30.12.2006   

EN

Official Journal of the European Union

L 404/1

(1)

Regulation (EC) No 999/2001 (3) is intended to provide a single legal framework for transmissible spongiform encephalopathies (TSEs) in the Community.

(2)

Regulation (EC) No 932/2005 of the European Parliament and of the Council of 8 June 2005 amending Regulation (EC) No 999/2001 as regards the extension of the period for transitional measures (4) prolonged the period of application of the transitional measures provided for in Regulation (EC) No 999/2001 until 1 July 2007 at the latest.

(3)

During the General Session of the World Organisation for Animal Health in May 2003, a Resolution was adopted to simplify the current international criteria for the classification of countries according to their Bovine Spongiform Encephalopathy (BSE) risk. A proposal was adopted at the General Session in May 2005. The Articles of Regulation (EC) No 999/2001 should be adapted to reflect the new internationally agreed categorisation system.

(4)

New developments concerning sampling and analysis will require comprehensive amendments to Annex X to Regulation (EC) No 999/2001. It is therefore necessary to make certain technical amendments to the existing definition of ‘rapid tests’ in Regulation (EC) No 999/2001 in order to facilitate amendment of the structure of that Annex at a later stage.

(5)

In the interests of clarity of Community legislation, it is appropriate to clarify that the definition of ‘mechanically separated meat’ provided for in other Community legislation on food safety should be applicable in Regulation (EC) No 999/2001 in the context of TSE eradication measures.

(6)

Regulation (EC) No 999/2001 establishes a monitoring programme for BSE and scrapie. In its opinion of 6-7 March 2003, the Scientific Steering Committee recommended the introduction of a monitoring programme for TSEs in cervids. Therefore the monitoring system provided for in that Regulation should be extended to other TSEs, with the possibility to adopt further measures to implement that system at a later stage.

(7)

A harmonised breeding programme to select for resistance to TSEs in ovine animals has been put in place as a transitional measure by Commission Decision 2003/100/EC of 13 February 2003 laying down minimum requirements for the establishment of breeding programmes for resistance to transmissible spongiform encephalopathies in sheep (5). Regulation (EC) No 999/2001 should be amended to provide a permanent legal basis for that programme, as well as the possibility of amending such programmes to take account of the evaluated scientific results and overall consequences of their implementation.

(8)

Regulation (EC) No 999/2001 prohibits the feeding of certain processed animal proteins to certain animals, with the possibility to provide for derogations. New developments concerning prohibitions on animal feeding may require amendments to be made to Annex IV to that Regulation. It is necessary to make certain technical amendments to the existing wording of the corresponding Article in order to facilitate amendment of the structure of that Annex at a later stage.

(9)

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 (6) establishes rules for the disposal of specified risk materials and animals infected by TSEs. Rules on transit through the Community of products of animal origin have now been adopted. Accordingly, in the interests of consistency of Community legislation, the existing rules in Regulation (EC) No 999/2001 on the disposal of such materials and animals should be replaced by a reference to Regulation (EC) No 1774/2002, and the reference to rules on transit in Regulation (EC) No 999/2001 should be deleted.

(10)

New developments concerning specified risk materials will also require comprehensive amendments to Annex V to Regulation (EC) No 999/2001. It is necessary to make certain technical amendments to the existing wording of the corresponding provisions of that Regulation in order to facilitate amendment of the structure of that Annex at a later stage.

(11)

Although stunning by injection of gas in the cranial cavity is prohibited within the Community, injection of gas may also occur after stunning. It is therefore necessary to amend the relevant provisions on slaughter methods in Regulation (EC) No 999/2001 with a view to prohibiting gas injection into the cranial cavity after stunning.

(12)

Commission Regulation (EC) No 1915/2003 amending Regulation (EC) No 999/2001 (7) sets out new provisions on eradication of scrapie in ovine and caprine animals. Accordingly, it is necessary to prohibit the movement of ovine and caprine animals from holdings where scrapie is officially suspected.

(13)

Based on evolving scientific knowledge, Regulation (EC) No 999/2001 should allow the extension to other species of the scope of the rules concerning the placing on the market and export of bovine, ovine and caprine animals, their semen, embryos and ova.

(14)

The opinion of the Scientific Steering Committee of 26 June 1998 indicates that certain restrictions regarding sourcing of raw material for the manufacture of di-calcium phosphate should be observed. Accordingly, di-calcium phosphate should be removed from the list of products which are not subject to restrictions on placing on the market under Regulation (EC) No 999/2001. The absence of restrictions applicable to milk and dairy products should be clarified.

(15)

Based on evolving scientific knowledge and risk classification, and notwithstanding the possibility to adopt safeguard measures, Regulation (EC) No 999/2001 should permit the adoption in accordance with the comitology procedure of more specific requirements for the placing on the market and export of products of animal origin originating from Member States or third countries with a controlled or undetermined risk of TSE.

(16)

The measures necessary for the implementation of Regulation (EC) No 999/2001 should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8).

