# Official Journal C 240/30 S

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 240 |
| | |
| English edition | Information and Notices | Volume 4830 September 2005 |

ISSN 1725-2423

Official Journal

of the European Union

C 240

English edition

Information and Notices

Volume 4830 September 2005

---

| Notice No | Contents | page |
| --- | --- | --- |
| | I   Information |
| | Commission |
| 2005/C 240/1 | Euro exchange rates | 1 |
| 2005/C 240/2 | Commission communication in the framework of the implementation of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (
  1
  ) | 2 |
| 2005/C 240/3 | 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
  ) | 17 |
| 2005/C 240/4 | Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections (
  1
  ) | 20 |
| 2005/C 240/5 | Publication of an application for registration pursuant to Article 6(2) of Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin | 23 |
| 2005/C 240/6 | Publication of an application for registration pursuant to Article 6(2) of Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin | 28 |
| 2005/C 240/7 | Publication of an application for registration pursuant to Article 6(2) of Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin | 32 |
| 2005/C 240/8 | State aid — The Netherlands — State aid No C 15/2005 (ex NN 34/2005) — Alleged irregular aid in favour of VAOP — Invitation to submit comments pursuant to Article 88(2) of the EC Treaty (
  1
  ) | 36 |
| 2005/C 240/9 | Announcement of the period for the monitoring and evaluation of the labour-rights situation in Belarus in view of the temporary withdrawal of benefits under the scheme of generalised tariff preferences (GSP) | 41 |
| 2005/C 240/0 | Non-opposition to a notified concentration (Case COMP/M.3938 — CRH/Quester) (
  1
  ) | 42 |

Notice No

Contents

page

I   Information

Commission

2005/C 240/1

Euro exchange rates

1

2005/C 240/2

Commission communication in the framework of the implementation of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (
  1
  )

1

2

2005/C 240/3

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

17

2005/C 240/4

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

1

20

2005/C 240/5

Publication of an application for registration pursuant to Article 6(2) of Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin

23

2005/C 240/6

Publication of an application for registration pursuant to Article 6(2) of Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin

28

2005/C 240/7

Publication of an application for registration pursuant to Article 6(2) of Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin

32

2005/C 240/8

State aid — The Netherlands — State aid No C 15/2005 (ex NN 34/2005) — Alleged irregular aid in favour of VAOP — Invitation to submit comments pursuant to Article 88(2) of the EC Treaty (
  1
  )

1

36

2005/C 240/9

Announcement of the period for the monitoring and evaluation of the labour-rights situation in Belarus in view of the temporary withdrawal of benefits under the scheme of generalised tariff preferences (GSP)

41

2005/C 240/0

Non-opposition to a notified concentration (Case COMP/M.3938 — CRH/Quester) (
  1
  )

1

42

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

---

(1)   Text with EEA relevance

1

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

EN

---

I Information

Commission

| 30.9.2005 | EN | Official Journal of the European Union | C 240/1 |
| --- | --- | --- | --- |

30.9.2005

EN

Official Journal of the European Union

C 240/1

---

Euro exchange rates (1)

29 September 2005

(2005/C 240/01)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2063 |
| JPY | Japanese yen | 135,92 |
| DKK | Danish krone | 7,4626 |
| GBP | Pound sterling | 0,68260 |
| SEK | Swedish krona | 9,3715 |
| CHF | Swiss franc | 1,5578 |
| ISK | Iceland króna | 75,72 |
| NOK | Norwegian krone | 7,8160 |
| BGN | Bulgarian lev | 1,9559 |
| CYP | Cyprus pound | 0,5731 |
| CZK | Czech koruna | 29,610 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 248,75 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,6961 |
| MTL | Maltese lira | 0,4293 |
| PLN | Polish zloty | 3,9009 |
| RON | Romanian leu | 3,5527 |
| SIT | Slovenian tolar | 239,53 |
| SKK | Slovak koruna | 38,870 |
| TRY | Turkish lira | 1,6270 |
| AUD | Australian dollar | 1,5831 |
| CAD | Canadian dollar | 1,4155 |
| HKD | Hong Kong dollar | 9,3590 |
| NZD | New Zealand dollar | 1,7386 |
| SGD | Singapore dollar | 2,0362 |
| KRW | South Korean won | 1 251,05 |
| ZAR | South African rand | 7,6876 |
| CNY | Chinese yuan renminbi | 9,7626 |
| HRK | Croatian kuna | 7,4345 |
| IDR | Indonesian rupiah | 12 430,92 |
| MYR | Malaysian ringgit | 4,548 |
| PHP | Philippine peso | 67,462 |
| RUB | Russian rouble | 34,3800 |
| THB | Thai baht | 49,529 |

Currency

Exchange rate

USD

US dollar

1,2063

JPY

Japanese yen

135,92

DKK

Danish krone

7,4626

GBP

Pound sterling

0,68260

SEK

Swedish krona

9,3715

CHF

Swiss franc

1,5578

ISK

Iceland króna

75,72

NOK

Norwegian krone

7,8160

BGN

Bulgarian lev

1,9559

CYP

Cyprus pound

0,5731

CZK

Czech koruna

29,610

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

248,75

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,6961

MTL

Maltese lira

0,4293

PLN

Polish zloty

3,9009

RON

Romanian leu

3,5527

SIT

Slovenian tolar

239,53

SKK

Slovak koruna

38,870

TRY

Turkish lira

1,6270

AUD

Australian dollar

1,5831

CAD

Canadian dollar

1,4155

HKD

Hong Kong dollar

9,3590

NZD

New Zealand dollar

1,7386

SGD

Singapore dollar

2,0362

KRW

South Korean won

1 251,05

ZAR

South African rand

7,6876

CNY

Chinese yuan renminbi

9,7626

HRK

Croatian kuna

7,4345

IDR

Indonesian rupiah

12 430,92

MYR

Malaysian ringgit

4,548

PHP

Philippine peso

67,462

RUB

Russian rouble

34,3800

THB

Thai baht

49,529

---

(1)

Source: reference exchange rate published by the ECB.

---

| 30.9.2005 | EN | Official Journal of the European Union | C 240/2 |
| --- | --- | --- | --- |

30.9.2005

EN

Official Journal of the European Union

C 240/2

---

Commission communication in the framework of the implementation of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

(2005/C 240/02)

(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 285:1996
  Sterilization — Steam sterilizers — Large sterilizers | — | |
| 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 455-1:2000
  Medical gloves for single use — Part 1: Requirements and testing for freedom from holes | EN 455-1:1993 | Date expired
  (30.4.2001) |
| CEN | EN 455-2:2000
  Medical gloves for single use — Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996) | EN 455-2:1995 | Date expired
  (30.4.2001) |
| CEN | EN 455-3:1999
  Medical gloves for single use — Part 3: Requirements and testing for biological evaluation | — | |
| CEN | EN 550:1994
  Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization | — | |
| CEN | EN 552:1994
  Sterilization of medical devices — Validation and routine control of sterilization by irradiation | — | |
| EN 552:1994/A1:1999 | Note 3 | Date expired
  (30.11.1999) |
| EN 552:1994/A2:2000 | Note 3 | Date expired
  (31.5.2001) |
| CEN | EN 554:1994
  Sterilization of medical devices — Validation and routine control of sterilization by moist heat | — | |
| 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 556-2:2003
  Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices | — | |
| 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 737-1:1998
  Medical gas pipeline systems — Part 1: Terminal units for compressed medical gases and vacuum | — | |
| CEN | EN 737-2:1998
  Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems — Basic requirements | — | |
| EN 737-2:1998/A1:1999 | Note 3 | Date expired
  (30.6.2000) |
| CEN | EN 737-3:1998
  Medical gas pipeline systems — Part 3: Pipelines for compressed medical gases and vacuum | — | |
| EN 737-3:1998/A1:1999 | Note 3 | Date expired
  (30.6.2000) |
| CEN | EN 737-4:1998
  Medical gas pipeline systems — Part 4: Terminal units for anaesthetic gas scavenging systems | — | |
| CEN | EN 738-1:1997
  Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow metering devices | — | |
| EN 738-1:1997/A1:2002 | Note 3 | Date expired
  (31.10.2002) |
| CEN | EN 738-2:1998
  Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators | — | |
| CEN | EN 738-3:1998
  Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves | — | |
| EN 738-3:1998/A1:2002 | Note 3 | Date expired
  (31.10.2002) |
| CEN | EN 738-4:1998
  Pressure regulators for use with medical gases — Part 4: Low-pressure regulators intended for incorporation into medical equipment | — | |
| EN 738-4:1998/A1:2002 | Note 3 | Date expired
  (31.10.2002) |
| CEN | EN 739:1998
  Low-pressure hose assemblies for use with medical gases | — | |
| EN 739:1998/A1:2002 | Note 3 | Date expired
  (31.10.2002) |
| CEN | EN 740:1998
  Anaesthetic workstations and their modules — Particular requirements | — | |
| EN 740:1998/A1:2004 | Note 3 | Date expired
  (31.7.2004) |
| EN 740:1998/AC:1998 | | |
| 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 794-3:1998
  Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators | — | |
| EN 794-3:1998/A1:2005 | Note 3 | 31.12.2005 |
| CEN | EN 864:1996
  Medical electrical equipment — Capnometers for use with humans — Particular requirements | — | |
| CEN | EN 867-2:1997
  Non-biological systems for use in sterilizers — Part 2: Process indicators (Class A) | — | |
| CEN | EN 867-3:1997
  Non-biological systems for use in sterilizers — Part 3: Specification for Class B indicators for use in the Bowie and Dick test | — | |
| CEN | EN 868-1:1997
  Packaging materials and systems for medical devices which are to be sterilized — Part 1: General requirements and test methods | — | |
| CEN | EN 980:2003
  Graphical symbols for use in the labelling of medical devices | EN 980:1996 | Date expired
  (31.10.2003) |
| CEN | EN 1041:1998
  Information supplied by the manufacturer with medical devices | — | |
| CEN | EN 1060-1:1995
  Non-invasive sphygmomanometers — Part 1: General requirements | — | |
| EN 1060-1:1995/A1:2002 | Note 3 | Date expired
  (30.11.2002) |
| CEN | EN 1060-2:1995
  Non-invasive sphygmomanometers — Part 2: Supplementary requirements for mechanical sphygmomanometers | — | |
| CEN | EN 1060-3:1997
  Non-invasive sphygmomanometers — Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems | — | |
| CEN | EN 1060-4:2004
  Non-invasive sphygmomanometers — Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers | — | |
| CEN | EN 1089-3:2004
  Transportable gas cylinders — Gas cylinder identification (excluding LPG) — Part 3: Colour coding | EN 1089-3:1997 | Date expired
  (31.10.2004) |
| CEN | EN 1174-1:1996
  Sterilization of medical devices — Estimation of the population of micro-organisms on product — Part 1: Requirements | — | |
| CEN | EN 1174-2:1996
  Sterilization of medical devices — Estimation of the population of micro-organisms on product — Part 2: Guidance | — | |
| CEN | EN 1174-3:1996
  Sterilization of medical devices — Estimation of the population of micro-organisms on product — Part 3: Guide to the methods for validation of microbiological techniques | — | |
| 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 1281-2:1995
  Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified) | — | |
| CEN | EN 1282-2:2005
  Tracheostomy tubes — Part 2: Paediatric tubes (ISO 5366-3:2001, modified) | EN 1282-2:1997 | 31.12.2005 |
| CEN | EN 1422:1997
  Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods | — | |
| CEN | EN 1618:1997
  Catheters other than intravascular catheters — Test methods for common properties | — | |
| CEN | EN 1639:2004
  Dentistry — Medical devices for dentistry — Instruments | EN 1639:1996 | Date expired
  (31.12.2004) |
| CEN | EN 1640:2004
  Dentistry — Medical devices for dentistry — Equipment | EN 1640:1996 | Date expired
  (31.12.2004) |
| CEN | EN 1641:2004
  Dentistry — Medical devices for dentistry — Materials | EN 1641:1996 | Date expired
  (31.12.2004) |
| CEN | EN 1642:2004
  Dentistry — Medical devices for dentistry — Dental implants | EN 1642:1996 | Date expired
  (31.12.2004) |
| CEN | EN 1707:1996
  Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Lock fittings | — | |
| CEN | EN 1782:1998
  Tracheal tubes and connectors | — | |
| CEN | EN 1789:1999
  Medical vehicles and their equipment — Road ambulances | — | |
| EN 1789:1999/A1:2003 | Note 3 | Date expired
  (30.9.2003) |
| CEN | EN 1820:2005
  Anaesthetic reservoir bags (ISO 5362:2000, modified) | EN 1820:1997 | 31.12.2005 |
| CEN | EN 1865:1999
  Specifications for stretchers and other patient handling equipment used in road ambulances | — | |
| CEN | EN 1970:2000
  Adjustable beds for disabled persons — Requirements and test methods | — | |
| EN 1970:2000/A1:2005 | Note 3 | 30.9.2005 |
| CEN | EN 1985:1998
  Walking aids — General requirements and test methods | — | |
| CEN | EN ISO 4074:2002
  Natural latex rubber condoms — Requirements and test methods (ISO 4074:2002) | EN 600:1996 | 31.8.2005 |
| 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 5356-1:2004
  Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets (ISO 5356-1:2004) | EN 1281-1:1997 | Date expired
  (30.11.2004) |
| CEN | EN ISO 5366-1:2004
  Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000) | EN 1282-1:1996 | Date expired
  (31.1.2005) |
| CEN | EN ISO 7376:2003
  Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation (ISO 7376:2003) | EN 1819:1997 | Date expired
  (30.6.2004) |
| CEN | EN ISO 7439:2002
  Copper-bearing intra-uterine contraceptive devices — Requirements, tests (ISO 7439:2002) | — | |
| CEN | EN ISO 7886-3:2005
  Sterile hypodermic syringes for single use — Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005) | — | |
| CEN | EN ISO 8185:1997
  Humidifiers for medical use — General requirements for humidification systems (ISO 8185:1997) | — | |
| CEN | EN ISO 8359:1996
  Oxygen concentrators for medical use — Safety requirements (ISO 8359:1996) | — | |
| CEN | EN ISO 8835-4:2004
  Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) | — | |
| CEN | EN ISO 8835-5:2004
  Inhalational anaesthesia systems — Part 5: Anaesthesia ventilators (ISO 8835-5:2004) | — | |
| EN ISO 8835-5:2004/AC:2004 | | |
| CEN | EN ISO 9360-1:2000
  Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) | — | |
| CEN | EN ISO 9360-2:2002
  Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) | — | |
| CEN | EN ISO 9713:2004
  Neurosurgical implants — Self-closing intracranial aneurysm clips (ISO 9713:2002) | — | |
| CEN | EN ISO 9919:2005
  Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) | EN 865:1997 | 30.9.2005 |
| CEN | EN ISO 10079-1:1999
  Medical suction equipment — Part 1: Electrically powered suction equipment — Safety requirements (ISO 10079-1:1999) | EN ISO 10079-1:1996 | Date expired
  (29.2.2000) |
| CEN | EN ISO 10079-2:1999
  Medical suction equipment — Part 2: Manually powered suction equipment (ISO 10079-2:1999) | EN ISO 10079-2:1996 | Date expired
  (29.2.2000) |
| CEN | EN ISO 10079-3:1999
  Medical suction equipment — Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1999) | EN ISO 10079-3:1996 | Date expired
  (29.2.2000) |
| CEN | EN ISO 10535:1998
  Hoists for the transfer of disabled persons — Requirements and test methods (ISO 10535:1998) | — | |
| CEN | EN ISO 10555-1:1996
  Sterile, single-use intravascular catheters — Part 1: General requirements (ISO 10555-1:1995) | — | |
| EN ISO 10555-1:1996/A1:1999 | Note 3 | Date expired
  (31.1.2000) |
| EN ISO 10555-1:1996/A2:2004 | Note 3 | Date expired
  (30.11.2004) |
| CEN | EN ISO 10651-2:2004
  Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) | EN 794-2:1997 | Date expired
  (31.1.2005) |
| CEN | EN ISO 10651-4:2002
  Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) | — | |
| CEN | EN ISO 10651-6:2004
  Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) | — | |
| CEN | EN ISO 10993-1:2003
  Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003) | — | |
| CEN | EN ISO 10993-3:2003
  Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003) | EN 30993-3:1993 | Date expired
  (30.4.2004) |
| CEN | EN ISO 10993-4:2002
  Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002) | EN 30993-4:1993 | Date expired
  (30.4.2003) |
| CEN | EN ISO 10993-5:1999
  Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999) | EN 30993-5:1994 | Date expired
  (30.11.1999) |
| CEN | EN ISO 10993-7:1995
  Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995) | — | |
| CEN | EN ISO 10993-9:1999
  Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) | — | |
| CEN | EN ISO 10993-10:2002
  Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) | EN ISO 10993-10:1995 | Date expired
  (31.3.2003) |
| CEN | EN ISO 10993-11:1995
  Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:1993) | — | |
| CEN | EN ISO 10993-12:2004
  Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2002) | EN ISO 10993-12:1996 | Date expired
  (31.5.2005) |
| CEN | EN ISO 10993-13:1998
  Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) | — | |
| CEN | EN ISO 10993-14:2001
  Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) | — | |
| CEN | EN ISO 10993-15:2000
  Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) | — | |
| CEN | EN ISO 10993-16:1997
  Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) | — | |
| CEN | EN ISO 10993-17:2002
  Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) | — | |
| CEN | EN ISO 11197:2004
  Medical supply units (ISO 11197:2004) | EN 793:1997 | Date expired
  (30.6.2005) |
| CEN | EN ISO 11990:2003
  Optics and optical instruments — Lasers and laser-related equipment — Determination of laser resistance of tracheal tube shafts (ISO 11990:2003) | EN ISO 11990:1999 | Date expired
  (31.10.2003) |
| CEN | EN 12006-1:1999
  Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 1: Heart valve substitutes | — | |
| CEN | EN 12006-2:1998
  Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 2: Vascular prostheses including cardiac valve conduits | — | |
| CEN | EN 12006-3:1998
  Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 3: Endovascular devices | — | |
| CEN | EN 12010:1998
  Non-active surgical implants — Joint replacement implants — Particular requirements | — | |
| CEN | EN 12011:1998
  Instrumentation to be used in association with non-active surgical implants — General requirements | — | |
| CEN | EN 12182:1999
  Technical aids for disabled persons — General requirements and test methods | — | |
| CEN | EN 12183:1999
  Manually propelled wheelchairs — Requirements and test methods | — | |
| CEN | EN 12184:1999
  Electrically powered wheelchairs, scooters and their charges — Requirements and test methods | — | |
| CEN | EN 12218:1998
  Rail systems for supporting medical equipment | — | |
| EN 12218:1998/A1:2002 | Note 3 | Date expired
  (31.10.2002) |
| 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 12342:1998
  Breathing tubes intended for use with anaesthetic apparatus and ventilators | — | |
| CEN | EN 12442-1:2000
  Animal tissues and their derivatives utilized in the manufacture of medical devices — Part 1: Analysis and management of risk | — | |
| CEN | EN 12442-2:2000
  Animal tissues and their derivatives utilized in the manufacture of medical devices — Part 2: Controls on sourcing, collection and handling | — | |
| CEN | EN 12442-3:2000
  Animal tissues and their derivatives utilized in the manufacture of medical devices — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents | — | |
| CEN | EN 12470-1:2000
  Clinical thermometers — Part 1: Metallic liquid-in-glass thermometers with maximum device | — | |
| CEN | EN 12470-2:2000
  Clinical thermometers — Part 2: Phase change type (dot matrix) thermometers | — | |
| CEN | EN 12470-3:2000
  Clinical thermometers — Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device | — | |
| CEN | EN 12470-4:2000
  Clinical thermometers — Part 4: Performance of electrical thermometers for continuous measurement | — | |
| CEN | EN 12470-5:2003
  Clinical thermometers — Part 5: Performance of infra-red ear thermometers (with maximum device) | — | |
| CEN | EN 12523:1999
  External limb prostheses and external orthoses — Requirements and test methods | — | |
| CEN | EN 12563:1998
  Non-active surgical implants — Joint replacement implants — Specific requirements for hip joint replacement implants | — | |
| CEN | EN 12564:1998
  Non-active surgical implants — Joint replacement implants — Specific requirements for knee joint replacement implants | — | |
| CEN | EN ISO 12870:2004
  Ophthalmic optics — Spectacle frames — Requirements and test methods (ISO 12870:2004) | EN ISO 12870:1997 | Date expired
  (28.2.2005) |
| CEN | EN 13014:2000
  Connections for gas sampling tubes to anaesthetic and respiratory equipment | — | |
| CEN | EN 13060:2004
  Small steam sterilizers | — | |
| CEN | EN 13220:1998
  Flow-metering devices for connection to terminal units of medical gas pipeline systems | — | |
| CEN | EN 13221:2000
  High-pressure flexible connections for use with medical gases | — | |
| CEN | EN 13328-1:2001
  Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance | — | |
| CEN | EN 13328-2:2002
  Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects | — | |
| EN 13328-2:2002/A1:2003 | Note 3 | Date expired
  (30.6.2004) |
| CEN | EN ISO 13485:2003
  Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) | EN ISO 13488:2000
  EN ISO 13485:2000 | 31.7.2006 |
| CEN | EN 13503-8:2000
  Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements (ISO 11979-8:1999, modified) | — | |
| CEN | EN 13544-1:2001
  Respiratory therapy equipment — Part 1: Nebulizing systems and their components | — | |
| EN 13544-1:2001/A1:2004 | Note 3 | Date expired
  (31.12.2004) |
| CEN | EN 13544-2:2002
  Respiratory therapy equipment — Part 2: Tubing and connectors | — | |
| CEN | EN 13544-3:2001
  Respiratory therapy equipment — Part 3: Air entrainment devices | — | |
| CEN | EN 13624:2003
  Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area — Test method and requirements (phase 2, step 1) | — | |
| CEN | EN 13718-1:2002
  Air, water and difficult terrain ambulances — Part 1: Medical device interface requirements for the continuity of patient care | — | |
| CEN | EN 13718-2:2002
  Air, water and difficult terrain ambulances — Part 2: Operational and technical requirements for the continuity of patient care | — | |
| CEN | EN 13726-1:2002
  Test methods for primary wound dressings — Part 1: Aspects of absorbency | — | |
| CEN | EN 13726-2:2002
  Test methods for primary wound dressings — Part 2: Moisture vapour transmission rate of permeable film dressings | — | |
| CEN | EN 13727:2003
  Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area — Test method and requirements (phase 2, step 1) | — | |
| CEN | EN 13795-1:2002
  Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Part 1: General requirements for manufacturers, processors and products | — | |
| CEN | EN 13795-2:2004
  Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 2: Test methods | — | |
| CEN | EN 13824:2004
  Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements | — | |
| CEN | EN 13826:2003
  Peak expiratory flow meters | — | |
| CEN | EN 13867:2002
  Concentrates for haemodialysis and related therapies | — | |
| CEN | EN 13976-1:2003
  Rescue systems — Transportation of incubators — Part 1: Interface conditions | — | |
| CEN | EN 13976-2:2003
  Rescue systems — Transportation of incubators — Part 2: System requirements | — | |
| CEN | EN 14079:2003
  Non-active medical devices — Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze | — | |
| CEN | EN ISO 14155-1:2003
  Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003) | EN 540:1993 | Date expired
  (31.8.2003) |
| CEN | EN ISO 14155-2:2003
  Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003) | — | |
| CEN | EN ISO 14160:1998
  Sterilization of single-use medical devices incorporating materials of animal origin — Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998) | — | |
| CEN | EN 14180:2003
  Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing | — | |
| CEN | EN 14299:2004
  Non active surgical implants — Particular requirements for cardiac and vascular implants — Specific requirements for arterial stents | — | |
| CEN | EN 14348:2005
  Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants — Test methods and requirements (phase 2, step 1) | — | |
| CEN | EN ISO 14408:2005
  Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information (ISO 14408:2005) | — | |
| CEN | EN ISO 14534:2002
  Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements (ISO 14534:2002) | EN ISO 14534:1997 | Date expired
  (31.12.2002) |
| CEN | EN ISO 14602:1998
  Non-active surgical implants — Implants for Osteosynthesis — Particular requirements (ISO 14602:1998) | — | |
| CEN | EN ISO 14630:2005
  Non-active surgical implants — General requirements (ISO 14630:2005) | EN ISO 14630:1997 | 30.11.2005 |
| CEN | EN ISO 14889:2003
  Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses (ISO 14889:2003) | EN ISO 14889:1997 | Date expired
  (30.11.2003) |
| 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 15001:2004
  Anaesthetic and respiratory equipment — Compatibility with oxygen (ISO 15001:2003) | — | |
| CEN | EN ISO 15004:1997
  Ophthalmic instruments — Fundamental requirements and test methods (ISO 15004:1997) | — | |
| CEN | EN ISO 15225:2000
  Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) | — | |
| EN ISO 15225:2000/A1:2004 | Note 3 | Date expired
  (31.8.2004) |
| CEN | EN ISO 15747:2005
  Plastics containers for intravenous injection (ISO 15747:2003) | — | |
| CEN | EN ISO 17510-1:2002
  Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy devices (ISO 17510-1:2002) | — | |
| CEN | EN ISO 17510-2:2003
  Sleep apnoea breathing therapy — Part 2: Masks and application accessories (ISO 17510-2:2003) | — | |
| CEN | EN ISO 17664:2004
  Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) | — | |
| CEN | EN ISO 18777:2005
  Transportable liquid oxygen systems for medical use — Particular requirements (ISO 18777:2005) | — | |
| CEN | EN ISO 18778:2005
  Respiratory equipment — Infant monitors — Particular requirements (ISO 18778:2005) | — | |
| CEN | EN ISO 18779:2005
  Medical devices for conserving oxygen and oxygen mixtures — Particular requirements (ISO 18779:2005) | — | |
| CEN | EN 20594-1:1993
  Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements (ISO 594-1:1986) | — | |
| EN 20594-1:1993/A1:1997 | Note 3 | Date expired
  (31.5.1998) |
| CEN | EN ISO 21647:2004
  Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004) | EN ISO 11196:1997
  EN 12598:1999 | Date expired
  (31.5.2005) |
| CEN | EN ISO 22612:2005
  Clothing for protection against infectious agents — Test method for resistance to dry microbial penetration (ISO 22612:2005) | — | |
| CEN | EN 27740:1992
  Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) | — | |
| EN 27740:1992/A1:1997 | Note 3 | Date expired
  (31.5.1998) |
| CEN | EN 30993-6:1994
  Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:1994) | — | |
| CEN | EN 46003:1999
  Quality systems — Medical devices — Particular requirements for the application of EN ISO 9003 | — | |

