Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies
Date: 2004-12-06
Institutions: European Commission
Subjects: EU control, animal disease, disease prevention, health control, health risk, marketing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 6.12.2004 
COM(2004) 775 final 

2004/0270 (COD) 

. 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EC) No 999/2001 laying down rules for the prevention, control 
and eradication of certain transmissible spongiform encephalopathies  

. 

(presented by the Commission) 

EN 

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EXPLANATORY MEMORANDUM 

Regulation (EC) No 999/2001 of the European parliament and of the Council of 22 May 2001 
laying  down  rules  for  the  prevention,  control  and  eradication  of  certain  transmissible 
spongiform  encephalopathies1  (TSE  Regulation)  provides  measures  targeting  all  animal  and 
public  health  risks  resulting  from  all  animal  TSE,  and  governing  the  entire  chain  of 
production  and  placing  on  the  market  of  live  animals  and  products  of  animal  origin.  This 
Regulation is applicable as of 1 July 2001.  

It  consolidated  much  of  the  previous  legislation  on  BSE  or  TSE,  including  rules  for  the 
monitoring of TSE in bovine, ovine and caprine animals, removal  of specified risk material 
and prohibitions concerning animal feeding. It also introduced new legislation for areas such 
as  eradication of TSE and trade rules covering the domestic market, intra-community trade, 
import and export. Furthermore it provided for the procedure, criteria and categories for the 
classification of countries according to BSE status.  

This proposal is an amendment to the TSE Regulation on various matters and in the light of 
new developments since the adoption of the Regulation.  

1. 

DETERMINATION OF BSE STATUS  

Regulation  (EC)  No  1128/2003  of  the  European  Parliament  and  of  the  Council 
amending the TSE Regulation as regards the extension of the period for transitional 
measures2 extended the application of the transitional measures under Article 23 of 
the TSE Regulation by two years, until 30 June 2005.  

Maintaining the present level of public health protection, the two-year extension of 
time  was  intended  to  allow  the  Commission  to  continue  its  attempts  to  reach  an 
agreement at international level on the determination of BSE status of countries. 

The  World  Organisation  for  Animal  health  (OIE)  presented  a  proposal  to  simplify 
the current criteria for the categorisation of countries according to their BSE risk for 
discussion at the General Session in May 2004. Since the Members did not express 
major objections to the proposal, a proposal for possible adoption will be presented 
at the OIE General session in May 2005 at the earliest. The intention is to reduce the 
number of categories, possibly in a step-wise way. To avoid multiple amendments to 
the Articles of the TSE Regulation pending the final modifications to the number of 
categories,  it  is  proposed  to  transfer  references  to  individual  categories  from  the 
Articles to the Annexes.  

1 

2 

OJ  L  147,  31.5.2001,  p.  1; 
(OJ L 274, 24.8.2004, p. 3). 
OJ L 160, 28.6.2003, p. 1. 

last  amended  Commission  Regulation  (EC)  No  1492/2004 

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Furthermore,  a  Resolution  was  adopted  at  the  OIE  General  Session  in  May  2003 
according  to  which  OIE  will  classify  all  countries  into  one  or  other  of  the  defined 
categories. It may be assumed that OIE will not conclude the final categorisation of 
countries according to their BSE risk before 1 July 2005. Therefore it is proposed to 
prolong  the  period  of  application  of  the  transitional  measures.  Therefore  it  is 
proposed to prolong the period of application of the transitional measures until 1 July 
2007. 

2. 

PREVENTION OF TSE 

In  its  opinion  of  6-7  March  2003,  the  Scientific  Steering  Committee  (SSC) 
recommended  to  start  a  monitoring  programme  for  TSEs  in  cervids.  The  TSE 
Regulation establishes a monitoring programme for BSE and scrapie. It is proposed 
to  extend  this  provision  to  other  TSEs,  in  particular  in  order  to  follow  the  SSC 
recommendation on cervids.  

