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 98  1  6.4.2013  
►M5 Commission Regulation (EU) No 555/2013 of 14 June 2013  L 164  11  18.6.2013  
►M6 Commission Regulation (EU) No 717/2013 of 25 July 2013  L 201  31  26.7.2013  
►M7 Commission Regulation (EU) No 185/2014 of 26 February 2014  L 57  21  27.2.2014  
►M8 Commission Regulation (EU) No 592/2014 of 3 June 2014  L 165  33  4.6.2014  
►M9 Commission Regulation (EU) 2015/9 of 6 January 2015  L 3  10  7.1.2015  
►M10  Commission Regulation (EU) 2017/172 of 1 February 2017  L 28  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  92  25.5.2017  
►M13  Commission Regulation (EU) 2017/1261 of 12 July 2017  L 182  31  13.7.2017  
►M14  Commission Regulation (EU) 2017/1262 of 12 July 2017  L 182  34  13.7.2017  
►M15  Commission Regulation (EU) 2019/319 of 6 February 2019  L 61  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 2019  L 185  26  11.7.2019  
Corrected by:  
►C1 Corrigendum, OJ L 226, 24.8.2013, p. 44 (294/2013)  02011R0142 — EN — 31.07.2019 — 015.001 — 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-products 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, other 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 and 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 for 
processed petfood set out in point 7(a) of Chapter II of Annex XIII;  
(c) dogchews which fulfil the specific requirements for dogchews set 
out in point 7(b) of Chapter II of Annex XIII;  
(d) hides and skins of ungulates which fulfil the specific requirements 
for the end point for those products set out in point C of Chapter V 
of Annex XIII;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 2
 
(e) wool and hair, which fulfil the specific requirements for the end point 
for those products set out in point B of Chapter VII of Annex XIII;  
(f) feathers and down, which fulfil the specific requirements for 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 point for that 
product set out in Chapter VIII of Annex XIII;  
(h) fish oil for the production of medicinal products which fulfils 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 for 
products from the multi-step catalytic process for the production 
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 Terrestrial Animal 
Health Code, 2010 edition, and in Chapter 1.3 of the Aquatic Animal 
Health Code, 2010 edition, shall be regarded as serious transmissible 
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 Annex 
II shall comply with the conditions for the feeding of fur animals with 
certain materials derived from bodies or parts of animals of the 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 ferti ­
lisers or soil improvers have been applied, as set out in Chapter II of 
Annex II.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 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 co- 
incineration of animal by-products and derived products shall only 
take place:  
(a) in incineration plants and co-incineration plants which have 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 have 
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 plants and 
co-incineration plants as referred to in point 1(b), in accordance with 
Article 24(1)(b) or (c) of Regulation (EC) No 1069/2009, if they 
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-incin ­
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 plants 
shall comply with the requirements of Chapter III of Annex III.  
▼M8 
6. Operators shall ensure that combustion plants other than those 
referred to in Section 2 of Chapter IV of Annex IV, under their 
control in which animal by-products or derived products are used as a 
fuel, comply with the general conditions and specific requirements set 
out in Chapters IV and V of Annex III respectively and are approved 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 and 
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 — 31.07.2019 — 015.001 — 4
 
8. For the use of manure of farmed animals 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 operator 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 authorised by 
the competent authorities of the Member State, that the combustion 
plant in which the manure of farmed animals is used as a fuel fully 
meets the requirements laid down in points B(3), 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 to 
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 Regulation 
(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 organisation 
authorised by that authority, during the first six months of the 
operating of the combustion plant, including the necessary 
temperature and emission measurements. After the results of those 
checks showed compliance with the requirements set out in points 
B(3), B(4) and B(5) and, where applicable, with point C(4) of 
Chapter V of Annex III to this Regulation, full approval can be 
granted.  
▼B 
Article 7  
Landfilling of certain Category 1 and 3 materials  
By way of derogation from Article 12 and Article 14(c) of Regulation 
(EC) No 1069/2009, the competent authority may authorise the disposal 
of the following Category 1 and 3 materials in an authorised landfill:  
(a) imported petfood or petfood produced from imported materials, 
from Category 1 material referred to in Article 8(c) of Regulation 
(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 animal 
by-products referred to in Articles 8 and 9 and Article 10(a) to 
(e) and (h) to (p) of that Regulation;  
(ii) at the time when they are destined for disposal, the materials:  
— 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 public or 
animal health.  ▼M14  02011R0142 — EN — 31.07.2019 — 015.001 — 5
 
Article 8  
Requirements for processing plants and other establishments  
1. Operators shall ensure that processing plants and other estab ­
lishments under their control comply with the following requirements 
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 Section 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 down 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 their 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, provided 
such methods are used in the establishment or plant;  
(c) the alternative processing methods set out in Chapter IV, provided 
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 transformation 
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 composting 
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 down in 
Annex V.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 6
 
3. The competent authority may authorise the use of alternative trans ­
formation parameters for biogas and composting plants subject to 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 which 
ensure the control of the risks to public and animal health.  
The competent authority shall in particular ensure that operators comply 
with the requirements of Chapter I of Annex VI.  
2. Operators shall comply with the special rules on research and 
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 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 
Member State of destination being informed by means of the TRACES 
system and agreeing to accept the consignment in accordance with 
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 which 
ensure the control of the risks to public and animal health.  
The competent authority shall in particular ensure that operators comply 
with the requirements of points 2, 3 and 4 of Section 1 of Chapter I of 
Annex VI.  
2. Operators shall comply with the special rules on trade samples and 
display items set out in Section 2 of Chapter I of Annex VI.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 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 Regulation 
(EC) No 1069/2009 and without the competent authority of the Member 
State of destination being informed by means of the TRACES system 
and agreeing to accept the consignment in accordance with 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 13  
Special feeding rules  
1. Operators may feed Category 2 material to the following animals, 
provided that such material comes from animals which were not killed 
or did not die as a result of the presence or suspected presence of a 
disease communicable to humans or animals, subject to compliance with 
the general requirements laid down in Section 1 of Chapter II of Annex 
VI and any other conditions that 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 
2. Operators may feed Category 3 material to the following animals 
subject to compliance with the general requirements laid down in 
Section 1 of Chapter II of Annex VI and any other conditions that 
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 containing 
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 conditions 
set out in Section 2 of Chapter II of Annex VI;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 8
 
(b) outside feeding stations, if appropriate without prior collection of 
the dead animals, to wild animals referred to point 1(a) of Section 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 containing 
specified risk materials and the use of material derived from zoo 
animals for the feeding of zoo animals subject to compliance with 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 comply 
with the following special rules set out in Chapter III of Annex VI:  
▼B 
(a) the special disposal rules for animal by-products set out in 
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, transport and 
disposal of small quantities of Category 3 materials as referred to in 
Article 10(f) of that Regulation by means referred to in Article 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 hereto.  
▼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 submitted by 
Member States or interested parties in accordance with the requirements 
of the standard format for applications for alternative methods set out in 
Annex VII.  
2. Member States shall designate national contact points to provide 
information on the competent authority responsible for evaluating appli ­
cations for authorisation of alternative methods of use or disposal of 
animal by-products.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 9
 
3. The Commission shall publish a list of national contact points 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-products 
or derived products shall keep records of consignments and related 
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 estab ­
lishment or plant handling animal by-products on the same site, 
provided that the transmission of risks to public and animal health 
between the establishments or plants is excluded by their layout 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 their control 
which have been approved by the competent authority, comply with the 
requirements set out in the following Chapters of Annex IX hereto 
where they carry out one or more of the following activities referred 
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 — 31.07.2019 — 015.001 — 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 animal by- 
products after their collection, by way of the following operations 
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 destined 
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;  
▼M9 
(c) Chapter III, where they store derived products for certain intended 
purposes as referred to in Article 24(1)(j) of that Regulation;  
(d) Chapter V, where they store on the farm animal by-products 
intended for subsequent disposal as referred to in Article 4 of that 
Regulation.  
▼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 registered 
operators shall handle animal by-products and derived products under 
the conditions set out in Chapter IV of Annex IX.  
2. Registered operators transporting animal by-products or derived 
products, other than between premises of the same operator, shall in 
particular comply with the conditions set out in point 2 of Chapter 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 from 
the obligation to notify, referred to in Article 23(1)(a) of Regulation 
(EC) No 1069/2009:  
(a) operators handling or generating game trophies or other preparations 
referred to in Chapter VI of Annex XIII hereto for private or non- 
commercial purposes;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 11
 
(b) operators handling or disposing research and diagnostic samples for 
educational purposes;  
▼M3 
(c) operators transporting dry untreated wool and hair, provided they 
are securely enclosed in packaging, and directly dispatched to a 
plant producing derived products for uses outside the feed chain 
or to a plant carrying out intermediate operations, under conditions 
which prevent the spreading of pathogenic agents;  
▼M9 
(d) operators using small quantities of Categories 2 and 3 materials 
referred to in Articles 9 and 10 of Regulation (EC) No 1069/2009 
or of products derived therefrom, for the purpose of direct supply of 
the products within the region to the final user, on the local market 
or to local retail establishments, if the competent authority does not 
consider such activity to present a risk of spreading any serious 
transmissible disease to humans or animals; this point shall not 
apply where those 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 chain.  
▼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 the first 
subparagraph of Article 47(1) of Regulation (EC) No 1069/2009 are:  
(a) drawn up in accordance with the technical specifications published 
on the Commission website (  1 ); 
(b) either entered in TRACES or accessible by means of TRACES as of 
31 October 2021 at the latest.  
▼B 
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 the 
placing on the market, other than the import, of the animal by-products 
and derived products destined for feeding to farmed animals excluding 
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;  ▼M2 02011R0142 — EN — 31.07.2019 — 015.001 — 12  
( 1 ) https://ec.europa.eu/food/sites/food/files/safety/docs/ 
fs-animal-products-app-est-technical_spec_04032012_en.pdf
 (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 set out in 
Chapter III.  
2. The competent authority may authorise the placing on the market, 
other than the import, of milk, milk-based products and milk-derived 
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 Annex X 
hereto, provided that those materials comply with the requirements for 
the derogation for the placing on the market of milk processed in 
accordance with national standards set out in Part II of that Section.  
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 soil 
improvers, and the use of such products, in particular their application 
to land, as provided for in Articles 15(1)(i) and 32(1) of Regulation 
(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:  
(a) guano from wild sea birds, collected in the Union or imported 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 meat-and- 
bone meal derived from Category 2 material or from processed animal 
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) No 
1069/2009, the competent authorities of a Member State of origin and 
of a Member State of destination, which share a common border may 
authorise the dispatch of manure between farms located in border 
regions of those two Member States subject to appropriate conditions 
for the control of any possible risks to public or animal health, such as 
obligations for the operators concerned to keep appropriate records, 
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 application of 
organic fertilisers and soil improvers to land.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 13
 
Article 23  
Intermediate products  
1. Intermediate products, imported into or in transit through the 
Union shall comply with the conditions controlling potential risks to 
public and animal health referred to in Annex XII hereto.  
2. Intermediate products which have been transported to an estab ­
lishment or plant referred to in point 3 of Annex XII hereto, may 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 transmission of 
diseases communicable to humans or animals, due to their purifi ­
cation or to other treatments to which the animal by-products in the 
intermediate product have been submitted, due to the concentration 
of animal by-products in the intermediate product or due to 
adequate bio-security measures for the handling of the intermediate 
products;  
(c) the establishment or plant keeps records on the amount of materials 
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 from 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 destination 
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 Point 35 of 
Annex I.  
▼B 
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 applied 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 placed 
on the market, other than imported, in accordance with the specific 
requirements for processed animal protein and other derived products 
set out in Chapter II of Annex X hereto, provided that Annex XIII 
hereto does not set out any specific requirements for such products.  
3. Operators shall comply with the requirements for the placing on 
the market, other than the import, of petfood, as referred to in Article 40 
of Regulation (EC) No 1069/2009, set out in Chapters I and II of Annex 
XIII hereto.  
4. Operators shall comply with the requirements for the placing on 
the market, other than the import, of derived products, as referred to in 
Article 40 of Regulation (EC) No 1069/2009, set out in Chapter I and 
Chapters III to XII of Annex XIII hereto.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 14
 
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 the 
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 the 
following shall not be subject to any animal health conditions:  
(a) wool and hair which has been factory-washed or which has been 
treated by another method which ensures that no unacceptable risks 
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 which 
consisting of the immersion of the wool and hair in series of baths 
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 producing 
derived products from wool and hair for the textile industry and 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 for 
at least 24 hours,  
— industrial scouring which consists of the immersion of wool and 
hair in a water-soluble detergent held at 60–70 °C,  
— storage, which may include the journey time, at 37 °C for eight 
days, 18 °C for 28 days or 4 °C for 120 days;  
(e) wool and hair that is dry and securely enclosed in packaging, 
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 into 
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,  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 15
 
— 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 Union 
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 requirements 
for the importation into and the transit through the Union of certain 
animal by-products and derived products, as referred to in Articles 41(3) 
and 42 of Regulation (EC) No 1069/2009, set out in Annex XIV hereto:  
(a) the specific requirements for the import and transit of Category 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 that 
Annex;  
(b) the specific requirements for the import and transit of animal by- 
products and derived products for uses outside the feed chain for 
farmed animals, set out in Chapter II of that 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 therein.  
▼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 derived 
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:  
(a) those materials must not be Category 1 materials derived from 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 following 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;  ▼M2 02011R0142 — EN — 31.07.2019 — 015.001 — 16
 
— 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.  
Article 27  
Importation and transit of research and diagnostic samples  
1. The competent authority may authorise the importation and the 
transit of research and diagnostic samples, comprising derived 
products or animal by-products, including the animal by-products 
referred to in Article 25(1), in accordance with conditions which 
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 authorised 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 entry into 
the Union to the authorised user.  
2. Operators shall present research and diagnostic samples which are 
intended to be imported via a Member State, other than the Member 
State of destination, at an approved Union border inspection post listed 
in Annex I to Decision 2009/821/EC. At the border inspection post, 
those research and diagnostic samples shall not be subject to veterinary 
checks in accordance with Chapter I of Directive 97/78/EC. The 
competent authority of the border inspection post shall inform the 
competent authority of the Member State of destination of the intro ­
duction of the research and diagnostic samples by means of the 
TRACES system.  
3. Operators handling research samples or diagnostic samples shall 
comply with the special requirements for disposal of research and diag ­
nostic samples set out in Section 1 of Chapter III of Annex XIV hereto.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 17
 
Article 28  
Importation and transit of trade samples and display items  
1. The competent authority may authorise the importation and the 
transit of trade samples in accordance with the special rules set out in 
point 1 of Section 2 of Chapter III of Annex XIV hereto.  
2. Operators handling trade samples shall comply with the special 
rules for handling and disposal of trade samples set out in points 2 and 
3 of Section 2 of Chapter III of Annex XIV hereto.  
3. The competent authority may authorise the importation and the 
transit of display items in accordance with the special rules for 
display items set out in Section 3 of Chapter III of Annex XIV hereto.  
4. Operators handling display items shall comply with the conditions 
for packaging, handling and disposal of display items set out in 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 of 
consignments of animal by-products coming from and destined to the 
Russian Federation directly or via another third country, by road or by 
rail through the Union, between approved Union border inspection posts 
listed in Annex I to Decision 2009/821/EC, provided that the following 
conditions are met:  
(a) the consignment shall be sealed with a serially numbered seal at the 
border inspection post of entry to the Union by the veterinary 
services of the competent authority;  
(b) the documents accompanying the consignment and referred to in 
Article 7 of Directive 97/78/EC shall be stamped ‘ONLY FOR 
TRANSIT TO RUSSIA VIA THE EU’ on each page by the 
official veterinarian of the competent authority responsible for the 
border inspection post;  
(c) the procedural requirements provided for in Article 11 of Directive 
97/78/EC shall be complied with;  
(d) the consignment is certified as acceptable for transit on the 
Common Veterinary Entry Document provided for in Annex III 
to Regulation (EC) No 136/2004 by the official veterinarian of 
the border inspection post of introduction.  
2. Unloading or storage, as defined in Article 12(4) or Article 13 of 
Directive 97/78/EC of such consignments shall not be allowed on the 
territory of a Member State.  
3. Regular audits shall be made by the competent authority to ensure 
that the number of consignments and the quantities of products leaving 
the Union territory matches the number and quantities entering.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 18
 
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 destined 
to third countries through the Union, by road, directly between the 
border inspection post of Nova Sela and the border inspection post of 
Ploče, shall be authorised provided that the following conditions are 
met: 
(a) the consignment is sealed with a serially numbered seal by the 
official veterinarian at the border inspection post of entry;  
(b) the documents accompanying the consignment and referred to in 
Article 7 of Directive 97/78/EC are stamped ‘ONLY FOR 
TRANSIT TO THIRD COUNTRIES VIA THE EU’ on each 
page by the official veterinarian at the border inspection post of 
entry;  
(c) the procedural requirements provided for in Article 11 of Directive 
97/78/EC are complied with;  
(d) the consignment is certified as acceptable for transit on the 
Common Veterinary Entry Document referred to in Article 2(1) 
of Regulation (EC) No 136/2004 by the official veterinarian at 
the border inspection post of entry.  
2. Unloading or storage, as defined in Article 12(4) or in Article 13 
of Directive 97/78/EC, of such consignments in the Union shall not be 
allowed.  
3. Regular audits shall be made by the competent authority to ensure 
that the number of consignments and the quantities of products leaving 
the Union matches the number and quantities entering the Union.  
▼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 which 
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 consignments 
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 accompanied by 
health certificates and declarations, in accordance with the models set 
out in Annex XV hereto, at the point of entry into the Union where the 
veterinary checks take place, as provided for in Directive 97/78/EC.  ▼M5 02011R0142 — EN — 31.07.2019 — 015.001 — 19
 
