# Official Journal C 103/28 A

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 103 |
| | |
| English edition | Information and Notices | Volume 4828 April 2005 |

ISSN 1725-2423

Official Journal

of the European Union

C 103

English edition

Information and Notices

Volume 4828 April 2005

---

| Notice No | Contents | page |
| --- | --- | --- |
| | I   Information |
| | Commission |
| 2005/C 103/1 | Euro exchange rates | 1 |
| 2005/C 103/2 | Commission communication in the framework of the implementation of Council Directive 93/42/EEC (
  1
  ) | 2 |
| 2005/C 103/3 | Commission communication in the framework of the implementation of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (
  1
  ) | 11 |
| 2005/C 103/4 | Communication from the French Government concerning Directive 94/22/EC of the European Parliament and of the Council of 30 May 1994 on the conditions for granting and using authorisations for the prospection, exploration and production of hydrocarbons (Notice regarding an application for an exclusive licence to prospect for liquid and gaseous hydrocarbons, designated the Carret Licence)
   (
  1
  ) | 14 |
| 2005/C 103/5 | Invitation to submit an application for authorisation to prospect for hydrocarbons in the area covered by the former Oosterwolde and Haulerwijk drilling permits on Dutch territory (
  1
  ) | 16 |
| 2005/C 103/6 | Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections (
  1
  ) | 17 |
| 2005/C 103/7 | Notice of initiation of an anti-dumping proceeding concerning imports of lever arch mechanisms originating in the People's Republic of China | 18 |
| 2005/C 103/8 | Prior notification of a concentration (Case COMP/M.3800 — BC Partners/Dometic) — Candidate case for simplified procedure (
  1
  ) | 22 |
| 2005/C 103/9 | Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections (
  1
  ) | 23 |
| | EUROPEAN ECONOMIC AREA |
| | EFTA Surveillance Authority |
| 2005/C 103/0 | 45th amendment of the State aid guidelines — EFTA Surveillance Authority decision to propose appropriate measures | 24 |
| 2005/C 103/1 | Authorisation of State aid pursuant to Article 61 of the EEA Agreement and Article 1(3) in Part I of Protocol 3 to the Surveillance and Court Agreement — The EFTA Surveillance Authority has decided that the notified measure is compatible with the EEA Agreement | 25 |
| 2005/C 103/2 | State aid — Norway — Notice by the EFTA Surveillance Authority to EFTA States, EU Member States and other interested parties — State aid measure 47875 (former SAM 030.03001) — Proposed aid scheme to utilise energy from final waste treatment plants | 26 |
| | EFTA Court |
| 2005/C 103/3 | Request for an Advisory Opinion from the EFTA Court by Markedsrådet by decision of that court of 7 July 2004 in the case of Pedicel AS v Sosial- og helsedirektoratet (Case E-4/04) | 27 |
| 2005/C 103/4 | Judgment of the Court of 5 May 2004 in Case E-4/03: EFTA Surveillance Authority v the Kingdom of Norway (Failure of a Contracting Party to fulfil its obligations — Article 8 of Directive 98/34/EC) | 28 |

Notice No

Contents

page

I   Information

Commission

2005/C 103/1

Euro exchange rates

1

2005/C 103/2

Commission communication in the framework of the implementation of Council Directive 93/42/EEC (
  1
  )

1

2

2005/C 103/3

Commission communication in the framework of the implementation of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (
  1
  )

1

11

2005/C 103/4

Communication from the French Government concerning Directive 94/22/EC of the European Parliament and of the Council of 30 May 1994 on the conditions for granting and using authorisations for the prospection, exploration and production of hydrocarbons (Notice regarding an application for an exclusive licence to prospect for liquid and gaseous hydrocarbons, designated the Carret Licence)
   (
  1
  )

(Notice regarding an application for an exclusive licence to prospect for liquid and gaseous hydrocarbons, designated the Carret Licence)

1

14

2005/C 103/5

Invitation to submit an application for authorisation to prospect for hydrocarbons in the area covered by the former Oosterwolde and Haulerwijk drilling permits on Dutch territory (
  1
  )

1

16

2005/C 103/6

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections (
  1
  )

1

17

2005/C 103/7

Notice of initiation of an anti-dumping proceeding concerning imports of lever arch mechanisms originating in the People's Republic of China

18

2005/C 103/8

Prior notification of a concentration (Case COMP/M.3800 — BC Partners/Dometic) — Candidate case for simplified procedure (
  1
  )

1

22

2005/C 103/9

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections (
  1
  )

1

23

EUROPEAN ECONOMIC AREA

EFTA Surveillance Authority

2005/C 103/0

45th amendment of the State aid guidelines — EFTA Surveillance Authority decision to propose appropriate measures

24

2005/C 103/1

Authorisation of State aid pursuant to Article 61 of the EEA Agreement and Article 1(3) in Part I of Protocol 3 to the Surveillance and Court Agreement — The EFTA Surveillance Authority has decided that the notified measure is compatible with the EEA Agreement

25

2005/C 103/2

State aid — Norway — Notice by the EFTA Surveillance Authority to EFTA States, EU Member States and other interested parties — State aid measure 47875 (former SAM 030.03001) — Proposed aid scheme to utilise energy from final waste treatment plants

26

EFTA Court

2005/C 103/3

Request for an Advisory Opinion from the EFTA Court by Markedsrådet by decision of that court of 7 July 2004 in the case of Pedicel AS v Sosial- og helsedirektoratet (Case E-4/04)

27

2005/C 103/4

Judgment of the Court of 5 May 2004 in Case E-4/03: EFTA Surveillance Authority v the Kingdom of Norway (Failure of a Contracting Party to fulfil its obligations — Article 8 of Directive 98/34/EC)

v

(Failure of a Contracting Party to fulfil its obligations — Article 8 of Directive 98/34/EC)

28

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

---

(1)   Text with EEA relevance

1

| EN | |
| --- | --- |

EN

---

I Information

Commission

| 28.4.2005 | EN | Official Journal of the European Union | C 103/1 |
| --- | --- | --- | --- |

28.4.2005

EN

Official Journal of the European Union

C 103/1

---

Euro exchange rates (1)

27 April 2005

(2005/C 103/01)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2920 |
| JPY | Japanese yen | 137,35 |
| DKK | Danish krone | 7,4472 |
| GBP | Pound sterling | 0,67960 |
| SEK | Swedish krona | 9,1403 |
| CHF | Swiss franc | 1,5434 |
| ISK | Iceland króna | 82,36 |
| NOK | Norwegian krone | 8,1270 |
| BGN | Bulgarian lev | 1,9559 |
| CYP | Cyprus pound | 0,5820 |
| CZK | Czech koruna | 30,225 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 249,52 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,6961 |
| MTL | Maltese lira | 0,4294 |
| PLN | Polish zloty | 4,2197 |
| ROL | Romanian leu | 36 160 |
| SIT | Slovenian tolar | 239,61 |
| SKK | Slovak koruna | 39,620 |
| TRY | Turkish lira | 1,7763 |
| AUD | Australian dollar | 1,6654 |
| CAD | Canadian dollar | 1,6121 |
| HKD | Hong Kong dollar | 10,0761 |
| NZD | New Zealand dollar | 1,7917 |
| SGD | Singapore dollar | 2,1290 |
| KRW | South Korean won | 1 295,75 |
| ZAR | South African rand | 7,8992 |
| CNY | Chinese yuan renminbi | 10,6932 |
| HRK | Croatian kuna | 7,3750 |
| IDR | Indonesian rupiah | 12 351,52 |
| MYR | Malaysian ringgit | 4,910 |
| PHP | Philippine peso | 70,253 |
| RUB | Russian rouble | 35,9250 |
| THB | Thai baht | 51,143 |

Currency

Exchange rate

USD

US dollar

1,2920

JPY

Japanese yen

137,35

DKK

Danish krone

7,4472

GBP

Pound sterling

0,67960

SEK

Swedish krona

9,1403

CHF

Swiss franc

1,5434

ISK

Iceland króna

82,36

NOK

Norwegian krone

8,1270

BGN

Bulgarian lev

1,9559

CYP

Cyprus pound

0,5820

CZK

Czech koruna

30,225

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

249,52

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,6961

MTL

Maltese lira

0,4294

PLN

Polish zloty

4,2197

ROL

Romanian leu

36 160

SIT

Slovenian tolar

239,61

SKK

Slovak koruna

39,620

TRY

Turkish lira

1,7763

AUD

Australian dollar

1,6654

CAD

Canadian dollar

1,6121

HKD

Hong Kong dollar

10,0761

NZD

New Zealand dollar

1,7917

SGD

Singapore dollar

2,1290

KRW

South Korean won

1 295,75

ZAR

South African rand

7,8992

CNY

Chinese yuan renminbi

10,6932

HRK

Croatian kuna

7,3750

IDR

Indonesian rupiah

12 351,52

MYR

Malaysian ringgit

4,910

PHP

Philippine peso

70,253

RUB

Russian rouble

35,9250

THB

Thai baht

51,143

---

(1)

Source: reference exchange rate published by the ECB.

---

| 28.4.2005 | EN | Official Journal of the European Union | C 103/2 |
| --- | --- | --- | --- |

28.4.2005

EN

Official Journal of the European Union

C 103/2

---

Commission communication in the framework of the implementation of Council Directive 93/42/EEC

(2005/C 103/02)

(Text with EEA relevance)

