In accordance with Directive 86/609/EEC, it is necessary to replace, reduce or refine
testing on vertebrate animals. Implementation of this Regulation should be based on the
use of alternative test methods, suitable for the assessment of health and environmental
hazards of chemicals, wherever possible. The use of animals should be avoided by
recourse to alternative methods validated by the Commission or international bodies, or
recognised by the Commission or the Agency as appropriate to meet the information
requirements under this Regulation. To this end, the Commission, following consultation
with relevant stakeholders, should propose to amend the future Commission Regulation on
test methods or this Regulation, where appropriate, to replace, reduce or refine animal
testing. The Commission and the Agency should ensure that reduction of animal testing is
a key consideration in the development and maintenance of guidance for stakeholders and
in the Agency's own procedures.
(48) This Regulation should be without prejudice to the full and complete application of the
Community competition rules.
(49) In order to avoid duplication of work, and in particular to reduce testing involving
vertebrate animals, the provisions concerning preparation and submission of registrations
and updates should require sharing of information where this is requested by any registrant.
If the information concerns vertebrate animals, the registrant should be obliged to request
it.