2006D0135 — EN — 02.06.2006 — 002.001

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►B COMMISSION DECISION of 22 February 2006 concerning certain protection measures in relation to highly pathogenic avian influenza in poultry in the Community (notified under document number C(2006) 597) (Text with EEA relevance) (2006/135/EC) (OJ L 052, 23.2.2006, p.41)

Amended by:









▼B

COMMISSION DECISION

of 22 February 2006

concerning certain protection measures in relation to highly pathogenic avian influenza in poultry in the Community

(notified under document number C(2006) 597)

(Text with EEA relevance)

(2006/135/EC)







THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market ( 1 ), and in particular Article 9(4) thereof, Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market ( 2 ), and in particular Article 10(4) thereof, Having regard to Regulation (EC) No 998/2003 of 26 May 2003 of the European Parliament and of the Council on the animal health requirements applicable to the non-commercial movement of pet animals and amending Council Directive 92/65/EEC ( 3 ), and in particular Article 18 thereof, Having regard to Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC ( 4 ), and in particular Article 66(2) thereof, Whereas: (1) Avian influenza is an infectious viral disease in poultry and birds, causing mortality and disturbances which can quickly take epizootic proportions liable to present a serious threat to animal health and to reduce sharply the profitability of poultry farming. Under certain circumstances the disease may also pose a risk to human health. There is a risk that the disease agent might be spread to other holdings, to wild birds and from one Member State to other Member States and third countries through the international trade in live birds or their products. (2) Highly pathogenic avian influenza A virus of subtype H5N1 has been isolated from wild birds in certain parts of the Community and in third countries adjacent to the Community or populated by migratory birds during winter. The likelihood of virus introduction with wild birds is increasing during the forthcoming migratory season. (3) Where an H5 avian influenza virus collected from poultry is isolated on the territory of a Member State and where, pending the determination of the neuraminidase (N) type or of the pathogenicity index, the clinical picture and the epidemiological circumstances justify the suspicion of highly pathogenic avian influenza caused by highly pathogenic influenza A virus of subtype H5N1 or the presence of highly pathogenic avian influenza, in particular of that subtype, has been confirmed, the affected Member State should apply certain protection measures to minimise the risk of disease spread. (4) These protective measures should be implemented in addition to those foreseen in the framework of Council Directive 92/40/EEC of 19 May 1992 introducing Community measures for the control of avian influenza ( 5 ). (5) However, the measures provided for in Directive 92/40/EEC are minimum control measures and require supplementary provisions notably on the movement of certain birds and of products from poultry and other birds originating in the zone affected by the disease. (6) Given the particular disease risk and the epidemiological situation with regard to highly pathogenic avian influenza and taking into account the severe economic impact the disease may have, in particular when occurring in Densely Populated Poultry Areas, supplementary measures should aim at reinforcing the local control measures, regionalising the affected Member State by separating the affected part of the territory from the disease free part thereof, and providing reassurance to the poultry sector and the trade partners about the safety of products dispatched from the disease free part of the country. (7) Taking account of the differences in disease risk in case of an outbreak of highly pathogenic avian influenza, a high risk area and a low risk area should be established by the affected Member State in close collaboration with the Commission. (8) If the epidemiological situation so requires, measures appropriate in relation to the areas concerned by the outbreak or suspected outbreak of highly pathogenic avian influenza should be taken, in particular by describing these areas, and keeping this description updated depending on the situation, in Annex I to the present Decision in accordance with the procedure provided for in Article 10(3) or (4) of Directive 90/425/EEC and Article 9(3) or (4) of Directive 89/662/EEC. (9) In the interests of consistency, it is appropriate to apply for the purposes of this Decision certain definitions provided for in Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC ( 6 ), Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs ( 7 ), Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin ( 8 ), Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health requirements applicable to the non-commercial movement of pet animals and amending Council Directive 92/65/EEC ( 9 ). (10) The measures laid down in Commission Decision 2005/734/EC of 19 October 2005 laying down biosecurity measures to reduce the risk of transmission of highly pathogenic avian influenza caused by Influenza virus A subtype H5N1 from birds living in the wild to poultry and other captive birds and providing for an early detection system in areas at particular risk ( 10 ) should be implemented in the areas affected by the disease. (11) Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC ( 11 ) provides for approved bodies, institutes and centres and a model certificate to accompany animals or their gametes between such approved premises in different Member States. A derogation from the transport restrictions should be envisaged for birds coming from and proceeding to bodies, institutes and centres approved in accordance with that Directive. (12) Transport of hatching eggs from the protection zones should be permitted under certain conditions. The dispatch of hatching eggs to other countries may be permitted subject in particular to compliance with the conditions referred to in Directive 2005/94/EC. In such cases the animal health certificates provided for in accordance with Directive 90/539/EEC should include a reference to this Decision. (13) The dispatch from protection zones of meat, minced meat, meat preparations and meat products should be permitted subject to certain conditions, in particular as regards compliance with certain requirements of Regulation (EC) No 853/2004 and of Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption ( 12 ). (14) Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption ( 13 ) establishes a list of treatments rendering meat from restricted areas safe, provides for the possibility to establish a specific identification mark and sets up the identification mark required for meat not authorised for placing on the market for animal health reasons. It is appropriate to permit the dispatch from the protection zones of meat bearing the health mark provided for in that Directive and meat products subjected to treatment referred to therein. (15) 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 ( 14 ) authorises the placing on the market of a range of animal by-products, such as gelatine for technical use, materials for pharmaceutical use and others, originating in areas of the Community under animal health restrictions, because those products are considered safe due to the specific conditions of production, processing and utilisation that effectively inactivate possible pathogens or prevent contact with susceptible animals. (16) This Decision should be reviewed in the light of the transposition of Directive 2005/94/EC by Member States. (17) Given the disease risk, protection measures should be adopted at Community level in order to address the particular risks in different areas. (18) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Whereas: HAS ADOPTED THIS DECISION:







