demons trated with 
reference to technical parameters which are specifically relate d to the 
equipment used in the process, the HACCP plan must also include  the 
technical limits which must be met, in particular energy uptake , number of 
pump strokes or dosage of chemicals.  
Information must be given on the critical and technical paramet ers that are to 
be monitored and recorded in a continuous manner or after defin ed intervals 
and on the methods used for measuring and monitoring.  
The variability of parameters under typical production conditio ns must be 
taken into account.  
The HACCP plan must reflect normal and abnormal/ emergency oper ating 
conditions including a breakdown of the process and it must spe cify possible 
corrective actions which are to be applied in the case of abnor mal/emergency 
operating conditions.  
5. The applications shall also contain sufficient information o n: 
(a) the risks associated with interdependent processes, and in particular on 
the outcome of an evaluation of possible indirect impacts, whic h may:  
(i) influence the level of risk reduction of a particular proce ss; 
(ii) arise from transport or storage of any products generated during the 
process and from the safe disposal of such products, including waste 
water.  
(b) the risks associated with the intended end use of the produ cts, in 
particular:  
(i) the intended end use of any products generated during the p rocess 
must be specified;  
(ii) the likely risks for human health and animal health and po ssible 
impacts on the environment must be assessed on the basis of the  
risk reduction estimated in accordance with point 2(d).  
6. Applications shall be submitted with documentary evidence, i n particular:  
(a) a flow diagram showing the functioning of the process;  
(b) the evidence referred to in point 2(d), as well as other ev idence aiming to 
substantiate the information provided in the framework of the a pplication 
as set out in point 2.  
7. Applications shall include a contact address for the interes ted party, which 
shall include the name and full address, telephone and/or fax n umber and/or 
the electronic mail address of a particular person that is resp onsible as or on 
behalf of the interested party.  ▼M1 02011R0142 — EN — 01.01.2021 — 021.001 — 80
 
ANNEX VIII  
COLLECTION, TRANSPORT AND TRACEABILITY  
CHAPTER I  
COLLECTION AND TRANSPORT  
Section 1  
Vehicles and containers  
1. As from the starting point in the manufacturing chain referr ed to in 
Article 4(1) of Regulation (EC) No 1069/2009, animal by-product s and 
derived products must be collected and transported in sealed ne w 
packaging or covered leak-proof containers or vehicles.  
2. Vehicles and reusable containers, and all reusable items of equipment or 
appliances that come into contact with animal by-products or de rived 
products, other than derived products which are placed on the m arket in 
accordance with Regulation (EC) No 767/2009 and which are store d and 
transported in accordance with Annex II to Regulation (EC) No 1 83/2005, 
must be maintained in a clean condition.  
In particular, unless they are dedicated to the carriage of par ticular animal 
by-products or derived products in a way which avoids cross-con tamination, 
they must be:  
(a) clean and dry before use; and  
(b) cleaned, washed and/or disinfected after each use to the ex tent necessary 
to avoid cross-contamination.  
3. Reusable containers must be dedicated to the carriage of a p articular animal 
by-product or derived product to the extent necessary to avoid 
cross-contamination.  
However, reusable containers may be used, provided the competen t authority 
has authorised such use:  
(a) for the carriage of different animal by-products or derived  products 
provided that they are cleaned and disinfected between the diff erent 
uses in a manner which prevents cross-contamination;  
(b) for the carriage of animal by-products or derived products referred to in 
Article 10(f) of Regulation (EC) No 1069/2009, following their use for 
the carriage of products intended for human consumption, under 
conditions which prevent cross-contamination.  
4. Packaging material must be disposed of, by incineration or b y other means in 
accordance with Union legislation.  
Section 2  
Temperature conditions  
1. The transport of animal by-products destined for the product ion of feed 
material or raw petfood must take place at an appropriate tempe rature, in 
the case of animal by-products from meat and meat products whic h have 
been destined for purposes other than human consumption, at a m aximum of 
7 °C, unless they are used for feeding purposes in accordance w ith Chapter I 
of Annex II, in order to avoid any risk to animal or public hea lth. ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 81
 
2. Unprocessed Category 3 material destined for the production of feed material 
or petfood must be stored and transported chilled, frozen or en siled, unless:  
(a) it is processed within 24 hours after collection or after t he end of storage 
in chilled or frozen form, if the subsequent transport takes pl ace in means 
of transport in which the storage temperature is maintained;  
(b) in the case of milk, milk-based products or milk-derived pr oducts which 
have not been subject to any of the treatments referred to in P art I of 
Section 4 of Chapter II of Annex X, it is transported chilled a nd in 
insulated containers, unless risks can be mitigated by other me asures, 
due to the characteristics of the material.  
3. The design of vehicles used for refrigerated transport must ensure the main­
tenance of an appropriate temperature throughout transport, and  allow that 
temperature to be monitored.  
Section 3  
Derogation for collection and transport of Category 3 material comprising of 
milk, milk-based products and milk-derived products  
Section 1 shall not apply to the collection and transportation of Category 3 
material comprising of milk, milk-based products and milk deriv ed products by 
operators of milk-processing establishments which have been app roved in 
accordance with Article 4 of Regulation (EC) No 853/2004, where  they are 
receiving products which they have previously delivered and whi ch are 
returned to them, in particular from their customers.  
Section 4  
Derogation for collection and transport of manure  
By way of derogation from Section 1, the competent authority ma y accept the 
collection and transport of manure transported between two poin ts located on the 
same farm or between farmers and users in the same Member State  under other 
conditions which provide for the prevention of unacceptable ris ks to public and 
animal health.  
CHAPTER II  
IDENTIFICATION  
1. All necessary measures must be taken to ensure that:  
(a) consignments of animal by-products and derived products are  identifiable 
and kept separate and identifiable during collection where the animal 
by-products originate and during transportation;  
(b) a marking substance for the identification of animal by-pro ducts or 
derived products of a specific category is only used for the ca tegory 
for which its use is required under this Regulation, or is esta blished or 
laid down pursuant to point 4;  
(c) consignments of animal by-products and derived products are  dispatched 
from one Member State to another Member State in packaging, 
containers or vehicles which are prominently and, at least for the 
period of transport, indelibly colour-coded for displaying info rmation 
as provided for in this Regulation on the surface or part of th e surface 
of a packaging, container or vehicle, or on a label or symbol a pplied to 
them as follows:  
(i) in the case of Category 1 materials, using the colour black ; ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 82
 
(ii) in the case of Category 2 materials (other than manure and  digestive 
tract content), using the colour yellow;  
(iii) in the case of Category 3 materials, using the colour gre en with a 
high content of blue to ensure that it is clearly distinguishab le from 
the other colours;  
(iv) in the case of imported consignments, the colour referred to for the 
respective material under points (i), (ii) and (iii), as from t he time 
when the consignment has passed the border inspection post of f irst 
entry into the Union.  
2. During transport and storage, a label attached to the packag ing, container or 
vehicle must:  
(a) clearly indicate the category of the animal by-products or of the derived 
products; and  
(b) bear the following words visibly and legibly displayed on t he packaging, 
a container or vehicle, as applicable:  
(i) in the case of Category 3 material, ‘not for human consumpt ion’;  
(ii) in the case of Category 2 material (other than manure and 
digestive tract content) and derived products from Category 2 
material, ‘not for animal consumption’; however, when 
Category 2 material is intended for the feeding of animals 
referred to in Article 18(1) of Regulation (EC) No 1069/2009 
under the conditions provided for or laid down in accordance 
with that Article, the label shall instead indicate ‘for feedin g to 
…’ completed with the name of the specific species of those 
animals for the feeding of which the material is intended;  
(iii) in the case of Category 1 material and derived products f rom 
Category 1 material where they are destined for  
— disposal, ‘for disposal only’;  
— the manufacture of petfood, ‘for manufacture of pet food 
only’;  
— the manufacture of a derived product referred to in Article 3 6 
of Regulation (EC) No 1069/2009, ‘for manufacture of 
derived products only. Not for human or animal consumption 
or for application to land’;  
(iv) in the case of milk, milk-based products, milk-derived pro ducts, 
colostrum and colostrum products, ‘not for human consumption’;  
(v) in the case of gelatine produced from Category 3 material, 
‘gelatine suitable for animal consumption’;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 83
 
(vi) in the case of collagen produced from Category 3 material,  
‘collagen suitable for animal consumption’;  
▼M23  
(vii) in the case of raw petfood, ‘Use as petfood only. Keep ap art from 
food. Wash hands and clean tools, utensils and surfaces after 
handling this product’;  
▼B 
(viii) in the case of fish and derived products from fish inten ded for 
feed for fish, and treated and packaged before distribution, th e 
name and address of the feed manufacturing establishment of 
origin, marked clearly and legibly, and  
— in the case of fishmeal from wild fish, bearing the words 
‘contains fishmeal from wild fish only – may be used for 
the feeding of farmed fish of all species’;  
— in the case of fishmeal from farmed fish, bearing the words 
‘contains fishmeal from farmed fish of the […] species only – 
may only be used for the feeding of farmed fish of other fish 
species’;  
— in the case of fishmeal from wild fish and from farmed fish, 
bearing the words ‘contains fishmeal from wild fish and 
farmed fish of the […] species – may only be used for the 
feeding of farmed fish of other fish species’;  
(ix) in the case of blood products from equidae for purposes ot her 
than in feed, ‘blood and blood products from equidae. Not for 
human or animal consumption’;  
(x) in the case of horns, hooves and other materials for the 
production of organic fertilisers and soil improvers referred t o 
in Section 12 of Chapter II of Annex XIV, ‘not for human or 
animal consumption’;  
(xi) in the case of organic fertilisers and soil improvers, ‘or ganic 
fertilisers or soil improvers/no grazing of farmed animals or u se 
of crops as herbage during at least 21 days following applicati on’; 
(xii) in the case of material used for feeding in accordance wi th 
Section 1 of Chapter II of Annex VI, the name and the address 
of the collection centre, and the indication ‘not for human 
consumption’;  
(xiii) in the case of manure and digestive tract content, ‘manu re’; 
(xiv) in the case of intermediate products, on the outer packag ing, 
bearing the words ‘for medicinal products/veterinary medicinal 
products/medical devices/active implantable medical devices/in 
vitro diagnostic medical devices/laboratory reagents only’;  
(xv) in the case of research and diagnostic samples, the words ‘for 
research and diagnostic purposes’, instead of the label text la id 
down in point (a);  
(xvi) in the case of trade samples, the words ‘trade sample not  for 
human consumption’, instead of the label text laid down in 
point (a);  
▼M1 
(xvii) in the case of display items, the words ‘display item no t for 
human consumption’, instead of the label text laid down in 
point (a);  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 84
 
(xviii) in the case of fish oil for the production of medicinal  products 
referred to in Chapter XIII of Annex XIII, the words ‘fish oil for 
the production of medicinal products’, instead of the label tex t 
laid down in point (a);  
▼M4 
(xix) in the case of manure which has been subject to the lime 
treatment set out in point I of Section 2 of Chapter IV of 
Annex IV, the words ‘manure-lime-mixture’;  
(xx) in the case of processed manure which has been subject to the 
treatment set out in point (b) and (c) of Section 2 of Chapter I of 
Annex XI, the words ‘processed manure’;  
▼M23  
(xxi) in the case of materials for detoxification referred to i n Chapter 
VII of Annex VIII, the words: ‘materials intended for detoxifi­
cation. Not fit for the placing on the market’;  
▼B 
(c) However, the label referred to in point (b)(xi) shall not b e required for 
the following organic fertilisers and soil improvers:  
(i) in ready-to-sell packages of not more than 50 kg in weight for use 
by the final consumer; or  
(ii) in big bags of not more than 1 000 kg in weight, provided that: 
— they are authorised by the competent authority of the Member 
State where the organic fertiliser or soil improver is to be ap plied 
to land,  
— it is indicated on those bags that they are not destined for appli­
cation to land to which farmed animals have access.  
3. Member States may establish systems or lay down rules for th e 
colour-coding of packaging, containers or vehicles used for the  transport of 
animal by-products and derived products originating in and rema ining on 
their territory, provided that those systems or rules do not co nfuse the 
colour-coding system provided for in point 1(c).  
4. Member States may establish systems or lay down rules for th e marking of 
animal by-products originating in and remaining on their territ ory provided 
that those systems or rules do not conflict with the marking re quirements set 
out for derived products in Chapter V of this Annex.  
5. By way of derogation from points 3 and 4, Member States may use the 
systems or rules referred to in those points for animal by-prod ucts originating 
in but not intended to remain on their territory if the Member State or third 
country of destination has communicated its agreement.  
6. However:  
(a) points 1 and 2 of this Chapter shall not apply to the ident ification of 
Category 3 material comprising of milk, milk-based products and  
milk-derived products, by operators of milk-processing establis hments 
which have been approved in accordance with Article 4 of 
Regulation (EC) No 853/2004, where they are receiving products 
which they have previously delivered and which are returned to them, 
in particular from their customers;  
(b) the competent authority may accept the identification of ma nure which is 
transported between two points located on the same farm or betw een 
farms and users located in the same Member State by other means , by 
way of derogation from points 1 and 2;  
(c) compound feeds as defined in Article 3(2)(h) of Regulation (EC) 
No 767/2009 which have been manufactured from animal by-product s 
or from derived products and which are packaged and placed on t he 
market as feed in accordance with Article 4 of Regulation (EC) 
No 767/2009 do not have to be identified in accordance with poi nt 1 
and they do not have to be labelled in accordance with point 2.  ▼M1 02011R0142 — EN — 01.01.2021 — 021.001 — 85
 
CHAPTER III  
COMMERCIAL DOCUMENTS AND HEALTH CERTIFICATES  
1. During transportation, a commercial document in accordance w ith the model 
set out in this Chapter, or, when required by this Regulation, a health 
certificate must accompany animal by-products and derived produ cts. 
However, such document or certificate shall not be necessary, p rovided that:  
(a) derived products from Category 3 material and organic ferti lisers and soil 
improvers are supplied within the same Member State by retailer s to final 
users other than business operators;  
(b) milk, milk-based products and milk-derived products which a re Category 
3 materials are collected and returned to operators of milk-pro cessing 
establishments, which have been approved in accordance with Art icle 4 
of Regulation (EC) No 853/2004, if those operators are receivin g 
products, in particular from their customers, which they have p reviously 
delivered;  
(c) compound feeds as defined in Article 3(2)(h) of Regulation (EC) 
No 767/2009 which have been manufactured from animal by-product s 
or from derived products, are placed on the market packaged and  labelled 
in accordance with Article 4 of Regulation (EC) No 767/2009.  
2. The commercial document must be produced at least in triplic ate (one 
original and two copies). The original must accompany the consi gnment to 
its final destination. The receiver must retain it. The produce r must retain one 
of the copies and the carrier the other.  
Member States may require that proof of the arrival of the cons ignments is 
provided by the TRACES system or by a fourth copy of the commer cial 
document which is sent back by the receiver to the producer.  
3. Health certificates must be issued and signed by the compete nt authority.  
4. A commercial document in accordance with the model set out u nder point 6 
shall accompany animal by-products and derived products as from  the 
starting point in the manufacturing chain referred to in Articl e 4(1) of 
Regulation (EC) No 1069/2009, during transportation within the Union.  
However, in addition to the authorisation to transmit informati on by way of 
an alternative system as referred to in the second subparagraph  of 
Article 21(3) of Regulation (EC) No 1069/2009, the competent au thority 
may authorise that animal by-products and derived products whic h are trans­
ported on its territory are accompanied by:  
(a) a different commercial document, in paper or in electronic form, 
provided that such commercial document contains the information  
referred to in point (f) of the Notes under point 6 of this Cha pter; 
(b) a commercial document in which the quantity of the material  is 
expressed in weight or volume of the material or in the number of 
packages.  
5. Records and related commercial documents or health certifica tes shall be 
kept for a period of at least two years for presentation to the  competent 
authority.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 86
 
6. Model commercial document  
Notes  
(a) Commercial documents shall be produced, according to the la yout of the 
model appearing in this Chapter.  
It shall contain, in the numbered order that appears in the mod el, the 
attestations that are required for the transportation of animal  by-products 
and derived products.  
(b) It shall be drawn up in one of the official languages of th e Member State 
of origin and of the Member State of destination, as appropriat e. 
However, it may also be drawn up in other official Union langua ges, if 
accompanied by an official translation or if previously agreed by the 
competent authority of the Member State of destination.  
(c) The original of each commercial document shall consist of a  single sheet 
of paper, both sides, or, where more text is required it shall be in such a 
form that all sheets of paper needed are demonstrably part of a n inte­
grated whole and indivisible.  
(d) If for reasons of identification of the items of the consig nment, additional 
sheets of paper are attached to the commercial document, these sheets of 
paper shall also be considered as forming part of the original document 
by the application of the signature of the person responsible f or the 
consignment, on each of the pages.  
(e) When the commercial document, including additional sheets o f paper 
referred to in point (d), comprises more than one page, each pa ge 
shall be numbered – (page number) of (total number of pages) – at 
the bottom of the page and shall bear the code number of the 
document that has been designated by the responsible person at the 
top of the page.  
(f) The original of the commercial document must be completed a nd signed 
by the responsible person.  
The commercial document must specify:  
(i) the date on which the material was taken from the premises;  
(ii) the description of the material, including  
— the identification of the material according to one of the 
categories referred to in Articles 8, 9 and 10 of 
Regulation (EC) No 1069/2009,  
— the animal species and the specific reference to the applicab le 
point in Article 10 of Regulation (EC) No 1069/2009 for 
Category 3 material and products derived therefrom which are 
destined for feeding and,  
— if applicable, the ear-tag number of the animal;  
(iii) the quantity of the material, in volume, weight or number  of 
packages;  
▼M16  
(iv) the name and address of the establishment or plant of orig in of the 
material and its approval or registration number assigned in 
accordance with Regulation (EC) No 1069/2009 or, where 
applicable, in accordance with Regulations (EC) 
No 852/2004 (  1 ), (EC) No 853/2004 (  2 ) or (EC) No 183/2005 of 
the European Parliament and of the Council (  3 ), and the nature and 
the method of the treatment, as applicable;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 87  
( 1 ) Regulation (EC) No 852/2004 of the European Parliament and of  the Council of 29 April 
2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1). 
( 2 ) Regulation (EC) No 853/2004 of the European Parliament and of  the Council of 29 April 
2004 laying down specific hygiene rules for food of animal orig in (OJ L 139, 30.4.2004, 
p. 55). 
( 3 ) Regulation (EC) No 183/2005 of the European Parliament and of  the Council of 
12 January 2005 laying down requirements for feed hygiene (OJ L  35, 8.2.2005, p. 1).
 (v) the name, the address and the registration number of the tr ansporter 
of the material;  
(vi) the name and address of the establishment or plant of dest ination 
and the registration or approval number assigned in accordance 
with Regulation (EC) No 1069/2009 or, where applicable, in 
accordance with Regulations (EC) No 852/2004 or (EC) 
No 183/2005;  
(vii) in case of transport in containers, the complete containe r identifi­
cation number (‘BIC code’) issued in accordance with the 
requirements of the Bureau International des Containers et du 
Transport Intermodal (  1 ); 
(viii) in case of export of processed animal protein and produc ts 
containing processed animal proteins as referred to in Annex IV  
to Regulation (EC) No 999/2001, the Member State of exit and 
border inspection post referred to in Commission Decision 
2009/821/EC (  2 ) of exit.  
▼B 
(g) The colour of the signature of the responsible person shall  be different to 
that of the printing.  
(h) The document reference number and the local reference numbe r shall 
only be issued once for the same consignment.  
▼M16  
(i) The competent authority responsible for the place of destin ation referred 
to in the second subparagraph of Article 48(3) of Regulation (E C) 
No 1069/2009 shall, within 15 working days of the receipt of th e 
information referred to in the first subparagraph of Article 48 (3) of 
that Regulation, inform the competent authority of the Member S tate 
of origin of the arrival of the consignment by means of TRACES.  ▼M16  02011R0142 — EN — 01.01.2021 — 021.001 — 88  
( 1 ) https://www.bic-code.org/identification-number/ 
( 2 ) Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved 
border inspection posts, laying down certain rules on the inspe ctions carried out by 
Commission veterinary experts and laying down the veterinary un its in Traces 
(OJ L 296, 12.11.2009, p. 1).
 Commercial document  
For the transport within the European Union of animal by-products and derived products not intended for human 
consumption in accordance with Regulation (EC) No 1069/2009
  ▼M16  02011R0142 — EN — 01.01.2021 — 021.001 — 89
 
▼M16  02011R0142 — EN — 01.01.2021 — 021.001 — 90
 
▼M16  02011R0142 — EN — 01.01.2021 — 021.001 — 91
 
▼M16  02011R0142 — EN — 01.01.2021 — 021.001 — 92
 
CHAPTER IV  
RECORDS  
Section 1  
General provisions  
1. The records as referred to in Article 22(1) of Regulation (E C) No 1069/2009 
for animal by-products and derived products, other than compoun d feeds as 
defined in Article 3(2)(h) of Regulation (EC) No 767/2009, whic h have been 
manufactured from animal by-products or from derived products a nd which 
are placed on the market in accordance with Article 4 of Regula tion (EC) 
No 767/2009, shall contain:  
(a) a description of:  
(i) the animal species for Category 3 material and derived prod ucts 
therefrom, destined for use as feed material and, if applicable , in 
the case of whole carcases and heads, the ear-tag number;  
(ii) the quantity of the material;  
(b) in the case of records kept by any person consigning animal  by-products 
or derived products, the following information:  
(i) the date on which the material was taken from the premises;  
(ii) the name and the address of the transporter and of the rec eiver and, 
if applicable, their approval or registration number;  
(c) in the case of records kept by any person transporting anim al by-products 
or derived products, the following information:  
(i) the date on which the material was taken from the premises;  
(ii) the place of origin of the material, from where the materi al is 
dispatched;  
(iii) the name and the address of the receiver and, if applicab le, its 
approval or registration number;  
(d) in the case of records kept by any person receiving animal by-products 
or derived products, the following information:  
(i) the date of reception of the material;  
(ii) the place of origin of the material, from where the materi al is 
dispatched;  
(iii) the name and address of the transporter.  
2. By way of derogation from point 1 of this Section, operators  do not have to 
keep the information referred to in point 1(a) and points (b)(i ), (c)(i) and (iii) 
and d(ii) and (iii) separately, if they keep a copy of the comm ercial document 
laid down in Chapter III for each consignment and make such inf ormation 
available in conjunction with the other information required un der point 1 of 
this Section.  
3. Operators of incineration plants and co-incineration plants shall keep records 
of the quantities and category of the animal by-products and de rived products 
incinerated or co-incinerated, as applicable, and the date at w hich those 
operations were carried out.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 93
 
Section 2  
Additional requirements in case of use for special feeding purposes  
In addition to the records required in accordance with Section 1, operators shall 
keep the following records in relation to relevant material if animal by-products 
are used for special feeding purposes in accordance with Chapte r II of Annex VI:  
1. in the case of final users, the quantity used, the animals t hat it is intended to 
be fed to and the date of use;  
2. in the case of collection centres:  
(i) the quantity handled or treated in accordance with point 4 of Section 1 of 
Chapter I of Annex VI;  
(ii) the name and address of each final user using the material ; 
(iii) the premises to which the material is taken for use;  
(iv) the quantity dispatched; and  
(v) the date on which the material was dispatched.  
Section 3  
Requirements in case of certain fur animals  
The operator of the farm referred to in Chapter I of Annex II s hall keep records 
at least of:  
(a) the number of furs and carcases of animals fed with materia ls originating of 
their own species; and  
(b) each consignment in order to ensure the traceability of the  material.  
Section 4  
Requirements for the application of certain organic fertilisers and soil 
improvers to land  
The person responsible for land to which organic fertilisers an d soil improvers, 
other than the materials referred to in the second paragraph of  Chapter II of 
Annex II are applied and to which farmed animals have access or  from which 
herbage is cut for feeding to farmed animals, shall keep record s of the following 
for a period of at least two years:  
1. the quantities of organic fertilisers and soil improvers app lied; 
2. the date on which the organic fertilisers and soil improvers  were applied to 
land and the places of such application;  
3. the dates, following the application of the organic fertilis er or soil improver, 
on which livestock has been allowed to graze on the land or on which the 
land has been cut for herbage to be used for feeding.  
Section 5  
Requirements for animal by-products derived from aquatic animals and 
feeding of fish  
Processing plants producing fishmeal or other feed originating from aquatic 
animals shall keep records of the following:  
(a) the quantities produced each day;  
(b) the species of origin, including an indication of whether t he aquatic animals 
were caught in the wild or produced in aquaculture;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 94
 
(c) in the case of fishmeal from farmed fish which is intended for feeding to 
farmed fish of another species, the scientific name of the spec ies of origin.  
Section 6  
Requirements for the burning and burial of animal by-products  
In the case of burning or burial of animal by-products as provi ded for in 
Article 19(1) of Regulation (EC) No 1069/2009, the person respo nsible for 
such burning or burial shall keep records of the following:  
(a) the quantities, categories and species of animal by-product s burned or buried;  
(b) the date and place of burning and burial.  
Section 7  
Requirements for photogelatine  
Operators of approved photographic factories referred to in Sec tion 11 of 
Chapter II of Annex XIV shall keep records detailing the purcha ses and uses 
of photogelatine, as well as the disposal of residues and surpl us material.  
CHAPTER V  
MARKING OF CERTAIN DERIVED PRODUCTS  
1. In processing plants for the processing of Category 1 or Cat egory 2 material, 
derived products shall be permanently marked with 
glyceroltriheptanoate (GTH) in such a way that:  
(a) GTH is added to derived products that have undergone a prec eding 
sanitising thermal treatment at a core temperature of at least 80 °C and 
remain subsequently protected from re-contamination;  
(b) all derived products contain homogenously throughout the su bstance a 
minimum concentration of at least 250 mg GTH per kg fat.  
2. The operators of processing plants referred to in point 1 sh all have in place a 
system of monitoring and recording of parameters suitable to de monstrate to 
the competent authority that the required homogeneous minimum c oncen­
tration of GTH is achieved.  
That monitoring and recording system shall include the determin ation of the 
content of intact GTH as triglyceride in a cleaned petroleum-et her 40-70 
extract of GTH from samples taken at regular intervals.  
3. The marking with GTH shall not be required for:  
(a) liquid derived products destined for biogas or composting p lants;  
(b) derived products used for feeding to fur animals in accorda nce with 
Chapter I of Annex II;  
(c) biodiesel produced in accordance with point D of Section 2 of 
Chapter IV of Annex IV;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 95
 
