Communication from the Commission to the European Parliament pursuant to Article 294(6) of the Treaty on the Functioning of the European Union concerning the Council's position at first reading on the adoption of a Directive of the European Parliament and of the Council on the protection of animals used for scientific purposes
Date: 2010-06-15
Institutions: European Commission
Subjects: animal experimentation, bio-ethics, drafting of EU law, protection of animals, scientific research, veterinary inspection

EN 

EN 

   EN 

 
 
EUROPEAN COMMISSION 

Brussels, 15.6.2010 
COM(2010) 324 final 

2008/0211 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to Article 294(6) of the Treaty on the Functioning of the European Union 

concerning the 

Council's position at first reading on the adoption of a Directive of the European 
Parliament and of the Council on the protection of animals used for scientific purposes 

EN 

   EN 

 
 
 
  
 
 
2008/0211 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to Article 294(6) of the Treaty on the Functioning of the European Union 

concerning the 

Council's position at first reading on the adoption of a Directive of the European 
Parliament and of the Council on the protection of animals used for scientific purposes 

1. 

BACKGROUND 

Date of transmission of the proposal to the EP and the 
Council(document COM(2008)543 final — 2008/0211 COD): 

7 November 2008 

Date  of  the  opinion  of  the  European  Economic  and  Social 
Committee: 

13 May  2009 

Date of the opinion of the Committee of the Regions: 

not applicable 

Date of the opinion of the European Parliament, first reading: 

5 May 2009 

Date  of  adoption  of  the  Council's  position  at  first  reading 
(qualified majority):  

3 June 2010 

2. 

OBJECTIVE OF THE COMMISSION PROPOSAL 

The  aim  of  the  revision  of  Directive  86/609/EEC  is  to  strengthen  the  protection  of  animals 
used for scientific purposes and contribute to the reduction of animal use and ensure that the 
animals  used  in  experiments  receive  appropriate  care  and  humane  treatment  in  line  with 
Article  13  of  the  Treaty  on  the  Functioning  of  European  Union  (TFEU)  which  recognises 
animals  as  sentient  beings,  as  well  as  to  integrate  fully  the  "Three  Rs"  principle  of 
replacement,  reduction  and  refinement  of  animal  use  into  legislation.  Furthermore,  specific 
provisions aim to reduce the use of non-human primates to an absolute minimum and lead to a 
gradual  phasing  out  of  wild-caught  non-human  primates  used  in  experiments.  The  use  of 
Great Apes is prohibited, however, with a safeguard clause to allow their exceptional use in 
strictly  defined  conditions.  Finally,  an  important  aim  of  the  revised  Directive  is  to  balance 
animal  welfare  concerns  with  the  obligation  to  pursue  research  for  the  benefit  of  human 
beings and the environment. It aims at ensuring a level playing field, throughout the EU, for 
industry  and  the  research  community.  Research  into  life  threatening  diseases  should  not  be 
hindered  and  European  research  should  not  be  disadvantaged  when  compared  with 
international counterparts. 

EN 

2 

   EN 

 
 
 
3. 

COMMENTS ON THE COUNCIL'S POSITION AT FIRST READING 

3.1. 

General comments 

The  European  Parliament  gave  its  opinion  at  first  reading  on  5  May  2009.  The  Parliament 
adopted  167  amendments  out  of  the  202  that  were  tabled.  It  is  important  to  note  that  when 
reacting to the Parliamentary amendments in first reading, the Commission moved little from 
its original proposal as the Council position on the proposal was not yet known.  

On  3  June  2010  the  Council  adopted  by  qualified  majority  its  position  in  a  pre-negotiated 
early  second-reading.  85  of  the  Parliament's  amendments  were  taken  into  account  in  the 
position of the Council. 

Out  of  167  amendments  adopted  by  the  Parliament,  76  were  acceptable  to  the  Commission 
either  fully,  in  part  or  in  principle.  The  Commission  considered  that  those  amendments 
clarified  the  text  and  were  consistent  with  the  general  objective  of  the  proposal.  The 
Commission  rejected  all  amendments  which  would  have  altered  the  nature  of  the  original 
objectives of the proposal, pending the views of the Council. The Commission considers that 
the  position  of  the  Council  does  not  radically  alter  the  approach  or  aims  of  the  original 
proposal overall, or change significantly the core elements therein. 

