COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 09.03.1998 
COM(1998) 160 final 
Proposal for a 
COUNCIL DECISION 
on the prohibition of the use of material presenting risks as regards transmissible 
spongiform encephalopathies and repealing Decision 97/534/EC 
(presented by the Commission) 

EXPLANATORY MEMORANDUM 
1. The decision replaces Commission Decision 97/534/EC laying down the rules on 
the prohibition of the use of material presenting risks as regards transmissible 
spongiform encephalopathies (SRM). It amends its provisions in respect of the 
following points : 
The list of SRM is enlarged in accordance with the opinion of the Scientific 
Steering Committee (SSC) of 9 December 1997. This list will apply as from 1 July 
1998. 
The Decision allows Member States and Third countries with regard to their 
exports to the Community to ask for a total or partial derogation from the SRM ban 
in the light of their geographical risk. The following procedure applies : 
Member States requesting a derogation must submit the data necessary to allow 
assessment of their geographical USE risk until 30 June 1998 at the latest, for these 
Member States, the entry into force of the enlarged Community SRM list will be 
suspended until 31 December 1998 in order to allow for the scientific assessment and 
the subsequent decision making. However, Member States with BSE cases in their 
cattle population have to apply SRM removal rules on the basis of a shorter list. 
However this list cannot be shorter than the list recommended by the Office 
international des Epizooties (OIE) in 1997. 
Third countries will also be invited to submit the necessary data in the same time 
scale. Imports from third countries, which have followed this invitation (except 
Switzerland which has native BSE cases), will be exempted from the requirement of 
SRM removal until 31 December 1998. I'or imports from Switzerland the 1997 OIE 
list of SRM will apply until this date. 
An exemption for Member States applying a compulsory single carcass test for 
bovines above a certain age is introduced in the Decision. As a precondition such 
tests must be approved by the Commission after validation will have been carried 
out. A derogation for relevant products derived from tested carcasses to be imported 
from third countries is also foreseen. 
A derogation for the use of SRM in certain products covered by sectoral 
legislation, e.g. medicinal and cosmetic products, and industrial products is foreseen. 
2. This decision is in accordance with the advice given by the SSC on 9 December 
1997 and improves consumer safety while avoiding unjustified trade, economic and 
technical consequences. In addition it allows for taking into account future scientific 
advice and for respecting WTO notification requirements. 
3. This decision will be combined with the reinforced implementation of existing 
measures for minimising the BSE risk and improved surveillance (see separate draft 
decision on epidemio-surveillance for TSE and amending Decision 94/474/EC). 
In the Standing Veterinary Committee meeting of 4 March Greece, Spain and 
Sweden supported the proposal. The Netherlands voted against the proposal because 
they feel TSEs are diseases for which régionalisation is impossible in principle. The 
United Kingdom, France, Luxembourg, Portugal and Belgium are against 
régionalisation before the criteria have been harmonised, but could accept 
régionalisation in future. Belgium, Denmark, Germany, Ireland, Italy, Austria and 
Finland are against the proposal because of the enlarged list of SRMs, which they 
consider unscientific and which would automatically come into force on 1 January 
1999, in the absence of a Commission decision. 
The Commission not having received a favourable opinion from the Standing 
Veterinary Committee, is required under Article 17 of Directive 89/662 to submit a 
porposal to the Council without delay. 
1 
PROPOSAL for a 
COUNCIL DECISION 
of 
on the prohibition of the use of material presenting risks as regards transmissible 
spongiform encephalopathies and repealing Decision 97/534/EC 
THE COUNCIL OF THE EUROPEAN UNION, 
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 intra-Community trade with a view to the completion of the 
internal market , as last amended by Directive 92/118/EEC , and in particular Article 9 
(4) thereof, 
I laving 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 to the completion of the internal market, as last amended by 
Directive 92/118/EEC, and in particular Article 10(4) thereof, 
Having regard to Council Directive 90/675/EEC of 10 December 1990 laying down the 
principles governing the organization of veterinary checks on products entering the 
Community from third countries , as last amended by Directive 96/43/EC5, and in 
particular Article 19 thereof, 
I laving regard the proposal of the Commission, 
1 OJ No L 395, 30.12.1989, p. 13. 
2 OJ No 1.62, 15.3.1993, p. 49. 
, OJNoL224, 18.8.1990, p. 29. 
