# L_2005037EN.01000901.xml

| 10.2.2005 | EN | Official Journal of the European Union | L 37/9 |
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10.2.2005

EN

Official Journal of the European Union

L 37/9

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COMMISSION REGULATION (EC) No 214/2005

of 9 February 2005

amending Annex III to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards monitoring of transmissible spongiform encephalopathies in 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 the first paragraph of Article 23 thereof,

Whereas:

| (1) | Regulation (EC) No 999/2001 lays down rules for the monitoring of transmissible spongiform encephalopathies (TSE) in caprine animals. |
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(1)

Regulation (EC) No 999/2001 lays down rules for the monitoring of transmissible spongiform encephalopathies (TSE) in caprine animals.

| (2) | On 28 January 2005, a panel of experts on TSEs in small ruminants, chaired by the Community Reference laboratory for TSEs (CRL), confirmed the detection of bovine spongiform encephalopathy (BSE) in a goat slaughtered in France. It was the first case of BSE in a small ruminant under natural conditions. |
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(2)

On 28 January 2005, a panel of experts on TSEs in small ruminants, chaired by the Community Reference laboratory for TSEs (CRL), confirmed the detection of bovine spongiform encephalopathy (BSE) in a goat slaughtered in France. It was the first case of BSE in a small ruminant under natural conditions.

| (3) | The former Scientific Steering Committee (SSC) adopted during its meeting on 4-5 April 2002 an opinion on safe sourcing of small ruminant materials should BSE become likely in small ruminants. In its opinion, adopted during its meeting of 26 November 2003, the Scientific Panel on Biological Hazards of the European Food Safety Authority (EFSA) endorsed the statement of the SSC opinion with regard to the TSE-related safety of certain small ruminant products. In its statement of 28 January 2005, the above Panel of EFSA also stresses that the significance of this single case of BSE infection in a goat in France is yet to be assessed. In order to do so, the results of an increased monitoring of TSEs in goats will be essential. |
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(3)

The former Scientific Steering Committee (SSC) adopted during its meeting on 4-5 April 2002 an opinion on safe sourcing of small ruminant materials should BSE become likely in small ruminants. In its opinion, adopted during its meeting of 26 November 2003, the Scientific Panel on Biological Hazards of the European Food Safety Authority (EFSA) endorsed the statement of the SSC opinion with regard to the TSE-related safety of certain small ruminant products. In its statement of 28 January 2005, the above Panel of EFSA also stresses that the significance of this single case of BSE infection in a goat in France is yet to be assessed. In order to do so, the results of an increased monitoring of TSEs in goats will be essential.

| (4) | In line with the SSC and EFSA opinions and statement above, the monitoring of goats should be extended in order to improve Community eradication programmes. Those programmes also increase the level of consumer protection, although the safe sourcing of goat products is further assured by the current measures, in particular the provisions on the removal of specified risk materials, in Regulation (EC) No 999/2001. |
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(4)

In line with the SSC and EFSA opinions and statement above, the monitoring of goats should be extended in order to improve Community eradication programmes. Those programmes also increase the level of consumer protection, although the safe sourcing of goat products is further assured by the current measures, in particular the provisions on the removal of specified risk materials, in Regulation (EC) No 999/2001.

| (5) | The extended monitoring should be based on a recommendation for a statistically valid survey by the CRL in order to determine the prevalence of BSE in goats as soon as possible and to improve knowledge of the geographical and within-flock distribution. It should therefore apply to all Member States with a focus on the Member States affected by BSE. |
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(5)

The extended monitoring should be based on a recommendation for a statistically valid survey by the CRL in order to determine the prevalence of BSE in goats as soon as possible and to improve knowledge of the geographical and within-flock distribution. It should therefore apply to all Member States with a focus on the Member States affected by BSE.

| (6) | Regulation (EC) No 999/2001 should therefore be amended accordingly. |
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(6)