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 disposal 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 principles 
for official controls laid down in Article 3 of Regulation (EC) No 
882/2004.  
2. The official controls referred to in paragraph 1 shall include 
checks on the keeping of records and other documents required by 
the rules laid down in this Regulation.  
3. The competent authority shall carry out the following official 
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 Chapter I;  
(b) official controls of other activities which involve the handling 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 which are 
applied to consignments of animal by-products or derived products.  
When the competent authority applies a seal to such consignment which 
is transported to a place of destination, it must inform the competent 
authority of the place of destination.  
5. The competent authority shall draw up the lists of establishments, 
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 of Annex 
XVI hereto.  
6. The competent authority of the Member State of destination shall 
decide upon the application by an operator concerning the acceptance or 
refusal of certain Category 1, Category 2 material and meat-and-bone 
meal or animal fat derived from Category 1 and Category 2 materials, 
within 20 calendar days from the date of receipt of such application 
provided that it has been submitted in one of the official languages of 
that Member State.  
▼M16  
7. Operators shall submit applications for the authorisation referred to 
in paragraph 6 in accordance with the standard format set out in 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 of 
Category 3 material is subsequently granted temporary approval for 
the processing of Category 1 or Category 2 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 3 material, 
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 — 31.07.2019 — 015.001 — 20
 
2. Where a plant or establishment approved for the processing of 
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 material, 
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 placing on the 
market of the following animal by-products and derived products for 
public health or animal health reasons other than the rules laid down in 
Union legislation, and in particular those laid down in Regulation (EC) 
No 1069/2009 and in this Regulation:  
(a) processed animal protein and other derived products referred to in 
Chapter II of Annex X hereto;  
(b) petfood and certain other derived products referred to in Annex XIII 
hereto;  
(c) animal by-products and the derived products imported into or 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 references to 
this Regulation.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 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 which 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 following:  
(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 exclude 
the subsequent use of the mixture for feeding purposes.  
2. For a transitional period until 31 January 2012, consignments of 
animal by-products and of derived products accompanied by a health 
certificate, declaration or commercial document, which has been 
completed and signed in accordance with the appropriate model set 
out in Annex X to Regulation (EC) No 1774/2002 shall continue to 
be accepted for importation into the Union, provided that such certifi ­
cates, declarations or documents were completed and signed before 
30 November 2011.  
▼M9 __________  
▼B 
Article 37  
This Regulation shall enter into force on the 20th day following 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 applicable in 
all Member States.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 22
 
ANNEX I  
DEFINITIONS AS REFERRED TO IN ARTICLE 2  
For the purpose of this Regulation, the following definitions shall apply:  
1. ‘ fur animals ’ means animals kept or reared for the production of fur and not 
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, including processed 
animal proteins, blood products, rendered fats, egg products, fish oil, fat 
derivatives, collagen, gelatine and hydrolysed proteins, dicalcium phosphate, 
tricalcium phosphate, milk, milk-based products, milk-derived products, 
colostrum, colostrum products and centrifuge or separator sludge;  
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 mixtures;  
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 fishmeal) 
so as to render them suitable for direct use as feed material or 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, milk-based 
products, milk-derived products, colostrum, colostrum products, centrifuge or 
separator sludge, gelatine, hydrolysed proteins and dicalcium phosphate, 
eggs and egg-products, including eggshells, tricalcium phosphate and 
collagen;  
6. ‘ blood meal ’ means processed animal protein derived from the heat 
treatment of blood or fractions of blood in accordance with Section 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, including 
those covered by Article 3(1)(e) of Council Directive 2006/88/EC (  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 destined for 
purposes other than human consumption;  
▼M11  
9. ‘fish oil ’ means oil derived from the processing of aquatic animals except 
sea mammals, including farmed aquatic invertebrates, including those 
covered by Article 3(1)(e) of Directive 2006/88/EC, and starfish of the  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 23  
( 1 ) Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for 
aquaculture animals and products thereof, and on the prevention and control of certain 
diseases in aquatic animals (OJ L 328, 24.11.2006, p. 14).
 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, obtained by 
the partial hydrolysis of collagen produced from bones, hides and skins, 
tendons and sinews of animals;  
13. ‘ greaves ’ means the protein-containing residue of rendering, after partial 
separation of fat and water;  
14. ‘ hydrolysed proteins ’ means polypeptides, peptides and aminoacids, and 
mixtures thereof, obtained by the hydrolysis of animal by-products;  
15. ‘ white water ’ means a mixture of milk, milk-based products or products 
derived thereof with water which is collected during the rinsing of dairy 
equipment including containers used for dairy products, prior to 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 petfood;  
▼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-products or 
derived products which:  
(a) contain Category 3 material, other than material referred to in 
Article 10(n), (o) and (p) of Regulation (EC) No 1069/2009; and  
(b) may contain imported Category 1 material comprising of animal 
by-products derived 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;  
▼B 
20. ‘ processed petfood ’ means petfood, other than raw petfood, which has been 
processed in accordance with point 3 of Chapter II of Annex XIII;  
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, including 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 — 31.07.2019 — 015.001 — 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, have 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 mineralised;  
27. ‘ meat-and-bone meal ’ means animal protein derived from the processing of 
Category 1 or Category 2 materials in accordance with one of the 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 prior 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, chilling 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 remain;  
▼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 unacceptable 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 derived 
products from wool for the textile industry and has undergone at least 
one of the following treatments:  
(i) chemical depilation by means of slaked lime or sodium sulphide;  
(ii) fumigation in formaldehyde in a hermetically sealed chamber for at 
least 24 hours;  
(iii) industrial scouring which consists of the immersion of wool 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 — 31.07.2019 — 015.001 — 25
 
(c) been treated by another method that ensures that no unacceptable 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 derived 
products from hair for the textile industry and has undergone at least 
one of the following treatments:  
(i) chemical depilation by means of slaked lime or sodium sulphide;  
(ii) fumigation in formaldehyde in a hermetically sealed chamber for at 
least 24 hours;  
(iii) industrial scouring which consists of the immersion of 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 
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 unacceptable 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 medicinal 
products, veterinary medicinal products, medical devices for medical 
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 production of 
a finished product;  
(ii) in validation or verification during a manufacturing process; or  
(iii) in quality control of a finished product;  
(b) whose design, transformation and manufacturing stages have been suffi ­
ciently completed in order to be regarded as a derived product and to 
qualify the material directly or as a component of a product for the 
purposes referred to in point (a);  
(c) which however requires some further manufacturing or transformation, 
such as mixing, coating, assembling or packaging to make it suitable for 
placing on the market or putting into service, as applicable, a medicinal 
product, veterinary medicinal product, medical device for medical and 
veterinary purposes, active implantable medical device,  in vitro  diag­
nostic medical devices for medical and veterinary purposes, laboratory 
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 
combination with substances of non-animal origin for specific laboratory 
use as a reagent or reagent product, calibrator or control material to 
detect, measure, examine or produce other substances;  ▼M2 02011R0142 — EN — 31.07.2019 — 015.001 — 26
 
37. ‘ product used for in vitro diagnosis ’ means a packaged product, ready for 
use, containing a blood product or another animal by-product, and 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 examination 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 the context of 
diagnostic activities or analysis for the promotion of progress in science and 
technology, in the context of educational or research activities;  
▼M9 
39. ‘ trade samples ’ means animal by-products or derived products intended for 
particular studies or analyses authorised by the competent authority in 
accordance with Article 17(1) of Regulation (EC) No 1069/2009 with a 
view to carrying out a production process, including the processing of 
animal by-products or derived products, the development of feedingstuff, 
pet food or derived products, or the testing of machinery or equipment;  
▼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 products, 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 Article 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 generated by 
incineration or co-incineration plants treating animal by-products 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 provided for in 
this Regulation on the surface or on part of the surface of a packaging, 
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, ferric salts, 
silicic salts, aldehydes and quinones, or other synthetic hardening agents;  
47. ‘ taxidermy ’ means the art of preparing, stuffing and mounting the skins of 
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 Union;  
49. ‘ processing methods ’ means the methods listed in Chapters III and IV of 
Annex IV;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 27
 
50. ‘ batch ’ means a unit of production produced in a single plant using uniform 
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 to 
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 Regulation (EC) 
No 1069/2009 are collected with the intention to be used for feeding 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 to 
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 material 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 defined 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 Regulation (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 (EC) 
No 1069/2009, in which animal by-products are processed in accordance 
with Annex IV and/or Annex X;  
59. ‘ growing media ’ means materials, including potting soil, other than soil  in 
situ, in which plants are grown and which is used independently from soil  in 
situ. ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 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 may 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 from 
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 mink ( Mustela 
vison ) may be fed with meat-and-bone meal or other products which have 
been processed in accordance with the processing methods set out in 
Chapter III of Annex IV and which are derived from bodies or parts of 
bodies of animals of the same species.  
3. The feeding referred to in points 1 and 2 shall take place under the following 
conditions:  
(a) Feeding shall only take place in farms:  
(i) which have been registered by the competent authority on the 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 the 
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 enter 
the food or feed chain of other animals than fur animals;  
(iv) which have had no known contact with any farm with a suspected 
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 of 
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 — 31.07.2019 — 015.001 — 29
 
(b) The operator of the farm shall ensure that meat-and-bone meal 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 production 
of fur.  
(c) In the event of any known or suspected contact with any farm with a 
suspected or confirmed outbreak of TSE, the operator of the farm must 
immediately:  
(i) inform the competent authority of such contact;  
(ii) cease the dispatch of fur animals to any destination without 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 animals with 
herbage from land, either by direct access of the animals to that 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 Article 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 following organic 
fertilisers or soil improvers have been applied to land:  
(a) manure and guano;  
(b) digestive tract content, milk, milk-based products, milk-derived 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 — 31.07.2019 — 015.001 — 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 referred to in 
Article 6(1)(b) of this Regulation shall ensure that the following 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 disposal, in 
accordance with conditions laid down by the competent authority.  
(b) Plants must have appropriate arrangements for the cleaning and 
disinfection of containers and vehicles in place, in particular in a 
designated area from which wastewater is disposed of in accordance 
with Union legislation, to avoid risks of contamination.  
(c) Plants must be located on a well-drained hardstanding.  
(d) Plants must have appropriate arrangements for protection against pests, 
such as insects, rodents and birds. A documented pest control programme 
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 prevent risks 
of contamination.  
(f) Cleaning procedures must be established and documented for all parts of 
the premises. Suitable equipment and cleaning agents must be provided 
for cleaning.  
(g) Hygiene control must include regular inspections of the environment 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 shall take all 
necessary precautions concerning the reception of animal by-products or 
derived products to prevent, or limit as far as practicable, direct risks to 
human or animal health.  
3. Animals must not have access to the plants, animal by-products and derived 
products that are awaiting incineration or co-incineration or to 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 incineration or 
co-incineration equipment and the livestock and their feed and 
bedding, with fencing where necessary;  ▼M8 02011R0142 — EN — 31.07.2019 — 015.001 — 31
 
(b) equipment must be dedicated entirely to the operation of the incinerator 
and not used elsewhere on the holding or, alternatively, cleaned and 
disinfected before such use;  
(c) personnel working in the plant must change their outer clothing 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 reincinerated or 
disposed of by other means, other than by disposal in an authorised 
landfill, in accordance with Articles 12, 13 and 14, as applicable, of 
Regulation (EC) No 1069/2009.  
Section 2  
Operating conditions  
Incineration or co-incineration plants shall be designed, equipped, 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 unfavourable 
conditions, to a temperature of 850 °C for at least 2 seconds or 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 the 
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 appropriate, 
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, including 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 conditions relevant 
to the incineration or co-incineration process.  
2. The approval issued by the competent authority, or conditions 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 presented in an 
appropriate fashion to enable the competent authority to verify compliance 
with the permitted operating conditions laid down in this Regulation in 
accordance with procedures to be decided upon by that authority.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 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 oper ­
ations as soon as practicable until normal operations can be 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 (high-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 temperature of the 
combustion gases after the last injection of combustion air falls below 
850 °C or 1100 °C, as applicable. It must also be used during plant 
start-up and shut-down operations to ensure that the temperature of 850 °C 
or of 1100 °C, as applicable, is maintained at all times during these oper ­
ations and as long as unburned material is in the chamber where the incin ­
eration 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 out by a 
continuous process, the plant must operate an automatic system to prevent 
the introduction of animal by-products or derived products at start-up, until 
the temperature of 850 °C or of 1100 °C, as applicable, has been reached, 
and whenever the temperature is not maintained.  
(c) The operator must operate the incineration plant in such manner 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 less than 5 % of 
the dry weight of the material. If necessary, appropriate techniques 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 unauthorised and 
accidental release of any polluting substances into soil, surface water and 
groundwater.  
2. Storage capacity shall be provided for contaminated rainwater 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 and such water 
can be tested and treated before discharge, when necessary.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 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 which are not 
required to have a permit to operate in accordance with Directive 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 Regulation (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 referred 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 Directive 
2009/156/EC, if authorised by the Member State;  
▼B 
(b) when Category 1 materials referred to in Article 8(b) of Regulation (EC) 
No 1069/2009 are introduced into the low-capacity plant, be equipped with 
an auxiliary burner;  
(c) operate in such way that the animal by-products are completely 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) shall 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 measures to 
ensure that cleaning and disinfection of containers and vehicles are 
carried out in a designated area of their premises from which the 
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 subpara ­
graph, containers and vehicles used for the transport of rendered fats may 
be cleaned and disinfected at the plant of loading 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 hard standing.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 34
 
(d) The combustion plants must have appropriate measures in place for the 
protection against pests. A documented pest control programme 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 prevent risks 
of contamination of equipment for handling of farmed animals or their 
feedstuffs.  
(f) Cleaning and disinfection procedures, must be established and docu ­
mented for all parts of the combustion plant. Suitable equipment and 
cleaning agents must be provided for cleaning.  
(g) Hygiene control must include regular inspections of the environment 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 stationary 
internal combustion engines located within approved or registered food 
or feed processing plants, the processing of food or feed on the 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 products to 
prevent or limit as far as practicable, risks to human or animal health and 
the environment.  
3. Animals must not have access to the combustion plant or to the 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 animals of food 
producing species:  
(a) there must be total physical separation between the combustion 
equipment and the animals including their feed and bedding;  
(b) equipment must be dedicated entirely to the operation of the combustion 
plant and not used elsewhere on the holding unless it had been effec ­
tively 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 awaiting combustion as 
a fuel and the combustion residues must be stored in a closed and covered 
dedicated area, or in covered and leak-proof containers.  
6. The combustion of animal by-products or derived products shall be carried 
out under conditions which prevent cross-contamination of feed for animals.  ▼M8 02011R0142 — EN — 31.07.2019 — 015.001 — 35
 
Section 2  
Operating conditions of combustion plants  
1. Combustion plants must be designed, built, equipped and operated 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 seconds to a 
temperature of 1 100 °C.  
The temperature must be measured near the inner wall or at another 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 automatically and 
presented in an appropriate fashion to enable the competent authority to 
verify compliance with the permitted operating conditions referred 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 fuel is combusted in 
such a way that the total organic carbon content of the slags and 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 harmfulness. 
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, including dust, shall 
take place in closed containers or in another way which prevents 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 operating 
conditions until normal operations can be resumed.  
2. Incompletely combusted animal by-products and derived products 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 authorised 
landfill.  ▼M8 02011R0142 — EN — 31.07.2019 — 015.001 — 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-products of all 
categories may be used provided it meets the following conditions:  
(a) unless fish oil or rendered fat is used which has been produced 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 for 
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 the 
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 another 
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 combustion 
engine shall be carried out as follows:  
(a) the fat fractions referred to in points 1(a) and (b) must be combusted:  
(i) under the conditions laid down in Section 2(1) of Chapter IV; or  
(ii) using process parameters achieving an equivalent outcome as the 
conditions under (i) and which are authorised by the competent 
authority;  
(b) the combustion of material of animal origin other than animal fat must 
not be permitted;  ▼M8 02011R0142 — EN — 31.07.2019 — 015.001 — 37
 
(c) the animal fat derived from Category 1 or Category 2 combusted in 
premises approved or registered in accordance with Regulations (EC) 
No 852/2004, (EC) No 853/2004, 183/2005, or in public places must 
have been processed with processing method 1 as set out in Chapter 
III of Annex IV;  
(d) the combustion of animal fat must be carried out in accordance with 
Union legislation for the protection of the environment, in particular, 
with reference to the standards and requirements of that legislation and 
the requirements regarding best available techniques for the control 
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 other process 
parameters, which ensure an equivalent environmental outcome may be 
authorised by the competent authority responsible for environmental 
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 exceeding 
5 MW.  
2. Starting material and scope:  
Exclusively unprocessed poultry manure, as referred to in Article 9(a) of 
Regulation (EC) No 1069/2009, to be used as a fuel for combustion 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 area to 
minimise the need for further handling and to prevent cross contami ­
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 directly 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 requirements 
set out in Section 2(2) of Chapter IV are met at all times during 
those operations and as long as unburned material is in the 
combustion chamber.  ▼M8 02011R0142 — EN — 31.07.2019 — 015.001 — 38
 
4. Emission limit values and monitoring requirements:  
(a) The emissions of sulphur dioxide, nitrogen oxides (namely the 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 per 
cent, after correction for the water vapour content of the waste gases:  
Pollutant  Emission limit value in mg/Nm  3 
Sulphur dioxide  50  
Nitrogen oxides (as NO  2 ) 200  
Particulate matter  10  
(b) The operator of the on-farm combustion plant shall carry out at least 
annual measurements of sulphur dioxide, nitrogen oxides and 
particulate matter.  
As an alternative to the measurements referred to in the first subpara ­
graph, other procedures, verified and approved by the competent auth ­
ority, 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 such 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 effective 
operation of that equipment shall be monitored continuously and the 
results thereof recorded.  
(e) In the event of non-compliance with the emission limit values referred 
to in point (a) or where an on-farm combustion plant does not meet 
the requirements of point 1 of Section 2 of Chapter IV, operators shall 
immediately inform the competent authority and take the measures 
necessary to ensure that compliance is restored within the shortest 
possible time. Where compliance cannot be restored, the competent 
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 planned 
change of the on-farm combustion plant which would affect its 
emissions at least one month before the date on which the change 
takes place.  
(b) The operator shall take the necessary measures to ensure that the 
periods of start-up and shut-down of the on-farm combustion plant 
and of any malfunctions are kept as short as possible. In the case of a 
malfunction or a breakdown of secondary abatement equipment, the 
operator shall immediately inform the competent authority.  ▼M8 02011R0142 — EN — 31.07.2019 — 015.001 — 39
 