(Publication of titles and references of harmonized standards under the directive)

| European Standardisation Organisation | Reference and title of the standard
  (and reference document) | Reference of the superseded standard | Date of cessation of presumption of conformity of the superseded standard
  Note 1 |
| --- | --- | --- | --- |
| CEN/CENELEC | EN 46003:1999
  Quality systems — Medical devices — Particular requirements for the application of EN ISO 9003 | None | — |
| CENELEC | EN 60118-13:1997
  Hearing aids — Part 13: Electromagnetic compatibility (EMC)
  (IEC 60118-13:1997) | None | — |
| CENELEC | EN 60522:1999
  Determination of the permanent filtration of X-ray tube assemblies
  (IEC 60522:1999) | None | — |
| CENELEC | EN 60580:2000
  Medical electrical equipment — Dose area product meters
  (IEC 60580:2000) | None | — |
| CENELEC | EN 60601-1:1990
  Medical electrical equipment — Part 1: General requirements for safety
  (IEC 60601-1:1988) | None | — |
| Amendment A1:1993 to EN 60601-1:1990
  (IEC 60601-1:1988/A1:1991) | Note 3 | — |
| Amendment A2:1995 to EN 60601-1:1990
  (IEC 60601-1:1988/A2:1995) | Note 3 | — |
| Amendment A13:1996 to EN 60601-1:1990 | Note 3 | Date expired (1.7.1996) |
| CENELEC | EN 60601-1-1:2001
  Medical electrical equipment — Part 1-1: General requirements for safety — Collateral standard: Safety requirements for medical electrical systems
  (IEC 60601-1-1:2000) | EN 60601-1-1:1993
  +A1:1996
  Note 2.1 | Date expired (1.12.2003) |
| CENELEC | EN 60601-1-2:2001
  Medical electrical equipment — Part 1-2: General requirements for safety — Collateral standard: Electromagnetic compatibility — Requirements and tests
  (IEC 60601-1-2:2001) | EN 60601-1-2:1993
  Note 2.1 | Date expired (1.11.2004) |
| CENELEC | EN 60601-1-3:1994
  Medical electrical equipment — Part 1: General requirements for safety — 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
  (IEC 60601-1-3:1994) | None | — |
| CENELEC | EN 60601-1-4:1996
  Medical electrical equipment — Part 1-4: General requirements for safety — Collateral standard: Programmable electrical medical systems
  (IEC 60601-1-4:1996) | None | — |
| Amendment A1:1999 to EN 60601-1-4:1996
  (IEC 60601-1-4:1996/A1:1999) | Note 3 | Date expired (1.12.2002) |
| CENELEC | EN 60601-2-1:1998
  Medical electrical equipment — Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV
  (IEC 60601-2-1:1998) | None | — |
| Amendment A1:2002 to EN 60601-2-1:1998
  (IEC 60601-2-1:1998/A1:2002) | Note 3 | 1.6.2005 |
| CENELEC | EN 60601-2-2:2000
  Medical electrical equipment — Part 2-2: Particular requirements for the safety of high frequency surgical equipment
  (IEC 60601-2-2:1998) | EN 60601-2-2:1993
  Note 2.1 | Date expired (1.8.2003) |
| CENELEC | EN 60601-2-3:1993
  Medical electrical equipment — Part 2: Particular requirements for the safety of short-wave therapy equipment
  (IEC 60601-2-3:1991) | None | — |
| Amendment A1:1998 to EN 60601-2-3:1993
  (IEC 60601-2-3:1991/A1:1998) | Note 3 | Date expired (1.7.2001) |
| CENELEC | EN 60601-2-4:2003
  Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac defibrillators
  (IEC 60601-2-4:2002) | None | — |
| CENELEC | EN 60601-2-5:2000
  Medical electrical equipment — Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
  (IEC 60601-2-5:2000) | None | — |
| CENELEC | EN 60601-2-7:1998
  Medical electrical equipment — Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
  (IEC 60601-2-7:1998) | None | — |
| CENELEC | EN 60601-2-8:1997
  Medical electrical equipment — Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
  (IEC 60601-2-8:1987) | None | — |
| Amendment A1:1997 to EN 60601-2-8:1997
  (IEC 60601-2-8:1987/A1:1997) | Note 3 | Date expired (1.6.1998) |
| CENELEC | EN 60601-2-9:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors
  (IEC 60601-2-9:1996) | None | — |
| CENELEC | EN 60601-2-10:2000
  Medical electrical equipment — Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
  (IEC 60601-2-10:1987) | None | — |
| Amendment A1:2001 to EN 60601-2-10:2000
  (IEC 60601-2-10:1987/A1:2001) | Note 3 | Date expired (1.11.2004) |
| CENELEC | EN 60601-2-11:1997
  Medical electrical equipment — Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
  (IEC 60601-2-11:1997) | None | — |
| CENELEC | EN 60601-2-16:1998
  Medical electrical equipment — Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
  (IEC 60601-2-16:1998) | None | — |
| CENELEC | EN 60601-2-17:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment
  (IEC 60601-2-17:1989) | None | — |
| Amendment A1:1996 to EN 60601-2-17:1996
  (IEC 60601-2-17:1989/A1:1996) | Note 3 | Date expired (1.3.1997) |
| CENELEC | EN 60601-2-17:2004
  Medical electrical equipment — Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
  (IEC 60601-2-17:2004) | EN 60601-2-17:1996 and its amendment
  Note 2.1 | 1.3.2007 |
| CENELEC | EN 60601-2-18:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of endoscopic equipment
  (IEC 60601-2-18:1996) | None | — |
| Amendment A1:2000 to EN 60601-2-18:1996
  (IEC 60601-2-18:1996/A1:2000) | Note 3 | Date expired (1.8.2003) |
| CENELEC | EN 60601-2-19:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of baby incubators
  (IEC 60601-2-19:1990) | None | — |
| Amendment A1:1996 to EN 60601-2-19:1996
  (IEC 60601-2-19:1990/A1:1996) | Note 3 | Date expired (13.6.1998) |
| CENELEC | EN 60601-2-20:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of transport incubators
  (IEC 60601-2-20:1990 + A1:1996) | None | — |
| CENELEC | EN 60601-2-21:1994
  Medical electrical equipment — Part 2: Particular requirements for the safety of infant radiant warmers
  (IEC 60601-2-21:1994) | None | — |
| Amendment A1:1996 to EN 60601-2-21:1994
  (IEC 60601-2-21:1994/A1:1996) | Note 3 | Date expired (13.6.1998) |
| CENELEC | EN 60601-2-22:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
  (IEC 60601-2-22:1995) | None | — |
| CENELEC | EN 60601-2-23:2000
  Medical electrical equipment — Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
  (IEC 60601-2-23:1999) | EN 60601-2-23:1997
  Note 2.1 | Date expired (1.1.2003) |
| CENELEC | EN 60601-2-24:1998
  Medical electrical equipment — Part 2-24: Particular requirements for the safety of infusion pumps and controllers
  (IEC 60601-2-24:1998) | None | — |
| CENELEC | EN 60601-2-25:1995
  Medical electrical equipment — Part 2-25: Particular requirements for the safety of electrocardiographs
  (IEC 60601-2-25:1993) | None | — |
| Amendment A1:1999 to EN 60601-2-25:1995
  (IEC 60601-2-25:1993/A1:1999) | Note 3 | Date expired (1.5.2002) |
| CENELEC | EN 60601-2-26:1994
  Medical electrical equipment — Part 2: Particular requirements for the safety of electroencephalographs
  (IEC 60601-2-26:1994) | None | — |
| CENELEC | EN 60601-2-26:2003
  Medical electrical equipment — Part 2-26: Particular requirements for the safety of electroencephalographs
  (IEC 60601-2-26:2002) | EN 60601-2-26:1994
  Note 2.1 | 1.3.2006 |
| CENELEC | EN 60601-2-27:1994
  Medical electrical equipment — Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment
  (IEC 60601-2-27:1994) | None | — |
| CENELEC | EN 60601-2-28:1993
  Medical electrical equipment — Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
  (IEC 60601-2-28:1993) | None | — |
| CENELEC | EN 60601-2-29:1999
  Medical electrical equipment — Part 2-29: Particular requirements for the safety of radiotherapy simulators
  (IEC 60601-2-29:1999) | EN 60601-2-29:1995
  +A1:1996
  Note 2.1 | Date expired (1.4.2002) |
| CENELEC | EN 60601-2-30:2000
  Medical electrical equipment — Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
  (IEC 60601-2-30:1999) | EN 60601-2-30:1995
  Note 2.1 | Date expired (1.2.2003) |
| CENELEC | EN 60601-2-31:1995
  Medical electrical equipment — Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
  (IEC 60601-2-31:1994) | None | — |
| Amendment A1:1998 to EN 60601-2-31:1995
  (IEC 60601-2-31:1994/A1:1998) | Note 3 | Date expired (1.1.2001) |
| CENELEC | EN 60601-2-32:1994
  Medical electrical equipment — Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
  (IEC 60601-2-32:1994) | None | — |
| CENELEC | EN 60601-2-33:1995
  Medical electrical equipment — Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
  (IEC 60601-2-33:1995) | None | — |
| Amendment A11:1997 to EN 60601-2-33:1995 | Note 3 | Date expired (13.6.1998) |
| CENELEC | EN 60601-2-33:2002
  Medical electrical equipment — Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
  (IEC 60601-2-33:2002) | EN 60601-2-33:1995 and its amendment
  Note 2.1 | 1.7.2005 |
| CENELEC | EN 60601-2-34:2000
  Medical electrical equipment — Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
  (IEC 60601-2-34:2000) | EN 60601-2-34:1995
  Note 2.1 | Date expired (1.11.2003) |
| CENELEC | EN 60601-2-35:1996
  Medical electrical equipment — Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use
  (IEC 60601-2-35:1996) | None | — |
| CENELEC | EN 60601-2-36:1997
  Medical electrical equipment — Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
  (IEC 60601-2-36:1997) | None | — |
| CENELEC | EN 60601-2-37:2001
  Medical electrical equipment — Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
  (IEC 60601-2-37:2001) | None | — |
| CENELEC | EN 60601-2-38:1996
  Medical electrical equipment — Part 2-38: Particular requirements for the safety of electrically operated hospital beds
  (IEC 60601-2-38:1996) | None | — |
| Amendment A1:2000 to EN 60601-2-38:1996
  (IEC 60601-2-38:1996/A1:1999) | Note 3 | Date expired (1.1.2003) |
| CENELEC | EN 60601-2-39:1999
  Medical electrical equipment — Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment
  (IEC 60601-2-39:1999) | None | — |
| CENELEC | EN 60601-2-40:1998
  Medical electrical equipment — Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
  (IEC 60601-2-40:1998) | None | — |
| CENELEC | EN 60601-2-41:2000
  Medical electrical equipment — Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis
  (IEC 60601-2-41:2000) | None | — |
| CENELEC | EN 60601-2-43:2000
  Medical electrical equipment — Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
  (IEC 60601-2-43:2000) | None | — |
| CENELEC | EN 60601-2-44:2001
  Medical electrical equipment — Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography
  (IEC 60601-2-44:2001) | EN 60601-2-44:1999
  Note 2.1 | Date expired (1.7.2004) |
| Amendment A1:2003 to EN 60601-2-44:2001
  (IEC 60601-2-44:2001/A1:2002) | Note 3 | 1.12.2005 |
| CENELEC | EN 60601-2-45:2001
  Medical electrical equipment — Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
  (IEC 60601-2-45:2001) | EN 60601-2-45:1998
  Note 2.1 | Date expired (1.7.2004) |
| CENELEC | EN 60601-2-46:1998
  Medical electrical equipment — Part 2-46: Particular requirements for the safety of operating tables
  (IEC 60601-2-46:1998) | None | — |
| CENELEC | EN 60601-2-47:2001
  Medical electrical equipment — Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
  (IEC 60601-2-47:2001) | None | — |
| CENELEC | EN 60601-2-49:2001
  Medical electrical equipment — Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
  (IEC 60601-2-49:2001) | None | — |
| CENELEC | EN 60601-2-50:2002
  Medical electrical equipment — Part 2-50: Particular requirements for the safety of infant phototherapy equipment
  (IEC 60601-2-50:2000) | None | — |
| CENELEC | EN 60601-2-51:2003
  Medical electrical equipment — Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
  (IEC 60601-2-51:2003) | None | — |
| CENELEC | EN 60627:2001
  Diagnostic X-ray imaging equipment — Characteristics of general purpose and mammographic anti-scatter grids
  (IEC 60627:2001) | None | — |
| CENELEC | EN 60645-1:2001
  Electroacoustics — Audiological equipment — Part 1: Pure-tone audiometers
  (IEC 60645-1:2001) | EN 60645-1:1994
  Note 2.1 | Date expired (1.10.2004) |
| CENELEC | EN 60645-2:1997
  Audiometers — Part 2: Equipment for speech audiometry
  (IEC 60645-2:1993) | None | — |
| CENELEC | EN 60645-3:1995
  Audiometers — Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes
  (IEC 60645-3:1994) | None | — |
| CENELEC | EN 60645-4:1995
  Audiometers — Part 4: Equipment for extended high-frequency audiometry
  (IEC 60645-4:1994) | None | — |
| CENELEC | EN 61217:1996
  Radiotherapy equipment — Coordinates, movements and scales
  (IEC 61217:1996) | None | — |
| Amendment A1:2001 to EN 61217:1996
  (IEC 61217:1996/A1:2000) | Note 3 | Date expired (1.12.2003) |
| CENELEC | EN 61223-3-1:1999
  Evaluation and routine testing in medical imaging departments — Part 3-1: Acceptance tests — Imaging performance of X-ray equipment for radiographic and radioscopic systems
  (IEC 61223-3-1:1999) | None | — |
| CENELEC | EN 61223-3-4:2000
  Evaluation and routine testing in medical imaging departments — Part 3-4: Acceptance tests — Imaging performance of dental X-ray equipment
  (IEC 61223-3-4:2000) | None | — |
| CENELEC | EN 61676:2002
  Medical electrical equipment — Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
  (IEC 61676:2002) | None | — |
| CENELEC | EN 62083:2001
  Medical electrical equipment — Requirements for the safety of radiotherapy treatment planning systems
  (IEC 62083:2000) | None | — |
| CENELEC | EN 62220-1:2004
  Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1: Determination of the detective quantum efficiency
  (IEC 62220-1:2003) | None | — |

