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"B COMMISSION DECISION
of 29 June 2000
regulating the use of material presenting risks as regards transmissible spongiform encephalopathies and
amending Decision 94/474/EC
(notified under document number C(2000) 1735)
(Text with EEA relevance)
(2000/418/EC)
(OJ L 158, 30.6.2000, p. 76)
Amended by:
Official Journal
No page date
"M1 Commission Decision 2001/2/EC of 27 December 2000 L 1 21 4.1.20012000D0418 — EN — 01.01.2001 — 001.001 — 1
COMMISSION DECISION
of 29 June 2000
regulating the use of material presenting risks as regards transmissible
spongiform encephalopathies and amending Decision 94/474/EC
(notified under document number C(2000) 1735)
(Text with EEA relevance)
(2000/418/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,Having regard to Council Directive 89/662/EEC of 11 December 1989
concerning veterinary checks in infra-Community trade with a view to the
completion of the internal market (
1), as last amended by Directive
92/118/EEC (2), and in particular Article 9(4) thereof,
Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning
veterinary and zootechnical checks applicable in infra-Community trade incertain live animals and products with a view to the completion of the internalmarket (
3), as last amended by Directive 92/118/EEC, and in particular Article
10(4) thereof,
Having regard to Council Directive 97/78/EC of 18 December 1997 laying
down the principles governing the organisation of veterinary checks onproducts entering the Community from third countries (
4), and in particular
Article 22 thereof,
Whereas:(1) Several distinct transmissible spongiform encephalopathies (TSEs)
have been recognised for many years as occuring separately in humans
and animals. Bovine Spongiform Encephalopathy (BSE) was firstrecognised in bovine animals in 1986 and in following years wasrecognised as occurnng in other species of animals. A new variant of
Creutzfeldt-Jakob Disease (v-CJD) was described in 1996. Evidence is
accumulating that the agent causing BSE is identical to that causingv-CJD.
(2) The Scientific Veterinary Committee in its opinion of 21 October
1996, recommended on the basis of its risk assessment that specifiedrisk materials, defined as brain, spinal cord and eyes from cattle, sheepand goats over one year of age and spleens from sheep and goats over
six months of age, should be removed from all human food and animal
feed chains in countries or regions where a potential risk wasidentified. It also recommended that, in the case of fallen bovineanimals, sheep and goats, either the specified risk materials should be
removed so that they do not enter any human food or animal feed
chain, or the whole carcass should be destroyed.
(3) The Scientific Steering Committee (SSC) adopted an opinion on 9
December 1997. It suggested a new and enlarged list of specified risk
materials and proposed that those materials should be excludedtemporarily from human and animal consumption depending on thegeographical source. It added dura mater, pituitary, dorsal root ganglia,
vertebral column, intestine and lung when animals are killed by certain
slaughter techniques, to the list recommended by the above opinion ofthe Scientific Veterinary Committee of 21 October 1996. The SSC
adopted on 14 April 2000 an opinion on the United Kingdom decision
to lift the ban on the consumption of meat on the bone. It concludedthat the risk from meat on the bone is negligible if the bones are notfrom the vertebral column or skull. It furthermore concluded that the
combined effect of several protection measures in the United Kingdom
results in an extremely small risk of human exposure to BSE fromvertebral column and dorsal root ganglia. This Committee adopted onthe same date an opinion on specified risk materials of small!B
(1) OJ L 395, 30.12.1989, p. 13.
(2) OJ L 62, 15.3.1993, p. 49.
(3) OJ L 224, 18.8.1990, p. 29.
(4) OJ L 24, 30.1.1998, p. 9.2000D0418 — EN — 01.01.2001 — 001.001 — 2
ruminants. It stated that skull (head excluding skin and tongue) and
spinal cord of all small ruminants above 12 months and the spleen ofsmall ruminants of all ages pose the highest risk. It also stated thatcertain unprocessed meat products, such as mechanically recovered
meat derived from the vertebral column of small ruminants constitutes
a significant potential risk.
(4) The Commission adopted on 18 November 1998 a proposal based on
Article 152(4) of the Treaty (COM(1998) 623 final) for a Regulationof the European Parliament and of the Council laying down rules forthe prevention and control of certain transmissible spongiform
encephalopathies (
1). That proposal was submitted to the European
Parliament and the Council on 7 January 1999. That proposal includesrules on the removal and disposal of specified risk materials. Theprovisions of this Decision will be repealed when that Regulation
enters into force.