C. Combustion plants in which manure of farmed animals other than 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 exceeding 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 with 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 in point 1. 
Manure of farmed animals other than poultry manure set out in point B 
generated outside the holding should not come in contact with farmed 
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 requirements 
set out in points B(3), B(4) and B(5).  
4. Derogation and transitional period:  
The Member State competent authority responsible for environmental 
issues may:  
(a) by way of derogation from point B(3)(b)(ii), grant combustion 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 of 
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 manual 
placement of horse manure as fuel in the combustion chamber 
when a total rated thermal input not exceeding 0,5 MW.  ▼M14  02011R0142 — EN — 31.07.2019 — 015.001 — 40
 
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 methods 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 registered 
in accordance with Regulation (EC) No 852/2004 or Regulation (EC) 
No 853/2004, unless the risks to public and animal health resulting 
from the processing of animal by-products, which originate from such 
slaughterhouses or other establishments, are mitigated by compliance 
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 the 
processing plant in a building that is completely separated from 
the slaughterhouse or other establishment;  
(ii) the following must be installed and operated in the processing 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 both 
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 plant 
and in the slaughterhouse or other establishment;  
(iv) unauthorised persons and animals must not have access to the 
processing plant.  
By way of derogation from points (i) to (iv), in the case of processing 
plants processing Category 3 material, the competent authority may 
authorise other conditions instead of those set out in those points, 
aimed at mitigating the risks to public and animal health, including the 
risks arising from the processing of Category 3 material, which originates 
from off-site establishments approved or registered in accordance 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 and 
Animal Health referred to in Article 52(1) of Regulation (EC) 
No 1069/2009 of the use made of this derogation by their competent 
authorities;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 41
 
(b) The processing plant must have a clean and unclean sector, adequately 
separated. The unclean sector must have a covered place to receive 
animal by-products and must be constructed in such a way that it 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 including lavatories, 
changing rooms and washbasins for staff;  
(d) The processing plant must have sufficient production capacity 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 crushed 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 these 
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 introduction of 
animal by-products, there must be a clear separation between the area of 
the plant where incoming material for processing is unloaded and the 
areas set aside for the processing of that product and the storage of the 
derived product.  
2. The processing plant must have adequate facilities for cleaning and 
disinfecting the containers or receptacles in which animal by-products 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 system meeting the 
requirements set out by the competent authority in accordance with Union 
legislation.  
5. The processing plant must have its own laboratory or make use of the 
services of an external laboratory. The laboratory must be equipped to 
carry out necessary analyses and be approved by the competent authority 
on the basis of an assessment of the capacity of the laboratory to carry out 
those analyses, be accredited according to internationally recognised 
standards or be subject to regular controls by the competent authority, to 
assess the capacity of the laboratory to carry out those analyses.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 42
 
6. If on the basis of a risk assessment, the volume of products treated requires 
the regular or permanent presence of the competent authority, the processing 
plants must have an adequately equipped lockable room for the exclusive use 
of the inspection service.  
Section 2  
Wastewater treatment  
1. Processing plants processing Category 1 material and other premises where 
specified risk material is removed, slaughterhouses and processing plants 
processing Category 2 material shall have a pre-treatment process 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 of 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 premises. 
No grinding, maceration or any other processing or application of pressure 
shall be carried out which could facilitate the passage of solid 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 Category 1 or 
Category 2 material, as appropriate, and disposed of in accordance with 
Regulation (EC) No 1069/2009.  
4. Wastewater having passed the pre-treatment process in premises referred to in 
point 1 and wastewater from other premises handling or processing animal 
by-products shall be treated in accordance with Union legislation, without 
restrictions in accordance with this Regulation.  
5. In addition to the requirements laid down in point 4, the competent authority 
may oblige operators to treat wastewater originating in the unclean sector of 
processing plants and in plants or establishments carrying out intermediate 
operations with Category 1 material or Category 2 material or storing 
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 by-products, 
including blood and milk, or derived products through the wastewater 
stream shall be prohibited.  
However, Category 3 material comprising of centrifuge or separator sludge 
may be disposed of through the wastewater stream, provided that it has been 
subject to one of the treatments for centrifuge or separator sludge 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 Category 2 materials 
must ensure the total separation of Category 1 material from Category 2 material 
from reception of the raw material until dispatch of the resulting derived product, 
unless a mixture of Category 1 material and Category 2 material is processed as 
Category 1 material.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 43
 
Section 4  
Specific requirements for the processing of Category 3 materials  
The following requirements shall apply in addition to the general 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 Category 2 materials, 
unless located in a completely separate building.  
2. However, the competent authority may authorise the processing of Category 3 
material on a site where handling or processing of Category 1 or Category 2 
material takes place, if cross-contamination is prevented due to:  
(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 processing, 
including the layout and the management of separate processing lines 
or of cleaning procedures which are excluding the propagation of any 
possible risks to public and animal health; and  
(c) the layout and the management of the areas for the temporary 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 packaging material or 
metallic pieces, in the animal by-products or derived products, if they are 
processing materials which are destined for feeding. Such foreign 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 documented pest 
control programme in place for the implementation of the arrangements for 
protection against pests, such as insects, rodents and birds, referred to in 
Article 25(1)(c) of that Regulation.  
Section 2  
General processing requirements  
1. Accurately calibrated gauges/recorders must be used to monitor continuously 
the processing conditions. Records must be kept to show the date of cali ­
bration of gauges/recorders.  
2. Material that may not have received the specified heat treatment, such as 
material discharged at start up or leakage from cookers, must be recirculated 
through the heat treatment or collected and reprocessed or disposed 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 pressure sterilisation 
(method 1), Category 1 and Category 2 material shall be processed in accordance 
with processing methods 2, 3, 4 or 5 as referred to in Chapter III.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 44
 
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 continuous system. 
Minimum processing standards must be specified for each applicable 
critical control point.  
2. In the case of chemical treatments which have been authorised by the 
competent authority as processing method 7 in accordance with point G of 
Chapter III, the critical control points that determine the extent of the chemical 
treatments applied shall include the pH adjustment achieved.  
3. Records shall be maintained for at least two years to show that the minimum 
process values for each critical control point are applied.  
4. Category 3 material shall be processed in accordance with any of the 
processing methods 1 to 5 or processing method 7, or, in the case of 
material originating from aquatic animals, with any of the processing 
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 processed is more 
than 50 millimetres, the animal by-products must be reduced in size 
using appropriate equipment, set so that the particle size after 
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 133 °C 
for at least 20 minutes without interruption at a pressure (absolute) of at 
least 3 bars. The pressure must be produced by the evacuation of all air 
in the sterilisation chamber and the replacement of the air by steam 
(‘saturated steam’); the heat treatment may be applied as the sole 
process or as a pre- or post-process sterilisation phase.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 45
 
3. The processing may be carried out in batch or continuous systems.  
B. Processing method 2  
Reduction  
1. If the particle size of the animal by-products to be processed is more 
than 150 millimetres, the animal by-products must be reduced in size 
using appropriate equipment, set so that the particle size after reduction 
is no greater than 150 millimetres. The effectiveness of the equipment 
must be checked daily and its condition recorded. If checks disclose 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 manner 
which ensures that a core temperature greater than 100 °C is achieved 
for at least 125 minutes, a core temperature greater than 110 °C is 
achieved for at least 120 minutes and a core temperature greater 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 processed is more 
than 30 millimetres, the animal by-products must be reduced in size 
using appropriate equipment, set so that the particle size after 
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 manner 
which ensures that a core temperature greater than 100 °C is achieved 
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 systems.  
D. Processing method 4  
Reduction  
1. If the particle size of the animal by-products to be processed is more 
than 30 millimetres, the animal by-products must be reduced in size 
using appropriate equipment, set so that the particle size after 
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 — 31.07.2019 — 015.001 — 46
 
Time, temperature and pressure  
2. After reduction the animal by-products must be placed in a vessel with 
added fat and heated in a manner which ensures that a core temperature 
greater than 100 °C is achieved for at least 16 minutes, a core 
temperature greater than 110 °C is achieved for at least 13 minutes, a 
core temperature greater than 120 °C is achieved for at least eight 
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 systems.  
E. Processing method 5  
Reduction  
1. If the particle size of the animal by-products to be processed is more 
than 20 millimetres, the animal by-products must be reduced in size 
using appropriate equipment, set so that the particle size after 
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 from 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 greater 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 systems.  
F. Processing method 6 (for Category 3 animal by-products originating from 
aquatic animal or aquatic invertebrates only)  
Reduction  
1. The animal by-products must be reduced to a particle size which 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 minutes; or  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 47
 
(b) a core temperature of at least 70 °C for at least 60 minutes.  
When using a continuous flow system, the progression of the product 
through the heat converter must be controlled by means of mechanical 
commands limiting its displacement in such way that at the end of the 
heat treatment operation the product has undergone a cycle which is 
sufficient in both time and temperature.  
3. The processing may be carried out in batch or continuous systems.  
G. Processing method 7  
1. Any processing method authorised by the competent authority where the 
following have been demonstrated by the operator to that authority:  
(a) the identification of relevant hazards in the starting material, in view 
of the origin of the material, and of the potential risks in view of the 
animal health status of the Member State or the area or zone where 
the method is to be used;  
(b) the capacity of the processing method to reduce those hazards to a 
level which does not pose any significant risks to public and animal 
health;  
(c) the sampling of the final product on a daily basis over a period of 30 
production days in compliance with the following microbiological 
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 processing 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. The 
information to be recorded and monitored must include the particle 
size, and, as appropriate, the critical temperature, the absolute time, 
pressure profile, raw material feed rate and fat recycling rate.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 48
 
3. By way of derogation from point 1, the competent authority may 
authorise the use of processing methods which have been approved 
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 suspend the 
application of processing methods referred to in points 1 and 3, if it 
obtains evidence that any of the circumstances specified in point 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 the marking 
of certain derived products set out in Chapter V of Annex VIII.  
However, such marking shall not be required for the following materials 
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 derived 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 results 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 alternative method.  
Section 2  
Processing standards  
A. Alkaline hydrolysis process  
1. Starting material  
For this process, animal by-products of all categories may be used.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 49
 
2. Processing method  
Alkaline hydrolysis shall be carried out according to the following 
processing standards:  
(a) Either a sodium hydroxide (NaOH) or potassium hydroxide (KOH) 
solution (or a combination thereof) must be used in an amount that 
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 neutralises the 
base, the added base must be adjusted so that the molar equivalency 
referred to is achieved.  
(b) Animal by-products must be placed in a steel alloy container. 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 animal 
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-products 
consisting of fish or of poultry materials.  
(d) The process must be carried out in a batch system and the material 
in the vessel must be constantly mixed in order to facilitate the 
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 used.  
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 steam 
application to the biolytic reactor;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 50
 
(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 that the 
requirements regarding time, temperature and pressure are achieved 
at the same time.  
C. High pressure hydrolysis biogas process  
1. Starting material  
For this process, animal by-products of all categories may be used.  
2. Processing method  
The high pressure hydrolysis biogas process shall be carried out 
according to the following processing standards:  
(a) The animal by-products must be first processed using processing 
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 defatted materials 
must be treated at a temperature of at least 220 °C for at least 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 system and 
the material is constantly mixed;  
(d) The animal by-products must be treated in such a manner that the 
requirements regarding time, temperature and pressure are achieved 
at the same time;  
(e) The resulting material must then be mixed with water and 
anaerobically fermented (biogas transformation) in a biogas reactor;  
(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 chilling 
(‘quenching’).  
D. Biodiesel production process  
1. Starting material  
For this process, a fat fraction derived from animal by-products of all 
categories may be used.  
2. Processing method  
Biodiesel production shall be carried out according to the following 
processing standards:  
(a) Unless fish oil or rendered fat are used which have been produced 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 — 31.07.2019 — 015.001 — 51
 
(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 esterfication 
and transesterfication.  
However, esterfication is not required for processed fat derived 
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 shall 
be carried out twice under the conditions described in this point 
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 by the 
competent authority.  
E. Brookes’ gasification process  
1. Starting material  
For this process, Category 2 and Category 3 material may be used.  
2. Processing method  
Brookes’ gasification shall be carried out according to the following 
processing standards:  
(a) The afterburner chamber must be warmed up using natural gas;  
(b) The animal by-products must be loaded into the primary chamber of 
the gasificator and the door must be closed. The primary chamber 
must have no burners and must be heated instead by the transfer of 
heat by conduction from the afterburner, which must be underneath 
the primary chamber. The only air admitted to the primary chamber 
must be via three inlet valves mounted on the main door to enhance 
the efficiency of the process;  
(c) The animal by-products must be volatilised into complex hydro ­
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 the after ­
burner chamber where they must be burned in the flame of a natural 
gas fired burner in the presence of excess air;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 52
 
(d) Each process unit must have two burners and two secondary air fans 
for back-up in case of burner or fan failure. The secondary chamber 
must be designed to give a minimum residence time of two seconds 
at a temperature of at least 950 °C under all conditions of 
combustion;  
(e) On leaving the secondary chamber the exhaust gases must pass 
through a barometric damper at the base of the stack, which cools 
and dilutes them with ambient air, maintaining a constant pressure 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 primary 
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-products of all 
categories may be used.  
2. Processing method  
Combustion of animal fat in a thermal boiler shall be carried out 
according to the following processing standards:  
(a) Unless fish oil or rendered fat are used which has been produced 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 which 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 in 
another plant, insoluble impurities in excess of 0,15 % by weight 
must be removed;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 53
 
(c) Following the process referred to in points (a) and (b), the 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 by the 
competent authority;  
(d) The combustion of material of animal origin other than animal fat 
must not be permitted;  
(e) The combustion of the fat derived from Category 1 and Category 2 
materials shall take place in the same plant where the fat is rendered 
with the aim of utilising the energy generated for the rendering 
processes. However, the competent authority may authorise the 
movement of that fat to other plants for combustion provided that:  
(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, with 
reference to the standards of that legislation regarding best 
available techniques for the control and monitoring of emissions.  
G. Thermomechanical biofuel production process  
1. Starting material  
For this process, manure and digestive tract content and Category 3 
material may be used.  
2. Processing method  
Thermomechanical biofuel production shall be carried out according 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 constantly 
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 larger than 20 
millimetres;  
(d) The animal by-products must be treated in such a manner that the 
requirements regarding time, temperature and pressure set out in 
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 must 
be kept at a temperature of at least 70 °C for at least one hour before 
being discharged as wastewater;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 54
 
(f) After the heat treatment of the material, the resulting biofuel from 
the converter must then be discharged and automatically conveyed 
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 % and 
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 set 
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 size 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 operating 
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 hours into a 
stockpile with a minimum size of two tonnes.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 55  
( 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 limes. European 
Committee for Standardisation,
 (f) At monitoring points which must be introduced into the stockpile, 
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 
corresponding 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 way of a 
validation according to the following requirements, that a process 
using a mixing device which is different from the mixing device 
referred to in point (d) or using dolime (CaOMgO) instead of quick 
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 mixture 
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, the 
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 zone 
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 which 
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 — 31.07.2019 — 015.001 — 56
 
(b) The use of rendered fats derived from Category 1 material for 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 filtration.  
(b) The pre-treated materials must be submitted to a multi-step catalytic 
process which consists of a hydro-deoxygenisation step, followed by 
an isomerisation step.  
The materials must be submitted to a pressure of at least 20 bars 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 (iii) of 
Regulation (EC) No 1069/2009;  
(b) Category 3 materials.  
2. Processing method  
2.1. The materials to be treated shall be collected at aquaculture 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 organic 
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 must 
be reduced into smaller soluble units, by the enzymes and the acid, 
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 animals 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 animals 
must have a pH of 4 or below and have a particle size of less than 
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 to 
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 written 
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 — 31.07.2019 — 015.001 — 57
 
L. Multiple-step catalytic hydro-treatment for the production of 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, including 
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-treatment 
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 bars 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 residues must 
be disposed of in accordance with point (i) or (ii), except where 
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 appropriate; 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 — 31.07.2019 — 015.001 — 58
 
(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 Section 2 may be 
transformed in a biogas plant and subsequently combusted rapidly at a 
minimum of 900°C, followed by rapid chilling (‘quenching’); where 
material referred to in Article 8(a) and (b) of Regulation (EC) 
No 1069/2009 has been used as starting material, the transformation 
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 distillation of 
biodiesel, used as a fuel without restrictions under this Regulation 
(end point);  
▼M4 
(ii) in the case of potassium sulphate, used for direct application 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 renewable 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 Regulation 
(end point);  
(ii) in the case of used clay from bleaching and sludge from the 
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 — 31.07.2019 — 015.001 — 59  
( 1 ) OJ L 135, 30.5.1991, p. 40.
 (d) the lime-treated mixture of pig and poultry manure may be applied to 
land as processed manure;  
(e) The final product derived from the ensilaging of fish material 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 Regulation; 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 production of 
renewable fuels may be:  
(i) in the case of renewable diesel, renewable jet fuel, renewable 
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) of 
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 — 31.07.2019 — 015.001 — 60
 
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/hygienisation unit, 
which cannot be by-passed for the animal by-products or derived products 
introduced with a maximum particle size of 12 mm before entering 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 /hygienisation unit shall 
not be mandatory for biogas plants that transform only:  
(a) Category 2 material that has been processed in accordance with 
processing method 1 as set out in Chapter III of Annex IV;  
(b) Category 3 material that has been processed in accordance with 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 processing methods 
1 to 7, as set out in Chapter III of Annex IV;  
(c) Category 3 material that has undergone pasteurisation/hygienisation in 
another approved plant;  
▼M4 
(d) animal by-products which may be applied to land without processing in 
accordance with Article 13(f) of Regulation (EC) No 1069/2009 and with 
this Regulation, if the competent authority does not consider them to 
present a risk of spreading any serious transmissible disease to 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 competent auth ­
ority:  
(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, where the 
digestion residues are subsequently composted or processed or 
disposed of in accordance with this Regulation.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 61
 
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 colostrum which 
accrues from those animals, the plant shall be located at a distance from the 
area where such animals are kept.  
That distance shall be determined in a manner which ensures that there is no 
unacceptable risk for the transmission of a disease communicable to humans 
or animals from the biogas plant.  
In all cases, there must be total physical separation between that 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 of an external 
laboratory. The laboratory must be equipped to carry out necessary analyses 
and be approved by the competent authority, be accredited according to 
internationally recognised standards or be subject to regular controls 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-products or derived 
products introduced into the plant, and it must be equipped with 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 system 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 Regulation.  
3. If the composting plant is located on or next to premises where farmed 
animals are kept and the composting plant does not only use manure, milk 
or colostrum which accrues from those animals, the composting plant shall be 
located at a distance from the area where animals are kept.  
That distance shall be determined in a manner which ensures that there is no 
unacceptable risk for the transmission of a disease communicable to humans 
or animals from the composting plant.  
In all cases, there must be total physical separation between that composting 
plant and the animals and their feed and bedding, with fencing where 
necessary.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 62
 