4 OJ No L 373, 31.12.1990, p. I. 
5 OJNoL 162, 1.7.1996, p. I. 
5" 
(1) Whereas under Directive 89/662/EEC and Directive 90/425/EEC, the Member 
State of origin or dispatch is required to implement on its territory the appropriate 
measures to prevent all situations likely to constitute a serious hazard to animals 
or to human health; 
(2) 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 
Encephalopathy Advisory Committee (SEAC) of the United Kingdom 
concluded that 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 September 1997 the Advisory Committee on 
Dangerous Pathogens (ACDP) concluded that the BSE agent should now be 
classified as a human pathogen; 
(3) Whereas Commission Decision 94/381/EC of 27 June 1994 concerning certain 
protection measures with regard to bovine spongiform encephalopathy and the 
feeding of mammalian derived protein ', as amended by Decision 95/60/LC7, 
prohibited the feeding of mammalian protein to ruminants throughout the 
Community; 
(4) Whereas Commission Decision 96/239/EC of 27 March 1996 on emergency 
measures to protect against bovine spongiform encephalopathy8, as amended by 
Decision 96/362/EC9, was adopted pending further evaluation of the new 
information and further measures to protect animal and public health; 
" OJNol, 172, 7.7.1994, p. 23. 
7 ()JNoL55, 11.3.1995, p. 43. 
K OJ No L 78, 28.3.1996, p. 47. 
9 OJNoL 139, 12.6.1996, p. 17. 
€ 
(5) Whereas Commission Decision 96/449/EC of 18 July 1996 on the approval of 
alternative heat treatment systems for processing animal waste with a view to the 
inactivation of spongiform encephalopathy agents , lays down the best available 
method for processing animal waste as regards spongiform encephalopathy 
agents; 
(6) Whereas a group of experts convened by WHO on 3 April 1996 recommended 
that no part or product of any animal which had shown signs of a transmissible 
spongiform encephalopathy (FSE) should enter any food chain (human or 
animal), and that countries should not permit tissues that are likely to contain the 
BSE agent to enter any food chain (human or animal); whereas the Scientific 
Veterinary Committee has assessed the measures needed in the whole 
Community in order to put the recommendations of that group of experts into 
effect; 
(7) Whereas the Scientific Veterinary Committee has concluded on the basis of its 
risk assessment that the rendering procedure using 133 °C at 3 bar for 20 minutes 
is the most important factor to assure the safety of meat-and-bone meal, but that 
this system cannot completely guarantee the complete removal of a TSE agent 
present in the material to be rendered if the system is challenged with material 
with high infcctivity; 
(8) Whereas the Scientific Veterinary Committee in its opinion of 21 October 1996 
recommended on the basis of its risk assessment that specified risk materials, 
defined as brain, spinal cord and eyes from cattle, sheep and goats over one year 
of age and spleens from sheep and goats over six months of age, should be 
removed from all food and feed chains in countries or regions where a potential 
risk is identified, and that, in the case of fallen cattle, sheep and goats, either the 
specified risk materials should be removed so that they do not enter any food or 
feed chain, or the whole carcase should be destroyed; 
10 OJ No L 184,24.7.1996, p. 43. 
((>) Whereas on the basis of the advice of the Scienlilic Veterinary Committee of 21 
October 1996, in accordance with the risk assessment carried out by that 
Committee, the Commission adopted Decision 97/534/EC of 30 July 1997 on the 
prohibition of the use of material presenting risks as regards transmissible 
spongiform encephalopathies , as amended by Decision 97/866/EC ; 
( 10) Whereas the Scientific Steering Committee (SSC) adopted an opinion on 9 
December 1997; whereas in this opinion the SSC suggested a new and enlarged 
list of specified risk materials and proposed that those materials should be 
excluded temporarily from human and animal consumption depending on the 
geographical source; 
(11) Whereas in the light of the new scientific advice it is necessary to amend the 
list of specific risk materials laid down in Decision 97/534/EC; whereas this 
list should apply as from 1 July 1998; whereas Member States and third 
countries in so far as concerns their exports to the Community should be 
allowed to ask for a total or partial derogation from the ban on specified risk 
materials in the light of their geographical risk; whereas it is necessary to 
establish a procedure for submission of the data necessary to allow assessment 
of the geographical BSE risk; whereas pending such scientific assessment and 
the subsequent decision on the matter, the application of the enlarged list of 
specified risk materials should be suspended until a date not later than 31 
December 1998; whereas, however, Member States and third countries with 
BSE cases in their bovine animal population and currently applying the 
removal of risk materials should at least remove the materials recommended by 
the World Organisation for Animal Health (Office international des Epizooties; 
OIE) in 1997; 