(5) Rules should be laid down concerning the production and placing on
the market of products of animal origin with respect to removal of, or
absence of, specified risk material. In particular, they should not beplaced on the market for human food, animal feed or fertiliser.However, those rules should not apply to cosmetic or medicinal
products or medical devices, or their starting materials or intermediate
products, for which other specific rules apply. They should also notapply to products of animal origin which do not pose a risk to animalor human health since they are intended for purposes other than human
food, animal feed or fertiliser. It is appropriate to ensure that products
of animal origin outside the scope of this Decision are kept separatefrom those within it unless they meet at least the same health standards
as the latter.
(6) Existing Community Directives provide for the protection of public
health in respect of the use of specified risk material in cosmetic or
medicinal products and medical devices placed on the market in the
Community. Therefore, those products may be excluded from thescope of this Decision.
(7) Commission Decision 98/272/EC of 23 April 1998 on epidemio-
surveillance for transmissible spongiform encephalopathies (
2)l a y s
down the rules for measures to be taken by Member States where a
transmissible spongiform encephalopathy (TSE) is suspected in an
animal, the minimum requirements for the monitoring of bovinespongiform encephalopathy (BSE) and scrapie and the rules forsampling and laboratory testing for the presence of a TSE. The
Commission has undertaken to amend Decision 98/272/EC with the
objective to improve the efficacy of the monitoring for BSE in bovineanimals by use of tests targeting in particular dead-onfarm (fallenstock) and emergency slaughtered animals. These measures are
expected to provide a better insight into the regional epidemiological
situation.
(8) Certain ruminant tissues should be designated as specified risk
materials on the basis of the pathogenesis of TSEs and theepidemiological status of the country or region of origin or residenceof the animal concerned. The specified risk materials should be
removed and disposed of in a manner that avoids any risk to human or
animal health. It is necessary for practical and precautionary reasons toexclude the use of spleens from sheep and goats irrespective of age,and mechanically recovered meat from the skull and vertebral column
of bovine animals, sheep and goats.
(9) The SSC and the Scientific Committee on Veterinary Measures
relating to Public Health recommended on the safety of certain
slaughter techniques in their opinions adopted on 9 December 1997and on 25 June 1999, and on 17 February 1998 respectively. Theyconcluded that certain slaughter techniques, notably pneumatic
stunning by gas injection and laceration of central nervous tissue by
means of an elongated rod-shaped instrument introduced into cranialcavity (‘pithing’) could cause the dissemination of potentially
contaminated central nervous tissue throughout the body during
slaughter. Council Directive 93/119/EC of 22 December 1993 on the!B
(1) OJ C 45, 19.2.1999, p. 2.
(2) OJ L 122, 24.4.1998, p. 59.2000D0418 — EN — 01.01.2001 — 001.001 — 3
protection of animals at the time of slaughter or killing (1), prohibits
the use of these techniques for the stunning and killing of animals.Therefore, the use of those techniques should not be permitted forother purposes in the Community, and upon import from countries or
regions with a risk of BSE.
(10) The Commission will review the provisions to take into account the
effectiveness of the feed ban and the need to remove vertebral columnfrom certain cattle subpopulations, as soon as possible in the light ofnew scientific information and assessments, as well as the devel-
opment of the recommendations of the World Organisation for Animal
Health (Office International des Epizooties), or any other relevantinformation available to the Commission. The review with respect tothe effective enforcement of the prohibition on the feeding of
ruminants with meat-and bone meal and greaves derived from
ruminants envisages confining the provisions of this Decision toanimals born before the date of the effectiveness of that ban.
(11) The SSC, in its opinion of 23 January 1998, has established the list of
factors determining the geographical risk in a given geographical zone,
and, in its opinion of 19 and 20 February 1998, the contents of a
complete dossier for epidemiological status with respect to TSEs. Onthe basis of these opinions the Commission issued Recommendation
98/477/EC (
2) of 22 July 1998 concerning information necessary to
support applications for the evaluation of the epidemiological status ofcountries with respect to transmissible spongiform encephalopathiesand inviting Member States and non-member countries to submit
dossiers according to this recommendation for recognition of their
epidemiological status. The Commission will review the provisions forthe import of products of animal origin as soon as possible in the lightof scientific assessments using the information submitted in accord-
ance with Recommendation 98/477/EC, as well as the development of
the recommendations of the World Organisation for Animal Health(Office International des Epizooties). It therefore repeats its invitationto submit a dossier in accordance with that Recommendation for those
countries that have not yet done so and will make every effort to obtain
a scientific assessment within 12 months of the dossier submission.
