1998D0256 — EN — 24.08.2002 — 003.001 — 1
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►B COUNCILDECISION
of16March1998
concerning emergency measures to protect against bovine spongiform encephalopathy, amending
Decision94/474/ECandrepealing Decision96/239/EC
(98/256/EC)
(OJ L 113, 15.4.1998, p. 32)
Amended by:
Official Journal
No page date
►M1CommissionDecision98/564/EC of 7 October 1998 L 273 37 9.10.1998
►M2CommissionDecision98/692/EC of 25 November 1998 L 328 28 4.12.1998
►M3CommissionDecision2002/670/EC of 20 August 2002 L 228 22 24.8.2002
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COUNCILDECISION
of16March1998
concerning emergency measures to protect against bovine spongi-
form encephalopathy, amending Decision 94/474/EC and repealing
Decision96/239/EC
(98/256/EC)
THE COUNCIL OF THE EUROPEAN UNION,
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 in certain live animals and products with a view tothe completion of the internal market(
1), 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 tothe completion of the internal market(
2), and in particular Article 9(4)
thereof,
Having regard to the proposal from the Commission,
(1)Whereas new information has been published in the United
Kingdom further supporting the hypothesis that exposure to the
bovine spongiform encephalopathy (BSE) agent is linked to the
new variant of Creutzfeldt Jacob Disease (CJD) in humans;whereas on 16 September 1997 the Spongiform EncephalopathyAdvisory Committee (SEAC) of the United Kingdom concludedthat recent research provided compelling new evidence that the
agent which causes BSE is identical to the agent which causes
the new variant of CJD in humans; whereas on 18 September1997 the Advisory Committee on Dangerous Pathogens (ACDP)concluded that the BSE agent should now be classified as ahumanpathogen ;
(2)Whereas, in those circumstances and as an emergency measure,
it is appropriate to prohibit temporarily the dispatch to the other
Member States of all bovine animals from the United Kingdomand of all products consisting entirely or in part of, or incorpor-ating materials derived from, bovine animals slaughtered in theUnited Kingdom which are liable to enter the human food oranimal feed chains or are destined for use in cosmetic, pharma-
ceutical or medical products; whereas inorder to preven t
deflections of trade, the same prohibitions should also apply toexports to third countries;
(3)Whereas, in order to protect animal and human health in theCommunity, the Commission adopted Decision 94/474/EC of
27 July 1994 concerning certain protection measures relating to
bovine spongiform encepahalopathy and repealing Decisions 89/469/EEC and 90/200/EEC(
3), Decision92/290/EEC of 14 May
1992 concerning certain protection measures relating to bovineembryos in respect of bovine spongiform encephalopathy (BSE)in the United Kingdom(
4), Decision94/381/EC of 27 Jun e 1994
concerning certain protection measures with regard to bovine
spongiform encephalopathy and the feeding of mammalianderived protein(
5) and Decision 96/449/EC of 18 July 1996 on1998D0256 — EN — 24.08.2002 — 003.001 — 2
(1) OJ L 224, 18. 8. 1990, p. 29. Directive as last amended by Directive 92/118/
EEC (OJ L 62, 15. 3. 1993, p. 49).
(2) OJ L 395, 30. 12. 1989, p. 13. Directive as last amended by Directive 92/
118/EEC.
(3) OJ L 194, 29. 7. 1994, p. 96. Decisionas last amen ded by Decision95/287/
EC (OJ L 181, 1. 8. 1995, p.40).
(4) OJ L 152, 4. 6. 1992, p. 37. Decisionas amen ded by the 1994 Act of Acces-
sion.
(5) OJ L 172, 7. 7. 1994, p. 23. Decisionas amen ded by Decision95/60/EC (OJ
L 55, 11. 3. 1995, p. 43).