11 OJN" L 216, 8.8.1997, p.95. 
12 OJL 351, 23.12.1997, p. 69. 
(12) Whereas Article 3.2.13.12 of the Animal Health Code of the OIE recommends 
that bovine brain, eyes, spinal cord, tonsils, thymus, spleen and distal ileum 
(tissues under study) and protein products derived from them from cattle over six 
months of age originating from countries with a high incidence of BSE should 
not be traded between countries; whereas that Code recommends in the same 
Article that bovine brain, eyes, spinal cord and distal ileum (tissues under study) 
and protein products derived from them from cattle over six months of age, 
originating from countries with a low incidence of BSE, which were born before 
the feed ban was effectively enforced should not be traded between countries; 
(13) Whereas it is necessary for practical and precautionary reasons to exclude the use 
of spleens from ovine and caprine animals, irrespective of age, and mechanically 
recovered meat from the vertebral column of bovine, ovine and caprine animals; 
(14) Whereas measures must be implemented in order to protect ruminants from 
scrapie pending a proper epidemiological evaluation of the situation in the 
Community; 
(15) Whereas certain Member States have already excluded certain material from the 
food and feed chains; whereas the United Kingdom has prohibited tissues in 
addition to those recommended by the Scientific Veterinary Committee; 
( 16) Whereas the United Kingdom is considered to be a country with a high incidence 
of BSE; whereas the tissues included on the list of specified bovine materials of 
the United Kingdom are in conformity with the list of the aforementioned Article 
of the Animal Health Code; whereas, therefore, the United Kingdom should be 
authorized to keep the existing national measures in respect of the removal of 
specified bovine material in force; 
( 17) Whereas a risk assessment based on accepted scientific methodology may show 
that there is a significantly higher risk of exposure of animals or humans to TSEs 
in certain Member Stales; whereas those Member States may take action in 
respect of the removal of additional risk material from animals slaughtered on 
their territory; 
(18) Whereas equivalent guarantees are required for imports from third countries; 
whereas the situation as regards TSEs may vary between countries and the import 
requirements may therefore be adapted to the particular situation of the countries 
of origin or dispatch; whereas the import of specified risk materials should be 
allowed only for the purposes for which their use in the Community is permitted; 
( 1 <)) Whereas the 20th Commission Directive 97/1 /EC of 10 January 1997 adapting to 
technical progress Annexes II, III, VI and VII of Council Directive 76/768/EEC 
on the approximation of the laws of the Member States relating to cosmetic 
products bans provisionally the marketing of cosmetic products containing 
bovine, ovine and caprine tissues and fluids from the encephalon, the spinal cord 
and the eyes, and the ingredients derived therefrom; whereas that Directive is 
being amended to take account of the provisions of Decision 97/534/EC; 
(20) Whereas the marketing of medicinal products in the Community is regulated by 
Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws 
of Member States relating to analytical, pharmaco-toxicological and clinical 
standards and protocols in respect of the testing of proprietary medicinal 
products , as last amended by Directive l)3/39/HHC , and by Council Directive 
81 /852/EEC of 28 September 1981 on the approximation of the laws of the 
Member States relating to analytical, pharmaco-toxicological and clinical 
standards and protocols in respect of the testing of veterinary medicinal 
products16, as last amended by Directive 93/40/EEC ; whereas these Directives 
n OJNoL 16, 18.1.1997, p. 85. 
14 OJNol, 147, 9.6.1975, p. I. 
15 OJ 1,214, 24.8.1993, p. 22. 
16 OJ No L 317, 6.11.1981, p. 16. 
10 
are being amended to take account of the provisions of Decision 97/534/EC; 
(21) Whereas the amendments to Directives 97/1/EC, 75/318/EEC and 81/852/EEC 
provide for the protection of public health in respect of the use of specified risk 
material in cosmetic and medicinal products placed on the market in the 
Community; whereas, therefore, the regulation of these products may be 
excluded from the scope of this Decision; whereas, however, there remains a 
need to allow for derogations for the production of medicinal products and 
medical devices, their starting materials or intermediate products, in those cases 
where the competent authority has determined that no satisfactory alternative 
exists; whereas the operation of any such derogation will be regulated by 
Community rules laid down elsewhere; 
(22) Whereas for in vitro diagnostic medical devices the use of SRM should remain 
possible where necessary for the correct performance of such products; 
whereas conditions of use of specified risk materials including related time 
schedules should be laid down in this Decision for medical devices within the 
IK 
meaning of Council Directive 90/385/EEC , as last amended by Directive 
93/68/EEC , and Council Directive 93/42/EEC ; whereas those conditions 
should not apply to in vitro medical devices; 
(23) Whereas the measures provided for in this Decision will further contribute to the 
safe sourcing, processing and use of ruminant material for food, feed, medicinal 
products, medical devices and cosmetic products; 
(24) Whereas there are no effective controls or tests which can determine whether or 
not particular tissues have been used in the manufacturing of products;; whereas, 
