2010/0146(NLE) | [ParlTrack]

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2010/0146(NLE) EU/Australia Agreement: mutual recognition in relation to conformity assessment, certificates and markings (amendment)

Progress: Procedure completed

Role	Committee	Rapporteur	Shadows
Lead	INTA	MOREIRA Vital ( S&D)	FJELLNER Christofer ( PPE), KAZAK Metin ( ALDE)

Lead committee dossier:

INTA/7/03045

Legal Basis:

TFEU 207-p4, TFEU 218-p6a

Subjects

Events

2012/12/29

Final act published in Official Journal

Details

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products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them.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.

Documents

Decision 2012/837
OJ L 359 29.12.2012, p. 0001

2012/11/13

EP/CSL - Act adopted by Council after consultation of Parliament

2012/11/13

EP - End of procedure in Parliament

2012/11/13

CSL - Council Meeting

2012/09/12

EP - Results of vote in Parliament

Documents

Results of vote in Parliament

2012/09/12

EP - Decision by Parliament, 1st reading/single reading

Details

The European Parliament adopted by 665 votes to 7, with 7 abstentions, a legislative resolution on the draft Council decision on the conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia.

The European Parliament gives its consent to the conclusion of the agreement.

Documents

T7-0330/2012

2012/06/25

EP - Committee report tabled for plenary, 1st reading/single reading

Details

The Committee on International Trade unanimously adopted the report drafted by Vital MOREIRA (ADLE, PT) in which it recommends the European Parliament to give its consent to the conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia.

Members welcome the improvements made to this Agreement which aim in particular to:

allow greater flexibility in the structure of sectoral annexes, remove unnecessary restrictions on trade between the parties, reduce the administrative burden related to management of the MRA, facilitate and clarify the operation of the MRA.

Documents

A7-0211/2012

2012/06/21

EP - Vote in committee, 1st reading/single reading

2012/03/13

EP - Committee referral announced in Parliament, 1st reading/single reading

2011/07/13

CSL - Document attached to the procedure

Documents

12150/2010

2011/07/13

EC - Legislative proposal published

Details

PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia.

PROPOSED ACT: Council Decision.

BACKGROUND: the Agreement between the European Community and Australia 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.

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 between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed.

BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget.

Documents

12124/2010

2010/10/08

EP - Committee draft report

Documents

PE450.683

2010/06/23

EP - Responsible Committee

2010/05/31

EC - Initial legislative proposal

Details

PROPOSED ACT: Council Decision.

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) of the Treaty on the Functioning of the European Union (TFEU).

CONTENT: the amendment is intended to:

A detailed assessment of the amendment follows.

BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget.

Documents

COM(2010)0270
EUR-Lex

2010/05/31

EC - Initial legislative proposal published

Details

PROPOSED ACT: Council Decision.

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) of the Treaty on the Functioning of the European Union (TFEU).

CONTENT: the amendment is intended to:

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.

BUDGETARY IMPLICATION: this proposal has no implications for the European Union's budget.

Documents

COM(2010)0270
EUR-Lex

Documents

Final act published in Official Journal: Decision 2012/837
Final act published in Official Journal: OJ L 359 29.12.2012, p. 0001
Results of vote in Parliament: Results of vote in Parliament
Decision by Parliament, 1st reading/single reading: T7-0330/2012
Committee report tabled for plenary, 1st reading/single reading: A7-0211/2012
Document attached to the procedure: 12150/2010
Legislative proposal published: 12124/2010
Committee draft report: PE450.683
Initial legislative proposal: COM(2010)0270
Initial legislative proposal: EUR-Lex
Initial legislative proposal published: COM(2010)0270
Initial legislative proposal published: EUR-Lex
Initial legislative proposal: COM(2010)0270 EUR-Lex
Committee draft report: PE450.683
Document attached to the procedure: 12150/2010

History

(these mark the time of scraping, not the official date of the change)