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the approval of alternative heat-treatment systems for processing
animal waste with a view to the inactivation of spongiform ence-phalopathy agents(
1);
(4)Whereas the United Kingdom has taken measures as a result ofthe publicationof in formationoncertaincases of CJD inthatMember State;
(5)Whereas the United Kingdom has banned the use of mammalianmeat-and-bone meal, regardless of its origin, for feeding farmanimals; whereas it is necessary to provide that mammalian
meat-and-bone meal and farm animal feed and fertilisers
containing mammalian meat-and-bone meal, which by theirnature could enter the farm animal feed chain, may not bedispatched from the United Kingdom;
(6)Whereas the risk of transmissible spongiform encephalopathies
(TSEs) entering the human food or animal feed chains through
the con sumptionof proteinderived from domestic carn ivores isconsidered low; whereas that risk can be further reduced byrequiring that domestic carnivores are not fed mammalian meat-and-bone meal originating in the United Kingdom; whereas it istherefore appropriate to provide that food for domestic carni-
vores which is produced in the United Kingdom but contains no
mammalian meat-and-bone meal originating in that country maybe dispatched from its territory to other Member States or tothird countries;
(7)Whereas the United Kingdom has taken measures to destroycertainbovin e tissues;
(8)Whereas CommissionDecision96/239/EC of 27 March 1996 onemergency measures to protect against bovine spongiform ence-phalopathy(
2), before its amendment by Decision 96/362/EC(3),
prohibited the dispatch from the United Kingdom to otherMember States and to third countries, in particular, of bovinesemen, and certain other products from the United Kingdom
obtained from bovine animals slaughtered in the United
Kingdom which are liable to enter the animal feed or humanfood chains and materials destined for use in medicinal products,cosmetics or pharmaceutical products;
(9)Whereas the Scientific Veterinary was consulted on 18 and 26April 1996; whereas, in the opinion of that Committee, bovine
semen is considered to be safe for animal health with respect to
BSE;
(10)Whereas the Scientific Committee on Cosmetology wasconsulted on the safety of certain bovine products on 11 April1996; whereas the LiaisonCommittee of EuropeanAssociation s
of the Perfume, Cosmetic Products and Toiletries Industries
(Colipa) has recommended its members not to use source mate-rials from United Kingdom bovine animals; whereas thatCommittee has declared that its members follow that recommen-dation; whereas Commission Directive 97/1/EC of 10 January1997 adapting to technical progress Annexes II, III, VI, and VII
to Council Directive 76/768/EEC on the approximation of the
laws of the Member States relating to cosmetic products(
4), has
provisionally prohibited the placing on the market of cosmeticproducts containing certain tissues and fluids;
(11)Whereas the Scientific Committee for food was consulted on thesafety of certainbovin e products on15 April 1996;
(12)Whereas the Committee for Proprietary Medicinal Products wasconsulted on 16 April 1996; whereas the pharmaceutical sectorhad already introduced measures relating to the sourcing of1998D0256 — EN — 24.08.2002 — 003.001 — 3
(1) OJ L 184, 24. 7. 1996, p. 43.
(2) OJ L 78, 28. 3. 1996, p. 47.
(3) OJ L 139, 12. 6. 1996, p. 17.
(4) OJ L 16, 18. 1. 1997, p. 85.
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materials and their treatment; whereas every medicinal product
undergoes a pre-marketing approval before it is placed on themarket by virtue of which the treatment process of any raw
material is evaluated; whereas at the request of the European
Agency for the Evaluation of Medicinal Products, all Commu-nity marketing authorisation holders, or applicants with apositive opinion from the Committee for Proprietary MedicinalProducts or the Committee for Veterinary Medicinal Products,
have confirmed that the products concerned do not contain
bovine tissue of United Kingdom origin;
(13)Whereas subsequently, additional information was made avail-able inorder to facilitate a more complete risk assessmen t;
whereas, on that basis, the Scientific Veterinary Committee on
26 April 1996 concluded that a combination of appropriate sour-cing of bovine materials used and the application of minimumprocessing standards whch have been shown effectively to inac-tivate the BSE agent together give good reassurances about thesafety of those materials for food or cosmetic use; whereas,
consequently, the Scientific Veterinary Committee has recom-
mended safety parameters for the production of those materialswhich are therefore considered to be safe;
(14)Whereas the Commission accordingly considered that certain
products, such as gelatinan d tallow, were safe;
(15)Whereas in 1988 the United Kingdom introduced a requirement
for animals affected with BSE to be completely destroyed;whereas the Council, at its meeting on 1, 2 and 3 April 1996,concluded that bovine animals over the age of 30 months should
not enter the human food or animal feed chains or be used for
cosmetic or pharmaceutical products; whereas such animalsshould not be used as source materials for certain bovineproducts;
(16)Whereas furthermore, certain bovine tissues should not be usedas source materials for those products;
(17)Whereas Decision96/362/EC amen ded Decision96/239/EC toexempt certain products, such as gelatin, tallow and bovine
semen, from the prohibition;
(18)Whereas the Scientific Veterinary Committee at its meeting on
17 July 1996 endorsed the report of the sub-group for BSE of26 June 1996, where it recommended that the risk assessmentfor gelatin established by the Scientific Veterinary Committee
on 26 April 1996 be reappraised in the light of the uncertainties
as to the inactivation of the BSE agent, due note being taken ofthe requirements of Decision 96/362/EC;
(19)Whereas Decision 96/362/EC laid down certain preconditions
which had to be met before the United Kingdom could dispatch
from its territory gelatinmade from raw materials from bovin eanimals; whereas those preconditions have not beeen fulfilledand such dispatch has not been authorised; whereas, however,in order to regualarise the situation, pending further scientificknowledge and advice, it is appropriate to withdraw the possibi-
lity of dispatch of gelatinmade from raw materials from bovin e
animals slaughtered in the United Kingdom for human food,animal feed, cosmetics pharmaceutical and medical purposes;whereas that is incon formity with the advice from the Multidis-ciplinary Scientific Committee of 3 April 1997, according to
which no production can be considered safe if the base material
used for gelatin production is potentially infectious;
(20)Whereas the United Kingdom should be permitted to dispatchrom its territory gelatin and di-calcium phosphate for technical
purposes made from raw material from bovine animals slaugh-
tered in the United Kingdom, provided that it is suitablylabelled;
