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"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)
(OJ L 311, 20.11.1998, p. 23)
Amended by:
Official Journal
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
"M3 Commission Decision 2000/104/EC of 31 January 2000 L 29 36 4.2.20001998D0653 — EN — 04.02.2000 — 003.001 — 1
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 Council Directive 90/425/EEC of 26 June 1990 concerning
veterinary and zootechnical checks applicable in intra-Community trade incertain live animals and products with a view to the completion of the internal
market (
1), as last amended by Directive 92/118/EEC (2), and in particular
Article 10(4) thereof,
Having regard to Council Directive 89/662/EEC of 11 December 1989
concerning veterinary checks in intra-Community trade with a view to thecompletion 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 encephalopathies
(TSEs) have been recognised for many years as occurring separately in
humans and animals; whereas bovine spongiform encephalopathy
(BSE) was first recognised in cattle in 1986 and in following years wasrecognised as occurring in other species of animals; whereas a newvariant of Creutzfeldt-Jakob Disease (nv-CJD) was described in 1996;
whereas evidence is accumulating that the agent causing BSE is
identical to that causing nv-CJD;
(2) Whereas 66 cases of BSE have been notified in Portugal between 1
January 1998 and 14 October 1998; whereas this leads to a BSE
incidence rate calculated over the past 12 months of 105,6 cases permillion animals over two years of age; whereas two cases have been
identified in animals born after implementation of the prohibition on
feeding mammalian derived protein to ruminants; whereas thedevelopment of the incidence of the disease indicates potentialrecycling and accumulation of the BSE agent in the Portuguese cattle
population;
(3) Whereas missions on BSE-related issues have been carried out in
Portugal by the Commission Office for Veterinary and Phytosanitary
Inspection and Control from 7 to 12 July 1996 and by the Food andVeterinary Office of the Commission from 15 to 21 June 1997 andfrom 11 to 15 May 1998; whereas those missions contributed to the
assessment of the application and effectiveness of measures to protect
against BSE; whereas those missions concluded that, despite importantimprovements, not all risk factors were adequately managed; whereasa follow-up mission was conducted by the food and Veterinary Office
from 28 September to 2 October 1998; whereas that mission
confirmed most of the findings of the previous missions and observed,despite an overall improvement, certain continued shortcomings in the
enforcement of the measures to control the risk factors; whereas the
sharp increase in the incidence of BSE, in particular since June 1998,raises serious concerns with regard to the development of the diseasein the near future; whereas on the basis of that mission it is concluded
that due to deficiencies existing until very recently in the implemen-
tation of Community legislation on identification and registration ofanimals, and of measures on TSE surveillance and BSE eradication, noadequate guarantees can be provided regarding the BSE history of the
herds of origin and herds through which bovine animals pass and
regarding the dams of bovine animals;
(4) Whereas the Scientific Steering Committee (SSC) adopted an opinion
on BSE risk on 27 March 1998; whereas in that opinion the SSC!B
(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 — 04.02.2000 — 003.001 — 2
recognised three major issues in considering the risk of BSE: first, the
risk of human exposure arising from the direct consumption ofpotentially infective material, secondly, the risk to man from ingestingor being exposed to processed, potentially infective material, and,
thirdly, the risk of propagating the infection by recycling the infective
material through animal feed; whereas the Code Commission of theInternational Office of Epizootics (OIE) also proposes that theassessment of the risk to human and animal health in countries, or
regions within countries, be based on a combination of the spread of
BSE and the application of measures to control the risk;
(5) Whereas, in those circumstances and as an emergency measure, it is
appropriate to prohibit temporarily the dispatch from Portugal to the
other Member States of all bovine animals and of all products obtained
from, or incorporating materials derived from, bovine animals whichare liable to enter the human food or animal feed chains or are destined
for use in cosmetic or medicinal products or medical devices; whereas