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 285:1996

Sterilization — Steam sterilizers — Large sterilizers

—

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 455-1:2000

Medical gloves for single use — Part 1: Requirements and testing for freedom from holes

EN 455-1:1993

Date expired

(30.4.2001)

CEN

EN 455-2:2000

Medical gloves for single use — Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996)

EN 455-2:1995

Date expired

(30.4.2001)

CEN

EN 455-3:1999

Medical gloves for single use — Part 3: Requirements and testing for biological evaluation

—

CEN

EN 550:1994

Sterilization of medical devices — Validation and routine control of ethylene oxide sterilization

—

CEN

EN 552:1994

Sterilization of medical devices — Validation and routine control of sterilization by irradiation

—

EN 552:1994/A1:1999

Note 3

Date expired

(30.11.1999)

EN 552:1994/A2:2000

Note 3

Date expired

(31.5.2001)

CEN

EN 554:1994

Sterilization of medical devices — Validation and routine control of sterilization by moist heat

—

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 556-2:2003

Sterilization of medical devices — Requirements for medical devices to be designated ‘STERILE’ — Part 2: Requirements for aseptically processed medical devices

—

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 737-1:1998

Medical gas pipeline systems — Part 1: Terminal units for compressed medical gases and vacuum

—

CEN

EN 737-2:1998

Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems — Basic requirements

—

EN 737-2:1998/A1:1999

Note 3

Date expired

(30.6.2000)

CEN

EN 737-3:1998

Medical gas pipeline systems — Part 3: Pipelines for compressed medical gases and vacuum

—

EN 737-3:1998/A1:1999

Note 3

Date expired

(30.6.2000)

CEN

EN 737-4:1998

Medical gas pipeline systems — Part 4: Terminal units for anaesthetic gas scavenging systems

—

CEN

EN 738-1:1997

Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow metering devices

—

EN 738-1:1997/A1:2002

Note 3

Date expired

(31.10.2002)

CEN

EN 738-2:1998

Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators

—

CEN

EN 738-3:1998

Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves

—

EN 738-3:1998/A1:2002

Note 3

Date expired

(31.10.2002)

CEN

EN 738-4:1998

Pressure regulators for use with medical gases — Part 4: Low-pressure regulators intended for incorporation into medical equipment

—

EN 738-4:1998/A1:2002

Note 3

Date expired

(31.10.2002)

CEN

EN 739:1998

Low-pressure hose assemblies for use with medical gases

—

EN 739:1998/A1:2002

Note 3

Date expired

(31.10.2002)

CEN

EN 740:1998

Anaesthetic workstations and their modules — Particular requirements

—

EN 740:1998/A1:2004

Note 3

Date expired

(31.7.2004)

EN 740:1998/AC:1998

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 794-3:1998

Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators

—

EN 794-3:1998/A1:2005

Note 3

31.12.2005

CEN

EN 864:1996

Medical electrical equipment — Capnometers for use with humans — Particular requirements

—

CEN

EN 867-2:1997

Non-biological systems for use in sterilizers — Part 2: Process indicators (Class A)

—

CEN

EN 867-3:1997

Non-biological systems for use in sterilizers — Part 3: Specification for Class B indicators for use in the Bowie and Dick test

—

CEN

EN 868-1:1997

Packaging materials and systems for medical devices which are to be sterilized — Part 1: General requirements and test methods

—

CEN

EN 980:2003

Graphical symbols for use in the labelling of medical devices

EN 980:1996

Date expired

(31.10.2003)

CEN

EN 1041:1998

Information supplied by the manufacturer with medical devices

—

CEN

EN 1060-1:1995

Non-invasive sphygmomanometers — Part 1: General requirements

—

EN 1060-1:1995/A1:2002

Note 3

Date expired

(30.11.2002)

CEN

EN 1060-2:1995

Non-invasive sphygmomanometers — Part 2: Supplementary requirements for mechanical sphygmomanometers

—

CEN

EN 1060-3:1997

Non-invasive sphygmomanometers — Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

—

CEN

EN 1060-4:2004

Non-invasive sphygmomanometers — Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

—

CEN

EN 1089-3:2004

Transportable gas cylinders — Gas cylinder identification (excluding LPG) — Part 3: Colour coding

EN 1089-3:1997

Date expired

(31.10.2004)

CEN

EN 1174-1:1996

Sterilization of medical devices — Estimation of the population of micro-organisms on product — Part 1: Requirements

—

CEN

EN 1174-2:1996

Sterilization of medical devices — Estimation of the population of micro-organisms on product — Part 2: Guidance

—

CEN

EN 1174-3:1996

Sterilization of medical devices — Estimation of the population of micro-organisms on product — Part 3: Guide to the methods for validation of microbiological techniques

—

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 1281-2:1995

Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified)

—

CEN

EN 1282-2:2005

Tracheostomy tubes — Part 2: Paediatric tubes (ISO 5366-3:2001, modified)

EN 1282-2:1997

31.12.2005

CEN

EN 1422:1997

Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods

—

CEN

EN 1618:1997

Catheters other than intravascular catheters — Test methods for common properties

—

CEN

EN 1639:2004

Dentistry — Medical devices for dentistry — Instruments

EN 1639:1996

Date expired

(31.12.2004)

CEN

EN 1640:2004

Dentistry — Medical devices for dentistry — Equipment

EN 1640:1996

Date expired

(31.12.2004)

CEN

EN 1641:2004

Dentistry — Medical devices for dentistry — Materials

EN 1641:1996

Date expired

(31.12.2004)

CEN

EN 1642:2004

Dentistry — Medical devices for dentistry — Dental implants

EN 1642:1996

Date expired

(31.12.2004)

CEN

EN 1707:1996

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Lock fittings

—

CEN

EN 1782:1998

Tracheal tubes and connectors

—

CEN

EN 1789:1999

Medical vehicles and their equipment — Road ambulances

—

EN 1789:1999/A1:2003

Note 3

Date expired

(30.9.2003)

CEN

EN 1820:2005

Anaesthetic reservoir bags (ISO 5362:2000, modified)

EN 1820:1997

31.12.2005

CEN

EN 1865:1999

Specifications for stretchers and other patient handling equipment used in road ambulances

—

CEN

EN 1970:2000

Adjustable beds for disabled persons — Requirements and test methods

—

EN 1970:2000/A1:2005

Note 3

30.9.2005

CEN

EN 1985:1998

Walking aids — General requirements and test methods

—

CEN

EN ISO 4074:2002

Natural latex rubber condoms — Requirements and test methods (ISO 4074:2002)

EN 600:1996

31.8.2005

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 5356-1:2004

Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets (ISO 5356-1:2004)

EN 1281-1:1997

Date expired

(30.11.2004)

CEN

EN ISO 5366-1:2004

Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)