(21)Whereas the United Kingdom should also be permitted todisptach from its territory gelatinproduced from raw material1998D0256 — EN — 24.08.2002 — 003.001 — 4
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from bovine animals not slaughtered in the United Kingdom;
whereas the United Kingdom has introduced a system of trace-ability for such gelatine to ensure that the origin of the raw
material is identifiable; whereas the Community rules should be
supplemented by formally introducing a system of traceability;whereas such a system should be introduced for other productswhich are exempted from the overall ban; whereas a system oflabelling should also be introduced;
(22)Whereas it is necessary to provide that products from bovineanimals not slaughtered in the United Kingdom should comefrom approved establishments under official veterinary control
which have a system inplace to en sure traceability to the origin
of the raw materials; whereas, however, dispatch of thoseproducts from the United Kingdom may take place inmediately,without prior inspection by the Commission;
(23)Whereas it is necessary to lay down appropriate guarantees forthe dispatch from the United Kingdom of certain productsobtained from bovine animals which were not slaughtered inthe United Kingdom;
(24)Whereas a reliable system of controls throughout the Communityis a precondition for the smooth functioning of the beef market;
whereas it is clear from the investigations by the Unit on Coor-
dination of Fraud Prevention (UCLAF) and the Food andVeterinary Office of the Commission that there are deficienciesin official controls on production of beef in the United Kingdomfor dispatch to other Member States and third countries; whereasit is, therefore, necessary to reinforce the system of veterinary
checks inorder to preven t fraud;
(25)Whereas reinforced checks should apply to all commercialconsignments of fresh meat of bovine animals moving into,
through or from the territory of the United Kingdom; whereas itis appropriate to require that all such consignments be sealed andunsealed by the competent authority and accompanied by veter-inary certificates and, in the case of intra-Community trade, torequire an official notification of the dispatch of a consignment
by means of the ANIMO system as referred to in Commission
Decision91/398/EEC of 19 July 1991 ona computerisednetwork linking veterinary authorities (ANIMO)(
1), or by fax;
(26)Whereas the veterinary supervision of the processing of meatderived from bovine animals slaughtered elsewhere than in theUnited Kingdom should also be reinforced;
(27)Whereas the United Kingdom put forward a first proposal for anexport certified herds scheme to the Commissionon25 February1997; whereas the Scientific Veterinary Committee concluded atits meeting of 11 June 1997 that that proposal was not adequate;
whereas the United Kingdom put forward a modified proposal
dated 1 July 1997; whereas the Scientific Veterinary Committeeissued anopin iononthat revised proposal on17 September 1997stating that the major obstacle to approving the scheme for theentire territory of the United Kingdom was the lack of a compre-hensive computerised movement and tracing system and
associated database for live cattle inGreat Britainbut that an
adequate system did apear to exist inNorthernIrelan d; whereasthe Committee concluded furthermore that small modificationscould be made to minor aspects of the scheme at the request ofthe competent Commission departments in order to comply with
certification or control requirements; whereas the Food and
Veterinary Office conducted a feasibility inspection in NorthernIreland from 3 to 7 November 1997; whereas the UnitedKingdom has agreed to further improvements in line with therecommendations made following that inspection; whereas,therefore, a partial lifting of the prohibition on the dispatch of1998D0256 — EN — 24.08.2002 — 003.001 — 5
(1) OJ L 221, 9. 8. 1991, p. 30.
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products from bovine animals slaughtered in Northern Ireland is
appropriate;
(28)Whereas inspections carried out by the Commission serviceshave shownthat the system of veterin ary checks inNorthernIreland is more effective; whereas, therefore, a step-by-stepapproach is appropriate, starting with the lifting of the prohibi-
tions on the dispatch of products from bovine animals
slaughtered, cut, processed and stored in establishments exclu-sively used for products destined for dispatch to other MemberStates and third countries, located in Northern Ireland; whereassubsequent steps will include the lifting of the prohibition on
the processing of eligible meat from Northern Ireland in Great
Britain, under conditions which will be laid down at a laterstage: whereas the Commissionwill immediately start in vesti-gating, with the authorities of the United Kingdom, by whatmeans and under what conditions those restrictions may befurther relaxed;
(29)Whereas in order to prevent fraud, meat derived from bovineanimals slaughtered in the United Kingdom should bear, in addi-tionto the health mark provided for inArticle 3(1)(A)(e) of
Council Directive 64/433/EEC of 26 June 1964 on health
problems affecting intra-Community trade in fresh meat(
1), a
distinct mark which cannot be confused with the Communityhealth mark;
(30)Whereas most of the provisions of Decision 94/474/EC are nolonger in conformity with the opinion of the Scientific Veter-inary Committee of 17 September 1997 and should therefore bedeleted;
(31)Whereas Decision 96/239/EC required the United Kingdom toprovide reports onthe BSE situationevery two weeks; whereasthat period has beenfoun d to be too short; whereas it should be
extended to one month;
(32)Whereas the Commission should continue to carry out Commu-
nity inspections in the United Kingdom to verify the application
of the measures provided for inthis Decision ;
(33)Whereas the foregoing entails a fundamental reworking of Deci-
sion96/239/EC; whereas, inthe in terests of clarity, that Decisionshould be repealed;
(34)Whereas this Decisionwill be reviewed inthe light of n ewscientific information;
(35)Whereas the Standing Veterinary Committee has not given afavourable opinion,
HAS ADOPTED THIS DECISION:
CHAPTER I
Live bovine animals, bovine embryos, meat-and-bone meal and
related products
Article 1
Pending an overall examination of the situation, and notwithstanding
Community provisions adopted to protect against BSE, the United
Kingdom shall ensure that the following are not dispatched from its
territory to other Member States or to third countries:
(a) live bovine animals;1998D0256 — EN — 24.08.2002 — 003.001 — 6
(1) OJ 121, 29. 7. 1964, p. 2012/64. Directive as last amended by Directive 95/
23/EC (OJ L 243, 11. 10. 1995, p. 7).▼M3
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(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 2
By way of derogation from Article 1, food destined for domestic carni-
vores containing material referred to in Article 1(b) may be dispatchedto other Member States or to third countries provided that those mate-rials did not originate from the United Kingdom and that the conditionslaid downinArticles 9 an d 10 are complied with.