(d) derived products obtained in accordance with Article 12(a)( ii) and (b)(ii) 
and Article 13(a)(ii) and (b)(ii) and Article 16(e) of Regulati on (EC) 
No 1069/2009, where such products are:  
(i) moved by a closed conveyer system, which may not be by-pass ed, 
and provided such a system has been authorised by the competent  
authority, from the processing plant for:  
— immediate direct incineration or co-incineration,  
— immediate use in accordance with a method approved for animal  
by-products of Category 1 and Category 2 in accordance with 
Chapter IV of Annex IV; or  
▼M1 
(ii) intended for research and other specific purposes as refer red to in 
Article 17 of Regulation (EC) No 1069/2009 which have been auth ­
orised by the competent authority;  
▼M13  
(e) renewable fuels produced from rendered fats, which are deri ved from 
Category 1 and Category 2 materials, in accordance with points J and L 
of Section 2 of Chapter IV of Annex IV.  
▼M4 
CHAPTER VI  
TRANSPORT OF DEAD PET ANIMALS  
The conditions in points 1 to 3 of Article 48 of Regulation (EC ) No 1069/2009 
regarding the advance authorisation by the competent authority in the Member 
States of destination and the use of TRACES shall not be requir ed in the case of 
the transport of a dead pet animal for incineration in an estab lishment or plant 
located in the border region of another Member State sharing a common border 
when the Member States conclude a bilateral agreement on the co ndition of the 
transport.  
▼M22  
CHAPTER VII  
TRANSPORT TO A DETOXIFICATION PLANT OF FISH OILS AND 
FISHMEAL INTENDED FOR THE PRODUCTION OF FEED 
MATERIAL  
1. Operators intending to transport fish oils and fishmeal of C ategory 3 materials 
intended for the production of feed from an approved processing  plant for the 
production of fish oils and fishmeal to a feed plant registered  or approved in 
accordance with Regulation (EC) No 1069/2009 and approved in ac cordance 
with Article 10(3) of Regulation (EC) No 183/2005 in another Me mber State 
for detoxification in accordance with the processes referred to  in 
Regulation (EU) 2015/786 shall apply to the competent authority  at the 
place of destination for acceptance of the consignment.  
The application shall be in the standard format for application s and auth­
orisations set out in Section 10 of Chapter III of Annex XVI to  
Regulation (EU) No 142/2011.  
2. The competent authority of the Member State of destination r eferred to in 
point 1 shall inform the operator of its decision on the consig nment by 
returning the application referred to in the second subparagrap h of point 1 
completed accordingly.  
3. The competent authority of the Member State of origin shall notify the 
competent authority of the Member State of destination, by mean s of the 
TRACES system in accordance with Decision 2004/292/EC, of the d ispatch 
of each consignment.  
4. Point 1 to 3 of this Chapter shall not apply to fish oils an d fishmeal of 
Category 3 materials placed on the market for the production of  feed in 
which excessive level(s) of dioxins and/or polychlorinated biph enyls (PCBs) 
were detected during official controls.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 96
 
ANNEX IX  
REQUIREMENTS APPLICABLE TO CERTAIN APPROVED AND 
REGISTERED ESTABLISHMENTS AND PLANTS  
CHAPTER I  
MANUFACTURING OF PETFOOD  
Establishments or plants manufacturing petfood as referred to i n Article 24(1)(e) 
of Regulation (EC) No 1069/2009 shall have adequate facilities for: 
(a) storing and treating incoming material in complete safety; and 
(b) disposing of unused animal by-products remaining after the production of the 
products in accordance with this Regulation, or such material m ust be sent to 
an incineration plant, a co-incineration plant, a processing pl ant or, in the 
case of Category 3 material, to a biogas or composting plant in  accordance 
with Articles 12, 13 and 14 of Regulation (EC) No 1069/2009 and  with this 
Regulation.  
CHAPTER II  
HANDLING OF ANIMAL BY-PRODUCTS AFTER THEIR 
COLLECTION  
The requirements of this Chapter shall apply to the storage of animal 
by-products, as referred to in Article 24(1)(i) of Regulation ( EC) 
No 1069/2009 and to the following operations involving the hand ling of 
animal by-products after their collection, as referred to in Ar ticle 24(1)(h) of 
that Regulation:  
(a) sorting;  
(b) cutting;  
(c) chilling;  
(d) freezing;  
(e) salting or other preservation processes;  
(f) removal of hides and skins;  
(g) removal of specified risk material;  
(h) operations involving the handling of animal by-products whi ch are carried 
out in compliance with obligations under Union veterinary legis lation, such 
as post-mortem examination or the taking of samples;  
(i) hygienisation/pasteurisation of animal by-products destined  for trans­
formation into biogas or composting, prior to such transformati on or 
composting in another establishment or plant in accordance with  Annex V 
hereto;  
▼M23  
(j) sieving;  
(k) phase transition processes of Category 3 materials, such as  blood thermo­
coagulation, blood centrifugation, containment as set out in Ch apter V to 
Annex IX hereto, hydrolyzing of hooves, pig bristles, feathers and hair, 
destined for processing with processing methods set out in this  Regulation.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 97
 
Section 1  
General requirements  
1. Premises and facilities where intermediate operations are ca rried out shall 
meet at least the following requirements:  
(a) They must be adequately separated from thoroughfares throug h which 
contamination may be spread and from other premises such as sla ughter­
houses. The layout of plants shall ensure the total separation of Category 
1 and Category 2 material from Category 3 material respectively , from 
reception until dispatch, unless in a completely separate build ing. 
(b) The plant must have a covered space to receive and dispatch  animal 
by-products, unless the animal by-products are being discharged  
through installations which prevent the spreading of risks to p ublic and 
animal health, such as through closed tubes for liquid animal 
by-products.  
(c) The plant must be constructed in such a way that it is easy  to clean and 
disinfect. Floors must be laid down in such a way as to facilit ate the 
draining of liquids.  
(d) The plant must have adequate facilities including lavatorie s, changing 
rooms, washbasins for staff and, if appropriate, office space w hich can 
be made available to the staff performing official controls.  
(e) The plant must have appropriate arrangements for protection  against 
pests, such as insects, rodents and birds.  
(f) Where it is necessary for the purpose of achieving the obje ctives of this 
Regulation, plants must have suitable temperature-controlled st orage 
facilities of sufficient capacity for maintaining animal by-pro ducts at 
appropriate temperatures and designed to allow the monitoring a nd 
recording of those temperatures.  
2. The plant shall be equipped with adequate facilities for cle aning and disin­
fecting the containers or receptacles in which animal by-produc ts are 
received and for the vehicles, other than ships, in which they are transported. 
Adequate facilities shall be available for the disinfecting of vehicle wheels.  
Section 2  
Hygiene requirements  
1. The sorting of animal by-products shall be carried out in su ch a way as to 
avoid any risk of the propagation of animal diseases.  
2. At all times during storage, animal by-products shall be han dled and stored 
separately from other goods and in such a way as to prevent any  propagation 
of pathogens.  
3. Animal by-products shall be stored properly, including under  appropriate 
temperature conditions, until re-dispatched.  
Section 3  
Processing standards for hygienisation/pasteurisation  
Hygienisation/pasteurisation as referred to in point (i) of the  initial paragraph of 
this Chapter shall be carried out in accordance with the proces sing standards 
referred to in point 1 of Section 1 of Chapter I of Annex V or in accordance with 
alternative transformation parameters which have been authorise d in accordance 
with point 1 of Section 2 of Chapter III of the same Annex.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 98
 
CHAPTER III  
REQUIREMENTS FOR STORAGE OF DERIVED PRODUCTS  
Section 1  
General requirements  
Premises and facilities storing derived products shall meet at least the following 
requirements:  
1. Premises and facilities storing derived products from Catego ry 3 material must 
not be at the same site as premises storing derived products fr om Category 1 
or Category 2 material, unless cross-contamination is prevented  due to the 
layout and management of the premises, such as by means of stor age in 
completely separate buildings.  
2. The plant must:  
(a) have a covered space to receive and dispatch the derived pr oducts, unless 
the derived products are:  
(i) being discharged through installations which prevent the sp reading of 
risks to public and animal health, such as through closed tubes  for 
liquid products; or  
(ii) received in packaging, such as in big bags, or in covered leak-proof 
containers or means of transport;  
(b) be constructed in such a way that it is easy to clean and d isinfect. Floors 
must be laid down in such a way as to facilitate the draining o f liquids;  
(c) have adequate facilities including lavatories, changing roo ms and 
washbasins for staff;  
(d) have appropriate arrangements for protection against pests,  such as 
insects, rodents and birds.  
3. The plant must have adequate facilities for cleaning and dis infecting the 
containers or receptacles in which the derived products are rec eived and the 
vehicles, other than ships, in which they are transported.  
4. Derived products must be stored properly until redispatched.  
Section 2  
Specific requirements for storage of certain milk, milk-based products and 
milk-derived products  
1. The storage of the products referred to in Part II of Sectio n 4 of Chapter II of 
Annex X shall take place at an appropriate temperature to avoid  any risk to 
public or animal health in a dedicated approved or registered s torage estab­
lishment or plant or in a dedicated, separate storage area with in an approved 
or registered storage establishment or plant.  
2. Samples of the final products taken during storage or at the  time of with­
drawal from storage, shall at least comply with the microbiolog ical standards 
set out in Chapter I of Annex X.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 99
 
CHAPTER IV  
REGISTERED OPERATORS  
1. Operators of registered plants or establishments or other re gistered operators 
shall handle animal by-products and derived products under the following 
conditions:  
(a) premises must be constructed in a way permitting their effe ctive cleaning 
and disinfection, where appropriate;  
(b) premises must have appropriate arrangements for protection against pests, 
such as insects, rodents and birds;  
(c) installations and equipment must be kept in hygienic condit ion, where 
necessary;  
(d) animal by-products and derived products must be stored unde r conditions 
preventing contamination.  
2. Operators shall keep records in a form which is accessible t o the competent 
authority.  
3. Registered operators transporting animal by-products or deri ved products, 
other than between premises of the same operator, shall in part icular:  
(a) have information at their disposal with regard to the ident ification of their 
vehicles, which allows the verification of the use of the vehic les for the 
transport of animal by-products or derived products;  
(b) clean and disinfect their vehicles, as appropriate;  
(c) take all other necessary measures to prevent contamination and the 
spreading of diseases communicable to humans or animals.  
▼M9 
CHAPTER V  
CONTAINMENT METHODS  
Section 1  
General provisions  
1. Materials resulting from a containment method may be used or  disposed of 
only within the Member State where that containment method is a uthorised by 
the competent authority.  
2. The competent authority of a Member State shall make the res ults of official 
controls available to the competent authority of another Member  State upon 
request, where a containment method is used for the first time in that Member 
State, in order to facilitate the introduction of the new conta inment method.  
Section 2  
Methodology  
A. Aerobic maturation and storage of dead-on-farm pigs and cert ain other 
porcine material with subsequent incineration or co-incineratio n. 
1. Member States concerned  
The process of aerobic maturation and storage of dead-on-farm p igs 
and certain other porcine material with subsequent incineration  or 
co-incineration may be used in France, Ireland, Latvia, Portuga l and 
the United Kingdom.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 100
 
Following aerobic maturation and storage of material, the compe tent 
authority of the Member State concerned must ensure that the 
materials are collected and disposed of within the territory of  that 
Member State.  
2. Starting materials  
For this process, only the following materials of animals of th e porcine 
species may be used:  
(a) Category 2 materials referred to in Article 9(f)(i) to (iii ) of 
Regulation (EC) No 1069/2009;  
(b) Category 3 materials referred to in Article 10(h) of 
Regulation (EC) No 1069/2009.  
This method is only applicable to the disposal of animals of th e 
porcine species originating in the same holding, provided this 
holding is not subject to restrictions due to a suspected or 
confirmed outbreak of a serious transmissible disease affecting  
animals of the porcine species. This method may not be used for  
animals which have died due to those diseases or have been kill ed 
for diseases control purposes, or parts of those animals.  
3. Methodology  
3.1. General principles  
The method is a process authorised by the competent authority.  
The site must be constructed and laid out in accordance with Un ion 
legislation for the protection of the environment, in order to prevent 
odours and risks to soil and groundwater.  
The operator 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 disease s; 
(c) put in place procedures to prevent the spreading of used sa wdust 
outside the closed system.  
The process must be carried out in a closed system which consis t of 
several cells, with a waterproof floor and delimited by solid w alls. 
Any waste water must be collected; the cells must be connected with a 
drainpipe fitted with a 6 mm grid to capture solids.  
Size and number of the cells must be adapted to the mortality l evel 
defined in the permanent written procedure referred to in Artic le 29(1) 
to (3) of Regulation (EC) No 1069/2009 with sufficient capacity  for 
farm mortalities occurring during an eight-month period at leas t. 
3.2. Phases  
3.2.1. Filling and storage phase  
The fallen pigs and other porcine material must be individually  
covered in sawdust and piled up until the cell is full. First a  layer 
of at least 30 centimetres of sawdust must be placed on the gro und. 
The carcasses and other porcine material must then be placed on  this 
first layer of sawdust and each layer of carcasses and other po rcine 
material must be covered with a layer of sawdust at least 30 cm  thick.  
Personnel must not walk on the stored material.  ▼M9 02011R0142 — EN — 01.01.2021 — 021.001 — 101
 
3.2.2. Maturing phase  
When the cell is full and a rise in temperature allows the degr adation 
of all the soft tissues, the maturation period starts and must last at least 
3 months.  
At the end of the filling and storage phase and during all of t he 
maturation phase, the operator must monitor the temperature in each 
cell with a temperature sensor placed between 40 cm and 60 cm 
beneath the pile surface of the latest built layer.  
The electronic reading and monitoring of the temperature must b e 
recorded by the operator.  
At the end of the filling and storage phase, the temperature mo nitoring 
is an indicator of a satisfactory pile layout. The temperature must be 
measured by an automatic recording device. The aim is to reach 55 °C 
during 3 consecutive days, revealing that the maturing process is 
active and that the pile layout is effective and that the matur ing 
phase has started.  
The operator must monitor the temperature once a day and the 
following measures shall be taken 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 removed after a 3 consecutive  
months maturing phase, or may remain stored on the premises 
awaiting a later removal;  
(b) where the temperature of 55 °C is not reached during 3 
consecutive days, measures defined in the permanent written 
procedure referred to in Article 29(1) to (3) of Regulation (EC ) 
No 1069/2009 must be set by the operator; if needed, the 
competent authority may stop the processing method and the 
material must be disposed of in compliance with Article 13 of 
the aforementioned Regulation.  
A time limit for the storage phase may be determined by the 
competent authority.  
3.2.3. Transport and incineration or co-incineration  
The transport of the resulted material after the maturation pha se to the 
approved incineration or co-incineration plant is subject to co ntrols 
referred to in Regulation (EC) No 1069/2009 or Directive 2008/9 8/EC.  
B. Hydrolysis with subsequent disposal  
1. Member States concerned  
The process of hydrolysis with subsequent disposal may be used in 
Ireland, Spain, Latvia, Portugal and the United Kingdom.  
Following hydrolysis, the authorising competent authority must ensure 
that the materials are collected and disposed of within the sam e 
Member State referred to above.  
2. Starting materials  
For this process, only the following materials of porcine origi n may be 
used:  
(a) Category 2 materials referred to in Article 9(f)(i) to (iii ) of 
Regulation (EC) No 1069/2009;  
(b) Category 3 materials referred to in Article 10(h) of that R egulation.  ▼M9 02011R0142 — EN — 01.01.2021 — 021.001 — 102
 
This method is only applicable to the disposal of animals of th e porcine 
species originating in the same holding and provided this holdi ng is not 
subject to prohibition due to a suspected or confirmed outbreak  of a 
serious transmissible disease affecting animals of the porcine species, or 
animals that have been killed for disease control purposes.  
3. Methodology  
Hydrolysis with subsequent disposal is a temporary storage on t he spot. It 
shall be carried out according to the following standards:  
(a) Following their collection on a holding for which the compe tent 
authority has authorised the use of the processing method, base d 
on an assessment of the animal density of the holding, the like ly 
mortality rate and the potential risks for public and animal he alth 
which may arise, the animal by-products must be placed into a 
container which has been constructed in accordance with point ( b) 
(‘the container’) and which has been placed at a dedicated site  in 
accordance with points (c) and (d) (‘the dedicated site’).  
(b) The container must:  
(i) have a device to close it;  
(ii) be waterproof, leak-proof and hermetically sealed;  
(iii) be coated in a way which prevents corrosion;  
(iv) be equipped with a device for controlling emissions in 
accordance with point (e).  
(c) The container must be placed in a dedicated site which is p hysically 
separate from the holding.  
That site must have dedicated access routes for the movement of  
materials and for collection vehicles.  
(d) The container and the site must be constructed 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 linked to a pipe for gaseous emission s, which 
must be equipped with appropriate filters to prevent the transm ission 
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 unautho rised 
opening is prevented.  
(g) The operator must put in place procedures to prevent the tr ans­
mission of diseases communicable to humans or animals by 
movements of personnel.  
(h) The operator must:  
(i) take preventive measures against birds, rodents, insects an d other 
vermin;  
(ii) put in place a documented pest control programme.  
(i) The operator must keep records of:  
(i) any placing of material into the container;  
(ii) any collection of hydrolysed material from the container.  ▼M9 02011R0142 — EN — 01.01.2021 — 021.001 — 103
 
(j) The operator must empty the container at regular intervals for a 
check:  
(i) for the absence of corrosion;  
(ii) to detect and prevent possible leakage of liquid materials  into the 
ground.  
(k) Following hydrolysis, the materials must be collected, 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 Category 3 materials.  
(l) The process must be carried out in a batch mode.  
(m) Any other handling or use of the hydrolysed materials, incl uding 
their application to land, shall be prohibited.  ▼M9 02011R0142 — EN — 01.01.2021 — 021.001 — 104
 
ANNEX X  
FEED MATERIALS  
CHAPTER I  
GENERAL REQUIREMENTS FOR THE PROCESSING AND PLACING 
ON THE MARKET  
Microbiological standards for derived products  
The following microbiological standards shall apply to derived products:  
Samples of the final products taken during or on withdrawal fro m storage at the 
processing plant must comply with the following standards:  
Salmonella: absence in 25 g: n = 5, c = 0, m = 0, M = 0  
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 g  
where:  
n = number of samples to be tested;  
m = threshold value for the number of bacteria; the result is c onsidered satis­
factory if the number of bacteria in all samples does not excee d m;  
M = maximum value for the number of bacteria; the result is con sidered unsat­
isfactory if the number of bacteria in one or more samples is M  or more; 
and 
c = number of samples the bacterial count of which may be betwe en m and M, 
the sample still being considered acceptable if the bacterial c ount of the 
other samples is m or less.  
However, the microbiological standards set out in this Chapter shall not apply to 
rendered fats and fish oil from the processing of animal by-pro ducts, when the 
processed animal protein, which is obtained during the same pro cessing, is 
subject to sampling to ensure compliance with those standards.  
CHAPTER II  
SPECIFIC REQUIREMENTS FOR PROCESSED ANIMAL PROTEIN 
AND OTHER DERIVED PRODUCTS  
Section 1  
Specific requirements for processed animal protein  
▼M12  
A. Raw materials  
1. Only animal by-products which are Category 3 material or pro ducts which 
are derived from such animal by-products, other than the Catego ry 3 
materials referred to in Article 10(n), (o) and (p) of Regulati on (EC) 
No 1069/2009, may be used for the production of processed anima l 
protein.  
2. Processed animal protein derived from farmed insects, intend ed for the 
production of feed for farmed animals other than fur animals, m ay only be 
obtained from the following insect species:  
(i) Black Soldier Fly ( Hermetia illucens ) and Common Housefly ( Musca 
domestica ); 
(ii) Yellow Mealworm ( Tenebrio molitor ) and Lesser Mealworm ( Alphi­
tobius diaperinus ); 
(iii) House cricket ( Acheta domesticus ), Banded cricket ( Gryllodes 
sigillatus ) and Field Cricket ( Gryllus assimilis ). ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 105
 
B. Processing standards  
1. Processed animal protein of mammalian origin must have been submitted 
to processing method 1 (pressure sterilisation) as set out in C hapter III of 
Annex IV.  
However,  
(a) porcine blood or fractions of porcine blood for the product ion of 
bloodmeal may have been submitted instead to any of the process ing 
methods 1 to 5 or processing method 7 as set out in Chapter III  of 
Annex IV, provided that in the case of processing method 7, a h eat 
treatment throughout its substance at a temperature of 80 °C ha s 
been applied;  
(b) processed animal protein of mammalian origin  
(i) may have been submitted to any of the processing methods 1 to 
5 or processing method 7, as set out in Chapter III of Annex IV , 
provided that it is subsequently disposed of or used as a fuel for 
combustion;  
(ii) where it is exclusively destined for use in petfood, it ma y have 
been submitted to any of the processing methods 1 to 5 or 
processing method 7, as set out in Chapter III of Annex IV, 
provided that it is:  
— transported in dedicated containers that are not used for the  
transport of animal by-products or feedingstuffs for farmed 
animals, and  
— consigned directly from a processing plant for Category 3 
material to the petfood plant or to an approved storage plant, 
from where it is directly consigned to a petfood plant.  
2. Non-mammalian processed animal protein, with the exception o f 
fishmeal, must have been submitted to any of processing methods  1 to 
5 or processing method 7, as set out in Chapter III of Annex IV . 
3. Fishmeal must have been submitted to:  
(a) any of the processing methods set out in Chapter III of Ann ex IV; or  
(b) another method which ensures that the product complies with  the 
microbiological standards for derived products set in Chapter I  of 
this Annex.  
C. Storage  
1. Processed animal protein must be packed and stored in new or  sterilised 
bags or stored in properly constructed bulk bins or in storage sheds.  
Sufficient measures must be taken to minimise condensation insi de bins, 
conveyors or elevators.  
2. Products in conveyors, elevators and bins must be protected from casual 
contamination.  
3. Equipment for handling processed animal protein must be main tained in 
a clean and dry condition and must have adequate inspection poi nts so 
that equipment can be examined for cleanliness.  
All storage facilities must be emptied and cleaned regularly, t o the extent 
necessary to prevent contamination.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 106
 
4. Processed animal protein must be kept dry.  
Leakages and condensation in the storage area must be prevented . 
Section 2  
Specific requirements for blood products  
A. Raw material  
Only blood referred to in Article 10(a) and Article 10(b)(i) of  
Regulation (EC) No 1069/2009 may be used for the production of blood 
products.  
B. Processing standards  
Blood products must have been submitted to:  
(a) any of the processing methods 1 to 5 or processing method 7 , as set out 
in Chapter III of Annex IV; or  
(b) another method which ensures that the blood product complie s with the 
microbiological standards for derived products set out in Chapt er I of this 
Annex.  
Section 3  
Specific requirements for rendered fats, fish oil and fat derivatives from 
Category 3 material  
A. Raw materials  
▼M9 
1. Rendered fats  
Only Category 3 material, other than Category 3 materials refer red to in 
Article 10(n), (o) and (p) of Regulation (EC) No 1069/2009, may  be 
used for the production of rendered fat.  
▼M11  
2. Fish oil  
Only Category 3 material referred to in Article 10(i), (j) and (l) of 
Regulation (EC) No 1069/2009 and Category 3 material of aquatic  
animal origin referred to in Article 10(e) and (f) of that Regu lation 
may be used for the production of fish oil.  
▼B 
B. Processing standards  
Unless the fish oil or rendered fats have been produced in acco rdance with 
Sections VIII or XII of Annex III to Regulation (EC) No 853/200 4, 
respectively, rendered fats must be produced using any of the p rocessing 
methods 1 to 5 or processing method 7, and fish oils may be pro duced:  
(a) using processing methods 1 to 7, as set out in Chapter III of Annex IV; 
or 
(b) in accordance with another method which ensures that the pr oduct 
complies with the microbiological standards for derived product s set 
out in Chapter I of this Annex.  
Rendered fats derived from ruminant animals must be purified in  such a way 
that the maximum level of remaining total insoluble impurities does not 
exceed 0,15 % in weight.  
Fat derivatives from Category 3 rendered fats or fish oil shall  be produced in 
accordance with one of the processing methods referred to in Ch apter III of 
Annex IV.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 107
 
C. Hygiene requirements  
Where rendered fat or fish oil is packaged, it must be packaged  in new 
containers or in containers that have been cleaned and disinfec ted if 
necessary for the prevention of contamination and all precautio ns must be 
taken to prevent its recontamination.  
Where bulk transport of those products is intended, the pipe, p umps and bulk 
tanks and any other bulk container or bulk road tanker used in the trans­
portation of the products from the manufacturing plant either d irectly on to 
the ship or into shore tanks or directly to plants must be clea n before use.  
Section 4  
Specific requirements for milk, colostrum and certain other products 
derived from milk or colostrum  
P a r t I  
G e n e r a l r e q u i r e m e n t s  
A. Raw material  
Only milk referred to in Article 10(e) of Regulation (EC) No 10 69/2009, 
other than centrifuge or separator sludge, and milk referred to  in Article 10(f) 
and (h) of Regulation (EC) No 1069/2009 may be used for the pro duction of 
milk, milk-based products and milk-derived products.  
Colostrum may only be used provided that it originates from liv e animals that 
did not show any signs of disease communicable through the colo strum to 
humans or animals.  
B. Processing standards  
1. Milk must be subjected to one of the following treatments:  
1.1. sterilisation at an F  0 (*) value of three or more;  
1.2. UHT (**) combined with one of the following:  
(a) a subsequent physical treatment, by:  
(i) a drying process, combined in the case of milk intended for  
feeding with additional heating to 72 °C or more; or  
(ii) lowering the pH below 6 for at least 1 hour;  
(b) the condition that the milk, milk-based product or milk-der ived 
product has been produced at least 21 days before shipping and 
that during that period no case of foot-and-mouth disease has 
been detected in the Member State of origin;  
1.3. HTST (***) applied twice;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 108  
(*) F  0 is the calculated killing effect on bacterial spores. An F  0 value of 3, 00 means that 
the coldest point in the product has been heated sufficiently t o achieve the same 
killing effect as 121 °C (250 °F) in three minutes with instant aneous heating and 
chilling. 
(**) UHT = Ultra High Temperature treatment at 132 °C for at le ast one second. 
(***) HTST = High Temperature Short Time pasteurisation at 72 ° C for at least 15 seconds 
or equivalent pasteurisation effect achieving a negative reacti on to a phosphatase test.
 1.4. HTST in combination with one of the following:  
(a) a subsequent physical treatment, by:  
(i) a drying process, combined in the case of milk intended for  
feeding with additional heating to 72 °C or more; or  
(ii) lowering the pH below 6,0 for at least 1 hour;  
(b) the condition that the milk, milk-based product or milk-der ived 
product has been produced at least 21 days before shipping and 
that during that period no case of foot-and-mouth disease has 
been detected in the Member State of origin.  
2. Milk-based products and milk-derived products must either be  subjected 
to at least one of the treatments provided for in point 1 or be  produced 
from milk treated in accordance with point 1.  
3. Whey to be fed to animals of species susceptible to foot-and -mouth 
disease and produced from milk treated in accordance with point  1  
must:  
(a) either be collected at least 16 hours following milk clotti ng and its 
pH must be recorded as below 6,0 before transport to animal 
holdings; or  
(b) have been produced at least 21 days before shipping and dur ing that 
period no case of foot-and-mouth disease has been detected in t he 
Member State of origin.  
4. In addition to the requirements set out in points 1, 2 and 3 , milk, 
milk-based products and milk-derived products must meet the 
following requirements:  
4.1. after completion of the processing, every precaution must be taken to 
prevent contamination of the products;  
4.2. the final product must be labelled so as to indicate that it contains 
Category 3 material and is not intended for human consumption, and 
it must be:  
(a) packed in new containers; or  
(b) transported in bulk in containers or other means of transpo rt that 
before use were thoroughly cleansed and disinfected.  
5. Raw milk must be produced under conditions offering adequate  guar­
antees as regards animal health.  
6. Colostrum and colostrum products must:  
6.1. be obtained from bovine animals kept on a holding on which  all bovine 
herds are recognised as officially tuberculosis-free, officiall y 
brucellosis-free and officially enzootic-bovine-leukosis-free a s defined 
in Article 2(2)(d), (f) and (j) of Directive 64/432/EEC;  
6.2. have been produced at least 21 days before shipping and du ring that 
period no case of foot-and-mouth disease has been detected in t he 
Member State of origin;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 109
 
