EU/Australia Agreement: mutual recognition in relation to conformity assessment, certificates and markings (amendment)

PURPOSE: to conclude the Agreement between the EU and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the EC and Australia.

NON-LEGISLATIVE ACT: Council Decision 2012/837/EU.

CONTENT: this Decision approves the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the EC and Australia.

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products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them.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 points of the Agreement are as 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 is 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 are deleted, in order to reflect the fact that the Joint Committee is co-chaired by the Parties;

·        simplification of the operation of the Agreement: a simpler procedure for the recognition, withdrawal of recognition and suspension of conformity assessment bodies is set up. 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 is limited to cases that have been contested by the other Party;

·        adaptations to the Annexes: to take account of technical progress and other factors such as enlargement of the European Union, the Agreement is amended in order to 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.

A parallel Agreement amending the Agreement with New Zealand on mutual recognition in relation to conformity assessment has been concluded.

ENTRY INTO FORCE: 18 July 2011.