1998D0653 — EN — 21.10.1999 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSION DECISION
of 18 November 1998
concerning emergency measures made necessary by the occurrence of bovine spongiform encephal-
opathy in Portugal
(notified under document number C(1998) 3544)
(Text with EEA relevance)
(98/653/EC)
(OJ L 311, 20.11.1998, p. 23)
Amended by:
OfficialJournal
No page date
►M1 Commission Decision 1999/517/EC of 28 July 1999 L 197 45 29.7.1999
►M2 Commission Decision 1999/713/EC of 21 October 1999 L 281 90 4.11.1999
1998D0653 — EN — 21.10.1999 — 002.001 — 2
▼B
COMMISSION DECISION
of 18 November 1998
concerning emergency measures made necessary by the occurrence
of bovine spongiform encephalopathy in Portugal
(notified under document number C(1998) 3544)
(Text with EEA relevance)
(98/653/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to CouncilDirective 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 thecompletion of the internal market (
1), as last amended by Directive
92/118/EEC (2), and in particular Article 10(4) thereof,
Having regard to CouncilDirective 89/662/EEC of 11 December 1989
concerning veterinary checks in intra-Community trade with a view tothe completion of the internal market (
3), as last amended by Directive
92/118/EEC, and in particular Article 9(4) thereof,
(1) Whereas several distinct transmissible spongiform encephalo-pathies (TSEs) have been recognised for many years as occurringseparately in humans and animals; whereas bovine spongiformencephalopathy (BSE) was first recognised in cattle in 1986 andin following years was recognised as occurring in other speciesof animals; whereas a new variant of Creutzfeldt-Jakob Disease(nv-CJD) was described in 1996; whereas evidence is accumu-lating that the agent causing BSE is identical to that causingnv-CJD;
(2) Whereas 66 cases of BSE have been notified in Portugalbetween1 January 1998 and 14 October 1998; whereas this leads to aBSE incidence rate calculated over the past 12 months of 105,6cases per million animals over two years of age; whereas twocases have been identified in animals born after implementationof the prohibition on feeding mammalian derived protein to rumi-nants; whereas the development of the incidence of the diseaseindicates potential recycling and accumulation of the BSE agentin the Portuguese cattle population;
(3) Whereas missions on BSE-related issues have been carried out inPortugalby the Commission Office for Veterinary and Phytosani-tary Inspection and Controlfrom 7 to 12 Jul y 1996 and by theFood and Veterinary Office of the Commission from 15 to 21June 1997 and from 11 to 15 May 1998; whereas those missionscontributed to the assessment of the application and effectivenessof measures to protect against BSE; whereas those missionsconcluded that, despite important improvements, not all riskfactors were adequately managed; whereas a follow-up missionwas conducted by the food and Veterinary Office from 28September to 2 October 1998; whereas that mission confirmedmost of the findings of the previous missions and observed,despite an overall improvement, certain continued shortcomingsin the enforcement of the measures to controlthe risk factors;whereas the sharp increase in the incidence of BSE, in particularsince June 1998, raises serious concerns with regard to the devel-opment of the disease in the near future; whereas on the basis ofthat mission it is concluded that due to deficiencies existing untilvery recently in the implementation of Community legislation on
(1) OJ L 224, 18. 8. 1990, p. 29.
(2) OJ L 62, 15. 3. 1993, p. 49.
(3) OJ L 395, 30. 12. 1989, p. 13.
