Joint CAAT-Europe / ecopa workshop, Berlin, 31.01 – 02.02.2011
Implementation of the new EU Directive 2010/63/EU on the protection of
animals used for scientific purposes: Opportunities for the 3Rs
The Situation in Germany
Roman Kolar
ecopa board member
Deputy Director
Animal Welfare Academy
German Animal Welfare Federation
The situation in Germany
OUTLINE
A) Major achievements re. 3Rs advancement:
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Funding
The Centre for Documentation and Evaluation of Alternatives
to Animal Experiments (ZEBET)
Academic activities
B) Transposition of Directive 2010/63/EU

(Legal requirements) – (state-of-the-art) = needs
German Animal Welfare Federation – Animal Welfare Academy
The situation in Germany
Funding
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Federal Ministry of Education and Research (BMBF)
Federal States
Centre for Documentation and Evaluation of Alternatives to
Animal Experiments (ZEBET)
Foundation set
Research awards
German Animal Welfare Federation – Animal Welfare Academy
Federal Ministry of Education and
Research (BMBF)

Since 1980/1981
Funding of projects of research and development in the
field of „methods to replace animal experiments”
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€ 4 Mio. annually during the most recent years
+ € 1.7 Mio. for special grant applications.

2000 – 2009: € 41.5 Mio for 152 research projects.
German Animal Welfare Federation – Animal Welfare Academy
Federal States

Baden-Württemberg: About € 300.000 per year
Rheinland-Pfalz: About € 80.000 per year
German Animal Welfare Federation – Animal Welfare Academy
ZEBET
- Centre for Documentation and Evaluation
of Alternatives to Animal Experiments within
the Federal Institute of Risk Assessment (BfR)
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
Approximately € 400.000 annually
2000-2010:
63 Projects funded to the amount of around € 4.000.000
German Animal Welfare Federation – Animal Welfare Academy
set
- Foundation for the Promotion of
Alternatives to Animal Testing
 established in March 1986
 initial industry funding of € 500.000  interest on the Foundation’s capital
 from 1993/94:
industry donations of € 120.000 – 220.000 annually
 from 2000:
industry donations of € 120.000 annually
from 2010:
industry donations of € 220.000 annually +
€ 100.000 provided by the German Federal Ministry of Food, Agriculture and
Consumer Protection (BMELV) for the next 4 years, (amount to be matched by
industry donors)
 1986-2010 : 50 projects
German Animal Welfare Federation – Animal Welfare Academy
Research Awards for 3R Methods
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Ministry of Consumer Protection: € 15.000
Baden Württemberg: Up to € 25.000
Hessen: € 15.000
Rheinland-Pfalz: € 20.000 every two years
DFG: € 50.000 (from a private donation)
German Animal Welfare Federation – Animal Welfare Academy
ZEBET
- Centre for Documentation and Evaluation
of Alternatives to Animal Experiments within
the Federal Institute of Risk Assessment (BfR)
 Established in 1989: First governmental research institution in charge of
alternatives to animal experiments worldwide
Mission: Replacement of animal experiments by alternative test methods,
particularly those experiments required by law, reduction of the number of test
animals to the minimum absolutely necessary, and alleviation of pain and
suffering of animals used in experiments.

German Animal Welfare Federation – Animal Welfare Academy
ZEBET
- Centre for Documentation and Evaluation
of Alternatives to Animal Experiments within
the Federal Institute of Risk Assessment (BfR)
Responsible for:
documenting alternatives to animal experimentation
 assessing and recommending them
 promoting their validation both nationally and internationally.