CHAPTER II
Materials derived from bovine animals slaughtered in the United
Kingdom
Article 3
Pending an overall examination of the situation, and notwithstanding
Community provisions adopted to protect against BSE, the UnitedKingdom shall ensure that the following are not dispatched from itsterritory to other Member States or to third countries, when derivedfrom bovine animals slaughtered in the United Kingdom:
(a) meat;
(b) products which are liable to enter the human food or animal feed
chains;
(c) materials which are destined for use in cosmetics or medical or
pharmaceutical products.
Article 4
1. By way of derogation from Article 3, the United Kingdom may
authorise the productionan d the dispatch from its territory to otherMember States or to 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 Annex I;
(b) tallow products and products derived from tallow by saponification,
transesterification or hydrolysis, where these are manufactured
from tallow produced inaccordan ce with this Article;
(c) samples, dispatched from the Veterinary Laboratory Agency,
Weybridge, to officially approved institutes, obtained from bovineanimals slaughtered in the United Kingdom and which are destinedfor use for the purpose of research into BSE and BSE diagnostic
tests.
2. The United Kingdom shall ensure that the products referred to in
paragraph 1 ►
M1(a) and (b) ◄are labelled or otherwise identified
to show the establishment of production and to indicate that they aresuitable for use inhumanfood, an imal feed, cosmetics or medical orpharmaceutical products.
3. The United Kingdom shall ensure that products referred to in
paragraph 1(a) which are dispatched to other Member States inaccor-dance with this Article are accompanied by a health certificate issuedby an official veterinarian stating that they conform to the conditionslaid down in this Decision and attesting to the frequency of official
controls carried out.
4. Before an establishment may commence or recommence the
dispatch of products pursuant to this Article, the United Kingdom shallforward to the Commissionan d the other Member States the list of the1998D0256 — EN — 24.08.2002 — 003.001 — 7
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establishments referred to in paragraph 1(a), identifying for each estab-
lishment the purpose for which it has been approved. It shall notify theCommission and the other Member States immediately of any amend-
ments to that list.
5. Community inspections shall be carried out on the implementa-
tionof official con trols inrespect of each of the products referred to
inparagraph 1 before the dispatch of those products may commen ceor recommence.
6. The Commission, after having consulted the Member States in the
framework of the Standing Veterinary Committee, shall set the date onwhich establishments may commence or recommence dispatch of theproducts referred to inparagraph 1(a).
Article 5
The United Kingdom shall ensure that gelatin, di-calcium phosphate,
collagen, tallow, tallow products and products derived from tallow bysaponification, transesterification or hydrolysis which are produced fortechnical use from raw materials derived from bovine animals slaugh-
tered in the United Kingdom are labelled or otherwise identified to
show the establishment of production and their unsuitability for use inhumanfood, an imal feed, cosmetics or medical or pharmaceuticalproducts.
Article 6
1. By way of derogation from Article 3, the United Kingdom may
authorise the dispatch to other Member States or third countries of thefollowing products derived from bovine animals born and reared in theUnited Kingdom which have been slaughtered in the United Kingdomin accordance with the conditions laid down in Article 7, Articles 9 to12 and Annex II, or as appropriate, Annex III:
(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’ as defined by Council Directive 77/99/EEC(3);
(d) food which is destined for domestic carnivores.
2. The fresh meat referred to inparagraph 1(a), if obtain ed from
animals more than nine months old, shall be deboned and all adherenttissues including obvious nervous and lymphatic tissues shall beremoved.
3. Cutting, storage and transport of the fresh meat referred to in
paragraph 1(a) shall be carried out in accordance with the conditions
laid down in Article 7, Articles 9 to 12 and Annex II or, as appropriate,
Annex III. The fresh meat may be used for the production of productsreferred to in (b), (c) and (d) in accordance with the conditions laiddown in this article, in Article 7, Articles 9 to 12 and Annex II or, asappropriate, Annex III.