Commission  Decision  No.  2003/100/EC3  introduced  a  harmonised  breeding 
programme  to  select  for  resistance  to  TSEs  in  ovine  animals  as  a  transitional 
measure.  It  is  proposed  to  introduce  a  permanent  legal  basis  for  the  breeding 
programme in the TSE Regulation.  

The  TSE  Regulation  prohibits  the  feeding  of  certain  processed  animal  proteins  to 
certain animals, with a possibility to extend the prohibition or lay down derogations 
in  Annex  IV.  In  order  to  make  comprehensive  amendments  to  the  Annex,  it  is 
proposed  to  make  certain  technical  amendments  to  the  present  wording  of  the 
corresponding Articles in order to develop the structure of the Annex. 

Regulation  (EC)  No  1774/2002  of  the  European  Parliament  and  of  the  Council  of 
3 October 2002 laying down health rules concerning animal by-products not intended 
for human consumption4 establishes the rules for disposal of specified risk materials 
and animals infected by TSEs. It is proposed to replace the present rules in the TSE 
Regulation on the disposal of specified risk materials and animals infected by TSEs 
with  a  reference  to  Regulation  (EC)  No  1774/2002  laying  down  health  rules 
concerning animal by-products not intended for human consumption.  

New  developments  concerning  specified  risk  materials  have  furthermore  led  to  a 
need  to  make  comprehensive  amendments  to  the  relevant  Annex.  It  is  proposed  to 
make  certain  technical  amendments  to  the  present  wording  of  the  corresponding 
Articles in order to develop the structure of the Annex. 

Although stunning by injection of gas into the cranial cavity is not authorised within 
the  European  Union,  injection  of  gas  may  also  occur  after  stunning.  It  is  therefore 
proposed  to  revise  the  present  provisions  on  slaughter  methods  with  a  view  to 
prohibit gas injection into the cranial cavity in connection with stunning. 

3 
4 

OJ L 41, 14.2.2003, p. 41. 
OJ L 273, 10.10.2002, p. 1. 

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It  is  proposed  to  align  the  definition  of  mechanically  recovered  meat  with  the 
definition used in other Community legislation on food safety. 

3. 

CONTROL AND ERADICATION OF TSES  

In  order  to  avoid  that  animals  are  moved  from  holdings  where  scrapie  is  officially 
suspected, it is proposed to lay down the same rules regarding movement restrictions 
as for bovine animals following the detection of a BSE suspect. 

4. 

PLACING ON THE MARKET  

To  take  account  of  possible  emerging  TSEs  in  other  species  it  is  proposed  to 
introduce a possibility to extend the scope of the current provisions on the placing on 
the  market  and  export  of  bovine,  ovine  and  caprine  animals,  their  semen,  embryos 
and ova in order to cover other species.  

The  Scientific  Steering  Committee  (SSC)  opinion  of  26  June  1998  indicates  that 
certain  restrictions  regarding  sourcing  of  raw  material  for  the  manufacture  of  di-
calcium  phosphate  should  be  observed.  It  is  proposed  to  remove  di-calcium 
phosphate from the list of products which the Regulation currently specifies shall not 
be subject to restrictions on placing on the market.  

Since  no  restrictions  apply  for  milk  for  human  consumption,  the  same  derogation 
should  apply  for  milk  not  intended  for  human  consumption  within  the  meaning  of 
Regulation  (EC)  No  1774/2002.  The  list  of  products  which  shall  not  be  subject  to 
restrictions  on  placing  on  the  market  by  the  Regulation  shall  be  modified 
accordingly.  

5. 

CONTROLS 

The  TSE  Regulation  provides  a  legal  basis  for  inspections  by  the  Food  and 
Veterinary  Office  (FVO)  only  within  the  Member  States.  Although  Commission 
Decision  98/140/EC  of  4  February  1998  laying  down  certain  detailed  rules 
concerning  on-the-spot  checks  carried  out  in  the  veterinary  field  by  Commission 
experts in third countries5 provides a general legal basis for Community inspections 
in Third countries, it should be advisable to provide within the TSE Regulation such 
legal provisions. It is proposed to amend the Regulation to provide for such checks. 