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

| (7) | In view of the importance to ensure the highest level of consumer protection and to evaluate the prevalence of BSE in goats, the amendments made by this Regulation should enter into force without delay. |
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(7)

In view of the importance to ensure the highest level of consumer protection and to evaluate the prevalence of BSE in goats, the amendments made by this Regulation should enter into force without delay.

| (8) | The monitoring programme in caprine animals should be reviewed after at least 6 months of effective monitoring and when the EFSA has delivered its opinion on a quantitative assessment of the residual risk posed by goat meat and meat products derived there from. |
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(8)

The monitoring programme in caprine animals should be reviewed after at least 6 months of effective monitoring and when the EFSA has delivered its opinion on a quantitative assessment of the residual risk posed by goat meat and meat products derived there from.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health Committee, |
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(9)

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

HAS ADOPTED THIS REGULATION:

Article 1

Annex III to Regulation (EC) No 999/2001 is 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, 9 February 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 36/2005 (OJ L 10, 13.1.2005, p. 9).

1

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ANNEX

In Annex III, in Part II of Chapter A, points 2 and 3 are replaced by the following:

‘2.   Monitoring in ovine and caprine animals slaughtered for human consumption

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

Ovine animals

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

| (b) | Caprine animals
  Member States shall test healthy slaughtered caprine animals in accordance with the sampling rules set out in point 4 and the minimum sample sizes listed in Table A.
  Where a Member State experiences difficulty in collecting sufficient numbers of healthy slaughtered caprine animals to reach its allotted minimum sample size, it may choose to replace a maximum of 50 % of its minimum sample size by testing dead caprine animals over the age of 18 months at the ratio of one to one and in addition to the minimum sample size set out in point 3.
  Table A






  Member State | Minimum sample size in healthy slaughtered caprine animals (1) |
| --- | --- | --- |
| Spain | 125 500 |
| France | 93 000 |
| Italy | 60 000 |
| Greece | 20 000 |
| Cyprus | 5 000 |
| Austria | 5 000 |
| Other Member States | all |

(b)

Caprine animals

Member States shall test healthy slaughtered caprine animals in accordance with the sampling rules set out in point 4 and the minimum sample sizes listed in Table A.

Where a Member State experiences difficulty in collecting sufficient numbers of healthy slaughtered caprine animals to reach its allotted minimum sample size, it may choose to replace a maximum of 50 % of its minimum sample size by testing dead caprine animals over the age of 18 months at the ratio of one to one and in addition to the minimum sample size set out in point 3.

Table A

Member State

Minimum sample size in healthy slaughtered caprine animals (1)

Spain

125 500

France

93 000

Italy

60 000

Greece

20 000

Cyprus

5 000

Austria

5 000

Other Member States

all

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

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

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

killed in the framework of a disease eradication campaign, or

| — | slaughtered for human consumption. |
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—

slaughtered for human consumption.

Table B

| 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 C

| Member State population of goats which have already kidded and goats mated | Minimum sample size of dead caprine animals (2) |
| --- | --- |
| > 750 000 | 10 000 |
| 250 000 -750 000 | 3 000 |
| 40 000 -250 000 | 1 000 |
| < 40 000 | 100 % up to 200’ |

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

Minimum sample size of dead caprine animals (2)

> 750 000

10 000

250 000 -750 000

3 000

40 000 -250 000

1 000

< 40 000

100 % up to 200’

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

1

(1)  Minimum sample sizes are set to take account of the size of the number of healthy slaughtered caprine animals and the prevalence of BSE in the individual Member State. They are also intended to provide achievable targets. The minimum sample sizes above 60 000 allow the detection of a prevalence of 0,0017 % with a 95 % confidence.

1

(1)  Minimum 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 minimum 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.

1

(2)  Minimum 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 minimum sample sizes of 10 000, 3 000, 1 000 and 200 animals will allow the detection of a prevalence of 0,03 %, 0,1 %, 0,3 % and 1,5 % respectively with a 95 % confidence.

2

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