(12) Commission Decision 94/474/EC of 27 July 1994 concerning certain
protection measures relating to bovine spongiform encephalopathy andrepealing Decisions 89/469/EEC and 90/200/EEC (
3), as last amended
by Decision 98/272/EEC, should be amended accordingly.
(13) On the basis of the advice of the Scientific Veterinary Committee of 21
October 1996, in accordance with the risk assessment carried out bythat Committee, the Commission adopted Decision 97/534/EC of 30July 1997 on the prohibition of the use of material presenting risks as
regards transmissible spongiform encephalopathies (
4), which was last
amended by Council Decision 1999/881/EC (5). In the light of the new
scientific advice, the development of international standards and
progress on the legislative process on adopting primary legislation in
this area, the definition of specified risk materials laid down inDecision 97/534/EC and the rules it lays down are no longerappropriate. This Decision should therefore be repealed.
(14) Separate rules may be adopted on the treatment and disposal of animal
by-products.
(15) The Standing Veterinary Committee has not given an opinion; the
Commission has therefore proposed these measures to the Council on
16.6.2000 in accordance with Article 17 of Directive 89/662/EEC, theCouncil being required to act within 15 days.
(16) However, the Council has not acted within the required time limit; the
Council has not decided against the proposed measures by simple
majority within the same time limit; these measures should now be
adopted by the Commission,!B
(1) OJ L 340, 31.12.1993, p. 21.
(2) OJ L 212, 30.7.1998, p. 58.
(3) OJ L 194, 29.7.1994, p. 96.
(4) OJ L 216, 8.8.1997, p. 95.
(5) OJ L 331, 23.12.1999, p. 78.2000D0418 — EN — 01.01.2001 — 001.001 — 4
HAS ADOPTED THIS DECISION:
Article 1
Scope
1. This Decision regulates the use of material presenting risks as regards
certain transmissible spongiform encephalopathies (TSEs). It shall apply tothe production and placing on the market of products of animal origin derivedfrom or containing material of the bovine, ovine or caprine animal species.
2. Articles 3 to 8 shall not apply to:
(a) cosmetic or medicinal products or medical devices, together with their
starting materials or intermediate products;
(b) products not destined for use in human food, animal feed or fertilisers,
together with their starting materials or intermediate products;
(c) products of animal origin destined for exhibition, teaching, research,
special studies or analysis, provided those products are not eventually
consumed by humans or by animals other than those kept for the research
projects concerned.
3. In order to avoid cross-contamination or substitution, products of animal
origin referred to in Article 1(1) shall be kept separate at all times from those
referred to in Article 1(2), unless the latter are handled or produced under atleast the same conditions of health protection in respect of TSEs.
Article 2
Definitions
For the purposes of this Decision, the following definitions shall apply:
1. ‘transmissible spongiform encephalopathies or TSEs’: all TSEs with the
exception of those occurring in humans;
2. ‘placing on the market’: any operation the purpose of which is to sell
products of animal origin covered by this Decision to a third party, or anyother form of supply against payment or free of charge to a third party, or
storage with a view to supply to a third party;
3. ‘products of animal origin’: any products derived from or containing a
product derived from any animal;
4. ‘starting materials’: raw materials or any other product of animal origin
from which, or with the help of which, the products referred to in Article
1(2)(a) and (b) are produced;
5. ‘fertilisers’: any substance containing products of animal origin utilised
on land to enhance growth of vegetation; it may include digestion
residues from bio-gas production or composting;
6. ‘competent authority’: the central authority of a Member State competent
to ensure compliance with the requirements of this Decision or any
authority to which that central authority has delegated such competence;
7. ‘specified risk material’: the tissues referred to in Annex I; unless
otherwise specified, it does not include products containing or derivedfrom those tissues;
8. ‘landfill site’: landfill site as defined by Council Directive
1999/31/EC (
1).
Article 3
Specified risk material
1. Member States shall ensure that after 1 October 2000 the specified risk
materials referred to in Annex I, point 1(a), and as appropriate point 1(b), are
removed and destroyed in accordance with Annex I, points 2 to 5.!B
(1) OJ L 182, 16.7.1999, p. 1.2000D0418 — EN — 01.01.2001 — 001.001 — 5
2. The specified risk materials or the processed material thereof may be
dispatched only for arrangements of eventual incineration in accordance withAnnex I, point 5, and, as appropriate, Article 7, paragraph (b).