6.3. have undergone a single HTST treatment (*);  
6.4. comply with the requirements set out in point 4 of this Pa rt. 
P a r t I I  
D e r o g a t i o n f o r t h e p l a c i n g o n t h e m a r k e t o f m i l k 
p r o c e s s e d i n a c c o r d a n c e w i t h n a t i o n a l s t a n d a r d s  
▼M4 
1. The requirements laid down in points 2 and 3 of this Part sh all apply to the 
processing, use and storage of milk, milk-based products and mi lk-derived 
products which are Category 3 material, as referred to in Artic le 10(e) of 
Regulation (EC) No 1069/2009, other than centrifuge or separato r sludge, and 
milk, milk-based products and milk-derived products referred to  in 
Article 10(f) and (h) of that Regulation, that have not been pr ocessed in 
accordance with Part I of this Section.  
▼B 
2. The competent authority shall authorise milk processing esta blishments 
approved or registered in accordance with Article 4 of Regulati on (EC) 
No 853/2004 to supply milk, milk-based products and milk-derive d 
products for the purposes referred to in point 3 of this Part p rovided the 
establishment concerned ensures the traceability of the product s. 
3. Milk, milk-based products and milk-derived products may be s upplied and 
used as feed material:  
(a) in the Member State concerned and in cross-border areas whe re the 
Member States concerned have a mutual agreement to that effect,  in 
the case of derived products, including white water, which have  been 
in contact with raw milk and/or milk pasteurised in accordance with the 
requirements for heat treatment set out in point II.1(a) or (b)  of Chapter II 
of Section IX of Annex III to Regulation (EC) No 853/2004, if t hose 
derived products have been subject to one of the following trea tments:  
(i) UHT;  
(ii) sterilisation whereby either an Fc value equal or greater than 3 is 
achieved, or which was carried out at a temperature of at least  
115 °C for 15 minutes or an equivalent combination of temperatu re 
and time;  
(iii) pasteurisation or sterilisation, other than that referred  to in point (ii), 
followed by:  
— in the case of dried milk or dried milk-based products or 
milk-derived products, a drying process;  
— in the case of an acidified milk product, a process by which the 
pH is reduced and kept for at least one hour at a level below 6 ; 
(b) in the Member State concerned,  
(i) in the case of derived products, including white water, whi ch have 
been in contact with milk that has only been pasteurised in 
accordance with the requirements for heat treatment set out in 
point II.1 (a) of Chapter II of Section IX of Annex III to 
Regulation (EC) No 853/2004, and whey produced from non 
heat-treated milk-based products, which has been collected at l east 
16 hours after milk clotting and where the pH must be recorded as < 
6,0 before supplying the whey for feeding, provided that they a re 
sent to a limited number of authorised animal holdings, fixed o n the 
basis of the risk assessment for the best and worst case scenar ios 
carried out by the Member State concerned in preparation of the  
contingency plans for epizootic diseases, in particular foot-an d- 
mouth disease;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 110  
(*) HTST = High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or 
equivalent pasteurisation effect achieving a negative reaction to a phosphatase test.
 (ii) in the case of raw products, including white water that ha s been in 
contact with raw milk and other products for which the treatmen ts 
referred to in point (a) and point (b)(i) cannot be ensured, pr ovided 
that they are sent to a limited number of authorised animal hol dings, 
fixed on the basis of a risk assessment for the best and worst case 
scenarios carried out by the Member State concerned in preparat ion 
of the contingency plans for epizootic diseases, in particular foot-and- 
mouth disease, and provided that the animals present in the aut h­
orised animal holdings can only be moved  
— either directly to a slaughterhouse located in the same Membe r 
State, or  
— to another holding in the same Member State, for which the 
competent authority guarantees that animals susceptible to 
foot-and-mouth disease may leave the holding only either 
directly to a slaughterhouse located in the same Member State, 
or if the animals have been dispatched to a holding not feeding  
the products referred to in this point (ii), after a 21-day sta ndstill 
period has elapsed from the introduction of the animals.  
4. The competent authority may authorise the supply of colostru m which does 
not comply with the conditions set out in point B.6 of Part I f rom one farmer 
to another farmer within the same Member State for feeding purp oses, under 
conditions which prevent the transmission of health risks.  
P a r t I I I  
S p e c i a l r e q u i r e m e n t s f o r c e n t r i f u g e o r s e p a r a t o r 
s l u d g e  
Category 3 material comprising of centrifuge or separator sludg e must have been 
subjected to a heat treatment of at least 70 °C for 60 minutes or of at least 80 °C 
for 30 minutes, before it may be placed on the market for feedi ng to farmed 
animals.  
▼M9 
By way of derogation from the first paragraph, the competent au thority may 
authorise alternative parameters for the heat treatment of cent rifuge or 
separator sludge destined for uses within Member States which h ave authorised 
those alternative parameters, provided operators can demonstrat e that the heat 
treatment according to the alternative parameters guarantees at  least the same risk 
reduction as the treatment carried out according to the paramet ers set out in the 
first paragraph.  
▼B 
Section 5  
Specific requirements for gelatine and hydrolysed protein  
A. Raw materials  
Only animal by-products which are Category 3 material or produc ts which 
are derived from such animal by-products, other than materials referred to in 
Article 10(m), (n), (o) and (p) of Regulation (EC) No 1069/2009  may be 
used for the production of gelatine and hydrolysed protein.  
B. Processing standards for gelatine  
1. Unless the gelatine has been produced in accordance with Sec tion XIV 
of Annex III to Regulation (EC) No 853/2004, it must be produce d by a 
process that ensures that Category 3 material is subjected to a  treatment 
with acid or alkali, followed by one or more rinses.  
The pH must be adjusted subsequently. Gelatine must be extracte d by 
heating one or several times in succession, followed by purific ation by 
means of filtration and sterilisation.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 111
 
2. After having been subjected to the processes referred to in point 1, 
gelatine may undergo a drying process and, where appropriate, a  
process of pulverisation or lamination.  
3. The use of preservatives, other than sulphur dioxide and hyd rogen 
peroxide, shall be prohibited.  
C. Other requirements for gelatine  
Gelatine must be wrapped, packaged, stored and transported unde r satis­
factory hygiene conditions.  
In particular:  
(a) a room or a dedicated place must be provided for storing ma terials for 
wrapping and packaging;  
(b) wrapping and packaging must take place in a room or in a pl ace intended 
for that purpose.  
D. Processing standards for hydrolysed protein  
Hydrolysed protein must be produced using a production process involving 
appropriate measures to minimise contamination. Hydrolysed prot ein derived 
from ruminants shall have a molecular weight below 10 000 Dalto n. 
In addition to the requirements of the first paragraph, hydroly sed proteins 
entirely or partly derived from ruminants’ hides and skins shal l be produced 
in a processing plant dedicated only to hydrolysed protein prod uction, using 
a process involving the preparation of raw Category 3 material by brining, 
liming and intensive washing followed by exposure of the materi al to:  
(a) a pH of more than 11 for more than three hours at a tempera ture of more 
than 80 °C and subsequently by heat treatment at more than 140 °C for 
30 minutes at more than 3,6 bar; or  
(b) a pH of 1 to 2, followed by a pH of more than 11, followed by heat 
treatment at 140 °C for 30 minutes at 3 bar.  
Section 6  
Specific requirements for dicalcium phosphate  
A. Raw materials  
Only animal by-products which are Category 3 material or produc ts which 
are derived from such animal by-products, other than materials referred to in 
Article 10(m), (n), (o) and (p) of Regulation (EC) No 1069/2009  may be 
used for the production of dicalcium phosphate.  
B. Processing standards  
1. Dicalcium phosphate must be produced by a process that compr ises the 
three following stages:  
(a) firstly, ensures that all bone that is Category 3 material is finely 
crushed and degreased with hot water and treated with dilute hy dro­
chloric acid (at a minimum concentration of 4 % and a pH of les s 
than 1,5) over a period of at least two days;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 112
 
(b) secondly, following the part of the process referred to in point (a), 
applies a treatment of the obtained phosphoric liquor with lime , 
resulting in a precipitate of dicalcium phosphate at pH 4 to 7;  
(c) finally, air-dries the precipitate of dicalcium phosphate w ith inlet 
temperature of 65 °C to 325 °C and end temperature between 
30 °C and 65 °C.  
2. Where dicalcium phosphate is derived from defatted bones, it  shall be 
derived from bones referred to in Article 10(a) of Regulation ( EC) 
No 1069/2009.  
Section 7  
Specific requirements for tricalcium phosphate  
A. Raw materials  
Only animal by-products which are Category 3 material or produc ts which 
are derived from such animal by-products, other than materials referred to in 
Article 10(m), (n), (o) and (p) of Regulation (EC) No 1069/2009  may be 
used for the production of tricalcium phosphate.  
B. Processing standards  
Tricalcium phosphate must be produced by a process that ensures : 
(a) that all bone that is Category 3 material is finely crushed  and degreased 
in counterflow with hot water (bone chips must be less than 14 mm);  
(b) continuous cooking with steam at 145 °C during 30 minutes a t 4 bars;  
(c) separation of the protein broth from the hydroxyapatite (tr icalcium 
phosphate) by centrifugation;  
(d) granulation of the tricalcium phosphate after drying in a f luidised bed 
with air at 200 °C.  
Section 8  
Specific requirements for collagen  
A. Raw materials  
Only animal by-products which are Category 3 material or produc ts which 
are derived from such animal by-products, other than materials referred to in 
Article 10(m), (n), (o) and (p) of Regulation (EC) No 1069/2009  may be 
used for the production of collagen.  
B. Processing standards  
1. Unless the collagen has been produced in accordance with the  
requirements for collagen set out in Section XV of Annex III to  
Regulation (EC) No 853/2004, it must be produced by a process 
ensuring that unprocessed Category 3 material is subjected to a  
treatment involving washing, pH adjustment using acid or alkali  
followed by one or more rinses, filtration and extrusion.  
After that treatment collagen may undergo a drying process.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 113
 
2. The use of preservatives, other than those permitted under U nion legis­
lation shall be prohibited.  
C. Other requirements  
Collagen must be wrapped, packaged, stored and transported unde r satis­
factory hygiene conditions. In particular:  
(a) a room or a dedicated place must be provided for storing ma terials for 
wrapping and packaging;  
(b) wrapping and packaging must take place in a room or in a pl ace intended 
for that purpose.  
Section 9  
Specific requirements for egg products  
A. Raw materials  
Only animal by-products referred to in Article 10(e) and (f) an d 
Article 10(k)(ii) of Regulation (EC) No 1069/2009 may be used f or the 
production of egg products.  
B. Processing standards  
Egg products must have been:  
(a) submitted to any of the processing methods 1 to 5 or proces sing method 
7 set out in Chapter III of Annex IV;  
(b) submitted to another method and parameters which ensure tha t the 
products comply with the microbiological standards for derived 
products set out in Chapter I; or  
(c) treated in accordance with the requirements for eggs and eg g products set 
out in Chapters I, II and III of Section X of Annex III to Regu lation (EC) 
No 853/2004.  
▼M4 
Section 10  
Specific requirements for feeding to farmed animals, other than fur animals, 
of certain Category 3 material referred to Article 10(f) of Regulation (EC) 
No 1069/2009  
Category 3 material comprising of foodstuffs containing product s of animal 
origin originating from Member States which are no longer inten ded for 
human consumption for commercial reasons or due to problems of manufacturing 
or packaging defects or other defects from which no risk to pub lic or animal 
health arise, referred to in Article 10(f) of Regulation (EC) N o 1069/2009, may 
be placed on the market for feeding to farmed animals, other th an fur animals, 
without further treatment, provided that the material:  
(i) has undergone processing as defined in Article 2(1)(m) of R egulation (EC) 
No 852/2004 or in accordance with this Regulation;  
(ii) is composed of or contain one or more of the following Cat egory 3 materials 
referred to in Article 10(f) of Regulation (EC) No 1069/2009:  
— milk,  
— milk-based products,  
— milk-derived products,  
— eggs,  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 114
 
— egg products,  
— honey,  
— rendered fats,  
— collagen,  
— gelatine;  
(iii) has not been in contact with any other Category 3 materia ls; and  
(iv) all necessary precautions have been taken to prevent the c ontamination of 
the material.  
▼B 
CHAPTER III  
REQUIREMENTS FOR CERTAIN FISH FEED AND FISHING BAITS  
1. Animal by-products from fish or aquatic invertebrates and de rived products 
therefrom that are intended as feed for farmed fish or for othe r aquaculture 
species shall:  
(a) be handled and processed separately from material not autho rised for 
that purpose;  
(b) originate  
(i) from wild fish or other aquatic animals, except sea mammals , 
landed for commercial purposes, or from animal by-products from  
wild fish originating in plants manufacturing fish products for  
human consumption; or  
(ii) from farmed fish, provided it is fed to farmed fish of ano ther 
species;  
(c) be processed in a processing plant in accordance with a met hod which 
ensures a microbiologically safe product, including with regard  to fish 
pathogens.  
2. The competent authority may lay down conditions, aimed at pr eventing 
unacceptable risks for the transmission of diseases communicabl e to 
humans or animals, for the use of aquatic animals and of aquati c and 
terrestrial invertebrates:  
(a) as feed for farmed fish or for aquatic invertebrates, when the animal 
by-products have not been processed in accordance with point 1( c); 
(b) as fishing bait, including bait for aquatic invertebrates.  ▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 115
 
ANNEX XI  
ORGANIC FERTILISERS AND SOIL IMPROVERS  
CHAPTER I  
REQUIREMENTS FOR UNPROCESSED MANURE, PROCESSED 
MANURE AND DERIVED PRODUCTS FROM PROCESSED MANURE  
Section 1  
Unprocessed manure  
1. Trade in unprocessed manure of species other than poultry or  equidae 
between Member States shall be subject to the following conditi ons, in 
addition to the consent of the Member State of destination refe rred to in 
Article 48(1) of Regulation (EC) No 1069/2009:  
(a) Trade in unprocessed manure of species other than poultry o r equidae 
shall be prohibited, except for manure:  
(i) from an area which is not subject to restrictions by virtue  of a 
serious transmissible disease; and  
(ii) intended for application, under the supervision of the com petent 
authorities, to land forming part of a single holding located o n 
both sides of the border of two Member States.  
(b) However, the competent authority of the Member State of des tination 
may, having regard to the origin of the manure, its destination  and 
health considerations, grant specific authorisation for the int roduction 
on to its territory of:  
(i) manure intended for:  
— processing in a plant for the manufacture of derived products  
which are destined for uses outside the feed chain, or  
— transformation into biogas or composting in accordance with 
Regulation (EC) No 1069/2009 and with Annex V to this Regu­
lation with a view to the manufacture of the products referred to 
in Section 2 of this Chapter.  
In those cases, the competent authority shall take account of t he 
origin of the manure when authorising the introduction to such 
plants; or  
(ii) manure intended for applying to land on a holding, provide d that the 
competent authority of the Member State of origin has 
communicated its agreement to such trade.  
(c) in the cases referred to in point (b), a health attestation  in accordance 
with the model set out in point 3 shall be added to the commerc ial 
document which accompanies the consignment of manure.  
2. Trade in unprocessed poultry manure between Member States sh all be 
subject to the following conditions, in addition to the consent  of the 
Member State of destination referred to in Article 48(1) of 
Regulation (EC) No 1069/2009:  
(a) the manure must originate in an area which is not subject t o restrictions 
by virtue of Newcastle disease or avian influenza;  
(b) in addition, unprocessed manure from poultry flocks vaccina ted against 
Newcastle disease must not be dispatched to a region which has 
obtained Newcastle disease non-vaccinating status pursuant to 
Article 15(2) of Directive 2009/158/EC; and  
(c) a health attestation in accordance with the model set out i n point 3 shall 
be added to the commercial document which accompanies the 
consignment of manure.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 116
 
3. Model health attestation to be added to the commercial docum ent:
 ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 117
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 118
 
4. Unprocessed manure of equidae may be traded between Member S tates, 
provided that the Member State of destination has given its con sent to the 
trade as referred to in Article 48(1) of Regulation (EC) No 106 9/2009, and 
provided it does not originate from a holding subject to animal  health 
restrictions pertaining to glanders, vesicular stomatitis, anth rax or rabies in 
accordance with Article 4(5) of Directive 2009/156/EC.  
5. In accordance with Article 48(1)(c)(ii) of Regulation (EC) N o 1069/2009, 
the competent authority of the Member State of destination may require 
operators dispatching unprocessed manure from another Member St ate: 
(a) to transmit further information in relation to an intended dispatch, such 
as precise geographical indications regarding the place where t he manure 
is to be unloaded; and  
(b) to store the manure before application to land.  
6. The competent authority may authorise the dispatch of manure  transported 
between two points located on the same farm subject to conditio ns for the 
control of possible health risks, such as obligations for the o perators 
concerned to keep appropriate records.  
Section 2  
Guano from bats, processed manure and derived products from processed 
manure  
▼M1 
The placing on the market of processed manure, derived products  from processed 
manure and guano from bats shall be subject to the following co nditions. In 
addition, in the case of guano from bats the consent of the Mem ber State of 
destination is required as referred to in Article 48(1) of Regu lation (EC) 
No 1069/2009:  
▼B 
(a) They must come from a plant for derived products for uses o utside the feed 
chain or from a biogas or a composting plant or from a plant fo r the manu­
facturing of organic fertilisers or soil improvers.  
(b) They shall have been subjected to a heat treatment process of at least 70 °C 
for at least 60 minutes and they shall have been subjected to r eduction in 
spore-forming bacteria and toxin formation, where they are iden tified as a 
relevant hazard.  
(c) However, the competent authority may authorise the use of o ther stan­
dardised process parameters than those referred to in point (b) , provided 
an applicant demonstrates that such parameters ensure minimisin g of 
biological risks.  
That demonstration shall include a validation, which shall be c arried out as 
follows:  
(i) Identification and analysis of possible hazards including t he impact of 
input material, based on a full definition of the processing co nditions, 
and a risk assessment, which evaluates how the specific process ing 
conditions are achieved in practice under normal and atypical s ituations.  
(ii) Validation of the intended process  
(ii-1) by measuring the reduction of viability/infectivity of e ndogenous 
indicator organisms during the process, where the indicator is:  
— consistently present in the raw material in high numbers,  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 119
 
— not less heat resistant to the lethal aspects of the treatmen t 
process, but also not significantly more resistant than the 
pathogens for which it is being used to monitor,  
— relatively easy to quantify and relatively easy to identify a nd 
confirm; or  
(ii-2) by measuring the reduction of viability/infectivity, dur ing 
exposure, of a well-characterised test organism or virus 
introduced in a suitable test body into the starting material.  
(iii) The validation referred to in point (ii) must demonstrate  that the process 
achieves the following overall risk reduction:  
— for thermal and chemical processes by reduction of  Enterococcus 
faecalis  by at least 5 log10 and by reduction of infectivity titre of 
thermoresistant viruses such as  parvovirus , where they are identified 
as a relevant hazard, by at least 3 log10,  
— for chemical processes also by reduction of resistant parasit es such 
as eggs of  Ascaris  sp. by at least 99,9 % (3 log10) of viable stages.  
(iv) Designing a complete control programme including procedure s for 
monitoring the process.  
(v) Measures ensuring continuous monitoring and supervision of the 
relevant process parameters fixed in the control programme when  
operating the plant.  
Details on the relevant process parameters used in a plant as w ell as other 
critical control points shall be recorded and maintained so tha t the owner, 
operator or their representative and the competent authority ca n monitor the 
operation of the plant. Information relating to a process autho rised under this 
point must be made available to the Commission on request;  
(d) Representative samples of the manure taken during or immedi ately after 
processing at the plant in order to monitor the process must co mply with 
the following standards:  
Escherichia coli : n = 5, c = 5, m = 0, M = 1 000 in 1 g;  
or 
Enterococcaceae : n = 5, c = 5, m = 0, M = 1 000 in 1 g;  
and 
Representative samples of the manure taken during or on withdra wal from 
storage at the plant of production or the biogas or composting plant must 
comply with the following standards:  
Salmonella: absence in 25 g: n = 5; c = 0; m = 0; M = 0  
where:  
n = number of samples to be tested;  
m = threshold value for the number of bacteria; the result is c onsidered 
satisfactory if the number of bacteria in all samples does not exceed m;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 120
 
M = maximum value for the number of bacteria; the result is con sidered 
unsatisfactory if the number of bacteria in one or more samples  is M 
or more; and  
c = number of samples the bacterial count of which may be betwe en m 
and M, the sample still being considered acceptable if the bact erial 
count of the other samples is m or less.  
Processed manure or processed manure products not complying wit h the 
standards in this point shall be regarded as unprocessed;  
(e) They must be stored in such a way that once processed conta mination 
or secondary infection and dampness is minimised. They must the refore be 
stored in:  
(i) well-sealed and insulated silos or properly constructed sto rage sheds; or  
(ii) properly sealed packs, such as plastic bags or ‘big bags’.  
CHAPTER II  
REQUIREMENTS FOR CERTAIN ORGANIC FERTILISERS AND SOIL 
IMPROVERS  
Section 1  
Conditions for the production  
1. Organic fertilisers and soil improvers, other than manure, d igestive tract 
content, compost, milk, milk-based products, milk-derived produ cts, 
colostrum, colostrum products and digestion residues from the t ransformation 
of animal by-products or derived products into biogas, shall be  produced by:  
(a) applying processing method 1 (pressure sterilisation), when  Category 2 
material is used as starting material;  
▼M4 
(b) using processed animal protein, including processed animal protein 
produced in accordance with point B.1(b)(ii) of Section 1 of Ch apter 
II of Annex X, which has been produced from Category 3 material  in 
accordance with Section 1 of Chapter II of Annex X, or material s which 
have been subject to another treatment, where such materials ma y be 
used for organic fertilisers and soil improvers in accordance w ith this 
Regulation; or  
▼B 
(c) by applying any of the processing methods 1 to 7, as set ou t in 
Chapter III of Annex IV, when Category 3 material is used as st arting 
material which is not used for the production of processed anim al 
protein.  
2. Organic fertilisers and soil improvers which consist of or w hich have been 
produced from meat-and-bone meal derived from Category 2 materi al or 
from processed animal protein, shall be mixed, in a registered establishment 
or plant, with a sufficient minimum proportion of a component w hich is 
authorised by the competent authority of the Member State where  the 
product is to be applied to land, in order to exclude the subse quent use of 
the mixture for feeding purposes.  
3. The competent authority shall authorise the component referr ed to in point 2 
according to the following:  
(a) the component shall consist of lime, manure, urine, compost  or digestion 
residues from the transformation of animal by-products into bio gas or 
other substances, such as mineral fertilisers, which are not us ed in animal 
feed and which exclude the subsequent use of the mixture for fe eding 
purposes according to good agricultural practice;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 121
 
(b) the component shall be determined based on an assessment of  the 
climatic and soil conditions for the use of the mixture as a fe rtiliser, 
on indications that the component renders the mixture unpalatab le to 
animals or it is otherwise effective in preventing misuse of th e mixture 
for feeding purposes and in accordance with the requirements la id down 
in Union legislation or, where applicable, national legislation , for the 
protection of the environment regarding the protection of soil and 
groundwater.  
The competent authority shall make the list of the authorised c omponents 
available to the Commission and to other Member States upon req uest. 
4. However, the requirements referred to in point 2 shall not a pply:  
(a) to organic fertilisers and soil improvers which are in read y-to-sell 
packages of not more than 50 kg in weight for use by the final 
consumer; or  
(b) to organic fertilisers and soil improvers in big bags of no t more than 
1 000 kg in weight, on the packages of which it is indicated th at the 
organic fertilisers are not destined to land to which farmed an imals have 
access, provided that the competent authority of the Member Sta te where 
the organic fertiliser or soil improver is to be applied to lan d, has auth­
orised the use of such big bags on the basis of an assessment o f the 
likelihood of a potential diversion of the materials to farms k eeping 
animals or to land to which farmed animals have access.  
5. Producers of organic fertilisers and soil improvers must ens ure that decon­
tamination of pathogens is carried out prior to their placing o n the market, in 
accordance with:  
— Chapter I of Annex X, in the case of processed animal protein  or derived 
products from Category 2 or Category 3 material,  
— Section 3 of Chapter III of Annex V in the case of compost an d digestion 
residues from the transformation of animal by-products or deriv ed 
products into biogas.  
Section 2  
Storage and transport  
After processing or transformation, organic fertilisers and soi l improvers shall be 
properly stored and transported:  
(a) in bulk, under appropriate conditions that prevent contamin ation;  
(b) packaged or in big bags, in the case of organic fertilisers  or soil improvers 
destined for sale to final users; or  
(c) in the case of storage on farm, in an adequate storage spac e to which no 
farmed animals have access.  
▼M9 
Section 3  
Requirements for approval of establishments or plants  
In order to be approved in accordance with Article 24(1)(f) of Regulation (EC) 
No 1069/2009, operators shall ensure that establishments or pla nts carrying out 
the activities referred to in point 1 of Section 1 meet the req uirements laid down 
in Article 8 of this Regulation and:  
(a) have adequate facilities for storage of incoming ingredient s to prevent 
cross-contamination and avoid contamination 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.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 122
 