EN 1282-1:1996

Date expired

(31.1.2005)

CEN

EN ISO 7376:2003

Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation (ISO 7376:2003)

EN 1819:1997

Date expired

(30.6.2004)

CEN

EN ISO 7439:2002

Copper-bearing intra-uterine contraceptive devices — Requirements, tests (ISO 7439:2002)

—

CEN

EN ISO 7886-3:2005

Sterile hypodermic syringes for single use — Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

—

CEN

EN ISO 8185:1997

Humidifiers for medical use — General requirements for humidification systems (ISO 8185:1997)

—

CEN

EN ISO 8359:1996

Oxygen concentrators for medical use — Safety requirements (ISO 8359:1996)

—

CEN

EN ISO 8835-4:2004

Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

—

CEN

EN ISO 8835-5:2004

Inhalational anaesthesia systems — Part 5: Anaesthesia ventilators (ISO 8835-5:2004)

—

EN ISO 8835-5:2004/AC:2004

CEN

EN ISO 9360-1:2000

Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)

—

CEN

EN ISO 9360-2:2002

Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)

—

CEN

EN ISO 9713:2004

Neurosurgical implants — Self-closing intracranial aneurysm clips (ISO 9713:2002)

—

CEN

EN ISO 9919:2005

Medical electrical equipment — Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)

EN 865:1997

30.9.2005

CEN

EN ISO 10079-1:1999

Medical suction equipment — Part 1: Electrically powered suction equipment — Safety requirements (ISO 10079-1:1999)

EN ISO 10079-1:1996

Date expired

(29.2.2000)

CEN

EN ISO 10079-2:1999

Medical suction equipment — Part 2: Manually powered suction equipment (ISO 10079-2:1999)

EN ISO 10079-2:1996

Date expired

(29.2.2000)

CEN

EN ISO 10079-3:1999

Medical suction equipment — Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1999)

EN ISO 10079-3:1996

Date expired

(29.2.2000)

CEN

EN ISO 10535:1998

Hoists for the transfer of disabled persons — Requirements and test methods (ISO 10535:1998)

—

CEN

EN ISO 10555-1:1996

Sterile, single-use intravascular catheters — Part 1: General requirements (ISO 10555-1:1995)

—

EN ISO 10555-1:1996/A1:1999

Note 3

Date expired

(31.1.2000)

EN ISO 10555-1:1996/A2:2004

Note 3

Date expired

(30.11.2004)

CEN

EN ISO 10651-2:2004

Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)

EN 794-2:1997

Date expired

(31.1.2005)

CEN

EN ISO 10651-4:2002

Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

—

CEN

EN ISO 10651-6:2004

Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)

—

CEN

EN ISO 10993-1:2003

Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003)

—

CEN

EN ISO 10993-3:2003

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

EN 30993-3:1993

Date expired

(30.4.2004)

CEN

EN ISO 10993-4:2002

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002)

EN 30993-4:1993

Date expired

(30.4.2003)

CEN

EN ISO 10993-5:1999

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

EN 30993-5:1994

Date expired

(30.11.1999)

CEN

EN ISO 10993-7:1995

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995)

—

CEN

EN ISO 10993-9:1999

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

—

CEN

EN ISO 10993-10:2002

Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002)

EN ISO 10993-10:1995

Date expired

(31.3.2003)

CEN

EN ISO 10993-11:1995

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity (ISO 10993-11:1993)

—

CEN

EN ISO 10993-12:2004

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (ISO 10993-12:2002)

EN ISO 10993-12:1996

Date expired

(31.5.2005)

CEN

EN ISO 10993-13:1998

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)

—

CEN

EN ISO 10993-14:2001

Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

—

CEN

EN ISO 10993-15:2000

Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)

—

CEN

EN ISO 10993-16:1997

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)

—

CEN

EN ISO 10993-17:2002

Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

—

CEN

EN ISO 11197:2004

Medical supply units (ISO 11197:2004)

EN 793:1997

Date expired

(30.6.2005)

CEN

EN ISO 11990:2003

Optics and optical instruments — Lasers and laser-related equipment — Determination of laser resistance of tracheal tube shafts (ISO 11990:2003)

EN ISO 11990:1999

Date expired

(31.10.2003)

CEN

EN 12006-1:1999

Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 1: Heart valve substitutes

—

CEN

EN 12006-2:1998

Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 2: Vascular prostheses including cardiac valve conduits

—

CEN

EN 12006-3:1998

Non active surgical implants — Particular requirements for cardiac and vascular implants — Part 3: Endovascular devices

—

CEN

EN 12010:1998

Non-active surgical implants — Joint replacement implants — Particular requirements

—

CEN

EN 12011:1998

Instrumentation to be used in association with non-active surgical implants — General requirements

—

CEN

EN 12182:1999

Technical aids for disabled persons — General requirements and test methods

—

CEN

EN 12183:1999

Manually propelled wheelchairs — Requirements and test methods

—

CEN

EN 12184:1999

Electrically powered wheelchairs, scooters and their charges — Requirements and test methods

—

CEN

EN 12218:1998

Rail systems for supporting medical equipment

—

EN 12218:1998/A1:2002

Note 3

Date expired

(31.10.2002)

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 12342:1998

Breathing tubes intended for use with anaesthetic apparatus and ventilators

—

CEN

EN 12442-1:2000

Animal tissues and their derivatives utilized in the manufacture of medical devices — Part 1: Analysis and management of risk

—

CEN

EN 12442-2:2000

Animal tissues and their derivatives utilized in the manufacture of medical devices — Part 2: Controls on sourcing, collection and handling

—

CEN

EN 12442-3:2000

Animal tissues and their derivatives utilized in the manufacture of medical devices — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents

—

CEN

EN 12470-1:2000

Clinical thermometers — Part 1: Metallic liquid-in-glass thermometers with maximum device

—

CEN

EN 12470-2:2000

Clinical thermometers — Part 2: Phase change type (dot matrix) thermometers

—

CEN

EN 12470-3:2000

Clinical thermometers — Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device

—

CEN

EN 12470-4:2000

Clinical thermometers — Part 4: Performance of electrical thermometers for continuous measurement

—

CEN

EN 12470-5:2003

Clinical thermometers — Part 5: Performance of infra-red ear thermometers (with maximum device)

—

CEN

EN 12523:1999

External limb prostheses and external orthoses — Requirements and test methods

—

CEN

EN 12563:1998

Non-active surgical implants — Joint replacement implants — Specific requirements for hip joint replacement implants

—

CEN

EN 12564:1998

Non-active surgical implants — Joint replacement implants — Specific requirements for knee joint replacement implants

—

CEN

EN ISO 12870:2004

Ophthalmic optics — Spectacle frames — Requirements and test methods (ISO 12870:2004)

EN ISO 12870:1997

Date expired

(28.2.2005)

CEN

EN 13014:2000

Connections for gas sampling tubes to anaesthetic and respiratory equipment

—

CEN

EN 13060:2004

Small steam sterilizers

—

CEN

EN 13220:1998

Flow-metering devices for connection to terminal units of medical gas pipeline systems

—

CEN

EN 13221:2000

High-pressure flexible connections for use with medical gases

—

CEN

EN 13328-1:2001

Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance

—

CEN

EN 13328-2:2002

Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects

—

EN 13328-2:2002/A1:2003

Note 3

Date expired

(30.6.2004)

CEN

EN ISO 13485:2003

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

EN ISO 13488:2000

EN ISO 13485:2000

31.7.2006

CEN

EN 13503-8:2000

Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements (ISO 11979-8:1999, modified)

—

CEN

EN 13544-1:2001

Respiratory therapy equipment — Part 1: Nebulizing systems and their components

—

EN 13544-1:2001/A1:2004

Note 3

Date expired

(31.12.2004)

CEN

EN 13544-2:2002

Respiratory therapy equipment — Part 2: Tubing and connectors

—

CEN

EN 13544-3:2001

Respiratory therapy equipment — Part 3: Air entrainment devices

—

CEN

EN 13624:2003

Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area — Test method and requirements (phase 2, step 1)

—

CEN

EN 13718-1:2002

Air, water and difficult terrain ambulances — Part 1: Medical device interface requirements for the continuity of patient care

—

CEN

EN 13718-2:2002

Air, water and difficult terrain ambulances — Part 2: Operational and technical requirements for the continuity of patient care

—

CEN

EN 13726-1:2002

Test methods for primary wound dressings — Part 1: Aspects of absorbency

—

CEN

EN 13726-2:2002

Test methods for primary wound dressings — Part 2: Moisture vapour transmission rate of permeable film dressings

—

CEN

EN 13727:2003

Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area — Test method and requirements (phase 2, step 1)

—

CEN

EN 13795-1:2002

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Part 1: General requirements for manufacturers, processors and products

—

CEN

EN 13795-2:2004

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 2: Test methods

—

CEN

EN 13824:2004

Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements

—

CEN

EN 13826:2003

Peak expiratory flow meters

—

CEN

EN 13867:2002

Concentrates for haemodialysis and related therapies

—

CEN

EN 13976-1:2003

Rescue systems — Transportation of incubators — Part 1: Interface conditions

—

CEN

EN 13976-2:2003

Rescue systems — Transportation of incubators — Part 2: System requirements

—

CEN

EN 14079:2003

Non-active medical devices — Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze

—

CEN

EN ISO 14155-1:2003

Clinical investigation of medical devices for human subjects — Part 1: General requirements (ISO 14155-1:2003)

EN 540:1993

Date expired

(31.8.2003)

CEN

EN ISO 14155-2:2003

Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)

—

CEN

EN ISO 14160:1998

Sterilization of single-use medical devices incorporating materials of animal origin — Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998)

—

CEN

EN 14180:2003

Sterilizers for medical purposes — Low temperature steam and formaldehyde sterilizers — Requirements and testing

—

CEN

EN 14299:2004

Non active surgical implants — Particular requirements for cardiac and vascular implants — Specific requirements for arterial stents

—

CEN

EN 14348:2005

Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants — Test methods and requirements (phase 2, step 1)

—

CEN

EN ISO 14408:2005

Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information (ISO 14408:2005)

—

CEN

EN ISO 14534:2002

Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements (ISO 14534:2002)

EN ISO 14534:1997

Date expired

(31.12.2002)

CEN

EN ISO 14602:1998

Non-active surgical implants — Implants for Osteosynthesis — Particular requirements (ISO 14602:1998)

—

CEN

EN ISO 14630:2005

Non-active surgical implants — General requirements (ISO 14630:2005)

EN ISO 14630:1997

30.11.2005

CEN

EN ISO 14889:2003

Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses (ISO 14889:2003)

EN ISO 14889:1997

Date expired

(30.11.2003)

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 15001:2004

Anaesthetic and respiratory equipment — Compatibility with oxygen (ISO 15001:2003)

—

CEN

EN ISO 15004:1997

Ophthalmic instruments — Fundamental requirements and test methods (ISO 15004:1997)

—

CEN

EN ISO 15225:2000

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

—

EN ISO 15225:2000/A1:2004

Note 3

Date expired

(31.8.2004)

CEN

EN ISO 15747:2005

Plastics containers for intravenous injection (ISO 15747:2003)

—

CEN

EN ISO 17510-1:2002

Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy devices (ISO 17510-1:2002)

—

CEN

EN ISO 17510-2:2003

Sleep apnoea breathing therapy — Part 2: Masks and application accessories (ISO 17510-2:2003)

—

CEN

EN ISO 17664:2004

Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)

—

CEN

EN ISO 18777:2005

Transportable liquid oxygen systems for medical use — Particular requirements (ISO 18777:2005)

—

CEN

EN ISO 18778:2005

Respiratory equipment — Infant monitors — Particular requirements (ISO 18778:2005)

—

CEN

EN ISO 18779:2005

Medical devices for conserving oxygen and oxygen mixtures — Particular requirements (ISO 18779:2005)

—

CEN

EN 20594-1:1993

Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements (ISO 594-1:1986)

—

EN 20594-1:1993/A1:1997

Note 3

Date expired

(31.5.1998)

CEN

EN ISO 21647:2004

Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)

EN ISO 11196:1997

EN 12598:1999

Date expired

(31.5.2005)

CEN

EN ISO 22612:2005

Clothing for protection against infectious agents — Test method for resistance to dry microbial penetration (ISO 22612:2005)

—

CEN

EN 27740:1992

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

—

EN 27740:1992/A1:1997

Note 3

Date expired

(31.5.1998)

CEN

EN 30993-6:1994

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (ISO 10993-6:1994)

—

CEN

EN 46003:1999

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

—

| 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.

---

| 30.9.2005 | EN | Official Journal of the European Union | C 240/17 |
| --- | --- | --- | --- |

30.9.2005

EN

Official Journal of the European Union

C 240/17

---

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 240/03)

(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 | — | |
| 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 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) | — | |
| 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
  EN ISO 13485:2000 | 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 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

—

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 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)

—

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

EN ISO 13485:2000

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 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.

---

| 30.9.2005 | EN | Official Journal of the European Union | C 240/20 |
| --- | --- | --- | --- |

30.9.2005

EN

Official Journal of the European Union

C 240/20

---

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

Cases where the Commission raises no objections

(2005/C 240/04)

(Text with EEA relevance)

Date of adoption of the decision:

Member State: France

Aid No: E10/2005

Title: France licence fee

Objective: Financing of the French public service broadcasting France Télévision

Legal basis: Loi no 49-1032 du 30 juillet 1949

Budget: the amount varies on an annual basis

Duration: The above statuses constitute the basis for the ongoing financing of the public service broadcasting entrusted to France Télévision

Other information: Commission decision declaring that the aids granted to France Télévision constitute existing State aids within the meaning of Article 1(b) Procedural Regulation (EC) No 659/1999. Following the Commission request, the French authorities committed to modify some aspects of French public service broadcasting financing scheme so as to ensure its current compatibility with the common market.

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: Luxembourg

Aid No: N 205 C/2004 and N 205 D/2004

Title: Framework law on aid to small and medium-sized enterprises

Objective: Environmental protection; promotion of R&D activities

Legal basis: loi portant création d'«un cadre général des régimes d'aides en faveur du secteur des classes moyennes»

Budget: EUR 1 million (environment) and EUR 500 000 (R&D)

Aid intensity or amount:

| — | up to 40 % excluding bonus for environmental aid |
| --- | --- |

—

up to 40 % excluding bonus for environmental aid

| — | 100 % + 15 % for aid to decontaminate polluted sites |
| --- | --- |

—

100 % + 15 % for aid to decontaminate polluted sites

| — | 25 %, 50 % and 75 % for research aid according to the stage of research, excluding bonus |
| --- | --- |

—

25 %, 50 % and 75 % for research aid according to the stage of research, excluding bonus

Duration: 6 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/secretariat_general/sgb/state_aids/

Date of adoption of the decision:

Member State: United Kingdom

Aid No: N 206/2003

Title: Waterborne Freight Grant (WFG)

Objective: To encourage modal shift of freight from road to water by granting aid to new/existing coastal, short sea or inland waterway services provided that they avoid lorry journeys and that they generate environmental benefits within the UK

Legal basis: Transport Act 2000, section 272; Transport (Scotland) Act 2001, section 71

Budget: A total budget of GBP 60 million for the Freight Facilities Grant Scheme (FFG) and for the Waterborne Freight Grant (WFG) will be provided.

Duration: 6 years

Other information: The scheme is complementary to the existing Freight Facilities Grant (FFG) scheme (1)

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: France

Aid No: N 312/2003

Title: Reform of the method of financing Industrial Technical Centres (Centres Techniques Industriels — CTI) and Professional Centres for Technical Development (Centres Professionnels de Développement Technique — CPDE)

Objective: To promote mechanical engineering products, consumer goods and building materials (Consumer goods, mechanical engineering products, building materials)

Legal basis: loi 2001-692 du 1er août 2001 et loi de finance annuelle

Duration: From the date of Commission approval until 31.12.2004

Other information: The beneficiaries are CTIs and CPDEs in the consumer goods, mechanical engineering and building materials sectors

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: Germany (Land Saxony)

Aid No: N 548/04

Title: Aid to the Development of new or novel products and methods in the Free State of Saxony. — Prolongation of the Scheme NN 32/98

Objective: R&D

Legal basis: Förderrichtlinie des Sächsischen Staatsministeriums für Wirtschaft und Arbeit über die Gewährung von Zuwendungen für Projekte zur Entwicklung neuer oder neuartiger Produkte und Verfahren im Freistaat Sachsen (Einzelbetriebliche Projektförderung) vom 7. Februar 2001;

Vorläufige Sächsische Haushaltsordnung (SäHo) vom 19. Dezember 1990;

Vorläufige Verwaltungsvorschrift zu §§ 23, 44 SäHo

Budget: EUR 225 million

Intensity or amount: 50 % for industrial research; 25 % for pre-competitive development; plus 10 % SME-bonus (where applicable); plus 10 % bonus for effective cooperation between public R&D institutes and firms

Duration: 1.1.2005 — 31.12.2009

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 States: Italy

Aid No: N 582/04

Title: Aid to biofuels/tax benefit

Objective: Environmental protection

Legal basis: Art. 21 par. 6 del Decreto Legislativo 25 ottobre 1995 n. 504; legge del 30.12.2004 n. 311 (finanziaria 2005)

Aid intensity or amount: EUR 561 267 000

Duration: Until 30.6.2010

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 (Wales)

Aid No: N 597/2003

Title: Wood Energy Business Scheme

Objective: The objective of the scheme is to encourage the use of wood as a renewable source of energy in Wales. It funds projects that help the emergence of a wood fuel market in Wales.