therefore; those tissues should be removed at slaughterhouses and subsequently 
destroyed; whereas Member States should also be authorised to permit their 
17 OJL 214, 24.8.1993, p. 31. 
18 OJNoL 189,20.7.1990, p. 17. 
19 OJL 220, 30.8.1993, p. 1 
20 OJL 169, 12.7.1993, p. 1. 
11 
removal at cutting plants, high-risk processing plants or premises referred to in 
Article 7 of Council Directive 90/667/EEC , as last amended by Directive 
92/118/EEC, and, as regards vertebral columns, at the point of sale to the 
consumer; 
(25) Whereas it is appropriate to provide for derogations to permit the use of 
materials covered by this Decision for teaching and research purposes, for the 
production of products for purposes other than human food, animal feed, 
medicinal products or cosmetic products and for feeding fur animals, in addition 
to the derogations referred to above in respect of medicinal products, medical 
devices and cosmetic products; 
(26) Whereas inspections were carried out in the Member States in 1996 and 1997 to 
check the implementation of Community measures on BSE; whereas the results 
of those inspections have revealed certain deficiencies, in particular in 
surveillance and implementation of the prohibition on use of mammalian protein 
in ruminant feed; whereas further inspections are necessary; 
(27) Whereas in view of previous trade in certain products, in particular meat and 
bone meal and live animals, the possible presence of TSE agents cannot be ruled 
out in any of the Member Slates; whereas further scientific evaluation is 
necessary before a linal assessment of the regional risk of the presence of TSE 
agents can be made; 
(28) Whereas this Decision will be reviewed in the light of new scientific information 
with regard to risk of exposure to TSEs resulting from infectivity in other animal 
species, age categories, tissues or materials not covered by this Decision; 
(29) Whereas the possibility exists that post-mortem tests for BSE may be 
developed and validated; whereas it is appropriate to provide for the approval 
of such tests to lay down rules for their use; whereas provision should be made 
()JN"L363, 27.12.1990, p.51 
12 
for an exemption for Member States applying a compulsory single carcass test 
for bovine animals above a certain age; 
(30) Whereas scientific investigations have indicated that stunning or killing by 
means of a gas injected into the cranial cavity and pithing may result in 
fragments of brain tissue entering the circulation and lodging in certain organs; 
whereas this could present a risk to consumers of those organs; whereas, 
therefore, those practices should be prohibited in areas where there is a risk 
from BSE; 
(31 ) Whereas for reasons of transparency Decision 97/534/EC should be repealed and 
replaced by this Decision; 
(32) Whereas the Standing Veterinary Committee has not given a favourable opinion, 
13 
HAS ADOPTED THIS DECISION: 
Article 1 
1. For the purposes of this Decision the following definitions shall apply: 
(a) "specified risk material" shall mean: 
(i) the skull, including the brain and dura mater, the pituitary 
gland, the eyes, the tonsils, the intestines from the duodenum 
to the rectum, the vertebral column, including the dorsal root 
ganglia, spinal cord and dura mater, of: 
bovine animals aged over 12 months, 
ovine and caprine animals which are aged over 12 
months or have a permanent incisor tooth erupted 
through the gum; 
(ii) the spleens of ovine and caprine animals; 
(b) "native case of BSE" shall mean a case of BSE for which an 
epidemiological investigation conducted by the competent authority 
led to the conclusion that exposure of the affected animal to the agent 
took place within the territory of the country concerned; 
(c) "pithing" shall mean the laceration after stunning of central nervous 
tissue by means of an elongated rodshaped instrument introduced into 
the cranial cavity. 
2. Unless otherwise specified, any reference to "specified risk material" in this 
Decision is a reference to the tissues specified in paragraph 1 (a), not to 
products containing or derived from those tissues. 
14 
Article 2 
I. Member Slates shall ensure that the following slaughter techniques are not 
used after 30 June 1998 on bovine, ovine and caprine animals whose meat is intended 
for human or animal consumption: 
(a) stunning by means of a gas injected into the cranial cavity or killing by 
that method; 
(b) pithing. 
2. The use of the vertebral column of bovine, ovine and caprine animals for the 
production of mechanically recovered meat shall be prohibited after 30 June 1998. This 
shall not apply to animals which are subjected to a test in accordance with Article 6. 
Article 3 
1. Member States shall ensure that after 30 June 1998 the specified risk 
materials from animals which died or were slaughtered on their territory, are 
removed under the direct supervision of an official of the competent authority and are 
destroyed in accordance with Article 4. 
2. The specified risk materials shall be removed at slaughterhouses. 
3. By way of derogation from paragraph 2, Member States may allow the 
removal of: 
(a) specilied risk material at cutting plants, high risk processing plants or 
premises referred to in Article 7 of Directive 90/667/EEC. Those 
establishments shall be approved for that purpose by the competent 
authority; 
15 
(b) the vertebral column at the point of sale to the consumer on their 
territory. 
4. The Commission may establish conditions, in particular with regard to 
checks, in accordance with the procedure laid down in Article 18 of Directive 
89/662/EEC. 
5. By way of derogation from paragraph 1, where bovine, ovine or caprine 
animals have died or have been killed in the context of disease control measures, 
their entire body may be destroyed by one of the methods referred to in Article 4 
without removal of the specified risk materials. 
Article 4 
Specified risk material shall be stained with a dye immediately on removal. All 
specilied risk material, including that obtained before 1 July 1998, shall be destroyed: 
(a) by incineration; or, 
(b) provided that the colour of the dye is detectable after processing, by 
processing followed by: 
(i) incineration; 
(ii) burning as fuel; or, 
(iii) another method, which precludes all risk of transmission of a TSE, 
and is authorized and supervised by the competent authority. 
