Commission Regulation (EU) No 142/2011Show full title

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;

(g)

fur which fulfils the conditions in Chapter VIII of Annex XIII.

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.

Article 6 Disposal by incineration and co-incineration

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.

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;

(e) maggots and worms for fishing bait.

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;

(e) maggots and worms for fishing bait.

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

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) and (e) of Regulation (EC) No 1069/2009, the disposal shall comply with the following special rules set out in Chapter III of Annex VI:

(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.

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;

(c)

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

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.

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.

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.

2. The placing on the market, including the import, of guano from wild sea birds is not subject to any animal health conditions.

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.

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 further mixing, coating, assembling, packaging or labelling.

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.

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 %.

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.

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.

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.

3. For a transitional period until 31 December 2012 and by way of derogation from Article 14 of Regulation (EC) No 1069/2009, Member States may authorise the collection, transport and disposal of Category 3 materials comprising products of animal origin, or of foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise, as referred to in Article 10(f) of that Regulation, by means other than burning or burial on site, as 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.

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.

Done at Brussels, 25 February 2011.

For the Commission

The President

José Manuel Barroso