1998D0653 — EN — 21.10.1999 — 002.001 — 3
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identification and registration of animals, and of measures on
TSE surveillance and BSE eradication, no adequate guaranteescan be provided regarding the BSE history of the herds of originand herds through which bovine animals pass and regarding thedams of bovine animals;
(4) Whereas the Scientific Steering Committee (SSC) adopted anopinion on BSE risk on 27 March 1998; whereas in that opinionthe SSC recognised three major issues in considering the risk ofBSE: first, the risk of human exposure arising from the directconsumption of potentially infective material, secondly, the riskto man from ingesting or being exposed to processed, potentiallyinfective material, and, thirdly, the risk of propagating the infec-tion by recycling the infective material through animal feed;whereas the Code Commission of the InternationalOffice ofEpizootics (OIE) also proposes that the assessment of the risk tohuman and animalheal th in countries, or regions within coun-tries, be based on a combination of the spread of BSE and theapplication of measures to control the risk;
(5) Whereas, in those circumstances and as an emergency measure, itis appropriate to prohibit temporarily the dispatch from Portugalto the other Member States of all bovine animals and of allproducts obtained from, or incorporating materials derived from,bovine animals which are liable to enter the human food oranimalfeed chains or are destined for use in cosmetic or medi-cinalproducts or medicaldevices; whereas in order to preventdeflections of trade, the same prohibitions should also apply toexports to third countries; whereas it is necessary to prohibittemporarily the dispatch from Portugal of mammalian meat-and-bone mealand animalfeed and fertil isers containing mammal ianmeat-and-bone meal, which by their nature could enter the animalfeed chain;
(6) Whereas the level of risk of propagating or introducing thedisease from live cattle to unaffected animal populations isconsidered to be considerable; whereas additional measuresproposed by Portugalto address the risk of exposing humans andanimals to infected material are considered to be adequate;whereas account should be taken of the effective implementationand assessment of effective enforcement of those measures;whereas, therefore, the prohibition on the dispatch of bovineproducts can be limited in time, provided that a risk assessmentconducted on the basis of the findings of a mission of the Foodand Veterinary Office, taking into account the evolution of thedisease, demonstrates that appropriate measures have been takento manage any risk, and that the relevant Community andnational measures are complied with and effectively enforced;whereas the period foreseen for the prohibition on the export ofmeat and certain other products could be reduced in the event ofa favourable outcome of such risk assessment;
(7) Whereas CouncilRegul ation (EC) No 820/97 of 21 April1997establishing a system for the identification and registration ofbovine animals and regarding the labelling of beef and beefproducts (
1) provides for a system enabling animals to be traced
back to the dam and herd of origin; whereas such a system is aprerequisite for effective eradication of BSE and it is necessaryfor Portugalto ensure that those Community provisions are effec-tively complied with;
(8) Whereas Commission Decision 98/272/EC of 23 April1998 onepidemio-surveillance for transmissible spongiform encephalo-pathies and amending Decision 94/474/EC (
2) provides for an
on-going education programme to encourage reporting of TSEs,the compulsory notification, movement restriction, possiblekilling, examination and destruction of suspect animals, the
(1) OJ L 117, 7. 5. 1997, p. 1.
(2) OJ L 122, 24. 4. 1998, p. 59.
1998D0653 — EN — 21.10.1999 — 002.001 — 4
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conducting of a sampling and monitoring programme and the
annualreporting to the Commission and the Member States ofthe results of this programme and in particular of the informationconcerning the number and outcome of clinical and epidemiolog-icalinvestigations of suspect animal s; whereas it is justified, inview of the seriousness of the situation, to require Portugaltoincrease the frequency of reporting to the Commission and theMember States to once every four weeks;
(9) Whereas Commission Decision 96/381/EC of 20 June 1996approving the measures to be implemented as regards bovinespongiform encephalopathy in Portugal (
1) refers to the principle,
laid down in point 6 of the conclusions of the Council meeting of1 to 3 April1996, that a programme to controlBSE and reducethe number of future cases should concentrate on removal ofanimals, or as appropriate herds, most likely to have beenexposed to infected meat-and-bone meal; whereas the main prin-ciples of the plan are:
(a) compulsory slaughter of animals identified as imported from
the United Kingdom, all animals in herds where cases ofBSE have occurred and all animals in other herds identifiedas belonging to the same birth cohort as affected animals;
(b) and improved system of health monitoring of holdings with
bovine animals and intensified surveillance of the feed manu-facturing industry to prevent the possible use of meat-and-bone meal;
whereas the Commission accepted under circumstances particular
to Portugaland to restore consumer confidence that a whol e herdslaughter policy be adopted in Portugal; whereas the planapproved by Decision 96/381/EC provides for the slaughter of allanimals belonging to the same birth cohort as affected animals;whereas, therefore, Portugal must identify all animals belongingto the same birth cohort regardless of whether the affectedanimals were born or reared in the same herd as that to whichthey belonged at the moment of confirmation of BSE or inanother herd;
(10) Whereas the provisions of CouncilDirective 82/894/EEC of 21December 1982 on the notification of animaldiseases within theCommunity (
2), as last amended by Commission Decision 98/
12/EC (3), require each Member State to notify directly to the
Commission, at least on the first working day of each week, thesecondary outbreaks of BSE confirmed in its territory;
(11) Whereas, in order to protect animaland human heal th in theCommunity, the Commission adopted Decision 94/381/EC of 27June 1994 concerning certain protection measures with regard tobovine spongiform encephalopathy and the feeding ofmammalian derived protein (
4), as amended by Decision 95/
60/EC (5), which prohibited the feeding of mammalian protein to
ruminants throughout the Community, Decision 96/449/EC of 18July 1996 on the approval of alternative heat treatment systemsfor processing animalwaste with a view to the inactivation ofspongiform encephalopathy agents (
6), which lays down the best
available method for processing animal waste as regards spongi-form encephalopathy agents, and Decision 97/735/EC of 21October 1997 concerning certain protection measures with regardto trade in certain types of mammalian animal waste (
7);
(1) OJ L 149, 22. 6. 1996, p. 25.