4. Each composting plant must have its own laboratory or make use of an 
external laboratory. The laboratory must be equipped to carry out necessary 
analyses and be approved by the competent authority, be accredited according 
to internationally recognised standards or be subject to regular 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 after arrival at 
the biogas or composting plant. They must be stored properly until treated.  
2. Containers, receptacles and vehicles used for transporting untreated 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 purpose.  
4. Cleaning procedures must be documented and established for all parts of the 
premises. Suitable equipment and cleaning agents must be provided for 
cleaning.  
5. Hygiene control must include regular inspections of the environment 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 biogas plant equipped 
with a pasteurisation/hygienisation unit must be submitted to the 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 products, 
colostrum and colostrum products may be used without pasteurisation/ ­
hygienisation as raw material in a biogas plant, if the competent authority 
does not consider them to present a risk of spreading any serious trans ­
missible disease to humans or animals.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 63
 
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 biogas plant 
without prior processing in accordance with Article 13(e)(ii) of 
Regulation (EC) No 1069/2009.  
2. Category 3 material which is used as raw material in a composting plant must 
be submitted to the following minimum requirements:  
(a) maximum particle size before entering the composting reactor: 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 prior 
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 other 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 shall 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 transformation 
conditions and parameters;  
(b) A risk assessment, which evaluates how the specific transformation 
conditions referred to in point (a) are achieved in practice under 
normal and atypical situations;  
(c) Validation of the intended process by measuring the reduction of 
viability/infectivity of:  
(i) endogenous indicator organisms during the process, where the 
indicator is:  
— consistently present in the raw material in high numbers,  
— not less heat resistant to the lethal aspects of the transformation 
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; or  
(ii) a well-characterised test organism or virus, during exposure, 
introduced in a suitable test body into the starting material.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 64
 
(d) The validation of the intended process referred to in point (c) must 
demonstrate that the process achieves the following overall risk 
reduction:  
(i) for thermal and chemical processes by:  
— a reduction of 5 log10 of  Enterococcus faecalis  or Salmonella 
Senftenberg  (775W, H2S negative),  
— reduction of infectivity titre of thermoresistant viruses such 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 operating 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 authorised under 
this point must be made available to the Commission on request.  
2. By way of derogation from point 1, pending the adoption of rules 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 equivalent effect 
regarding the reduction of pathogens, for:  
(a) catering waste used as the only animal by-product in a biogas 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 — 31.07.2019 — 015.001 — 65
 
(viii) eggs;  
(ix) egg products;  
▼M9 
(x) 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;  
(xi) mixture of animal by-products referred to in point 2(b) with 
non-animal by-product materials.  
▼B 
3. Where the materials referred to in point 2(b) or derived products referred to 
in Article 10(g) of Regulation (EC) No 1069/2009 are the only starting 
material of animal origin being treated in a biogas or composting plant, the 
competent authority may authorise the use of specific requirements other than 
those specified in this Chapter provided that it:  
(a) does not consider that those materials present a risk of spreading any 
serious transmissible disease to humans or animals;  
▼M9 
(b) considers that the digestion residues or compost are unprocessed material 
and obliges operators to handle them in accordance with Regulation (EC) 
No 1069/2009, with this Regulation or, in the case of compost or 
digestion residues derived from catering waste, to recover or dispose of 
in accordance with the environmental legislation.  
▼B 
4. Operators may place on the market digestion residues and compost, which 
have been produced according to parameters which have been authorised by 
the competent authority:  
(a) in accordance with point 1;  
(b) in accordance with points 2 and 3, only within the Member State where 
those parameters have been authorised.  
Section 3  
Standards for digestion residues and compost  
1. (a) Representative samples of the digestion residues or compost taken during 
or immediately after transformation at the biogas plant or composting at 
the composting plant in order to monitor the process must comply 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 standards:  
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 considered 
satisfactory if the number of bacteria in all samples does not exceed m;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 66
 
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 sample still being considered acceptable if the bacterial count of 
the other samples is m or less.  
▼M10  
2. Digestion residues or compost other than those referred to in 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 the case of 
Salmonella handled or disposed of in accordance with the instructions of 
the competent authority.  
▼M1 
3. When animal by-products are transformed into biogas or composted together 
with materials which are not of animal origin, the competent authority may 
authorise operators to take representative samples after the pasteurisation 
referred to in point 1(a) of Section 1 of Chapter I or after composting 
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 order to 
monitor the efficiency of the transformation or composting of the animal 
by-products, as applicable.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 67
 
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 diagnostic samples 
are accompanied by a commercial document, which must specify:  
(a) the description of the material and the animal species of origin;  
(b) the category of the material;  
(c) the quantity of the material;  
(d) the place of origin and 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/or user.  
2. Users that handle research and diagnostic samples shall take all necessary 
measures to avoid the spreading of diseases communicable to humans or 
animals during the handling of the materials under their control, in particular 
by way of the application of good laboratory practice.  
3. Any subsequent use of research and diagnostic samples for purposes other 
than those referred to in point 38 of Annex I shall be prohibited.  
4. Unless they are kept for reference purposes, research and diagnostic 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 referred to in 
Article 8 (a)(iv), Article 8(c) and (d) and Article 9 and Article 10 of 
Regulation (EC) No 1069/2009 which are part of cell cultures, laboratory 
kits or laboratory samples, by a treatment under conditions which are at 
least equivalent to the validated method for steam autoclaves (  1 ) and 
subsequent disposal as waste or wastewater in accordance with relevant 
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 — 31.07.2019 — 015.001 — 68  
( 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 products.  
6. By way of derogation from points 1, 4 and 5, the competent authority may 
accept the handling and disposal of research and diagnostic samples for 
educational purposes under other conditions which ensure that no 
unacceptable risks for public or animal health arise.  
Section 2  
Trade samples and display items  
1. Trade samples and display items may only be transported, used 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 shall 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 such 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, dispatched 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 competent 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 Annex VIII.  
2. Collection centres shall be registered by the competent authority, provided 
that: 
(a) they comply with the requirements for plants carrying out the intermediate 
operations set out in Chapter II of Annex IX; and  
(b) they have adequate facilities for destroying unused material, 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 for Category 2 
material as a collection centre.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 69
 
4. Operators of collection centres supplying material, other than animal 
by-products originating from aquatic animals and from aquatic invertebrates, 
to final users must ensure that it undergoes one of the following treatments:  
(a) denaturing with a solution of a colouring agent; the solution must be of 
such a strength that the colouring on the stained material is clearly visible 
and does not disappear when the coloured materials are subject to freezing 
or chilling, and the whole surface of all pieces of material must 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 every 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 following 
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 — 31.07.2019 — 015.001 — 70
 
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 — 31.07.2019 — 015.001 — 71
 
(iii) one of the species of the orders Falconiformes or Strigiformes, which 
are listed in Annex I to Directive 2009/147/EC, in special protection 
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 provided that:  
(i) the feeding is not used as an alternative way of disposal of specified 
risk materials or the disposal of fallen ruminant stock containing such 
material posing a TSE risk;  
(ii) an appropriate surveillance system for TSEs as laid down in 
Regulation (EC) No 999/2001 is in place involving regular laboratory 
testing of samples for TSE;  
(c) The competent authority must ensure coordination with any other 
competent authorities responsible for the supervision of the requirements 
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 habitat, 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 Regu ­
lation.  
(f) The operator responsible for the feeding shall:  
(i) dedicate an area to the feeding that is enclosed and to which access is 
limited to animals of the species to be conserved, if appropriate by 
fences or by other means which correspond to the natural feeding 
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 used for 
feeding are tested prior to that use with a negative result, in the TSE 
monitoring programme carried out in accordance with Annex III to 
Regulation (EC) No 999/2001 and, if applicable, in accordance with 
a Decision adopted in accordance with the second subparagraph of 
Article 6(1b) of that Regulation; and  
(iii) keep records at least of the number, nature, estimated weight and 
origin of the carcases of the animals used for feeding, the date of the 
feeding, the location where feeding took place and if applicable, 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 include certain 
species of necrophagous birds in that Member State, including an expla ­
nation of the reasons why it is necessary to feed such birds with 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 — 31.07.2019 — 015.001 — 72
 
Section 3  
Feeding of wild animals outside feeding stations  
The competent authority may authorise the use of Category 1 material 
comprising of entire bodies or parts of dead animals containing specified risk 
materials outside feeding stations, if appropriate without prior 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 an assessment of 
the specific situation of the species concerned and their habitat, 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 following conditions:  
(a) The feeding zone must not extend to areas where intensive farming of 
animals takes place;  
(b) Farmed animals in holdings or herds in the feeding zone must 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 holding or 
herd, until the risk can be excluded;  
(ii) a suspected or confirmed outbreak of a serious disease transmissible 
to humans or animals in a holding or herd, until the risk can be 
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 the 
species to be conserved, seasonal feeding restrictions, movement 
restrictions for farmed animals and other measures intended to 
control possible risks of transmission of a disease communicable to 
humans or animals, such as measures relating to species present in 
the feeding zone for the feeding of which the animal by-products 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, in 
relation to the measures referred to under point (i);  
(iii) the conditions for the imposition of penalties as referred 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 collection of the dead 
animals, an estimate of the likely mortality rate of farmed animals 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 potential risks of 
disease transmission.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 73
 
Section 4  
Feeding of zoo animals with Category 1 material  
The competent authority may authorise the use of Category 1 material 
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 grant such auth ­
orisations provided that:  
(i) the feeding is not used as an alternative way of disposal of 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 parts of dead 
animals containing specified risk material, which originates from bovine 
animals is used, an appropriate surveillance system for TSEs as laid 
down in Regulation (EC) No 999/2001 is in place involving regular 
laboratory testing of samples for TSEs;  
(b) The authorisation granted by the competent authority must be immediately 
suspended in the case of:  
(i) a suspected or confirmed link to the spread of TSEs until the 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 animal other 
than the zoo animals for which the authorisation has been granted have 
access to the material for the feeding;  
(ii) ensure that ruminant animals intended to be used for feeding are 
included in the TSE monitoring programme carried out in accordance 
with Annex III to Regulation (EC) No 999/2001 and, if applicable, in 
accordance with a Decision adopted in accordance with the second 
subparagraph of Article 6(1b) of that Regulation;  
(iii) keep records at least of the number, nature, estimated weight and origin 
of the bodies of the animals used for feeding, the results of the 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 Regulation (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 — 31.07.2019 — 015.001 — 74
 
(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 located 
within a range of distance sufficient to enable the competent authority 
to manage the prevention of the risk to animal and public health and the 
environment.  
2. The burning of animal by-products on the sites referred to in 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 reduced to 
ash; 
(b) without endangering human health;  
(c) without using processes or methods which could harm the environment, 
in particular when they could result in risks to water, air, soil and plants 
and animals or through noise or odours;  
(d) under conditions which ensure that any resulting ash is disposed 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 carried 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 endangering human 
health and using processes or methods which do not harm the 
environment, in particular when they could result in risks to water, 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-products 
from the place of origin to the place of disposal must be carried out under 
the following conditions:  
(a) the animal by-products are transported in secure, leak-proof containers or 
vehicles;  
(b) the loading and unloading of the animal by-products is supervised 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-products are 
thoroughly cleansed and disinfected after unloading of the animal 
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 Regulation (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 State concerned;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 75
 
(c) 10 % of the porcine population of the Member State concerned; and  
(d) a percentage of the population of other species which is determined by the 
competent authority, on the basis of an assessment of the possible risks for 
public and animal health which arise from the disposal of animals 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 authority may 
authorise the disposal by burning or burial on site, as referred 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 not 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 disposal of the 
Category 3 materials referred to in Article 10(f) of that Regulation 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 animal health;  
(c) the competent authority carries out regular checks, including checks on the 
records kept by operators, in the establishments or plants where the materials 
are collected, to ensure compliance with the provisions of this Section.  
▼M9 __________  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 76
 
ANNEX VII  
STANDARD FORMAT FOR APPLICATIONS FOR ALTERNATIVE 
METHODS  
CHAPTER I  
Language regime  
1. Applications for authorisation of an alternative method of use or disposal of 
animal by-products or derived products as referred to in Article 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 language other than 
English shall validate the official translation of their application, which 
EFSA shall provide, prior to the assessment.  
The period referred to in Article 20(5) of Regulation (EC) No 1069/2009 
shall only start once the interested party has validated the official 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 particular 
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 Regulation (EC) 
No 1069/2009 including the physical status of those materials and, if 
applicable, any pre-treatment to which those materials have been 
submitted and indicating any materials other than animal by-products 
which are to be used in the process.  
(b) include a HACCP protocol and a flow diagram which clearly indicates 
the individual steps of the process, identifies the parameters critical for 
the inactivation of relevant pathogens such as temperature, pressure, 
exposure time, adjustment of the pH value and particle size and is 
complemented by technical data sheets of the equipment used during 
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 products 
generated during the process, including the waste water, at least to 
the degree achieved by the processing standards laid down in this 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 — 31.07.2019 — 015.001 — 77
 
3. Validated direct measurements as referred to in paragraph 2(d) above shall 
mean:  
(a) measuring the reduction of viability/infectivity of: endogenous 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 process, but 
also not significantly more resistant than the pathogens for which 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 introduced 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 additive, 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 representative;  
(iv) justifying the number of tests performed and the selection of 
measuring points;  
(v) indicating the sensitivity and the specificity of the detection 
methods used;  
(vi) providing data on the repeatability and statistical variability 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 measurements of all 
factors leading to the risk reduction which demonstrate that these 
factors are homogenously applied throughout the treated batch.  
4. The HACCP plan referred to in paragraph 2(b) must be based on the critical 
parameters which are used to obtain the risk reduction, in particular:  
— temperature,  
— pressure,  
— time, and  
— microbiological criteria.  ▼M1 02011R0142 — EN — 31.07.2019 — 015.001 — 78
 
The critical limits retained in the HACCP plan must be defined, based on the 
results of the experimental validation and/ or of the model provided.  
If the successful functioning of the process can only be demonstrated with 
reference to technical parameters which are specifically related 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 parameters that are to 
be monitored and recorded in a continuous manner or after defined intervals 
and on the methods used for measuring and monitoring.  
The variability of parameters under typical production conditions must be 
taken into account.  
The HACCP plan must reflect normal and abnormal/ emergency operating 
conditions including a breakdown of the process and it must specify possible 
corrective actions which are to be applied in the case of abnormal/emergency 
operating conditions.  
5. The applications shall also contain sufficient information on:  
(a) the risks associated with interdependent processes, and in particular on 
the outcome of an evaluation of possible indirect impacts, which may:  
(i) influence the level of risk reduction of a particular process;  
(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 products, in 
particular:  
(i) the intended end use of any products generated during the process 
must be specified;  
(ii) the likely risks for human health and animal health and possible 
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, in particular:  
(a) a flow diagram showing the functioning of the process;  
(b) the evidence referred to in point 2(d), as well as other evidence aiming to 
substantiate the information provided in the framework of the application 
as set out in point 2.  
7. Applications shall include a contact address for the interested party, which 
shall include the name and full address, telephone and/or fax number and/or 
the electronic mail address of a particular person that is responsible as or on 
behalf of the interested party.  ▼M1 02011R0142 — EN — 31.07.2019 — 015.001 — 79
 
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 referred to in 
Article 4(1) of Regulation (EC) No 1069/2009, animal by-products and 
derived products must be collected and transported in sealed new 
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 derived 
products, other than derived products which are placed on the market in 
accordance with Regulation (EC) No 767/2009 and which are stored and 
transported in accordance with Annex II to Regulation (EC) No 183/2005, 
must be maintained in a clean condition.  
In particular, unless they are dedicated to the carriage of particular animal 
by-products or derived products in a way which avoids cross-contamination, 
they must be:  
(a) clean and dry before use; and  
(b) cleaned, washed and/or disinfected after each use to the extent necessary 
to avoid cross-contamination.  
3. Reusable containers must be dedicated to the carriage of a particular animal 
by-product or derived product to the extent necessary to avoid 
cross-contamination.  
However, reusable containers may be used, provided the competent 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 different 
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 by other means in 
accordance with Union legislation.  
Section 2  
Temperature conditions  
1. The transport of animal by-products destined for the production of feed 
material or raw petfood must take place at an appropriate temperature, in 
the case of animal by-products from meat and meat products which have 
been destined for purposes other than human consumption, at a maximum of 
7 °C, unless they are used for feeding purposes in accordance with Chapter I 
of Annex II, in order to avoid any risk to animal or public health.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 80
 
2. Unprocessed Category 3 material destined for the production of feed material 
or petfood must be stored and transported chilled, frozen or ensiled, unless:  
(a) it is processed within 24 hours after collection or after the end of storage 
in chilled or frozen form, if the subsequent transport takes place in means 
of transport in which the storage temperature is maintained;  
(b) in the case of milk, milk-based products or milk-derived products which 
have not been subject to any of the treatments referred to in Part I of 
Section 4 of Chapter II of Annex X, it is transported chilled and in 
insulated containers, unless risks can be mitigated by other measures, 
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 derived products by 
operators of milk-processing establishments 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.  
Section 4  
Derogation for collection and transport of manure  
By way of derogation from Section 1, the competent authority may accept the 
collection and transport of manure transported between two points 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 risks 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-products or 
derived products of a specific category is only used for the category 
for which its use is required under this Regulation, or is established 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 information 
as provided for in this Regulation on the surface or part of the surface 
of a packaging, container or vehicle, or on a label or symbol applied to 
them as follows:  
(i) in the case of Category 1 materials, using the colour black;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 81
 
(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 green with a 
high content of blue to ensure that it is clearly distinguishable 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 the time 
when the consignment has passed the border inspection post of first 
entry into the Union.  
2. During transport and storage, a label attached to the packaging, 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 the packaging, 
a container or vehicle, as applicable:  
(i) in the case of Category 3 material, ‘not for human consumption’;  
(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 feeding 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 from 
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 36 
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 products, 
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 — 31.07.2019 — 015.001 — 82
 
