# Official Journal L 10/13 J

| | ISSN 1725-2555 |
| --- | --- |
| Official Journal
  of the European Union | L 10 |
| | |
| English edition | Legislation | Volume 4813 January 2005 |

ISSN 1725-2555

Official Journal

of the European Union

L 10

English edition

Legislation

Volume 4813 January 2005

---

| Contents | | I   Acts whose publication is obligatory | page |
| --- | --- | --- | --- |
| | | Commission Regulation (EC) No 34/2005 of 12 January 2005 establishing the standard import values for determining the entry price of certain fruit and vegetables | 1 |
| | * | Commission Regulation (EC) No 35/2005 of 11 January 2005 establishing unit values for the determination of the customs value of certain perishable goods | 3 |
| | * | Commission Regulation (EC) No 36/2005 of 12 January 2005 amending Annexes III and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards epidemio-surveillance for transmissible spongiform encephalopathies in bovine, ovine and caprine animals (
  1
  ) | 9 |
| | * | Commission Regulation (EC) No 37/2005 of 12 January 2005 on the monitoring of temperatures in the means of transport, warehousing and storage of quick-frozen foodstuffs intended for human consumption (
  1
  ) | 18 |
| | | Commission Regulation (EC) No 38/2005 of 12 January 2005 fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and amending Regulation (EC) No 1484/95 | 20 |

Contents

I   Acts whose publication is obligatory

page

Commission Regulation (EC) No 34/2005 of 12 January 2005 establishing the standard import values for determining the entry price of certain fruit and vegetables

1

*

Commission Regulation (EC) No 35/2005 of 11 January 2005 establishing unit values for the determination of the customs value of certain perishable goods

3

*

Commission Regulation (EC) No 36/2005 of 12 January 2005 amending Annexes III and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards epidemio-surveillance for transmissible spongiform encephalopathies in bovine, ovine and caprine animals (
  1
  )

1

9

*

Commission Regulation (EC) No 37/2005 of 12 January 2005 on the monitoring of temperatures in the means of transport, warehousing and storage of quick-frozen foodstuffs intended for human consumption (
  1
  )

1

18

Commission Regulation (EC) No 38/2005 of 12 January 2005 fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and amending Regulation (EC) No 1484/95

20

| | | II   Acts whose publication is not obligatory |
| --- | --- | --- |
| | | Council |
| | * | Information relating to the entry into force of the Agreement between the European Community and Canada on trade in wines and spirit drinks | 22 |

II   Acts whose publication is not obligatory

Council

*

Information relating to the entry into force of the Agreement between the European Community and Canada on trade in wines and spirit drinks

22

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

---

(1)   Text with EEA relevance

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

---

I Acts whose publication is obligatory

| 13.1.2005 | EN | Official Journal of the European Union | L 10/1 |
| --- | --- | --- | --- |

13.1.2005

EN

Official Journal of the European Union

L 10/1

---

COMMISSION REGULATION (EC) No 34/2005

of 12 January 2005

establishing the standard import values for determining the entry price of certain fruit and vegetables

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Commission Regulation (EC) No 3223/94 of 21 December 1994 on detailed rules for the application of the import arrangements for fruit and vegetables (1), and in particular Article 4(1) thereof,

Whereas:

| (1) | Regulation (EC) No 3223/94 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in the Annex thereto. |
| --- | --- |

(1)

Regulation (EC) No 3223/94 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in the Annex thereto.

| (2) | In compliance with the above criteria, the standard import values must be fixed at the levels set out in the Annex to this Regulation, |
| --- | --- |

(2)

In compliance with the above criteria, the standard import values must be fixed at the levels set out in the Annex to this Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 4 of Regulation (EC) No 3223/94 shall be fixed as indicated in the Annex hereto.

Article 2

This Regulation shall enter into force on 13 January 2005.

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

Done at Brussels, 12 January 2005.

For the Commission

J. M. SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

---

(1)  
  OJ L 337, 24.12.1994, p. 66. Regulation as last amended by Regulation (EC) No 1947/2002 (OJ L 299, 1.11.2002, p. 17).

1

---

ANNEX

to Commission Regulation of 12 January 2005 establishing the standard import values for determining the entry price of certain fruit and vegetables

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | 052 | 98,1 |
| 204 | 101,8 |
| 999 | 100,0 |
| 0707 00 05 | 052 | 138,3 |
| 999 | 138,3 |
| 0709 90 70 | 052 | 142,0 |
| 204 | 195,6 |
| 999 | 168,8 |
| 0805 10 20 | 052 | 61,6 |
| 204 | 51,7 |
| 220 | 43,0 |
| 448 | 34,6 |
| 999 | 47,7 |
| 0805 20 10 | 204 | 70,4 |
| 999 | 70,4 |
| 0805 20 30 , 0805 20 50 , 0805 20 70 , 0805 20 90 | 052 | 65,1 |
| 204 | 51,9 |
| 400 | 79,0 |
| 464 | 139,9 |
| 624 | 58,7 |
| 999 | 78,9 |
| 0805 50 10 | 052 | 49,3 |
| 608 | 16,0 |
| 999 | 32,7 |
| 0808 10 80 | 400 | 97,3 |
| 404 | 105,3 |
| 720 | 64,0 |
| 999 | 88,9 |
| 0808 20 50 | 400 | 102,1 |
| 999 | 102,1 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

052

98,1

204

101,8

999

100,0

0707 00 05

052

138,3

999

138,3

0709 90 70

052

142,0

204

195,6

999

168,8

0805 10 20

052

61,6

204

51,7

220

43,0

448

34,6

999

47,7

0805 20 10

204

70,4

999

70,4

0805 20 30 , 0805 20 50 , 0805 20 70 , 0805 20 90

052

65,1

204

51,9

400

79,0

464

139,9

624

58,7

999

78,9

0805 50 10

052

49,3

608

16,0

999

32,7

0808 10 80

400

97,3

404

105,3

720

64,0

999

88,9

0808 20 50

400

102,1

999

102,1

---

(1)  Country nomenclature as fixed by Commission Regulation (EC) No 2081/2003 (OJ L 313, 28.11.2003, p. 11). Code ‘
  999
  ’ stands for ‘of other origin’.

---

| 13.1.2005 | EN | Official Journal of the European Union | L 10/3 |
| --- | --- | --- | --- |

13.1.2005

EN

Official Journal of the European Union

L 10/3

---

COMMISSION REGULATION (EC) No 35/2005

of 11 January 2005

establishing unit values for the determination of the customs value of certain perishable goods

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (1),

Having regard to Commission Regulation (EEC) No 2454/93 (2) laying down provisions for the implementation of Regulation (EEC) No 2913/92, and in particular Article 173(1) thereof,

Whereas:

| (1) | Articles 173 to 177 of Regulation (EEC) No 2454/93 provide that the Commission shall periodically establish unit values for the products referred to in the classification in Annex 26 to that Regulation. |
| --- | --- |

(1)

Articles 173 to 177 of Regulation (EEC) No 2454/93 provide that the Commission shall periodically establish unit values for the products referred to in the classification in Annex 26 to that Regulation.

| (2) | The result of applying the rules and criteria laid down in the abovementioned Articles to the elements communicated to the Commission in accordance with Article 173(2) of Regulation (EEC) No 2454/93 is that unit values set out in the Annex to this Regulation should be established in regard to the products in question, |
| --- | --- |

(2)

The result of applying the rules and criteria laid down in the abovementioned Articles to the elements communicated to the Commission in accordance with Article 173(2) of Regulation (EEC) No 2454/93 is that unit values set out in the Annex to this Regulation should be established in regard to the products in question,

HAS ADOPTED THIS REGULATION:

Article 1

The unit values provided for in Article 173(1) of Regulation (EEC) No 2454/93 are hereby established as set out in the table in the Annex hereto.

Article 2

This Regulation shall enter into force on 14 January 2005.

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

Done at Brussels, 11 January 2005.

For the Commission

Günter VERHEUGEN

Vice-President

---

(1)  
  OJ L 302, 19.10.1992, p. 1. Regulation as last amended by Regulation (EC) No 2700/2000 (OJ L 311, 12.12.2000, p. 17).

1

(2)  
  OJ L 253, 11.10.1993, p. 1. Regulation as last amended by Commission Regulation (EC) No 2286/2003 (OJ L 343, 31.12.2003, p. 1).