Legal basis: 1967 Forestry Act

Budget: GBP 6 million (EUR 9 million) for the whole duration of the scheme.

Aid intensity or amount: Up to 40 % of eligible costs, with a bonus of 5 % in regions covered by Article 87(3)(c) and 10 % in regions covered by Article 87(3)(a). A further 10 % may be added for SMEs.

Duration: 3 years (until September 2007)

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: Belgium (Flemish region)

Aid No: N 608/2004

Title: Combined Heat and Power certificates

Objective: Environmental protection (Energy)

Legal basis: Besluit van de Vlaamse regering van 5 maart 2004 houdende de openbaredienstverplichting ter bevordering van de elektriciteitsopwekking in kwalitatieve warmtekrachtinstallaties

Intensity or amount: The measure does not constitute aid.

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/

---

(1)  N 649/2001 — UK — Freight Facilities Grant; Commission decision of 20.12.2001.

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| 30.9.2005 | EN | Official Journal of the European Union | C 240/23 |
| --- | --- | --- | --- |

30.9.2005

EN

Official Journal of the European Union

C 240/23

---

Publication of an application for registration pursuant to Article 6(2) of Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin

(2005/C 240/05)

This publication confers the right to object to the application pursuant to Articles 7 and 12d of the abovementioned Regulation. Any objection to this application must be submitted via the competent authority in a Member State, in a WTO member country or in a third country recognized in accordance with Article 12(3) within a time limit of six months from the date of this publication. The arguments for publication are set out below, in particular under 4.6, and are considered to justify the application within the meaning of Regulation (EEC) No 2081/92.

SUMMARY

COUNCIL REGULATION (EEC) No 2081/92

‘CAROTA DELL'ALTOPIANO DEL FUCINO’

EC No: IT/00270/21.01.2003

PDO ( ) PGI (X)

This note is a summary produced for information. For full details, interested parties and in particular the producers of the products covered by the PDO and the PGI in question are invited to consult the full version of the specifications at national services or associations or at the competent services of the European Commission (1).

1.   Responsible department in the Member State:

| Name: | Ministero delle Politiche Agricole e Forestali |
| --- | --- |
| Address: | Via XX Settembre n. 20 — I-00187 Roma |
| Tel.: | (06) 481 99 68 |
| Fax: | (06) 42 01 31 26 |
| E-mail: | qtc3@politicheagricole.it |

Name:

Ministero delle Politiche Agricole e Forestali

Address:

Via XX Settembre n. 20 — I-00187 Roma

Tel.:

(06) 481 99 68

Fax:

(06) 42 01 31 26

E-mail:

qtc3@politicheagricole.it

2.   Group:

2.1   Name: Consorzio di Tutela e valorizzazione degli ortaggi dell'altopiano del Fucino

2.2   Address:

| P.zza Torlonia, 91 67051 Avezzano (AQ) |
| --- |
| Tel.: (39) 863 50 22 31 |

P.zza Torlonia, 91 67051 Avezzano (AQ)

Tel.: (39) 863 50 22 31

2.3   Composition: producers/processors (x) other ( )

3.   Type of product:

Class 1.6 Fresh and processed fruits, vegetables and cereals — Carrot

4.   Specification:

(summary of requirements under Article 4(2))

4.1   Name: ‘Carota dell'Altopiano del Fucino’

4.2   Description: PGI ‘Carota dell'Altopiano del Fucino’ denotes carrots from the cultivar of the species ‘Daucus carota L.’, from the following varieties: MAESTRO (Vilmorin); PRESTO (Vilmorin); CONCERTO (Vilmorin); NAPOLI (Bejo); NANDOR (Clause); and DORDOGNE (SG).

The product should have the following characteristics:

Shape: cylindrical with a rounded tip, no root hairs.

Colour: intense orange, including the neck.

Content:

saccharose >3 %;

beta carotene >100 mg/kg;

ascorbic acid >5 mg/kg;

protein >1,2 %;

fibre >1,2 %.

Physical characteristics: crunchy flesh, breaking cleanly.

For all varieties, the commercial grade should be Extra and Prima.

4.3   Geographical area: The production area of ‘Carota dell'Altopiano del Fucino’ is the whole of the Altopiano del Fucino.

Its outer limit is defined by the Strada Provinciale Circonfucense and includes areas of land, subdivided by farm tracks and numbered plots, which are part of the following municipalities within the province of L'Aquila: Avezzano and surrounding villages, Celano and surrounding villages, Cerchio, Aielli, Collarmele, Pescina and surrounding villages, S. Benedetto dei Marsi, Gioia nei Marsi and surrounding villages, Lecce dei Marsi, Ortucchio, Trasacco, and Luco dei Marsi.

4.4   Proof of origin: Field cultivation of carrots began in the Altopiano del Fucino in 1950. The considerable income generated by the crop caught the attention of the farmers who consequently introduced carrots into the classic crop rotation in use in the Altopiano del Fucino.

Together with the economic benefits, carrot cultivation has extended the length of the crop rotation cycle, significantly reducing problems such as the development of plant diseases or the phenomenon of soil fatigue which has caused so many problems for crops in Fucino. In this regard, it should be emphasised that the right crop rotation is now relied upon for controlling sugar beet and potato nematodes — again made possible thanks to the introduction of the carrot — unlike the past approach of using fumigant nematicides.

The success of this crop makes it the key crop within the Altopiano del Fucino vegetable sector, as can also be seen in its popularity and renown on both national and foreign markets. This renown leads many producers to use the name ‘Fucino’ to market products that come from other production areas. This means that there is a need to guarantee the origin of the product through procedures to ensure the traceability of the various phases of production and checks on the producers and land areas where the Fucino carrot is grown, which should be listed in special registers. These checks should be carried out by an inspection body accredited by the Ministry of Agricultural and Forestry Policies, which should also check that PGI ‘Carota dell'Altopiano del Fucino’ adheres to the provisions of the product specification.

4.5   Method of production: The production techniques are the usual methods of carrot cultivation which can be broken down into the following steps:

Preparing the sowing bed by ploughing, milling to refine the surface, rolling, and fertilising without manure (to avoid browning the roots as a result of the organic matter decomposing during the growing cycle).

Sowing is entirely mechanical to ensure uniform distribution of the seeds and optimal crop density. The seed is planted in rows 35-40 cm apart, while within the row the seeds are planted in bands 5-7 cm wide, or alternatively in continuous double rows. The seed is planted at a depth of 0,5-1,5 cm.

Crop rotation must use a minimum four-year cycle.

Cultivation techniques are normally carried out mechanically.

Hoeing should take place at least once for pest control purposes and to reduce the compactness of the soil in order to ensure that the root can develop smoothly without constrictions or bending; and earthing up should take place at least once to avoid the neck turning green.

Irrigation should take place frequently with modest amounts of water which must not exceed 400 mc/ha per watering, using sprinklers. During the summer (July and August), irrigation, if necessary, must take place during the night or at the latest in the early morning.

Harvesting is carried out according to the most suitable degree of ripeness for the destination of the product and the type of packaging; it is done pursuant to the quality rules established by Community law and the characteristics set out in point 4.2.

When the product is intended for preservation, it should be harvested only when fully ripe and not before the period laid down for the cultivar, bearing in mind weather conditions, in order to ensure that the qualitative and organoleptic characteristics are preserved and maintained. During the summer (July and August), harvesting must be done in the early morning or late afternoon to avoid the product being exposed to the sun.

Once the carrots have been harvested, within four hours they must be transported to preparation centres where, before washing and packaging, they are chilled in order to ensure that their crunchiness, skin colour and flavour are maintained.

4.6   Link: The wide availability of the product within the area in question has encouraged related activities of preparation and packaging of the product as well as the establishment of processing plants to make the carrots into cubes or juices. All of this has contributed to creating a system which combines the excellent soil and climatic conditions of the area with the high level of specialisation of workers within the sector, whether as farmers or sellers, and the wealth of processing facilities, all of which ensures that the area is renowned for its carrots.

The Altopiano del Fucino, an area particularly well-known for vegetable production, is in south-central Italy, in the region known as the ‘Regione dei Parchi’ [parks region], Abruzzo.

The area is entirely flat, at a height of 700 m above sea level, 16 000 hectares in area, and surrounded by mountains of particular environmental interest such as those in the Abruzzo National Park, the Velino-Sirente park and Mounts Ernici and Simbruini.

Its agricultural origins go back no further than the end of the 19th century when Prince Alessandro Torlonia completed drainage of what was considered the third main lake of Italy: Il Lago del Fucino [the lake of Fucino].

Given this, the Altopiano del Fucino can be defined as ‘a young land, very productive and uncontaminated’, which, thanks to the nature of the soil and a particularly favourable climate, gives its vegetables unique organoleptic and nutritional characteristics which are recognised and appreciated by European consumers.

The soil is sandy-loam with a high level of active lime; the pH is between subalkaline and alkaline, with high levels of organic matter that can be attributed to the abundant manuring carried out by Fucino farmers every other year.

The climate is influenced by the presence of the surrounding mountain chains, the altitude and the relative humidity produced by the dense network of canals which ensure both that water needs are met during the growing season and that excess water is collected in winter. Essentially, winters are harsh and rainy while in the summer the whole area is affected by the heat, principally in July and half of August; and, as a result of the altitude, the temperature in the area varies considerably between night and day.

Following the land reclamation, crop development began with the first crops of potatoes and sugar beet, after which other crops, including carrots, were established in the Altopiano del Fucino, not just in order to have a better crop rotation but also to expand the specialisation of the farmers through their own initiative.

In the carrot, Fucino has found its primary crop, thanks in part to the unique qualities that the land itself gives the product.

Precisely because of the very loose and unstructured nature of the soil itself, the carrots produced in Fucino are notable for the shape of the vegetable which is mainly cylindrical with a rounded tip, free of root hairs and with no deep scarring where the leaves emerge, with a smooth skin and the whole root has an intense orange colour. Further characteristics can be found in terms of nutrients: carrots from the Altopiano del Fucino have high, well-balanced ascorbic acid (5 mg/kg) and total sugar contents. The carbohydrate content is above average and is accompanied by a 1,2 % protein content, while the fibre content (1,8 %) makes the trace amounts (calcium, iron, phosphorus and potassium) more easily absorbed.

The vitamins in ‘Carota dell'Altopiano del Fucino’ are another typical element which makes the product readily distinguishable: thiamine, riboflavin and above all carotene (> 100 mg/kg) are present at high levels.

4.7   Inspection body:

| Name: | AGROQUALITA |
| --- | --- |
| Address: | Via Montebello n. 8 — I-00185 Roma |
| Tel. | (06) 47 82 24 63 |
| Fax: | (06) 47 82 24 39 |

Name:

AGROQUALITA

Address:

Via Montebello n. 8 — I-00185 Roma

Tel.

(06) 47 82 24 63

Fax:

(06) 47 82 24 39

4.8   Labelling: The product should be marketed in suitable new packaging, made of wood, cardboard or plastic and identified by a suitable label bearing the following details:

the words ‘CAROTA DELL'ALTOPIANO DEL FUCINO IGP INDICAZIONE GEOGRAFICA PROTETTA’ in lettering at least twice the size of any other information on the label;

all details of the name, business name and address of the producing/packaging company and anything else required by the relevant legislation;

no additional information beyond what is set out in this specification is permitted.

Products prepared using PGI ‘Carota dell'Altopiano del Fucino’ as a raw material, even after preparation and processing, may be marketed in packaging bearing reference to the PGI, without using the Community logo, provided that:

PGI ‘Carota dell'Altopiano del Fucino’, certified as such, is the only type of carrot used;

companies using PGI ‘Carota dell'Altopiano del Fucino’ are listed in a special register held and updated by the body authorised by the Ministry of Agricultural and Forestry Policies, and inspected by it purely in terms of the protected product.

Where PGI ‘Carota dell'Altopiano del Fucino’ is not used exclusively, it may only be referred to, according to current legislation, as one of the ingredients of the product containing it or into which it has been processed or made.

Logo

The upper part of the logo consists of the words ‘Carota dell'Altopiano del Fucino’ in green Pantone P.C.S. (S 274-1 CVS), outlined in black, in the font Cooper blk hd bt, with an obvious variation in height to represent high ground in the middle of the phrase (Altopiano) and lower ground at the end (Fucino). Below are the words INDICAZIONE GEOGRAFICA PROTETTA in Arial rounded mt bold, in white surrounded by Pantone reflex blue. To the left of the wording is the EC PGI logo.

4.9   National requirements: —

---

(1)  European Commission, Directorate-General for Agriculture and Rural Development, Agricultural Products Quality Policy Unit, B-1049 Brussels.

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| 30.9.2005 | EN | Official Journal of the European Union | C 240/28 |
| --- | --- | --- | --- |

30.9.2005

EN

Official Journal of the European Union

C 240/28

---

Publication of an application for registration pursuant to Article 6(2) of Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin

(2005/C 240/06)

This publication confers the right to object to the application pursuant to Articles 7 and 12d of the abovementioned Regulation. Any objection to this application must be submitted via the competent authority in a Member State, in a WTO member country or in a third country recognized in accordance with Article 12(3) within a time limit of six months from the date of this publication. The arguments for publication are set out below, in particular under 4.6, and are considered to justify the application within the meaning of Regulation (EEC) No 2081/92.

SUMMARY

COUNCIL REGULATION (EEC) No 2081/92

‘PATACA DE GALICIA’ OR ‘PATATA DE GALICIA’.

EC No: ES/00205/06.09.2001

PDO ( ) PGI (X)

This summary has been drawn up for information purposes only. For full details, in particular of producers of the PGI concerned, please consult the complete version of the product specification obtainable at national level or from the European Commission (1).

1.   Responsible department in the Member State:

| Name: | Ministerio de Agricultura, Pesca y Alimentación
  Dirección General de Alimentación
  Subdirección General de Denominaciones de Calidad y Relaciones Interprofesionales y Contractuales |
| --- | --- |
| Address: | Paseo Infanta Isabel, 1, E-28071 Madrid |
| Tel.: | (34) 913 47 53 94 |
| Fax: | (34) 913 47 54 10 |

Name:

Ministerio de Agricultura, Pesca y Alimentación

Dirección General de Alimentación

Subdirección General de Denominaciones de Calidad y Relaciones Interprofesionales y Contractuales

Address:

Paseo Infanta Isabel, 1, E-28071 Madrid

Tel.:

(34) 913 47 53 94

Fax:

(34) 913 47 54 10

2.   Group:

2.1.A.   Name: S.A.T. N447 XUGA — A Limia.

2.2.A.   Address: Porto Alto. Xinzo de Limia. Ourense.

2.1.B.   Name: Cooperativa de Santaballa

2.2.B.   Address: Santaballa. Vilalba. Lugo.

2.3.   Composition: Producers/processors (x) others ( )

3.   Type of product:

Class 1.6. Fruit, vegetables and cereals — potato.

4.   Specification:

(Summary of requirements under Article 4(2))

4.1   Name: ‘Pataca de Galicia’ or ‘Patata de Galicia’.

4.2.   Description: Potato tubers for human consumption of the variety Solanum tuberosum L. cv. Kennebec.

The potatoes have a diameter of 40 mm to 80 mm (calculated as the length of one side of a square mesh through which the potato just passes without forcing) and the following characteristics:

oval to round form,

shallow eyes,

thin, smooth, bright yellow skin,

white flesh,

texture: firm to the touch, creamy when cooked, substantial in the mouth,

suitability for consumption: excellent, due to high dry-matter content and quality of colour, aroma and taste when cooked,

other characteristics: over 18 % dry matter and less than 0,4 % reducing sugars.

4.3.   Geographical area: The product protected by the PGI is grown and packed in an area comprising four subzones of the Autonomous Community of Galicia:

‘Bergantiños’: comprising the Municipalities of Carballo, Coristanco, Laracha, Malpica and Ponteceso (in the Province of La Coruña).