16 
Article 5 
1. Member States may derogate from the provisions of Articles 3 and 4 to allow 
the burning or burial of specified risk material or entire bodies in the circumstances set 
out in Article 3(2) of Directive 90/667/EEC. 
2. Member Slates may derogate from the provisions of Articles 3 and 4 to allow 
the use of specified risk material: 
(a) for the purposes of teaching or research in officially recognized 
establishments; 
(b) for feeding fur animals. 
3. Member Stales may derogate from the provisions of Article 4 to allow the use 
of specified risk material: 
(a) for the production of medicinal products, their starting materials or 
intermediate products subject to the provisions of Directives 
75/318/EEC and 81/852/EEC; 
(b) for the production of in-vitro diagnostic medical devices and of medical 
devices within the meaning of Directive 93/42/EEC which are not 
intended to come into direct contact with patients, including their 
starting materials or intermediate products; 
(c) for the production of medical devices within the meaning of Directive 
90/385/EEC and of Directive 93/42/EEC which are intended to come in 
direct contact with patients, including their starting materials or 
intermediate products; further conditions are laid down in Annex II; 
17 
(d) for the production of cosmetic products, their starting materials or 
intermediate products, subject to the provisions of Directive 
76/768/EEC; 
(e) for the production of products other than those referred to in points (a) 
to (d) which are not intended for use in human food, animal feed or 
fertilisers. 
Article 6 
I. Member States may authorise, as an alternative to the removal of specilicd 
risk materials provided for in Articles 3 and 12 or by way of derogation from the 
prohibition laid down in Article 2 (2), the application of a post-slaughter test which 
has been approved in accordance with Article 18 of Directive 89/662/EEC, provided 
that at least: 
(a) tests are be carried out in the slaughterhouses on all bovine animals 
aged over 12 months, and as appropriate, on all ovine and caprine 
animals which are aged over 12 months or have a permanent incisor 
tooth erupted through the gum; 
(b) the spleens of ovine and caprine animals are removed and destroyed in 
accordance with Article 4; 
(c) no bovine, ovine or caprine material leaves the slaughterhouse before 
the results of the tests on all slaughtered animals produced in the same 
batch, that is after one process of cleaning and disinfection of the 
slaughterchain and before the next, have been received and accepted 
by the competent authority; 
(d) when a post-slaughter test gives a positive result, all bovine, ovine and 
caprine material produced in the same batch after the last process of 
cleaning and disinfection of the slaughterchain is destroyed in 
accordance with Article 4. 
2. With respect to products referred to in Annex III which may be imported into 
the Community, third countries may authorise as an alternative to the removal of 
specified risk materials, the application of a post-slaughter test which has been 
approved in accordance with this Decision, provided that at least the conditions set 
out in paragraph 1 are met. 
Article 7 
1. To ensure that this Decision is applied correctly, Member States shall carry out 
frequent official controls, particularly in slaughterhouses, cutting plants, animal waste 
processing plants, high risk processing plants or premises referred to in Article 7 of 
Directive 90/667/EEC, points of sale to the consumer and storage facilities, and shall 
take measures to avoid contamination. 
2. Member States shall set up a system to ensure and check that: 
(a) where derogations have been granted in accordance with Article 3 (3) 
for the removal of specified risk materials at establishments other than 
slaughterhouses, those materials are completely separated from other 
waste, are collected separately, and are destroyed in accordance with 
Article 4; 
(b) specified risk materials for which derogations have been granted in 
accordance with Article 5 (2) and (3) are exclusively used for the 
authorised purpose; 
19 
(c) where live bovine, ovine or caprine animals originating from Member 
States or third countries in which native cases of BSE have occurred are 
received by Member States in which no native cases of BSE have 
occurred in accordance with Article 12 (3), those animals remain under 
official supervision until their slaughter or until dispatch from their 
territory. 
Article 8 
1. Without prejudice to Article 5 (2) and (3), the import into the Community of 
specified risk material shall be prohibited after 30 June 1998. 
2. In order to be imported into the Community after 30 June 1998, products of 
animal origin listed in Annex III which contain material derived from bovine, ovine or 
caprine animals produced after 30 June 1998 and are intended for human food or 
animal feed must be accompanied by the appropriate certificate, as required by 
Community legislation, supplemented by a declaration signed by the competent 
authority of the country of production, worded as follows: 
"The product docs not contain, and is not derived from, specified risk 
material, as defined in Commission Decision [98/ /EC], which was 
produced after 30 June 1998 or mechanically recovered meat obtained 
from the vertebral column of bovine, ovine or caprine animals after 30 
June 1998." 
or, 
"The product contains, or is derived from, material produced after 30 
June 1998 of bovine, ovine or caprine animals which were tested and 
found negative for the presence of BSE using a test which was approved 
in accordance with Commission Decision [98/—/EC]". 
20 
Article 9 
Member Stales may lake further precautionary action in relation to animals slaughtered 
on their own territory. 
