Progress: Procedure completed
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | INTA |
MOREIRA Vital ( S&D)
|
FJELLNER Christofer ( PPE),
KAZAK Metin ( ALDE)
|
Lead committee dossier:
Legal Basis:
TFEU 207-p4, TFEU 218-p6a
Legal Basis:
TFEU 207-p4, TFEU 218-p6aSubjects
Events
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products GMP (Good Manufacturing Practices) inspection and batch certification and on medical devices have been superseded by changes in technical and administrative practice and by changes in the organisations listed therein, and the opportunity has been taken to revise them.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.
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.
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.
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.
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.
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.
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
- 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: T7-0330/2012
- Committee report tabled for plenary, 1st reading/single reading: A7-0211/2012
- Legislative proposal: 12124/2010
- Document attached to the procedure: 12150/2010
- Legislative proposal published: 12124/2010
- Committee draft report: PE450.683
- Preparatory document: COM(2010)0270
- Preparatory document: EUR-Lex
- Preparatory document: COM(2010)0270
- Preparatory document: EUR-Lex
- Preparatory document: COM(2010)0270 EUR-Lex
- Committee draft report: PE450.683
- Legislative proposal: 12124/2010
- Document attached to the procedure: 12150/2010
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.pdfNew
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2010/0270/COM_COM(2010)0270_EN.pdf |
| docs/2 |
|
| events/1/date |
Old
2011-07-13T00:00:00New
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=ENNew
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.pdfNew
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=PE450.683New
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.pdfNew
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 readingNew
Committee referral announced in Parliament |
| events/3/type |
Old
Vote in committee, 1st reading/single readingNew
Vote in committee |
| events/4/docs/0/url |
Old
http://www.europarl.europa.eu/doceo/document/A-7-2012-0211_EN.htmlNew
https://www.europarl.europa.eu/doceo/document/A-7-2012-0211_EN.html |
| events/6 |
|
| events/6 |
|
| procedure/Modified legal basis |
Rules of Procedure EP 159
|
| procedure/Other legal basis |
Rules of Procedure EP 159
|
| committees/0 |
|
| committees/0 |
|
| docs/0/type |
Old
Initial legislative proposalNew
Preparatory document |
| events/0 |
|
| events/0 |
|
| events/4/docs/0/url |
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2012-211&language=ENNew
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-2012-330New
http://www.europarl.europa.eu/doceo/document/TA-7-2012-0330_EN.html |
| procedure/Modified legal basis |
Old
Rules of Procedure EP 150New
Rules of Procedure EP 159 |
| activities |
|
| commission |
|
| committees/0 |
|
| committees/0 |
|
| council |
|
| docs |
|
| events |
|
| other |
|
| procedure/Modified legal basis |
Old
Rules of Procedure of the European Parliament EP 150New
Rules of Procedure EP 150 |
| procedure/dossier_of_the_committee |
Old
INTA/7/03045New
|
| procedure/final/url |
Old
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012D0837New
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012D0837 |
| procedure/subject |
Old
New
|
| links/European Commission/title |
Old
PreLexNew
EUR-Lex |
| activities |
|
| committees |
|
| links |
|
| other |
|
| procedure |
|