4. The bovine animals referred to in paragraph 1 shall be slaugh-
tered at different times from cattle which do not meet the
requirements of Annex II, or as appropriate, Annex III. There shall be
a secure sorting and separation of live animals prior to slaughter toensure that only eligible animals enter the slaughter line during timeperiods dedicated to such slaughter. Before the commencement of aperiod of slaughter of eligible animals, the slaughter hall must first becleansed and disinfected.
5. The dispatch of products referred to in Annex III may commence
1 August 1999.1998D0256 — EN — 24.08.2002 — 003.001 — 8
(1) OJ L 195, 28.7.1999, p. 42.
(2) OJ 121, 29.7.1964, p. 2012/64.
(3) OJ L 368, 31.12.1994, p. 10.▼M3
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Article 7
1. The meat and products referred to in Article 6(1) shall be marked
or labelled with an additional distinct mark which cannot be confusedwith the Community health mark.
2. Meat and products as referred to in Article 6(1) which are
destined for placing on the market in the United Kingdom shall notbear the additional mark referred to in paragraph 1 of this Article.
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 thoseproducts leave the establishment. The Community health mark shallnot be removed except where that is unavoidable in the cutting process.
3. The United Kingdom shall forward to the Commission and the
other Member States the model of the additional mark referred to inparagraph 1 before dispatch commences.
CHAPTER III
Materials derived from bovine animals not slaughtered in the
UnitedKingdom
Article 8
The United Kingdom shall ensure that the provisions of Articles 9 to
13 are complied with when the following products derived from bovine
animals not slaughtered in the United Kingdom are dispatched from itsterritory to other Member States or to third 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, tallow products, and
products derived from tallow by saponification, transesterificationor hydrolysis, amino acids, peptides and collagen which are liableto enter the human food or animal feed chains, or are destined foruse incosmetics or medical or pharmaceutical products.
Article 9
1. The products referred to inArticle 8 shall come from an d, as
appropriate, have passed through, establishments in the UnitedKingdom:
(a) which have beenapproved by the compteten t authority;
(b) which are under official veterinary 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 inplace a system of tracin g the raw material which
will guarantee the origin of the material throughout the whole
productionchain ;
(d) which have put inplace a registrationsystem of amoun ts 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 10, 11 and 12.
2. The United Kingdom shall forward to the Commission and the
other Member States the list of establishments which meet the condi-tions referred to in paragraph 1, identifying for each establishment thepurpose for which it has beenapproved. It shall n otify the Commissionand the Member States immediately of any amendments to that list.1998D0256 — EN — 24.08.2002 — 003.001 — 9
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Article 10
1. Products referred to inArticle 8(a) to (d) shall come from an d, as
appropriate, have passed through establishments in the United Kingdom
inwhich:
(a) all unloading, processing, storage or other handling and loading of
products takes place under official supervision;
(b) (i) non-packaged 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 downinthis Article, inArticles 6, 9, 11, 12 an d 13 an d are keptunder the seal of the competent authority when the latter isnot present;
(ii) packaged products are stored incold stores so as to provide a
clear and effective segregation from bovine products which do
not comply with the conditions laid down in this Article and inArticles 6, 9, 11, 12 and 13;
(c) the products, with the exceptionof the products referred to in
Article 8(d), are marked or labelled with an additional distinctmark which cannot be confused with the Community health mark;
(d) the products eligible for dispatch from the United Kingdom within
the meaning of this Article and Articles 9, 11, 12 and 13, butdestined for placing on the market in the United Kingdom do notbear 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 productsleave the establishment.
The United Kingdom 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 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 onlyat 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 givento auxiliaries at the time whenthey are to be used.
3. The products referred to inparagraph 1 shall be tran sported by
means of transport that are sealed by the competent authority.
Whenthose products are dispatched to other Member States, they shall
be accompanied by a health certificate issued by an official veteri-
narian stating that the conditions referred to in this Article and
Articles 9, 11, 12 and 13 are met, identifying all establishments wherethey were obtained, processed, handled or stored and identifying alllabels and ►
M2the relevant numbers in the consignment ensuring
traceability of each individual unit ◄.
Meat shall be accompanied by the health certificate referred to in
Annex IV to Directive 64/433/EEC identifying in the ‘Identificationof Meat’ sectionof the certificate all labels an d ►
M2the relevant
numbers in the consignment ensuring traceability of each individualunit◄.
The following words shall be added to all certificates:
‘produced inaccordan ce with Decision98/256/EC’.
Where those products are dispatched to third countries, they shall be
accompanied by a health certificate, issued by an official veterinarian,1998D0256 — EN — 24.08.2002 — 003.001 — 10
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stating that the conditions laid down in Decision 98/256/EC have been
complied with.
4. The United Kingdom shall inform the competent authority of the
place of destination of each consignment by means of the Animosystem or by fax.