Article 10 
1. Member States or third countries may apply for derogations from the provisions 
of this Decision, in the light of their epidemiological status with respect to TSEs. 
2. Member States or third countries wishing to apply for derogations as referred to 
in paragraph I shall submit to the Commission before 1 July 1998 an application, 
together with supporting documents, for recognition of their epidemiological status 
with respect to TSEs compiled in at least one of the official languages of the 
Community, in accordance with the provisions laid down in Annex I. 
3. Without prejudice to Articles 11 and 12 (1), Member States which submit an 
application in accordance with paragraph 2 shall not be obliged to apply this Decision 
to animals which were bom on and have never left their territory, or to animals bom or 
reared on the territory of another country which has likewise submitted an application 
in accordance with paragraph 2. 
4. Without prejudice to Article 11 (2) and Article 12 (2) and (3), third countries 
which submit an application in accordance with paragraph 2 shall not be obliged to 
apply Article 8. 
5. The Commission shall communicate to the Member States, within the 
framework of the Standing Veterinary Committee, the names of the Member States or 
third countries which have applied for derogations as referred to in paragraph 1. 
21 
Article 11 
1. The conditions which arc to apply to Member States and third countries 
which have submitted an application in accordance with Article 10 shall be laid down 
by decision taken in accordance with the procedure laid down in Article 18 of Directive 
89/662/EEC after consultation of the appropriate Scientific Committee and if necessary 
after Community inspections.. 
2. The Commission shall take a Decision in accordance with paragraph 1 before 
1 January 1999. Where such a Decision is not taken, the provisions of Articles 2 and 
3 and, as appropriate, Article 8 (2) shall apply. 
Article 12 
1. Notwithstanding Articles 10 and 11, Member States in which native cases of 
BSE have occurred shall ensure that from 1 July 1998 at the latest, or, where the first 
native case of BSE occurs after 31 May 1998, no later than one month after official 
confirmation thereof, the brains, eyes spinal cord and distal ileum of bovine animals 
aged over 12 months are removed in accordance with the conditions laid down in 
Article 3(1) and (2) from animals which died or were slaughtered on their territory 
and are destroyed in accordance with Article 4. 
2. Notwithstanding Articles 10 and 11, in order to be imported into the 
Community after 30 June 1998, products of animal origin listed in Annex III which 
contain material derived from bovine animals produced after 30 June 1998 in third 
countries in which native cases of BSE have occurred, and are intended for human 
consumption or animal feed, must from 1 July 1998 at the latest, or where the first 
native case of BSE occurs after 31 May 1998, no later than one month after official 
confirmation thereof, be accompanied by the appropriate certificate, as required by 
Community legislation, supplemented by a declaration signed by the competent 
authority of the country of production, worded as follows: 
22 
"The product does not contain and is not derived from brains, eyes, 
spinal cord and distal ileum of bovine animals aged over 12 months as 
referred to in Commission Decision [98/ /EC] which were obtained 
after 30 June 1998 or mechanically recovered meat obtained from the 
vertebral column of bovine animals after 30 June 1998." 
or, 
"The product contains or is derived from material produced after 30 
June 1998 of bovine animals which were tested and found negative for 
the presence of BSE using a test which was approved in accordance 
with Commission Decision [98/—/EC] ". 
However, where the first native case of BSE occurs after 31 May 1998 the date 
referred to in the declaration may be replaced by a date no later than one month after 
official confirmation thereof. 
3. Notwithstanding Articles 10 and 11, where animals coming from countries in 
which native cases of BSE have occurred are to be slaughtered after 30 June 1998 in 
(he territory of Member States in which no native cases have occurred: 
(a) the Member State of destination shall ensure that the specified risk 
materials, or at least the risk materials referred to in paragraph 1, are 
removed from those animals and destroyed in accordance with Article 
4. Those animals shall be slaughtered in slaughterhouses approved for 
that purpose by the competent authority and at the end of the normal 
slaughtering process. 
23 
(b) the Member State of dispatch shall ensure that: 
(i) the animal health certificates are supplemented by the 
following words to be entered for bovine animals in the section 
"Health data concerning bovine animals" of the certificate 
22 
referred to in Annex l; to Council Directive 97/12/EC : 
The animals listed below were bom or reared ( ) in a 
Member State or third country ( ) in which native cases 
of BSE have occurred'; or, 
( ) Delete if not appropriate 
for ovine and caprine animals at the request of the Member 
State of destination, in section V "Health information" of the 
certificates referred to in Annex E to Council Directive 
9I/68/EEC21: 
'the animals listed below were born or reared (') in a 
Member State or third country ( ) in which native cases 
of BSE have occurred'. 
( ) Delete if not appropriate 
(ii) the competent authority of the place of destination is informed 
of the nature of the bovine animals, or, at the request of the 
Member State of destination, of the nature of the ovine and 
caprine animals, in each consignment by means of a 
specifically coded AN I MO message or by fax; 
22 OJNoL 109, 25.4.1997, p.I. 
23OJNoL46, 19.2.1991, p. 19. 
