02011R0142 — EN — 02.08.2017 — 012.001

This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B COMMISSION REGULATION (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (Text with EEA relevance) (OJ L 054 26.2.2011, p. 1)

Amended by:





Corrected by:









▼B

COMMISSION REGULATION (EU) No 142/2011

of 25 February 2011

implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive

(Text with EEA relevance)







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;

▼M1

(g) fur which fulfils the special requirements for the end point for that product set out in Chapter VIII of Annex XIII;

(h) fish oil for the production of medicinal products which fulfils the special requirements for the end point for that product set out in Chapter XIII of Annex XIII;

▼M4

(i) gasoline and fuels which fulfil the specific requirements for products from the multi-step catalytic process for the production of renewable fuels set out in point 2(c) of Section 3 of Chapter IV of Annex IV;

(j) oleochemical products derived from rendered fats and which fulfil the requirements set out in Chapter XI of Annex XIII;

▼M13

(k) renewable diesel, renewable jet fuel, renewable propane and renewable gasoline which fulfil the specific requirements for products from the multi-step catalytic hydro-treatment for the production of renewable fuels set out in point 2(f) of Section 3 of Chapter IV of Annex IV.

▼B

Article 4

Serious transmissible diseases

The diseases listed by the OIE in Article 1.2.3 of the Terrestrial Animal Health Code, 2010 edition, and in Chapter 1.3 of the Aquatic Animal Health Code, 2010 edition, shall be regarded as serious transmissible diseases for the purposes of general animal health restrictions, as provided for in Article 6(1)(b)(ii) of Regulation (EC) No 1069/2009.







CHAPTER II

DISPOSAL AND USE OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS

Article 5

Restrictions on the use of animal by-products and derived products

1. Operators in the Member States referred to in Chapter I of Annex II shall comply with the conditions for the feeding of fur animals with certain materials derived from bodies or parts of animals of the same species set out in the same Chapter.

2. Operators shall comply with the restrictions on the feeding of farmed animals with herbage from land to which certain organic fertilisers or soil improvers have been applied, as set out in Chapter II of Annex II.

▼M8

Article 6

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

▼B

1. The competent authority shall ensure that incineration and co-incineration of animal by-products and derived products shall only take place:

(a) in incineration plants and co-incineration plants which have been granted a permit in accordance with Directive 2000/76/EC; or

(b) for plants not required to have a permit under Directive 2000/76/EC, in incineration and co-incineration plants which have been approved by the competent authority to carry out disposal by incineration, or disposal or recovery of animal by-products or derived products, if they are waste, by co-incineration, in accordance with Article 24(1)(b) or (c) of Regulation (EC) No 1069/2009.

2. The competent authority shall only approve incineration plants and co-incineration plants as referred to in point 1(b), in accordance with Article 24(1)(b) or (c) of Regulation (EC) No 1069/2009, if they comply with the requirements set out in Annex III hereto.

3. Operators of incineration plants and co-incineration plants shall comply with the general requirements for incineration and co-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.

▼M8

6. Operators shall ensure that combustion plants other than those referred to in Section 2 of Chapter IV of Annex IV, under their control in which animal by-products or derived products are used as a fuel, comply with the general conditions and specific requirements set out in Chapters IV and V of Annex III respectively and are approved by the competent authority in accordance with Article 24(1)(d) of 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.

▼M14

8. For the use of manure of farmed animals as a fuel for combustion as set out in Chapter V of Annex III, the following rules shall apply in addition to those referred to in paragraph 7 of this Article:

(a) the application for approval that is submitted by the operator to the competent authority in accordance with Article 24(1)(d) of 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 is used as a fuel fully meets the requirements laid down in points B(3), B(4) and B(5) of Chapter V of Annex III to this Regulation, without prejudice to the possibility for the competent authorities of the Member State to grant a derogation from compliance with certain provisions in accordance with point C(4) of Chapter V of Annex III;

(b) the procedure for approval provided for in Article 44 of Regulation (EC) No 1069/2009 shall not be completed until at least two consecutive checks, one of them unannounced, have been carried out by the competent authority or by a professional organisation authorised by that authority, during the first six months of the operating of the combustion plant, including the necessary temperature and emission measurements. After the results of those checks showed compliance with the requirements set out in points B(3), B(4) and B(5) and, where applicable, with point C(4) of Chapter V of Annex III to this Regulation, full approval can be granted.

