PURPOSE: conclusion of the Agreement between the
European Union and New Zealand amending the Agreement on mutual
recognition in relation to conformity assessment between the
European Community and New Zealand.
NON-LEGISLATIVE ACT: Council Decision 2012/828/EU on
the conclusion of the Agreement between the European Union and New
Zealand amending the Agreement on mutual recognition in relation to
conformity assessment between the European Community and New
Zealand.
BACKGROUND: the Agreement on mutual recognition in
relation to conformity assessment between the European Community
and New Zealand entered into force on 1 January 1999.
In accordance with Council Decision 2011/464/EU, the
Agreement between the European Union and New Zealand amending the
Agreement on mutual recognition in relation to conformity
assessment between the European Community and New Zealand was
signed by the Commission on 23 February 2012, subject to its
conclusion.
The Agreement should be concluded on behalf of the
EU.
CONTENT: with this Decision, the Agreement between the
European Union and New Zealand amending the Agreement on mutual
recognition in relation to conformity assessment between the
European Community and New Zealand is hereby approved on behalf of
the Union.
Main amendments to the basic Agreement: the amendments are intended to:
- allow greater flexibility in the structure of Sectoral
Annexes to the Agreement on Mutual Recognition;
- remove unnecessary restrictions on trade between the
Parties;
- reduce the administrative burden related to management
of the Agreement;
- facilitate and clarify the operation of the
Agreement.
In addition, the Sectoral Annexes on medicinal
products GMP (Good Manufacturing Practices) inspection and batch
certification and on medical devices have been superseded by
changes in technical and administrative practice and by changes in
the organisations listed therein, and the opportunity has been
taken to revise them.
The main technical amendments made to the Agreement
are as follows:
A detailed assessment of the amendments
follows:
- scope: in order to
remove unnecessary restrictions on trade, the restriction in
Article 4 of the application of the Agreement to industrial
products that originate in the Parties according to
non-preferential rules of origin will be deleted. As amended, the
Agreement on Mutual Recognition will apply to all products covered
by it, irrespective of their origin.
- comitology: the
references to the Chair of the Joint Committee will be deleted from
Articles 8 and 12, in order to reflect the fact that the Joint
Committee is co-chaired by the Parties;
- simplification of the operation of the
Agreement: in order to simplify
operation of the Agreement on Mutual Recognition, a simpler
procedure for the recognition, withdrawal of recognition and
suspension of conformity assessment bodies will be set up in
Article 12. As a result, a decision by a designating authority to
designate or withdraw designation of a conformity assessment body
will no longer need to be given effect by an amendment to a
Sectoral Annex; the need for the Joint Committee to take action
will be limited to cases that have been contested by the other
Party;
- adaptations to the Annexes: in order to make timely adaptations to the Sectoral
Annexes to take account of technical progress and other factors
such as enlargement of the European Union, Article 12 will also be
amended in order to explicitly empower the Joint Committee to amend
the Sectoral Annexes in areas other than to give effect to the
decision by a designating authority to designate or withdraw
designation of a particular conformity assessment body, and also to
adopt new Sectoral Annexes;
- sectoral Annex: the
Sectoral Annex on medicinal products and medical devices have been
revised to take account of developments in technical and
administrative practice, changes introduced by the Amendment to the
main body of the Agreement on Mutual Recognition, updates in the
organisations listed, and changes to the Parties' legislation
affecting this sector. The principle of operation of this Sectoral
Annex remains unchanged.
ENTRY INTO FORCE: the Decision shall enter into force
on 13 November 2012. The date of entry into force of the Agreement
will be published in the Official Journal of the European Union by
the General Secretariat of the Council.