The recitals have been modified to reflect the changes that were made to the substantial part 
of  the  text.  The  Commission’s  position  with  regard  to  the  amendments  of  the  European 
Parliament to the enacting terms is as follows:  

3.2. 

Detailed comments 

3.2.1.  Parliamentary  amendments  accepted  by  the  Commission  in  full,  in  part  or  in 
principle and incorporated in full, in part or in principle in the Council's position at 
first reading. 

41 amendments (31, 33, 43, 48, 49, 56, 59, 64, 68, 69, 71, 78, 79, 81, 82, 84, 85, 87, 98, 100, 
101, 102, 105, 108, 109, 114, 115, 116, 117, 119, 121, 126, 129, 145, 150, 161, 168, 169, 170, 
185,  194)  were  accepted  by  the  Commission  and  incorporated  to  varying  degrees  in  the 
Council's position. 

Amendments 69, 161 and 185 introduced a new annex providing detailed criteria for the four 
severity classes of procedures, criteria which were originally foreseen as part of implementing 
acts. However, the Commission welcomed this amendment and convened an expert meeting 
to agree on the detailed criteria. This allowed the annex to be updated by the Presidency with 
the latest expert understanding of the severity classes. 

3.2.2.  Parliamentary amendments rejected by the Commission but incorporated in full, in 

part or in principle in the Council's position 

At the time of responding to the EP first reading report, the Commission kept to its original 
proposal  as  the  position  of  the  Member  States  on  these  provisions  was  not  yet  known. 
Therefore,  at  that  point  in  time,  it  was  likely  that  the  Commission  would  be  able  accept  a 
greater number of amendments once Member State views were known. 

44 amendments (28, 30, 35, 37, 47, 50, 52, 53, 54, 60, 61, 65, 66, 67, 70, 72, 73, 74, 75 76, 
77, 86, 89, 91, 92, 97, 103, 110, 112, 123, 124, 125, 127, 135, 136, 139, 140, 141, 142, 193, 

EN 

3 

   EN 

 
151, 152, 160, 175) were rejected by the Commission but have been incorporated in full, in 
part  or  in  principle  in  the  Council's  position.  These  are  all  considered  acceptable  by  the 
Commission as they do not endanger the original objectives as set out by the Commisison or, 
if altering these objectives marginally, could still be acceptable in the spirit of compromise to 
reach an early second reading political agreement. On specific amendments. 

Amendment 30 narrowed the scope of the proposal without taking into account the scientific 
knowledge  available  today  on  the sentience  of  a  wider  range  of  species  and  life  forms  than 
now  protected.  In  addition  to  vertebrate  species  including  their  larval  forms,  the  scope  now 
covers  foetal  forms  only  of  mammals  from  the  last  third  of  their  development  and 
cephalopods as the only group of invertebrate animals. The Commission can accept this in the 
spirit of overall compromise; 

Concerning amendment 54, to allow the adoption of stricter measures, it is important to note 
that it was not acceptable to the Commission as one of the objectives of the revision was the 
harmonisation of the single market. The final agreement allows for the maintenance of stricter 
measures, but not the adoption of new ones. 

Amendment  60  asked  for  a  feasibility  study  to  be  carried  out  on  the  sole  use  of  second  or 
higher  generation  purpose-bred  non-human  primates,  and  a  modification  of  the  deadline  set 
out by the Commission for sole use of these animals. The Commission proposal was based on 
a  solid  impact  assessment  which  had  included  a  feasibility  assessment,  therefore  in  the 
Commission's  view  making  a  feasibility  study  superfluous.  The  concerns  of  the  EP  were, 
however,  shared  by  the  Member  States  and  the  resulting  text  reflects  the  amendment  to  a 
certain  degree.  The  feasibility  was  linked  by  the  Parliament  to  sourcing  animals  from  self-
sustaining colonies in amendment 61. The Council separated the two obligations and inserted 
a  requirement  for  the  Commission  to  conduct  a  further  study  to  analyse  the  feasibility  of 
sourcing animals only from self-sustaining colonies; 

