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"B COUNCIL DECISION
of 16 March 1998
concerning emergency measures to protect against bovine spongiform encephalopathy, amending Decision
94/474/EC and repealing Decision 96/239/EC
(98/256/EC)
(OJ L 113, 15.4.1998, p. 32)
Amended by:
Official Journal
No page date
"M1 Commission Decision 98/564/EC of 7 October 1998 L 273 37 9.10.1998
"M2 Commission Decision 98/692/EC of 25 November 1998 L 328 28 4.12.19981998D0256 — EN — 04.12.1998 — 002.001 — 1
COUNCIL DECISION
of 16 March 1998
concerning emergency measures to protect against bovine spongiform
encephalopathy, amending Decision 94/474/EC and repealing Decision
96/239/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 incertain live animals and products with a view to the 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 to the
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 variantof Creutzfeldt Jacob Disease (CJD) in humans; whereas on 16September 1997 the Spongiform Encephalopathy Advisory Committee
(SEAC) of the United Kingdom concluded that recent research
provided compelling new evidence that the agent which causes BSE isidentical to the agent which causes the new variant of CJD in humans;
whereas on 18 September 1997 the Advisory Committee on Dangerous
Pathogens (ACDP) concluded that the BSE agent should now beclassified as a human pathogen;
(2) Whereas, in those circumstances and as an emergency measure, it is
appropriate to prohibit temporarily the dispatch to the other MemberStates of all bovine animals from the United Kingdom and of allproducts consisting entirely or in part of, or incorporating materials
derived from, bovine animals slaughtered in the United Kingdom
which are liable to enter the human food or animal feed chains or aredestined for use in cosmetic, pharmaceutical or medical products;whereas in order to prevent deflections of trade, the same prohibitions
should also apply to exports to third countries;
(3) Whereas, in order to protect animal and human health in the
Community, 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/EECand 90/200/EEC (
3), Decision 92/290/EEC of 14 May 1992 concerning
certain protection measures relating to bovine embryos in respect of
bovine spongiform encephalopathy (BSE) in the United Kingdom (4),
Decision 94/381/EC of 27 June 1994 concerning certain protectionmeasures with regard to bovine spongiform encephalopathy and the
feeding of mammalian derived protein (
5) and Decision 96/449/EC of
18 July 1996 on the approval of alternative heat-treatment systems forprocessing animal waste with a view to the inactivation of spongiformencephalopathy agents (
6);
(4) Whereas the United Kingdom has taken measures as a result of the
publication of information on certain cases of CJD in that MemberState;!B
(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. Decision as last amended by Decision 95/287/EC (OJ
L 181, 1. 8. 1995, p.40).
(4) OJ L 152, 4. 6. 1992, p. 37. Decision as amended by the 1994 Act of Accession.
(5) OJ L 172, 7. 7. 1994, p. 23. Decision as amended by Decision 95/60/EC (OJ L 55,
11. 3. 1995, p. 43).
