BETA


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

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead INTA MOREIRA Vital (icon: S&D S&D) FJELLNER Christofer (icon: PPE PPE), KAZAK Metin (icon: ALDE ALDE)
Lead committee dossier:
Legal Basis:
TFEU 207-p4, TFEU 218-p6a

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products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them.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

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
2012/09/12
   EP - Decision by Parliament
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
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
2012/06/21
   EP - Vote in committee
2012/03/13
   EP - Committee referral announced in Parliament
2011/07/13
   CSL - Legislative proposal
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.

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.

Documents
2011/07/13
   CSL - Document attached to the procedure
Documents
2011/07/12
   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.

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.

Documents
2010/10/08
   EP - Committee draft report
Documents
2010/06/23
   EP - MOREIRA Vital (S&D) appointed as rapporteur in INTA
2010/05/31
   EC - Preparatory document
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) 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.

2010/05/31
   EP - Preparatory document
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) 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.

Documents

History

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

docs/0/docs/0/url
Old
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf
New
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf
docs/2
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 title: 12124/2010
summary
type
Legislative proposal
body
CSL
events/1/date
Old
2011-07-13T00:00:00
New
2011-07-12T00:00:00
links/National parliaments/url
Old
http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=NLE&year=2010&number=0146&appLng=EN
New
https://ipexl.europarl.europa.eu/IPEXL-WEB/dossier/code=NLE&year=2010&number=0146&appLng=EN
docs/0/docs/0/url
Old
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf
New
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf
docs/1/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.683
New
https://www.europarl.europa.eu/doceo/document/INTA-PR-450683_EN.html
events/0/docs/0/url
Old
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf
New
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf
events/2/type
Old
Committee referral announced in Parliament, 1st reading/single reading
New
Committee referral announced in Parliament
events/3/type
Old
Vote in committee, 1st reading/single reading
New
Vote in committee
events/4/docs/0/url
Old
http://www.europarl.europa.eu/doceo/document/A-7-2012-0211_EN.html
New
https://www.europarl.europa.eu/doceo/document/A-7-2012-0211_EN.html
events/6
date
2012-09-12T00:00:00
type
Decision by Parliament
body
EP
docs
url: https://www.europarl.europa.eu/doceo/document/TA-7-2012-0330_EN.html title: T7-0330/2012
summary
events/6
date
2012-09-12T00:00:00
type
Decision by Parliament, 1st reading/single reading
body
EP
docs
url: http://www.europarl.europa.eu/doceo/document/TA-7-2012-0330_EN.html title: T7-0330/2012
summary
procedure/Modified legal basis
Rules of Procedure EP 159
procedure/Other legal basis
Rules of Procedure EP 159
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
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
docs/0/type
Old
Initial legislative proposal
New
Preparatory document
events/0
date
2010-05-31T00:00:00
type
Preparatory document
body
EP
docs
summary
events/0
date
2010-05-31T00:00:00
type
Initial legislative proposal published
body
EC
docs
summary
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
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
committees/0
body
EP
shadows
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
links/European Commission/title
Old
PreLex
New
EUR-Lex
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
European Commission
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
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
subject