(vi) in the case of collagen produced from Category 3 material, 
‘collagen suitable for animal consumption’;  
(vii) in the case of raw petfood, ‘as pet food only’;  
(viii) in the case of fish and derived products from fish intended for 
feed for fish, and treated and packaged before distribution, the 
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 other 
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 to 
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, ‘organic 
fertilisers or soil improvers/no grazing of farmed animals or use 
of crops as herbage during at least 21 days following application’;  
(xii) in the case of material used for feeding in accordance with 
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, ‘manure’;  
(xiv) in the case of intermediate products, on the outer packaging, 
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 laid 
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 not for 
human consumption’, instead of the label text laid down in 
point (a);  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 83
 
(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 text 
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’.  
▼B 
(c) However, the label referred to in point (b)(xi) shall not be 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 applied 
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 the 
colour-coding of packaging, containers or vehicles used for the transport of 
animal by-products and derived products originating in and remaining on 
their territory, provided that those systems or rules do not confuse the 
colour-coding system provided for in point 1(c).  
4. Member States may establish systems or lay down rules for the marking of 
animal by-products originating in and remaining on their territory provided 
that those systems or rules do not conflict with the marking requirements 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-products 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 identification of 
Category 3 material comprising of milk, milk-based products and 
milk-derived products, by operators of milk-processing establishments 
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 manure which is 
transported between two points located on the same farm or between 
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-products 
or from derived products and which are packaged and placed on the 
market as feed in accordance with Article 4 of Regulation (EC) 
No 767/2009 do not have to be identified in accordance with point 1 
and they do not have to be labelled in accordance with point 2.  ▼M1 02011R0142 — EN — 31.07.2019 — 015.001 — 84
 
CHAPTER III  
COMMERCIAL DOCUMENTS AND HEALTH CERTIFICATES  
1. During transportation, a commercial document in accordance with the model 
set out in this Chapter, or, when required by this Regulation, a health 
certificate must accompany animal by-products and derived products.  
However, such document or certificate shall not be necessary, provided that:  
(a) derived products from Category 3 material and organic fertilisers and soil 
improvers are supplied within the same Member State by retailers to final 
users other than business operators;  
(b) milk, milk-based products and milk-derived products which are Category 
3 materials are collected and returned to operators of milk-processing 
establishments, which have been approved in accordance with Article 4 
of Regulation (EC) No 853/2004, if those operators are receiving 
products, in particular from their customers, which they have previously 
delivered;  
(c) compound feeds as defined in Article 3(2)(h) of Regulation (EC) 
No 767/2009 which have been manufactured from animal by-products 
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 triplicate (one 
original and two copies). The original must accompany the consignment to 
its final destination. The receiver must retain it. The producer must retain one 
of the copies and the carrier the other.  
Member States may require that proof of the arrival of the consignments is 
provided by the TRACES system or by a fourth copy of the commercial 
document which is sent back by the receiver to the producer.  
3. Health certificates must be issued and signed by the competent authority.  
4. A commercial document in accordance with the model set out under point 6 
shall accompany animal by-products and derived products as from the 
starting point in the manufacturing chain referred to in Article 4(1) of 
Regulation (EC) No 1069/2009, during transportation within the Union.  
However, in addition to the authorisation to transmit information 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 authority 
may authorise that animal by-products and derived products which 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 Chapter;  
(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 certificates shall be 
kept for a period of at least two years for presentation to the competent 
authority.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 85
 
6. Model commercial document  
Notes  
(a) Commercial documents shall be produced, according to the layout of the 
model appearing in this Chapter.  
It shall contain, in the numbered order that appears in the model, 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 the Member State 
of origin and of the Member State of destination, as appropriate.  
However, it may also be drawn up in other official Union languages, 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 an inte ­
grated whole and indivisible.  
(d) If for reasons of identification of the items of the consignment, 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 for the 
consignment, on each of the pages.  
(e) When the commercial document, including additional sheets of paper 
referred to in point (d), 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 
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 and 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 applicable 
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 origin of the 
material and its approval or registration number assigned in 
accordance with Regulation (EC) No 1069/2009 or, where appli ­
cable, 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 — 31.07.2019 — 015.001 — 86  
( 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 origin (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 transporter 
of the material;  
(vi) the name and address of the establishment or plant of destination 
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 container 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 products 
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 number shall 
only be issued once for the same consignment.  
▼M16  
(i) The competent authority responsible for the place of destination referred 
to in the second subparagraph of Article 48(3) of Regulation (EC) 
No 1069/2009 shall, within 15 working days of the receipt of the 
information referred to in the first subparagraph of Article 48(3) of 
that Regulation, inform the competent authority of the Member State 
of origin of the arrival of the consignment by means of TRACES.  ▼M16  02011R0142 — EN — 31.07.2019 — 015.001 — 87  
( 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 inspections carried out by 
Commission veterinary experts and laying down the veterinary units 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 — 31.07.2019 — 015.001 — 88
 
▼M16  02011R0142 — EN — 31.07.2019 — 015.001 — 89
 
▼M16  02011R0142 — EN — 31.07.2019 — 015.001 — 90
 
▼M16  02011R0142 — EN — 31.07.2019 — 015.001 — 91
 
CHAPTER IV  
RECORDS  
Section 1  
General provisions  
1. The records as referred to in Article 22(1) of Regulation (EC) No 1069/2009 
for animal by-products and derived products, other than compound feeds as 
defined in Article 3(2)(h) of Regulation (EC) No 767/2009, which have been 
manufactured from animal by-products or from derived products and which 
are placed on the market in accordance with Article 4 of Regulation (EC) 
No 767/2009, shall contain:  
(a) a description of:  
(i) the animal species for Category 3 material and derived products 
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 receiver and, 
if applicable, their approval or registration number;  
(c) in the case of records kept by any person transporting animal 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 material is 
dispatched;  
(iii) the name and the address of the receiver and, if applicable, 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 material 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 commercial document 
laid down in Chapter III for each consignment and make such information 
available in conjunction with the other information required under 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 derived products 
incinerated or co-incinerated, as applicable, and the date at which those 
operations were carried out.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 92
 
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 Chapter II of Annex VI:  
1. in the case of final users, the quantity used, the animals that 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 shall keep records 
at least of:  
(a) the number of furs and carcases of animals fed with materials 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 and 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 records of the following 
for a period of at least two years:  
1. the quantities of organic fertilisers and soil improvers applied;  
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 fertiliser 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 the aquatic animals 
were caught in the wild or produced in aquaculture;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 93
 
(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 species 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 provided for in 
Article 19(1) of Regulation (EC) No 1069/2009, the person responsible for 
such burning or burial shall keep records of the following:  
(a) the quantities, categories and species of animal by-products 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 Section 11 of 
Chapter II of Annex XIV shall keep records detailing the purchases and uses 
of photogelatine, as well as the disposal of residues and surplus material.  
CHAPTER V  
MARKING OF CERTAIN DERIVED PRODUCTS  
1. In processing plants for the processing of Category 1 or Category 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 preceding 
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 substance a 
minimum concentration of at least 250 mg GTH per kg fat.  
2. The operators of processing plants referred to in point 1 shall have in place a 
system of monitoring and recording of parameters suitable to demonstrate to 
the competent authority that the required homogeneous minimum concen ­
tration of GTH is achieved.  
That monitoring and recording system shall include the determination of the 
content of intact GTH as triglyceride in a cleaned petroleum-ether 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 plants;  
(b) derived products used for feeding to fur animals in accordance 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 — 31.07.2019 — 015.001 — 94
 
(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 Regulation (EC) 
No 1069/2009, where such products are:  
(i) moved by a closed conveyer system, which may not be by-passed, 
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 referred 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 derived 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 required in the case of 
the transport of a dead pet animal for incineration in an establishment 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 condition of the 
transport.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 95
 
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 in 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 must be sent to 
an incineration plant, a co-incineration plant, a processing plant 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 handling of 
animal by-products after their collection, as referred to in Article 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 which are carried 
out in compliance with obligations under Union veterinary legislation, 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 transformation or 
composting in another establishment or plant in accordance with Annex V 
hereto;  
(j) sieving.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 96
 
Section 1  
General requirements  
1. Premises and facilities where intermediate operations are carried out shall 
meet at least the following requirements:  
(a) They must be adequately separated from thoroughfares through which 
contamination may be spread and from other premises such as slaughter ­
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 building.  
(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 public 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 facilitate the 
draining of liquids.  
(d) The plant must have adequate facilities including lavatories, changing 
rooms, washbasins for staff and, if appropriate, office space which 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 objectives of this 
Regulation, plants must have suitable temperature-controlled storage 
facilities of sufficient capacity for maintaining animal by-products at 
appropriate temperatures and designed to allow the monitoring and 
recording of those temperatures.  
2. The plant shall be equipped with adequate facilities for cleaning and 
disinfecting the containers or receptacles in which animal by-products 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 such a way as to 
avoid any risk of the propagation of animal diseases.  
2. At all times during storage, animal by-products shall be handled 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 processing 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 authorised in accordance 
with point 1 of Section 2 of Chapter III of the same Annex.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 97
 
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 Category 3 material must 
not be at the same site as premises storing derived products from 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 storage in 
completely separate buildings.  
2. The plant must:  
(a) have a covered space to receive and dispatch the derived products, unless 
the derived products are:  
(i) being discharged through installations which prevent the spreading 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 disinfect. Floors 
must be laid down in such a way as to facilitate the draining of liquids;  
(c) have adequate facilities including lavatories, changing rooms and wash ­
basins 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 disinfecting the 
containers or receptacles in which the derived products are received 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 Section 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 storage estab ­
lishment or plant or in a dedicated, separate storage area within 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 microbiological standards 
set out in Chapter I of Annex X.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 98
 
CHAPTER IV  
REGISTERED OPERATORS  
1. Operators of registered plants or establishments or other registered operators 
shall handle animal by-products and derived products under the following 
conditions:  
(a) premises must be constructed in a way permitting their effective 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 condition, where 
necessary;  
(d) animal by-products and derived products must be stored under conditions 
preventing contamination.  
2. Operators shall keep records in a form which is accessible to the competent 
authority.  
3. Registered operators transporting animal by-products or derived products, 
other than between premises of the same operator, shall in particular:  
(a) have information at their disposal with regard to the identification of their 
vehicles, which allows the verification of the use of the vehicles 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 authorised by 
the competent authority.  
2. The competent authority of a Member State shall make the results 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 containment method.  
Section 2  
Methodology  
A. Aerobic maturation and storage of dead-on-farm pigs and certain other 
porcine material with subsequent incineration or co-incineration.  
1. Member States concerned  
The process of aerobic maturation and storage of dead-on-farm pigs 
and certain other porcine material with subsequent incineration or 
co-incineration may be used in France, Ireland, Latvia, Portugal and 
the United Kingdom.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 99
 
Following aerobic maturation and storage of material, the competent 
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 the 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 the 
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 killed 
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 Union 
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 diseases;  
(c) put in place procedures to prevent the spreading of used sawdust 
outside the closed system.  
The process must be carried out in a closed system which consist of 
several cells, with a waterproof floor and delimited by solid walls. 
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 level 
defined in the permanent written procedure referred to in Article 29(1) 
to (3) of Regulation (EC) No 1069/2009 with sufficient capacity for 
farm mortalities occurring during an eight-month period at least.  
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 ground. 
The carcasses and other porcine material must then be placed on this 
first layer of sawdust and each layer of carcasses and other porcine 
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 — 31.07.2019 — 015.001 — 100
 
3.2.2. Maturing phase  
When the cell is full and a rise in temperature allows the degradation 
of all the soft tissues, the maturation period starts and must last at least 
3 months.  
At the end of the filling and storage phase and during all of the 
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 be 
recorded by the operator.  
At the end of the filling and storage phase, the temperature monitoring 
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 maturing 
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 phase to the 
approved incineration or co-incineration plant is subject to controls 
referred to in Regulation (EC) No 1069/2009 or Directive 2008/98/EC.  
B. Hydrolysis with subsequent disposal  
1. Member States 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 same 
Member State referred to above.  
2. Starting materials  
For this process, only the following materials of porcine origin 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 Regulation.  ▼M9 02011R0142 — EN — 31.07.2019 — 015.001 — 101
 
This method is only applicable to the disposal of animals of the porcine 
species originating in the same holding and provided this holding is not 
subject to prohibition due to a 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 the spot. It 
shall be carried out according to the following standards:  
(a) Following their collection on a holding for which the competent 
authority has authorised the use of the processing method, based 
on an assessment of the animal density of the holding, the likely 
mortality rate and the potential risks for public and animal health 
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 physically 
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 emissions, which 
must be equipped with appropriate filters to prevent the transmission 
of diseases communicable to humans and animals.  
(f) The container must be closed for the process of hydrolysis for a 
period of at least three months, in such a way that any unauthorised 
opening is prevented.  
(g) The operator must put in place procedures to prevent the trans ­
mission of diseases communicable to humans or animals by 
movements of personnel.  
(h) The operator must:  
(i) take preventive measures against birds, rodents, insects and 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 — 31.07.2019 — 015.001 — 102
 
(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, including 
their application to land, shall be prohibited.  ▼M9 02011R0142 — EN — 31.07.2019 — 015.001 — 103
 
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 from 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 considered satis ­
factory if the number of bacteria in all samples does not exceed m;  
M = maximum value for the number of bacteria; the result is considered 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 between m and M, 
the sample still being considered acceptable if the bacterial count 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-products, when the 
processed animal protein, which is obtained during the same processing, 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 products which 
are derived from such animal by-products, other than the Category 3 
materials referred to in Article 10(n), (o) and (p) of Regulation (EC) 
No 1069/2009, may be used for the production of processed animal 
protein.  
2. Processed animal protein derived from farmed insects, intended for the 
production of feed for farmed animals other than fur animals, may 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 — 31.07.2019 — 015.001 — 104
 
B. Processing standards  
1. Processed animal protein of mammalian origin must have been submitted 
to processing method 1 (pressure sterilisation) as set out in Chapter III of 
Annex IV.  
However,  
(a) porcine blood or fractions of porcine blood for the production of 
bloodmeal may have been submitted instead to any of the processing 
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 heat 
treatment throughout its substance at a temperature of 80 °C has 
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 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:  
— 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 of 
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 Annex 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 inside 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 maintained in 
a clean and dry condition and must have adequate inspection points so 
that equipment can be examined for cleanliness.  
All storage facilities must be emptied and cleaned regularly, to the extent 
necessary to prevent contamination.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 105
 
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 complies with the 
microbiological standards for derived products set out in Chapter 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 referred 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 Regulation 
may be used for the production of fish oil.  
▼B 
B. Processing standards  
Unless the fish oil or rendered fats have been produced in accordance with 
Sections VIII or XII of Annex III to Regulation (EC) No 853/2004, respect ­
ively, rendered fats must be produced using any of the processing methods 1 
to 5 or processing method 7, and fish oils may be produced:  
(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 product 
complies with the microbiological standards for derived products 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 Chapter III of 
Annex IV.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 106
 
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 disinfected if 
necessary for the prevention of contamination and all precautions must be 
taken to prevent its recontamination.  
Where bulk transport of those products is intended, the pipe, pumps 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 directly on to 
the ship or into shore tanks or directly to plants must be clean 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 1069/2009, 
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 production of 
milk, milk-based products and milk-derived products.  
Colostrum may only be used provided that it originates from live animals that 
did not show any signs of disease communicable through the colostrum 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-derived 
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 — 31.07.2019 — 015.001 — 107  
(*) 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 to achieve the same 
killing effect as 121 °C (250 °F) in three minutes with instantaneous heating and 
chilling. 
(**) UHT = Ultra High Temperature treatment at 132 °C for at least one second. 
(***) 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.
 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-derived 
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 clotting 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 during that 
period no case of foot-and-mouth disease has been detected in the 
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 transport 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, officially 
brucellosis-free and officially enzootic-bovine-leukosis-free as 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 during that 
period no case of foot-and-mouth disease has been detected in the 
Member State of origin;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 108
 
6.3. have undergone a single HTST treatment (*);  
6.4. comply with the requirements set out in point 4 of this Part.  
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 shall apply to the 
processing, use and storage of milk, milk-based products and milk-derived 
products which are Category 3 material, as referred to in Article 10(e) of 
Regulation (EC) No 1069/2009, other than centrifuge or separator 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 processed in 
accordance with Part I of this Section.  
▼B 
2. The competent authority shall authorise milk processing establishments 
approved or registered in accordance with Article 4 of Regulation (EC) 
No 853/2004 to supply milk, milk-based products and milk-derived 
products for the purposes referred to in point 3 of this Part provided the 
establishment concerned ensures the traceability of the products.  
3. Milk, milk-based products and milk-derived products may be supplied and 
used as feed material:  
(a) in the Member State concerned and in cross-border areas where 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 those 
derived products have been subject to one of the following treatments:  
(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 temperature 
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, which 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 least 
16 hours after milk clotting and where the pH must be recorded as < 
6,0 before supplying the whey for feeding, provided that they are 
sent to a limited number of authorised animal holdings, fixed on the 
basis of the risk assessment for the best and worst case scenarios 
carried out by the Member State concerned in preparation of the 
contingency plans for epizootic diseases, in particular foot-and- 
mouth disease;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 109  
(*) 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 has been in 
contact with raw milk and other products for which the treatments 
referred to in point (a) and point (b)(i) cannot be ensured, provided 
that they are sent to a limited number of authorised animal holdings, 
fixed on the basis of a risk assessment for the best and worst case 
scenarios carried out by the Member State concerned in preparation 
of the contingency plans for epizootic diseases, in particular foot-and- 
mouth disease, and provided that the animals present in the auth ­
orised animal holdings can only be moved  
— either directly to a slaughterhouse located in the same Member 
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 standstill 
period has elapsed from the introduction of the animals.  
4. The competent authority may authorise the supply of colostrum which does 
not comply with the conditions set out in point B.6 of Part I from one farmer 
to another farmer within the same Member State for feeding purposes, 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 sludge 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 feeding to farmed 
animals.  
▼M9 
By way of derogation from the first paragraph, the competent authority may 
authorise alternative parameters for the heat treatment of centrifuge or 
separator sludge destined for uses within Member States which have authorised 
those alternative parameters, provided operators can demonstrate that the heat 
treatment according to the alternative parameters guarantees at least the same risk 
reduction as the treatment carried out according to the parameters 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 products 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 Section XIV 
of Annex III to Regulation (EC) No 853/2004, it must be produced 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 extracted by 
heating one or several times in succession, followed by purification by 
means of filtration and sterilisation.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 110
 