European Standardisation Organisation

Reference and title of the standard

(and reference document)

Reference of the superseded standard

Date of cessation of presumption of conformity of the superseded standard

Note 1

CEN/CENELEC

EN 46003:1999

Quality systems — Medical devices — Particular requirements for the application of EN ISO 9003

None

—

CENELEC

EN 60118-13:1997

Hearing aids — Part 13: Electromagnetic compatibility (EMC)

(IEC 60118-13:1997)

None

—

CENELEC

EN 60522:1999

Determination of the permanent filtration of X-ray tube assemblies

(IEC 60522:1999)

None

—

CENELEC

EN 60580:2000

Medical electrical equipment — Dose area product meters

(IEC 60580:2000)

None

—

CENELEC

EN 60601-1:1990

Medical electrical equipment — Part 1: General requirements for safety

(IEC 60601-1:1988)

None

—

Amendment A1:1993 to EN 60601-1:1990

(IEC 60601-1:1988/A1:1991)

Note 3

—

Amendment A2:1995 to EN 60601-1:1990

(IEC 60601-1:1988/A2:1995)

Note 3

—

Amendment A13:1996 to EN 60601-1:1990

Note 3

Date expired (1.7.1996)

CENELEC

EN 60601-1-1:2001

Medical electrical equipment — Part 1-1: General requirements for safety — Collateral standard: Safety requirements for medical electrical systems

(IEC 60601-1-1:2000)

EN 60601-1-1:1993

+A1:1996

Note 2.1

Date expired (1.12.2003)

CENELEC

EN 60601-1-2:2001

Medical electrical equipment — Part 1-2: General requirements for safety — Collateral standard: Electromagnetic compatibility — Requirements and tests

(IEC 60601-1-2:2001)

EN 60601-1-2:1993

Note 2.1

Date expired (1.11.2004)

CENELEC

EN 60601-1-3:1994

Medical electrical equipment — Part 1: General requirements for safety — 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment

(IEC 60601-1-3:1994)

None

—

CENELEC

EN 60601-1-4:1996

Medical electrical equipment — Part 1-4: General requirements for safety — Collateral standard: Programmable electrical medical systems

(IEC 60601-1-4:1996)

None

—

Amendment A1:1999 to EN 60601-1-4:1996

(IEC 60601-1-4:1996/A1:1999)

Note 3

Date expired (1.12.2002)

CENELEC

EN 60601-2-1:1998

Medical electrical equipment — Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV

(IEC 60601-2-1:1998)

None

—

Amendment A1:2002 to EN 60601-2-1:1998

(IEC 60601-2-1:1998/A1:2002)

Note 3

1.6.2005

CENELEC

EN 60601-2-2:2000

Medical electrical equipment — Part 2-2: Particular requirements for the safety of high frequency surgical equipment

(IEC 60601-2-2:1998)

EN 60601-2-2:1993

Note 2.1

Date expired (1.8.2003)

CENELEC

EN 60601-2-3:1993

Medical electrical equipment — Part 2: Particular requirements for the safety of short-wave therapy equipment

(IEC 60601-2-3:1991)

None

—

Amendment A1:1998 to EN 60601-2-3:1993

(IEC 60601-2-3:1991/A1:1998)

Note 3

Date expired (1.7.2001)

CENELEC

EN 60601-2-4:2003

Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac defibrillators

(IEC 60601-2-4:2002)

None

—

CENELEC

EN 60601-2-5:2000

Medical electrical equipment — Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment

(IEC 60601-2-5:2000)

None

—

CENELEC

EN 60601-2-7:1998

Medical electrical equipment — Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators

(IEC 60601-2-7:1998)

None

—

CENELEC

EN 60601-2-8:1997

Medical electrical equipment — Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

(IEC 60601-2-8:1987)

None

—

Amendment A1:1997 to EN 60601-2-8:1997

(IEC 60601-2-8:1987/A1:1997)

Note 3

Date expired (1.6.1998)

CENELEC

EN 60601-2-9:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors

(IEC 60601-2-9:1996)

None

—

CENELEC

EN 60601-2-10:2000

Medical electrical equipment — Part 2-10: Particular requirements for the safety of nerve and muscle stimulators

(IEC 60601-2-10:1987)

None

—

Amendment A1:2001 to EN 60601-2-10:2000

(IEC 60601-2-10:1987/A1:2001)

Note 3

Date expired (1.11.2004)

CENELEC

EN 60601-2-11:1997

Medical electrical equipment — Part 2-11: Particular requirements for the safety of gamma beam therapy equipment

(IEC 60601-2-11:1997)

None

—

CENELEC

EN 60601-2-16:1998

Medical electrical equipment — Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

(IEC 60601-2-16:1998)

None

—

CENELEC

EN 60601-2-17:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment

(IEC 60601-2-17:1989)

None

—

Amendment A1:1996 to EN 60601-2-17:1996

(IEC 60601-2-17:1989/A1:1996)

Note 3

Date expired (1.3.1997)

CENELEC

EN 60601-2-17:2004

Medical electrical equipment — Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment

(IEC 60601-2-17:2004)

EN 60601-2-17:1996 and its amendment

Note 2.1

1.3.2007

CENELEC

EN 60601-2-18:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of endoscopic equipment

(IEC 60601-2-18:1996)

None

—

Amendment A1:2000 to EN 60601-2-18:1996

(IEC 60601-2-18:1996/A1:2000)

Note 3

Date expired (1.8.2003)

CENELEC

EN 60601-2-19:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of baby incubators

(IEC 60601-2-19:1990)

None

—

Amendment A1:1996 to EN 60601-2-19:1996

(IEC 60601-2-19:1990/A1:1996)

Note 3

Date expired (13.6.1998)

CENELEC

EN 60601-2-20:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of transport incubators

(IEC 60601-2-20:1990 + A1:1996)

None

—

CENELEC

EN 60601-2-21:1994

Medical electrical equipment — Part 2: Particular requirements for the safety of infant radiant warmers

(IEC 60601-2-21:1994)

None

—

Amendment A1:1996 to EN 60601-2-21:1994

(IEC 60601-2-21:1994/A1:1996)

Note 3

Date expired (13.6.1998)

CENELEC

EN 60601-2-22:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment

(IEC 60601-2-22:1995)

None

—

CENELEC

EN 60601-2-23:2000

Medical electrical equipment — Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment

(IEC 60601-2-23:1999)

EN 60601-2-23:1997

Note 2.1

Date expired (1.1.2003)

CENELEC

EN 60601-2-24:1998

Medical electrical equipment — Part 2-24: Particular requirements for the safety of infusion pumps and controllers

(IEC 60601-2-24:1998)

None

—

CENELEC

EN 60601-2-25:1995

Medical electrical equipment — Part 2-25: Particular requirements for the safety of electrocardiographs

(IEC 60601-2-25:1993)

None

—

Amendment A1:1999 to EN 60601-2-25:1995

(IEC 60601-2-25:1993/A1:1999)

Note 3

Date expired (1.5.2002)

CENELEC

EN 60601-2-26:1994

Medical electrical equipment — Part 2: Particular requirements for the safety of electroencephalographs

(IEC 60601-2-26:1994)

None

—

CENELEC

EN 60601-2-26:2003

Medical electrical equipment — Part 2-26: Particular requirements for the safety of electroencephalographs

(IEC 60601-2-26:2002)

EN 60601-2-26:1994

Note 2.1

1.3.2006

CENELEC

EN 60601-2-27:1994

Medical electrical equipment — Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment

(IEC 60601-2-27:1994)

None

—

CENELEC

EN 60601-2-28:1993

Medical electrical equipment — Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

(IEC 60601-2-28:1993)

None

—

CENELEC

EN 60601-2-29:1999

Medical electrical equipment — Part 2-29: Particular requirements for the safety of radiotherapy simulators

(IEC 60601-2-29:1999)

EN 60601-2-29:1995

+A1:1996

Note 2.1

Date expired (1.4.2002)

CENELEC

EN 60601-2-30:2000

Medical electrical equipment — Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

(IEC 60601-2-30:1999)

EN 60601-2-30:1995

Note 2.1

Date expired (1.2.2003)

CENELEC

EN 60601-2-31:1995

Medical electrical equipment — Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source

(IEC 60601-2-31:1994)

None

—

Amendment A1:1998 to EN 60601-2-31:1995

(IEC 60601-2-31:1994/A1:1998)