Article 11
Without prejudice to Article 7(2) and Article 10(1)(d), where products
referred to inArticle 8(a) come from an d, as appropriate, have passedthrough establishments in the United Kingdom, the Community healthmarks shall not be removed except where that is unavoidable in thecutting process.
Article 12
The products referred to inArticle 8(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 accor-dance with this Decision and, as appropriate, that they are suitable foruse inhumanfood, an imal feed, cosmetics or medical or pharmaceu-tical products.
Article 13
1. A Member State which dispatches meat as referred to inArticle
8(a) from an establishment or Community approved border inspectionpost in its territory through the territory of the United Kingdom or toan establishment approved in accordance with Article 9 shall ensurethat 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 inArticle 8(a) shall be tran sported inan
officially sealed vehicle.
The seal may be broken only for official inspection purposes.
3. A Member State which dispatches products referred to inArticle
8(e) or any raw materials for use in the production of those products toan establishment approved in accordance with Article 9 shall ensurethat they are labelled or otherwise identified to show the establishment
and Member State in which they were produced.
CHAPTER IV
Finalprovisions
Article 14
The Commission shall carry out Community inspections on-the-spot in
the United Kingdom to verify the application of the provisions of this
Decision , inparticular inrelationto the implemen tationof officialcontrols.
Article 15
The United Kingdom shall send the Commission every month a report
onthe applicationof the protective measures takenagain st BSE, in
accordance with national and Community provisions.
Article 16
This Decision shall be reviewed regularly in the light of new scientific
information. This Decision shall be amended, where appropriate, afterconsultation of the appropriate Scientific Committee, in accordancewith the procedure laid downinArticle 18 of Directive 89/662/EEC.1998D0256 — EN — 24.08.2002 — 003.001 — 11
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Article 17
Member States shall adopt the necessary measures to comply with this
Decision. They shall immediately inform the Commission thereof.
Article 18
Decision94/474/EC is hereby amen ded as follows:1. Article 1 shall be deleted;
2. inArticle 3, paragraphs 1 an d 2 shall be deleted;
3. Article 4 shall be deleted.
Article 19
Decision96/239/EC is hereby repealed.
Article 20
This Decisionis addressed to the Member States.1998D0256 — EN — 24.08.2002 — 003.001 — 12
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ANNEX I
CHAPTER 1
1. The following products may be exported from the United Kingdom by virtue
of Articles 4 to 7:
(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 > 11, followed by heat treatment at 140 ºC for 30 minutes at 3
bar,
(b) tallow and tallow products produced from material from animals fit for
human consumption which has 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 and animals over 30 months
of age may not be used as source materials (as provided for by Commission
Regulation(EC) No 716/96)(
1) for productionof 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 the United Kingdom from
material derived from bovine animals slaughtered in the United
Kingdom
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(2), in
which the following minimum conditions are achieved:
CHAPTER I (Batch/atmospheric/natural fat)
150 mm particle size maximum
Temperature > 100 ºC >110ºC > 120 ºC
Time 125 min120min 50 min
CHAPTER II (Batch/pressure/natural fat)
50 mm particle size maximum
Temperature > 100 ºC >133ºC
Time 25 min20 min
Pressure (absolute) 3 bar
CHAPTER III (Continuous/atmospheric/natural fat)
30 mm particle size maximum
Temperature > 100 ºC >110ºC > 120 ºC
Time 95 min55 min 13 min
CHAPTER IV and VI (Continuous/atmospheric/added fat and continuous/pres-
sure/added fat)
30 mm particle size maximum
Temperature > 100 ºC >110ºC > 120 ºC >130ºC
Time 16 min13 min 8 min 3 min
CHAPTER VII (Continuous/atmospheric/defatted)
20 mm particle size maximum
Temperature > 80 ºC >100ºC
Time 120 min60 min
The above temperature/time requirements may run concurrently.1998D0256 — EN — 24.08.2002 — 003.001 — 13
(1) OJ L 99, 20. 4. 1996, p. 14.
(2) OJ L 359, 9. 12. 1992, p. 23.
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2. The United Kingdom may authorise plants only if they have been shown
by methods laid down in Section B to be operating in accordance with
the conditions set out in point 1.
3. Batch systems which achieve the parameters laid downinpoin t 2 for
continuous systems operating in accordance with Chapters III, IV, VI or
VII may also be authorised.
B.Procedures for the validation of plants for the processing of animal
waste of ruminant origin for the production of tallow in the United
Kingdom,usingmethodsdescribedintheAnnextoDecision92/562/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
at regular intervals.
3.Particle size — all systems
CHAPTER 3
Human food, animal feed, medical or pharmaceutical products, their
startingmaterials orintermediateproducts
Tallow derivatives may be used provided that they are produced by anappro-
priate, validated and strictly certified method such as:
1. transesterification or hydrolysis at not less than 200 ºC for not less than 20
minutes under pressure (glycerol, fatty acids and fatty acid esters produc-
tion); or,
2. saponification with NaOH 12M (glycerol and soap production):
— in a batch process: at not less than 95 ºC for not less than three hours; or,
— in a continuous process: at not less than 140 ºC, 2 bars for not less than
eight minutes, or equivalent.