2

---

ANNEX

| Code | Description | Amount of unit values per 100 kg |
| --- | --- | --- |
| Species, varieties, CN code | EUR
  LTL
  SEK | CYP
  LVL
  GBP | CZK
  MTL | DKK
  PLN | EEK
  SIT | HUF
  SKK |
| 1.10 | New potatoes
  0701 90 50 | 59,80 | 34,73 | 1 812,23 | 444,93 | 935,72 | 14 865,98 |
| 206,49 | 41,67 | 25,89 | 244,67 | 14 339,11 | 2 308,90 |
| 540,01 | 42,03 | | | | |
| 1.30 | Onions (other than seed)
  0703 10 19 | 7,28 | 4,23 | 220,61 | 54,16 | 113,91 | 1 809,66 |
| 25,14 | 5,07 | 3,15 | 29,78 | 1 745,53 | 281,07 |
| 65,74 | 5,12 | | | | |
| 1.40 | Garlic
  0703 20 00 | 123,62 | 71,79 | 3 746,07 | 919,72 | 1 934,24 | 30 729,53 |
| 426,84 | 86,14 | 53,52 | 505,76 | 29 640,44 | 4 772,73 |
| 1 116,27 | 86,88 | | | | |
| 1.50 | Leeks
  ex 0703 90 00 | 57,07 | 33,14 | 1 729,35 | 424,59 | 892,93 | 14 186,14 |
| 197,05 | 39,77 | 24,71 | 233,48 | 13 683,36 | 2 203,31 |
| 515,32 | 40,11 | | | | |
| 1.60 | Cauliflowers
  0704 10 00 | — | — | — | — | — | — |
| 1.80 | White cabbages and red cabbages
  0704 90 10 | 48,73 | 28,30 | 1 476,67 | 362,55 | 762,46 | 12 113,30 |
| 168,25 | 33,96 | 21,10 | 199,36 | 11 683,99 | 1 881,37 |
| 440,02 | 34,25 | | | | |
| 1.90 | Sprouting broccoli or calabrese (Brassica oleracea L. convar. botrytis (L.) Alef var. italica Plenck)
  ex 0704 90 90 | 61,43 | 35,67 | 1 861,51 | 457,03 | 961,17 | 15 270,27 |
| 212,11 | 42,80 | 26,59 | 251,32 | 14 729,07 | 2 371,69 |
| 554,70 | 43,17 | | | | |
| 1.100 | Chinese cabbage
  ex 0704 90 90 | 75,36 | 43,76 | 2 283,63 | 560,67 | 1 179,13 | 18 732,99 |
| 260,20 | 52,51 | 32,62 | 308,31 | 18 069,07 | 2 909,50 |
| 680,49 | 52,96 | | | | |
| 1.110 | Cabbage lettuce (head lettuce)
  0705 11 00 | — | — | — | — | — | — |
| 1.130 | Carrots
  ex 0706 10 00 | 26,74 | 15,53 | 810,30 | 198,94 | 418,39 | 6 647,03 |
| 92,33 | 18,63 | 11,58 | 109,40 | 6 411,45 | 1 032,38 |
| 241,46 | 18,79 | | | | |
| 1.140 | Radishes
  ex 0706 90 90 | 55,40 | 32,17 | 1 678,72 | 412,15 | 866,79 | 13 770,79 |
| 191,28 | 38,60 | 23,98 | 226,64 | 13 282,73 | 2 138,80 |
| 500,23 | 38,93 | | | | |
| 1.160 | Peas (Pisum sativum)
  0708 10 00 | 312,06 | 181,21 | 9 456,36 | 2 321,70 | 4 882,68 | 77 571,92 |
| 1 077,48 | 217,44 | 135,09 | 1 276,70 | 74 822,67 | 12 048,02 |
| 2 817,84 | 219,32 | | | | |
| 1.170 | Beans: | | | | | | |
| 1.170.1 | — | Beans (Vigna spp., Phaseolus spp.)
  ex 0708 20 00 |

Code

Description

Amount of unit values per 100 kg

Species, varieties, CN code

EUR

LTL

SEK

CYP

LVL

GBP

CZK

MTL

DKK

PLN

EEK

SIT

HUF

SKK

1.10

New potatoes

0701 90 50

59,80

34,73

1 812,23

444,93

935,72

14 865,98

206,49

41,67

25,89

244,67

14 339,11

2 308,90

540,01

42,03

1.30

Onions (other than seed)

0703 10 19

7,28

4,23

220,61

54,16

113,91

1 809,66

25,14

5,07

3,15

29,78

1 745,53

281,07

65,74

5,12

1.40

Garlic

0703 20 00

123,62

71,79

3 746,07

919,72

1 934,24

30 729,53

426,84

86,14

53,52

505,76

29 640,44

4 772,73

1 116,27

86,88

1.50

Leeks

ex 0703 90 00

57,07

33,14

1 729,35

424,59

892,93

14 186,14

197,05

39,77

24,71

233,48

13 683,36

2 203,31

515,32

40,11

1.60

Cauliflowers

0704 10 00

—

—

—

—

—

—

1.80

White cabbages and red cabbages

0704 90 10

48,73

28,30

1 476,67

362,55

762,46

12 113,30

168,25

33,96

21,10

199,36

11 683,99

1 881,37

440,02

34,25

1.90

Sprouting broccoli or calabrese (Brassica oleracea L. convar. botrytis (L.) Alef var. italica Plenck)

ex 0704 90 90

61,43

35,67

1 861,51

457,03

961,17

15 270,27

212,11

42,80

26,59

251,32

14 729,07

2 371,69

554,70

43,17

1.100

Chinese cabbage

ex 0704 90 90

75,36

43,76

2 283,63

560,67

1 179,13

18 732,99

260,20

52,51

32,62

308,31

18 069,07

2 909,50

680,49

52,96

1.110

Cabbage lettuce (head lettuce)

0705 11 00

—

—

—

—

—

—

1.130

Carrots

ex 0706 10 00

26,74

15,53

810,30

198,94

418,39

6 647,03

92,33

18,63

11,58

109,40

6 411,45

1 032,38

241,46

18,79

1.140

Radishes

ex 0706 90 90

55,40

32,17

1 678,72

412,15

866,79

13 770,79

191,28

38,60

23,98

226,64

13 282,73

2 138,80

500,23

38,93

1.160

Peas (Pisum sativum)

0708 10 00

312,06

181,21

9 456,36

2 321,70

4 882,68

77 571,92

1 077,48

217,44

135,09

1 276,70

74 822,67

12 048,02

2 817,84

219,32

1.170

Beans:

1.170.1

—

Beans (Vigna spp., Phaseolus spp.)

ex 0708 20 00

144,43

83,87

4 376,62

1 074,54

2 259,82

35 902,09

498,68

100,64

62,52

590,89

34 629,67

5 576,10

1 304,16

101,50

1.170.2

| — | Beans (Phaseolus spp., vulgaris var. Compressus Savi)
  ex 0708 20 00 |
| --- | --- |

—

Beans (Phaseolus spp., vulgaris var. Compressus Savi)

ex 0708 20 00

141,05

81,91

4 274,24

1 049,40

2 206,95

35 062,21

487,02

98,28

61,06

577,06

33 819,56

5 445,66

1 273,65

99,13

1.180

Broad beans

ex 0708 90 00

—

—

—

—

—

—

1.190

Globe artichokes

0709 10 00

—

—

—

—

—

—

1.200

Asparagus:

1.200.1

| — | green
  ex 0709 20 00 |
| --- | --- |

—

green

ex 0709 20 00

244,91

142,22

7 421,53

1 822,11

3 832,02

60 879,88

845,63

170,65

106,02

1 001,98

58 722,21

9 455,51

2 211,49

172,12

1.200.2

| — | other
  ex 0709 20 00 |
| --- | --- |

—

other

ex 0709 20 00

552,28

320,71

16 735,87

4 108,94

8 641,37

137 286,81

1 906,93

384,83

239,08

2 259,51

132 421,18

21 322,59

4 987,02

388,15

1.210

Aubergines (eggplants)

0709 30 00

122,19

70,95

3 702,58

909,04

1 911,78

30 372,77

421,88

85,14

52,89

499,88

29 296,32

4 717,32

1 103,31

85,87

1.220

Ribbed celery (Apium graveolens L., var. dulce (Mill.) Pers.)