Article 1

Subject matter, scope and definitions

1. This Decision lays down certain protection measures to be applied in cases of highly pathogenic avian influenza in poultry in the territory of a Member State (hereinafter the ‘affected Member State’), caused by influenza A virus of subtype H5 suspected (‘suspected outbreak’) or confirmed (‘outbreak’) to be of the neuraminidase type N1, in order to prevent the spread of avian influenza into the disease free parts of the Community through movement of poultry, other birds as well as products thereof.

2. Except as otherwise provided, the definitions of Directive 2005/94/EC shall apply. In addition, the following definitions shall apply:

(a) ‘hatching eggs’ means eggs as defined in Article 2(2) of Directive 90/539/EEC;

(b) ‘wild feathered game’ means game as defined in point 1.5, second indent, and point 1.7 of Annex I to Regulation (EC) No 853/2004;

(c) ‘other captive birds’ means birds as defined in point 6 of Article 2 of Directive 2005/94/EC, including: (i) pet animals of the bird species as referred to in Article 3(a) of Regulation (EC) No 998/2003, and (ii) birds destined for approved bodies, institutes or centres as defined in Article 2(1) (c) of Directive 92/65/EEC.

3. For the purpose of this Decision the following shall also apply:

(a) The area listed in Part A of Annex I, hereinafter ‘area A’, shall be considered the area at higher risk including, but not limited to, the protection zone established in accordance with paragraphs 2 and 3 of Article 9 and the surveillance zones established in accordance paragraph 4 of Article 9 of Directive 92/40/EEC.

(b) The area listed in Part B of Annex I, hereinafter ‘area B’, shall separate area A from the disease free part of the affected Member State, if such part is identified, and the risk of disease in this area shall be considered minimal.

4. The measures set down in this Decision shall be applied without prejudice to the measures to be applied in the event of an outbreak of avian influenza in poultry taken in accordance with Directive 92/40/EEC.

