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.
PROPOSED ACT: Council Decision.
BACKGROUND: the Agreement between the European
Community and New Zealand on mutual recognition in relation to
conformity assessment entered into force on 1 January 1999. With a
view to further improving and simplifying the functioning of the
Agreement on Mutual Recognition, the Parties have decided to amend
some of its provisions.
On the basis of the negotiating directives from the
Council, the Commission initialled negotiated and initialled an
Amendment to the Agreement on Mutual Recognition.
IMPACT ASSESSMENT: no impact assessment was carried
out.
LEGAL BASIS: Article 207(4), first subparagraph, in
conjunction with Article 218(6)(a)(v) of the Treaty on the
Functioning of the European Union (TFEU).
CONTENT: the amendment is 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certification and on medical devices have been superseded by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.
A detailed assessment of the amendment
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.
The Agreement on mutual recognition in relation to
conformity assessment, certificates and markings between the
European Union and Australia is identical in
form to the Agreement, and is therefore being amended in parallel
in order to retain coherence between the Agreements.
BUDGETARY IMPLICATION: this proposal has no
implications for the European Union’s budget.