(2) OJ L 378, 31. 12. 1982, p. 58.
(3) OJ L 4, 8. 1. 1998, p. 63.
(4) OJ L 172, 7. 7. 1994, p. 23.
(5) OJ L 55, 11. 3. 1995, p. 43.
(6) OJ L 184, 24. 7. 1996, p. 43.
(7) OJ L 294, 28. 10. 1997, p. 7.
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(12) Whereas Portugalhas taken measures as notified to the Commis-
sion on 12 October 1998, including measures to prohibit theincorporation of meat-and-bone mealin any animalfeed and torequire the destruction of meat-and-bone meal; whereas subse-quently commitments were given to recall and destroy any stocksof meat-and-bone meal, and of animal feed that containsmeat-and-bone meal, present in animal waste processing estab-lishments, feedingstuff producing plants, agricultural establish-ments or any other place; whereas those measures are consideredto reduce the risk of propagating the disease through animalfeed;
(13) Whereas Portugalhas taken measures to destroy certain riskmaterials as notified to the Commission on 12 October 1998,including the bovine, ovine, and caprine tissues defined as speci-fied risk materials in Commission Decision 97/534/EC of 30 July1997 on the prohibition of the use of materialpresenting risks asregards transmissible spongiform encephalopathies (
1), as last
amended by CouncilDecision 98/248/EC (2); whereas those
measures are considered to reduce the risk of exposing humans oranimals directly or indirectly to the BSE agent present in riskmaterials;
(14) Whereas, in those circumstances and as an emergency measure, itis appropriate to require Portugalto impl ement programmes todemonstrate effective compliance with all relevant Communitylegislation, this Decision and relevant national legislation, and toreport in detailto the Commission every four weeks on theoutcome of those programmes;
(15) Whereas strict conditions should apply to derogations from theprohibition for certain products and for products derived frombovine animals slaughtered outside Portugal;
(16) Whereas, in view of the epidemiological situation and the move-ments of live cattle to the autonomous region of the Azores, thisDecision should not apply to that region;
(17) Whereas, with a view to giving financialsupport to the effortsmade by Portugal, the Commission will, as soon as possible,propose appropriate measures;
(18) Whereas the Commission should continue to carry outCommunity inspections in Portugalto verify the appl ication ofthe measures provided for in this Decision;
(19) Whereas, pending an overall examination of the situation, thisDecision should be reviewed in the light of new scientific infor-mation;
(20) Whereas the measures provided for in this Decision are inaccordance with the opinion of the Standing VeterinaryCommittee,
HAS ADOPTED THIS DECISION:
CHAPTER I
SCOPE
Article 1
1. Notwithstanding Community provisions adopted to protect against
bovine spongiform encephalopathy (BSE), this Decision lays downemergency measures made necessary by the occurrence of BSE inPortugal.
(1) OJ L 216, 8. 8. 1997, p. 95.
(2) OJ L 102, 2. 4. 1998, p. 26.
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2. The provisions of this Decision shall not apply to the autonomous
region of the Azores.
However, Portugal shall ensure that the provisions of Articles 2 to 12
are applied to the dispatch of consignments from the other parts ofPortugalto 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 third countries:
(a) live bovine animals and bovine embryos;
(b) meat meal, bone meal, and meat-and-bone meal of mammalian
origin;
(c) animalfeed and fertil isers containing materialreferred to in (b).
▼M2
Article 3
1. By way of derogation from Article 2, Portugal may authorise the
dispatch from its territory to:
(a) other Member States or to third countries of food destined for
domestic carnivores containing materialreferred to in Articl e 2(b)provided that the materialdid not originate from Portugaland thatthe conditions laid down in Articles 8 and 9 are complied with;
(b) other Member States of materialreferred to in Articl e 2(b) and (c)
for the purpose of incineration in accordance with the conditionslaid down in Annex I;
(c) other Member States of fighting bulls in accordance with the condi-
tions laid down in Annex II.