Article 2

Establishment of areas A and B

1. Immediately following an outbreak or suspected outbreak of highly pathogenic avian influenza caused by influenza A virus of subtype H5 suspected or confirmed to be of the neuraminidase type N1, the affected Member State shall establish areas A and B, having regard to the geographical, administrative, ecological and epizootiological factors relating to avian influenza, and notify them to the Commission, to the other Member States and, as appropriate, to the public.

2. The Commission, in collaboration with the affected Member State, shall examine the areas established by the affected Member State and take the appropriate measures in relation to those areas pursuant to Article 9(3) and (4) of Directive 89/662/EEC or to Article 10(3) or (4) of Directive 90/425/EEC.

3. If the neuraminidase type is confirmed as being different from N1, or the virus as of low pathogenicity, the affected Member State shall abolish the measures taken by it in relation to the areas concerned and notify the Commission and the other Member States.

The Commission, in collaboration with the affected Member State, shall take the appropriate measures pursuant to Article 9(3) or (4) of Directive 89/662/EEC and to Article 10(3) or (4) of Directive 90/425/EEC.

4. If the presence of a highly pathogenic influenza A virus, notably of the subtype H5N1, is confirmed in poultry, the affected Member States shall:

(a) notify the Commission and the other Member States,

(b) apply the measures provided for in Article 3(1) and (2) for as long as is necessary having regard to the geographical, administrative, ecological and epizootiological factors relating to avian influenza until the date indicated in Annex I and in any case for at least 21 days in the case of the protection zone and 30 days in the case of the surveillance zone after the date of completion of the preliminary cleansing and disinfection on the outbreak holding in accordance with Article 11 of Directive 92/40/EEC,

(c) keep the Commission and the other Member States informed about any development with regard to those areas.

The Commission, in collaboration with the affected Member State, shall take the appropriate measures pursuant to Article 9(3) or (4) of Directive 89/662/EEC and to Article 10(3) or (4) of Directive 90/425/EEC.

Article 3

General prohibition

1. The affected Member State shall ensure that no live poultry and live birds other than poultry, and hatching eggs thereof are:

(a) dispatched from areas A and B to other Member States and to third countries;

(b) dispatched from areas A and B to the remaining part of the national territory of the affected Member State;

(c) transported within areas A and B; and

(d) moved between areas A and B.

2. The affected Member State shall ensure that no products other than hatching eggs of the species referred to in paragraph 1 and of wild feathered game are:

(a) dispatched from areas A and B to other Member States and to third countries;

(b) dispatched from areas A and B to the remaining part of the national territory of the affected Member State; and

(c) transported between areas A and B.

Article 4

Derogations for live birds and day-old chicks

1. By way of derogation from Article 3(1), the affected Member State may authorise the transport of poultry or farmed feathered game, including spent laying hens,

(a) from holdings in the protection zone for immediate slaughter to a slaughterhouse preferably located in the protection zone, if that is not possible, to a slaughterhouse outside the protection zone in the affected Member State which is designated by the competent authority;

(b) from holdings in the surveillance zone, during the 15 days following the establishment of the zone, directly to a slaughterhouse within or outside the surveillance zone in the affected Member State which is designated by the competent authority;

(c) from holdings in area A situated either within the surveillance zone after 15 days following its establishment or outside the surveillance zone, or in area B, to slaughterhouses in the affected Member State designated by the competent authority;

(d) from holdings situated outside the area A or area B for immediate slaughter in a slaughterhouse designated by the competent authority and situated in area A or area B;

(e) from holdings situated outside the area A or area B in transit by major highways or railways through area A outside the protection zone or area B.

