# L_2006360EN.01013301.xml

| 19.12.2006 | EN | Official Journal of the European Union | L 360/133 |
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19.12.2006

EN

Official Journal of the European Union

L 360/133

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COMMISSION REGULATION (EC) No 1877/2006

of 18 December 2006

amending Regulation (EC) No 878/2004 laying down transitional measures in accordance with Regulation (EC) No 1774/2002 for certain animal by-products classified as Category 1 and 2 materials and intended for technical purposes

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community

Having regard to Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (1), and in particular Articles 4(4), 5(4) and 32(1) thereof,

Whereas:

| (1) | Regulation (EC) No 1774/2002 lays down health rules concerning animal by-products not intended for human consumption. That Regulation defines animal by-products as Categories 1, 2 and 3 materials, depending on the risk arising from such products. |
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(1)

Regulation (EC) No 1774/2002 lays down health rules concerning animal by-products not intended for human consumption. That Regulation defines animal by-products as Categories 1, 2 and 3 materials, depending on the risk arising from such products.

| (2) | In accordance with that Regulation, animal by-products other than Category 1 or 3 materials are defined as Category 2 material, irrespective of any further considerations regarding the risk arising from such products. The permitted use of animal by-products for feeding purposes is dependent on whether such material is defined as Category 1, 2 or 3 materials. While certain Category 3 material may be used for feeding purposes, Category 2 material is generally excluded from such use. |
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(2)

In accordance with that Regulation, animal by-products other than Category 1 or 3 materials are defined as Category 2 material, irrespective of any further considerations regarding the risk arising from such products. The permitted use of animal by-products for feeding purposes is dependent on whether such material is defined as Category 1, 2 or 3 materials. While certain Category 3 material may be used for feeding purposes, Category 2 material is generally excluded from such use.

| (3) | However, certain animal by-products which may be considered as posing a low risk do not come within the definition of Category 3 material in Regulation (EC) No 1774/2002. The definition of such material, by default, as Category 2 material does not correspond with the risks arising from such products. |
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(3)

However, certain animal by-products which may be considered as posing a low risk do not come within the definition of Category 3 material in Regulation (EC) No 1774/2002. The definition of such material, by default, as Category 2 material does not correspond with the risks arising from such products.

| (4) | Commission Regulation (EC) No 878/2004 of 29 April 2004 laying down transitional measures in accordance with Regulation (EC) No 1774/2002 for certain animal by-products classified as Category 1 and 2 materials and intended for technical purposes (2) was adopted in order to permit the continued placing on the market, export, import and transit of certain animal by-products defined as Category 1 and 2 material, intended exclusively for technical uses. |
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(4)

Commission Regulation (EC) No 878/2004 of 29 April 2004 laying down transitional measures in accordance with Regulation (EC) No 1774/2002 for certain animal by-products classified as Category 1 and 2 materials and intended for technical purposes (2) was adopted in order to permit the continued placing on the market, export, import and transit of certain animal by-products defined as Category 1 and 2 material, intended exclusively for technical uses.

| (5) | The Report on animal by-products (3) adopted by the Commission on 21 October 2005 and presented to the Council on 24 October 2005 reflects the difficulties concerning the definition of certain material as Category 2 material and envisages a number of amendments to Regulation (EC) No 1774/2002 in the course of the review of that legislation scheduled to start from the end of 2006. |
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(5)

The Report on animal by-products (3) adopted by the Commission on 21 October 2005 and presented to the Council on 24 October 2005 reflects the difficulties concerning the definition of certain material as Category 2 material and envisages a number of amendments to Regulation (EC) No 1774/2002 in the course of the review of that legislation scheduled to start from the end of 2006.

| (6) | Pending those amendments it should be possible to use certain low risk animal by-products presently defined as Category 2 material for certain feeding and for technical purposes. Accordingly, the scope of Regulation (EC) No 878/2004 should be extended in order to permit the use of certain Category 2 low risk material for the manufacture of technical products and for certain feeding purposes. |
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(6)

Pending those amendments it should be possible to use certain low risk animal by-products presently defined as Category 2 material for certain feeding and for technical purposes. Accordingly, the scope of Regulation (EC) No 878/2004 should be extended in order to permit the use of certain Category 2 low risk material for the manufacture of technical products and for certain feeding purposes.

| (7) | Regulation (EC) No 878/2004 should therefore be amended accordingly. |
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(7)

Regulation (EC) No 878/2004 should therefore be amended accordingly.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Commission Regulation (EC) No 878/2004 is amended as follows:

| 1. | The title is replaced by the following:

  ‘Commission Regulation (EC) No 878/2004 of 29 April 2004 laying down transitional measures for certain animal by-products defined as Category 1 and 2 materials, in accordance with Regulation (EC) No 1774/2002 of the European Parliament and of the Council’. |
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1.

