Guide to the implementation of directives based on the New ...

More documents

Recommendations

Info

❝ Market surveillance ❞ No 515/97 on mutual assistance between <strong>the</strong> administrative authorities <strong>of</strong> <strong>the</strong> Member States and cooperation between <strong>the</strong> latter and <strong>the</strong> Commission <strong>to</strong> ensure correct application <strong>of</strong> <strong>the</strong> law on cus<strong>to</strong>ms and agricultural matters are applicable as appropriate. This is <strong>the</strong> case, in particular, where <strong>the</strong> endorsement ‘Dangerous product — release for free circulation not authorised — Regulation (EEC) No 339/93’ or ‘Product not in conformity — release for free circulation not authorised — Regulation (EEC) No 339/93’ are added <strong>to</strong> <strong>the</strong> commercial invoice and <strong>to</strong> any o<strong>the</strong>r relevant document accompanying products imported from third countries. 61
9. External aspects 9.1. Agreement on <strong>the</strong> European Economic Area ● The Agreement on <strong>the</strong> European Economic Area is established between <strong>the</strong> European Community and Iceland, Liechtenstein and Norway. The Agreement extends <strong>the</strong> single market <strong>to</strong> <strong>the</strong>se three EFTA States. experts <strong>of</strong> <strong>the</strong>se States in <strong>the</strong> same way as it seeks advice from experts <strong>of</strong> <strong>the</strong> Member States. As regards <strong>the</strong> committees assisting <strong>the</strong> Commission in its work, close cooperation has been established. The EEA Council meets biannually, and <strong>the</strong> EEA Joint Parliamentary Committee and <strong>the</strong> EEA Consultative Committee regularly. 9.1.1. Basic elements <strong>of</strong> <strong>the</strong> Agreement The Agreement on <strong>the</strong> European Economic Area, in force since 1 January 1994, covers all New Approach <strong>directives</strong>, and o<strong>the</strong>r Community legislation and acquis relevant <strong>to</strong> <strong>the</strong> free circulation <strong>of</strong> products. Hence, it extends <strong>the</strong> single market <strong>to</strong> <strong>the</strong> so-called EEA EFTA States: Iceland, Liechtenstein and Norway. The objective <strong>of</strong> <strong>the</strong> EEA Agreement is <strong>to</strong> establish a dynamic and homogeneous European Economic Area, <strong>based</strong> on common rules and equal conditions <strong>of</strong> competition. The Agreement is amended on a continuous basis through decisions <strong>of</strong> <strong>the</strong> EEA Joint Committee following changes in relevant Community legislation. To arrive at and maintain a uniform interpretation and application <strong>of</strong> <strong>the</strong> Agreement an EFTA Court and an EFTA Surveillance Authority have been established. Rights conferred and obligations imposed upon <strong>the</strong> Member States, or <strong>the</strong>ir public entities, undertakings, or individuals in relation <strong>to</strong> each o<strong>the</strong>r, are, according <strong>to</strong> <strong>the</strong> EEA Agreement, unders<strong>to</strong>od <strong>to</strong> be conferred or imposed in <strong>the</strong> same way also upon <strong>the</strong> EEA EFTA States. This ensures that <strong>the</strong> EEA EFTA States, and <strong>the</strong>ir economic opera<strong>to</strong>rs, are subject <strong>to</strong> <strong>the</strong> same rights and obligations as <strong>the</strong>ir counterparts in <strong>the</strong> Community. For instance, <strong>the</strong> New Approach <strong>directives</strong> are applied in exactly <strong>the</strong> same way in <strong>the</strong> EEA EFTA States as in <strong>the</strong> Member States — although <strong>the</strong> administrative procedures concerning notification bodies and <strong>the</strong> safeguard clause are modified. Therefore, all guidance applicable <strong>to</strong> <strong>the</strong> Member States according <strong>to</strong> this <strong>Guide</strong> applies also <strong>to</strong> <strong>the</strong> EEA EFTA States. For <strong>the</strong> purpose <strong>of</strong> <strong>the</strong> EEA Agreement references <strong>to</strong> <strong>the</strong> Community or <strong>the</strong> common market in <strong>the</strong> EU/EEA acts are unders<strong>to</strong>od <strong>to</strong> be references <strong>to</strong> <strong>the</strong> terri<strong>to</strong>ries <strong>of</strong> <strong>the</strong> Contracting Parties. Accordingly, a product is not only placed on <strong>the</strong> Community market, but on <strong>the</strong> EEA market. The