Note 3

Date expired (1.1.2001)

CENELEC

EN 60601-2-32:1994

Medical electrical equipment — Part 2: Particular requirements for the safety of associated equipment of X-ray equipment

(IEC 60601-2-32:1994)

None

—

CENELEC

EN 60601-2-33:1995

Medical electrical equipment — Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

(IEC 60601-2-33:1995)

None

—

Amendment A11:1997 to EN 60601-2-33:1995

Note 3

Date expired (13.6.1998)

CENELEC

EN 60601-2-33:2002

Medical electrical equipment — Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

(IEC 60601-2-33:2002)

EN 60601-2-33:1995 and its amendment

Note 2.1

1.7.2005

CENELEC

EN 60601-2-34:2000

Medical electrical equipment — Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment

(IEC 60601-2-34:2000)

EN 60601-2-34:1995

Note 2.1

Date expired (1.11.2003)

CENELEC

EN 60601-2-35:1996

Medical electrical equipment — Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use

(IEC 60601-2-35:1996)

None

—

CENELEC

EN 60601-2-36:1997

Medical electrical equipment — Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy

(IEC 60601-2-36:1997)

None

—

CENELEC

EN 60601-2-37:2001

Medical electrical equipment — Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

(IEC 60601-2-37:2001)

None

—

CENELEC

EN 60601-2-38:1996

Medical electrical equipment — Part 2-38: Particular requirements for the safety of electrically operated hospital beds

(IEC 60601-2-38:1996)

None

—

Amendment A1:2000 to EN 60601-2-38:1996

(IEC 60601-2-38:1996/A1:1999)

Note 3

Date expired (1.1.2003)

CENELEC

EN 60601-2-39:1999

Medical electrical equipment — Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment

(IEC 60601-2-39:1999)

None

—

CENELEC

EN 60601-2-40:1998

Medical electrical equipment — Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment

(IEC 60601-2-40:1998)

None

—

CENELEC

EN 60601-2-41:2000

Medical electrical equipment — Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis

(IEC 60601-2-41:2000)

None

—

CENELEC

EN 60601-2-43:2000

Medical electrical equipment — Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures

(IEC 60601-2-43:2000)

None

—

CENELEC

EN 60601-2-44:2001

Medical electrical equipment — Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography

(IEC 60601-2-44:2001)

EN 60601-2-44:1999

Note 2.1

Date expired (1.7.2004)

Amendment A1:2003 to EN 60601-2-44:2001

(IEC 60601-2-44:2001/A1:2002)

Note 3

1.12.2005

CENELEC

EN 60601-2-45:2001

Medical electrical equipment — Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices

(IEC 60601-2-45:2001)

EN 60601-2-45:1998

Note 2.1

Date expired (1.7.2004)

CENELEC

EN 60601-2-46:1998

Medical electrical equipment — Part 2-46: Particular requirements for the safety of operating tables

(IEC 60601-2-46:1998)

None

—

CENELEC

EN 60601-2-47:2001

Medical electrical equipment — Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

(IEC 60601-2-47:2001)

None

—

CENELEC

EN 60601-2-49:2001

Medical electrical equipment — Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment

(IEC 60601-2-49:2001)

None

—

CENELEC

EN 60601-2-50:2002

Medical electrical equipment — Part 2-50: Particular requirements for the safety of infant phototherapy equipment

(IEC 60601-2-50:2000)

None

—

CENELEC

EN 60601-2-51:2003

Medical electrical equipment — Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs

(IEC 60601-2-51:2003)

None

—

CENELEC

EN 60627:2001

Diagnostic X-ray imaging equipment — Characteristics of general purpose and mammographic anti-scatter grids

(IEC 60627:2001)

None

—

CENELEC

EN 60645-1:2001

Electroacoustics — Audiological equipment — Part 1: Pure-tone audiometers

(IEC 60645-1:2001)

EN 60645-1:1994

Note 2.1

Date expired (1.10.2004)

CENELEC

EN 60645-2:1997

Audiometers — Part 2: Equipment for speech audiometry

(IEC 60645-2:1993)

None

—

CENELEC

EN 60645-3:1995

Audiometers — Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes

(IEC 60645-3:1994)

None

—

CENELEC

EN 60645-4:1995

Audiometers — Part 4: Equipment for extended high-frequency audiometry

(IEC 60645-4:1994)

None

—

CENELEC

EN 61217:1996

Radiotherapy equipment — Coordinates, movements and scales

(IEC 61217:1996)

None

—

Amendment A1:2001 to EN 61217:1996

(IEC 61217:1996/A1:2000)

Note 3

Date expired (1.12.2003)

CENELEC

EN 61223-3-1:1999

Evaluation and routine testing in medical imaging departments — Part 3-1: Acceptance tests — Imaging performance of X-ray equipment for radiographic and radioscopic systems

(IEC 61223-3-1:1999)

None

—

CENELEC

EN 61223-3-4:2000

Evaluation and routine testing in medical imaging departments — Part 3-4: Acceptance tests — Imaging performance of dental X-ray equipment

(IEC 61223-3-4:2000)

None

—

CENELEC

EN 61676:2002

Medical electrical equipment — Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology

(IEC 61676:2002)

None

—

CENELEC

EN 62083:2001

Medical electrical equipment — Requirements for the safety of radiotherapy treatment planning systems

(IEC 62083:2000)

None

—

CENELEC

EN 62220-1:2004

Medical electrical equipment — Characteristics of digital X-ray imaging devices — Part 1: Determination of the detective quantum efficiency

(IEC 62220-1:2003)

None

—

| Note 1: | Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |

Note 1:

Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

| Note 2.1: | The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. |
| --- | --- |

Note 2.1:

The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

| Note 3: | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 4) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. |
| --- | --- |

Note 3:

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 4) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

Example: For EN 60601-1:1990, the following applies:

| CENELEC | EN 60601-1:1990
  Medical electrical equipment
  Part 1: General requirements for safety
  IEC 60601-1:1988

  [The referenced standard is EN 60601-1:1990] | None

  [There is no superseded standard] | — |
| --- | --- | --- | --- |
| Amendment A1:1993 to EN 60601-1:1990
  IEC 60601-1:1988/A1:1991
  [The referenced standard is EN 60601-1:1990

  +A1:1993 to EN 60601-1:1990] | Note 3

  [The superseded standard is EN 60601-1:1990] | — |
| Amendment A2:1995 to EN 60601-1:1990
  IEC 60601-1:1988/A2:1995
  [The referenced standard is EN 60601-1:1990
  +A1:1993 to EN 60601-1:1990

  +A2:1995 to EN60601-1:1990] | Note 3
  [The superseded standard is EN 60601-1:1990

  - A1:1993] | — |
| Amendment A13:1996 to EN 60601-1:1990
  [The referenced standard is EN 60601-1:1990
  - A1:1993 to EN 60601-1:1990
  - A2:1995 to EN 60601-1:1990

  - A13:1996 to EN 60601-1:1990] | Note 3
  [The superseded standard is EN 60601-1:1990
  - A1:1993

  - A2:1995] | Date expired (1.7.1996) |

CENELEC

EN 60601-1:1990

Medical electrical equipment

Part 1: General requirements for safety

IEC 60601-1:1988

[The referenced standard is EN 60601-1:1990]

None

[There is no superseded standard]

—

Amendment A1:1993 to EN 60601-1:1990

IEC 60601-1:1988/A1:1991

[The referenced standard is EN 60601-1:1990

+A1:1993 to EN 60601-1:1990]

Note 3

[The superseded standard is EN 60601-1:1990]

—

Amendment A2:1995 to EN 60601-1:1990

IEC 60601-1:1988/A2:1995

[The referenced standard is EN 60601-1:1990

+A1:1993 to EN 60601-1:1990

+A2:1995 to EN60601-1:1990]

Note 3

[The superseded standard is EN 60601-1:1990

- A1:1993]

—

Amendment A13:1996 to EN 60601-1:1990

[The referenced standard is EN 60601-1:1990

- A1:1993 to EN 60601-1:1990

- A2:1995 to EN 60601-1:1990

- A13:1996 to EN 60601-1:1990]

Note 3

[The superseded standard is EN 60601-1:1990

- A1:1993

- A2:1995]

Date expired (1.7.1996)

---

| 28.4.2005 | EN | Official Journal of the European Union | C 103/11 |
| --- | --- | --- | --- |

28.4.2005

EN

Official Journal of the European Union

C 103/11

---

Commission communication in the framework of the implementation of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

(2005/C 103/03)

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the directive)

| ESO (1) | Reference and title of the harmonised standard
  (and reference document) | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  Note 1 |
| --- | --- | --- | --- |
| CEN | EN 375:2001
  Information supplied by the manufacturer with in vitro diagnostic reagents for professional use | — | |
| CEN | EN 376:2002
  Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing | — | |
| CEN | EN 556-1:2001
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices | EN 556:1994 | Date expired (30.4.2002) |
| CEN | EN 591:2001
  Instructions for use for in vitro diagnostic instruments for professional use | — | |
| CEN | EN 592:2002
  Instructions for use for in vitro diagnostic instruments for self-testing | — | |
| CEN | EN 794-1:1997
  Lung ventilators — Part 1: Particular requirements for critical care ventilators | — | |
| EN 794-1:1997/A1:2000 | Note 3 | Date expired (31.5.2001) |
| CEN | EN 928:1995
  In vitro diagnostic systems — Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices | — | |
| CEN | EN 980:2003
  Graphical symbols for use in the labelling of medical devices | EN 980:1996 | Date expired (31.10.2003) |
| CEN | EN 1280-1:1997
  Agent specific filling systems for anaesthetic vaporizers — Part 1: Rectangular keyed filling systems | — | |
| EN 1280-1:1997/A1:2000 | Note 3 | Date expired (24.11.2000) |
| CEN | EN ISO 4135:2001
  Anaesthetic and respiratory equipment — Vocabulary (ISO 4135:2001) | EN ISO 4135:1996 | Date expired (28.2.2002) |
| CEN | EN ISO 10993-8:2000
  Biological evaluation of medical devices — Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000) | — | |
| CEN | EN 12286:1998
  In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures | — | |
| EN 12286:1998/A1:2000 | Note 3 | Date expired (24.11.2000) |
| CEN | EN 12287:1999
  In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials | — | |
| CEN | EN 12322:1999
  In vitro diagnostic medical devices — Culture media for microbiology — Performance criteria for culture media | — | |
| EN 12322:1999/A1:2001 | Note 3 | Date expired (30.4.2002) |
| CEN | EN ISO 13485:2003
  Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) | EN ISO 13488:2000 | 31.7.2006 |
| CEN | EN 13532:2002
  General requirements for in vitro diagnostic medical devices for self-testing | — | |
| CEN | EN 13612:2002
  Performance evaluation of in vitro diagnostic medical devices | — | |
| CEN | EN 13640:2002
  Stability testing of in vitro diagnostic reagents | — | |
| CEN | EN 13641:2002
  Elimination or reduction of risk of infection related to in vitro diagnostic reagents | — | |
| CEN | EN 13975:2003
  Sampling procedures used for acceptance testing of in vitro diagnostic medical devices — Statistical aspects | — | |
| CEN | EN 14254:2004
  In vitro diagnostic medical devices — Single-use receptacles for the collection of specimens, other than blood, from humans | — | |
| CEN | EN 14820:2004
  Single-use containers for human venous blood specimen collection | — | |
| CEN | EN ISO 14937:2000
  Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000) | — | |
| CEN | EN ISO 14971:2000
  Medical devices — Application of risk management to medical devices (ISO 14971:2000) | EN 1441:1997 | Date expired (31.3.2004) |
| EN ISO 14971:2000/A1:2003 | Note 3 | Date expired (31.3.2004) |
| CEN | EN ISO 15197:2003
  In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003) | — | |
| CEN | EN ISO 15225:2000
  Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) | — | |
| CEN | EN ISO 17511:2003
  In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) | — | |
| CEN | EN ISO 18153:2003
  In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003) | — | |