The proposal has no implications for the budget of the European Community. 

5 

OJ L 38 , 12.2.1998, p. 14. 

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2004/0270 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EC) No 999/2001 laying down rules for the prevention, control 
and eradication of certain transmissible spongiform encephalopathies  

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 152(4)(b) thereof, 

Having regard to the proposal from the Commission6, 

Having regard to the opinion of the European Economic and Social Committee7, 

Having consulted the Committee of the Regions8, 

Whereas: 

(1) 

(2) 

(3) 

6 
7 
8 
9 

10 

Regulation  (EC)  No  999/2001  of  the  European  Parliament  and  of  the  Council  of 
22 May 2001 laying down rules for the prevention, control and eradication of certain 
transmissible  spongiform  encephalopathies9  is  intended  to  provide  a  single  legal 
framework for transmissible spongiform encephalopathies (TSEs) in the Community. 

Regulation  (EC)  No  1128/2003  of  the  European  Parliament  and  of  the  Council  of 
16 June 2003 amending Regulation (EC) No 999/2001 as regards the extension of the 
period  for  transitional  measures10  prolonged  the  period  of  application  of  the 
transitional measures provided for in Regulation (EC) No 999/2001 until 1 July 2005 
at the latest. It is appropriate to make certain amendments to the permanent provisions 
of that Regulation before that date. 

During the General Session of the World Organisation for Animal health in May 2003, 
a  Resolution  was  adopted  to  simplify  the  current  international  criteria  for  the 
classification  of  countries  according  to  their  Bovine  Spongiform  Encephalopathy 
(BSE) risk. A proposal for possible adoption will be presented to the General Session 
in May 2005. The intention is to reduce the number of categories, possibly in a step-
by-step  approach.  To  avoid  multiple  amendments  to  the  Articles  of  Regulation  (EC) 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 1492/2004 
(OJ L 274, 24.8.2004, p. 3). 
OJ L 160, 28.6.2003, p. 1. 

EN 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

No  999/2001  when  following  such  developments, references to individual categories 
should be transferred from the Articles of that Regulation to the Annexes.  

New  developments  concerning  sampling  and  analysis  will  require  comprehensive 
amendments to the Annex X to Regulation (EC) No 999/2001. It is therefore necessary 
to  make  certain  technical  amendments  to  the  existing  definition  of  ‘rapid  tests’  in 
Regulation  (EC)  No  999/2001  in  order  to  facilitate  amending  the  structure  of  this 
Annex at a later stage. 

In the interests of clarity of Community legislation, it is appropriate to clarify that the 
definition of ‘mechanically separated meat’ in Regulation (EC) No 999/2001 provided 
for in other Community legislation on food safety is applicable in the context of TSE 
eradication measures.  

Regulation  (EC)  No  999/2001  establishes  a  monitoring  programme  for  BSE  and 
scrapie.  In  its  opinion  of  6-7  March  2003,  the  Scientific  Steering  Committee 
recommended  the  introduction  of  a  monitoring  programme  for  TSEs  in  cervids. 
Therefore the monitoring system provided for in that Regulation should be extended to 
other TSEs, with the possibility to adopt further measures to implement that system at 
a later stage.  

It is necessary to introduce a harmonised breeding programme to select for resistance 
to  TSEs  in  ovine  animals.  Such  a  programme  has  already  been  put  in  place  as  a 
transitional measure by Commission Decision No 2003/100/EC of 13 February 2003 
laying down minimum requirements for the establishment of breeding programmes for 
resistance 
(EC) 
No 999/2001  should  be  amended  to  provide  a  permanent  legal  basis  for  that 
programme. 

transmissible  spongiform  encephalopathies11.  Regulation 

to 

Regulation  (EC)  No  999/2001  prohibits  the  feeding  of  certain  processed  animal 
proteins  to  certain  animals,  with  the  possibility  to  provide  for  derogations.  New 
developments concerning prohibitions on animal feeding may require amendments to 
be  made  to  Annex  IV  to  that  Regulation.  It  is  necessary  to  make  certain  technical 
amendments to the existing wording of the corresponding Article in order to develop 
the structure of that Annex at a later stage.  