24 
(c) the third country of dispatch shall ensure that: 
(i) the appropriate animal health certificates are supplemented by 
the following words, to be entered in the appropriate sections 
on health information for bovine animals: 
'the animals listed below were born or reared ( ) in a 
Member State or third cour 
of BSE have occurred'; or, Member State or third country ( ) in which native cases 
( ) Delete if not appropriate 
for ovine and caprine animals at the request of the Member 
State of destination: 
The animals listed below were born or reared ( ) in a 
Member Slate or third country ( ) in which native cases 
of BSE have occurred' 
( ) Delete if not appropriate 
(ii) the competent authority of the place of destination is informed 
of the nature of the bovine animals, or, at the request of the 
Member State of destination, of the nature of the ovine and 
caprine animals, in each consignment by fax. 
25 
Article 13 
1. This Decision shall be without prejudice to the provisions of Decision 
96/239/EC and Decision 94/474/EEC. 
2. Decision 97/534/EC is hereby repealed and references to that Decision shall 
be construed as references to the present Decision. 
Article 14 
This Decision and the decisions referred to in Article 11 (1) shall be reviewed regularly 
in the light of new epidemiological information and scientific information with regard 
to criteria for determining the level of risk in specific regions and to the risk of 
exposure to TSEs resulting from infectivity in other animal species, age categories, 
tissues or materials. Where necessary, this Decision shall be amended in accordance 
with the procedure laid down in Article 18 of Directive 89/662/EEC after consultation 
oflhe appropriate Scientific Committee. 
Article 15 
This Decision shall apply from 1 April 1998. It does not apply to products as 
referred to in this Decision, containing or derived from specified risk materials 
produced before 1 July 1998. 
26 
Article 16 
This Decision is addressed to the Member States. 
Done at Brussels For the Council 
27 
ANNEX1 
Information to be submitted in support of an application for recognition of 
epidemiological status under article 10 
All data must be provided on an annual basis and preferably from 1980 onwards, but 
at least from 1988. 
Applicant Slates must make every effort to provide comprehensive and consistent 
information. Data which are not provided or are regarded as incomplete or as 
unsatisfactory may have to be replaced by worst case assumption for the purposes of a 
risk assessment. 
Information must be provided on: 
1. Structure and dynamics of the bovine, ovine and caprine animal populations 
(a) absolute numbers of animals per species and breed, alive and at time of slaughter; 
(b) age distributions of animals per species and breed, sex and type; 
(c) age distribution of animals per species and breed, sex and type at time of 
slaughter; 
(d) geographical distribution of the animals by species and breeds; 
(e) geographical distribution of the animals by husbandry systems, herd sizes and 
production purposes; 
(0 system of identification and capacities for tracing of animals. 
2. Animal trade 
(a) imports and exports; 
(b) trade within the geographical area; 
(c) imports of embryos and semen; 
(d) use made of imported animals, embryos or semen; 
(e) mechanisms used by slaughterhouses to identify animals and their origins, as well 
as data from these procedures. 
3. Animal feed 
(a) domestic production of Meat and Bone Meal (MBM), and its use per species and 
husbandry system (in particularly the proportion of the domestically produced 
MBM fed to bovine, ovine and caprine animals); 
(b) imports of MBM, specifying country of origin, and its use per species and 
husbandry system (in particularly the proportion of that MBM fed to bovine, ovine 
and caprine animals);. 
(c) exported MBM, specifying country of destination. 
28 
4. Meat and bone meal (MBM) bans 
(a) complete description; 
(b) dates of introduction; 
(c) actual implementation, policing and compliance figures; 
(d) possibilities of cross-contamination with other feed. 
5. Specified bovine offal (SBO) and specified risk materials (SRM) bans 
(a) complete description; 
(b) dates of introduction; 
(c) actual implementation, policing and compliance figures. 
6. Surveillance of TSE, with particular reference to BSE and scrapie 
(a) incidence oflaboratory confirmed cases of BSE and scrapie; 
(b) age distribution, geographical distribution, and countries of origin of cases; 
(c) incidence of neurological disorders in which TSE could not be excluded on 
clinical grounds in any animal species; 
(d) methodologies and programmes of surveillance and recording of clinical cases of 
BSE and scrapie, including awareness training for farmers, veterinarians, 
supervisory bodies and authorities; 
(e) incentives for reporting cases, compensation and reward schemes; 
(I) methodologies oflaboratory confirmation and recording of suspect cases of BSE 
and scrapie; 
(g) strains of BSE and scrapie agents possibly involved; 
(h) existing systems or current plans for targeted active surveillance. 
