02011R0142 — EN — 30.06.2020 — 019.002


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

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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 054 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

►M18

COMMISSION DELEGATED REGULATION (EU) 2019/2122 of 10 October 2019

  L 321

45

12.12.2019

►M19

COMMISSION DELEGATED REGULATION (EU) 2019/2124 of 10 October 2019

  L 321

73

12.12.2019

►M20

COMMISSION IMPLEMENTING REGULATION (EU) 2020/207 of 14 February 2020

  L 43

69

17.2.2020

►M21

COMMISSION REGULATION (EU) 2020/735 of 2 June 2020

  L 172

3

3.6.2020

►M22

COMMISSION REGULATION (EU) 2020/757 of 8 June 2020

  L 179

5

9.6.2020

►M23

COMMISSION REGULATION (EU) 2020/762 of 9 June 2020

  L 182

3

10.6.2020

►M24

COMMISSION REGULATION (EU) 2020/797 of 17 June 2020

  L 194

1

18.6.2020


Corrected by:

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Corrigendum, OJ L 226, 24.8.2013, p.  44 (294/2013)




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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;

(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;

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(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;

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(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;

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(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.

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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 fertilisers or soil improvers have been applied, as set out in Chapter II of Annex II.

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Article 6

Disposal by incineration, disposal or recovery by co-incineration and use as a fuel for combustion

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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-incineration 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.

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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 Regulation (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.

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8.  For the use of manure of farmed animals or meat-and-bone meal 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 Regulation (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 or meat-and-bone meal is used as a fuel meets the requirements laid down in points B(3) for manure, and (D) in case of meat-and-bone meal as well as the requirements set out for both fuels in points B(4) and B(5) of Chapter V of Annex III to this Regulation, without prejudice to the possibility for the competent authorities of the Member State 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) for manure, and (D) for meat-and-bone meal and, where applicable, with point C(4) or point D(5) of Chapter V of Annex III to this Regulation, full approval can be granted.

(c) 

the combustion of meat-and-bone meal in combustion plants referred to in points A, B and C of Chapter V of Annex III to this Regulation shall not be authorised.

▼B

Article 7

Landfilling of certain Category 1 and 3 materials

By way of derogation from Article 12 and Article 14(c) of 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 Regulation (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.

Article 8

Requirements for processing plants and other establishments

1.  Operators shall ensure that processing plants and other establishments 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.

3.  The competent authority may authorise the use of alternative transformation 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 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 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.

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;

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(e) 

maggots and worms for fishing bait;

(f) 

circus animals.

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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;

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(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 necrophagous 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) 

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

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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:

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(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.

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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 applications for authorisation of alternative methods of use or disposal of animal by-products.

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 identification 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 establishment 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) 

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 transformation or composting in another establishment or plant in accordance with Annex V hereto;

(x) 

sieving;

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(xi) 

phase transition processes of Category 3 materials, such as:

— 
blood thermocoagulation,
— 
blood centrifugation,
— 
containment as set out in Chapter V to Annex IX hereto,
— 
hydrolysing of hooves, pig bristles, feathers and hair

destined for processing with processing methods set out in this Regulation;

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(c) 

Chapter III, where they store derived products for certain intended purposes as referred to in Article 24(1)(j) of that Regulation;

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(d) 

Chapter V, where they store on the farm animal by-products as referred to in point (h) or (i) of Article 24(1) of that Regulation, provided that unprocessed animal by-products are subsequently disposed of as referred to in Article 4 of that Regulation;

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(e) 

Where the operations referred to in points (i) to (vii) and (xi) of point (b) take place on the site of the approved establishment or plant referred to in Article 26(1) of Regulation (EC) No 1069/2009 generating those materials, the competent authority may authorise the operation without registration in accordance with Article 23 or approval in accordance with Article 24(1)(h) of that Regulation, provided that the animal by-products are stored, transported and disposed of or used as unprocessed animal by-products in accordance with Regulation (EC) No 1069/2009.

▼B

Article 20

Requirements concerning certain registered establishments and plants handling animal by-products and derived products

1.  Operators of registered plants or establishments or other 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.

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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) 

operators handling or disposing research and diagnostic samples for educational purposes;

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(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;

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(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;

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(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.

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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;

(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.

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3.  The transport of fish oils and fishmeal of Category 3 materials for the production of feed material, other than those imported from a third country, from an approved processing plant for the production of fishmeal and fish oil to a feed plant registered or approved in accordance with Regulation (EC) No 1069/2009 and approved in accordance with Article 10(3) of Regulation (EC) No 183/2005 in another Member State for detoxification in accordance with the processes referred to in Commission Regulation (EU) 2015/786 ( 2 ) shall be carried out in accordance with the rules set out in Chapter VII of Annex VIII.