‘Terra Cha-A Mariña’: the entirety of the Municipalities of Abadín, Alfoz, Barreiros, Cospeito, Foz, Lourenzá Mondoñedo, Ribadeo, Trabada, Valadouro, Vilalba and Xermade (Province of Lugo).

‘Lemos’: the Municipalities of Monforte, Pantón and Saviñao (Province of Lugo).

A Limia: the entirety of the Municipalities of Baltar, Os Blancos, Calvos de Randín, Porqueira, Rairíz de Veiga, Sandiás, Sarreaus, Trasmiras, Vilar de Santos and Xinzo de Limia; and the parishes of Coedo and Torneiros in the Municipality of Allaríz; the parishes of Atas, Cualedro, Lucenza, Vilela and A Xironda in the Municipality of Cualedro; the parishes of Bóveda, Padreda, Seiró and Vilar de Barrio in the Municipality of Vilar de Barrio and the parishes of A Abeleda, Bobadela a Pinta, A Graña and Sobradelo in the Municipality of Xunqueira de Ambía (Province of Ourense).

4.4.   Proof of origin: The only potatoes eligible are Kennebecs for human consumption, grown from certified seed, or from the controlled re-utilisation of seed from the same holding, on suitable (disease-free) land located in the aforementioned subzones and registered with the Consejo Regulador (Regulatory Board).

Likewise only warehouses and packaging plants located in the said subzones and registered with the Consejo Regulador may package the product in question.

The potatoes are stored and packed in the subzones concerned in order to conserve their specific characteristics. Storage and packing facilities are traditionally located in the districts growing the best quality product, which allows for smoother and more efficient operation of the inspection body. The aim is also to minimise the risk of deterioration of the product during transport (increased risk of bumps, inappropriate temperatures, etc.) and unsuitable storage conditions.

The Consejo Regulador will, based on standard EN-45011's general criteria for product certification bodies, guarantee product traceability through a programme of inspection, identification and monitoring of the land sown (as given in the annual sowing declaration). It will also commission an outside company (extraneous to the sector) to conduct a quality control and improvement programme covering storage, handling, packaging and labelling.

4.5.   Method of production: The final product must meet the following minimum quality criteria: typical Kennebec appearance; whole, healthy and clean; free from cuts and bruises and with well-formed skins; firm and eyeless; no external defects, spots, nicks, deformations or discoloration; sufficient humidity; no extraneous tastes or smells.

Production must follow traditional methods throughout; the same plot may not be sown two years in succession; only certified seed or seed from the holding may be used; each plant must be given 75 × 32-35 cm of space; fertilisers must be organic with a correct C-N balance being maintained; earthing up is obligatory; there may be no watering in the 30 days prior to harvesting.

The maximum permitted yield for marketing under the PGI is 22 t/ha for non-irrigated land and 35 t/ha for irrigated land.

Produce must be sorted and packaged according to diameter (always between 40 and 80 mm) and place of origin. Packaging must be prior-approved by the Consejo Regulador, and feature sizes of 15, 10, 5, 4, 3, 2 and 1 kg net weight (25 kg is allowable for customers in the restaurant or hotel sectors.).

Produce must be transported separately in specialised vehicles and stored in premises prepared for the purpose and approved by the Consejo Regulador.

4.6.   Link:

Historical

Potato-growing in Galicia is mentioned as far back as 1607 but its real importance and social role date from the mid-18th century with the first legal disputes between peasants and tithe-collectors (1736). Its biggest expansion followed the 1768-69 cereals crisis, since when it has played a key role in the region's demographics.

Since the late 18th century, potato-growing (whether on irrigated or non-irrigated land) has been one of the most distinctive features of Galicia's agricultural landscape, as well as forming the nutritional basis both for the human population and for stockrearing (especially cattle and pigs) in the region.

The arrival of the potato and the generalisation of its growing contributed enormously to the development of subsistence mixed cropping; to this day almost all crop rotation in Galicia includes potatoes.

Natural

Relief: In general in Galicia higher altitudes are suitable for forestry and extensive livestock farming, intermediate areas for extensive tillage and free-range stockrearing and valleys and low-lying areas are excellent for fruit and vegetable growing.

Climate: Thanks to local climatic conditions, soil characteristics and painstaking growing practices, produce is of exceptional culinary quality. This fact, well known to traders and consumers, has made the quality Galician potato a much appreciated product commanding higher prices on both regional and national markets.

The relevant climatic conditions are plentiful rainfall (1 000-1 500 mm annually in the subzones in question) and mild temperatures, which allow for optimum growth of the potato plant without recourse to irrigation, facilitating continuous tuber development. A dry season in August and September, during which soil moisture drops, means that potatoes lose water just before harvesting and ripen perfectly, forming a robust and uniform skin, both of which factors (skin and water loss) enhance their conservability and culinary quality.

Soils: Recommended are loose-textured, non-stony soils, whose organic matter content is not too high. Predominant in the production areas are loamy and loamy-sandy soils with pH values of 5 to 6,5 — perfect for this crop. This texture allows tubers to form thin, uniform skins and to harvest clean (no need for washing). The slightly acidic pH militates against scab (a disease that turns the potato's skin rough and scabby, making it unsellable due to its unpleasant appearance).

Abundant manuring of the soil (about 25 to 30 tonnes per hectare) greatly benefits the crop's culinary quality.

4.7.   Inspection body:

| Name: | Consejo Regulador de la Denominación Específica ‘Pataca de Galicia’ |
| --- | --- |
| Address: | Finca Devesa, s/n. N-525, p.k. 200. 32630. Xinzo de Limia. Ourense |
| Tel.: | 988-46 26 50 |
| Fax: | 988-46 26 50 |

Name:

Consejo Regulador de la Denominación Específica ‘Pataca de Galicia’

Address:

Finca Devesa, s/n. N-525, p.k. 200. 32630. Xinzo de Limia. Ourense

Tel.:

988-46 26 50

Fax:

988-46 26 50

The Consejo Regulador meets the requirements of standard EN-45011, so conforming to Article 10 of Regulation (EEC) No 2081/92.

4.8.   Labelling: One third of the front of the packaging must be occupied by the designation logo and the words Protected Geographical Indication ‘Pataca de Galicia’. The packaging must also bear a numbered label issued by the Consejo Regulador, on which the logo is repeated.

4.9.   National requirements:

| — | Law No 25/1970 of 2 December 1970 on rules governing viticulture, wine and spirits. |
| --- | --- |

—

Law No 25/1970 of 2 December 1970 on rules governing viticulture, wine and spirits.

| — | Decree No 835/1972 of 28 March 1972 on detailed rules for the implementation of Law No 25/1970. |
| --- | --- |

—

Decree No 835/1972 of 28 March 1972 on detailed rules for the implementation of Law No 25/1970.

| — | Order of 25 January 1994 specifying the correlation between Spanish law and Regulation (EEC) No 2081/92 as regards designations of origin and geographical indications for agricultural products and foodstuffs. |
| --- | --- |

—

Order of 25 January 1994 specifying the correlation between Spanish law and Regulation (EEC) No 2081/92 as regards designations of origin and geographical indications for agricultural products and foodstuffs.

| — | Royal Decree 1643/1999 of 22 October 1999 laying down rules on the processing of applications for entry in the Community Register of Protected Designations of Origin and Protected Geographical Indications. |
| --- | --- |

—

Royal Decree 1643/1999 of 22 October 1999 laying down rules on the processing of applications for entry in the Community Register of Protected Designations of Origin and Protected Geographical Indications.

---

(1)  European Commission, Directorate-General for Agriculture, Agricultural product quality policy, B-1049 Brussels.

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| 30.9.2005 | EN | Official Journal of the European Union | C 240/32 |
| --- | --- | --- | --- |

30.9.2005

EN

Official Journal of the European Union

C 240/32

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Publication of an application for registration pursuant to Article 6(2) of Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin

(2005/C 240/07)

This publication confers the right to object to the application pursuant to Articles 7 and 12d of the abovementioned Regulation. Any objection to this application must be submitted via the competent authority in a Member State, in a WTO member country or in a third country recognized in accordance with Article 12(3) within a time limit of six months from the date of this publication. The arguments for publication are set out below, in particular under 4.6, and are considered to justify the application within the meaning of Regulation (EEC) No 2081/92.

SUMMARY

COUNCIL REGULATION (EEC) No 2081/92

‘CLÉMENTINE DE CORSE’

EC No: FR/00300/02.07.2003

PDO ( ) PGI ( X )

This summary has been drawn up for information purposes only. For full details, in particular for the producers of the PDO or PGI concerned, please consult the complete version of the product specification obtainable at national level or from the European Commission (1).

1.   Responsible department in the Member State:

| Name: | Institut National des Appellations d'Origine (INAO) |
| --- | --- |
| Address: | 51, rue d'Anjou, F-75008 Paris |
| Tel.: | (33-1) 53 89 80 00 |
| Fax: | (33-1) 42 25 57 97 |
| e-mail: | info@inao.gouv.fr |

Name:

Institut National des Appellations d'Origine (INAO)

Address:

51, rue d'Anjou, F-75008 Paris

Tel.:

(33-1) 53 89 80 00

Fax:

(33-1) 42 25 57 97

e-mail:

info@inao.gouv.fr

2.   Group:

2.1   Name: Association pour la Défense et la Promotion de la Clémentine de Corse (APRODEC)

2.2   Address:

| Maison Verte 15, avenue Jean Zuccarelli — F-20200 Bastia |
| --- |
| Tel.: (04-95) 31 74 34 |
| Fax: (04-95) 31 74 34 |
| e-mail: www.aprodec@wanadoo.fr |

Maison Verte 15, avenue Jean Zuccarelli — F-20200 Bastia

Tel.: (04-95) 31 74 34

Fax: (04-95) 31 74 34

e-mail: www.aprodec@wanadoo.fr

2.3   Composition: Producers/processors (X) Other (X): Nursery gardeners

3.   Type of product:

Class 1.6. Fresh or processed fruit, vegetables and cereals.

4.   Specification

(summary of requirements under Article 4(2))

4.1   Name: ‘Clémentine de Corse’

4.2   Description: The ‘Clémentine de Corse’ is a pipless clementine (Citrus clementina) which should have the following characteristics:

a reddish-orange colour with up to 1/5 of the surface area of the peel green,

medium-sized to small, with a maximum cross-section diameter of between 46 and 68 mm,

a minimum juice content of 42 %,

a tart taste,

an internal ripeness defined by the proportion (E/A) of sugar content of its juice (E), expressed in Brix concentration, to the acidity of the same juice (A) expressed in grams of citric acid per 100 g. The proportion E/A should be between 8 and 17, where the acidity level is between 0.65 and 1.4,

at least 30 % of the fruit marketed with one or two leaves attached to the stalk.

4.3   Geographical area: The Clémentine de Corse's geographical production area covers the territory or part of the territory of certain municipalities in the Haute-Corse and Corse-du-Sud Departments, which make up the island of Corsica in the Mediterranean. Most of the territory lies in coastal areas and is defined by altitude, slope and distance from the sea (see paragraph 4.6).

Production, harvesting and packaging operations are all done in the PGI area.

4.4   Proof of origin: Each operator is inspected in advance and authorised by the applicant group and the certification body. An initial identification of each orchard block ensures traceability, which is maintained throughout the various stages leading to the final consumer.

Each holding has an orchard list identifying the clementine tree parcels and orchard blocks. A grower's notebook makes it possible to keep track of the type of work carried out by grower and by orchard block. Each consignment of fruit harvested is identified by grower and by orchard block. It keeps this identification number on delivery to the packing station, for the ‘in’ and ‘out’ registration and on dispatching and transporting.

At the stage of sale to the final consumer, the packs are consequently identified by a number which includes the number of the packaged batch, the number of the packing station, the number of the holding and the orchard block from which the batch comes.

4.5   Method of production: The production system used by Corsican citrus fruit growers is based on agronomic management measures applied by orchard block.

An ‘orchard block’ is a number of clementine trees satisfying the following conditions: they comprise a single variety, are found in a homogeneous area (from the point of view of soil, exposure, altitude), managed in a uniform way, independent of other orchard blocks on the holding (times and methods of fertilising, irrigating, health protection, various treatments, pruning, harvesting etc.)

The know-how, obtained by pooling the experience of growers, the result of twenty years of local agronomic research and the development of tools to aid network decision-making make it possible to obtain a homogeneous and specific quality of fruit.

The clementine trees are pruned each year.

Fertilisation and irrigation are adjusted on the basis of regularly measured agronomic and analytic parameters. Parcels must have an irrigation system.

The fruit is harvested manually as soon as the fruit has attained its optimum colour and ripeness on the tree. There are several pickings to optimise the homogeneity of the batches harvested. The fruit is picked with its leaves to guarantee freshness.

Once the fruit has been picked, it may not be treated chemically. The use of colour enhancers is prohibited. At the packing stage the clementines are merely coated in natural wax and selected to comply with the quality standards for the ‘Corsican clementine’.

Size grading and packing operations take place in the PGI area to preserve the quality of the fruit, ensure produce traceability and facilitate checks on these stages of production. The rules on sizing, adopted collectively by the operators, make it possible to achieve a strict definition of a given size class. Fruit certified under the PGI comprises only sizes 1 to 5. The final PGI approval is based on packed consignments.

The packaging guarantees the identification and quality of the fruit until it is sold to the final consumer.

4.6   Link: While the cultivation of clementine trees plays an important part in the island's present-day economy, the tradition of growing citrus fruit is very old in Corsica. Some authors date its introduction from the very beginning of the Christian era with orchards situated especially on the terraces of the east coast foothills up to Cap Corse and Balagna. Apart from citrons, abandoned as cash crops on account of exceptionally bad weather conditions whose consequences were accentuated by an unfavourable economic situation, the island's old citrus fruit orchard also comprises orange, mandarin and lemon tree plantations, to which numerous writers allude and which survive here and there, bearing witness to the citrus-growing history of the island.

When the clementine tree was discovered in Algeria in the 1920s, plants were frequently brought to Corsica and planted there. Thereafter, detailed technical and economic studies conducted by the San Giuliano Agricultural Research Station, set up in Corsica at the end of the 1950s, demonstrated that the clementine tree should be given pride of place in citrus-growing in this region.

From 1964, citrus growers had no hesitation in planting clementine trees extensively. Nowadays, the Corsican orchard covers more than 2 000 hectares and gives an average yield of 22 000 tonnes.

Today it may be said that the Clémentine de Corse is clearly renowned and that the leaf attached to it is closely associated with its origin. The Corsican clementine is considered to be a specific product in terms of its qualities (size, taste, juiciness and colour).

That said, the specific qualities, while influenced by the growers, also reflect the soil and climate of the island, and its very insularity:

The citrus growing soil of the PGI area of Corsica is distinguished from the soil frequently found elsewhere in the Mediterranean by its granite and slate origins and by its often more acid and lighter character, resembling the soil found in temperate maritime climates. This soil makes it possible to develop specific rootstocks which give the fruit a special quality.

The maritime influence and neighbouring presence of mountains give the production area a special climate typified by moderate temperatures, high rainfall and atmospheric humidity, which help to produce a fruit with a specific colour and taste (more acidic, less sweet).

In addition, the fact that Corsica is an island helps to keep the clementine trees free from various serious viral diseases. The small size of the orchards, together with the mountainous terrain, is conducive to a better control over the evolution of parasites which could affect the fruit.

These are all reasons why the geographical area has been defined as where these soil and climatic conditions are to be found, together with a certain number of easily identifiable distinct criteria for indicating location, as follows:

Altitude: only areas between 2 and 300 metres are taken into consideration. Below two metres the soil is systematically unfavourable (salt, hydromorphic, peatland, too sandy). Above 300 metres the slope and climate are unfavourable.

Slope: it should be less than 25 %.

Distance from the sea: it should be less than 15 km, the limit for benefiting from the maritime climate.

4.7   Inspection body:

| Name: | CERTIPAQ. Centre de Certification des Produits Agricoles et Alimentaires de Qualité.
  Approved Certification Body under No CC 14 and accredited, in accordance with standard EN 45011, by COFRAC (Comité Français d'Accréditation) under No 7-10/97. |
| --- | --- |
| Address: | 9, avenue Georges V — 75008 Paris |
| Tel.: | 01 45 30 92 92 |
| Fax: | 01 45 30 93 00 |
| e-mail: | certipaq@certpaq.com |

Name:

CERTIPAQ. Centre de Certification des Produits Agricoles et Alimentaires de Qualité.

Approved Certification Body under No CC 14 and accredited, in accordance with standard EN 45011, by COFRAC (Comité Français d'Accréditation) under No 7-10/97.