ESO (1)

Reference and title of the harmonised standard

(and reference document)

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

Note 1

CEN

EN 375:2001

Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

—

CEN

EN 376:2002

Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing

—

CEN

EN 556-1:2001

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 1: Requirements for terminally sterilized medical devices

EN 556:1994

Date expired (30.4.2002)

CEN

EN 591:2001

Instructions for use for in vitro diagnostic instruments for professional use

—

CEN

EN 592:2002

Instructions for use for in vitro diagnostic instruments for self-testing

—

CEN

EN 794-1:1997

Lung ventilators — Part 1: Particular requirements for critical care ventilators

—

EN 794-1:1997/A1:2000

Note 3

Date expired (31.5.2001)

CEN

EN 928:1995

In vitro diagnostic systems — Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices

—

CEN

EN 980:2003

Graphical symbols for use in the labelling of medical devices

EN 980:1996

Date expired (31.10.2003)

CEN

EN 1280-1:1997

Agent specific filling systems for anaesthetic vaporizers — Part 1: Rectangular keyed filling systems

—

EN 1280-1:1997/A1:2000

Note 3

Date expired (24.11.2000)

CEN

EN ISO 4135:2001

Anaesthetic and respiratory equipment — Vocabulary (ISO 4135:2001)

EN ISO 4135:1996

Date expired (28.2.2002)

CEN

EN ISO 10993-8:2000

Biological evaluation of medical devices — Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000)

—

CEN

EN 12286:1998

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures

—

EN 12286:1998/A1:2000

Note 3

Date expired (24.11.2000)

CEN

EN 12287:1999

In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials

—

CEN

EN 12322:1999

In vitro diagnostic medical devices — Culture media for microbiology — Performance criteria for culture media

—

EN 12322:1999/A1:2001

Note 3

Date expired (30.4.2002)

CEN

EN ISO 13485:2003

Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003)

EN ISO 13488:2000

31.7.2006

CEN

EN 13532:2002

General requirements for in vitro diagnostic medical devices for self-testing

—

CEN

EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

—

CEN

EN 13640:2002

Stability testing of in vitro diagnostic reagents

—

CEN

EN 13641:2002

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

—

CEN

EN 13975:2003

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices — Statistical aspects

—

CEN

EN 14254:2004

In vitro diagnostic medical devices — Single-use receptacles for the collection of specimens, other than blood, from humans

—

CEN

EN 14820:2004

Single-use containers for human venous blood specimen collection

—

CEN

EN ISO 14937:2000

Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000)

—

CEN

EN ISO 14971:2000

Medical devices — Application of risk management to medical devices (ISO 14971:2000)

EN 1441:1997

Date expired (31.3.2004)

EN ISO 14971:2000/A1:2003

Note 3

Date expired (31.3.2004)

CEN

EN ISO 15197:2003

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)

—

CEN

EN ISO 15225:2000

Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000)

—

CEN

EN ISO 17511:2003

In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

—

CEN

EN ISO 18153:2003

In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

—

| Note 1 | Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |

Note 1

Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

| Note 3 | In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. |
| --- | --- |

Note 3

In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

NOTE:

| — | Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to Directive 98/34/EC (2) of the European Parliament and of the Council amended by Directive 98/48/EC (3). |
| --- | --- |

—

Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to Directive 98/34/EC (2) of the European Parliament and of the Council amended by Directive 98/48/EC (3).

| — | Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the Community languages. |
| --- | --- |

—

Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the Community languages.

More information about harmonised standards on the Internet at:

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/

---

(1)  ESO:  European Standardisation Organisation:

| — | CEN: rue de Stassart 36, B-1050 Brussels, tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cenorm.be) |
| --- | --- |

—

CEN: rue de Stassart 36, B-1050 Brussels, tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cenorm.be)

| — | CENELEC: rue de Stassart 35, B-1050 Brussels, tel. (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org) |
| --- | --- |

—

CENELEC: rue de Stassart 35, B-1050 Brussels, tel. (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org)

| — | ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org) |
| --- | --- |

—

ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, tel. (33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org)

(2)  OJ L 204, 21.7.1998, p. 37.

(3)  OJ L 217, 5.8.1998, p. 18.

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| 28.4.2005 | EN | Official Journal of the European Union | C 103/14 |
| --- | --- | --- | --- |

28.4.2005

EN

Official Journal of the European Union

C 103/14

---

Communication from the French Government concerning Directive 94/22/EC of the European Parliament and of the Council of 30 May 1994 on the conditions for granting and using authorisations for the prospection, exploration and production of hydrocarbons (1)

(Notice regarding an application for an exclusive licence to prospect for liquid and gaseous hydrocarbons, designated the ‘Carret Licence’)

(2005/C 103/04)

(Text with EEA relevance)

By request of 17 November 2004, Esso Rep, a company with registered offices at 2, rue des Martinets, Rueil Malmaison, 92500 (France), and Lundin Gascogne SNC, a company with registered offices at Maclaunay, Montmirail, 515210 (France), applied jointly and severally for an exclusive four-year licence to prospect for liquid and gaseous hydrocarbons in an area of approximately 173 km2, designated the ‘Carret Licence’, covering part of the department of the Gironde, part of the seabed off that department and an area of sea off the same department.

The perimeter of the area covered by this licence is made up of the meridian and parallel arcs successively joining the vertices defined below by their geographical coordinates, the original meridian being that of Paris (the Greenwich coordinates are given for information):

| Vertices | Longitude | Latitude |
| --- | --- | --- |
| A | 4.00° W (1° 15′ 46′′ W) | 49.80° N (44° 49′ 12′′ N) |
| B | 3.90° W (1° 10′ 22′′ W) | 49.80° N (44° 49′ 12′′ N) |
| C | 3.90° W (1° 10′ 22′′ W) | 49.70° N (44° 43′ 48′′ N) |
| D | 3.80° W (1° 04′ 58′′ W) | 49.70° N (44° 43′ 48′′ N) |
| E | 3.80° W (1° 04′ 58′′ W) | 49.60° N (44° 38′ 24′′ N) |
| F | 3.88° W (1° 09′ 15′′ W) | 49.60° N (44° 38′ 24′′ N) |
| G | 3.88° W (1° 09′ 15′′ W) | 49.62° N (44° 39′ 32′′ N) |
| H | 3.89° W (1° 09′ 47′′ W) | 49.62° N (44° 39′ 32′′ N) |
| I | 3.89° W (1° 09′ 47′′ W) | 49.63° N (44° 40′ 05′′ N) |
| J | 3.92° W (1° 11′ 25′′ W) | 49.63° N (44° 40′ 05′′ N) |
| K | 3.92° W (1° 11′ 25′′ W) | 49.66° N (44° 41′ 42′′ N) |
| L | 3.93° W (1° 11′ 57′′ W) | 49.66° N (44° 41′ 42′′ N) |
| M | 3.93° W (1° 11′ 57′′ W) | 49.68° N (44° 42′ 47′′ N) |
| N | 3.98° W (1° 14′ 39′′ W) | 49.68° N (44° 42′ 47′′ N) |
| O | 3.98° W (1° 14′ 39′′ W) | 49.66° N (44° 41′ 42′′ N) |
| P | 3.99° W (1° 15′ 12′′ W) | 49.66° N (44° 41′ 42′′ N) |
| Q | 3.99° W (1° 15′ 12′′ W) | 49.63° N (44° 40′ 05′′ N) |
| R | 3.97° W (1° 14′ 08′′ W) | 49.63° N (44° 40′ 05′′ N) |
| S | 3.97° W (1° 14′ 08′′ W) | 49.60° N (44° 38′ 24′′ N) |
| T | 4.00° W (1° 15′ 46′′ W) | 49.60° N (44° 38′ 24′′ N) |

Vertices

Longitude

Latitude

A

4.00° W (1° 15′ 46′′ W)

49.80° N (44° 49′ 12′′ N)

B

3.90° W (1° 10′ 22′′ W)

49.80° N (44° 49′ 12′′ N)

C

3.90° W (1° 10′ 22′′ W)

49.70° N (44° 43′ 48′′ N)

D

3.80° W (1° 04′ 58′′ W)

49.70° N (44° 43′ 48′′ N)

E

3.80° W (1° 04′ 58′′ W)

49.60° N (44° 38′ 24′′ N)

F

3.88° W (1° 09′ 15′′ W)

49.60° N (44° 38′ 24′′ N)

G

3.88° W (1° 09′ 15′′ W)

49.62° N (44° 39′ 32′′ N)

H

3.89° W (1° 09′ 47′′ W)

49.62° N (44° 39′ 32′′ N)

I

3.89° W (1° 09′ 47′′ W)

49.63° N (44° 40′ 05′′ N)

J

3.92° W (1° 11′ 25′′ W)

49.63° N (44° 40′ 05′′ N)

K

3.92° W (1° 11′ 25′′ W)

49.66° N (44° 41′ 42′′ N)

L

3.93° W (1° 11′ 57′′ W)

49.66° N (44° 41′ 42′′ N)

M

3.93° W (1° 11′ 57′′ W)

49.68° N (44° 42′ 47′′ N)

N

3.98° W (1° 14′ 39′′ W)

49.68° N (44° 42′ 47′′ N)

O

3.98° W (1° 14′ 39′′ W)

49.66° N (44° 41′ 42′′ N)

P

3.99° W (1° 15′ 12′′ W)

49.66° N (44° 41′ 42′′ N)

Q

3.99° W (1° 15′ 12′′ W)

49.63° N (44° 40′ 05′′ N)

R

3.97° W (1° 14′ 08′′ W)

49.63° N (44° 40′ 05′′ N)

S

3.97° W (1° 14′ 08′′ W)

49.60° N (44° 38′ 24′′ N)

T

4.00° W (1° 15′ 46′′ W)

49.60° N (44° 38′ 24′′ N)

Interested companies may, within ninety days of the publication of this notice, submit a competing application in accordance with the procedure summarised in the ‘Notice regarding the granting of mining rights for hydrocarbons in France’ published in
  Official Journal of the European Communities C 374 of 30 December 1994, page 11, and established by Decree 95-427 of 19 April 1995 regarding mining rights (Journal officiel de la République française of 22 April 1995).

