COMMISSION DECISION
of 18 April 2001
concerning measures made necessary by the occurrence of bovine spongiform encephalopathy in Portugal and implementing a date-based export scheme
(notified under document number C(2001) 834)
(Text with EEA relevance)
(2001/376/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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), as last amended by Directive 92/118/EEC (2), 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 (3), as last amended by Directive 92/118/EEC, and in particular Article 10(4) thereof,
Whereas:
(1)
Commission Decision 98/653/EC of 18 November 1998 concerning emergency measures made necessary by the occurrence of bovine spongiform encephalopathy (BSE) in Portugal (4), as last amended by Decision 2000/104/EC (5), prohibits the dispatch and export of bovine products.
(2)
The current BSE incidence rate in Portugal calculated over the past 12 months per 1 000 000 bovine animals over 24 months of age is 170. According to the Animal Health Code of the International Office for Epizootics (IOE/OIE), 2000 edition, a country or zone will be classified as having a high incidence of BSE if the BSE incidence rate, calculated over the past 12 months, has been greater than 100 cases per 1 000 000 animals within the cattle population over 24 months of age in the country or zone.
(3)
The Animal Health Code of the IOE/OIE recommends that bovine meat and meat products from countries or zones classified as having a high incidence of BSE should be eligible for trade only under certain strict conditions, such as an effective feed ban, a permanent system for the identification of cattle enabling animals to be traced back to the herd and dam of origin, the removal of specified risk materials and the slaughter and complete destruction of certain higher risk animals, such as offspring and birth cohorts of BSE cases.
(4)
The IOE/OIE further recommends that bovine meat and products should be eligible for trade only on the basis of one of two schemes: either a certified herds scheme, indicating that the products have been derived from animals born, raised and having remained in herds without BSE cases for the last seven years, or a date-based scheme, indicating that the products were derived from animals born after the date of an effective feed ban.
(5)
A ban on the feeding of mammalian protein to farmed animals and of mammalian fat to ruminants was introduced in Portugal on 4 December 1998, at the same time the keeping, storage and marketing of mammalian protein and certain fats was prohibited and the recall of existing stocks was organised.
(6)
A mission carried out in Portugal by the Food and Veterinary Office from 14 to 18 June 1999 concluded that the recall of existing stocks was completed and that the controls on the effectiveness of the feed ban were applied properly.
(7)
A ban on the use of specified risk materials in human food or animal feed was introduced in Portugal on 4 December 1998. The ban has been extended in accordance with Commission Decision 2000/418/EC of 29 June 2000 regulating the use of material presenting risks as regards transmissible spongiform encephalopathies (6), as amended by Decision 2001/2/EC (7).
(8)
According to the national BSE eradication plan in place in Portugal, birth cohorts and offspring of BSE cases shall be slaughtered and destroyed.
(9)
A new centralised national system for identification and registration of bovine animals (SNIRB) was introduced in Portugal as of 1 July 1999.
(10)
Portugal presented its first request for a date-based export scheme with a view to permitting, subject to certain conditions, the dispatch of products from animals born after a certain date to the Commission on 3 December 1999. These technical proposals were subsequently amended and supplemented on 18 February, 24 March, 27 July and 22 September. The amended and supplemented proposals provide a suitable framework for allowing the dispatch and export of products derived from bovine animals slaughtered in Portugal.
(11)
The measures for implementation of the export scheme and the offspring cull will be examined by the Food and Veterinary Office of the Commission before the dispatch of meat and meat products may commence. If that examination is satisfactory the Commission will set the date on which dispatch may commence.
(12)
Decision 98/653/EC includes provisions allowing the dispatch of fighting bulls from Portugal for bullfights in other Member States. It is necessary to establish a procedure allowing the fighting bulls to be returned to Portugal, if they are not used in the bullfight. Furthermore the rules on the treatment of carcases of fighting bulls of Portuguese origin should be clarified.
(13)
In the interests of clarity Decision 98/653/EC should be repealed.
(14)
The measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,
HAS ADOPTED THIS DECISION:
CHAPTER I
Scope
Article 1
1. Notwithstanding Community provisions adopted to protect against bovine spongiform encephalopathy (BSE), this Decision lays down specific rules made necessary by the occurrence of BSE in Portugal.
2. The provisions of this Decision applying to Portugal shall not apply however to the Autonomous region of the Azores. The provisions of this Decision applying to Member States other than Portugal shall apply also to the Autonomous region of the Azores. In particular, Portugal shall ensure that the provisions of Articles 2 to 14 are applied to the dispatch of consignments from the other parts of Portugal to the Azores.