2020-01-19Show (8) Changes | Timetravel

committees/0	type Responsible Committee body EP associated False committee_full International Trade committee INTA rapporteur name: MOREIRA Vital date: 2010-06-23T00:00:00 group: Progressive Alliance of Socialists and Democrats abbr: S&D shadows name: FJELLNER Christofer group: European People's Party (Christian Democrats) abbr: PPE name: KAZAK Metin group: Alliance of Liberals and Democrats for Europe abbr: ALDE
committees/0	type Responsible Committee body EP associated False committee_full International Trade committee INTA date 2010-06-23T00:00:00 rapporteur name: MOREIRA Vital group: Progressive Alliance of Socialists and Democrats abbr: S&D shadows name: FJELLNER Christofer group: European People's Party (Christian Democrats) abbr: PPE name: KAZAK Metin group: Alliance of Liberals and Democrats for Europe abbr: ALDE
docs/0/type	Old Initial legislative proposal New Preparatory document
events/0	date 2010-05-31T00:00:00 type Preparatory document body EP docs url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf title: COM(2010)0270 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270 title: EUR-Lex summary PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia 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) 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 between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union's budget.
events/0	date 2010-05-31T00:00:00 type Initial legislative proposal published body EC docs url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf title: COM(2010)0270 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270 title: EUR-Lex summary PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia 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) 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 between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union's budget.
events/4/docs/0/url	Old http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2012-211&language=EN New http://www.europarl.europa.eu/doceo/document/A-7-2012-0211_EN.html
events/6/docs/0/url	Old http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-330 New http://www.europarl.europa.eu/doceo/document/TA-7-2012-0330_EN.html
procedure/Modified legal basis	Old Rules of Procedure EP 150 New Rules of Procedure EP 159