ANNEX XII  
INTERMEDIATE PRODUCTS  
In accordance with Article 34(2) of Regulation (EC) No 1069/200 9, the 
following conditions shall apply to the importation and transit  through the 
Union of intermediate products:  
1. The import and transit of intermediate products shall be aut horised, provided 
that: 
(a) they are derived from the following materials:  
(i) Category 3 material, other than materials referred to in Ar ticle 10(c), 
(n), (o) and (p) of Regulation (EC) No 1069/2009;  
(ii) products generated by the animals referred to in Article 1 0(i), (l) and 
(m) of Regulation (EC) No 1069/2009; or  
(iii) mixtures of the materials referred to in points (i) and ( ii); 
(b) in the case of intermediate products destined for the produ ction of medical 
devices, in vitro diagnostic medical devices and laboratory rea gents, they 
are derived from:  
(i) materials which fulfil the criteria referred to in point (a ), except that 
they may have originated from animals which have been submitted  to 
illegal treatment as defined in Article 1(2)(d) of Directive 96 /22/EC 
or Article 2(b) of Directive 96/23/EC;  
(ii) Category 2 material referred to in Article 9(f) and (h) of  
Regulation (EC) No 1069/2009; or  
(iii) mixtures of the materials referred to in points (i) and ( ii); 
(c) in the case of intermediate products destined for the produ ction of active 
implantable medical devices, medicinal products and veterinary medicinal 
products, they are derived from the materials referred to in po int (b), 
where the competent authority considers the use of such materia ls 
justified for the protection of public or animal health;  
(d) they come from a third country listed as a member of the Wo rld Organi­
sation for Animal Health (OIE) in the OIE bulletin;  
(e) they come from an establishment or plant registered or appr oved by the 
competent authority of a third country referred to in point (d) , in 
accordance with the conditions set out in point 2;  
(f) each consignment is accompanied by a declaration of the imp orter in 
accordance with the model declaration set out in Chapter 20 of 
Annex XV, which must be at least in one of the official languag es of 
the Member State in which the inspection at the border inspecti on post 
must be carried out and of the Member State of destination; the se Member 
States may allow the use of other languages and request officia l trans­
lations for declarations in such other languages;  
(g) in the case of materials referred to in point (b), the impo rter demonstrates 
to the competent authority that the materials:  
(i) do not carry any risk of transmission of a disease communic able to 
humans or animals; or  
(ii) are transported under conditions which prevent the transmi ssion of 
any diseases communicable to humans or animals.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 123
 
2. An establishment or plant may be registered or approved by t he competent 
authority of a third country, as referred to in point 1(e), pro vided that:  
(a) the operator or owner of the plant or his representative:  
(i) demonstrates that the plant has adequate facilities for the  trans­
formation of the materials referred to in point 1(a), (b) or (c ), as 
applicable, to ensure the completion of the necessary design, t rans­
formation and manufacturing stages;  
(ii) establishes and implements methods of monitoring and check ing the 
critical control points on the basis of the process used;  
(iii) keeps a record of the information obtained pursuant to po int (ii) for a 
period of at least two years for submission to the competent 
authority;  
(iv) informs the competent authority if any available informati on reveals 
the existence of a serious animal health or public health risk;  
(b) the competent authority of the third country carries out, a t regular 
intervals, inspections of the establishment or plant and superv ises the 
plant in accordance with the following conditions:  
(i) the frequency of inspections and supervision shall depend o n the size 
of the plant, the type of products manufactured, risk assessmen t and 
guarantees offered, based on a system of checks which has been set 
up in accordance with the hazard analysis and critical control 
points (HACCP) principles;  
(ii) if the inspection carried out by the competent authority r eveals that 
the provisions of this Regulation are not being complied with, the 
competent authority shall take appropriate action;  
(iii) the competent authority shall draw up a list of establish ments or 
plants approved or registered in accordance with this Annex and  
shall assign an official number to each plant, which identifies  the 
establishment or plant with respect to the nature of its activi ties; that 
list and subsequent amendments to it shall be submitted to the 
Member State where the inspection at the border inspection post  
must be carried out and to the Member State of destination.  
▼M9 
3. The intermediate products imported into the Union shall be c hecked at the 
border inspection post in accordance with Article 4 of Directiv e 97/78/EC and 
transported directly from the border inspection post either to:  
(a) a registered establishment or plant for the production of l aboratory 
reagents, medical devices and  in vitro  diagnostic medical devices for 
veterinary purposes or the derived products referred to in Arti cle 33 of 
Regulation (EC) No 1069/2009, where the intermediate products m ust be 
further mixed, used for coating, assembled or packaged before t hey are 
placed on the market or put into services in accordance with th e Union 
legislation applicable to the derived product;  
▼B 
(b) an establishment or plant which has been approved for the s torage of 
animal by-products in accordance with Article 24(1)(i) of 
Regulation (EC) No 1069/2009, from where they must only be disp atched 
to an establishment or plant referred to in (a) of this point f or the uses 
referred to in (a).  
4. Intermediate products in transit through the Union shall be transported in 
accordance with Article 11 of Directive 97/78/EC.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 124
 
5. The official veterinarian at the border inspection post conc erned shall inform 
the authority in charge of the establishment or plant at the pl ace of destination 
of the consignment by means of the TRACES system.  
6. The operator or owner of the establishment or plant of desti nation or his 
representative shall keep records in accordance with Article 22  of 
Regulation (EC) No 1069/2009 and shall provide the competent au thority 
on request with the necessary details of purchases, sales, uses , stocks and 
disposals of surplus of the intermediate products for the purpo ses of 
checking compliance with this Regulation.  
7. The competent authority shall ensure, in accordance with Dir ective 97/78/EC, 
that the consignments of intermediate products are sent from th e Member 
State where the inspection at the border inspection post must b e carried out 
to the plant of destination, as referred to in point 3 or, in t he case of transit, to 
the border inspection post of exit.  
8. The competent authority shall carry out documentary checks a t regular 
intervals for the purpose of reconciliation of the quantities o f intermediate 
products imported on the one hand, and stocked, used, dispatche d or disposed 
of on the other, in order to check compliance with this Regulat ion. 
9. For consignments of intermediate products in transit, the co mpetent authorities 
responsible for the border inspection posts of entry and of exi t respectively 
shall cooperate as necessary to ensure that effective checks ar e carried out and 
to ensure the traceability of such consignments.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 125
 
ANNEX XIII  
PETFOOD AND CERTAIN OTHER DERIVED PRODUCTS  
CHAPTER I  
General requirements  
Petfood plants and establishments or plants producing derived p roducts referred 
to in this Annex shall have adequate facilities for:  
(a) storing and treating incoming material under conditions whi ch prevent the 
introduction of risks to public and animal health;  
(b) disposing of unused animal by-products and derived products  remaining after 
production, unless the unused material is sent for processing o r disposal to 
another establishment or plant, in accordance with this Regulat ion. 
CHAPTER II  
Specific requirements for petfood, including dogchews  
1. Raw petfood  
Operators may only manufacture raw petfood from Category 3 mate rial 
referred to in Article 10(a) and Article 10(b)(i) and (ii) of R egulation (EC) 
No 1069/2009.  
Raw petfood must be packed in new packaging preventing any leak age. 
Effective steps must be taken to ensure that the product is not  exposed to 
contamination throughout the production chain and up to the poi nt of sale.  
2. Raw material for processed petfood and for dogchews  
Operators may manufacture processed petfood and dogchews only f rom:  
(a) Category 3 material, other than material referred to in Art icle 10(n), (o) 
and (p) of Regulation (EC) No 1069/2009; and  
(b) in the case of imported petfood or petfood produced from im ported 
materials, from Category 1 material comprising of animal by-pro ducts 
derived from animals which have been submitted to illegal treat ment as 
defined in Article 1(2)(d) of Directive 96/22/EC or Article 2(b ) of 
Directive 96/23/EC.  
3. Processed petfood  
(a) Canned petfood must be subjected to heat treatment to a min imum Fc 
value of 3.  
(b) Processed petfood other than canned petfood must:  
(i) be subjected to a heat treatment of at least 90 °C througho ut the 
substance of the final product;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 126
 
(ii) be subjected to a heat treatment to at least 90 °C of the ingredients 
of animal origin; or  
(iii) be produced as regards feed material of animal origin exc lusively 
using:  
— animal by-products or derived products from meat or meat 
products which have been subject to a heat treatment of at 
least 90 °C throughout their substance;  
— the following derived products which have been produced in 
accordance with the requirements of this Regulation: milk and 
milk-based products, gelatine, hydrolysed protein, egg products , 
collagen, blood products referred to in Section 2 of Chapter II  of 
Annex X, processed animal protein including fishmeal, rendered 
fat, fish oils, dicalcium phosphate, tricalcium phosphate or 
flavouring innards;  
(iv) if authorised by the competent authority, be subject to a treatment 
such as drying or fermentation, which ensures that the petfood poses 
no unacceptable risks to public and animal health;  
(v) in the case of animal by-products referred to in Article 10 (l) and (m) 
of Regulation (EC) No 1069/2009 and in the case of animal 
by-products generated by aquatic animals, aquatic and terrestri al 
invertebrates, and if authorised by the competent authority, be  
subject to a treatment which ensures that the petfood poses no unac­
ceptable risks to public and animal health.  
After production, every precaution must be taken to ensure that  such 
processed petfood is not exposed to contamination.  
The processed petfood must be packaged in new packaging.  
4. Dogchews must be subjected to a treatment that is sufficient  to destroy 
pathogenic organisms, including salmonella.  
After that treatment, every precaution must be taken to ensure that such 
dogchews are not exposed to contamination.  
The dogchews must be packed in new packaging.  
5. Random samples must be taken from dogchews and from processe d petfood, 
other than from canned petfood and other than from such process ed petfood 
which has been treated in accordance in point 3(b)(v), during p roduction 
and/or during storage (before dispatch) to verify compliance wi th the 
following standards:  
Salmonella: absence in 25 g, n = 5, c = 0, m = 0, M = 0.  
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 g  
Where:  
n = number of samples to be tested;  
m = threshold value for the number of bacteria; the result shal l be 
considered satisfactory if the number of bacteria in all sample s does 
not exceed m;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 127
 
M = maximum value for the number of bacteria; the result shall be 
considered unsatisfactory if the number of bacteria in one or m ore 
samples is M or more; and  
c = number of samples the bacterial count of which may be betwe en m 
and M, the sample shall still be considered acceptable if the b acterial 
count of the other samples is m or less.  
▼M23  
6. Random samples must be taken from raw petfood during product ion and/or 
during storage (before dispatch) to verify compliance with the following 
standards:  
Salmonella: absence in 25 g, n = 5, c = 0, m = 0, M = 0.  
The process of production of raw petfood shall meet the followi ng process 
hygiene criterion:  
Enterobacteriaceae: n = 5, c = 2, m = 500 in 1 g, M = 5 000 in 1 g 
Where:  
n = number of samples to be tested;  
m = threshold value for the number of bacteria; the result shal l be 
considered satisfactory if the number of bacteria in all sample s does 
not exceed m;  
M = maximum value for the number of bacteria; the result shall be 
considered unsatisfactory if the number of bacteria in one or m ore 
samples is M or more; and  
c = number of samples the bacterial count of which may be betwe en m and 
M, the sample shall still be considered acceptable if the bacte rial count 
of the other samples is m or less.  
Operators shall take measures, as part of their procedures base d on hazard 
analysis and critical control points (HACCP) principles, to ens ure that the 
supply, handling and processing of raw materials and raw petfoo d under their 
control are carried out in such a way that the above mentioned safety 
standards and the process hygiene criterion are met. In the cas e the safety 
standards and the process hygiene criterion are not meet the op erator shall 
take proportionate corrective actions in accordance with the wr itten 
procedure referred to in the introductory sentence of Article 2 9(1) of 
Regulation (EC) No 1069/2009 and the procedures based on HACCP prin­
ciples as set out in points (e) and (f) of Article 29(2) of tha t Regulation.  
The non-compliance and, where determined, its cause, the applie d corrective 
actions and the results of the control measures shall be notifi ed to the 
competent authority. Where the competent authority is not satis fied that 
the necessary corrective actions have been taken it can impose on the 
operator extra actions, including labelling for handling, and m ay require 
the microbiological investigation of further samples to be take n by the 
operator.  
▼B 
7. End point for processed petfood and dogchews  
The following may be placed on the market without restrictions in 
accordance with this Regulation:  
(a) processed petfood  
(i) which has been manufactured and packaged in the Union in 
accordance with point 3 and which has been tested in accordance  
with point 5; or  
(ii) which has been subject to veterinary checks in accordance with 
Directive 97/78/EC at a border inspection post.  
(b) dogchews  
(i) which have been manufactured and packaged in the Union in 
accordance with point 4 and which has been tested in accordance  
with point 5; or  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 128
 
(ii) which have been subject to veterinary checks in accordance  with 
Directive 97/78/EC at a border inspection post.  
CHAPTER III  
Specific requirements for flavouring innards for the manufacture of petfood  
1. Operators may only use animal by-products which may be used as raw 
material for processed petfood and dogchews in accordance with point 2 
of Chapter II for the production of liquid or dehydrated derive d products 
used to enhance the palatability values of petfood.  
2. Flavouring innards must have been submitted to a treatment m ethod and 
parameters, which ensure that the product complies with the mic robiological 
standards set out in point 5 of Chapter II of this Annex. After  treatment, 
every precaution must be taken to ensure that the product is no t exposed to 
contamination.  
3. The end product must be:  
(a) packed in new or sterilised packaging; or  
(b) transported in bulk in containers or other means of transpo rt that were 
thoroughly cleaned and disinfected.  
CHAPTER IV  
Specific requirements for blood and blood products from equidae  
The placing on the market of blood and blood products from equi dae for 
purposes other than in feed shall be subject to the following c onditions:  
1. Blood may be placed on the market for such purposes provided  that it has 
been collected:  
(a) from equidae which:  
(i) at inspection on the date of blood collection do not show c linical 
signs of any of the compulsorily notifiable diseases listed in Annex I 
to Directive 2009/156/EC and of equine influenza, equine piro­
plasmosis, equine rhinopneumonitis and equine viral arteritis l isted 
in point 4 of Article 1.2.3. of the Terrestrial Animal Health C ode of 
the OIE, 2010 edition;  
(ii) have been kept for a period of at least 30 days prior to t he date of 
and during blood collection on holdings under veterinary superv ision 
which were not subject to a prohibition order pursuant to Artic le 4(5) 
of Directive 2009/156/EC or restrictions pursuant to Article 5 of that 
Directive;  
(iii) for the periods laid down in Article 4(5) of Directive 20 09/156/EC 
had no contact with equidae from holdings which were subject to  a  
prohibition order for animal health reasons pursuant to that Ar ticle 
and for a period of at least 40 days prior to the date of and d uring 
blood collection had no contact with equidae from a Member Stat e or 
third country not considered free of African horse sickness in 
accordance with points (a) and (b) of the first subparagraph of  
Article 5(2) of that Directive;  
(b) under veterinary supervision either:  
(i) in slaughterhouses registered or approved in accordance wit h 
Regulation (EC) No 853/2004; or  
(ii) in facilities approved, furnished with a veterinary approv al number 
and supervised by the competent authority for the purpose of 
collecting blood from equidae for the production of blood produ cts 
for purposes other than feeding.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 129
 
2. Blood products may be placed on the market for such purposes  provided that:  
(a) all precautions have been taken to avoid contamination of t he blood 
products with pathogenic agents during production, handling and  
packaging;  
(b) the blood products have been produced from blood which:  
(i) either fulfils the conditions set out in point 1(a); or  
(ii) has been subjected to at least one of the following treatm ents, 
followed by an effectiveness check, for the inactivation of pos sible 
causative pathogens for African horse sickness, equine encephal o­
myelitis of all types including Venezuelan equine encephalomyel itis, 
equine infectious anaemia, vesicular stomatitis and glanders ( Burk­
holderia mallei ): 
— heat treatment at a temperature of 65 °C for at least three h ours,  
— irradiation at 25 kGy by gamma rays,  
— change in pH to pH 5 for two hours,  
— heat treatment of at least 80 °C throughout their substance.  
3. Blood and blood products from equidae must be packed in seal ed imper­
meable containers which, in the case of blood from equidae, bea r the 
approval number of the slaughterhouse or facilities of collecti on referred to 
in point 1(b).  
CHAPTER V  
Specific requirements for hides and skins of ungulates and products derived 
therefrom  
A. Establishments and plants  
The competent authority may authorise plants handling hides and  skins, 
including limed hides, to supply trimmings and splittings of th ese hides 
and skins for the production of gelatine for animal consumption , organic 
fertilisers or soil improvers, provided that:  
(a) the plant has storage rooms with hard floors and smooth wal ls that are 
easy to clean and disinfect and, where appropriate, provided wi th refrig­
eration facilities;  
(b) the storage rooms are kept in a satisfactory state of clean liness and 
repair, so that they do not constitute a source of contaminatio n for the 
raw materials;  
(c) if raw material not in conformity with this Chapter is stor ed and/or 
processed in these premises, it must be segregated from raw mat erial 
in conformity with this Chapter throughout the period of receip t, storage, 
processing and dispatch;  
(d) in the case of trimmings and splittings derived from limed hides, the 
trimmings and splittings are submitted to a treatment which ens ures that 
no risks to public and animal health remain before being used f or the 
production of:  
(i) gelatine for animal consumption; or  
(ii) organic fertilisers or soil improvers.  
B. Placing on the market of animal by-products and of derived p roducts  
1. Untreated hides and skins may be placed on the market subjec t to the 
health conditions applicable to fresh meat pursuant to Directiv e 
2002/99/EC.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 130
 
2. Treated hides and skins may be placed on the market, provide d that:  
(a) they have not been in contact with other animal products or  live 
animals presenting a risk of spreading a serious transmissible disease;  
(b) the commercial document laid down in Chapter III of Annex V III 
contains a statement indicating that all precautions have been taken to 
avoid contamination with pathogenic agents.  
C. End point for hides and skins  
1. Hides and skins of ungulates which pursuant to the decision of an 
operator are destined for purposes other than human consumption , and 
which comply with the requirements of Regulation (EC) No 853/20 04 for 
raw materials for gelatine or collagen intended for use in food  may be 
placed on the market without restrictions in accordance with th is Regu­
lation.  
2. The following treated hides and skins may be placed on the m arket 
without restrictions in accordance with this Regulation:  
(a) hides and skins having undergone the complete process of ta nning;  
(b) ‘wet blue’;  
(c) ‘pickled pelts’;  
(d) limed hides (treated with lime and in brine at a pH of 12 t o 13 for at 
least eight hours).  
3. By way of derogation from point C.2, the competent authority  may 
require that consignments of treated hides and skins referred t o in 
point 2(c) and (d) are accompanied by a commercial document in 
accordance with the model set out under point 6 of Chapter III of 
Annex VIII, when they are supplied to establishments or plants 
producing petfood, organic fertilisers or soil improvers or tra nsforming 
those materials into biogas.  
CHAPTER VI  
Specific requirements for game trophies and other preparations from 
animals  
A. The provisions of this Chapter are without prejudice to the measures for the 
protection of wild fauna, adopted pursuant to Regulation (EC) N o 338/97.  
B. Safe sourcing  
Game trophies and other preparations from animals, where for th e prep­
aration the animal by-products have been submitted to a treatme nt or are 
presented in a state which does not pose any health risks, may be placed on 
the market, provided they originate from:  
(a) species other than ungulates, birds and animals of the biol ogical class 
Insecta or Arachnida; and  
(b) animals originating in an area not subject to restrictions as a result of the 
presence of serious transmissible diseases to which animals of the species 
concerned are susceptible.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 131
 
C. Safe treatment  
1. Game trophies or other preparations from animals, where for the prep­
aration the animal by-products have been submitted to a treatme nt or are 
presented in a state which does not pose any health risks, may be placed 
on the market, provided they:  
(a) originate from ungulates or birds which have undergone a co mplete 
taxidermy treatment ensuring their preservation at ambient 
temperatures;  
(b) are mounted ungulates or birds or mounted parts of such ani mals;  
▼M4 
(c) have been subject to an anatomical preparation such as by p lasti­
nation;  
(d) are animals of the biological class Insecta or Arachnida wh ich have 
been subject to a treatment, such as drying, to prevent any tra ns­
mission of diseases communicable to humans or animals; or  
▼M23  
(e) are objects in natural history collections or for the promo tion of 
science and are  
(i) preserved in media, such as alcohol or formaldehyde, which 
allow display of the items;  
(ii) embedded completely in micro-slides; or  
(iii) composed of entire skeletons or parts thereof, bones or t eeth, to 
be exchanged exclusively between museums and educational 
institutions;  
▼M4 
(f) are processed DNA samples intended for repositories for the  
promotion of biodiversity research, ecology, medical and veteri nary 
science or biology.  
▼B 
2. Game trophies or other preparations, other than those referr ed to under 
points B and C.1, which come from animals originating in an are a subject 
to restrictions as a result of the presence of serious transmis sible diseases 
to which animals of the species concerned are susceptible, may be placed 
on the market, provided that:  
(a) in the case of game trophies or other preparations solely o f bone, 
horns, hooves, claws, antlers or teeth,  
(i) they have been immersed in boiling water for an appropriate  
time so as to ensure that any matter other than bone, horns, 
hooves, claws, antlers or teeth is removed;  
(ii) they have been disinfected with a product authorised by th e 
competent authority, in particular with hydrogen peroxide 
where parts consisting of bone are concerned;  
(iii) they have been packaged, immediately after treatment, wit hout 
being in contact with other products of animal origin likely to  
contaminate them, in individual, transparent and closed package s 
so as to avoid any subsequent contamination; and  
(iv) they are accompanied by a health certificate certifying th at the 
conditions set out in (i), (ii) and (iii) have been met;  
(b) in case of game trophies or other preparations consisting s olely of 
hides or skin,  
(i) they have been:  
— dried,  
— dry- or wet-salted for a period of at least 14 days before th e 
date of dispatch, or  
— subject to a preservation process other than tanning;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 132
 
(ii) they have been packaged, immediately after treatment, with out 
being in contact with other products of animal origin likely to  
contaminate them, in individual, transparent and closed package s 
so as to avoid any subsequent contamination; and  
(iii) they are accompanied by a commercial document or a health  
certificate certifying that the conditions set out in (i) and ( ii) 
have been met.  
CHAPTER VII  
Specific requirements for wool, hair, pig bristles, feathers, parts of feathers 
and down  
A. Raw material  
1. Untreated wool, untreated hair, untreated pig bristles and u ntreated 
feathers, parts of feathers and down must be Category 3 materia ls 
referred to in Article 10(b) (iii), (iv) and (v) and Article 10 (h) and (n) 
of Regulation (EC) No 1069/2009.  
They must be securely enclosed in packaging and dry.  
However, in the case of untreated feathers, parts of feathers a nd down 
sent directly from the slaughterhouse to the processing plant, the 
competent authority may allow a derogation from the requirement  to 
dry materials transported on its territory, provided that:  
(a) all necessary measures are taken to avoid any possible spre ad of 
disease;  
(b) the transport takes place in waterproof containers and/or v ehicles 
which must be cleaned and disinfected immediately after each us e. 
▼M2 
2. Movements of pig bristles and wool and hair of animals of th e porcine 
species from regions in which African swine fever is endemic sh all be 
prohibited except for pig bristles and wool and hair of animals  of the 
porcine species that have:  
▼B 
(a) been boiled, dyed or bleached; or  
(b) undergone some other form of treatment which is certain to kill 
pathogenic agents, provided that evidence to this effect is 
submitted in the form of a certificate from the veterinarian 
responsible for the place of origin. Factory washing may not be  
regarded as a form of treatment for the purposes of this provis ion. 
3. The provisions of point 1 shall not apply to decorative feat hers or 
feathers:  
(a) carried by travellers for their private use; or  
(b) in the form of consignments sent to private individuals for  
non-industrial purposes.  
B. End point for wool and hair  
Factory-washed wool and hair, and wool and hair which has been treated by 
another method which ensures that no unacceptable risks remain,  may be 
placed on the market without restrictions in accordance with th is Regulation.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 133
 
Member States may authorise the placing on the market of untrea ted wool 
and hair from farms or from establishments or plants which have  been 
registered in accordance with Article 23 of Regulation (EC) No 1069/2009 
or approved in accordance with Article 24(1)(i) of the same Reg ulation on 
their territory without restrictions in accordance with this Re gulation, if they 
are satisfied that no unacceptable risks to public and animal h ealth arise from 
the wool and from the hair.  
▼M2 
Wool and hair produced from animals other than those of the por cine species 
may be placed on the market without restrictions in accordance with this 
Regulation, provided:  
(a) it has undergone factory-washing which consists of the imme rsion of the 
wool and hair in series of baths of water, soap and sodium hydr oxide or 
potassium hydroxide; or  
(b) it is dispatched directly to a plant producing derived prod ucts from wool 
or hair for the textile industry and such wool or hair has unde rgone at 
least one of the following treatments:  
(i) chemical depilation by means of slaked lime or sodium sulph ide; 
(ii) fumigation in formaldehyde in a hermetically sealed chambe r for at 
least 24 hours;  
(iii) industrial scouring which consists of the immersion of wo ol and hair 
in a water-soluble detergent held at 60–70 °C;  
(iv) storage, which may include the journey time, at 37 °C for eight 
days, 18 °C for 28 days or 4 °C for 120 days.  
▼B 
C. End point for feathers and down  
Feathers, parts of feathers and down which have been factory-wa shed and 
treated with hot steam at 100 °C for at least 30 minutes may be  placed on the 
market without restrictions in accordance with this Regulation.  
CHAPTER VIII  
Specific requirements for furs  
End point  
Furs which have been dried at an ambient temperature of 18 °C f or two days at a 
humidity of 55 % may be placed on the market without restrictio ns in accordance 
with this Regulation.  
CHAPTER IX  
Specific requirements for apiculture by-products  
Apiculture by-products intended exclusively for use in apicultu re must:  
1. not come from an area which is subject of a prohibition orde r associated with 
an occurrence of:  
(a) American foulbrood ( Paenibacillus larvae larvae ), except where the 
competent authority has assessed the risk to be negligible, iss ued a 
specific authorisation for use only in that Member State, and t aken all 
other necessary measures to ensure no spread of that disease;  
(b) acariosis ( Acarapis woodi  (Rennie)), except where the area of destination 
has obtained additional guarantees in accordance with Article 1 4(2) of 
Directive 92/65/EEC;  
(c) small hive beetle ( Aethina tumida ); or ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 134
 