Article 4
Mechanically recovered meat
Member States shall ensure that bones of the head and vertebral columns of
bovine, ovine and caprine animals shall not be used for the production ofmechanically recovered meat after 1 October 2000.
Article 5
Slaughter techniques
Member States shall ensure that the laceration, after stunning, of central
nervous tissue by means of an elongated rod-shaped instrument introduced
into cranial cavity shall not be used after 31 December 2000 on their territory
on bovine, ovine or caprine animals whose meat is destined for human oranimal consumption.
Article 6
Import into the Community
1. The specified risk materials referred to in Annex I, point 1(a) shall not be
imported into the Community after 31 March 2001.
2. (a) Where the products of animal origin listed in Annex II, containing
material derived from bovine, ovine or caprine animals, are imported
into the Community after 31 March 2001 from third countries or
regions thereof, the appropriate health certificate shall be supple-mented by a declaration signed by the competent authority of thecountry of production, worded as follows:
‘The product of animal origin does not contain, and is not derived
from, specified risk material as defined in Annex I, point 1(a) ofDecision […/…], produced after 31 March 2001, or mechanically
recovered meat obtained from the bones of the head or vertebral
column of bovine, ovine or caprine animals, produced after 31 March2001. The animals have not been slaughtered, after 31 March 2001,after stunning by means of a gas injected into the cranial cavity or
killed instantaneously by the same method, or slaughtered after
laceration, after stunning, of central nervous tissue by means of anelongated rod-shaped instrument introduced into the cranial cavity.’
(b) Any reference to ‘products of animal origin’ in this Article is a
reference to the products of animal origin listed in Annex II, not to
other products of animal origin containing or derived from those
products of animal origin.
3. The provisions of paragraphs 1 and 2 shall only apply to import from
third countries:
(a) which have not submitted a dossier to the Commission in support of their
request to be exempted from these provisions;
(b) which have submitted such a dossier but for which the outcome of a risk
assessment identifying all potential risk factors is not satisfactory.
Article 7
Official controls
Member States shall carry out frequent official controls to verify the correct
application of this Decision and ensure that measures are taken to avoid
contamination, particularly in slaughterhouses, cutting plants, animal wasteprocessing plants, high risk processing plants or premises authorised by theMember States in accordance with Article 7 of Council Directive
90/667/EEC (
1), points of sale to the consumer, landfill sites and other!B
(1) OJ L 363, 27.12.1990, p. 51.2000D0418 — EN — 01.01.2001 — 001.001 — 6
facilities for storage or incineration. They shall in particular set up a system to
ensure and check that:
(a) specified risk materials used in the production of products referred to in
Article 1(2) are exclusively used for the authorised purpose;
(b) specified risk materials, in particular where the removal takes place at
establishments or premises other than slaughterhouses, are completelyseparated from other waste not destined for incineration, are collectedseparately and are disposed of in accordance with Article 3 and Annex I.
Member States may decide to allow dispatch of heads or carcasses
containing specified risk material to another Member State afteragreement with that other Member State both to receive the material
and to the specific conditions to be applied to such movements.
Article 8
Review
1. This Decision shall be reviewed regularly in the light of new scientific
information with regard to the risk of exposure to TSEs.
2. This Decision shall be amended acting in accordance with the appropriate
procedure:
(a) to take account of the dates of effective enforcement of the prohibition on
the feeding of mammalian, or as appropriate, ruminant protein to
ruminants, in each country or region thereof;
(b) to allow the use of vertebral column and dorsal root ganglia from bovine
animals in or coming from the United Kingdom of Great Britain and
Northern Ireland and Portugal or regions thereof;
(c) to exempt certain third countries from the provisions of Article 6,
paragraphs 1 and 2.
Article 9
Amendments
Article 3(3) of Decision 94/474/EEC is hereby amended as follows:
(a) point (a) is deleted;
(b) in point (c), ‘the implementation of (a) and (b)’ is replaced by ‘the
implementation of (b)’.
Article 10
Repeal
1. Decision 97/534/EC is repealed on 30 June 2000.
2. References to Decision 97/534/EC shall be construed as references to this
Decision.