▼B

Article 7

Landfilling of certain Category 1 and 3 materials

By way of derogation from Article 12 and Article 14(c) of Regulation (EC) No 1069/2009, the competent authority may authorise the disposal of the following Category 1 and 3 materials in an authorised landfill:

(a) imported petfood or petfood produced from imported materials, from Category 1 material referred to in Article 8(c) of Regulation (EC) No 1069/2009;

(b) Category 3 material referred to in Article 10(f) and (g) of 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;

▼M4

(e) maggots and worms for fishing bait;

(f) circus animals.

▼B

2. Operators may feed Category 3 material to the following animals subject to compliance with the general requirements laid down in Section 1 of Chapter II of Annex VI and any other conditions that may be laid down by the competent authority:

(a) zoo animals;

(b) fur animals;

(c) dogs from recognised kennels or packs of hounds;

(d) dogs and cats in shelters;

▼M4

(e) maggots and worms for fishing bait;

(f) circus animals.

▼B

Article 14

Feeding of certain species in and outside feeding stations and in zoos

1. The competent authority may authorise the use of Category 1 material consisting of entire bodies or parts of dead animals containing specified risk material for the feeding:

(a) in feeding stations, to endangered or protected species of 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

▼M4

If the competent authority authorises the disposal of animal by-products by way of the derogation provided for in Article 19(1)(a), (b), (c), (e) and (f) of Regulation (EC) No 1069/2009, the disposal shall comply with the following special rules set out in Chapter III of Annex VI:

▼B

(a) the special disposal rules for animal by-products set out in Section 1;

(b) the rules for the burning and burial of animal by-products in remote areas set out in Section 2;

(c) the rules for the burning and burial of bees and apiculture by-products set out in Section 3.

▼M9

By way of derogation from Article 14 of Regulation (EC) No 1069/2009, Member States may authorise the collection, transport and disposal of small quantities of Category 3 materials as referred to in Article 10(f) of that Regulation by means referred to in Article 19(1)(d) of that Regulation, subject to compliance with the requirements for disposal by other means set out in Chapter IV of Annex VI hereto.

▼B







CHAPTER IV

AUTHORISATIONS OF ALTERNATIVE METHODS

Article 16

Standard format for applications for authorisation of alternative methods

1. Applications for authorisation of alternative methods of use or disposal of animal by-products or derived products, as referred to in Article 20(1) of Regulation (EC) No 1069/2009, shall be submitted by Member States or interested parties in accordance with the requirements of the standard format for applications for alternative methods set out in Annex VII.

2. Member States shall designate national contact points to provide information on the competent authority responsible for evaluating 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;

▼M9

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

(d) Chapter V, where they store on the farm animal by-products intended for subsequent disposal as referred to in Article 4 of that Regulation.

▼B

Article 20

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

1. Operators of registered plants or establishments or other registered operators shall handle animal by-products and derived products under the conditions set out in Chapter IV of Annex IX.

2. Registered operators transporting animal by-products or derived products, other than between premises of the same operator, shall in particular comply with the conditions set out in point 2 of Chapter IV of Annex IX.

3. Paragraphs 1 and 2 shall not apply to:

(a) approved operators who are transporting animal by-products or derived products as an ancillary activity;

(b) operators who have been registered for transport activities in accordance with Regulation (EC) No 183/2005.

▼M2

4. The competent authority may exempt the following operators from the obligation to notify, referred to in Article 23(1)(a) of Regulation (EC) No 1069/2009:

(a) operators handling or generating game trophies or other preparations referred to in Chapter VI of Annex XIII hereto for private or non-commercial purposes;

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

▼M3

(c) operators transporting dry untreated wool and hair, provided they are securely enclosed in packaging, and directly dispatched to a plant producing derived products for uses outside the feed chain or to a plant carrying out intermediate operations, under conditions which prevent the spreading of pathogenic agents;

▼M9

(d) operators using small quantities of Categories 2 and 3 materials referred to in Articles 9 and 10 of Regulation (EC) No 1069/2009 or of products derived therefrom, for the purpose of direct supply of the products within the region to the final user, on the local market or to local retail establishments, if the competent authority does not consider such activity to present a risk of spreading any serious transmissible disease to humans or animals; this point shall not apply where those materials are used as feed for farmed animals other than fur animals;

▼M9

(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.