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 hydrogen 
peroxide, shall be prohibited.  
C. Other requirements for gelatine  
Gelatine must be wrapped, packaged, stored and transported under satis ­
factory hygiene conditions.  
In particular:  
(a) a room or a dedicated place must be provided for storing materials for 
wrapping and packaging;  
(b) wrapping and packaging must take place in a room or in a place 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 protein derived 
from ruminants shall have a molecular weight below 10 000 Dalton.  
In addition to the requirements of the first paragraph, hydrolysed proteins 
entirely or partly derived from ruminants’ hides and skins shall be produced 
in a processing plant dedicated only to hydrolysed protein production, using 
a process involving the preparation of raw Category 3 material by brining, 
liming and intensive washing followed by exposure of the material to:  
(a) a pH of more than 11 for more than three hours at a temperature 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 products 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 comprises 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 hydro ­
chloric acid (at a minimum concentration of 4 % and a pH of less 
than 1,5) over a period of at least two days;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 111
 
(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 with 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 products 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 at 4 bars;  
(c) separation of the protein broth from the hydroxyapatite (tricalcium phos ­
phate) by centrifugation;  
(d) granulation of the tricalcium phosphate after drying in a fluidised 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 products 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 — 31.07.2019 — 015.001 — 112
 
2. The use of preservatives, other than those permitted under Union legis ­
lation shall be prohibited.  
C. Other requirements  
Collagen must be wrapped, packaged, stored and transported under satis ­
factory hygiene conditions. In particular:  
(a) a room or a dedicated place must be provided for storing materials for 
wrapping and packaging;  
(b) wrapping and packaging must take place in a room or in a place 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) and 
Article 10(k)(ii) of Regulation (EC) No 1069/2009 may be used for 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 processing method 
7 set out in Chapter III of Annex IV;  
(b) submitted to another method and parameters which ensure that 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 egg products set 
out in Chapters I, II and III of Section X of Annex III to Regulation (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 products of animal 
origin originating from Member States which are no longer intended for 
human consumption for commercial reasons or due to problems of manufacturing 
or packaging defects or other defects from which no risk to public or animal 
health arise, referred to in Article 10(f) of Regulation (EC) No 1069/2009, may 
be placed on the market for feeding to farmed animals, other than fur animals, 
without further treatment, provided that the material:  
(i) has undergone processing as defined in Article 2(1)(m) of Regulation (EC) 
No 852/2004 or in accordance with this Regulation;  
(ii) is composed of or contain one or more of the following Category 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 — 31.07.2019 — 015.001 — 113
 
— egg products,  
— honey,  
— rendered fats,  
— collagen,  
— gelatine;  
(iii) has not been in contact with any other Category 3 materials; and  
(iv) all necessary precautions have been taken to prevent the contamination of 
the material.  
▼B 
CHAPTER III  
REQUIREMENTS FOR CERTAIN FISH FEED AND FISHING BAITS  
1. Animal by-products from fish or aquatic invertebrates and derived products 
therefrom that are intended as feed for farmed fish or for other aquaculture 
species shall:  
(a) be handled and processed separately from material not authorised 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 another 
species;  
(c) be processed in a processing plant in accordance with a method which 
ensures a microbiologically safe product, including with regard to fish 
pathogens.  
2. The competent authority may lay down conditions, aimed at preventing 
unacceptable risks for the transmission of diseases communicable to 
humans or animals, for the use of aquatic animals and of aquatic 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 — 31.07.2019 — 015.001 — 114
 
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 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) Trade in unprocessed manure of species other than poultry or 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 competent 
authorities, to land forming part of a single holding located on 
both sides of the border of two Member States.  
(b) However, the competent authority of the Member State of destination 
may, having regard to the origin of the manure, its destination and 
health considerations, grant specific authorisation for the introduction 
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 the 
origin of the manure when authorising the introduction to such 
plants; or  
(ii) manure intended for applying to land on a holding, provided 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 commercial 
document which accompanies the consignment of manure.  
2. Trade in unprocessed poultry manure between Member States shall 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 to restrictions 
by virtue of Newcastle disease or avian influenza;  
(b) in addition, unprocessed manure from poultry flocks vaccinated 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 in point 3 shall 
be added to the commercial document which accompanies the 
consignment of manure.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 115
 
3. Model health attestation to be added to the commercial document:
  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 116
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 117
 
4. Unprocessed manure of equidae may be traded between Member States, 
provided that the Member State of destination has given its consent to the 
trade as referred to in Article 48(1) of Regulation (EC) No 1069/2009, and 
provided it does not originate from a holding subject to animal health 
restrictions pertaining to glanders, vesicular stomatitis, anthrax 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) No 1069/2009, 
the competent authority of the Member State of destination may require 
operators dispatching unprocessed manure from another Member State:  
(a) to transmit further information in relation to an intended dispatch, such 
as precise geographical indications regarding the place where the 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 conditions for the 
control of possible health risks, such as obligations for the operators 
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 conditions. In 
addition, in the case of guano from bats the consent of the Member State of 
destination is required as referred to in Article 48(1) of Regulation (EC) 
No 1069/2009:  
▼B 
(a) They must come from a plant for derived products for uses outside the feed 
chain or from a biogas or a composting plant or from a plant for 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 reduction in 
spore-forming bacteria and toxin formation, where they are identified as a 
relevant hazard.  
(c) However, the competent authority may authorise the use of other stan ­
dardised process parameters than those referred to in point (b), provided 
an applicant demonstrates that such parameters ensure minimising of 
biological risks.  
That demonstration shall include a validation, which shall be carried out as 
follows:  
(i) Identification and analysis of possible hazards including the impact of 
input material, based on a full definition of the processing conditions, 
and a risk assessment, which evaluates how the specific processing 
conditions are achieved in practice under normal and atypical situations.  
(ii) Validation of the intended process  
(ii-1) by measuring the reduction of viability/infectivity of endogenous 
indicator organisms during the process, where the indicator is:  
— consistently present in the raw material in high numbers,  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 118
 
— not less heat resistant to the lethal aspects of the treatment 
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 and 
confirm; or  
(ii-2) by measuring the reduction of viability/infectivity, during 
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 parasites such 
as eggs of  Ascaris  sp. by at least 99,9 % (3 log10) of viable stages.  
(iv) Designing a complete control programme including procedures 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 well as other 
critical control points shall be recorded and maintained so that the owner, 
operator or their representative and the competent authority can monitor the 
operation of the plant. Information relating to a process authorised under this 
point must be made available to the Commission on request;  
(d) Representative samples of the manure taken during or immediately after 
processing at the plant in order to monitor the process must comply 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 withdrawal 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 considered 
satisfactory if the number of bacteria in all samples does not exceed m;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 119
 
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 sample still being considered acceptable if the bacterial 
count of the other samples is m or less.  
Processed manure or processed manure products not complying with the 
standards in this point shall be regarded as unprocessed;  
(e) They must be stored in such a way that once processed contamination 
or secondary infection and dampness is minimised. They must therefore be 
stored in:  
(i) well-sealed and insulated silos or properly constructed storage 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, digestive tract 
content, compost, milk, milk-based products, milk-derived products, 
colostrum, colostrum products and digestion residues from the transformation 
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 Chapter 
II of Annex X, which has been produced from Category 3 material in 
accordance with Section 1 of Chapter II of Annex X, or materials which 
have been subject to another treatment, where such materials may be 
used for organic fertilisers and soil improvers in accordance with this 
Regulation; or  
▼B 
(c) by applying any of the processing methods 1 to 7, as set out in 
Chapter III of Annex IV, when Category 3 material is used as starting 
material which is not used for the production of processed animal 
protein.  
2. Organic fertilisers and soil improvers which consist of or which have been 
produced from meat-and-bone meal derived from Category 2 material or 
from processed animal protein, shall be mixed, in a registered establishment 
or plant, with a sufficient minimum proportion of a component which is 
authorised by the competent authority of the Member State where the 
product is to be applied to land, in order to exclude the subsequent use of 
the mixture for feeding purposes.  
3. The competent authority shall authorise the component referred 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 biogas or 
other substances, such as mineral fertilisers, which are not used in animal 
feed and which exclude the subsequent use of the mixture for feeding 
purposes according to good agricultural practice;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 120
 
(b) the component shall be determined based on an assessment of the 
climatic and soil conditions for the use of the mixture as a fertiliser, 
on indications that the component renders the mixture unpalatable to 
animals or it is otherwise effective in preventing misuse of the mixture 
for feeding purposes and in accordance with the requirements laid 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 components 
available to the Commission and to other Member States upon request.  
4. However, the requirements referred to in point 2 shall not apply:  
(a) to organic fertilisers and soil improvers which are in ready-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 not more than 
1 000 kg in weight, on the packages of which it is indicated that the 
organic fertilisers are not destined to land to which farmed animals have 
access, provided that the competent authority of the Member State where 
the organic fertiliser or soil improver is to be applied to land, has auth ­
orised the use of such big bags on the basis of an assessment of the 
likelihood of a potential diversion of the materials to farms keeping 
animals or to land to which farmed animals have access.  
5. Producers of organic fertilisers and soil improvers must ensure that decon ­
tamination of pathogens is carried out prior to their placing on 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 and digestion 
residues from the transformation of animal by-products or derived 
products into biogas.  
Section 2  
Storage and transport  
After processing or transformation, organic fertilisers and soil improvers shall be 
properly stored and transported:  
(a) in bulk, under appropriate conditions that prevent contamination;  
(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 space 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 plants carrying out 
the activities referred to in point 1 of Section 1 meet the requirements laid down 
in Article 8 of this Regulation and:  
(a) have adequate facilities for storage of incoming ingredients to prevent 
cross-contamination and avoid 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 — 31.07.2019 — 015.001 — 121
 
ANNEX XII  
INTERMEDIATE PRODUCTS  
In accordance with Article 34(2) of Regulation (EC) No 1069/2009, 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 authorised, provided 
that: 
(a) they are derived from the following materials:  
(i) Category 3 material, other than materials referred to in Article 10(c), 
(n), (o) and (p) of Regulation (EC) No 1069/2009;  
(ii) products generated by the animals referred to in Article 10(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 production of medical 
devices, in vitro diagnostic medical devices and laboratory reagents, 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 production of active 
implantable medical devices, medicinal products and veterinary medicinal 
products, they are derived from the materials referred to in point (b), 
where the competent authority considers the use of such materials 
justified for the protection of public or animal health;  
(d) they come from a third country listed as a member of the World Organi ­
sation for Animal Health (OIE) in the OIE bulletin;  
(e) they come from an establishment or plant registered or approved 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 importer in 
accordance with the model declaration set out in Chapter 20 of 
Annex XV, which must be at least in one of the official languages of 
the Member State in which the inspection at the border inspection post 
must be carried out and of the Member State of destination; these Member 
States may allow the use of other languages and request official trans ­
lations for declarations in such other languages;  
(g) in the case of materials referred to in point (b), the importer demonstrates 
to the competent authority that the materials:  
(i) do not carry any risk of transmission of a disease communicable to 
humans or animals; or  
(ii) are transported under conditions which prevent the transmission of 
any diseases communicable to humans or animals.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 122
 
2. An establishment or plant may be registered or approved by the competent 
authority of a third country, as referred to in point 1(e), provided 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, trans ­
formation and manufacturing stages;  
(ii) establishes and implements methods of monitoring and checking the 
critical control points on the basis of the process used;  
(iii) keeps a record of the information obtained pursuant to point (ii) for a 
period of at least two years for submission to the competent auth ­
ority;  
(iv) informs the competent authority if any available information reveals 
the existence of a serious animal health or public health risk;  
(b) the competent authority of the third country carries out, at regular 
intervals, inspections of the establishment or plant and supervises the 
plant in accordance with the following conditions:  
(i) the frequency of inspections and supervision shall depend on the size 
of the plant, the type of products manufactured, risk assessment 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 reveals 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 establishments 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 activities; 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 checked at the 
border inspection post in accordance with Article 4 of Directive 97/78/EC and 
transported directly from the border inspection post either to:  
(a) a registered establishment or plant for the production of laboratory 
reagents, medical devices and  in vitro  diagnostic medical devices for 
veterinary purposes or the derived products referred to in Article 33 of 
Regulation (EC) No 1069/2009, where the intermediate products must be 
further mixed, used for coating, assembled or packaged before they are 
placed on the market or put into services in accordance with the Union 
legislation applicable to the derived product;  
▼B 
(b) an establishment or plant which has been approved for the storage of 
animal by-products in accordance with Article 24(1)(i) of 
Regulation (EC) No 1069/2009, from where they must only be dispatched 
to an establishment or plant referred to in (a) of this point for 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 — 31.07.2019 — 015.001 — 123
 
5. The official veterinarian at the border inspection post concerned shall inform 
the authority in charge of the establishment or plant at the place of destination 
of the consignment by means of the TRACES system.  
6. The operator or owner of the establishment or plant of destination or his 
representative shall keep records in accordance with Article 22 of 
Regulation (EC) No 1069/2009 and shall provide the competent authority 
on request with the necessary details of purchases, sales, uses, stocks and 
disposals of surplus of the intermediate products for the purposes of 
checking compliance with this Regulation.  
7. The competent authority shall ensure, in accordance with Directive 97/78/EC, 
that the consignments of intermediate products are sent from the Member 
State where the inspection at the border inspection post must be carried out 
to the plant of destination, as referred to in point 3 or, in the case of transit, to 
the border inspection post of exit.  
8. The competent authority shall carry out documentary checks at regular 
intervals for the purpose of reconciliation of the quantities of intermediate 
products imported on the one hand, and stocked, used, dispatched or disposed 
of on the other, in order to check compliance with this Regulation.  
9. For consignments of intermediate products in transit, the competent authorities 
responsible for the border inspection posts of entry and of exit respectively 
shall cooperate as necessary to ensure that effective checks are carried out and 
to ensure the traceability of such consignments.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 124
 
ANNEX XIII  
PETFOOD AND CERTAIN OTHER DERIVED PRODUCTS  
CHAPTER I  
General requirements  
Petfood plants and establishments or plants producing derived products referred 
to in this Annex shall have adequate facilities for:  
(a) storing and treating incoming material under conditions which 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 or disposal to 
another establishment or plant, in accordance with this Regulation.  
CHAPTER II  
Specific requirements for petfood, including dogchews  
1. Raw petfood  
Operators may only manufacture raw petfood from Category 3 material 
referred to in Article 10(a) and Article 10(b)(i) and (ii) of Regulation (EC) 
No 1069/2009.  
Raw petfood must be packed in new packaging preventing any leakage.  
Effective steps must be taken to ensure that the product is not exposed to 
contamination throughout the production chain and up to the point of sale.  
2. Raw material for processed petfood and for dogchews  
Operators may manufacture processed petfood and dogchews only from:  
(a) Category 3 material, other than material referred to in Article 10(n), (o) 
and (p) of Regulation (EC) No 1069/2009; and  
(b) in the case of imported petfood or petfood produced from imported 
materials, from Category 1 material comprising of animal by-products 
derived 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.  
3. Processed petfood  
(a) Canned petfood must be subjected to heat treatment to a minimum Fc 
value of 3.  
(b) Processed petfood other than canned petfood must:  
(i) be subjected to a heat treatment of at least 90 °C throughout the 
substance of the final product;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 125
 
(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 exclusively 
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 terrestrial 
invertebrates, and if authorised by the competent authority, be 
subject to a treatment which ensures that the petfood poses no 
unacceptable 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 processed petfood, 
other than from canned petfood and other than from such processed petfood 
which has been treated in accordance in point 3(b)(v), during production 
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.  
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 shall be 
considered satisfactory if the number of bacteria in all samples does 
not exceed m;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 126
 
M = maximum value for the number of bacteria; the result shall be 
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 sample shall still be considered acceptable if the bacterial 
count of the other samples is m or less.  
6. Random samples must be taken from raw petfood during production 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.  
Enterobacteriaceae: n = 5, c = 2, m = 10, M = 5 000 in 1 g  
Where:  
n = number of samples to be tested;  
m = threshold value for the number of bacteria; the result shall be 
considered satisfactory if the number of bacteria in all samples 
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 more 
samples is M or more; and  
c = number of samples the bacterial count of which may be between m 
and M, the sample shall still be considered acceptable if the bacterial 
count of the other samples is m or less.  
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  
(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 derived products 
used to enhance the palatability values of petfood.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 127
 
2. Flavouring innards must have been submitted to a treatment method and 
parameters, which ensure that the product complies with the microbiological 
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 not 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 transport 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 equidae for 
purposes other than in feed shall be subject to the following conditions:  
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 clinical 
signs of any of the compulsorily notifiable diseases listed in Annex I 
to Directive 2009/156/EC and of equine influenza, equine piroplas ­
mosis, equine rhinopneumonitis and equine viral arteritis listed in 
point 4 of Article 1.2.3. of the Terrestrial Animal Health Code of 
the OIE, 2010 edition;  
(ii) have been kept for a period of at least 30 days prior to the date of 
and during blood collection on holdings under veterinary supervision 
which were not subject to a prohibition order pursuant to Article 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 2009/156/EC 
had no contact with equidae from holdings which were subject to a 
prohibition order for animal health reasons pursuant to that Article 
and for a period of at least 40 days prior to the date of and during 
blood collection had no contact with equidae from a Member State 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 with 
Regulation (EC) No 853/2004; or  
(ii) in facilities approved, furnished with a veterinary approval number 
and supervised by the competent authority for the purpose of 
collecting blood from equidae for the production of blood products 
for purposes other than feeding.  
2. Blood products may be placed on the market for such purposes provided that:  
(a) all precautions have been taken to avoid contamination of the blood 
products with pathogenic agents during production, handling and pack ­
aging;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 128
 