ex 0709 40 00

93,50

54,30

2 833,33

695,63

1 462,96

23 242,23

322,84

65,15

40,48

382,53

22 418,50

3 609,85

844,29

65,71

1.230

Chantarelles

0709 59 10

926,44

537,98

28 073,91

6 892,62

14 495,64

230 294,46

3 198,81

645,54

401,06

3 790,25

222 132,52

35 768,00

8 365,57

651,10

1.240

Sweet peppers

0709 60 10

142,68

82,86

4 323,76

1 061,56

2 232,52

35 468,46

492,66

99,42

61,77

583,75

34 211,41

5 508,76

1 288,41

100,28

1.250

Fennel

0709 90 50

—

—

—

—

—

—

1.270

Sweet potatoes, whole, fresh (intended for human consumption)

0714 20 10

93,68

54,40

2 838,85

696,99

1 465,81

23 287,52

323,47

65,28

40,56

383,27

22 462,18

3 616,88

845,93

65,84

2.10

Chestnuts (Castanea spp.) fresh

ex 0802 40 00

—

—

—

—

—

—

2.30

Pineapples, fresh

ex 0804 30 00

82,83

48,10

2 509,91

616,23

1 295,96

20 589,16

285,99

57,71

35,86

338,86

19 859,45

3 197,79

747,91

58,21

2.40

Avocados, fresh

ex 0804 40 00

127,32

73,94

3 858,29

947,27

1 992,18

31 650,10

439,62

88,72

55,12

520,91

30 528,38

4 915,71

1 149,71

89,48

2.50

Guavas and mangoes, fresh

ex 0804 50

—

—

—

—

—

—

2.60

Sweet oranges, fresh:

2.60.1

| — | Sanguines and semi-sanguines
  0805 10 10 |
| --- | --- |

—

Sanguines and semi-sanguines

0805 10 10

—

—

—

—

—

—

—

—

—

—

—

—

—

—

2.60.2

| — | Navels, navelines, navelates, salustianas, vernas, Valencia lates, Maltese, shamoutis, ovalis, trovita and hamlins
  0805 10 30 |
| --- | --- |

—

Navels, navelines, navelates, salustianas, vernas, Valencia lates, Maltese, shamoutis, ovalis, trovita and hamlins

0805 10 30

—

—

—

—

—

—

—

—

—

—

—

—

—

—

2.60.3

| — | Others
  0805 10 50 |
| --- | --- |

—

Others

0805 10 50

—

—

—

—

—

—

—

—

—

—

—

—

—

—

2.70

Mandarins (including tangerines and satsumas), fresh; clementines, wilkings and similar citrus hybrids, fresh:

2.70.1

| — | Clementines
  ex 0805 20 10 |
| --- | --- |

—

Clementines

ex 0805 20 10

—

—

—

—

—

—

—

—

—

—

—

—

—

—

2.70.2

| — | Monreales and satsumas
  ex 0805 20 30 |
| --- | --- |

—

Monreales and satsumas

ex 0805 20 30

—

—

—

—

—

—

—

—

—

—

—

—

—

—

2.70.3

| — | Mandarines and wilkings
  ex 0805 20 50 |
| --- | --- |

—

Mandarines and wilkings

ex 0805 20 50

—

—

—

—

—

—

—

—

—

—

—

—

—

—

2.70.4

| — | Tangerines and others
  ex 0805 20 70
  ex 0805 20 90 |
| --- | --- |

—

Tangerines and others

ex 0805 20 70

ex 0805 20 90

—

—

—

—

—

—

—

—

—

—

—

—

—

—

2.85

Limes (Citrus aurantifolia, Citrus latifolia), fresh

0805 50 90

172,79

100,34

5 236,07

1 285,54

2 703,58

42 952,26

596,61

120,40

74,80

706,92

41 429,98

6 671,10

1 560,26

121,44

2.90

Grapefruit, fresh:

2.90.1

| — | white
  ex 0805 40 00 |
| --- | --- |

—

white

ex 0805 40 00

71,36

41,44

2 162,42

530,91

1 116,54

17 738,67

246,39

49,72

30,89

291,95

17 109,99

2 755,07

644,37

50,15

2.90.2

| — | pink
  ex 0805 40 00 |
| --- | --- |

—

pink

ex 0805 40 00

79,23

46,01

2 400,84

589,45

1 239,65

19 694,47

273,56

55,21

34,30

324,14

18 996,47

3 058,83

715,41

55,68

2.100

Table grapes

0806 10 10

216,38

125,65

6 557,03

1 609,86

3 385,65

53 788,29

747,12

150,78

93,67

885,26

51 881,96

8 354,08

1 953,89

152,07

2.110

Water melons

0807 11 00

38,25

22,21

1 159,09

284,58

598,48

9 508,19

132,07

26,65

16,56

156,49

9 171,20

1 476,76

345,39

26,88

2.120

Melons (other than water melons):

2.120.1

| — | Amarillo, cuper, honey dew (including cantalene), onteniente, piel de sapo (including verde liso), rochet, tendral, futuro
  ex 0807 19 00 |
| --- | --- |

—

Amarillo, cuper, honey dew (including cantalene), onteniente, piel de sapo (including verde liso), rochet, tendral, futuro

ex 0807 19 00

59,59

34,60

1 805,66

443,32

932,33

14 812,06

205,74

41,52

25,80

243,78

14 287,10

2 300,52

538,06

41,88

2.120.2

| — | Other
  ex 0807 19 00 |
| --- | --- |

—

Other

ex 0807 19 00

97,96

56,89

2 968,50

728,82

1 532,75

24 351,07

338,24

68,26

42,41

400,78

23 488,04

3 782,07

884,57

68,85

2.140

Pears

2.140.1

| — | Pears — nashi (Pyrus pyrifolia),
  Pears — Ya (Pyrus bretscheideri)
  ex 0808 20 50 |
| --- | --- |

—

Pears — nashi (Pyrus pyrifolia),

Pears — Ya (Pyrus bretscheideri)

ex 0808 20 50

—

—

—

—

—

—

—

—

—

—

—

—

—

—

2.140.2

| — | Other
  ex 0808 20 50 |
| --- | --- |

—

Other

ex 0808 20 50

—

—

—

—

—

—

—

—

—

—

—

—

—

—

2.150

Apricots

0809 10 00

128,37

74,55

3 890,13

955,09

2 008,62

31 911,31

443,25

89,45

55,57

525,21

30 780,33

4 956,28

1 159,20

90,22

2.160

Cherries

0809 20 95

0809 20 05

480,07

278,78

14 547,55

3 571,67

7 511,46

119 335,68

1 657,58

334,51

207,82

1 964,06

115 106,26

18 534,52

4 334,93

337,39

2.170

Peaches

0809 30 90

203,78

118,33

6 175,09

1 516,09

3 188,43

50 655,16

703,61

141,99

88,22

833,70

48 859,88

7 867,46

1 840,08

143,22

2.180

Nectarines

ex 0809 30 10

158,91

92,28

4 815,53

1 182,29

2 486,44

39 502,47

548,69

110,73

68,79

650,14

38 102,45

6 135,29

1 434,95

111,68

2.190

Plums

0809 40 05

166,89

96,91

5 057,31

1 241,65

2 611,28

41 485,84

576,24

116,29

72,25

682,79

40 015,53

6 443,34

1 507,00

117,29

2.200

Strawberries

0810 10 00

179,43

104,19

5 437,20

1 334,92

2 807,44

44 602,16

619,53

125,03

77,67

734,08

43 021,40

6 927,35

1 620,20

126,10

2.205

Raspberries

0810 20 10

304,95

177,08

9 240,90

2 268,80

4 771,43

75 804,47

1 052,93

212,49

132,01

1 247,61

73 117,86

11 773,51

2 753,64

214,32

2.210

Fruit of the species Vaccinium myrtillus

0810 40 30

988,97

574,29

29 968,76

7 357,84

15 474,02

245 838,16

3 414,72

689,11

428,13

4 046,07

237 125,34

38 182,15

8 930,20

695,05

2.220

Kiwi fruit (Actinidia chinensis Planch.)