▼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.

Article 22

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

1. Operators shall comply with the requirements for the placing on the market, other than the import, of organic fertilisers and soil improvers, and the use of such products, in particular their application to land, as provided for in Articles 15(1)(i) and 32(1) of Regulation (EC) No 1069/2009, set out in Annex XI hereto.

▼M9

2. The placing on the market of the following is not subject to any animal health conditions:

(a) guano from wild sea birds, collected in the Union or imported from third countries;

(b) ready-to-sell growing media, other than that imported, with a content of less than:

(i) 5 % in volume of derived products of Category 3 material or of Category 2 material other than processed manure;

(ii) 50 % in volume of processed manure.

▼B

3. The competent authority of the Member State where an organic fertiliser or a soil improver, which has been produced from meat-and-bone meal derived from Category 2 material or from processed animal protein, is to be applied to land, shall authorise one or more components which are to be mixed with those materials, in accordance with Article 32(1)(d) of Regulation (EC) No 1069/2009, according to the criteria set out in point 3 of Section 1 of Chapter II of Annex XI hereto.

4. By way of derogation from Article 48(1) of Regulation (EC) No 1069/2009, the competent authorities of a Member State of origin and of a Member State of destination, which share a common border may authorise the dispatch of manure between farms located in border regions of those two Member States subject to appropriate conditions for the control of any possible risks to public or animal health, such as obligations for the operators concerned to keep appropriate records, which are laid down in a bilateral agreement.

5. As provided for in Article 30(1) of Regulation (EC) No 1069/2009, the competent authorities of the Member States shall encourage, where necessary, the development, dissemination and use of national guides for good agricultural practice for the application of organic fertilisers and soil improvers to land.

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.

▼M9

3. The operator or owner of the establishment or plant of destination of intermediate products or his representative shall use and/or dispatch the intermediate products exclusively for use in manufacturing according to the definition of intermediate products under Point 35 of Annex I.

▼B

Article 24

Petfood and other derived products

1. The use of Category 1 material referred to in Article 8(a),(b), (d) and (e) of Regulation (EC) No 1069/2009 for the manufacture of derived products which are intended to be ingested by or applied to humans or animals, other than for derived products referred to in Articles 33 and 36 of that Regulation shall be prohibited.

2. Where an animal by-product or a derived product may be used for feeding to farmed animals or for other purposes referred to in Article 36(a) of Regulation (EC) No 1069/2009, they shall be placed on the market, other than imported, in accordance with the specific requirements for processed animal protein and other derived products set out in Chapter II of Annex X hereto, provided that Annex XIII hereto does not set out any specific requirements for such products.

3. Operators shall comply with the requirements for the placing on the market, other than the import, of petfood, as referred to in Article 40 of Regulation (EC) No 1069/2009, set out in Chapters I and II of Annex XIII hereto.

4. Operators shall comply with the requirements for the placing on the market, other than the import, of derived products, as referred to in Article 40 of Regulation (EC) No 1069/2009, set out in Chapter I and Chapters III to XII of Annex XIII hereto.







CHAPTER VIII

IMPORT, TRANSIT AND EXPORT

Article 25

Import, transit and export of animal by-products and of derived products

1. The importation into and the transit through the Union of the following animal by-products shall be prohibited:

(a) unprocessed manure;

(b) untreated feathers and parts of feathers and down;

(c) beeswax in the form of honeycomb.