Cosmeticproducts,startingmaterialsorintermediateproducts
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 ºC, 40 bars for 20 minutes
(glycerol and fatty acids and esters); or,
2. saponification with NaOH 12M (glycerol and soap):
— ina batch process: at 95 ºC for three hours; or,
— in a continuous process: at 140 ºC, 2 bars for eight minutes or equivalent.1998D0256 — EN — 24.08.2002 — 003.001 — 14
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ANNEX II
EXPORTCERTIFIEDHERDSSCHEME(ECHS)
1. Fresh meat, and products referred to in Article 6(1)(b), (c) and (d) from that
meat, derived from bovine animals slaughtered in Northern Ireland, may be
dispatched from the United Kingdom in application of the provisions of
Article 6 when obtained from ECHS-eligible animals which originate from
ECHS-eligible herds. If obtained from animals more than nine months old,
the fresh meat shall be deboned and all adherent tissues including obvious
nervous and lymphatic tissues shall be removed.
ECHS-eligible herds
2. 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
and animal identification numbers.
3. A herd is ECHS-eligible whenfor at least eight years, there has beenn o
confirmed case of BSE, nor a suspect case for which the diagnosis of BSE
has not been ruled out, in any animal which was still in or had moved
through or from the herd.
4. A herd that has been in existence for less than eight years may be consid-
ered ECHS-eligible, after a thorough epidemiological investigation by the
competent veterinary authority, on condition that:
(a) all animals born or moved into the newly established herd complied
with the conditions set out in point 6(a), (c), (d) and (e); and,
(b) the herd has complied with the conditions set out in point 3 during its
entire existence.
5. If a herd is newly established on a holding which experienced a confirmed
case of BSE in any animal which was still in or had moved through or from
a herd on that holding, the newly established herd can only be ECHS-
eligible after a thorough epidemiological investigation by the competent
veterinary authority, taking into account compliance with each of the
following conditions to the satisfaction of the competent veterinary
authority:
(a) all animals of the affected herd previously established on the same
holding have been removed or killed;
(b) all feed has been removed and destroyed and all feed containers thor-
oughly cleansed;
(c) all buildings have been emptied and thoroughly cleansed before the new
animals were admitted;
(d) all conditions set out in point 4 have been complied with.
ECHS-eligible animals
6. A bovine animal is ECHS-eligible if it has been born and reared in Northern
Ireland and at the time of slaughter:
(a) the animal has been clearly identifiable throughout its life, enabling it to
be traced back to the herd and dam of origin; all records of its birth,
identity and movements are recorded on an official computerised
tracing system;
(b) it is more than six months but less than 30 months of age, determined
by reference to an official computer record of its date of birth;
(c) its dam has lived for at least six months after its birth;
(d) its dam has not developed BSE and is not suspected of having
contracted BSE;
(e) the herd of birth of the animal and all herds through which it has ever
moved are ECHS-eligible.
7. The official computerised tracing system referred to in point 6(a) will be
accepted only where it has been in operation for sufficient time to contain
all the information relating to the lifetime and movements of the animals
needed to check compliance with the requirements of this Decision, and
only in respect of animals born after the system came into operation. Histor-
ical data loaded into a computer for any period before the system was
operational will not be accepted for this purpose.1998D0256 — EN — 24.08.2002 — 003.001 — 15
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Controls
8. If any animal presented for slaughter or any circumstance surrounding its
slaughter does not meet all of the requirements of this Decision, the animal
must be automatically rejected. If that information becomes available after
slaughter, the competent authority must immediately cease issuing certifi-
cates, and cancel issued certificates. If dispatch has already taken place,
the competent authority must notify the competent authority of the place
of destination. The competent authority of the place of destination must
take the appropriate measures.
9. Slaughter of ECHS-eligible animals must take place in slaughterhouses
which operate a system of time separationas set out inArticle 6(4).
10. The competent authority must ensure that procedures used in the cutting
plants ensure that the following lymph nodes have been removed:
popliteal, ischiatic, superficial inguinal, deep inguinal, medial and lateral
iliac, renal prefemoral, lumbar, costocervical, sternal, prescapular, axilliary
and caudal deep cervical.
11. Meat must be traceable back to the herd of the ECHS-eligible animal, or
after cutting, to the animals cut in the same batch, by means of the compu-
terised tracing system until the time of slaughter. After slaughter, labels
must be capable of tracing fresh meat and products referred to in Article
6(1)(b) and (c) back to the herd to enable the consignment concerned to be
recalled. Food for domestic carnivores must be traceable by means of
accompanying documents and records.
12. All approved ECHS-eligible carcasses must have individual numbers corre-
lated with the ear tag number.
13. The United Kingdom must have detailed protocols in place covering:
(a) tracing and controls prior to slaughter;
(b) controls during slaughter;
(c) controls during processing of food for domestic carnivores;
(d) all labelling and certification requirements after slaughter to the point of
sale.
14. The competent authority must set up a system for recording checks on
compliance so that control can be demonstrated.