Address:

9, avenue Georges V — 75008 Paris

Tel.:

01 45 30 92 92

Fax:

01 45 30 93 00

e-mail:

certipaq@certpaq.com

4.8   Labelling: The specific presentation for dispatching fruit under the PGI ‘Clémentine de Corse’ and the special labels on the packaging are validated by the inspection body.

In addition to the compulsory information in line with the commercial regulatory requirements, the following terms should appear on the unit packets ‘Protected Geographical Indication: Clémentine de Corse’.

4.9   National requirements: —

---

(1)  European Commission, Directorate-General for Agriculture and Rural Development, Agricultural product quality policy, B-1049 Brussels.

---

| 30.9.2005 | EN | Official Journal of the European Union | C 240/36 |
| --- | --- | --- | --- |

30.9.2005

EN

Official Journal of the European Union

C 240/36

---

STATE AID — THE NETHERLANDS

State aid No C 15/2005 (ex NN 34/2005)

Alleged irregular aid in favour of VAOP

Invitation to submit comments pursuant to Article 88(2) of the EC Treaty

(2005/C 240/08)

(Text with EEA relevance)

By means of the letter dated 3 May 2005 reproduced in the authentic language on the pages following this summary, the Commission notified The Netherlands of its decision to initiate the procedure laid down in Article 88(2) of the EC Treaty concerning the abovementioned measure.

Interested parties may submit their comments on the measure in respect of which the Commission is initiating the procedure within one month of the date of publication of this summary and the following letter, to:

| European Commission |
| --- |
| Directorate-General for Competition |
| State Aid Greffe |
| SPA 3, 6/5 |
| B-1049 Brussels |
| Fax (32-2) 296 12 42 |

European Commission

Directorate-General for Competition

State Aid Greffe

SPA 3, 6/5

B-1049 Brussels

Fax (32-2) 296 12 42

These comments will be communicated to The Netherlands. Confidential treatment of the identity of the interested party submitting the comments may be requested in writing, stating the reasons for the request.

TEXT OF SUMMARY

DESCRIPTION

| (1) | VAOP, which stands for Association of Suppliers of Waste Paper (‘Vereniging van Aanbieders van Oud Papier’), was created at the beginning of the nineties by several local districts of The Netherlands. The aim of this cooperative company with limited liability was to organise the optimal collection, initial treatment (sorting/pressing) and sale of the waste paper coming from the territory of the participating local districts. As VAOP subcontracts to other companies most of the work, like the transport and initial treatment, it had only 20 employees for a turnover of EUR 27,5 million in 2002. It charges the local authorities for the cost of collection and initial treatment of the waste paper coming from their territory but also transfer to them the revenues generated by the sale of the waste paper to the producers of recycled paper. The growth of VAOP activities was very important during the nineties. Its market share on the Dutch market of waste paper collection reached between 25 and 30 % at the beginning of the years 2000. It is also an important player on the market of waste paper initial treatment (sorting/pressing). In parallel, VAOP entered the Dutch market of glass splinter collection, where it became one of the market leaders. |
| --- | --- |

(1)

VAOP, which stands for Association of Suppliers of Waste Paper (‘Vereniging van Aanbieders van Oud Papier’), was created at the beginning of the nineties by several local districts of The Netherlands. The aim of this cooperative company with limited liability was to organise the optimal collection, initial treatment (sorting/pressing) and sale of the waste paper coming from the territory of the participating local districts. As VAOP subcontracts to other companies most of the work, like the transport and initial treatment, it had only 20 employees for a turnover of EUR 27,5 million in 2002. It charges the local authorities for the cost of collection and initial treatment of the waste paper coming from their territory but also transfer to them the revenues generated by the sale of the waste paper to the producers of recycled paper. The growth of VAOP activities was very important during the nineties. Its market share on the Dutch market of waste paper collection reached between 25 and 30 % at the beginning of the years 2000. It is also an important player on the market of waste paper initial treatment (sorting/pressing). In parallel, VAOP entered the Dutch market of glass splinter collection, where it became one of the market leaders.

| (2) | Whereas the Dutch law entrusts local authorities with the duty to collect separately waste paper and to offer it on the market for recycling, nothing precise is said about the operational organisation of these tasks. Therefore, a majority of Dutch local districts organise public tender procedures in order to award these works. VAOP regularly participates in these procedures and then enters in direct competition with private sector companies which offer the same services. |
| --- | --- |

(2)

Whereas the Dutch law entrusts local authorities with the duty to collect separately waste paper and to offer it on the market for recycling, nothing precise is said about the operational organisation of these tasks. Therefore, a majority of Dutch local districts organise public tender procedures in order to award these works. VAOP regularly participates in these procedures and then enters in direct competition with private sector companies which offer the same services.

| (3) | Two loans provided by public entities are the object of the current procedure. Firstly, in March 1998, the bank BNG granted a credit facility of NLG 16,3 million (EUR 7,4 million) to VAOP. On 31 December 1997, the consolidated balance sheet of VAOP indicated that the equity amounted to NLG 0,8 million (EUR 0,4 million) and the total of the balance sheet was NLG 17,3 million (EUR 7,9 million). Secondly, in the course of 2001, the local authorities accepted to transform overdue payments owed to them — in their role as suppliers of waste paper — by VAOP into a subordinated loan of NLG 3 million (EUR 1,3 million). VAOP had undergone heavy losses at the end of 2000. On 31 December 2000, the consolidated accounts of VAOP showed a negative equity of NLG 3,4 million (EUR 1,5 million). At the same date, the total of the balance sheet was NLG 32,1 million (EUR 14,5 million). |
| --- | --- |

(3)

Two loans provided by public entities are the object of the current procedure. Firstly, in March 1998, the bank BNG granted a credit facility of NLG 16,3 million (EUR 7,4 million) to VAOP. On 31 December 1997, the consolidated balance sheet of VAOP indicated that the equity amounted to NLG 0,8 million (EUR 0,4 million) and the total of the balance sheet was NLG 17,3 million (EUR 7,9 million). Secondly, in the course of 2001, the local authorities accepted to transform overdue payments owed to them — in their role as suppliers of waste paper — by VAOP into a subordinated loan of NLG 3 million (EUR 1,3 million). VAOP had undergone heavy losses at the end of 2000. On 31 December 2000, the consolidated accounts of VAOP showed a negative equity of NLG 3,4 million (EUR 1,5 million). At the same date, the total of the balance sheet was NLG 32,1 million (EUR 14,5 million).

ASSESSMENT

| (4) | The size of the loan granted by BNG compared among others to the size of VAOP's equity at that moment is above any level which would have been acceptable for a private sector bank in that situation. As there was nearly no equity to buffer against unfavourable developments and absorb a certain level of losses, the probability of default was very high. BNG requested securities in the form of mortgages on part of the receivables but the value of this collateral was a lot smaller than the amount of the loans provided. In order to receive such a bulky financing, a company facing market economy creditors would have needed more equity. Therefore, BNG's loan allowed VAOP to develop itself more rapidly, to participate to more public tender procedures and to quote lower prices. |
| --- | --- |

(4)

The size of the loan granted by BNG compared among others to the size of VAOP's equity at that moment is above any level which would have been acceptable for a private sector bank in that situation. As there was nearly no equity to buffer against unfavourable developments and absorb a certain level of losses, the probability of default was very high. BNG requested securities in the form of mortgages on part of the receivables but the value of this collateral was a lot smaller than the amount of the loans provided. In order to receive such a bulky financing, a company facing market economy creditors would have needed more equity. Therefore, BNG's loan allowed VAOP to develop itself more rapidly, to participate to more public tender procedures and to quote lower prices.

| (5) | The second measure — the EUR 1,3 million subordinated loan granted by the local districts — took place in the first half of 2001, when the finances of VAOP were in dire straits. VAOP's equity was very negative. In addition, there existed a very important amount of senior debt. Finally, nearly all the assets were already covered by mortgages in favour of BNG. In short, bankruptcy probability was high and if this had occurred the subordinated creditors could not have expected to recover anything. At that moment, the local authorities concerned were already creditors of VAOP, who owed to them payments in their role as suppliers of waste paper. A market economy creditor might have preferred to transform his receivables into a loan instead of requesting the bankruptcy of VAOP which could have potentially led to the partial or total loss of the receivables. However, in the case at stake, the Commission doubts that the conditions of the loan would have been acceptable for a market economy creditor. In conclusion, the provision of the subordinated loan concerned creates an advantage for VAOP. |
| --- | --- |

(5)

The second measure — the EUR 1,3 million subordinated loan granted by the local districts — took place in the first half of 2001, when the finances of VAOP were in dire straits. VAOP's equity was very negative. In addition, there existed a very important amount of senior debt. Finally, nearly all the assets were already covered by mortgages in favour of BNG. In short, bankruptcy probability was high and if this had occurred the subordinated creditors could not have expected to recover anything. At that moment, the local authorities concerned were already creditors of VAOP, who owed to them payments in their role as suppliers of waste paper. A market economy creditor might have preferred to transform his receivables into a loan instead of requesting the bankruptcy of VAOP which could have potentially led to the partial or total loss of the receivables. However, in the case at stake, the Commission doubts that the conditions of the loan would have been acceptable for a market economy creditor. In conclusion, the provision of the subordinated loan concerned creates an advantage for VAOP.

| (6) | These two measures qualify as State aid pursuant to Article 87(1) of the EC Treaty. |
| --- | --- |

(6)

These two measures qualify as State aid pursuant to Article 87(1) of the EC Treaty.

| (7) | None of the exemptions laid down in Article 87(2) and Article 87(3) to the general prohibition of State aid provided with Article 87(1) seem to be applicable to the present case. Regarding Article 86(2), the Commission notes that the two aid measures were neither targeted at nor had the effect of ensuring the recycling of paper in parts of The Netherlands. VAOP has several competitors and there is no indication that these latter or other potential newcomers could not have provided the waste collection services provided by VAOP since 1998. |
| --- | --- |

(7)

None of the exemptions laid down in Article 87(2) and Article 87(3) to the general prohibition of State aid provided with Article 87(1) seem to be applicable to the present case. Regarding Article 86(2), the Commission notes that the two aid measures were neither targeted at nor had the effect of ensuring the recycling of paper in parts of The Netherlands. VAOP has several competitors and there is no indication that these latter or other potential newcomers could not have provided the waste collection services provided by VAOP since 1998.

| (8) | Therefore, the Commission doubts whether the aid can be found compatible with the common market. |
| --- | --- |

(8)

Therefore, the Commission doubts whether the aid can be found compatible with the common market.

In accordance with Article 14 of Council Regulation (EC) No 659/1999, all unlawful aid can be subject to recovery from the recipient.

TEXT OF LETTER

‘Met dit schrijven stelt de Commissie Nederland ervan in kennis dat zij, na onderzoek van de door uw autoriteiten verstrekte informatie over de bovengenoemde maatregel, heeft besloten de procedure van artikel 88, lid 2, van het EG-Verdrag in te leiden.

1.   PROCEDURE

| (1) | Bij brief van 12 juni 2002, die werd ingeschreven op 17 juni 2002, ontving de Commissie een klacht tegen vier vermeende onrechtmatige steunmaatregelen ten behoeve van VAOP, te weten een gedeeltelijke vrijstelling van de vennootschapsbelasting en belasting op toegevoegde waarde, het verstrekken van een lening, alsmede het verstrekken van een achtergestelde lening. Bij brieven van 30 juli 2002 en 6 december 2002 verzocht de Commissie de Nederlandse autoriteiten om inlichtingen, die zij ontving bij brieven van 10 oktober 2002 respectievelijk 10 februari 2003. Op 29 april 2003 had een bijeenkomst plaats tussen de klager en de diensten van de Commissie. Bij brief van 5 mei 2003 deelde de klager de Commissie mee dat hij voornemens was bij de Nederlandse autoriteiten meer informatie over de zaak in te winnen en dat hij op basis hiervan zijn klacht vervolgens zou heroriënteren naar bepaalde steunmaatregelen. Bij brief van 13 september 2004, ingeschreven op 17 september 2004, verschafte de klager aanvullende gegevens, met name over de financiële situatie van VAOP en liet hij weten voornemens te zijn de klacht te beperken tot de door de BNG aan VAOP verstrekte lening. Op basis van dit nieuwe document verzocht de Commissie de Nederlandse autoriteiten bij brief van 21 oktober 2004 om aanvullende inlichtingen, die zij verschaften bij brief van 17 december 2004, ingeschreven op 3 januari 2005. |
| --- | --- |

(1)

Bij brief van 12 juni 2002, die werd ingeschreven op 17 juni 2002, ontving de Commissie een klacht tegen vier vermeende onrechtmatige steunmaatregelen ten behoeve van VAOP, te weten een gedeeltelijke vrijstelling van de vennootschapsbelasting en belasting op toegevoegde waarde, het verstrekken van een lening, alsmede het verstrekken van een achtergestelde lening. Bij brieven van 30 juli 2002 en 6 december 2002 verzocht de Commissie de Nederlandse autoriteiten om inlichtingen, die zij ontving bij brieven van 10 oktober 2002 respectievelijk 10 februari 2003. Op 29 april 2003 had een bijeenkomst plaats tussen de klager en de diensten van de Commissie. Bij brief van 5 mei 2003 deelde de klager de Commissie mee dat hij voornemens was bij de Nederlandse autoriteiten meer informatie over de zaak in te winnen en dat hij op basis hiervan zijn klacht vervolgens zou heroriënteren naar bepaalde steunmaatregelen. Bij brief van 13 september 2004, ingeschreven op 17 september 2004, verschafte de klager aanvullende gegevens, met name over de financiële situatie van VAOP en liet hij weten voornemens te zijn de klacht te beperken tot de door de BNG aan VAOP verstrekte lening. Op basis van dit nieuwe document verzocht de Commissie de Nederlandse autoriteiten bij brief van 21 oktober 2004 om aanvullende inlichtingen, die zij verschaften bij brief van 17 december 2004, ingeschreven op 3 januari 2005.

2.   BESCHRIJVING

2.1.   De begunstigde

| (2) | VAOP (Vereniging van Aanbieders van Oud Papier) werd begin jaren '90 door verscheidene Nederlandse gemeenten opgericht. Deze coöperatieve vereniging met uitgesloten aansprakelijkheid had ten doel de optimale inzameling, bewerking (sorteren/persen) en verkoop van het afvalpapier dat van het grondgebied van de deelnemende gemeenten afkomstig is. |
| --- | --- |

(2)

VAOP (Vereniging van Aanbieders van Oud Papier) werd begin jaren '90 door verscheidene Nederlandse gemeenten opgericht. Deze coöperatieve vereniging met uitgesloten aansprakelijkheid had ten doel de optimale inzameling, bewerking (sorteren/persen) en verkoop van het afvalpapier dat van het grondgebied van de deelnemende gemeenten afkomstig is.

| (3) | Aangezien VAOP de meeste werkzaamheden aan andere bedrijven uitbesteedt, zoals het vervoer en de bewerking, had het in 2002 slechts 20 personeelsleden bij een omzet van 27,5 miljoen EUR. VAOP brengt de plaatselijke autoriteiten de kosten in rekening voor de inzameling en bewerking van het van hun grondgebied afkomstige afvalpapier maar draagt ook aan hen de inkomsten over die door de verkoop van het afvalpapier aan de producenten van kringlooppapier worden gegenereerd. |
| --- | --- |

(3)

Aangezien VAOP de meeste werkzaamheden aan andere bedrijven uitbesteedt, zoals het vervoer en de bewerking, had het in 2002 slechts 20 personeelsleden bij een omzet van 27,5 miljoen EUR. VAOP brengt de plaatselijke autoriteiten de kosten in rekening voor de inzameling en bewerking van het van hun grondgebied afkomstige afvalpapier maar draagt ook aan hen de inkomsten over die door de verkoop van het afvalpapier aan de producenten van kringlooppapier worden gegenereerd.

| (4) | De oorspronkelijke coöperatie is Coöperatieve Vereniging VAOP u.a. In de loop van de jaren heeft deze moedermaatschappij verscheidene dochterondernemingen in het leven geroepen om het operationele gedeelte van haar activiteiten in onder te brengen. Deze dochterondernemingen zijn naamloze vennootschappen. De Commissie zal al deze ondernemingen onderzoeken als een één enkele economische entiteit vormende groep omdat de moedermaatschappij in alle dochterondernemingen een meerderheidsbelang bezit. Deze participaties worden overgenomen in de geconsolideerde rekening van de moedermaatschappij. Daarnaast heeft BNG, de voornaamste crediteur van VAOP, slechts één kredietovereenkomst met de groep gesloten, en heeft zij niet een overeenkomst met iedere afzonderlijke onderneming; niettemin zijn in deze overeenkomst ook per onderneming kredietlimieten vastgelegd. Tenslotte zijn er verscheidene financiële overdrachten en zekerheden tussen de verschillende ondernemingen van de groep. Zo is bijvoorbeeld iedere onderneming tegenover BNG aansprakelijk voor de schulden van een andere tot de groep behorende onderneming. |
| --- | --- |

(4)

De oorspronkelijke coöperatie is Coöperatieve Vereniging VAOP u.a. In de loop van de jaren heeft deze moedermaatschappij verscheidene dochterondernemingen in het leven geroepen om het operationele gedeelte van haar activiteiten in onder te brengen. Deze dochterondernemingen zijn naamloze vennootschappen. De Commissie zal al deze ondernemingen onderzoeken als een één enkele economische entiteit vormende groep omdat de moedermaatschappij in alle dochterondernemingen een meerderheidsbelang bezit. Deze participaties worden overgenomen in de geconsolideerde rekening van de moedermaatschappij. Daarnaast heeft BNG, de voornaamste crediteur van VAOP, slechts één kredietovereenkomst met de groep gesloten, en heeft zij niet een overeenkomst met iedere afzonderlijke onderneming; niettemin zijn in deze overeenkomst ook per onderneming kredietlimieten vastgelegd. Tenslotte zijn er verscheidene financiële overdrachten en zekerheden tussen de verschillende ondernemingen van de groep. Zo is bijvoorbeeld iedere onderneming tegenover BNG aansprakelijk voor de schulden van een andere tot de groep behorende onderneming.