▼M2

2. The importation into and the transit through the Union of the following shall not be subject to any animal health conditions:

(a) wool and hair which has been factory-washed or which has been treated by another method which ensures that no unacceptable risks remain;

(b) furs which have been dried at an ambient temperature of 18 °C for a period of at least two days at a humidity of 55 %;

(c) wool and hair produced from animals other than those of the porcine species, which has been treated by factory-washing which consisting of the immersion of the wool and hair in series of baths of water, soap and sodium hydroxide or potassium hydroxide;

(d) wool and hair produced from animals other than those of the porcine species, which is dispatched directly to a plant producing derived products from wool and hair for the textile industry and has been treated by at least one of the following methods:

— chemical depilation by means of slaked lime or sodium sulphide,

— fumigation in formaldehyde in a hermetically sealed chamber for at least 24 hours,

— industrial scouring which consists of the immersion of wool and hair in a water-soluble detergent held at 60–70 °C,

— storage, which may include the journey time, at 37 °C for eight days, 18 °C for 28 days or 4 °C for 120 days;

(e) wool and hair that is dry and securely enclosed in packaging, produced from animals other than those of the porcine species, which is intended for dispatch to a plant producing derived products from wool and hair for the textile industry and meets all of the following requirements:

(i) it was produced at least 21 days before the date of entry into the Union kept in a third country or region thereof which is

— listed in Part 1 of Annex II to Regulation (EU) No 206/2010 and authorised for imports into the Union of fresh meat of ruminants not subject to supplementary 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.

▼M10

4. The rules set out in Chapter V of Annex XIV shall apply to exports from the Union of the derived products specified therein.

▼B

Article 26

Placing on the market, including importation, and export of certain Category 1 materials

The competent authority may authorise the placing on the market, including the importation, and the export of hides and skins derived from animals which have been submitted to an illegal treatment as defined in Article 1(2)(d) of Directive 96/22/EC or in Article 2(b) of Directive 96/23/EC, and of ruminant intestines with or without content and of bones and bone products containing vertebral column and skull, subject to compliance with the following requirements:

(a) those materials must not be Category 1 materials derived from any of the following animals:

(i) animals suspected of being infected by a TSE in accordance with Regulation (EC) No 999/2001;

(ii) animals in which the presence of a TSE has been officially confirmed;

(iii) animals killed in the context of TSE eradication measures;

(b) those materials must not be intended for any of the following uses:

(i) feeding;

(ii) application to land from which farmed animals are fed;

(iii) the manufacture of:

— cosmetic products as defined in Article 1(1) of Directive 76/768/EEC;

— 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.

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.

2. Operators shall present research and diagnostic samples which are intended to be imported via a Member State, other than the Member State of destination, at an approved Union border inspection post listed in Annex I to Decision 2009/821/EC. At the border inspection post, those research and diagnostic samples shall not be subject to veterinary checks in accordance with Chapter I of Directive 97/78/EC. The competent authority of the border inspection post shall inform the competent authority of the Member State of destination of the introduction of the research and diagnostic samples by means of the TRACES system.

3. Operators handling research samples or diagnostic samples shall comply with the special requirements for disposal of research and 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;

(b) the documents accompanying the consignment and referred to in Article 7 of Directive 97/78/EC shall be stamped ‘ONLY FOR TRANSIT TO RUSSIA VIA THE EU’ on each page by the official veterinarian of the competent authority responsible for the border inspection post;

(c) the procedural requirements provided for in Article 11 of Directive 97/78/EC shall be complied with;

(d) the consignment is certified as acceptable for transit on the Common Veterinary Entry Document provided for in Annex III to Regulation (EC) No 136/2004 by the official veterinarian of the border inspection post of introduction.

2. Unloading or storage, as defined in Article 12(4) or Article 13 of Directive 97/78/EC of such consignments shall not be allowed on the territory of a Member State.

3. Regular audits shall be made by the competent authority to ensure that the number of consignments and the quantities of products leaving the Union territory matches the number and quantities entering.

▼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;

(b) the documents accompanying the consignment and referred to in Article 7 of Directive 97/78/EC are stamped ‘ONLY FOR TRANSIT TO THIRD COUNTRIES VIA THE EU’ on each page by the official veterinarian at the border inspection post of entry;

(c) the procedural requirements provided for in Article 11 of Directive 97/78/EC are complied with;

(d) the consignment is certified as acceptable for transit on the Common Veterinary Entry Document referred to in Article 2(1) of Regulation (EC) No 136/2004 by the official veterinarian at the border inspection post of entry.