in order to prevent deflections of trade, the same prohibitions shouldalso apply to exports to third countries; whereas it is necessary toprohibit temporarily the dispatch from Portugal of mammalian
meat-and-bone meal and animal feed and fertilisers containing
mammalian meat-and-bone meal, which by their nature could enterthe animal feed chain;
(6) Whereas the level of risk of propagating or introducing the disease
from live cattle to unaffected animal populations is considered to be
considerable; whereas additional measures proposed by Portugal toaddress the risk of exposing humans and animals to infected materialare considered to be adequate; whereas account should be taken of the
effective implementation and assessment of effective enforcement of
those measures; whereas, therefore, the prohibition on the dispatch ofbovine products can be limited in time, provided that a risk assessment
conducted on the basis of the findings of a mission of the Food and
Veterinary Office, taking into account the evolution of the disease,demonstrates that appropriate measures have been taken to manageany risk, and that the relevant Community and national measures are
complied with and effectively enforced; whereas the period foreseen
for the prohibition on the export of meat and certain other productscould be reduced in the event of a favourable outcome of such riskassessment;
(7) Whereas Council Regulation (EC) No 820/97 of 21 April 1997
establishing a system for the identification and registration of bovineanimals and regarding the labelling of beef and beef products (
1)
provides for a system enabling animals to be traced back to the dam
and herd of origin; whereas such a system is a prerequisite for effective
eradication of BSE and it is necessary for Portugal to ensure that thoseCommunity provisions are effectively complied with;
(8) Whereas Commission Decision 98/272/EC of 23 April 1998 on
epidemio-surveillance for transmissible spongiform encephalopathies
and amending Decision 94/474/EC (
2) provides for an on-going
education programme to encourage reporting of TSEs, the compulsory
notification, movement restriction, possible killing, examination and
destruction of suspect animals, the conducting of a sampling andmonitoring programme and the annual reporting to the Commissionand the Member States of the results of this programme and in
particular of the information concerning the number and outcome of
clinical and epidemiological investigations of suspect animals;whereas it is justified, in view of the seriousness of the situation, torequire Portugal to increase the frequency of reporting to the
Commission and the Member States to once every four weeks;
(9) Whereas Commission Decision 96/381/EC of 20 June 1996 approving
the measures to be implemented as regards bovine spongiformencephalopathy in Portugal (
3) refers to the principle, laid down in
point 6 of the conclusions of the Council meeting of 1 to 3 April 1996,
that a programme to control BSE and reduce the number of futurecases should concentrate on removal of animals, or as appropriate
herds, most likely to have been exposed to infected meat-and-bone
meal; whereas the main principles of the plan are:!B
(1) OJ L 117, 7. 5. 1997, p. 1.
(2) OJ L 122, 24. 4. 1998, p. 59.
(3) OJ L 149, 22. 6. 1996, p. 25.1998D0653 — EN — 04.02.2000 — 003.001 — 3
(a) compulsory slaughter of animals identified as imported from the
United Kingdom, all animals in herds where cases of BSE haveoccurred and all animals in other herds identified as belonging tothe same birth cohort as affected animals;
(b) and improved system of health monitoring of holdings with bovine
animals and intensified surveillance of the feed manufacturingindustry to prevent the possible use of meat-and-bone meal;
whereas the Commission accepted under circumstances particular to
Portugal and to restore consumer confidence that a whole herd
slaughter policy be adopted in Portugal; whereas the plan approved byDecision 96/381/EC provides for the slaughter of all animalsbelonging to the same birth cohort as affected animals; whereas,
therefore, Portugal must identify all animals belonging to the same
birth cohort regardless of whether the affected animals were born orreared in the same herd as that to which they belonged at the momentof confirmation of BSE or in another herd;
(10) Whereas the provisions of Council Directive 82/894/EEC of 21
December 1982 on the notification of animal diseases within theCommunity (
1), as last amended by Commission Decision
98/12/EC (2), require each Member State to notify directly to the
Commission, at least on the first working day of each week, the