(17)

In particular, the Commission should be empowered to adopt decisions approving the rapid tests, adapting the age of the animals, introducing the tolerance level, allowing feeding of young animals of ruminant species with proteins derived from fish and extending certain provisions to other animal species; to establish rules providing for exemptions from the requirement to remove and destroy specific risk material; to establish criteria to demonstrate improvement of the epidemiological situation and criteria for granting exemptions from certain restrictions as well as production processes. Since those measures are of general scope and are designed to amend non-essential elements of Regulation (EC) No 999/2001 and/or to supplement that Regulation by the addition of new non-essential elements, those measures should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(18)

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

1)

the following recital shall be inserted:

2)

the following recitals shall be inserted:

3)

in Article 3, paragraph 1 shall be amended as follows:

4)

Article 5 is hereby amended as follows:

5)

Article 6 is hereby amended as follows:

6)

the following Article shall be inserted:

‘Article 6a

Breeding Programmes

1.   Member States may introduce breeding programmes to select for resistance to TSEs in their ovine populations. Those programmes shall include a framework to recognise the TSE-resistant status of certain flocks and may be extended to include other animal species based on scientific evidence corroborating the resistance to TSE of particular genotypes of those species.

2.   Specific rules for the programmes provided for in paragraph 1 of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).

3.   Member States which introduce breeding programmes shall submit regular reports to the Commission in order to enable the programmes to be scientifically evaluated, in particular with regard to their impact on the incidence of TSEs but also on genetic diversity and variability and on the maintenance of old or rare ovine breeds or of those that are well-adapted to a particular region. The scientific results and overall consequences of the breeding programmes shall be evaluated regularly, and where necessary, those programmes shall be amended accordingly.’;

7)

Article 7 is hereby amended as follows:

8)

in Article 8, paragraphs 1 to 5 shall be replaced by the following:

‘1.   The specified risk material shall be removed and disposed of in accordance with Annex V to this Regulation and with Regulation (EC) No 1774/2002. It shall not be imported into the Community. The list of specified risk material referred to in Annex V shall include at least the brain, spinal cord, eyes and tonsils of bovine animals aged over 12 months and the vertebral column of bovine animals above an age to be determined in accordance with the procedure referred to in Article 24(3). Taking into account the different risk categories laid down in the first subparagraph of Article 5(1) and the requirements of Article 6(1a) and (1b) (b), the list of specified risk material in Annex V shall be amended accordingly.

2.   Paragraph 1 of this Article shall not apply to tissues from animals which have undergone an alternative test approved for that distinct purpose in accordance with the procedure referred to in Article 24(3) provided that this test is listed in Annex X, is applied under the conditions provided for in Annex V and the test results are negative.

The Member States which authorise the use of an alternative test pursuant to this paragraph shall inform the other Member States and the Commission.

3.   In Member States, or regions thereof, with a controlled or undetermined BSE risk, the laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injection into the cranial cavity in connection with stunning, shall not be used on bovine, ovine or caprine animals whose meat is intended for human or animal consumption.

4.   The data relating to age set out in Annex V may be adjusted. Such adjustments shall be based on the latest proven scientific findings concerning the statistical probability of the occurrence of a TSE in the relevant age groups of the Community's bovine, ovine and caprine population.

5.   Rules providing for exemptions from paragraphs 1 to 4 of this Article may be adopted in accordance with the procedure referred to in Article 24(3), with regard to the date of the effective enforcement of the feeding prohibition provided for in Article 7(1) or, as appropriate for third countries or regions thereof with a controlled BSE risk, with regard to the date of the effective enforcement of the ban of mammalian protein in feed for ruminants with a view to limiting the requirements to remove and destroy specified risk material to animals born before that date in the countries or regions concerned.’;

9)

in Article 9, paragraphs 1 and 2 shall be replaced by the following:

‘1.   The products of animal origin listed in Annex VI shall be produced using production processes approved in accordance with the procedure referred to in Article 24(3).

2.   Bones of bovine, ovine and caprine animals from countries or regions with a controlled or undetermined BSE risk shall not be used for the production of mechanically separated meat (MSM). Before 1 July 2008, the Member States shall submit a report to the Commission on the use and the production method of MSM in their territory. This report shall include a statement as to whether the Member State intends to continue with the production of MSM.

The Commission shall thereupon present a communication to the European Parliament and the Council on the future necessity and use of MSM in the Community, including the information policy towards consumers.’;

10)

Article 12 is hereby amended as follows:

11)

in Article 13, paragraph 1 is hereby amended as follows:

12)

in Article 15, paragraph 3 shall be replaced by the following:

‘3.   In accordance with the procedure referred to in Article 24(3), the provisions of paragraphs 1 and 2 may be extended to other animal species.

4.   Rules for implementing this Article may be adopted in accordance with the procedure referred to in Article 24(2).’;

13)

Article 16 is hereby amended as follows:

14)

the following Article shall be inserted:

‘Article 23a

The following measures which are designed to amend non-essential elements of this Regulation, including by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 24(3):

15)

Article 24 shall be replaced by the following:

‘Article 24

Committees

1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health. However, the Standing Committee on Zootechnics shall also be consulted by the Commission with regard to Article 6a.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The time-limits referred to in Article 5(6) of that Decision shall be three months and, in the case of safeguard measures referred to in Article 4(2) of this Regulation, 15 days.

3.   Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

16)

the following Article shall be inserted:

‘Article 24a

Decisions to be adopted in accordance with one of the procedures referred to in Article 24 shall be based on an appropriate assessment of the possible risks for human and animal health and shall, taking into account existing scientific evidence, maintain, or if scientifically justified increase, the level of protection of human and animal health ensured in the Community.’.