2. Unloading or storage, as defined in Article 12(4) or in Article 13 of Directive 97/78/EC, of such consignments in the Union shall not be allowed.

3. Regular audits shall be made by the competent authority to ensure that the number of consignments and the quantities of products leaving the Union matches the number and quantities entering the Union.

▼B

Article 30

Lists of establishments and plants in third countries

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

Each list shall be kept up to date regularly.

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.







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.

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.

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;

▼M11

7. ‘fishmeal’ means processed animal protein derived from aquatic animals except sea mammals, including farmed aquatic invertebrates, including those covered by Article 3(1)(e) of Council Directive 2006/88/EC ( 1 ), and starfish of the species Asterias rubens which are harvested in a mollusc production area;

▼B

8. ‘rendered fats’ means either fats derived from the processing of:

(a) animal by-products; or

(b) products for human consumption, which an operator has destined for purposes other than human consumption;

▼M11

9. ‘fish oil’ means oil derived from the processing of aquatic animals except sea mammals, including farmed aquatic invertebrates, including those covered by Article 3(1)(e) of Directive 2006/88/EC, and starfish of the species Asterias rubens which are harvested in a mollusc production area, or oil from the processing of fish for human consumption, which an operator has destined for purposes other than human consumption;

▼B

10. ‘apiculture by-products’ means honey, beeswax, royal jelly, propolis or pollen not intended for human consumption;

11. ‘collagen’ means protein-based products derived from hides, skins, bones and tendons of animals;

12. ‘gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals;

13. ‘greaves’ means the protein-containing residue of rendering, after partial separation of fat and water;

14. ‘hydrolysed proteins’ means polypeptides, peptides and aminoacids, and mixtures thereof, obtained by the hydrolysis of animal by-products;

15. ‘white water’ means a mixture of milk, milk-based products or products derived thereof with water which is collected during the rinsing of dairy equipment including containers used for dairy products, prior to their cleaning and disinfection;

16. ‘canned petfood’ means heat-processed petfood contained within a hermetically sealed container;

17. ‘dogchews’ means products for pet animals to chew, produced from untanned hides and skins of ungulates or from other material of animal origin;

18. ‘flavouring innards’ means a liquid or dehydrated derived product of animal origin used to enhance the palatability values of petfood;

▼M4

19. ‘petfood’ means feed, other than material referred to in Article 24(2), for use as feed for pet animals, and dogchews consisting of animal by-products or derived products which:

(a) contain Category 3 material, other than material referred to in Article 10(n), (o) and (p) of Regulation (EC) No 1069/2009; and

(b) may contain imported Category 1 material comprising of animal by-products derived from animals which have been submitted to illegal treatment as defined in Article 1(2)(d) of Directive 96/22/EC or Article 2(b) of Directive 96/23/EC;

▼B

20. ‘processed petfood’ means petfood, other than raw petfood, which has been processed in accordance with point 3 of Chapter II of Annex XIII;

21. ‘raw petfood’ means petfood containing certain Category 3 material which has not undergone any preserving process other than chilling or freezing;

22. ‘catering waste’ means all waste food, including used cooking oil originating in restaurants, catering facilities and kitchens, including central kitchens and household kitchens;

▼M4

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

▼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;

▼M2

31. ‘untreated wool’ means wool, other than wool which has:

(a) undergone factory washing;

(b) been obtained from tanning;

(c) been treated by another method that ensures that no unacceptable risks remain;

(d) been produced from animals other than those of the porcine species, and has undergone factory-washing which consisting of the immersion of the wool in series of baths of water, soap and sodium hydroxide or potassium hydroxide; or

(e) been produced from animals other than those of the porcine species, is intended for being dispatched directly to a plant producing derived products from wool for the textile industry and has undergone at least one of the following treatments:

(i) chemical depilation by means of slaked lime or sodium sulphide;

(ii) fumigation in formaldehyde in a hermetically sealed chamber for at least 24 hours;