The title is replaced by the following:

‘Commission Regulation (EC) No 878/2004 of 29 April 2004 laying down transitional measures for certain animal by-products defined as Category 1 and 2 materials, in accordance with Regulation (EC) No 1774/2002 of the European Parliament and of the Council’.

| 2. | Article 1 is replaced by the following:

  ‘Article 1
  Scope

  1.   This Regulation shall apply to the following animal by-products, defined as Category 1 or Category 2 material in Regulation (EC) No 1774/2002 and intended exclusively for technical uses:






  (a) | hides and skins derived from animals which have been treated with substances which are prohibited pursuant to Council Directive 96/22/EC (*1); |
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2.

Article 1 is replaced by the following:

‘Article 1

Scope

1.   This Regulation shall apply to the following animal by-products, defined as Category 1 or Category 2 material in Regulation (EC) No 1774/2002 and intended exclusively for technical uses:

(a)

hides and skins derived from animals which have been treated with substances which are prohibited pursuant to Council Directive 96/22/EC (*1);

| (b) | rendered fats derived from Category 1 material produced using Method 1 as referred to in Chapter III of Annex V to Regulation (EC) No 1774/2002, which in the case of rendered fats from ruminant animals have been purified so that the maximum level of remaining total insoluble impurities does not exceed 0,15 % in weight, and derived fat derivatives complying with at least the standards in Chapter III of Annex VI to Regulation (EC) No 1774/2002; |
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(b)

rendered fats derived from Category 1 material produced using Method 1 as referred to in Chapter III of Annex V to Regulation (EC) No 1774/2002, which in the case of rendered fats from ruminant animals have been purified so that the maximum level of remaining total insoluble impurities does not exceed 0,15 % in weight, and derived fat derivatives complying with at least the standards in Chapter III of Annex VI to Regulation (EC) No 1774/2002;

| (c) | ruminant intestines (with or without content); and |
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(c)

ruminant intestines (with or without content); and

| (d) | bone and bone products containing vertebral columns and skull, and bovine horns which have been removed from the skull using a method which has left the cranial cavity intact. |
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(d)

bone and bone products containing vertebral columns and skull, and bovine horns which have been removed from the skull using a method which has left the cranial cavity intact.

However, this Regulation shall not apply to animal by-products derived from animals referred to in Article 4(1)(a)(i) and (ii) of Regulation (EC) No 1774/2002.

2.   This Regulation shall apply to the following animal by-products, defined as Category 2 material in Regulation (EC) No 1774/2002 in accordance with Article 5(1)(g) of that Regulation, which are intended for feeding to animals other than farmed land animals, for feeding to farmed fur animals or for technical uses, including fishing baits:

| (a) | terrestrial invertebrates other than species pathogenic to animals or to humans, including any of their transformation forms, such as larvae; |
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(a)

terrestrial invertebrates other than species pathogenic to animals or to humans, including any of their transformation forms, such as larvae;

| (b) | aquatic animals, except sea mammals, if not originating from aquaculture; |
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(b)

aquatic animals, except sea mammals, if not originating from aquaculture;

| (c) | aquaculture animals bred specifically for the purpose of using them as fishing bait provided the bait are not used in aquaculture without prior processing; |
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(c)

aquaculture animals bred specifically for the purpose of using them as fishing bait provided the bait are not used in aquaculture without prior processing;

| (d) | animals belonging to the zoological orders of Rodentia and Lagomorpha, including those kept as farmed animals for the production of products of animal origin; and |
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(d)

animals belonging to the zoological orders of Rodentia and Lagomorpha, including those kept as farmed animals for the production of products of animal origin; and

| (e) | products derived from or produced by the animals referred to in (a) to (d), such as fish eggs, but excluding meal derived from animals referred to in (d). |
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(e)

products derived from or produced by the animals referred to in (a) to (d), such as fish eggs, but excluding meal derived from animals referred to in (d).

(*1)  
  OJ L 125, 23.5.1996, p. 3.’."

*1

| 3. | The following Article 1a is inserted:

  ‘Article 1a
  Derogation regarding commercial documents and health certificates
  By way of derogation from point 1 of Chapter III of Annex II to Regulation (EC) No 1774/2002, animal by-products referred to in Article 1(2) of the present Regulation may be supplied by retailers to final users other than business operators without being accompanied during transportation by a commercial document or, when required by Regulation (EC) No 1774/2002, a health certificate.’ |
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3.