2. The derogation provided for in paragraph 1(b) or paragraph 1(c)
shall apply only if the Member State of destination has authorised thereceipt of the materialor the animal s referred to therein.
3. Member States of destination shall inform the Commission and the
other Member States of the list of incineration plants authorised toreceive the material referred to in paragraph 1(b) and the list of bullfightarenas and connected premises authorised to receive fighting bulls.
4. The Member State of destination shall ensure that the material
referred to in paragraph 1(b) is incinerated in accordance with Annex Iand that fighting bulls, after having been used for the purpose asreferred to in Annex II, are incinerated.
5. The Member State of destination shall keep full records demon-
strating compliance with the Article.
6. The Commission, after having verified on-the-spot in the Member
State of destination the application, as appropriate, of the provisions ofthis Article on the basis of a Community inspection and after havinginformed the Member States, shall set the date on which the dispatch ofthe materialreferred to in paragraph 1(b) may commence.
7. The Commission, after having assessed the protocols referred to in
Annex II point 13 and after having informed the Member States, shallset the date on which the dispatch of the fighting bulls may commence.
▼
B
CHAPTER III
MATERIALS DERIVED FROM BOVINE ANIMALS SLAUGHTERED IN
PORTUGAL
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Article 4
Portugalshal lensure that until ►M11. February 2000 ◄the
following are not dispatched from its territory to other Member Statesor to third countries, when derived from bovine animals slaughtered inPortugal:
(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 medicaldevices.
Article 5
1. By way of derogation from Article 4, Portugal may authorise the
production and the dispatch from its territory to other Member States orto third countries of:
(a) amino acids, peptides and tallow, which have been produced in
establishments under official veterinary supervision which havebeen shown to be operating in accordance with the conditions setout in the ►
M2Annex III ◄;
(b) tallow products and products derived from tallow by saponification,
transesterification or hydrolysis, where these are manufactured fromtallow produced in accordance with this Article;
(c) samples, dispatched from the national veterinary laboratories in
Lisbon and Porto to officially approved institutes, obtained frombovine animals slaughtered in Portugal and which are destined foruse for the purpose of laboratory examination or research into BSEand BSE diagnostic tests.
2. Portugalshal lensure that the products referred to in paragraph
1(a) and (b) are labelled or otherwise identified to show the establish-ment of production and to indicate that they are suitable for use inhuman food, animalfeed, cosmetics, medicinalproducts or medicaldevices.
3. Portugalshal lensure that products referred to in paragraph 1(a)
which are dispatched to other Member States in accordance with thisArticle are accompanied by a health certificate issued by an officialveterinarian stating that they conform to the conditions laid down in thisDecision and attesting to the frequency of officialcontrol s carried out.
4. Before an establishment may commence or recommence the
dispatch of products pursuant to this Article, Portugal shall forward tothe Commission and the other Member States the list of the establish-ments referred to in paragraph 1(a), identifying for each establishmentthe purpose for which it has been approved. It shall notify the Commis-sion and the other Member States immediately of any amendments tothat list.
Article 6
Portugal shall ensure that gelatin, di-calcium phosphate, collagen,
tallow, tallow products and products derived from tallow by saponifica-tion, transesterification or hydrolysis which are produced for technicaluse from raw materials derived from bovine animals slaughtered inPortugal are labelled or otherwise identified to show the establishmentof production and their unsuitability for use in human food, animal feed,cosmetics, medicinalproducts or medicaldevices.
CHAPTER IV
MATERIALS DERIVED FROM BOVINE ANIMALS NOT SLAUGH-
TERED IN PORTUGAL
Article 7
Portugalshal lensure that the provisions of Articl es 8 to 12 are
complied with when the following products derived from bovine
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animals not slaughtered in Portugal are dispatched from its territory to
other Member States or to third countries:
(a) ‘fresh meat' as defined by CouncilDirective 64/433/EEC (1);
(b) ‘minced meat' and ‘meat preparations' as defined by Council
Directive 94/65/EC (2);
(c) ‘meat products' and‘other products of animalorigin' as defined by
CouncilDirective 77/99/EEC (3);
(d) food which is destined for domestic carnivores;
(e) gelatin and di-calcium phosphate, tallow, tallow products, and prod-
ucts derived from tallow by saponification, transesterification orhydrolysis, amino acids, peptides and collagen which are liable toenter the human food or animalfeed chains, or are destined for usein cosmetic or medicinalproducts or medicaldevices.