Further information can be obtained from the Ministry of Economic Affairs, Finance and Industry (Directorate-General for Energy and Raw Materials, Directorate for Energy and Mineral Resources, Bureau of Mining Legislation), 61, Boulevard Vincent Auriol, Télédoc 133, F-75703 Paris Cedex 13, France, (tel. (33) 144 97 23 02; fax (33) 144 97 05 70).

---

(1)  OJ L 164, 30.6.1994, p. 3.

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| 28.4.2005 | EN | Official Journal of the European Union | C 103/16 |
| --- | --- | --- | --- |

28.4.2005

EN

Official Journal of the European Union

C 103/16

---

Invitation to submit an application for authorisation to prospect for hydrocarbons in the area covered by the former Oosterwolde and Haulerwijk drilling permits on Dutch territory

(2005/C 103/05)

(Text with EEA relevance)

The Minister of Economic Affairs of the Kingdom of the Netherlands hereby serves notice that an application for authorisation to prospect for hydrocarbons has been received for the area covered by the former Oosterwolde and Haulerwijk drilling permits, as referred to in Article 1 of the former Oosterwolde drilling permit of 31 July 1998, Ref. E/EOG/MW/98025320 (Stcrt. (Government Gazette) 1998, No 149) and the former Haulerwijk drilling permit of 22 December 1994, Ref. E/EOG/MW/94053336 (Stcrt. (Government Gazette) 1995, No 7).

With reference to Article 3(2) of Directive 94/22/EC of the European Parliament and of the Council of 30 May 1994 on the conditions for granting and using authorisations for the prospecting, exploration and production of hydrocarbons and the publication as described in Article 15 of the Mining Act (Stb. (Bulletin of Acts and Decrees) 2002, 542), the Minister of Economic Affairs invites interested parties to submit an application for authorisation to prospect for hydrocarbons in the area covered by the former Oosterwolde and Haulerwijk drilling permits.

Applications may be submitted for 13 weeks following the publication of this invitation in the Official Journal of the European Union and should be sent to the Minister of Economic Affairs, for the attention of the Director of Energy Production, and marked ‘personal’, Prinses Beatrixlaan 5, 2595 AK, The Hague. Applications submitted following the expiry of this period will not be considered.

A decision on the applications will be taken not later than nine months after the expiry date.

Further information can be obtained by telephoning the following number: (31) 70 379 66 94.

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| 28.4.2005 | EN | Official Journal of the European Union | C 103/17 |
| --- | --- | --- | --- |

28.4.2005

EN

Official Journal of the European Union

C 103/17

---

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty

Cases where the Commission raises no objections

(2005/C 103/06)

(Text with EEA relevance)

Date of adoption of the decision:

Member State: Finland

Aid No: N 58/04 and N 60/04

Title: Rescue and restructuring aid to SME's in Finland

Objective: Scheme concerning Rescue and Restructuring aid in all sectors (except coal, steel and air traffic sector)

Legal basis: Laki valtion erityisrahoitusyhtiöstä (443/1998) ja laki valtion erityisrahoitusyhtiön luotto- ja takaustoiminnasta (445/1998). Finnvera oyj will be the public body who is in charge of the application and implementation of the notified aid scheme.

Budget: Annual total budget of EUR 4,45 million

Aid intensity or amount: Not exceeding EUR 10 million per eligible SME

Duration:

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://europa.eu.int/comm/secretariat_general/sgb/state_aids/

Date of adoption of the decision:

Member State: Czech Republic

Aid No: N 206/2004

Title: State aid for the promotion of biofuels

Objective: Environmental aid

Legal basis: Zákon č. 353/2003 Sb. o spotřebních daních

Zákon č. 256/2000 Sb. o Státním zemědělském intervenčním fondu

Budget: around EUR 66 million annually

Duration:

| 1. | Six years (excise duty reduction) |
| --- | --- |

1.

Six years (excise duty reduction)

| 2. | Until 30 December 2006 (direct grant) |
| --- | --- |

2.

Until 30 December 2006 (direct grant)

Other information: The Czech Republic committed itself to monitor annually the production cost and modify the scheme accordingly if overcompensation occurs.

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://europa.eu.int/comm/secretariat_general/sgb/state_aids/

Date of adoption of the decision:

Member State: United Kingdom

Aid No: N 407/2003

Title: Reduced rate of excise duty on bioethanol used for road transport

Objective: Environmental aid

Legal basis: Finance bill 2004

Duration: 1 January 2005 — 31 December 2010

Other information: The UK committed itself to monitor annually the production cost and modify the scheme accordingly if overcompensation occurs.

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://europa.eu.int/comm/secretariat_general/sgb/state_aids/

Date of adoption:

Member State: United Kingdom

Aid No: N 591/2004

Title: Aid to Ford Motor Company

Objective: Training

Legal basis: Section 4 RDA act 1998

Aid intensity or amount: EUR 14 624 125

The authentic text of the decision, from which all confidential information has been removed, can be found at:

http://europa.eu.int/comm/secretariat_general/sgb/state_aids/

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| 28.4.2005 | EN | Official Journal of the European Union | C 103/18 |
| --- | --- | --- | --- |

28.4.2005

EN

Official Journal of the European Union

C 103/18

---

Notice of initiation of an anti-dumping proceeding concerning imports of lever arch mechanisms originating in the People's Republic of China

(2005/C 103/07)

The Commission has received a complaint pursuant to Article 5 of Council Regulation (EC) No 384/96 (1) (‘the basic Regulation’), alleging that imports of lever arch mechanisms, originating in the People's Republic of China (‘the country concerned’), are being dumped and are thereby causing material injury to the Community industry.

1.   Complaint

The complaint was lodged on 14 March 2005 by Community producers Interkov spol.s.r.o, MI.ME.CA. S.r.l. and Niko Metallurgical company, d.d.Zelezniki (‘the complainant’) representing a major proportion, in this case more than 50 % of the total Community production of lever arch mechanisms.

2.   Product

The product allegedly being dumped is lever arch mechanisms generally used for archiving sheets and other documents in binders or files. They consist of arched sturdy metal elements (normally two) on a back plate and having at least one opening trigger that permits inserting and filing of sheets and other documents, originating in the People's Republic of China (‘the product concerned’), normally declared within CN code ex 8305 10 00. This CN code is only given for information.

3.   Allegation of dumping

In view of the provisions of Article 2(7) of the basic Regulation, the complainant established normal value for the People's Republic of China on the basis of a constructed normal value in a market economy country, which is mentioned in paragraph 5.1(d) of this notice. The allegation of dumping is based on a comparison of normal value, thus calculated, with the export prices of the product concerned when sold for export to the Community.

On this basis, the dumping margin calculated is significant.

4.   Allegation of injury

The complainant has provided evidence that imports of the product concerned from the People's Republic of China have increased overall in absolute terms and/or have increased in terms of market share.

It is alleged that the volume and/or the prices of the imported product concerned have, among other consequences, had a negative impact on the level of prices charged by the Community industry, resulting in substantial adverse effects on the financial situation of the Community industry.

5.   Procedure

Having determined, after consulting the Advisory Committee, that the complaint has been lodged by or on behalf of the Community industry and that there is sufficient evidence to justify the initiation of a proceeding, the Commission hereby initiates an investigation pursuant to Article 5 of the basic Regulation.

5.1.   Procedure for the determination of dumping and injury

The investigation will determine whether the product concerned originating in the People's Republic of China is being dumped and whether this dumping has caused injury.

(a)   Sampling

In view of the apparent large number of parties involved in this proceeding, the Commission may decide to apply sampling in accordance with Article 17 of the basic Regulation.

(i)   Sampling for importers

In order to enable the Commission to decide whether sampling is necessary and, if so, to select a sample, all importers, or representatives acting on their behalf, are hereby requested to make themselves known to the Commission and to provide the following information on their company or companies within the time limit set in paragraph 6(b)(i) and in the formats indicated in paragraph 7 of this notice:

| — | name, address, e-mail address, telephone, and fax, and/or telex numbers and contact person, |
| --- | --- |

—

name, address, e-mail address, telephone, and fax, and/or telex numbers and contact person,

| — | the total turnover in euro of the company during the period of 1 January 2004 to 31 December 2004. |
| --- | --- |

—

the total turnover in euro of the company during the period of 1 January 2004 to 31 December 2004.

| — | the total number of employees, |
| --- | --- |

—

the total number of employees,

| — | the precise activities of the company with regard to the product concerned, |
| --- | --- |

—

the precise activities of the company with regard to the product concerned,

| — | the volume in units and value in euro of imports into and resales made in the Community market during the period of 1 January 2004 to 31 December 2004 of the imported product concerned originating in the People's Republic of China, |
| --- | --- |

—

the volume in units and value in euro of imports into and resales made in the Community market during the period of 1 January 2004 to 31 December 2004 of the imported product concerned originating in the People's Republic of China,

| — | the names and the precise activities of all related companies (2) involved in the production and/or selling of the product concerned, |
| --- | --- |

—

the names and the precise activities of all related companies (2) involved in the production and/or selling of the product concerned,

| — | any other relevant information that would assist the Commission in the selection of the sample, |
| --- | --- |

—

any other relevant information that would assist the Commission in the selection of the sample,

| — | an indication of whether the company or companies agree to their inclusion in the sample, which implies replying to a questionnaire and accepting an on-the-spot investigation of their response. |
| --- | --- |

—

an indication of whether the company or companies agree to their inclusion in the sample, which implies replying to a questionnaire and accepting an on-the-spot investigation of their response.

In order to obtain the information it deems necessary for the selection of the sample of importers, the Commission will, in addition, contact any known associations of importers.

(ii)   Final selection of the sample

All interested parties wishing to submit any relevant information regarding the selection of the sample must do so within the time limit set in paragraph 6(b)(ii) of this notice.

The Commission intends to make the final selection of the sample after having consulted the parties concerned that have expressed their willingness to be included in the sample.

Companies included in the sample must reply to a questionnaire within the time limit set in paragraph 6(b)(iii) of this notice and must cooperate within the framework of the investigation.