Also:
in-house research
 separate budget for external projects

German Animal Welfare Federation – Animal Welfare Academy
ZEBET
- Centre for Documentation and Evaluation
of Alternatives to Animal Experiments within
the Federal Institute of Risk Assessment (BfR)
Information centre for alternative methods for CA in charge of enforcement of
the legal requirements on animal experiments.
 database AnimAlt-ZEBET (free of charge; in English).
German Animal Welfare Federation – Animal Welfare Academy
Academic 3Rs activities
Chair for Alternative Methods:
 University of Konstanz: University
Projects and/or departments specifically addressing 3Rs issues:
 University of Erlangen
 University of Veterinary Medicine Hannover
 University of Berlin
 University of Giessen
German Animal Welfare Federation – Animal Welfare Academy
Transposition of Directive 2010/63/EU
The CA carrying out the project evaluation must consider expertise in
3Rs, animal husbandry etc. (Art. 38(3))
Situation in Germany:
 members of local ethical committees may be competent in the
required areas; no standards etc. exist; these committees are based
on voluntary work
 CA may request advice from ZEBET, but ZEBET’s capacity is clearly
limited
 national competence centre is needed that can cope with the to be
expected workload and provides professional expertise in all relevant
areas
German Animal Welfare Federation – Animal Welfare Academy
Transposition of Directive 2010/63/EU
MS can establish programmes for the sharing of organs and tissues of
killed animals (Art. 18).
Situation in Germany:
no such programme exists
 to be set up
German Animal Welfare Federation – Animal Welfare Academy
Transposition of Directive 2010/63/EU
MS shall contribute to the development and validation of 3Rs
a) Establish 3Rs centres (Art. 47) including the provision of qualified labs
for validation studies (Art 47(2)) and a single contact point to provide
advice on suitability of methods proposed for validation (Art 47(5))
Situation in Germany:
With ZEBET Germany already has such a centre
 other areas of animal use need to be included (apart from toxicology)
German Animal Welfare Federation – Animal Welfare Academy
Transposition of Directive 2010/63/EU
MS shall contribute to the development and validation of 3Rs
b) Specific funds for the development and validation of 3Rs methods /
strategies.
Situation in Germany:
Germany already has funding provided by BMBF, ZEBET, set foundation,
and 2 Federal States
 increased and more strategic funding needed
 being the major research community in Germany, the DFG must be
involved to provide special funding for alternative methods
German Animal Welfare Federation – Animal Welfare Academy
Transposition of Directive 2010/63/EU
MS shall ensure the dissemination of info on the 3Rs (Art. 47 (4))
Situation in Germany:
ZEBET runs a database on 3Rs of mainly toxicological animal tests.
 other areas of animal use need to be included
ZEBET holds courses on 3Rs; there are also some academic activities in that regard
+ those of the national LASA (GV-SOLAS)
 establishment of specific education and training courses on 3Rs at universities
and other institutions
 comprehensive system needed for the regular distribution of relevant info on the
3Rs to, and education & training of, all those that are involved in animal research and
the authorisation thereof
German Animal Welfare Federation – Animal Welfare Academy
Transposition of Directive 2010/63/EU
MS shall contribute to the development and validation of 3Rs
+
MS shall ensure the dissemination of info on the 3Rs (Art. 47 (4))
Situation in Germany:
Scarce focussed academic activities in the field of the 3Rs; the only
chair on alternative methods is based on a private donation
 Promotion and funding of chairs/departments/institutes for animalfree research at German universities
German Animal Welfare Federation – Animal Welfare Academy
Transposition of Directive 2010/63/EU
MS shall ensure that each breeder, supplier and user sets up an animalwelfare-body (Art. 27)
Situation in Germany:
presently some of the tasks of the future animal-welfare-body are dealt with
by the animal welfare officer. Not foreseen for breeders and suppliers. Not
necessarily knowledgeable in 3Rs. The efficiency of the AWO strongly
depends of personal motivation.
 to be set-up also for breeders and suppliers; 3Rs experts needed; how to
avoid conflicts of interest?
German Animal Welfare Federation – Animal Welfare Academy
Transposition of Directive 2010/63/EU
MS shall establish national committees for the protection of animals used for
scientific purposes to advise CA and animal welfare bodies - also with a
view to 3Rs issues (Art. 49)
Situation in Germany:
no national committee for this specific purpose exists; present national
animal welfare committee not suited for this purpose
 to be set-up; 3Rs experts needed
German Animal Welfare Federation – Animal Welfare Academy
Joint CAAT-Europe / ecopa workshop, Berlin, 31.01 – 02.02.2011
Thank you for your attention!
German Animal Welfare Federation – Animal Welfare Academy