(iii) industrial scouring which consists of the immersion of wool in a water-soluble detergent held at 60–70 °C;

(iv) storage, which may include the journey time, at 37 °C for eight days, 18 °C for 28 days or 4 °C for 120 days;

32. ‘untreated hair’ means hair, other than hair which has:

(a) undergone factory washing;

(b) been obtained from tanning;

(c) been treated by another method that ensures that no unacceptable risks remain;

(d) been produced from animals other than those of the porcine species, and has undergone factory-washing which consisting of the immersion of the hair in series of baths of water, soap and sodium hydroxide or potassium hydroxide; or

(e) been produced from animals other than those of the porcine species, is intended for being dispatched directly to a plant producing derived products from hair for the textile industry and has undergone at least one of the following treatments:

(i) chemical depilation by means of slaked lime or sodium sulphide;

(ii) fumigation in formaldehyde in a hermetically sealed chamber for at least 24 hours;

(iii) industrial scouring which consists of the immersion of hair in a water-soluble detergent held at 60–70 °C;

(iv) storage, which may include the journey time, at 37 °C for eight days, 18 °C for 28 days or 4 °C for 120 days;

▼B

33. ‘untreated pig bristles’ means pig bristles, other than pig bristles which have:

(a) undergone factory washing;

(b) been obtained from tanning; or

(c) been treated by another method that ensures that no unacceptable risks remain;

34. ‘display item’ means animal by-products or derived products intended for exhibitions or artistic activities;

▼M9

35. ‘intermediate product’ means a derived product:

(a) which is intended for uses within the manufacturing of medicinal products, veterinary medicinal products, medical devices for medical and veterinary purposes, active implantable medical devices, in vitro diagnostic medical devices for medical and veterinary purposes, laboratory reagents or cosmetic products as follows:

(i) as material in a manufacturing process or in the final production of a finished product;

(ii) in validation or verification during a manufacturing process; or

(iii) in quality control of a finished product;

(b) whose design, transformation and manufacturing stages have been 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;

▼M9

39. ‘trade samples’ means animal by-products or derived products intended for particular studies or analyses authorised by the competent authority in accordance with Article 17(1) of Regulation (EC) No 1069/2009 with a view to carrying out a production process, including the processing of animal by-products or derived products, the development of feedingstuff, pet food or derived products, or the testing of machinery or equipment;

▼B

40. ‘co-incineration’ means the recovery or disposal of animal by-products or derived products, if they are waste, in a co-incineration plant;

41. ‘combustion’ means a process involving the oxidisation of fuel in order to use the energy value of the animal by-products or derived products, if they are not waste;

42. ‘incineration’ means the disposal of animal by-products or derived products as waste, in an incineration plant, as defined in point 4 of Article 3 of Directive 2000/76/EC;

43. ‘incineration and co-incineration residues’ means any residues as defined in point 13 of Article 3 of Directive 2000/76/EC, which are generated by incineration or co-incineration plants treating animal by-products or derived products;

44. ‘colour-coding’ means the systematic use of colours as set out in point 1(c) of Chapter II of Annex VIII for displaying information as provided for in this Regulation on the surface or on part of the surface of a packaging, container or vehicle, or on a label or symbol applied to them;

45. ‘intermediate operations’ means the operations, other than storage, referred to in Article 19(b);

46. ‘tanning’ means the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents;

47. ‘taxidermy’ means the art of preparing, stuffing and mounting the skins of animals with lifelike effect, so that no unacceptable risks to public and animal health may be transmitted through the mounted skin;

48. ‘trade’ means trade in goods between Member States as referred to in Article 28 of the Treaty on the Functioning of the European Union;

49. ‘processing methods’ means the methods listed in Chapters III and IV of Annex IV;

50. ‘batch’ means a unit of production produced in a single plant using uniform production parameters, such as the origin of the materials, or a number of such units, when produced in continuous order in a single plant and stored together as a shipping unit;

51. ‘hermetically sealed container’ means a container that is designed and intended to be secure against the entry of micro-organisms;

