Alternatives to
Animal Testing
ILSI Europe's 2017
Annual Symposium
30-31 March 2017
Dr. Katrin Schütte
DG Environment,
European Commission
Contents
1) 1) Directive 2010/63/EU –
From legislation to application
2) 2) Scientific Conference:
Non-animal Approaches – the Way Forward
3) 3) The European Partnership for Alternative
Approaches to Animal Testing (EPAA)
Directive 2010/63/EU
• Significant increase in animal welfare
• Level playing field for industry and academia
• Active promotion and implementation of the
principle of the Three Rs as a legal obligation
Biologicals
Environment
Pesticides
DIRECTIVE 2010/63/EU
Biocides
Pharmaceuticals
Agriculture
[Cosmetics]
RTD
Framework programs
Horizon 2020
REACH
Chemicals
Food safety
Acknowledging that…
• Animals, including non-human primates, are still
needed today for research and testing
• The ultimate goal is to replace the use of animals
• Animals have intrinsic value in themselves which
must be respected
• The principle of the Three Rs is the key to more
humane and better science
• REPLACEMENT
•
REDUCTION
• REFINEMENT
Three Rs and the Directive
I. Application of existing Three Rs approaches
• central in project planning, evaluation, during the
course of the project and after
II. Development, validation and promotion of
new alternatives / Three Rs approaches
• New tools for the development, validation and
uptake of alternative approaches to progress
towards the ultimate goal of full replacement
Formal establishment of
EURL ECVAM
• Legal basis embedded in the Directive (Art. 48)
• Extended scope covering now also basic and
applied research
• New resources for the validation (EU-NETVAL)
(Art. 47)
• PARERE established to ensure regulatory
relevance (Art. 47)
New tools and obligations
under 2010/63/EU
• Three Rs a legal obligation - full replacement set as the
ultimate goal
• Systematic project evaluation and authorisation
• New roles and functions (e.g. Animal Welfare Body,
Designated Veterinarian, National Committee)
• Binding housing and care standards
• Increased transparency and better enforcement
• New structures for the validation and regulatory
acceptance of alternatives
Legal framework
• Transposition
completed
• Conformity
check ongoing
Compliance - Legislative process
Implementation
- tools and
guidance
Operational
structures
National
legislation
Application,
enforcement,
reporting
Experience
and review
Designated
veterinarian
CAs for
project
evaluation
and RA
National
Committees
and
MS National
Contact Points
Animal
Welfare
Body
Project leaders,
animal
technologists
animal care takers
Legislation, codes of practice, guidance
Efficient COMMUNICATION
Education, training and competence
Inspectors
Named
responsible
persons
Testing to satisfy regulatory
purposes under the Directive –
issues identified
• Who is responsible for compliance with
obligations under both the Directive and sector
legislation (e.g. REACH, food or feed safety
regulation)?
• How to make the information on (new)
alternative approaches reach the right person
at the right time?
Responsibilities under 2010/63
 Draw the attention of users to their legal
obligation to apply alternatives as soon as
these become available
 Include a standard phrasing in the project
authorisation decisions for projects that
involve testing carried out to satisfy
regulatory requirements
Need to communicate & collaborate!
More information at:
http://ec.europa.eu/animals-in-science
Member State authorities for Directive 2010/63/EU
National Contact Points as per Article 59 of the Directive:
http://ec.europa.eu/environment/chemicals/lab_animals/ms_en.htm
© Novo Nordisk
Photographs © iStockphoto
Why this conference?
• European Citizens' Initiative STOP VIVISECTION!
(2015) had requested with 1.17 million signatures
to end all animal testing and to annul DIR
2010/63/EC
• COM response on 3 June 2015 was negative
about their key request but positive to their
request to engage in a scientific dialogue with
stakeholders
 scientific stakeholder conference Dec 6&7
2016 (Action 4 in written response)
Participants
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23 different countries
320 people attended in person (of which 80% scientists)
200 participants on-line
Academia and research institutes
Chemical, pharma and cosmetics industry
Contract testing laboratories
Governmental agencies
(ECVAM/ECHA/EMA/EDQM/EPA/NIH-NICEATM,…)
Publishers
Research funding organisations
Patient groups to citizens’ groups
Many NGOs active on animal welfare.
Talks & panel discussions
in 6 moderated sessions
• Animal Testing Today
• Biomedical research: strengths & limitations of
Alternatives
• Regulatory testing: strengths & limitations of
Alternatives
• Knowledge sharing on Alternatives & Commission
funding
• Responsible Research
• The Future: the way forward
Exhibition & posters on alternatives
• SEURAT/EU-TOX
• NC3Rs
• DG ENV
• JRC/EURL ECVAM
• EPAA
Happy participants
What next?
• Conference materials (Programme, report, videos,
presentations, posters, participant list) will be available
on DG ENV animals website in March
http://ec.europa.eu/animals-in-science
• JRC Action 1- report published
http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EUBookshop-Site/en_GB/-/EUR/ViewPublicationStart?PublicationKey=LBNA28234
• Aim to follow up
on recommendations
in context of on-going
activities as well as
the EU Pilot Project
The European Partnership for Alternative
Approaches to Animal Testing
– of interest also for ILSI member
companies?
1.
WHAT IS EPAA?
STATUS
Partnership between European Commission & Industry
stakeholders.
PURPOSE
To facilitate development, acceptance and validation of
alternative approaches.
MILESTONES
Created in 2005. Renewed for the 2nd time in 2015.
SCOPE
Operates across 7 industry sectors. Covers Regulatory testing.
1.
EPAA VISION & MISSION
Vision
The vision of EPAA is the replacement, reduction and refinement (3Rs) of
animal use for meeting regulatory requirements through better and more
predictive science.
Mission
- Promote development and acceptance of alternative methods
- Enhance international collaboration & mutual recognition of
alternatives
- Foster knowledge sharing on 3Rs among the partners
- Facilitate dialogue between stakeholders contributing to animal
welfare
1. EPAA Membership
Companies & SMEs
 5 Commission Directorate Generals (DG)
 7 European trade federations for 7 industry sectors
 35 Companies
European Commission
DG Industry
DG Environment
DG Joint Research
Center
DG Research
European Industry Federations
DG Health & Food
Safety
1. EPAA Remit
7 industry sectors committed to support alternative
methods for regulatory safety testing and/or
quality & potency testing:
-
Animal Health
Chemicals
Cosmetics
Crop Protection
Fragrances
Pharmaceuticals (incl. vaccines)
Soaps & Detergents
- Food and Feed?
1.
-
EPAA Ongoing Projects list
Harmonization of 3Rs in Biologicals
Exposure predictions (ADME)
Human rabies vaccines (potency test replacement)
Clostridial vaccines (validation of alternative to inprocess control tests)
Advancing 3Rs in Regulatory Toxicology:
Carcinogenicity
Acute toxicity testing
Skin sensitisation – optimised strategies
Skin sensitisation – difficult substances
Thank you
for your attention!