Article 11
Application
This Decision shall apply from 30 June 2000.
Article 12
Addressees
This Decision is addressed to the Member States.!B2000D0418 — EN — 01.01.2001 — 001.001 — 7
ANNEX I
Specified risk material
1. (a) The following tissues shall be designated as specified risk material in all
Member States and regions thereof:
(i) the skull including the brains and eyes, the tonsils, the spinal cord of
bovine animals aged over 12 months, and the intestines from theduodenum to the rectum of bovine animals of all ages;
(ii) the skull including the brains and eyes, the tonsils and the spinal cord
of ovine and caprine animals aged over 12 months or that have apermanent incisor erupted through the gum, and the spleen of ovineand caprine animals of all ages.
(b) In addition to the specified risk material listed in point 1(a) the following
tissues shall be designated as specified risk material in the UnitedKingdom of Great Britain and Northern Ireland and in Portugal with theexception of the Autonomous Region of the Azores:
(i) the entire head excluding the tongue, including the brains, eyes,
trigeminal ganglia and tonsils; the thymus; the spleen and spinal cordof bovine animals aged over six months;
(ii) the vertebral column, including dorsal root ganglia, of bovine animals
aged over 30 months.
2. Member States shall ensure that the specified risk materials are removed at:
(a) slaughterhouses;
(b) cutting plants, high risk processing plants or premises referred to in Article
3 and 7 of Directive 90/667/EEC, under the supervision of a designatedagent appointed by the competent authority. Those establishments shall beapproved for that purpose by the competent authority.
Where specified risk materials are not removed from dead animals not
slaughtered for human consumption, the parts of the body containing thespecified risk materials or the entire body shall be treated as specified riskmaterial.
However, the vertebral column may be removed at the point of sale to the
consumer on their territory.
3. Member States shall ensure that all specified risk material is stained with a dye
and, as appropriate, marked with a marker immediately on removal, and iscompletely destroyed:
(a) by incineration without pre-processing; or,
(b) provided that the dye or marker remains detectable, after pre-processing:
(i) in accordance with the systems described in Chapters I to IV , VI and
VII of Annex to Commission Decision 92/562/EEC (
1):
— by incineration;
— by co-incineration;
(ii) in accordance with at least the standards referred to in Annex I to
Council Decision 1999/534/EC (2), by burial in an approved landfill
site.
4. Member States may derogate from the provisions of points 2 and 3 to allow the
incineration or burial of specified risk material or entire bodies, without priorstaining, or, as appropriate, removal of the specified risk materials, in thecircumstances set out in Article 3(2) of Directive 90/667/EEC and by a method,which precludes all risk of transmission of a TSE, and is authorised andsupervised by the competent authority, in particular where animals have died, or
have been killed in the context of disease control measures.
5. Member States may send specified risk material or the processed material
thereof to other Member States for incineration under the conditions laid downin Article 4(2) of Commission Decision 97/735/EC (
3), as applicable.
This Decision may be amended on request of a Member State to allow the
dispatch of specified risk material or the processed material thereof to third!B
(1) OJ L 359, 9.12.1992, p. 23.
(2) OJ L 204, 4.8.1999, p. 37.
(3) OJ L 294, 28.10.1997, p. 7.!M1
!B2000D0418 — EN — 01.01.2001 — 001.001 — 8
countries for incineration. The Commission shall at the same time adopt the
conditions governing the exportation.!B2000D0418 — EN — 01.01.2001 — 001.001 — 9
ANNEX II
The following products of animal origin shall be subject to restrictions on
import into the Community pursuant to Article 6(1):
(a) ‘fresh meat’: fresh meat as defined by Council Directive 64/433/EEC (1)
on health problems affecting intra-Community trade in fresh meat;
(b) ‘minced meat’ and ‘meat preparations’: minced meat and meat prepara-
tions as defined by Council Directive 94/65/EC (2);
(c) ‘meat products’: meat products as defined by Council Directive 77/99/
EEC (3);
(d) ‘processed animal protein’, as referred to by Directive 92/118/EEC;
(e) ‘bovine intestines’ as referred to in Article 2(b)(v) of Directive 77/99/EEC.!B
(1) OJ L 121, 29.7.1964, p. 2012/64.
(2) OJ L 368, 31.12.1994, p. 10.
(3) OJ L 26, 31.1.1977, p. 85.!M12000D0418 — EN — 01.01.2001 — 001.001 — 10