Article 8
1. The products referred to in Article 7 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 officialveterinary supervision or, in the case of
products derived from tallow by saponification, transesterificationor 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 thewhole production chain;
(d) which have put in place a registration system of amounts of
incoming and outgoing materials to allow for cross-checkingconsignments 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 thisArticle and Articles 9, 10 and 11.
2. Portugalshal lforward to the Commission and the other Member
States the list of establishments which meet the conditions referred to inparagraph 1, identifying for each establishment the purpose for which ithas been approved. It shall notify the Commission and the MemberStates immediately of any amendments to that list.
Article 9
1. Products referred to in Article 7(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 whichdo not comply with the conditions laid down in this Article and inArticles 8, 10, 11 and 12 and are kept locked under the seal of thecompetent authority when the latter is not present;
(c) in which the products are marked or labelled with an additional
distinct mark which cannot be confused with the Community healthmark;
(d) in which the products eligible for dispatch from Portugal under this
Article and Articles 8, 10, 11 and 12, but destined for placing on themarket in Portugaldo not bear the additionalmark referred to inpoint (c). Where such a mark is present, it shall be cancelled or
(1) OJ 121, 29. 7. 1964, p. 2012/64.
(2) OJ L 368, 31. 12. 1994, p. 10.
(3) OJ L 26, 31. 1. 1977, p. 85.
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removed from the meat or cancelled from the label at the time that
meat or those products leave the establishment.
Portugalshal lforward to the Commission and the other Member States
the modelof the additionalmark.
2. For the purposes of the health marking and application of addi-
tional marks provided for in Community legislation, the competentauthority 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 atthe time of marking and for the length of time required for thatpurpose;
(b) any labels bearing a health mark or an additional mark. Those labels
shall be serially numbered and the requisite quantity may be givento 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.
When those products are dispatched to other Member States, they shall
be accompanied by a health certificate issued by an official veterinarianstating that the conditions referred to in this Article and Articles 8, 10,11 and 12 are met, identifying all establishments where they wereobtained, processed, handled or stored and identifying all labels andtheir serialnumbers in the consignment.
Meat shall be accompanied by the health certificate referred to in Annex
IV to Directive 64/433/EEC identifying in the Identification of meatsection of the certificate all labels and their serial numbers in theconsignment.
The following words shall be added to all certificates: ‘produced in
accordance with Commission Decision 98/653/EC.'
4. Portugalshal linform the competent authority of the pl ace of
destination of each consignment by means of the ANIMO system asreferred to in Commission Decision 91/398/EEC (
1), or by fax.
Article 10
Without prejudice to Article 9(1) (d), where products referred to in
Article 7(a) come from and, as appropriate, have passed through estab-lishments in Portugal, the health marks shall not be removed exceptwhere that is unavoidable in the cutting process.
Article 11
The products referred to in Article 7(e) which are dispatched to other
Member States shall be labelled in order to identify the establishment ofproduction and to indicate that they have been produced in accordancewith this Decision and, as appropriate, that they are suitable for use inhuman food, animalfeed, cosmetics, medicinalproducts or medicaldevices.
Article 12
1. A Member State which dispatches meat as referred to in Article
7(a) from an establishment or Community approved border inspectionpost in its territory through the territory of Portugalor to an establ ish-ment approved in accordance with Article 8 shall ensure that the meat isaccompanied by a veterinary certificate issued by an officialveteri-narian or the certificate issued by the competent authority of the borderinspection post.
(1) OJ L 221, 9. 8. 1991, p. 30.
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The originals of all certificates shall accompany the consignment to theestablishment of its destination.
2. The meat as referred to in Article 7(a) shall be transported in an
officially sealed vehicle.
The sealmay be broken onl y for officialinspection purposes.3. A Member State which dispatches products referred to in Article
7(e) or any raw materials for use in the production of those products toan establishment approved in accordance with Article 8 shall ensure thatthey are labelled or otherwise identified to show the establishment andMember State in which they were produced.
CHAPTER V
MONITORING, REPORTS AND INSPECTIONS
Article 13
1. Portugal shall complete the efforts undertaken, and implement a
programme to demonstrate effective compliance with all relevantCommunity legislation on identification and registration of animals, thenotification of animal diseases, epidemio-surveillance for transmissiblespongiform encephalopathy (TSE) and with all other Community legis-lation to protect against BSE.