(d) Tropilaelaps mite ( Tropilaelaps  spp.); and  
2. meet the requirements provided for in Article 8(a) of Direct ive 92/65/EEC.  
CHAPTER X  
Specific requirements for rendered fats from Category 1 or Category 2 
materials for oleochemical purposes  
1. Rendered fats derived from Category 1 material or from Categ ory 2 material 
which are destined for oleochemical purposes must be produced u sing any of 
the processing methods 1 to 5 as set out in Chapter III of Anne x IV.  
2. Rendered fats derived from ruminant animals must be purified  in such a way 
that the maximum level of remaining total insoluble impurities does not 
exceed 0,15 % in weight.  
CHAPTER XI  
Specific requirements for fat derivatives  
1. The following processes may be used to produce fat derivativ es from rendered 
fats derived from Category 1 and Category 2 material:  
▼M23  
(a) transesterification or hydrolysis at a temperature of at le ast 200 °C, under 
corresponding appropriate pressure, for at least 20 minutes (gl ycerol, fatty 
acids and esters);  
▼B 
(b) saponification with NaOH 12M (glycerol and soap):  
(i) in a batch process at 95 °C for three hours; or  
(ii) in a continuous process at 140 °C 2 bars (2 000 hPa) for e ight 
minutes; or  
(c) hydrogenation at 160 °C at 12 bars (12 000 hPa) for 20 minu tes. 
2. Fat derivatives produced in accordance with this Chapter may  only be placed 
on the market:  
(a) for uses other than in feed, cosmetics and medicinal produc ts; 
(b) in addition, in the case of fat derivatives from Category 1  material, for 
uses other than in organic fertilisers and soil improvers.  
▼M4 
3. End point for products derived from rendered fats:  
Fat derivatives which have been processed as referred to in poi nt 1 may be 
placed on the market for uses indicated in point 2 without rest rictions in 
accordance with this Regulation.  
▼B 
CHAPTER XII  
Specific requirements for horns and horn products, excluding horn meal, 
and hooves and hoof products, excluding hoof meal, intended for the 
production of organic fertilisers or soil improvers  
The placing on the market of horns and horn products, excluding  horn meal, and 
hooves and hoof products, excluding hoof meal, intended for the  production of 
organic fertilisers or soil improvers shall be subject to the f ollowing conditions:  
(a) they must originate from animals that:  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 135
 
(i) either have been slaughtered in a slaughterhouse, after und ergoing an 
ante-mortem inspection, and were found fit, as a result of such  
inspection, for slaughter for human consumption in accordance w ith 
Union legislation; or  
(ii) did not show clinical signs of any disease communicable th rough that 
product to humans or animals;  
(b) they must have undergone a heat treatment for one hour at a  core temperature 
of at least 80 °C;  
(c) the horns must be removed without opening the cranial cavit y; 
(d) at any stage of processing, storage or transport, every pre caution shall be 
taken to avoid cross-contamination;  
(e) they shall be packed either in new packaging or containers;  or transported in 
vehicles or bulk containers which have been disinfected prior t o loading 
using a product approved by the competent authority;  
(f) the packaging or containers must:  
(i) indicate the type of product (such as horns, horn products,  hooves or 
hoof products);  
(ii) be marked with the name and address of the approved or reg istered 
establishment or plant of destination.  
▼M1 
CHAPTER XIII  
Specific requirements for fish oil for the production of medicinal products  
End point for fish oil for the production of medicinal products  
Fish oil derived from the materials referred to in point A.2 of  Section 3 of 
Chapter II of Annex X, which has been de-acidified with a NaOH solution at 
a temperature of 80 °C or more and which has subsequently been purified by 
distillation at a temperature of 200 °C or more, may be placed on the market for 
the production of medicinal products without restrictions in ac cordance with this 
Regulation.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 136
 
ANNEX XIV  
IMPORTATION, EXPORT AND TRANSIT  
CHAPTER I  
SPECIFIC REQUIREMENTS FOR THE IMPORTATION INTO AND 
TRANSIT THROUGH THE UNION OF CATEGORY 3 MATERIAL 
AND DERIVED PRODUCTS FOR USES IN THE FEED CHAIN 
OTHER THAN FOR PETFOOD OR FOR FEED TO FUR ANIMALS  
Section 1  
As referred to in Article 41(1)(a) and Article 41(3) of Regulat ion (EC) 
No 1069/2009, the following requirements shall apply to importe d consignments 
of Category 3 material and derived products therefrom for uses in the feed chain 
other than for petfood or for feed to fur animals and consignme nts of such 
materials and products in transit:  
(a) they must consist of or have been produced from, as applica ble, Category 3 
material referred to in the column ‘raw materials’ of Table 1;  
(b) they must comply with the import and transit conditions set  out in the 
column ‘import and transit conditions’ of Table 1;  
▼M4 
(c) they must come from a third country or part of a third coun try listed in the 
column ‘third countries’ list’ of Table 1;  
(d) they must come from an establishment or plant which is regi stered or 
approved by the competent authority of the third country, as ap plicable, 
and which is on the list of such establishments and plants refe rred to in 
Article 30; and  
(e) they must be:  
(i) accompanied during transportation to the point of entry int o the Union 
where the veterinary checks take place by the health certificat e referred 
to in the column ‘certificates/model documents’ of Table 1; or  
(ii) presented at the point of entry into the Union where the v eterinary 
checks take place accompanied by a document corresponding to th e 
model referred to in the column ‘certificates/model documents’ of 
Table 1.  
__________  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 137
 02011R0142 — EN — 01.01.2021 — 021.001 — 138
 ▼B 
Table 1  
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
▼M12  
1 Processed animal protein, 
including mixtures and 
products other than 
petfood containing such 
protein, and compound 
feeds containing such 
proteins as defined in 
Article 3(2)(h) of 
Regulation (EC) No 767/ 
2009  Category 3 materials referred to in 
Article 10(a), (b), (d), (e), (f), (h), 
(i), (j), (k), (l) and (m).  (a) The processed animal protein must 
have been produced in accordance 
with Section 1 of Chapter II of 
Annex X; and 
(b) the processed animal protein shall 
comply with the additional 
requirements set out in Section 2 of 
this Chapter.  (a) In the case of processed animal 
proteins excluding fishmeal: 
Third countries listed in Part 1 of 
Annex II to Regulation (EU) No 206/ 
2010. 
(b) In the case of fishmeal: 
Third countries listed in Annex II to 
Decision 2006/766/EC.  (a) In the case of processed 
animal protein other than 
those derived from farmed 
insects: 
Annex XV, Chapter 1. 
(b) In the case of processed 
animal protein derived 
from farmed insects: 
Annex XV, Chapter 1a.  
▼B 
2 Blood products for feed 
material  Category 3 materials referred to in 
Article 10 (a) and (b)(i).  ►M9 The blood products must have been 
produced in accordance with Section 2 of 
Chapter II of Annex X and Section 5 of 
Chapter I of Annex XIV. ◄  (a) In the case of blood products from 
ungulates: 
Third countries or parts of third 
countries listed in Part 1 of Annex II 
to Regulation (EU) No 206/2010, from 
which imports of all categories of fresh 
meat of the respective species are auth­
orised. 
(b) In the case of blood products from 
other species: 
Third countries listed in Part 1 of 
Annex II to Regulation (EU) 
No 206/2010.  Annex XV, Chapter 4(B).
 02011R0142 — EN — 01.01.2021 — 021.001 — 139
 ▼B 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
3 Rendered fats and fish 
oil (a) In the case of rendered fats 
excluding fish oil: Category 
3 materials referred to in 
Article 10(a), (b), (d), (e), 
(f), (g), (h), (i), (j) and (k). 
(b) In the case of fish oil: 
Category 3 materials referred 
to in Article 10(e), (f), (i) 
and (j).  (a) The rendered fat and the fish oil must 
have been produced in accordance with 
Section 3 of Chapter II of Annex X; 
and 
(b) The rendered fat shall comply with the 
additional requirements set out in 
Section 3 of this Chapter.  (a) In the case of rendered fats excluding 
fish oil: 
Third countries listed in Part 1 of 
Annex II to Regulation (EU) 
No 206/2010. 
(b) In the case of fish oil: 
Third countries listed in Annex II to 
Decision 2006/766/EC.  (a) In the case of rendered fats 
excluding fish oil: 
Annex XV, Chapter 10 (A). 
(b) In the case of fish oil: 
Annex XV, Chapter 9.  
4 Milk, milk-based 
products and 
milk-derived products, 
colostrum, colostrum 
products  (a) Milk, milk-based products: 
Category 3 materials referred 
to in Article 10(e), (f) and (h). 
(b) Colostrum, colostrum 
products 
Category 3 materials from 
live animals that did not 
show any signs of disease 
transmissible through the 
colostrums to humans or 
animals.  The milk, milk-based products, colostrum 
and colostrum products shall comply with 
the requirements set out in Section 4 of this 
Chapter.  (a) In the case of milk and milk-based 
products: 
Authorised third countries listed in 
Annex I to Regulation (EU) 
No 605/2010. 
(b) In the case of colostrum and colostrum 
products: 
Third countries listed as authorised in 
column ‘A’ of Annex I to 
Regulation (EU) No 605/2010.  (a) In the case of milk, 
milk-based products and 
milk-derived products: 
Annex XV, Chapter 2(A). 
(b) In the case of colostrum 
and colostrums products: 
Annex XV, Chapter 2(B).
 02011R0142 — EN — 01.01.2021 — 021.001 — 140
 ▼B 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
▼M17  
5 Gelatine and hydrolysed 
protein  Category 3 materials referred to in 
Article 10(a), (b), (e), (f), (g), (i) 
and (j), and, in the case of 
hydrolysed protein: Category 3 
materials referred to in 
Article 10(d), (h) and (k).  The gelatine and the hydrolysed protein 
must have been produced in accordance 
with Section 5 of Chapter II of Annex X.  (a) Third countries listed in Part 1 of 
Annex II to Regulation (EU) No 206/ 
2010, and the following countries: 
(KR) South Korea 
(MY) Malaysia 
(PK) Pakistan 
(TW) Taiwan 
(EG) Egypt 
(b) In the case of gelatine and hydrolysed 
proteins from fish: Third countries 
listed in Annex II to Decision 2006/ 
766/EC.  (a) In the case of gelatine: 
Annex XV, Chapter 11. 
(b) In the case of hydrolysed 
protein: Annex XV, 
Chapter 12.  
▼B 
6 Dicalcium phosphate  Category 3 materials referred to in 
Article 10(a), (b), (d),(e), (f), (g), 
(h), (i), (j) and (k).  The dicalcium phosphate must have been 
produced in accordance with Section 6 of 
Chapter II of Annex X.  Third countries listed in Part 1 of Annex II 
to Regulation (EU) No 206/2010, and the 
following countries: 
(KR) South Korea 
(MY) Malaysia 
(PK) Pakistan 
(TW) Taiwan.  Annex XV, Chapter 12.
 02011R0142 — EN — 01.01.2021 — 021.001 — 141
 ▼B 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
7 Tricalcium phosphate  Category 3 materials referred to in 
Article 10(a), (b), (d),(e), (f), (g), 
(h), (i) and (k).  The tricalcium phosphate must have been 
produced in accordance with Section 7 of 
Chapter II of Annex X.  Third countries listed in Part 1 of Annex II 
to Regulation (EU) No 206/2010, and the 
following countries: 
(KR) South Korea 
(MY) Malaysia 
(PK) Pakistan 
(TW) Taiwan.  Annex XV, Chapter 12.  
8 Collagen  Category 3 materials referred to in 
Article 10(a), (b), (e), (f), (g), (i) 
and (j).  The collagen must have been produced in 
accordance with Section 8 of Chapter II of 
Annex X.  Third countries listed in Part 1 of Annex II 
to Regulation (EU) No 206/2010, and the 
following countries: 
(KR) South Korea 
(MY) Malaysia 
(PK) Pakistan 
(TW) Taiwan.  Annex XV, Chapter 11.  
9 Egg products  Category 3 materials referred to in 
Article 10(e), (f) and (k)(ii).  The egg products must have been produced 
in accordance with Section 9 of Chapter II 
of Annex X.  Third countries listed in Part 1 of Annex II 
to Regulation (EU) No 206/2010, and third 
countries or parts of third countries from 
which Member States authorise imports of 
fresh poultrymeat, eggs and egg products, 
which are listed in Part 1 of Annex I to 
Regulation (EC) No 798/2008.  Annex XV, Chapter 15.
Section 2  
▼M1 
Imports of processed animal protein, including mixtures and products other 
than petfood containing such protein, and compound feeds containing such 
protein as defined in Article 3(2)(h) of Regulation (EC) No 767/2009  
▼B 
The following requirements shall apply to the importation of pr ocessed animal 
protein:  
1. Before consignments are released for free circulation within  the Union, the 
competent authority must sample processed animal protein from i mported 
consignments at the border inspection post to ensure compliance  with the 
general requirements of Chapter I of Annex X.  
The competent authority must:  
(a) sample each consignment of products carried in bulk;  
(b) carry out random sampling of consignments of products packa ged in the 
manufacturing plant of origin.  
2. By way of derogation from point 1, when six consecutive test s on bulk 
consignments originating in a given third country prove negativ e, the 
competent authority of the border inspection post may carry out  random 
sampling of subsequent bulk consignments from that third countr y. 
If one of those random samples proves positive, the competent a uthority 
carrying out the sampling must inform the competent authority o f the third 
country of origin so that it can take appropriate measures to r emedy the 
situation.  
The competent authority of the third country of origin must bri ng these 
measures to the attention of the competent authority carrying o ut the 
sampling.  
In the event of a further positive result from the same source,  the competent 
authority of the border inspection post must sample each consig nment from 
the same source until six consecutive tests again prove negativ e. 
3. Competent authorities must keep a record for at least three years of the results 
of sampling carried out on all consignments that have undergone  sampling.  
4. Where a consignment imported into the Union proves to be pos itive for 
salmonella or where it does not meet the microbiological standa rds for enter­
obacteriaceae set out in Chapter I of Annex X, it must either:  
(a) be dealt with in accordance with the procedure laid down by  
Article 17(2)(a) of Directive 97/78/EC; or  
(b) reprocessed in a processing plant or decontaminated by a tr eatment auth­
orised by the competent authority. The consignment must not be released 
until it has been treated, tested for salmonella or enterobacte riaceae, as 
necessary, by the competent authority in accordance with Chapte r I of 
Annex X, and a negative result obtained.  
▼M12  
5. Processed animal protein obtained from farmed insects may be  imported into 
the Union provided that it has been produced in compliance with  the 
following conditions:  
(a) the insects belong to one of the following species:  
— Black Soldier Fly ( Hermetia illucens ) and Common Housefly ( Musca 
domestica ), ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 142
 
— Yellow Mealworm ( Tenebrio molitor ) and Lesser Mealworm ( Alphi­
tobius diaperinus ), 
— House cricket ( Acheta domesticus ), Banded cricket ( Gryllodes 
sigillatus ) and Field Cricket ( Gryllus assimilis ); 
(b) the substrate for the feeding of insects may only contain p roducts of 
non-animal origin or the following products of animal origin of  
Category 3 material:  
— fishmeal,  
— blood products from non-ruminants,  
— di and tricalcium phosphate of animal origin,  
— hydrolysed proteins from non-ruminants,  
— hydrolysed proteins from hides and skins of ruminants,  
— gelatine and collagen from non-ruminants,  
— eggs and egg products,  
— milk, milk based-products, milk-derived products and colostru m, 
— honey,  
— rendered fats;  
(c) the substrate for the feeding of insects and the insects or  their larvae have 
not been in contact with any other materials of animal origin t han those 
mentioned in point (b) and the substrate did not contain manure , catering 
waste or other waste.  
▼B 
Section 3  
Imports of rendered fats  
The following requirements shall apply to the importation of re ndered fats:  
Rendered fat shall:  
(a) be entirely or partly derived from porcine raw material and  come from a third 
country or a part of the territory of a third country free from  foot-and-mouth 
disease for the previous 24 months and free from classical swin e fever and 
African swine fever for the previous 12 months;  
(b) be entirely or partly derived from poultry raw material and  come from a third 
country or a part of the territory of a third country free from  Newcastle 
disease and avian influenza for the previous six months;  
(c) be entirely or partly derived from ruminant raw material an d come from a 
third country or a part of the territory of a third country fre e from foot-and- 
mouth disease for the previous 24 months and free from rinderpe st for the 
previous 12 months; or  
(d) where there has been an outbreak of one of the diseases ref erred to in points 
(a), (b) and (c) during the relevant period referred to in thos e points, have 
been subjected to one of the following heat treatments:  
(i) at least 70 °C for at least 30 minutes; or  
(ii) at least 90 °C for at least 15 minutes.  
Details of the critical control points shall be recorded by ope rators and 
maintained so that the owner, operator or their representative and, as 
necessary, the competent authority can monitor the operation of  the plant; 
and the recorded information shall include the particle size, c ritical 
temperature and, as appropriate, the absolute time, pressure pr ofile, raw 
material feed rate and fat recycling rate.  ▼M12  02011R0142 — EN — 01.01.2021 — 021.001 — 143
 
Section 4  
Imports of milk, milk-based products, milk-derived products, colostrum and 
colostrum products  
A. The following requirements shall apply to the importation of  milk, 
milk-based products, milk-derived products, colostrum and colos trum 
products:  
1. Milk, milk-based products and milk-derived products shall:  
(a) have undergone at least one of the treatments provided for in points 
1.1, 1.2, 1.3 and point (a) of point B.1.4 of Part I of Section  4 of 
Chapter II of Annex X;  
(b) comply with points B.2 and B.4, and, in the case of whey, p oint B.3 
of Part I of Section 4 of Chapter II of Annex X.  
2. By way of derogation from point B.1.4 of Part I of Section 4  of 
Chapter II of Annex X, milk, milk-based products and milk-deriv ed 
products may be imported from third countries so authorised in column 
‘A’ of Annex I to Regulation (EU) No 605/2010, provided that th e milk, 
milk-based products or milk-derived products have undergone a s ingle 
HTST treatment and:  
(a) have not been shipped before a period of at least 21 days h as elapsed 
after production and during that period no case of foot-and-mou th 
disease has been detected in the exporting third country; or  
(b) have been presented at a border inspection post of entry in to the 
Union at least 21 days after production and during that period no 
case of foot-and-mouth disease has been detected in the exporti ng 
third country.  
B. The following requirements shall apply to the importation of  colostrum and 
colostrum products:  
1. The materials shall have undergone a single HTST treatment a nd: 
(a) have not been shipped before a period of at least 21 days h as elapsed 
after production and during that period no case of foot-and-mou th 
disease has been detected in the exporting third country; or  
(b) have been presented at a border inspection post of entry in to the 
Union at least 21 days after production and during that period no 
case of foot-and-mouth disease has been detected in the exporti ng 
third country.  
2. The materials shall have been obtained from bovine animals s ubject to 
regular veterinary inspections to ensure that they come from ho ldings on 
which all bovine herds are:  
(a) either recognised as officially tuberculosis-free and offic ially 
brucellosis-free as defined in Article 2(2)(d) and (f) of Direc tive 
64/432/EEC or not restricted under the national legislation of the 
third country of origin of the colostrum regarding eradication of 
tuberculosis and brucellosis; and  
(b) either recognised as official enzootic-bovine-leukosis-free  as defined 
in Article 2(2)(j) of Directive 64/432/EEC or included in an of ficial 
system for the control of enzootic bovine leukosis and there ha s been 
no evidence as a result of clinical and laboratory testing of t his 
disease in the herd during the past two years.  
3. After completion of the processing, every precaution shall h ave been 
taken to prevent contamination of the colostrum or colostrum pr oducts.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 144
 