2. By way of derogation from Article 3(1), the affected Member State may authorise the transport of day-old chicks:

(a) from a hatchery situated in the protection zone to a holding within the protection or surveillance zone at which there are no other poultry and which is placed under the official control provided for in Article 8(2) of Directive 92/40/EEC;

(b) from a hatchery situated in the surveillance zone to a holding or shed of such holding in the same Member State provided that appropriate biosecurity measures are applied and the holding is placed under official surveillance following the transport and day-old chicks shall remain on the holding of destination for at least 21 days;

(c) from a hatchery situated in area A in the surveillance zone to any holding provided, they are hatched from eggs collected from holdings situated outside the protection and surveillance zone, and that the hatchery can ensure by its logistics and biosecurity working conditions that no contact has occurred between these eggs and any other hatching eggs or day-old-chicks originating from poultry flocks within those zones and which are therefore of a different health status;

(d) from a hatchery situated in the part of area A outside the surveillance zone or in area B, and at least 10 km away from any suspected or infected hatchery or holding, to holdings under official control in the affected Member State;

(e) from a hatchery situated in the part of area A outside the protection zone or in area B to holdings within or outside the area A, provided that the day-old chicks are hatched from eggs complying with the requirements in Article 5(1)(d).

3. By way of derogation from Article 3(1), the affected Member State may authorise the transport of ready-to-lay pullets, turkeys for fattening and other poultry or farmed feathered game:

(a) from holdings in the protection zone to a holding within the surveillance zone at which there are no other poultry and which is placed under the official control provided for in Article 8(2) of Directive 92/40/EEC;

(b) from holdings in the surveillance zone after the 15 days following its establishment to a holding in which there is no other poultry in the same Member State; that holding shall be placed under official surveillance following the arrival of the ready-to-lay poultry and the ready-to-lay poultry shall remain on the holding of destination for at least 21 days;

(c) from holdings situated in the part of area A outside the surveillance zone or area B, and at least 10 km away from any suspected holding, to holdings under official control in the affected Member State.

4. By way of derogation from Article 3(1), the affected Member State may authorise transport of birds accompanying their owner to premises outside the area A or area B, if the consignment either consists of not more than 5 caged birds from holdings not keeping poultry or is destined for a quarantine established in accordance with Decision 2000/666/EC, and the birds are accompanied by a veterinary certificate in accordance with the model set up in Annex II, certifying compliance with the established animal health conditions, where required based on owners’ declaration in accordance with the model set up in Annex III.

5. The animal health certificates in accordance with Model 2 of Annex IV to Council Directive 90/539/EEC accompanying consignments of day-old chicks referred to in paragraph 2(c) and (e) shall include the words:

‘The consignment complies with the animal health conditions laid down in Commission Decision 2006/135/EC.’

6. Movements allowed in paragraphs 1(a), 2(a) and 3(a) shall be directly executed, under official control. They shall be authorised only after the official veterinarian has carried out a health inspection of the holding. The means of transport used must be cleaned and disinfected before and after use.

Article 5

Derogations for hatching eggs

1. By way of derogation from Article 3(1), the affected Member State may authorise the dispatch of hatching eggs:

(a) collected on holdings situated on the day of collection in the protection zone to a hatchery designated by the competent authority; provided the eggs and their packing are disinfected before dispatch;

(b) collected in holdings situated on the day of collection in the surveillance zone to a hatchery in the affected Member State which is designated by the competent authority, provided the eggs and their packaging are disinfected before dispatch;

(c) collected in holdings situated on the day of collection in area A outside the surveillance zone or area B, and at least 10 km away from any suspect holding, to a designated hatchery in the affected Member State, or following agreement between the competent authorities, to a designated hatchery in another Member State or third country;

(d) collected from holdings in area A outside the protection or surveillance zone or in area B on which the poultry has tested negative in a serological survey for avian influenza capable of detecting 5 % prevalence of disease with at least a 95 % level of confidence and traceability is ensured, to hatcheries within or outside the areas A or B.

2. Movements allowed in paragraph 1(a) shall be directly executed, under official control and only after the official veterinarian has carried out a health inspection of the holding and the means of transport are cleaned and disinfected before and after use.

3. The animal health certificates in accordance with Model 1 of Annex IV to Council Directive 90/539/EEC accompanying consignments of hatching eggs referred to in paragraph 1(c) and (d) to other Member States shall include the words:

‘The consignment complies with the animal health conditions laid down in Commission Decision 2006/135/EC.’