2. Portugalshal ladopt a programme to demonstrate effective compl i-
ance with:
(a) the provisions of this Decision;
(b) the relevant national measures to protect against BSE, in particular
those on the eradication of BSE.
3. The programmes referred to in paragraphs 1 and 2 shall include a
permanent monitoring of the application of the provisions and whereappropriate physicalexamination by an approved method of the prod-ucts concerned.
Article 14
Portugalshal lsend the Commission every four weeks a report on the
application of the protective measures taken against TSEs in accordancewith Community and nationalprovisions and on the resul ts of theprogrammes referred to in Article 13.
Article 15
The Commission shall carry out Community inspections on-the-spot in
Portugalto:
(a) verify the application of the provisions of this Decision, in partic-
ular in relation to the implementation of official controls;
(b) to examine the development of the incidence of the disease, the
effective enforcement of the relevant national measures and toconduct a risk assessment demonstrating whether appropriate meas-ures to manage any risk have been taken.
CHAPTER VI
FINAL PROVISIONS
Article 16
1. This Decision shall be reviewed within 18 months after its adop-
tion at the latest, pending an overall examination of the situation, inparticular in view of the development of the incidence of the diseaseand the effective enforcement of the relevant measures, and in the lightof new scientific information.
2. At the request of Portugal, this Decision shall be amended to take
account of different controlsystems that provide equival ent guaranteesto the measures provided for in Articles 5 to 12.
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3. This Decision shall be amended, where appropriate, after consulta-tion of the appropriate scientific committee, in accordance with theprocedure laid down in Article 17 of Directive 89/662/EEC.
Article 17
Member States shall adopt the necessary measures to comply with this
Decision. They shall immediately inform the Commission thereof.
Article 18
This Decision is addressed to the Member States.
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ANNEX I
A.Conditions for the dispatch of meat meal, bone meal and meat-and-bone
meal of mammalian origin as well as animal feed and fertilisers
containing such material as referred to in Article 3(1)(b)
1. An officialcertificate as l aid down in part B of this Annex must accompany
the material.
2. Al lcontainers must be marked with the words ‘Not for animalconsumption
or incineration only' in the languages of the Member State of origin, destina-tion and transit, and, where materialis in bags inside an outer container, tehbags must be marked as above.
3. The material must be transported in officially sealed covered containers in
such a way as to prevent loss an conveyed directly to an incineration plant asreferred to in Article 3(3).
4. Portugalmust inform by means of the ANIMO system the competent
authority of the place of destination and all Member States of transit of eachconsignment using the codes set out in Title I, Chapter I.3, point 12(2) andTitle III point D4(1) of Commission Decision 93/70/EEC (
1). The words
‘Not for animalconsumption — For incineration onl y' must be contained inthe ANIMO message.
5. The Member State of destination must inform the competent authority of the
place of origin of the arrival of the consignment by sending a copy of theofficialcertificate as referred to in point 1, signed by the competent authorityof the place of destination, to the competent authority of the place of originby fax or any other means.
6. The Member State of destination must have detailed protocols in place
covering:
(a) controls on arrival, storage and movement of each consigment, in partic-
ular unsealing of containers and reconciliation of weight,
(b) controls on certificates and ANIMO messages,
(c) the measures referred to in point 5,
(d) controls on the cleaning of the containers,
(e) controls on the incineration of the material,
(f) records at the incineration plant,
(g) measures in case of irregularities.
(1) OJ L 25, 2.2.1993, p. 34.
1998D0653 — EN — 21.10.1999 — 002.001 — 13
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B.OFFICIAL CERTIFICATE
for meat meal, bone meal and meat-and-bone meal of mammalian origin as well as animal feed and
fertilisers containing such material for the purpose of incineration
Member State of destination: ..............................................................................................................
Reference number of the official certificate: .............................................................................................
Member State of origin: ....................................................................................................................
Responsible ministry: .......................................................................................................................
Certifying department: .....................................................................................................................
I.Identification of the consignment
Nature of packaging: .......................................................................................................................
Number of packages: .................................................................................................................... (1)
Net weight: ............................................................................................................................... ...
II.Origin of the consignment
Address of the establishment: .............................................................................................................
III.Destination of the consignment
The mammalian animal waste will be sentfrom:............................................................................................................................... ...........
(place of loading)
to:............................................................................................................................ .................
(country and place of destination)
by the following means of transport:
Type:............................................................................................................................... ..........