(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 treatments, 
followed by an effectiveness check, for the inactivation of possible 
causative pathogens for African horse sickness, equine encephalo ­
myelitis of all types including Venezuelan equine encephalomyelitis, 
equine infectious anaemia, vesicular stomatitis and glanders ( Burk­
holderia mallei ): 
— heat treatment at a temperature of 65 °C for at least three hours,  
— 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 sealed imper ­
meable containers which, in the case of blood from equidae, bear the 
approval number of the slaughterhouse or facilities of collection 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 these 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 walls that are 
easy to clean and disinfect and, where appropriate, provided with refrig ­
eration facilities;  
(b) the storage rooms are kept in a satisfactory state of cleanliness and 
repair, so that they do not constitute a source of contamination for the 
raw materials;  
(c) if raw material not in conformity with this Chapter is stored and/or 
processed in these premises, it must be segregated from raw material 
in conformity with this Chapter throughout the period of receipt, 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 ensures that 
no risks to public and animal health remain before being used for 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 products  
1. Untreated hides and skins may be placed on the market subject to the 
health conditions applicable to fresh meat pursuant to Directive 
2002/99/EC.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 129
 
2. Treated hides and skins may be placed on the market, provided 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 VIII 
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 853/2004 for 
raw materials for gelatine or collagen intended for use in food may be 
placed on the market without restrictions in accordance with this Regu ­
lation.  
2. The following treated hides and skins may be placed on the market 
without restrictions in accordance with this Regulation:  
(a) hides and skins having undergone the complete process of tanning;  
(b) ‘wet blue’;  
(c) ‘pickled pelts’;  
(d) limed hides (treated with lime and in brine at a pH of 12 to 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 to 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 transforming 
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) No 338/97.  
B. Safe sourcing  
Game trophies and other preparations from animals, where for the prep ­
aration the animal by-products have been submitted to a treatment 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 biological 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 — 31.07.2019 — 015.001 — 130
 
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 treatment 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 complete 
taxidermy treatment ensuring their preservation at ambient tempera ­
tures;  
(b) are mounted ungulates or birds or mounted parts of such animals;  
▼M4 
(c) have been subject to an anatomical preparation such as by plasti ­
nation;  
(d) are animals of the biological class Insecta or Arachnida which have 
been subject to a treatment, such as drying, to prevent any trans ­
mission of diseases communicable to humans or animals; or  
(e) are objects in natural history collections or for the promotion of 
science and they have been:  
(i) preserved in media, such as alcohol or formaldehyde, which 
allow display of the items; or  
(ii) embedded completely on micro-slides;  
(f) are processed DNA samples intended for repositories for the 
promotion of biodiversity research, ecology, medical and veterinary 
science or biology.  
▼B 
2. Game trophies or other preparations, other than those referred to under 
points B and C.1, which come from animals originating in an area subject 
to restrictions as a result of the presence of serious transmissible 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 of 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 the 
competent authority, in particular with hydrogen peroxide 
where parts consisting of bone are concerned;  
(iii) they have been packaged, immediately after treatment, without 
being in contact with other products of animal origin likely to 
contaminate them, in individual, transparent and closed packages 
so as to avoid any subsequent contamination; and  
(iv) they are accompanied by a health certificate certifying that the 
conditions set out in (i), (ii) and (iii) have been met;  
(b) in case of game trophies or other preparations consisting solely of 
hides or skin,  
(i) they have been:  
— dried,  
— dry- or wet-salted for a period of at least 14 days before the 
date of dispatch, or  
— subject to a preservation process other than tanning;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 131
 
(ii) they have been packaged, immediately after treatment, without 
being in contact with other products of animal origin likely to 
contaminate them, in individual, transparent and closed packages 
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 untreated 
feathers, parts of feathers and down must be Category 3 materials 
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 and 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 spread of 
disease;  
(b) the transport takes place in waterproof containers and/or vehicles 
which must be cleaned and disinfected immediately after each use.  
▼M2 
2. Movements of pig bristles and wool and hair of animals of the porcine 
species from regions in which African swine fever is endemic shall 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 provision.  
3. The provisions of point 1 shall not apply to decorative feathers 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 this Regulation.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 132
 
Member States may authorise the placing on the market of untreated 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 Regulation on 
their territory without restrictions in accordance with this Regulation, if they 
are satisfied that no unacceptable risks to public and animal health arise from 
the wool and from the hair.  
▼M2 
Wool and hair produced from animals other than those of the porcine 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 immersion of the 
wool and hair in series of baths of water, soap and sodium hydroxide or 
potassium hydroxide; or  
(b) it is dispatched directly to a plant producing derived products from wool 
or hair for the textile industry and such wool or hair has undergone at 
least one of the following treatments:  
(i) chemical depilation by means of slaked lime or sodium sulphide;  
(ii) fumigation in formaldehyde in a hermetically sealed chamber for at 
least 24 hours;  
(iii) industrial scouring which consists of the immersion of wool 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-washed 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 for two days at a 
humidity of 55 % may be placed on the market without restrictions in accordance 
with this Regulation.  
CHAPTER IX  
Specific requirements for apiculture by-products  
Apiculture by-products intended exclusively for use in apiculture must:  
1. not come from an area which is subject of a prohibition order associated with 
an occurrence of:  
(a) American foulbrood ( Paenibacillus larvae larvae ), except where the 
competent authority has assessed the risk to be negligible, issued a 
specific authorisation for use only in that Member State, and taken 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 14(2) of 
Directive 92/65/EEC;  
(c) small hive beetle ( Aethina tumida ); or ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 133
 
(d) Tropilaelaps mite ( Tropilaelaps  spp.); and  
2. meet the requirements provided for in Article 8(a) of Directive 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 Category 2 material 
which are destined for oleochemical purposes must be produced using any of 
the processing methods 1 to 5 as set out in Chapter III of Annex 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 derivatives from rendered 
fats derived from Category 1 and Category 2 material:  
(a) transesterification or hydrolysis at least 200 °C, under corresponding 
appropriate pressure, for 20 minutes (glycerol, fatty acids and esters);  
(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 eight 
minutes; or  
(c) hydrogenation at 160 °C at 12 bars (12 000 hPa) for 20 minutes.  
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 products;  
(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 point 1 may be 
placed on the market for uses indicated in point 2 without restrictions 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 following conditions:  
(a) they must originate from animals that:  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 134
 
(i) either have been slaughtered in a slaughterhouse, after undergoing an 
ante-mortem inspection, and were found fit, as a result of such 
inspection, for slaughter for human consumption in accordance with 
Union legislation; or  
(ii) did not show clinical signs of any disease communicable through 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 cavity;  
(d) at any stage of processing, storage or transport, every precaution 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 to 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 registered 
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 accordance with this 
Regulation.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 135
 
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 Regulation (EC) 
No 1069/2009, the following requirements shall apply to imported 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 consignments of such 
materials and products in transit:  
(a) they must consist of or have been produced from, as applicable, 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 country listed in the 
column ‘third countries’ list’ of Table 1;  
(d) they must come from an establishment or plant which is registered or 
approved by the competent authority of the third country, as applicable, 
and which is on the list of such establishments and plants referred to in 
Article 30; and  
(e) they must be:  
(i) accompanied during transportation to the point of entry into the Union 
where the veterinary checks take place by the health certificate referred 
to in the column ‘certificates/model documents’ of Table 1; or  
(ii) presented at the point of entry into the Union where the veterinary 
checks take place accompanied by a document corresponding to the 
model referred to in the column ‘certificates/model documents’ of 
Table 1.  
__________  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 136
 02011R0142 — EN — 31.07.2019 — 015.001 — 137
 ▼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 — 31.07.2019 — 015.001 — 138
 ▼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 — 31.07.2019 — 015.001 — 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  
▼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 — 31.07.2019 — 015.001 — 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  
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 processed animal 
protein:  
1. Before consignments are released for free circulation within the Union, the 
competent authority must sample processed animal protein from imported 
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 packaged in the 
manufacturing plant of origin.  
2. By way of derogation from point 1, when six consecutive tests on bulk 
consignments originating in a given third country prove negative, the 
competent authority of the border inspection post may carry out random 
sampling of subsequent bulk consignments from that third country.  
If one of those random samples proves positive, the competent authority 
carrying out the sampling must inform the competent authority of the third 
country of origin so that it can take appropriate measures to remedy the 
situation.  
The competent authority of the third country of origin must bring these 
measures to the attention of the competent authority carrying out 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 consignment from 
the same source until six consecutive tests again prove negative.  
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 positive for 
salmonella or where it does not meet the microbiological standards 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 treatment auth ­
orised by the competent authority. The consignment must not be released 
until it has been treated, tested for salmonella or enterobacteriaceae, as 
necessary, by the competent authority in accordance with Chapter 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 — 31.07.2019 — 015.001 — 141
 
— 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 products 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 colostrum,  
— 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 than 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 rendered 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 swine 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 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 rinderpest for the 
previous 12 months; or  
(d) where there has been an outbreak of one of the diseases referred to in points 
(a), (b) and (c) during the relevant period referred to in those 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 operators 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, critical 
temperature and, as appropriate, the absolute time, pressure profile, raw 
material feed rate and fat recycling rate.  ▼M12  02011R0142 — EN — 31.07.2019 — 015.001 — 142
 
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 colostrum 
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, point 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-derived 
products may be imported from third countries so authorised in column 
‘A’ of Annex I to Regulation (EU) No 605/2010, provided that the milk, 
milk-based products or milk-derived products have undergone a single 
HTST treatment and:  
(a) have not been shipped before a period of at least 21 days has elapsed 
after production and during that period no case of foot-and-mouth 
disease has been detected in the exporting third country; or  
(b) have been presented at a border inspection post of entry into the 
Union at least 21 days after production and during that period no 
case of foot-and-mouth disease has been detected in the exporting 
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 and:  
(a) have not been shipped before a period of at least 21 days has elapsed 
after production and during that period no case of foot-and-mouth 
disease has been detected in the exporting third country; or  
(b) have been presented at a border inspection post of entry into the 
Union at least 21 days after production and during that period no 
case of foot-and-mouth disease has been detected in the exporting 
third country.  
2. The materials shall have been obtained from bovine animals subject to 
regular veterinary inspections to ensure that they come from holdings on 
which all bovine herds are:  
(a) either recognised as officially tuberculosis-free and officially 
brucellosis-free as defined in Article 2(2)(d) and (f) of Directive 
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 official 
system for the control of enzootic bovine leukosis and there has been 
no evidence as a result of clinical and laboratory testing of this 
disease in the herd during the past two years.  
3. After completion of the processing, every precaution shall have been 
taken to prevent contamination of the colostrum or colostrum products.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 143
 
4. The final product must bear a label so as to indicate that it 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 transport 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 blood products, 
including spray dried blood and blood plasma which have been derived from 
porcine animals intended for the feeding of porcine animals:  
These derived products must be:  
(a) subjected to a heat treatment at a temperature of at least 80 °C throughout the 
substance and the dry blood and blood plasma is of not more than 8 % 
moisture with a water activity (Aw) of less than 0,60;  
(b) stored in dry warehouse conditions under room temperature for 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 to imported 
consignments of animal by-products and derived products for uses 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-products 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 country listed in the 
column ‘third countries’ list’ of Table 2;  
(d) they must come from an establishment or plant which is registered or 
approved by the competent authority of the third country, as applicable, 
and which is on the list of such establishments and plants referred to in 
Article 30; and  
(e) they must be:  
(i) accompanied during transportation to the point of entry into the Union 
where the veterinary checks take place by the health certificate referred 
to in the column ‘certificates/model documents’ of Table 2; or  
(ii) presented at the point of entry into the Union where the veterinary 
checks take place accompanied by a document corresponding to the 
model referred to in the column ‘certificates/model documents’ of 
Table 2.  
__________  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 144
 02011R0142 — EN — 31.07.2019 — 015.001 — 145
 ▼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 — 31.07.2019 — 015.001 — 146
 ▼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 — 31.07.2019 — 015.001 — 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 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 — 31.07.2019 — 015.001 — 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  
(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 — 31.07.2019 — 015.001 — 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  
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 import ­
ation. 
(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 — 31.07.2019 — 015.001 — 150
 ▼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 — 31.07.2019 — 015.001 — 151
 ▼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 honey ­
comb: 
(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 import ­
ation.  (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 — 31.07.2019 — 015.001 — 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  
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.  
▼M10  
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:  (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 — 31.07.2019 — 015.001 — 153
 ▼M10  
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, and the following countries: 
(JP) Japan 
(EC) Ecuador 
(LK) Sri Lanka 
(TW) Taiwan. 
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 — 31.07.2019 — 015.001 — 154
 ▼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 — 31.07.2019 — 015.001 — 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  
(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 — 31.07.2019 — 015.001 — 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  
▼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 — 31.07.2019 — 015.001 — 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  
▼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 — 31.07.2019 — 015.001 — 158
 ▼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 — 31.07.2019 — 015.001 — 159
 ▼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 and 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 production of 
derived products for uses outside the feed chain for farmed animals which 
meets the specific conditions laid down in this Regulation or from the 
establishment of collection.  
▼M4 
2. The blood from which blood products for the manufacture of derived 
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 derived products for 
uses outside the feed chain for farmed animals which have been derived 
from animals belonging to the taxa Artiodactyla, Perissodactyla and Probos ­
cidea, 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 treatments 
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 effectiveness 
check;  
(iii) heat treatment of at least 80 °C throughout their substance, 
followed by an effectiveness check;  
(iv) in the case of animals other than Suidae and Tayassuidae only: 
change in pH to pH 5 for two hours, followed by an effectiveness 
check;  
(b) in the case of blood products not treated in accordance with 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 months 
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 — 31.07.2019 — 015.001 — 160
 
— 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 of 
destination and all precautions, including safe disposal of waste, 
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 must be 
complied with:  
(a) in the third country or region of origin no case of vesicular stomatitis 
and bluetongue (including the presence of seropositive animals) has 
been recorded for a period of at least 12 months and vaccination 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 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 plant of 
destination and all precautions, including safe disposal of waste, 
unused or surplus material, must be taken to avoid risks of spreading 
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 of swine 
vesicular disease, classical swine fever and African swine fever has been 
recorded for a period of at least 12 months, vaccination has not been carried 
out against those diseases for a period of at least 12 months and one of the 
following conditions are complied with:  
(a) in the country or region of origin no case of vesicular stomatitis 
(including the presence of seropositive animals) has been recorded 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 susceptible species;  
(b) 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 of destination and all precautions, including 
safe disposal of waste, unused or surplus material, must be taken 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 treatments 
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 — 31.07.2019 — 015.001 — 161
 
(ii) irradiation at 25 kGy by gamma rays, followed by an effectiveness 
check;  
(iii) heat treatment of at least 70 °C throughout their substance, 
followed by an effectiveness check;  
(b) in case of blood products not treated in accordance with point (a) the 
products must originate from a third country or region:  
(i) which has been free from Newcastle disease and highly pathogenic 
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 vaccination 
against avian influenza;  
(iii) where the poultry or other avian species from which the products 
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 and 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 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 equidae in facilities approved and furnished with a veterinary 
approval number and supervised by the competent authority of the 
country of collection for the purpose of collecting blood from equidae 
for the production of blood products for purposes other than feeding.  
▼B 
2. The blood products must comply with the conditions set out in 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 which 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 under veterinary 
supervision in the third country of collection which during that 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 least two years;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 162
 
(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), including 
a careful examination of mucous membranes from the trachea, 
larynx, nasal cavities and sinuses and their ramifications, after 
splitting the head in the median plane and excising the nasal septum;  
▼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 which has been 
approved or registered by the competent authority of the third country.  
4. Blood and blood products shall be packed and labelled in accordance 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 and 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 applicable 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 been 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 at 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 country of 
origin for a period of at least three months before being slaughtered 
or since birth in the case of animals less that three months old;  
(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 mouth 
disease in the previous 30 days, and around which within a radius of 
10 km there has been no case of foot-and-mouth disease for 30 days;  
(iii) in the case of hides and skins from swine, animals that come from 
holdings in which there has been no outbreak of swine vesicular 
disease in the previous 30 days, or of classical or African swine 
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 — 31.07.2019 — 015.001 — 163
 
(iv) animals that have passed the ante-mortem health inspection at the 
slaughterhouse during the 24 hours before slaughter and have shown 
no evidence of foot-and-mouth disease, rinderpest, classical swine 
fever, African swine fever or swine vesicular disease; and  
(c) they have undergone all precautions to avoid recontamination 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 accordance 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 row 5 of 
Table 2 set out in Section 1 from which imports of fresh meat of 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 appearing 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 in point 
28(a), (b) and (c) of Annex I and after treatment have been kept 
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 have 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 dispatch.  
Section 5  
Imports of game trophies and other preparations from animals  
The following requirements shall apply to the import of game trophies and other 
preparations from animals:  
1. Game trophies or other preparations from animals which fulfil 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 ungulates, being 
solely comprised of bones, horns, hooves, claws, antlers, teeth, hides or skins, 
from third countries may be imported if they comply with the requirements 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 — 31.07.2019 — 015.001 — 164
 
However, in the case of dry-salted or wet-salted skins transported 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 to restrictions 
as a result of the presence of serious transmissible diseases to which 
animals of the species concerned are susceptible;  
(b) they were packaged without being in contact with other products of 
animal origin likely to contaminate them, in individual, transparent 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 carried by travellers for 
their private use or consignments of treated feathers or down sent to private 
individuals for non-industrial purposes; or  
(b) if they are accompanied by a commercial document stating that the feathers 
and parts of feathers or down have been treated with a steam current or by 
another method that ensures that no unacceptable risks remain and are 
securely enclosed in packaging and dry; and  
(c) unless the commercial document states that they have been factory-washed 
and treated with hot steam at 100 °C for at least 30 minutes, they 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 horn products 
(excluding horn meal) and hooves and hoof products (excluding hoof meal) 
may be imported to produce derived products for uses outside the feed chain 
if: 
(a) the products are dried before export to the Union and not chilled 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 transhipped 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 — 31.07.2019 — 015.001 — 165
 