If sufficient cooperation is not forthcoming, the Commission may base its findings, in accordance with Articles 17(4) and 18 of the basic Regulation, on the facts available. A finding based on facts available may be less advantageous to the party concerned, as explained in paragraph 8 of this notice.

(b)   Questionnaires

In order to obtain the information it deems necessary for its investigation, the Commission will send questionnaires to the Community industry and to any association of producers in the Community, to the exporters/producers in the People's Republic of China, to any association of exporters/producers, to the sampled importers, to any association of importers named in the complaint, and to the authorities of the exporting countries concerned.

In any event, all parties should contact the Commission forthwith by fax, but not later than the time limit set out in paragraph 6(a)(i) of this notice, in order to find out whether they are listed in the complaint and, if necessary, request a questionnaire, given that the time limit set in paragraph 6(a)(ii) of this notice applies to all such interested parties.

(c)   Collection of information and holding of hearings

All interested parties are hereby invited to make their views known, submit information other than questionnaire replies and to provide supporting evidence. This information and supporting evidence has to reach the Commission within the time limit set in paragraph 6(a)(ii) of this notice.

Furthermore, the Commission may hear interested parties, provided that they make a request showing that there are particular reasons why they should be heard. This request must be made within the time limit set in paragraph 6(a)(iii) of this notice.

(d)   Selection of the market economy country

In accordance with Article 2(7)(a) of the basic Regulation, it is envisaged to choose India as an appropriate market economy country for the purpose of establishing normal value in respect of the People's Republic of China. Interested parties are hereby invited to comment on the appropriateness of this choice within the specific time limit set in paragraph 6(c) of this notice.

(e)   Market economy status

For those exporters/producers in the People's Republic of China who claim and provide sufficient evidence that they operate under market economy conditions, i.e. that they meet the criteria laid down in Article 2(7)(c) of the basic Regulation, normal value will be determined in accordance with Article 2(7)(b) of the basic Regulation. Exporters/producers intending to submit duly substantiated claims must do so within the specific time limit set in paragraph 6(d) of this notice. The Commission will send claim forms to all exporters/producers in the People's Republic of China named in the complaint and to any association of exporters/producers named in the complaint, as well as to the authorities of the People's Republic of China.

5.2.   Procedure for assessment of Community interest

In accordance with Article 21 of the basic Regulation and in the event that the allegations of dumping and injury caused thereby are substantiated, a decision will be reached as to whether the adoption of anti-dumping measures would not be against the Community interest. For this reason the Community industry, importers, their representative associations, representative users and representative consumer organisations, provided that they prove that there is an objective link between their activity and the product concerned, may, within the general time limits set in paragraph 6(a)(ii) of this notice, make themselves known and provide the Commission with information. The parties which have acted in conformity with the precedent sentence may request a hearing setting the particular reasons why they should be heard within the time limit set in paragraph 6(a)(iii) of this notice. It should be noted that any information submitted pursuant to Article 21 will only be taken into account if supported by factual evidence at the time of submission.

6.   Time limits

(a)   General time limits

(i)   For parties to request a questionnaire or other claim forms

All interested parties should request a questionnaire or other claim forms as soon as possible, but not later than 10 days after the publication of this notice in the Official Journal of the European Union.

(ii)   For parties to make themselves known, to submit questionnaire replies and any other information

All interested parties, if their representations are to be taken into account during the investigation, must make themselves known by contacting the Commission, present their views and submit questionnaire replies or any other information within 40 days of the date of publication of this notice in the Official Journal of the European Union, unless otherwise specified. Attention is drawn to the fact that the exercise of most procedural rights set out in the basic Regulation depends on the party's making itself known within the aforementioned period.

Companies selected in a sample must submit questionnaire replies within the time limits specified in paragraph 6(b)(iii) of this notice.

(iii)   Hearings

All interested parties may also apply to be heard by the Commission within the same 40 day time limit.

(b)   Specific time limit in respect of sampling

| (i) | The information specified in paragraph 5.1(a)(i) should reach the Commission within 15 days of the date of publication of this notice in the Official Journal of the European Union, given that the Commission intends to consult parties concerned that have expressed their willingness to be included in the sample on its final selection within a period of 21 days of the publication of this notice in the Official Journal of the European Union. |
| --- | --- |

(i)

The information specified in paragraph 5.1(a)(i) should reach the Commission within 15 days of the date of publication of this notice in the Official Journal of the European Union, given that the Commission intends to consult parties concerned that have expressed their willingness to be included in the sample on its final selection within a period of 21 days of the publication of this notice in the Official Journal of the European Union.

| (ii) | All other information relevant for the selection of the sample as referred to in 5.1(a)(ii) must reach the Commission within a period of 21 days of the publication of this notice in the Official Journal of the European Union. |
| --- | --- |

(ii)

All other information relevant for the selection of the sample as referred to in 5.1(a)(ii) must reach the Commission within a period of 21 days of the publication of this notice in the Official Journal of the European Union.

| (iii) | The questionnaire replies from sampled parties must reach the Commission within 37 days from the date of the notification of their inclusion in the sample. |
| --- | --- |

(iii)

The questionnaire replies from sampled parties must reach the Commission within 37 days from the date of the notification of their inclusion in the sample.

(c)   Specific time limit for the selection of the market economy country

Parties to the investigation may wish to comment on the appropriateness of India which, as mentioned in paragraph 5.1(d) of this notice, is envisaged as a market-economy country for the purpose of establishing normal value in respect of the People's Republic of China. These comments must reach the Commission within 10 days of the date of publication of this notice in the Official Journal of the European Union.

(d)   Specific time limit for submission of claims for market economy status and/or for individual treatment

Duly substantiated claims for market economy status (as mentioned in paragraph 5.1(e) of this notice) and/or for individual treatment pursuant to Article 9(5) of the basic Regulation, must reach the Commission within 21 days of the date of publication of this notice in the Official Journal of the European Union.

7.   Written submissions, questionnaire replies and correspondence

All submissions and requests made by interested parties must be made in writing (not in electronic format, unless otherwise specified) and must indicate the name, address, e-mail address, telephone and fax, and/or telex numbers of the interested party. All written submissions, including the information requested in this notice, questionnaire replies and correspondence provided by interested parties on a confidential basis shall be labelled as ‘Limited’ (3) and, in accordance with Article 19(2) of the basic Regulation, shall be accompanied by a non-confidential version, which will be labelled ‘For inspection by interested parties’.

Commission address for correspondence:

| European Commission |
| --- |
| Directorate General for Trade |
| Directorate B |
| Office: J-79 5/16 |
| B-1049 Brussels |
| Fax (32-2) 295 65 05 |

European Commission

Directorate General for Trade

Directorate B

Office: J-79 5/16

B-1049 Brussels

Fax (32-2) 295 65 05

8.   Non-cooperation

In cases in which any interested party refuses access to or does not provide the necessary information within the time limits, or significantly impedes the investigation, provisional or final findings, affirmative or negative, may be made in accordance with Article 18 of the basic Regulation, on the basis of the facts available.

Where it is found that any interested party has supplied false or misleading information, the information shall be disregarded and use may be made of the facts available. If an interested party does not cooperate or cooperates only partially and findings are therefore based on facts available in accordance with Article 18 of the basic Regulation, the result may be less favourable to that party than if it had cooperated.

9.   Schedule of the investigation

The investigation will be concluded, according to Article 6(9) of the basic Regulation within 15 months of the date of the publication of this notice in the Official Journal of the European Union. According to Article 7(1) of the basic Regulation, provisional measures may be imposed no later than 9 months from the publication of this notice in the Official Journal of the European Union.

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(1)  OJ L 56, 6.3.1996, p. 1. Regulation as last amended by Council Regulation (EC) No 461/2004 (OJ L 77, 13.3.2004, p. 12).

(2)  For guidance on the meaning of related companies, please refer to Article 143 of Commission Regulation (EEC) No 2454/93 concerning the implementation of the Community Customs Code (OJ L 253, 11.10.1993, p. 1).

(3)  This means that the document is for internal use only. It is protected pursuant to Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council (OJ L 145, 31.5.2001, p. 43). It is a confidential document pursuant to Article 19 of Council Regulation (EC) No 384/96 (OJ L 56, 6.3.1996, p. 1) and Article 6 of the WTO Agreement on Implementation of Article VI of the GATT 1994 (Anti-dumping Agreement).

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| 28.4.2005 | EN | Official Journal of the European Union | C 103/22 |
| --- | --- | --- | --- |

28.4.2005

EN

Official Journal of the European Union

C 103/22

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Prior notification of a concentration

(Case COMP/M.3800 — BC Partners/Dometic)

Candidate case for simplified procedure

(2005/C 103/08)

(Text with EEA relevance)

| 1. | On 21 April 2005 the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which funds managed by CIE Management II Ltd (‘CIEM’, UK), controlled by BC Partners Holdings Ltd (‘BCPH’) acquire within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of Dometic International AB and Dometic Corporation (‘Dometic’, Sweden), by way of purchase of shares |
| --- | --- |

1.

On 21 April 2005 the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which funds managed by CIE Management II Ltd (‘CIEM’, UK), controlled by BC Partners Holdings Ltd (‘BCPH’) acquire within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of Dometic International AB and Dometic Corporation (‘Dometic’, Sweden), by way of purchase of shares

| 2. | The business activities of the undertakings concerned are:






  — | CIEM: private equity investment, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

CIEM: private equity investment,

| — | Dometic: refrigerators, air conditioners, and other products for recreational vehicles, the marine industry, hotels, and other applications. |
| --- | --- |

—

Dometic: refrigerators, air conditioners, and other products for recreational vehicles, the marine industry, hotels, and other applications.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (No (32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.3800 — BC Partners/Dometic, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition, |
| Merger Registry |
| J-70 |
| B-1049 Brussels |

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (No (32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.3800 — BC Partners/Dometic, to the following address:

European Commission

Directorate-General for Competition,

Merger Registry

J-70

B-1049 Brussels

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(1)  OJ L 24, 29.1.2004, p. 1.

(2)  OJ C 56, 5.3.2005, p. 32.

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| 28.4.2005 | EN | Official Journal of the European Union | C 103/23 |
| --- | --- | --- | --- |

28.4.2005

EN

Official Journal of the European Union

C 103/23

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Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty

Cases where the Commission raises no objections

(2005/C 103/09)

(Text with EEA relevance)

Date of adoption of the decision:

Member State: Italy (Tuscany)

No of the aid: N 315/2003

Title: Regional animal breeding plan

Objective: Investment aid, quality programmes, start-up aid to producers groups responsible for the supervision of the use of quality labels and agro-environment aid.

Legal basis: Delibera del Consiglio regionale n. 4 del 16.06.2003‘Piano zootecnico regionale’.