CHAPTER II
Live bovine animals, bovine embryos, meat-and-bone meal and related products
Article 2
Portugal shall ensure that the following are not dispatched from its territory to other Member States or to non-member countries:
(a)
live bovine animals and bovine embryos;
(b)
meat meal, bone meal, and meat-and-bone meal of mammalian origin;
(c)
animal feed and fertilisers containing material referred to in point (b).
Article 3
By way of derogation from Article 2(a), Portugal may authorise the dispatch to other Member States which have given their authorisation of fighting bulls in accordance with the conditions laid down in Annex I.
Member States shall inform the Commission and the other Member States of the list of bullfight arenas and connected premises authorised to receive fighting bulls.
Member States of destination shall ensure that the carcases of the fighting bulls are incinerated after the bull fights in accordance with the conditions laid down in Annex I. Where the fighting bulls are not used in bullfights, Member States of destination shall ensure that the animals are either killed and incinerated, or sent back to Portugal, in accordance with the conditions laid down in Annex I.
Member States of destination shall keep full records demonstrating compliance with this Article.
Article 4
By way of derogation from Article 2(b), Portugal may authorise the dispatch of food destined for domestic carnivores containing material referred to in that provision from its territory to other Member States or to non-member countries, provided that the material did not originate from Portugal and that the conditions laid down in Articles 14, 16, 17 and 18 are complied with.
Article 5
By way of derogation from Article 2(b) and (c), Portugal may authorise the dispatch to other Member States which have given their authorisation of material referred to in those provisions for the purpose of incineration in accordance with the conditions laid down in Annex II.
Member States of destination shall inform the Commission and the other Member States of the list of incineration plants authorised to receive that material.
Member States of destination shall ensure that that material is incinerated in accordance with Annex II.
Member States of destination shall keep full records demonstrating compliance with this Article.
CHAPTER III
Materials derived from bovine animals slaughtered in Portugal
Article 6
Portugal shall ensure that the following are not dispatched from its territory to other Member States or to non-member countries, when derived from bovine animals slaughtered in Portugal:
(a)
meat;
(b)
products which are liable to enter the human food or animal feed chains;
(c)
materials which are destined for use in cosmetic or medicinal products or medical devices.
Article 7
By way of derogation from Article 6, Portugal may authorise the dispatch from its territory to other Member States or to non-member countries of amino acids, peptides and tallow, produced in establishments under official veterinary supervision which have been shown to be operating in accordance with the conditions set out in Annex III.
Those products shall be labelled or otherwise identified to show the establishment of production, and to indicate that they are suitable for use in human food, animal feed, cosmetics, medicinal products or medical devices.
Where those products are dispatched to other Member States, they shall be accompanied by a health certificate issued by an official veterinarian stating that they conform to the conditions laid down in this Decision and attesting to the frequency of official controls carried out.
Portugal shall forward to the Commission and the other Member States the list of the establishments referred to in the first paragraph, identifying for each establishment the purpose for which it has been approved. It shall notify the Commission and the other Member States immediately of any amendments to that list.
Article 8
By way of derogation from Article 6, Portugal may authorise the dispatch from its territory to other Member States or to non-member countries of:
(a)
products containing tallow produced in accordance with Article 7;
(b)
products derived from tallow by saponification, transesterification or hydrolysis produced in accordance with the conditions set out in Annex III.
Those products shall be labelled or otherwise identified to show the establishment of production, and to indicate that they are suitable for use in human food, animal feed, cosmetics, medicinal products or medical devices.
Article 9
By way of derogation from Article 6, Portugal may authorise the dispatch from the national veterinary laboratories in Lisbon and Porto to officially approved institutes in other Member States or non-member countries of samples obtained from bovine animals slaughtered in Portugal which are destined for laboratory examination or research into BSE and BSE diagnostic tests.
Article 10
Portugal shall ensure that gelatin, di-calcium phosphate, collagen, tallow, products containing tallow and products derived from tallow by saponification, transesterification or hydrolysis which are produced for technical use from raw materials derived from bovine animals slaughtered in Portugal are labelled or otherwise identified to show the establishment of production and their unsuitability for use in human food, animal feed, cosmetics, medicinal products or medical devices.
Article 11
1. By way of derogation from Article 6, Portugal may authorise the dispatch to other Member States or to non-member countries of the following products derived from bovine animals born and reared in Portugal which have been slaughtered in Portugal in slaughterhouses which are not used for the slaughter of any ineligible bovine animal, in accordance with the conditions laid down in this Article, Articles 12, 16, 17 and 18 and Annex IV:
(a)
‘fresh meat’ as defined by Council Directive 64/433/EEC (8);
(b)
‘minced meat’ and ‘meat preparations’ as defined by Council Directive 94/65/EC (9);
(c)
‘meat products’ as defined by Council Directive 77/99/EEC (10);
(d)
food which is destined for domestic carnivores.