secondary outbreaks of BSE confirmed in its territory;
(11) Whereas, in order to protect animal and human health in the
Community, the Commission adopted Decision 94/381/EC of 27 June
1994 concerning certain protection measures with regard to bovine
spongiform encephalopathy and the feeding of mammalian derivedprotein (
3), as amended by Decision 95/60/EC (4), which prohibited the
feeding of mammalian protein to ruminants throughout the Commu-
nity, Decision 96/449/EC of 18 July 1996 on the approval of alternative
heat treatment systems for processing animal waste with a view to theinactivation of spongiform encephalopathy agents (
5), which lays down
the best available method for processing animal waste as regards
spongiform encephalopathy agents, and Decision 97/735/EC of 21
October 1997 concerning certain protection measures with regard totrade in certain types of mammalian animal waste (
6);
(12) Whereas Portugal has taken measures as notified to the Commission
on 12 October 1998, including measures to prohibit the incorporation
of meat-and-bone meal in any animal feed and to require thedestruction of meat-and-bone meal; whereas subsequently commit-
ments were given to recall and destroy any stocks of meat-and-bone
meal, and of animal feed that contains meat-and-bone meal, present inanimal waste processing establishments, feedingstuff producing plants,agricultural establishments or any other place; whereas those measures
are considered to reduce the risk of propagating the disease through
animal feed;
(13) Whereas Portugal has taken measures to destroy certain risk materials
as notified to the Commission on 12 October 1998, including the
bovine, ovine, and caprine tissues defined as specified risk materials in
Commission Decision 97/534/EC of 30 July 1997 on the prohibition ofthe use of material presenting risks as regards transmissible spongi-form encephalopathies (
7), as last amended by Council Decision
98/248/EC (8); whereas those measures are considered to reduce the
risk of exposing humans or animals directly or indirectly to the BSEagent present in risk materials;
(14) Whereas, in those circumstances and as an emergency measure, it is
appropriate to require Portugal to implement programmes to demon-
strate effective compliance with all relevant Community legislation,this Decision and relevant national legislation, and to report in detail tothe Commission every four weeks on the outcome of those
programmes;!B
(1) OJ L 378, 31. 12. 1982, p. 58.
(2) OJ L 4, 8. 1. 1998, p. 63.
(3) OJ L 172, 7. 7. 1994, p. 23.
(4) OJ L 55, 11. 3. 1995, p. 43.
(5) OJ L 184, 24. 7. 1996, p. 43.
(6) OJ L 294, 28. 10. 1997, p. 7.
(7) OJ L 216, 8. 8. 1997, p. 95.
(8) OJ L 102, 2. 4. 1998, p. 26.1998D0653 — EN — 04.02.2000 — 003.001 — 4
(15) Whereas strict conditions should apply to derogations from the
prohibition for certain products and for products derived from bovineanimals slaughtered outside Portugal;
(16) Whereas, in view of the epidemiological situation and the movements
of live cattle to the autonomous region of the Azores, this Decisionshould not apply to that region;
(17) Whereas, with a view to giving financial support to the efforts made by
Portugal, the Commission will, as soon as possible, propose
appropriate measures;
(18) Whereas the Commission should continue to carry out Community
inspections in Portugal to verify the application of the measures
provided for in this Decision;
(19) Whereas, pending an overall examination of the situation, this
Decision should be reviewed in the light of new scientific information;
(20) Whereas 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 emergencymeasures made necessary by the occurrence of BSE in Portugal.
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 of Portugal to theAzores.
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) animal feed and fertilisers containing material referred to in (b).
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 material referred to in Article 2(b) provided that the
material did not originate from Portugal and that the conditions laid down
in Articles 8 and 9 are complied with;
(b) other Member States of material referred to in Article 2(b) and (c) for the
purpose of incineration in accordance with the conditions laid down inAnnex I;
(c) other Member States of fighting bulls in accordance with the conditions
laid down in Annex II.!B
!M21998D0653 — EN — 04.02.2000 — 003.001 — 5
2. The derogation provided for in paragraph 1(b) or paragraph 1(c) shall
apply only if the Member State of destination has authorised the receipt of thematerial or the animals referred to therein.