Plate number or name of the vessel: ......................................................................................................
Number of the seal: .........................................................................................................................
Name and address of consignor: ..........................................................................................................
Name and address of consignee: ..........................................................................................................
ATTESTATION:
The undersigned official veterinarian certifies that the product described above contains meat meal, bone meal or
meat-and-bone meal of mammalian origin or animal feed or fertilisers containing such material, which cannot be used forpurposes other than incineration.
The material does not contain material from bovine animals suspected or confirmed of having contracted BSE, nor from
other bovine animals killed under a BSE eradication measure pursuant to Commission Decision 96/381/EC.
Done at ...................................,
(place)on ..........................................
(date)
Stamp (2)
........................................................................
(signature of the official) (2)
........................................................................
(name in capital letters, qualifications and title)
(1) Only applicable if not in bulk.
(2)The signature and stam pmust be in a colour different to that of the printing.
1998D0653 — EN — 21.10.1999 — 002.001 — 14
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ANNEX II
Conditions for the dispatch of fighting bulls as referred to in Article 3(1)(c)
1. Male bovine animals may be dispatched from Portugal for the purpose of
bullfights in application of Article 3(1)(c) when those animals are certified tomeet the conditions laid down in point (3) and come from herds in which nocase of BSE has occurred in the last seven years and which are certified tomeet the conditions laid down in point 2. The competent authorities shallensure that the conditions with respect to the controls set out in this Annexare complied with.
Herd conditions
2. (a) A herd is a group of animals forming a separate and distinct unit, that is
a group of animals which were managed, housed and kept separatelyfrom any other group of animals and which were identified with uniqueherd and animalidentification numbers.
(b) A herd is eligible where for at least seven years there has been no
confirmed case of BSE, nor a suspect case for which the diagnosis ofBSE has not been ruled out, in any animal which was still in or hadmoved through or from the herd.
Animal conditions
3. A bovine animal is eligible if:
(a) it has been clearly identifiable throughout its life, enabling it to be traced
back to the herd and dam of origin;
(b) its dam has lived at least six months after its birth;
(c) its dam has not developed BSE and is not suspected of having
contracted BSE;
(d) the herd of birth of the animaland al lherds through which it has ever
moved are eligible.
Transport
4. Section C of the health certificate referred to in Annex F, Model I of Council
Directive 64/432/EEC (
1) shall be supplemented by the following words:
‘The animals comply with the conditions laid down in Commission Decision
98/653/EC, Annex II, points 1,2 and 3.'
5. The animals must be transported in sealed vehicles and conveyed directly to
a bullfight arena or connected premises as referred to in Article 3(3).
6. The transport must be arranged in such a way that the animals can be
transported in compliance with the rules of Council Directive 91/628/EECwithout breaking the seal . In exceptionalcases the sealmay be broken forreasons of animalwel fare. In such cases an officialveterinarian must becalled immediately on-the-spot to identify the animals and reseal the vehicle.
7. Portugalmust inform by means of the ANIMO system the competent
authority of the place of destination and all Member States of transit of eachconsignment. The words ‘Fighting bulls in accordance with Article 3 ofCommission Decision 98/653/EC' must be contained in the ANIMOmessage.
Measures in the Member State of destination
8. The Member State of destination must inform the competent authority of the
place of origin of the arrival of the consignment by sending a copy of theofficialcertificate as referred to in point 4, signed by the competent authority
(1) OJ 121, 29.7.1964, p. 1977/64.
1998D0653 — EN — 21.10.1999 — 002.001 — 15
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of the place of destination, to the competent authority of the place of origin
by fax or any other means.
9. The animals must be kept in isolated connected premises as referred to in
point 5 before the bull fight.
10. If the animals are not killed in the event, they must be killed immediately
after the bull fight and in any case within 10 days on arrival.
11. The carcases of the animals must be destroyed by incineration.12. The transport vehicles and all connected premises where the fighting bulls
are kept must be cleansed and disinfected immediately after removal of theanimals.
13. The Member State of destination must have detailed protocols in place
covering:
(a) controls on arrival of each animal, in particular unsealing of transport
vehicles, certificates and identification of animals;
(b) ANIMO messages and the measures referred to in point 8;
(c) controls on the keeping and handling of the animals before, during and
after the event;
(d) controls that the animals are killed and that the carcases and all other
body parts including the hide are destroyed by incineration, and thatthey do not end up in the food or feed chain or in fertilisers;
(e) cleansing and disinfection of the transport vehicles and the connected
premises where the animals are kept;
(f) records at the bullfight arena and connected premises;
(g) measures in case of irregularities.