2. The fresh meat referred to in paragraph 1(a) shall be deboned and all adherent tissues, including obvious nervous and lymphatic tissues, shall be removed in cutting plants in Portugal which are not used for cutting any ineligible bovine products.
3. The products referred to in paragraph 1(b), (c) and (d) shall be produced from fresh meat as referred to in paragraph 1(a) in establishments in Portugal which are not used for the production of any ineligible bovine products, in accordance with the conditions laid down in this Article, in Articles 12, 16, 17 and 18 and Annex IV.
4. Cold storage of the products referred to in paragraph 1 shall take place in Portugal in chambers which are not used for storing any ineligible bovine products and are kept locked under the seal of the competent authority when the latter is not present. Cutting, storage and transport shall be carried out in accordance with the conditions laid down in this Article, in Articles 12, 16, 17 and 18 and Annex IV.
5. For the purpose of this Article, eligible products means products referred to in paragraph 1 and products derived from bovine animals not slaughtered in Portugal which comply with the conditions laid down in Articles 14 to 19.
6. For the purpose of this Decision ‘chamber’ shall mean a room or any other structure within a room which provides a secure lockable physical barrier.
Article 12
1. The meat and products referred to in Article 11(1) shall be marked or labelled with an additional distinct mark which cannot be confused with the Community health mark or the additional distinct mark referred to in Article 14.
2. Where that meat and those products are destined for placing on the market in Portugal, they shall not bear that additional mark. If such a mark is present, it shall be cancelled or removed from the meat or cancelled from the label at the time that meat or those products leave the establishment as referred to in Articles 15 and 16. The Community health mark shall not be removed except where that is unavoidable in the cutting process.
3. Portugal shall forward to the Commission and the other Member States the model of the additional mark referred to in paragraph 1 before dispatch commences.
CHAPTER IV
Materials derived from bovine animals not slaughtered in Portugal
Article 13
Portugal shall ensure that the provisions of this Chapter are complied with when the following products derived from bovine animals not slaughtered in Portugal are dispatched from its territory to other Member States or to non-member countries:
(a)
‘fresh meat’ as defined by Directive 64/433/EEC;
(b)
‘minced meat’ and ‘meat preparations’ as defined by Directive 94/65/EC;
(c)
‘meat products’ and ‘other products of animal origin’ as defined by Directive 77/99/EEC;
(d)
food which is destined for domestic carnivores;
(e)
gelatin and di-calcium phosphate, tallow, products containing tallow, and products derived from tallow by saponification, transesterification or hydrolysis, amino acids, peptides and collagen which are liable to enter the human food or animal feed chains, or are destined for use in cosmetic or medicinal products or medical devices.
Article 14
1. The meat and products referred to in Article 13(a) to (c) shall be marked or labelled with an additional distinct mark which cannot be confused with the Community health mark or the additional distinct mark referred to in Article 12.
2. Where that meat and those products are destined for placing on the market in Portugal, they shall not bear that additional mark. If such a mark is present, it shall be cancelled or removed from the meat or cancelled from the label at the time that meat or those products leave the establishment as referred to in Articles 15 and 16. The Community health mark shall not be removed except where that is unavoidable in the cutting process.
3. Portugal shall forward to the Commission and the other Member States the model of the additional mark referred to in paragraph 1 before dispatch commences.
Article 15
The products referred to in Article 13(e) which are dispatched to other Member States shall be labelled in order to identify the establishment of production and to indicate that they have been produced in accordance with this Decision and, as appropriate, that they are suitable for use in human food, animal feed, cosmetics, medicinal products or medical devices.
CHAPTER V
Establishments and certification
Article 16
1. The products referred to in Articles 11 and 13 shall come from and, as appropriate, have passed through, establishments in Portugal:
(a)
which have been approved by the competent authority;
(b)
which are under official veterinary supervision or, in the case of products derived from tallow by saponification, transesterification or hydrolysis, under the supervision of the competent authority;
(c)
which have put in place a system of tracing of the raw material which will guarantee the origin of the material throughout the whole production chain;
(d)
which have put in place a registration system of amounts of incoming and outgoing materials to allow for cross-checking consignments entering or leaving;
(e)
in which the products are unloaded, processed, stored, handled, loaded and transported separately from, or at different times from, products which do not comply with the conditions laid down in this Article and Articles 11, 12, 14, 15, 17 and 18.
2. Portugal shall forward to the Commission and the other Member States the list of establishments which meet the conditions referred to in paragraph 1, identifying for each establishment the purpose for which it has been approved. It shall notify the Commission and the Member States immediately of any amendments to that list.