EEA Agreement ensures a close cooperation between <strong>the</strong> Commission and <strong>the</strong> administration <strong>of</strong> <strong>the</strong> EEA EFTA States. The Commission seeks informal advice from 9.1.2. Notification <strong>of</strong> bodies Procedures for notification <strong>of</strong> conformity assessment bodies from <strong>the</strong> EEA EFTA States have been established <strong>based</strong> on provisions <strong>of</strong> <strong>the</strong> EEA Agreement. The request for allocation <strong>of</strong> an identification number is first presented <strong>to</strong> <strong>the</strong> EFTA Secretariat, applying <strong>the</strong> same notification form as in <strong>the</strong> Community. The Secretariat verifies its formal correctness and transmits <strong>the</strong> application <strong>to</strong> <strong>the</strong> Commission with a request for an identification number (or for an extension <strong>of</strong> <strong>the</strong> use <strong>of</strong> <strong>the</strong> identification number <strong>to</strong> new <strong>directives</strong>/tasks). The Commission allocates <strong>the</strong> number and communicates it via <strong>the</strong> Secretariat <strong>to</strong> <strong>the</strong> notifying country. After this <strong>the</strong> EEA EFTA State makes a formal notification <strong>to</strong> <strong>the</strong> o<strong>the</strong>r EEA EFTA States, <strong>the</strong> EFTA Surveillance Authority and <strong>the</strong> Secretariat. The Surveillance Authority examines <strong>the</strong> notification and informs <strong>the</strong> Commission, which keeps an updated list <strong>of</strong> notified bodies from <strong>the</strong> Member States and <strong>the</strong> EEA EFTA States, and publishes it in <strong>the</strong> Official Journal. When a notified body ceases <strong>to</strong> fulfil <strong>the</strong> requirements or its obligations, <strong>the</strong> EEA EFTA State has <strong>the</strong> responsibility <strong>to</strong> withdraw <strong>the</strong> notification. The Member State must also publish this information, and inform <strong>the</strong> o<strong>the</strong>r EEA EFTA States, <strong>the</strong> EFTA Surveillance Authority and <strong>the</strong> Secretariat. The Surveillance Authority informs <strong>the</strong> Commission about <strong>the</strong> withdrawal, which will <strong>the</strong>n update <strong>the</strong> list <strong>of</strong> notified bodies. 9.1.3. Safeguard clause procedure The EFTA Surveillance Authority is responsible for <strong>the</strong> examination <strong>of</strong> <strong>the</strong> safeguard clause notifications from <strong>the</strong> EEA EFTA States. The Authority consults all parties concerned and exchanges information with <strong>the</strong> Commission on <strong>the</strong> proceedings <strong>of</strong> <strong>the</strong> case. The Authority transmits its decision <strong>to</strong> <strong>the</strong> EEA EFTA States and <strong>the</strong> Commission for fur<strong>the</strong>r actions. If an EEA EFTA State does not follow <strong>the</strong> decision, <strong>the</strong> Surveillance Authority can initiate an infringement procedure. In cases where a Member State triggers a safeguard 62
Page 1 and 2:
Guide to</
Page 3 and 4:
This document is available on <stro
Page 5 and 6:
IMPORTANT NOTICE This Guide
Page 7 and 8:
❝ Guide
Page 9 and 10:
❝ Guide
Page 11 and 12: ❝ Guide
Page 16 and 17: 2. Scope of New Ap
Page 18 and 19: ❝ Scope of New A
Page 20 and 21: ❝ Scope of New A
Page 22 and 23: 3. Responsibilities The manufacture
Page 24 and 25: ❝ Responsibilities ❞ administra
Page 26 and 27: ❝ Responsibilities ❞ Many produ
Page 28 and 29: 4. Compliance with directiv
Page 30 and 31: ❝ Compliance with directi
Page 32 and 33: 5. Conformity assessment procedure
Page 34 and 35: ❝ Conformity assessment procedure
Page 36 and 37: ❝ Conformity assessment procedure
Page 38 and 39: ❝ Notified bodies ❞ Table 6/1
Page 40 and 41: ❝ Notified bodies ❞ national le
Page 42 and 43: ❝ Notified bodies ❞ Notified bo
Page 44 and 45: ❝ Notified bodies ❞ The coordin
Page 46 and 47: ❝ CE marking ❞ ● the<
Page 48 and 49: 8. Market surveillance Enforcement
Page 50 and 51: ❝ Market surveillance ❞ Althoug
Page 52 and 53: ❝ Market surveillance ❞ conform
Page 54 and 55: ❝ Market surveillance ❞ fall wi
Page 56 and 57: ❝ Market surveillance ❞ product
Page 58 and 59: ❝ Market surveillance ❞ 8.6.1.
Page 60 and 61: ❝ Market surveillance ❞ mission
Page 64 and 65: ❝ External aspects ❞ clause, co
Page 66: ❝ External aspects ❞ place, ass
Page 113:
❝ Guide
Page 118:
8 6 2 CO-22-99-014-EN-C EUR OFFICE
show all

Guide to the implementation of directives based on the New ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?