3. Member States of destination shall inform the Commission and the other
Member States of the list of incineration plants authorised to receive the
material referred to in paragraph 1(b) and the list of bullfight arenas 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 I and that fightingbulls, after having been used for the purpose as referred to in Annex II, areincinerated.
5. The Member State of destination shall keep full records demonstrating
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 of this Article
on the basis of a Community inspection and after having informed theMember States, shall set the date on which the dispatch of the 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, shall set the date on
which the dispatch of the fighting bulls may commence.
CHAPTER III
MATERIALS DERIVED FROM BOVINE ANIMALS SLAUGHTERED
IN PORTUGAL
Article 4
Portugal shall ensure that
"M3 3 the following are not
dispatched from its territory to other Member States or to third 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 5
1. By way of derogation from Article 4, Portugal may authorise the
production and the dispatch from its territory to other Member States or to
third countries of:
(a) amino acids, peptides and tallow, which have been produced in
establishments under official veterinary supervision which have beenshown to be operating in accordance with the conditions set out in the
"M2 Annex III 3;
(b) tallow products and products derived from tallow by saponification,
transesterification or hydrolysis, where these are manufactured from
tallow produced in accordance with this Article;
(c) samples, dispatched from the national veterinary laboratories in Lisbon
and Porto to officially approved institutes, obtained from bovine animalsslaughtered in Portugal and which are destined for use for the purpose of
laboratory examination or research into BSE and BSE diagnostic tests.
2. Portugal shall ensure that the products referred to in paragraph 1(a) and
(b) are labelled or otherwise identified to show the establishment of
production and to indicate that they are suitable for use in human food, animalfeed, cosmetics, medicinal products or medical devices.
3. Portugal shall ensure that products referred to in paragraph 1(a) which are
dispatched to other Member States in accordance with this Article are
accompanied by a health certificate issued by an official veterinarian stating
that they conform to the conditions laid down in this Decision and attesting tothe frequency of official controls carried out.!M2
!B1998D0653 — EN — 04.02.2000 — 003.001 — 6
4. Before an establishment may commence or recommence the dispatch of
products pursuant to this Article, Portugal shall forward to the Commissionand the other Member States the list of the establishments referred to inparagraph 1(a), 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 6
Portugal shall ensure that gelatin, di-calcium phosphate, collagen, tallow,
tallow products and products der ived from tallow by sa ponification,
transesterification or hydrolysis which are produced for technical use fromraw 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, medicinalproducts or medical devices.
CHAPTER IV
MATERIALS DERIVED FROM BOVINE ANIMALS NOT
SLAUGHTERED IN PORTUGAL
Article 7
Portugal shall ensure that the provisions of Articles 8 to 12 are complied with
when the following products derived from bovine animals not slaughtered inPortugal are dispatched from its territory to other Member States or to thirdcountries:
(a) ‘fresh meat’ as defined by Council Directive 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 animal origin’ as defined by
Council Directive 77/99/EEC (3);
(d) food which is destined for domestic carnivores;
(e) gelatin and di-calcium phosphate, tallow, tallow products, and products
derived from tallow by saponification, transesterification or hydrolysis,
amino acids, peptides and collagen which are liable to enter the humanfood or animal feed chains, or are destined for use in cosmetic ormedicinal products or medical devices.
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 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 productionchain;
(d) which have put in place a registration system of amounts of incoming and
outgoing materials to allow for cross-checking consignments entering orleaving;
(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 9, 10 and 11.!B
(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. 85.1998D0653 — EN — 04.02.2000 — 003.001 — 7
2. Portugal shall forward to the Commission and the other Member States
the list of establishments which meet the conditions referred to in paragraph1, identifying for each establishment the purpose for which it has beenapproved. It shall notify the Commission and the Member States 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 which do not
comply with the conditions laid down in this Article and in Articles 8, 10,11 and 12 and are kept locked under the seal of the competent authoritywhen 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 health mark;
(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 Portugal do not bear the additional mark referred to in point (c).Where 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.