0810 50 00

142,14

82,54

4 307,27

1 057,51

2 224,01

35 333,16

490,78

99,04

61,53

581,52

34 080,91

5 487,74

1 283,50

99,90

2.230

Pomegranates

ex 0810 90 95

170,93

99,26

5 179,69

1 271,70

2 674,47

42 489,78

590,19

119,10

74,00

699,31

40 983,89

6 599,27

1 543,46

120,13

2.240

Khakis (including sharon fruit)

ex 0810 90 95

111,15

64,54

3 368,08

826,92

1 739,07

27 628,85

383,77

77,45

48,12

454,72

26 649,64

4 291,15

1 003,63

78,11

2.250

Lychees

ex 0810 90

—

—

—

—

—

—

---

| 13.1.2005 | EN | Official Journal of the European Union | L 10/9 |
| --- | --- | --- | --- |

13.1.2005

EN

Official Journal of the European Union

L 10/9

---

COMMISSION REGULATION (EC) No 36/2005

of 12 January 2005

amending Annexes III and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards epidemio-surveillance for transmissible spongiform encephalopathies in bovine, ovine and caprine animals

(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 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (1), and in particular Article 23 thereof,

Whereas:

| (1) | Regulation (EC) No 999/2001 lays down rules for the monitoring of transmissible spongiform encephalopathies (TSEs) in bovine, ovine and caprine animals. |
| --- | --- |

(1)

Regulation (EC) No 999/2001 lays down rules for the monitoring of transmissible spongiform encephalopathies (TSEs) in bovine, ovine and caprine animals.

| (2) | In its opinion of 4 and 5 April 2002 on a strategy to investigate the possible presence of bovine spongiform encephalopathy (BSE) in small ruminants, the Scientific Steering Committee (SSC) recommended a strategy for such investigation concerning the Community’s small ruminant population. |
| --- | --- |

(2)

In its opinion of 4 and 5 April 2002 on a strategy to investigate the possible presence of bovine spongiform encephalopathy (BSE) in small ruminants, the Scientific Steering Committee (SSC) recommended a strategy for such investigation concerning the Community’s small ruminant population.

| (3) | A panel of experts on strain typing has been assembled by the Community Reference Laboratory (CRL) for TSEs for further defining the strategy recommended by the SSC. The strategy includes firstly implementing a screening method of all confirmed TSE cases in small ruminants at the level of the national reference laboratories. Secondly, a ring trial with at least three different methods in selected laboratories under the heading of the CRL to be carried out on all cases in which the first screening test could not exclude BSE. Finally, mouse strain typing is required if the outcome of the molecular typing methods needs confirmation. |
| --- | --- |

(3)

A panel of experts on strain typing has been assembled by the Community Reference Laboratory (CRL) for TSEs for further defining the strategy recommended by the SSC. The strategy includes firstly implementing a screening method of all confirmed TSE cases in small ruminants at the level of the national reference laboratories. Secondly, a ring trial with at least three different methods in selected laboratories under the heading of the CRL to be carried out on all cases in which the first screening test could not exclude BSE. Finally, mouse strain typing is required if the outcome of the molecular typing methods needs confirmation.

| (4) | It is necessary to ensure that brain material of an optimal quality and in sufficient quantity from positive scrapie cases is delivered to the laboratories carrying out confirmatory examinations. |
| --- | --- |

(4)

It is necessary to ensure that brain material of an optimal quality and in sufficient quantity from positive scrapie cases is delivered to the laboratories carrying out confirmatory examinations.

| (5) | When molecular typing of confirmed scrapie cases reveals a BSE-like or unusual isolate, it is desirable that the competent authority should have access to brain material from other infected animals on the holding, to further assist the investigation of the case. |
| --- | --- |

(5)

When molecular typing of confirmed scrapie cases reveals a BSE-like or unusual isolate, it is desirable that the competent authority should have access to brain material from other infected animals on the holding, to further assist the investigation of the case.

| (6) | Four laboratories have successfully participated in a ring trial conducted by the CRL between July 2003 and March 2004 to test their proficiency in using molecular typing methods. The CRL should organise proficiency testing for other laboratories in the use of one of these molecular typing methods before April 2005. |
| --- | --- |

(6)

Four laboratories have successfully participated in a ring trial conducted by the CRL between July 2003 and March 2004 to test their proficiency in using molecular typing methods. The CRL should organise proficiency testing for other laboratories in the use of one of these molecular typing methods before April 2005.

| (7) | In the meantime, in view of the necessity to extend and accelerate the monitoring of caprine animals following a suspect case found in a goat, and considering the information forwarded to the CRL panel of experts by the laboratories of certain Member States on their capacity to carry out molecular testing, those laboratories should be provisionally approved for such testing pending the results of the proficiency test. |
| --- | --- |

(7)

In the meantime, in view of the necessity to extend and accelerate the monitoring of caprine animals following a suspect case found in a goat, and considering the information forwarded to the CRL panel of experts by the laboratories of certain Member States on their capacity to carry out molecular testing, those laboratories should be provisionally approved for such testing pending the results of the proficiency test.

| (8) | Member States are submitting monthly TSE reports on a voluntary basis in addition to the annual report required by Article 6(4) of Regulation (EC) No 999/2001. The information forwarded in the annual and monthly reports should be harmonised and additional information, in particular on the age distribution of tested bovine animals, should be provided in order to evaluate the prevalence of BSE in different age groups. |
| --- | --- |

(8)

Member States are submitting monthly TSE reports on a voluntary basis in addition to the annual report required by Article 6(4) of Regulation (EC) No 999/2001. The information forwarded in the annual and monthly reports should be harmonised and additional information, in particular on the age distribution of tested bovine animals, should be provided in order to evaluate the prevalence of BSE in different age groups.

| (9) | Regulation (EC) No 999/2001 should therefore be amended accordingly. |
| --- | --- |

(9)

Regulation (EC) No 999/2001 should therefore be amended accordingly.

| (10) | In view of the increasing urgency to differentiate BSE from scrapie, the amendments made by this Regulation should enter into force without delay. |
| --- | --- |

(10)

In view of the increasing urgency to differentiate BSE from scrapie, the amendments made by this Regulation should enter into force without delay.

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(11)

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

Annexes III and X to Regulation (EC) No 999/2001 are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 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, 12 January 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

---

(1)  
  OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 1993/2004 (OJ L 344, 20.11.2004, p. 12).

1

---

ANNEX

Annexes III and X to Regulation (EC) No 999/2001 are amended as follows:

| 1. | In Annex III, Chapter A, Part II and III and Chapter B, Part I are replaced by the following:
  ‘II.   MONITORING IN OVINE AND CAPRINE ANIMALS
  1.   General
  Monitoring in ovine and caprine animals shall be carried out in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2.(b).
  2.   Monitoring in ovine animals slaughtered for human consumption
  Member States in which the population of ewes and ewe lambs put to the ram exceeds 750 000 animals shall test in accordance with the sampling rules laid down in point 4 a minimum annual sample of 10 000 ovine animals slaughtered for human consumption (*1).
  3.   Monitoring in ovine and caprine animals not slaughtered for human consumption
  Member States shall test in accordance with the sampling rules laid down in point 4 and the sample sizes indicated in table A and table B respectively, ovine and caprine animals which have died or been killed, but which were not:






  — | killed in the framework of a disease eradication campaign, or |
| --- | --- | --- |

1.

In Annex III, Chapter A, Part II and III and Chapter B, Part I are replaced by the following:

‘II.   MONITORING IN OVINE AND CAPRINE ANIMALS

1.   General

Monitoring in ovine and caprine animals shall be carried out in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2.(b).

2.   Monitoring in ovine animals slaughtered for human consumption

Member States in which the population of ewes and ewe lambs put to the ram exceeds 750 000 animals shall test in accordance with the sampling rules laid down in point 4 a minimum annual sample of 10 000 ovine animals slaughtered for human consumption (*1).

3.   Monitoring in ovine and caprine animals not slaughtered for human consumption

Member States shall test in accordance with the sampling rules laid down in point 4 and the sample sizes indicated in table A and table B respectively, ovine and caprine animals which have died or been killed, but which were not:

—

killed in the framework of a disease eradication campaign, or

| — | slaughtered for human consumption. |
| --- | --- |

—

slaughtered for human consumption.

Table A

| Member State population of ewes and ewe lambs put to the ram | Minimum sample size of dead ovine animals (1) |
| --- | --- |
| > 750 000 | 10 000 |
| 100 000 -750 000 | 1 500 |
| 40 000 -100 000 | 500 |
| < 40 000 | 100 |

Member State population of ewes and ewe lambs put to the ram

Minimum sample size of dead ovine animals (1)

> 750 000

10 000

100 000 -750 000

1 500

40 000 -100 000

500

< 40 000

100

Table B

| Member State population of goats which have already kidded and goats mated | Minimum sample size of dead caprine animals (2) |
| --- | --- |
| > 750 000 | 5 000 |
| 250 000 -750 000 | 1 500 |
| 40 000 -250 000 | 500 |
| < 40 000 | 50 |

Member State population of goats which have already kidded and goats mated

Minimum sample size of dead caprine animals (2)

> 750 000

5 000

250 000 -750 000

1 500

40 000 -250 000

500

< 40 000

50

4.   Sampling rules applicable to the animals referred to in points 2 and 3

The animals shall be over 18 months of age or have more than two permanent incisors erupted through the gum.