Article 6

Derogations for meat, minced meat, meat preparations, mechanically separated meat and meat products

1. By way of derogation from Article 3(2), the affected Member State shall authorise the dispatch of:

(a) fresh meat from poultry, including meat from ratites, referred to in Article 4(1) (a) and (b) if such meat is marked with the identification mark provided for in Annex II to Directive 2002/99/EC and is intended for transport to an establishment for treatment as required for avian influenza in table 1(a), (b) or (c) of Annex III to that Directive;

(b) fresh meat from poultry, including meat from ratites, originating in area A, outside the protection zone and the surveillance zones during 15 days following its establishment, or area B, or produced from poultry referred to in Article 4(1)(d) and produced in accordance with Annex II and Sections II and III of Annex III to Regulation (EC) No 853/2004 and controlled in accordance with Sections I, II, III, and Chapters V and VII of Section IV of Annex I to Regulation (EC) No 854/2004;

(c) minced meat, meat preparations, mechanically separated meat and meat products containing meat referred to in point (b) and produced in accordance with Sections V and VI of Annex III to Regulation (EC) No 853/2004;

(d) fresh meat from poultry and farmed feathered game, minced meat and meat preparations and mechanically separated meat containing such meat, obtained from slaughter poultry or farmed feathered game originating in the part of area A outside the protection zone from area A or area B into the remaining part of its national territory of, if such meat: (i) was identified with a round stamp as setup in accordance with Article 4(2) of Directive 2002/99/EC in Annex IV to the present Decision; and (ii) was obtained, cut, stored and transported separately from other fresh meat from poultry or farmed feathered game destined for dispatch to other Member States or for exports to third countries; and (iii) is used in such a way as to avoid it being introduced into meat products or meat preparations intended for placing on the market in other Member States or for export to third countries, unless it has undergone the treatment as required for avian influenza specified in table 1(a), (b) or (c) of Annex III to Directive 2002/99/EC.

2. By way of derogation from Article 3(2), the affected Member State shall authorise the dispatch of:

(a) fresh meat from wild feathered game originating in area A or area B, if such meat is marked with the health mark provided for in Annex II to Directive 2002/99/EC and is intended for transport to an establishment for treatment as required for avian influenza in table 1(a), (b) or (c) of Annex III to that Directive;

(b) meat products produced from meat from wild feathered game originating in area A or in area B which were subjected to a treatment as required for avian influenza in table 1(a), (b) or (c) of Annex III to Directive 2002/99/EC;

(c) fresh meat from wild feathered game originating outside the areas A and B and produced in establishments within area A or area B in accordance with Section IV of Annex III to Regulation (EC) No 853/2004 and controlled in accordance with Chapter VIII of Section IV of Annex I to Regulation (EC) No 854/2004;

(d) minced meat, meat preparations, mechanically separated meat and meat products containing meat referred to in point (c) and produced in establishments situated in area A or area B in accordance with Sections V and VI of Annex III to Regulation (EC) No 853/2004.

3. The affected Member State shall ensure that the products referred to in paragraphs 1(b), (c) and 2(b), (c), (d) are accompanied by commercial documents stating:

‘The consignment complies with the animal health conditions laid down in Commission Decision 2006/135/EC.’

Article 7

Derogations for eggs for human consumption and egg products

1. By way of derogation from Article 3(2), the affected Member State may authorise the dispatch of eggs collected from holdings in the protection or surveillance zone:

(a) for human consumption to a packing centre designated by the competent authority, provided that they are packed in disposable packaging and that all biosecurity measures required by the competent authority are applied;

(b) to an establishment for the manufacture of egg products as set out in Chapter II of Section X of Annex III to Regulation (EC) No 853/2004 to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004;

(c) for disposal in accordance with Regulation (EC) No 1774/2002.

2. By way of derogation from Article 3(2), the dispatch to any destination shall be allowed for:

(a) eggs for human consumption collected from holdings in area A, outside the protection or surveillance zone, or area B;

(b) pasteurised egg products in accordance with Chapter II of Section X of Annex III to Regulation (EC) No 853/2004.