Amendments 73, 74  and 75 were not  in line with the  Commission's policy objective not to 
allow  for  a  re-use  of  animals  having  already  been  subject  to  a  ‘moderate’  procedure.  The 
Presidency modified the text in-line with the EP's wishes, allowing for a systematic re-use of 
animals already subject to 'moderate' procedures where the subsequent procedure can also be 
of  'moderate'  severity.  However,  all  Three  Rs  (the  principle  of  replacement,  reduction  and 
refinement  of  the  use  of  animals  in  procedures)  have  to  be  balanced  when  projects  are 
evaluated,  including  decisions  on  re-use,  and  thus  this  amendment  can  be  acceptable  to  the 
Commission; 

Amendment  103  was  not  in  line  with  the  policy  objectives  to  improve  enforcement.  The 
proposed  frequency  of  inspections  was  based  on  the  conclusions  by  the  Technical  Expert 
Working Group. Furthermore, one of the main criticisms of the current Directive has been the 
lack of compliance and enforcement both of which are directly linked to inspections. The final 
text  puts  the  emphasis  on  risk  analysis,  however,  requiring  a  minimum  of  one  third  of  user 
establishments to be inspected annually, with the exceptions of breeders, suppliers and users 
of  non-human  primates  which  require  annual  inspections.  An  appropriate  proportion  of 
inspections shall be carried out without prior notice. This is acceptable to the Commission as 
part of the overall compromise; 

Amendment 125 was rejected by the Commission as it was unclear what could be conceived 
as  a  "standardised  procedure"  outside  regulatory  testing.  However,  the  final  wording  was 
clarified  further,  and  Member  States  may  now  allow  the  authorisation  of  multiple  generic 

EN 

4 

   EN 

 
projects  which  are  also  carried  out  for  production  or  diagnostic  purposes  with  established 
methods, in addition to those carried out to satisfy regulatory requirements; 

Amendment  139  was  partly  incorporated  into  the  text  through  the  requirement  for  an  EU 
reference  laboratory  for  the  validation  of  alternative  methods  and  its  related  tasks  in  a  new 
Annex VII covering alternatives in the field of basic, applied research and regulatory testing; 

Amendments 140 and 193 were both partly covered; Member Sates are required to identify 
and  nominate  suitable  specialised  and  qualified  laboratories  for  validation  studies,  which 
support the objectives as set out by the Commission. 

3.2.3.  Parliamentary  amendments  accepted  in  full,  in  part  or  in  principle  by  the 

Commission but not incorporated in the Council's position 

18 amendments (29, 38, 39, 44, 46, 58, 83, 93, 94, 95, 96, 104, 143, 144, 148, 155, 156, 186) 
were accepted in full, in part or in principle by the Commission  but  not incorporated in  the 
Council's position. However, it is important to note that a number of these were considered to 
be already covered in other articles or an Annex and thus considered superfluous.  

In light of the political agreement, these amendments are unlikely to be re-tabled. 

It  is  important  to  note  amendments  155  and  156  which  increased  the  transitional  period 
foreseen  in  Annex  III  for  moving  to  second  or  higher  generation  purpose  bred  macaques 
(linked  with  amendments  60  and  61 above). The final text increased the transitional period, 
however,  linking  it  to  a  feasibility  study  under  Article  10(1).  The  feasibility  study  must  be 
completed no later than 7 years after the date of entry into force of this Directive. 

3.2.4.  Parliamentary  amendments  rejected  by  the  Commission  and  the  Council  and  not 

incorporated in the Council's position 

37 amendments (32, 34, 36, 40, 41, 42, 51, 55, 57, 62, 63, 80, 88, 90, 99, 111, 113, 118, 120, 
122,  128,  131,  132,  134,  137,  138,  147,  153,  154,  157,  158,  159,  167,  176,  178,  180,  187) 
were rejected by both institutions. 

As  a  result  of  the  political  agreement  on  the  text,  these  amendments  are  unlikely  to  be  re-
tabled.  