The age of the animals shall be estimated on the basis of dentition, obvious signs of maturity, or any other reliable information.

The sample selection shall be designed with a view to avoid the over-representation of any group as regards the origin, age, breed, production type or any other characteristic.

Multiple sampling in the same flock shall be avoided, wherever possible.

The Member States shall put in place a system to check, on a targeted or other basis, that animals are not being diverted from sampling.

The sampling shall be representative for each region and season.

However, Member States may decide to exclude from the sampling remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this derogation shall inform the Commission thereof, and shall submit a list of those remote areas where the derogation applies. The derogation shall not cover more than 10 % of the ovine and caprine population in the Member State concerned.

5.   Monitoring in infected flocks

From 1 October 2003, animals over 12 months or which have a permanent incisor erupted through the gum, and which are killed for destruction in accordance with the provisions of Annex VII, point 2(b)(i) or (ii) or point 2(c), shall be tested based on the selection of a simple random sample, in accordance with the sample size indicated in the following table.

| Number of animals over 12 months or which have a permanent incisor erupted through the gum, killed for destruction in the herd or flock | Minimum sample size |
| --- | --- |
| 70 or less | All eligible animals |
| 80 | 68 |
| 90 | 73 |
| 100 | 78 |
| 120 | 86 |
| 140 | 92 |
| 160 | 97 |
| 180 | 101 |
| 200 | 105 |
| 250 | 112 |
| 300 | 117 |
| 350 | 121 |
| 400 | 124 |
| 450 | 127 |
| 500 or more | 150 |

Number of animals over 12 months or which have a permanent incisor erupted through the gum, killed for destruction in the herd or flock

Minimum sample size

70 or less

All eligible animals

80

68

90

73

100

78

120

86

140

92

160

97

180

101

200

105

250

112

300

117

350

121

400

124

450

127

500 or more

150

Where possible, the killing and subsequent sampling shall be delayed until the result of primary molecular testing carried out for the further examination of positive scrapie cases under the provisions of Annex X, Chapter C, point 3.2.(c)(i) is known.

6.   Monitoring in other animals

In addition to the monitoring programmes set out in points 2, 3 and 4, Member States may on a voluntary basis carry out monitoring in other animals, in particular:

| — | animals used for dairy production, |
| --- | --- |

—

animals used for dairy production,

| — | animals originating from countries with indigenous TSEs, |
| --- | --- |

—

animals originating from countries with indigenous TSEs,

| — | animals which have consumed potentially contaminated feedingstuffs, |
| --- | --- |

—

animals which have consumed potentially contaminated feedingstuffs,

| — | animals born or derived from TSE infected dams. |
| --- | --- |

—

animals born or derived from TSE infected dams.

7.   Measures following testing of ovine and caprine animals

| 7.1. | Where an ovine or caprine animal slaughtered for human consumption has been selected for TSE testing in accordance with point 2, its carcase shall not be marked with the health marking provided for in Chapter XI of Annex I to Directive 64/433/EEC until a negative result to the rapid test has been obtained. |
| --- | --- |

7.1.

| 7.2. | Member States may derogate from point 7.1. where a system approved by the competent authority is in place in the slaughterhouse ensuring that all parts of an animal can be traced and that no parts of the animals tested bearing the health mark can leave the slaughterhouse until a negative result to the rapid test has been obtained. |
| --- | --- |

7.2.

| 7.3. | All parts of the body of a tested animal, including the hide, shall be retained under official control until a negative result has been obtained to the rapid test, except for animal by-products directly disposed of in accordance with Articles 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002. |
| --- | --- |

7.3.

| 7.4. | Except for the material to be retained in conjunction with the records provided for in Chapter B, Part III of this Annex, all parts of the body of an animal found positive to the rapid test, including the hide, shall be directly disposed of in accordance with Articles 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002. |
| --- | --- |

7.4.

8.   Genotyping

| 8.1. | The prion protein genotype shall be determined for each positive TSE case in sheep. TSE cases found in resistant genotypes (sheep of genotypes which encode alanine on both alleles at codon 136, arginine on both alleles at codon 154 and arginine on both alleles at codon 171) shall immediately be reported to the Commission. Where possible, such cases shall be submitted for strain-typing. Where strain-typing of such cases is not possible, the herd of origin and all other herds where the animal has been kept shall be subjected to enhanced monitoring with a view to finding other TSE cases for strain-typing. |
| --- | --- |

8.1.

| 8.2. | In addition to the animals genotyped under the provisions of point 8.1., the prion protein genotype of a minimum sample of ovine animals shall be determined. In the case of Member States with an adult sheep population of more than 750 000 adult animals, this minimum sample shall consist of at least 600 animals. In the case of other Member States the minimum sample shall consist of at least 100 animals. The samples may be chosen from animals slaughtered for human consumption, from animals dead-on farm or from live animals. The sampling should be representative of the entire ovine population. |
| --- | --- |

8.2.

III.   MONITORING IN OTHER ANIMAL SPECIES

Member States may on a voluntary basis carry out monitoring for TSEs in animal species other than bovine, ovine and caprine animals.’

(*1)  The minimum sample size has been calculated to detect a prevalence in slaughtered animals of 0,03 % with a 95 % confidence."

‘CHAPTER B

REPORTING AND RECORDING REQUIREMENTS

I.   REQUIREMENTS ON MEMBER STATES

A.   Information to be presented by Member States in their annual report as provided for in Article 6(4)

| 1. | The number of suspected cases placed under official movement restrictions in accordance with Article 12(1), per animal species. |
| --- | --- |

1.

| 2. | The number of suspected cases subject to laboratory examination in accordance with Article 12(2), per animal species, including the results of the rapid and confirmatory tests (number of positives and negatives) and, with regard to bovine animals, an estimation of the age distribution of all tested animals. The age distribution should be grouped whenever possible as follows: “below 24 months”, distribution per 12 months between 24 and 155 months, and “above 155 months” of age. |
| --- | --- |

2.

| 3. | The number of flocks where suspected cases in ovine and caprine animals have been reported and investigated pursuant to Article 12(1) and (2). |
| --- | --- |

3.

| 4. | The number of bovine animals tested within each subpopulation referred to in Chapter A, Part (I), points 2.1., 2.2., 2.3., 3.1., 4.1., 4.2., 4.3. and 5. The method for the sample selection, the results of the rapid and confirmatory tests and an estimation of the age distribution of the tested animals grouped as set out in point 2 shall be provided. |
| --- | --- |

4.

| 5. | The number of ovine and caprine animals and flocks tested within each subpopulation referred to in Chapter A, Part II, points 2, 3 and 5 together with the method for sample selection and the results of the rapid and confirmatory tests. |
| --- | --- |

5.

| 6. | The geographical distribution, including the country of origin if not the same as the reporting country, of positive cases of BSE and scrapie. The year, and where possible the month of birth shall be given for each TSE case in bovine, ovine and caprine animals. TSE cases which have been considered atypical and the reasons why shall be indicated. For scrapie cases, the results of the primary molecular testing with a discriminatory immuno-blotting, referred to in Annex X, Chapter C, point 3.2.(c)(i), shall be reported. |
| --- | --- |

6.

| 7. | In animals other than bovine, ovine and caprine, the number of samples and confirmed TSE cases per species. |
| --- | --- |

7.

| 8. | The genotype, and where possible the breed, of each ovine animal either found positive to TSE or sampled in accordance with Chapter A, Part II, points 8.1. and 8.2. |
| --- | --- |

8.