3. The affected Member State shall ensure that consignments of eggs for human consumption referred to in paragraph 1(a) are accompanied by commercial documents stating:

‘The consignment complies with the animal health conditions laid down in Commission Decision 2006/135/EC.’

Article 8

Derogation for animal by-products

1. By way of derogation from Article 3(2), the affected Member State shall authorise:

(a) the dispatch from area A or area B of the animal by products complying with the conditions set up in Chapters II (A), III (B), IV (A), VI (A and B), VII (A), VIII (A), IX (A)and X (A) of Annex VII, and Chapters II (B), III (II) (A) and VII (A) (1)(a) of Annex VIII to Regulation (EC) No 1774/2002;

(b) the dispatch from area B of untreated feathers or parts of feathers in accordance with Chapter VIII (A) (1) (a) of Annex VIII to Regulation (EC) No 1774/2002, produced from poultry or farmed feathered game;

(c) the dispatch from area A or area B of feathers and parts of feathers that have been treated with a steam current, or by some other method that ensures that no pathogens remains, produced from poultry or farmed feathered game.

2. The affected Member State shall ensure that the products referred to in paragraph 1(b) and (c) of this Article are accompanied by a commercial document in accordance with Chapter X of Annex II to Regulation (EC) No 1774/2002 stating, in the case of the products referred to in paragraph 1(c) of this Article, in point 6.1 of that document that those products have been treated with a steam current or by some other method ensuring that no pathogens remains.

However, that commercial document shall not be required for processed decorative feathers, processed feathers carried by travellers for their private use or consignments of processed feathers sent to private individuals for non-industrial purpose.

Article 9

Conditions for movements

1. Where movements of animals or products thereof covered by this Decision are authorised under Articles 4, 5, 6, 7 and 8, the authorisation shall be based on the favourable outcome of a risk assessment carried out by the competent authority and all appropriate biosecurity measures shall be taken to avoid the spread of avian influenza.

2. Where the dispatch, movement or transport of products referred to in paragraph 1 are authorised under Articles 5, 6, 7 and 8, subject to justified conditions or limitations, they must be obtained, handled, treated, stored and transported without compromising the animal health status of other products fulfilling all the animal health requirements for trade, placing on the market or export to third countries.

Article 10

Compliance and Information

All Member States shall immediately adopt and publish the measures necessary to comply with this Decision. They shall immediately inform the Commission thereof.

The affected Member State shall apply those measures as soon as it reasonably suspects the presence of highly pathogenic avian influenza virus, in particular of the subtype H5N1, in poultry.

The affected Member State shall regularly provide to the Commission and the other Member States the necessary information on the epidemiology of the disease and, where appropriate the additional control and surveillance measures and the awareness campaigns implemented.

Article 11

Addressee

This Decision is addressed to the Member States.

▼M4









ANNEX I

PART A

Area A as referred to in Article 2(1):







ISO Country Code Member State Area A Date until applicable Code Name DK DENMARK The municipalities of: ÅRSLEV KERTEMINDE LANGESKOV MUNKEBO NYBORG ODENSE ØRBÆK OTTERUP RINGE RYSLINGE ULLERSLEV 28.6.2006

PART B

Area B as referred to in Article 2(2):







ISO Country Code Member State Area B Date until applicable Code Name DK DENMARK ADNS 00700 The county of: FUNEN 28.6.2006

▼B









ANNEX II

Model certificate for the movement of pet birds in accordance with Article 4(4):









ANNEX III

Declaration of the owner or representative of the owner of the pet birds as required by Article 4 (4):









ANNEX IV

Details of the identification mark referred to in Article 6 (1) (d) (i):







Dimensions: XYZ () = 8 mm 1234 () = 11 mm Circle outer diameter = not less than 30 mm Line thickness of circle = 3 mm (1) means the relevant country code provided for in point 6 of Part B of Section I of Annex II to Regulation (EC) No 853/2004. (2) means the approval number of the establishment referred to in point 7 of Part B of Section I of Annex II to Regulation (EC) No 853/2004.