2. Each consignment must be accompanied by a commercial document stamped 
by the competent authority supervising the establishment of origin, 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/dried horns/ ­
dried horn products/dried hooves/dried hoof products), and  
(d) confirmation of the fact that the product was:  
(i) derived from healthy animals slaughtered in a slaughterhouse;  
(ii) dried for a period of 42 days at an average temperature of at least 
20 °C;  
(iii) heated for one hour to at least 80 °C to the core before drying;  
(iv) ashed for one hour to at least 800 °C to the core before drying;  
(v) underwent an acidification process such that the pH was maintained 
at less than 6 to the core for at least one hour before drying, and  
is not intended at any stage to be diverted for any use in food, feed 
material, organic fertilisers or soil improvers.  
3. On dispatch to the Union, the material must be enclosed in sealed 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 registered 
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 that Directive, 
the material must be transported directly to the registered establishment 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 uses 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 way to 
prevent spoiling between dispatch and delivery to the establishment or 
plant of destination;  
2. the animal by-products have undergone all precautions to avoid contami ­
nation with pathogenic agents;  
3. the animal by-products were packed in new packaging preventing any 
leakage or in packaging which has been cleaned and disinfected before use;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 166
 
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 that Directive, 
the animal by-products are transported directly either to:  
(a) a petfood plant or to a registered establishment or plant of destination, 
which has provided a guarantee that the animal by-products shall be 
used only for the purpose of producing the products for which it has 
been registered or approved, as applicable, as specified by the 
competent authority if necessary, and shall not leave the establishment 
or plant untreated other than for direct disposal;  
(b) an establishment or plant which has been approved in accordance 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 purposes, as 
specified by the competent authority if necessary; or  
(d) an establishment or plant which has been approved in accordance with 
Article 24(1)(a) of Regulation (EC) No 1069/2009; and  
5.1. in the case of raw material for petfood production referred to in 
Article 35(a)(ii) of Regulation (EC) No 1069/2009, the raw material 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 each frozen 
block, or, when the raw material is transported in pallets which are not 
divided into separate consignments during transport to the petfood plant 
of destination, on each outer side of each pallet, in such a way 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 the third 
country before entry into the Union by spraying it with liquefied 
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 approved in 
accordance with Article 24(1)(h) of Regulation (EC) No 1069/2009, 
in accordance with point 4(b) of this Section and from there directly 
to the petfood plant referred to under (i), provided that the plant of 
destination:  
— only handles material covered by this point 5.1, or  
— only handles material destined for a petfood plant as referred 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 prior to 
use of the material for the manufacture of petfood, in accordance with 
the conditions applicable to petfood produced from Category 3 material 
set out in Chapter II of Annex XIII;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 167
 
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 marked 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 of destination;  
6. In the petfood plant of destination, raw material for petfood production 
referred to in Article 35(a)(ii) of Regulation (EC) No 1069/2009 shall be 
stored before production, used and disposed of under conditions authorised 
by the competent authority, which allow official controls on the amounts of 
material received, used for production and disposed of, if applicable.  
The competent authority may authorise the operator of the petfood 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 medical devices, 
may be imported, provided:  
(a) they are derived from:  
▼M4 
(i) in the case of materials destined for the production of biodiesel or 
oleochemical products, 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 organic 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 Category 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 renewable fuels 
referred to in point J of Section 2 of Chapter IV of Annex IV of 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 referred 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 of that 
Regulation;  
▼B 
(b) they have been processed by processing method 1 (pressure sterilisation) 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 impurities in excess of 
0,15 % by weight have been removed;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 168
 
(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 97/78/EC, and in 
accordance with the conditions laid down in Article 8(4) of that Directive, 
the rendered fats are transported directly to the registered establishment or 
plant of destination, under conditions which prevent contamination; 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 accompanying 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 material, that the 
products:  
(i) have been produced using a method that at least meets the standards 
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 cosmetics, 
pharmaceuticals and medical devices;  
(c) in the case of fat derivatives produced from Category 1 material, that the 
products must not be used in organic fertilisers and soil improvers, 
cosmetics, pharmaceuticals and medical devices; however, they may be 
used for other purposes outside the feed chain for farmed animals.  
2. The health certificate referred to in point 1 must be presented 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 accompany 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 that Directive, 
the fat derivatives shall be transported directly to the registered establishment 
or plant of destination.  
Section 11  
Imports of photogelatine  
1. Gelatine which has been produced from material containing bovine vertebral 
column comprising of Category 1 material in accordance with Article 8(b) of 
Regulation (EC) No 1069/2009 and which is intended for the photographic 
industry (photogelatine) may be imported, provided the photogelatine:  
(a) originates from one of the plants of origin indicated in Table 3;  
(b) has been produced in accordance with point 6;  
(c) is imported through one of the border inspection posts of first entry into 
the Union indicated in Table 3; and  
(d) is destined for production in an approved photographic factory indicated 
in Table 3.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 169
 
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 — 31.07.2019 — 015.001 — 170
 
2. Once the photogelatine has entered the Member State of destination, it shall 
not be traded between Member States but shall only be used in the approved 
photographic factory in the same Member State of destination and 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 that 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 from any 
products intended for food or feed.  
5. In the approved photographic factory of destination, the operator 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 disposal only’ in 
vehicles under satisfactory hygiene conditions;  
(b) disposed of in accordance with Article 12(a)(i) of Regulation (EC) 
No 1069/2009 or exported to the third country of origin in accordance 
with Regulation (EC) No 1013/2006.  
6. Photogelatine shall be produced according to the following requirements:  
(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 that raw 
material is treated by processing method 1 (pressure sterilisation) as 
referred to in Chapter III of Annex IV or subjected to a treatment with 
acid or alkali for a period of at least two days, washing with water, and:  
(i) following an acid treatment, treating with alkaline solution for a 
period of at least 20 days; or  
(ii) following an acid treatment, treating with an acid solution 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 point (b), the 
photogelatine may undergo a drying process and, where appropriate, a 
process of pulverisation or lamination.  
(d) The photogelatine shall be wrapped, packaged in new packages, 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 thoroughly 
cleaned and inspected before reuse.  
(e) Wrapping and packages containing the photogelatine must carry the 
words ‘photogelatine for the photographic industry only’.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 171
 
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 hoof products, 
excluding hoof meal, intended for the production of organic fertilizers or soil 
improvers, may be imported, provided that:  
1. they have been produced in accordance with Chapter XII of Annex XIII; and  
2. they are conveyed 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, directly to an approved or registered establishment 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 derived 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 produced in and 
dispatched from third countries or parts of third countries, from which 
Member States authorise imports of fresh meat of domestic bovine 
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-based 
products or milk-derived products, authorised third countries listed 
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 — 31.07.2019 — 015.001 — 172
 
(c) 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, they are transported directly to the approved or registered 
establishment or plant indicated in the authorisation of competent auth ­
ority.  
2. Unless the trade samples are kept for reference purposes, they 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 testing shall be carried 
out: 
(a) with dedicated equipment; or  
(b) with equipment which is cleaned and disinfected before it is 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 accordance with the 
following conditions:  
(a) they originate from third countries referred to in the column ‘third coun ­
tries’ list’ of row 14 of Table 2 of Section 1 of Chapter II;  
(b) their introduction has been authorised in advance by the competent 
authority of the Member State where the display item is intended to 
be used;  
(c) following the veterinary checks provided for in Directive 97/78/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 origin;  
(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 — 31.07.2019 — 015.001 — 173
 
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 such 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, other 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 following materials 
for purposes other than feeding to farmed land animals, except for feeding to 
fur animals, provided there is no unacceptable risk for the transmission of 
diseases communicable to humans or animals:  
(a) animal by-products from aquatic animals and derived products from 
aquatic animals;  
(b) aquatic invertebrates and derived products from aquatic invertebrates;  
(c) terrestrial invertebrates, including any of their transformation 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 point 1 shall take place 
in accordance with sanitary certification requirements in accordance with 
national rules.  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 174
 
CHAPTER V  
RULES FOR THE EXPORT OF CERTAIN DERIVED PRODUCTS  
Rules applicable to the export of the derived products listed below as referred to 
in Article 25(4):  
Derived products  Rules for export  
1 Processed manure and organic 
fertilizers, compost or digestion 
residues from biogas trans ­
formation containing no other 
animal by-products or derived 
products than processed manure  Processed manure and organic 
fertilizers, compost or digestion 
residues from biogas trans ­
formation containing no other 
animal by-products or derived 
products than processed manure 
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.  ▼M10  02011R0142 — EN — 31.07.2019 — 015.001 — 175
 
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-products 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 
additional 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 — 31.07.2019 — 015.001 — 176
 
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
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▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 178
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 179
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 180
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 181
 
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▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 183
 
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 — 31.07.2019 — 015.001 — 184
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 185
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 186
 
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▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 188
 
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▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 190
 
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 — 31.07.2019 — 015.001 — 191
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 192
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 193
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 194
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 195
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 196
 
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 — 31.07.2019 — 015.001 — 197
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 198
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 199
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 200
 
CHAPTER 3(A)  
Health certificate  
For canned petfood intended for dispatch to or for transit through  ( 2 ) the 
European Union
  ▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 201
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 202
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 203
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 204
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 205
 
(CHAPTER 3(B)  
Health certificate  
For processed petfood other than canned petfood, intended for dispatch to or for 
transit through  ( 2 ) the European Union
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▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 207
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 208
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 209
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 210
 
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▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 212
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 213
 
CHAPTER 3(C)  
Health certificate  
For dogchews intended for dispatch to or for transit through  ( 2 ) the European 
Union
  ▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 214
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 215
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 216
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 217
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 218
 
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 — 31.07.2019 — 015.001 — 219
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 220
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 221
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 222
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 223
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 224
 
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 — 31.07.2019 — 015.001 — 225
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 226
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 227
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 228
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 229
 
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 — 31.07.2019 — 015.001 — 230
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 231
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 232
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 233
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 234
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 235
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 236
 
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 — 31.07.2019 — 015.001 — 237
 
▼M4 02011R0142 — EN — 31.07.2019 — 015.001 — 238
 
▼M4 02011R0142 — EN — 31.07.2019 — 015.001 — 239
 
▼M4 02011R0142 — EN — 31.07.2019 — 015.001 — 240
 
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 — 31.07.2019 — 015.001 — 241
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 242
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 243
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 244
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 245
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 246
 
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 — 31.07.2019 — 015.001 — 247
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 248
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 249
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 250
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 251
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 252
 
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 — 31.07.2019 — 015.001 — 253
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 254
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 255
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 256
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 257
 
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 — 31.07.2019 — 015.001 — 258
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 259
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 260
 
CHAPTER 5(B)  
Health certificate  
For treated hides and skins of ungulates, intended for dispatch to or for transit 
through  ( 2 ) the European Union
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▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 262
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 263
 
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 — 31.07.2019 — 015.001 — 264
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 265
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 266
 
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 — 31.07.2019 — 015.001 — 267
 
▼M4 02011R0142 — EN — 31.07.2019 — 015.001 — 268
 
▼M4 02011R0142 — EN — 31.07.2019 — 015.001 — 269
 
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 — 31.07.2019 — 015.001 — 270
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 271
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 272
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 273
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 274
 
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 — 31.07.2019 — 015.001 — 275
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 276
 
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 — 31.07.2019 — 015.001 — 277
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 278
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 279
 
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 — 31.07.2019 — 015.001 — 280
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 281
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 282
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 283
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 284
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 285
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 286
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 287
 
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 — 31.07.2019 — 015.001 — 288
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 289
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 290
 
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 — 31.07.2019 — 015.001 — 291
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 292
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 293
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 294
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 295
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 296
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 297
 
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 — 31.07.2019 — 015.001 — 298
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 299
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 300
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 301
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 302
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 303
 
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 — 31.07.2019 — 015.001 — 304
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 305
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 306
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 307
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 308
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 309
 
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 — 31.07.2019 — 015.001 — 310
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 311
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 312
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 313
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 314
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 315
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 316
 
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 — 31.07.2019 — 015.001 — 317
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 318
 
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 — 31.07.2019 — 015.001 — 319
 
▼M4 02011R0142 — EN — 31.07.2019 — 015.001 — 320
 
▼M4 02011R0142 — EN — 31.07.2019 — 015.001 — 321
 
▼M4 02011R0142 — EN — 31.07.2019 — 015.001 — 322
 
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 — 31.07.2019 — 015.001 — 323
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 324
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 325
 
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 — 31.07.2019 — 015.001 — 326
 
▼M4 02011R0142 — EN — 31.07.2019 — 015.001 — 327
 
▼M4 02011R0142 — EN — 31.07.2019 — 015.001 — 328
 
CHAPTER 16  
Model declaration
  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 329
 
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 — 31.07.2019 — 015.001 — 330
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 331
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 332
 
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 — 31.07.2019 — 015.001 — 333
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 334
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 335
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 336
 
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
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▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 338
 
▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 339
 
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
  ▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 340
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 341
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 342
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 343
 
▼M15  02011R0142 — EN — 31.07.2019 — 015.001 — 344
 
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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▼M2 02011R0142 — EN — 31.07.2019 — 015.001 — 346
 
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 1069/2009 and 
with this Regulation.  
It shall, in particular:  
(a) check:  
(i) the general conditions of hygiene of the premises, equipment 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 procedure 
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 necessary, 
the taking of samples;  
(iv) the standards of the products after processing; the analyses and tests 
must be carried out in accordance with scientifically recognised 
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 compliance 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 the processing 
plant and to records, commercial documents and health certificates.  
Section 2  
Validation procedures  
1. Prior to issuing an approval for a processing plant, as provided for in 
Article 44(1) of Regulation (EC) No 1069/2009, the competent authority 
must check that a validation of the processing plant has been carried 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) including the material 
process rate for continuous systems;  
(c) the compliance with the specific process requirements laid down by this 
Regulation; and  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 347
 
(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 thermocouple and it 
must be plotted against real time;  
(b) the pressure stage must be monitored with a permanent pressure gauge; 
pressure must be plotted against real time;  
(c) the processing time must be shown by time/temperature and time/ ­
pressure diagrams.  
At least once a year the thermocouple and the pressure gauge must be 
calibrated.  
3. In the case of a continuous pressure system:  
(a) the temperature and the pressure must be monitored with thermocouples, 
or an infrared temperature gun, and pressure gauges must be used at 
defined positions throughout the process system in such a way that 
temperature and pressure comply with the required conditions inside 
the whole continuous system or in a section of it; the temperature and 
pressure must be plotted against real time;  
(b) measurement of the minimum transit time inside the whole relevant part 
of the continuous system where the temperature and pressure comply 
with the required conditions, must be provided to the competent auth ­
orities, using insoluble markers, such as manganese dioxide, or a method 
which offers equivalent guarantees.  
Accurate measurement and control of the material process rate is 
essential and must be measured during the validation test in relation 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 least once 
a year.  
4. The competent authority must repeat the checks on the validation procedures 
when it considers it necessary, and in any case each time any significant 
alterations are made to the process, such as modifications of the 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, plants and 
operators  
In order to assist Member States in making up-to-date lists of registered and 
approved establishments, plants and operators available to other Member 
States and to the public, the Commission shall provide a website which 
shall contain links to the national websites provided by each Member 
State, as referred to in point 2(a).  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 348
 
2. Format for national websites  
(a) Each Member State shall provide the Commission with a linking address 
to a single national website containing the master list of all registered 
and approved establishments, plants and operators on its territory 
(‘master list’).  
(b) Each master list shall consist of one sheet and shall be completed 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 Annex VIII to this 
Regulation to ascertain compliance with this Regulation and may, where 
necessary, request the testing of additional samples in accordance 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 incineration plant for incin ­
eration of specified risk materials before approval, and at least once a year to 
monitor compliance with Regulation (EC) No 1069/2009 and with this Regu ­
lation.  
Section 3  
Official controls in remote areas  
In the case of disposal of animal by-products in remote areas in 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 ensure 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 of 
Annex IV and which are derived from the bodies or parts of bodies of 
animals of the same species;  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 349
 
(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; and  
(ii) appropriate TSE surveillance involving regular sampling and 
laboratory examination for TSEs.  
2. The samples referred to in point 1(b)(ii) shall include samples taken from 
animals showing neurological symptoms and from older breeding animals.  
Section 5  
Official controls regarding collection centres  
1. The competent authority shall:  
(a) include collection centres into the list drawn up in accordance 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 Regulation (EC) 
No 1069/2009.  
2. The competent authority shall carry out official controls at collection centres 
in order to verify compliance with this Regulation.  
▼M4 
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 Sections 2, 3 and 4 of 
Chapter II of Annex VI and shall carry out appropriate TSE surveillance 
involving regular sampling and laboratory examination for TSEs.  
Those samples shall include samples taken from suspected animals 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 entire chain of 
production and use of organic fertilisers and soil improvers subject to the 
restrictions referred to in Chapter II of Annex II.  
Those controls shall include checks on the mixing with a component referred to 
in point 2 of Section 1 of Chapter II of Annex XI, and checks on the stocks of 
such products kept on farm and the records kept in accordance with 
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 approved 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 posts 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 — 31.07.2019 — 015.001 — 350
 
Section 9  
Official controls regarding certain imported rendered fats  
The competent authority shall carry out documentary checks in registered estab ­
lishments or plants receiving rendered fats which have been imported in 
accordance with Section 9 of Chapter II of Annex XIV on the channelling 
chain from the border inspection posts of first entry to the registered estab ­
lishment or plant for the purpose of reconciliation of the quantities of products 
imported, used and disposed of.  
▼M16  
Section 10  
Standard format for applications for certain authorisations in intra-Union 
trade  
Operators shall inform the competent authority of the Member State of origin and 
apply to the competent authority of the Member State of destination 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, and fish oil or 
fishmeal of Category 3 materials intended for detoxification in accordance with 
the following format in TRACES:  ▼B 02011R0142 — EN — 31.07.2019 — 015.001 — 351
 
▼M16  02011R0142 — EN — 31.07.2019 — 015.001 — 352
 
▼M16  02011R0142 — EN — 31.07.2019 — 015.001 — 353
 
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 of Section 2 of 
Chapter V of Annex IX.  
Such controls shall, for the purpose of reconciliation of the quantities of 
hydrolysed materials dispatched and disposed of, include documentary checks:  
(a) of the amount of materials which are hydrolysed at the site;  
(b) in the establishments or plants where the hydrolysed materials 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 control visit to a site, 
where a container for the hydrolysis is located, shall be carried out every time 
hydrolysed material is collected from the container.  
Following the period of the first 12 months of operation, a control 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.  
▼M14  
Section 12  
Official controls regarding plants approved for the combustion of animal 
by-products  
The competent authority shall carry out documentary checks in accordance 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 — 31.07.2019 — 015.001 — 354