B.   Reporting periods

The compilation of reports containing the information referred to in A and forwarded to the Commission on a monthly basis or, with regard to the information referred to in point 8 on a quarterly basis, may constitute the annual report as required by Article 6(4), provided that the information is updated whenever additional information becomes available.’

| 2. | In Annex X, Chapter C is replaced by the following:

  ‘CHAPTER C
  Sampling and laboratory testing
  1.   Sampling
  Any samples intended to be examined for the presence of a TSE shall be collected using the methods and protocols laid down in the latest edition of the Manual for diagnostic tests and vaccines for Terrestrial Animals of the International Office for Epizooties (IOE/OIE) (“the Manual”). In the absence of OIE methods and protocols, and to ensure that sufficient material is available, the competent authority shall ensure the use of sampling methods and protocols in accordance with guidelines issued by the Community Reference Laboratory. In particular the competent authority shall try to collect part of the cerebellum and the whole brain stem of small ruminants and shall keep at least half of the collected tissues fresh but not frozen until the result of the rapid or confirmatory test is negative.
  The samples shall be correctly marked as to the identity of the sampled animal.
  2.   Laboratories
  Any laboratory examination for TSE shall be carried out in laboratories approved for that purpose by the competent authority.
  3.   Methods and protocols
  3.1.   Laboratory testing for the presence of BSE in bovine animals
  (a)   Suspect cases
  Samples from bovine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall be subject to a histopathological examination as laid down in the latest edition of the Manual, except where the material is autolysed. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the tissues shall be subjected to an examination by one of the other diagnostic methods laid down in the Manual (immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy). However, rapid tests cannot be used for this purpose.
  If the result of one of those examinations is positive, the animals shall be regarded a positive BSE case.
  (b)   BSE monitoring
  Samples from bovine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part I (Monitoring in bovine animals) shall be examined by a rapid test.
  When the result of the rapid test is inconclusive or positive, the sample shall immediately be subject to confirmatory examinations in an official laboratory. The confirmatory examination shall start by a histopathological examination of the brainstem as laid down in the latest edition of the Manual, except where the material is autolysed or otherwise not suitable for examination by histopathology. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the sample shall be subjected to an examination by one of the other diagnostic methods referred to in (a).
  An animal shall be regarded a positive BSE case, if the result of the rapid test is positive or inconclusive, and either






  — | the result of the subsequent histopathological examination is positive, or |
| --- | --- | --- |

2.

In Annex X, Chapter C is replaced by the following:

‘CHAPTER C

Sampling and laboratory testing

1.   Sampling

Any samples intended to be examined for the presence of a TSE shall be collected using the methods and protocols laid down in the latest edition of the Manual for diagnostic tests and vaccines for Terrestrial Animals of the International Office for Epizooties (IOE/OIE) (“the Manual”). In the absence of OIE methods and protocols, and to ensure that sufficient material is available, the competent authority shall ensure the use of sampling methods and protocols in accordance with guidelines issued by the Community Reference Laboratory. In particular the competent authority shall try to collect part of the cerebellum and the whole brain stem of small ruminants and shall keep at least half of the collected tissues fresh but not frozen until the result of the rapid or confirmatory test is negative.

The samples shall be correctly marked as to the identity of the sampled animal.

2.   Laboratories

Any laboratory examination for TSE shall be carried out in laboratories approved for that purpose by the competent authority.

3.   Methods and protocols

3.1.   Laboratory testing for the presence of BSE in bovine animals

(a)   Suspect cases

Samples from bovine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall be subject to a histopathological examination as laid down in the latest edition of the Manual, except where the material is autolysed. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the tissues shall be subjected to an examination by one of the other diagnostic methods laid down in the Manual (immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy). However, rapid tests cannot be used for this purpose.

If the result of one of those examinations is positive, the animals shall be regarded a positive BSE case.

(b)   BSE monitoring

Samples from bovine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part I (Monitoring in bovine animals) shall be examined by a rapid test.

When the result of the rapid test is inconclusive or positive, the sample shall immediately be subject to confirmatory examinations in an official laboratory. The confirmatory examination shall start by a histopathological examination of the brainstem as laid down in the latest edition of the Manual, except where the material is autolysed or otherwise not suitable for examination by histopathology. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the sample shall be subjected to an examination by one of the other diagnostic methods referred to in (a).

An animal shall be regarded a positive BSE case, if the result of the rapid test is positive or inconclusive, and either

—

the result of the subsequent histopathological examination is positive, or

| — | the result of another diagnostic method referred to in (a) is positive. |
| --- | --- |

—

the result of another diagnostic method referred to in (a) is positive.

3.2.   Laboratory testing for the presence of TSE in ovine and caprine animals

(a)   Suspect cases

Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall be subject to a histopathological examination as laid down in the latest edition of the Manual, except where the material is autolysed. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the sample shall be subjected to an examination by immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy, as laid down in the Manual. However, rapid tests cannot be used for this purpose.

If the result of one of those examinations is positive, the animal shall be regarded a positive scrapie case.

(b)   Scrapie monitoring

Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part II (Monitoring in ovine and caprine animals) shall be examined by a rapid test.

When the result of the rapid test is inconclusive or positive, the brainstem shall immediately be sent to an official laboratory for confirmatory examinations by immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy, as referred to in (a). If the result of the confirmatory examination is negative or inconclusive, additional confirmatory testing shall be carried out according the guidelines of the Community Reference Laboratory.

If the result of one of the confirmatory examination is positive, the animal shall be regarded a positive scrapie case.

(c)   Further examination of positive scrapie cases

| (i) | Primary molecular testing with a discriminatory immuno-blotting
  Samples from clinical suspect cases and from animals tested in accordance with Annex III, Chapter A, Part II, points 2 and 3 which are regarded as positive scrapie cases following the examinations referred to in points (a) or (b), or which display characteristics which are deemed by the testing laboratory to merit investigation, shall be forwarded for further examination by a primary molecular typing method to:






  — | Agence Française de Sécurité Sanitaire des Aliments, Laboratoire de pathologie bovine, 31, avenue Tony Garnier, BP 7033, F-69342, Lyon Cedex, France, or |
| --- | --- | --- |

(i)

Primary molecular testing with a discriminatory immuno-blotting

Samples from clinical suspect cases and from animals tested in accordance with Annex III, Chapter A, Part II, points 2 and 3 which are regarded as positive scrapie cases following the examinations referred to in points (a) or (b), or which display characteristics which are deemed by the testing laboratory to merit investigation, shall be forwarded for further examination by a primary molecular typing method to:

—

Agence Française de Sécurité Sanitaire des Aliments, Laboratoire de pathologie bovine, 31, avenue Tony Garnier, BP 7033, F-69342, Lyon Cedex, France, or

| — | Veterinary Laboratories Agency, Woodham Lane, New Haw, Addlestone, Surrey KT15 3NB, United Kingdom, or |
| --- | --- |

—

Veterinary Laboratories Agency, Woodham Lane, New Haw, Addlestone, Surrey KT15 3NB, United Kingdom, or

| — | to a laboratory, appointed by the competent authority, which has participated successfully in proficiency testing organised by the Community Reference Laboratory for the use of a molecular typing method, or |
| --- | --- |

—

to a laboratory, appointed by the competent authority, which has participated successfully in proficiency testing organised by the Community Reference Laboratory for the use of a molecular typing method, or

| — | on a provisional basis until 1 May 2005, the laboratories approved for this purpose by the CRL panel of experts. |
| --- | --- |

—

on a provisional basis until 1 May 2005, the laboratories approved for this purpose by the CRL panel of experts.

| (ii) | Ring trial with additional molecular testing methods
  Samples from scrapie cases in which the presence of BSE cannot be excluded according to the guidelines issued by the Community Reference Laboratory by the primary molecular testing referred to in (i), shall be forwarded immediately to the laboratories listed in point (d) after consultation with the Community Reference Laboratory, and with all the relevant information available. They shall be submitted to a ring trial with at least:






  — | a second discriminatory immuno-blotting, |
| --- | --- | --- |

(ii)

Ring trial with additional molecular testing methods

Samples from scrapie cases in which the presence of BSE cannot be excluded according to the guidelines issued by the Community Reference Laboratory by the primary molecular testing referred to in (i), shall be forwarded immediately to the laboratories listed in point (d) after consultation with the Community Reference Laboratory, and with all the relevant information available. They shall be submitted to a ring trial with at least:

—

a second discriminatory immuno-blotting,

| — | a discriminatory immunocytochemistry, and |
| --- | --- |

—

a discriminatory immunocytochemistry, and

| — | a discriminatory ELISA (Enzyme linked ImmunoSorbent Assay) |
| --- | --- |

—

a discriminatory ELISA (Enzyme linked ImmunoSorbent Assay)

carried out in the laboratories approved for the relevant method as listed in point (d). Where samples are unsuitable for immunocytochemistry, the Community Reference Laboratory will direct appropriate alternative testing within the ring trial.

The results shall be interpreted by the Community Reference Laboratory assisted by a panel of experts including a representative of the relevant National Reference Laboratory. The Commission shall be informed immediately about the outcome of that interpretation. Samples indicative for BSE by three different methods and samples inconclusive in the ring trial shall be further analysed by a mouse bioassay for final confirmation.