▼B

Article 22

Placing on the market and use of organic fertilisers and soil improvers

1.  Operators shall comply with the requirements for the placing on the market, other than the import, of organic fertilisers and 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.

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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.

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 establishment 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 purification 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.

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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.



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.

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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 guarantees A and F mentioned therein,
— 
free of foot-and-mouth disease, and, in the case of wool and hair from sheep and goats, of sheep pox and goat pox in accordance with the basic general criteria listed in Annex II to Directive 2004/68/EC;
(ii) 

it is accompanied by a importers' declaration as required in accordance with Chapter 21 of Annex XV;

(iii) 

it was presented by the operator to one of the approved Union border inspection posts listed in Annex I to Decision 2009/821/EC where it passed with satisfactory result the documentary 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;

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(c) 

the specific requirements for animal by-products and derived products originating from, and returning to, the Union following a refusal of entry by a third country, set out in Chapter VI of that Annex.

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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;
— 
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 certification requirements laid down in national legislation;

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(e) 

the materials originating from a Member State and returning to that Member State following a refusal of entry by a third country, must comply with the specific requirements set out in Chapter VI of Annex XIV.

▼B

Article 27

Importation and transit of research and diagnostic samples

1.  The competent authority may authorise the importation and 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 destination; and

(b) 

the consignment must be sent directly from the point of entry into the Union to the authorised user.

▼M18 —————

▼B

3.  Operators handling research samples or diagnostic samples shall comply with the special requirements for disposal of research and diagnostic samples set out in Section 1 of Chapter III of Annex XIV hereto.

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.

▼M19 —————

▼M5

Article 29a

Specific requirements for transit through Croatia of animal by-products coming from Bosnia and Herzegovina and destined to third countries

1.  The movements of consignments of animal by-products and derived products coming from Bosnia and Herzegovina and 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.

▼M19 —————

▼B

Article 30

Lists of establishments and plants in third countries

Lists of establishments and plants in third countries shall be entered into the TRACES system in accordance with technical specifications which are published by the Commission on its website.

Each list shall be kept up to date regularly.

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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.

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By way of derogation from the first paragraph, animal by-products and derived products originating from, and returning to, the Union following a refusal of entry by a third country, must comply with the specific requirements set out in Chapter VI of Annex XIV.

▼B



CHAPTER IX

OFFICIAL CONTROLS

Article 32

Official controls

1.  The competent authority shall take the necessary measures to control the entire chain of collection, transport, use and 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.

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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.

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.

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 certificates, 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.




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;

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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 ( 3 ), 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;

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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 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;

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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 originating in restaurants, catering facilities and kitchens, including central kitchens and household kitchens;

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23. 

digestion residues’ means residues, including the liquid fraction, resulting from the transformation of animal by-products in a biogas plant;

▼B

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;

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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;

(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;

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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 sufficiently 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 diagnostic 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;

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 abnormality 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;

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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;

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;

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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;

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59. 

growing media’ means materials, including potting soil, other than soil in situ, in which plants or mushrooms are grown and which is used independently from soil in situ;

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60. 

process hygiene criterion’ means a criterion indicating the acceptable functioning of the production process. Such a criterion is not applicable to products placed on the market. It sets an indicative contamination value above which corrective actions are required in order to maintain the hygiene of the process in compliance with general requirements for the safety of feed.

▼B




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:

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(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 spongiform 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) 

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.




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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;

(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 1 100 °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 legislation 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.

Section 5

Abnormal operating

In the case of a breakdown, or abnormal operating conditions of an incineration plant or a co-incineration plant, the operator shall reduce or close down operations as soon as practicable until normal operations can 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 1 100 °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 1 100 °C, as applicable, is maintained at all times during these operations and as long as unburned material is in the chamber where the incineration or co-incineration is carried out.

(b) 

When animal by-products or derived products are introduced into the chamber where the incineration or co-incineration is carried 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 1 100 °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.

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:

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(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.

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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 subparagraph, 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.

(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 documented 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 effectively cleaned and disinfected before such use;

(c) 

personnel working in the combustion plant must change their outer clothing and footwear and take personal hygiene measures before handling animals on this or any other holding or their feed or bedding material.

5. The animal by-products and derived products that are 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.

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 representative 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.

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 authorised 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;

(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 contamination 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.