Theestablishment
15. To obtainapproval, the establishmen t must, inadditionto all other require-
ments of this Decision, devise and implement a system whereby the ECHS-
eligible meat and/or ECHS-eligible product is identifiable and all meat can
be traced back to its herds of origin, or after cutting, to the animals cut in
the same batch. The system must facilitate full traceability of the meat or
products at all stages and records must be retained for at least two years.
Details of the system to be employed must be given, in writing, by the
management of the establishment to the competent authority.
16. The competent authority must assess, approve and monitor the system
provided by the establishment in order to ensure that it provides full segre-
gation and traceability both backwards and forwards.1998D0256 — EN — 24.08.2002 — 003.001 — 16
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ANNEX III
DATE-BASEDEXPORTSCHEME(DBES)
1. Fresh meat, and products referred to in Article 6(1)(b), (c) and (d) from that
meat, derived from bovine animals slaughtered in the United Kingdom, may
be dispatched from the United Kingdom in application of the provisions of
Article 6 when obtained from DBES-eligible animals born after 1 August
1996. If obtained from animals more than nine months old, the fresh meat
shall be deboned and all adherent tissues including obvious nervous and
lymphatic tissues shall be removed.
2. Before dispatch pursuant to point 1 may commence, the United Kingdom
must have implemented and effectively enforced a programme for the
killing and incineration of all offspring born after 1 August 1996 of dams
in which BSE has been confirmed before 25 November 1998, and must
have killed and incinerated all cattle found alive which were identified
under this programme.
Should confirmation take place after 25 November 1998, offspring born
after 1 August 1996 of dams inwhich BSE has beencon firmed, must be
identified, slaughtered and incinerated without delay.
DBES-eligibleanimals
3. A bovine animal is DBES-eligible if it has been born and reared in the
United Kingdom and at the time of slaughter the following conditions are
shownto have beenmet:
(a) the animal has been clearly identifiable throughout its life, enabling it to
be traced back to the dam and herd of origin; its unique eartag number,
date and holding of birth and all movements after birth are recorded
either inthe an imal's official passport or onanofficial computerised
identification and tracing system; the identity of its dam is known;
(b) the animal is more than six months but less than 30 months of age,
determined by reference to an official computer record of its date of
birth, and in the case of animals from Great Britain, the animal's official
passport;
(c) the competent authority has obtained and verified positive official
evidence that the dam of the animal has lived for at least six months
after the birth of the eligible animal;
(d) the dam of the animal has not developed BSE and is not suspected of
having contracted BSE.
Controls
4. If any animal presented for slaughter or any circumstance surrounding its
slaughter does not meet all of the requirements of this Decision, the animal
must be automatically rejected. If that information becomes available after
slaughter, the competent authority must immediately cease issuing certifi-
cates, and cancel issued certificates. If dispatch has already taken place,
the competent authority must notify the competent authority of the place
of destination. The competent authority of the place of destination must
take the appropriate measures.
5. Slaughter of DBES-eligible animals must take place in slaughterhouses
which operate a system of time separationas described inArticle 6(4).
Slaughter in Northern Ireland of DBES-eligible animals originating from
Great Britain, or vice versa, is only authorised if access to all relevant data
is ensured.
6. The competent authority must ensure that procedures used in the cutting
plants ensure that the following lymph nodes have been removed:
popliteal, ischiatic, superficial inguinal, deep inguinal, medial and lateral
iliac, renal prefemoral, lumbar, costocervical, sternal, prescapular, axilliary
and caudal deep cervical.
7. Meat must be traceable back to the DBES-eligible animal, or after cutting,
to the animals cut in the same batch, by means of an official tracing system
until the time of slaughter. After slaughter, labels must be capable of tracing
fresh meat and products referred to in Article 6(1)(b) and (c) back to the
eligible animal to enable the consignment concerned to be recalled. Food1998D0256 — EN — 24.08.2002 — 003.001 — 17
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for domestic carnivores must be traceable by means of accompanying docu-
ments and records.
8. All approved DBES-eligible carcasses must have individual numbers corre-
lated with the ear tag number.
9. The United Kingdom must have detailed protocols in place covering:
(a) tracing and controls prior to slaughter;
(b) controls during slaughter;
(c) controls during processing of food for domestic carnivores;
(d) all labelling and certification requirements after slaughter to the point of
sale.
10. The competent authority must set up a system for recording checks on
compliance so that control can be demonstrated.
Theestablishment
11. To obtainapproval, the establishmen t must, inadditionto all other require-
ments of this Decision, devise and implement a system whereby the DBES-
eligible meat and/or DBES-eligible product is identifiable and all meat can
be traced back to the DBES-eligible animal, or after cutting, to the animals
cut inthe same batch. The system must facilitate full traceability of the
meat or products at all stages and records must be retained for at least two
years. Details of the system to be employed must be given, in writing, by
the management of the establishment to the competent authority.
12. The competent authority must assess, approve and monitor the system
provided by the establishment in order to ensure that it provides full segre-
gation and traceability both backwards and forwards.1998D0256 — EN — 24.08.2002 — 003.001 — 18