Further testing of samples taken from infected flocks on the same holding in accordance with the provisions of Annex III, Chapter A, Part II, point 5, shall be carried out in accordance with the advice of the Community Reference Laboratory, after consultation with the relevant National Reference Laboratory.

(d)   Laboratories approved for performing further examination by molecular typing methods

The laboratories approved for further molecular typing are:

| | Agence Française de Sécurité Sanitaire des Aliments |
| --- | --- |
| Laboratoire de pathologie bovine |
| 31, avenue Tony Garnier |
| BP 7033 |
| F-69342 Lyon Cedex |

Agence Française de Sécurité Sanitaire des Aliments

Laboratoire de pathologie bovine

31, avenue Tony Garnier

BP 7033

F-69342 Lyon Cedex

| | Centre CEA Fontenay-aux-Roses, BP 6 |
| --- | --- |
| F-92265 Fontenay-aux-Roses Cedex |

Centre CEA Fontenay-aux-Roses, BP 6

F-92265 Fontenay-aux-Roses Cedex

| | Service de Pharmacologie et d’Immunologie |
| --- | --- |
| Centre CEA Saclay, bâtiment 136 |
| F-91191 Gif-sur-Yvette Cedex |

Service de Pharmacologie et d’Immunologie

Centre CEA Saclay, bâtiment 136

F-91191 Gif-sur-Yvette Cedex

| | Veterinary Laboratories Agency |
| --- | --- |
| Woodham Lane |
| New Haw |
| Addlestone |
| Surrey KT15 3NB |
| United Kingdom |

Veterinary Laboratories Agency

Woodham Lane

New Haw

Addlestone

Surrey KT15 3NB

United Kingdom

3.3.   Laboratory testing for the presence of TSEs in species other than those referred to in points 3.1. and 3.2.

Where methods and protocols are established for tests carried out to confirm the suspected presence of a TSE in a species other than bovine, ovine and caprine, they shall include at least a histopathological examination of brain tissue. The competent authority may also require laboratory tests such as immunocytochemistry, immuno-blotting, demonstration of characteristic fibrils by electron microscopy or other methods designed to detect the disease associated form of the prion protein. In any case at least one other laboratory examination shall be carried out if the initial histopathological examination is negative or inconclusive. At least three different examinations shall be carried out in the event of the first appearance of the disease.

In particular, where BSE is suspected in a species other than bovine animals, samples shall be submitted for strain-typing, where possible.

4.   Rapid tests

For the purposes of carrying out the rapid tests in accordance with Article 5(3) and Article 6(1), the following methods shall be used as rapid tests:

| — | immuno-blotting test based on a western blotting procedure for the detection of the protease-resistant fragment PrPRes (Prionics-Check Western test), |
| --- | --- |

—

immuno-blotting test based on a western blotting procedure for the detection of the protease-resistant fragment PrPRes (Prionics-Check Western test),

| — | chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test), |
| --- | --- |

—

chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test),

| — | sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad TeSeE test, the former Bio-Rad Platelia test), |
| --- | --- |

—

sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad TeSeE test, the former Bio-Rad Platelia test),

| — | microplate based immunoassay (ELISA) which detects protease-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test), |
| --- | --- |

—

microplate based immunoassay (ELISA) which detects protease-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test),

| — | automated conformation-dependent immunoassay comparing the reactivity of a detection antibody to the protease-sensitive and protease-resistant forms of PrPSc (some fraction of the protease-resistant PrPSc is equivalent to PrPRes) and to PrPC (InPro CDI-5 test). |
| --- | --- |

—

automated conformation-dependent immunoassay comparing the reactivity of a detection antibody to the protease-sensitive and protease-resistant forms of PrPSc (some fraction of the protease-resistant PrPSc is equivalent to PrPRes) and to PrPC (InPro CDI-5 test).

The producer of the rapid tests must have a quality assurance system in place agreed by the Community Reference Laboratory, which ensures that the test performance does not change. The producer must provide the test protocol to the Community Reference Laboratory.

Modifications to rapid tests or to test protocols may only be made following advance notification to the Community Reference Laboratory, and provided that the Community Reference Laboratory finds that the modification does not reduce the sensitivity, specificity or reliability of the rapid test. That finding shall be communicated to the Commission and to the National Reference Laboratories.

5.   Alternative tests

(To be defined)’

---

(*1)  The minimum sample size has been calculated to detect a prevalence in slaughtered animals of 0,03 % with a 95 % confidence.’

---

(1)  Sample sizes are set to take account of the size of the ovine populations in the individual Member States and are intended to provide achievable targets. The sample sizes of 10 000, 1 500, 500 and 100 animals will allow the detection of a prevalence of 0,03 %, 0,2 %, 0,6 % and 3 % respectively with a 95 % confidence.

(2)  Sample sizes are set to take account of the size of the caprine populations in the individual Member States and are intended to provide achievable targets. The sample sizes of 5 000, 1 500, 500 and 50 animals will allow the detection of a prevalence of 0,06 %, 0,2 %, 0,6 % and 6 % respectively with a 95 % confidence. Where a Member State experiences difficulty in collecting sufficient numbers of dead caprine animals to reach its allotted sample size, it may choose to supplement its sample by testing caprine animals slaughtered for human consumption over the age of 18 months at the ratio of three caprine animals slaughtered for human consumption to one dead caprine animal.

---

| 13.1.2005 | EN | Official Journal of the European Union | L 10/18 |
| --- | --- | --- | --- |

13.1.2005

EN

Official Journal of the European Union

L 10/18

---

COMMISSION REGULATION (EC) No 37/2005

of 12 January 2005

on the monitoring of temperatures in the means of transport, warehousing and storage of quick-frozen foodstuffs intended for human consumption

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 89/108/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to quick-frozen foodstuffs for human consumption (1), and in particular Article 11 thereof,

Whereas:

| (1) | Commission Directive 92/1/EEC of 13 January 1992 on the monitoring of temperatures in the means of transport, warehousing and storage of quick-frozen foodstuffs intended for human consumption (2) provides requirements in order to ensure that temperatures required by Directive 89/108/EEC are fully maintained. |
| --- | --- |

(1)

Commission Directive 92/1/EEC of 13 January 1992 on the monitoring of temperatures in the means of transport, warehousing and storage of quick-frozen foodstuffs intended for human consumption (2) provides requirements in order to ensure that temperatures required by Directive 89/108/EEC are fully maintained.

| (2) | When Commission Directive 92/1/EEC was adopted, no European standard for instruments for monitoring temperatures in means of transport, warehousing and storage of quick-frozen foodstuffs had been established. |
| --- | --- |

(2)

When Commission Directive 92/1/EEC was adopted, no European standard for instruments for monitoring temperatures in means of transport, warehousing and storage of quick-frozen foodstuffs had been established.

| (3) | The European Committee for Standardisation established standards regarding the instruments for recording air temperatures and thermometers in 1999 and 2001. The use of those uniform standards would ensure that the equipment used for monitoring temperatures of foodstuffs complies with a harmonised set of technical requirements. |
| --- | --- |

(3)

The European Committee for Standardisation established standards regarding the instruments for recording air temperatures and thermometers in 1999 and 2001. The use of those uniform standards would ensure that the equipment used for monitoring temperatures of foodstuffs complies with a harmonised set of technical requirements.

| (4) | In order to facilitate a gradual application of those measures by operators, the use of measuring instruments installed according to legislation in force before the adoption of this Regulation should be allowed during a transitional period. |
| --- | --- |

(4)

In order to facilitate a gradual application of those measures by operators, the use of measuring instruments installed according to legislation in force before the adoption of this Regulation should be allowed during a transitional period.

| (5) | Commission Directive 92/1/EEC provides for a derogation as regards transport of quick-frozen foodstuffs by rail. This derogation is no longer justified and should be terminated after a transitional period. |
| --- | --- |

(5)

Commission Directive 92/1/EEC provides for a derogation as regards transport of quick-frozen foodstuffs by rail. This derogation is no longer justified and should be terminated after a transitional period.

| (6) | The imposition of temperature-recording requirements on small equipment used in retail trade would be excessive and therefore the existing derogations for retail display cabinets and small cold chambers used in retail outlets for storing stocks should be maintained. |
| --- | --- |

(6)

The imposition of temperature-recording requirements on small equipment used in retail trade would be excessive and therefore the existing derogations for retail display cabinets and small cold chambers used in retail outlets for storing stocks should be maintained.

| (7) | It is advisable to ensure the direct applicability of the new standards for measuring equipment and of the technical rules already contained in Directive 92/1/EEC. In the interest of consistency and uniformity of Community legislation it is appropriate to repeal Directive 92/1/EEC and replace it by this Regulation. |
| --- | --- |

(7)

It is advisable to ensure the direct applicability of the new standards for measuring equipment and of the technical rules already contained in Directive 92/1/EEC. In the interest of consistency and uniformity of Community legislation it is appropriate to repeal Directive 92/1/EEC and replace it by this Regulation.

| (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, |
| --- | --- |

(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

Subject matter and scope

This Regulation concerns the monitoring of the temperature in the means of transport, warehousing and storage used for quick-frozen foodstuffs.