2019-07-06Show (12) Changes | Timetravel

activities	date: 2010-05-31T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf title: COM(2010)0270 type: Initial legislative proposal published celexid: CELEX:52010PC0270:EN body: EC commission: DG: url: http://ec.europa.eu/trade/ title: Trade Commissioner: DE GUCHT Karel type: Initial legislative proposal published date: 2011-07-13T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=12124%2F10&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC type: Legislative proposal published title: 12124/2010 body: EC commission: DG: url: http://ec.europa.eu/trade/ title: Trade Commissioner: DE GUCHT Karel type: Legislative proposal published date: 2012-03-13T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP shadows: group: PPE name: FJELLNER Christofer group: ALDE name: KAZAK Metin responsible: True committee: INTA date: 2010-06-23T00:00:00 committee_full: International Trade rapporteur: group: S&D name: MOREIRA Vital date: 2012-06-21T00:00:00 body: EP type: Vote in committee, 1st reading/single reading committees: body: EP shadows: group: PPE name: FJELLNER Christofer group: ALDE name: KAZAK Metin responsible: True committee: INTA date: 2010-06-23T00:00:00 committee_full: International Trade rapporteur: group: S&D name: MOREIRA Vital body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2012-211&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A7-0211/2012 type: Committee report tabled for plenary, 1st reading/single reading committees: body: EP shadows: group: PPE name: FJELLNER Christofer group: ALDE name: KAZAK Metin responsible: True committee: INTA date: 2010-06-23T00:00:00 committee_full: International Trade rapporteur: group: S&D name: MOREIRA Vital date: 2012-06-25T00:00:00 date: 2012-09-12T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=21793&l=en type: Results of vote in Parliament title: Results of vote in Parliament url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-330 type: Decision by Parliament, 1st reading/single reading title: T7-0330/2012 body: EP type: Results of vote in Parliament date: 2012-11-13T00:00:00 body: CSL type: Council Meeting council: Economic and Financial Affairs ECOFIN meeting_id: 3198 date: 2012-11-13T00:00:00 body: EP type: End of procedure in Parliament date: 2012-11-13T00:00:00 body: EP/CSL type: Act adopted by Council after consultation of Parliament date: 2012-12-29T00:00:00 type: Final act published in Official Journal docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012D0837 title: Decision 2012/837 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2012:359:TOC title: OJ L 359 29.12.2012, p. 0001
commission	body: EC dg: Trade commissioner: DE GUCHT Karel
committees/0	type Responsible Committee body EP associated False committee_full International Trade committee INTA date 2010-06-23T00:00:00 rapporteur name: MOREIRA Vital group: Progressive Alliance of Socialists and Democrats abbr: S&D shadows name: FJELLNER Christofer group: European People's Party (Christian Democrats) abbr: PPE name: KAZAK Metin group: Alliance of Liberals and Democrats for Europe abbr: ALDE
committees/0	body EP shadows group: PPE name: FJELLNER Christofer group: ALDE name: KAZAK Metin responsible True committee INTA date 2010-06-23T00:00:00 committee_full International Trade rapporteur group: S&D name: MOREIRA Vital
council	body: CSL type: Council Meeting council: Economic and Financial Affairs ECOFIN meeting_id: 3198 url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=SMPL&ROWSPP=25&RESULTSET=1&NRROWS=500&DOC_LANCD=EN&ORDERBY=DOC_DATE+DESC&CONTENTS=3198*&MEET_DATE=13/11/2012 date: 2012-11-13T00:00:00
docs	date: 2010-05-31T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf title: COM(2010)0270 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270 title: EUR-Lex summary: PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia 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) 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 between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. type: Initial legislative proposal body: EC date: 2010-10-08T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683 title: PE450.683 type: Committee draft report body: EP date: 2011-07-13T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=12150%2F10&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 12150/2010 type: Document attached to the procedure body: CSL
events	date: 2010-05-31T00:00:00 type: Initial legislative proposal published body: EC docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf title: COM(2010)0270 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2010&nu_doc=270 title: EUR-Lex summary: PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia 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) 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 between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union's budget. date: 2011-07-13T00:00:00 type: Legislative proposal published body: EC docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=12124%2F10&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 12124/2010 summary: PURPOSE: conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. PROPOSED ACT: Council Decision. BACKGROUND: the Agreement between the European Community and Australia 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 between the European Community and New Zealand on mutual recognition in relation to conformity assessment is in effect identical to the Agreement on Mutual Recognition with Australia. A parallel Agreement amending the Agreement with New Zealand will be proposed. BUDGETARY IMPLICATION: this proposal has no implications for the European Union’s budget. date: 2012-03-13T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP date: 2012-06-21T00:00:00 type: Vote in committee, 1st reading/single reading body: EP date: 2012-06-25T00:00:00 type: Committee report tabled for plenary, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2012-211&language=EN title: A7-0211/2012 summary: The Committee on International Trade unanimously adopted the report drafted by Vital MOREIRA (ADLE, PT) in which it recommends the European Parliament to give its consent to the conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. Members welcome the improvements made to this Agreement which aim in particular to: allow greater flexibility in the structure of sectoral annexes, remove unnecessary restrictions on trade between the parties, reduce the administrative burden related to management of the MRA, facilitate and clarify the operation of the MRA. date: 2012-09-12T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=21793&l=en title: Results of vote in Parliament date: 2012-09-12T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-330 title: T7-0330/2012 summary: The European Parliament adopted by 665 votes to 7, with 7 abstentions, a legislative resolution on the draft Council decision on the conclusion of the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia. The European Parliament gives its consent to the conclusion of the agreement. date: 2012-11-13T00:00:00 type: Act adopted by Council after consultation of Parliament body: EP/CSL date: 2012-11-13T00:00:00 type: End of procedure in Parliament body: EP date: 2012-12-29T00:00:00 type: Final act published in Official Journal summary: 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. docs: title: Decision 2012/837 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012D0837 title: OJ L 359 29.12.2012, p. 0001 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2012:359:TOC
other	body: EC dg: url: http://ec.europa.eu/trade/ title: Trade commissioner: DE GUCHT Karel
procedure/Modified legal basis	Old Rules of Procedure of the European Parliament EP 150 New Rules of Procedure EP 150
procedure/dossier_of_the_committee	Old INTA/7/03045 New INTA/7/03045
procedure/final/url	Old http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012D0837 New https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012D0837
procedure/subject	Old 2.10.03 Standardisation, EC standards and trademark, certification, compliance 6.20.03 Bilateral economic and trade agreements and relations New 2.10.03 Standardisation, EC/EU standards and trade mark, certification, compliance 6.20.03 Bilateral economic and trade agreements and relations