3.2.5.  Changes made by the Council to the proposal 

The Council proposed the following main changes to the Commission’s proposal: 

•  Authorisation  of  persons  (Article  24):  A  three-way  authorisation  (authorisation  of 
establishments,  persons  and  projects)  was  the  central  pillar  of  the  Commission  proposal, 
essential  for  enhancement  of  animal  welfare,  and  ensuring  compliance.  The  current 
compromise  text  removes  the  requirement  to  authorise  personnel  working  with  animals 
and replaces it by a requirement to name a person who is responsible for the training and 
competence  of  personnel  dealing  with  animals.  This  is  departing  from  the  Commission's 
initial  proposal  but  could  be  accepted  in  a  spirit  of  compromise  as  still  a  clear  line  of 
responsibility can be identified to secure the competence of personnel.  

•  The Commission proposal to have each MS nominate a national reference laboratory, was 
replaced by a more flexible system of identifying and nominating suitable specialised and 

EN 

5 

   EN 

 
qualified laboratories as per the needs of the validation studies at hand (Article 47). This 
allows  for  a  better  utilisation  of  available  resources  whilst  introducing  a  long-term 
commitment  to  the  promotion  of  alternative  methods.  Furthermore,  the  same  article 
requires each Member State to appoint a single point of contact to provide advice on the 
regulatory  relevance  of  alternative  methods.  This  will  streamline  communication  and 
further  contribute  to  a  speedy  uptake  of  alternative  methods.  In  addition,  Article  46 
requires an EU reference laboratory for the validation of altenative methods to be set up. 
Since the objectives as set by the Commission are not altered and are likely to be achieved 
equally by the proposed measures, the Commission can accept these changes. 

•  Finally, to achieve a compromise between the institutions, two additional safeguard clauses 
were  introduced  which  can  only  be  evoked  on  exceptional  and  justifiable  grounds;  to 
surpass the upper limit of pain that the animal can be subjected to and to allow the use of 
non-human primates in applied research in areas that are not linked with debilitiating and 
life-threatening  conditions  in  humans.  In  the  name  of  the  overall  compromise,  the 
Commission can accept these. 

4. 

CONCLUSION 

In  its  assessment  of  Parliament’s  First  Reading  and  of  the  Council’s  Common  Position,  the 
Commission  has  taken  into  account  the  views  of  both  institutions  of  the  decision  making 
process. The subject matter is a difficult one and needs to consider the interests of a number 
of  different  stakeholder  groups,  sometimes  with  opposing  views  and  needs.  These  were 
mirrored in the discussions with the EP and the Council, however, the Commission considers 
that an appropriate balance has been found.  

The final text retains all key objectives that the Commission had set for the revision; namely 
to address the current problems of the uneven playing field, to fully incorporate the principle 
of  the  "Three  Rs",  including  the  promotion  of  the  alternatives  to  animal  testing,  and  to 
improve significantly the welfare of the animals still needed for scientific purposes. The EP's 
first  reading  report  put  a  lot  of  emphasis  on  the  reduction  of  administrative  burden  and  the 
continuity and viability of European research and industry relying still on the use of animals. 
The Council has addressed Parliament’s concerns by providing for more flexible rules for the 
implementation of project authorisation as well as for re-use of animals and by agreeing on a 
risk management based inspection scheme to ensure appropriate enforcement and compliance 
with the revised Directive. The concerns of administrative burden have inter alia been taken 
into account in more generous transposition times of the housing and care standards as well as 
in the way in which animal welfare bodies are to be implemented. Finally, both institutions 
voiced  the  need  for  further  promotion  of  alternatives  to  animal  testing.  In  response  an  EU 
reference  laboratory  for  the  validation  of  alternative  methods,  supported  by  Member  States' 
efforts to bring in further resources in terms of suitable specialised laboratories, is envisaged.  

The  Commission  supports  the  Common  Position  which  it  believes  strikes  the  right  balance 
between the needs of the industry and research community whilst upgrading and harmonising 
the animal welfare standards for animals used or intended to be used for scientific purposes. 
The Commission calls upon the Parliament and the Council to facilitate an early adoption of 
the Directive which will allow the efforts to be concentrated on the preparation for a uniform 
transposition and implementation. 

EN 

6 

   EN 

 
ANNEX 

Statement of the European Parliament, the Council and the Commission on Article 290 
TFEU 

The  European  Parliament,  Council  and  Commission  declare  that  the  provisions  of  this 
Directive  shall  be  without  prejudice  to  any  future  position  of  the  institutions  as  regards  the 
implementation of Article 290 TFEU or individual legislative acts containing such provisions. 

EN 

7 

   EN