(6) OJ L 184, 24. 7. 1996, p. 43.1998D0256 — EN — 04.12.1998 — 002.001 — 2
(5) Whereas the United Kingdom has banned the use of mammalian
meat-and-bone meal, regardless of its origin, for feeding farm animals;whereas it is necessary to provide that mammalian meat-and-bonemeal and farm animal feed and fertilisers containing mammalian
meat-and-bone meal, which by their nature could enter the farm
animal feed chain, may not be dispatched from the United Kingdom;
(6) Whereas the risk of transmissible spongiform encephalopathies (TSEs)
entering the human food or animal feed chains through the
consumption of protein derived from domestic carnivores is considered
low; whereas that risk can be further reduced by requiring thatdomestic carnivores are not fed mammalian meat-and-bone mealoriginating in the United Kingdom; whereas it is therefore appropriate
to provide that food for domestic carnivores which is produced in the
United Kingdom but contains no mammalian meat-and-bone mealoriginating in that country may be dispatched from its territory to otherMember States or to third countries;
(7) Whereas the United Kingdom has taken measures to destroy certain
bovine tissues;
(8) Whereas Commission Decision 96/239/EC of 27 March 1996 on
emergency measures to protect against bovine spongiform encepha-lopathy (
1), before its amendment by Decision 96/362/EC (2), pro-
hibited the dispatch from the United Kingdom to other Member States
and to third countries, in particular, of bovine semen, and certain otherproducts from the United Kingdom obtained from bovine animalsslaughtered in the United Kingdom which are liable to enter the animal
feed or human food chains and materials destined for use in medicinal
products, cosmetics or pharmaceutical products;
(9) Whereas the Scientific Veterinary was consulted on 18 and 26 April
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 was consulted on
the safety of certain bovine products on 11 April 1996; whereas theLiaison Committee of European Associations of the Perfume,Cosmetic Products and Toiletries Industries (Colipa) has recom-
mended its members not to use source materials from United Kingdom
bovine animals; whereas that Committee has declared that its membersfollow that recommendation; whereas Commission Directive 97/1/ECof 10 January 1997 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 (
3), has
provisionally prohibited the placing on the market of cosmetic
products containing certain tissues and fluids;
(11) Whereas the Scientific Committee for food was consulted on the safety
of certain bovine products on 15 April 1996;
(12) Whereas the Committee for Proprietary Medicinal Products was
consulted on 16 April 1996; whereas the pharmaceutical sector hadalready introduced measures relating to the sourcing of materials and
their treatment; whereas every medicinal product undergoes a
pre-marketing approval before it is placed on the market by virtue ofwhich the treatment process of any raw material is evaluated; whereas
at the request of the European Agency for the Evaluation of Medicinal
Products, all Community marketing authorisation holders, or appli-cants with a positive opinion from the Committee for ProprietaryMedicinal Products 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 available in
order to facilitate a more complete risk assessment; whereas, on thatbasis, the Scientific Veterinary Committee on 26 April 1996 concluded
that a combination of appropriate sourcing of bovine materials used
and the application of minimum processing standards whch have beenshown effectively to inactivate the BSE agent together give good
reassurances about the safety of those materials for food or cosmetic
use; whereas, consequently, the Scientific Veterinary Committee has!B
(1) OJ L 78, 28. 3. 1996, p. 47.
(2) OJ L 139, 12. 6. 1996, p. 17.
(3) OJ L 16, 18. 1. 1997, p. 85.1998D0256 — EN — 04.12.1998 — 002.001 — 3
recommended safety parameters for the production of those materials
which are therefore considered to be safe;
(14) Whereas the Commission accordingly considered that certain products,
such as gelatin and tallow, were safe;
(15) Whereas in 1988 the United Kingdom introduced a requirement for
animals affected with BSE to be completely destroyed; whereas theCouncil, 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 pharmaceuticalproducts; whereas such animals should not be used as source materialsfor certain bovine products;
(16) Whereas furthermore, certain bovine tissues should not be used as
source materials for those products;
(17) Whereas Decision 96/362/EC amended Decision 96/239/EC to exempt
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 of 26 June 1996,
where it recommended that the risk assessment for gelatin establishedby the Scientific Veterinary Committee on 26 April 1996 bereappraised in the light of the uncertainties as to the inactivation of
the BSE agent, due note being taken of the 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 gelatin made from raw materials from bovine animals;whereas those preconditions have not beeen fulfilled and such dispatchhas not been authorised; whereas, however, in order to regualarise the
situation, pending further scientific knowledge and advice, it is
appropriate to withdraw the possibility of dispatch of gelatin madefrom raw materials from bovine animals slaughtered in the UnitedKingdom for human food, animal feed, cosmetics pharmaceutical and
medical purposes; whereas that is in conformity with the advice from
the Multidisciplinary Scientific Committee of 3 April 1997, accordingto 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 dispatch rom its
territory gelatin and di-calcium phosphate for technical purposes madefrom raw material from bovine animals slaughtered in the United