Article 2

Monitoring and recording of the temperature

1.   The means of transport, warehousing and storage of quick-frozen foodstuffs shall be fitted with suitable recording instruments to monitor, at frequent and regular intervals, the air temperature to which the quick-frozen foodstuffs are subjected.

2.   From 1 January 2006, all measuring instruments used for the purpose of monitoring the temperature, as provided for in paragraph 1, shall comply with EN 12830, EN 13485 and EN 13486 standards. Food operators shall keep all relevant documents permitting verification that the instruments referred to above conform to the relevant EN standard.

However, measuring instruments installed up to 31 December 2005, according to legislation in force before the adoption of this Regulation, may continue to be used until 31 December 2009 at the latest.

3.   Temperature recording shall be dated and stored by the food operator for a period of at least one year, or for a longer period taking into account the nature and the shelf life of the quick-frozen foodstuffs.

Article 3

Derogations from Article 2

1.   By way of derogation from Article 2, the air temperature during storage in retail display cabinets, and in the course of local distribution, shall only be measured by at least one easily visible thermometer.

In the case of open retail cabinets:

| (a) | the maximum load line of the cabinet shall be clearly marked; |
| --- | --- |

(a)

the maximum load line of the cabinet shall be clearly marked;

| (b) | the thermometer shall indicate the temperature at the air return side at the level of that mark. |
| --- | --- |

(b)

the thermometer shall indicate the temperature at the air return side at the level of that mark.

2.   The competent authority may grant derogations from the requirement laid down in Article 2 in the case of cold store facilities of less than 10 m3 for storing stock in retail outlets, so as to permit the air temperature to be measured by an easily visible thermometer.

Article 4

Repeal

Commission Directive 92/1/EEC is repealed.

Article 5

Entry into force and applicability

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

Official Journal of the European Union

However, for transport by rail it shall apply from 1 January 2006.

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

Done at Brussels, 12 January 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

---

(1)  
  OJ L 40, 11.2.1989, p. 34. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

1

(2)  
  OJ L 34, 11.2.1992, p. 30.

2

---

| 13.1.2005 | EN | Official Journal of the European Union | L 10/20 |
| --- | --- | --- | --- |

13.1.2005

EN

Official Journal of the European Union

L 10/20

---

COMMISSION REGULATION (EC) No 38/2005

of 12 January 2005

fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and amending Regulation (EC) No 1484/95

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 2771/75 of 29 October 1975 on the common organisation of the market in eggs (1), and in particular Article 5(4) thereof,

Having regard to Council Regulation (EEC) No 2777/75 of 29 October 1975 on the common organisation of the market in poultrymeat (2), and in particular Article 5(4) thereof,

Having regard to Council Regulation (EEC) No 2783/75 of 29 October 1975 on the common system of trade for ovalbumin and lactalbumin (3), and in particular Article 3(4) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 1484/95 (4), fixes detailed rules for implementing the system of additional import duties and fixes representative prices in the poultrymeat and egg sectors and for egg albumin. |
| --- | --- |

(1)

Commission Regulation (EC) No 1484/95 (4), fixes detailed rules for implementing the system of additional import duties and fixes representative prices in the poultrymeat and egg sectors and for egg albumin.

| (2) | It results from regular monitoring of the information providing the basis for the verification of the import prices in the poultrymeat and egg sectors and for egg albumin that the representative prices for imports of certain products should be amended taking into account variations of prices according to origin. Therefore, representative prices should be published. |
| --- | --- |

(2)

It results from regular monitoring of the information providing the basis for the verification of the import prices in the poultrymeat and egg sectors and for egg albumin that the representative prices for imports of certain products should be amended taking into account variations of prices according to origin. Therefore, representative prices should be published.

| (3) | It is necessary to apply this amendment as soon as possible, given the situation on the market. |
| --- | --- |

(3)

It is necessary to apply this amendment as soon as possible, given the situation on the market.

| (4) | The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Poultrymeat and Eggs, |
| --- | --- |

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Poultrymeat and Eggs,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EC) No 1484/95 is hereby replaced by the Annex hereto.

Article 2

This Regulation shall enter into force on 13 January 2005.

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

Done at Brussels, 12 January 2005.

For the Commission

J. M. SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

---

(1)  
  OJ L 282, 1.11.1975, p. 49. Regulation as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

1

(2)  
  OJ L 282, 1.11.1975, p. 77. Regulation as last amended by Regulation (EC) No 806/2003.

2

(3)  
  OJ L 282, 1.11.1975, p. 104. Regulation as last amended by Commission Regulation (EC) No 2916/95 (OJ L 305, 19.12.1995, p. 49).

3

(4)  
  OJ L 145, 29.6.1995, p. 47. Regulation as last amended by Regulation (EC) No 2129/2004 (OJ L 368, 15.12.2004, p. 7).

4

---

ANNEX

to the Commission Regulation of 12 January 2005 fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and amending Regulation (EC) No 1484/95

‘ANNEX I

| CN code | Description | Representative price
  (EUR/100 kg) | Security referred to in Article 3(3)
  (EUR/100 kg) | Origin (1) |
| --- | --- | --- | --- | --- |
| 0207 12 90 | Chickens, plucked and drawn, without heads and feet and without necks, hearts, livers and gizzards, known as “65 % chickens”, or otherwise presented, frozen | 82,0 | 11 | 01 |
| 78,8 | 12 | 03 |
| 0207 14 10 | Boneless cuts of fowl of the species Gallus domesticus, frozen | 134,5 | 63 | 01 |
| 140,0 | 60 | 02 |
| 153,1 | 54 | 03 |
| 254,6 | 14 | 04 |
| 0207 25 10 | Turkeys, plucked and drawn, without heads and feet and without necks, hearts, livers and gizzards, know as “80 %” turkeys, frozen | 86,7 | 26 | 01 |
| 0207 27 10 | Boneless cuts of turkey, frozen | 180,7 | 38 | 01 |
| 240,0 | 17 | 04 |
| 1602 32 11 | Preparations of uncooked fowl of the species Gallus domesticus | 148,7 | 50 | 01 |
| 151,5 | 49 | 03 ’ |

CN code

Description

Representative price

(EUR/100 kg)

Security referred to in Article 3(3)

(EUR/100 kg)

Origin (1)

0207 12 90

Chickens, plucked and drawn, without heads and feet and without necks, hearts, livers and gizzards, known as “65 % chickens”, or otherwise presented, frozen

82,0

11

01

78,8

12

03

0207 14 10

Boneless cuts of fowl of the species Gallus domesticus, frozen

134,5

63

01

140,0

60

02

153,1

54

03

254,6

14

04

0207 25 10

Turkeys, plucked and drawn, without heads and feet and without necks, hearts, livers and gizzards, know as “80 %” turkeys, frozen

86,7

26

01

0207 27 10

Boneless cuts of turkey, frozen

180,7

38

01

240,0

17

04

1602 32 11

Preparations of uncooked fowl of the species Gallus domesticus

148,7

50

01

151,5

49

03 ’

---

(1)  Origin of imports:

1

| 01 | Brazil |
| --- | --- |
| 02 | Thailand |
| 03 | Argentina |
| 04 | Chile. |

01

Brazil

02

Thailand

03

Argentina

04

Chile.

---

II Acts whose publication is not obligatory

Council

| 13.1.2005 | EN | Official Journal of the European Union | L 10/22 |
| --- | --- | --- | --- |

13.1.2005

EN

Official Journal of the European Union

L 10/22

---

Information relating to the entry into force of the Agreement between the European Community and Canada on trade in wines and spirit drinks

The Agreement between the European Community and Canada on trade in wines and spirit drinks (1), entered into force on 1 June 2004, the procedures provided for in Article 41 of the Agreement having been completed on 27 April 2004.

---

(1)  
  OJ L 35 of 6.2.2004, p. 3.

1

---