The following Article 1a is inserted:

‘Article 1a

Derogation regarding commercial documents and health certificates

By way of derogation from point 1 of Chapter III of Annex II to Regulation (EC) No 1774/2002, animal by-products referred to in Article 1(2) of the present Regulation may be supplied by retailers to final users other than business operators without being accompanied during transportation by a commercial document or, when required by Regulation (EC) No 1774/2002, a health certificate.’

| 4. | In the second sentence of Article 2 the reference to ‘points (c) and (d) of Article 1’ is replaced by the reference to ‘points (c) and (d) of Article 1(1)’. |
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4.

In the second sentence of Article 2 the reference to ‘points (c) and (d) of Article 1’ is replaced by the reference to ‘points (c) and (d) of Article 1(1)’.

| 5. | In the second sentence of Article 3 the reference to ‘point (a) of Article 5’ is replaced by the reference to ‘paragraphs (1) or (2), as appropriate, of Article 5’. |
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5.

In the second sentence of Article 3 the reference to ‘point (a) of Article 5’ is replaced by the reference to ‘paragraphs (1) or (2), as appropriate, of Article 5’.

| 6. | The last sentence of Article 4(2) is replaced by the following:

  ‘As regards animal by-products referred to in Article 1 (1), imported consignments and consignments in transit shall be channelled in accordance with the monitoring procedure provided for in Article 8 (4) of Council Directive 97/78/EC (*2)


  (*2)  
  OJ L 24, 30.1.1998, p. 9.’." |
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6.

The last sentence of Article 4(2) is replaced by the following:

‘As regards animal by-products referred to in Article 1 (1), imported consignments and consignments in transit shall be channelled in accordance with the monitoring procedure provided for in Article 8 (4) of Council Directive 97/78/EC (*2)

*2

(*2)  
  OJ L 24, 30.1.1998, p. 9.’."

*2

| 7. | Article 5 is replaced by the following:

  ‘Article 5
  Labelling, delivery, record keeping and treatment requirements

  1.   In addition to the identification requirements provided for in Chapter I of Annex II to Regulation (EC) No 1774/2002, all packages of animal by-products referred to in Article 1(1) of the present Regulation, shall bear a label indicating “PROHIBITED IN FOOD, FEED, FERTILISERS, COSMETICS, MEDICINAL PRODUCTS AND MEDICAL DEVICES”.
  However, in case of animal by-products intended for medicinal products in accordance with Community legislation a different label may be used which shall indicate “DESTINED FOR MEDICINAL PRODUCTS ONLY”.


  2.   All packages of animal by-products referred to in Article 1(2), shall bear a label indicating “NOT FOR HUMAN CONSUMPTION”, unless they are dispatched in ready-to-sell packages, indicating that the content is destined for the feeding to pets only or for the use as fishing bait.


  3.   The animal by-products referred to in Article 1 of the present Regulation shall be delivered to a technical plant dedicated to the use of such materials and which has been approved in accordance with Article 18(1) of Regulation (EC) No 1774/2002.
  The animal by-products referred to in Article 1(2) may also be delivered:






  (a) | to an intermediate plant approved in accordance with Article 10(1) of Regulation (EC) No 1774/2002; |
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7.

Article 5 is replaced by the following:

‘Article 5

Labelling, delivery, record keeping and treatment requirements

1.   In addition to the identification requirements provided for in Chapter I of Annex II to Regulation (EC) No 1774/2002, all packages of animal by-products referred to in Article 1(1) of the present Regulation, shall bear a label indicating “PROHIBITED IN FOOD, FEED, FERTILISERS, COSMETICS, MEDICINAL PRODUCTS AND MEDICAL DEVICES”.

However, in case of animal by-products intended for medicinal products in accordance with Community legislation a different label may be used which shall indicate “DESTINED FOR MEDICINAL PRODUCTS ONLY”.

2.   All packages of animal by-products referred to in Article 1(2), shall bear a label indicating “NOT FOR HUMAN CONSUMPTION”, unless they are dispatched in ready-to-sell packages, indicating that the content is destined for the feeding to pets only or for the use as fishing bait.

3.   The animal by-products referred to in Article 1 of the present Regulation shall be delivered to a technical plant dedicated to the use of such materials and which has been approved in accordance with Article 18(1) of Regulation (EC) No 1774/2002.