Regulation  (EC)  No  1774/2002  of  the  European  Parliament  and  of  the  Council  of  3 
October  2002  laying  down  health  rules  concerning  animal  by-products  not  intended 
for human consumption12 establishes rules for the disposal of specified risk materials 
and animals infected by TSEs. Rules on transit through the Community of products of 
animal origin have now been adopted. Accordingly, in the interests of consistency of 
Community  legislation,  the  existing  rules  in  Regulation  (EC)  No  999/2001  on  the 
disposal of such materials and animals should be replaced by a reference to Regulation 
(EC)  No  1774/2002,  and  the  reference  to  rules  on  transit  in  Regulation  (EC) 
No 999/2001 should be deleted.  

11 
12 

OJ L 41, 14.2.2003, p. 41. 
OJ L 273, 10.10.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 668/2004 
(OJ L 112, 19.4.2004, p. 1). 

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(10)  New  developments  concerning  specified 

require 
comprehensive  amendments  to  the  Annex  V  to  Regulation  (EC)  No  999/2001.  It  is 
necessary  to  make  certain  technical  amendments  to  the  existing  wording  of  the 
corresponding  provisions  of  that  Regulation  in  order  to  develop  the  structure  of  that 
Annex at a later stage. 

risk  materials  will  also 

(11)  Although  stunning  by  injection  of  gas  in  the  cranial  cavity  is  prohibited  within  the 
Community, injection of gas may also occur after stunning. It is therefore necessary to 
amend the relevant provisions on slaughter methods in that Regulation with a view to 
prohibit gas injection into the cranial cavity after stunning. 

(12)  Regulation  (EC)  No  999/2001,  as  amended  by  Commission  Regulation  (EC) 
No 1915/2003 amending Regulation (EC) 999/2001 of the European Parliament and of 
the  Council  as  regards  the  trade  and  import  of  ovine  and  caprine  animals  and  the 
measures following the confirmation of transmissible spongiform encephalopathies in 
bovine, ovine and caprine animals13, sets out new provisions on eradication of scrapie 
in ovine and caprine animals. Accordingly, it is necessary to prohibit the movement of 
ovine and caprine animals from holdings where scrapie is officially suspected.  

(13)  Based  on  evolving  scientific  knowledge,  the  Regulation  should  allow  to  extend  to 
other species the scope of the rules concerning the placing on the market and export of 
bovine, ovine and caprine animals, their semen, embryos and ova.  

(14)  The opinion of the Scientific Steering Committee (SSC) of 26 June 1998 indicates that 
certain  restrictions  regarding  sourcing  of  raw  material  for  the  manufacture  of  di-
calcium phosphate should be observed. Accordingly, di-calcium phosphate should be 
removed from the list of products which are not subject to restrictions on placing on 
the market under Regulation (EC) No 999/2001. The absence of restrictions applicable 
to milk and dairy products should be clarified.  

(15)  Based  on  evolving  scientific  knowledge  and  risk  classification,  and  notwithstanding 
the  possibility  to  adopt  safeguard  measures,  Regulation  (EC)  No  999/2001  should 
permit  the  adoption  in  accordance  with  the  comitology  procedure  of  more  specific 
requirements  for  the  placing  on  the  market  and  export  of  products  of  animal  origin 
originating from Member States or third countries with a high risk of TSE.  