2.2.   De markt

| (5) | De activiteiten van VAOP maakten in de jaren '90 een zeer belangrijke groei door. Het marktaandeel van VAOP op de Nederlandse markt voor de inzameling van oud papier bereikte in de eerste jaren van het nieuwe millennium 25 tot 30 %. VAOP is daarnaast een belangrijke speler op de markt voor het bewerken van afvalpapier (sorteren/persen). Parallel hieraan betrad VAOP de markt voor de inzameling van afvalglas, waar het een van de marktleiders werd. |
| --- | --- |

(5)

De activiteiten van VAOP maakten in de jaren '90 een zeer belangrijke groei door. Het marktaandeel van VAOP op de Nederlandse markt voor de inzameling van oud papier bereikte in de eerste jaren van het nieuwe millennium 25 tot 30 %. VAOP is daarnaast een belangrijke speler op de markt voor het bewerken van afvalpapier (sorteren/persen). Parallel hieraan betrad VAOP de markt voor de inzameling van afvalglas, waar het een van de marktleiders werd.

| (6) | Hoewel de Nederlandse wetgeving aan plaatselijke autoriteiten de taak oplegt om afvalpapier gescheiden in te zamelen en voor hergebruik op de markt aan te bieden, wordt de wijze waarop aan deze taken invulling wordt gegeven niet in de wet geregeld. Daarom organiseren de meeste Nederlandse gemeenten aanbestedingsprocedures om deze werkzaamheden uit te besteden. VAOP neemt regelmatig deel aan deze procedures. Bij deze gelegenheden treedt VAOP rechtstreeks in concurrentie met bedrijven van de private sector die dezelfde diensten aanbieden. Het feit dat VAOP, indien geselecteerd, de meeste activiteiten aan derden uitbesteedt verandert niets aan de afbakening van de markt waarop VAOP actief is, namelijk de markt waarop zij opdrachten binnenhaalt en waar zij door het ontvangen van staatssteun de concurrentie zou kunnen vervalsen. |
| --- | --- |

(6)

Hoewel de Nederlandse wetgeving aan plaatselijke autoriteiten de taak oplegt om afvalpapier gescheiden in te zamelen en voor hergebruik op de markt aan te bieden, wordt de wijze waarop aan deze taken invulling wordt gegeven niet in de wet geregeld. Daarom organiseren de meeste Nederlandse gemeenten aanbestedingsprocedures om deze werkzaamheden uit te besteden. VAOP neemt regelmatig deel aan deze procedures. Bij deze gelegenheden treedt VAOP rechtstreeks in concurrentie met bedrijven van de private sector die dezelfde diensten aanbieden. Het feit dat VAOP, indien geselecteerd, de meeste activiteiten aan derden uitbesteedt verandert niets aan de afbakening van de markt waarop VAOP actief is, namelijk de markt waarop zij opdrachten binnenhaalt en waar zij door het ontvangen van staatssteun de concurrentie zou kunnen vervalsen.

| (7) | Het feit dat de plaatselijke overheid — indien deze aan het einde van de aanbestedingsprocedure VAOP kiest — lid kan worden van de coöperatie VAOP doet niets af aan de conclusie dat VAOP als dienstverlener actief is op een markt waar concurrentie is. Deze toetreding “achteraf” maakt immers VAOP niet tot een onderdeel van de plaatselijke overheid die optreedt op een bevoegdheidsterrein dat door de wet exclusief aan hem is toegekend en waar geen concurrentie bestaat. Dit wordt bevestigd door het feit dat de Nederlandse belastingdienst VAOP niet als lokale overheid maar als een gewone onderneming behandelt. |
| --- | --- |

(7)

Het feit dat de plaatselijke overheid — indien deze aan het einde van de aanbestedingsprocedure VAOP kiest — lid kan worden van de coöperatie VAOP doet niets af aan de conclusie dat VAOP als dienstverlener actief is op een markt waar concurrentie is. Deze toetreding “achteraf” maakt immers VAOP niet tot een onderdeel van de plaatselijke overheid die optreedt op een bevoegdheidsterrein dat door de wet exclusief aan hem is toegekend en waar geen concurrentie bestaat. Dit wordt bevestigd door het feit dat de Nederlandse belastingdienst VAOP niet als lokale overheid maar als een gewone onderneming behandelt.

2.3.   De twee maatregelen

| (8) | Ten eerste kende BNG (Bank Nederlandse Gemeenten) in maart 1998 een kredietfaciliteit van 16,3 miljoen NLG (7,4 miljoen EUR) aan VAOP toe. Op 31 december 1997 gaf de geconsolideerde balans van VAOP aan dat het eigen kapitaal 0,8 miljoen NLG (0,4 miljoen EUR) beliep en het balanstotaal 17,3 miljoen NLG (7,9 miljoen EUR) bedroeg. Een jaar later beliepen eigen kapitaal en balanstotaal, na de toekenning van de lening, 0,09 miljoen NLG (0,04 miljoen EUR) respectievelijk 29,1 miljoen NLG (13,2 miljoen EUR). |
| --- | --- |

(8)

Ten eerste kende BNG (Bank Nederlandse Gemeenten) in maart 1998 een kredietfaciliteit van 16,3 miljoen NLG (7,4 miljoen EUR) aan VAOP toe. Op 31 december 1997 gaf de geconsolideerde balans van VAOP aan dat het eigen kapitaal 0,8 miljoen NLG (0,4 miljoen EUR) beliep en het balanstotaal 17,3 miljoen NLG (7,9 miljoen EUR) bedroeg. Een jaar later beliepen eigen kapitaal en balanstotaal, na de toekenning van de lening, 0,09 miljoen NLG (0,04 miljoen EUR) respectievelijk 29,1 miljoen NLG (13,2 miljoen EUR).

| (9) | Ten tweede hebben de lokale overheden er — in hun rol als leverancier van afvalpapier — in de loop van 2001 mee ingestemd dat aan hen door VAOP verschuldigde laattijdige betalingen in een achtergestelde lening van 3 miljoen NLG (13 miljoen EUR) werd omgezet. VAOP had eind 2000 zware verliezen geleden na het faillissement van een van haar dochterondernemingen. Op 31 december 2000 lieten de geconsolideerde rekeningen van VAOP een negatief eigen vermogen zien van 3,4 miljoen NLG (1,5 miljoen EUR). Op dezelfde datum bedroeg het balanstotaal 32,1 miljoen NLG (14,5 miljoen EUR). |
| --- | --- |

(9)

Ten tweede hebben de lokale overheden er — in hun rol als leverancier van afvalpapier — in de loop van 2001 mee ingestemd dat aan hen door VAOP verschuldigde laattijdige betalingen in een achtergestelde lening van 3 miljoen NLG (13 miljoen EUR) werd omgezet. VAOP had eind 2000 zware verliezen geleden na het faillissement van een van haar dochterondernemingen. Op 31 december 2000 lieten de geconsolideerde rekeningen van VAOP een negatief eigen vermogen zien van 3,4 miljoen NLG (1,5 miljoen EUR). Op dezelfde datum bedroeg het balanstotaal 32,1 miljoen NLG (14,5 miljoen EUR).

3.   BEOORDELING

3.1.   Bestaan van steun

Staatsmiddelen en toerekenbaarheid

| (10) | Beide maatregelen worden gefinancierd met staatsmiddelen, hetzij direct door de lokale overheden hetzij indirect door BNG die 100 % eigendom is van de Staat, de provinciën en de gemeenten die onder hun controle vallen. |
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(10)

Beide maatregelen worden gefinancierd met staatsmiddelen, hetzij direct door de lokale overheden hetzij indirect door BNG die 100 % eigendom is van de Staat, de provinciën en de gemeenten die onder hun controle vallen.

| (11) | Terwijl de tweede maatregel rechtstreeks aan de autoriteiten kan worden toegeschreven, doet de eerste, te weten de door BNG verleende kredietfaciliteit, de kwestie van toerekenbaarheid aan de staat rijzen. In het onderhavige geval wijzen verschillende elementen erop dat BNG niet als een gewone commerciële bank, maar onder de invloed van de overheid is opgetreden. Het aandelenbezit in BNG is beperkt tot entiteiten van de Nederlandse overheidssector. Verschillende leden van de Raad van Commissarissen zijn afkomstig van lokale, provinciale en nationale overheden. Volgens de gegevens waarover de Commissie beschikt vormden deze leden tot 2003 de meerderheid van de Raad van Commissarissen. Op zijn website presenteert BNG zich als “een bank van en voor overheden en instellingen voor het maatschappelijk belang”. Aandeelhouders van de BNG zijn onder meer de lokale en regionale autoriteiten die de eigendom van en zeggenschap over VAOP hebben. Tenslotte lijkt, zoals hieronder wordt aangetoond, de gewraakte transactie onaanvaardbaar voor een schuldeiser in een markteconomie. Dit wijst erop dat BNG in het kader van deze transactie is opgetreden als een overheidsinstantie die de commerciële dochteronderneming van verwante overheidsinstanties wil helpen, en niet als een bank in het kader van het normale verloop van haar kredietactiviteiten. |
| --- | --- |

(11)

Terwijl de tweede maatregel rechtstreeks aan de autoriteiten kan worden toegeschreven, doet de eerste, te weten de door BNG verleende kredietfaciliteit, de kwestie van toerekenbaarheid aan de staat rijzen. In het onderhavige geval wijzen verschillende elementen erop dat BNG niet als een gewone commerciële bank, maar onder de invloed van de overheid is opgetreden. Het aandelenbezit in BNG is beperkt tot entiteiten van de Nederlandse overheidssector. Verschillende leden van de Raad van Commissarissen zijn afkomstig van lokale, provinciale en nationale overheden. Volgens de gegevens waarover de Commissie beschikt vormden deze leden tot 2003 de meerderheid van de Raad van Commissarissen. Op zijn website presenteert BNG zich als “een bank van en voor overheden en instellingen voor het maatschappelijk belang”. Aandeelhouders van de BNG zijn onder meer de lokale en regionale autoriteiten die de eigendom van en zeggenschap over VAOP hebben. Tenslotte lijkt, zoals hieronder wordt aangetoond, de gewraakte transactie onaanvaardbaar voor een schuldeiser in een markteconomie. Dit wijst erop dat BNG in het kader van deze transactie is opgetreden als een overheidsinstantie die de commerciële dochteronderneming van verwante overheidsinstanties wil helpen, en niet als een bank in het kader van het normale verloop van haar kredietactiviteiten.

Voordeel

| (12) | De omvang van de door BNG verstrekte lening lijkt, in vergelijking onder meer met de omvang van het eigen vermogen van VAOP op dat tijdstip, boven een niveau te liggen dat in die situatie voor een bank van de private sector aanvaardbaar was geweest. Aangezien er vrijwel geen eigen vermogen was als buffer in geval van ongunstige ontwikkelingen en om bepaalde verliezen te absorberen, was de kans op wanbetaling zeer groot. BNG verlangde zekerheden in de vorm van hypotheekrechten over een deel van de vorderingen ten einde in geval van faillissement meer geld te kunnen terugvorderen. De waarde van deze zekerheden was echter veel geringer dan het bedrag van de verstrekte leningen. |
| --- | --- |

(12)

De omvang van de door BNG verstrekte lening lijkt, in vergelijking onder meer met de omvang van het eigen vermogen van VAOP op dat tijdstip, boven een niveau te liggen dat in die situatie voor een bank van de private sector aanvaardbaar was geweest. Aangezien er vrijwel geen eigen vermogen was als buffer in geval van ongunstige ontwikkelingen en om bepaalde verliezen te absorberen, was de kans op wanbetaling zeer groot. BNG verlangde zekerheden in de vorm van hypotheekrechten over een deel van de vorderingen ten einde in geval van faillissement meer geld te kunnen terugvorderen. De waarde van deze zekerheden was echter veel geringer dan het bedrag van de verstrekte leningen.

| (13) | Om een zo omvangrijke financiering te krijgen zou een onderneming tegenover particuliere schuldeisers in een markteconomie meer eigen vermogen nodig hebben gehad. Het staat buiten kijf dat aandelenfinanciering meer kost dan schuldfinanciering en dat dit soort financiële middelen moeilijker is aan te trekken. |
| --- | --- |

(13)

Om een zo omvangrijke financiering te krijgen zou een onderneming tegenover particuliere schuldeisers in een markteconomie meer eigen vermogen nodig hebben gehad. Het staat buiten kijf dat aandelenfinanciering meer kost dan schuldfinanciering en dat dit soort financiële middelen moeilijker is aan te trekken.

| (14) | De lening van BNG lijkt dan ook een aanzienlijk voordeel te hebben verschaft omdat deze VAOP in staat stelde zich sneller te ontwikkelen, op meer aanbestedingen in te schrijven en lagere prijzen op te geven. |
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(14)

De lening van BNG lijkt dan ook een aanzienlijk voordeel te hebben verschaft omdat deze VAOP in staat stelde zich sneller te ontwikkelen, op meer aanbestedingen in te schrijven en lagere prijzen op te geven.

| (15) | De tweede maatregel — de door de gemeenten verstrekte achtergestelde lening van 1,3 miljoen EUR — vond plaats in het eerste halfjaar van 2001, toen VAOP er financieel slecht voorstond. Op dat tijdstip had VAOP een negatief eigen vermogen van 3,4 miljoen NLG (1,5 miljoen EUR). Daarnaast was er nog een aanzienlijk bedrag aan niet-achtergestelde schulden. Ook waren bijna alle activa al bezwaard door hypotheekrechten ten gunste van BNG. Kortom: de waarschijnlijkheid van een faillissement was groot en indien dit zich inderdaad had voorgedaan hadden de achtergestelde crediteuren niets meer kunnen invorderen. |
| --- | --- |

(15)

De tweede maatregel — de door de gemeenten verstrekte achtergestelde lening van 1,3 miljoen EUR — vond plaats in het eerste halfjaar van 2001, toen VAOP er financieel slecht voorstond. Op dat tijdstip had VAOP een negatief eigen vermogen van 3,4 miljoen NLG (1,5 miljoen EUR). Daarnaast was er nog een aanzienlijk bedrag aan niet-achtergestelde schulden. Ook waren bijna alle activa al bezwaard door hypotheekrechten ten gunste van BNG. Kortom: de waarschijnlijkheid van een faillissement was groot en indien dit zich inderdaad had voorgedaan hadden de achtergestelde crediteuren niets meer kunnen invorderen.

| (16) | Op dat ogenblik waren de betrokken lokale overheden al schuldeisers van VAOP, dat aan hen — in hun hoedanigheid van leveranciers van afvalpapier — betalingen schuldig was. Na een vergelijking van het verwachte verlies in elk scenario had een schuldeiser in een markteconomie er mogelijk de voorkeur aan gegeven zijn vorderingen in een lening om te zetten in plaats van het faillissement van VAOP aan te vragen, hetgeen potentieel het gedeeltelijke of totale verlies van de vorderingen tot gevolg had kunnen hebben. Het verstrekken van de lening zou derhalve op zich mogelijkerwijs niet automatisch steun uitmaken. De Commissie betwijfelt in het onderhavige geval echter of de voorwaarden van de lening voor een schuldeiser in een markteconomie aanvaardbaar zouden zijn geweest. De gemeenten hadden namelijk een rente moeten verlangen die in overeenstemming was met het risico. Daarnaast hadden zij er niet mee mogen instemmen dat zij de meest achtergestelde schuldeiser van VAOP werden terwijl hun bestaande vorderingen van een hogere rangorde waren. Het feit dat de lening achtergesteld is maakt terugvordering in geval van faillissement aanzienlijk minder waarschijnlijk. |
| --- | --- |