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/Nm3 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/Nm3

Sulphur dioxide

50

Nitrogen oxides (as NO2)

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 subparagraph, other procedures, verified and approved by the competent authority, may be used to determine the emissions of sulphur dioxide.

Monitoring shall be carried out by or on behalf of the operator in accordance with CEN standards. Where CEN standards are not available, ISO, national or other international standards which ensure the provision of data of an equivalent scientific quality shall apply.

(c) 

All results shall be recorded, processed and presented in 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.

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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/m3, 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.

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D.    Combustion plants in which meat-and-bone meal 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:

Meat-and-bone meal of Category 1 and Category 2 materials, to be used as a fuel for combustion in accordance with the requirements set out in point 3 alone or in a mixture of meat-and-bone meal, rendered fat and manure.

3. 

Specific requirements for meat-and-bone meal used as a fuel for combustion:

(a) 

meat-and-bone meal shall be stored in the combustion plant securely in a closed storage protected from access of animals and shall not be sent to another destination unless authorised by the competent authority in case of break down or abnormal operating conditions;

(b) 

the combustion plant must be equipped with:

(i) 

an automatic or continuous fuel management system to place the fuel directly in the combustion chamber without further 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.

4. 

Methodology:

Combustion plants in which meat-and-bone meal of Category 1 or Category 2 materials is used as a fuel shall comply with the general requirements set out in Chapter IV and the specific requirements set out in points B(4) and B(5) of this Chapter.

5. 

Derogation and transitional period:

The Member State competent authority responsible for environmental issues may by way of derogation from point 3(b)(ii), grant combustion plants operating on 3 June 2020 an additional time period of maximum 4 years to comply with the second subparagraph of point 2 of Section 2 of Chapter IV.

▼B




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 slaughterhouses 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 slaughterhouse 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) 

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.

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.

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 installation 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 calibration 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.

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.

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.

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) 

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.

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

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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;

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(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.

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) 

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

(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 (H2SO4) 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 hydrocarbons 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 afterburner chamber where they must be burned in the flame of a natural gas fired burner in the presence of excess air;

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(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 850 °C under all conditions of combustion;

▼B

(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;

(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 1 100 °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 legislation 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;

(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.

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▼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 ( 4 ) 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 ( 5 ).

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.

(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 sterilisation);

(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.

(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.

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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 transported 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.

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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;

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(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:

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(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;

(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);

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(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 ( 6 );
(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;

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(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;

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(d) 

the lime-treated mixture of pig and poultry manure may be applied to land as processed manure;

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(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;

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(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.

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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.

▼B




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;

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(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 authority:

(i) 

the animal by-products referred to in Article 10(f) of Regulation (EC) No 1069/2009, which have undergone processing as defined in Article 2(1)(m) of Regulation (EC) No 852/2004 at the time when they are destined for purposes other than human consumption;

(ii) 

the animal by-products referred to in Article 10(g) of Regulation (EC) No 1069/2009; or

(iii) 

animal by-products which are transformed into biogas, where the digestion residues are subsequently composted or processed or disposed of in accordance with this Regulation.

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 appropriate, 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.

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 transmissible disease to humans or animals.

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.

(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 monitoring 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 maintained 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;

(viii) 

eggs;

(ix) 

egg products;

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(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;

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(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;

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(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;

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.

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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.

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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




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 ( 7 ) 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.

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

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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.

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:

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(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

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

(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 Regulation.
(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 explanation 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.

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.

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 authorisations 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

(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;

(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 establishment 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.

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▼B




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

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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 Regulation 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.

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.

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.

▼B




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.

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 maintenance 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;

(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’;

(vi) 

in the case of collagen produced from Category 3 material, ‘collagen suitable for animal consumption’;

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(vii) 

in the case of raw petfood, ‘Use as petfood only. Keep apart from food. Wash hands and clean tools, utensils and surfaces after handling this product’;

▼B

(viii) 

in the case of fish and derived products from fish 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);

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(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);

(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);

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(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’;

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(xxi) 

in the case of materials for detoxification referred to in Chapter VII of Annex VIII, the words: ‘materials intended for detoxification. Not fit for the placing on the market’;

▼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 application 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.

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 transported 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.

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 integrated 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;

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(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 applicable, in accordance with Regulations (EC) No 852/2004 ( 8 ), (EC) No 853/2004 ( 9 ) or (EC) No 183/2005 of the European Parliament and of the Council ( 10 ), and the nature and the method of the treatment, as applicable;

(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 identification number (‘BIC code’) issued in accordance with the requirements of the Bureau International des Containers et du Transport Intermodal ( 11 );

(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 ( 12 ) of exit.

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(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.

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(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.

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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