(16)  Regulation  (EC)  No  999/2001  does  not  provide  for  on-the-spot  checks  in  third 
countries to verify the criteria for classification and the fulfilment of requirements for 
the export of animals and animal products to the Community. Pending the application 
of Regulation (EC) No 882/200414, Regulation (EC) No 999/2001 should be amended 
to provide for such checks.  

(17)  Due  to  the  developments  in  the  World  Organisation  for  Animal  Health  the  final 
classification of countries according to their BSE risk is not expected to be completed 
by 1 July 2005. Therefore it is necessary to further prolong the period of application of 
the transitional measures provided for in Regulation (EC) No 999/2001. 

13 
14 

OJ L 283, 31.10.2003, p. 29. 
OJ L 165, 30.4.2004, p. 1. Regulation of the European Parliament and of the Council of 29 April 2004 
on official controls performed to ensure the verification of compliance with feed and food law, animal 
health and animal welfare rules. 

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(18)  Regulation (EC) No 999/2001 should be amended accordingly, 

HAVE ADOPTED THIS REGULATION: 

Article 1 

Regulation (EC) No 999/2001 is hereby amended as follows: 

(1) 

Article 3, paragraph 1 is amended as follows: 

(a) 

point (l) shall be replaced by the following: 

‘(l) 

rapid  tests:  the  screening  methods  listed  in  Annex  X,  for  which  the 
results are known within 24 hours;’ 

(b) 

the following point (n) shall be added: 

‘(n)  mechanically separated meat: meat as defined in point 1.14 of Annex I to 
Regulation  (EC)  No  853/2004  of  the  European  Parliament  and  of  the 
Council 15.’ 

(2) 

In Article 5, paragraph 4 shall be replaced by the following: 

‘4.  Member  States  or  third  countries  which  have  not  submitted  an  application  in 
accordance with the second subparagraph of paragraph 1 shall, with respect to 
the dispatch from their territory of live animals and products of animal origin, 
comply with the import requirements applicable to countries with a high BSE 
risk, until they have submitted such an application and a final decision has been 
taken on their BSE status.’  

(3) 

Article 6 is amended as follows: 

(a) 

paragraph 1 shall be replaced by the following: 

‘1.  Each Member State shall carry out an annual monitoring programme for 
TSEs in accordance with Annex III. Where appropriate, that programme 
shall include a screening procedure using rapid tests. 

Rapid  tests  shall  be  approved  for  that  purpose  in  accordance  with  the 
procedure referred to in Article 24(2) and listed in Annex X.’ 

(b) 

the following paragraph 5 shall be added: 

’5.  Rules  for  the  implementation  of  this  Article  shall  be  adopted  in 

accordance with the procedure referred to in Article 24(2).’ 

15 

OJ L 139, 30.4.2004, p. 55. 

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(4) 

The following Article 6a shall be inserted: 

‘Article 6a 
Breeding Programmes 

1.  Member States shall introduce breeding programmes to select for resistance to 
TSEs in their ovine populations. Those programmes shall include a framework 
to recognise the TSE-resistant status of certain flocks. 

2. 

3. 

The breeding programmes provided in paragraph 1 may be extended to include 
other animal species based on scientific evidence corroborating the resistance 
to TSE of particular genotypes of those species. 

Specific  rules  for  the  programmes  provided  for  in  paragraphs  1  and  2  of  this 
Article  shall  be  adopted  in  accordance  with  the  procedure  referred  to  in 
Article 24(2).  Those  rules  shall  set  a  harmonised  framework  for  the 
programmes  provided  for  in  paragraphs  1  and  2  of  this  Article.  They  may 
provide  for  certain  Member  States  to  be  exempted  from  the  requirements  of 
paragraphs 1 and 2, based on epidemiological factors.’ 

(5) 

In Article 7, paragraphs 2, 3 and 4 shall be replaced by the following: 

‘2.  The prohibition provided for in paragraph 1 shall be extended to animals and 

products of animal origin in accordance with Annex IV. 

3. 

Paragraphs  1  and  2  shall  apply  without  prejudice  to  the  provisions  set  out  in 
Annex IV. 