Kingdom, provided that it is suitably labelled;
(21) Whereas the United Kingdom should also be permitted to disptach
from its territory gelatin produced from raw material from bovine
animals not slaughtered in the United Kingdom; whereas the United
Kingdom has introduced a system of traceability for such gelatine toensure that the origin of the raw material is identifiable; whereas theCommunity rules should be supplemented by formally introducing a
system of traceability; whereas such a system should be introduced for
other products which are exempted from the overall ban; whereas asystem of labelling should also be introduced;
(22) Whereas it is necessary to provide that products from bovine animals
not slaughtered in the United Kingdom should come from approvedestablishments under official veterinary control which have a system inplace to ensure traceability to the origin of the raw materials; whereas,
however, dispatch of those products from the United Kingdom may
take place inmediately, without prior inspection by the Commission;
(23) Whereas it is necessary to lay down appropriate guarantees for the
dispatch from the United Kingdom of certain products obtained from
bovine animals which were not slaughtered in the United Kingdom;
(24) Whereas a reliable system of controls throughout the Community is a
precondition for the smooth functioning of the beef market; whereas it
is clear from the investigations by the Unit on Coordination of Fraud
Prevention (UCLAF) and the Food and Veterinary Office of theCommission that there are deficiencies in official controls onproduction of beef in the United Kingdom for dispatch to other
Member States and third countries; whereas it is, therefore, necessary
to reinforce the system of veterinary checks in order to prevent fraud;!B1998D0256 — EN — 04.12.1998 — 002.001 — 4
(25) Whereas reinforced checks should apply to all commercial con-
signments of fresh meat of bovine animals moving into, through orfrom the territory of the United Kingdom; whereas it is appropriate torequire that all such consignments be sealed and unsealed by the
competent authority and accompanied by veterinary certificates and, in
the case of intra-Community trade, to require an official notification ofthe dispatch of a consignment by means of the ANIMO system asreferred to in Commission Decision 91/398/EEC of 19 July 1991 on a
computerised network linking veterinary authorities (ANIMO) (
1), or
by fax;
(26) Whereas the veterinary supervision of the processing of meat derived
from bovine animals slaughtered elsewhere than in the United
Kingdom should also be reinforced;
(27) Whereas the United Kingdom put forward a first proposal for an
export certified herds scheme to the Commission on 25 February1997; whereas the Scientific Veterinary Committee concluded at itsmeeting 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 Committee issued an opinionon that revised proposal on 17 September 1997 stating that the major
obstacle to approving the scheme for the entire territory of the United
Kingdom was the lack of a comprehensive computerised movementand tracing system and associated database for live cattle in GreatBritain but that an adequate system did apear to exist in Northern
Ireland; whereas the Committee concluded furthermore that small
modifications could be made to minor aspects of the scheme at therequest of the competent Commission departments in order to complywith certification or control requirements; whereas the Food and
Veterinary Office conducted a feasibility inspection in Northern
Ireland from 3 to 7 November 1997; whereas the United Kingdom hasagreed to further improvements in line with the recommendations
made following that inspection; whereas, therefore, a partial lifting of
the prohibition on the dispatch of products from bovine animalsslaughtered in Northern Ireland is appropriate;
(28) Whereas inspections carried out by the Commission services have
shown that the system of veterinary checks in Northern Ireland is more
effective; whereas, therefore, a step-by-step approach is appropriate,
starting with the lifting of the prohibitions on the dispatch of productsfrom bovine animals slaughtered, cut, processed and stored inestablishments exclusively used for products destined for dispatch to
other Member States and third countries, located in Northern Ireland;
whereas subsequent steps will include the lifting of the prohibition onthe processing of eligible meat from Northern Ireland in Great Britain,
under conditions which will be laid down at a later stage: whereas the
Commission will immediately start investigating, with the authoritiesof the United Kingdom, by what means and under what conditionsthose restrictions may be further relaxed;
(29) Whereas in order to prevent fraud, meat derived from bovine animals
slaughtered in the United Kingdom should bear, in addition to the
health mark provided for in Article 3(1)(A)(e) of Council Directive64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat (
2), a distinct mark which cannot be
confused with the Community health mark;
(30) Whereas most of the provisions of Decision 94/474/EC are no longer
in conformity with the opinion of the Scientific Veterinary Committeeof 17 September 1997 and should therefore be deleted;
(31) Whereas Decision 96/239/EC required the United Kingdom to provide
reports on the BSE situation every two weeks; whereas that period has
been found to be too short; whereas it should be extended to onemonth;
(32) Whereas the Commission should continue to carry out Community
inspections in the United Kingdom to verify the application of the
measures provided for in this Decision;!B
(1) OJ L 221, 9. 8. 1991, p. 30.