52. ‘biogas plant’ means a plant in which animal by-products or derived products are at least part of the material which is submitted to biological degradation under anaerobic conditions;

53. ‘collection centres’ means premises other than processing plants in which the animal by-products referred to in Article 18(1) of Regulation (EC) No 1069/2009 are collected with the intention to be used for feeding to the animals referred to in the same Article;

54. ‘composting plant’ means a plant in which animal by-products or derived products are at least part of the material which is submitted to biological degradation under aerobic conditions;

55. ‘co-incineration plant’ means any stationary or mobile plant whose main purpose is the generation of energy or the production of material products as defined in point 5 of Article 3 of Directive 2000/76/EC;

56. ‘incineration plant’ means any stationary or mobile technical unit and equipment dedicated to the thermal treatment of waste as defined in point 4 of Article 3 of Directive 2000/76/EC;

57. ‘petfood plant’ means premises or facilities for the production of petfood or flavouring innards, as referred to in Article 24(1)(e) of Regulation (EC) No 1069/2009;

▼M9

58. ‘processing plant’ means premises or facilities for the processing of animal by-products as referred to in Article 24(1)(a) of Regulation (EC) No 1069/2009, in which animal by-products are processed in accordance with Annex IV and/or Annex X;

▼M9

59. ‘growing media’ means materials, including potting soil, other than soil in situ, in which plants are grown and which is used independently from soil in situ.

▼B









ANNEX II

RESTRICTIONS ON THE USE OF ANIMAL BY-PRODUCTS

CHAPTER I

Intra-species recycling of fur animals

1. In Estonia, Latvia and Finland, the following fur animals may be fed with meat-and-bone meal or other products which have been processed in accordance with Chapter III of Annex IV and which are derived from bodies or parts of bodies of animals of the same species:

▼M1

(a) foxes (Vulpes vulpes and Alopex lagopus);

▼B

(b) raccoon dogs (Nyctereutes procyonides).

2. In Estonia and Latvia, fur animals of the species American mink (Mustela vison) may be fed with meat-and-bone meal or other products which have been processed in accordance with the processing methods set out in Chapter III of Annex IV and which are derived from bodies or parts of bodies of animals of the same species.

3. The feeding referred to in points 1 and 2 shall take place under the following conditions:

(a) Feeding shall only take place in farms:

(i) which have been registered by the competent authority on the basis of an application that is accompanied by documentation proving that there is no reason to suspect the presence of the TSE agent in the population of the species covered by the application;

(ii) where an appropriate surveillance system for transmissible 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.









▼M8

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:

▼M9

(a) only be used for the disposal of:

(i) dead pet animals referred to in Article 8(a)(iii) of Regulation (EC) No 1069/2009;

(ii) Category 1 materials referred to in Article 8(b), (e) and (f), Category 2 materials referred to in Article 9 or Category 3 materials referred to in Article 10 of that Regulation; and

(iii) dead individually identified equine animals from holdings not subject to health restrictions in accordance with Article 4(5) or 5 of Directive 2009/156/EC, if authorised by the Member State;

▼B

(b) when Category 1 materials referred to in Article 8(b) of Regulation (EC) No 1069/2009 are introduced into the low-capacity plant, be equipped with an auxiliary burner;

(c) operate in such way that the animal by-products are completely reduced to ash.

▼M8

CHAPTER IV

GENERAL REQUIREMENTS FOR THE USE OF ANIMAL BY-PRODUCTS AND DERIVED PRODUCTS AS A FUEL

Section 1

General requirements regarding the combustion of animal by-products and derived products as a fuel

1. Operators of combustion plants referred to in Article 6(6) shall ensure that the following conditions are met in the combustion plants under their control:

(a) Animal by-products and derived products intended to be used as a fuel must be utilised for that purpose as soon as possible or safely stored until used.

(b) The combustion plants must have in place appropriate measures to ensure that cleaning and disinfection of containers and vehicles are carried out in a designated area of their premises from which the wastewater can be collected and disposed of in accordance with Union legislation, to avoid risks of contamination of the environment.

By way of derogation from the requirements set out in the first 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.

▼M14

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.

▼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 compe