4.  A decision may be taken, under the procedure referred  to  in Article 24(2), to 
restrict the placing on the market or export of protein derived from mammals 
where such restriction is necessary to prevent the transmission of TSEs.’  

(6) 

In Article 8, paragraphs 1, 2 and 3 shall be replaced by the following: 

‘1.  The  specified  risk  material  shall  be  removed  and  disposed  of  in  accordance 
with Annex V to this Regulation and Regulation (EC) No 1774/2002. It shall 
not be imported into the Community. 

2. 

Paragraph 1 shall not apply to tissues from animals which have undergone an 
alternative  test  approved  for  that  distinct  purpose  in  accordance  with  the 
procedure  referred  to  in  Article  24(2)  provided  that  this  test  is  listed  in 
Annex X, is applied under the conditions provided for in Annex V and the test 
results are negative. 

The  Member  States  which  authorise  an  alternative  test  pursuant  to  this 
paragraph shall inform the other Member States and the Commission. 

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3. 

In  Member  States,  or  regions  thereof,  where  the  removal  of  specified  risk 
material  is  required  as  set  out  in  Annex  V,  the  laceration,  after  stunning,  of 
central  nervous  tissue  by  means  of  an  elongated  rodshaped  instrument 
introduced into the cranial cavity, or by means of gas injection into the cranial 
cavity in connection to stunning, shall not be used on bovine, ovine or caprine 
animals whose meat is destined for human or animal consumption.’ 

(7) 

In Article 8, paragraph 5 shall be replaced by the following: 

‘5.  By  way  of  derogation  from  paragraphs  1  to  4,  a  decision  may  be  adopted  in 
accordance with the procedure referred to in Article 24(2), with regard to the 
date  of  the  effective  enforcement  of  the  feeding  prohibition  provided  for  in 
Article 7(1) or, as appropriate for a third country or region thereof with a BSE 
risk, the date of the effective enforcement of the ban of mammalian protein in 
feed  for  ruminants  with  a  view  to  limiting  the  requirement  to  remove  and 
destroy  specified  risk  material  to  animals  born  before  that  date  in  those 
countries or regions. ’ 

(8) 

In Article 9, paragraphs 1 and 2 shall be replaced by the following: 

‘1.  The  products  of  animal  origin  listed  in  Annex  VI  shall  be  produced  in 
accordance  with  production  processes  approved  in  accordance  with  the 
procedure referred to in Article 24(2).  

2. 

Bones of the head, and vertebral columns of bovine, ovine and caprine animals 
from  countries,  or  regions  thereof,  with  a  BSE  risk,  shall  not  be  used  for  the 
production of mechanically separated meat.’ 

(9) 

Article 12 is amended as follows: 

(a) 

paragraph 1 shall be replaced by the following: 

‘1.  Any animal suspected of being infected by a TSE shall be either placed 
under an official movement restriction until the results of a clinical and 
epidemiological  examination  carried  out  by  the  competent  authority  are 
known, or killed for laboratory examination under official control.  

If a TSE is suspected in a bovine, ovine or caprine animal at a holding in 
a  Member  State,  all  other  bovine,  ovine  or  caprine  animals  from  that 
holding  shall  be  placed  under  an  official  movement  restriction  until  the 
results of that examination are available. 

However,  if  there  is  evidence  that  the  holding  where  the  animal  was 
present when the TSE was suspected is unlikely to be the holding where 
the animal could have been exposed to the TSE, the competent authority 
may  decide  that  only  the  animal  suspected  of  being  infected  shall  be 
placed under an official movement restriction.  

If  considered  necessary,  the  competent  authority  may  also  decide  that 
other  holdings  or  only  the  holding  of  exposure  shall  be  placed  under 
official control depending on the epidemiological information available. 