(2) 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).1998D0256 — EN — 04.12.1998 — 002.001 — 5
(33) Whereas the foregoing entails a fundamental reworking of Decision
96/239/EC; whereas, in the interests of clarity, that Decision should berepealed;
(34) Whereas this Decision will be reviewed in the light of new scientific
information;
(35) Whereas the Standing Veterinary Committee has not given a favour-
able 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 otherMember 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 2
By way of derogation from Article 1, food destined for domestic carnivores
containing material referred to in Article 1(b) may be dispatched to otherMember States or to third countries provided that those materials did not
originate from the United Kingdom and that the conditions laid down in
Articles 9 and 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 United Kingdomshall ensure that the following are not dispatched from its territory to other
Member States or to third countries, when derived from 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 production and the dispatch from its territory to other Member States or tothird countries of:
(a) amino acids, peptides and tallow, which have been produced in
establishments under official veterinary supervision which have been
shown to be operating in accordance with the conditions set out in Annex
I;
(b) tallow products and products derived from tallow by saponification,
transesterification or hydrolysis, where these are manufactured fromtallow produced in accordance with this Article;!B1998D0256 — EN — 04.12.1998 — 002.001 — 6
!M1
(c) samples, dispatched from the Veterinary Laboratory Agency, Weybridge,
to officially approved institutes, obtained from bovine animals slaught-
ered in the United Kingdom and which are destined for use for thepurpose 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) 3are labelled or otherwise identified to show
the establishment of production and to indicate that they are suitable for use inhuman food, animal feed, cosmetics or medical or pharmaceutical products.
3. The United Kingdom shall ensure that products referred to in paragraph
1(a) which are dispatched to other Member States in accordance with thisArticle are accompanied by a health certificate issued by an officialveterinarian stating that they conform to the conditions laid down in 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 shall forward to the
Commission and the other Member States the list of the establishments
referred to in paragraph 1(a), identifying for each establishment the purposefor which it has been approved. It shall notify the Commission and the otherMember States immediately of any amendments to that list.
5. Community inspections shall be carried out on the implementation of
official controls in respect of each of the products referred to in paragraph 1before the dispatch of those products may commence or recommence.
6. The Commission, after having consulted the Member States in the
framework of the Standing Veterinary Committee, shall set the date on whichestablishments may commence or recommence dispatch of the productsreferred to in paragraph 1(a).
Article 5
The United Kingdom shall ensure that gelatin, di-calcium phosphate,
collagen, tallow, tallow products and products derived from tallow by
saponification, transesterification or hydrolysis which are produced for
technical use from raw materials derived from bovine animals slaughtered inthe United Kingdom are labelled or otherwise identified to show the
establishment of production and their unsuitability for use in human food,
animal feed, cosmetics or medical or pharmaceutical products.
Article 6
1. By way of derogation from Article 3, the United Kingdom may authorise
the dispatch to other Member States or to third countries of the followingproducts derived from bovine animals born and reared in the United Kingdomwhich have been slaughtered in the United Kingdom in slaughterhouses which
are not used for the slaughter of any ineligible bovine animal, in accordance
with the conditions laid down in this Article, Article 7, Articles 9 to 12 andAnnex II or, as appropriate, Annex III:
(a) ‘fresh meat’ as defined by Directive 64/433/EEC;
(b) ‘minced meat’ and ‘meat preparations’ as defined by Council Directive
94/65/EC (
1);
(c) ‘meat products’ as defined by Council Directive 77/99/EEC (2);
(d) food which is destined for domestic carnivores.
