Luxemboug
April 14, 2014

The Council today adopted a regulation on compliance measures for users from the
Nagoya Protocol on access to genetic resources and the fair and equitable sharing of
benefits arising from their utilization in the Union (PE-COS 131/13).

Today's final adoption of the legislation by the Council follows an agreement reached at
first reading with the European Parliament. The European Parliament voted at its plenary
session of 11 March 2014.

The regulation is aimed at establishing a framework governing compliance with
requirements for access to genetic resources and for benefit-sharing in accordance with the
Nagoya Protocol. Its implementation will also contribute to the conservation of biological
diversity and the sustainable use of its components.

The regulation will oblige users (such as the feed and food industry, the pharmaceutical
and cosmetics industry and researchers) to exercise due diligence to ascertain that genetic
resources and associated traditional knowledge which they utilise have been accessed in
accordance with the applicable legal requirements, and that the benefits are fairly and
equitably shared in accordance with mutually agreed terms. The regulation will apply to
genetic resources over which states exercise sovereign rights and to traditional knowledge
associated with genetic resources that are accessed after the entry into force of the Nagoya
Protocol for the Union.

Every member state will designate one or more competent authorities responsible for the
application of the regulation. The competent authorities will, inter alia, carry out checks to
verify users’ compliance with their obligations. The Commission will make public a list of
such authorities, including on the internet, and keep it up-to-date. The Commission will
establish and maintain an internet-based and easily accessible register of collections of
genetic resources within the EU.

In addition, the regulation provides for complementary measures obliging the Commission
and member states, inter alia, to promote and encourage information and awareness raising
and training activities to help all stakeholders understand their obligations and the
implementation of this regulation as well as to encourage the development of, in particular,
sectoral codes of conduct, guidelines and best practices, particularly where they would
benefit academic, university and non-commercial researchers and small and medium-sized
enterprises.

Background

The Convention on Biological Diversity is the main international instrument providing a
general framework for the conservation and sustainable use of biodiversity and the fair and
equitable sharing of the benefits arising out of the utilisation of genetic resources.
The Nagoya Protocol to the Convention on Biological Diversity on Access to Genetic
Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization is
an international treaty adopted in October 2010 in Nagoya, Japan. It elaborates further the
general rules of the Convention on access and monetary and non-monetary benefit-sharing
in relation to the utilization of genetic resources and traditional knowledge associated with
genetic resources.

Website: http://europa.eu

Published: May 1, 2014