Article 17
1. Products referred to in Article 11 and Article 13(a) to (d) shall come from and, as appropriate, have passed through establishments in Portugal:
(a)
in which all unloading, processing, storage or other handling and loading of products takes place under official supervision;
(b)
in which the products are stored in cold stores in chambers which are not used at the same time for storing any bovine products which do not comply with the conditions laid down in this Article, and in Articles 11, 12, 14, 15, 16, 18 and 19 and are kept locked under the seal of the competent authority when the latter is not present.
2. For the purposes of the health marking and application of additional marks provided for in Articles 12 and 14, the competent authority shall keep and maintain under its responsibility:
(a)
the instruments intended for meat health-marking and application of additional marks, which may be handed over to auxiliaries only at the time of marking and for the length of time required for that purpose;
(b)
any labels bearing a health mark or an additional mark. Those labels shall be serially numbered and the requisite quantity may be given to auxiliaries at the time when they are to be used.
3. The products referred to in paragraph 1 shall be transported in means of transport that are sealed by the competent authority.
Article 18
1. Products as referred to in Article 11 and Article 13(a) to (d) dispatched to other Member States shall be accompanied by a health certificate issued by an official veterinarian stating that the conditions referred to in this Article and Articles 11, 17 and 19 are met, identifying all establishments where they were obtained, processed, handled or stored and identifying all labels and the relevant numbers in the consignment ensuring traceability of each individual unit.
2. Meat shall be accompanied by the health certificate referred to in Annex IV to Directive 64/433/EEC identifying in the ‘Identification of meat’ section of the certificate all labels and the relevant numbers in the consignment ensuring traceability of each individual unit.
3. The following words shall be added to all certificates: ‘produced in accordance with Commission Decision 2001/376/EC’.
4. Portugal shall inform the competent authority of the place of destination of each consignment by means of the ANIMO system as referred to in Commission Decision 91/398/EEC (11), or by fax.
5. Where those products are dispatched to non-member countries, they shall be accompanied by a health certificate, issued by an official veterinarian, stating that the conditions laid down in this Decision have been complied with.
CHAPTER VI
Transit and receipt of material from other Member States
Article 19
1. A Member State which dispatches meat as referred to in Article 13(a) from an establishment or Community approved border inspection post in its territory through the territory of Portugal or to an establishment approved in accordance with Article 16 shall ensure that the meat is accompanied by a veterinary certificate issued by an official veterinarian or the certificate issued by the competent authority of the border inspection post.
The originals of all certificates shall accompany the consignment to the establishment of its destination.
2. The meat as referred to in Article 13(a) shall be transported in an officially sealed vehicle.
The seal may be broken only for official inspection purposes.
3. A Member State which dispatches products referred to in Article 13(e) or any raw materials for use in the production of those products to an establishment approved in accordance with Article 16 shall ensure that they are labelled or otherwise identified to show the establishment and Member State in which they were produced.
CHAPTER VII
Monitoring, reports and inspections
Article 20
Every four weeks Portugal shall send the Commission a report on the application of the protective measures taken against transmissible spongiform encephalopathies (TSEs) in accordance with Community and national provisions.
Article 21
The Commission shall carry out Community inspections on-the-spot:
(a)
in Portugal to verify the implementation of official controls in respect of each of the products referred to in Articles 7 and 8 before the dispatch of these products may commence or recommence;
(b)
in Portugal to verify the applications of the provisions in Articles 11 and 12 and Annex IV before the dispatch of the products referred to in Article 11 may commence;
(c)
in Portugal to verify the application of the provisions of this Decision, in particular in relation to the implementation of official controls;
(d)
in Portugal to examine the development of the incidence of the disease, the effective enforcement of the relevant national measures and to conduct a risk assessment demonstrating whether appropriate measures to manage any risk have been taken;
(e)
in the Member State of destination to verify the application, as appropriate, of the provisions in Article 5 and Annex II before the dispatch of the material referred to in Article 5 may commence.
Article 22
1. The date on which the dispatch of fighting bulls may commence pursuant to Article 3 shall be determined by the Commission after having assessed the protocols referred to in Annex I, point 18 and after having informed the Member States.
2. The dates on which the dispatch of material and products may commence or recommence pursuant to Articles 5, 7 and 11 shall be determined by the Commission taking account of the inspections referred to in Article 21 and after having informed the Member States.
CHAPTER VIII
Final provisions
Article 23
Member States shall adopt the necessary measures to comply with this Decision. They shall immediately inform the Commission thereof.
Article 24
Decision 98/653/EC is repealed.
References to the repealed Decision shall be construed as references to this Decision.
Article 25
This Decision is addressed to the Member States.
Done at Brussels, 18 April 2001.