2. The fresh meat referred to in paragraph 1(a) shall be deboned and all
adherent tissues, including obvious nervous and lymphatic tissues, shall be
removed in cutting plants in the United Kingdom which are not used for
cutting any ineligible bovine products. Cold storage shall take place in theUnited Kingdom in chambers which are not used for storing any ineligiblebovine products and are kept locked under the seal of the competent authority
when the latter is not present. Cutting, storage and transport shall be carried
out in accordance with the conditions laid down in Article 7, Articles 9 to 12and Annex II or, as appropriate, Annex III.
(1) OJ L 368, 31.12.1994, p. 10.
(2) OJ L 26, 31.1.1977, p. 85.!B
!M21998D0256 — EN — 04.12.1998 — 002.001 — 7
3. The fresh meat referred to in paragraph 1(a) may be used for the
production of products referred to in paragraph 1(b), (c) and (d) inestablishments in the United Kingdom which are not used for the productionof any ineligible bovine products, in accordance with the conditions laid down
in this Article, in Article 7, Articles 9 to 12 and Annex II or, as appropriate,
Annex III.
4. For the purposes of this Article, eligible products means products referred
to in paragraph 1 and products derived from bovine animals not slaughtered inthe United Kingdom which comply with the conditions laid down in Articles
9 to 13.
5. The Commission, after having verified the application of all the
provisions of this Decision on the basis of Community inspections and afterhaving informed the Member States, shall set the date on which dispatch of
the products referred to in Annex III may commence.
6. The Commission shall review the provisions of this Article at least every
three months and shall take appropriate measures in accordance with theprocedure laid down in Article 17 of Directive 89/662/EEC.
7. For the purpose of this Decision ‘“chamber’ shall mean a room or any
other structure within a room which provides a secure lockable physical
barrier.
Article 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 confused with theCommunity 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 not bear 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 atthe time that meat or those products leave the establishment. The Community
health mark shall not 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 in paragraph 1before dispatch commences.
CHAPTER III
Materials derived from bovine animals not slaughtered in the United
Kingdom
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 its territory to otherMember 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, 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 cosmetics or
medical or pharmaceutical products.
Article 9
1. The products referred to in Article 8 shall come from and, as appropriate,
have passed through, establishments in the United Kingdom:
(a) which have been approved by the comptetent authority;!M2
!B1998D0256 — EN — 04.12.1998 — 002.001 — 8
(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 the raw material which will
guarantee the origin of the material throughout the whole production
chain;
(d) which have put in place a registration system of amounts of incoming and
outgoing materials to allow for cross-checking consignments entering or
leaving;
(e) in which the products are unloaded, processed, stored, handled, loaded
and transported separately from, or at different times from, productswhich do not comply with the conditions laid down in this Article 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 conditions referredto in paragraph 1, identifying for each establishment the purpose for which it
has been approved. It shall notify the Commission and the Member States
immediately of any amendments to that list.
Article 10
1. Products referred to in Article 8(a) to (d) shall come from and, 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) 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 withthe conditions laid down in this Article, in
"M2Articles 6, 9, 11, 12 and
133and are kept locked under the seal of the competent authority when
the latter is not present;
(c) the products, with the exception of the products referred to in Article
8(d), are marked or labelled with an additional distinct mark 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, but destined forplacing on the market in the United Kingdom 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 thetime that meat or those products leave 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 additional
marks provided for in Community legislation, the competent authority shallkeep 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 time ofmarking 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 by 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 9, 11, 12 and 13 aremet, identifying all establishments where they were obtained, processed,
handled or stored and identifying all labels and
"M2the relevant numbers in
the consignment ensuring traceability of each individual unit 3.