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Under  the  procedure  referred  to  in  Article  24(2)  and  by  way  of 
derogation  from  the  official  movement  restrictions  provided  for  in  this 
paragraph,  a  Member  State  may  be  exempted  from  implementing  such 
restrictions if it applies measures offering equivalent safeguards.’ 

(b)  paragraph 3 shall be replaced by the following: 

‘3.  All parts of the body of the suspect animal shall be either retained under 
official control until a negative diagnosis has been made, or disposed of 
in accordance with Regulation (EC) No 1774/2002. ’ 

(10) 

In Article 13, paragraph 1 is amended as follows: 

(a) 

point (a) shall be replaced by the following: 

‘(a)  all parts of the body of the animal shall be disposed of in accordance with 
Regulation (EC) No 1774/2002 except for material retained for records in 
accordance with Annex III, Chapter B of this Regulation.’ 

(b)  point (c) shall be replaced by the following: 

‘(c)  all animals and products thereof at risk, as listed in Annex VII, point 2 to 
this  Regulation,  identified  by  the  inquiry  referred  to  in  point  (b)  of  this 
paragraph shall be killed and disposed of in accordance with Regulation 
(EC) No 1774/2002.’ 

(11) 

In Article 15, paragraph 3 shall be replaced by the following:  

‘3. 

In accordance with the procedure referred to in Article 24(2), the provisions of 
paragraphs 1 and 2 may be extended to other animal species, and detailed rules 
for implementing this Article may be adopted.’ 

(12) 

Article 16 is amended as follows: 

(a) 

in paragraph 1, point (b) shall be replaced by the following: 

‘(b)  milk  and  dairy  products,  hides  and  skins,  and  gelatine  and  collagen 

derived from hides and skins.’ 

(b)  paragraphs 2 and 3 shall be replaced by the following: 

‘2.  Products of animal origin imported from a third country with a BSE risk 
shall  come  from  healthy  bovine,  ovine  and  caprine  animals  which  have 
not  been  subjected  to  a  laceration  of  the  central  nervous  tissue  or  gas 
injection into the cranial cavity as referred to in Article 8(3).  

3. 

Further conditions applicable to the placing on the market and export of 
products of animal origin originating in a Member State or third country, 
or  a  region  thereof,  with  a  high  risk  of  BSE,  shall  be  adopted  in 
accordance with the procedure laid down in Article 24(2).’ 

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(13) 

Article 21 shall be replaced by the following: 

‘Article 21 
Community controls 

1. 

Experts  from  the  Commission  may  carry  out  on-the-spot  checks  in  co-
operation  with  the  competent  authorities  of  the  Member  States,  insofar  as  is 
necessary for the uniform application of this Regulation. The Member State in 
whose territory those checks are carried out shall provide the experts with all 
the  assistance  necessary  for  carrying  out  their  duties.  The  Commission  shall 
inform the competent authority of the results of those checks. 

Experts  from  the  Commission  and  the  Member  States  may  carry  out  on-the-
spot checks in third countries in order to verify whether the conditions relevant 
for the export from such countries are fulfilled.  

The  experts  from  the  Member  States  responsible  for  those  checks  shall  be 
appointed  by  the  Commission,  acting  on  a  proposal  from  the  Member  States. 
The  checks  shall  be  made  on  behalf  of  the  Community  which  shall  bear  the 
cost of any expenditure in this connection 

2. 

3. 

Community  checks  concerning  third  countries  shall  be  made  in  accordance 
with Directive 97/78/EC. 

Rules  for  the  application  of  paragraph  1  shall  be  adopted  in  accordance  with 
the procedure referred to in Article 24(2).” 

(14) 

In Article 23, the second paragraph shall be replaced by the following: 

‘In  accordance  with  that  procedure,  transitional  measures  shall  be  adopted  for  a 
period ending on 1 July 2007 at the latest, to permit the change-over from the current 
arrangements to the arrangements established by this Regulation.’ 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 2 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, […] 

For the European Parliament 
The President 

For the Council 
The President 

EN 

12 

   EN