Budget: EUR 31 600 000

Aid intensity or amount: As detailed in the letter to the Member State

Duration: 5 years

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://europa.eu.int/comm/sg/sgb/state_aids/

Date of adoption of the decision:

Member State: Germany (Niedersachsen)

No of the aid: N 331/2003

Title: Aid for the costs of transporting and destroying fallen stock

Objective: According to paragraph 3, section 3, point 3 of the Niedersächsisches Ausführungsgesetz zum Tierkörperbeseitigungsgesetz (AGTierKGB) the owners of fallen stock bear the costs of their pick-up, transport, storage, processing and rendering. However, paragraph 3 point 4 of the AGTierKBG provides that 100 % of the costs of pick-up and transport and 75 % of destruction costs of fallen stock are borne by the Land Niedersachsen. The remaining 25 % of the destruction costs is paid directly by the owner of the fallen stock to a central payment agency to be established. If the costs specified in paragraph 3, section 3 point 3 of the AGTierKBG relate to fallen stock on which TSE tests have to be performed by law the Land Niedersachsen reimburses 100 % of such costs to the owner of animals.

Legal basis: Niedersächsisches Ausführungsgesetz zum Tierkörperbeseitigungsgesetz; Niedersächsische Richtlinie über die Gewährung von staatlichen Beihilfen für die Entfernung und Beseitigung von Falltieren.

Budget: EUR 26,5 million per year

Aid intensity or amount: Variable

Duration: Unlimited

Other information: The German authorities have specified that when the present contracts between the carcass disposal firms and the municipal districts or cities expire these service providers will be chosen in an open procedure according to market principles.

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://europa.eu.int/comm/secretariat_general/sgb/state_aids/

Date of adoption of the decision:

Member State: The Netherlands

Aid No: N 528/2002

Title: Subsidy scheme for combating salmonella in the poultry sector

Objective: Compensation of poultry farmers for animals culled and hatching eggs destroyed due to salmonella infection.

Legal basis: Artikelen 2 en 4 van de Kaderwet LNV-subsidies (Framework act on subsidies of the ministry of agriculture, nature and fisheries (Articles 2 and 4)).

Budget: EUR 800 000 in 2002/EUR 600 000 in 2003

Aid intensity or amount: 100 %

Duration: indefinite

The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:

http://europa.eu.int/comm/sg/sgb/state_aids/

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EUROPEAN ECONOMIC AREA

EFTA Surveillance Authority

| 28.4.2005 | EN | Official Journal of the European Union | C 103/24 |
| --- | --- | --- | --- |

28.4.2005

EN

Official Journal of the European Union

C 103/24

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45th amendment of the State aid guidelines

EFTA Surveillance Authority decision to propose appropriate measures

(2005/C 103/10)

Date of adoption:

EFTA State: n.a.

Case No: 47815

Title: Amendments to Chapter 24A on ‘State aid to maritime transport’ and Annex VIII of the Authority's State Aid Guidelines by replacing Chapter 24 A and Annex VIII with a new text and proposal for appropriate measures.

Legal basis: College Decision No 62/04/COL

Decision: The appropriate measures, proposed by the Authority and accepted by the EFTA States are as follows:

to amend their existing aid schemes relating to State aid covered by the amended Chapter 24A and Annex VIII of the Authority's State Aid Guidelines so to comply with the Guidelines by 30 June 2005 at the latest.

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| 28.4.2005 | EN | Official Journal of the European Union | C 103/25 |
| --- | --- | --- | --- |

28.4.2005

EN

Official Journal of the European Union

C 103/25

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Authorisation of State aid pursuant to Article 61 of the EEA Agreement and Article 1(3) in Part I of Protocol 3 to the Surveillance and Court Agreement

The EFTA Surveillance Authority has decided that the notified measure is compatible with the EEA Agreement

(2005/C 103/11)

Date of adoption:

EFTA State: Norway

Aid No: 55363

Title: Prolongation of a temporary grant scheme for the shipbuilding industry

Objective: To offset the adverse effects caused by the unfair competitive practices of the Republic of Korea

Legal basis: Act relating to State aid (‘Lov om offentlig støtte av 27 november 1992’) and Regulation amending Regulation on State Aid to Shipbuilding (‘Forskrift om endring av forskrift 19. mars 1999 nr. 246 om gjennomføring av EØS-avtalens bestemmelser om offentlig støtte til skipsbyggingsindustrien’) implementing Council Regulation (EC) No 502/2004 amending Regulation (EC) No 1177/2002 concerning a temporary mechanism to shipbuilding as incorporated into Annex XV to the EEA Agreement by EEA Joint Committee Decision No 80/2004 of 8 June 2004.

Budget: NOK 300 million, some EUR 37 million (the total period from 15 March 2003 until 31 March 2005)

Duration: Prolongation from 1 April 2004 until 31 March 2005.

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| 28.4.2005 | EN | Official Journal of the European Union | C 103/26 |
| --- | --- | --- | --- |

28.4.2005

EN

Official Journal of the European Union

C 103/26

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STATE AID — NORWAY

Notice by the EFTA Surveillance Authority to EFTA States, EU Member States and other interested parties

State aid measure 47875 (former SAM 030.03001) — Proposed aid scheme to utilise energy from final waste treatment plants

(2005/C 103/12)

By letter dated 29 January 2003, the Norwegian Government notified the EFTA Surveillance Authority of a proposal for an aid scheme which intended to grant direct state support to waste incineration plants and landfills for the utilization of energy produced in the waste treatment process.

On 11 December 2003, the Authority initiated the formal investigation procedure laid down in Article 1(2) in Part I of Protocol 3 to the Surveillance and Court Agreement in respect of the proposed aid scheme. The decision was published in the EEA Section of and the EEA Supplement to the Official Journal of the European Union
   (1).

By letter dated 28 June 2004, the Norwegian authorities withdrew the above notification.

As the Norwegian Government has withdrawn the notification and does not intend to grant the aid initially notified, the Authority has decided to close the proceedings initiated under Article 1(2) in Part I of Protocol 3 to the Surveillance and Court Agreement.

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(1)  OJ C 82, 1.4.2004, p. 6, as well as in EEA Supplements to the Official Journal of the European Union No 16 of 1.4.2004, p. 1.

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EFTA Court

| 28.4.2005 | EN | Official Journal of the European Union | C 103/27 |
| --- | --- | --- | --- |

28.4.2005

EN

Official Journal of the European Union

C 103/27

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Request for an Advisory Opinion from the EFTA Court by Markedsrådet by decision of that court of 7 July 2004 in the case of Pedicel AS v Sosial- og helsedirektoratet

(Case E-4/04)

(2005/C 103/13)

A request has been made to the EFTA Court by decision of 7 July 2004 of Markedsrådet (the Market Council), Oslo, Norway, which was received at the Court Registry on 9 July 2004, for an Advisory Opinion in the case of Pedicel AS v Sosial- og helsedirektoratet, on the following questions:

| 1. | Since wine is not included in the product coverage of Article 8(3) of the EEA Agreement:
  should the Agreement — including Article 18 and Article 23 cf. Protocol 47 — be so understood that Article 11 and/or Article 36 are applicable to wine? |
| --- | --- |

1.

Since wine is not included in the product coverage of Article 8(3) of the EEA Agreement:

should the Agreement — including Article 18 and Article 23 cf. Protocol 47 — be so understood that Article 11 and/or Article 36 are applicable to wine?

| 2. | Should Article 11 and/or Article 36 of the EEA Agreement be so understood that they are applicable to national legislation that contains a general prohibition against the advertising of alcoholic beverages, such as in the Act on the sale of alcoholic beverages, section 9-2 et al.? |
| --- | --- |

2.

Should Article 11 and/or Article 36 of the EEA Agreement be so understood that they are applicable to national legislation that contains a general prohibition against the advertising of alcoholic beverages, such as in the Act on the sale of alcoholic beverages, section 9-2 et al.?

| 3. | If question 2 is answered in the affirmative: Can such a prohibition nevertheless be maintained out of concerns for public health, and if so, is it in conformity with the proportionality principle of EEA law?
  When answering this question, it should be indicated to what extent the application of a general precautionary principle in this field would be in conformity with the case law of the EFTA Court/Court of Justice of the European Communities. |
| --- | --- |

3.

If question 2 is answered in the affirmative: Can such a prohibition nevertheless be maintained out of concerns for public health, and if so, is it in conformity with the proportionality principle of EEA law?

When answering this question, it should be indicated to what extent the application of a general precautionary principle in this field would be in conformity with the case law of the EFTA Court/Court of Justice of the European Communities.

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| 28.4.2005 | EN | Official Journal of the European Union | C 103/28 |
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28.4.2005

EN

Official Journal of the European Union

C 103/28

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JUDGMENT OF THE COURT

of 5 May 2004

in Case E-4/03: EFTA Surveillance Authority v the Kingdom of Norway

(Failure of a Contracting Party to fulfil its obligations — Article 8 of Directive 98/34/EC)

(2005/C 103/14)

In Case E-4/03, EFTA Surveillance Authority v the Kingdom of Norway — Application for a declaration that, by adopting Regulation No 853 of 28 August 1998 regarding type approval of gaming machines (forskrift av 28. august 1998 nr. 853 om typegodkjenning av gevinstautomater) without previously notifying the EFTA Surveillance Authority at the drafting stage, the Kingdom of Norway has failed to fulfil its obligation under Article 8 of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations, as amended and adapted to the EEA Agreement by Protocol 1 thereto, the Court, composed of: Carl Baudenbacher, President, Per Tresselt and Thorgeir Örlygsson (Judge-Rapporteur), Judges, gave judgment of 5 May 2004, the operative part of which is as follows:

| 1. | Declares that, by adopting Regulation No 853 of 28 August 1998 regarding type approval of gaming machines, without previously notifying the EFTA Surveillance Authority at the drafting stage, the Kingdom of Norway has failed to fulfil its obligation under Article 8 of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations, as amended by Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998, adapted to the EEA Agreement by Protocol 1 thereto, and referred to in point 1 of Chapter XIX of Annex II to the EEA Agreement. |
| --- | --- |

1.

Declares that, by adopting Regulation No 853 of 28 August 1998 regarding type approval of gaming machines, without previously notifying the EFTA Surveillance Authority at the drafting stage, the Kingdom of Norway has failed to fulfil its obligation under Article 8 of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations, as amended by Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998, adapted to the EEA Agreement by Protocol 1 thereto, and referred to in point 1 of Chapter XIX of Annex II to the EEA Agreement.

| 2. | Orders the Kingdom of Norway to pay the costs of the proceedings. |
| --- | --- |

2.

Orders the Kingdom of Norway to pay the costs of the proceedings.

---