4. The final product must bear a label so as to indicate that i t contains 
Category 3 material and is not intended for human consumption, and it 
must have been:  
(a) packed in new containers; or  
(b) transported in bulk in containers or other means of transpo rt that 
before use were thoroughly cleaned and disinfected.  
▼M9 
Section 5  
Imports of blood products for the feeding of farmed animals  
The following requirements shall apply to the importation of bl ood products, 
including spray dried blood and blood plasma which have been de rived 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 tha n 8 % 
moisture with a water activity (Aw) of less than 0,60;  
(b) stored in dry warehouse conditions under room temperature f or at least 6 
weeks.  
▼B 
CHAPTER II  
SPECIFIC REQUIREMENTS FOR THE IMPORTATION INTO AND 
TRANSIT THROUGH THE UNION OF ANIMAL BY-PRODUCTS AND 
DERIVED PRODUCTS FOR USES OUTSIDE THE FEED CHAIN FOR 
FARMED ANIMALS OTHER THAN FUR ANIMALS  
Section 1  
Specific requirements  
As referred to in Article 41(1)(a) and (2)(c) and Article 41(3)  of Regulation (EC) 
No 1069/2009, the following specific requirements shall apply t o imported 
consignments of animal by-products and derived products for use s outside the 
feed chain for farmed animals and consignments of such products  in transit:  
(a) they must consist of or have been produced from animal by-p roducts referred 
to in the column ‘raw materials’ of Table 2;  
(b) they must comply with the import and transit conditions set  out in the 
column ‘import and transit conditions’ of Table 2;  
▼M4 
(c) they must come from a third country or part of a third coun try listed in the 
column ‘third countries’ list’ of Table 2;  
(d) they must come from an establishment or plant which is regi stered or 
approved by the competent authority of the third country, as ap plicable, 
and which is on the list of such establishments and plants refe rred to in 
Article 30; and  
(e) they must be:  
(i) accompanied during transportation to the point of entry int o the Union 
where the veterinary checks take place by the health certificat e referred 
to in the column ‘certificates/model documents’ of Table 2; or  
(ii) presented at the point of entry into the Union where the v eterinary 
checks take place accompanied by a document corresponding to th e 
model referred to in the column ‘certificates/model documents’ of 
Table 2.  
__________  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 145
 02011R0142 — EN — 01.01.2021 — 021.001 — 146
 ▼B 
Table 2  
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
1 Processed manure, 
derived products from 
processed manure and 
guano from bats  Category 2 material referred to in 
Article 9(a).  The processed manure, the derived 
products from processed manure and the 
guano from bats must have been 
produced in accordance with Section 2 of 
Chapter I of Annex XI.  Third countries listed in: 
(a) Part 1 of Annex II to Regulation (EU) 
No 206/2010; 
(b) Annex I to Decision 2004/211/EC; or 
(c) Part 1 of Annex I to Regulation (EC) 
No 798/2008.  Annex XV, Chapter 17.  
2 Blood products, 
еxcluding from equidae, 
for the manufacture of 
derived products for 
uses outside the feed 
chain for farmed animals  Category 1 material referred to in 
Article 8(c) and (d) and Category 
3 material referred to in 
Article 10(a), (b), (d) and (h).  The blood products must have been 
produced in accordance with Section 2.  The following third countries: 
(a) in the case of untreated blood products 
of ungulates: 
Third countries or parts of third 
countries listed in Part 1 of Annex II 
to Regulation (EU) No 206/2010 from 
which imports of fresh meat of any 
domestic ungulate species is authorised 
and only for the period indicated in 
column 7 and 8 of that Part. 
Japan. 
(b) in the case of untreated blood products 
of poultry and other avian species: 
Third countries or parts of third 
countries listed in Part 1 of Annex I 
to Regulation (EC) No 798/2008. 
Japan. 
(c) in the case of untreated blood products 
of other animals:  (a) In the case of untreated 
blood products: 
Annex XV, Chapter 4 (C). 
(b) In the case of treated blood 
products: 
Annex XV, Chapter 4 (D).
 02011R0142 — EN — 01.01.2021 — 021.001 — 147
 ▼B 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
Third countries listed either in Part 1 of 
Annex II to Regulation (EU) 
No 206/2010, in Part 1 of Annex I to 
Regulation (EC) No 798/2008, or in 
Part 1 of Annex I to Regulation (EC) 
No 119/2009. 
Japan. 
(d) in the case of treated blood products of 
any species: 
Third countries listed in Part 1 to 
Annex II of Regulation (EU) 
No 206/2010, in Part 1 of Annex I to 
Regulation (EC) No 798/2008 or in 
Part 1 of Annex I to Regulation (EC) 
No 119/2009. 
Japan.  
3 Blood and blood 
products from equidae  Category 3 materials referred to in 
Article 10(a), (b), (d) and (h).  The blood and the blood products shall 
comply with the requirements set out in 
Section 3.  The following third countries: 
(a) in the case of blood that has been 
collected in accordance with point 1 
of Chapter IV of Annex XIII or 
where blood products have been 
produced in accordance with point 
2(b)(i) of that Chapter: 
Third countries or parts of third 
countries listed in Annex I to 
Decision 2004/211/EC, from which 
the importation of equidae for 
breeding and production is allowed. 
(b) in the case of blood products which 
have been treated in accordance with 
point 2(b)(ii) of Chapter IV of 
Annex XIII:  Annex XV, Chapter 4(A).
 02011R0142 — EN — 01.01.2021 — 021.001 — 148
 ▼B 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
Third countries listed in Part 1 of 
Annex II to Regulation (EU) 
No 206/2010, from which Member 
States authorise imports of fresh meat 
of domestic equidae.  
4 Fresh or chilled hides 
and skins of ungulates  Category 3 materials referred to in 
Article 10 (a) and (b)(iii).  The hides and skins shall comply with the 
requirements set out in Section 4, points 1 
and 4.  The hides and skins come from a third 
country, or, in the case of regionalisation 
in accordance with Union legislation, a part 
of a third country listed in Part 1 of 
Annex II to Regulation (EU) 
No 206/2010, from which Member States 
authorise imports of fresh meat from the 
same species.  Annex XV, Chapter 5(A).  
5 Treated hides and skins 
of ungulates  Category 3 materials referred to in 
Article 10 (a), (b)(i) and (iii) and 
(n). The hides and skins shall comply with the 
requirements set out in Section 4, points 2, 
3 and 4.  (a) In the case of treated hides and skins of 
ungulates: 
Third countries or parts of third 
countries listed in Part 1 of Annex II 
to Regulation (EU) No 206/2010. 
(b) In the case of treated hides and skins of 
ruminants that are intended for dispatch 
to the European Union and which have 
been kept separate for 21 days or will 
undergo transport for 21 uninterrupted 
days before importation: 
Any third country.  (a) In the case of treated hides 
and skins of ungulates, 
other than those which 
comply with the 
requirements set out in 
Section 4, point 2: 
Annex XV, Chapter 5(B). 
(b) In the case of treated hides 
and skins of ruminants and 
of equidae that are intended 
for dispatch to the 
European Union and 
which have been kept 
separate for 21 days or 
will undergo transport for 
21 uninterrupted days 
before importation: 
The official declaration set 
out in Annex XV, 
Chapter 5(C).
 02011R0142 — EN — 01.01.2021 — 021.001 — 149
 ▼B 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
(c) In the case of treated hides 
and skins of ungulates 
which comply with the 
requirements set out in 
Section 4, point 2: 
No certificate is required.  
6 Game trophies and other 
preparations from 
animals  Category 2 materials referred to in 
Article 9, point (f) derived from 
wild animals not suspected of 
being infected with a disease 
communicable to humans or 
animals and Category 3 material 
referred to in Article 10(a), 
(b)(i), (iii) and (v) and (n).  The game trophies and other preparations 
shall comply with the requirements set out 
in Section 5.  (a) In the case of game trophies and other 
preparations referred to in Section 5, 
point 2: 
Any third country. 
(b) In the case of game trophies and other 
preparations referred to in Section 5, 
point 3: 
(i) Game trophies from birds: 
Third countries listed in Part 1 of 
Annex I to Regulation (EC) 
No 798/2008, from which the 
Member States authorise imports 
of fresh poultrymeat, and the 
following countries: 
(GL) Greenland 
(TN) Tunisia. 
(ii) Game trophies from ungulates: 
Third countries listed in the appro­
priate columns for fresh meat of 
ungulates in Part 1 of Annex II to 
Regulation (EU) No 206/2010, 
including any restrictions laid 
down in the column for special 
remarks for fresh meat.  (a) In the case of game 
trophies referred to in 
Section 5, point 2: 
Annex XV, Chapter 6(A). 
(b) In the case of game 
trophies referred to in 
Section 5, point 3: 
Annex XV, Chapter 6(B). 
(c) In the case of game 
trophies referred to in 
Section 5, point 1: 
No certificate is required.
 02011R0142 — EN — 01.01.2021 — 021.001 — 150
 ▼B 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
7 Pig bristles  Category 3 materials referred to in 
Article 10 (b)(iv).  The pig bristles must have been obtained 
from animals originating, and slaughtered 
in a slaughterhouse, in the third country 
of origin.  (a) In the case of untreated pig bristles: 
Third countries, or, in the case of 
regionalisation, regions thereof, listed 
in part 1 of Annex II to 
Regulation (EU) No 206/2010, which 
are free of African swine fever for the 
12 months prior to the date of 
importation. 
(b) In the case of treated pig bristles: 
Third countries listed in part 1 of 
Annex II to Regulation (EU) 
No 206/2010, which may not be free 
of African swine fever for the last 12 
months prior to the date of importation.  (a) If no case of African swine 
fever has occurred during 
the 12 previous months: 
Annex XV, Chapter 7(A). 
(b) In case one or more cases 
of African swine fever have 
occurred during the 
previous 12 months: 
Annex XV, Chapter 7(B).  
▼M2 
8 Untreated wool and hair 
produced from animals 
other than those of the 
porcine species  Category 3 materials referred to in 
Article 10(h) and (n).  (1) The dry untreated wool and hair must 
be 
(a) securely enclosed in packaging; 
and 
(b) sent directly to a plant producing 
derived products for uses outside 
the feed chain or a plant carrying 
out intermediate operations, under 
conditions which prevent the 
spreading of pathogenic agents.  (1) Any third country.  (1) For imports of untreated 
wool and hair, no health 
certificate is required.
 02011R0142 — EN — 01.01.2021 — 021.001 — 151
 ▼M2 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
(2) The wool and hair are wool and hair as 
referred to in Article 25(2)(e).  (2) Third country or region thereof 
(a) listed in Part 1 of Annex II to 
Regulation (EU) No 206/2010 and 
authorised for imports into the 
Union of fresh meat of ruminants 
not subject to supplementary guar­
antees A and F mentioned therein; 
and 
(b) free of foot-and-mouth disease and, 
in case of wool and hair of sheep 
and goats, of sheep pox and goat 
pox in accordance with Annex II to 
Council Directive 2004/68/EC.  (2) A declaration of the 
importer in accordance 
with Chapter 21 of 
Annex XV is required.  
▼B 
9 Treated feathers, parts of 
feathers and down  Category 3 materials referred to in 
Article 10 (b)(v) and (h) and (n).  The treated feathers or parts of feathers 
shall comply with the requirements set 
out in Section 6.  Any third country.  For imports of treated feathers, 
parts of feathers and down, no 
health certificate is required.
 02011R0142 — EN — 01.01.2021 — 021.001 — 152
 ▼B 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
10 Apiculture by-products  Category 3 materials referred to in 
Article 10 (e).  (a) In the case of apiculture by-products 
intended for use in apiculture, other 
than beeswax in the form of 
honeycomb: 
(i) The apiculture by-products have 
been subjected to a temperature of 
– 12°C or lower temperature for at 
least 24 hours; or 
(ii) In the case of beeswax, the 
material has been processed in 
accordance with any of the 
processing methods 1 to 5 or 
processing method 7, as set out in 
Chapter III of Annex IV, and 
refined before importation. 
(b) In the case of beeswax, other than 
beeswax in the form of honeycomb, 
for purposes other than feeding to 
farmed animals, the beeswax has been 
refined or processed in accordance with 
any of the processing methods 1 to 5 
or processing method 7, as set out in 
Chapter III of Annex IV before 
importation.  (a) In the case of apiculture by-products 
intended for use in apiculture: 
Third countries listed in Part 1 of 
Annex II to Regulation (EU) 
No 206/2010, and the following 
country: 
(CM) Cameroon. 
(b) In the case of beeswax for purposes 
other than feeding to farmed animals: 
Any third country.  (a) In the case of apiculture 
by-products intended for 
use in apiculture: 
Annex XV, Chapter 13. 
(b) In the case of beeswax for 
purposes other than feeding 
to farmed animals: 
A commercial document 
attesting the refinement or 
processing.
 02011R0142 — EN — 01.01.2021 — 021.001 — 153
 ▼B 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
11 Bones and bone products 
(excluding bone meal), 
horns and horn products 
(excluding horn meal) 
and hooves and hoof 
products (excluding 
hoof meal) for uses 
other than as feed 
material, organic 
fertiliser or soil improver  Category 3 materials referred to in 
Article 10(a) (b)(i) and (iii), (e) 
and (h).  The products shall comply with the 
requirements set out in Section 7.  Any third country.  The products shall be accom­
panied by: 
(a) a commercial document as 
et out in Section 7, point 2; 
and 
(b) a declaration of the 
importer in accordance 
with Annex XV, 
Chapter 16 in at least one 
official language of the 
Member State through 
which the consignment 
first enters the Union and 
in at least one official 
language of the Member 
State of destination.  
▼M25  
12 Petfood, including 
dogchews  (a) In the case of processed 
petfood and of dogchews: 
materials referred to in 
Article 35(a)(i) and (ii). 
(b) In the case of raw petfood: 
materials referred to in 
Article 35(a)(iii).  The petfood and the dogchews must have 
been produced in accordance with Chapter 
II of Annex XIII.  (a) In the case of raw petfood: 
Third countries listed in Part 1 of 
Annex II to Regulation (EU) No 206/ 
2010 or in Annex I to Regulation (EC) 
No 798/2008, from which Member 
States authorise imports of fresh meat 
from the same species and where only 
bone-in meat is authorised. 
In the case of fish materials, third 
countries listed in Annex II to 
Decision 2006/766/EC. 
(b) In the case of dogchews and petfood 
other than raw petfood: 
Third countries listed in Part 1 of 
Annex II to Regulation (EU) No 206/ 
2010, and the following countries:  (a) In the case of canned 
petfood: Annex XV, 
Chapter 3(A). 
(b) In the case of processed 
petfood other than canned 
petfood: Annex XV, 
Chapter 3(B). 
(c) In the case of dogchews: 
Annex XV, Chapter 3(C). 
(d) In the case of raw petfood: 
Annex XV, Chapter 3(D).
 02011R0142 — EN — 01.01.2021 — 021.001 — 154
 ▼M25  
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
(JP) Japan 
(EC) Ecuador 
(LK) Sri Lanka 
(TW) Taiwan 
(SA) Saudi Arabia (only processed 
petfood of poultry origin) 
(GE) Georgia (only processed petfood 
other than canned petfood) 
In the case of processed petfood 
derived from fish materials, third 
countries listed in Annex II to 
Decision 2006/766/EC.  
▼M17  
13 Flavouring innards for 
the manufacture of 
petfood  Materials referred to in 
Article 35(a)  The flavouring innards must have been 
produced in accordance with Chapter III 
of Annex XIII.  Third countries listed in Part 1 of Annex II 
to Regulation (EU) No 206/2010, from 
which Member States authorise imports of 
fresh meat from the same species and 
where only bone-in meat is authorised. 
In the case of flavouring innards from fish 
materials, third countries listed in Annex II 
to Decision 2006/766/EC. 
In the case of flavouring innards of poultry 
origin, third countries listed in Part 1 of 
Annex I to Regulation (EC) No 798/2008, 
from which Member States authorise 
imports of fresh poultry meat. 
In the case of flavouring innards from 
certain wild land mammals and leporidae, 
third countries listed in Part 1 of Annex I 
to Regulation (EC) No 119/2009 from 
which Member States authorise imports of 
fresh meat from the same species.  Annex XV, Chapter 3(E).
 02011R0142 — EN — 01.01.2021 — 021.001 — 155
 ▼B 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
14 Animal by-products for 
the manufacture of 
petfood other than raw 
petfood and of derived 
products for uses 
outside the feed chain  ►M4 (a) Category 3 materials 
referred to in Article 10(a) 
to (m). ◄ 
(b) In the case of materials for the 
manufacture of petfood, 
Category 1 materials referred 
to in Article 8(c). 
(c) In the case of fur for the 
manufacture of derived 
products, Category 3 
materials referred to in 
Article 10(n).  The products shall comply with the 
requirements set out in Section 8.  (a) In the case of animal by-products for 
the manufacture of petfood: 
(i) In the case of animal by-products 
from bovine, ovine, caprine, 
porcine and equine animals, 
including farmed and wild 
animals: 
Third countries or parts of third 
countries listed in Part 1 of 
Annex II to Regulation (EU) 
No 206/2010, from which 
imports of fresh meat for human 
consumption is authorised. 
(ii) Raw material from poultry 
including ratites: 
Third countries or parts of third 
countries from which Member 
States authorise imports of fresh 
poultrymeat, which are listed in 
Part 1 of Annex I to 
Regulation (EC) No 798/2008. 
(iii) Raw material from fish: 
Third countries listed in Annex II 
to Decision 2006/766/EC. 
(iv) Raw material from other wild land 
mammals and leporidae: 
Third countries listed in Part 1 of 
Annex II to Regulation (EU) 
No 206/2010 or in Part 1 of 
Annex I to Regulation (EC) 
No 798/2008.  (a) In the case of animal 
by-products for the manu­
facture of processed 
petfood: 
Annex XV, Chapter 3(F). 
(b) In the case of animal 
by-products for the manu­
facture of products for 
uses outside the feed chain 
for farmed animals: 
Annex XV, Chapter 8.
 02011R0142 — EN — 01.01.2021 — 021.001 — 156
 ▼B 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
(b) In the case of animal by-products for 
the manufacture of pharmaceuticals: 
Third countries listed in Part 1 of 
Annex II to Regulation (EU) 
No 206/2010, in Part 1 of Annex I to 
Regulation (EC) No 798/2008 or in 
Part 1 of Annex I to Regulation (EC) 
No 119/2009, and the following third 
countries: 
(JP) Japan 
(PH) Philippines 
(TW) Taiwan. 
(c) In the case of animal by-products for 
the manufacture of products for uses 
outside the feed chain for farmed 
animals, other than pharmaceuticals: 
Third countries listed in Part 1 of 
Annex II to Regulation (EU) 
No 206/2010 from which imports of 
fresh meat of the respective species is 
authorised, in Part 1 of Annex I to 
Regulation (EC) No 798/2008, in Part 
1 of Annex I to Regulation (EC) 
No 119/2009, or, in the case of 
material from fish, third countries 
listed in Annex II to Decision 
2006/766/EC.
 02011R0142 — EN — 01.01.2021 — 021.001 — 157
 ▼B 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
▼M4 
15 Animal by-products for 
use as raw petfood  Category 3 materials referred to in 
Article 10(a) and Article 10(b)(i) 
and (ii).  The products shall comply with the 
requirements set out in Section 8.  Third countries listed in Part 1 of Annex II 
to Regulation (EU) No 206/2010 or in 
Annex I to Regulation (EC) No 798/2008, 
from which Member States authorise 
imports of fresh meat from the same 
species and where only bone in meat is 
authorised. 
In the case of fish materials, third countries 
listed in Annex II to Decision 2006/766/EC.  Annex XV, Chapter 3(D).  
16 Animal by-products for 
use in feed for fur 
animals  Category 3 materials referred to in 
Article 10(a) to (m)  The products shall comply with the 
requirements set out in Section 8.  Third countries listed in part 1 of Annex II 
to Commission Regulation (EU) No 206/ 
2010, or in Annex I to Regulation (EC) 
No 798/2008, from which Member States 
authorise imports of fresh meat from the 
same species and where only bone in meat 
is authorised. 
In the case of fish materials, third countries 
listed in Annex II to Decision 2006/766/EC.  Annex XV, Chapter 3(D).
 02011R0142 — EN — 01.01.2021 — 021.001 — 158
 ▼B 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
▼M17  
17 Rendered fats for certain 
purposes outside the feed 
chain for farmed animals  (a) In the case of materials 
destined for the production 
of biodiesel, oleochemical 
products or renewable fuels 
referred to in point L of 
Section 2 of Chapter IV of 
Annex IV: Categories 1, 2 
and 3 materials referred to in 
Articles 8, 9 and 10. 
(b) In the case of materials 
destined to the production of 
renewable fuels referred to in 
point J of Section 2 of 
Chapter IV of Annex IV: 
Category 2 and 3 materials 
referred to in Articles 9 
and 10. 
(c) In the case of materials 
destined to organic fertilisers 
and soil improvers: 
Category 2 materials referred 
to in Article 9, points (c), (d) 
and (f)(i) and Category 3 
materials referred to in 
Article 10, other than in 
points (c) and (p).  The rendered fats shall comply with the 
requirements set out in Section 9.  Third countries listed in Part 1 of Annex II 
to Regulation (EU) No 206/2010 and, in the 
case of fish materials, third countries listed 
in Annex II to Decision 2006/766/EC.  Chapter 10(B) of Annex XV.
 02011R0142 — EN — 01.01.2021 — 021.001 — 159
 ▼M17  
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
(d) In the case of materials 
destined to other purposes: 
Category 1 materials referred 
to in Article 8, points (b), (c) 
and (d), Category 2 materials 
referred to in Article 9, 
points (c), (d) and (f)(i) and 
Category 3 materials referred 
to in Article 10, other than in 
points (c) and (p).  
▼M4 
18 Fat derivatives  (a) In the case of fat derivatives 
for uses outside the feed chain 
for farmed animals: 
Category 1 materials referred 
to in Article 8(b), (c) and (d), 
Category 2 materials referred 
to in Article 9(c) and (d) and 
Article 9(f)(i) and Category 3 
materials referred to in 
Article 10. 
(b) In the case of fat derivatives 
for use as feed: 
Category 3 materials other 
than materials referred to in 
Article 10(n), (o) and (p);  The fat derivatives shall comply with the 
requirements set out in Section 10.  Any third country.  (a) In the case of fat 
derivatives for uses outside 
the feed chain for farmed 
animals: 
Annex XV, Chapter 14(A). 
(b) In the case of fat 
derivatives for use as feed: 
Annex XV, Chapter 14(B).
 02011R0142 — EN — 01.01.2021 — 021.001 — 160
 ▼B 
No Product  Raw materials (reference to provisions 
of Regulation (EC) No 1069/2009)  Import and transit conditions  Third countries’ lists  Certificates/model documents  
19 Photogelatine  Category 1 materials referred to in 
Article 8(b) and Category 3 
materials referred to in Article 10.  The imported photogelatine shall comply 
with the requirements set out in Section 11.  Photogelatine may only be imported from 
establishments of origin in the United 
States and in Japan that are authorised in 
accordance with Section 11.  Annex XV, Chapter 19.  
20 Horns and horn 
products, excluding 
horn meal, and hooves 
and hoof products, 
excluding hoof meal, 
for the production of 
organic fertilisers or soil 
improvers  Category 3 materials referred to in 
Article 10(a), (b), (h) and (n).  The products shall comply with the 
requirements set out in Section 12.  Any third country.  Annex XV, Chapter 18.
Section 2  
Imports of blood and blood products, excluding from equidae, for the 
manufacture of derived products for uses outside the feed chain for 
farmed animals  
The following requirements shall apply to the import of blood a nd blood 
products, excluding those from equidae, for the manufacture of derived 
products for uses outside the feed chain for farmed animals:  
1. The blood products must originate from a plant for the produ ction of 
derived products for uses outside the feed chain for farmed ani mals which 
meets the specific conditions laid down in this Regulation or f rom the 
establishment of collection.  
▼M4 
2. The blood from which blood products for the manufacture of d erived 
products for uses outside the feed chain for farmed animals are  produced 
must have been collected under veterinary supervision:  
(a) in slaughterhouses:  
(i) approved in accordance with Regulation (EC) No 853/2004; or  
(ii) approved and supervised by the competent authority of the country 
of collection; or  
(b) from live animals in facilities approved and supervised by the competent 
authority of the country of collection.  
▼B 
3.1. In the case of blood products for the manufacture of deriv ed products for 
uses outside the feed chain for farmed animals which have been derived 
from animals belonging to the taxa Artiodactyla, Perissodactyla  and 
Proboscidea, including their crossbreeds, they must comply with  the 
conditions of either point (a) or (b):  
(a) the products must have undergone one of the following treat ments 
guaranteeing the absence of pathogens of the diseases referred to in 
point (b):  
(i) heat treatment at a temperature of 65 °C for at least three  hours, 
followed by an effectiveness check;  
(ii) irradiation at 25 kGy by gamma rays, followed by an effect iveness 
check;  
(iii) heat treatment of at least 80 °C throughout their substan ce, 
followed by an effectiveness check;  
(iv) in the case of animals other than Suidae and Tayassuidae o nly: 
change in pH to pH 5 for two hours, followed by an effectivenes s 
check;  
(b) in the case of blood products not treated in accordance wit h point (a) the 
products must originate from a third country or region:  
(i) where no case of rinderpest, peste des petits ruminants and  Rift 
Valley fever has been recorded for a period of at least 12 mont hs 
and in which vaccination has not been carried out against those  
diseases for a period of at least 12 months;  
(ii) where no case of foot-and-mouth disease has been recorded for a 
period of at least 12 months, and,  
— in which vaccination has not been carried out against this 
disease for a period of at least 12 months, or  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 161
 
— in which vaccination programmes against foot-and-mouth 
disease are being officially carried out and controlled in 
domestic ruminant animals for a period of at least 12 months; 
in this case, following the veterinary checks provided for in 
Directive 97/78/EC, and in accordance with the conditions laid 
down in Article 8(4) of that Directive, the products must be 
transported directly to the registered establishment or plant o f 
destination and all precautions, including safe disposal of was te, 
unused or surplus material, must be taken to avoid risks of 
spreading diseases to animals or humans.  
3.2. In addition to point (b)(i) and (ii) of point 3.1, in the case of animals other 
than Suidae and Tayassuidae, one of the following conditions mu st be 
complied with:  
(a) in the third country or region of origin no case of vesicul ar stomatitis 
and bluetongue (including the presence of seropositive animals)  has 
been recorded for a period of at least 12 months and vaccinatio n has 
not been carried out against those diseases for a period of at least 12 
months in the susceptible species;  
(b) following the veterinary checks provided for in Directive 9 7/78/EC, and 
in accordance with the conditions laid down in Article 8(4) of that 
Directive, the products must be transported directly to the pla nt of 
destination and all precautions, including safe disposal of was te, 
unused or surplus material, must be taken to avoid risks of spr eading 
diseases to animals or humans.  
3.3. In addition to point (b)(i) and (ii) of point 3.1, in the case of Suidae and 
Tayassuidae, in the third country or region of origin no case o f swine 
vesicular disease, classical swine fever and African swine feve r has been 
recorded for a period of at least 12 months, vaccination has no t been carried 
out against those diseases for a period of at least 12 months a nd one of the 
following conditions are complied with:  
(a) in the country or region of origin no case of vesicular sto matitis 
(including the presence of seropositive animals) has been recor ded for 
a period of 12 months and vaccination has not been carried out against 
this disease for a period of at least 12 months in the suscepti ble species;  
(b) following the veterinary checks provided for in Directive 9 7/78/EC, and 
in accordance with the conditions laid down in Article 8(4) of that 
Directive, the products must be transported directly to the reg istered 
establishment or plant of destination and all precautions, incl uding 
safe disposal of waste, unused or surplus material, must be tak en to 
avoid risks of spreading diseases to animals or humans.  
4. In the case of blood products for the manufacture of derived  products for 
uses outside the feed chain for farmed animals which have been derived 
from poultry and other avian species, they must comply with the  following 
conditions of either point (a) or (b):  
(a) the products must have undergone one of the following treat ments 
guaranteeing the absence of pathogens of the diseases referred to in 
point (b):  
(i) heat treatment at a temperature of 65 °C for at least three  hours, 
followed by an effectiveness check;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 162
 
(ii) irradiation at 25 kGy by gamma rays, followed by an effect iveness 
check;  
(iii) heat treatment of at least 70 °C throughout their substan ce, 
followed by an effectiveness check;  
(b) in case of blood products not treated in accordance with po int (a) the 
products must originate from a third country or region:  
(i) which has been free from Newcastle disease and highly patho genic 
avian influenza as listed in the Terrestrial Animal Health Code  of 
the OIE, 2010 edition;  
(ii) which during the last 12 months has not carried out vaccin ation 
against avian influenza;  
(iii) where the poultry or other avian species from which the p roducts 
derive have not been vaccinated against Newcastle disease with 
vaccines prepared from a Newcastle disease master strain 
showing a higher pathogenicity than lentogenic virus strains.  
Section 3  
Imports of blood and blood products from equidae  
The following requirements shall apply to the import of blood a nd blood 
products from equidae:  
▼M4 
1. The blood must comply with the conditions set out in point 1 (a) of Chapter 
IV of Annex XIII and must be collected under veterinary supervi sion:  
(a) in slaughterhouses:  
(i) approved in accordance with Regulation (EC) No 853/2004; or  
(ii) approved and supervised by the competent authority of the country 
of collection; or  
(b) from live equidae in facilities approved and furnished with  a veterinary 
approval number and supervised by the competent authority of th e 
country of collection for the purpose of collecting blood from equidae 
for the production of blood products for purposes other than fe eding.  
▼B 
2. The blood products must comply with the conditions set out i n point 2 of 
Chapter IV of Annex XIII.  
In addition, the blood products referred to in point 2(b)(i) of  Chapter IV of 
Annex XIII must be produced from blood collected from equidae w hich have 
been kept for a period of at least three months, or since birth  if less than 
three months old, prior to the date of collection on holdings u nder veterinary 
supervision in the third country of collection which during tha t period and 
the period of blood collection has been free of:  
(a) African horse sickness in accordance with points (a) and (b ) of the first 
subparagraph of Article 5(2) of Directive 2009/156/EC;  
(b) Venezuelan equine encephalomyelitis for a period of at leas t two years;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 163
 
(c) glanders:  
(i) for a period of three years; or  
(ii) for a period of six months where the animals have shown no  clinical 
signs of glanders ( Burkholderia mallei ) during the post-mortem 
inspection in the slaughterhouse referred to in point 1(a), inc luding 
a careful examination of mucous membranes from the trachea, 
larynx, nasal cavities and sinuses and their ramifications, aft er 
splitting the head in the median plane and excising the nasal s eptum;  
▼M4 
(d) in the case of blood products other than serum and plasma, vesicular 
stomatitis for a period of at least six months.  
▼B 
3. Blood products must come from an establishment or plant whic h has been 
approved or registered by the competent authority of the third country.  
4. Blood and blood products shall be packed and labelled in acc ordance with 
point 3 of Chapter IV of Annex XIII.  
Section 4  
Imports of hides and skins of ungulates  
The following requirements shall apply to the import of hides a nd skins of 
ungulates:  
1. Fresh or chilled hides and skins may be imported if:  
(a) they come from a third country referred to in the applicabl e column of 
row 4 of Table 2 set out in Section 1 which, as appropriate to the species 
concerned:  
(i) for a period of at least 12 months before dispatch, has bee n free from 
all of the following diseases:  
— classical swine fever,  
— African swine fever, and  
— Rinderpest; and  
(ii) has been free from foot-and-mouth disease for a period of at least 12 
months before the date of dispatch and where, for a period of a t least 
12 months before the date of dispatch, no vaccination has been 
carried out against that disease;  
(b) they have been obtained from:  
(i) animals that have remained in the territory of the third co untry of 
origin for a period of at least three months before being slaug htered 
or since birth in the case of animals less that three months ol d; 
(ii) in the case of hides and skins from bi-ungulates, animals that come 
from holdings in which there has been no outbreak of foot-and m outh 
disease in the previous 30 days, and around which within a radi us of 
10 km there has been no case of foot-and-mouth disease for 30 d ays; 
(iii) in the case of hides and skins from swine, animals that c ome from 
holdings in which there has been no outbreak of swine vesicular  
disease in the previous 30 days, or of classical or African swi ne 
fever in the previous 40 days, and around which within a radius  of 
10 km there has been no case of these diseases for 30 days; or  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 164
 
(iv) animals that have passed the ante-mortem health inspection  at the 
slaughterhouse during the 24 hours before slaughter and have sh own 
no evidence of foot-and-mouth disease, rinderpest, classical sw ine 
fever, African swine fever or swine vesicular disease; and  
(c) they have undergone all precautions to avoid recontaminatio n with 
pathogenic agents.  
2. Treated hides and skins referred to in point C.2 of Chapter V of Annex XIII 
may be imported without any restrictions.  
3. Other treated hides and skins may be imported if:  
(a) they come either from:  
(i) a third country or, in the case of regionalisation in accor dance with 
Union legislation, from a part of a third country, appearing on  the list 
set out in point (a) of the column ‘third countries’ list’ of r ow 5 of 
Table 2 set out in Section 1 from which imports of fresh meat o f the 
corresponding species are authorised and they have been treated  as 
referred to in point 28(a), (b) and (c) of Annex I;  
(ii) a third country appearing on the list set out in point (a)  of the 
applicable column of row 5 of Table 2 set out in Section 1 and 
they have been treated as referred to in point 28(c) or (d) of 
Annex I; or  
(iii) equidae or ruminant animals from a third country appearin g on the 
list set out in point (b) of the column ‘third countries’ list’  of row 5 
of Table 2 of Section 1, and have been treated as referred to i n point 
28(a), (b) and (c) of Annex I and after treatment have been kep t 
separate for a period of at least 21 days; and  
(b) in the case of salted hides and skins transported by ship, they have been 
treated as referred to in point 28(b) or (c) of Annex I and hav e been kept 
separated after treatment during transportation for a period of  at least 14 
days in the case of the treatment referred to in point 28(b) or  seven days 
in the case of the treatment referred to in point 28(c) before importation 
and the health certificate accompanying the consignment attests  such 
treatment and the duration of the transportation.  
4. Fresh, chilled or treated hides and skins of ungulates must be imported in 
containers, road vehicles, railway wagons or bales sealed under  the responsi­
bility of the competent authority of the third country of dispa tch. 
Section 5  
Imports of game trophies and other preparations from animals  
The following requirements shall apply to the import of game tr ophies and other 
preparations from animals:  
1. Game trophies or other preparations from animals which fulfi l the conditions 
referred to in points B and C.1 of Chapter VI of Annex XIII may  be imported 
without restrictions.  
2. Treated game trophies or other preparations from birds and u ngulates, being 
solely comprised of bones, horns, hooves, claws, antlers, teeth , hides or skins, 
from third countries may be imported if they comply with the re quirements of 
point C.1(a) and point C.2(a), (i) to (iii) and (b)(i) and (ii)  of Chapter VI of 
Annex XIII.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 165
 