7. Rendering and feed processing 
(a) all rendering and feed processing systems used; 
(b) nature of the records of rendering and processing plants; 
(c) quantitative and qualitative parameters of MBM and tallow production by each of 
the processing systems; 
(d) the geographical areas from which the rendered materials originate; 
(e) the type of raw material used; 
(f) parameters on separate processing lines for materials from healthy and suspected 
animals; 
(g) transport and storage systems for MBM or feed containing MBM. 
8. BSE or scrapie related culling 
(a) culling criteria; 
(b) date of introduction of the culling scheme and of any subsequent modification; 
(c) animals culled (details as specified in point 1 ); 
(d) sizes of herds in which animals were culled. 
29 
ANNEX H 
Use of specified risk materials for the production of medical devices 
Specified risk material must not be used for the manufacture of active 
implantable medical devices within the meaning of Directive 90/385/EEC and 
of medical devices within the meaning of Directive 93/42/EEC which are 
intended to come in direct contact with patients, unless the use of such 
material is authorized in accordance with this Decision. 
Without prejudice to point 1 and unless the use of specified risk material is 
authorized in accordance with this Decision: 
(a) tallow derivatives may be used provided that they are produced 
following an appropriate, documented and validated method such as : 
transesterilication or hydrolysis at not less than 200°C for not 
less than 20 minutes under pressure (glycerol, fatty acids and 
fatty acid esters production); 
saponification with NaOH 12 M : 
batch process : at not less than 95 °C for not less than 3 
hours, 
continuous process : at not less than I40°C for not less 
than 8 minutes under pressure or equivalent.; 
(b) materials of bovine, ovine or caprine origin which may be derived from 
specified risk material may be used until 30 September 1999 as 
reagents or where they are only indirectly associated with the 
manufacturing process or disappear from that manufacturing process, 
unless there are no adequate alternatives; 
30 
(c) intestinal material of bovine, ovine or caprine origin may be used for 
the production of sutures provided that: 
that raw material is sourced from countries where there is 
reliable evidence that no native cases of BSE have occurred, 
sourcing is subject to veterinary control and inspection, 
that raw material used originated from animals certified by a 
veterinarian as being fit for human consumption, 
evidence on safety of sourcing, including health attestations is 
retained by the manufacturer and 
all relevant production processes are carried out in accordance 
with legal requirements so as to provide optimal security; 
(d) materials of bovine, ovine or caprine origin which may be derived from 
specific risk material may be used until 31 March 2000 at the latest in 
the production of medical devices, for which and for so long as there 
are no satisfactory alternatives. 
3. Where materials of bovine, ovine or caprine origin are used, a risk assessment 
must be performed which addresses all relevant aspects, including those in 
relation to the sourcing, nature and quantities of animal material used, 
production processes and conditions of use of finished devices. The above 
mentioned procedure shall be documented. 
4. Compliance with the provisions this Annex must be verified in the framework 
of application of the procedures laid down in Directives 90/385/EEC and 
93/42/EEC. 
5. Without prejudice to Article 15, the provisions of this Annex must apply to 
medical devices manufactured,, after 31 March 1999 at the latest. 
31 
ANNEX III 
(Products referred to in Article 6 (2), Article 8 (2) and Article 12 (2)) 
(a) 'Fresh meat', as defined by Council Directive 64/433/EEC ; 
(b) 'Minced meat' and 'meal preparations', as defined by Council Directive 
94/65/EC2; 
(c) 'Meat products' and 'other products of animal origin', as defined by Council 
Directive 77/99/EEC3; 
(d) 'Milk products', as defined by Council Directive 92/46/EEC , which are destined 
for human consumption and containing gelatin or tallow; 
(e) 'Milk products', as defined by Council Directive 92/118/EEC, which are 
destined for animal consumption and containing gelatin or tallow; 
(0 'Fishery products', as defined by Council Directive 91/493/EEC\ which are 
destined for human consumption and containing gelatin or tallow; 
(g) 'Egg products', as defined by Council Directive 89/437/EEC , which are 
destined for human consumption and containing gelatin or tallow; 
(h) 'Snails or frogs' legs', as referred to in Council Directive 92/118/EEC, which are 
destined for human consumption and containing gelatin or tallow; 
(i) 'Rendered fats', as referred to by Council Directive 92/118/EEC; 
(j) 'Gelatin', as referred to in Council Directive 92/118/EEC; 
(k) 'Petfood', as referred to in Council Directive 92/118/EEC; 
(I) 'Processed animal protein', as referred to in Council Directive 92/118/EEC; 
(m) 'Bones' and 'bone products', as referred to in Council Directive 92/118/EEC; 
(n) 'Raw material for the manufacture of animal feedingstuffs', as referred to in 
Council Directive 92/118/EEC. 
1 OJ No L 121, 29.7.1964, p. 2012/64. 
2 OJ No L 368, 31.12.1994, p. 10. 
3 OJ No L 26, 31.1.1977, p.85. 
4 OJNoL268, 14.9.1992, p. 1. 
5 OJ No L 268, 24.9.1991, p. 15. 
6 OJ No L 212,22.7.1989, p. 87. 
32 

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