(16)

Op dat ogenblik waren de betrokken lokale overheden al schuldeisers van VAOP, dat aan hen — in hun hoedanigheid van leveranciers van afvalpapier — betalingen schuldig was. Na een vergelijking van het verwachte verlies in elk scenario had een schuldeiser in een markteconomie er mogelijk de voorkeur aan gegeven zijn vorderingen in een lening om te zetten in plaats van het faillissement van VAOP aan te vragen, hetgeen potentieel het gedeeltelijke of totale verlies van de vorderingen tot gevolg had kunnen hebben. Het verstrekken van de lening zou derhalve op zich mogelijkerwijs niet automatisch steun uitmaken. De Commissie betwijfelt in het onderhavige geval echter of de voorwaarden van de lening voor een schuldeiser in een markteconomie aanvaardbaar zouden zijn geweest. De gemeenten hadden namelijk een rente moeten verlangen die in overeenstemming was met het risico. Daarnaast hadden zij er niet mee mogen instemmen dat zij de meest achtergestelde schuldeiser van VAOP werden terwijl hun bestaande vorderingen van een hogere rangorde waren. Het feit dat de lening achtergesteld is maakt terugvordering in geval van faillissement aanzienlijk minder waarschijnlijk.

| (17) | De verstrekkers van de achtergestelde lening waren ook de aandeelhouders van VAOP. Daarom moesten zij, bij het evalueren van potentiële verliezen in geval van faillissement (in vergelijking met de verliezen bij omzetting van de bestaande vorderingen in een lening), rekening houden met het verwachte verlies op hun bestaande vorderingen en op de waarde van hun aandelen. In beginsel zou deze stand van zaken de aandeelhouders ertoe kunnen aanzetten zich ten aanzien van de voorwaarden van de lening soepeler op te stellen om de waarde van hun aandelen te behouden indien deze houding hun algemeen een financieel gunstiger resultaat kon waarborgen. Redelijkerwijs kan echter worden aangenomen dat de waarde van hun aandelen op het tijdstip waarop de lening werd verstrekt te verwaarlozen was aangezien de boekwaarde van het aandelenkapitaal ver onder nul lag. Een drastische ommekeer ten goede viel niet te verwachten en het faillissement dreigde. Onder deze omstandigheden was er voor de lokale overheden geen bijzondere reden om soepeler voorwaarden voor de lening te aanvaarden aangezien deze opoffering alleen ten goede zou zijn gekomen aan de overige crediteuren van VAOP en niet aan hen als aandeelhouders. |
| --- | --- |

(17)

De verstrekkers van de achtergestelde lening waren ook de aandeelhouders van VAOP. Daarom moesten zij, bij het evalueren van potentiële verliezen in geval van faillissement (in vergelijking met de verliezen bij omzetting van de bestaande vorderingen in een lening), rekening houden met het verwachte verlies op hun bestaande vorderingen en op de waarde van hun aandelen. In beginsel zou deze stand van zaken de aandeelhouders ertoe kunnen aanzetten zich ten aanzien van de voorwaarden van de lening soepeler op te stellen om de waarde van hun aandelen te behouden indien deze houding hun algemeen een financieel gunstiger resultaat kon waarborgen. Redelijkerwijs kan echter worden aangenomen dat de waarde van hun aandelen op het tijdstip waarop de lening werd verstrekt te verwaarlozen was aangezien de boekwaarde van het aandelenkapitaal ver onder nul lag. Een drastische ommekeer ten goede viel niet te verwachten en het faillissement dreigde. Onder deze omstandigheden was er voor de lokale overheden geen bijzondere reden om soepeler voorwaarden voor de lening te aanvaarden aangezien deze opoffering alleen ten goede zou zijn gekomen aan de overige crediteuren van VAOP en niet aan hen als aandeelhouders.

| (18) | Concluderend kan worden gezegd dat de achtergestelde lening een voordeel voor VAOP lijkt te hebben verschaft dat de onderneming onder normale marktvoorwaarden niet zou hebben gekregen. |
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(18)

Concluderend kan worden gezegd dat de achtergestelde lening een voordeel voor VAOP lijkt te hebben verschaft dat de onderneming onder normale marktvoorwaarden niet zou hebben gekregen.

Selectiviteit

| (19) | VAOP is de enige begunstigde van de maatregelen. |
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(19)

VAOP is de enige begunstigde van de maatregelen.

Gevolgen voor het handelsverkeer tussen lidstaten

| (20) | Enkele rechtstreekse concurrenten van VAOP zijn dochters van buitenlandse maatschappijen. De steun verhindert daarom potentieel dat buitenlandse bedrijven zich op de Nederlandse markt vestigen of hun activiteiten daar uitbreiden. Daarnaast bestaat er ten aanzien van het afvalpapier en glas dat door VAOP wordt ingezameld een intensieve handel. Zo ondertekende VAOP een 10-jarige overeenkomst voor de levering van 2 miljoen ton afvalpapier met een dochteronderneming van Stora Enso in Langerbrugge, België. VAOP verkoopt haar papier ook aan Aziatische kopers. |
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(20)

Enkele rechtstreekse concurrenten van VAOP zijn dochters van buitenlandse maatschappijen. De steun verhindert daarom potentieel dat buitenlandse bedrijven zich op de Nederlandse markt vestigen of hun activiteiten daar uitbreiden. Daarnaast bestaat er ten aanzien van het afvalpapier en glas dat door VAOP wordt ingezameld een intensieve handel. Zo ondertekende VAOP een 10-jarige overeenkomst voor de levering van 2 miljoen ton afvalpapier met een dochteronderneming van Stora Enso in Langerbrugge, België. VAOP verkoopt haar papier ook aan Aziatische kopers.

| (21) | Concluderend lijken deze twee maatregelen te kunnen worden aangemerkt als staatssteun overeenkomstig artikel 87, lid 1, van het EG-Verdrag. |
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(21)

Concluderend lijken deze twee maatregelen te kunnen worden aangemerkt als staatssteun overeenkomstig artikel 87, lid 1, van het EG-Verdrag.

3.2.   Verenigbaarheid met het Verdrag

| (22) | Geen van de uitzonderingsbepalingen van artikel 87, lid 2 is op het onderhavige geval van toepassing. Wat artikel 87, lid 3 betreft, merkt de Commissie op dat de regio Hilversum, waar VAOP is gevestigd, niet in aanmerking komt voor regionale steun uit hoofde van artikel 87, lid 3, onder a) en c). De uitzonderingsbepalingen van artikel 87, lid 3, onder b) en d) zijn uiteraard niet van toepassing. |
| --- | --- |

(22)

Geen van de uitzonderingsbepalingen van artikel 87, lid 2 is op het onderhavige geval van toepassing. Wat artikel 87, lid 3 betreft, merkt de Commissie op dat de regio Hilversum, waar VAOP is gevestigd, niet in aanmerking komt voor regionale steun uit hoofde van artikel 87, lid 3, onder a) en c). De uitzonderingsbepalingen van artikel 87, lid 3, onder b) en d) zijn uiteraard niet van toepassing.

| (23) | Wat artikel 87, lid 3, onder c) betreft, merkt de Commissie op dat VAOP als een middelgroot bedrijf kan worden aangemerkt. De KMO-verordening (1) is evenwel niet van toepassing aangezien beide maatregelen exploitatiesteun vormen zonder dat er enige voorwaarden aan zijn verbonden. |
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(23)

Wat artikel 87, lid 3, onder c) betreft, merkt de Commissie op dat VAOP als een middelgroot bedrijf kan worden aangemerkt. De KMO-verordening (1) is evenwel niet van toepassing aangezien beide maatregelen exploitatiesteun vormen zonder dat er enige voorwaarden aan zijn verbonden.

| (24) | Op grond van artikel 87, lid 3, onder c), kan steun ten behoeve van het milieu verenigbaar worden geacht. In dit verband heeft de Commissie de communautaire kaderregeling inzake staatssteun ten behoeve van het milieu (2) vastgesteld. Aangezien de beide steunmaatregelen echter niet verbonden zijn aan maatregelen ter bescherming van het milieu als zodanig, lijken de bepalingen van deze kaderregeling niet van toepassing te zijn. |
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(24)

Op grond van artikel 87, lid 3, onder c), kan steun ten behoeve van het milieu verenigbaar worden geacht. In dit verband heeft de Commissie de communautaire kaderregeling inzake staatssteun ten behoeve van het milieu (2) vastgesteld. Aangezien de beide steunmaatregelen echter niet verbonden zijn aan maatregelen ter bescherming van het milieu als zodanig, lijken de bepalingen van deze kaderregeling niet van toepassing te zijn.

| (25) | Reddings- en herstructureringssteun voor ondernemingen kan eveneens op basis van artikel 87, lid 3, onder c) als verenigbaar worden beschouwd. De richtsnoeren voor reddings- en herstructureringssteun (3) lijken echter niet op de twee steunmaatregelen in kwestie van toepassing te zijn. Ten eerste heeft BNG de lening verstrekt op een tijdstip waarop de onderneming niet in moeilijkheden verkeerde in de zin van de richtsnoeren. Ten tweede werd de lening van de lokale overheden verstrekt op een tijdstip waarop de onderneming zich in moeilijkheden bevond maar blijkbaar geen deel uitmaakte van een omvangrijk herstructureringsplan waarmee de onderneming haar levensvatbaarheid op lange termijn had kunnen herstellen, aangezien er bijvoorbeeld geen herkapitalisatie plaatsvond om het eigen vermogen van de onderneming te herstellen dat derhalve in sterke mate negatief bleef. |
| --- | --- |

(25)

Reddings- en herstructureringssteun voor ondernemingen kan eveneens op basis van artikel 87, lid 3, onder c) als verenigbaar worden beschouwd. De richtsnoeren voor reddings- en herstructureringssteun (3) lijken echter niet op de twee steunmaatregelen in kwestie van toepassing te zijn. Ten eerste heeft BNG de lening verstrekt op een tijdstip waarop de onderneming niet in moeilijkheden verkeerde in de zin van de richtsnoeren. Ten tweede werd de lening van de lokale overheden verstrekt op een tijdstip waarop de onderneming zich in moeilijkheden bevond maar blijkbaar geen deel uitmaakte van een omvangrijk herstructureringsplan waarmee de onderneming haar levensvatbaarheid op lange termijn had kunnen herstellen, aangezien er bijvoorbeeld geen herkapitalisatie plaatsvond om het eigen vermogen van de onderneming te herstellen dat derhalve in sterke mate negatief bleef.

| (26) | Tenslotte wijst de Commissie erop dat de bepalingen in artikel 86, lid 2 niet op het onderhavige geval van toepassing lijken. Met de twee steunmaatregelen werd niet het verlenen van een dienst van algemeen economisch belang beoogd of bewerkstelligd, te weten de inzameling en bewerking van afvalpapier in delen van Nederland, welke dienst anders niet zou zijn verricht. De Commissie wijst er namelijk op dat VAOP verscheidene concurrenten heeft en niets wijst erop dat laatstgenoemden of andere potentiële nieuwkomers de diensten op het gebied van afvalinzameling die sedert 1998 door VAOP worden verstrekt, niet hadden kunnen verrichten. |
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(26)

Tenslotte wijst de Commissie erop dat de bepalingen in artikel 86, lid 2 niet op het onderhavige geval van toepassing lijken. Met de twee steunmaatregelen werd niet het verlenen van een dienst van algemeen economisch belang beoogd of bewerkstelligd, te weten de inzameling en bewerking van afvalpapier in delen van Nederland, welke dienst anders niet zou zijn verricht. De Commissie wijst er namelijk op dat VAOP verscheidene concurrenten heeft en niets wijst erop dat laatstgenoemden of andere potentiële nieuwkomers de diensten op het gebied van afvalinzameling die sedert 1998 door VAOP worden verstrekt, niet hadden kunnen verrichten.

| (27) | De Commissie betwijfelt dan ook of de steun als verenigbaar met de gemeenschappelijke markt kan worden beschouwd. |
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(27)

De Commissie betwijfelt dan ook of de steun als verenigbaar met de gemeenschappelijke markt kan worden beschouwd.

4.   CONCLUSIE

Gelet op de bovenstaande overwegingen verzoekt de Commissie Nederland, in het kader van de procedure van artikel 88, lid 2, van het EG-Verdrag, binnen één maand vanaf de datum van ontvangst van dit schrijven zijn opmerkingen te maken en alle dienstige inlichtingen te verstrekken voor de beoordeling van de steun. De Commissie wil onder andere precieze gegevens ontvangen over de aan de twee leningen in kwestie verbonden voorwaarden en rente. In dit verband verzoekt de Commissie Nederland haar inzichten over de toerekenbaarheid met betrekking tot de BNG-lening en het in hogervermelde twee maatregelen vervatte voordeel te willen meedelen. Voorts wenst zij gegevens te ontvangen over de economische en financiële ontwikkeling van onderneming, inclusief de mogelijke terugbetaling van twee leningen, sedert de toekenning van deze twee steunmaatregelen. Zij verzoekt uw autoriteiten onverwijld een afschrift van dit schrijven aan de potentiële begunstigden van de steunmaatregel te doen toekomen.’

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(1)  PB L 10 van 13.1.2001, blz. 33.

1

(2)  PB C 37 van 3.2.2001, blz. 3.

2

(3)  Aangezien de maatregelen van 1998 en 2001 dateren, moeten zij worden onderzocht op basis van de in PB C 368 van 23.12.1994, blz. 12 gepubliceerde richtsnoeren voor de eerste maatregel en op basis van de in PB C 288 van 9.10.1999, blz. 2 gepubliceerde richtsnoeren voor de tweede.

3

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| 30.9.2005 | EN | Official Journal of the European Union | C 240/41 |
| --- | --- | --- | --- |

30.9.2005

EN

Official Journal of the European Union

C 240/41

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Announcement (1) of the period for the monitoring and evaluation of the labour-rights situation in Belarus in view of the temporary withdrawal of benefits under the scheme of generalised tariff preferences (GSP)

(2005/C 240/09)

Under Article 26(1)(b) of Council Regulation (EC) No 2501/2001 (2) applying a scheme of generalised tariff preferences, the preferential arrangements may be withdrawn from a GSP beneficiary country for ‘serious and systematic violation of the freedom of association, the right to collective bargaining or the principle of non-discrimination in respect of employment and occupation, or use of child labour, as defined in the relevant ILO conventions’.

On the basis of information received from the International Confederation of Free Trade Unions (ICFTU), the European Trade Union Confederation (ETUC) and the World Confederation of Labour (WCL), the Commission carried out an investigation on the alleged systematic and serious violations of the freedom of association in Belarus, as defined in ILO Conventions Nos 87 and 98.

The Commission considers that the findings justify the temporary withdrawal for the reason given in Article 26(1)(b) and has decided, in accordance with the procedure laid down in Article 39 of Regulation (EC) No 2501/2001, to monitor and evaluate the situation in Belarus for a period of six months. The Commission intends to submit to the Council a proposal for the temporary withdrawal of the trade preferences granted under Regulation (EC) No 2501/2001 unless, before the end of the period, Belarus makes a commitment to take the measures necessary to conform within eight months with the principles referred to in the 1998 ILO Declaration on Fundamental Principles and Rights at Work, as expressed in the twelve recommendations of the ILO Commission of Enquiry report of July 2004.

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(1)  Commission Decision of 17 August 2005 on the monitoring and evaluation of the labour-rights situation in Belarus for temporary withdrawal of trade preferences.

(2)  OJ L 346, 31.12.2001, p. 1.

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| 30.9.2005 | EN | Official Journal of the European Union | C 240/42 |
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30.9.2005

EN

Official Journal of the European Union

C 240/42

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Non-opposition to a notified concentration

(Case COMP/M.3938 — CRH/Quester)

(2005/C 240/10)

(Text with EEA relevance)

On 15 September 2005, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

| — | from the Europa competition web site (http://europa.eu.int/comm/competition/mergers/cases/). This web site provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
| --- | --- |

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from the Europa competition web site (http://europa.eu.int/comm/competition/mergers/cases/). This web site provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,

| — | in electronic form on the EUR-Lex website under document number 32005M3938. EUR-Lex is the on-line access to European law. (http://europa.eu.int/eur-lex/lex) |
| --- | --- |

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in electronic form on the EUR-Lex website under document number 32005M3938. EUR-Lex is the on-line access to European law. (http://europa.eu.int/eur-lex/lex)

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