However, in the case of dry-salted or wet-salted skins transpor ted by ship, the 
skins need not be salted 14 days before dispatch, provided that  they are salted 
for 14 days before importation.  
3. Game trophies or other preparations from birds and ungulates  consisting of 
entire anatomical parts, not having been treated in any way may  be imported 
if: 
(a) they come from animals originating in an area not subject t o restrictions 
as a result of the presence of serious transmissible diseases t o which 
animals of the species concerned are susceptible;  
(b) they were packaged without being in contact with other prod ucts of 
animal origin likely to contaminate them, in individual, transp arent and 
closed packages so as to avoid any subsequent contamination.  
Section 6  
Imports of treated feathers, parts of feathers and down  
Treated feathers and parts of feathers and down may be imported : 
(a) if they are treated decorative feathers, treated feathers c arried by travellers for 
their private use or consignments of treated feathers or down s ent to private 
individuals for non-industrial purposes; or  
(b) if they are accompanied by a commercial document stating th at the feathers 
and parts of feathers or down have been treated with a steam cu rrent or by 
another method that ensures that no unacceptable risks remain a nd are 
securely enclosed in packaging and dry; and  
(c) unless the commercial document states that they have been f actory-washed 
and treated with hot steam at 100 °C for at least 30 minutes, t hey are sent to 
a registered establishment or plant for such treatment.  
Section 7  
Imports of bones and bone products (excluding bone meal), horns and horn 
products (excluding horn meal) and hooves and hoof products (excluding 
hoof meal) intended for use other than as feed material, organic fertilisers or 
soil improvers  
1. Bones and bone products (excluding bone meal), horns and hor n products 
(excluding horn meal) and hooves and hoof products (excluding h oof meal) 
may be imported to produce derived products for uses outside th e feed chain 
if: 
(a) the products are dried before export to the Union and not c hilled or 
frozen;  
▼M9 
(b) the products are conveyed from the third country of origin directly to a 
border inspection post of entry into the Union and are not tran shipped at 
any port or place outside the Union;  
▼B 
(c) following the document checks provided for in Directive 97/ 78/EC, the 
products are conveyed directly to the registered establishment or plant of 
destination.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 166
 
2. Each consignment must be accompanied by a commercial documen t stamped 
by the competent authority supervising the establishment of ori gin, including 
the following information:  
(a) the third country of origin;  
(b) the name of the establishment or plant of production;  
(c) the nature of the product (dried bone/dried bone product/dr ied horns/­
dried horn products/dried hooves/dried hoof products), and  
▼M23  
(d) confirmation that the product is not intended at any stage to be diverted 
for any use in the manufacturing of food, feed material, organi c fertilisers 
or soil improvers, and  
(i) was derived from healthy animals slaughtered in a slaughter house; 
and 
(ii) either was dried for a period of 42 days at an average tem perature of 
at least 20 °C; and/or  
(iii) was heated for one hour to a temperature of at least 80 ° C to the 
core; and/or  
(iv) was incinerated to ash for one hour at a temperature of at  least 
800 °C to the core; and/or  
(v) underwent an acidification process such that the pH was mai ntained 
for at least one hour at less than 6 to the core.  
▼B 
3. On dispatch to the Union, the material must be enclosed in s ealed containers 
or vehicles or carried in bulk in a ship.  
If transported in containers, the containers, and in all cases all the accom­
panying documents, must bear the name and the address of the re gistered 
establishment or plant of destination.  
4. Following the veterinary checks provided for in Directive 97 /78/EC, and in 
accordance with the conditions laid down in Article 8(4) of tha t Directive, 
the material must be transported directly to the registered est ablishment or 
plant of destination.  
Section 8  
Imports of animal by-products for the manufacture of feed for fur animals, 
petfood, other than raw petfood, and derived products for uses outside the 
feed chain for farmed animals  
Animal by-products intended for the manufacture of feed for fur  animals, 
petfood, other than raw petfood, and for derived products for u ses outside the 
feed chain for farmed animals may be imported provided that:  
1. the animal by-products have been deep-frozen at the plant of  origin or have 
been preserved in accordance with Union legislation in such a w ay to 
prevent spoiling between dispatch and delivery to the establish ment or 
plant of destination;  
2. the animal by-products have undergone all precautions to avo id contami­
nation with pathogenic agents;  
3. the animal by-products were packed in new packaging preventi ng any 
leakage or in packaging which has been cleaned and disinfected before use;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 167
 
4. following the veterinary checks provided for in Directive 97 /78/EC, and in 
accordance with the conditions laid down in Article 8(4) of tha t Directive, 
the animal by-products are transported directly either to:  
(a) a petfood plant or to a registered establishment or plant o f destination, 
which has provided a guarantee that the animal by-products shal l be 
used only for the purpose of producing the products for which i t has 
been registered or approved, as applicable, as specified by the  
competent authority if necessary, and shall not leave the estab lishment 
or plant untreated other than for direct disposal;  
(b) an establishment or plant which has been approved in accord ance with 
Article 24(1)(h) of Regulation (EC) No 1069/2009;  
(c) a registered user or collection centre, which has provided a guarantee 
that the animal by-products shall be used only for permitted pu rposes, as 
specified by the competent authority if necessary; or  
(d) an establishment or plant which has been approved in accord ance with 
Article 24(1)(a) of Regulation (EC) No 1069/2009; and  
5.1. in the case of raw material for petfood production referre d to in 
Article 35(a)(ii) of Regulation (EC) No 1069/2009, the raw mate rial shall:  
(a) be marked in the third country before entry into the Union by a cross of 
liquefied charcoal or activated carbon, on each outer side of e ach frozen 
block, or, when the raw material is transported in pallets whic h are not 
divided into separate consignments during transport to the petf ood plant 
of destination, on each outer side of each pallet, in such a wa y that the 
marking covers at least 70 % of the diagonal length of the side  of the 
frozen block and is at least 10 cm in width;  
(b) in the case of material which is not frozen, be marked in t he third 
country before entry into the Union by spraying it with liquefi ed 
charcoal or by applying charcoal powder in such a way that the 
charcoal is clearly visible on the material;  
(c) be transported directly to:  
(i) the petfood plant of destination in accordance with point 4 (a); or  
(ii) an establishment or plant of destination which has been ap proved in 
accordance with Article 24(1)(h) of Regulation (EC) No 1069/200 9, 
in accordance with point 4(b) of this Section and from there di rectly 
to the petfood plant referred to under (i), provided that the p lant of 
destination:  
— only handles material covered by this point 5.1, or  
— only handles material destined for a petfood plant as referre d to 
under (i); and  
(d) be manipulated to remove the marking provided for in points  (a) and (b) 
only in the petfood plant of destination and only immediately p rior to 
use of the material for the manufacture of petfood, in accordan ce with 
the conditions applicable to petfood produced from Category 3 m aterial 
set out in Chapter II of Annex XIII;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 168
 
5.2. in the case of consignments made up of raw material, which  has been 
treated as referred to in point 5.1 above and other non-treated  raw 
material, all the raw materials in the consignment have been ma rked as 
laid down in point 5.1(a) and (b) above;  
5.3. the marking referred to in point 5.1(a) and (b) and point 5.2 remains visible 
from the dispatch and until the delivery to the petfood plant o f destination;  
6. In the petfood plant of destination, raw material for petfoo d production 
referred to in Article 35(a)(ii) of Regulation (EC) No 1069/200 9 shall be 
stored before production, used and disposed of under conditions  authorised 
by the competent authority, which allow official controls on th e amounts of 
material received, used for production and disposed of, if appl icable.  
The competent authority may authorise the operator of the petfo od plant to 
store such materials together with Category 3 material.  
Section 9  
Imports of rendered fats for certain purposes outside the feed chain for 
farmed animals  
Rendered fats which are not destined to the production of feed for farmed 
animals, the manufacture of cosmetics, medicinal products or me dical devices, 
may be imported, provided:  
(a) they are derived from:  
▼M23  
(i) in the case of materials destined for the production of bio diesel, oleo­
chemical products or for the production of renewable fuels whic h have 
undergone the treatment referred to in point L of Section 2 of Chapter 
IV of Annex IV, animal by-products referred to in Articles 8, 9  and 10 
of Regulation (EC) No 1069/2009;  
▼B 
(ii) in the case of materials destined to the production of org anic fertilisers 
and soil improvers, Category 2 materials referred to in points (c), (d) 
and (f)(i) of Article 9 of Regulation (EC) No 1069/2009, or Cat egory 3 
materials, other than materials referred to in points (c) and ( p) of 
Article 10 of Regulation (EC) No 1069/2009;  
▼M1 
(iii) in the case of materials destined to the production of re newable fuels 
referred to in point J of Section 2 of Chapter IV of Annex IV o f this 
Regulation, Category 2 materials referred to in Article 9 of 
Regulation (EC) No 1069/2009 and Category 3 materials referred to 
in Article 10 of that Regulation;  
(iv) in the case of other materials Category 1 materials referr ed to in points 
(b), (c) and (d) of Article 8 of Regulation (EC) No 1069/2009, Category 
2 materials referred to in points (c) and (d) and point (f)(i) of Article 9 
of Regulation (EC) No 1069/2009 or Category 3 materials, other than 
the materials referred to in points (c) and (p) of Article 10 o f that 
Regulation;  
▼B 
(b) they have been processed by processing method 1 (pressure s terilisation) or 
in accordance with one of the other processing methods referred  to in 
Chapter III of Annex IV;  
(c) in the case of fat from ruminant origin, insoluble impuriti es in excess of 
0,15 % by weight have been removed;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 169
 
(d) they have been marked before shipment to the Union so that the minimum 
concentration of GTH referred to in point 1(b) of Chapter V of Annex VIII is 
achieved;  
(e) following the veterinary checks provided for in Directive 9 7/78/EC, and in 
accordance with the conditions laid down in Article 8(4) of tha t Directive, 
the rendered fats are transported directly to the registered es tablishment or 
plant of destination, under conditions which prevent contaminat ion; and  
(f) they bear labels, on the packaging or container indicating ‘NOT FOR 
HUMAN OR ANIMAL CONSUMPTION’.  
Section 10  
Imports of fat derivatives  
1. Fat derivatives may be imported if the health certificate ac companying the 
consignment certifies:  
(a) whether the fat derivatives derive from Category 1, 2 or 3 materials;  
(b) in the case of fat derivatives produced from Category 2 mat erial, that the 
products:  
(i) have been produced using a method that at least meets the s tandards 
of one of the processes referred to in point 1 of Chapter XI of  
Annex XIII; and  
(ii) shall only be used in organic fertiliser or soil improvers  or other uses 
outside the feed chain for farmed animals, other than in cosmet ics, 
pharmaceuticals and medical devices;  
(c) in the case of fat derivatives produced from Category 1 mat erial, that the 
products must not be used in organic fertilisers and soil impro vers, 
cosmetics, pharmaceuticals and medical devices; however, they m ay be 
used for other purposes outside the feed chain for farmed anima ls. 
2. The health certificate referred to in point 1 must be presen ted to the 
competent authority at the border inspection post at the first point of entry 
of the goods into the Union, and thereafter a copy must accompa ny the 
consignment until its arrival at the plant of destination.  
3. Following the veterinary checks provided for in Directive 97 /78/EC, and in 
accordance with the conditions laid down in Article 8(4) of tha t Directive, 
the fat derivatives shall be transported directly to the regist ered establishment 
or plant of destination.  
Section 11  
Imports of photogelatine  
1. Gelatine which has been produced from material containing bo vine vertebral 
column comprising of Category 1 material in accordance with Art icle 8(b) of 
Regulation (EC) No 1069/2009 and which is intended for the phot ographic 
industry (photogelatine) may be imported, provided the photogel atine:  
(a) originates from one of the plants of origin indicated in Ta ble 3;  
(b) has been produced in accordance with point 6;  
(c) is imported through one of the border inspection posts of f irst entry into 
the Union indicated in Table 3; and  
(d) is destined for production in an approved photographic fact ory indicated 
in Table 3.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 170
 
Table 3  
Imports of photogelatine  
Third country of 
origin  Plants of origin  Member State of 
destination  Border inspection post of 
first entry into the Union  Approved photographic 
factories  
Japan  Nitta Gelatin Inc., 
2-22 Futamata 
Yao-City, Osaka 
581-0024 Japan 
Jellie Co. Ltd. 
7-1, Wakabayashi 
2-Chome, 
Wakabayashi-ku, 
Sendai-City; 
Miyagi, 
982 Japan 
NIPPI Inc. Gelatine 
Division 
1 Yumizawa-Cho 
Fujinomiya City 
Shizuoka 
418-0073 Japan  The Netherlands  Rotterdam  FujifilmEurope, 
Oudenstaart 1, 
5047 TK Tilburg, 
The Netherlands  
Nitta Gelatin Inc., 
2-22 Futamata 
Yao-City, Osaka 
581-0024 Japan  United Kingdom  Liverpool 
Felixstowe 
Heathrow  Kodak Ltd. 
Headstone Drive, 
Harrow, Middlesex, 
HA4 4TY, 
United Kingdom  
Czech Republic  Hamburg  FOMA Bohemia, 
spol. SRO 
Jana Krušinky 
1604 
501 04 Hradec 
Králove, 
Czech Republic  
United States  Eastman Gelatine 
Corporation, 
227 Washington 
Street, 
Peabody, 
MA, 01960 USA 
Gelita North 
America, 
2445 Port Neal 
Industrial Road 
Sergeant Bluff, 
Iowa, 51054 USA  United Kingdom  Liverpool 
Felixstowe 
Heathrow  Kodak Ltd. 
Headstone Drive, 
Harrow, Middlesex, 
HA4 4TY, 
United Kingdom  
Czech Republic  Hamburg  FOMA Bohemia spol. 
SRO 
Jana Krušinky 
1604 
501 04 Hradec 
Králove, 
Czech Republic  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 171
 
2. Once the photogelatine has entered the Member State of desti nation, it shall 
not be traded between Member States but shall only be used in t he approved 
photographic factory in the same Member State of destination an d solely for 
photographic production purposes.  
3. Following the veterinary checks provided for in Directive 97 /78/EC, and in 
accordance with the conditions laid down in Article 8(4) of tha t Directive, 
the photogelatine shall be transported directly to the approved  photographic 
factory of destination.  
4. The transport referred to in point 3 shall be carried out in  vehicles or 
containers in which the photogelatine is physically separated f rom any 
products intended for food or feed.  
5. In the approved photographic factory of destination, the ope rator shall ensure 
that any surpluses or residues of and other waste derived from the photoge­
latine are:  
(a) transported in sealed leak-proof containers labelled ‘for d isposal only’ in 
vehicles under satisfactory hygiene conditions;  
(b) disposed of in accordance with Article 12(a)(i) of Regulati on (EC) 
No 1069/2009 or exported to the third country of origin in acco rdance 
with Regulation (EC) No 1013/2006.  
6. Photogelatine shall be produced according to the following r equirements:  
(a) Photogelatine shall only be produced in plants which do not  produce 
gelatine for food or feed intended for dispatch to the European  Union, 
and which are approved by the competent authority of the third country 
concerned.  
(b) Photogelatine shall be produced by a process that ensures t hat raw 
material is treated by processing method 1 (pressure sterilisat ion) as 
referred to in Chapter III of Annex IV or subjected to a treatm ent with 
acid or alkali for a period of at least two days, washing with water, and:  
(i) following an acid treatment, treating with alkaline solutio n for a 
period of at least 20 days; or  
(ii) following an acid treatment, treating with an acid solutio n for a 
period of 10 to 12 hours.  
The pH must then be adjusted and the material purified by means  of 
filtration and sterilisation at 138°C to 140°C for 4 seconds.  
(c) After having been subjected to the process referred to in p oint (b), the 
photogelatine may undergo a drying process and, where appropria te, a 
process of pulverisation or lamination.  
(d) The photogelatine shall be wrapped, packaged in new package s, stored 
and transported in sealed leak-proof, labelled containers in a vehicle 
under satisfactory hygiene conditions.  
If leakage is observed, the vehicle and containers shall be tho roughly 
cleaned and inspected before reuse.  
(e) Wrapping and packages containing the photogelatine must car ry the 
words ‘photogelatine for the photographic industry only’.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 172
 
Section 12  
Imports of horns and horn products, excluding horn meal, and hooves and 
hoof products, excluding hoof meal, intended for the production of organic 
fertilisers or soil improvers  
Horns and horn products, excluding horn meal, and hooves and ho of products, 
excluding hoof meal, intended for the production of organic fer tilizers or soil 
improvers, may be imported, provided that:  
1. they have been produced in accordance with Chapter XII of An nex XIII; and  
2. they are conveyed following the veterinary checks provided f or in Directive 
97/78/EC, and in accordance with the conditions laid down in Ar ticle 8(4) of 
that Directive, directly to an approved or registered establish ment or plant.  
CHAPTER III  
SPECIAL RULES FOR CERTAIN SAMPLES  
Section 1  
Research and diagnostic samples  
Unless they are kept for reference purposes or redispatched to the third country 
of origin, research and diagnostic samples and any products der ived from the use 
of those samples shall be disposed of:  
(a) as waste by incineration;  
(b) by pressure sterilisation and subsequent disposal or use in  accordance with 
Articles 12 to 14 of Regulation (EC) No 1069/2009; or  
(c) in accordance with point 4(b) of Section 1 of Chapter I of Annex VI in case:  
(i) of quantities not exceeding 2 000 ml; and  
(ii) provided the samples or derived products have been produce d in and 
dispatched from third countries or parts of third countries, fr om which 
Member States authorise imports of fresh meat of domestic bovin e 
animals, which are listed in Part I of Annex II to Regulation ( EU) 
No 206/2010.  
Section 2  
Trade samples  
1. The competent authority may authorise the import and transit  of trade 
samples, provided that:  
(a) they originate from:  
(i) third countries referred to in the column ‘third countries’  list’ of row 
14 of Table 2 of Section 1 of Chapter II of this Annex;  
(ii) in the case of trade samples which consist of milk, milk-b ased 
products or milk-derived products, authorised third countries l isted 
in Annex I to Regulation (EU) No 605/2010;  
(b) they are accompanied by a health certificate as referred to  in Chapter 8 
of Annex XV; and  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 173
 
(c) following the veterinary checks provided for in Directive 9 7/78/EC, and 
in accordance with the conditions laid down in Article 8(4) of that 
Directive, they are transported directly to the approved or reg istered 
establishment or plant indicated in the authorisation of compet ent 
authority.  
2. Unless the trade samples are kept for reference purposes, th ey shall be:  
(a) disposed of or used in accordance with Articles 12, 13 and 14 of 
Regulation (EC) No 1069/2009; or  
(b) redispatched to the third country of origin.  
3. If trade samples are used for testing of machinery, the test ing shall be carried 
out: 
(a) with dedicated equipment; or  
(b) with equipment which is cleaned and disinfected before it i s used for 
purposes other than the testing.  
During transport to the approved or registered establishment or  plant, the 
trade samples must be packaged in leak-proof containers.  
Section 3  
Display items  
1. Import and transit of display items shall take place in acco rdance with the 
following conditions:  
(a) they originate from third countries referred to in the colu mn ‘third 
countries’ list’ of row 14 of Table 2 of Section 1 of Chapter I I; 
(b) their introduction has been authorised in advance by the co mpetent 
authority of the Member State where the display item is intende d to 
be used;  
(c) following the veterinary checks provided for in Directive 9 7/78/EC, 
display items must be sent directly to the authorised user.  
2. Each consignment must be packed in packaging preventing any leakage and 
must be accompanied by a commercial document which specifies:  
(a) the description of the material and the animal species of o rigin;  
(b) the category of the material;  
(c) the quantity of the material;  
(d) the place of dispatch of the material;  
(e) the name and the address of the consignor;  
(f) the name and the address of the consignee; and  
(g) details allowing the identification of the authorisation of  the competent 
authority of destination.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 174
 
3. After the exhibition or after the artistic activity has been  concluded, display 
items shall be:  
(a) redispatched to the third country of origin;  
(b) dispatched to another Member State or third country, if suc h dispatch has 
been authorised by the competent authority of the Member State or third 
country of destination in advance; or  
(c) disposed of in accordance with Articles 12, 13 and 14 of 
Regulation (EC) No 1069/2009.  
CHAPTER IV  
SPECIFIC REQUIREMENTS FOR CERTAIN MOVEMENTS OF 
ANIMAL BY-PRODUCTS  
Section 1  
Imports of certain Category 1 materials  
Materials referred to in Article 26 shall be imported under the  following 
conditions:  
1. The materials shall be imported with a label attached to the  packaging, 
container or vehicle which indicates ‘Prohibited in food, feed,  fertilisers, 
cosmetics, medicinal products and medical devices’.  
2. The materials shall be directly delivered to an approved or registered estab­
lishment or plant for the manufacture of derived products, othe r than the 
products referred to in point 1.  
3. Unused or surplus materials shall be used or disposed of in accordance with 
Article 12 of Regulation (EC) No 1069/2009.  
Section 2  
Imports of certain materials for purposes other than feeding to farmed land 
animals  
1. The competent authority may authorise the import of the foll owing materials 
for purposes other than feeding to farmed land animals, except for feeding to 
fur animals, provided there is no unacceptable risk for the tra nsmission of 
diseases communicable to humans or animals:  
(a) animal by-products from aquatic animals and derived product s from 
aquatic animals;  
(b) aquatic invertebrates and derived products from aquatic inv ertebrates;  
(c) terrestrial invertebrates, including any of their transform ation forms, such 
as larvae, and derived products therefrom;  
(d) products generated by the animals referred to in points (a) , (b) and (c), 
such as fish eggs;  
(e) Category 3 material comprising of animals and parts thereof  of the zool­
ogical orders of Rodentia and Lagomorpha.  
2. Imports of consignments of the materials referred to in poin t 1 shall take place 
in accordance with sanitary certification requirements in accor dance with 
national rules.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 175
 
CHAPTER V  
RULES FOR THE EXPORT OF CERTAIN DERIVED PRODUCTS  
Rules applicable to the export of the derived products listed b elow as referred to 
in Article 25(4):  
▼M23  
Derived products  Rules for export  
1 — Processed manure 
— Organic fertilizers, compost or 
digestion residues from biogas 
transformation containing no 
other animal by-products or 
derived products than 
processed manure 
— Processed animal protein 
containing processed manure 
as a mixing component  The following derived products must 
comply at least with the conditions set 
out in points (a), (b), (d) and (e) of 
Section 2 of Chapter I of Annex XI: 
— Processed manure 
— Organic fertilizers, compost or 
digestion residues from biogas 
transformation containing no other 
animal by-products or derived 
products than processed manure 
— Processed manure as a mixing 
component in processed animal 
protein  
2 Blood products and inter­
mediate products  Blood, blood products and intermediate 
products produced in the EU or imported 
into the EU in accordance with health 
requirements laid down in Annex XII or 
Sections 2 and 3 of Chapter II of this 
Annex  for use outside the feed chain of 
farm animals , provided they comply with 
the import requirements of the third country 
of destination.  
▼M26  
3 Meat-and-bone meal of 
Category 1 materials.  Meat-and-bone meal (MBM) of 
Category 1 material intended as a fuel 
for combustion shall only be exported 
from Ireland to the United Kingdom (  1 ), 
under the following conditions: 
(a) the competent authority of Ireland 
has authorised the export to the 
combustion plant in the United 
Kingdom not later than 
31 December 2023, provided such 
movements of MBM of Category 1 
materials intended for disposal have 
taken place from that Member State 
prior to 1 January 2021 under the 
conditions laid down in 
Article 6(6), (7) and (8); 
(b) the combustion plant of destination 
is authorised for the combustion of 
imported MBM of Category 1 
materials in the import license 
issued by the United Kingdom;  ▼M10  02011R0142 — EN — 01.01.2021 — 021.001 — 176
 
Derived products  Rules for export  
(c) the MBM of Category 1 material 
— was obtained solely from the 
processing in accordance with 
the Processing method 1 
(pressure sterilisation) 2, 3, 4 
or 5 referred to in Chapter III 
of Annex IV, 
— is marked in accordance with 
Chapter V of Annex VIII; 
(d) the consignment of MBM is sent in 
sealed containers directly from the 
processing plant or storage plant 
referred to in Article 24(1)(a) or 
(j)(ii) of Regulation (EC) 
No 1069/2009 to the combustion 
plant of destination; 
(e) operators shall present 
consignments of MBM to the 
border control post of exit; 
(f) the competent authority of the 
border control post of exit shall 
carry out official controls on the 
consignments referred to in point 
(e), in particular on the integrity 
of the seal. 
In case the integrity of the seal is 
compromised, the rules set out in 
Article 138(2)(d) and (g) of Regu­
lation (EU) 2017/625 of the 
European Parliament and of the 
Council (  2 ) shall apply; 
(g) the competent authority at the 
border control post shall inform, 
via TRACES, the competent 
authority indicated in box I.4 of 
the commercial document of the 
arrival of the consignment at the 
point of exit and, where applicable, 
of the outcome of the verification 
of the seal and of any corrective 
action taken. 
The competent authority 
responsible for the processing 
plant of origin shall carry out risk 
based official controls to verify 
compliance with the first 
paragraph and to verify that, for 
each consignment of MBM, the 
confirmation of the control carried 
out at the exit point was received 
from the competent authority of the 
border control post, through 
TRACES.  ▼M26  02011R0142 — EN — 01.01.2021 — 021.001 — 177
 