Portugal shall forward to the Commission and the other Member States the
model of the additional mark.
2. For the purposes of the health marking and application of additional
marks provided for in Community legislation, 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 thetime 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.
When those products are dispatched to other Member States, they shall be
accompanied by a health certificate issued by an official veterinarian statingthat the conditions referred to in this Article and Articles 8, 10, 11 and 12 are
met, identifying all establishments where they were obtained, processed,
handled or stored and identifying all labels and their serial numbers in theconsignment.
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 their serial numbers in the consignment.
The following words shall be added to all certificates:
‘produced in accordance with Commission Decision 98/653/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 (
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 establishments inPortugal, the health marks shall not be removed except where that is
unavoidable in the cutting process.!B
(1) OJ L 221, 9. 8. 1991, p. 30.1998D0653 — EN — 04.02.2000 — 003.001 — 8
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 of production
and to indicate that they have been produced in accordance with this Decisionand, as appropriate, that they are suitable for use in human food, animal feed,cosmetics, medicinal products or medical devices.
Article 12
1. A Member State which dispatches meat as referred to in Article 7(a) from
an establishment or Community approved border inspection post in itsterritory through the territory of Portugal or to an establishment approved in
accordance with Article 8 shall ensure that the meat is accompanied by a
veterinary certificate issued by an official veterinarian or the certificateissued 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 7(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 7(e) or
any raw materials for use in the production of those products to anestablishment approved in accordance with Article 8 shall ensure that they are
labelled or otherwise identified to show the establishment and Member 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 relevant Communitylegislation on identification and registration of animals, the notification of
animal diseases, epidemio-surveillance for transmissible spongiform encep-
halopathy (TSE) and with all other Community legislation to protect againstBSE.
2. Portugal shall adopt a programme to demonstrate effective compliance
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 physical examination by an approved method of the products
concerned.
Article 14
Portugal shall send the Commission every four weeks a report on the
application of the protective measures taken against TSEs in accordance with
Community and national provisions and on the results of the programmes
referred to in Article 13.
Article 15
The Commission shall carry out Community inspections on-the-spot in
Portugal to:
(a) verify the application of the provisions of this Decision, in particular 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 to conduct a risk!B1998D0653 — EN — 04.02.2000 — 003.001 — 9
assessment demonstrating whether appropriate measures to manage any
risk have been taken.
CHAPTER VI
FINAL PROVISIONS
Article 16
1. This Decision shall be reviewed by 18 May 2000 at the latest, pending an
overall examination of the situation, in particular in view of the developmentof the incidence of the disease and the effective enforcement of the relevant
measures, in the light of the date-based scheme proposed by Portugal.
2. At the request of Portugal, this Decision shall be amended to take account
of different control systems that provide equivalent guarantees to themeasures provided for in Articles 5 to 12.
3. This Decision shall be amended, where appropriate, after consultation of
the appropriate scientific committee, in accordance with the procedure laiddown 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.!B
!M3
!B1998D0653 — EN — 04.02.2000 — 003.001 — 10
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 official certificate as laid down in part B of this Annex must accompany the
material.
2. All containers must be marked with the words ‘Not for animal consumption or
incineration only’ in the languages of the Member State of origin, destinationand transit, and, where material is in bags inside an outer container, teh bagsmust 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 as referred
to in Article 3(3).
4. Portugal must inform by means of the ANIMO system the competent authority
of the place of destination and all Member States of transit of each consignmentusing the codes set out in Title I, Chapter I.3, point 12(2) and Title III pointD4(1) of Commission Decision 93/70/EEC (
1). The words ‘Not for animal
consumption — For incineration only’ must be contained in the ANIMOmessage.
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 theofficial certificate as referred to in point 1, signed by the competent authority ofthe place of destination, to the competent authority of the place of origin by faxor 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
particular 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.!