1998D0653 — EN — 21.10.1999 — 002.001 — 16
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ANNEX III
▼B
CHAPTER 1
1. The following products may be exported from Portugal in application of the
provisions of Article 5:
(a) amino acids and peptides produced from hides and skins by a process
which involves exposure of the material to a pH of 1 to 2, followed by aph of>11, followed by heat treatment of 140 °C for 30 minutes at 3 bar;
(b) tallow and tallow products produced from material from animals fit for
human consumption which have been subjected to one of the processesdescribed in Chapter 2;
(c) products derived from tallow by one of the processes described in
Chapter 3.
2. Products referred to in point 1 must be filtered after production.3. Bovine animals which are showing signs of BSE may not be used as source
materialfor production of the products referred to in point 1.
4. The following tissues may not be used for production of products referred to
in point 1: skull, vertebral column, brain, spinal cord, eye, tonsil, thymus,intestine or spleen.
CHAPTER 2
A.Production standards for tallow produced in Portugal from material
derived from bovine animals slaughtered in Portugal
1. Tallow may be produced only in systems described in Chapters I to IV, VI
and VII of the Annex to Commission Decision 92/562/EEC (
1), in which the
following minimum conditions are achieved:
CHAPTER I (batch/atmospheric/naturalfat) 150 mm particl e size maximum
Temperature >100 °C>110 °C>120 °C
Time 125 min. 120 min. 50 min.
CHAPTER II (batch/pressure/naturalfat) 50 mm particl e size maximum
Temperature >100 °C>133 °C
Time 25 min. 20 min.
Pressure (absolute) 3 bar
CHAPTER III (continuous/atmospheric/naturalfat) 30 mm particl e size maximum
Temperature >100 °C>110 °C>120 °C
Time 95 min. 55 min. 13 min.
CHAPTERS IV and VI (continuous/atmospheric/added fat and continuous/pressure/added fat)
30 mm particle size maximum
Temperature >100 °C>110 °C>120 °C>130 °C
Time 16 min. 13 min. 8 min. 3 min.
CHAPTER VII (continuous/atmospheric/defatted) 20 mm particle size maximum
(1) OJ L 359, 9. 12. 1992, p. 23.
1998D0653 — EN — 21.10.1999 — 002.001 — 17
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Temperature >80°C>100 °C
Time 120 min. 60 min.
The above temperature/time requirements may run concurrently.
2. Portugal may authorize plants only if they have been shown by methods laid
down in Section B to be operating in accordance with the conditions set outin point 1.
3. Batch systems which achieve the parameters laid down in point 2 for contin-
uous systems operating in accordance with Chapters III, IV, VI or VII mayalso be authorised.
B.Procedures for the validation of plants for the processing of animal waste
of ruminant origin for the production of tallow in Portugal, usingmethods described in the Annex to Decision 92/562/EEC
1. Temperature — continuous and batch systems
Temperature monitoring devices must be situated regularly throughout the
equipment in order to record temperature at different stages in the process.Records should be kept and calibrations completed at regular intervals.
2. Pressure (Chapter II only)
Pressure monitoring devices must be installed in order to record pressure at
stages in the process. Records must be kept and calibrations completed atregular intervals.
3. Particle size — all systems
CHAPTER 3
Human food, animal feed, medicinal products or medical devices, their
starting materials or intermediate products
Tallow derivatives may be used provided that they are produced by an appro-
priate, validated and strictly certified method such as:
1. transesterification or hydrolysis at not less than 200 °C for not less than
20 minutes under pressure (glycerol, fatty acids and fatty acid estersproduction); or,
2. saponification with NaOH 12M (glycerol and soap production):
— in a batch process: at not less than 95 °C for not less than 3 hours, or
— in a continuous process: at not less than 140 °C, 2 bars for not less
than 8 minutes, or equivalent.
Cosmetic products, starting materials or intermediate products
Tallow derivatives may be used provided that the following methods have been
used and strictly certified by the producer:
1. transesterification or hydrolysis at at least 200 °C, 40 bars for 20 minutes
(glycerol and fatty acids and esters); or,
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2. saponification with NaOH 12M (glycerol and soap):
— in a batch process: at 95 °C for 3 hours, or
— in a continuous process: at 140 °C, 2 bars for 8 minutes or equivalent.