Derived products  Rules for export  
In case of non-compliance, the 
competent authority may prohibit such 
movements of a consignment of MBM 
of Category 1 material intended as a 
fuel for combustion in accordance 
with Article 138(2)(d) of Regulation 
(EU) 2017/625.  
( 1 ) In accordance with the Agreement on the withdrawal of the Uni ted Kingdom of Great 
Britain and Northern Ireland from the European Union and the Eu ropean Atomic Energy 
Community, and in particular Article 5(4) of the Protocol on Ir eland/Northern Ireland in 
conjunction with Annex 2 to that Protocol, for the purposes of this Annex references to 
the United Kingdom do not include Northern Ireland. 
( 2 ) Regulation (EU) 2017/625 of the European Parliament and of th e Council of 15 March 
2017 on official controls and other official activities perform ed to ensure the application 
of food and feed law, rules on animal health and welfare, plant  health and plant 
protection products, amending Regulations (EC) No 999/2001, (EC ) No 396/2005, 
(EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) N o 652/2014, 
(EU) 2016/429 and (EU) 2016/2031 of the European Parliament and  of the Council, 
Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Co uncil Directives 
98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing 
Regulations (EC) No 854/2004 and (EC) No 882/2004 of the Europe an Parliament 
and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/ 
496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 9 2/438/EEC 
(Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).  
▼M24  
CHAPTER VI  
REQUIREMENTS FOR THE ENTRY OF CONSIGNMENTS OF 
ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS ORIGINATING 
FROM, AND RETURNING TO, THE UNION FOLLOWING REFUSAL 
OF ENTRY BY A THIRD COUNTRY  
Section 1  
Unpackaged or in bulk animal by-products and derived products, 
originating from, and returning to, the Union following refusal of entry by 
a third country not listed as a whole or part of its territory in Annex XIV  
1. The competent authority at the border control post shall onl y authorise the 
entry into the Union of consignments of unpackaged or in bulk a nimal 
by-products or derived products originating from, and returning  to, the 
Union following a refusal of entry by a third country not liste d as a whole 
or part of its territory in Annex XIV for the entry into the Un ion of the type 
of product, where the following conditions are met:  
(a) the consignment is accompanied by the official certificate or document, 
either in its original or as authenticated copy, or by the elec tronic 
equivalent of such certificate or document generated by use of 
IMSOC (  1 ), issued by the competent authority of the Member State of 
export;  
(b) the consignment is accompanied by a declaration from the co mpetent 
authority in the Member State of destination in which that auth ority 
agrees to receive the consignment and indicates the place of de stination;  ▼M26  02011R0142 — EN — 01.01.2021 — 021.001 — 178  
( 1 ) Commission Implementing Regulation (EU) 2019/1715 of 30 Septe mber 2019 laying 
down rules for the functioning of the information management sy stem for official 
controls and its system components (‘the IMSOC Regulation’) (OJ  L 261, 14.10.2019, 
p. 37).
 (c) the consignment complies with both of the following conditi ons: 
(i) it has remained sealed with an intact original seal, if the  application of 
a seal prior to leaving the Union was mentioned in the original  
certificate referred to in point 1(a) or another official docum ent 
issued by an authority in the Union;  
(ii) it is accompanied by an official declaration of the compet ent authority 
or other public authority of the third country which refused th e entry 
of the consignment indicating the reason for the refusal.  
2. By way of derogation from point 1(a), in the case where the consignment was 
exported without accompanying official certificate or document,  the origin of 
the consignment shall be authenticated in another way based on documented 
evidence presented by the operator responsible for the consignm ent. 
3. The transport of consignments of products referred to in poi nt 1 from the 
border control post to the place of destination shall be monito red in 
accordance with Article 2 of Commission Delegated Regulation (E U) 
2019/1666.  
Section 2  
Unpackaged or in bulk animal by-products and derived products originating 
from, and returning to, the Union following refusal of entry by a third 
country listed as a whole or part of its territory in Annex XIV  
1. The competent authority at the border control post shall onl y authorise the 
entry into the Union of consignments of unpackaged or in bulk a nimal 
by-products or derived products originating from, and returning  to, the 
Union following a refusal of entry by a third country listed as  a whole or 
part of its territory in Annex XIV for the entry into the Union  of the type of 
product, where the requirements set out in points 1(a), (b) and  (c)(ii), 2 and 3 
of Section 1 are met.  
2. Where the products referred to in point 1 have been unloaded , stored, 
re-loaded or the original seal has been replaced in or upon ent ry into the 
third country or part of its territory listed in Annex XIV, the  consignment 
shall be accompanied by an official declaration of the competen t authority or 
other public authority of that third country or territory:  
(a) indicating the place and date of unloading, storage and re- loading and the 
seal number put on the container after reloading;  
(b) confirming that:  
(i) the seal on the vehicle or container of the consignment was  only 
broken for the purpose of official controls;  
(ii) the products were handled only to the extent necessary, an d in 
particular  
— at the appropriate temperature required for the relevant type s of 
animal by-products or derived products; and  
— in a way that prevents cross contamination of the products du ring 
the controls;  
(iii) the vehicle or container was immediately re-sealed after the official 
controls  
(c) indicating the reasons for unloading and storage.  ▼M24  02011R0142 — EN — 01.01.2021 — 021.001 — 179
 
Section 3  
Packaged animal by-products and derived products originating from, and 
returning to, the Union following a refusal of entry by a third country  
1. The competent authority at the border control post shall onl y authorise the 
entry into the Union of consignments of packaged animal by-prod ucts or 
derived products originating from, and returning to, the Union following a 
refusal of entry by a third country where the requirements set out in Section 1 
are met and the individual packaging of the products has remain ed intact as 
compared to its state before exportation.  
2. Where the products referred to in point 1 have been unloaded  in a third 
country, the consignment is accompanied by an official declarat ion of the 
competent authority or other public authority of the third coun try attesting 
that the products:  
(a) have not been subjected to any handling other than unloadin g, storage and 
re-loading;  
(b) were handled at the required temperature for the relevant t ypes of animal 
by-products or derived products.  ▼M24  02011R0142 — EN — 01.01.2021 — 021.001 — 180
 
ANNEX XV  
MODEL HEALTH CERTIFICATES  
The model health certificates in this Annex shall apply to the importation from third countries and 
to the transit through the European Union of the animal by-prod ucts and the derived products 
referred to in the respective model health certificates.  
Notes  
(a) Veterinary certificates shall be 
produced by the exporting third 
country, based on the models set out 
in this Annex, according to the layout 
of the model that corresponds to the 
animal by-products or derived 
products concerned. They shall 
contain, in the numbered order that 
appears in the model, the attestations 
that are required for any third country 
and, as the case may be, those supple­
mentary guarantees that are required 
for the exporting third country or part 
thereof.  
(b) Where the model certificate states that 
certain statements shall be kept as 
appropriate, statements which are not 
relevant may be crossed out and 
initialled and stamped by the certifying 
officer, or completely deleted from the 
certificate.  
(c) The original of each certificate shall 
consist of a single sheet of paper, 
both sides, or, where more text is 
required; it shall be in such a form 
that all sheets of paper needed are 
part of an integrated whole and indi­
visible.  
(d) It shall be drawn up in at least one of 
the official languages of the EU 
Member State in which the inspection 
at the border post shall be carried out 
and of the EU Member State of desti­
nation. However, these Member States 
may allow other languages, accom­
panied, if necessary, by an official 
translation.  
(e) If for reasons of identification of the 
items of the consignment, additional 
sheets of paper are attached to the 
certificate, these sheets of paper shall 
also be considered as forming part of 
the original of the certificate by the 
application of the signature and stamp 
of the certifying official veterinarian, in 
each of the sheets of paper.  (f) When the certificate, including addi­
tional schedules referred to in e), 
comprises more than one page, each 
page shall be numbered – ( page 
number ) of ( total number of pages ) – 
at the bottom of the page and shall 
bear the code number of the certificate 
that has been designated by the 
competent authority at the top of the 
page.  
(g) The original of the certificate must be 
completed and signed by an official 
veterinarian. In doing so, the 
competent authorities of the exporting 
country shall ensure that the principles 
of certification equivalent to those laid 
down in Directive 96/93/EC are 
followed.  
(h) The colour of the signature shall be 
different to that of the printing. The 
same rule applies to stamps other 
than those embossed or watermark.  
(i) The original of the certificate must 
accompany the consignment at the 
EU border inspection post.  
(j) If health certificates are used for 
consignments in transit, box No I.5 
(‘Consignee’) of the relevant health 
certificate shall be completed with the 
name and address of the border 
inspection post through which the 
consignment is intended to leave the 
European Union.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 181
 
CHAPTER 1  
Health certificate  
For processed animal protein, other than those derived from farmed insects, not 
intended for human consumption, including mixtures and products other than 
petfood containing such protein, for dispatch to or for transit through  ( 2 ) the 
European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 182
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 183
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 184
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 185
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 186
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 187
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 188
 
CHAPTER 1a  
Health certificate  
For processed animal protein derived from farmed insects not intended for 
human consumption, including mixtures and products other than petfood 
containing such protein, for dispatch to or for transit through  ( 2 ) the 
European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 189
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 190
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 191
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 192
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 193
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 194
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 195
 
CHAPTER 2(A)  
Health certificate  
For milk, milk-based products and milk-derived products not intended for human 
consumption for dispatch to or transit through (  2 ) the European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 196
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 197
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 198
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 199
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 200
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 201
 
CHAPTER 2(B)  
Health certificate  
For colostrum and colostrum products from bovine animals not intended for 
human consumption for dispatch to or transit through  ( 2 ) the European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 202
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 203
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 204
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 205
 
CHAPTER 3(A)  
Health certificate  
For canned petfood intended for dispatch to or for transit through  ( 2 ) the 
European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 206
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 207
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 208
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 209
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 210
 
(CHAPTER 3(B)  
Health certificate  
For processed petfood other than canned petfood, intended for dispatch to or for 
transit through  ( 2 ) the European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 211
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 212
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 213
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 214
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 215
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 216
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 217
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 218
 
CHAPTER 3(C)  
Health certificate  
For dogchews intended for dispatch to or for transit through  ( 2 ) the European 
Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 219
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 220
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 221
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 222
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 223
 
CHAPTER 3(D)  
Health certificate  
For raw petfood for direct sale or animal by-products to be fed to fur animals, 
intended for dispatch to or for transit through  ( 2 ) the European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 224
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 225
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 226
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 227
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 228
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 229
 
CHAPTER 3(E)  
Health certificate  
For flavouring innards for use in the manufacture of petfood, intended for 
dispatch to or for transit through  ( 2 ) the European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 230
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 231
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 232
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 233
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 234
 
CHAPTER 3(F)  
Health certificate  
For animal by-products  ( 3 ) for the manufacture of petfood, intended for dispatch 
to or for transit through  ( 2 ) the European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 235
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 236
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 237
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 238
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 239
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 240
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 241
 
CHAPTER 4(A)  
Health certificate  
For the import of blood and blood products from equidae to be used outside the 
feed chain, for dispatch to or for transit through  ( 2 ) the European Union
  ▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 242
 
▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 243
 
▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 244
 
▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 245
 
CHAPTER 4(B)  
Health certificate  
For blood products not intended for human consumption that could be used as 
feed material, intended for dispatch to or for transit through  ( 2 ) the European 
Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 246
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 247
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 248
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 249
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 250
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 251
 
CHAPTER 4(C)  
Health certificate  
For untreated blood products, excluding those of equidae, for the manufacture of 
derived products for purposes outside the feed chain for farmed animals, 
intended for dispatch to or for transit through  ( 2 ) the European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 252
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 253
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 254
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 255
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 256
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 257
 
CHAPTER 4(D)  
Health certificate  
For treated blood products, excluding those of equidae, for the manufacture of 
derived products for purposes outside the feed chain for farmed animals, 
intended for dispatch to or for transit through  ( 2 ) the European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 258
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 259
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 260
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 261
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 262
 
CHAPTER 5(A)  
Health certificate  
For fresh or chilled hides and skins of ungulates, intended for dispatch to or for 
transit through  ( 2 ) the European Union
  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 263
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 264
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 265
 
CHAPTER 5(B)  
Health certificate  
For treated hides and skins of ungulates, intended for dispatch to or for transit 
through  ( 2 ) the European Union
  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 266
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 267
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 268
 
CHAPTER 5(C)  
Official declaration  
For treated hides and skins of ruminants and of equidae that are intended for 
dispatch to or for transit through  ( 1 ) the European Union and have been kept 
separate for 21 days or will undergo transport for 21 uninterrupted days before 
importation
  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 269
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 270
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 271
 
CHAPTER 6(A)  
Health certificate  
For treated game trophies and other preparations of birds and ungulates, 
consisting only of bones, horns, hooves, claws, antlers, teeth, hides or skins, 
for dispatch to or for transit through  ( 2 ) the European Union
  ▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 272
 
▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 273
 
▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 274
 
CHAPTER 6(B)  
Health certificate  
For game trophies or other preparations of birds and ungulates consisting of 
entire parts which have not been treated, intended for dispatch to or for transit 
through  ( 2 ) the European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 275
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 276
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 277
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 278
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 279
 
CHAPTER 7(A)  
Health certificate  
For pig bristles from third countries or regions thereof that are free from African 
swine fever, intended for dispatch to or for transit through  ( 2 ) the European 
Union
  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 280
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 281
 
CHAPTER 7(B)  
Health certificate  
For pig bristles from third countries or regions thereof that are not free from 
African swine fever, intended for dispatch to or for transit through  ( 2 ) the 
European Union
  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 282
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 283
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 284
 
CHAPTER 8  
Health certificate  
For animal by-products to be used for purposes outside the feed chain or for 
trade samples  ( 2 ), intended for dispatch to or for transit through  ( 2 ) the 
European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 285
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 286
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 287
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 288
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 289
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 290
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 291
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 292
 
CHAPTER 9  
Health certificate  
For fish oil not intended for human consumption to be used as feed material or 
for purposes outside the feed chain, intended for dispatch to or for transit 
through  ( 2 ) the European Union
  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 293
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 294
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 295
 
CHAPTER 10(A)  
Health certificate  
For rendered fats not intended for human consumption to be used as feed 
material, intended for dispatch to or for transit through  ( 2 ) the European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 296
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 297
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 298
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 299
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 300
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 301
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 302
 
CHAPTER 10(B)  
Health certificate  
For rendered fats not intended for human consumption to be used for certain 
purposes outside the feed chain, intended for dispatch to or for transit through  ( 2 ) 
the European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 303
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 304
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 305
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 306
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 307
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 308
 
CHAPTER 11  
Health certificate  
For gelatine and collagen not intended for human consumption to be used as 
feed material or for purposes outside the feed chain, intended for dispatch to or 
for transit through  ( 2 ) the European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 309
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 310
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 311
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 312
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 313
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 314
 
CHAPTER 12  
Health certificate  
For hydrolysed protein, dicalcium phosphate and tricalcium phosphate not 
intended for human consumption to be used as feed material or for uses 
outside the feed chain, intended for dispatch to or for transit through  ( 2 ) the 
European Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 315
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 316
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 317
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 318
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 319
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 320
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 321
 
CHAPTER 13  
Health certificate  
For apiculture by-products intended exclusively for use in apiculture, intended 
for dispatch to or for transit through  ( 2 ) the European Union
  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 322
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 323
 
CHAPTER 14(A)  
Health certificate  
For fat derivatives not intended for human consumption to be used outside the 
feed chain, intended for dispatch to or for transit through  ( 2 ) the European 
Union
  ▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 324
 
▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 325
 
▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 326
 
▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 327
 
CHAPTER 14(B)  
Health certificate  
For fat derivatives not intended for human consumption to be used as feed or 
outside the feed chain, intended for dispatch to or for transit through  ( 2 ) the 
European Union
  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 328
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 329
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 330
 
CHAPTER 15  
Health certificate  
For egg products not intended for human consumption that could be used as feed 
material, intended for dispatch to or for transit through  ( 2 ) the European Union
  ▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 331
 
▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 332
 
▼M4 02011R0142 — EN — 01.01.2021 — 021.001 — 333
 
CHAPTER 16  
Model declaration
  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 334
 
CHAPTER 17  
Health certificate  
For processed manure, derived products from processed manure and guano from 
bats intended for dispatch to or for transit through  ( 2 ) the European Union
  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 335
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 336
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 337
 
CHAPTER 18  
Health certificate  
For horns and horn products, excluding horn meal, and hooves and hoof 
products, excluding hoof meal, intended for the production of organic fertilisers 
or soil improvers intended for dispatch to or for transit through  ( 2 ) the European 
Union
  ▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 338
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 339
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 340
 
▼M15  02011R0142 — EN — 01.01.2021 — 021.001 — 341
 
CHAPTER 19  
Health certificate  
For gelatine not intended for human consumption to be used by the photographic 
industry, intended for dispatch to the European Union
  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 342
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 343
 
▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 344
 
CHAPTER 20  
Model declaration  
Declaration for the import from third countries and for the transit through  ( 2 ) 
the European Union of intermediate products to be used for the manufacture of 
medicinal products, veterinary medicinal products, medical devices for medical 
and veterinary purposes, active implantable medical devices, in vitro diagnostics 
medical devices for medical and veterinary purposes, laboratory reagents and 
cosmetic products
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CHAPTER 21  
Model declaration  
Declaration by the importer of untreated wool and hair referred to in 
Article 25(2)(e) for import to the European Union
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ANNEX XVI  
OFFICIAL CONTROLS  
CHAPTER I  
OFFICIAL CONTROLS IN PROCESSING PLANTS  
Section 1  
Supervision of the production  
1. The competent authority shall supervise processing plants to  ensure 
compliance with the requirements of Regulation (EC) No 1069/200 9 and 
with this Regulation.  
It shall, in particular:  
(a) check:  
(i) the general conditions of hygiene of the premises, equipmen t and 
staff;  
(ii) the efficacy of the own checks carried out by the operator  of the 
processing plant, in accordance with Article 28 of Regulation ( EC) 
No 1069/2009; such checks must include an examination of the 
results of those checks and if necessary, the taking of samples ; 
(iii) the effective implementation of the permanent written pro cedure 
based on the HACCP principles in accordance with Article 29(1) 
of Regulation (EC) No 1069/2009; such checks must include an 
examination of the results of this implementation and if necess ary, 
the taking of samples;  
(iv) the standards of the products after processing; the analys es and tests 
must be carried out in accordance with scientifically recognise d 
methods, in particular, those laid down in Union legislation or , 
where no such methods are laid down in Union legislation, in 
accordance with recognised international standards or, in their  
absence, national standards; and  
(v) the storage conditions;  
(b) take any samples required for laboratory tests; and  
(c) make any other checks it considers necessary to ensure comp liance with 
Regulation (EC) No 1069/2009 and with this Regulation.  
2. To allow it to carry out its responsibilities under point 1,  the competent 
authority must have free access at all times to all parts of th e processing 
plant and to records, commercial documents and health certifica tes. 
Section 2  
Validation procedures  
1. Prior to issuing an approval for a processing plant, as prov ided for in 
Article 44(1) of Regulation (EC) No 1069/2009, the competent au thority 
must check that a validation of the processing plant has been c arried out 
by the operator in accordance with the following procedures and  indicators:  
(a) a description of the process by a process flow diagram;  
(b) an identification of critical control points (CCPs) includi ng the material 
process rate for continuous systems;  
(c) the compliance with the specific process requirements laid down by this 
Regulation; and  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 352
 
(d) the achievement of the following requirements:  
(i) particle size for batch-pressure and continuous processes, defined by 
the mincer hole or the anvil gap size;  
(ii) temperature, pressure, processing time and, in the case of  continuous 
processing systems, the material processing rate, as specified in 
points 2 and 3.  
2. In the case of a batch pressure system:  
(a) the temperature must be monitored with a permanent thermoco uple and it 
must be plotted against real time;  
(b) the pressure stage must be monitored with a permanent press ure gauge; 
pressure must be plotted against real time;  
(c) the processing time must be shown by time/temperature and t ime/­
pressure diagrams.  
At least once a year the thermocouple and the pressure gauge mu st be 
calibrated.  
3. In the case of a continuous pressure system:  
(a) the temperature and the pressure must be monitored with the rmocouples, 
or an infrared temperature gun, and pressure gauges must be use d at 
defined positions throughout the process system in such a way t hat 
temperature and pressure comply with the required conditions in side 
the whole continuous system or in a section of it; the temperat ure and 
pressure must be plotted against real time;  
(b) measurement of the minimum transit time inside the whole re levant part 
of the continuous system where the temperature and pressure com ply 
with the required conditions, must be provided to the competent  
authorities, using insoluble markers, such as manganese dioxide , or a 
method which offers equivalent guarantees.  
Accurate measurement and control of the material process rate i s 
essential and must be measured during the validation test in re lation to 
a CCP that can be continuously monitored such as:  
(i) feed screw revolutions per minute (rev./min.);  
(ii) the electric power (amps at given voltage);  
(iii) the evaporation/condensation rate; or  
(iv) the number of pump strokes per unit time.  
All measuring and monitoring equipment must be calibrated at le ast once 
a year.  
4. The competent authority must repeat the checks on the valida tion procedures 
when it considers it necessary, and in any case each time any s ignificant 
alterations are made to the process, such as modifications of t he machinery 
or changes of raw materials.  
CHAPTER II  
LISTS OF REGISTERED AND APPROVED ESTABLISHMENTS, 
PLANTS AND OPERATORS  
1. Access to lists of registered and approved establishments, p lants and 
operators  
In order to assist Member States in making up-to-date lists of registered and 
approved establishments, plants and operators available to othe r Member 
States and to the public, the Commission shall provide a websit e which 
shall contain links to the national websites provided by each M ember 
State, as referred to in point 2(a).  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 353
 
2. Format for national websites  
(a) Each Member State shall provide the Commission with a linki ng address 
to a single national website containing the master list of all registered 
and approved establishments, plants and operators on its territ ory 
(‘master list’).  
(b) Each master list shall consist of one sheet and shall be co mpleted in one 
or more official languages of the Union.  
3. The layout, including the relevant information and codes, of  master lists shall 
follow the technical specifications which are published by the Commission 
on its website.  
CHAPTER III  
SPECIFIC REQUIREMENTS FOR OFFICIAL CONTROLS  
Section 1  
Official controls regarding marking of derived products  
The competent authority shall carry out a performance check of the monitoring 
and recording system referred to in point 2 of Chapter V of Ann ex VIII to this 
Regulation to ascertain compliance with this Regulation and may , where 
necessary, request the testing of additional samples in accorda nce with the 
method referred to in the second paragraph of the same point.  
Section 2  
Official controls in low-capacity incineration plants  
The competent authority shall inspect a low-capacity incinerati on plant for incin­
eration of specified risk materials before approval, and at lea st once a year to 
monitor compliance with Regulation (EC) No 1069/2009 and with t his Regu­
lation.  
Section 3  
Official controls in remote areas  
In the case of disposal of animal by-products in remote areas i n accordance with 
Article 19(1)(b) of Regulation (EC) No 1069/2009, the competent  authority shall 
monitor regularly the areas categorised as remote areas to ensu re that those areas 
and the disposal operations are properly controlled.  
Section 4  
Official controls in registered farms for the feeding of fur animals  
1. The competent authority shall take the necessary measures to  control:  
(a) the appropriate composition, processing and use of the feed  containing 
meat-and-bone meal or other products which have been processed in 
accordance with the processing methods set out in Chapter III o f 
Annex IV and which are derived from the bodies or parts of bodi es of 
animals of the same species;  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 354
 
(b) that the animals are fed with the feed referred to in point  (a), including:  
(i) strict supervision of the health status of those animals; a nd 
(ii) appropriate TSE surveillance involving regular sampling an d 
laboratory examination for TSEs.  
2. The samples referred to in point 1(b)(ii) shall include samp les taken from 
animals showing neurological symptoms and from older breeding a nimals.  
Section 5  
Official controls regarding collection centres  
1. The competent authority shall:  
(a) include collection centres into the list drawn up in accord ance with 
Article 47(1) of Regulation (EC) No 1069/2009;  
(b) assign an official number to each collection centre; and  
(c) update the list of collection centres and make it available  together with 
the list drawn up in accordance with Article 47(1) of Regulatio n (EC) 
No 1069/2009.  
2. The competent authority shall carry out official controls at  collection centres 
in order to verify compliance with this Regulation.  
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Section 6  
Official controls regarding the feeding of wild animals and certain zoo 
animals with Category 1 material  
The competent authority shall monitor the health status of the farmed animals in 
the region where feeding is carried out as referred to in Secti ons 2, 3 and 4 of 
Chapter II of Annex VI and shall carry out appropriate TSE surv eillance 
involving regular sampling and laboratory examination for TSEs.  
Those samples shall include samples taken from suspected animal s and from 
older breeding animals.  
▼B 
Section 7  
Official controls regarding the application of certain organic fertilisers and 
soil improvers  
The competent authority shall carry out controls along the enti re chain of 
production and use of organic fertilisers and soil improvers su bject to the 
restrictions referred to in Chapter II of Annex II.  
Those controls shall include checks on the mixing with a compon ent referred to 
in point 2 of Section 1 of Chapter II of Annex XI, and checks o n the stocks of 
such products kept on farm and the records kept in accordance w ith 
Regulation (EC) No 1069/2009 and with this Regulation.  
Section 8  
Official controls regarding approved photographic factories  
The competent authority shall carry out documentary checks in a pproved photo­
graphic factories referred to in Table 3 of point 1 of Section 11 of Chapter II of 
Annex XIV on the channelling chain from the border inspection p osts of first 
entry to the approved photographic factories for the purpose of  reconciliation of 
the quantities of products imported, used and disposed of.  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 355
 
Section 9  
Official controls regarding certain imported rendered fats  
The competent authority shall carry out documentary checks in r egistered estab­
lishments or plants receiving rendered fats which have been imp orted in 
accordance with Section 9 of Chapter II of Annex XIV on the cha nnelling 
chain from the border inspection posts of first entry to the re gistered estab­
lishment or plant for the purpose of reconciliation of the quan tities of products 
imported, used and disposed of.  
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Section 10  
Standard format for applications for certain authorisations in intra-Union 
trade  
Operators shall inform the competent authority of the Member St ate of origin and 
apply to the competent authority of the Member State of destina tion for the 
authorisation of the dispatch of animal by-products and derived  products 
referred to in Article 48(1) of Regulation (EC) No 1069/2009, a nd fish oil or 
fishmeal of Category 3 materials intended for detoxification in  accordance with 
the following format in TRACES:  ▼B 02011R0142 — EN — 01.01.2021 — 021.001 — 356
 
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Section 11  
Official controls regarding hydrolysis with subsequent disposal  
The competent authority shall carry out controls at sites where  hydrolysis with 
subsequent disposal is carried out in accordance with point B o f Section 2 of 
Chapter V of Annex IX.  
Such controls shall, for the purpose of reconciliation of the q uantities of 
hydrolysed materials dispatched and disposed of, include docume ntary checks:  
(a) of the amount of materials which are hydrolysed at the site ; 
(b) in the establishments or plants where the hydrolysed materi als are disposed 
of. 
Controls shall be carried out regularly on the basis of a risk assessment.  
During the period of the first 12 months of operation, a contro l visit to a site, 
where a container for the hydrolysis is located, shall be carri ed out every time 
hydrolysed material is collected from the container.  
Following the period of the first 12 months of operation, a con trol visit to such 
sites shall be carried out every time the container is emptied and checked for the 
absence of corrosion and leaking in accordance with point B(3)( j) of Section 2 of 
Chapter V of Annex IX.  
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Section 12  
Official controls regarding plants approved for the combustion of animal 
by-products  
The competent authority shall carry out documentary checks in a ccordance with 
the procedures referred to in Article 6(7) and (8) in approved plants referred to in 
Chapter V of Annex III.  ▼M9 02011R0142 — EN — 01.01.2021 — 021.001 — 359