The animal by-products referred to in Article 1(2) may also be delivered:

(a)

to an intermediate plant approved in accordance with Article 10(1) of Regulation (EC) No 1774/2002;

| (b) | to a storage plant approved in accordance with Article 11(1) of Regulation (EC) No 1774/2002; |
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(b)

to a storage plant approved in accordance with Article 11(1) of Regulation (EC) No 1774/2002;

| (c) | to a petfood plant approved in accordance with Article 18(1) of Regulation (EC) No 1774/2002; |
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(c)

to a petfood plant approved in accordance with Article 18(1) of Regulation (EC) No 1774/2002;

| (d) | to a holding or establishment keeping animals in accordance with the requirements referred to in Article 23(2)(c) of Regulation (EC) No 1774/2002; |
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(d)

to a holding or establishment keeping animals in accordance with the requirements referred to in Article 23(2)(c) of Regulation (EC) No 1774/2002;

| (e) | to the place of manufacture or the manufacturing establishment, as appropriate, of






  (i) | cosmetic products in accordance with Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (*3), |
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(e)

to the place of manufacture or the manufacturing establishment, as appropriate, of

(i)

cosmetic products in accordance with Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (*3),

| (ii) | veterinary medicinal products in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (*4), |
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(ii)

veterinary medicinal products in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (*4),

| (iii) | medicinal products in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (*5), |
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(iii)

medicinal products in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (*5),

| (iv) | medical devices in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (*6) or |
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(iv)

medical devices in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (*6) or

| (v) | in vitro diagnostic devices in accordance with Directive 98/79/EC of the European Parliament and the Council of 27 October 1998 on in vitro diagnostic medical devices (*7); or |
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(v)

in vitro diagnostic devices in accordance with Directive 98/79/EC of the European Parliament and the Council of 27 October 1998 on in vitro diagnostic medical devices (*7); or

| (f) | directly for retail sale where the animal by-products are:






  (i) | dispatched in ready-to-sell packages bearing a label with a clear indication that the content is only destined for:






  — | the feeding to pets; or fishing bait |
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(f)

directly for retail sale where the animal by-products are:

(i)

dispatched in ready-to-sell packages bearing a label with a clear indication that the content is only destined for:

—

the feeding to pets; or fishing bait

| (ii) | dried by a treatment sufficient to destroy pathogenic organisms, including salmonella; or |
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(ii)

dried by a treatment sufficient to destroy pathogenic organisms, including salmonella; or

| (iii) | in the case of animal by-products referred to in Article 1(2)(b), (c) and, as regards Rodentia, (d) deep frozen; |
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(iii)

in the case of animal by-products referred to in Article 1(2)(b), (c) and, as regards Rodentia, (d) deep frozen;

Without prejudice to Commission Regulation (EC) No 811/2003 of 12 May 2003 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the intra-species recycling ban for fish, the burial and burning of animal by-products and certain transitional measures (*8), the animal by-products referred to in Article 1(2)(b) of the present Regulation may also be delivered for the use as feed material to a holding or establishment keeping aquatic animals.

4.   The owner, operator or their representative of the plants, holdings or establishments referred to in paragraph 3 of this Article shall:

| (a) | keep records in accordance with Article 9 of Regulation (EC) No 1774/2002; |
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(a)

keep records in accordance with Article 9 of Regulation (EC) No 1774/2002;

| (b) | ensure that the animal by-products are subjected, where appropriate, to a treatment which satisfies the competent authority in such a way that the resulting material does not pose a risk to animal and public health; |
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(b)

ensure that the animal by-products are subjected, where appropriate, to a treatment which satisfies the competent authority in such a way that the resulting material does not pose a risk to animal and public health;

| (c) | further dispatch or use the animal by-products exclusively for purposes authorised by the competent authority. |
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(c)

further dispatch or use the animal by-products exclusively for purposes authorised by the competent authority.

(*3)  
  OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive (EC) No 2006/78, (OJ L 271, 30.9.2006, p. 56)."

*3

(*4)  
  OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58)."

*4

(*5)  
  OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34)."

*5

(*6)  
  OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1)."

*6

(*7)  
  OJ L 331, 7.12.1998, p. 1. Directive as amended by Regulation (EC) No 1882/2003."

*7

(*8)  
  OJ L 117, 13.5.2003, p. 14.’
  "

*8

| 8. | In Article 7(b) the reference to ‘Article 5(c)’ is replaced by the reference to ‘Article 5(3)’. |
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8.

In Article 7(b) the reference to ‘Article 5(c)’ is replaced by the reference to ‘Article 5(3)’.

Article 2

This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 18 December 2006.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 273, 10.10.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 208/2006 (OJ L 36, 8.2.2006, p. 25).

1

(2)  
  OJ L 162, 30.4.2004, p. 62.

2

(3)  COM(2005) 521 final.

3

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