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 "M2the relevant numbers in the consignment
ensuring traceability of each individual unit 3.!B1998D0256 — EN — 04.12.1998 — 002.001 — 9
The following words shall be added to all certificates:‘produced in
accordance with Decision 98/256/EC’.
Where those products are dispatched to third countries, they shall be
accompanied by a health certificate, issued by an official veterinarian, statingthat 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 Animo system or by fax.
Article 11
Without prejudice to Article 7(2) and Article 10(1)(d), where products
referred to in Article 8(a) come from and, as appropriate, have passed through
establishments in the United Kingdom, the Community health marks shall not
be removed except where that is unavoidable in the cutting process.
Article 12
The products referred to in Article 8(e) which are dispatched to other Member
States shall be labelled in order to identify the establishment of productionand to indicate that they have been produced in accordance with this Decision
and, as appropriate, that they are suitable for use in human food, animal feed,
cosmetics or medical or pharmaceutical products.
Article 13
1. A Member State which dispatches meat as referred to in Article 8(a) from
an establishment or Community approved border inspection post in its
territory through the territory of the United Kingdom or to an establishmentapproved in accordance with Article 9 shall ensure that the meat is
accompanied by a veterinary certificate issued by an official veterinarian or
the certificate issued by the competent authority of the border inspection post.
The originals of all certificates shall accompany the consignment to the
establishment of its destination.
2. The meat as referred to in Article 8(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 8(e) or
any raw materials for use in the production of those products to an
establishment approved in accordance with Article 9 shall ensure that they are
labelled or otherwise identified to show the establishment and Member Statein which they were produced.
CHAPTER IV
Final provisions
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 in relation to the implementation of official controls.
Article 15
The United Kingdom shall send the Commission every month a report on the
application of the protective measures taken against 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, after
consultation of the appropriate Scientific Committee, in accordance with theprocedure laid down in Article 18 of Directive 89/662/EEC.!B
!M2
!B1998D0256 — EN — 04.12.1998 — 002.001 — 10
Article 17
Member States shall adopt the necessary measures to comply with this
Decision. They shall immediately inform the Commission thereof.
Article 18
Decision 94/474/EC is hereby amended as follows:
1. Article 1 shall be deleted;2. in Article 3, paragraphs 1 and 2 shall be deleted;
3. Article 4 shall be deleted.
Article 19
Decision 96/239/EC is hereby repealed.
Article 20
This Decision is addressed to the Member States.!B1998D0256 — EN — 04.12.1998 — 002.001 — 11
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
of411, followed by heat treatment at 140 °C 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 processesdescribed in Chapter 2;
(c) products derived from tallow by one of the processes described in Chapter
3.
2. Products referred to in point 1 must be filtered after production.3. Bovine animals which are showing signs of BSE 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 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 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 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
CHAPTER 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
The above temperature/time requirements may run concurrently.
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 theconditions set out in point 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 VIImay also be authorised.!
B
(1) OJ L 99, 20. 4. 1996, p. 14.
(2) OJ L 359, 9. 12. 1992, p. 23.1998D0256 — EN — 04.12.1998 — 002.001 — 12
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, usingmethods described in the Annex to Decision 92/562/EEC
1.Temperature — continuous and batch systems
Temperature monitoring devices must be situated regularly throughout the
equipment in order to record temperature at different stages in the process.Records should be kept and calibrations completed at regular intervals.
2.Pressure (Chapter II only)
Pressure monitoring devices must be installed in order to record pressure at
stages in the process. Records must be kept and calibrations completed atregular intervals.
3.Particle size — all systems
CHAPTER 3
Human food, animal feed, medical or pharmaceutical products, 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 three hours; or,— in a continuous process: at not less than 140 °C, 2 bars for not less than eight
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 three hours; or,
— in a continuous process: at 140 °C, 2 bars for eight minutes or equivalent.!