M1
(1) OJ L 25, 2.2.1993, p. 34.1998D0653 — EN — 04.02.2000 — 003.001 — 11
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
MemberStateofdestination: ..............................................................................................................
Referencenumberoftheofficialcertificate: .............................................................................................
MemberStateoforigin: ....................................................................................................................
Responsibleministry: .......................................................................................................................
Certifyingdepartment: .....................................................................................................................
I.Identification of the consignment
Natureofpackaging: .......................................................................................................................
Numberofpackages: ....................................................................................................................(1)
Netweight:............................................................................................................................... ...
II.Origin of the consignment
Addressoftheestablishment: .............................................................................................................
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:............................................................................................................................... ..........
Platenumberornameofthevessel: ......................................................................................................
Numberoftheseal: .........................................................................................................................
Nameandaddressofconsignor: ..........................................................................................................
Nameandaddressofconsignee: ..........................................................................................................
ATTESTATION:
The undersigned official veterinarian certifies that the product described above contains meat meal, bone meal or
meat-and-bonemealofmammalianoriginoranimalfeedorfertiliserscontainingsuchmaterial,whichcannotbeusedforpurposes other than incineration.
ThematerialdoesnotcontainmaterialfrombovineanimalssuspectedorconfirmedofhavingcontractedBSE,norfrom
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 stamp must be in a colour different to that of the printing.’!M11998D0653 — EN — 04.02.2000 — 003.001 — 12
!M2
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 no
case of BSE has occurred in the last seven years and which are certified to meet
the conditions laid down in point 2. The competent authorities shall ensure thatthe conditions with respect to the controls set out in this Annex are compliedwith.
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 separately from
any other group of animals and which were identified with unique herd andanimal identification 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 of BSEhas not been ruled out, in any animal which was still in or had movedthrough 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 animal and all herds 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/EEC
without breaking the seal. In exceptional cases the seal may be broken forreasons of animal welfare. In such cases an official veterinarian must be calledimmediately on-the-spot to identify the animals and reseal the vehicle.
7. Portugal must 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 of
Commission Decision 98/653/EC’ must be contained in the ANIMO message.
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 theofficial certificate as referred to in point 4, signed by the competent authority ofthe 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 the animals.
(1) OJ 121, 29.7.1964, p. 1977/64.1998D0653 — EN — 04.02.2000 — 003.001 — 13
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 that they do notend 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.!
M21998D0653 — EN — 04.02.2000 — 003.001 — 14
!M2
ANNEX III
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 a ph of 411,
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 processes described inChapter 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
material for 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, intestineor 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/natural fat) 150 mm particle size maximum
Temperature 4100 °C 4110 °C 4120 °C
Time 125 min. 120 min. 50 min.
CHAPTER II (batch/pressure/natural fat) 50 mm particle size maximum
Temperature 4100 °C 4133 °C
Time 25 min. 20 min.Pressure (absolute) 3 bar
CHAPTER III (continuous/atmospheric/natural fat) 30 mm particle size maximum
Temperature 4100 °C 4110 °C 4120 °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 4100 °C 4110 °C 4120 °C 4130 °C
Time 16 min. 13 min. 8 min. 3 min.
CHAPTER VII (continuous/atmospheric/defatted) 20 mm particle size maximum
Temperature 480 °C 4100 °C
Time 120 min. 60 min.
(1) OJ L 359, 9. 12. 1992, p. 23.!B1998D0653 — EN — 04.02.2000 — 003.001 — 15
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 out inpoint 1.
3. Batch systems which achieve the parameters laid down in point 2 for continuous
systems operating in accordance with Chapters III, IV , VI or VII may also beauthorised.
B. Procedures for the validation of plants for the processing of animal waste of
ruminant origin for the production of tallow in Portugal, using methods 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 appropriate,
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 esters production); 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,
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.!
B1998D0653 — EN — 04.02.2000 — 003.001 — 16