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activities	date: 2010-05-31T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf celexid: CELEX:52010PC0270:EN type: Initial legislative proposal published title: COM(2010)0270 type: Initial legislative proposal published body: EC commission: DG: url: http://ec.europa.eu/trade/ title: Trade Commissioner: DE GUCHT Karel date: 2011-07-13T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=12124%2F10&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC type: Legislative proposal published title: 12124/2010 type: Legislative proposal published body: EC commission: DG: url: http://ec.europa.eu/trade/ title: Trade Commissioner: DE GUCHT Karel date: 2012-03-13T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP shadows: group: PPE name: FJELLNER Christofer group: ALDE name: KAZAK Metin responsible: True committee: INTA date: 2010-06-23T00:00:00 committee_full: International Trade rapporteur: group: S&D name: MOREIRA Vital date: 2012-06-21T00:00:00 body: EP type: Vote in committee, 1st reading/single reading committees: body: EP shadows: group: PPE name: FJELLNER Christofer group: ALDE name: KAZAK Metin responsible: True committee: INTA date: 2010-06-23T00:00:00 committee_full: International Trade rapporteur: group: S&D name: MOREIRA Vital body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2012-211&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A7-0211/2012 type: Committee report tabled for plenary, 1st reading/single reading committees: body: EP shadows: group: PPE name: FJELLNER Christofer group: ALDE name: KAZAK Metin responsible: True committee: INTA date: 2010-06-23T00:00:00 committee_full: International Trade rapporteur: group: S&D name: MOREIRA Vital date: 2012-06-25T00:00:00 date: 2012-09-12T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=21793&l=en type: Results of vote in Parliament title: Results of vote in Parliament url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-330 type: Decision by Parliament, 1st reading/single reading title: T7-0330/2012 body: EP type: Results of vote in Parliament date: 2012-11-13T00:00:00 body: CSL type: Council Meeting council: Economic and Financial Affairs ECOFIN meeting_id: 3198 date: 2012-11-13T00:00:00 body: EP type: End of procedure in Parliament date: 2012-11-13T00:00:00 body: EP/CSL type: Act adopted by Council after consultation of Parliament date: 2012-12-29T00:00:00 type: Final act published in Official Journal docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012D0837 title: Decision 2012/837 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2012:359:TOC title: OJ L 359 29.12.2012, p. 0001
committees	body: EP shadows: group: PPE name: FJELLNER Christofer group: ALDE name: KAZAK Metin responsible: True committee: INTA date: 2010-06-23T00:00:00 committee_full: International Trade rapporteur: group: S&D name: MOREIRA Vital
links	National parliaments url: http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=EN title: IPEX European Commission url: http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=NLE&DocYear=2010&DocNum=0146 title: PreLex
other	body: EC dg: url: http://ec.europa.eu/trade/ title: Trade commissioner: DE GUCHT Karel
procedure	dossier_of_the_committee INTA/7/03045 geographical_area Australia reference 2010/0146(NLE) instrument Decision legal_basis Treaty on the Functioning of the EU TFEU 207-p4 Treaty on the Functioning of the EU TFEU 218-p6a stage_reached Procedure completed subtype Consent by Parliament Modified legal basis Rules of Procedure of the European Parliament EP 150 title EU/Australia Agreement: mutual recognition in relation to conformity assessment, certificates and markings (amendment) type NLE - Non-legislative enactments final url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012D0837 title: Decision 2012/837 subject 2.10.03 Standardisation, EC standards and trademark, certification, compliance 6.20.03 Bilateral economic and trade agreements and relations

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