B1998D0256 — EN — 04.12.1998 — 002.001 — 13
ANNEX II
EXPORT CERTIFIED HERDS SCHEME (ECHS)
1. Deboned 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 bedispatched from the United Kingdom in application of the provisions of Article6 when obtained from ECHS-eligible animals which originate from ECHS-eligible herds.
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 othergroup of animals and which were identified with unique herd and animalidentification numbers.
3. A herd is ECHS-eligible when for at least eight years, there has been no
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 considered
ECHS-eligible, after a thorough epidemiological investigation by the competentveterinary 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 onthat holding, the newly established herd can only be ECHS-eligible after athorough 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 thoroughly
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, identityand 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 allthe 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. Historical data loaded into acomputer for any period before the system was operational will not be acceptedfor this purpose.
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!
M21998D0256 — EN — 04.12.1998 — 002.001 — 14
must be automatically rejected. If that information becomes available after
slaughter, the competent authority must immediately cease issuing certificates,and cancel issued certificates. If dispatch has already taken place, the competentauthority must notify the competent authority of the place of destination. Thecompetent authority of the place of destination must take the appropriatemeasures.
9. Slaughter of ECHS-eligible animals must take place in slaughterhouses, in
Northern Ireland, which are not used for slaughter of any bovine animal whichis not eligible under the Date-based Export Scheme (DBES) or under the ECHS.
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 andcaudal 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 computerisedtracing system until the time of slaughter. After slaughter, labels must becapable 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 fordomestic carnivores must be traceable by means of accompanying documents
and records.
12. All approved ECHS-eligible carcasses must have individual numbers correlated
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.
The establishment
15. To obtain approval, the establishment must, in addition to all other requirements
of this Decision, devise and implement a system whereby the ECHS-eligiblemeat and/or ECHS-eligible product is identifiable and all meat can be tracedback 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 stagesand 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 segregation and
traceability both backwards and forwards.!
M21998D0256 — EN — 04.12.1998 — 002.001 — 15
ANNEX III
DATE-BASED EXPORT SCHEME (DBES)
1. Deboned 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 maybe dispatched from the United Kingdom in application of the provisions ofArticle 6 when obtained from DBES-eligible animals born after 1 August 1996.
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 andincinerated 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 in which BSE has been confirmed, must be identified,slaughtered and incinerated without delay.
DBES-eligible animals
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 shown tohave been met:
(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, dateand holding of birth and all movements after birth are recorded either inthe animal’s official passport or on an official computerised identificationand 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 animalmust be automatically rejected. If that information becomes available afterslaughter, the competent authority must immediately cease issuing certificates,and cancel issued certificates. If dispatch has already taken place, the competentauthority 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
are not used for slaughter of any bovine animal which is not eligible under the
DBES when located in Great Britain, or under the DBES as well as under theECHS when located in Northern Ireland. Slaughter of DBES-eligible animalsoriginating from Great Britain in Northern Ireland, or, vice versa , originating
from Northern Ireland in Great Britain, is only authorised if access to allrelevant 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 andcaudal 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 untilthe time of slaughter. After slaughter, labels must be capable of tracing freshmeat and products referred to in Article 6(1)(b) and (c) back to the eligibleanimal to enable the consignment concerned to be recalled. Food for domestic
carnivores must be traceable by means of accompanying documents and
records.
8. All approved DBES-eligible carcasses must have individual numbers correlated
with the ear tag number.
9. The United Kingdom must have detailed protocols in place covering:
(a) tracing and controls prior to slaughter;!
M21998D0256 — EN — 04.12.1998 — 002.001 — 16
(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.
The establishment
11. To obtain approval, the establishment must, in addition to all other requirements
of this Decision, devise and implement a system whereby the DBES-eligiblemeat 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 in the
same batch. The system must facilitate full traceability of the meat or productsat all stages and records must be retained for at least two years. Details of thesystem to be employed must be given, in writing, by the management of theestablishment 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 segregation andtraceability both backwards and forwards.!
M21998D0256 — EN — 04.12.1998 — 002.001 — 17